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Comparison of Hemodynamic Performance of Self-Expandable CoreValve Versus Balloon-Expandable Edwards SAPIEN Aortic Valves Inserted by Catheter for Aortic Stenosis
... Some clinical studies reported that Doppler-derived TPGs are lower and EOAs are larger in SE than in BE THVs. [5][6][7] However, other clinical or in vitro studies suggest that the magnitude of pressure recovery, and thus the difference in the Doppler versus catheter TPGs, are more pronounced in BE versus SE THVs. 8,9 These studies found that, although BE THVs had higher Doppler TPGs, their catheter-derived TPGs were similar or lower compared to SE THVs. ...
... Some clinical studies found that SE THVs have lower Doppler-derived TPGs and larger EOAs compared to BE THVs. [5][6][7] However, an in vitro study by Hatoum et al reported that the Doppler TPGs are indeed higher, but the catheter TPGs are similar or even lower in BE versus SE THVs. 8 The authors of this previous study postulated that these The results obtained in the present in vitro study are also consistent with those reported in previous clinical studies. ...
... 8 The authors of this previous study postulated that these The results obtained in the present in vitro study are also consistent with those reported in previous clinical studies. [5][6][7]9,18,19 ...
Objectives:
The objective of this in vitro study was to compare Doppler versus catheter transvalvular pressure gradients (TPG) in third generations balloon-expandable (BE) versus self-expanding (SE) transcatheter heart valves (THV).
Background:
TPG is a key parameter to assess and follow valve hemodynamic function following transcatheter aortic valve implantation (TAVI). It remains uncertain and debated whether, and to which extent, TPGs differ according to the type of THV, that is, BE versus SE and to the method used for TPG measurement, that is, Doppler echocardiography versus cardiac catheterization.
Methods:
The CoreValve EVOLUT PRO 26 mm and the SAPIEN 3 23 mm THVs were tested in a left heart simulator using a 21 mm aortic annulus under following conditions: heart rate: 70 bpm, mean aortic pressure: 100 mmHg, stroke volume: 30, 70 and 100 ml. Mean TPGs were measured by continuous-wave Doppler and by micro-tip pressure catheters positioned in the left ventricle and at 50 mm downstream to the tip of the THV leaflets.
Results:
Doppler TPGs (9.5 ± 3.9 mmHg) were on average 40.5 ± 13.9% higher (p < 0.001) than catheter TPGs (6.3 ± 3.4 mmHg). Both Doppler and catheter TPGs were lower (p = 0.003) in the SE versus BE THVs (Doppler: 8.7 ± 3.5 vs. 10.7 ± 4.6; catheter: 5.0 ± 1.7 mmHg vs. 7.1 ± 2.2). The Doppler versus catheter difference in TPG increased with the higher flow conditions. The Doppler versus catheter difference in TPG was similar in BE versus SE THVs (3.6 ± 1.1 vs. 3.7 ± 1.4 mmHg or 42 ± 9 vs. 47 ± 9%; p = 0.58) overall and in each flow conditions.
Conclusion:
The Doppler TPGs are, on average, 40% higher than the catheter TPGs for both BE and SE THVs. The SE THV had lower Doppler and catheter TPGs compared to the BE THV, at normal and high flow states. The absolute and percent differences between Doppler versus catheter TPGs were similar in BE versus SE THVs.
... In our study, we found that MCV had lower incidence of overall and moderate PPM than ESV. Consistently, the pooled results showed that MCV 9,[12][13][14]17,18,22,31,33,37 had lower mean trans-vavular mean gradient than ESV [9][10][11]14,16,[19][20][21]23,25,32 (MCV,9.3 mmHg vs ESV, 10.2 mmHg, P < 0.001). ...
... In our study, we found that MCV had lower incidence of overall and moderate PPM than ESV. Consistently, the pooled results showed that MCV 9,[12][13][14]17,18,22,31,33,37 had lower mean trans-vavular mean gradient than ESV [9][10][11]14,16,[19][20][21]23,25,32 (MCV,9.3 mmHg vs ESV, 10.2 mmHg, P < 0.001). ...
... As we all known, MCV is a supra-annular design with an hour-glass shape stent and a flared inflow. A self-expanding design may confer greater conformity to the native valve and left ventricular outflow tract morphology than the intra-annular design of ESV 14 . Therefore, when patients with high risk for PPM, a self-expandable MCV may be a preferential choice. ...
The aim of this study was to investigate the incidence, predictors and outcome of prosthesis-patient mismatch (PPM) following transcatheter aortic valve replacement (TAVR). A total of 30 articles incorporating 4,691 patients were identified. The pooled incidences of overall, moderate and severe PPM following TAVR were 33.0%, 25.0% and 11.0% respectively. Medtronic CoreValve (MCV) had lower incidence of overall (32% vs: 40%, P < 0.0001) and moderate (23% vs 32%, P < 0.0001) than Edwards Sapien (ESV). PPM was associated with a younger age, smaller annulus diameter and lower left ventricular ejection fraction in comparison with those patients without PPM. Post-dilation (OR, 0.51, 95% CI, 0.38 to 0.68, p < 0.001) during TAVR would decrease the incidence of PPM. Although PPM was common after TAVR, no significant differences were observed both in short- and mid-term all-cause mortality (30 day: OR: 1.1, 95% CI, 0.70 to 1.73 and 2 year: OR: 1.01, 95% CI, 0.74 to 1.38) between patients with PPM and those without PPM. In conclusion, despite being common after TAVR, the incidence of PPM was lower than that of surgical aortic valve replacement (SAVR) and decreased with the experience accumulating, and PPM was not seen to impact on short- and mid-term survival, regardless of its magnitude.
... 64 Some studies support that the SAPIEN valve might be associated with higher gradients and lower orifice areas, and that this valve might carry a higher risk of coronary artery obstruction. 6,63 However, as randomized controlled trials comparing devices for TAVR are pending, no evidence-based recommendation for one of the devices can be given. ...
... 83,86 In contrast, if a clinically apparent neurologic event has occurred, mortality is increased. 20,34,50,63 In part A of the PARTNER Trial, the 30-day prevalence of neurologic events was significantly higher after TAVR than after SAVR (5.5% vs 2.4%, P = 0.04), whereas the rate of major stroke showed a tendency toward higher prevalence after TAVR but did not reach significance (3.8% vs 2.4%, P = 0.2). 17 A detailed analysis of neurologic events in the PARTNER Trial by Miller et al 20 showed that there is an early phase after the procedure during which the risk of stroke is significantly increased with TAVR. 20 During follow-up, the risk for neurologic events is primarily influenced by patient-related risk factors such as history of stroke, atrial fibrillation, and cerebrovascular disease, not by the procedure chosen. ...
... 40 This is most likely to be due to the design of the CoreValve System. 1,10,40,[63][64][65][66]88,91,92 In view of the risk of delayed AV block, it has been recommended that patients be monitored for at least 24-48 hours post-procedure, perhaps for even longer after CoreValve implantation or if there are preexisting conduction abnormalities or any that are newly developed after TAVR. 6,7,78,79 submit your manuscript | www.dovepress.com ...
Anneke Damberg, Carina Benstoem, Ruediger Autschbach, Andreas GoetzenichDepartment of Cardiovascular and Thoracic Surgery, University Clinic RWTH Aachen, Aachen, GermanyAbstract: The standard treatment for symptomatic severe aortic valve stenosis is surgical aortic valve replacement. Over the last decade, transcatheter aortic valve replacement has emerged as an option for patients judged inoperable. It might also constitute an alternative for high-risk patients, even though which patients might benefit from this approach is still being discussed and remains controversial. Transcatheter heart valve replacement is a rapidly spreading technology. However, a number of problems still need to be addressed, such as paravalvular regurgitation, stroke rate, and postoperative conduction disturbances. Further, the durability of transcatheter heart valves remains unclear. Randomized clinical trials and long-term follow-up will help define the role of transcatheter heart valve replacement in aortic stenosis therapy.Keywords: TAVI, aortic valve replacement, transcatheter surgery
... It is noteworthy that in this study, the self-expanding valve was the only device available at that time. It has been shown in several studies that self-expanding CoreValve prosthesis is associated with a lower residual gradient and greater valve area than balloon-expandable Edwards SAPIEN prosthesis [20]. This superior antegrade hemodynamic performance could be explained by it being at supra-annular position, thus, it may exert a lower resistance 8 towards left ventricular outflow [20]. ...
... It has been shown in several studies that self-expanding CoreValve prosthesis is associated with a lower residual gradient and greater valve area than balloon-expandable Edwards SAPIEN prosthesis [20]. This superior antegrade hemodynamic performance could be explained by it being at supra-annular position, thus, it may exert a lower resistance 8 towards left ventricular outflow [20]. Moreover, the longer inflow tract may help impose a lower flow contraction to the valve anatomic orifice. ...
Background:
To investigate the individual sequential hemodynamic changes after transcatheter aortic valve implantation (TAVI), especially for patients with bicuspid aortic valve (BAV), in comparison with tricuspid aortic valve (TAV).
Methods:
The study population comprised 85 patients with severe aortic stenosis who underwent TAVI for BAV (n = 49) or TAV (n = 36) with at least two serial echocardiographic follow-ups. Doppler echocardiography was scheduled to be performed at discharge and 1, 3, 6 months and 1 year after the procedure. Δ peak transvalvular velocities and Δ mean transvalvular gradients were calculated as the difference at follow-up time points and discharge. Paravalvular leak (PVL) was assessed as another indicator for prosthesis performance.
Results:
Comparisons between patients with BAV and TAV revealed similar gradient performances (1.00 [-2.00, 2.00] vs. 1.00 [-0.25, 5.00] mm Hg, p = 0.57 at 1 month; -0.71 ± 7.52 vs. 1.55 ± 3.97 mm Hg, p = 0.21 at 3 months; 0.96 ± 7.81 vs. 1.53 ± 5.85 mm Hg, p = 0.79 at 6 months; 1.00 [-0.50, 2.25] vs. 3.00 [-0.50, 7.50] mm Hg, p = 0.07 at 1 year). Moreover, the incidence of ≥ mild PVL was not significantly different in patients with BAV and TAV during follow-up (34.88% vs. 19.35%, p = 0.14 at 1 month; 45.83% vs. 27.27%, p = 0.19 at 3 months; 30.00% vs. 23.53%, p = 0.89 at 6 months; 30.00% vs. 17.65%, p = 0.56 at 1 year).
Conclusions:
TAVI is effective and applicable in BAV anatomy with sustained and acceptable mid-term prosthesis hemodynamic performance.
... The evolution of prosthesis iterations, including both self-expanding and balloon-expandable transcatheter heart valves, has been shown to reduce the incidence of PPM after TAVR [33]. However, comparisons between self-expandable CoreValve bioprostheses and balloon-expandable Edwards Sapien bioprostheses have revealed that while the CoreValve shows better hemodynamic performance, the incidence of PVL is higher with this prosthesis compared to the Edwards Sapien valve [34]. Additionally, next-generation selfexpanding valves (ACURATE neo) have demonstrated better hemodynamic performance and lower rates of severe PPM compared to balloon-expandable transcatheter aortic valves in patients with small aortic annuli [35]. ...
Transcatheter aortic valve replacement (TAVR) has increasingly become a fundamental approach for treating aortic valve stenosis (AVS), especially in high surgical risk patients. This case study underscores the criticality of meticulous procedural planning and precise valve selection in patients with severe AVS compounded by obesity. We report a case of a patient who, after receiving a 26 mm Edwards Sapiens 3 valve, presented with worsening exertional dyspnea and a declining indexed effective orifice area (EOAi). This deterioration indicated early structural valve deterioration (SVD), presumably due to patient-prosthesis mismatch (PPM). A subsequent valve-in-valve (ViV) TAVR using a 29 mm Medtronic Evolut Fx valve was successfully executed, leading to a notable improvement in EOAi. This case study emphasizes the complexities inherent in valve choice and sizing in TAVR, particularly highlighting the impact of PPM on obese patients and its potential to precipitate early SVD. The report further explores the emerging strategies in addressing TAVR valve dysfunctions via ViV interventions, shedding light on the nuanced and dynamic nature of TAVR management in obese patients. It advocates for tailored treatment strategies in managing such intricate cases, demonstrating the evolving landscape of TAVR procedures.
... Previous studies have demonstrated differences in hemodynamic performance between first generation SEV and BEV. The CoreValve SEV, when compared to the SAPIEN BEV, was found to have a significantly lower residual gradient [59]. Both types of new generation valves have shown improved hemodynamic performance. ...
Background
The postoperative outcomes of transcatheter aortic valve replacement (TAVR) with the new generation of self-expanding valves (SEV) and balloon-expandable valves (BEV) remain uncertain.
Methods
We conducted a meta-analysis based on randomized controlled trials (RCTs) and propensity score-matched (PSM) studies to evaluate the performance of the new generation TAVR devices, with a focus on Edwards SAPIEN 3/Ultra BEV, Medtronic Evolut R/PRO SEV, and Boston ACURATE neo SEV. Our primary endpoints were mortality and complications at both 30 days and one year post-operation.
Results
A total of 4 RCTs and 14 PSM studies were included. Our findings showed no significant difference between SEV and BEV regarding 30-day and 1-year mortality rates. ACURATE SEV required less permanent pacemaker implantation (PPI) at 30-day as compared to SAPIEN BEV, while Evolut SEV required a higher rate of PPI than SAPIEN BEV. The incidence of stroke, major or life-threatening bleeding (MLTB), major vascular complications (MVC), coronary artery obstruction (CAO) and acute kidney injury (AKI) did not differ significantly between the two groups. SEV had a larger effective orifice area (EOA) and lower mean transvalvular gradients (MPG) compared to BEV. However, there was an increased risk of paravalvular leakage (PVL) associated with SEV.
Conclusions
In terms of 30-day mortality, stroke, bleeding, MVC, AKI, CAO, and one-year mortality, there was comparability between the two valve types following TAVR. SEV was associated with better hemodynamic outcomes, except for a higher incidence of PVL. Compared to SAPIEN BEV, ACURATE SEV had a lower risk of PPI at 30 days, while Evolut SEV was associated with a higher risk of PPI. These findings underscore the importance of personalized valve selection.
... Interestingly, a recent series by Raschpichler et al (1) suggests that the lack of CA in patients receiving balloon-expandable intra-annular devices is associated to a greater rate of transvalvular gradients, although prospective case series have not confirmed this end. If confirmed, a group-effect cannot be assumed, in particular when referred to supra-annular devices, whose behavior in former studies has constantly demonstrated better gradients and lower rate of prosthesis-patient mismatch than the Edwards series (2,3,4). Moreover, the use of supra-annular self-expandable Evolut R/PRO (EP) (Medtronic, USA) was an independent predictor of failed coronary catheter canulation in the RE-ACCESS study (5), suggesting particular relevance of adequate coronary alignment when this device is used. ...
Background: Impact of commissural alignment (CA) strategies with self-expandable supra-annular transcatheter aortic valves (TAVR) has not been investigated yet.
Methods: Multicentric ambispective study including patients who underwent self-expandable TAVR in 7 centers with the Evolut Pro/Pro+ (EP)(Medtronic, USA) and Acurate neo2 (AN2)(Boston Scientific, USA). Comparison of those with CA attempt vs. those with no CA attempt was performed. The degree of commissural misalignment (CMA) was assessed by computed tomography/angiography and 1-year transvalvular gradients/regurgitation evaluated by echocardiography. A matched comparison according to annular dimensions/eccentricity, prosthesis size/type, and baseline left ventricular function and gradients was performed.
Results: A total of 557 patients, mean age 80.7±6.6 years, 61.4% men, and STS score of 4.3±3.1% were analyzed. A CA technique was attempted in 215 patients (38.6%), including 113 patients with AN2 and 102 patients with EP. None/mild CMA was found in 158 (73.5% vs. 43.6% if no CA attempted, p<0.001) with no differences between devices (AN2:75.2%; EP:71.6%, p=0.545). Patients with moderate/severe CMA had a greater aortic peak gradient (22.3±8.7 vs. 19.7±8.5, p=0.001), significantly greater progression of both peak (p=0.002) and mean gradients (p=0.001) after matching, and higher rate of central aortic regurgitation (1.2% vs. 0.4%, p=0.005) at 1-year, but not a greater proportion of patients with mean gradient ≥10mmHg.
Conclusions: The use of CA strategies significantly reduced the rate of CMA for the self-expandable TAVR devices ACN2 and EP which was associated to lower transvalvular gradients and intra-prosthetic regurgitation progression at 1-year although no criteria of structural deterioration were met at this follow up. Clinicaltrials.org: NCT05097183
... 99,100 SE valves might also be associated with a higher PVL. [101][102][103] In a meta-analysis study by Dayan et al., 96 PPM predictors were reported as female sex, hypertension, older age, diabetes, and renal failure. They also reported lower mortality associated with PPM in patients with a higher body mass index. ...
Transcatheter aortic valve replacement (TAVR) is a rapidly growing field enabling replacement of diseased aortic valves without the need for open heart surgery. However, due to the nature of the procedure and nonremoval of the diseased tissue, there are rates of complications ranging from tissue rupture and coronary obstruction to paravalvular leak, valve thrombosis, and permanent pacemaker implantation. In recent years, computational modeling has shown a great deal of promise in its capabilities to understand the biomechanical implications of TAVR as well as help preoperatively predict risks inherent to device–patient-specific anatomy biomechanical interaction. This includes intricate replication of stent and leaflet designs and tested and validated simulated deployments with structural and fluid mechanical simulations. This review outlines current biomechanical understanding of device-related complications from TAVR and related predictive strategies using computational modeling. An outlook on future modeling strategies highlighting reduced order modeling which could significantly reduce the high time and cost that are required for computational prediction of TAVR outcomes is presented in this review paper. A summary of current commercial/in-development software is presented in the final section.
... 9,10 Among transcatheter valves, self-expanding valves with supraannular design are generally associated with a lower prevalence of PPM compared with balloon-expandable valves. 11,12 Parameters Used to Define Patient Prosthesis Mismatch Indexed Effective Orifice Area Indexed EOA ¼ EOA of prosthesis/patient's BSA Indexed EOA is only a parameter that has been found to consistently correlate with postoperative gradients. 1 ...
Concept of patient prosthesis mismatch came into existence from 1978 onward when Rahimtoola first defined it as “mismatch can be considered to be present when the effective prosthetic valve area, after insertion into the patient, is less than that of a normal human valve.” Patient prosthesis mismatch produces higher than expected pressure gradient through normally functioning valve. Since insertion of first ball caged mechanical valve in descending aorta by Dr. Charles Hufnagel in 1952, prosthetic valve had undergone tremendous improvement in terms of valve design, hemodynamics, durability, and thrombogenicity. Despite these marked changes in valve design, prosthetic valves are still subjected to inherent complications.
... Previous studies demonstrated that MCV implantation was related to better hemodynamic performance than ESV implantation. It was observed that maximum and MG were significantly lower and the effective orifice area was significantly larger with an MCV compared with an ESV (34)(35)(36)(37). In this study, both valves demonstrated significant decreases in MG following TAVI, and MG remained low and stable over time. ...
Objective:
The long-term durability of transcatheter aortic bioprosthetic valves continues to be a major concern. Standardized criteria of the structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) have recently been defined. Limited studies have evaluated the long-term durability of transcatheter aortic valve implantation (TAVI) according to these new definitions. We aim to analyze the durability of TAVI beyond 5 years and to report the frequency of SVD and BVF.
Methods:
A total of 89 patients who had undergone TAVI and had theoretically completed at least 5 years after the procedure were included. Either a Medtronic CoreValve or an Edwards SAPIEN XT valve were implanted in the patients. New standardized definitions were used to evaluate SVD and BVF.
Results:
The mean age of the patients was 78.70±6.95 years. SVD occured in 4 (4.5%) patients during 6 years of follow-up. Severe SVD was observed in 2 patients (2.2%), and these patients had the New York Heart Association class II symptoms. Both patients with severe SVD also met the criteria of BVF. Moderate SVD was observed in 2 patients (2.2%), and these patients had no valve-related symptoms. Of the 4 SVD cases, 2 were associated with increased mean transaortic gradients, whereas the remaining 2 cases were associated with intraprosthetic aortic regurgitation. All patients with SVD are still alive, and none of them have required aortic valve reintervention.
Conclusion:
Although first-generation TAVI devices were used, we determined the low rate of SVD and BVF at the 6-year follow-up. It may be suggested that there is no major concern associated with TAVI even with first-generation devices regarding long-term durability.
... Thus, while incidence of PPM is generally higher with SAVR than TAVI, and with BEV than with SEV TAVI (67,70,76,107,108), it is interesting to note that, counterintuitively, its prognostic relevance seems to be more important in SAVR than TAVI, and with SEV than with BEV TAVI (38,64,69,70). The conflicting evidence suggesting that PPM may have a different impact on outcomes according to the type of aortic valve replacement may not derive merely from differences deriving from the approach of valve replacement or from the type of valve, but rather, it likely stems from study and measurement methodological differences, that is, baseline characteristics of enrolled study populations and intrinsic limitations in measurement of parameters needed to estimate EOA after implantation, thus, to identify and quantify PPM, as already described (32). ...
Prosthesis–patient mismatch (PPM) is present when the effective area of a prosthetic valve inserted into a patient is inferior to that of a normal human valve; the hemodynamic consequence of a valve too small compared with the size of the patient's body is the generation of higher than expected transprosthetic gradients. Despite evidence of increased risk of short- and long-term mortality and of structural valve degeneration in patients with PPM after surgical aortic valve replacement, its clinical impact in patients subject to transcatheter aortic valve implantation (TAVI) is yet unclear. We aim to review and update on the definition and incidence of PPM after TAVI, and its prognostic implications in the overall population and in higher-risk subgroups, such as small aortic annuli or valve-in-valve procedures. Last, we will focus on the armamentarium available in order to reduce risk of PPM when planning a TAVI procedure.
... Another metaanalysis, including 8015 patients, observed a significant increase in late mortality in patients with MR and a self expandable valve, although the meta-regression analysis did not reveal a statistical difference according to valve type [7]. Several factors have been postulated to explain this observation including the higher rate of moderate-severe residual paravalvular leak following self expandable valve implantation that may increased the negative effect on survival in patients with concomitant MR [22,23]. In order to ensure an optimal clinical outcome, newer devices have been designed to target post TAVI paravalvular leak with the introduction of adaptive seal surrounding the ventricular portion of the prosthesis (eg, Sapien 3 and Evolut PRO) or with the ability to reposition the valve in cases of suboptimal deployment (eg, Evolut R and Evolut PRO). ...
Background
Concomitant mitral regurgitation (MR) impaired prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). It has been suggested that the use of first generation self-expandable valve in patients with significant MR is associated with worse outcome as compared with balloon expandable valve. However, the impact of newer generation transcatheter devices on MR has not been investigated so far. We aim to assess the prognostic impact of MR in patients undergoing TAVI with the first-generation vs. the latest generation of self-expandable valves.
Methods
We analyzed 2964 consecutive patients who underwent TAVI. Patients were classified into 4 groups according to the degree of baseline MR and the generation of self expandable valve implanted.
Results
Of 1234 patients with moderate or severe MR, 817 were treated with first generation and 417 patients with second generation valves. Whereas, of 1730 patients with no or mild MR, 1130 were treated with first generation and 600 patients with second generation valves. Although, concomitant moderate-severe MR was found to be an independent predictor of mortality after TAVI, the use of newer generation self expandable valves was associated with higher survival rate at 1 year irrespective of the degree of preprocedural MR. At multivariable analysis the use of newer generation valve was associated with MR improvement throughout 1 year follow-up.
Conclusion
Baseline moderate-severe MR is associated with an increase in mortality after TAVI. However, the degree of preprocedural MR doesn't impact survival when a second generation self expandable valve is used.
... While some studies suggest that self-expanding valves may have lower frequency of PPM as compared with balloon-expandable valves 20,21 others reported similar rates of PPM between the two valve types. 22 We report similar rates of PPM in patients receiving ...
Objective: Patient‐prosthesis mismatch (PPM) is associated with poor outcomes after aortic valve replacement. The aim of this study was to assess the accuracy of indexed effective orifice area (EOAi) charts in predicting PPM after transcatheter aortic valve replacement (TAVR).
Methods: A retrospective review of 346 TAVR patients from January 2017 to November 2018 was performed. EOAi was predicted for patients based on published predictive tables using valve type, annulus diameter, and body surface area. Actual EOAi was calculated based on intraoperative transesophageal echocardiogram (TEE) measurements. PPM was defined by EOAi ≤ 0.85 cm2/m2. The accuracy of predicted PPM was assessed. Differences in clinical outcomes, including mean gradient, length of stay, mortality, complications, and change in Kansas City cardiomyopathy questionnaire score as an indicator of quality of life, were evaluated based on actual PPM.
Results: Of the 346 patients analyzed, 44 (12.7%) of patients had PPM on intraoperative TEE. Of the 182 patients who received Sapien 3 valves, 42 (23.1%) were predicted to have PPM while 25 (13.7%) had actual PPM. Of the 164 patients who received Evolut valves, 3 (1.8%) were predicted to have PPM while 19 (11.6%) had actual PPM. EOAi charts had poor sensitivity (40.0% for Sapien 3; 5.25% for Evolut) and positive predictive value (23.8% for Sapien 3; 33.3% for Evolut) for both valve types.
Conclusion: Preoperative prediction of PPM in TAVR patients using tables of expected EOA demonstrates significant variation from actual PPM. The utility of EOAi charts to predict PPM in patients undergoing TAVR may be limited.
... Previous comparisons between balloon and self-expandable valves showed better valve hemodynamic with the Corevalve system. 2,[16][17][18][19] Among patients with large annuli, our study found a small difference in mean gradient in favor of the 34-mm ER group. However, the clinical impact of this Aortic valve mean gradient, mm Hg 9.0 (6.9-11.0) ...
Background:
Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement.
Methods:
A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported.
Results:
Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group.
Conclusions:
In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.
... Sapien TM is made of bovine tissue mounted on a cobolt-chromium metal frame and is balloon-expandable (Figure 3), while the Corevalve TM (presently named Evolut TM ) is made of porcine pericardium mounted on self-expandable nitinol (Figure 4). 22 Extensive, controlled, clinical studies have been undertaken demonstrating benefits compared to surgery of this transcatheter approach first in high-then in intermediate-and finally in low-risk patients. 23 In several markets transcatheter aortic valve implantation (TAVI) is now more common than surgical valve implantation. ...
The last several decades have witnessed a huge expansion of surgical and interventional treatment of cardiac disease. Axel Cappelen from Oslo, Norway was one of the first to operate on the heart, something that had until then, been considered foolish and without chance of success.1 Cappelen dared to operate on the heart in spite of Billroth's stark warning against such "unwise" attempts as he ligated a bleeding coronary artery caused by a stabbing injury. Most of the innovation in recent years has been within the interventional cardiology domain in contrast to the first 7 decades of the 20th century, when surgeons dominated. Cardiac surgeons have developed less invasive procedures, although the most common surgical incision is based on the time-honoured and large median sternotomy incision. Many surgeons continue to prefer the concept of "Grosse Chirurgen, Grosse Schnitte" and have stayed away from minimisation and continue to use direct vision, usually augmented by magnification glasses, median sternotomy and cardiopulmonary bypass (CPB). However, new technology has made the need for CPB less important2 . In this article a selection of recently developed devices for cardiac intervention will be described.
... Data from registries reporting the use of balloonexpandable valves evidenced no impact on late mortality with a 100% of incidence (37,43,53,76). Conversely when evaluating the data from several report describing the use of self-expandable system, we found a higher rate of moderateto-severe aortic regurgitation after TAVR (41,(77)(78)(79)(80)(81), that could have a detrimental effect on LV remodeling and increase the exposure of patients with moderate to severe MR to adverse outcomes. Although difference in survival was detected when compare two systems of implant; however, a final word about which type of transcatheter heart valve therapy is optimal remains an objective for future studies. ...
Patients undergoing transcatheter aortic valve replacement (TAVR) might have an associated significant MR that can potentially lead to left ventricular (LV) failure after procedure. Considering the specific alterations in the mitral valve in TAVR scenario and the widespread use of TAVR in recent years, it appears important to know and understand the anatomical, functional and clinical implications to develop adequate strategies for the future. Patients with severe mitral regurgitation (MR) have been generally excluded from randomized clinical trials, making poor the impact that associated MR can have on clinical outcomes after TAVR. Several factors must be considered whose presence influences the severity of MR. For example, the elevated prevalence of coronary disease with consequent ischemic MR may account for LV dilation observed at the end stage of aortic stenosis. Evidence randomized studies and registries suggests that the rate of concomitant moderate-to-severe MR in patients undergoing TAVR oscillates between 2% and 33%, and patients with moderate to severe MR may have hemodynamic frailty with clinical deterioration during mechanical intervention. Short- and long-term outcomes, including cardiac mortality, appear to be influenced by the existence of preoperative moderate-to-severe MR or by the postprocedural worsening of mild MR, generally due to adverse LV remodeling. The incidence and the prognostic effect of concomitant MR in patients undergoing TAVR requires specific attention as might trigger adjunctive strategy treatment which should be carefully evaluated in clinical trials.
Keywords:
Mitral regurgitation (MR); mitral valve; transcatheter aortic valve; transcatheter aortic valve replacement (TAVR).
... The difference in the hemodynamic performance of the earlier generation Sapien and CoreValve is well documented. In a case-matched study, the self-expanding CoreValve was associated with a significantly lower residual gradient as compared to the Sapien Valve (29). Similar to their predecessors, our results indicate superior antegrade hemodynamic performance of Evolut R as compared to the Sapien 3 device. ...
The aim of this study was to systematically search literature and conduct a meta-analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66-1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83-3.54; P=0.14; I2=0%). Both mean [random; mean difference (MD) = -3.96; 95% CI, -4.61 to -3.31; P<0.00001, I2=0%] and peak (random; MD = -6.85; 95% CI, -8.22 to -5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30-day mortality (OR, 1.32; 95% CI, 0.45-3.87; P=0.62; I2=0%) or 30-day stroke outcomes (OR, 0.76; 95% CI, 0.32-1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short-term complications. The differences between the 2 devices for post-operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi-center randomized controlled trial to provide stronger evidence on this subject.
... Prevalence of post-TAVR paravalvular regurgitation (PVR) was estimated as high as 100%, with up to 39% moderate to severe PVR among patients who underwent TAVR using an early generation valve [35,36]. Fortunately, the rate of PVR C moderate has decreased significantly, even to 0%, with newer-generation valves [37]. ...
Aortic stenosis (AS) is the most common valvular disease that can lead to increased afterload, left ventricular (LV) remodeling, and myocardial fibrosis. We reviewed the literature addressing the impact of transcatheter aortic valve replacement (TAVR) on LV remodeling and patients’ outcomes by elimination of AS-related high afterload. TAVR reduces afterload and improves LV remodeling recovery. However, myocardial fibrosis may not completely reverse after the TAVR. The LV diastolic dysfunction (LVDD) induced by AS is an independent predictor of post-TAVR mortality, and mortality increases with severity of LVDD. The impact of diastolic dysfunction on patient outcomes emerges at 30 days but continues to persist during mid-term follow-up. Based on severity of the baseline LVDD, some patients may tolerate post-TAVR aortic regurgitation (AR), but even minimal post-TAVR AR in patients with severe baseline LVDD can have an additive negative impact on survival. It is crucial to consider TAVR prior to development of advanced LVDD. Appropriate device selection and deployment technique are important in improvement of TAVR outcomes via elimination of AR.
... In cohorts of patients with first-generation THVs matched for aortic annulus size, Nombela-Franco et al. (9) found that the CoreValve was associated with more PVR but, in contrast, less PPM and residual gradients compared with the SAPIEN THV. The Besides the incidence of PVR and PPM, it is also important to consider the impact of these complications on clinical outcomes. ...
... A major limitation of the trial is that most patients in the SEV group were treated with the old-generation of the CoreValve system. Residual PVL has been traditionally greater with SEV, especially with previous generation, compared to balloon expandable THV and to newer generation of SEV (9,13,14). In fact, in the REPRISE III, a post hoc analysis with limited number of patients treated with the Evolut-R showed that PVL was below <3% without differences compared to Lotus valve (<1%). ...
... Important measurements include the peak and mean transvalvular gradients, effective orifice area (EOA) by the continuity equation, and Doppler velocity index (DVI). Recent clinical trial data and registries have reported "normal" values for both early iterations of the balloon-expandable and self-expanding valves based on implanted valve size (12,13). Similar to common practice with surgical prostheses, a complete assessment of prosthetic valve function requires an understanding of the construct and appearance of each THV and the normal function of each type and size of implanted valve. ...
Objectives:
This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves.
Background:
Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function.
Methods:
We collected the Echocardiography Core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves.
Results:
For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA = 1.70 ± 0.49 cm2 with mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA = 1.67 ± 0.46 cm2 with mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA = 1.66 ± 0.38 cm2 with mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA = 1.88 ± 0.56 cm2 with mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA = 2.01 ± 0.65 cm2 with mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001).
Conclusions:
Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed.
... This finding is not surprising, however, because in other nonrandomized studies, the supra-annular Core Valve has consistently shown larger valve areas or lower mean gradients compared with annular devices. 16 What is unexpected is the 8.6% (n = 48) of patients in the Lotus group (compared with 1.2% of the Core Valve patients) who qualified as having mild stenosis at 30 days. Despite this suboptimal hemodynamic result, there seemed to be no shortterm difference in outcomes in the group as a whole or for each valve type, although more valve thrombosis was seen with the Lotus Valve. ...
... As opposed to surgical PHVs, the EOA of a given prosthesis size varies significantly depending on the patient's aortic annulus size [22,23]. Selfexpanding THVs generally have somewhat larger EOAs and lower gradients compared to the balloon expandable THVs but higher incidence of PVR [24,25]. ...
Doppler-echocardiography is the primary imaging modality to assess the structural and functional integrity of aortic prosthetic heart valves (PHVs). A comprehensive approach that integrates several parameters of PHV structure and function measured in multiple views by transthoracic (TTE) or transoesophageal (TEE) echocardiography is essential to appropriately detect and quantitate PHV dysfunction and complications. Other imaging modalities such as cinefluoroscopy, MDCT, CMR, and nuclear imaging are valuable additional tools in the diagnosis and management of PHV dysfunction and complications, particularly when Doppler-echocardiography is inconclusive or discordant with clinical status. TEE, cinefluoroscopy, and MDCT are particularly helpful to identify the abnormalities in the morphology and/or mobility of the PHV leaflet/occluder as well as to assess the paravalvular lesions. CMR may be useful to corroborate the severity of PHV regurgitation, and particularly paravalvular regurgitation in patients with transcatheter aortic valves.
... Although still developing, two TAVR valves have been most widely utilized: the balloon expandable Edwards Sapien valve and the self-expanding Medtronic CoreValve (Medtronic, Minneapolis, Minnesota). These two valves have differing hemodynamic profiles, with the CoreValve possessing a supra-annular and funnel shape design that may further increase EOA and lower gradient (5). ...
Patient prosthesis mismatch (PPM) can occur when a prosthetic aortic valve has an effective orifice area (EOA) less than that of a native valve. A recent study by Zorn and colleagues evaluated the incidence and significance of PPM in high risk patients with severe aortic stenosis who were randomized to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). TAVR is associated with decreased incidence of severe PPM compared to traditional SAVR valves. Severe PPM increases risk for death at 1 year postoperatively in high risk patients. The increased incidence of PPM is largely due to differences in valve design and should encourage development of newer SAVR valves to reduce risk for PPM. In addition more vigorous approaches to root enlargement in small annulus should be performed with SAVR to prevent PPM.
... The incidence of moderate PPM reported in these series of patients who received balloon-expandable or self-expanding transcatheter heart valves (THVs) is between 18 and 32 % and that of severe PPM is between 2 and 9 % [18][19][20][21][22]. Some studies suggest that self-expanding THVs are associated with lower prevalence of severe PPM [23,24]. ...
Opinion statement:
Prosthesis-patient mismatch (PPM) occurs when the effective orifice area (EOA) of a normally functioning prosthesis is too small in relation to the patient's body size, resulting in abnormally high postoperative gradients. PPM is frequent following aortic valve replacement (AVR), and it is associated with increased risk of morbidity and mortality proportionally to its severity. Differential diagnosis between PPM and prosthetic valve stenosis is made by comparing the measured valve effective orifice area, by assessing the changes in valve area and gradient during follow-up and by evaluating leaflet morphology and mobility. Preventive strategies to avoid or minimize PPM should be implemented especially in the patients who are at high risk for severe PPM and in those who have vulnerability factors to PPM. Transcatheter AVR may be superior to surgical AVR for the prevention of PPM and associated adverse cardiac events, particularly in the subset of patients with a small (<21 mm) aortic annulus. In this article, we discuss the most updated data regarding the diagnosis, clinical impact, and prevention of PPM after AVR.
... The high-rate of self-expandable prosthesis may partially explain both facts. The supravalvular position of the leaflets in this device has been related to better transvalvular gradients when compared to conventional surgery and to balloon-expandable prosthesis [37,38]. What is more, the use of this prosthesis has been associated to higher rate of paravalvular leak, which indeed was related to higher mortality [39,40]. ...
Background:
Recently, the use of transcatheter aortic valve implantation (TAVI) in intermediate-low risk patients has been evaluated in the PARTNER II randomized trial. However, in the last years, this therapy has been employed in this scenario with underreported results, as compared to surgical aortic valve replacement (SAVR).
Methods:
We enrolled 362 consecutive patients with severe symptomatic aortic stenosis and intermediate-low surgical risk (logEuroSCORE < 20%), treated in our center with TAVI (103 patients) or single SAVR (259 patients) between 2009 and 2014. Patients were matched according to age, gender, logEuroSCORE, and use of bioprosthesis.
Results:
Mean age of the patients was 73 ± 10.4 years, and 40.3% were women. LogEuroSCORE and STS score were 7.0 ± 4.4% and 4.2 ± 2.5%, respectively, with mean LVEF of 52 ± 9%. There were no differences regarding other comorbidities. The length-of-hospitalization was 11 ± 5 days after TAVI vs. 17 ± 9days after SAVR (p = 0.003). After matched comparison, no differences in terms of in-hospital mortality (5.7% after TAVI vs. 2.9% after SAVR, p = 0.687) and 1-year mortality (11.4% vs. 7.1%, p = 0.381) were found. The combined endpoint of stroke and mortality at 1-year was also similar between both groups (15.7% in TAVI patients vs. 14.4% after SAVR, p = 0.136). Multivariate analysis determined that aortic regurgitation (AR) was an independent predictor of mortality (OR = 3.623, 95% CI [1.267-10.358], p = 0.016). Although the rate of AR was higher after TAVI, none of the patients treated with the newest generation devices (10.7%) presented more than a mild degree of AR.
Conclusions:
TAVI is feasible and shows comparable results to surgery in terms of early, 1-year mortality, as well as cerebrovascular events in patients with severe aortic stenosis and intermediate-low operative risk. Better transvalvular gradients, yet higher rates of AR were found, however, newer devices presented comparable rate of AR.
Background: Distinct clinical differences exist between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) used in transcatheter aortic valve replacement (TAVR) for aortic stenosis. However, randomised data on comparative outcomes are limited. The aim of this meta-analysis was to analyse the differences in short- and longer-term clinical outcomes between the two valve designs. Methods: A comprehensive literature search for all studies up to and including April 2020 on the clinical outcomes of BEVs versus SEVs was performed. Study outcomes were divided into short term (in-hospital or 30 days), intermediate term (1 year) and long term (3 years). The primary outcome was all-cause mortality. Secondary endpoints were stroke or transient ischaemic attack (TIA), life-threatening or major bleeding, at least moderate paravalvular leak (PVL), permanent pacemaker (PPM) implantation, aortic valve area (AVA) and aortic valve mean pressure gradient (AV MPG). Results: A total of 41 studies (BEV, n=23,892; SEV, n=22,055) were included. At in-hospital/30 days, all-cause mortality favoured BEV (OR 0.85; 95% CI [0.75–0.96]). BEV had lower rates of PVL (OR 0.42; 95% CI [0.35–0.51]) and PPM (OR 0.56; 95% CI [0.44–0.72]), but smaller AVA (mean −0.09 cm2; 95% CI [−0.17, 0.00]) and higher AV MPG (mean 2.54 mmHg; 95% CI [1.84–3.23]). There were no significant differences in the incidence of stroke/TIA or bleeding between the two valve designs. At 1 year a lower PPM implantation rate (OR 0.44; 95% CI [0.37–0.52]), fewer PVLs (OR 0.26; 95% CI [0.09–0.77]), smaller AVA (mean −0.23 cm2; 95% CI [−0.35, −0.10]) and higher AV MPG (mean 6.05 mmHg; 95% CI [1.74–10.36]) were observed with BEV. No significant differences were observed in mortality, stroke/TIA or bleeding. There was no significant difference in mortality at 3 years between the two valve designs. Conclusion: In the short–intermediate term, SEVs had better valve haemodynamics but had higher PVL and PPM implantation rates than BEVs. However, there were no differences in intermediate–long-term mortality, stroke or TIA, or bleeding complications. A better understanding of these differences will enable TAVR operators to tailor their valve choice based on individual patient profile.
Aortic valve stenosis ( AS ) is the most common acquired valve disease in developed countries. Surgical aortic valve replacement ( SAVR ) was the only effective treatment option for patients with AS until the introduction of transcatheter aortic valve replacement ( TAVR ). TAVR has become a cornerstone in the management of patients with AS, and in the last few years, the total number of annual TAVR procedures has exceeded the number of SAVR procedures in the United States. TAVR valves have undergone substantial modifications to improve their performance. As TAVR technologies continue to evolve, new devices differing in their design will become available to fit more clinical needs of patients. Although the majority of patients can be successfully treated with any one of a number of devices, currently there is no one ideal valve that can fit all patients. Therefore, a multitude of factors should be considered when selecting a TAVR device for your patient, to obtain the best results. This chapter will summarize different types of TAVR devices available or under investigation and what patient, anatomic, or device‐specific factors should be considered when selecting among TAVR devices.
Significant mitral regurgitation (MR) is commonly observed in patients with severe aortic stenosis (AS) in a complex multivalvular disease scenario. Recent data suggest a coexistence of the two conditions in nearly 25–30% of patients undergoing transcatheter aortic valve implantation (TAVI) [1, 2], a proportion which is likely to increase in the next future. Although most of the evidence proposes concomitant MR as a reliable predictor of worse outcomes in TAVI candidates, whether (and to what extent) this condition independently impact on patients’ outcomes remains controversial.
Backgrounds
Evaluation of prosthesis-patient mismatch (P-PM) after transcatheter aortic valve replacement (TAVR) by transthoracic echocardiography (TTE) has provided conflicting results regarding its impact on outcomes. Whether post-TAVR computed tomography angiography (CTA) evaluation of P-PM can improve our understanding is unknown. We aimed to evaluate the inter-modality (TTE vs. CTA) agreement, inter-valve platform (balloon-expanding valve [BEV] vs. self-expandable valve [SEV]) differences in P-PM severity, and outcomes related to P-PM after TAVR.
Methods
We analyzed patients with both CTA and TTE before and after TAVR. Indexed effective orifice area was calculated using two methods: TTE-derived left ventricular outflow tract (LVOT) area from measured diameter and post-TAVR CTA-measured area. Body size specific cut-offs for P-PM severity were used: for body mass index (BMI) <30kg/m², moderate=0.66 to 0.85cm²/m² and severe≤0.65cm²/m²; for BMI ≥30kg/m², moderate=0.56 to 0.70cm²/m² and severe≤0.55cm²/m².
Results
A total of 447 patients were included (median age, 83 years; 54% male). The prevalence of P-PM (moderate or severe) was lower with CTA vs. TTE (3.5% vs. 19.5%, p<0.001). The prevalence of P-PM measured by TTE was more common in BEV compared to SEV (p=0.002), while CTA assessment showed no difference in P-PM incidence and severity between TAVR platforms (p=0.40). In multivariable analysis, CTA-defined but not TTE-defined P-PM was associated with mortality after TAVR (HR:3.97;95%CI,1.55-10.2;p=0.004). Both CTA-defined and TTE-defined P-PM were associated with the composite of death and heart failure rehospitalization.
Conclusion
Although post-TAVR CTA substantially downgraded the prevalence of P-PM compared to TTE, it identified a subset of patients with clinically relevant P-PM which associated with outcomes.
Resumen
Introducción y objetivos
El implante percutáneo de válvula aórtica (TAVI) autoexpandible (AE) es particularmente útil para pacientes con estenosis aórtica y accesos vasculares pequeños, anillo pequeño y ostium coronario bajo. Sin embargo, aún no está claro si el resultado clínico y hemodinámico es comparable entre los distintos dispositivos AE. Nuestro objetivo es determinar diferencias clínicas y hemodinámicas entre dispositivos, ajustando por características basales.
Métodos
Se analizaron los casos tratados con TAVI-AE en 4 instituciones. Se incluyeron características basales y al seguimiento, y el análisis de los ecocardiogramas fue centralizado y ciego. Se compararon los 4 dispositivos tras emparejar 1:1 por grado de calcificación, dimensiones del anillo, superficie corporal y función ventricular.
Resultados
Se incluyó a 514 pacientes (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico: 88). No hubo diferencias en las escalas de riesgo. No se detectaron diferencias en insuficiencia aórtica tras el TAVI ni en las tasas de mortalidad hospitalaria (2,7%). La tasa de implante de marcapasos mostró diferencias significativas (p = 0,049), con la mayor tasa tras Portico (23%) y la menor tras ACURATE neo (9,5%). La Evolut R/PRO y la ALLEGRA presentaron tasas del 15,9 y el 21,2%. Tras el ajuste, la comparación mostró mayor gradiente residual y menor área valvular aórtica indexada con ACURATE neo que con ALLEGRA (p = 0,001), pero con esta se produjo la mayor tasa de embolización del dispositivo y una tendencia estadística a mayor tasa de eventos cerebrovasculares.
Conclusiones
La comparación de 4 TAVI-AE tras ajustar por diferencias basales no demostró diferencias en las tasas de insuficiencia aórtica periprotésica ni en la mortalidad hospitalaria.
Introduction and objectives
Aortic self-expandable (SE) transcatheter aortic valve implantation (TAVI) devices are particularly useful for patients with aortic stenosis and small/tortuous vessels, small aortic annuli, or low coronary ostia. However, it is unclear whether the growing range of SE devices shows comparable hemodynamic and clinical outcomes. We aimed to determine the differential hemodynamic (residual valve area and regurgitation) and clinical outcomes of these devices in comparable scenarios.
Methods
All patients were enrolled from 4 institutions and were managed with 4 different SE TAVI devices. Baseline and follow-up clinical data were collected and echocardiographic tests blindly and centrally analyzed. Patients were compared according to valve type and a 1:1 matched comparison was performed according to degree of calcification, aortic annulus dimensions, left ventricular ejection fraction, and body surface area.
Results
In total, 514 patients were included (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico, 88). Surgical risk scores were comparable in the unmatched population. No differences were observed in the post-TAVI regurgitation rate and in in-hospital mortality (2.7%). The rate of pacemaker implantation at discharge was significantly different among devices (P = .049), with Portico showing the highest rate (23%) and ACURATE neo the lowest (9.5%); Evolut R/PRO and ALLEGRA had rates of 15.9% and 21.2%, respectively. The adjusted comparison showed worse residual TAVI gradients and aortic valve area with ACURATE neo vs ALLEGRA (P = .001) but the latter had higher risk of valve embolization and a tendency for more cerebrovascular events.
Conclusions
A matched comparison of 4 SE TAVI devices showed no differences regarding residual aortic regurgitation and in-hospital mortality.
Importance:
Aortic valve stenosis (AS) is the most common manifestation of acquired valvular heart disease in developed countries. Several large-scale randomized clinical trials investigating the entire spectrum of patients with severe symptomatic AS from low to prohibitive risk have established transcatheter aortic valve replacement (TAVR) as a safe and effective alternative to surgical aortic valve replacement.
Observations:
There are currently only 3 types of TAVR devices commercially available in the US, but several other valve types are undergoing clinical trials in the US. Because of fundamental differences in engineering features, each TAVR device type has specific strengths and limitations. This review aims to provide an overview of design features and clinical outcomes of various TAVR devices that are either commercially available or undergoing clinical investigation.
Conclusions and relevance:
Given the lack of large-scale head-to-head comparisons of various TAVR devices and the rapid development of new device iterations, there is insufficient evidence to claim superiority of one device type over another. Nonetheless, as each TAVR device has unique design characteristics, certain patient-related and anatomy-related factors may slightly favor one or several particular designs.
This chapter covers the fundamental aspects of intraprocedural imaging, related to the surgical replacement or repair of the aortic valve and its corresponding transcatheter, the TAVI.
This study aimed to compare the hemodynamic performance of transcatheter and surgical aortic valves in patients with severe symptomatic aortic stenosis and small aortic annulus (SAA) and to determine the valve hemodynamics according to transcatheter valve type. Consecutive surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients with SAA were case-matched (1:1) on the basis of sex, body surface area, aortic annulus diameter, and left ventricular ejection fraction. A total of 357 patients in each group constituted the final study population. A second match on the basis of aortic annulus diameter and valve/annulus calcium burden was performed within the TAVR group to compare the valve performance between balloon- (n = 52) and self-expanding (n = 52) transcatheter valve systems (BEV, SEV). The echocardiograms performed at hospital discharge were used for evaluating valve hemodynamics. The mean annulus diameter of the study population was 19.2 ± 0.3 mm. The TAVR group (vs SAVR) exhibited lower mean gradient (12 ± 7 mm Hg vs 15 ± 6 mm Hg, p <0.001), larger effective orifice area (1.46 ± 0.39 cm2 vs 1.25 ± 0.37 cm2, p <0.001) and a lower rate of severe prosthesis-patient mismatch (PPM) (14% vs 24%, p = 0.001). Moderate-severe AR was present in 2.5% of the TAVR recipients versus none patient in the SAVR group. There were no differences in valve hemodynamics between balloon-expanding transcatheter valve system and self-expanding transcatheter valve system, and similar rates of severe PPM were observed in both groups (p = 0.488). In conclusion, TAVR presented superior valve hemodynamics and lower incidence of severe PPM compared with SAVR in SAA patients. Similar valve performance results were observed between transcatheter valve types.
Over the last ten year, transcatheter aortic valve replacement (TAVR) has gained acceptance for patients at prohibitive, high and intermediate risk for surgical aortic valve replacement (SAVR). Recent evidence supports the utilization of TAVR in low surgical risk patients: two independent randomized trials have demonstrated short and mid-term clinical benefits of transfemoral TAVR over SAVR for endpoints such as all-cause mortality, stroke and re-hospitalizations.
The aim of the current manuscript is to provide an overview of the most important randomized clinical trials comparing TAVR with SAVR according to surgical risk, discuss the remaining challenges of TAVR and identify patients in whom open surgery remains the best practice in presence of severe AS. We also discuss how the emergence of TAVR as a suitable alternative for low risk patients changes the Heart Team evaluation and treatment selection process.
Objectives:
This study sought to compare the frequency of prosthesis-patient mismatch (PPM) with self-expandable valves (SEV) to balloon-expandable valves (BEV).
Background:
PPM has been associated with increased mortality after transcatheter aortic valve replacement. Data on the frequency of PPM as a function of supra-annular or intra-annular position of transcatheter heart valves are insufficient.
Methods:
A total of 757 patients treated with SEV (CoreValve, Evolut R) and BEV (SAPIEN THV/XT/3) were enrolled in the present analysis between August 2007 and June 2017. PPM was classified based on discharge prosthetic effective orifice area indexed to body surface area (BSA) as severe (<0.65 cm2/m2) or moderate (0.65 to 0.85 cm2/m2) in the general population, and as severe (<0.60 cm2/m2) or moderate (0.60 to 0.90 cm2/m2) in the obese population (body mass index ≥30 kg/m2).
Results:
Propensity score matching resulted in 224 matched pairs. At discharge, SEV were associated with a lower incidence of PPM compared with BEV (PPM, 33.5% vs. 46.9%, p = 0.004; severe PPM, 6.7% vs. 15.6%, p = 0.003). The lower frequency of severe PPM in SEV was observed even in patients with larger annulus. Although patients with BSA >1.83 m2 had a significantly lower incidence of PPM with SEV compared with BEV, there was no significant difference in patients with BSA ≤1.83 m2. We found no impact of PPM on cardiovascular mortality or New York Heart Association functional class at 1 year.
Conclusions:
SEV were associated with a lower frequency of PPM compared with BEV irrespective of annulus area. The difference was mainly driven by larger patients with BSA >1.83 m2.
Transcatheter aortic valve implantation (TAVI) is now an established treatment option for both high and intermediate operative risk patients with severe symptomatic aortic stenosis. The number of patients undergoing TAVI has increased over the last decade warranting continued technological improvements in transcatheter heart valve (THV) systems. The novel CENTERA self-expanding THV (Edwards Lifesciences, CA, USA) received CE approval this year. It is deliverable through a 14Fr sheath and has a unique motorized delivery system. The CENTERA-2 study results demonstrated a favorable survival rate at 30 days (99%), as well as a low need for new permanent pacemaker implantation (4.9%). 1-year outcomes reported a low incidence of >moderate paravalvular leak (0.6%) and consistently favorable THV hemodynamics making this a competitive THV for patients with severe aortic stenosis.
Objectives
To investigate the impact of the introduction of the next generation self‐expanding (SE) and balloon‐expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR).
Background
PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs.
Methods
PPM was assessed at 30 days post‐TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363).
Results
The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95–0.99], P = 0.002), history of myocardial infarction (2.09 [1.00–4.34], P = 0.049), annulus maximum diameter (0.84 [0.77–0.92], P < 0.001), and THV oversizing (0.90 [0.87–0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23–8.53], P = 0.017 and 5.79[2.33–14.36], P < 0.001).
Conclusions
The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.
Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with symptomatic severe aortic stenosis [1] and a good alternative to surgical aortic valve replacement for patients at high surgical risk [2]. Worldwide, two types of transcatheter heart valves (THVs) have been most used to date: the balloon-expandable Edwards valve (Cribier-Edwards, Edwards SAPIEN, SAPIEN XT, and SAPIEN 3; Edwards Lifesciences, Irvine, CA) and the self-expandable CoreValve system (CoreValve, Evolut, Evolut R; Medtronic, Minneapolis, MN). In the past few years, other transcatheter valves have also received CE mark approval and are now commonly used (e.g., Direct Flow, Lotus Valve, Portico, JenaValve, Symetis). Despite significant progress in the technology of transcatheter valves over the last decade, several complications remain associated with this less-invasive procedure. This chapter seeks to review the major significant complications following TAVR. Methods of prevention and treatment of those hurdles will also be appraised.
Resumen
Introducción y objetivos
Las válvulas SAPIEN 3 (S3) y Medtronic Evolut R (EVR) son prótesis transcatéter de segunda generación, diseñadas para reducir el grado de insuficiencia aórtica (IAo) paravalvular. El objetivo es comparar la hemodinámica valvular en un estudio de casos emparejados con análisis ecocardiográfico independiente.
Métodos
De una población de 201 pacientes tratados con implante percutáneo de válvula aórtica, se emparejó a un total de 144 (S3, n = 80; EVR, n = 64) en función del diámetro del anillo y de la puntuación de calcio aórtico medidos por tomografía computarizada. Los ecocardiogramas de seguimiento basal, al mes y a los 6 meses se analizaron de manera independiente y centralizada.
Resultados
No se observaron diferencias respecto a las características basales clínicas y ecocardiográficas. La prótesis EVR mostró un mejor perfil hemodinámico evaluado mediante gradiente aórtico máximo (EVR frente a S3, 13 ± 7 frente a 20 ± 10; p < 0,001), gradiente aórtico medio (7 ± 3 frente a 11 ± 6; p < 0,001) e índice de velocidad Doppler (0,65 ± 0,15 frente a 0,51 ± 0,16; p < 0,001). Por otro lado, la tasa de IAo paravalvular moderada-grave o de cualquier grado de IAo paravalvular (≥ leve) fue mayor en el grupo de EVR (el 11 y el 50%) que en el de S3 (el 2,5 y el 21%; p < 0,05), con mayor número de chorros regurgitantes (p < 0,001).
Conclusiones
En una cohorte de casos emparejados tratados con implante percutáneo de válvula aórtica de segunda generación, la S3 se asoció con una menor tasa de IAo paravalvular y mayor gradiente transprotésico residual que con la EVR.
Background
The CENTERA transcatheter heart valve (THV) is a low-profile, self-expanding nitinol valve made from bovine pericardial tissue that is 14-F compatible with a motorized delivery system allowing for repositionability.
Objectives
The pivotal study evaluated safety and efficacy of this THV in high–surgical-risk study patients with severe symptomatic aortic stenosis.
Methods
Implantations were completed in 23 centers. Clinical and echocardiographic outcomes were assessed at baseline, discharge, and 30 days. Major events were adjudicated by an independent clinical events committee. Echocardiograms and computed tomography scans were reviewed by core laboratories. The primary endpoint was all-cause mortality at 30 days.
Results
Between March 25, 2015 and July 5, 2016, 203 patients with severe symptomatic aortic stenosis and increased surgical risk, as determined by the heart team, were treated by transfemoral THV implantation (age 82.7 ± 5.5 years, 67.5% female, 68.0% New York Heart Association functional class III/IV). At 30 days, mortality was 1%, disabling stroke occurred in 2.5% of patients, and New York Heart Association functional class I/II was observed in 93.0% of patients. Effective orifice area increased from 0.71 ± 0.20 cm² to 1.88 ± 0.43 cm² (p < 0.001). Mean aortic transvalvular gradient decreased from 40.5 ± 13.2 mm Hg to 7.2 ± 2.8 mm Hg at 30 days post-procedure (p < 0.001). Paravalvular aortic regurgitation at 30 days was moderate or higher in 0.6% of patients. A new permanent pacemaker was implanted in 4.5% of patients receiving the THV (4.9% for patients at risk).
Conclusions
The herein described THV is safe and effective at 30 days with low mortality, significant improvements in hemodynamic outcomes, and low incidence of adverse events. Of particular interest is the low incidence of permanent pacemaker implantations. (Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560)
Transcatheter aortic valve implantation (TAVI) has become a widely accepted treatment for the management of patients with severe aortic stenosis who are deemed prohibitive or high risk for conventional surgical replacement [1]. As data continue to emerge on the safety and efficacy of TAVI in patients who are at intermediate or low surgical risk, the utilization of TAVI for symptomatic severe aortic stenosis patients will increase in the near future. [2–6] Over eight TAVI devices are available in Europe, but the only valves approved for use in the USA are the Edwards SAPIEN balloon-expandable valve (Edwards Lifesciences, Irvine, CA) and the Medtronic self-expanding Evolut R and classic CoreValve (Medtronic, Minneapolis, MN). [7] The SAPIEN XT and the SAPIEN 3 valves are now approved for intermediate-surgical-risk patients.
OBJECTIVES: We herein aimed to compare acute 30-day outcomes of latest-generation self-expandable and balloon-expandable transcatheter heart valves.
METHODS: From 2012 through 2016, 104 consecutive patients (study group, 69.2% female, 81.7 ± 5.5 years, logEuroSCORE I 15.9 ± 9.3%) received transfemoral transcatheter aortic valve implantation using the Symetis ACURATE neo® transcatheter heart valve. A control group of patients after transfemoral transcatheter aortic valve implantation with the Edwards Sapien 3™ transcatheter heart valve was retrieved from our database and matched to the study group. Data were retrospectively analysed according to updated Valve Academic Research Consortium definitions.
RESULTS: Device success was 94.2% (98 of 104) and 98.1% (102 of 104) in study and control groups, respectively (P = 0.157). All-cause 30-day mortality was 3.9 (4 of 104) vs 0.9% (1 of 104) (P = 0.317). Resultant transvalvular peak/mean gradients and effective orifice area were 14.2 ± 5.7 vs 22.6 ± 6.8 mmHg (P < 0.001)/7.3 ± 2.8 vs 11.8 ± 3.5 mmHg (P < 0.001) and 2.0 ± 0.4 vs 1.7 ± 0.4 cm2 (P = 0.063). Paravalvular leakage ≥moderate was observed in 4.8% (5 of 104) and 1.9% (2 of 104) (P = 0.257). Rate of permanent pacemaker implantation was 10.6% (11 of 104) vs 16.4% (17 of 104) (P = 0.239).
CONCLUSIONS: Next-generation self-expandable transcatheter heart valves preserve superiority in terms of post-interventional haemodynamics without presenting former drawbacks: rate of postoperative permanent pacemaker implantation and severity of residual paravalvular leakage were similar to balloon-expandable transcatheter heart valves.
Trans-catheter aortic valve implantation (TAVI) is the treatment of choice for inoperable and high risk patients with severe aortic stenosis. Our objectives were to elucidate potential differences in clinical outcomes and safety between balloon-expandable versus self-expandable trans-catheter heart valves (THV). We performed a retrospective cohort study of all trans-femoral TAVI procedures in Ontario, Canada from 2007-2013. Patients were categorized into either balloon-expandable or self-expandable THV groups. The primary outcomes were 30-day and 1-year death, with secondary outcomes of all-cause readmission. Safety outcomes included bleeding, permanent pacemaker implantation, need for a 2nd THV device, post-procedural para-valvular aortic regurgitation, stroke, vascular access complication and intensive care unit (ICU) length of stay. Inverse probability of treatment weighted regression analyses using a propensity score were used to account for differences in baseline confounders. Our cohort consisted of 714 patients, of whom 397 received a self-expandable THV while 317 had a balloon-expandable THV system. There were no differences in death or all-cause readmission. In terms of safety, the self-expandable group was associated with significantly higher rates of in-hospital stroke (p-value <0.05), need for a 2nd THV device (5.3% vs 2.7%; p-value 0.013) and permanent pacemaker (22.6% vs 8.9%; p-value <0.001), while the balloon-expandable group had more vascular access site complications (23.1% vs 16.7%; p-value 0.002). Thus, we found similar clinical outcomes of death or readmission for patients undergoing trans-femoral TAVI with either balloon-expandable or self-expandable THV systems. However, there were important differences in their safety profiles.
Prosthesis-patient mismatch (PPM) is defined as a small effective orifice area (EOA) of a normally functioning prosthetic valve in relation to patient body size. Even moderate impediment to forward flow has been associated with an increase in all-cause mortality. We report an unusual cause of PPM where a transcatheter implantation of a large EOA valve in an aortic position results in relative PPM in a patient with morbid obesity.
The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits.
At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation.
The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001).
A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
Transcatheter aortic valve implantation (TAVI) is a new therapy for severe aortic stenosis in high-risk patients. So far, no reference values for the echocardiographic assessment of this new class of heart valves have been established. The aim of our study was to determine Doppler haemodynamics and the effective orifice area (EOA).
We retrospectively analysed the earliest transthoracic echocardiographic examinations of 146 stable patients after successful TAVI (median 8±20 days). Doppler examinations were analysed for peak instantaneous velocity, peak, and the mean systolic gradient. EOA was determined using the continuity equation. Patients with severe paravalvular aortic or mitral valve regurgitation were excluded. The overall peak instantaneous velocity (n=146) was 2.0±0.4 m/s with a peak systolic gradient of 17.1±7.4 mmHg and a mean gradient of 9.3±4.5 mmHg. The mean EOA was 1.82±0.43 cm2 with an indexed EOA of 1.0±0.27 cm2/m2. In general, all prostheses showed similar values-with the exception of the Edwards Sapien 23 mm which was associated with higher velocities and peak pressure gradients.
Our study establishes the normal range for Doppler haemodynamics of four transcatheter aortic valve prostheses. Compared with previously published data of surgically implanted bioprostheses percutaneous valves tend to have similar EOA values but lower mean peak velocities and pressure gradients. In comparison with physiological haemodynamics; however, this new class of heart valves is still associated with a mild obstruction.
Numerous studies have linked prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR) to adverse outcomes. Its correlation with long-term survival has been described but with contradicting results. This systematic review and meta-analysis of observational studies aims to determine the hazard of PPM after AVR.
The Medline and EMBase databases were searched for English-language original publications. Two researchers independently screened studies and extracted data. Pooled estimates were obtained by random effects model. Subgroup analyses were performed to detect sources of heterogeneity. The search yielded 348 potentially relevant studies; 34 were included comprising 27 186 patients and 133 141 patient-years. Defined by the universally accredited indexed effective orifice area <0.85 cm(2)/m(2), 44.2% of patients were categorized as having PPM. In 34.2 and 9.8% of patients moderate (0.65-0.85 cm(2)/m(2)) and severe (<0.65 cm(2)/m(2)) PPM was present, respectively. Prosthesis-patient mismatch was associated with a statistically significant increase in all-cause mortality (HR = 1.34, 95% CI: 1.18-1.51), but only a trend to an increase in cardiac-related mortality (HR = 1.51, 95% CI: 0.88-2.60) was recognized. Analysis by severity of PPM demonstrated that both moderate and severe PPM increased all-cause mortality (HR = 1.19, 95% CI: 1.07-1.33 and HR = 1.84, 95% CI: 1.38-2.45) and cardiac-related mortality (HR = 1.32, 95% CI: 1.02-1.71 and HR = 6.46, 95% CI: 2.79-14.97). Further analyses showed a consistent effect over separate time intervals during follow-up.
Prosthesis-patient mismatch is associated with an increase in all-cause and cardiac-related mortality over long-term follow-up. We recommend that current efforts to prevent PPM should receive more emphasis and a widespread acceptance to improve long-term survival after AVR.
This study was undertaken to compare the hemodynamic performance of a percutaneous bioprosthesis to that of surgically implanted (stented and stentless) bioprostheses for the treatment of severe aortic stenosis.
Fifty patients who underwent percutaneous aortic valve implantation (PAVI) with the Cribier-Edwards or Edwards SAPIEN bioprosthetic valve (Edwards Lifesciences, Inc., Irvine, California) were matched 1:1 for sex, aortic annulus diameter, left ventricular ejection fraction, body surface area, and body mass index, with 2 groups of 50 patients who underwent surgical aortic valve replacement (SAVR) with a stented valve (Edwards Perimount Magna [SAVR-ST group]), or a stentless valve (Medtronic Freestyle, Medtronic, Minneapolis, Minnesota [SAVR-SL group]). Doppler echocardiographic data were prospectively obtained before the intervention, at discharge, and at 6- to 12-month follow-up.
Mean transprosthetic gradient at discharge was lower (p < 0.001) in the PAVI group (10 +/- 4 mm Hg) compared with the SAVR-ST (13 +/- 5 mm Hg) and SAVR-SL (14 +/- 6 mm Hg) groups. Aortic regurgitation (AR) occurred more frequently in the PAVI group (mild: 42%, moderate: 8%) compared with the SAVR-ST (mild: 10%, moderate: 0%) and SAVR-SL (mild: 12%, moderate: 0%) groups (p < 0.0001). At follow-up, the mean gradient in the PAVI group remained lower (p < 0.001) than that of the SAVR-ST group, but was similar to that of the SAVR-SL group. The incidence of severe prosthesis-patient mismatch was significantly lower (p = 0.007) in the PAVI group (6%) compared with the SAVR-ST (28%) and SAVR-SL (20%) groups. However, the incidence of AR remained higher (p < 0.0001) in the PAVI group compared with the 2 other groups.
PAVI provided superior hemodynamic performance compared with the surgical bioprostheses in terms of transprosthetic gradient and prevention of severe prosthesis-patient mismatch, but was associated with a higher incidence of AR.
Background:
Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry.
Methods and results:
The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients.
Conclusions:
The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.
Objectives:
Prosthesis-patient mismatch (PPM) is defined as a too small effective orifice area (EOA) of the prosthetic valve in relation to the patient's body size and has been documented to be related to adverse outcomes after conventional aortic valve replacement (AVR). Aim of this study was to analyze the incidence of PPM after transcatheter aortic valve implantation (T-AVI) using the Edwards SAPIEN prosthesis and its relation to postoperative outcome.
Methods:
200 consecutive high-risk patients underwent transapical aortic valve implantation (TA-AVI) between February 2006 and January 2009 and fulfilled 1 year follow-up were included. Severe PPM was defined as indexed EOA (EOAi) <0.65 cm2/m2 and moderate PPM as EOAi = 0.65-0.85 cm2/m2, EOA was calculated from transthoracic echocardiographic (TTE) measurements using the continuity equation. Total 112 patients with sufficient postoperative TTE image quality formed the study group.
Results:
EOAi increased from 0.3 ± 0.1 cm2/m2 (preoperatively) to 1.1 ± 0.4 cm2/m2 after TA-AVI (p < 0.001). According to the standard definitions, PPM was seen in 38.4% of the patients and 9.8% presented with severe PPM. The occurrence of PPM had neither an effect on clinical outcome in terms of NYHA class nor on survival. Patients with PPM had significantly higher postoperative transprosthetic gradients (mean gradient 10.4 ± 4.1 versus 7.1 ± 3.0 mm Hg, p < 0.001). Based on the in vitro EOA data obtained from pulse duplicator measurements, however, none of the patients was judged to have PPM.
Conclusion:
Transcatheter AVI provides good antegrade hemodynamic function and EOAi improves significantly. According to standardized evaluations PPM occurs after TA-AVI, but it is not associated with adverse outcomes. Thus use of the continuity equation may not adequately reflect the situation after T-AVI or the current definition of PPM is not suitable for T-AVI prostheses.
A better understanding of the mechanisms producing the radial force in transcatheter heart valves is essential in order to reduce the reported cases of migration and atrio-ventricular block and improve the effectiveness of the treatment. This paper presents a numerical study of the different mechanisms responsible for the radial force exerted on the aortic annulus by self-expanding and balloon-expandable prostheses. The behavior of the Medtronic CoreValve (self-expanding) and the Edwards SAPIEN (balloon-expandable) devices, both of size 26, has been simulated and compared. The results indicate that, for both prostheses, the radial force may vary considerably within the recommended functional range for the valve implantation and is substantially higher at the smallest annular sizes. In particular, in the case of the self-expanding valve the radial force is essentially dependent on the diameter of the left ventricular outflow tract, while for the balloon-expandable valve the radial force produced is influenced by both the geometry and stiffness of the host tissue. The outcomes of this study provide a better insight into the phenomenon and useful information that could support the development of improved solutions.
This study sought to evaluate the predictive factors, effects, and safety of balloon post-dilation (BPD) for the treatment of significant paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI).
Very few data exist on BPD after TAVI with a balloon-expandable valve.
A total of 211 patients who underwent TAVI with a balloon-expandable valve were included. BPD was performed after TAVI if paravalvular AR ≥ 2 was identified by transesophageal echocardiography. Clinical events and echocardiographic data were prospectively recorded, and median follow-up was 12 (6 to 24) months.
BPD was performed in 59 patients (28%), leading to a reduction in at least 1 degree of AR in 71% of patients, with residual AR <2 in 54% of the patients. The predictors of the need for BPD were the degree of valve calcification and transfemoral approach, with valve calcification volume >2,200 and >3,800 mm(3) best determining the need for and a poor response to BPD, respectively. Patients who underwent BPD had a higher incidence of cerebrovascular events at 30 days (11.9% vs. 2.0%, p = 0.006), with most (83%) events within the 24 h after the procedure occurring in patients who had BPD. No significant changes in valve area or AR degree were observed at follow-up in BPD and no-BPD groups.
BPD was needed in about one-fourth of the patients undergoing TAVI with a balloon-expandable valve and was successful in about one-half of them. A higher degree of valve calcification and transfemoral approach predicted the need for BPD. BPD was not associated with any deleterious effect on valve function at mid-term follow-up, but a higher rate of cerebrovascular events was observed in patients who had BPD.
Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2.
All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause.
A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival.
This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).
The advent of transcatheter aortic valve replacement (TAVR) is one of the most widely anticipated advances in the care of patients with severe aortic stenosis. This procedure is unique in many ways, one of which is the need for a multimodality imaging team-based approach throughout the continuum of the care of TAVR patients. Pre-procedural planning, intra-procedural implantation optimization, and long-term follow-up of patients undergoing TAVR require the expert use of various imaging modalities, each of which has its own strengths and limitations. Divided into 3 sections (pre-procedural, intraprocedural, and long-term follow-up), this review offers a single source for expert opinion and evidence-based guidance on how to incorporate the various modalities at each step in the care of a TAVR patient. Although much has been learned in the short span of time since TAVR was introduced, recommendations are offered for clinically relevant research that will lead to refinement of best practice strategies for incorporating multimodality imaging into TAVR patient care.
In an effort to define the gold standard for annular sizing for transcatheter aortic valve replacement (TAVR), we sought to critically analyze and compare the predictive value of multiple measures of the aortic annulus for post-TAVR paravalvular (PV) regurgitation and then assess the impact of a novel cross-sectional computed tomographic (CT) approach to annular sizing.
Recent studies have shown clear discrepancies between conventional 2-dimensional (2D) echocardiographic and CT measurements. In terms of aortic annular measurement for TAVR, such findings have lacked the outcome analysis required to inform clinical practice.
The discriminatory value of multiple CT annular measures for post-TAVR PV aortic regurgitation was compared with 2D echocardiographic measures. TAVR outcomes with device selection according to aortic annular sizing using a traditional 2D transesophageal echocardiography-guided or a novel CT-guided approach were also studied.
In receiver-operating characteristic models, cross-sectional CT parameters had the highest discriminatory value for post-TAVR PV regurgitation: This was with the area under the curve for [maximal cross-sectional diameter minus prosthesis size] of 0.82 (95% confidence interval: 0.69 to 0.94; p < 0.001) and that for [circumference-derived cross-sectional diameter minus prosthesis size] of 0.81 (95% confidence interval: 0.7 to 0.94; p < 0.001). In contrast, traditional echocardiographic measures were nondiscriminatory in relation to post-TAVR PV aortic regurgitation. The prospective application of a CT-guided annular sizing approach resulted in less PV aortic regurgitation of grade worse than mild after TAVR (7.5% vs. 21.9%; p = 0.045).
Our data lend strong support to 3-dimensional cross-sectional measures, using CT as the new gold standard for aortic annular evaluation for TAVR with the Edwards SAPIEN device.
This study sought to analyze multidetector computed tomography (MDCT) 3-dimensional aortic annular dimensions for the prediction of paravalvular aortic regurgitation (PAR) following transcatheter aortic valve replacement (TAVR).
Moderate or severe PAR after TAVR is associated with increased morbidity and mortality.
A total of 109 consecutive patients underwent MDCT pre-TAVR with a balloon expandable aortic valve. Differences between transcatheter heart valve (THV) size and MDCT measures of annular size (mean diameter, area, and circumference) were analyzed concerning prediction of PAR. Patients with THV malposition (n = 7) were excluded. In 50 patients, MDCT was repeated after TAVR to assess THV eccentricity (1 - short diameter/long diameter) and expansion (MDCT measured THV area/nominal THV area).
Moderate or severe PAR (13 of 102) was associated with THV undersizing (THV diameter - mean diameter = -0.7 ± 1.4 mm vs. 0.9 ± 1.8 mm for trivial to mild PAR, p < 0.01). The difference between THV size and MDCT annular size was predictive of PAR (mean diameter: area under the curve [AUC]: 0.81, 95% confidence interval [CI]: 0.68 to 0.88; area: AUC: 0.80, 95% CI: 0.65 to 0.90; circumference: AUC: 0.76, 95% CI: 0.59 to 0.91). Annular eccentricity was not associated with PAR (AUC: 0.58, 95% CI: 0.46 to 0.75). We found that 35.3% (36 of 102) and 45.1% (46 of 102) of THVs were undersized relative to the MDCT mean diameter and area, respectively. THV oversizing relative to the annular area was not associated with THV eccentricity or underexpansion (oversized vs. undersized THVs; expansion: 102.7 ± 5.3% vs. 106.1 ± 5.6%, p = 0.03; eccentricity: median: 1.7% [interquartile range: 1.4% to 3.0%] vs. 1.7% [interquartile range: 1.1% to 2.7%], p = 0.28).
MDCT-derived 3-dimensional aortic annular measurements are predictive of moderate or severe PAR following TAVR. Oversizing of THVs may reduce the risk of moderate or severe PAR.
Objectives:
Transcatheter aortic valve implantation (TAVI) has become an important therapeutic option for high-risk patients with severe aortic valve stenosis. Patient-prosthesis mismatch (P-PM) is an important determinant of morbidity and mortality after open aortic valve replacement. The objective of our study was to evaluate P-PM incidence and its impact on survival in a large cohort of patients treated with TAVI.
Methods and results:
We retrospectively analyzed transesophageal echocardiographic data of 278 consecutive patients (Society of Thoracic Surgeons score 18.5 ± 15.3, age 80 ± 8 years) who underwent transapical TAVI with Edwards Sapien valves between April 2008 and March 2011. Effective orifice area was calculated using the continuity equation and indexed with body surface area (iEOA). P-PM was stratified as severe (iEOA < 0.65 cm(2)/cm(2)) and moderate (iEOA, 0.65-0.85 cm(2)/m(2)). Midterm survival (up to 30 months) was analyzed by Kaplan-Meier curves and log-rank tests. There was no P-PM in 181 (65.1%) patients; moderate P-PM was found in 76 (27.3%) patients and severe P-PM in 21 (7.6%). Thirty-day survival was 96.0%, 97.3%, and 90.5%. The 3-month survival was 91%, 90%, and 66%, respectively (P = .0013). Combination of severe P-PM with peak pressure gradients greater than 10 mm Hg further reduced the 3-month survival to 48%. Additionally, mean survival time in patients with an ejection fraction less than 50% was significantly shorter than in patients with an ejection fraction greater than 50% (20.8 ± 1.5 vs 24.1 ± 0.8 months; P = .027).
Conclusions:
P-PM is found in patients undergoing transapical TAVI. Severe mismatch is accompanied by high early mortality, especially when combined with increased pressure gradients.
The percutaneously implanted Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA) consists of cusps mounted within a stent. The individual impact of the stent and cusps on transvalvular flow and its implications for the echocardiographic assessment of valve function have not been previously reported.
The study group consisted of 40 patients who underwent successful implantation with the SAPIEN valve. Pulsed Doppler was recorded with sample volumes immediately proximal to the stent (prestent), within the stent but proximal to the cusps (in-stent precusp), and distal to the cusps (in-stent postcusp). The Doppler velocity index and effective orifice area were calculated using both prestent and in-stent precusp velocities to represent "subvalvular" flow and continuous-wave recordings of the left ventricular outflow tract and aortic valve to represent postvalvular flow.
In all patients, there was flow acceleration at two levels: in-stent precusp and in-stent postcusp. The mean in-stent precusp peak velocities were significantly higher than the prestent values (1.5 ± 0.2 vs 1.0 ± 0.2 m/sec, P < .0001). Effective orifice area and Doppler velocity index calculated using the prestent versus in-stent precusp velocities were also significantly different (1.79 ± 0.34 vs 2.54 ± 0.46 cm(2), P < .0001, and 0.48 ± 0.12 vs 0.73 ± 0.13, P < .0001, respectively).
The SAPIEN valve demonstrates flow acceleration at two levels, representing contributions of both the stent and valve cusps to the total valve gradient. Failure to recognize this phenomenon may result in inappropriate selection of the in-stent precusp pulsed Doppler spectrum to represent "subvalvular" flow, thereby overestimating the effective orifice area and Doppler velocity index.
The first human transcatheter aortic valve implantation (TAVI) in 2002, and several subsequent single-center series, showed the feasibility of this new approach for the treatment of patients with severe aortic stenosis who were considered to be at very high or prohibitive surgical risk. More-recent multicenter registries have confirmed the safety and efficacy of this procedure, despite a very-high-risk patient profile. Moreover, the randomized, controlled PARTNER trial has confirmed both the superiority of TAVI over medical treatment in patients not considered to be candidates for standard surgical aortic valve replacement and the noninferiority of TAVI compared with surgical aortic valve replacement in high-risk patients. The hemodynamics of transcatheter valves are usually excellent, although residual paravalvular aortic regurgitation (usually trivial or mild) is frequent. Stroke, major vascular complications, and conduction disturbances leading to permanent pacemaker implantation remain among the most-concerning periprocedural complications of TAVI. Nevertheless, promising preliminary data exist for long-term outcomes following TAVI, 'valve-in-valve' TAVI for surgical prosthesis dysfunction, and for the treatment of lower-risk patients. Improvements in transcatheter valve technology, optimization of procedural and midterm results, and confirmation of long-term durability of transcatheter valve prostheses will determine the expansion of TAVI towards the treatment of a broader spectrum of patients.
The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term.
Although a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients.
The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010.
Survival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model.
Midterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year.
The objectives were to compare different Doppler echocardiographic methods for the measurement of prosthetic valve effective orifice area (EOA) following transcatheter aortic valve implantation (TAVI) and to determine the factors influencing the EOA of transcatheter balloon expandable valves.
Previous studies have used different methods for the measurement of the valve EOA following TAVI. Factors influencing the EOA of transcatheter valves are unknown.
A total of 122 patients underwent TAVI with the use of the Edwards-SAPIEN valve (Edwards Lifesciences, Irvine, California). The EOA was measured by transthoracic echocardiography at hospital discharge, 6 months and 1 year after TAVI with the use of 2 methods as described in previous studies. In Method #1 (EOA(1)), LVOT diameter (LVOTd) entered in the continuity equation was measured at the base of prosthesis cusps whereas, in Method #2 (EOA(2)), LVOTd was measured immediately proximal to the prosthesis stent.
The average EOA(2) (1.57 ± 0.41 cm(2)) was larger (p < 0.01) than the EOA(1) (1.21 ± 0.38 cm(2)). Accordingly, incidence of severe PPM (indexed EOA ≤0.65 cm(2)/m(2)) was 3-fold lower with the use of EOA(2) than with EOA(1) (9% vs. 33%; p < 0.001). Mean transprosthetic gradient correlated better (p = 0.03) with indexed EOA(2) (r = -0.70, p < 0.0001) than with indexed EOA(1) (r = -0.58, p < 0.0001). Intraobserver and interobserver variability were lower for EOA(2) compared to EOA(1) (intra: 5% vs. 7%, p = 0.06; inter: 6% vs. 14%; p < 0.001). Aortic annulus size was the sole independent determinant (p = 0.01) of prosthetic valve EOA(2). The average EOA varied from 1.37 ± 0.23 cm(2) for aortic annulus size <19 mm up to 1.90 ± 0.17 cm(2) for size >23 mm.
When estimating the EOA of Edwards-SAPIEN valves by Doppler-echocardiography, it is recommended to use the LVOT diameter and velocity measured immediately proximal to the stent. The main determinant of the EOA of transcatheter valves is the patient's annulus size and these valves provide excellent hemodynamics even in patients with a small aortic annulus.
This study examined the mid-term hemodynamic and clinical impact of prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable valves.
PPM can be observed after aortic valve surgery. However, little is known about the incidence of PPM in patients undergoing TAVI.
Echocardiography and clinical assessment were performed in 165 patients at baseline, before hospital discharge, and at 6 months after TAVI. PPM was defined as an indexed effective orifice area ≤0.85 cm(2)/m(2).
Thirty patients (18.2%) showed PPM before hospital discharge. At baseline, patients with PPM had a larger body surface area (1.84 ± 0.18 m(2) vs. 1.73 ± 0.18 m(2), p = 0.003) and a greater severity of aortic stenosis (indexed valve area 0.35 ± 0.09 cm(2)/m(2) vs. 0.40 ± 0.10 cm(2)/m(2), p = 0.005) than patients without PPM. Patients with PPM demonstrated a slower and smaller reduction in mean transaortic gradient, limited left ventricular (LV) mass regression, and left atrial volume reduction over 6 months compared with patients without PPM. LV filling pressure, measured by E/e', tended to remain elevated in patients with PPM. Importantly, a higher proportion of patients with PPM did not improve in New York Heart Association functional class compared with patients without PPM (36.7% vs. 1.5%, p < 0.001), although major adverse valve-related and cardiovascular events did not differ between the 2 groups.
PPM may be observed after TAVI and when present may be accompanied by less favorable changes in transvalvular hemodynamics, limited LV mass regression, persistent elevated LV filling pressure, and less improvement in clinical functional status.
Location of aortic valve calcium (AVC) can be better visualized on contrast-enhanced multidetector row computed tomography. The present evaluation examined whether AVC severity and its location could influence paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation. A total of 79 patients (age 80 ± 7 years, 49% men) with preprocedural multidetector row computed tomography were included. Volumetric AVC quantification and its location were assessed. Transesophageal echocardiography was performed to assess the presence and site of AR after transcatheter aortic valve implantation. Receiver operating characteristic curves were generated to evaluate the usefulness of AVC in determining paravalvular AR at a specific site. Postprocedural AR of grade 1 or more was observed in 63 patients. In most patients (n = 56, 71%), AR was of paravalvular origin. Calcium at the aortic wall of each valve cusp had the largest area under the curve (0.93, p <0.001) in predicting paravalvular AR at the aortic wall site compared to calcium at the valvular edge or body (area under the curve 0.58 and 0.67, respectively). Calcium at the valvular commissure was better than calcium at the valvular edge (area under the curve 0.94 vs 0.71) in predicting paravavular AR originating from the corresponding commissure. In conclusion, contrast-enhanced multidetector row computed tomography can be performed to quantify AVC. Both AVC severity and its exact location are important in determining paravalvular AR after transcatheter aortic valve implantation.
Significant aortic regurgitation (AR) is rare following surgical aortic valve replacement and has been associated with worse outcome. Following transcatheter aortic valve implantation (TAVI), AR is common, but little is known about its determinants and its effect on clinical outcome.
To evaluate early outcome and risk factors possibly associated with AR after TAVI.
Data were analysed from 690 patients with severe aortic stenosis treated with TAVI enrolled in the prospective multicentre German transcatheter aortic valve interventions registry. The occurrence of AR was evaluated angiographically after device deployment and removal of the catheter and guidewire. Significant AR was defined as AR≥2/4.
The study population's mean age was 81.4±6.3 years and men represented 44%. The mean logistic Euroscore was 20.4±13.1%. Overall, 84% of patients received the Medtronic CoreValve system and 16% received the Edwards Sapien valve. Significant AR occurred in 119 patients (17.2%). Factors independently associated with significant AR were aortic valve area (adjusted OR=0.10), annulus measurement by transoesophageal echocardiography (adjusted OR=1.94), male gender (adjusted OR=1.80), cardiogenic shock (adjusted OR=1.94) and renal failure (adjusted OR=0.53). In-hospital death rates were significantly higher in patients with significant AR than in those with no/mild AR (15.1% vs 6.7%, OR=2.50, 95% CI 1.37 to 4.55), as were rates of low cardiac output (20% vs 4.4%) and respiratory failure (16.5% vs 7.1%). Using multivariate analysis, the presence of post-procedural AR≥2/4 remained a strong independent predictor of in-hospital death (adjusted OR=2.43, 95% CI 1.22 to 4.85).
Significant AR after TAVI is common and is associated with increased in-hospital mortality. Long-term follow-up is critical to further define the impact of residual AR on clinical outcome. Until these data become available, every effort should be made to prevent and treat this complication.
A prosthesis-patient mismatch (PPM) is present when the prosthetic valve is too small in relation to the patient's body size. The purpose of the present study was to investigate the frequency of PPM after the implantation of the Medtronic CoreValve System, and its relation to the clinical outcome. The indexed effective orifice area (EOA) was measured in 74 patients with symptomatic severe aortic stenosis, who had undergone successful transcatheter aortic valve implantation with the Medtronic CoreValve System, at baseline and discharge. PPM was defined as severe (indexed EOA <0.65 cm(2)/m(2)) or moderate (indexed EOA 0.65 to 0.85 cm(2)/m(2)). The indexed EOA increased from 0.35 +/- 0.13 to 0.97 +/- 0.34 cm(2)/m(2) after transcatheter aortic valve implantation (p <0.001) and was accompanied by significant clinical improvement. Severe and moderate PPMs were found in 16% and 23% of patients, respectively. Patients with severe PPM were more symptomatic and had a smaller indexed EOA at baseline than those with moderate or no PPM (0.28 +/- 0.09 vs 0.36 +/- 0.12 cm(2)/m(2), p <0.05). Functional status and mortality at 30 days and 6 months was not significantly different between the patients with severe PPM and those with moderate or no PPM. In conclusion, the indexed EOA increased significantly after transcatheter aortic valve implantation. Severe PPM was observed in 16% of the patients and was not associated with the clinical outcome.
Stent deployment within stenotic native aortic valves has been shown to depend on valve anatomy (presence of bicuspid valve or not). This study investigated the influence of stent stiffness on stent expansion.
The study included 88 patients with severe aortic stenosis, and 36 (41%) had bicuspid aortic valves. Two self-expandable stents with different radial force were deployed intraoperatively inside stenotic aortic valves before surgical aortic valve replacement. Patients in group B received a stent stiffer than that in group A. Effect of stent radial force on stent shape and incidence of paraprosthetic gaps was determined.
Noncircular stent deployment was more frequent in bicuspid (81%) than in tricuspid aortic valves (33%; p < 0.0001). Increasing stent radial force significantly improved stent shape in tricuspid valves (circular shape: 60% in group A vs 93% in group B; p = 0.005) but had no significant effect in bicuspid valves (12.5% in group A vs 27% in group B;p = 0.394). Likewise, incidence of paraprosthetic gaps was significantly reduced with the stiff stent in tricuspid valves (64% in group A vs 30% in group B, p = 0.025) but not in bicuspid valves (50% in group A vs 60% in group B; p= 0.722).
Increased stent radial force had a favorable effect on stent deployment in tricuspid but not in bicuspid valves. In bicuspid valves, stent maldeployment was constant. Leaflet distortion of implanted valved stent might be a concern in this setting.
The aim of this study was to assess the influence of amount and distribution of calcifications of the aortic valve and the left ventricular outflow tract on the acute procedural outcome of patients undergoing transcatheter aortic valve implantation (TAVI).
Transcatheter aortic valve implantation is a new percutaneous technique especially for elderly, high-risk patients with significant aortic valve stenosis (AS). After TAVI, post-interventional paravalvular aortic regurgitations (PAR) can occur, which is believed to be related partially to valve calcifications.
We prospectively analyzed 100 symptomatic patients with severe AS scheduled for TAVI with the CoreValve ReValving (Medtronic, Minneapolis, Minnesota) prosthesis. In all patients, a native and contrast-enhanced multislice cardiac computed tomography was performed pre-interventionally. Calcification load of the valve and the adjacent outflow tract was estimated by the Agatston Score (AgS), and the amount and distribution of calcification was semi-quantitatively assessed and graded on a 1 to 4 scale (device "landing zone" calcification score [DLZ-CS]). Aortography was performed to evaluate the PAR pre-interventionally, after initial device release (PAR0) and after termination of the procedure (PAR1). Transthoracic echocardiography was performed 2 weeks after implantation (PAR2).
The AgS and DLZ-CS showed a significant correlation with the grade of PAR0 (AgS: r = 0.329, p = 0.001; DLZ-CS: r = 0.356, p < 0.001), PAR1 (AgS: r = 0.254, p = 0.011; DLZ-CS: r = 0.240, p = 0.016), and PAR2 (AgS: r = 0.341, p = 0.001; DLZ-CS: r = 0.300, p = 0.002). Both scores (AgS and DLZ-CS) showed a significant positive correlation (r = 0.858, p < 0.001).
Calcification in the CoreValve device "landing zone" shows a significant positive correlation to PAR after TAVI. Furthermore, the need for "second maneuvers" (i.e., post-dilation after initial device release) can be predicted by these calcification scores (AgS and DLZ-CS).
Prosthesis-patient mismatch (P-PM) is an important determinant of morbidity and mortality following open aortic valve replacement. The aims of this study were to report its incidence and determinants following transcatheter aortic valve implantation (TAVI) with the Corevalve bioprosthesis, which have-thus far-not been described.
Patients with severe calcific aortic stenosis received TAVI with the Corevalve bioprosthesis via transfemoral route. Following TAVI, moderate P-PM was defined as indexed aortic valve effective orifice area (AVAi) < or =0.85 cm(2)/m(2) and severe P-PM as AVAi < or =0.65 cm(2)/m(2). Clinical, echocardiographic, and procedural factors relating to P-PM were studied. Optimal device position was defined on fluoroscopy as final position of the proximal aspect of the Corevalve stent frame 5-10 mm below the native aortic annulus. Between January 2007 and January 2009, 50 consecutive patients underwent TAVI in a single centre with the Corevalve bioprosthesis. Mean age was 82.8 years (SD 5.9; 70-93) and 48% were male. P-PM occurred in 16 of 50 cases (32%). Optimal position was achieved in 50% of cases. P-PM was unrelated to age, annulus size, LVOT size, Corevalve size, aortic angulation, ejection fraction, and sex. It was inversely correlated to optimal position (Spearman rho r = -0.34, P = 0.015). Those with optimal positioning had a 16% incidence of P-PM relative to 48% of those with suboptimal positioning (Pearson chi(2) P = 0.015).
The incidence of P-PM following TAVI with the Corevalve bioprosthesis is compared favourably with that seen after AVR with conventional open stented bioprostheses and its occurrence is influenced by device positioning.
Valve replacement remains common in the adult patient despite advances in valve repair. While a physical examination can alert the clinician to the presence of valve dysfunction, diagnostic methods are often needed to assess the function of the prosthesis. Echocardiography with Doppler is currently the method of choice for non-invasive evaluation of prosthetic valves. A recently published "Guidelines and Standards" document from the American Society of Echocardiography (ASE) offers a review of echocardiographic and Doppler techniques used in assessing prosthetic valves and, for the first time, provides general recommendations for evaluating prosthetic valve function. The guidelines have been endorsed by prominent national and international professional health organizations including the American Heart Association, the American College of Cardiology, and the European Association of Echocardiography. I was honoured to chair the ASE writing group of international experts on prosthetic valves and will review the salient features of these guidelines, particularly pertaining to the commonly implanted valves in the aortic and mitral positions.
This study was designed to evaluate the effect of valve prosthesis-patient mismatch (PPM) on late survival after aortic valve replacement (AVR) and to determine if this effect is modulated by patient age, body mass index (BMI), and pre-operative left ventricular (LV) function.
We recently reported that PPM is an independent predictor of operative mortality after AVR, particularly when associated with LV dysfunction.
The indexed valve effective orifice area (EOA) was estimated in 2,576 patients having survived AVR and was used to define PPM as not clinically significant if it was >0.85 cm(2)/m(2), as moderate if >0.65 and < or =0.85 cm(2)/m(2), and severe if < or =0.65 cm(2)/m(2).
After adjustment for other risk factors, severe PPM was associated with increased late overall mortality (hazard ratio [HR]: 1.38; p = 0.03) and cardiovascular mortality (HR: 1.63; p = 0.0006) in the whole cohort. Severe PPM was also associated with increased overall mortality in patients <70 years old (HR: 1.77; p = 0.002) and in patients with a BMI <30 kg/m(2) (HR: 2.1; p = 0.006), but had no impact in older patients or in obese patients. Moderate PPM was a predictor of mortality in patients with LV ejection fraction <50% (HR: 1.21; p = 0.01), but not in patients with preserved LV function.
Moderate PPM is associated with increased late mortality in patients with LV dysfunction, but with normal prognosis in those with preserved LV function. Notwithstanding the previously demonstrated deleterious effect of severe PPM on early mortality, this factor appears to increase late mortality only in patients <70 years old and/or with a BMI <30 kg/m(2) or an LV ejection fraction <50%.
Prosthesis-patient mismatch (PPM) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size. Its main haemodynamic consequence is to generate higher than expected gradients through normally functioning prosthetic valves. This review updates the present knowledge about the impact of PPM on clinical outcomes. PPM is common (20-70% of aortic valve replacements) and has been shown to be associated with worse haemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival. Moreover, as opposed to most other risk factors, PPM can largely be prevented by using a prospective strategy at the time of operation.
Recommendations for evaluation of prosthetic valves with echocardiography and Doppler ultrasound.
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Recommendations for evaluation of prosthetic valves with echocardiography and Doppler ultrasound
- Zoghbi