No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
The role of echocardiography in transcatheter aortic valve implantation
Abstract
Transcatheter aortic valve implantation (TAVI) is an effective and less invasive treatment for the increasing population of individuals with severe aortic stenosis (AS). Echocardiography is crucial in the assessment of AS patients from pre- to post-procedure. Transthoracic echocardiography (TTE) may be used to assess patient suitability for TAVI, as well as evaluate the severity of AS, the aortic valve complex, aortic valve morphology, mitral regurgitation (MR), and left ventricular function. Transesophageal echocardiography (TEE) is usually used as an intra-procedural monitoring tool to provide feedback during the procedure, to assess prosthetic valve function, and to detect complications rapidly before and after balloon aortic valvuloplasty (BAV) or transcatheter heart valve (THV) deployment. In this review, the role of echocardiography in the pre-, intra-, and post-TAVI procedure periods is described in detail.
... A common complication of TAVR is Aortic regurgitation (AR), with unknown etiologies and clinical effects. According to the form of evaluation (angiography vs. echocardiography, quantitative vs. semiquantitative), AR incidence following TAVR ranges from 40% to 67% [6,7] for negligible to mild cases and from 7% to 20% for moderate to extreme cases. Valve regurgitation that is clinically significant following TAVR is poorly characterized and is a matter of critical concern at the moment. ...
... Aortic regurgitation (AR) is a common TAVR complication. AR incidence post-TAVR ranges from 40% to 67% and from 7% to 20% for trivial to mild and for moderate to severe leaks, respectively [6,7]. it would be of high clinical relevance to determine the predictive Our study reported a smaller size of the prosthesis lead to improper apposition on the native valve, and large aortic annulus was important in prediction of PVR post TAVI. A smaller annulus size is considered defensive against PVL presence, which is explained by the annulus greater congruence with THV. ...
Background: Aortic regurgitation (AR), which has ill-defined predictors and an unknown long-term influence on outcomes, is a significant transcatheter aortic valve replacement (TAVR) constraint. Objective: this research aimed to assess the prevalence, identify predictors, and evaluate the outcomes of aortic regurgitation following trans catheter aortic valve implantation (TAVI). 1. To calculate the prevalence of aortic regurgitation in elderly patients receiving trans catheter aortic valve implantation who have severe symptomatic aortic stenosis. 2. To determine aortic regurgitation risk factors after trans catheter aortic valve implantation. Methods: From November 2017 to November 2020, this prospective observational study was done in the National Heart Institute on severe aortic valve stenosis patients above 65 years who were candidates for aortic valve replacement from the outpatient department. Results: LVEF significantly improved. Compared to before TAVI (55.08 ± 9.71), LVEF elevated to 58.9 ± 8.8 (P<0.001). Twenty-five patients (83.3%) showed class III/IV, four patients (13.3%) showed class II, and one patient (3.3%) showed class I before TAVI. While after TAVI, three patients (10%) only showed NYHA class III/IV, six patients (20 %) in class II, and 21 patients (70%) improved to be in class I. The left ventricular mass index mean was 158 ±32.37 before TAVI and 133.50 ±21.96 after TAVI (p<0.001). Compared to before TAVI (0.75 ± 0.2), mean aortic valve area was improved to 2.0 ± 0.2 following TAVI (P<0.001). A significant reduction in the mean pressure gradient from 47 ± 11.08 mmHg across the native valve prior to TAVI to 10.28 ± 3.21 mmHg across the prosthetic valve following TAVI (P <0.001). Expert commentary: The clinical and results of TAVR devices were clearly outlined in literature study. The study showed a high incidence of pacemaker implantation with Core valve and aortic regurgitation. This information strongly supports the need for a randomized trial with sufficient power to compare the most recent self-expandable valve generation to balloon expandable valves. In the 2019 PARTNER 3 prospective randomized trial, it was discovered that, when compared to surgical management, low-risk patients (defined as STS 4%) had a lower risk of the composite outcome of stroke, death, and rehospitalization at 1 year. Additionally, it was shown that TAVR had a lower risk of stroke and required less time in the hospital (3 days as opposed to 7, P0.001) than surgery [1]. In addition, despite an elevated permanent pacemaker implantation rate, the 2019 Medtronic Evolut Transcatheter Aortic Valve Replacement revealed no inferiority for composite all-cause stroke and death, as well as a statistically significant decrease in the rates of life-threatening bleeding, acute kidney injury and atrial fibrillation, compared with SAVR at 30 days following the procedure [2]. Conclusion: According to the study in high-risk patients with severe symptomatic aortic stenosis, TAVI is alternative, viable, safe, and successful therapy compared to traditional open-heart surgery.
... І сторичною подією, від якої розпочинається відлік формування нового підходу в лікуванні пацієнтів з вираженим аортальним стенозом (АС), є вперше опубліковані результати успішної імплантації біопротеза, вбудованого в каркас стента [8]. У 2002 р. ...
... ст. [8]. Показник швидкості, розрахований як відношення швидкості на виносному тракті лівого шлуночка (ВТЛШ) та швидко-сті на аортальному клапані, також може використовуватися для визначення ступеня АС (при 0,25 -виражений). ...
The aim – to systematize information on key features of echocardiographic evaluation of transcatheter aortic valve implantation (TAVI) procedure stages and their effectiveness in cardiac surgery, in patients with severe aortic valve stenosis.Materials and methods. We initiated a single-center clinical study to evaluate the XPand device and initial analysis of the primary results was performed. Patients met the inclusion criteria underwent a full range of examinations and TAVI procedures using the XPand device. The key parameters for echocardiographic examination in TAVI, which influence the formation of further procedure strategy, have been determined for the cardiac surgeon.Results and discussion. Based on the determined echocardiographic parameters, we obtained the primary outcomes of TAVI XPand in patients (n=7), the result of implantation was good. Minimal paravalvular insufficiency absence was found in 71.5 % of patients and minimal insufficiency in 14,5 %. In one patient to moderate insufficiency was observed. There was a statistically significant improvement in the ejection fraction (p<0.05) and a decrease in the mean gradient at the aortic valve (p<0.01).Conclusions. Echocardiographic parameters at all TAVI stages in patients over 75 years allow to control the implementation of the procedure and to improve the immediate post procedural outcome. The first experience of using the novel device for transcatheter implantation of the XPand aortic valve prosthesis confirms its effectiveness and safety in elderly patients with severe aortic stenosis.
... The use of fusion techniques to overlay 3D-TEE and fluoroscopy can outline the annulus with higher precision [12,16]. It is critical to consider that proper positioning and deployment will depend on the type of device used (balloon-expandable, self-expanding, and mechanically expanded), and each case should be tailored according to the valve size, the characteristics and dimensions of the aortic root, and the location of the left main coronary artery [15,17]. ...
Cardiac structural and valve interventions have remained surgical procedures for several decades. The ability to directly visualize the region of interest during surgery made imaging of these structures pre- and postsurgery a secondary tool to compliment surgical visualization. The last two decades, however, have seen rapid advances in catheter-based percutaneous structural heart interventions (SHIs). Due to the “blind” nature of these interventions, imaging plays a crucial role in the success of these procedures. Fluoroscopy is used universally in all percutaneous cardiac SHIs and helps primarily in the visualization of catheters and devices. However, success of these procedures requires visualization of intracardiac soft tissue structures. Due to its portable nature and rapid ability to show cardiac structures online, transesophageal echocardiography (TEE) has become an integral tool for guidance for all percutaneous SHI. Transcatheter aortic valve replacement—one of the earliest catheter-based procedures—while initially dependent on TEE, has largely been replaced by preprocedural cardiac CT for accurate assessment of valve sizing. Developments in echocardiography now allow live three-dimensional (3D) visualization of cardiac structures mimicking surgical anatomy during TEE. Besides showing actual 3D intracardiac structures, 3D-TEE allows visualization of the interaction of intracardiac catheters and devices with soft tissue cardiac structures, thereby becoming a “second pair of eyes” for the operator. Real-time 3D-TEE now plays an important role complementing multiplane two dimensional and biplane TEE during such interventions. In this review, we discuss the incremental role of 3D-TEE during various SHIs performed today.
... Moreover, calcifications within the aortic complex [left ventricle outflow tract (LVOT), aortic annulus (AA), aortic valve cusps, sinus of valsalva, sinotubular junction] should be identified as predictive of post-procedural AR, annular rupture, root perforation, aortic wall hematoma, and dissection. 38 In TAVI, correctly selecting the prosthesis size is paramount as oversizing the transcatheter aortic valve can result in aortic annular rupture, whereas undersizing can lead to increased paravalvular leak, or even worse, valve migration. 39 Although CT represents the primary method of choice for prosthesis sizing based on AA measurements, in patients with contraindication to CT, 3D-TTE or transesophageal (TEE) measurement of the AA, defined as a virtual ring with three anatomical anchors at the nadir of each aortic leaflet 40 can represent an alternative method for prosthesis sizing. ...
Non-invasive cardiovascular imaging owns a pivotal role in the preoperative assessment of patients for transcatheter aortic valve implantation (TAVI), providing a wide range of crucial information to select the patients who will benefit the most and have the procedure done safely.
Although advanced cardiac imaging with cardiac computed tomography is routinely used for a detailed anatomic assessment before TAVI, echocardiography remains the first imaging modality to assess aortic stenosis severity and to provide essential functional information.
This document results from the collaboration between the Italian Society of Cardiology (SIC) and the Italian Society of Medical and Interventional Radiology (SIRM), aiming to produce an updated consensus statement about the pre-procedural imaging assessment in patient for TAVI. The writing committee is composed of radiologists and cardiologists, experts in the field of cardiac imaging and structural heart diseases.
Part 1 of the document, after a brief overview of the clinical indication and basic technical aspects of TAVI, will focus on the role of echocardiography in TAVI pre-procedural planning.
... TTE has been the first-line for imaging in VHD due to its inexpensiveness, simplicity and availability. It provides real-time hemodynamic information, and can be employed with exercise or dobutamine stress testing (1)(2)(3)(4). It has decent spatial resolution, providing detailed images of valvular structures for determining the etiology of the disease. ...
In terms of valvular heart disease (VHD) imaging, transthoracic echocardiography (TTE) is the preferred first choice because of its widespread availability. Other modalities, such as transesophageal echocardiography, computed tomography and magnetic resonance imaging, have played a supplementary role in diagnosis for severity, deciding the timing/type of treatment, detection of post procedural complications, and prognostic predictions. However, there are few consensuses on how to employ these modalities, as the evidence is not extensive as that for TTE. On the other hand, these imaging modalities also have their own unique strengths. If employed properly, these modalities have the potential to play a more prominent role in clinical decision making. In this review, we focus on the potential, limitations and application of current imaging modalities in the management of left-sided VHD.
... The role of pre-interventional work-up with computed tomography and echocardiography has been discussed in detail before [23,24]. In regard to the intraprocedural TEE guidance, available evidence from previous trials does not support its routine use. ...
Introduction:
Severe aortic stenosis (AS) is an ever-growing healthcare problem in ageing populations. Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of AS. However, TAVI in patients who have undergone mitral valve replacement (MVR) is associated with increased risk of mitral valve damage. Limited data exist on TAVI in patients with AS who underwent MVR in the past.
Aim:
To retrospectively assess the clinical characteristics, detailed echocardiographic and computed tomography measurements, procedural and in-hospital outcome as well as any valve intervention or major adverse cardiovascular events according to VARC-2 criteria at follow-up of patients with a history of MVR, who underwent TAVI.
Material and methods:
Seventeen patients with a history of mitral valve operation, in whom TAVI was performed between 2010 and 2018, were identified. Of these, 15 underwent previous MVR.
Results:
Overall, TAVI resulted in a decrease of mean transaortic gradient by 38.3 ±14 mm Hg (p < 0.001) and a decrease of maximal transaortic gradient by 58.6 ±27.6 mm Hg (p < 0.001). A successful immediate result was obtained in 14 (93.3%) patients. One tamponade occurred during TAVI, which was successfully treated with pericardiocentesis. Post-procedurally, no significant changes in transmitral gradients or mitral regurgitations were observed. Two patients died after hospital discharge, one due to possible internal bleeding and the other due to infection.
Conclusions:
TAVI in patients after MVR is feasible. Meticulous preinterventional echocardiographic and computed tomography planning is essential. Although recommended in previous reports, TEE guidance may not necessarily be obligatory during the procedure.
... TF-TAVI has emerged as a promising, minimally invasive alternative for high-risk patients with severe aortic stenosis (10,11). We are a high-volume centre for TAVI procedures, and our interventional cardiologists rely on the anaesthesiologists for echocardiography during TAVI and other structural heart procedures. ...
Abstract
Objective: Surgical aortic valve replacement requires a comprehensive transoesophageal echocardiography (TEE) assessment before and
after the intervention by cardiac anaesthesiologists. For patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI),
TEE is not routinely used. We started using transthoracic echocardiography (TTE) as a diagnostic and monitoring modality during TF-TAVI
procedures. The aim of this study is to examine the usefulness of TTE before and after TF-TAVI. We hypothesised that TTE can serve as a
screening tool in TF-TAVI patients and help rule out significant paravalvular leaks (PVLs), and serve as a monitoring tool.
Methods: A retrospective, observational study of 24 patients who underwent TF-TAVI with perioperative TTE over a 3-month period was
conducted. Intraoperatively, two TTE examinations were performed. The first was a baseline pre-procedural TTE examination after anaesthetic
induction, and the second was performed after TAVI valve implantation. Both pre- and post-procedural examinations included five
focused TTE views. PVLs were graded as none, non-significant (trace or mild) or significant (moderate or severe).
Results: The average age and median body mass index of the patients were 82 years and 28.5 kg m-2, respectively. The average time recorded
for the pre- and post-TAVI TTE examinations were approximately 4 and 5.5 min, respectively. Non-significant PVL was detected in 6 (25%)
patients, and no leak was detected in 18 (75%) patients.
Conclusion: A focused TTE examination was found to be a useful adjunct during TF-TAVI for a cardiac anaesthesiologist in the absence
of TEE, and useful in ruling out significant PVLs.
Rationale and objectives:
Aortic stenosis (AS) is one of the most common valvular heart disease. Symptomatic AS is associated with a high mortality rate which prompts fast intervention. The introduction of transcatheter aortic valve replacement (TAVR) has drastically improved the outcome of high surgical risk for mortality patients with severe AS. However, this procedure requires the employment of multimodality imaging in the pre-procedural planning, intra-procedural optimization, and post-procedural follow-up stages. This also requires an accurate understanding of the indications, measurements, strength, and limitations of each imaging modality during the different TAVR stages.
Conclusion:
In this review, we aim to outline to radiologists the evidence-based approach and indications of different imaging modalities through the pre, peri, and post TAVR stages.
Background: Monitored anesthesia care (MAC) has become more widely used during transcatheter aortic valve replacement (TAVR) to avoid the complications of general anesthesia (GA).
Methods: We included consecutive patients who underwent transfemoral-TAVR at our institution between January 2012 and April 2017. We compared outcomes with GA versus MAC.
Results: Of 998 patients, MAC was used in 43.9%. MAC was associated with shorter procedural time (96.9 ± 30.9 vs. 135 ± 64.6 mins; p < .001), fluoroscopy time (20.4 ± 8.9 vs. 29±18.7 mins; p<.001), lower contrast volume (45.5±27 vs. 60.4±43cc; p < .001), and decreased radiation exposure (12,869 ± 8,099 vs. 20,630 ± 16,276 cGy- cm2; p < .001). Patients who underwent MAC had a briefer median (IQR) intensive care unit stay [23.3 (21–24) vs. 23.4 (20.8–26) hrs; p < .001], and hospital stay [2 (2, 3) vs. 3 (2–6) days; p < .001], and were more frequently discharged to home (93.4% vs. 82.9%; p < .001). MAC was associated with lower mortality at 30 days (0.5% vs. 2.9%; log-rank p = .012; adjHR 0.22, 95% CI 0.06–0.82; p = .024), but not at 1 year (11.7% vs. 14.6%; log-rank p = .157) or 3 years (36.8% vs. 38.4%; log-rank p = 0.433). There were no differ- ences in major adverse cardiac and cerebrovascular events (MACCE) at either 30 days (4.6% vs. 9.3%; log-rank p = .14) or 1 year (21.1% vs. 21.5%; log-rank p = .653). Similar findings were seen among patients who received newer-generation SAPIEN-3 valves. Conclusion: Utilizing MAC and omitting intraprocedural transesophageal echocardi- ography during TAVR seems to be more efficient without compromising safety.Better TAVR outcomes can be achieved with newer generation valves without needing GA.
KEYWORDS
conscious sedation, GA, general anesthesia, MAC, monitored anesthesia care, TAVR
Catheter-induced mitral regurgitation (MR) caused by mitral papillary muscle rupture can be a fatal complication of transcatheter aortic valve implantation (TAVI). We report a case involving an 89-year-old man who presented with symptomatic severe aortic stenosis. In addition, preoperative echocardiography showed accessory mitral valve tissue. Although moderate MR developed immediately after TAVI, severe MR caused by anterolateral papillary muscle rupture occurred 3 months after TAVI. As only a few case series have been published, our case report adds to the evidence base for this treatment strategy.
Introduction
Indications for transcatheter aortic valve replacement (TAVR) are progressively extending to younger and lower risk patients. In this scenario, minimizing periprocedural complications and optimizing procedural result are both crucial to achieve an excellent long-term outcome.
Areas covered
In this review, we summarize the main strategies that can be adopted before, during, and after TAVR to predict and prevent complications, to optimize procedural results and ultimately improve outcomes, with an emphasis on more recent evidence, new devices, and new techniques.
Expert opinion
In the next future TAVR will probably represent the first treatment option for patients affected by aortic valve stenosis who are candidates to receive a biological valve. Continuous refinement of TAVR devices has been key to allow safer and most effective procedures and further progress is expected. Development of new techniques and devices, such as ultrasound-guided puncture and intravascular lithotripsy, will expand safety and eligibility to transfemoral procedures. Effective preemptive measures for coronary occlusion have been developed. Open issues include cerebral protection, re-access to coronary arteries, post-procedural management, and therapy.
With increasing age valvular heart disease is among the most frequent diseases of the heart. Relevant valvular disease impairs not only the long-term prognosis but also physical resilience, activities of daily living and the quality of life. In cases of middle to high-grade symptomatic cardiac defects, valve replacement or valve reconstruction is still the surgical procedure of choice; however, in recent years the transcatheter percutaneous aortic valve replacement (TAVI) procedure has become more prominent for the most frequent defect, aortic valve stenosis. This article provides an overview of the aftercare and rehabilitation of patients following a TAVI intervention.
Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement in selected patients with severe symptomatic aortic stenosis (AS) and high surgical risk. The planning and follow-up of TAVI requires an array of imaging techniques, each has advantages and limitations. Echocardiography and multidetector computer tomography (MDCT) have established applications in patient selection and procedure guidance, but are limited in some patients. TAVI applications of cardiovascular magnetic resonance imaging (CMRI) are emerging. CMRI can provide the structural and functional imaging details required for TAVI procedure in away comparable or superior to that obtained by echocardiography and MDCT combined. In this review, we look at the continuously evolving role of CMRI as a complimentary or an alternative to more established imaging techniques and address the advantages and disadvantages of CMRI in this setting. We discuss the role of CMRI in selecting anatomically suitable patients for the TAVI procedure and in the post-TAVI follow-up with particular emphasis on its applications for assessing AS severity and haemodynamic impact, vascular imaging for TAVI access route, quantification of paravalvular leaks and LV remodelling in the post TAVI setting as well as providing imaging biomarkers tool for AS risk-stratification.
Objectives
To determine the effect of introducing several procedural refinements of transfemoral transcatheter aortic valve implantation (TAVI) on clinical outcomes and costs.
Design
Retrospective analysis comparing two consecutive 1-year periods, before and after the introduction of procedural refinements.
Setting
Tertiary hospital aortic valve programme.
Participants
Consecutive patients undergoing transfemoral TAVI treated between April 2014 and August 2015 using the initial setup (n=70; control group) or between September 2015 and August 2016 after the introduction of procedural refinements (n=89).
Interventions
Introduction of conscious sedation, percutaneous access and closure, omission of transoesophageal echocardiography during the procedure, and an early discharge procedure.
Outcome measures
Procedural characteristics, complications and outcomes; length of stay in intensive care unit (ICU) and hospital; hospital-related direct costs associated with TAVI.
Results
There were no statistically significant differences in the incidence of complications or mortality between the two groups. The mean length of stay in the ICU was significantly shorter in the procedural-refinement group compared with the control group (5.1 vs 57.2 hours, p<0.001), as was the mean length of hospital stay (4.7 vs 6.6 days, p<0.001). The total cost per TAVI procedure was significantly lower, by £3580, in the procedural-refinement group (p<0.001). This was largely driven by lower ICU costs.
Conclusions
Among patients undergoing transfemoral TAVI, procedural refinement facilitated a shorter stay in ICU and earlier discharge from hospital and was cost saving compared with the previous setup.
Background
A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation.
Methods
We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]).
Results
Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P=0.01 in the clinical trial; and 0% and 29%, respectively, P=0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P=0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P=0.007).
Conclusions
Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation. (Funded by St. Jude Medical and Cedars–Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.)
Background
Real-time three-dimensional transthoracic echocardiography (3DTTE) has been developed and provides detailed 3D information, noninvasively. However, the accuracy and usefulness of 3DTTE in the evaluation of aortic root geometry are still not clear.
Methods
2DTTE and 3DTTE were performed in 161 patients with various cardiac diseases. Multidetector computed tomography (MDCT) was performed in 35 of the 161 patients. The diameters and areas of the aortic annulus were evaluated by these three methods and compared. To evaluate the shape of the aortic annuli, eccentricity index (EI) (1 − minimum diameter/long-axis diameter) were calculated.
Results
Maximum dimensions of the aortic annulus measured by MDCT were significantly larger than those by 3DTTE and 2DTTE. The aortic annular areas measured by MDCT and 3DTTE were significantly larger than areas by 2DTTE. A good correlation (r = 0.85) was observed between the areas obtained by 3DTTE and MDCT; however, the correlation between the values by 2DTTE and MDCT was rough (r = 0.44). EI values in 46 % of the patients were greater than 0.1, i.e., the aortic annulus was elliptical.
Conclusion
The images obtained by 3DTTE provided accurate values of the aortic annular area, which were equal to the values measured by MDCT. 3DTTE is a useful method to evaluate the aortic annular geometry.
To evaluate the main baseline and procedural characteristics, management and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO).
Very few data exist on CO following TAVI.
This multicenter registry included a total of 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, gender, prior CABG, transcatheter valve type and size).
Baseline and procedural variables associated with CO were older age (p<0.001), female sex (p<0.001), no prior CABG (p=0.043), the use of a balloon-expandable valve (p=0.023), and prior surgical aortic bioprosthesis (p=0.045). The left coronary artery (LCA) was the one most commonly involved (88.6%). The mean LCA ostia height and sinus of Valsalva (SOV) diameters were lower in patients with obstruction compared to matched controls (10.7±0.4mm vs. 13.3±0.3mm, OR: 2.17, 95%CI 1.62-2.90, and 28.3±0.8mm vs. 31.3±0.6mm, OR: 1.37, 95%CI 1.13-1.66). Most patients presented with persistent severe hypotension (68.2%) and ECG changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases, being successful in 81.8%. Thirty-day mortality was of 40.9%. After a median follow-up of 12 (2-18) months, the cumulative mortality rate was of 45.5% and there were no cases of stent thrombosis or reintervention.
Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a prior surgical bioprosthesis. Lower lying coronary ostium and shallow SOV were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.
Background:
Aortic root rupture is a major concern with balloon-expandable transcatheter aortic valve replacement (TAVR). We sought to identify predictors of aortic root rupture during balloon-expandable TAVR by using multidetector computed tomography.
Methods and results:
Thirty-one consecutive patients who experienced left ventricular outflow tract (LVOT)/annular/aortic contained/noncontained rupture during TAVR were collected from 16 centers. A caliper-matched sample of 31 consecutive patients without annular rupture, who underwent pre-TAVR multidetector computed tomography served as a control group. Multidetector computed tomography assessment included short- and long-axis diameters and cross-sectional area of the sinotubular junction, annulus, and LVOT, and the presence, location, and extent of calcification of the LVOT, as well. There were no significant differences between the 2 groups in any preoperative clinical and echocardiographic variables. Aortic root rupture was identified in 20 patients and periaortic hematoma in 11. Patients with root rupture had a higher degree of subannular/LVOT calcification quantified by the Agatston score (181.2±211.0 versus 22.5±37.6, P<0.001), and a higher frequency of ≥20% annular area oversizing (79.4% versus 29.0%, P<0.001) and balloon postdilatation (22.6% versus 0.0%, P=0.005). In conditional logistic regression analysis for the matched data, moderate/severe LVOT/subannular calcifications (odds ratio, 10.92; 95% confidence interval, 3.23-36.91; P<0.001) and prosthesis oversizing ≥20% (odds ratio, 8.38; 95% confidence interval, 2.67-26.33; P<0.001) were associated with aortic root contained/noncontained rupture.
Conclusions:
This study demonstrates that LVOT calcification and aggressive annular area oversizing are associated with an increased risk of aortic root rupture during TAVR with balloon-expandable prostheses. Larger studies are warranted to confirm these findings.
The objective of this study was to examine the value of stress-echocardiography in patients with paradoxical low-flow, low-gradient (PLFLG) aortic stenosis (AS). The projected aortic valve area (AVAProj) at a normal flow rate was calculated in 55 patients with PLFLG AS. In the subset of patients (n = 13) who underwent an aortic valve replacement within 3 months after stress echocardiography, AVAProj correlated better with the valve weight compared to traditional resting and stress echocardiographic parameters of AS severity (AVAProj: r = -0.78 vs. other parameters: r = 0.46 to 0.56). In the whole group (N = 55), 18 (33%) patients had an AVAProj >1.0 cm(2), being consistent with the presence of pseudo severe AS. The AVAProj was also superior to traditional parameters of stenosis severity for predicting outcomes (hazard ratio: 1.32/0.1 cm(2) decrease in AVAProj). In patients with PLFLG AS, the measurement of AVAproj derived from stress echocardiography is helpful to determine the actual severity of the stenosis and predict risk of adverse events.
In the current era of expanding catheter-based and complex repair procedures to treat aortic valve (AV) diseases, growing consideration is being given to understanding the functional anatomy of the AV complex. Echocardiography is the primary imaging modality to assess and follow-up AV diseases, and the recent three-dimensional (3D) capabilities allow clinicians to appreciate the functional complexity of the aortic root in the beating heart. Despite being subject to several limitations, 3D echocardiography (3DE) holds promise as a more suitable imaging backup for aortic interventions of mounting complexity and for circumventing some of their current complications. In this review, we discuss the key principles of 3DE for assessing the AV pathology and the incremental clinical benefits in comparison with conventional 2DE and Doppler echocardiography, justifying its implementation in the diagnostic workup of aortic diseases. In view of an effective clinical use, a brief section is dedicated to the acquisition modalities, display, and interpretation of various abnormalities by 3DE.
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.).
Background
Transcatheter aortic valve implantation (TAVI), widely used to treat high-risk patients with severe symptomatic aortic stenosis, has recently been extended to younger patients at lower operative risk in whom long-term durability of TAVI devices is an important concern. Therefore, we conducted a systematic review and meta-analysis of observational studies addressing the frequency of structural valve deterioration (SVD) after TAVI.
Methods
We searched Medline, Embase, Cochrane Database of Systematic Reviews, and Cochrane CENTRAL from 2002 to September 2016. We included observational studies following patients with TAVI for at least 2 years. Independently and in duplicate, we evaluated study eligibility, extracted data, and assessed risk of bias for SVD post-TAVI. Our review used the GRADE system to assess quality of evidence. We pooled incidence rates using a random effects model.
Results
Thirteen studies including 8914 patients, with a median follow-up between 1.6 and 5 years, reported an incidence of SVD post-TAVI between 0 to 1.34 per 100 patient years. The pooled incidence of SVD was 28.08 per 10 000 patients/year (95% CI 2.46 to 73.44 per 100 patient years). Of those who developed SVD, 12% underwent valve re-intervention. Confidence in the evidence was moderate due to inconsistency among studies.
Conclusion
Structural valve deterioration is probably an infrequent event within the first 5 years after TAVI. Ascertaining the impact of SVD and the need for valve-related re-interventions to inform recommendations for patients with a longer life-expectancy will require studies including a large number of patients with longer follow-up (>10 years).
OBJECTIVES: This study sought to evaluate, through a systematic review of the published data, the main baseline characteristics, management, and clinical outcomes of patients suffering coronary obstruction as a complication of transcatheter aortic valve implantation (TAVI).
BACKGROUND: Very few data exist on coronary obstruction after TAVI.
METHODS: Studies published between 2002 and 2012, with regard to coronary obstruction as a complication of TAVI, were identified with a systematic electronic search. Only the studies reporting data on the main baseline and procedural characteristics, management of the complication, and clinical outcomes were analyzed.
RESULTS: A total of 18 publications describing 24 patients were identified. Most (83%) patients were women, with a mean age of 83 ± 7 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 25.1 ± 12.0%. Mean left coronary artery (LCA) ostium height and aortic root width were 10.3 ± 1.6 mm and 27.8 ± 2.8 mm, respectively. Most patients (88%) had received a balloon-expandable valve, and coronary obstruction occurred more frequently in the LCA (88%). Percutaneous coronary intervention was attempted in 23 cases (95.8%) and was successful in all but 2 patients (91.3%). At 30-day follow-up, there were no cases of stent thrombosis or repeat revascularization, and the mortality rate was 8.3%.
CONCLUSIONS: Reported cases of coronary obstruction after TAVI occurred more frequently in women, in patients receiving a balloon-expandable valve, and the LCA was the most commonly involved artery. Percutaneous coronary intervention was a feasible and successful treatment in most cases. Continuous efforts should be made to identify the factors associated with this life-threatening complication to implement the appropriate measures for its prevention.
Echocardiography is the key tool for the diagnosis and evaluation of aortic stenosis. Because clinical decision-making is based on the echocardiographic assessment of its severity, it is essential that standards are adopted to maintain accuracy and consistency across echocardiographic laboratories. Detailed recommendations for the echocardiographic assessment of valve stenosis were published by the European Association of Echocardiography and the American Society of Echocardiography in 2009. In the meantime, numerous new studies on aortic stenosis have been published with particular new insights into the difficult subgroup of low gradient aortic stenosis making an update of recommendations necessary. The document focuses in particular on the optimization of left ventricular outflow tract assessment, low flow, low gradient aortic stenosis with preserved ejection fraction, a new classification of aortic stenosis by gradient, flow and ejection fraction, and a grading algorithm for an integrated and stepwise approach of aortic stenosis assessment in clinical practice.
Objectives:
This study sought to clarify the incidence and predictors of hypoattenuated leaflet thickening (HALT) and mid-term outcomes after transcatheter aortic valve replacement.
Background:
HALT detected on multidetector computed tomography (MDCT) scanning raised concerns about possible subclinical leaflet thrombosis.
Methods:
We studied 70 of 100 consecutive patients from a single-center registry who underwent implantation with the Edwards SAPIEN-XT device. MDCT results, echocardiographic data, and laboratory findings obtained at the 6-month and 1-year follow-ups were analyzed.
Results:
Of 70 patients, MDCT scans revealed HALT in 1 patient (1.4%) at discharge, 7 (10.0%) at 6 months, and 10 (14.3%) at 1 year post-transcatheter aortic valve replacement cumulatively. The degree of leaflet immobility correlated with the HALT area on 4-dimensional MDCT (r = 0.68) on the basis of data from 10 patients. HALT was associated with male sex (70% vs. 25%; p = 0.008) and larger sinus of Valsalva (31.0 ± 2.0 mm vs. 28.6 ± 2.6 mm; p = 0.005). HALT was found in 3 of 49 patients with a 23-mm bioprosthesis and in 7 of 21 patients with a 26-mm bioprosthesis (6.1% vs. 33.3%; p = 0.006). D-dimer levels were significantly increased in the HALT group at the 6-month (2.3 μg/ml [interquartile range (IQR): 2.1 to 6.1 μg/ml] vs. 1.1 μg/ml [IQR: 0.8 to 2.2 μg/ml]; p = 0.002) and 1-year (2.7 μg/ml [IQR: 1.7 to 4.8 μg/ml] vs. 1.2 μg/ml [IQR: 0.9 to 2.1 μg/ml]; p = 0.006) follow-ups, despite no differences at discharge. The pressure gradient was decreased in the HALT group at the 1-year follow-up (8.3 ± 0.8 mm Hg vs. 11.1 ± 4.9 mm Hg; p = 0.005). After detecting HALT, additional anticoagulation therapy was not administered. Clinical outcomes, including all-cause mortality (0% vs. 1.7%; p = 1.00) and stroke (0% vs. 0%; p = 1.00), were similar between the groups.
Conclusions:
HALT with reduced leaflet motion was not rare but usually subclinical. Valve hemodynamics and mid-term outcomes were uneventful even without additional anticoagulant therapy in our limited number of cases. Male sex, larger sinus and bioprosthesis size, and elevated D-dimer levels during follow-up were associated with this phenomenon.
Background
Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients.
Methods
We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort.
Results
The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.
Conclusions
In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.)
Few data are available about whether aortic root calcification may impact the outcomes after transcatheter aortic valve implantation (TAVI).
This study sought to evaluate the impact of aortic root calcification volume on clinical outcome after TAVI with balloon expandable Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California).
A total of 162 TAVI patients (aged 84.0 [Interquartile Range (IQR) 81.0-84.0] years, Logistic EuroSCORE 14.5 [IQR 9.8-25.1]) with preprocedural MDCT were studied. Aortic root calcification volume was measured by MDCT image and using the dedicated software for aortic valve assessment (the automated 3mensio(TM) Valves 5.1, sp1, 3mensio Pie Medical Imaging BV, Maastricht, the Netherlands). A valve calcification index (VCI) was defined as calcification volume (mm(3) )/body surface area (mm(2) ).
VCI was significantly higher among patients with 30-day mortality. A VCI threshold of 517.4 (area under the curve 0.69, 95% CI 0.50-0.87, P = 0.03) predicted a higher incidence of annulus rupture (9.1 vs. 0.9%, P = 0.02) and cardiac tamponade (12.7 vs. 1.9%, P < 0.01), lower device success (83.6% vs. 95.3%, P < 0.01) and 30-day survival rate (80.0% vs. 97.2%, P < 0.01). Multivariate logistic regression analysis showed only ejection fraction and VCI were identified as independent predictors of 30-day mortality (Odds ratio 0.948 [95% confidence interval 0.909-0.988], P = 0.012, Odds ratio 1.003 [95% confidence interval 1.001-1.005], P = 0.013, respectively).
Significantly worse acute clinical outcomes after Edwards valve implantation were observed in patients with large amount of aortic annulus calcifications quantitatively measured by dedicated MDCT software. Application of VCI may prove helpful in prediction of clinical outcomes after TAVI. © 2015 Wiley Periodicals, Inc.
© 2015 Wiley Periodicals, Inc.
Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) thrombosis.
THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post-transcatheter aortic valve implantation was 181 days (interquartile range, 45-313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months.
THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography.
© 2015 American Heart Association, Inc.
Although the highest aortic valve velocity was thought to be obtained from imaging windows other than the apex in about 20% of patients with severe aortic stenosis (AS), its occurrence appears to be increasing as the age of patients has increased with the application of transcatheter aortic valve replacement. The aim of this study was to determine the frequency with which the highest peak jet velocity (Vmax) is found at each imaging window, the degree to which neglecting nonapical imaging windows underestimates AS severity, and factors influencing the location of the optimal imaging window in contemporary patients.
Echocardiograms obtained in 100 consecutive patients with severe AS from January 3 to May 23, 2012, in which all imaging windows were interrogated, were retrospectively analyzed. AS severity (aortic valve area and mean gradient) was calculated on the basis of the apical imaging window alone and the imaging window with the highest peak jet velocity. The left ventricular-aortic root angle measured in the parasternal long-axis view as well as clinical variables were correlated with the location of highest peak jet velocity.
Vmax was most frequently obtained in the right parasternal window (50%), followed by the apex (39%). Subjects with acute angulation more commonly had Vmax at the right parasternal window (65% vs 43%, P = .05) and less commonly had Vmax at the apical window (19% vs 48%, P = .005), but Vmax was still located outside the apical imaging window in 52% of patients with obtuse aortic root angles. If nonapical windows were neglected, 8% of patients (eight of 100) were misclassified from high-gradient severe AS to low-gradient severe AS, and another 15% (15 of 100) with severe AS (aortic valve area < 1.0 cm(2)) were misclassified as having moderate AS (aortic valve area > 1.0 cm(2)).
In this contemporary cohort, Vmax was located outside the apical imaging window in 61% of patients, and neglecting the nonapical imaging windows resulted in the misclassification of AS severity in 23% of patients. Aortic root angulation as measured by two-dimensional echocardiography influences the location of Vmax modestly. Despite increasing time constraints on many echocardiography laboratories, these data confirm that routine Doppler interrogation from multiple imaging windows is critical to accurately determine the severity of AS in contemporary clinical practice.
Copyright © 2015 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.
-We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of IE after TAVI.
-This multicenter registry included 53 patients (mean age 79±8 years, men: 57%) who suffered IE following TAVI of 7,944 patients after a mean follow-up of 1.1±1.2 years (incidence of 0.67%; 0.50% within the first year post-TAVI). Mean time from TAVI was 6 (IQR: 1-14) months. Orotracheal intubation (HR: 3.87, 95%CI: 1.55-9.64, P=.004) and the self-expandable CoreValve system (HR: 3.12, 95% CI: 1.37-7.14, P=.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets: 39%, stent frame: 17%, mitral valve: 21%). At least one complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve in 4 and 2 patients, respectively). The in-hospital mortality rate was 47.2%, and increased up to 66% at 1-year follow-up. IE complications such as heart failure (p=0.037) or septic shock (p=0.002) were associated with increased in-hospital mortality.
-The incidence of IE at 1-year after TAVI was of 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphyloccoci and enteroccoci were the most common agents. While most patients presented at least one complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.
Whether the prognosis of paradoxical low-gradient severe aortic stenosis (PLG-SAS), especially due to paradoxical low-flow low-gradient SAS (PLFLG-SAS), is malignant in any specific ethnicity, including Japanese, remains unclear.
We retrospectively enrolled 385 consecutive Japanese patients (age, 76±8 years; 148 men) with moderate AS [MAS: 0.6≤indexed aortic valve area (iAVA)<0.85cm(2)/m(2)] or SAS (iAVA <0.6cm(2)/m(2)) with preserved left ventricular ejection fraction (≥50%). SAS patients were divided into PLG-SAS and high-gradient (HG)-SAS according to the transvalvular mean gradient (40mmHg). PLG-SAS was categorized into 2 groups: normal-flow (NF) LG-SAS [stroke volume index (SVi) ≥35mL/m(2)] and PLFLG-SAS (SVi <35mL/m(2)). Endpoints were all-cause death and major adverse cardio-cerebrovascular events (MACE).
During a median follow-up of 15 months, 31 patients died and 48 suffered MACE. All-cause death and MACE rates in PLG-SAS and PLFLG-SAS were significantly lower than those in HG-SAS and similar to those in MAS. On multivariate analysis, neither PLG-SAS nor PLFLG-SAS were independent determinants for all-cause death compared with MAS [MAS as reference, PLG-SAS: hazard ratio (HR) 0.47, p=0.32; PLFLG-SAS: HR 0.01, p=0.20; HG-SAS: HR 3.37, 95% confidence interval 1.24-9.74, p=0.02].
In Japanese patients, the prognoses of PLG-SAS and PLFLG-SAS were better than that of HG-SAS and similar to that of MAS, being better than that in Western populations.
Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
The aims of this study were to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after transcatheter aortic valve replacement (TAVR) and standard therapy for severe aortic stenosis (AS) and to assess LV ejection fraction (LVEF) recovery and its impact on subsequent clinical outcomes.
Cohort B of the Placement of AoRtic TraNscathetER Valves trial randomised 342 inoperable patients with severe AS to TAVR or standard therapy. We defined LV dysfunction as an LVEF <50% and LVEF improvement as an absolute increase in LVEF ≥10% at 30 days.
Baseline LV dysfunction did not affect survival after TAVR but was associated with increased cardiac mortality at 1 year with standard therapy (59.3% vs 45.8% with normal LVEF; HR=1.71 (95% CI 1.08 to 2.71); p=0.02). In those with LV dysfunction, LVEF improvement occurred in 48.7% and 30.4% of TAVR and standard therapy patients, respectively (p=0.08), and was independently predicted by relative wall thickness and receipt of TAVR. LVEF improvement with standard therapy portended reduced all-cause mortality at 1 year (28.6% vs 65.6% without LVEF improvement; HR=0.32 (95% CI 0.11 to 0.93); p=0.03) but not at 2 years.
In inoperable patients with severe AS, mild-to-moderate LV dysfunction is associated with higher cardiac mortality with standard therapy but not TAVR. A subset of patients undergoing standard therapy with LV dysfunction demonstrates LVEF improvement and favourable 1-year but not 2-year survival. TAVR improves survival and should be considered the standard of care for inoperable patients with AS and LVEF >20%.
ClinicalTrials.gov Unique Identifier #NCT00530894.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Background:
Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV).
Objectives:
This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV.
Methods:
We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV.
Results:
A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥ 2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03).
Conclusions:
TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.
Background
Little is known about the incidence of prosthesis-patient mismatch (PPM) and its impact on outcomes after transcatheter aortic valve replacement (TAVR).
Objectives
The objectives of this study were: 1) to compare the incidence of PPM in the TAVR and surgical aortic valve replacement (SAVR) randomized control trial (RCT) arms of the PARTNER (Placement of AoRTic TraNscathetER Valves) I Trial cohort A; and 2) to assess the impact of PPM on regression of left ventricular (LV) hypertrophy and mortality in these 2 arms and in the TAVR nonrandomized continued access (NRCA) registry cohort.
Methods
The PARTNER Trial cohort A randomized patients 1:1 to TAVR or bioprosthetic SAVR. Postoperative PPM was defined as absent if the indexed effective orifice area (EOA) was >0.85 cm2/m2, moderate if the indexed EOA was ≥0.65 but ≤0.85 cm2/m2, or severe if the indexed EOA was <0.65 cm2/m2. LV mass regression and mortality were analyzed using the SAVR-RCT (n = 270), TAVR-RCT (n = 304), and TAVR-NRCA (n = 1,637) cohorts.
Results
The incidence of PPM was 60.0% (severe: 28.1%) in the SAVR-RCT cohort versus 46.4% (severe: 19.7%) in the TAVR-RCT cohort (p < 0.001) and 43.8% (severe: 13.6%) in the TAVR-NRCA cohort. In patients with an aortic annulus diameter <20 mm, severe PPM developed in 33.7% undergoing SAVR compared with 19.0% undergoing TAVR (p = 0.002). PPM was an independent predictor of less LV mass regression at 1 year in the SAVR-RCT (p = 0.017) and TAVR-NRCA (p = 0.012) cohorts but not in the TAVR-RCT cohort (p = 0.35). Severe PPM was an independent predictor of 2-year mortality in the SAVR-RCT cohort (hazard ratio [HR]: 1.78; p = 0.041) but not in the TAVR-RCT cohort (HR: 0.58; p = 0.11). In the TAVR-NRCA cohort, severe PPM was not a predictor of 1-year mortality in all patients (HR: 1.05; p = 0.60) but did independently predict mortality in the subset of patients with no post-procedural aortic regurgitation (HR: 1.88; p = 0.02).
Conclusions
In patients with severe aortic stenosis and high surgical risk, PPM is more frequent and more often severe after SAVR than TAVR. Patients with PPM after SAVR have worse survival and less LV mass regression than those without PPM. Severe PPM also has a significant impact on survival after TAVR in the subset of patients with no post-procedural aortic regurgitation. TAVR may be preferable to SAVR in patients with a small aortic annulus who are susceptible to PPM to avoid its adverse impact on LV mass regression and survival. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)
Objectives:
This study sought to determine the impact of quantity and location of aortic valve calcification (AVC) on paravalvular regurgitation (PVR) and rates of post-dilation (PD) immediately after transcatheter aortic valve replacement (TAVR).
Background:
The impact of AVC in different locations within the aortic valve complex is incompletely understood.
Methods:
This study analyzed 150 patients with severe, symptomatic aortic stenosis who underwent TAVR. Total AVC volume scores were calculated from contrast-enhanced multidetector row computed tomography imaging. AVC was divided by leaflet sector and region (Leaflet, Annulus, left ventricular outflow tract [LVOT]), and a combination of LVOT and Annulus (AnnulusLVOT). Asymmetry was assessed. Receiver-operating characteristic analysis was performed with greater than or equal to mild PVR and PD as classification variables. Logistic regression was performed.
Results:
Quantity of and asymmetry of AVC for all regions of the aortic valve complex predicted greater than or equal to mild PVR by receiver-operating characteristic analysis (area under the curve = 0.635 to 0.689), except Leaflet asymmetry. Receiver-operating characteristic analysis for PD was significant for quantity and asymmetry of AVC in all regions, with higher area under the curve values than for PVR (area under the curve = 0.648 to 0.741). On multivariable analysis, Leaflet and AnnulusLVOT calcification were independent predictors of both PVR and PD regardless of multidetector row computed tomography area cover index.
Conclusions:
Quantity and asymmetry of AVC in all regions of the aortic valve complex predict greater than or equal to mild PVR and performance of PD, with the exception of Leaflet asymmetry. Quantity of AnnulusLVOT and Leaflet calcification independently predict PVR and PD when taking into account multidetector row computed tomography area cover index.
Significant mitral regurgitation (MR) is frequent in patients with severe aortic stenosis. In these cases, concomitant mitral valve repair or replacement is usually performed at the time of surgical aortic valve replacement. Transcatheter aortic valve replacement (TAVR) has recently been consolidated as an alternative for patients at high or prohibitive surgical risk. However, concomitant significant MR in this setting is typically left untreated. Moderate to severe MR following aortic valve replacement is therefore a relevant entity in the TAVR era. The purpose of this review is to present the current knowledge on the clinical impact and post-procedural evolution of concomitant significant MR in patients with severe aortic stenosis undergoing AVR (SAVR and TAVR). This information should contribute to improving both the clinical decision-making process in and management of this challenging group of patients.
-Previous studies have shown cross-sectional three-dimensional (3D) transesophageal echocardiography (TEE) measurements to severely underestimate multi-detector row computed tomography (MDCT) measurements for the assessment of aortic annulus prior to transcatheter aortic valve replacement (TAVR). This study compares annulus measurements from 3D-TEE employing off-label use of commercially available software to MDCT measurements, and assesses their ability to predict paravalvular regurgitation (PVR).
-100 patients with severe, symptomatic aortic stenosis who had both contrast MDCT and 3D-TEE for annulus assessment prior to balloon-expandable TAVR were analyzed. Annulus area, perimeter, and orthogonal maximum and minimum diameters were measured. Receiver-operating characteristic (ROC) analysis was performed with mild or greater PVR as the classification variable. 3D-TEE and MDCT cross-sectional perimeter and area measurements were strongly correlated (r = 0.93-0.94, p < 0.0001), however, the small differences (≤ 1%) were statistically significant (p = 0.0002 and 0.0074, respectively). Discriminatory ability for ≥ mild PVR was good for both MDCT (area under the curve for perimeter and area cover index = 0.715 and 0.709, respectively) and 3D-TEE (area under the curve for perimeter and area cover index = 0.709 and 0.694, respectively). Differences in ROC analysis between MDCT and 3D-TEE perimeter and area cover indexes were not statistically significant (p = 0.15 and 0.35, respectively).
-Annulus measurements using a new method for analyzing 3D-TEE images closely approximate those of MDCT. Annulus measurements from both modalities predict mild or greater PVR with equivalent accuracy.
We report a high-risk patient with severe symptomatic aortic stenosis who showed systolic anterior motion of the mitral valve (SAM) and severe mitral regurgitation immediately after transcatheter aortic valve replacement (TAVR). The patient did not have either SAM or mitral regurgitation, but showed significant septal hypertrophy on preoperative transthoracic echocardiography which could be associated with the occurrence of SAM. Caution should be exercised in patients with significant interventricular septal hypertrophy before TAVR.
Little is known of the prognostic significance of mitral regurgitation (MR) on transcatheter aortic valve replacement (TAVR), the impact of TAVR on MR severity, and the variables associated with possible post-TAVR improvement of MR. We evaluated these issues in a multicenter registry of patients undergoing CoreValve Revalving System-TAVR (CRS-TAVR).
Among 1007 consecutive patients, 670(66.5%), 243(24.1%) and 94(9.3%) presented with none/mild, moderate, and severe MR, respectively. At 1-month post-TAVR, patients with severe or moderate MR showed comparable mortality rates (OR 1.1(0.7-1.55),p=0.2), but both were significantly higher compared to patients with mild/none MR [OR 2.2(1.78-3.28),p<0.001 and OR 1.9(1.1-3.3),p=0.02, respectively]. One-year mortality was also similar between patients with severe or moderate MR (HR 1.4 (0.94-2.4), p=0.06) and still significantly higher compared to patients with mild/none MR [HR 1.7(1.2-3.41),p<0.001, and HR 1.4(1.2-2.2),p=0.03, respectively]. Severe pulmonary hypertension(SPH), atrial fibrillation(AF), and MR more than mild, but not an improvement of ≥1 grade in MR severity, were independent predictors of mortality at 1-year. At 1-year, an improved MR was observed in 47% and 35% of patients with severe and moderate MR, respectively. The rate of "low implant" was consistent across groups with improved, unchanged or worsened MR. A functional etiology of MR, the absence of SPH and AF independently predicted the MR severity improvement.
Baseline MR greater than mild is associated with higher mortality after CRS-TAVR. A significant improvement of MR was more likely in patients with functional MR, without SPH or AF. The improvement of MR did not independently predict mortality.
Objectives:
To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health.
Background:
Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials.
Methods and results:
The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the U.S. Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included: 1) respect for the historical legacy of surgical valve guidelines; 2) identification of pathophysiological mechanisms associated with clinical events; 3) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended.
Conclusions:
Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes.
Background:
Bicuspid aortic valve (BAV) is regarded as a relative contraindication to transcatheter aortic valve implantation attributable to the risk of uneven expansion of the bioprosthesis. The purpose of this study was to evaluate the efficacy and safety of transcatheter aortic valve implantation in patients with BAV.
Methods and results:
Of 470 patients included in our prospective transcatheter aortic valve implantation database (October 2006-January 2012), 229 consecutive patients undergoing both echocardiography and multidetector computed tomography were analyzed. We compared clinical outcomes in patients with vs patients without BAV. In this series of 229 patients, BAV was detected by multidetector computed tomography in 21 patients (9.2%). BAV was identified by transthoracic and transoesophageal echocardiography in only 9 of these 21 patients. Patients were 83.1±6.6 years old, and European system for cardiac operative risk evaluation score was 20.0%±11.4%. The BAV group was similar to the non-BAV group except for diabetes mellitus (4.8% vs 24.0%; P=0.05). The aortic annulus diameter in BAV patients was not significantly larger by multidetector computed tomography (24.7±3.0 vs 23.7±1.9 mm; P=0.07). The CoreValve was used more frequently in the BAV group (47.6% vs 16.3%; P=0.002). There was no significant difference in device success (100% vs 92.8%; P=0.37), risk of annulus rupture (0% vs 1.4%; P=1.00), or valve migration (0% vs 1.4%; P=1.00) in BAV patients compared with non-BAV patients. Post-procedural mean gradient (10.0±3.4 vs 9.7±4.1 mm Hg; P=0.58), aortic regurgitation ≥2 of 4 (19.0% vs 14.9%; P=0.54), 30-day mortality (4.8% vs 8.2%; P=1.00), and 30-day combined safety end point (14.3% vs 13.5%; P=1.00) were also similar in both groups.
Conclusions:
In selected BAV patients, transcatheter aortic valve implantation may be associated with low complication rate, efficacy, and acceptable outcomes similar to those in non-BAV patients.
Objectives:
The purpose of this study was to evaluate the prevalence of aortic stenosis (AS) in the elderly and to estimate the current and future number of candidates for transcatheter aortic valve replacement (TAVR).
Background:
Severe AS is a major cause of morbidity and mortality in the elderly. A proportion of these patients is at high or prohibitive risk for surgical aortic valve replacement, and is now considered for TAVR.
Methods:
A systematic search was conducted in multiple databases, and prevalence rates of patients (>75 years) were pooled. A model was based on a second systematic literature search of studies on decision making in AS. Monte Carlo simulations were performed to estimate the number of TAVR candidates in 19 European countries and North America.
Results:
Data from 7 studies (n = 9,723 subjects) were used. The pooled prevalence of all AS in the elderly was 12.4% (95% confidence interval [CI]: 6.6% to 18.2%), and the prevalence of severe AS was 3.4% (95% CI: 1.1% to 5.7%). Among elderly patients with severe AS, 75.6% (95% CI: 65.8% to 85.4%) were symptomatic, and 40.5% (95% CI: 35.8% to 45.1%) of these patients were not treated surgically. Of those, 40.3% (95% CI: 33.8% to 46.7%) received TAVR. Of the high-risk patients, 5.2% were TAVR candidates. Projections showed that there are approximately 189,836 (95% CI: 80,281 to 347,372) TAVR candidates in the European countries and 102,558 (95% CI: 43,612 to 187,002) in North America. Annually, there are 17,712 (95% CI: 7,590 to 32,691) new TAVR candidates in the European countries and 9,189 (95% CI: 3,898 to 16,682) in North America.
Conclusions:
With a pooled prevalence of 3.4%, the burden of disease among the elderly due to severe AS is substantial. Under the current indications, approximately 290,000 elderly patients with severe AS are TAVR candidates. Nearly 27,000 patients become eligible for TAVR annually.
Background:
The prognosis and treatment of patients with low-flow (LF) severe aortic stenosis are controversial.
Methods and results:
The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with severe aortic stenosis to medical management versus transcatheter aortic valve replacement (TAVR; inoperable cohort) and surgical aortic valve replacement versus TAVR (high-risk cohort). Among 971 patients with evaluable echocardiograms (92%), LF (stroke volume index ≤35 mL/m(2)) was observed in 530 (55%); LF and low ejection fraction (<50%) in 225 (23%); and LF, low ejection fraction, and low mean gradient (<40 mm Hg) in 147 (15%). Two-year mortality was significantly higher in patients with LF compared with those with normal stroke volume index (47% versus 34%; hazard ratio, 1.5; 95% confidence interval, 1.25-1.89; P=0.006). In the inoperable cohort, patients with LF had higher mortality than those with normal flow, but both groups improved with TAVR (46% versus 76% with LF and 38% versus 53% with normal flow; P<0.001). In the high-risk cohort, there was no difference between TAVR and surgical aortic valve replacement. In patients with paradoxical LF and low gradient (preserved ejection fraction), TAVR reduced 1-year mortality from 66% to 35% (hazard ratio, 0.38; P=0.02). LF was an independent predictor of mortality in all patient cohorts (hazard ratio, ≈1.5), whereas ejection fraction and gradient were not.
Conclusions:
LF is common in severe aortic stenosis and independently predicts mortality. Survival is improved with TAVR compared with medical management and similar with TAVR and surgical aortic valve replacement. A measure of flow (stroke volume index) should be included in the evaluation and therapeutic decision making of patients with severe aortic stenosis.
Clinical trial registration:
URL: http://www.clinicaltrial.gov. Unique identifier: NCT0053089.4.
Objectives:
This study sought to compare echocardiographic findings in patients with critical aortic stenosis following surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
Background:
The PARTNER (Placement of Aortic Transcatheter Valves) trial randomized patients 1:1 to SAVR or TAVR.
Methods:
Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, 1 year, and 2 years after the procedure and analyzed in a core laboratory. For the analysis of post-implantation variables, the first interpretable study (≤6 months) was used.
Results:
Both groups showed a decrease in aortic valve gradients and increase in effective orifice area (EOA) (p < 0.0001), which remained stable over 2 years. Compared with SAVR, TAVR resulted in larger indexed EOA (p = 0.038), less prosthesis-patient mismatch (p = 0.019), and more total and paravalvular aortic regurgitation (p < 0.0001). Baseline echocardiographic univariate predictors of death were lower peak transaortic gradient in TAVR patients, and low left ventricular diastolic volume, low stroke volume, and greater severity of mitral regurgitation in SAVR patients. Post-implantation echocardiographic univariate predictors of death were: larger left ventricular diastolic volume, left ventricular systolic volume and EOA, decreased ejection fraction, and greater aortic regurgitation in TAVR patients; and smaller left ventricular systolic and diastolic volumes, low stroke volume, smaller EOA, and prosthesis-patient mismatch in SAVR patients.
Conclusions:
Patients randomized to either SAVR or TAVR experience enduring, significant reductions in transaortic gradients and increase in EOA. Compared with SAVR, TAVR patients had higher indexed EOA, lower prosthesis-patient mismatch, and more aortic regurgitation. Univariate predictors of death for the TAVR and SAVR groups differed and might allow future refinement in patient selection. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
OBJECTIVES: This study sought to evaluate, through a systematic review of the published data, the main baseline characteristics, management, and clinical outcomes of patients suffering coronary obstruction as a complication of transcatheter aortic valve implantation (TAVI). BACKGROUND: Very few data exist on coronary obstruction after TAVI. METHODS: Studies published between 2002 and 2012, with regard to coronary obstruction as a complication of TAVI, were identified with a systematic electronic search. Only the studies reporting data on the main baseline and procedural characteristics, management of the complication, and clinical outcomes were analyzed. RESULTS: A total of 18 publications describing 24 patients were identified. Most (83%) patients were women, with a mean age of 83 ± 7 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 25.1 ± 12%. Mean left coronary artery (LCA) ostium height and aortic root width were 10.3 ± 1.6 mm and 27.8 ± 2.8 mm, respectively. Most patients (88%) had received a balloon-expandable valve, and coronary obstruction occurred more frequently in the LCA (88%). Percutaneous coronary intervention was attempted in 23 cases (95.8%) and was successful in all but 2 patients (91.3%). At 30-day follow-up, there were no cases of stent thrombosis or repeat revascularization, and the mortality rate was 8.3%. CONCLUSIONS: Reported cases of coronary obstruction after TAVI occurred more frequently in women, in patients receiving a balloon-expandable valve, and the LCA was the most commonly involved artery. Percutaneous coronary intervention was a feasible and successful treatment in most cases. Continuous efforts should be made to identify the factors associated with this life-threatening complication to implement the appropriate measures for its prevention.
Background:
There is a paucity of long-term data comparing biological versus mechanical aortic valve prostheses in older individuals.
Methods and results:
We performed follow-up of patients aged 65 to 80 years undergoing aortic valve replacement with a biological (n=24 410) or mechanical (n=14 789) prosthesis from 1991 to 1999 at 605 centers within the Society of Thoracic Surgeons Adult Cardiac Surgery Database using Medicare inpatient claims (mean, 12.6 years; maximum, 17 years; minimum, 8 years), and outcomes were compared by propensity methods. Among Medicare-linked patients undergoing aortic valve replacement (mean age, 73 years), both reoperation (4.0%) and endocarditis (1.9%) were uncommon to 12 years; however, the risk for other adverse outcomes was high, including death (66.5%), stroke (14.1%), and bleeding (17.9%). Compared with those receiving a mechanical valve, patients given a bioprosthesis had a similar adjusted risk for death (hazard ratio, 1.04; 95% confidence interval, 1.01-1.07), higher risks for reoperation (hazard ratio, 2.55; 95% confidence interval, 2.14-3.03) and endocarditis (hazard ratio, 1.60; 95% confidence interval, 1.31-1.94), and lower risks for stroke (hazard ratio, 0.87; 95% confidence interval, 0.82-0.93) and bleeding (hazard ratio, 0.66; 95% confidence interval, 0.62-0.70). Although these results were generally consistent among patient subgroups, bioprosthesis patients aged 65 to 69 years had a substantially elevated 12-year absolute risk of reoperation (10.5%).
Conclusions:
Among patients undergoing aortic valve replacement, long-term mortality rates were similar for those who received bioprosthetic versus mechanical valves. Bioprostheses were associated with a higher long-term risk of reoperation and endocarditis but a lower risk of stroke and hemorrhage. These risks varied as a function of a patient's age and comorbidities.
BACKGROUND: Aortic regurgitation (AR) is an important limitation of transcatheter aortic valve replacement (TAVR) with ill-defined predictors and unclear long term impact on outcomes. We sought to analyze currently published literature to establish the incidence, impact and predictors of post TAVR AR. METHODS AND RESULTS: Studies published between 2002 and 2012 with regards to TAVR were identified using an electronic search and reviewed using the random effects model of DerSimonian and Laird. From 3871 initial citations, 45 studies reporting on 12,926 patients (CoreValve 5,261 and Edward's valve 7,279) were included in the analysis of incidence and outcomes of post TAVR AR. The pooled estimate for moderate or severe AR post TAVR was 11.7% (95% CI 9.6% to 14.1%). Moderate or severe AR was more common with use of the CoreValve (16.0% vs. 9.1%, p =0.005). The presence of moderate or severe AR post TAVR increased mortality at 30 days (OR 2.95, 95% CI 1.73- 5.02) and at 1 year, (HR 2.27, 95% CI - 1.84-2.81). Mild AR was also associated with an increased hazard for mortality (HR 1.829, 95% CI 1.005-3.329) that was however overturned by sensitivity analysis. Twenty five studies reported on predictors of post TAVR AR. Implantation depth, valve under sizing and Agatston calcium score (r=0.47, p = 0.001) were identified as important predictors. CONCLUSION: Moderate or severe aortic regurgitation is common after TAVR and is an adverse prognostic indicator of short and long term survival. Incidence of moderate or severe AR is higher with use of the CoreValve. Mild AR may be associated with increased long term mortality. Every effort should therefore be made to minimize AR by a comprehensive pre procedural planning and meticulous procedural execution.
Objectives: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. Background: A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Methods and Results: Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, the Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiography recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. Conclusions: This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).
Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed or preserved left ventricular ejection fraction (LVEF), and both situations are among the most challenging encountered in patients with valvular heart disease. In both cases, the decrease in gradient relative to AS severity is due to a reduction in transvalvular flow. The main challenge in patients with depressed LVEF is to distinguish between true severe versus pseudosevere stenosis and to accurately assess the severity of myocardial impairment. Paradoxical LF-LG severe AS despite a normal LVEF is a recently described entity that is characterized by pronounced LV concentric remodeling, small LV cavity size, and a restrictive physiology leading to impaired LV filling, altered myocardial function, and worse prognosis. Until recently, this entity was often misdiagnosed, thereby causing underestimation of AS severity and inappropriate delays for surgery. Hence, the main challenge in these patients is proper diagnosis, often requiring diagnostic tests other than Doppler echocardiography. The present paper proposes to review the diagnostic and therapeutic management specificities of LF-LG AS with and without depressed LV function.
The aim of this study was to investigate the effects of transcatheter aortic valve implantation (TAVI) on left ventricular (LV) hypertrophy and diastolic function in patients with severe aortic valve stenosis (AVS). There are few and conflicting data on LV mass remodeling and LV diastolic function after TAVI.
Echocardiography and clinical assessment were performed at baseline and at 6 months in high-risk patients affected by severe AVS who underwent TAVI.
One hundred thirty-five patients successfully underwent TAVI. Peak transvalvular aortic pressure gradient and mean transvalvular aortic pressure gradient were reduced from 87 ± 25 to 18 ± 7 mm Hg and from 54 ± 14 to 9 ± 4 mm Hg, respectively (P < .001), accompanied by significant clinical improvement. The mean LV ejection fraction improved from 50 ± 13% to 54 ± 11% during follow-up (P = .009). At 6-month follow-up, interventricular septal wall thickness regressed from 14 ± 2 to 12 ± 1 mm and posterior wall thickness from 13 ± 3 to 11 ± 2 mm (P < .001). LV mass and LV mass index decreased from 332 ± 106 to 228 ± 58 g (P < .001) and from 191 ± 58 to 132 ± 30 g/m(2) (P < .001), respectively. Ninety-seven patients (72%) showed improvements in LV diastolic filling pattern. The mean e' value increased from 4.1 ± 1.7 to 5.6 ± 2.2 cm/sec, and the mean E/e' ratio decreased from 24 ± 7 to 17 ± 6 (P < .001) after TAVI.
Significant LV mass reverse remodeling associated with improvement in LV systolic and diastolic function was found in patients with severe AVS 6 months after TAVI. These changes may have relevant clinical prognostic value.
Objectives
Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis.
Background
Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated.
Methods
We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild ( n = 67), moderate ( n = 392), and severe ( n = 906) valve calcification, determined by visual estimation by the operator.
Results
Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak‐to‐peak gradient before the intervention ( P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification ( P < 0.01 for procedure and P < 0.05 for fluoroscopy).
During the periprocedural period there were no differences among the groups regarding in‐hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35).
During 30‐day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions.
Conclusions
Our results of a real‐world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly. © 2012 Wiley Periodicals, Inc.
The aim of this study was to evaluate the impact of mitral regurgitation (MR) on outcomes after transcatheter aortic valve replacement (TAVR) and the impact of TAVR on MR.
Little is known of the influence of MR on outcomes after TAVR.
The outcomes of patients with mild or less (n = 319), moderate (n = 89), and severe (n = 43) MR were evaluated after TAVR at 2 Canadian centers.
Patients with moderate or severe MR had a higher mortality rate than those with mild or less MR during the 30 days after TAVR (adjusted hazard ratio: 2.10; 95% confidence interval: 1.12 to 3.94; p = 0.02). However, the mortality rates after 30 days were similar (adjusted hazard ratio: 0.82; 95% confidence interval: 0.50 to 1.34; p = 0.42). One year after TAVR, moderate MR had improved in 58%, remained moderate in 17%, and worsened to severe in 1%, and 24% of patients had died. Severe MR had improved in 49% and remained severe in 16%, and 35% of patients had died. Multivariate predictors of improved MR at 1 year (vs. unchanged MR, worse MR, or death) were a mean transaortic gradient ≥ 40 mm Hg, functional (as opposed to structural) MR, the absence of pulmonary hypertension, and the absence of atrial fibrillation.
Moderate or severe MR in patients undergoing TAVR is associated with a higher early, but not late, mortality rate. At 1-year follow-up, MR was improved in 55% of patients with moderate or severe MR at baseline. Improvement was more likely in patients with high transaortic gradients, with functional MR, without pulmonary hypertension and without atrial fibrillation.
The present study sought to elucidate the geometry of the left ventricular outflow tract (LVOT) in patients with aortic stenosis and its effect on the accuracy of the continuity equation-based aortic valve area (AVA) estimation. Real-time 3-dimensional transesophageal echocardiography (RT3D-TEE) provides high-resolution images of LVOT in patients with aortic stenosis. Thus, AVA is derived reliably with the continuity equation. Forty patients with aortic stenosis who underwent 2-dimensional transthoracic echocardiography (2D-TTE), 2-dimensional transesophageal echocardiography (2D-TEE), and RT3D-TEE were studied. In 2D-TTE and 2D-TEE, the LVOT areas were calculated as π × (LVOT dimension/2)(2). In RT3D-TEE, the LVOT areas and ellipticity ([diameter of the anteroposterior axis]/[diameter of the medial-lateral axis]) were evaluated by planimetry. The AVA is then determined using planimetry and the continuity equation method. LVOT shape was found to be elliptical (ellipticity of 0.80 ± 0.08). Accordingly, the LVOT areas measured by 2D-TTE (median 3.7 cm(2), interquartile range 3.1 to 4.1) and 2D-TEE (median 3.7 cm(2), interquartile range 3.1 to 4.0) were smaller than those by 3D-TEE (median 4.6 cm(2), interquartile range 3.9 to 5.3; p <0.05 vs both 2D-TTE and 2D-TEE). RT3D-TEE yielded a larger continuity equation-based AVA (median 1.0 cm(2), interquartile range 0.79 to 1.3, p <0.05 vs both 2D-TTE and 2D-TEE) than 2D-TTE (median 0.77 cm(2), interquartile range 0.64 to 0.94) and 2D-TEE (median 0.76 cm(2), interquartile range 0.62 to 0.95). Additionally, the continuity equation-based AVA by RT3D-TEE was consistent with the planimetry method. In conclusion, RT3D-TEE might allow more accurate evaluation of the elliptical LVOT geometry and continuity equation-based AVA in patients with aortic stenosis than 2D-TTE and 2D-TEE.
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 determine the most reproducible multidetector computed tomography (MDCT) measurements of the aortic annulus and to determine methods to improve the applicability of these measurements for transcatheter aortic valve implantation.
The reproducibility and applicability of MDCT annular measurements to guide transcatheter aortic valve implantation remain unclear.
Annular measurements were performed in 50 patients planed for transcatheter aortic valve implantation in multiple planes: basal ring (short- and long-axis, mean diameter, area-derived diameter), coronal, sagittal, and 3-chamber projections. A theoretical model was developed taking into account the differences between the most reproducible MDCT measurements and transesophageal echocardiography to guide valve size choice.
The most reproducible measurements were the area-derived diameter and basal ring average diameter (inter-reader intraclass correlation coefficient: 0.87 [95% confidence interval: 0.81 to 0.92] and 0.80 [95% confidence interval: 0.70 to 0.87]; respectively; intrareader >0.90 for all readers). These were generally larger than transesophageal echocardiography diameters (mean difference of 1.5 ± 1.6 mm and 1.1 ± 1.7 mm, respectively). When a strategy of valve-sizing is undertaken using these CT measurements using an echocardiographic sizing scale, a different THV size would be selected in 44% and 40% of cases, respectively. When adjusting the sizing cutoffs to account for the differences in observed diameters, this was reduced to 10% to 12% (p < 0.01 for both, respectively).
The most reproducible MDCT measurements of the annulus are the area-derived diameter and basal ring average diameter, with derived values generally larger than those obtained with echocardiography. If MDCT is used for valve sizing, a strategy incorporating these differences may be important. MDCT using these easily derived measurements may be ideally suited to sizing transcatheter aortic valves as they account for the eccentricity of the aortic annulus, are reproducible, and are noninvasive.
Transcatheter aortic valve implantation is an emerging technique for the treatment of aortic valve stenosis in high-risk patients. Detailed knowledge of aortic root anatomy, including specific information on the extent of native cusp calcifications, is required. The aim of this study was to evaluate whether echocardiographic assessment of aortic stenosis using a calcification score is useful to predict outcomes of transcatheter aortic valve implantation in elderly high-risk patients.
Detailed preoperative digitalized transesophageal echocardiographic images were available from 103 patients treated by transapical transcatheter aortic valve implantation between February 2006 and February 2009. On the basis of a previously published study, an index score was developed to describe the extent of valve calcification ranging from 0 to 8 (normal to diffuse calcification).
The median age of patients was 82.2 ± 5.9 years. The mean logistic European System for Cardiac Operative Risk Evaluation was 33.0% ± 16.3%. Mild paravalvular leak was present in 43 patients (42.2%), and a moderate paravalvular leak was observed in 5 patients (4.9%). Severe regurgitation was not observed in any patient. Logistic regression analysis revealed that the transcatheter aortic valve implantation echocardiographic calcification score is associated with the presence of moderate paravalvular aortic regurgitation (odds ratio, 8.5; 95% confidence interval, 1.2-58.9; P = .0001) and overall moderate aortic regurgitation (odds ratio, 3.6; 95% confidence interval, 1.2-10.4; P = .0006).
Transesophageal echocardiography demonstrates detailed anatomic information of the calcification patterns of the aortic valve and root and thus plays an important role in the screening of patients undergoing transcatheter aortic valve implantation. The transcatheter aortic valve implantation echocardiographic calcification score allowed prediction of the risk of postoperative paravalvular and overall aortic regurgitation.