No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Characteristics and Outcomes of Patients With Severe Aortic Stenosis Discussed by the Multidisciplinary “Heart Team” According to Treatment Allocation
Abstract
Background:
Transcatheter aortic valve implantation (TAVI) is an alternative and effective contemporary intervention to surgical aortic valve replacement (SAVR) for patients with severe aortic valve disease at increased surgical risk. Guidelines recommend a multidisciplinary "Heart Team" (MHT) review of patients considered for a TAVI procedure, but this has been little studied. We reviewed the characteristics, treatments and outcomes of such patients reviewed by the MHT at our centre.
Methods:
Data on consecutive patients with severe aortic valve stenosis discussed by the Auckland City Hospital MHT from June 2011 to August 2016 were obtained from clinical records. Patient characteristics, treatment and outcomes were analysed using standard statistical methods.
Results:
Over the 5-year period 243 patients (mean age 80.2 ± 8.0 years, 60% male) were presented at the MHT meeting. TAVI was recommended for 200, SAVR for 26 and medical therapy for 17 patients, with no significant difference in mean age (80.2 ± 8.3, 80.4 ± 6.1, 80.4 ± 7.3 years, respectively) or EuroSCORE II (6.5 ± 4.7%, 5.3 ± 3.6%, 6.7 ± 4.3%, respectively). Over time, there was an increase in the number of patients discussed and treated, with no change in their mean age, but the mean EuroSCORE II significantly decreased (TAVI p = 0.026, SAVR p = 0.004). Survival after TAVI and SAVR was similar to that of the age-matched general population, but superior to medical therapy p = 0.002 (93% (n = 162), 84% (n = 21) and 73% (n = 18) at one year and 85% (n = 149), 84% (n = 21) and 54% (n = 13) at 2 years, respectively).
Conclusions:
An increasing number of patients were discussed at the MHT meeting with the majority undergoing TAVI, with a similar age and EuroSCORE II to those allocated SAVR or medical therapy. Survival following TAVI and SAVR was superior to medical therapy and similar to the age-matched general population. These findings suggest that the MHT process is robust, consistent and appropriately allocating a limited treatment resource.
... However, while the idea of HT is generally adopted in the medical society, no clear consensus on how HT should cooperate and what the desired goals are is established; most importantly, long-term results of HT decisions implementation and patients satisfaction are still poorly investigated. To our knowledge, some research papers regarding the influence of HT decisions on prognosis of AS-patients are available in the literature [4][5][6][7][8][9][10][11][12][13][14][15][16]; however, there are still few studies describing real-life HT cooperation, and more evidence investigating HT consistency and significance of decision making and performance on hard clinical endpoints are required. The purpose of this study is to evaluate AS-patients management, long-term outcomes and quality of life following HT decisions implementation in the daily clinical practice of a tertiary cardiovascular care center. ...
... Even more importantly, more clinical trials comparing treatment options for AS-patients mainly focus on interventional strategy and neglect the long-term outcomes and quality of life of patients enrolled to conservative management after HT evaluation. Only in few reports some data concerning this issue are available [8,9,[14][15][16]. In our experience, such a cohort of patients consulting due to AS is quite large and the problem of their future care remains pressing. ...
Background:
This retrospective study was proposed to investigate outcomes of patients with severe aortic stenosis (AS) after implementation of various treatment strategies following dedicated Heart Team (HT) decisions.
Methods:
Primary and secondary endpoints and quality of life during a median follow-up of 866 days of patients with severe AS qualified after HT discussion to: optimal medical treatment (OMT) alone, OMT and transcather aortic valve replacement (TAVR) or OMT and surgical aortic valve replacement (SAVR) were evaluated. As the primary endpoint composite of all-cause mortality, non-fatal disabling strokes and non-fatal rehospitalizations for AS were considered, while other clinical outcomes were determined as secondary endpoints.
Results:
From 2016 to 2019, 176 HT meetings were held, and a total of 482 participants with severe AS and completely implemented HT decisions (OMT, TAVR and SAVR for 79, 318 and 85, respectively) were included in the final analysis. SAVR and TAVR were found to be superior to OMT for primary and all secondary endpoints (p < 0.05). Comparing interventional strategies only, TAVR was associated with reduced risk of acute kidney injury, new onset of atrial fibrillation and major bleeding, while the superiority of SAVR for major vascular complications and need for permanent pacemaker implantation was observed (p < 0.05). The quality of life assessed at the end of follow-up was significantly better for patients who underwent TAVR or SAVR than in OMT-group (p < 0.05).
Conclusions:
We demonstrated that after careful implementation of HT decisions interventional strategies compared to OMT only provide superior outcomes and quality of life for patients with AS.
... No significant differences in age or perioperative risk assessed by EuroSCORE II between these three groups were observed. The authors reported that survival outcomes after TAVI and SAVR were similar with each other (93% vs. 84% for SAVR at 1 year and 85% vs. 84% for SAVR at 2 years) and similar to the age-matched general population with both being longer than for patients receiving only OMT (73% and 54% at 1-and 2-years, respectively, p = 0.002) [34]. A total number of 286 high-risk patients with AS discussed by HT and qualified for SAVR (n = 53), TAVR (n = 210) and OMT (n = 23) were prospectively evaluated with median (IQR) follow-up of 18 (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26) months in the study of Tirado-Conte G, et al. ...
The multidisciplinary Heart Team (HT) remains the standard of care for highly-burdened patients with coronary artery disease (CAD) and valvular heart disease (VHD) and is widely adopted in the medical community and supported by European and American guidelines. An approach of highly-experienced specialists, taking into account numerous clinical factors, risk assessment, long-term prognosis and patients preferences seems to be the most rational option for individuals with. Some studies suggest that HT management may positively impact adherence to current recommendations and encourage the incorporation of patient preferences through the use of shared-decision making. Evidence from randomized-controlled trials are scarce and we still have to satisfy with observational studies. Furthermore, we still do not know how HT should cooperate, what goals are desired and most importantly, how HT decisions affect long-term outcomes and patient’s satisfaction. This review aimed to comprehensively discuss the available evidence establishing the role of HT for providing optimal care for patients with CAD and VHD. We believe that the need for research to recognize the HT definition and range of its functioning is an important issue for further exploration. Improved techniques of interventional cardiology, minimally-invasive surgeries and new drugs determine future perspectives of HT conceptualization, but also add new issues to the complexity of HT cooperation. Regardless of which direction HT has evolved, its concept should be continued and refined to improve healthcare standards.
... Based on current European recommendations for MR-treatment the role of HT is poorly underlined with class IIb and level C, while in American guidelines with class IIa/b from nonrandomized trials [2,3]. There is growing evidence confirming the multidisciplinary approach of HT for management of many CV diseases -coronary artery disease [11][12][13][14][15], aortic stenosis [16][17][18][19][20] and AF [21] which has demonstrated great merit. Only for the safety and efficacy of the HT concept in MR filling the gaps with evidence is still urgent, whereas only two papers on this issue are currently available in the literature [4,5]. ...
BACKGROUND: This study was purposed to investigate which treatment strategy was associated with the most favourable prognosis for patients with severe mitral regurgitation (MR) following Heart Team (HT)-decisions implementation. METHODS: In this retrospective study, long-term outcomes of patients with severe MR qualified after HT discussion to: optimal medical treatment (OMT) alone, OMT and MitraClip (MC) procedure or OMT and mitral valve replacement (MVR) were evaluated. The primary endpoint was defined as cardiovascular (CV) death and the secondary endpoints included all-cause mortality, myocardial infarctions (MI), strokes, hospitalizations for heart failure exacerbation and CV events during a mean (standard deviation [SD]) follow-up of 29 (15) months. RESULTS: From 2016 to 2019, 176 HT meetings were held and a total of 157 participants (mean age [SD] = 71.0 [9.2], 63.7% male) with severe MR and completely implemented HT decisions (OMT, MC or MVR for 53, 58 and 46 patients, respectively) were included into final analysis. Comparing OMT, MC and MVR groups statistically significant differences between the implemented procedures and occurrence of primary and secondary endpoints with the most frequent in OMT-group were observed (p < 0.05). However, for interventional strategy MC was non-inferior to MVR for all endpoints (p > 0.05). General health status assessed at the end of follow-up were significantly the lowest for MVR, then for MC and the highest for OMT-group (p < 0.01). CONCLUSIONS: In the present study it was demonstrated that after careful HT evaluation of patients with severe MR at high risk of surgery, percutaneous strategy (MC) can be considered as equivalent to surgical treatment (MVR) with non-inferior outcomes.
Background
The heart team (HT) approach, recommended for managing cardiovascular diseases (CVDs), emphasizes multidisciplinary collaboration. Despite its potential benefits, evidence on its effectiveness and implementation is varied and sparse. This review assesses the HT approach's impact on patient outcomes and care delivery in cardiovascular care.
Methods
A systematic review was conducted across MEDLINE, EMBASE, PubMed, Cochrane, and Google Scholar up to July 2023, focusing on studies that implemented an HT approach in coronary and heart valve disease management. Exclusion criteria included non-human studies, case reports, and studies not focusing on HT outcomes.
Results
From 6270 identified articles, 20 met the inclusion criteria. These studies demonstrated significant variability in HT composition and organisation, coupled with a lack of standardized metrics for evaluating clinical outcomes and the impact of the HT. Significant variability was observed in HT composition, with 13 of the 20 studies did not utilize structured templates, those that did demonstrated more consistent decision-making. In mitral valve interventions, HTs were linked to reduced in-hospital mortality and improved long-term survival (5-year survival probability of 0.74 vs 0.70, p = 0.04). In aortic valve interventions, 80% of patients underwent tailored valve procedures following HT evaluation.
Conclusion
The HT approach in cardiovascular care demonstrates improved patient outcomes, particularly in specialized interventions for mitral and aortic valve diseases and CAD management. Despite these positive findings, the variability in HT implementation and the need for standardized outcome metrics call for further advances to optimize this collaborative care model.
Background
A multidisciplinary approach might be pivotal for the management of patients with valvular heart disease (VHD), but clinical outcome data are lacking.
Methods and Results
At our institution, since 2014, internal guidelines recommended heart team consultations for patients with VHD. The clinical/echocardiographic characteristics, treatment recommendations, performed treatment, and early clinical outcomes of consecutive, hospitalized patients with VHD undergoing heart team evaluation were collected. Surgical risk was prospectively assessed by the EuroSCORE II and STS‐PROM. The primary end point of the study was early mortality. A total of 1004 patients with VHD with high clinical complexity (mean age, 75 years; mean EuroSCORE II, 9.4%; mean STS‐PROM, 5.6%; 48% ischemic heart disease; 29% chronic kidney disease, 9% oncologic/hematologic diseases) were enrolled. The heart team recommended an interventional treatment for 807 (80%) patients and conservative management for 197 (20%) patients. Management crossovers occurred in only 5% of patients. The recommended intervention was cardiac surgery for 230 (23%) patients, percutaneous treatment in 516 (51%) patients, and hybrid treatment in 61 (6%) patients. Early mortality occurred in 24 patients (2.4%) and was independently predicted by aortic stenosis, left ventricular ejection fraction, pulmonary artery systolic pressure, and conservative management recommendation. In patients referred to treatment, observed early mortality (1.7%) was significantly lower ( P <0.001) than expected on the bases of both the STS‐PROM (5.2%) and EuroSCORE II (9.7%).
Conclusions
Within the limitations of its single‐center and observational design, the present study suggests that heart team–based management of patients with complex VHD is feasible and allows referral to a wide spectrum of interventions with promising early clinical results.
Background In patients eligible for coronary artery bypass grafting, no data assess the importance of the Heart Team in programming the best surgical strategy for patients with diffuse coronary artery disease (CAD). This study aims to determine the contribution of the Heart Team in predicting the feasibility of coronary artery bypass graft and angiographic surgical success in these patients based on visual angiographic analysis.
Methods Patients with diffuse and severe CAD undergoing incomplete coronary artery bypass graft surgery were prospectively included. One-year postoperative coronary angiograms were obtained to evaluate graft occlusion. Two clinical cardiologists, two cardiovascular surgeons, and one interventional cardiologist retrospectively analyzed preoperative angiograms. A subjective scale was applied at a single moment to quantify the chance of successful coronary artery bypass grafting for each coronary territory with anatomical indication for revascularization. Based on individual scores, the Heart Team's and the specialists' scores were calculated and compared.
Results The examiners evaluated 154 coronary territories, of which 85 (55.2%) were protected. The Heart Team's accuracy for predicting the angiographic success of the surgery was 74.9%, almost equal to that of the surgeons alone (73.2%). Only the interventional cardiologist predicted left anterior descending territory grafting success. The Heart Team had good specificity and reasonable sensitivity, and the surgeons had high sensitivity and low specificity in predicting angiographic success.
Conclusion The multispecialty Heart Team achieved good accuracy in predicting the angiographic coronary artery bypass graft success in patients with diffuse CAD, with a high specificity and reasonable sensitivity.
Objectives
Previous studies indicate frailty to be associated with poor outcomes following transcatheter aortic valve implantation (TAVI), but there is limited evidence from multicentre registries. The aim was to investigate the independent association of frailty with TAVI outcomes, and the prognostic utility of adding frailty into existing clinical prediction models (CPMs).
Design
The UK TAVI registry incorporated three frailty measures since 2013: Canadian Study of Health and Ageing, KATZ and poor mobility. We investigated the associations between these frailty measures with short-term and long-term outcomes, using logistic regression to estimate multivariable adjusted ORs, and Cox proportional hazards models to explore long-term survival. We compared the predictive performance of existing TAVI CPMs before and after updating them to include each frailty measure.
Setting
All patients who underwent a TAVI procedure in England or Wales between 2013 and 2014.
Participants
2624 TAVI procedures were analysed in this study.
Primary and secondary outcomes
The primary endpoints in this study were 30-day mortality and long-term survival. The Valve Academic Research Consortium (VARC)-2 composite early safety endpoint was considered as a secondary outcome.
Results
KATZ <6 (OR 2.10, 95% CI 1.39 to 3.15) and poor mobility (OR 2.15, 95% CI 1.41 to 3.28) predicted 30-day mortality after multivariable adjustment. All frailty measures were associated with increased odds of the VARC-2 composite early safety endpoint. We observed a significant increase in the area under the receiver operating characteristic curves by approximately 5% after adding KATZ <6 or poor mobility into the TAVI CPMs. Risk stratification agreement was significantly improved by the addition of each frailty measure, with an increase in intraclass correlation coefficient of between 0.15 and 0.31.
Conclusion
Frailty was associated with worse outcomes following TAVI, and incorporating frailty metrics significantly improved the predictive performance of existing CPMs. Physician-estimated frailty measures could aid TAVI risk stratification, until more objective scales are routinely collected.
Background:
We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery.
Methods:
We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing.
Results:
A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke.
Conclusions:
In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).
To update the European System for Cardiac Operative Risk Evaluation (EuroSCORE) risk model.
A dedicated website collected prospective risk and outcome data on 22,381 consecutive patients undergoing major cardiac surgery in 154 hospitals in 43 countries over a 12-week period (May-July 2010). Completeness and accuracy were validated during data collection using mandatory field entry, error and range checks and after data collection using summary feedback confirmation by responsible officers and multiple logic checks. Information was obtained on existing EuroSCORE risk factors and additional factors proven to influence risk from research conducted since the original model. The primary outcome was mortality at the base hospital. Secondary outcomes were mortality at 30 and 90 days. The data set was divided into a developmental subset for logistic regression modelling and a validation subset for model testing. A logistic risk model (EuroSCORE II) was then constructed and tested.
Compared with the original 1995 EuroSCORE database (in brackets), the mean age was up at 64.7 (62.5) with 31% females (28%). More patients had New York Heart Association class IV, extracardiac arteriopathy, renal and pulmonary dysfunction. Overall mortality was 3.9% (4.6%). When applied to the current data, the old risk models overpredicted mortality (actual: 3.9%; additive predicted: 5.8%; logistic predicted: 7.57%). EuroSCORE II was well calibrated on testing in the validation data subset of 5553 patients (actual mortality: 4.18%; predicted: 3.95%). Very good discrimination was maintained with an area under the receiver operating characteristic curve of 0.8095.
Cardiac surgical mortality has significantly reduced in the last 15 years despite older and sicker patients. EuroSCORE II is better calibrated than the original model yet preserves powerful discrimination. It is proposed for the future assessment of cardiac surgical risk.
The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement.
At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement.
The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.
In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).
Risk scores provide an important contribution to clinical decision-making, but their validity has been questioned in patients with valvular heart disease (VHD), since current scores have been mainly derived and validated in adults undergoing coronary bypass surgery. The Working Group on Valvular Heart Disease of the European Society of Cardiology reviewed the performance of currently available scores when applied to VHD, in order to guide clinical practice and future development of new scores.
The most widely used risk scores (EuroSCORE, STS, and Ambler score) were reviewed, analysing variables included and their predictive ability when applied to patients with VHD. These scores provide relatively good discrimination, i.e. a gross estimation of risk category, but cannot be used to estimate the exact operative mortality in an individual patient because of unsatisfactory calibration.
Current risk scores do not provide a reliable estimate of exact operative mortality in an individual patient with VHD. They should therefore be interpreted with caution and only used as part of an integrated approach, which incorporates other patient characteristics, the clinical context, and local outcome data. Future risk scores should include additional variables, such as cognitive and functional capacity and be prospectively validated in high-risk patients. Specific risk models should also be developed for newer interventions, such as transcatheter aortic valve implantation.
Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.
We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause.
A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.
In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
Background
Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk.
Methods
We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement.
Results
A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, −5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group.
Conclusions
TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910.)
Background:
Transcatheter aortic valve implantation (TAVI) is considered for severe aortic valve disease at high and now intermediate risk for surgical aortic valve replacement. Risk stratification plays a critical role decision-making for intervention and modality. We compared the prognostic utility of surgical risk scores for TAVI in this meta-analysis.
Methods:
MEDLINE, Embase, Cochrane and Web of Science databases from 1 January 1980 to 31 December 2015 were searched. Studies were systematically reviewed for inclusion, and data extracted for pooled analyses.
Results:
Amongst 1688 articles searched, 47 full-text articles were screened and 24 studies (12,346 TAVI cases) included for analyses. Pooled c-statistics (95% confidence interval) for operative mortality were EuroSCORE 0.62 (0.57-0.67), EuroSCORE II 0.62 (0.59-0.66), STS Score 0.62 (0.59-0.65). Pooled calibration odds ratios (95%CI) were EuroSCORE 0.31 (0.25-0.38), EuroSCORE II 1.26 (1.06-1.51), STS 0.95 (0.72-1.27). C-statistics (95%CI) for 1-year mortality were EuroSCORE 0.62 (0.57-0.67), EuroSCORE II 0.66 (0.61-0.71) and STS Score 0.58 (0.53-0.64).
Conclusion:
Surgical risk scores at most modestly discriminated operative and 1-year mortality. The EuroSCORE grossly over-estimated operative mortality while the EuroSCORE II and STS Scores fitted better to TAVI outcomes with their own limitations. There is a need for the development and validation of TAVI-specific risk models.
Background:
Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement.
Methods:
In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes.
Findings:
At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of -9·2%; 90% CI -12·4 to -6; p<0·0001) and superior (-9·2%, 95% CI -13·0 to -5·4; p<0·0001) to surgical valve replacement.
Interpretation:
TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients.
Funding:
None.
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.)
Transcatheter aortic valve implantation (TAVI) has spawned the evolution of novel catheter-based therapies for a variety of cardiovascular conditions. Newer device iterations are delivering lower peri- and early post-procedural complication rates in patients with aortic stenosis, who were otherwise deemed too high risk for conventional surgical valve replacement. Yet beyond the post-procedural period, a considerable portion of current TAVI recipients fail to derive a benefit from TAVI, either dying or displaying a lack of clinical and functional improvement. Considerable interest now lies in better identifying factors likely to predict futility post-TAVI. Implicit in this are the critical roles of frailty, disability, and a multimorbidity patient assessment. In this review, we outline the roles that a variety of medical comorbidities play in determining futile post-TAVI outcomes, including the critical role of frailty underlying the identification of patients unlikely to benefit from TAVI. We discuss various TAVI risk scores, and further propose that by combining such scores along with frailty parameters and the presence of specific organ failure, a more accurate and holistic assessment of potential TAVI-related futility could be achieved.
Application of a Heart Team approach is now a central concept in the care of patients with severe aortic stenosis. It has Class I recommendations from American and European professional societies and is required for reimbursement for transcatheter aortic valve replacement in the United States. The rationale for changing traditional practice models is to improve patient selection, procedural planning, and management of patients at high or prohibitive surgical risk, thus improving outcomes. Although the concept is intuitive, a clear definition of the Heart Team, and data supporting its effectiveness, are lacking. Other specialties, including oncology, provide a precedent for investigation of the use of a multidisciplinary team and its impact on patient care. We highlight the need for clear definitions and shared metrics to advance our understanding of an optimal Heart Team approach, focusing on patient, clinician, and health system outcomes.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Aims: Little is known about how "Heart Team" treatment decisions among patients suitable for either surgical aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI) are made under routine conditions. Methods and results: The "Heart Team" decision-making process was analysed with respect to124 patients of a non-randomised prospective clinical trial that included patients aged ≥75 years: 41 patients underwent AVR and 83 underwent TAVI. By use of the non-parametric classification and regression tree (CART) methodology, 21 baseline parameters were tested to reconstruct the decision process retrospectively. Next, multivariate logistic and Cox regression models were fitted to evaluate the decision and outcome relevance (two-year survival) of the parameters as identified in the CART procedure. For patients with a baseline EuroSCORE I ≥13.48%, no further cut-off points were identified and the majority of these patients underwent TAVI. Among patients with a baseline EuroSCORE I <13.48%, age and left ventricular ejection fraction (LVEF) were identified as further relevant decision parameters. The decision relevance of EuroSCORE I (p=0.003), age (p=0.024) and LVEF (p=0.047) were confirmed by multivariate analysis; however, outcome relevance can be confirmed for EuroSCORE I (p=0.015) only, while treatment decision (TAVI or AVR) was not a significant predictor of mortality (p=0.655). Conclusions: Despite or even because of the systematic risk selection according to EuroSCORE I values, we observed two-year survival rates of about 75% regardless of whether the patient received TAVI or AVR, suggesting that the decisions made by the "Heart Team" were appropriate. German Clinical Trial Register Nr. DRKS00000797.
Objective
Current preoperative assessments for cardiac surgery, such as the EuroSCORE II and the Society of Thoracic Surgeons risk score, are limited in their ability to predict postoperative outcomes. This is thought to be due to the reliance on chronological age as a predictor of health. In geriatrics, frailty assessments have been developed as a tool in determining physiological functioning capacity. Whether frailty predicts postoperative outcomes independent of existing cardiac preoperative risk scores remains unknown.
Methods
We performed a systematic review to determine the association of frailty with negative postoperative outcomes such as major adverse cardiac and cerebrovascular events (MACCE) in patients undergoing cardiac surgery. We searched Pubmed, EMBASE, Cochrane library and Ageline from inception till July 2013, and screened 5913 abstracts for potential inclusion. Of these, six studies examined the relationship between objective frailty assessments and postoperative outcomes. Our included studies evaluated 4,756 patients undergoing cardiac surgery.
Results
Frailty, defined using multiple criteria, had a strong positive relationship with the risk of MACCE (Odds Ratio 4.89 CI 1.64 – 14.60). Relationships were stronger in older patients undergoing TAVR than younger patients undergoing CABG and valvular surgery. (Hazard Ratio for Frailty in TAVR 3.31 – 4.89 vs Hazard Ratio for Non-TAVR 1.10 – 3.16)
Conclusion
Patients deemed frail, determined using an objective assessment tool, have a higher likelihood of experiencing mortality, morbidity, functional decline and MACCE following cardiac surgery, regardless of definition. Further study is needed to determine which components of frailty are most predictive of negative postoperative outcomes, prior to integration in risk prediction scores.
The management of complex cardiovascular disease has changed markedly with the development of new strategies of care, an increasing amount of scientific evidence-based data and appropriate use criteria. Applying this plethora of information and synthesizing it for presentation and recommendations to the patient and family have assumed central importance. To facilitate this process of patient centric evidence-based care multidisciplinary Heart Teams have become identified as cornerstones. While specific strategies for implementation of these teams will vary, this broad approach will become the standard of cardiovascular care.
Despite different aetiologies, acquired aortic stenosis is a self-maintaining, slowly progressive process with good long-term prognosis. In 142 patients with mild stenosis, there was clinical progression within 10 years of the initial diagnosis in only 12% of patients. Twenty-five years after the diagnosis had been established, the severity of aortic stenosis was clinically unchanged in 38%, while 25% of patients had moderate stenosis and 35% had undergone valve replacement. Progression of moderate aortic stenosis was more rapid: the average time interval between the manifestation of moderate aortic stenosis and surgery was 13.4 years. Age at the onset of initial symptoms was related to aetiology: 39 +/- 18 years with rheumatic aortic stenoses, 48 +/- 6 years in patients with bicuspid valves who had no history of rheumatic fever, infective endocarditis or myocarditis, and 66 +/- 12 years in degenerative, calcific stenoses of tricuspid aortic valves. Patients with haemodynamically severe stenosis who had refused the recommended operation (n = 55) had an overall poor prognosis: mean survival averaged 23 +/- 5 months and the five-year probability of survival was 18 +/- 7%. All these patients died within 12 years of observation. Mean survival after the occurrence of angina pectoris was 45 +/- 13 months, after syncope 27 +/- 15 months, and after first occurrence of left heart failure 11 +/- 10 months.
New Zealand Cohort Life Tables [Internet].
- Statistics New Zealand