Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

Self-Expanding Versus Balloon-Expandable Valve: Are We at the Cusp of Delivering a Perfect Transcatheter Aortic Valve?

Robotic aortic valve replacement

The following are highlights from the new series, Circulation: Cardiovascular Quality and Outcomes Topic Reviews. This series will summarize the most important manuscripts, as selected by the Editor, which have been published in the Circulation portfolio. The objective of this new series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes as well as general cardiology audience. The studies included in this article represent the most significant research in the area of valvular heart disease. ( Circ Cardiovasc Quality and Outcomes . 2012;5:-e103.) In recent years, no field of clinical cardiology has experienced a great influx of transformational therapeutic options as has the area of valvular heart disease. Treatment of severe aortic stenosis (AS) has been revolutionized by transcatheter aortic valve replacement (TAVR), which has been shown to improve life expectancy and functional outcomes in patients with inoperable AS1,2 and to have short-term outcomes comparable to surgical aortic valve replacement (AVR) in patients at high perioperative risk.3,4 Analogously, mitral valve disease has been amenable to percutaneous valve replacement,5,6 as well as clipping procedures7 that can substantively reduce severe mitral regurgitation (MR) and improve functional outcomes. Even right-sided heart disease involving valves in pulmonary8,9 and tricuspid10 positions has been treated successfully with endovascular techniques. Yet, even with this growing focus on percutaneous valvular interventions, open surgical techniques remain the dominant treatment strategies and standard of care for most advanced lesions. Surgical valve repair and replacement account for 10% to 20% of all cardiac surgical procedures,11–13 approximately two thirds of which are for AS.11–13 For patients undergoing surgery, there remains considerable debate about risk stratification,14 intraoperative technique,15 and postoperative …

The Deployment of Valve Academic Research Consortium 3 (VARC-3): New Endpoints, Broader Definitions, and Plenty of Unanswered Questions

The AVATAR Trial for Severe Asymptomatic Aortic Stenosis: Wait or Operate?

Although transcatheter aortic valve implantation (TAVI) is officially indicated for severe aortic stenosis (AS) patients at intermediate or higher surgical risk, the procedure is now increasingly being performed in patients who are at low surgical risk. Data on the benefit of TAVI in this patient population are limited. We therefore aimed to perform an updated meta-analysis of all published randomised controlled trials (RCTs) and propensity score-matched studies comparing TAVI versus surgical aortic valve replacement (SAVR) in patients at low surgical risk. We conducted a systematic review and meta-analysis of RCTs and observational studies with propensity score matching (PSM) of TAVI versus SAVR in patients who are at low surgical risk (mean STS score <4% and/or logistic EuroSCORE <10%). The primary outcome was mortality (examined at 30 days, one year and the longest available follow-up). The secondary outcomes included procedural complications. Nine studies (n=6,124) were included. TAVI was associated with a numerically, but not statistically, significant reduced mortality at 30 days (1.45% vs 2.1%, p=0.05), and similar mortality at one year (5.1% vs 5.0%, p=0.74) and a median of two years (10.8% vs 9.8%, p=0.15). For both time points, there was significant heterogeneity between RCT/PSM studies, with the former suggesting survival advantage for TAVI and the latter for SAVR. In terms of periprocedural complications, TAVI was associated with reduced risk for stroke, bleeding and renal failure and an increase in vascular complications and pacemaker implantation. In patients who are at low surgical risk, TAVI seems to be associated with equivalent mortality up to a median follow-up of two years compared to SAVR. More data are required before TAVI can be routinely considered as an alternative to SAVR in low-risk patients.

Surgical aortic valve replacement (SAVR) is the commonly used approach for aortic valve replacement (AVR) in patients with aortic stenosis at low or intermediate surgical risk. However, transcatheter aortic valve replacement (TAVR) has emerged as an alternative to SAVR for AVR. This meta-analysis aims to assess the comparative efficacy and safety of TAVR versus SAVR in low-to-intermediate surgical risk patients by analyzing temporal trends in the outcomes of TAVR and SAVR at various follow-up intervals, providing a more detailed understanding. A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception up to May 2024 to identify eligible randomized controlled trials (RCTs). Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% CIs. A total of 17 studies reporting data at different follow-ups for nine trials were included (n=9092). No statistically significant difference was observed between TAVR and SAVR for reducing all-cause death at 30 days, 1 year, and 2 years but significantly increased risk with TAVR at 5 years or longer follow-up (RR=1.13, 95% CI: 1.03-1.23). However, TAVR was associated with a significantly decreased risk for cardiac death at 1-year follow-up (RR=0.79, 95% CI: 0.64-0.96) and comparable risk for cardiac death at 30 days, 2 years, and 5 years or longer follow-up when compared with SAVR. No statistically significant difference was observed between TAVR and SAVR for reducing the risk of myocardial infarction (MI) at 30 days, 1 year, 2 years, and 5 years or longer follow-up.TAVR was associated with a significantly lower risk of major bleeding events at 30 days (RR=0.38, 95% CI: 0.21-0.67); lower risk of acute kidney injury (AKI) at 30 days (RR=0.38, 95% CI: 0.26-0.54) and 1 year (RR=0.58, 95% CI: 0.41-0.82) and lower risk of new onset or worsening atrial fibrillation (AF) at 30 days (RR=0.25, 95% CI: 0.18-0.34), 1 year (RR=0.26, 95% CI: 0.16-0.41) and 2 years (RR=0.32, 95% CI: 0.20-0.49) when compared with SAVR. However, TAVR was associated with a significantly increased risk of permanent pacemaker implantation (PPI) at 30 days (RR: 2.62, 95% CI: 1.40-4.91), at 1 year (RR: 2.19, 95% CI: 1.24-3.87), at 2 years (RR: 2.74, 95% CI: 1.31-5.71), and beyond 5 years (RR: 1.95, 95% CI: 1.20-3.15). TAVR was also associated with a significantly increased risk of prosthetic valve thrombosis at 2 years (RR=2.70, 95% CI: 1.08-6.71), though no significant association was observed at 30 days, 1 year, or 5 years. Similarly, no significant differences were observed in aortic-valve reintervention rates at 30 days, 2 years, or 5 years, but TAVR showed a significantly increased risk at 1 year (RR=1.98, 95% CI: 1.21-3.24). TAVR was associated with a significantly increased risk of major vascular complications at 30 days (RR=2.37, 95% CI: 1.38-4.04) and a significantly increased risk of TIA at 2 years (RR: 1.43, 95% CI: 1.02-2.00, I2=0%). The risk of hospitalizations was comparable between the groups. TAVR and SAVR demonstrated comparable rates of all-cause death up to 2 years of follow-up. However, at 5 years or longer follow-up, TAVR was associated with a higher risk of all-cause death. While TAVR showed certain procedural advantages, such as a lower risk of major bleeding, AKI, and new-onset or worsening AF, the choice between TAVR and SAVR in patients with low or intermediate surgical risk should consider long-term outcomes, with SAVR potentially being more favorable due to better survival observed on longer follow-up durations.

Transcatheter Aortic Valve Replacement in Low-Risk Patients at Four or More Years

Highlights From the Circulation Family of Journals.

P1851Long-term outcomes of transcatheter versus surgical aortic valve replacement in low risk, elderly patients with severe aortic stenosis

Transcatheter aortic valve replacement (TAVR) has become a mainstay in treatment for patients with severe aortic stenosis who are considered high-risk surgical candidates. The use of TAVR in low-risk patients with severe aortic stenosis is being explored as an alternative to surgical aortic valve replacement (SAVR). Recent results from the Medtronic Evolut Low Risk trial and the Placement of Aortic Transcatheter Valves (PARTNER) 3 trial shed light on the use of TAVR in low-risk surgical candidates. The Evolut Low Risk trial compared TAVR with a self-expanding supra-annular bioprosthesis to SAVR in 1468 patients with severe aortic stenosis who were low surgical risk. Patients with a mean age of 74 and a mean Society of Thoracic Surgeons (STS) risk score of 1.9% were randomized to either TAVR or SAVR groups. Using the composite end point of death or disabling stroke at 24 months, the study found an incidence of 5.3% in the TAVR arm and 6.7% in the surgical arm. The Evolut Low Risk trial thus concluded that TAVR was statistically noninferior but not superior to SAVR (difference, -1.4 percentage points; 95% Bayesian credible interval for the difference, -4.9 to 2.1; posterior probability of noninferiority, >0.999). The PARTNER 3 trial assigned 1,000 patients with severe aortic stenosis and low surgical risk to either TAVR with transfemoral placement of balloon expandable valve or SAVR. Patients with a mean age of 73 and a mean STS score of 1.9% were randomized to either TAVR or SAVR groups. With respect to the primary endpoint of composite death from any cause, stroke, or rehospitalization, the study found an occurrence of 8.5% in TAVR and 15.1% in SAVR, confirming both noninferiority and superiority in the TAVR group [absolute difference, -6.6 percentage points; 95% confidence interval (CI), -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority]. Both the Evolut low risk trial and the PARTNER 3 trial provide evidence that the use of TAVR extends beyond the scope of high and intermediate risk surgical patients and is at the very least equivalent to SAVR in the treatment low-risk surgical candidates when using a transfemoral approach in patients without bicuspid aortic valves. In this article we provide an extensive review on the Evolute low risk and PARTNER 3 trials, including a discussion on clinically relevant outcomes.

Background: Transcatheter aortic valve replacement (TAVR) is an established alternative treatment strategy to surgical aortic valve replacement (SAVR) in select patients with severe aortic stenosis (AS). Obstructive sleep apnea (OSA) is associated with increased perioperative morbidity and mortality. We sought to compare the in-hospital outcomes after SAVR and TAVR in patients with severe AS and OSA. Methods: We identified patients who underwent either SAVR or TAVR in the Nationwide Inpatient Sample (NIS) between 2012 and 2015 using ICD-9-CM procedure codes 35.21, 35.22 and 35.05, 35.06, respectively. We identified OSA with code 327.23. A 1:1 propensity-matched cohort was created to examine the primary endpoint of in-hospital mortality. Secondary endpoints included hospital length of stay (LOS), cost, and post-procedural complications. Results: We identified 1113 matched-pairs of TAVR and SAVR patients. The need for non-invasive ventilation was similar between TAVR and SAVR, respectively (9.3% vs. 10.4%, OR 0.88, p=0.36). However, TAVR patients had fewer respiratory complications, including pneumonia (0.5% vs. 1.3%, OR 0.43, p=0.08), acute respiratory failure (12.8% vs. 23.4%, OR 0.48), re-intubation (3.3% vs. 8.0%, OR 0.40), and tracheostomy (0.5% vs. 3.0%, OR 0.18), all p&lt;0.001. TAVR was also associated with significantly lower rates of acute myocardial infarction (1.9% vs. 4.7%, OR 0.39, p&lt;0.001), bleeding requiring blood transfusion (14.0% vs. 38.0%, OR 0.27, p&lt;0.001), and acute kidney injury (5.1% vs. 7.4%, OR 0.68, p&lt;0.03). However, TAVR did portend a greater risk of permanent pacemaker (PPM) implantation (24.7% vs. 6.8%, OR 4.55, p &lt;0.001). Although in-hospital mortality was similar between TAVR and SAVR (2.8% vs. 2.3%, OR 1.19, p=0.51), TAVR was associated with lower total median cost and shorter LOS ($206,585 vs. $222,805.50, p&lt;0.012 and 5 vs. 8 days, p&lt;0.001, respectively). Conclusions: In patients with severe AS and OSA, in-hospital mortality was comparable between TAVR and SAVR. Aside from higher risk of PPM implantation, TAVR was associated with significantly less post-operative complications, decreased total cost, and shorter LOS. These findings suggest that TAVR may be the preferred option in patients with severe AS and OSA.

The CoreValve US High-Risk Clinical Study compared clinical outcomes and serial echocardiographic findings in patients with severe aortic valve stenosis after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis or surgical aortic valve replacement (SAVR). Eligible patients were randomly assigned 1:1 to TAVR with a self-expanding bioprosthesis or SAVR (N=747). Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, and 1 year after the procedure and were analyzed at a central core laboratory. Compared with SAVR patients (N=357), TAVR patients (N=390) had a lower mean aortic valve gradient, larger valve area, and less patient-prosthesis mismatch (all P<0.001), but more paravalvular regurgitation at discharge, which decreased at 1 year. SAVR patients experienced significant right ventricular systolic dysfunction at discharge and 1 month with normal right ventricular function at 1 year. One-year all-cause mortality was 14.2% for TAVR and 19.1% for SAVR patients. Preimplantation aortic regurgitation ≥mild was associated with reduced mortality hazard for both the TAVR (hazard ratio 0.48, 95% confidence interval 0.27-0.85; P=0.01) and the SAVR groups (hazard ratio 0.53, 95% confidence interval 0.32-0.87; P=0.01). Aortic regurgitation ≥mild after TAVR was associated with increased risk for all-cause mortality (hazard ratio 1.95, 95% confidence interval 1.08-3.53; P=0.03). In patients with severe aortic stenosis at increased surgical risk, TAVR was associated with better systolic valve performance, similar left ventricular remodeling, more paravalvular regurgitation, and less right ventricular systolic dysfunction compared with SAVR. Despite an overall mortality reduction for the TAVR group, ≥mild aortic valve regurgitation after TAVR was associated with an increased mortality hazard. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.

Background Referral rates and outcomes of cardiac rehabilitation have not been evaluated in patients with transcatheter aortic valve replacement or compared with surgical aortic valve replacement. Method A retrospective cohort study was conducted in 488 patients who underwent transcatheter aortic valve replacement ( n = 199) and surgical aortic valve replacement ( n = 289) from a university-based statewide transcatheter aortic valve replacement/surgical aortic valve replacement program during 2015-2017. Cardiac rehabilitation consisted of supervised exercise, diet education, and stress and depression management. We compared changes from baseline in exercise duration and intensity during cardiac rehabilitation sessions, quality-of-life (36-Item Short-Form Health Survey), and psychosocial measures (anxiety, depression, mood, social support, and diet) between transcatheter aortic valve replacement and surgical aortic valve replacement patients using t-test and chi-square analyses. Results Of 488 patients, cardiac rehabilitation referral rates were similar at 41% (transcatheter aortic valve replacement 81/199 versus surgical aortic valve replacement 117/289), but enrollment rates were lower in transcatheter aortic valve replacement (27/199, 14%) versus surgical aortic valve replacement (102/289, 35%, p < 0.01). Among eligible patients, cardiac rehabilitation completion rates were lower in transcatheter aortic valve replacement (12%) than surgical aortic valve replacement (32%). Exercise intensity during cardiac rehabilitation improved in both groups in a similar fashion (transcatheter aortic valve replacement 1.03 ± 1.09 versus surgical aortic valve replacement 1.34 ± 1.15 metabolic equivalents), but increase in exercise duration was higher in transcatheter aortic valve replacement patients versus surgical aortic valve replacement patients (14.52 ± 6.42 versus 10.67 ± 8.38 min, p = 0.02). Improvement in physical composite score was higher in surgical aortic valve replacement versus transcatheter aortic valve replacement (8.72 ± 7.87 versus 2.36 ± 7.6, p = 0.02) while improvement in mental composite score was higher in transcatheter aortic valve replacement (8.19 ± 8.50) versus surgical aortic valve replacement (1.18 ± 7.23, p = 0.02). There was no significant difference between the two groups in improvement in psychosocial measures. Conclusion Cardiac rehabilitation enrollment was low in transcatheter aortic valve replacement patients versus surgical aortic valve replacement patients despite similar referral rates. Improvement in functional and quality-of-life performance was achieved in both transcatheter aortic valve replacement and surgical aortic valve replacement. Future studies should address obstacles for enrollment of transcatheter aortic valve replacement patients.

Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33–0.95; p = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42–1.07; p = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17–0.39; p < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14–0.65; p < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14–0.58; p = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31–11.99; p = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33–9.07; p = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41–1.25; p = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53–1.83; p = 0.96), and MI (RR = 0.75; 95% CI 0.43–1.29; p = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.