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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 .).

Importance: Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk., Objective: The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR., Design, Setting, and Participants: The CoreValve US Pivotal High Risk Trial was a multicenter, randomized, noninferiority trial. This retrospective analysis evaluated patients who underwent an attempted implant and had an STS PROM of 7% or less. The trial was performed at 45 US sites. Patients had severe aortic stenosis and were at increased surgical risk based on their STS PROM score and other risk factors., Interventions: Eligible patients were randomly assigned (1:1) to self-expanding TAVR or to SAVR., Main Outcomes and Measures: We retrospectively stratified patients by the overall median STS PROM score (7%) and analyzed clinical outcomes and quality of life using the Kansas City Cardiomyopathy Questionnaire in patients with an STS PROM score of 7% or less., Results: The mean (SD) ages were 81.5 (7.6) years for the TAVR group and 81.2 years (6.6) for the SAVR group. A little more than half were men (57.9% in the TAVR group and 55.8% in the SAVR group). Of 750 patients who underwent attempted implantation, 383 (202 TAVR and 181 SAVR) had an STS PROM of 7% or less (median [interquartile range]: TAVR, 5.3% [4.3%-6.1%]; SAVR, 5.3% [4.1%-5.9%]). Two-year all-cause mortality for TAVR vs SAVR was 15.0% (95% CI, 8.9-10.0) vs 26.3% (95% CI, 19.7-33.0) (log rank P = .01). The 2-year rate of stroke for TAVR vs SAVR was 11.3% vs 15.1% (log rank P = .50). Quality of life by the Kansas City Cardiomyopathy Questionnaire summary score showed significant and equivalent increases in both groups at 2 years (mean [SD] TAVR, 20.0 [25.0]; SAVR, 18.6 [23.6]; P = .71; both P < .001 compared with baseline). Medical benefit, defined as alive with a Kansas City Cardiomyopathy Questionnaire summary score of at least 60 and a less than 10-point decrease from baseline, was similar between groups at 2 years (TAVR, 51.0%; SAVR, 44.4%; P = .28)., Conclusions and Relevance: Self-expanding TAVR compares favorably with SAVR in high-risk patients with STS PROM scores traditionally considered intermediate risk., Trial Registration: Clinicaltrials.gov Identifier: NCT01240902.

Objectives: The CoreValve Extreme Risk US Pivotal Trial enrolled patients with symptomatic severe aortic stenosis deemed unsuitable for surgical aortic valve replacement. Implants were attempted using transfemoral access (n = 489) or an alternative access (n = 150). In present analysis, we sought to examine the safety and efficacy of CoreValve transcatheter aortic valve replacement using alternative access., Methods: The present study included 150 patients with prohibitive iliofemoral anatomy who were treated with the CoreValve transcatheter heart valve delivered by way of the subclavian artery (n = 70) or a direct aortic approach (n = 80). The echocardiograms were read by an independent core laboratory. The primary endpoint was all-cause mortality or major stroke at 12 months., Results: The preoperative aortic valve area was 0.72 ± 0.27 cm(2) and mean aortic valve gradient was 49.5 ± 17.0 mm Hg. After the transcatheter aortic valve replacement, the effective aortic valve area was 1.82 ± 0.64 cm(2) at 1 month and 1.85 ± 0.51 cm(2) at 12 months. The mean aortic valve gradient was 9.7 ± 5.8 mm Hg at 30 days and 9.5 ± 5.7 mm Hg at 12 months. The death or major stroke rate was 15.3% at 30 days and 39.4% at 12 months. The individual rate of all-cause mortality and major stroke was 11.3% and 7.5% at 30 days and 36.0% and 9.1% at 12 months., Conclusions: These data demonstrate that the CoreValve transcatheter heart valve delivered by an alternative access provides a suitable alternative for treatment of extreme risk patients with symptomatic severe aortic stenosis, who have prohibitive iliofemoral anatomy and no surgical options., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Post-operative atrial fibrillation (POAF) is common after aortic valve replacement (AVR) and is associated with worse outcomes. We performed a meta-analysis of randomized controlled trials comparing Surgical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) for incidence of POAF at 30 days. Methods: We searched databases from 1/1/1990 to 1/1/2020 for randomized studies comparing TAVR and SAVR. POAF was defined as either worsening or new-onset atrial fibrillation. Random effects model was used to estimate the risk of POAF with TAVR vs SAVR in all trials, and in subgroups (low, intermediate, high risk, and in self-expandable vs balloon expandable valves). Sensitivity analysis was performed including only studies reporting new-onset atrial fibrillation Results: Seven RCTs were identified that enrolled 7,934 patients (3,999 to TAVR and 3,935 to SAVR). The overall incidence of POAF was 9.7% after TAVR and 33.3% after SAVR. TAVR was associated with a lower risk of POAF compared with SAVR (OR 0.21 [0.18-0.24]; P < 0.0001). Compared with SAVR, TAVR was associated with a significantly lower risk of POAF in the high-risk cohort (OR 0.37 [0.27-0.49]; P < 0.0001), in the intermediate-risk cohort (OR 0.23 [0.19-0.28]; P < 0.0001), low-risk cohort (OR 0.13 [0.10-0.16]; P < 0.0001). Sensitivity analysis of 4 trials including only new-onset POAF showed similar summary estimates (OR 0.21, 95% CI [0.18-0.25]; P< 0.0001). Conclusions: TAVR is associated with a significantly lower risk of post-operative atrial fibrillation compared with SAVR in all strata. Further studies are needed to identify the contribution of post-operative atrial fibrillation to the differences in clinical outcomes after TAVR and SAVR. [ABSTRACT FROM AUTHOR]