Background— The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. Methods and Results— Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0–10 days; 4.1% of strokes) and a late phase (11–365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m 2 ), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke. Conclusions— Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR. Clinical Trial Registrations— URL: http://www.clinicaltrials.gov . Unique identifiers: NCT01240902, NCT01531374.

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.

BACKGROUND:In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery. OBJECTIVES:This study sought to determine whether this clinical benefit was sustained over time. METHODS:Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure. RESULTS:A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group. CONCLUSIONS:Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve(®) System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

BACKGROUND The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis.OBJECTIVES Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained.METHODS Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1: 1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients.RESULTS A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01).CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902) (C) 2015 by the American College of Cardiology Foundation.

OBJECTIVE:Cardiac surgical mortality has improved during the last decade despite the aging of the population. An integrated US health plan developed a heart valve registry to track outcomes and complications of heart valve operations. This database was used for longitudinal evaluation of mitral valve (MV) outcomes from 1999 to 2008 at four affiliated hospitals.METHODS:We identified 3130 patients in the Apollo database who underwent 3180 initial MV procedures. Internal administrative and Social Security Administration databases were merged to determine survival rates. Electronic health records were searched to ascertain demographics, comorbidities, and postoperative complications. Cox regression was used to evaluate mean survival and identify risk factors.RESULTS:The procedures included 1160 mechanical valve replacements, 1159 tissue valve replacements, and 861 annuloplasties. The mean age of patients undergoing these procedures was 58 ± 11 years, 69 ± 12 years, and 62 ± 12 years, respectively. Mean survival was 8.9 ± 0.1 years for mechanical valve replacement, 7.0 ± 0.1 years for tissue valve replacement, and 7.7 ± 0.1 years for annuloplasty. Early in the study, there was a preference for implanting mechanical MVs. Beginning in 2003, more patients received tissue valve replacements rather than mechanical valves. Over time, there was an increasing trend of annuloplasty. Cox regression analysis identified the following risk factors for increased ten-year mortality: tissue valve implantation; advanced age; female sex; nonelective, nonisolated procedure; diabetes; postoperative use of banked blood products; previous cardiovascular intervention; dialysis; and longer perfusion time. Hospital location, reoperation, preoperative anticoagulation, and cardiogenic shock were not statistically significant risk factors.CONCLUSIONS:When controlling for other risk factors, we observed a lower long-term survival rate for tissue valve replacement compared with mechanical valve replacement. Integrating electronic health records with existing electronic databases provided near-real-time analysis of longitudinal cardiac surgical outcomes.

Survival estimates of patients with aortic dissection commonly come from tertiary care centers; such estimates may be biased by referral and selection bias. The survival of unselected patients with aortic dissection by gender in the community remains poorly defined. Aortic dissection cases were