Outcomes in the Randomized CoreValve US Pivotal High Risk Trial in Patients With a Society of Thoracic Surgeons Risk Score of 7% or Less.

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.

Surgical ventricular remodeling for patients with clinically advanced congestive heart failure and severe left ventricular dysfunction.

BACKGROUND: Surgical ventricular remodeling (SVR) is an accepted therapy for post-infarction ventricular remodeling. Current literature on SVR outcomes has focused on heterogeneous populations with regard to left ventricular function and New York Heart Association (NYHA) class. We assessed outcomes after SVR in patients with advanced congestive heart failure (CHF) (NYHA Class III/IV) and a pre-operative ejection fraction (EF) < or =20%. METHODS: Data were analyzed for 51 consecutive SVR patients from January 2002 to June 2004. Cardiac catheterization, echocardiography and magnetic resonance imaging (MRI) identified 62.7% (32 of 51) of patients with an EF < or =20%, with the majority having an EF < or =15% (65.6%; 21 of 32). Cox regression analysis was performed to determine predictors of mortality in patients with an EF < or =20%. Follow-up was 100% (32 of 32) complete. RESULTS: Mean age was 61.9 +/- 10.3 (range 40 to 80) years with a male:female ratio of 27:5. Operative mortality was 6.3% (2 of 32). Twenty-two percent (7 of 32) had concomitant mitral valve procedures. Follow-up demonstrated a statistically significant improvement in left ventricular volumes and EF in survivors. Cox regression analysis identified the following to be significant predictors of mortality: pre-operative left ventricular end-systolic volume index >130 ml/m2; pre-operative diabetes; and intra-aortic balloon pump usage. Pre-operatively, all patients (32 of 32) were categorized as NYHA Class III/IV, with 69% (22 of 32) improving to NYHA Class I/II at follow-up (p < 0.01). Survival did not differ statistically between patients with an EF < or =20% and an EF >20% (n = 19). CONCLUSIONS: Our results indicate that SVR improves left ventricular function and functional status for patients with advanced CHF and a pre-operative EF < or =20%. Therefore, SVR is a viable surgical alternative for patients with severe left ventricular dysfunction.