Faculty Bibliography

AIMS: Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV). METHODS AND RESULTS: Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm2. CONCLUSIONS: The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation. TRIAL REGISTRATION: ClinicalTrials.gov #NCT01314313.

OBJECTIVES: The study sought to examine the feasibility, safety, and intermediate-term outcomes in patients undergoing percutaneous transvenous transcatheter mitral valve implantation in failed bioprosthesis, ring annuloplasty, and calcific mitral stenosis. BACKGROUND: Surgical mitral valve replacement in patients with previous surgery or severe mitral annular calcification (MAC) is often associated with high or prohibitive risk. METHODS: Percutaneous transfemoral antegrade transseptal implantation of Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California) was performed in 48 patients with degenerated mitral bioprosthesis (n = 33), previous ring annuloplasty (n = 9), and severe MAC (n = 6). RESULTS: The mean Society of Thoracic Surgeons risk score was 13.2 +/- 7.4% with a mean age 76 +/- 11 years. Acute procedural success was achieved in 42 of 48 patients (88%) in the overall group and 31 of 33 (94%) in the failed bioprosthetic mitral valve group and success rate of 11 of 15 (73%) in patients with failed annuloplasty rings and MAC. After successful procedure, no patients had > mild residual mitral prosthetic or periprosthetic regurgitation; mean transvalvular gradients were 6 +/- 2.5 mm Hg. Thirty-day survival free of death and cardiovascular surgery was 85% in the overall group and 91% in the failed bioprosthetic mitral valve subgroup. CONCLUSIONS: Transfemoral percutaneous transvenous mitral valve implantation in high-risk patients with degenerated bioprosthesis is safe, effective, and associated with rapid improvement in hemodynamics, short length of stays, and improved functional status. Percutaneous mitral valve implantation in patients with failed annuloplasty rings and severe MAC is a promising therapy with significant short-term morbidity and mortality that requires further study.

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.