Faculty Bibliography
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239
DIRECT HOME DISCHARGE AND LIKELIHOOD OF 30-DAY HOSPITAL READMISSION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR): FINDINGS FROM THE STS/ACC TVT REGISTRY [Meeting Abstract]
ISI:000397342301755
ISSN: 1558-3597
CID: 2528922
Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study
OBJECTIVES: This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement. BACKGROUND: A novel self-expandable TAV bioprosthesis was designed to provide a low-profile delivery system, conformable annular sealing, and the ability to resheath and reposition during deployment. METHODS: The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. An independent echocardiography laboratory was used to evaluate hemodynamic outcomes. RESULTS: Patients were elderly (83.3 +/- 7.2 years of age) and had high surgical risk (Society of Thoracic Surgeons predicted risk of mortality of 7.4 +/- 3.4%). The majority of patients (89.5%) were treated by iliofemoral access. Resheathing or recapturing was performed in 22.6% of patients; more than 1 valve was required in 3 patients (1.3%). The 30-day outcomes included all-cause mortality (2.5%), disabling stroke (3.3%), major vascular complications (7.5%), life-threatening or disabling bleeding (7.1%), and new permanent pacemaker (16.4%). AV hemodynamics were markedly improved at 30 days: the mean AV gradient was reduced from 48.2 +/- 13.0 mm Hg to 7.8 +/- 3.1 mm Hg (p < 0.001) and AV area increased from 0.6 +/- 0.2 cm2 to 1.9 +/- 0.5 cm2 (p < 0.001). Moderate residual paravalvular leak was identified in 5.3% of patients. CONCLUSIONS: We conclude that this novel self-expanding TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery. (Medtronic CoreValve Evolut R U.S. Clinical Study; NCT02207569).
PMID: 28183466
ISSN: 1876-7605
CID: 2437492
Sex-Specific Differences After Transcatheter or Surgical Aortic Valve Replacement in Intermediate Risk Patients: An Analysis from the PARTNER 2 Randomized Trial [Meeting Abstract]
ISI:000398590400212
ISSN: 0735-1097
CID: 3589372
Transcatheter Aortic Valve Replacement with a Repositionable Self-expanding Bioprosthesis in Patients With Severe Aortic Stenosis at High Risk for Surgery: One-Year Results from the Evolut R US Pivotal Study [Meeting Abstract]
ISI:000397332900038
ISSN: 0735-1097
CID: 3589362
Journal of thoracic & cardiovascular surgery. 2016:152(5):e103-e104.DOI: 10.1016/j.jtcvs.2016.07.057
Rethinking the gold standard of correction for paravalvular leak: Why correct when you can prevent?
PMID: 27663523
ISSN: 1097-685x
CID: 2255082
Evaluation of Flow After Transcatheter Aortic Valve Replacement in Patients With Low-Flow Aortic Stenosis: A Secondary Analysis of the PARTNER Randomized Clinical Trial
Importance: Low-flow (LF) severe aortic stenosis (AS) is an independent predictor of mortality in patients undergoing aortic valve replacement (AVR). Little is known about improvement in flow after AVR and its effects on survival. Objective: To determine whether higher flow (left-ventricular stroke volume index [LVSVI]) after transcatheter AVR (TAVR) would indicate better clinical outcomes in this at-risk population. Design, Setting, and Participants: A substudy analysis of data from the Placement of Aortic Transcatheter Valves (PARTNER) randomized clinical trial and continued-access registry was conducted. A total of 984 participants with evaluable echocardiograms and baseline LF AS (LVSVI
PMID: 27437665
ISSN: 2380-6591
CID: 2185412
Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis
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.
PMID: 27190101
ISSN: 1522-9645
CID: 2112172
Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification
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.
PMID: 27085576
ISSN: 1876-7605
CID: 2079852
Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis
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.
PMID: 27053442
ISSN: 1474-547x
CID: 2066202
Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation
BACKGROUND:In a trial comparing coronary-artery bypass grafting (CABG) alone with CABG plus mitral-valve repair in patients with moderate ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI) or survival after 1 year. Concomitant mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation, but patients had more adverse events. We now report 2-year outcomes. METHODS:We randomly assigned 301 patients to undergo either CABG alone or the combined procedure. Patients were followed for 2 years for clinical and echocardiographic outcomes. RESULTS:At 2 years, the mean (±SD) LVESVI was 41.2±20.0 ml per square meter of body-surface area in the CABG-alone group and 43.2±20.6 ml per square meter in the combined-procedure group (mean improvement over baseline, -14.1 ml per square meter and -14.6 ml per square meter, respectively). The rate of death was 10.6% in the CABG-alone group and 10.0% in the combined-procedure group (hazard ratio in the combined-procedure group, 0.90; 95% confidence interval, 0.45 to 1.83; P=0.78). There was no significant between-group difference in the rank-based assessment of the LVESVI (including death) at 2 years (z score, 0.38; P=0.71). The 2-year rate of moderate or severe residual mitral regurgitation was higher in the CABG-alone group than in the combined-procedure group (32.3% vs. 11.2%, P<0.001). Overall rates of hospital readmission and serious adverse events were similar in the two groups, but neurologic events and supraventricular arrhythmias remained more frequent in the combined-procedure group. CONCLUSIONS:In patients with moderate ischemic mitral regurgitation undergoing CABG, the addition of mitral-valve repair did not lead to significant differences in left ventricular reverse remodeling at 2 years. Mitral-valve repair provided a more durable correction of mitral regurgitation but did not significantly improve survival or reduce overall adverse events or readmissions and was associated with an early hazard of increased neurologic events and supraventricular arrhythmias. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).
PMID: 27040451
ISSN: 1533-4406
CID: 5451202
