One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis

Abstract

Background:In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the lowprofile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Methods:Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. results: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. conclusions:In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.

Minimally invasive aortic valve replacement—where are we?

“…Over the years, the larger sheaths employed during deployment of the older generation valves have been replaced with the low-profile delivery mechanisms both for the balloon-expandable and self-expandable valves. This was seen in the Sapien 3 (S3) observational study which found comparable rates of vascular complications between TAVR with the low profile S3 valve and SAVR (9,10). The S3 valve also carries the advantage of the polytetrafluoroethylene (PTFE) skirt which has been shown to reduce the rates of PVR, a feature not present in the earlier generation Sapien valves (9,10 The Evolut R valve, the newer generation self-expandable valve, carries the benefit of a low profile delivery, which will likely transfer into a lower risk of vascular complications as well.…”

“…This was seen in the Sapien 3 (S3) observational study which found comparable rates of vascular complications between TAVR with the low profile S3 valve and SAVR (9,10). The S3 valve also carries the advantage of the polytetrafluoroethylene (PTFE) skirt which has been shown to reduce the rates of PVR, a feature not present in the earlier generation Sapien valves (9,10 The Evolut R valve, the newer generation self-expandable valve, carries the benefit of a low profile delivery, which will likely transfer into a lower risk of vascular complications as well. In addition, the repositionable and retrievable nature of the Evolut R valve gives operators an additional level of confidence while deploying the percutaneous valves (Figure 1).…”

“…Although the rates of neurological complications for SAVR have been relatively stable over the years, the rates of neurological complications with TAVR have steadily declined since the initial reports from the PARTNER trial (9,10). A meta-analysis evaluating the trend in the rates of neurological complications for patients undergoing TAVR found a significant decline in rates of stroke attributable to improved valve designs and operator experiences (11).…”

Aortic Valve Annular Sizing

“…Postoperative peak and mean gradients were similar between Medtronic and Edwards Lifesciences' valves (peak 28.6±2.2 versus 25.7±1.7 mm Hg; P=0.27, mean 14.6±1.0 versus 13.5±0.9; P=0.43, respectively; data not displayed in tables). For comparison, the mean gradient from the 1-year PARTNER 3 High Risk Registry for the SAPIEN 3 valve was 12.9 mmHg for a size 23 valve, 10.6 mmHg for a size 26 valve, and 9.1 mmHg for a size 29 valve at 30 days 13 ; the mean gradient from the 3-year CoreValve Pivotal High Risk Trial similarly showed a mean composite gradient of all valve sizes of 7.62±3.57 mm Hg. 14 There was no significant difference in ellipticity between the groups.…”

Von Willebrand factor, paravalvular leak, and a new vista for TAVR

“…The study was confined to patients treated with a Sapien XT valve. This valve has largely been supplanted by the Sapien S3 valve, whose annular skirt appears to have reduced the frequency of aortic regurgitation significantly (12), as has the design of other new valves (13). Additionally, neither HMW-multimer ratios nor CT-ADP have been assessed in patients treated with self-expanding valves.…”