Log in to MyACC
Long-Term Outcomes of TAVR: REPRISE III Analysis
Quick Takes
- The current study compared 5-year outcomes among high-risk patients undergoing TAVR using the mechanical Lotus valve (no longer commercially available) vs. the self-expanding CoreValve/EvolutR.
- Regardless of valve used, slightly over one-half of the patients died and about 10% had a disabling stroke during 5 years of follow-up.
- The Lotus valve was associated with nearly a 40% permanent pacemaker rate (vs. 27%) and significantly higher rates of prosthetic valve thrombosis.
Study Questions:
What are 5-year outcomes comparing the mechanically expanded Lotus valve with the self-expanding CoreValve transcatheter platforms?
Methods:
This prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021. Valve Academic Research Consortium-2 endpoints, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up.
Results:
A total of 912 patients (mean [standard deviation] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group versus 52.8% in the CoreValve/EvolutR group (p = 0.59). Disabling stroke was less frequent with the Lotus valve versus CoreValve/EvolutR (cumulative event rates, 8.3% vs. 12.2%; p = 0.04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs. 15.3%; p = 0.38). Insertion of a new permanent pacemaker (PPM) (38.9% vs. 27.3%; p < 0.001) and detection of prosthetic aortic valve thrombosis (5.8% v.s 1.8%; p = 0.007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs. 2.6%; p < 0.001) and required the use of a second valve (1.0% vs. 3.8%; p < 0.001) during the procedure compared with those who received the CoreValve/EvolutR. Compared with the Lotus valve group, the CoreValve/EvolutR group had a significantly lower mean (standard deviation) aortic gradient (7.8 [4.2] mm Hg vs. 12.6 [6.7] mm Hg; p < 0.001) and larger valve areas (1.57 [0.56] cm2 vs. 1.42 [0.42] cm2; p = 0.10).
After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs. 0%; p = 0.31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs. 7.8%; p = 0.006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups.
Conclusions:
The authors concluded the REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective.
Perspective:
This final 5-year analysis from the REPRISE III trial compared the mechanical Lotus valve (no longer commercially available) to the self-expanding CoreValve/EvolutR TAVR platform. Regardless of valve used, slightly over one-half of the patients died and about 10% had a disabling stroke during 5 years of follow-up. The Lotus valve was associated with nearly a 40% PPM rate and significantly higher rates of prosthetic valve thrombosis. These findings add important information regarding long-term outcomes among patient undergoing TAVR using earlier iterations of the valve.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Pacemaker, Artificial, Risk Factors, Stroke, Thrombosis, Transcatheter Aortic Valve Replacement, Vascular Diseases
< Back to Listings
