Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve System : 30-Day Primary Endpoint Results From the REPRISE II Study

Background

Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR).

Objectives

The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis.

Methods

Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria.

Results

Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 ± 0.2 cm². The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR.

Conclusions

REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance; NCT01627691)     

Imaging and Functional Testing to Assess Clinical and Subclinical Neurological Events After Transcatheter or Surgical Aortic Valve Replacement : A Comprehensive Review

Neurological events after transcatheter (TAVR) or surgical aortic valve replacement (SAVR) are potentially devastating and associated with a poor prognosis. With technological improvements and increased operator experience, their incidence is markedly declining, justifying the need for surrogate endpoints to be used in future comparative trials. Moreover, imaging studies after TAVR and SAVR suggest that neurological events are mainly embolic in nature; however, there is significant discrepancy between imaging findings and clinically overt symptoms, raising the possibility of more subtle subclinical cognitive decline. Different modalities have been used to assess both overt and subclinical neurological events after SAVR and TAVR. The purpose of this report is to systematically review and describe currently used imaging, functional, and neurocognitive testing modalities and to better understand how they could be integrated in future prospective studies.