EXPAND: Next-Generation MitraClip NTR, XTR Safe, Effective For Primary MR Patients
The MitraClip NTR and XTR device systems are safe and effective for patients with primary mitral regurgitation (MR), according to results of the EXPAND trial presented March 30 in a Featured Clinical Research session during ACC.20/WCC.
D. Scott Lim, MD, et al., looked at post-marketing, real-world outcomes of patients with significant primary MR treated with the next-generation MitraClip NTR and XTR systems. The researchers also evaluated MR reduction outcomes and confirmed the safety and effectiveness of the devices for MR treatment.
The study included patients with symptomatic MR (≥3+) who were eligible to receive the MitraClip system based on approved indications. The final study cohort included 422 patients with primary or mixed MR etiology. The implant rate was 99.5% and acute procedural success rate was 94.5%, both higher than in previous analyses. Median fluoroscopy and procedure times were 18 and 82 minutes, respectively. Patients spent a median of one day in the hospital. The MitraClip XTR system was used more frequently to treat primary MR (46.2%), compared with the NTR system (34.8%). In addition, MitraClip XTR or NTR and XTR were used more frequently in patients with severe baseline MR (≥3+).
At 30 days, the all-cause death rate was 2.4%. No patients experienced myocardial infarction at 30 days, while 1.2% experienced stroke and 0.9% had a nonelective cardiovascular surgery to treat device-related complications. In addition, at 30 days, MR reduction to none/trace was achieved in 27.7% of primary MR subjects, while MR ≤1+ was achieved in 86.9% and MR ≤2+ was achieved in 97.3%.
According to the researchers, the study represents the first contemporary report of 30-day clinical outcomes in patients with primary MR treated with the next-generation MitraClip NTR and XTR devices. The researchers note that MR ≤1 was achieved more often with MitraClip NTR and XTR devices than previously reported in earlier trials. The EXPAND trial confirms the safety and efficacy of next-generation MitraClip NTR and XTR device systems in primary MR patients in a contemporary, real-world setting, they conclude.
Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Interventions, Interventions and Structural Heart Disease
Keywords: ACC Annual Scientific Session, acc20, Mitral Valve, Heart Valve Prosthesis Implantation, Heart Valve Diseases, Heart Defects, Congenital
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