The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures.

BACKGROUND: Clinical evidence is commonly obtained through individual trials that are time-, cost- and resource-consuming, and which often leave unanswered clinically relevant questions. Umbrella studies have been developed to address the need for more efficient and flexible trial structures, predominantly for cancer treatments. The umbrella concept foresees data collection within a unifying trial structure, to which one or more substudies may be added at any time to address product- or therapy-specific questions. To our knowledge, the umbrella concept has not yet been used in the medical device area, but it may offer similar advantages as in other settings, particularly in areas where multiple therapies are available within one large treatment area. METHODS: The MANTRA study (NCT05002543) is a prospective, global, post-marketing clinical follow-up study. The aim is to collect safety and device performance data covering the Corcym cardiac surgery portfolio for the treatment of aortic, mitral, and tricuspid valve diseases. The study uses a master protocol that outlines the main common parameters, and the specific questions are addressed in three substudies. The primary endpoints are device success at 30 days. Secondary endpoints include safety- and device performance-related data at 30 days, 1 year, and then annually through to 10 years. All endpoints are defined according to the more recent guidelines for heart valve procedures. Additionally, procedure and hospitalization information are collected, including Enhanced Recovery after Surgery in sites using such protocols, and patient outcome measures such as New York Heart Association classification and quality-of-life questionnaires. RESULTS: The study started in June 2021. Enrollment in all three substudies is ongoing. CONCLUSIONS: The MANTRA study will provide contemporary information on the long-term outcomes of medical devices for the treatment of aortic, mitral, and tricuspid heart valve diseases in routine clinical practice. The umbrella approach adopted in the study has the potential of longitudinally assessing long-term efficacy of the devices and the flexibility to investigate new research questions as they arise.

The sutureless aortic valve at 1 year: A large multicenter cohort study.

OBJECTIVE: Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year. METHODS: From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%. RESULTS: One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up. CONCLUSIONS: The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.