Early Results of a Real-World Cohort of Patients Receiving Transcatheter Mitral Valve Implantation Using Dedicated Devices

 

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Objectives: To date transcatheter mitral valve implantation (TMVI) has mostly been performed in the context of highly selective early feasibility trials (EFTs). This study reports early single-center experience in a real-world TMVI cohort outside study protocol restrictions.

Methods: From 2016 to 2020, a total of 37 patients received TMVI treatment at our site. Of these, 13 patients were treated using the Tendyne (Abbott Medical, Illinois, USA; n = 9) or TIARA (Neovasc Inc., British Columbia, Canada; n = 4) transapical TMVR systems as part of compassionate use programs or as early commercial implants by an interdisciplinary heart team in a hybrid OR. After informed consent was given clinical and echocardiographic data were prospectively collected at baseline, discharge and follow-up.

Result: All patients (median age: 77 years, 66.7% female) were severely symptomatic (NYHA III/IV) and were classified as high surgical risk (logEuroSCORE II 8.1%, STS Score 4.1%). Mitral regurgitation (MR) etiology was primary (46.2%), secondary (38.5%) or mixed (15.4%). Reduced stroke volume index (<35 mL/min) was found in 53.8% of patients. Reasons for trial screen failure in noncommercial implants were impaired RV function, three moderate TR and status post aortic valve replacement, in 72.7, 63.6, and 63.6%, respectively. Severe mitral annulus calcification was present in four patients.

Procedural success rate was 100% and all patients were extubated immediately in the OR. Median procedure time was 150 minutes. Cardiac index as assessed by Swan Ganz catheterization increased from 1.71 L/min/m² before to 1.85 L/min/m² after TMVI (median, p = 0.06) and sPAP was significantly reduced from 48 to 38 mm Hg (median, p = 0.008). Echocardiography at discharge demonstrated trace/no valvular MR in all patients, in one patient mild paravalvular leakage was found, and low mean transmitral gradients with a median of 3.0 mm Hg. Furthermore, LVEDV was reduced significantly from 114.6 to 86.5 mL (median, p = 0.03). Symptomatic relief with NYHA class of £ II was achieved in the majority of patients. Mortality was 0.0% after 30 days (n = 0/11) and 18.2% (n = 2/11) at 6 months with 1 cardiovascular death.

Conclusion: In this real-world TMVI cohort of selected patients, acute safety and efficacy and favorable hemodynamic outcomes were demonstrated. TMVI may further complement treatment algorithms for high-risk patients with severe MR if these preliminary results are confirmed in larger patient cohorts.

Publication History

Article published online:
19 February 2021

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