Log in to MyACC
Transcatheter Mitral Valve Replacement Outcomes in Severe MR
Quick Takes
- Among 100 high-risk patients with severe, symptomatic mitral regurgitation who were selected to undergo transcatheter mitral valve replacement via transapical approach, 39 had died at 2 years postintervention.
- The annualized rate of heart failure hospitalization at 2 years postprocedure was 0.51 events per patient-year, compared with 1.30 in the 6 months prior to intervention (p < 0.0001).
- No structural valve deterioration was observed at 2 years postintervention.
Study Questions:
What are the 2-year outcomes of transcatheter mitral valve replacement (TMVR) in severe symptomatic mitral regurgitation (MR)?
Methods:
The Expanded Clinical Study of the Tendyne Mitral Valve System is a prospective, international, nonrandomized study of the Tendyne Mitral Valve System, a valve deployed transapically without cardiopulmonary bypass. The first 100 patients enrolled in the study were included in this analysis. Inclusion criteria were grade 3+ or 4+ native MR, symptomatic heart failure (New York Heart Association [NYHA] class II or greater), and high surgical risk. Notable exclusion criteria were left ventricular (LV) end-diastolic diameter >70 mm, LV ejection fraction <30%, severe mitral annular or leaflet calcification, left atrial or LV thrombus, severe tricuspid regurgitation, severe right ventricular (RV) dysfunction, and severe pulmonary hypertension (pulmonary artery systolic pressure >70 mm Hg).
Valve implantation was performed via left anterolateral thoracotomy with general anesthesia. Postoperatively, patients received warfarin anticoagulation for 3 months (international normalized ratio goal, 2.5-3.5), as six thrombotic events occurred early in the study and prompted a change in protocol. Clinical and echocardiographic follow-up was performed at 1, 3, 6, and 12 months postintervention and annually thereafter. Outcomes of interest included all-cause and cardiovascular mortality, heart failure hospitalization (HFH), and MR grade.
Results:
Of the 100 patients in the study cohort (mean age 74.7 ± 8.0 years, 69% male, Society of Thoracic Surgeons perioperative risk of mortality 7.8 ± 5.7%), 89% had secondary MR or mixed pathology. Mitral prostheses were successfully implanted in 97 patients. No intraprocedural deaths occurred, but six patients died prior to hospital discharge, and 17 died within 90 days postintervention. At 2 years, 39 patients had died (34 cardiovascular deaths), and 12 had withdrawn from the study or missed their follow-up visits; the remaining 49 patients completed 2-year follow-up evaluation. The cumulative number of patients requiring HFH at 2 years was 37. The annualized rate of HFH at 2 years postprocedure was 0.51 (interquartile range [IQR], 0.36-0.72) events per patient-year, compared with 1.30 (IQR, 0.93-1.81) in the 6 months prior to intervention (p < 0.0001).
Regarding device-specific adverse events, no patients had structural valve deterioration, and five patients required reintervention (four in the first postprocedural year) for paravalvular leak (two patients), valve malposition or migration (two patients), and endocarditis (one patient). At 2 years, 41 patients (93.2%) had no MR, and the remaining three patients (6.8%) had grade 1+ MR. Mitral valve mean gradient at 2 years was 3.21 ± 1.37 mm Hg, not significantly changed from baseline postintervention. Paired comparison showed that mean LV ejection fraction decreased from 45.6 ± 9.4% at baseline to 39.8 ± 9.5% at 2 years (p = 0.001), and estimated RV systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (p = 0.005). Prior to intervention, 66/100 (66%) patients were in NYHA class III or IV, whereas at 2-year follow up, 40/49 surviving patients (81.6%) were in NYHA class I or II.
Conclusions:
In selected high-risk patients with severe symptomatic MR, TMVR resulted in reduced MR severity, symptomatic improvement, and lower risk of HFH at 2 years postintervention. Mortality was highest during the first 90 days postintervention. No structural valve deterioration was observed.
Perspective:
The 30-day and 1-year outcomes of this study have been published previously (Muller et al., J Am Coll Cardiol 2017;69:381-91 and Sorajja et al., J Am Coll Cardiol 2019;73:1250-60, respectively). The fact that structural valve deterioration was not observed at the 2-year mark is encouraging. This was a single-arm, nonrandomized study, excluding patients with extensive mitral valve calcification. The ongoing SUMMIT study (clinicaltrials.gov; NCT03433274), randomizing patients to Tendyne TMVR or MitraClip transcatheter edge-to-edge repair (TEER), will help establish the anatomic and clinical characteristics that predict success with these two therapies.
Clinical Topics: Anticoagulation Management, Cardiac Surgery, Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Valvular Heart Disease, Vascular Medicine, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Pulmonary Hypertension, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Echocardiography/Ultrasound, Hypertension, Mitral Regurgitation
Keywords: Anticoagulants, Blood Pressure, Cardiac Surgical Procedures, Echocardiography, Endocarditis, Geriatrics, Heart Failure, Heart Valve Diseases, Hypertension, Pulmonary, Mitral Valve Insufficiency, Patient Discharge, Prostheses and Implants, Stroke Volume, Thoracotomy, Thrombosis, Tricuspid Valve Insufficiency
< Back to Listings
