Combined strategy of transcatheter edge-to-edge repair of mitral valve and percutaneous mechanical circulatory support device to treat high-risk patients with severe mitral regurgitation and cardiogenic shock.

BACKGROUND: Acute mitral regurgitation (MR) associated with cardiogenic shock (CS) is a medical emergency with excessive in-hospital mortality. The vast majority of these patients are turned down for corrective surgery. The combined strategy of transcatheter edge-to-edge repair of mitral valves and percutaneous mechanical circulatory support devices to treat high-risk patients with severe mitral regurgitation and cardiogenic shock has not been evaluated in randomized controlled trials.

AIMS: In this multicenter registry we aimed to assess the outcomes (all-cause mortality, other important secondary outcomes included freedom from 30-day cardiac death or cardiac readmission, 30-day all-cause mortality, 30-day cardiovascular mortality, and 30-day MACE events) of the combined strategy of Transcatheter Edge-to-Edge Repair of Mitral Valve and Percutaneous Mechanical Circulatory Support Device to Treat High-Risk Patients with Severe Mitral Regurgitation and Cardiogenic Shock.

METHODS: This multicenter registry retrospectively evaluated all consecutive patients who presented with severe MR, had persistent cardiogenic shock (CS) despite appropriate therapy (including mechanical circulatory support [MCS]), were turned down for surgery due to operative risk from acuity at presentation, and were considered for TEER by a heart team.

RESULTS: Twenty-one consecutive patients with severe acute or acute-on-chronic MR (anatomy suitable for M-TEER) and CS who were undergoing TEER after surgical turndown were included. Mean age was 63 years (SD ± 12.4), 71 % males, mean Society of Thoracic Surgeons Score predicted risk of mortality (STS-PROM) was 20.1 ± 19.2 % (range: 3.1 to 82), 71 % required mechanical ventilation, 52 % had pulmonary edema, 48 % had index acute myocardial infarction (AMI), 19 % required dialysis, 100 % had Impella™ in place. Immediate procedural outcomes included 100 % technical success, MR grade 1.2+ (mild, p < 0.001), and no events for device-device interaction were observed. The primary outcome of in-hospital all-cause mortality was 4.7 % (1 death from multiorgan failure). All-cause mortality at 30 days was 14 %, and three patients died. The procedural success rate was 81 %, with one readmission for DVT that was treated with oral anticoagulation, and none of the patients required mitral valve reintervention at 30-day follow up. Echocardiography at 30 days revealed an MR grade of ≤2+ (mild or moderate) in 94 %, and mean LVEF improved from baseline to 30 days (24.3 ± 11.3 % vs 30.5 ± 14 % respectively) (p = 0.001).

CONCLUSIONS: Patients with severe mitral regurgitation and cardiogenic shock, who are at high risk for surgery, were treated with a combined approach of percutaneous mechanical circulatory support and transcatheter edge-to-edge repair of MV. We found this approach safe and it effectively improved mortality and symptoms. Larger studies and clinical trials are required to evaluate the effectiveness of this combined approach prospectively.