Introduction Recent series have demonstrated the benefit of trans-catheter edge-to-edge mitral valve repair (TEER) in acutely ill hospitalised patients with severe mitral regurgitation (MR) and intractable heart failure despite intensive intravenous therapy. We describe our cumulative experience with such patients at the Sheba Medical Centre over a 10 year period. Purpose The purpose of this study was to evaluate the safety and efficacy of TEER in hospitalized patients with acute decompensated heart failure and severe MR that was deemed to play a major role in the patients' deterioration. Methods We included 30 hospitalised patients with intractable heart failure and MR ≥3+ (20 males; mean age 74.2±10.6 years; 10 had cardiogenic shock). MR was primary in 4, secondary in 24 and mixed in 2 patients. Acute results were assessed by echocardiography prior to discharge and safety was evaluated clinically, according to the occurrence of procedure-related adverse events. Mortality data were drawn from the national death registry. Results TEER devices were successfully implanted in 28 patients. Early (POD 1) procedure-failure was noted in one patient due to recurrence of flail. There was no peri-procedural mortality. Two patients were hemodynamically unstable during the procedure. One patient had peri-procedural access site bleeding necessitating blood transfusion. Following intervention, 16 patients required ICU care (mean stay 4.8±2.5 days), shock was recorded in 7 patients, 16 required hemodynamic support, and 8 required invasive ventilation. At 30 days 7 patients had died and an additional 4 died 1 to 6 months following intervention. However, mortality in the remaining patients was low with only 3 additional deaths up to 4 years after the procedure (80% of patients alive at 6 months). MR reduction was achieved in 24 patients (to ≤mild in 10 and to moderate in 11). At 12 months follow up MR severity was mild in 3 (37.5%) and moderate in 5 (62.5%) patients. Only 1 patient reported HF rehospitalisation during the year following the procedure. Conclusion TEER for hospitalised patients with severe MR and intractable heart failure is safe, associated with high early mortality, and good long-term outcome for patients alive 6 months after the procedure. More research is needed to better characterise patients likely to benefit from TEER in this clinical scenario. Funding Acknowledgement Type of funding sources: None.
Introduction The COAPT trial established the benefit of trans-catheter edge-to-edge mitral valve repair (TEER) for patients with symptomatic secondary mitral regurgitation (MR). However, patients with severe LV dilatation were excluded from this study. Furthermore, disproportionate LV dilatation has been proposed as a possible explanation for the lack of benefit in the Mitra-FR trial. Purpose The purpose of this study was to evaluate the safety and efficacy of TEER in patients with severe LV dilatation. Methods We categorized patients with secondary MR and severe LV dilatation based on LVEDD/BSA ratio using a cut-off of >3.6cm/m2 in men and >3.7cm/m2 in women. Results We included 121 patients, 25 patients with severe LV dilatation (S) and 96 without (NS). Mean LVEDD was 68.9±6.6mm in the S group vs 58.5±6.5mm in the NS group. Compared to the NS patients, patients with severe LV dilatation were younger (age 69±10 vs 74±10 years), had lower LVEF (37+14% vs 29+7%), and lower GFR (44±21 vs 55±26). There was no significant difference in MR grade (3.3 vs 3.3), however the S group had numerically greater EROA (EROA 0.45 vs 0.35). No significant differences were noted in NYHA class (2.8 vs 2.76) or SPAP (59mmHg for both). Peri-procedural adverse events were rare in both groups. One peri-procedural death was noted, 2 patients underwent urgent dialysis, 1 had cardiogenic shock, and 2 had prolonged ventilation after the procedure, all of these occurred in the NS group. At 1-year follow-up, there was marked improvement in MR grade (2.4±1.4 vs 2.2±1.2 for S and NS respectively). Both groups had a small reduction in LVEDD of about 3mm. Patients in the S group had improved GFR at 1-year follow-up (44±21 to 51±32). No differences were noted in 1, 2, or 5 year mortality between groups (Figures). Conclusion Trans-catheter edge-to-edge mitral valve repair in patients with severe LV dilatation is safe and seems to provide similar short-and long-term outcomes compared to patients with less severe dilatation. Further studies are needed to establish the efficacy of TEER for these patients. Funding Acknowledgement Type of funding sources: None.
Background Transcatheter edge-to-edge mitral valve repair (TEER) has been established as a therapy for severe symptomatic mitral regurgitation (MR) in stable patients, and it has recently emerged as a reasonable option for acutely ill patients. The aim of this study was to evaluate the safety and efficacy of TEER in hospitalized patients with acute decompensated heart failure (HF) and severe MR that was deemed to play a major role in their deterioration. Methods We included 31 patients who underwent emergent TEER for MR ≥ 3+ from 2012 to 2022 at Sheba Medical Center. Outcomes included procedural safety, procedural success, all-cause mortality, HF readmission, and functional improvement. Outcomes were evaluated at 3 months and at 1 year. Data were obtained retrospectively by chart review. Results Implantation of a TEER device was achieved in 97% of patients, and reduction in MR severity of at least two grades and final MR ≤ 2+ at discharge was achieved in 74%. No intra-procedural mortality or life-threatening complications were noted. Mortality at 30 days was 23%. No excess mortality occurred beyond 6 months, with a total mortality of 41%. At 1 year all survivors had MR ≤ 2+, all were free of HF hospitalizations, and 88% were at New York Heart Association class ≤ II. Conclusions Mitral valve TEER for patients with acute decompensated HF and significant MR is safe, feasible, and achieves substantial reduction in MR severity. Despite high early mortality, procedural success is associated with good long-term clinical outcomes for patients surviving longer than 6 months.
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