Transcatheter Mitral Valve-in-Valve and Valve-in-Ring Replacement in High-Risk Surgical Patients: Feasibility, Safety, and Longitudinal Outcomes in a Single-Center Experience.

BACKGROUND: Transcatheter mitral valve-in-valve (TMVIV) or valve-in-ring (TMVIR) replacement has shown early promise in patients deemed poor surgical candidates as a less invasive alternative to conventional reoperative mitral valve (MV) replacement.
OBJECTIVE: This retrospective, single-center study reviewed the procedural outcomes of all TMVIV and TMVIR procedures between 2013-2018 at a large tertiary referral center serving the southeastern United States. An analysis of patient safety measures was also performed, with a retrospective assessment of relative procedural safety that included preoperative risk stratification and postoperative mortality predictors, operative time, average blood loss, length of hospital stay, and readmission rates.
METHODS: This study included 24 patients with severe MV disease and medical comorbidities who were considered too high risk for conventional MV replacement. All patients underwent TMVIV or TMVIR with Edwards Sapien XT or S3 transcatheter valves (Edwards Lifesciences). A secure database of patient demographics, preoperative risk assessment, and procedural data was created and included technical success rates, blood loss, operative time, and intraoperative and immediate postoperative complications. Subsequent follow-up of patient outcomes reported here include those collected at 30 days, 180 days, and 1 year.
RESULTS: Of the 24 patients in our study, 16 received TMVIV and 8 received TMVIR implantation. Each procedure was performed successfully under general anesthesia via transseptal approach (n = 17) or transapical approach (n = 7), with only 1 patient (8.2%) requiring late operative reintervention 252 days post op. Average procedural time was 76 min and average blood loss was <75 mL, with 20/24 patients (83%) successfully extubated on postoperative day 0. Length of Intensive Care Unit stay was 1.7 ± 1.4 days and length of total inpatient stay was 2.8 ± 1.8 days. Echocardiograms were collected immediately post op, at 30 days, at 180 days, and subsequently at yearly intervals; follow-up demonstrated excellent prosthetic valve function with low transvalvular gradients, and no evidence of valve embolization or thrombosis. In patients with follow-up data available at 1 year (n = 13), there were no readmissions at 30 days or 180 days, and only 1 admission (8.3%) during the first postoperative year for symptoms related to congestive heart failure (CHF).
CONCLUSION: TMVIV and TMVIR can be safe and effective in a patient population considered at prohibitive risk for conventional surgery. These procedures can be performed efficiently in a hybrid operating room, with relatively short procedural times and high rates of early extubation. Procedural complications, mortality, and readmission rates for CHF at 30 days, 180 days, and 1 year were very low in this high-risk cohort.