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OBJECTIVES: To overcome some of the challenges of endoscopic minimally invasive valve surgery, an automated annular suturing device has been used in aortic and mitral valve replacement surgeries. The current study investigates early clinical outcomes of patients who received aortic or mitral valve replacement with the help of the RAM® device as first experiences in minimally invasive valve surgery. METHODS: Between September 2020 and June 2023, 66 consecutive patients (mean age 61.8 ± 11 years) underwent endoscopic minimally invasive aortic or mitral valve replacement through right anterior mini-thoracotomy at 2 cardiac surgery referral centres in Germany. The RAM® device was used in all Patients. 3.5 and 5.0 sizes were used in 16.7% and 83.3% of patients, respectively. Aortic, mitral and double valve surgery was performed in 81.8%, 15.2% and 1.5% of patients, respectively. Clinical data were prospectively entered into our institutional database. RESULTS: Cardiopulmonary bypass time and cross-clamping time were 97.9 ± 20.9 and 66 ± 15.7 min, respectively. Intensive care unit and hospital stays were 1 [1-2] and 9 [7-13] days, respectively. No paravalvular leak and no other intraoperative complications occurred. 30-day and in-hospital mortality were zero. Conversion to sternotomy occurred in 1 (1.5%) patient due to bleeding. CONCLUSIONS: The usage of the RAM® device is a safe, feasible and effective approach to the endoscopic implantation of aortic or mitral valves and yield excellent early outcomes. Larger size studies are needed to evaluate the efficacy and safety of RAM® device.
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INTRODUCTION: Aortic valve replacement (AVR) via right anterior mini-thoracotomy (RAMT) is less traumatic than via other surgical routes; using a novel aortic valve may confer long-term resistance against valve deterioration, and thus be useful in younger, more active patients. Here we aim to validate using the INSPIRIS RESILIA valve with minimally invasive RAMT. METHODS: Between April 2017 and June 2019, 100 patients underwent video-assisted minimally invasive AVR by RAMT, using the INSPIRIS RESILIA aortic valve. Cannulation for cardiopulmonary bypass (CPB) was through femoral vessels. Clinical data were prospectively entered into our institutional database. RESULTS: Cardiopulmonary bypass (CPB) and cross-clamping times were 79 ± 38 and 41 ± 17 min. Surgical access was successful in 100% of cases. There were no cases of intraoperative mortality, 30-day mortality, cerebrovascular events, rethoracotomy for bleeding, valve-related reoperation, right internal mammary artery injury, or conversion to sternotomy. Intensive care and hospital stays were 2 ± 1 and 6 ± 3 days, respectively. One patient had a pacemaker fitted. Postoperative dialysis was necessary in one patient. Trace to mild aortic valve regurgitation occurred in two patients. No structural valve deterioration (SVD) and paravalvular leak were seen. At 1-year follow-up mean effective orifice area (EOA) was 1.8 ± 0.1 cm2, peak gradient was 22.1 ± 3.1 mmHg, and mean gradient was 11.5 ± 2.3 mmHg. CONCLUSION: Our preliminary experience suggests that RAMT for AVR using the INSPIRIS RESILIA aortic valve is safe, effective, and reproducible. Larger studies are needed to evaluate the long-term efficacy and durability of this new valve.