First experiences with automated annular suturing device in totally endoscopic aortic and mitral valve replacement.

OBJECTIVES: To overcome some of the challenges of endoscopic minimally invasive valve surgery (MIVS), 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 MIVS. 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 two cardiac surgery referral centers 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.

Multicentre experience of sutureless prostheses inside degenerated stentless aortic valves and bioroots.

OBJECTIVES: Patients with failed stentless aortic prostheses are a challenging population to treat, as reoperative procedures may be complex and catheter-based treatments are associated with a high rate of procedural events. Reoperative surgery using sutureless valves may be an alternative. METHODS: In this multicentre experience, we assess outcomes of 17 patients who underwent reoperative surgery using the Perceval valve (Corcym UK Limited, London, UK) inside Freestyle prosthesis (Medtronic Inc., Dublin, Ireland) or bioroots from 2018 to 2023. RESULTS: Mean age was 71.1 ± standard deviation 15.1 years and mean EuroSCORE II was 13.5 ± 15.8%, Society of Thoracic Surgeons Score was 5.9 ± 11.7%. Mean transvalvular gradient at baseline was 25.3 ± 19.9 mmHg and left ventricular ejection fraction was 53.5 ± standard deviation 8.5%. In 70.6% (12/17), moderate or severe aortic regurgitation was present. Implant success was 100%. Aortic cross-clamp time was 44.5 ± standard deviation 23.6 min. No patient needed a pacemaker and no mild paravalvular regurgitation occurred. Mean gradient was 12.5 ± 4.7 mmHg; 30-day mortality was 5.9% (1/17). CONCLUSIONS: Rate of mortality was lower than predicted by EuroSCORE II in these high-risk patients and haemodynamic outcomes were favourable. Heart teams should consider this treatment concept when discussing patients with failed stentless valves or bioroots.

Totally Endoscopic Replacement of the Ascending Aorta and the Aortic Root including the Aortic Valve via Right Mini-Thoracotomy: A Multicenter Study.

Background: Recently, minimally invasive access via right anterolateral mini-thoracotomy (RAMT) has been gaining popularity in cardiac surgery. This approach is also an option for surgeons performing aortic surgery. The aim of this study is to present our surgical method, highlighting the total endoscopic minimally invasive approach via RAMT for replacement of the ascending aorta (AAR) with or without involvement of the aortic root and the aortic valve. Methods: Clinical data of 44 patients from three participating institutions with AAR with or without involvement of the aortic valve or aortic root via RAMT between April 2017 and February 2024 were retrospectively analyzed. According to surgical procedure, patients were divided into two groups, in the AAR and in the Wheat/Bentall group with concomitant valve or root replacement. Operative time, length of ventilation, perioperative outcome, length of intensive care unit (ICU) as well as postoperative hospital stay, and mid- and long-term results were retrospectively analyzed. Results: Mean age was 61.4 ± 10.7 years old with a frequency of male gender of 63.6%. Mean cardiopulmonary bypass (CBP) time and aortic cross-clamping time was 94.9 ± 32.5 min and 63.8 ± 25.9 min, respectively. CPB and aortic clamp time were significantly lower in AAR group. In the first 24 h, the mean drainage volume was 790.3 ± 423.6 mL. Re-thoracotomy due to bleeding was zero. Sternotomy was able to be avoided in all patients. Patients stayed 35.9 ± 23.5 h at ICU and were discharged 7.8 ± 3.0 days following surgery from hospital. Mean ventilation time was 5.8 ± 7.6 h. All patients survived and 30-day mortality was 0.0%. At a median follow-up time of 18.2 months, all patients were alive. The results were similar in both groups. Conclusions: The full endoscopic RAMT approach with 3D visualization is a safe, feasible and promising technique that can be transferred in the field of aortic surgery without compromising surgical quality, postoperative outcomes, or patient safety when performed by an experienced team in a high-volume center.

Totally endoscopic micro-invasive aortic valve replacement.

Micro-invasive totally endoscopic aortic valve replacement surgery is a minimally invasive cardiac procedure that can be performed with the help of several techniques and technologies that employ the latest innovations in instrumentation and technological advances in the field, thereby greatly limiting the overall invasiveness of the procedure. With the help of a 3-dimensional camera, long instruments, a very small thoracotomy and a soft-tissue retractor without any rib retractor, the aortic valve can be easily and safely accessed for replacement. The other main features of these techniques are extracorporeal circulation that is achieved through peripheral percutaneous cannulation of the femoral vessels, antegrade cardioplegia, the use of automated devices for suturing the valvular ring and the prosthetic suture cuff, namely the RAM device, the Sew-Easy device and the Cor-Knot Mini device. Additionally, an automated vascular closure device such as the MANTA device is later used to close the femoral artery following decannulation.

Case report: Video-assisted minimally invasive mitral and pulmonary valve replacement as reoperation in patient with situs inversus totalis.

Dextrocardia with situs inversus totalis is a rare congenital condition. We report herein a first experience of video-assisted minimally invasive mitral and pulmonary valve replacement through right anterior mini-thoracotomy as reoperation in patient with this complex anomaly. The good clinical and cosmetic results demonstrate that this innovative technique can be safely performed even in difficult anatomical conditions.

Transmitral Septal Myectomy and Mitral Valve Surgery via Right Mini-Thoracotomy.

BACKGROUND: Transmitral myectomy for symptomatic hypertrophic obstructive cardiomyopathy is possible with existence of substantial mitral valve disease. We present herein our experience of minimally invasive transmitral septal myectomy combined with mitral valve surgery through right anterior mini-thoracotomy in the past 4 years at our institution. METHODS: Between March 2017 and October 2020, 14 patients with hypertrophic obstructive cardiomyopathy and mitral valve disease required minimally invasive transmitral septal myectomy combined with mitral valve reconstruction or replacement at our institution. Mean age of patients was 54.2 ± 11.4 and 42.9% (n = 6) were female. Twelve patients (85.1%) were in New York Heart Association class III to IV and 6 patients (42.9%) presented with persistent atrial fibrillation. Clinical data were prospectively entered into our institutional database. RESULTS: Cardiopulmonary bypass time accounted for 140.2 ± 32.6 minutes and the myocardial ischemic time was 78.5 ± 12.4 minutes. Thirty-day mortality and overall mortality were zero. Peak ventricular outflow gradient decreased from 75.2 ± 12.7 to 9.4 ± 2.3 mm Hg (p < 0.0001). Simultaneously, mitral valve reconstruction and replacement were performed in 11 (78.6%) and 3 (21.4%) patients, respectively. No systolic anterior motion was seen in patients with mitral valve repair. No conversion to full sternotomy and/or rethoracotomy was noted. During a mean follow-up period of 24 ± 13 months, no patient required reoperation, no recurrence mitral regurgitation, and left ventricular outflow tract obstruction. CONCLUSION: Transmitral septal myectomy combined with mitral valve surgery through right anterior mini-thoracotomy can be performed safely with excellent surgical outcomes.

Clinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center.

BACKGROUND AND AIM: Bioprosthetic surgical aortic valve replacement (SAVR) is increasingly adopted in younger patients. We aimed to analyze mid-term follow-up data after SAVR to assess the performance of the prosthesis. METHODS: Data were collected from a single-center series of 154 patients, who underwent SAVR with a bioprosthetic heart valve with the RESILIA tissue at our Heart Centre in Siegburg. All procedural and midterm patient outcomes were documented. RESULTS: Patients had a mean age of 56.8 ± 9.9 years, 35.7% were female, and the mean logistic European system for cardiac operative risk evaluation (EuroSCORE) was 3.4 ± 3.6%. Diabetes (12.3%), atrial fibrillation (10.4%), and chronic obstructive pulmonary disease (COPD) (5.8%) were common comorbidities. The mean surgery duration was 163.8 ± 73.4 min, with the 23 mm (34.4%) and 25 mm (33.8%) heart valves being most frequently implanted. At 3-year follow-up, mean pressure gradient was 13.9 ± 5.9 mmHg, peak gradient was 23.6 ± 7.7 mmHg, and effective orifice area (EOA) was 1.9 ± 0.4 cm². No patient died during the operation, 3 (2.1%) patients within 30 days, and 4 (2.7%) thereafter with an overall mortality of n = 7. Of the surviving patients, 97.8% were in New York Heart Association (NYHA) class I/II and none had structural valve deterioration (SVD). CONCLUSION: Results of our single-center study indicate favorable procedural outcomes. The safety outcomes confirm preliminary earlier results of this novel bioprosthesis but include more patients and a longer midterm follow-up.

Comparison of Right Anterior Mini-Thoracotomy Versus Partial Upper Sternotomy in Aortic Valve Replacement.

INTRODUCTION: Propensity score analysis of midterm outcomes after isolated aortic valve replacement through right anterior mini-thoracotomy and partial upper sternotomy could provide information about the most beneficial minimally invasive technique for the patient based on the preoperative risk factors. METHODS: Between March 2015 and February 2021, 694 minimally invasive isolated aortic valve surgeries were performed at our institution. Among these, 441 right anterior mini-thoracotomies and 253 partial upper sternotomies were performed. A propensity score analysis was performed in 202 matched pairs. RESULTS: Cardiopulmonary bypass time and cross-clamp time were significantly shorter in the right anterior mini-thoracotomy group than in the partial upper sternotomy group (p = 0.001 and p < 0.001, respectively). Time to first mobilization and hospital stay were significantly shorter in the right anterior mini-thoracotomy group than in the partial upper sternotomy group (p = 0.005, p = 0.001, respectively). A significantly lower incidence of revision surgery was noted in the right anterior mini-thoracotomy group than in the partial upper sternotomy group (p = 0.046). No significant differences in 30-day mortality (p = 1.000) and 1-year mortality (p = 0.543) were noted. Kaplan-Meier survival estimates were 96.3% in the right anterior mini-thoracotomy group and 92.7% in the partial upper sternotomy group after 4 years (log rank 0.169), respectively. CONCLUSIONS: Despite the technical challenges, right anterior mini-thoracotomy can be chosen as first-line strategy for isolated aortic valve replacement. For patients unsuitable for this technique, the partial upper sternotomy remains a safe method that can be performed by a wide range of surgeons.

Modification of reconstruction of left ventricular outflow tract, aortic root and the intervalvular fibrous body for extensive infective endocarditis: a single-centre experience.

OBJECTIVES: Extensive infective endocarditis (IE) stays a serious life-threatening disease with high mortality and morbidity. The aim of this study is to analyse our experience with our modified surgical technique for extensive IE during the last 4 years. METHODS: Between March 2017 and February 2021, all patients with extensive IE required our modified technique consisting of a radical surgical resection of all infected cardiac tissues, the replacement of infected valves and a reconstruction of the intervalvular fibrous body, the aortic root and the left ventricular outflow tract with modified elephant trunk were included in this study. RESULTS: Our modified technique was performed on 41 patients during the study period. The age median was 74 [interquartile range (IQR): 66.5-76.5] and 61.0% (n = 25) were female. Thirty-three patients (80.5%) were in New York Heart Association Class III-IV and 7 patients (17.1%) in cardiogenic shock. The median logistic European system for cardiac operative risk evaluation II as predicted risk of mortality was 35% (IQR: 28-78%). The median cardiopulmonary bypass time and cross-clamping time were 126 (IQR: 86.5-191) and 78 (IQR: 55.5-108) min, respectively. Intraoperative mortality and 30-day mortality were 4.8% (2 patients) and 19.5% (8 patients), respectively. Low cardiac output with necessity for mechanical support, stroke and new renal dialysis developed in 9.8% (4 patients), 17.1% (7 patients) and 22.0% (9 patients), respectively. New pacemaker implantation was noted in 39.0% (16 patients). Intensive care stay and hospital stay had medians of 6 (IQR: 5-12) and 14 (IQR: 12.5-20.5) days, respectively. One-year mortality and 4-year mortality were 34.1% (14 patients) and 39.0% (16 patients), respectively. Kaplan-Meier survival estimates were 60.3% (95% confidence interval: 46.2-78.6%) at 3 years. CONCLUSIONS: Our modified technique can be performed in patients with extensive IE with acceptable early and mid-term morbidity and mortality. We believe that this technique is an available option for this ill-fated group of patients.

Percutaneous versus surgical femoral access in minimally invasive cardiac operations.

OBJECTIVES: Both surgical and percutaneous femoral accesses for the establishment of extracorporeal circulation are used in minimally invasive cardiac surgeries. The goal of this study was to compare the outcomes with the MANTA vascular closure device after percutaneous arterial decannulation via the surgical approach. METHODS: Between November 2018 and January 2021, a total of 490 consecutive patients underwent minimally invasive cardiac operations at our institution. Cannulation and decannulation of femoral vessels were under direct vision surgically or percutaneously. The MANTA system was used to close the femoral artery in all patients with percutaneous cannulation. Demographic, clinical and procedural data were collected retrospectively. RESULTS: Surgical cut-down and suture closure of the femoral artery was performed in 222 patients (45.3%); percutaneous access and closure with the MANTA system was used in 268 patients (54.7%). The surgical group presented a significantly higher incidence of any access site complication compared to the percutaneous group [18 patients (8.1%) vs 6 patients (2.2%); P = 0.003]. Lymph fistula and wound healing disorders occurred more frequently in the surgical group (3.2% vs 0% [P = 0.004] and 3.6% vs 0% [P = 0.002], respectively). Median procedural duration and stays in the intensive care unit were significantly lower in the percutaneous group {127 [interquartile range (IQR) 97-158] min vs 150 (IQR 117-185) min (P < 0.001) and 1 (IQR 1-2) day vs 2 (IQR 1-3) days (P = 0.008), respectively}. CONCLUSIONS: Percutaneous access and closure with the MANTA system are feasible, safe and associated with lower incidences of all-cause access site complications and shorter stays in the intensive care unit compared to surgical access and closure in minimally invasive cardiac surgeries.

Lessons learned from 10 years of experience with minimally invasive cardiac surgery.

Since its inception more than a quarter of a century ago, minimally invasive cardiac surgery has attracted the increasing interest of cardiac surgeons worldwide. The need to surgically treat patients with smaller and better-tolerated incisions coupled with high-quality clinical outcomes, particularly in structural heart disease, has become imperative to keep pace with the evolution of transcatheter valve implantation. We have learned numerous lessons from our longstanding experience in this field of surgical care, especially in terms of endoscopic access via mini-thoracotomy. To improve the safety and efficacy of this minimally invasive endoscopic access, this study summarizes and highlights the lessons we have learned, acting as a template for newly established cardiac surgeons in minimally invasive techniques.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

The First 100 Cases of Two Innovations Combined: Video-Assisted Minimally Invasive Aortic Valve Replacement Through Right Anterior Mini-Thoracotomy Using a Novel Aortic Prosthesis.

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.

Video-Assisted Minimally Invasive Aortic Valve Replacement Through Right Anterior Minithoracotomy for All Comers With Aortic Valve Disease.

OBJECTIVE: Right anterior minithoracotomy is a promising technique for aortic valve replacement and has shown excellent results in terms of mortality and morbidity. Against this background, we analyzed our institutional experience in this technique during the last 3 years. METHODS: Between April 2017 and March 2019, 513 consecutive all comers with aortic valve disease underwent video-assisted minimally invasive aortic valve replacement through a 3-cm skin incision as right anterior minithoracotomy at our institution. A camera and automatic fastener technology were used for the valve implantation in all patients. Clinical data were prospectively entered into our institutional database. RESULTS: Cardiopulmonary bypass time accounted for 68 ± 24 min and the myocardial ischemic time 38 ± 12 minutes. Thirty-day mortality and overall mortality was 0.4% (2 patients) and 1.4% (7 patients), respectively. Postoperative cerebrovascular events were noted in 8 patients (1.5%). Intensive care stay and hospital stay were 2 ± 2 and 9 ± 7 days, respectively. Pacemaker implantation, injury of the right internal mammary artery, and conversion to full sternotomy were noted in 7 patients (1.4%), 3 patients (0.6%), and 1 patient (0.2%), respectively. Paravalvular leak need to intervention was noted in 2 patients (0.4%). Rethoracotomy rate was 2% (11 patients). Transient postoperative dialysis was necessary for 14 patients (3%). CONCLUSIONS: Video-assisted minimally invasive aortic valve replacement through the right anterior minithoracotomy is a safe approach and yields excellent outcomes in high-volume centers. The use of a camera and automatic fastener technology facilitates this procedure.

First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery.

BACKGROUND: To more minimize the minimally invasive valve surgeries, percutaneous vascular access and closure has been used for the establishment of extracorporeal circulation. This study investigates early clinical outcomes of patients who received MANTA for femoral artery closure as first experiences in minimally invasive valve surgery. METHODS: Between January 2019 and July 2019, 103 consecutive patients (mean age: 58 ± 11 years) underwent video-assisted minimally invasive valve surgery through right anterior minithoracotomy at two cardiac surgery referral centers in Germany. Percutaneous cannulation for cardiopulmonary bypass and femoral artery closure with MANTA were performed in all patients: 18-F and 14-F MANTA were used in 88 (85.4%) and 15 (14.6%) patient, respectively. Mitral, aortic, tricuspid, and double valve surgeries were performed in 51 (49.5%), 39 (37.9%), 7 (6.8%), and 6 (5.8%), patients, respectively. Clinical data were prospectively entered into our institutional database. RESULTS: Cardiopulmonary bypass time and cross-clamping time were 69 ± 23 and 38 ± 14 minutes, respectively. Except for two patients with late pseudoaneurysm on 15th and 23th postoperative day, neither major nor minor vascular complications nor vascular closure device failure according to the Valve Academic Research Consortium-2 definition criteria was observed. Additionally, no wound healing disorders or conversion to surgical closure was observed. CONCLUSIONS: MANTA as percutaneous femoral artery closure after decannulation of cardiopulmonary bypass is a safe, feasible, and effective approach and yields excellent early outcomes. Larger size studies are needed to evaluate more the efficacy and safety of MANTA.