Minimally Invasive Surgery through Right Mini-Thoracotomy for Mitral Valve Infective Endocarditis: Contraindicated or Safely Possible?

Background: Mitral valve infective endocarditis (IE) still has a high mortality. Minimally invasive mitral valve surgery (MIMVS) is technically more challenging, especially in patients with endocarditis. Here, we compare the early postoperative outcome of patients with endocarditis and other indications for MIMVS. Methods: Two groups were formed, one consisting of patients who underwent surgery because of mitral valve endocarditis (IE group: n = 75) and the other group consisting of patients who had another indication for MIMVS (non-IE group: n = 862). Patients were observed for 30 postoperative days. Data were retrospectively reviewed and collected from January 2011 to September 2023. Results: Patients from the IE group were younger (60 vs. 68 years; p < 0.001) and had a higher preoperative history of stroke (26% vs. 6%; p < 0.001) with neurological symptoms (26% vs. 9%; p < 0.001). No difference was seen in overall surgery time (211 vs. 206 min; p = 0.71), time on cardiopulmonary bypass (137 vs. 137 min; p = 0.42) and aortic clamping time (76 vs. 78 min; p = 0.42). Concerning postoperative data, the IE group had a higher requirement of erythrocyte transfusion (2 vs. 0; p = 0.041). But no difference was seen in the need for a mitral valve redo procedure, bleeding, postoperative stroke, cerebral bleeding, new-onset dialysis, overall intubation time, sepsis, pacemaker implantation, wound healing disorders and 30-day mortality. Conclusions: Minimally invasive mitral valve surgery in patients with mitral valve endocarditis is feasible and safe. Infective endocarditis should not be considered as a contraindication for MIMVS.

Hypothermic Ventricular Fibrillation in Redo Minimally Invasive Mitral Valve Surgery: A Promising Solution for a Surgical Challenge.

Background: Minimally invasive mitral valve surgery (MIMVS) is a treatment for severe mitral valve pathologies. In redo cases, especially after coronary artery bypass grafting (CABG) surgery with patent mammary bypass grafts, establishing aortic clamping followed by antegrade cardioplegia application might be challenging. Here, we present the outcome of hypothermic ventricular fibrillation as an alternative to conventional cardioprotection. Methods: Patients who underwent MIMVS either received hypothermic ventricular fibrillation (study group, n = 48) or antegrade cardioprotection (control group, n = 840) and were observed for 30 postoperative days. Data were retrospectively analyzed and collected from January 2011 until December 2022. Results: Patients in the study group had a higher preoperative prevalence of renal insufficiency (p = 0.001), extracardiac arteriopathy (p = 0.001), insulin-dependent diabetes mellitus (p = 0.001) and chronic lung disease (p = 0.036). Furthermore, they had a longer surgery time and a lower repair rate (p < 0.001). No difference, however, was seen in postoperative incidences of stroke (p = 0.26), myocardial infarction (p = 1) and mitral valve re-operation (p = 1) as well as 30-day mortality (p = 0.1) and postoperative mitral valve insufficiency or stenosis. Conclusions: The patients who underwent redo MIMVS with hypothermic ventricular fibrillation did not have worse outcomes or more serious adverse events compared to the patients who received routine conventional cardioprotection. Therefore, the use of hypothermic ventricular fibrillation appears to be a promising cardioprotective technique in this challenging patient population requiring redo MIMVS.

Minimally Invasive Approach for Replacement of the Ascending Aorta towards the Proximal Aortic Arch.

Objectives: In recent years, minimally invasive approaches have been used with increasing frequency, even for more complex aortic procedures. However, evidence on the practicability and safety of expanding minimally invasive techniques from isolated operations of the ascending aorta towards more complex operations such as the hemiarch replacement is still scarce to date. Methods: A total of 86 patients undergoing elective surgical replacement of the ascending aorta with (n = 40) or without (n = 46) concomitant proximal aortic arch replacement between 2009 and 2023 were analyzed in a retrospective single-center analysis. Groups were compared regarding operation times, intra- and postoperative complications and long-term survival. Results: Operation times and ventilation times were significantly longer in the hemiarch replacement group. Despite this, no statistically significant differences between the two groups were observed for the duration of the ICU and hospital stay and postoperative complication rates. At ten-year follow-up, overall survival was 82.6% after isolated ascending aorta replacement and 86.3% after hemiarch replacement (p = 0.441). Conclusions: Expanding the indication for minimally invasive aortic surgery towards the proximal aortic arch resulted in comparable postoperative complication rates, length of hospital stay and overall long-term survival compared to the well-established minimally invasive isolated supracommissural ascending aorta replacement.

Minimally Invasive Direct Coronary Artery Bypass Grafting: Sixteen Years of Single-Center Experience.

Background: Coronary artery disease is a major cause of death globally. Minimally invasive direct coronary artery bypass (MIDCAB), using a small left anterior thoracotomy, aims to provide a less invasive alternative to traditional procedures, potentially improving patient outcomes with reduced recovery times. Methods: This retrospective, non-randomized study analyzed 310 patients who underwent MIDCAB between July 1999 and April 2022. Data were collected on demographics, clinical characteristics, operative and postoperative outcomes, and follow-up mortality and morbidity. Statistical analysis was conducted using IBM SPSS, with survival curves generated via the Kaplan-Meier method. Results: The cohort had a mean age of 63.3 ± 10.9 years, with 30.6% females. The majority of surgeries were elective (76.1%), with an average operating time of 129.7 ± 35.3 min. The median rate of intraoperative blood transfusions was 0.0 (CI 0.0-2.0) Units. The mean in-hospital stay was 8.7 ± 5.5 days, and the median ICU stay was just one day. Early postoperative complications were minimal, with a 0.64% in-hospital mortality rate. The 6-month and 1-year mortalities were 0.97%, with a 10-year survival rate of 94.3%. There were two cases of perioperative myocardial infarction and no instances of stroke or new onset dialysis. Conclusions: The MIDCAB approach demonstrates significant benefits in terms of patient recovery and long-term outcomes, offering a viable and effective alternative for patients suitable for less invasive procedures. Our results suggest that MIDCAB is a safe option with favorable survival rates, justifying its consideration in high-volume centers focused on minimally invasive techniques.

Surgical Therapy of Infective Prosthesis Endocarditis following TAVI: A Single Center's Experience.

BACKGROUND/OBJECTIVES: Infective prosthesis endocarditis (IE) following transcatheter aortic valve implantation (TAVI) presents significant management challenges, marked by high mortality rates. This study reviews our center's experience with surgical interventions for IE in patients post-TAVI, focusing on outcomes, challenges, and procedural complexities, and providing an overview of the limited literature surrounding this subject. METHODS: This study was executed as a comprehensive retrospective analysis, targeting the clinical outcomes of surgical treatment in patients presenting with PVE following TAVI procedures at our institution. From July 2017 to July 2022, we identified five patients who had previously undergone transfemoral transcatheter aortic valve implantation and were later diagnosed with PVE needing surgery, strictly adhering to the modified Duke criteria. RESULTS: All surgical procedures were reported successful with no intra- or postoperative mortality. Patients were predominantly male (80%), with an average age of 76 ± 8.6 years, presenting mostly with dyspnea (NYHA Class II). The mean follow-up was between 121 and 1973 days, with outcomes showing no occurrences of stroke, myocardial infarction, or major bleeding. One patient expired from unrelated causes 3.7 years post-surgery. The operative and postoperative protocols demonstrated effective disease management with enhanced survival and minimal complications. CONCLUSIONS: The surgical treatment of IE following TAVI, though challenging, can be successfully achieved with careful patient selection and a multidisciplinary approach. The favorable outcomes suggest that surgical intervention remains a viable option for managing this high-risk patient group. Our study also highlights the scarce literature available on this topic, suggesting an urgent need for more comprehensive research to enhance understanding and improve treatment strategies. Future studies with larger cohorts are needed to further validate these findings and refine surgical strategies for this growing patient population.

Hemodynamical Evaluation of a New Surgically Implanted Pulsatile Right Ventricular Assist Device Driven by a Conventional Intra-Aortic Balloon Pump Console.

Severe right heart failure, often overlooked and challenging to manage, has prompted a growing interest in innovative approaches to provide functional support. This study uses experimentation in large porcine models to introduce a novel prototype of a pulsatile mechanical circulatory support device and document its effects when deployed as a right ventricular assist device (RVAD). The pulsatile ventricular assist platform (pVAP), featuring a membrane pump driven by an intra-aortic balloon pump console, actively generates pulsatile flow to propel right ventricular blood into the pulmonary artery. This novel prototype demonstrates promising potential in addressing the challenges of right heart failure management. After preliminary in vitro assessments, the pVAP was tested on seven porcine models in a healthy state and after the induction of right ventricular failure. During the procedure, a set of standard (ie, standard-of-care) hemodynamic measurements was obtained. Additionally, invasive pressure-volume loop analysis was employed to examine left ventricular hemodynamics. Results indicated that activation of the pVAP during right ventricular failure significantly improved systemic hemodynamics and enhanced left ventricular function. This study sheds light on the potential of the pVAP in managing right heart failure.

Implementation of Endoscopic Minimally Invasive Mitral Valve Replacement Surgery With Automated Suturing Technology.

In the evolving landscape of cardiac surgery, this article explores the potential of minimally invasive mitral valve replacement procedures as a viable alternative to conventional surgical techniques. Leveraging advancements in automated suturing devices and video endoscopy, our work aims to demonstrate that minimally invasive approaches can be applied across a broad spectrum of surgical scenarios. Herein we highlight preoperative diagnostics and operative techniques, with a focus on infra-axillary anterolateral minithoracotomy as the access point. Our technique utilizes technology from LSI SOLUTIONS® (Victor, NY, USA), including the RAM® Device for automated suturing, which has an ergonomic design and safety features. The device's capabilities are further enhanced by the SEW-EASY® Device, the RAM® RING, and the COR-KNOT MINI® Device, which streamline suture management and securement. This work outlines how these technological advancements can mitigate concerns about technical complexity and learning curves, thereby encouraging wider adoption of minimally invasive techniques. Clinical benefits may include reduced surgical trauma, quicker recovery, and cost-effectiveness, making it a compelling option in an era of aggressively promoted transcatheter interventions.

The Surgical Treatment of Infective Endocarditis: A Comprehensive Review.

Infective endocarditis (IE) is a severe cardiac complication with high mortality rates, especially when surgical intervention is delayed or absent. This review addresses the expanding role of surgery in managing IE, focusing on the variation in surgical treatment rates, the impact of patient demographics, and the effectiveness of different surgical approaches. Despite varying global data, a notable increase in surgical interventions for IE is evident, with over 50% of patients undergoing surgery in tertiary centres. This review synthesizes information from focused literature searches up to July 2023, covering preoperative to postoperative considerations and surgical strategies for IE. Key preoperative concerns include accurate diagnosis, appropriate antimicrobial treatment, and the timing of surgery, which is particularly crucial for patients with heart failure or at risk of embolism. Surgical approaches vary based on valve involvement, with mitral valve repair showing promising outcomes compared to replacement. Aortic valve surgery, traditionally favouring replacement, now includes repair as a viable option. Emerging techniques such as sutureless valves and aortic homografts are explored, highlighting their potential advantages in specific IE cases. The review also delves into high-risk groups like intravenous drug users and the elderly, emphasizing the need for tailored surgical strategies. With an increasing number of patients presenting with prosthetic valve endocarditis and device-related IE, the review underscores the importance of comprehensive management strategies encompassing surgical and medical interventions. Overall, this review provides a comprehensive overview of current evidence in the surgical management of IE, highlighting the necessity of a multidisciplinary approach and ongoing research to optimize patient outcomes.

Risk factors, prevention, and therapy of intraluminal stent thrombosis in frozen elephant trunk prostheses-what we know so far.

Intraluminal thrombus formation (ILT) is a recently discovered and highly clinically relevant complication after frozen elephant trunk implantation in cardiovascular surgery. In this phenomenon, a thrombus forms within the lumen of the stent graft component of the frozen elephant trunk prosthesis and puts the patient at risk for downstream embolization with visceral or lower limb ischemia. Incidence of ILT reported in the currently available studies ranges from 6% to 17% of patients after frozen elephant trunk implantation. Adverse thromboembolic events include acute occlusion of the celiac and superior mesenteric arteries, both renal arteries as well as acute lower limb ischemia due to iliac or femoral artery embolization that not infrequently require interventional or open embolectomy. Therefore, the presence of ILT is associated with increased short-term mortality and morbidity. Currently proposed strategies to avoid ILT formation include a more aggressive anticoagulation management, minimization of postoperative coagulation factor application, and even technical optimizations of the stent graft portion itself. If ILT is manifested, the therapeutic strategies tested to date are long-term escalation of anticoagulation and early endovascular extension of the FET stent graft with overstenting of the intraluminal thrombus. The long-term efficiency of these prophylactic and therapeutic measures has yet to be proven. Nonetheless, all surgeons performing the frozen elephant trunk procedure must be aware of the risk of ILT formation to facilitate a timely diagnosis and therapy.

Impact of Intercostal Artery Reinsertion on Neurological Outcome after Thoracoabdominal Aortic Replacement: A 25-Year Single-Center Experience.

BACKGROUND: Intercostal artery reinsertion (ICAR) during thoracoabdominal aortic replacement remains controversial. While some groups recommend the reinsertion of as many arteries as possible, others consider the sacrifice of multiple intercostals practicable. This study investigates the impact of intercostal artery reinsertion or sacrifice on neurological outcomes and long-term survival after thoracoabdominal aortic repair. METHODS: A total of 349 consecutive patients undergoing thoracoabdominal aortic replacement at our institution between 1996 and 2021 were analyzed in a retrospective single-center study. ICAR was performed in 213 patients, while all intercostal arteries were ligated and sacrificed in the remaining cases. The neurological outcome was analyzed regarding temporary and permanent paraplegia or paraparesis. RESULTS: No statistically significant differences were observed between the ICAR and non ICAR groups regarding the cumulative endpoint of transient and permanent spinal cord-related complications (12.2% vs. 11.8%, p = 0.9). Operation, bypass, and cross-clamp times were significantly longer in the ICAR group. Likewise, prolonged mechanical ventilation was more often necessary in the ICAR group (26.4% vs. 16.9%, p = 0.03). Overall long-term survival was similar in both groups in the Kaplan-Meier analysis. CONCLUSION: Omitting ICAR during thoracoabdominal aortic replacement may reduce operation and cross-clamp times and thus minimize the duration of intraoperative spinal cord hypoperfusion.

Towards a Standardized Classification of the Hepatobiliary Manifestations in Cystic Fibrosis (CFHBI): A Joint ESPGHAN/NASPGHAN Position Paper.

The broad spectrum of hepatobiliary involvement in cystic fibrosis (CF) has been commonly referred to as cystic fibrosis liver disease (CFLD). However, differences in the definitions of CFLD have led to variations in reported prevalence, incidence rates, and standardized recommendations for diagnosis and therapies. Harmonizing the description of the spectrum of hepatobiliary involvement in all people with CF (pwCF) is deemed essential for providing a reliable account of the natural history, which in turn supports the development of meaningful clinical outcomes in patient care and research. Recognizing this necessity, The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) commissioned and tasked a committee to develop and propose a systematic classification of the CF hepatobiliary manifestations to increase uniformity, accuracy, and comparability for clinical, registry, and research purposes. This report describes the committee's combined expert position statement on hepatobiliary involvement in CF, which has been endorsed by NASPGHAN and ESPGHAN. We recommend using CFHBI (Cystic Fibrosis Hepato-Biliary Involvement) as the updated term to describe and classify all hepatobiliary manifestations in all pwCF. CFHBI encompasses the current extensive spectrum of phenotypical, clinical, or diagnostic expressions of liver involvement observed in pwCF. We present a schematic categorization of CFHBI, which may also be used to track and classify the changes and development of CFHBI in pwCF over time. The proposed classification for CFHBI is based on expert consensus and has not been validated for clinical practice and research purposes. Achieving validation should be an important aim for future research.

Left ventricular assist device implantation and concomitant mitral valve surgery: A systematic review and meta-analysis.

BACKGROUND: The management of concomitant valvular lesions in patients undergoing left ventricular assist device (LVAD) implantation remains a topic of debate. This systematic review and meta-analysis aimed to evaluate the existing evidence on postoperative outcomes following LVAD implantation, with and without concomitant MV surgery. METHODS: A systematic database search was conducted as per PRISMA guidelines, of original articles comparing LVAD alone to LVAD plus concomitant MV surgery up to February 2023. The primary outcomes assessed were overall mortality and early mortality, while secondary outcomes included stroke, need for right ventricular assist device (RVAD) implantation, postoperative mitral valve regurgitation, major bleeding, and renal dysfunction. RESULTS: The meta-analysis included 10 studies comprising 32 184 patients. It revealed that concomitant MV surgery during LVAD implantation did not significantly affect overall mortality (OR:0.83; 95% CI: 0.53 to 1.29; p = 0.40), early mortality (OR:1.17; 95% CI: 0.63 to 2.17; p = 0.63), stroke, need for RVAD implantation, postoperative mitral valve regurgitation, major bleeding, or renal dysfunction. These findings suggest that concomitant MV surgery appears not to confer additional benefits in terms of these clinical outcomes. CONCLUSION: Based on the available evidence, concomitant MV surgery during LVAD implantation does not appear to have a significant impact on postoperative outcomes. However, decision-making regarding MV surgery should be individualized, considering patient-specific factors and characteristics. Further research with prospective studies focusing on specific patient populations and newer LVAD devices is warranted to provide more robust evidence and guide clinical practice in the management of valvular lesions in LVAD recipients.

Machine learning algorithms for the prognostication of abdominal aortic aneurysm progression: a systematic review.

INTRODUCTION: Abdominal aortic aneurysm (AAA), often characterized by an abdominal aortic diameter over 3.0 cm, is managed through screening, surveillance, and surgical intervention. AAA growth can be heterogeneous and rupture carries a high mortality rate, with size and certain risk factors influencing rupture risk. Research is ongoing to accurately predict individual AAA growth rates for personalized management. Machine learning, a subset of artificial intelligence, has shown promise in various medical fields, including endoleak detection post-EVAR. However, its application for predicting AAA growth remains insufficiently explored, thus necessitating further investigation. Subsequently, this paper aims to summarize the current status of machine learning in predicting AAA growth. EVIDENCE ACQUISITION: A systematic database search of Embase, MEDLINE, Cochrane, PubMed and Google Scholar from inception till December 2022 was conducted of original articles that discussed the use of machine learning in predicting AAA growth using the aforementioned databases. EVIDENCE SYNTHESIS: Overall, 2742 articles were extracted, of which seven retrospective studies involving 410 patients were included using a predetermined criteria. Six out of seven studies applied a supervised learning approach for their machine learning (ML) models, with considerable diversity observed within specific ML models. The majority of the studies concluded that machine learning models perform better in predicting AAA growth in comparison to reference models. All studies focused on predicting AAA growth over specified durations. Maximal luminal diameter was the most frequently used indicator, with alternative predictors being AAA volume, ILT (intraluminal thrombus) and flow-medicated diameter (FMD). CONCLUSIONS: The nascent field of applying machine learning (ML) for Abdominal Aortic Aneurysm (AAA) expansion prediction exhibits potential to enhance predictive accuracy across diverse parameters. Future studies must emphasize evidencing clinical utility in a healthcare system context, thereby ensuring patient outcome improvement. This will necessitate addressing key ethical implications in establishing prospective studies related to this topic and collaboration among pivotal stakeholders within the AI field.

Antibacterial copper-filled TiO2 coating of cardiovascular implants to prevent infective endocarditis-A pilot study.

BACKGROUND: Infective endocarditis (IE) poses a significant health risk, especially in patients with prosthetic heart valves. Despite advances in treatment, mortality rates remain high. This study aims to investigate the antibacterial properties of a copper titanium dioxide (4× Cu-TiO2) coating on cardiovascular implants against Staphylococcus aureus, a common causative agent of IE. METHODS: Titanium oxide carriers functionalized with copper ions were employed as an antibacterial coating for heart and vascular prostheses. The coating's antibacterial efficacy was assessed using S. aureus ATCC 29213. Microscopic evaluations were conducted on both biological and artificial materials. Antibacterial activity was qualitatively assessed via a modified disc diffusion method and quantitatively measured through colony counts in NaCl suspensions. RESULTS: The coating process was successfully applied to all tested cardiovascular prosthetic materials. Qualitative assessments of antibacterial effectiveness revealed an absence of bacterial growth in the area directly beneath the coated valve. Quantitative evaluations showed a significant reduction in bacterial colonization on coated mechanical valves, with 2.95 × 104 CFU per valve, compared to 1.91 × 105 CFU in control valves. CONCLUSIONS: The 4× Cu-TiO2 coating demonstrated promising antibacterial properties against S. aureus, suggesting its potential as an effective strategy for reducing the risk of bacterial colonization of cardiovascular implants. Further studies are needed to assess the longevity of the coating and its efficacy against other pathogens.

Hostile Hemodynamics in Distal Stent Graft-Induced New Entry Prior to Aortic Rupture: A Comparison of Transient versus Steady-State CFD Simulations.

BACKGROUND: Computational fluid dynamics (CFD) simulations model blood flow in aortic pathologies. The aim of our study was to understand the local hemodynamic environment at the site of rupture in distal stent graft-induced new entry (dSINE) after frozen elephant trunk with a clinically time efficient steady-flow simulation versus transient simulations. METHODS: Steady-state simulations were performed for dSINE, prior and after its development and prior to aortic rupture. To account for potential turbulences due geometric changes at the dSINE location, Reynolds-averaged Navier-Stokes equations with the realizable k-ε model for turbulences were applied. Transient simulations were performed for comparison. Hemodynamic parameters were assessed at various locations of the aorta. RESULTS: Post-dSINE, jet-like flow due to luminal narrowing was observed which increased prior to rupture and resulted in focal neighbored regions of high and low wall shear stress (WSS). Prior to rupture, aortic diameter at the rupture site increased lowering WSS at the entire aortic circumference. Concurrently, WSS and turbulence increased locally above the entry tear at the inner aortic curvature. Turbulent kinetic energy and WSS elevation in the downstream aorta demonstrated enhanced stress on the native aorta. Results of steady-state simulations were in good qualitative agreement with transient simulations. CONCLUSION: Steady-flow CFD simulations feasible at clinical time scales prior to aortic rupture reveal a hostile hemodynamic environment at the dSINE rupture site in agreement with lengthy transient simulations. Consequently, our developed approach may be of value in treatment planning where a fast assessment of the local hemodynamic environment is essential.

Expanding the Minimally Invasive Approach towards the Ascending Aorta-A Practical Overview of the Currently Available Techniques.

Minimally invasive techniques have gained immense importance in cardiovascular surgery. While minimal access strategies for coronary and mitral valve surgery are already widely accepted and often used as standard approaches, the application of minimally invasive techniques is currently expanded towards more complex operations of the ascending aorta as well. In this new and developing field, various techniques have been established and reported ranging from upper hemisternotomy approaches, which allow even extensive operations of the ascending aorta to be performed through a minimally invasive access to sternal sparing thoracotomy strategies, which completely avoid sternal trauma during ascending aorta replacements. All of these techniques place high demands on patient selection, preoperative planning, and practical surgical implementation. Application of these strategies is currently limited to high-volume centers and highly experienced surgeons. This narrative review gives an overview of the currently available techniques with a special focus on the practical execution as well as the advantages and disadvantages of the currently available techniques. The first results demonstrate the practicability and safety of minimally invasive techniques for replacement of the ascending aorta in a well-selected patient population. With success and complication rates comparable to classic full sternotomy, the proof of concept for minimally invasive replacement of the ascending aorta is now achieved.

Short-term mechanical support with the Impella 5.x for mitral valve surgery in advanced heart failure-protected cardiac surgery.

Introduction: Surgical treatment of patients with mitral valve regurgitation and advanced heart failure remains challenging. In order to avoid peri-operative low cardiac output, Impella 5.0 or 5.5 (5.x), implanted electively in a one-stage procedure, may serve as a peri-operative short-term mechanical circulatory support system (st-MCS) in patients undergoing mitral valve surgery. Methods: Between July 2017 and April 2022, 11 consecutive patients underwent high-risk mitral valve surgery for mitral regurgitation supported with an Impella 5.x system (Abiomed, Inc. Danvers, MA). All patients were discussed in the heart team and were either not eligible for transcatheter edge-to-edge repair (TEER) or surgery was considered favorable. In all cases, the indication for Impella 5.x implantation was made during the preoperative planning phase. Results: The mean age at the time of surgery was 61.6 ± 7.7 years. All patients presented with mitral regurgitation due to either ischemic (n = 5) or dilatative (n = 6) cardiomyopathy with a mean ejection fraction of 21 ± 4% (EuroScore II 6.1 ± 2.5). Uneventful mitral valve repair (n = 8) or replacement (n = 3) was performed via median sternotomy (n = 8) or right lateral mini thoracotomy (n = 3). In six patients, concomitant procedures, either tricuspid valve repair, aortic valve replacement or CABG were necessary. The mean duration on Impella support was 8 ± 5 days. All, but one patient, were successfully weaned from st-MCS, with no Impella-related complications. 30-day survival was 90.9%. Conclusion: Protected cardiac surgery with st-MCS using the Impella 5.x is safe and feasible when applied in high-risk mitral valve surgery without st-MCS-related complications, resulting in excellent outcomes. This strategy might offer an alternative and comprehensive approach for the treatment of patients with mitral regurgitation in advanced heart failure, deemed ineligible for TEER or with need of concomitant surgery.

Impact of Paravalvular Leak on Outcomes After Transcatheter Aortic Valve Implantation: Meta-Analysis of Kaplan-Meier-derived Individual Patient Data.

Background: Paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) is frequent and the impact of mild PVL on outcomes remains uncertain. Our study aimed to evaluate the impact of PVL on TAVI outcomes. Methods: To analyze late outcomes of patients after TAVI according to the presence and severity of PVL, PubMed/MEDLINE, EMBASE and Google Scholar were searched for studies that reported rates of all-cause mortality/survival and/or rehospitalization and/or cardiovascular mortality accompanied by at least one Kaplan-Meier curve for any of these outcomes. We adopted a 2-stage approach to reconstruct individual patient data based on the published Kaplan-Meier graphs. Results: Thirty-eight studies with Kaplan-Meier curves met our eligibility criteria including over 25,000 patients. Patients with any degree of PVL after TAVI had a significantly higher risk of overall mortality (hazard ratio (HR), 1.52; 95% confidence interval (CI), 1.43-1.61; p < 0.001), rehospitalization (HR, 1.81; 95% CI, 1.54-2.12; p < 0.001), and cardiovascular mortality (HR, 1.52; 95% CI, 1.33-1.75; p < 0.001) over time. These findings remained consistent when we stratified the results for the methods of assessment of PVL (i.e., echocardiography vs. angiography) and PVL severity. Both moderate/severe PVL and mild PVL were associated with increased risk of overall mortality (p < 0.001), rehospitalization (p < 0.001), and cardiovascular mortality (p < 0.001) during follow-up. Conclusions: Patients with PVL, even if mild, experience higher risk of all-cause mortality, rehospitalization, and cardiovascular mortality following TAVI. These findings provide support to the implementation of procedural strategies to prevent any degree of PVL at the time of TAVI.