IntroductionBased on European guidelines, transcatheter aortic valve implementation (TAVI) could be the therapy of choice in patients with severe aortic stenosis aged >= 75 years. In the... Show moreIntroductionBased on European guidelines, transcatheter aortic valve implementation (TAVI) could be the therapy of choice in patients with severe aortic stenosis aged >= 75 years. In the Netherlands, there has been a debate between healthcare providers and the National Health Care Institute regarding reimbursement for TAVI, which resulted in an indication document that defines TAVI patients who are eligible for reimbursement. This document has been effective since 1 January 2021.MethodsWe extracted data from the Netherlands Heart Registry for patients who underwent biological surgical aortic valve replacement (SAVR) or TAVI in the Netherlands from 2018 through 2021. We compared baseline characteristics and variables from the indication document for the subsequent years and age groups. We also analysed the annual SAVR/TAVI ratio.ResultsThe total number of patients treated with SAVR or TAVI was constant in 2018-2021. Baseline characteristics of patients treated with TAVI did not differ throughout the years. The SAVR/TAVI ratio shifted towards a higher percentage of TAVI from 2018 to 2019. From 2019 to 2020, the TAVI percentage was constant. Since the implementation of the indication document (in 2021), a change in the SAVR/TAVI ratio was not found either.ConclusionSince the implementation of the national indication document for AVR in 2021, no major effect was seen for the SAVR versus TAVI landscape in the Netherlands. Show less
Groenen, H.; Jalalzadeh, H.; Buis, D.R.; Dreissen, Y.E.M.; Goosen, J.H.M.; Griekspoor, M.; ... ; Boermeester, M.A. 2023
BackgroundThe evidence on prophylactic use of negative pressure wound therapy on primary closed incisional wounds (iNPWT) for the prevention of surgical site infections (SSI) is confusing and... Show moreBackgroundThe evidence on prophylactic use of negative pressure wound therapy on primary closed incisional wounds (iNPWT) for the prevention of surgical site infections (SSI) is confusing and ambiguous. Implementation in daily practice is impaired by inconsistent recommendations in current international guidelines and published meta-analyses. More recently, multiple new randomised controlled trials (RCTs) have been published. We aimed to provide an overview of all meta-analyses and their characteristics; to conduct a new and up-to-date systematic review and meta-analysis and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment; and to explore the additive value of new RCTs with a trial sequential analysis (TSA).MethodsPubMed, Embase and Cochrane CENTRAL databases were searched from database inception to October 24, 2022. We identified existing meta-analyses covering all surgical specialties and RCTs studying the effect of iNPWT compared with standard dressings in all types of surgery on the incidence of SSI, wound dehiscence, reoperation, seroma, hematoma, mortality, readmission rate, skin blistering, skin necrosis, pain, and adverse effects of the intervention. We calculated relative risks (RR) with corresponding 95% confidence intervals (CI) using a Mantel-Haenszel random-effects model. We assessed publication bias with a comparison-adjusted funnel plot. TSA was used to assess the risk of random error. The certainty of evidence was evaluated using the Cochrane Risk of Bias-2 (RoB2) tool and GRADE approach. This study is registered with PROSPERO, CRD42022312995.FindingsWe identified eight previously published general meta-analyses investigating iNPWT and compared their results to present meta-analysis. For the updated systematic review, 57 RCTs with 13,744 patients were included in the quantitative analysis for SSI, yielding a RR of 0.67 (95% CI: 0.59–0.76, I2 = 21%) for iNPWT compared with standard dressing. Certainty of evidence was high. Compared with previous meta-analyses, the RR stabilised, and the confidence interval narrowed. In the TSA, the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit, confirming the robustness of the summary effect estimate from the meta-analysis.InterpretationIn this up-to-date meta-analysis, GRADE assessment shows high-certainty evidence that iNPWT is effective in reducing SSI, and uncertainty is less than in previous meta-analyses. TSA indicated that further trials are unlikely to change the effect estimate for the outcome SSI; therefore, if future research is to be conducted on iNPWT, it is crucial to consider what the findings will contribute to the existing robust evidence. Show less
Palmen, M.; Navarra, E.; Bonatti, J.; Franke, U.; Cerny, S.; Musumeci, F.; ... ; Pereda, D. 2022
BackgroundEuropean surgeons were the first worldwide to use robotic techniques in cardiac surgery and major steps in procedure development were taken in Europe. After a hype in the early 2000s case... Show moreBackgroundEuropean surgeons were the first worldwide to use robotic techniques in cardiac surgery and major steps in procedure development were taken in Europe. After a hype in the early 2000s case numbers decreased but due to technological improvements renewed interest can be noted. We assessed the current activities and outcomes in robotically assisted cardiac surgery on the European continent. MethodsData were collected in an international anonymized registry of 26 European centers with a robotic cardiac surgery program. ResultsDuring a 4-year period (2016-2019), 2,563 procedures were carried out [30.0% female, 58.5 (15.4) years old, EuroSCORE II 1.56 (1.74)], including robotically assisted coronary bypass grafting (n = 1266, 49.4%), robotic mitral or tricuspid valve surgery (n = 945, 36.9%), isolated atrial septal defect closure (n = 225, 8.8%), left atrial myxoma resection (n = 54, 2.1%), and other procedures (n = 73, 2.8%). The number of procedures doubled during the study period (from n = 435 in 2016 to n = 923 in 2019). The mean cardiopulmonary bypass time in pump assisted cases was 148.6 (63.5) min and the myocardial ischemic time was 88.7 (46.1) min. Conversion to larger thoracic incisions was required in 56 cases (2.2%). Perioperative rates of revision for bleeding, stroke, and mortality were 56 (2.2%), 6 (0.2 %), and 27 (1.1%), respectively. Median postoperative hospital length of stay was 6.6 (6.6) days. ConclusionRobotic cardiac surgery case numbers in Europe are growing fast, including a large spectrum of procedures. Conversion rates are low and clinical outcomes are favorable, indicating safe conduct of these high-tech minimally invasive procedures. Show less
Cane, F.; Verhegghe, B.; Beule, M. de; Bertrand, P.B.; Geest, R.J. van der; Segers, P.; Santis, G. de 2018
