Herbert Gutermann

Sutureless aortic valve prostheses reduce surgical times and facilitate minimally invasive approaches, improving patient outcomes. However, it remains unclear whether these devices provide specific benefits to female patients, in whom sex-related differences in valve surgery outcomes remain a matter of debate. Up to September 2024, 535 subjects (261 women) received Perceval Plus at 35 investigational sites from Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting observational prospective registry. Moreover, meta-regression was performed to assess whether sex modifies outcomes. Men have a larger body size (body surface area: male 2.0 ± 0.2 vs female 1.8 ± 0.2, P < .001), resulting in a larger prosthesis size (size S: male 2.9% vs female 34.9%). Surgery was still significantly faster in women (cross-clamp time: male 63.7 ± 29.4 min vs female 56.8 ± 29.4 min, P = .002), partly because approximately 10% of procedures in male patients were combined, increasing duration. Early outcomes were comparable between sexes (hospital deaths: male 3 [1.1%] vs female 5 [1.9%], P = .49). At follow-up, no significant differences were observed (follow-up deaths: male 9 [3.3%] vs female 5 [1.9%], P = .42). Meta-regression showed no effect of female sex prevalence. Our registry and meta-regression analysis did not reveal significant differences in outcomes between men and women. Preoperative characteristics, however, differ between sexes and may influence outcomes and prosthesis choice. Long-term conclusions are limited by the current follow-up duration and will be further explored as data collection progresses. NCT05002543, ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05002543)

Objectives: This study aimed to evaluate the long-term efficacy and safety of isolated and hybrid thoracoscopic atrial fibrillation (AF) ablation using a bipolar irrigated radiofrequency clamp in a multicentre registry. Methods: A retrospective multicentre registry of patients undergoing AF ablation using the bipolar clamp was conducted over the past 13 years (2010-2023). The primary efficacy outcome was freedom of atrial tachyarrhythmias (ATAs), with and without the use of Class I/III antiarrhythmic drugs (AADs). Antiarrhythmic drug use during follow-up was not uniformly documented across centres. The primary safety outcome was the rate of periprocedural complications. Results: The cohort of 678 patients consisted of a minority of female patients (17.4%), with most patients having longstanding persistent AF (LSPAF) (66.7%), a mean duration of 61 months of AF duration and 33.3% had undergone prior catheter ablation. Freedom from ATA while allowing Class I/III AAD use was 82.3%, 71.5%, and 52.4% at 1, 3, and 5 years, respectively. Freedom from ATA off Class I/III AAD declined from 71.7% at 1 year to 44.2% at 5 years, underscoring the progressive nature of AF and the need for long-term rhythm strategies. Women presented with a more advanced cardiovascular risk profile than men, including older age (60.3 vs 57.3 years), higher CHA2DS2-VA-scores, and more comorbidities. Despite these differences, there were no significant sex-based differences in long-term ATA freedom. There were no significant unadjusted differences in long-term ATA freedom between paroxysmal AF (PAF) and non-PAF. Major complication rate was low. Conclusions: Isolated and hybrid thoracoscopic AF ablation using the Gemini Clamp demonstrated favourable outcomes with a low complication rate. However, variability in ATA detection methods among centres may have influenced the primary outcome and should be considered when interpreting long-term efficacy results. Clinical trial registry number: METC-number 2022-3561.