Sex-Related Outcome After Sutureless Aortic Valve Replacement With Perceval Plus: Results From a Global Registry and Meta-Regression.

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

CLINICAL REGISTRATION NUMBER: NCT05002543, ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05002543).