Dataset Information

Gender Differences after Transcatheter Aortic Valve Replacement (TAVR): Insights from the Italian Clinical Service Project.

ABSTRACT:

Background

TAVR is a safe alternative to surgical aortic valve replacement (SAVR); however, sex-related differences are still debated. This research aimed to examine gender differences in a real-world transcatheter aortic valve replacement (TAVR) cohort.

Methods

All-comer aortic stenosis (AS) patients undergoing TAVR with a Medtronic valve across 19 Italian sites were prospectively included in the Italian Clinical Service Project (NCT01007474) between 2007 and 2019. The primary endpoint was 1-year mortality. We also investigated 3-year mortality, and ischemic and hemorrhagic endpoints, and we performed a propensity score matching to assemble patients with similar baseline characteristics.

Results

Out of 3821 patients, 2149 (56.2%) women were enrolled. Compared with men, women were older (83 ± 6 vs. 81 ± 6 years, p < 0.001), more likely to present severe renal impairment (GFR ≤ 30 mL/min, 26.3% vs. 16.3%, p < 0.001) but had less previous cardiovascular events (all p < 0.001), with a higher mean Society of Thoracic Surgeons (STS) score (7.8% ± 7.1% vs. 7.2 ± 7.5, p < 0.001) and a greater mean aortic gradient (52.4 ± 15.3 vs. 47.3 ± 12.8 mmHg, p < 0.001). Transfemoral TAVR was performed more frequently in women (87.2% vs. 82.1%, p < 0.001), with a higher rate of major vascular complications and life-threatening bleeding (3.9% vs. 2.4%, p = 0.012 and 2.5% vs. 1.4%, p = 0.024). One-year mortality differed between female and male (11.5% vs. 15.0%, p = 0.002), and this difference persisted after adjustment for significant confounding variables (Adj.HR1yr 1.47, 95%IC 1.18-1.82, p < 0.001). Three-year mortality was also significantly lower in women compared with men (19.8% vs. 24.9%, p < 0.001) even after adjustment for age, STS score, eGFR, diabetes and severe COPD (Adj.HR3yr 1.42, 95%IC 1.21-1.68, p < 0.001). These results were confirmed in 689 pairs after propensity score matching.

Conclusion

Despite higher rates of peri-procedural complications, women presented better survival than men. This better adaptive response to TAVR may be driven by sex-specific factors.

SUBMITTER: Denegri A

PROVIDER: S-EPMC8472227 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Transcatheter mitral valve replacement (TMVR) is currently being investigated as a procedural alternative to surgical mitral valve repair or replacement (SMVR). Early data from first-in-man trials with current devices suggest that TMVR is technically feasible but carries a high mortality. This is substantially different from the early success transcatheter aortic valve replacement (TAVR) has seen and is related to complexities of the mitral valve anatomy, differences in pathology that require mitral valve replacement as well as the impact that mitral valve replacement has on physiology and cardiac function, irrespective of the modality by which the mitral valve is replaced. Importantly, in the case of TAVR, a less invasive method is offered to accomplish the same as the traditional surgical intervention. On the other hand, valve replacement is not the recommended treatment option for the majority of mitral valve disease, and in fact is avoided whenever possible during surgery given the shortened life expectancy and increased morbidity with mitral valve replacement. Another distinction between TAVR and TMVR is the etiology and natural progression of the underlying disease and driving factors for intervention that are vastly different between aortic and mitral valve disease. The primary aortic disease treated has been aortic stenosis, which has several etiologic factors that cause a similar physiologic dysfunction and risk. Aortic valve replacement leads to improved survival and quality of life. The primary mitral valve disease targeted is regurgitation, which occurs as a primary valve defect and as a secondary consequence of ventricular dysfunction. Primary mitral regurgitation is treated by valve repair with excellent long-term outcomes. Secondary regurgitation has poor long-term outcomes with current commonly used repair techniques and limited data exists showing that correction of the regurgitation improves survival. Adoption of TMVR will require overcoming the anatomic challenges as well as generating data that supports improved survival and/or quality of life.