Article Impact Level: HIGH Data Quality: STRONG Summary of European Heart Journal, ehad663. https://doi.org/10.1093/eurheartj/ehad663 Dr. Sebastien Hascoët et al.
Points
- The study analyzed data from 840 patients who underwent transcatheter pulmonary valve implantation (TPVI) using the SAPIEN 3 valve for right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD).
- The success rate of valve implantation was high at 98.5%, with a median follow-up duration of 20.3 months.
- The most common diagnosis among the patients was conotruncal defect, and approximately half of them had a native or patched RVOT.
- The study reported incidences of infective endocarditis, pulmonary valve replacement, and pulmonary valve thrombosis at different time points after TPVI, with lower rates observed in patients with larger valves.
- Overall, the outcomes of TPVI using the SAPIEN 3 valve were favorable in patients with CHD, including those with native or patched RVOTs, highlighting the effectiveness and safety of this treatment approach.
Summary
Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). The EUROPULMS3 registry of SAPIEN 3-TPVI investigated insufficiently documented outcomes of TPVI with the SAPIEN 3 valve.
In this observational cohort from 35 centers in 15 countries, patient-related, procedural, and follow-up outcome data were retrospectively assessed.
Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was a conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively.
Outcomes of SAPIEN 3 TPVI were favorable in patients with CHD, half of whom had native or patched RVOTs. The success rate of valve implantation was high at 98.5%. The incidence of infective endocarditis, pulmonary valve replacement, and pulmonary valve thrombosis was reported at different time points after TPVI, providing valuable information on the long-term outcomes of this procedure. The study highlights the effectiveness and safety of TPVI with the SAPIEN 3 valve in improving outcomes for patients with RVOT dysfunction related to CHD.
Link to the article: https://academic.oup.com/eurheartj/advance-article-abstract/doi/10.1093/eurheartj/ehad663/7329124
References Hascoët, S., Bentham, J. R., Giugno, L., Betrián-Blasco, P., Kempny, A., Houeijeh, A., Baho, H., Sharma, S.-R., Jones, M. I., Biernacka, E. K., Combes, N., Georgiev, S., Bouvaist, H., Martins, J. D., Kantzis, M., Turner, M., Schubert, S., Jalal, Z., Butera, G., … Ystgaard, M. B. (2023). Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: An international registry. European Heart Journal, ehad663. https://doi.org/10.1093/eurheartj/ehad663
