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Long-term (10 Years) Resultsof Transcatheter Mitral Valve-in-valve Implantation For Degenerated Surgical Mitral Bioprosthesis
Edoardo Zancanaro1, Sergio Berti2, Tommaso Hinna Danesi1.
1Brigham and Women's Hospital, Boston, MA, USA, 2Massa Monaterio Foundation, Massa, Italy.
BackgroundReoperation of failed bioprosthetic mitral valves is associated with significant morbidity and mortality. Surgical mitral bioprosthetic valves are radiopaque, stented, and circular and therefore ideal for transcatheter procedures with the fluoro-technique. Transcatheter mitral valve-in-valve (MViV) replacement was explored early in the development of THVs with transfemoral (TF) and transapical (TA) approaches. TS MViV involves transoesophageal echo-guided TS puncture and over-the-wire delivery of the THV through an expandable 14F or 16F sheath in the femoral vein. Transapical access includes surgical exposure, access, and closure of the left ventricular apex. With the availability of the low-profile SAPIEN 3 valve and growing physician experience with TS procedures, TS SAPIEN 3 MViV has become the predominant MViV procedure and is associated with higher procedural success and lower 30-day mortality than predicted by the STS score.The present study aims to assess the > 10-year follow-up outcomes in terms of mortality, gender diversity, and echocardiographic outcomes as the first of its kind since, till the present day, only results at 3 years have been published.
Methods Participating centres used standardized definitions to collect clinical information, including patient demographic characteristics, comorbidities, functional status, quality of life indexes, procedural details, and patient outcomes from consecutive MViV cases using commercially approved devices of the Sapien family (Edwards Lifesciences). All consecutive patients undergoing transcatheter mitral valve replacement at 11 participating centres between January 2010 and January 2023 were enrolled. The primary objective of the study was to assess contemporary outcomes of MViV using the SAPIEN XT/3/3 Ultra THV. The primary endpoint was all-cause mortality and cardiac death at >10 years together with procedural technical success defined per Mitral Valve Academic Research Consortium (MVARC) criteria at the exit from the catheterization laboratory or the hybrid room as the patient being alive with successful access, delivery, and retrieval of the device delivery system, successful deployment, and correct position of the first intended device, and freedom from emergency surgery or re-intervention associated with the device or procedural access. All adverse outcomes were defined using MVARC definitions. The secondary endpoint was the assessment of results based on differentiation for gender and access as well as echocardiographic VIV performance.
Results A total of 265 patients underwent mitral VIV due to bioprosthetic degeneration between January 2010 and January 2023 at 11 participating centres. They have been subdivided by the two principal technical approaches: transfemoral (TF) with 117 (44%) pts and transapical (TA) with 148 (55.8%) pts. From the total cohort, 47 pts have been treated with Sapien XT, 213 with Sapien 3, and 5 with Sapien 3 Ultra. Most of the patients were of female sex (59.2%), and the EuroScore II for surgical re-operation was 16.1%. Mixed disease (48%) was more common than mitral regurgitation (29%) and stenosis (22%). The presence of paravalvular mitral regurgitation (PVL) was seen as severe in 3.4 %, while 5,6% for mild to moderate. The mean gradient was 11 mmHg for the entire cohort. 69.8% of the total cohort was in class NYHA III with a mean LVEF of 54%. There were no significant demographic differences between patients undergoing TS and TA. Nevertheless, in TF, there was more severe PVL (5%)(p-value: 0.001) and severe grade of stenosis (54.7%) and regurgitation (57%)(p-value< 0.0001). SAPIEN 3 valves were implanted in 213 pts, including the 29-mm (89/203[43,8%]) and 26-mm (109/203 [50%]) sizes, while the 23-mm (15/203 [7.3%]) valve was implanted infrequently. For SAPIEN XT (47 (17%) total implanted), 26-mm was implanted in 23/47 (48.9%), 29-mm in 20/47 (40%), 23-mm in 4/47(8.5%), and 20-mm in 1/47(2.1%). Concerning the SAPIEN 3 Ultra instead, only 5 26-mm were used. Pre-dilatation was performed in 8 pts and post-dilation in 24 pts; only 1 patient received both pre- and post-dilatation. No significant difference was found between TA and TF access, with the exception of LVOT obstruction (3,4% for TA and 0 for TF). Overall, 1.5% of the patients underwent surgical conversion, and embolization occurred in 1%. Technical success has been established in around 97,7% of the total cohort without difference between groups. 3.3% died during hospitalization without difference between groups (P-value=0.735). The first endpoint of general survival from the total cohort was 91.3% at 10 years. Freedom from cardiac death (CV death) was 96.6% in the total cohort at 10 years. Concerning the difference between access, the general survival is established at 97.4% in TF while 86.3% in TA (p-value =0,050). Freedom from CV death was 99.1% in TF and 94.5 in TA (p-value=0.209). In gender analysis differentiation, the general survival in females was 98.5% in TF and 85.6% in TA at 10 years (p-value=0.056). Instead, in the case of freedom from CV death, it was 93,3% in TA and 98,5% in TF at 13 years (p-value=0.333). No predictors have been identified as significant for survival at more than 10 years at univariate and multivariate analysis. Late complications defined by MVARC (>10 years) have been seen only in 6 patients (including HALT and Thrombosis), and only 1 patient has been re-operated due to severe prosthesis impaired thrombosis. 4 patients underwent permanent pacemaker implantationsThe mean Δ for mean gradient comparing 1 to 10 years in the general population is -0,13 mmHg (CI 95 %) with a p-value=0.11, showing no significant increase. Regarding the changes in symptoms (identified by NYHA class), from baseline to 1 year till 10 years, 90% improve by at least 1 class while only 0,8% show a worsening. The principal improvement from classes IV/III to I/II has been seen at 1 year, with a stabilization till 10 years.
Conclusions Transcatheter MViV using a balloon-expandable valve is associated with high technical success, a low complication rate, and a solid long-term benefit in terms of survival. Transseptal access was associated with lower mortality compared with TA access. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthesis who have favourable anatomy, electing bioprosthetic valve replacement.
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