Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data.
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Waggoner Thomas, Garcia Santiago, Chakravarty Tarun, Makar Moody, Latib Azeem, Kipperman Robert M, Zahr Firas, Hanson Ivan, Sinha Anjan K, Sharma Rahul P, Depta Jeremiah P, Castellanos Jorge A, Kodali Susheel, Krishnaswamy Amar, Whisenant Brian, Menees Daniel, Lim D Scott, Gilani Fahad, Sanchez Carlos E, Gheewala Neil, Gada Hemal, Kapadia Samir, Ramanathan P Kasi, Shah Pinak B, Renard Brian, Theodos Gus, Yaryura Ricardo, Gardner Blake, Steinberg Daniel H, Gnall Eric, Kaddissi Georges, Chhatriwalla Adnan K, Frangieh Antonio H, Eleid Mackram F, Géneréux Philippe, Saxon John T, Villablanca Pedro, Matar Fadi, Agarwal Himanshu, Chetcuti Stanley, Frisoli Tiberio, Makkar Raj
Аннотация
OBJECTIVES: The authors report early U.S. commercial experience with the PASCAL Precision system.
METHODS: Patients with DMR treated with the PASCAL Precision system in the United States were analyzed from the STS/ACC TVT Registry. Procedural, clinical, echocardiographic, functional, and quality-of-life outcomes to 30 days were assessed. All outcomes, including echocardiographic assessments, were site-assessed.
RESULTS: In 1,995 DMR patients, the median age was 81.6 years, and 57.0% were male. Median STS-PROM for mitral valve repair was 3.6%, and 69.4% were in NYHA functional class III/IV. Mixed etiology (DMR + other etiology) was present in 11.4%, and 66.9% had complex anatomy (annular/leaflet calcification, mitral valve area <4 cm2, bileaflet flail/prolapse/tethering, or mitral stenosis). The device was successfully implanted in 97.7%. MR reduction was significant at 30 days with 94.2% achieving ≤moderate MR and 72.6% ≤mild MR (P < 0.001 vs baseline). Patients experienced significant functional and quality-of-life improvements with a mean 21.0-point increase in Kansas City Cardiomyopathy Questionnaire score and 84.6% in NYHA functional class I/II (all P < 0.001). Mitral valve reintervention and single-leaflet device attachment rates were 0.4% and 0.5%, respectively, and all-cause mortality, cardiovascular mortality, and heart failure readmission rates were 2.2%, 1.2%, and 2.6%, respectively, at 30 days.
CONCLUSIONS: Early U.S. STS/ACC TVT Registry commercial experience confirms the safety and effectiveness of the novel PASCAL Precision system in the treatment of a broad population of real-world DMR patients.