Early Outcomes of Two Large Mitral Valve Transcatheter Edge-to-Edge Repair Devices-A Propensity Score Matched Multicenter Comparison.
Philipp von SteinHendrik WienemannJennifer von SteinAtsushi SugiuraTetsu TenakaRefik KavsurCan ÖztürkMarcel WeberJean Marc HaurandPatrick HornTobias KisterAmir Abbas MahabadiNiklas F BoederTobias Friedrich RufMuhammed GerçekChristoph MuesChristina GrothusenJulia NovotnyLudwig WeckbachHenning GuthoffFelix RudolphAmin PolzinStephan BaldusTienush RassafHolger ThieleHelge MöllmannMalte KelmVolker RudolphRalph Stephan von BardelebenHolger NefPeter LuedikePhilipp LurzJörg HausleiterRoman PfisterVictor MauriPublished in: Journal of clinical medicine (2024)
Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results : PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm 2 vs. 2.3 cm 2 ; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality ( p = 0.204) or reduction in NYHA-FC to ≤II ( p > 0.999). Conclusions : Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR.
Keyphrases
- mitral valve
- newly diagnosed
- ejection fraction
- patients undergoing
- magnetic resonance
- clinical trial
- left ventricular
- prognostic factors
- intensive care unit
- machine learning
- risk factors
- adipose tissue
- hepatitis b virus
- pulmonary hypertension
- liver failure
- big data
- cardiovascular events
- artificial intelligence
- weight loss