經(jīng)皮二尖瓣修復(fù)術(shù)mitraclip的研究進(jìn)展-在線瀏覽
2024-12-20 11:35本頁面
【正文】 ％的患者存在功能性 MR， 73％存在退行性 MR。研究有效終點(diǎn) 12月時(shí)無死亡、無需外科手術(shù)且二尖瓣反流 ≤ 2+； 27 Investigational Device only in the . Not available for sale in the . ACCESS EU – ESC 2020 Mitraclip技術(shù)研究進(jìn)展 ? 12月時(shí)， MitraClip組有效終點(diǎn)率為 55％，而外科手術(shù)組為 73％（ P=）； ? 二尖瓣反流 3+4+度的發(fā)生率分別 MitraClip組 vs 手術(shù)組分別為 21％和 20％； ? 需要再次外科手術(shù) MitraClip組和手術(shù)組分別為 20％和2％； ? 在 ≥ 70歲和功能性二尖瓣反流亞組中，外科手術(shù)在有效終點(diǎn)的優(yōu)勢不明顯，提示 ≥ 70歲和功能性二尖瓣反流患者更適合 MitraClip。排除輸血因素后， MitraClip組的其他不良事件發(fā)生率依低于手術(shù)組。 30 Investigational Device only in the . Not available for sale in the . ACCESS EU – ESC 2020 Mitraclip技術(shù)研究進(jìn)展 ? ACCESSEU研究旨在分析在臨床實(shí)踐中行 MitraClip手術(shù)的患者人口學(xué)特征，并評(píng)估 MitraClip術(shù)后患者的臨床預(yù)后。在這些人群中，MitraClip手術(shù)效果較佳，住院死亡率以及不良事件發(fā)生率均較低。 SD), years 67 177。 10 74 177。 SD NA NA 23 177。 SD 5 177。 8 NA STS Mortality Risk ≥ 12%, (%) 6 48 NA Male Gender, (%) 64 61 64 Coronary Artery Disease, (%) 47 81 63 Previous Cardiovascular Surgery, (%) 23 58 37 Myocardial Infarction, (%) 22 49 32 Cerebrovascular Disease, (%) 8 21 13 Moderate to Severe Renal Failure, (%) 3 31 42 Atrial Fibrillation, (%) 33 64 68 NYHA Functional Class III or IV, (%) 50 86 85 33 Investigational Device only in the . Not available for sale in the . ACCESS EU – ESC 2020 基線資料 Demographics and Comorbidities EVEREST II RCT Device Patients N=178 EVEREST II High Surgical Risk Cohort N=211 ACCESS EU – MitraClip Patients N=567 Mitral Regurgitation Grade ≥ 3+, (%) 96 86 98 Ejection Fraction 40%, (%) 6 28 53 Functional MR, (%) 27 71 77 Ischemic NA NA 42 Nonischemic NA NA 58 Degenerative MR, (%) 73 29 23 34 Investigational Device only in the . Not available for sale in the . ACCESS EU – ESC 2020 MitraClip Implant Rate and Number of Clips Implanted % Implant Rate N=567 0 . 2 %2 . 6 %3 6 . 7 %6 0 . 1 %0 . 4 %0%20%40%60%80%100%Percent0 M i tr aC l i p s (N= 2 )1 M i tr aC l i p (N= 3 4 1 )2 M i tr aC l i p s (N= 2 0 8 )3 M i tr aC l i p s (N= 1 5 )4 M i tr aC l i p s (N= 1 )`35 Investigational Device only in the . Not available for sale in the . ACCESS EU – ESC 2020 30天終點(diǎn)事件 EuroSCORE高危 Logistic回歸 1Year Events* All Patients N=567 Logistic EuroSCORE ≥20% N=253 Logistic EuroSCORE 20% N=314 pvalue Death 19 (%) 11 (%) 8 (%) ns Stroke 4 (%) 3 (%) 1 (%) ns Myocardial Infarction 4 (%) 2 (%) 2 (%) ns Renal Failure 27 (%) 16 (%) 11 (%) ns Respiratory Failure 4 (%) 3 (%) 1 (%) ns Need for Resuscitation 10 (%) 7 (%) 3 (%) ns Cardiac Tamponade 6 (%) 3 (%) 3 (%) ns Bleeding Complications 22 (%) 12 (%) 10 (%) ns * As reported by the sites 36 Investigational Device only in the . Not available for sale in the . ACCESS EU – ESC 2020 Site Reported Safety Events At 1 Year 1Year Events* All Patients N=567 Logistic EuroSCORE ≥20% N=253 Logistic EuroSCORE 20% N=314 pvalue Death 98 (%) 58 (%) 40 (%) Stroke 6 (%) 4 (%) 2 (%) ns Myocardial Infarction 8 (%) 5 (%) 3 (%) ns Renal Failure 49 (%) 29
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