MitraClip

MitraClip
  • 文章类型: Journal Article
    背景:对于患有功能性二尖瓣反流(FMR)和症状性心力衰竭(HF)的患者,经二尖瓣导管边缘对边缘修复(M-TEER)的随机试验产生了相互矛盾的结果.
    目的:本研究旨在评估M-TEER对住院率的影响,并探讨M-TEER对在接受M-TEER之前有或没有近期HF住院史的患者的影响。
    方法:RESHAPE-HF2(MitraClip装置在心力衰竭中的随机调查:在临床上有意义的功能性二尖瓣反流患者中的第2项试验)包括有症状的HF和中度至重度FMR患者(平均有效反流孔口面积0.25cm2;14%>0.40cm2,23%<0.20cm2),并显示alM-TEER降低了心力衰竭的住院质量和我们现在报告了在随机化前12个月内住院率和HF住院患者亚组(n=333)的预设分析结果。
    结果:在24个月时,首次心血管死亡或HF住院的时间(HR:0.65;95%CI:0.49-0.85;P=0.002),复发性CV住院率(比率[RR]:0.75;95%CI:0.57-0.99;P=0.046),复发性CV住院和全因死亡率的复合率(RR:0.74;95%CI:0.57-0.95;P=0.017),复发性CV死亡和CV住院(RR:0.76;95%CI:0.58-0.99;P=0.040),M-TEER组均较低。M-TEER组与对照组患者因任何原因反复住院的RR为0.82(95%CI:0.63-1.07;P=0.15)。随机接受M-TEER的患者因死亡或HF住院而损失的天数较少(13.9%[95%CI:13.0%-14.8%]vs17.4%[95%CI:16.4%-18.4%]随访时间;P<0.0001,1,067vs1,776天;P<0.0001)。随机接受M-TEER的患者在随访30天和6、12和24个月时也有更好的NYHA功能分级(P<0.0001)。随机分组前HF住院史与M-TEER对复发性HF住院和CV死亡(P交互作用=0.03)和24个月内复发性HF住院(P交互作用=0.06)的复合率和更大的获益相关。
    结论:这些结果表明,在有症状的HF和中度至重度FMR患者中,除了最佳的指导药物治疗外,还应考虑M-TEER的更广泛的应用。特别是那些有最近因HF住院史的人。
    BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results.
    OBJECTIVE: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER.
    METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization.
    RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06).
    CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.
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  • 文章类型: Journal Article
    评估中度至重度二尖瓣反流(MR)和心源性休克(CS)患者的经导管边缘至边缘修复(TEER)与单独的医疗管理相比是否可以改善预后。
    单中心,回顾性研究在城市三级转诊中心进行.
    拉什大学医学中心,美国。
    2012年至2021年期间出现CS和中度至重度MR的成年患者纳入研究。
    接受Mitraclip的二尖瓣TEER与单独的医疗管理。
    主要不良心血管事件(MACE)定义为心血管死亡,心力衰竭入院,中风,在30天评估心肌梗塞,6个月,和1年。次要结果是30天和6个月时纽约心脏协会(NYHA)分类的变化。
    有28名患者纳入医疗管理,33名患者纳入二尖瓣TEER组。干预组在30天时MACE降低(24.2%vs.46.4%,p≤0.001)和6个月(27%vs.75%,p=0.002),虽然不是在1年(29.4%vs.41.7%,p=0.42)。在30天,与单独的医疗管理相比,二尖瓣TEER组更多的患者提高到NYHAI/II级(10[35.7%]vs.16[50%],p=0.043)。在6个月时,NYHAI/II类没有差异(7[43.7%]与13[54.2%],p=0.63)。
    使用Mitraclip™系统的二尖瓣TEER可改善CS患者的中期心血管疾病,但不能改善死亡率。
    UNASSIGNED: Assessing if Transcatheter Edge to Edge Repair (TEER) with Mitraclip™ in patients with moderate to severe mitral regurgitation (MR) and cardiogenic shock (CS) improves outcomes compared to medical management alone.
    UNASSIGNED: A single-center, retrospective study was performed in an urban tertiary referral center.
    UNASSIGNED: Rush University Medical Center, United States.
    UNASSIGNED: Adult patients presenting with CS and moderate to severe MR between 2012 and 2021 were included.
    UNASSIGNED: Undergoing Mitral TEER with Mitraclip versus medical management alone.
    UNASSIGNED: Major adverse cardiovascular events (MACE) defined as cardiovascular death, heart failure admission, stroke, and myocardial infarction assessed at 30 days, 6 months, and 1 year. The secondary outcome was a change in New York Heart Association (NYHA) classification at 30 days and 6 months.
    UNASSIGNED: There were 28 patients included in the medical management and 33 in the mitral valve TEER groups. There was a decreased MACE in the intervention group at 30 days (24.2 % vs. 46.4 %, p ≤0.001) and 6 months (27 % vs. 75 %, p = 0.002), though not at 1 year (29.4 % vs. 41.7 %, p = 0.42). At 30 days, more patients in the mitral valve TEER group improved to NYHA classes I/II compared to medical management alone (10 [35.7 %] vs. 16 [50 %], p = 0.043). There were no differences in NYHA classes I/II at 6 months (7 [43.7 %] vs. 13 [54.2 %], p = 0.63).
    UNASSIGNED: Mitral valve TEER using the Mitraclip™ system improves mid-term cardiovascular compared to medical management alone in patients with CS but does not improve mortality.
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  • 文章类型: Case Reports
    一名76岁的女性,具有复杂的病史,在二尖瓣导管边缘到边缘修复(TEER)2个月后接受Watchman(波士顿科学公司)放置。Watchman放置前的术前检查证实左上肺静脉中存在血栓。术后二尖瓣TEER经食管超声心动图显示左心房附件或肺静脉无血栓。我们认为,由于二尖瓣TEER过程中的上皮损伤,左上肺静脉中的血栓是继发的。
    A 76-year-old female with a complicated medical history presented for Watchman (Boston Scientific) placement 2 months after mitral valve transcatheter edge-to-edge repair (TEER). Preoperative workup before Watchman placement confirmed the presence of a thrombus in the left superior pulmonary vein. Post-procedure mitral valve TEER transesophageal echocardiogram showed no thrombus in the left atrium appendage or pulmonary veins. We believe the thrombus in the left superior pulmonary vein occurred secondarily due to epithelium damage during the mitral valve TEER.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    二尖瓣经导管边缘到边缘修复(TEER)后的残余二尖瓣反流(MR)与较差的结果相关。这项研究旨在确定继发性MR患者TEER后不良残留MR的超声心动图预测因子。
    在这项回顾性单中心研究中,我们确定了所有在2016年至2021年间接受TEER的继发性MR患者.术前和术中经食管超声心动图图像进行了回顾。主要结果是欠佳的残余MR,定义为术后经食管超声心动图的≥2+残余MR。术前超声心动图参数与主要结果的相关性通过逻辑回归进行测试。
    65例(69±15岁;49%的女性)继发MR患者接受了使用MitraClip的TEER。所有患者术前均有中重度或重度(3-4+)MR,平均左心室射血分数为35%,纽约心脏协会出现III类症状。程序性成功,定义为≤2+MR后TEER,达到94%。在38%中观察到次优的残余MR。次优残余MR的独立预测因子包括双异常MR(比值比[OR],7.95;95%CI,1.50-42.3;P=0.02),二维前后径(OR,6.46;95%CI,每厘米1.85-22.51;P<0.01),和二尖瓣面积与左心室舒张末期容积之比(OR,0.69;95%CI,0.50-0.93/mm2/mL;P=0.02)。
    某些超声心动图特征,包括双法定MR,更大的环形直径,二尖瓣面积与左心室舒张末期容积的比值较小,与TEER后的次优残余MR相关。这些术前测量可以优化那些考虑TEER的次级MR的患者选择。
    UNASSIGNED: Residual mitral regurgitation (MR) following mitral valve transcatheter edge-to-edge repair (TEER) is associated with worse outcomes. This study sought to identify echocardiographic predictors of suboptimal residual MR after TEER in patients with secondary MR.
    UNASSIGNED: In this retrospective single-center study, we identified all patients with secondary MR who underwent TEER between 2016 and 2021. Pre- and intraprocedural transesophageal echocardiographic images were reviewed. The primary outcome was suboptimal residual MR, defined as ≥2+ residual MR on postprocedural transesophageal echocardiography. The association of preprocedural echocardiographic parameters with the primary outcome was tested via logistic regression.
    UNASSIGNED: Sixty-five patients (69 ± 15 years; 49% women) with secondary MR underwent TEER with MitraClip. All patients had moderate-severe or severe (3-4+) MR preoperatively, with an average left ventricular ejection fraction of 35% and New York Heart Association class III symptoms. Procedural success, defined as ≤2+ MR post-TEER, was achieved in 94%. A suboptimal residual MR was observed in 38%. Independent predictors of suboptimal residual MR included bicommissural MR (odds ratio [OR], 7.95; 95% CI, 1.50-42.3; P = .02), 2-dimensional anteroposterior diameter (OR, 6.46; 95% CI, 1.85-22.51 per cm; P < .01), and mitral valve area to left ventricular end-diastolic volume ratio (OR, 0.69; 95% CI, 0.50-0.93 per mm2/mL; P = .02).
    UNASSIGNED: Certain echocardiographic features, including bicommissural MR, a larger annular diameter, and a smaller ratio of mitral valve area to left ventricular end-diastolic volume, are associated with suboptimal residual MR following TEER. These preprocedural measurements may optimize patient selection in those with secondary MR being considered for TEER.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    早期病例报告表明,使用MitraClip的经导管边缘到边缘修复(TEER)治疗因梗死后乳头状肌破裂(PMR)引起的急性二尖瓣返流(MR)可能是手术风险过高的患者的替代方法。然而,缺乏连续接受这种疾病治疗的患者的数据.
    要定义程序特征,药物使用,血液动力学参数,和成像数据,我们介绍了2018年6月至2020年11月在拉荷亚斯克里普斯纪念医院接受TEER治疗的5例来自梗死后PMR的急性MR患者.
    在所有病例中都能成功降低MR并改善血流动力学。尽管程序上取得了成功,5例患者中只有1例存活至出院.
    TEER可能是由于梗塞后PMR引起的急性MR的有效治疗方法,可以降低MR并改善血流动力学。存活到出院很少,提示TEER可能仅适用于选定的患者。
    UNASSIGNED: Early case reports have suggested that transcatheter edge-to-edge repair (TEER) with the MitraClip for the treatment of acute mitral regurgitation (MR) due to post-infarction papillary muscle rupture (PMR) may be an alternative for patients at prohibitive surgical risk. However, data on consecutive patients treated for this condition is lacking.
    UNASSIGNED: To define the procedural characteristics, medication use, hemodynamic parameters, and imaging data, we present 5 consecutive patients with acute MR from postinfarction PMR treated with TEER at Scripps Memorial Hospital La Jolla between June 2018 and November 2020.
    UNASSIGNED: Successful reduction of MR and improved hemodynamics were achieved in all cases. Despite the procedural success, only 1 of the 5 patients survived until hospital discharge.
    UNASSIGNED: TEER may be an effective treatment for acute MR due to postinfarction PMR to reduce MR and improve hemodynamics. Survival to discharge was infrequent, suggesting that TEER may be appropriate only in selected patients.
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