St Paul's Hospital, Vancouver, British Columbia, Canada.
German Heart Center, Munich, Germany.
JAMA. 2014 Jul;312(2):162-70. doi: 10.1001/jama.2014.7246.
IMPORTANCE: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed. OBJECTIVE: To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves. DESIGN, SETTING, AND PARTICIPANTS: Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves. MAIN OUTCOMES AND MEASURES: Survival, stroke, and New York Heart Association functional class. RESULTS: Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008). CONCLUSIONS AND RELEVANCE: In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.
重要性:由于生物假体的植入而不是机械瓣膜的大量应用,预计在未来几年内,患者将越来越多地出现退行性生物假体。经导管主动脉瓣瓣中瓣植入术是一种治疗结构性瓣膜恶化的微创方法;然而,对于该手术的生存情况还没有进行全面的评估。 目的:确定退行性生物假体瓣内经导管瓣中瓣植入术后患者的生存情况。 设计、地点和参与者:使用多国瓣膜瓣中瓣登记处评估了相关生存率,该登记处包括 55 个中心的 459 名退行性生物假体瓣膜患者,这些患者在 2007 年至 2013 年 5 月期间接受了瓣膜瓣中瓣植入术(平均年龄 77.6[SD,9.8]岁;56%为男性;中位数胸外科医生死亡率预测评分 9.8%[四分位距,7.7%-16%])。外科瓣膜分为小(≤21mm;29.7%)、中(>21mm 且<25mm;39.3%)和大(≥25mm;31%)。植入的器械包括球囊扩张式和自扩张式瓣膜。 主要结果和测量指标:生存、卒中和纽约心脏协会功能分级。 结果:生物假体失效的模式为狭窄(n=181[39.4%])、反流(n=139[30.3%])和联合(n=139[30.3%])。狭窄组中小瓣膜的比例较高(37%比反流组和联合组的 20.9%和 26.6%,P=0.005)。在瓣膜瓣中瓣植入术后 1 个月内,35 例(7.6%)患者死亡,8 例(1.7%)发生大卒,313 例(92.6%)存活患者心功能状态良好(纽约心脏协会分级 I/II)。总体 1 年 Kaplan-Meier 生存率为 83.2%(95%CI,80.8%-84.7%;62 例死亡事件;228 例幸存者)。狭窄组患者 1 年生存率较差(76.6%[95%CI,68.9%-83.1%;34 例死亡;86 例存活]),与反流组(91.2%[95%CI,85.7%-96.7%;10 例死亡;76 例存活])和联合组(83.9%[95%CI,76.8%-91%;18 例死亡;66 例存活])相比(P=0.01)。同样,小瓣膜患者的 1 年生存率也较差(74.8%[95%CI,66.2%-83.4%;27 例死亡;57 例存活))与中瓣膜(81.8%[95%CI,75.3%-88.3%;26 例死亡;92 例存活))和大瓣膜(93.3%[95%CI,85.7%-96.7%;7 例死亡;73 例存活])相比(P=0.001)。1 年内死亡的相关因素包括外科生物假体小(≤21mm;危险比,2.04;95%CI,1.14-3.67;P=0.02)和基线狭窄(与反流相比;危险比,3.07;95%CI,1.33-7.08;P=0.008)。 结论和相关性:在退行性生物假体主动脉瓣瓣中瓣植入术患者的登记处中,总体 1 年生存率为 83.2%。小生物假体患者和主要外科瓣膜狭窄患者的生存率较低。
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