Salizzoni Stefano, D'Onofrio Augusto, Agrifoglio Marco, Colombo Antonio, Chieffo Alaide, Cioni Micaela, Besola Laura, Regesta Tommaso, Rapetto Filippo, Tarantini Giuseppe, Napodano Massimo, Gabbieri Davide, Saia Francesco, Tamburino Corrado, Ribichini Flavio, Cugola Diego, Aiello Marco, Sanna Francesco, Iadanza Alessandro, Pompei Esmeralda, Stefàno Pierluigi, Cappai Antioco, Minati Alessandro, Cassese Mauro, Martinelli Gian Luca, Agostinelli Andrea, Fiorilli Rosario, Casilli Francesco, Reale Maurizio, Bedogni Francesco, Petronio Anna Sonia, Mozzillo Rosa Alba, Bonmassari Roberto, Briguori Carlo, Liso Armando, Sardella Gennaro, Bruschi Giuseppe, Fiorina Claudia, Filippini Claudia, Moretti Claudio, D'Amico Maurizio, La Torre Michele, Conrotto Federico, Di Bartolomeo Roberto, Gerosa Gino, Rinaldi Mauro
Department of Surgical Sciences, University of Turin, Turin, Italy
Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
Eur J Cardiothorac Surg. 2016 Dec;50(6):1139-1148. doi: 10.1093/ejcts/ezw218. Epub 2016 Jul 12.
The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy.
The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality.
Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively).
TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.
这项多中心研究的目的是报告意大利所有接受球囊扩张式装置经导管主动脉瓣植入术（TAVI）患者的临床经验。
意大利经导管球囊扩张瓣膜注册研究（ITER）是一项真实世界注册研究，纳入了自Sapien（美国加利福尼亚州尔湾市爱德华兹生命科学公司）生物假体在意大利临床应用以来接受TAVI的患者。2007年至2012年，1904例患者在意大利33个中心登记接受TAVI。结局根据更新后的瓣膜学术研究联盟（VARC-2）定义进行分类。进行多变量分析以确定全因死亡率的独立预测因素。
平均年龄为81.7（标准差：6.2）岁，1147例（60.2%）患者为女性。平均逻辑欧洲心脏手术风险评估系统（EuroSCORE）为21.1%（标准差：13.7）。分别有1252例（65.8%）、630例（33.1%）、18例（0.9%）和4例（0.2%）患者接受了经股动脉、经心尖、经主动脉和经腋动脉TAVI。手术死亡率为7.2%（137例患者）。VARC-2结局如下：装置成功率为88.1%；致残性卒中为1.0%；危及生命和大出血分别为9.8%和10.5%；主要血管并发症为9.7%；急性肾损伤为8.2%；≤72小时急性心肌梗死为1.5%。116例（6.1%）患者围手术期需要植入起搏器。出院时，平均跨瓣压差为10.7（标准差：4.5）mmHg。术后轻度、中度或重度瓣周漏发生率分别为32.1%、5.0%和0.4%。共报告了444/1767（25.1%）例出院后死亡：其中，168例（37.8%）被归类为心源性死亡。全因死亡率的术前独立预测因素为男性（风险比：1.395；95%置信区间：1.052 - 1.849）；超重，体重指数（BMI）25 - 30 kg/m²（风险比：0.775；95%置信区间：0.616 - 0.974）；血清肌酐水平（每增加1 mg/dl；风险比：1.314；95%置信区间：1.167 - 1.480）；血红蛋白水平（每增加1 g/dl；风险比：0.905；95%置信区间：0.833 - 0.984）；术前危急状态（风险比：2.282；95%置信区间：1.384 - 3.761）；神经功能障碍（风险比：1.552；95%置信区间：1.060 - 2.272）；心房颤动（风险比：1.556；95%置信区间：1.213 - 1.995）；起搏器心律（风险比：1.948；95%置信区间：1.310 - 2.896）；纽约心脏协会（NYHA）心功能Ⅲ级或Ⅳ级（风险比：1.800；95%置信区间：1.205 - 2.689或风险比：2.331；95%置信区间：1.392 - 3.903）。
在“真实世界”中，使用球囊扩张式装置进行TAVI在生存、技术成功、瓣膜相关不良事件和血流动力学性能方面显示出良好的中期结局。
