Petzina Rainer, Lutter Georg, Wolf Christin, Kühl Constantin, Freitag-Wolf Sandra, Panholzer Bernd, Bramlage Peter, Frey Norbert, Cremer Jochen, Frank Derk
Department for Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Germany
Department for Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Germany.
Interact Cardiovasc Thorac Surg. 2017 Jan;24(1):55-62. doi: 10.1093/icvts/ivw277. Epub 2016 Sep 5.
To evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves via transaortic (TAo) access.
A total of 100 consecutive patients with severe symptomatic aortic stenosis undergoing TAo-transcatheter aortic valve implantation (TAVI) were included in this observational registry (November 2012-December 2014). Periprocedural and post-procedural outcomes were assessed.
Of these 100 patients, 1 received a Medtronic CoreValve. Therefore, this patient was subsequently removed from the analysis. Ninety-nine consecutive TAo-TAVI patients received a balloon-expandable transcatheter heart valve (Sapien). The SAPIEN-XT valve was implanted in 53 patients and the SAPIEN-3 valve in 46 patients. Fluoroscopy time was shorter in the SAPIEN-3 cases (5.6 ± 2.5 vs 8.1 ± 5.1 min, SAPIEN-XT; P = 0.004), with fewer patients requiring dilatation after the operation (20.5% SAPIEN-3 vs 64.2% SAPIEN-XT; P < 0.0001). There were no other significant differences in procedural characteristics between the two valves. All-cause 30-day mortality was 5.1% overall, with comparable outcomes for the two valves (5.7 and 4.4% for SAPIEN-XT and SAPIEN-3 valves, respectively; OR: 1.32; 95% CI: 0.21-8.27; P = 1.0). New atrial fibrillation (13.1%) and acute kidney injury (11.1%) were the most common complications during the 30 days post-procedure. The number of new pacemakers was low (6.1%), with no differences found between the two valve groups. A comparison of 100 TAo- and 42 TA-TAVI implanted in the same period demonstrated similar results in short- (P = 0.31) and long-term (P = 0.99) mortality rates.
The efficacy and safety of the Edwards SAPIEN-XT or SAPIEN-3 heart valves via TAo access were demonstrated by high procedural success and low complication rates. The data indicate that this approach is a viable alternative to established access routes.
评估经主动脉（TAo）途径植入爱德华兹SAPIEN-XT或SAPIEN-3经导管心脏瓣膜的疗效和安全性。
本观察性注册研究纳入了100例连续接受TAo经导管主动脉瓣植入术（TAVI）治疗的有症状重度主动脉瓣狭窄患者（2012年11月至2014年12月）。评估围手术期和术后结果。
在这100例患者中，1例接受了美敦力CoreValve。因此，该患者随后被排除在分析之外。99例连续接受TAo-TAVI的患者接受了球囊扩张式经导管心脏瓣膜（Sapien）。53例患者植入了SAPIEN-XT瓣膜，46例患者植入了SAPIEN-3瓣膜。SAPIEN-3组的透视时间较短（SAPIEN-XT组为8.1±5.1分钟，SAPIEN-3组为5.6±2.5分钟；P = 0.004），术后需要扩张的患者较少（SAPIEN-3组为20.5%，SAPIEN-XT组为64.2%；P < 0.0001）。两种瓣膜在手术特征方面没有其他显著差异。30天全因死亡率总体为5.1%，两种瓣膜的结果相当（SAPIEN-XT瓣膜和SAPIEN-3瓣膜分别为5.7%和4.4%；OR：1.32；95%CI：0.21-8.27；P = 1.0）。新发房颤（13.1%）和急性肾损伤（11.1%）是术后30天内最常见的并发症。新安装起搏器的数量较少（6.1%），两组瓣膜之间未发现差异。同期植入的100例TAo-TAVI和42例经胸TAVI的短期（P = 0.31）和长期（P = 0.99）死亡率结果相似。
通过TAo途径植入爱德华兹SAPIEN-XT或SAPIEN-3心脏瓣膜具有较高的手术成功率和较低的并发症发生率，证明了其疗效和安全性。数据表明，这种方法是现有途径的可行替代方案。
