Prunea Dan M, Geissler Raffael, Achim Alexandru, Stark Cosima, Kanoun Schnur Sadeek S, Strobl Brigitte, Bugger Heiko, Luha Olev, Zirngast Birgit, Schmidt Albrecht, Zirlik Andreas, Toth Gabor G
Department of Cardiology, University Heart Center Graz, Medical University of Graz, Graz, Austria.
"Niculae Stăncioiu" Heart Institute, University of Medicine and Pharmacy "Iuliu Hatieganu", Cluj-Napoca, Romania.
Catheter Cardiovasc Interv. 2025 Aug;106(2):1032-1040. doi: 10.1002/ccd.31647. Epub 2025 Jun 2.
Valve degeneration after DirectFlow implantation poses a challenge for valve-in-valve procedures due to its fragile polymeric structure and embolization risk. This study analyzes long-term follow-up of patients who underwent TAVI with DF to understand valve degeneration tendencies.
In this single-center registry, we included all patients who underwent DF implantation in our center. Clinical characteristics and echocardiographic parameters were assessed at baseline and during the latest follow-up. Long-term overall survival was analyzed. Outcome data was compared with a matched cohort of patients who underwent TAVI with other commercial devices during the same period.
From 2014 to 2017, 67 patients with significant aortic stenosis were treated with DF; 36 (54%) were male, mean age 83 ± 7 years. Left ventricular ejection fraction was 50 ± 13% with a mean gradient of 46 ± 15 mmHg. Post-procedural echocardiography showed a mean gradient of 16 ± 8 mmHg, markedly higher than the reference group (8 ± 3 mmHg; p < 0.01). This residual gradient showed no progression during follow-up at 20 [9; 39] months (16 ± 9 mmHg; p = 0.52). Overall survival was comparable between DF and the reference group at 12 months (6% vs. 4%, HR 1.37, 95% CI 0.31-6.02) and maximal follow-up of 39 ± 25 months (31% vs. 25%, HR 1.44, 95% CI 0.76-2.73).
According to this single center experience, DF devices resulted in higher residual gradients; however, no signs of faster degeneration or worse long-term outcomes were observed compared to other devices.
DirectFlow瓣膜植入术后瓣膜退变因其脆弱的聚合物结构和栓塞风险，给瓣中瓣手术带来了挑战。本研究分析了接受DirectFlow经导管主动脉瓣植入术（TAVI）患者的长期随访情况，以了解瓣膜退变趋势。
在这个单中心注册研究中，我们纳入了在本中心接受DirectFlow瓣膜植入的所有患者。在基线和最新随访时评估临床特征和超声心动图参数。分析长期总生存率。将结果数据与同期接受其他商用器械TAVI的匹配队列患者进行比较。
2014年至2017年，67例重度主动脉瓣狭窄患者接受了DirectFlow瓣膜治疗；36例（54%）为男性，平均年龄83±7岁。左心室射血分数为50±13%，平均压差为46±15mmHg。术后超声心动图显示平均压差为16±8mmHg，明显高于参考组（8±3mmHg；p<0.01）。在20[9；39]个月的随访期间，这种残余压差没有进展（16±9mmHg；p=0.52）。DirectFlow瓣膜组和参考组在12个月时的总生存率相当（6%对4%，风险比1.37，95%置信区间0.31 - 6.02），在最长39±25个月的随访中也是如此（31%对25%，风险比1.44，95%置信区间0.76 - 2.73）。
根据这一单中心经验，DirectFlow瓣膜导致更高的残余压差；然而，与其他器械相比，未观察到更快退变或更差长期结果的迹象。
