Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.
Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.
Ann Thorac Surg. 2021 Apr;111(4):1331-1337. doi: 10.1016/j.athoracsur.2020.06.064. Epub 2020 Aug 28.
Because our center participated in the first-in-human trial with Perceval (LivaNova, Sallugia, Italy) in 2007, this series represents the longest available clinical follow-up (11 years) with sutureless technology in aortic valve replacement.
We collected all clinical and echocardiographic follow-up in 468 consecutive patients who received Perceval at our institution between 2007 and 2017. In 57% of cases, surgery was combined with coronary artery bypass grafting (39%), mitral valve surgery (17%), or other procedures (13%).
Mean age was 79 years, mean EuroSCORE II was 5.1 ± 5.5 (range, 0.8-67) and mean Society of Thoracic Surgeons score was 5.8 ± 5.5. Mean cross-clamp times for isolated and combined procedures were 39 and 79 minutes, respectively. Observed all-cause 30-day mortality was 3.2%, with an early stroke rate of 1.8%. Pacemaker implantation rate was 7.9% overall, but only 3.9% in patients without preexisting conduction or rhythm disorders. All-cause mortality at 1 and 2 years was 8.8% ± 1.3% and 13.2% ± 1.6%, respectively. At the latest echocardiographic follow-up (mean, 3 years; range, 1-11 years), peak and mean gradients were 23 ± 10 mm Hg and 13 ± 6 mm Hg, respectively. During follow-up, we explanted 5 valves for endocarditis, and none for structural valve degeneration.
After more than 11 years of continued clinical use of the Perceval sutureless valve, we observe low mortality and stroke rates, with good hemodynamic behavior of the valve. None of our patients was reoperated for structural valve degeneration. Because of the key benefits of this rapid-deployment valve, it has an added value in surgical aortic valve replacement.
由于我们中心于 2007 年参与了首例人类 Perceval（LivaNova，意大利萨卢贾）试验，因此该系列代表了最长的可获得的临床随访（11 年），涉及无缝线技术的主动脉瓣置换术。
我们收集了 2007 年至 2017 年期间在我们中心接受 Perceval 治疗的 468 例连续患者的所有临床和超声心动图随访数据。在 57%的病例中，手术与冠状动脉旁路移植术（39%）、二尖瓣手术（17%）或其他手术（13%）相结合。
平均年龄为 79 岁，平均 EuroSCORE II 为 5.1±5.5（范围，0.8-67），平均胸外科医生协会评分（STS）为 5.8±5.5。单纯手术和联合手术的平均体外循环时间分别为 39 分钟和 79 分钟。观察到全因 30 天死亡率为 3.2%，早期卒中发生率为 1.8%。总体起搏器植入率为 7.9%，但无预先存在的传导或节律障碍的患者中仅为 3.9%。1 年和 2 年的全因死亡率分别为 8.8%±1.3%和 13.2%±1.6%。在最新的超声心动图随访（平均 3 年；范围 1-11 年）时，峰值和平均梯度分别为 23±10mmHg 和 13±6mmHg。随访期间，我们因心内膜炎而取出了 5 个瓣膜，没有因结构性瓣膜退化而取出。
在持续使用 Perceval 无缝线瓣膜超过 11 年后，我们观察到死亡率和卒中率较低，瓣膜的血液动力学表现良好。我们没有患者因结构性瓣膜退化而再次手术。由于这种快速部署瓣膜的关键优势，它在主动脉瓣置换手术中具有附加价值。
