Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Cardiology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria, Spain.
EuroIntervention. 2023 Sep 18;19(7):580-588. doi: 10.4244/EIJ-D-23-00344.
Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting.
We aimed to evaluate the safety and feasibility of Myval in NCAR.
This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed.
A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047).
Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.
经导管主动脉瓣置换术（TAVR）在非钙化性主动脉瓣反流（NCAR）中的应用属于超适应证。球囊扩张式的 Myval 具有在此种情况下适用的特大尺寸（30.5 毫米和 32 毫米）。
评估 Myval 在 NCAR 中的安全性和可行性。
这是一项国际性、多中心、观察性研究，纳入了所有接受 Myval 装置 TAVR 治疗的症状性严重 NCAR 连续患者。对图像进行了中心分析。
共纳入 113 例患者，其中 64.6%为男性，平均年龄为 78.4±7.5 岁，胸外科医师协会评分 2.7±1.7%。59.3%的患者存在主动脉根部扩张，7.1%为二叶瓣，瓣环面积平均为 638.6±106.0mm。瓣环面积超出特大尺寸推荐范围的病例占 2.6%，92%（中位数 4cc，最多 9cc）增加了额外的容积。95 例（84.1%）患者使用特大尺寸，平均过度扩张 17.9±11.0%。技术成功率为 94.7%；残余≥中度主动脉瓣反流发生率为 8.9%，起搏器使用率为 22.2%。无瓣环破裂、心脏压塞或主动脉夹层发生，但 4 例（3.5%）患者发生瓣膜栓塞（1 例顺行，3 例心室），均发生在左心室流出道呈锥形的患者中（p=0.007）。30 天和 1 年死亡率分别为 5.3%和 9.7%。技术成功与更好的生存率相关（97.1% vs 72.7%；p=0.012），而瓣膜栓塞是死亡率的主要决定因素（p=0.047）。
Myval 是一种可行且安全的选择，适用于有选择的不能手术的 NCAR 患者，中期结果良好，且过度扩张对器械耐久性无影响。
