J-Valve用于不同瓣位生物瓣衰败瓣中瓣治疗的单中心临床研究

Transcatheter valve-in-valve implantation using the J-Valve for bioprosthetic degeneration at different anatomic positions:A single-center experience

目的总结在不同瓣位外科生物瓣衰败患者中采用J-Valve介入瓣膜行瓣中瓣治疗的早期结果及临床经验。方法回顾性分析2020年4月—2021年8月因不同瓣位外科生物瓣衰败于广东省人民医院心外科行介入瓣中瓣手术连续39例患者的临床资料,均采用J-Valve介入瓣膜。其中经导管二尖瓣瓣中瓣(transcatheter mitral valve-in-valve,TMViV)植入术35例、经导管主动脉瓣瓣中瓣(transcatheter aortic valve-in-valve,TAViV)植入术1例、经导管三尖瓣瓣中瓣(transcatheter tricuspid valve-in-valve,TTViV)植入术1例、TMViV同期行TAViV植入术1例、TMViV同期行经导管主动脉瓣置换术(transcatheter aortic valve replacement,TAVR)及二尖瓣瓣周漏封堵术1例。结果单纯行TMViV植入术的35例患者中,男17例、女18例,平均年龄(72.6±10.8)岁,两次手术平均间隔时间(10.5±2.7)年,平均美国胸外科医师协会及欧洲心脏手术风险评估系统Ⅱ评分为12.95%±9.61%及13.91%±8.94%。瓣膜植入成功率97.1%。手术中无死亡,1例患者因介入瓣膜向左心室移位而中转开胸,1例患者因心脏压塞再次开胸止血,1例患者出现轻度左心室流出道梗阻。术后30 d内1例患者因颅内出血行开颅手术,无患者出现死亡、脑卒中、植入永久起搏器、心包积液及因心源性疾病再入院。平均随访(6.0±4.4)个月,二尖瓣平均跨瓣压差较术前明显改善[(10.4±2.0)mm Hg vs.(5.5±1.2)mm Hg,P<0.05],所有患者纽约心脏协会心功能分级均达Ⅰ级或Ⅱ级。其余4例非单纯TMViV植入术的患者中,1例经心尖TAViV植入术及1例经右心房TTViV植入术的患者手术过程顺利,无术中及术后并发症;1例经心尖途径同期行TMViV及TAViV植入术的患者术后16 d因严重肺出血及多脏器功能衰竭死亡;1例经心尖途径同期行TMViV植入联合TAVR及二尖瓣瓣周漏封堵术的患者术后10 d因肺部真菌感染致感染性休克死亡。结论采用J-Valve介入瓣膜在生物瓣衰败的高危患者中行二尖瓣瓣中瓣植入术可取得良好的早期临床效果,亦可安全应用于主动脉瓣或三尖瓣位生物瓣衰败的瓣中瓣治疗,为不同瓣位生物瓣衰败患者提供了一个可替代外科手术的新选择,但同期行多瓣位介入手术时仍需非常谨慎。

Objective To summarize the early results and clinical experience of using the J-Valve for transcatheter valve-in-valve implantation in patients with degenerated bioprosthesis at different anatomic positions.Methods A retrospective analysis was conducted to evaluate the short-term outcomes of 39 consecutive patients who underwent transcatheter valve-in-valve implantation using the J-Valve System in the Department of Cardiac Surgery of Guangdong Provincial People’s Hospital from April 2020 to August 2021 due to bioprosthetic degeneration at different anatomic positions.Among them,35 patients underwent transcatheter mitral valve-in-valve(TMViV)implantation,1 transcatheter aortic valve-in-valve(TAViV)implantation,1 transcatheter tricuspid valve-in-valve(TTViV)implantation,1 TMViV implantation with simultaneous TAViV implantation,and another one TMViV implantation with simultaneous transcatheter aortic valve replacement(TAVR)and perivalvular leakage(PVL)closure.Results Among the 35 patients who underwent isolated TMViV implantation,17 were male and 18 were female with a mean age of72.6±10.8 years.Mean duration between two operations was 10.5±2.7 years.The mean Society of Thoracic Surgeons and EuroSCOREⅡscores were 12.95%±9.61%and 13.91%±8.94%,respectively.The device success rate was 97.1%and no death occured during the operation.One patient was transferred to thoracotomy due to device displacement,1 was reopened for uncontrolled bleeding,and 1 presented left ventricular outflow tract obstruction.One patient underwent craniotomy due to intracranial hemorrhage within 30 days after surgery,and no other complications occurred including death,stroke,permanent pacemaker implantation,cardiac tamponade,or re-hospitalization.The mean follow-up time was 6.0±4.4 months,the mean mitral valve gradient was significantly improved(10.4±2.0 mm Hg vs.5.5±1.2 mm Hg,P<0.05),and the New York Heart Association class≤Ⅱin all the patients at the last follow-up.Among the other 4 patients who did not undergo isolated TMViV implantation,the transapical TAViV implantation and the trans-right atrium TTViV implantation were successful without intra-or post-operative complications.The patient who underwent TMViV and TAViV implantation simultaneously via transapical approach died of severe pulmonary hemorrhage and multiple organ failure 16 days after surgery.The other patient who underwent transapical TMViV combined with TAVR and PVL closure died of septic shock 10 days after the surgery.Conclusion Transcatheter valve-in-valve implantation using the JValve system is shown to be a safe and effective procedure to treat mitral,aortic and tricuspid bioprosthetic valve dysfunction in high-risk patients,providing a new alternative to surgical surgery for degenerated bioprosthesis at different anatomic positions.However,simultaneous different valves intervention should be very cautious.