Bertelli Michele, Toniolo Sebastiano, Ziacchi Matteo, Gasperetti Alessio, Schiavone Marco, Arosio Roberto, Capobianco Claudio, Mitacchione Gianfranco, Statuto Giovanni, Angeletti Andrea, Martignani Cristian, Diemberger Igor, Forleo Giovanni Battista, Biffi Mauro
IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40122 Bologna, Italy.
Unità Operativa di Cardiologia, ASST-Fatebenefratelli-Sacco, Ospedale Luigi Sacco University, 20157 Milano, Italy.
J Clin Med. 2022 Oct 14;11(20):6071. doi: 10.3390/jcm11206071.
(1) Background: Leadless (LL) stimulation is perceived to lower surgical, vascular, and lead-related complications compared to transvenous (TV) pacemakers, yet controlled studies are lacking and real-life experience is non-conclusive. (2) Aim: To prospectively analyse survival and complication rates in leadless versus transvenous VVIR pacemakers. (3) Methods: Prospective analysis of mortality and complications in 344 consecutive VVIR TV and LL pacemaker recipients between June 2015 and May 2021. Indications for VVIR pacing were "slow" AF, atrio-ventricular block in AF or in sinus rhythm in bedridden cognitively impaired patients. LL indication was based on individualised clinical judgement. (4) Results: 72 patients received LL and 272 TV VVIR pacemakers. LL pacemaker indications included ongoing/expected chronic haemodialysis, superior venous access issues, active lifestyle with low pacing percentage expected, frailty causing high bleeding/infectious risk, previous valvular endocarditis, or device infection requiring extraction. No significant difference in the overall acute and long-term complication rate was observed between LL and TV cohorts, with greater mortality occurring in TV due to selection of older patients. (5) Conclusions: Given the low complication rate and life expectancy in this contemporary VVIR cohort, extending LL indications to all VVIR candidates is unlikely to provide clear-cut benefits. Considering the higher costs of LL technology, careful patient selection is mandatory for LL PMs to become advantageous, i.e., in the presence of vascular access issues, high bleeding/infectious risk, and long life expectancy, rendering lead-related issues and repeated surgery relevant in the long-term perspective.
(1) 背景：与经静脉（TV）起搏器相比，无导线（LL）起搏被认为可降低手术、血管及导线相关并发症，但缺乏对照研究，实际经验也尚无定论。(2) 目的：前瞻性分析无导线与经静脉VVIR起搏器的生存率和并发症发生率。(3) 方法：对2015年6月至2021年5月期间连续接受344例VVIR TV和LL起搏器植入的患者的死亡率和并发症进行前瞻性分析。VVIR起搏的适应证为“缓慢”房颤、房颤或卧床认知障碍患者窦性心律时的房室传导阻滞。LL适应证基于个体化临床判断。(4) 结果：72例患者接受了LL起搏器，272例接受了TV VVIR起搏器。LL起搏器适应证包括正在进行/预期进行的慢性血液透析、上腔静脉通路问题、预期起搏百分比低的积极生活方式、因身体虚弱导致高出血/感染风险、既往瓣膜性心内膜炎或需要拔除的器械感染。LL组和TV组之间在总体急性和长期并发症发生率上未观察到显著差异，由于选择了年龄较大的患者，TV组的死亡率更高。(5) 结论：鉴于这个当代VVIR队列中的低并发症发生率和预期寿命，将LL适应证扩展至所有VVIR候选患者不太可能带来明确益处。考虑到LL技术成本较高，对于LL起搏器要想具有优势，必须仔细选择患者，即在存在血管通路问题、高出血/感染风险和预期寿命长的情况下，从长远来看，导线相关问题和重复手术才具有相关性。
