Available online 19 April 2025

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Current guidelines and expert consensus recommend different time thresholds of temporary pacemaker (TM) indwelling in patients with conduction block after transcatheter aortic valve replacement (TAVR). Accordingly, this lack of clinical evidence and effective strategies has resulted in extensive variations in permanent pacemaker (PPM) implantation patterns, potentially leading to over-early PPM implantation. The use of a temporary permanent pacemaker (TPPM), which involves an active fixation pacing lead and an external pulse generator secured to the skin surface, may be effective and safe in these patients. TPPM may improve postoperative mobility and facilitate early discharge, while providing prolonged and stable pacing for the recovery of conduction block, thereby reducing unnecessary PPM implantation.

DESIGN

The RECOVER trial is a prospective, multicenter, open-label, randomized controlled study comparing TPPM versus TM in patients with conduction block after TAVR. The trial will enroll 160 subjects across 13 sites in China. Inclusion criteria include patients with persistent third-degree atrioventricular block (AVB), second-degree AVB, first-degree AVB with symptoms (PR interval > 300ms), alternating bundle branch block or bifascicular block with syncope/blackness related symptoms occurred during TAVR procedure or within 1 month after TAVR. Enrolled patients will be randomized 1:1 to the TPPM group for a 1-month bridge or the TM group for conventional 24-48h pacing. The primary effectiveness endpoint is the rate of PPM implantation at 6 months after the occurrence of AVB. Secondary effectiveness endpoint is the rate of PPM implantation at 1 month after the occurrence of AVB. Safety endpoints include all-cause mortality and TPPM/TM/PPM procedure-related complications during the 6-month follow-up. Key data collected will include sociodemographic information, medical history, electrocardiograph, HOLTER, echocardiography, contrast-enhanced cardiac CT, details of procedures and pacemaker interrogation. Indication for PPM implantation will be adjudicated by an independent pacing electrophysiologist committee.

CONCLUSION

The RECOVER trial will evaluate whether TPPM is superior to conventional TM in reducing the rate of PPM implantation in patients with conduction block after TAVR, with a buffer period to distinguish whether conduction block is reversible or persistent.

CURRENT STATUS

The trial is still enrolling participants (with 14 enrolled as of Jan 01, 2025)

TRIAL REGISTRATIONRandomized controlled trial to compare temporary permanent pacemaker versus temporary pacemaker in patients with conduction block after transcatheter aortic valve replacement. Chinese Clinical Trial Registry ChiCTR2400087536. Registered at 30 July 2024. https://www.chictr.org.cn/showproj.html?proj=227719.Section snippetsBackground

Transcatheter aortic valve replacement (TAVR) is a well-established treatment for symptomatic severe aortic stenosis across the entire surgical risk spectrum. New-onset conduction block that require permanent pacemaker (PPM) implantation are common complications and a major concern 1,2.

Despite the rapid adoption of TAVR, limited data exist regarding the optimal timing for PPM implantation after TAVR. Guidelines for cardiac pacing recommend varying time thresholds for PPM implantation, ranging

Study design

The RECOVER trial is a prospective, multicenter, open-label, randomized controlled study. Thirteen valvular heart disease centers agree to participate. Consecutive patients with conduction block after TAVR will be screened. According to current guideline or expert consensus 3, 4, 5, 6, PPM should be considered for all patients who met the inclusion criteria at enrollment. However, in this study, TPPM is proposed as a bridge to recovery or eventual PPM implantation. The steering committees will

Discussion

In the single arm observational study by our team, 688 consecutive TAVR recipients were screen, and a total of 70 patients received TPPMs as a 1-month bridge. Specifically, 54 patients presented with third-degree AVB, 6 with high-grade AVB, and 10 with first-degree AVB plus LBBB. Ultimately, 75.7% of these patients did not require PPM implantation. Among them, 18.6% experienced resolution of the conduction block within 48 hours, while 57.1% showed recovery after 48 hours 14. The results

Funding

Beijing Science and Technology Plan 2022 from Beijing Municipal Science & Technology Commission (Z221100007422117), Beijing, China.

Conflict of interest

We declare no competing interests.

CRediT authorship contribution statement

Zhengming Jiang: Conceptualization. Sanshuai Chang: Writing – original draft, Methodology, Conceptualization. Ling Tao: Resources, Investigation. Jianfang Luo: Resources, Investigation. Guosheng Fu: Resources, Investigation. Yan Wang: Resources, Investigation. Wenzhi Pan: Resources, Investigation. Lianglong Chen: Resources, Investigation. Zhenfei Fang: Resources, Investigation. Yan Li: Resources, Investigation. Ming Bai: Resources, Investigation. Bo Yu: Resources, Investigation. Xiang Cheng:

Declaration of competing interest

All authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Acknowledgments

We would like to express our gratitude to the Beijing Municipal Science & Technology Commission for the financial support. We are grateful for the all the RECOVER investigators and research staff.

References (22)Michele Brignole et al.ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC)

Eur Heart J

(2013)

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