Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis

Darlington, Daniel N.; Brown, Philip King; Carvalho, Vanessa; Bourne, Hayley; Mayer, Joseph; Jones, Nathen; Walker, Vincent; Siddiqui, Shoaib; Patwala, Ashish; Kwok, Chun Shing

doi:10.1016/j.ipej.2021.12.001

Cited by 14 publications

(10 citation statements)

References 32 publications

(33 reference statements)

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“…In agreement with the current literature, our study confirms the low complication rate in TV VVIR recipients, with a substantial reduction relative to historical transvenous cohorts and with no significant difference compared to leadless recipients both in terms of perioperative and long-term complications. Indeed, a recent meta-analysis on four studies including TV control cohorts (344 LL vs. 400 TV patients in total) showed no difference in incidence of haematoma, pericardial effusion, device dislocation, any complication, and death between LL and TV PMs, with a 3.11% pooled complication rate [ 16 ]. Importantly, the latter figure, comparable to our study, corroborates the notion that contemporary TV complication rates are significantly lower than historical ones [ 6 , 17 ].…”

Section: Discussionmentioning

confidence: 99%

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Bertelli

Toniolo

Ziacchi

et al. 2022

JCM

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(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.

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Section: Discussionmentioning

confidence: 99%

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Bertelli

Toniolo

Ziacchi

et al. 2022

JCM

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“…This type of pacemaker also does not affect the appearance of the patient, and there are no complications related to a pacemaker sac or guide wire (Amin et al, 2018;Boveda et al, 2018;Duray et al, 2017;Niu et al, 2018;Roberts et al, 2017). A previous meta-analysis suggested that the safety and efficacy of a leadless pacemaker in patients with univentricular pacing are similar to those of a transvenous pacemaker (Darlington et al, 2022).…”

Section: Discussionmentioning

confidence: 99%

Initial studies on the implanting sites of high and low ventricular septa using leadless cardiac pacemakers

Dong

Guo

et al. 2023

Noninvasive Electrocardiol

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Objective To study the safety and electrical characteristics of various implanting sites of the Micra pacemaker. Method A total of 15 patients from Beijing Anzhen Hospital, Capital Medical University, were included, who were implanted with Micra leadless pacemakers and allocated to either the high ventricular septum group (eight patients) or the low ventricular septum group (seven patients) based on their individual patient factors and clinical conditions. The baseline of the patients, the implanting area, the electrocardiogram change after implantation, the implantation data, the threshold, R wave, impedance, and the date of the 1‐month follow‐up were then analyzed. With all of the data, the characteristics of different implantation sites of the Micra pacemaker were determined. Results Overall, the thresholds were low at implantation and remained stable over the 1‐, 3‐, 6‐month, 1‐, 2‐, 3‐, and 4‐year follow‐ups. On comparing the two groups, there was no difference in QRS duration at pacing (140.00 [40.00] ms vs. 179.00 [50.00] ms), threshold at implantation (0.38 [0.22] mV vs. 0.63 [1.00] mV), R wave at implantation ([10.85 ± 4.71] V vs. [7.26 ± 2.98] V), or impedance at implantation ([906.25 ± 162.39] Ω vs. [750.00 ± 173.40] Ω). While the difference in QRS duration between the two groups was not significant, the QRS duration of the high ventricular septum group exhibited a reduced tendency compared with that of the low ventricular group. The corrected QT interval during pacing exhibited a significant difference (440.00 [80.00] ms vs. 520.00 [100.00] ms; p < .05). For the 1‐, 3‐, 6‐month, 1‐, 2‐, 3‐, and 4‐year follow‐ups, there was no difference between the threshold of the high ventricular septum group and that of the low ventricular septum group (p > .05). Conclusion High ventricular septum pacing appears to be a safe site for implantation of the Micra pacemaker. It could entail a shorter QRS duration at pacing and could be more physiological than low ventricular septum pacing.

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“…The analyses were based on the comparison with a historical TPM cohort and a long-term follow-up period [ 20 , 21 ]. However, a meta-analysis on four studies showed no difference in the incidences of any complications between LPMs and TPMs [ 22 ]. Moreover, in a prospective analysis, no significant difference at an almost 2 year complication rate was observed between LPMs and TPMs [ 23 ], which could be because the contemporary complication rate of TPMs is significantly lower than the historical one as a result of standard implantation procedures and improved techniques.…”

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Tong

Sun

2023

JCM

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Leadless pacemakers (LPMs) have emerged as an alternative to conventional transvenous pacemakers to eliminate the complications associated with leads and subcutaneous pockets. However, LPMs still present with complications, such as cardiac perforation, dislodgment, vascular complications, infection, and tricuspid valve regurgitation. Furthermore, the efficacy of the leadless VDD LPMs is influenced by the unachievable 100% atrioventricular synchrony. In this article, we review the available data on the strategy selection, including appropriate patient selection, procedure techniques, device design, and post-implant programming, to minimize the complication rate and maximize the efficacy, and we summarize the clinical settings in which a choice must be made between VVI LPMs, VDD LPMs, or conventional transvenous pacemakers. In addition, we provide an outlook for the technology for the realization of true dual-chamber leadless and battery-less pacemakers.

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Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis

Cited by 14 publications

References 32 publications

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Initial studies on the implanting sites of high and low ventricular septa using leadless cardiac pacemakers

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

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