Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice

Palmisano, Pietro; Iacopino, Saverio; Vivo, Stefano De; D’Agostino, Carlo; Tomasi, Luca; Startari, Umberto; Ziacchi, Matteo; Pisanó, Ennio; Santobuono, Vincenzo Ezio; Caccavo, Vincenzo Paolo; Sgarito, Giuseppe; Rillo, Mariano; Nicosia, Antonino; Zucchelli, Giulio

doi:10.1016/j.ijcard.2022.07.040

Cited by 10 publications

(6 citation statements)

References 38 publications

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“…The research conducted by Toshimasa shed light on the effective utilization of leadless pacemakers, as evidenced by the absence of any occurrences of device dislocation or malfunction over a period of 12 months [ 12 ]. In contrast, Pietro’s study emphasized a heightened susceptibility to infection linked to leadless pacemakers, suggesting the inclusion of conventional cardiac implantable electronic devices (CIEDs) in the deliberation of implantation choices [ 13 ]. In the field of pediatrics, Nestoras discovered a notable prevalence of 11 % in lead malfunction, with ventricular lead fractures being the primary cause.…”

Section: Resultsmentioning

confidence: 99%

A Systematic Review and Meta-analysis of the Prevalence and Risk Factors in Cardiac Implantable Electronic Device Malfunction

Saeed,

AlShafea,

AlQthami

et al. 2023

Journal of the Saudi Heart Association

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Introduction Cardiac implantable electronic devices (CIED) include permanent pacemakers (PPMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. They treat several cardiac issues and are dependent on batteries; however, similar to any medical equipment, they can fail. The prevalence and risk factors for CIED malfunction must be understood for earlier detection and better patient outcomes. Material and methods A comprehensive search was conducted through electronic bibliographic sources (PubMed and Cochrane) until January 2023 in order to identify reviews, cohort studies and case reports pertaining to CIED. The primary outcome is the probability of CIED malfunction. The secondary outcome concerned significant risk factors. Two authors independently extracted articles by utilizing pre-established data fields. Using a random-effects model, the aggregated prevalence and 95 % confidence intervals (CIs) were computed. Results The meta-analysis comprised eight review articles, twenty-two retrospective studies, and thirty-seven case reports from the systematic review. The eight review articles contained a CIED malfunction of 4.03 % (random-effects model). The pooled prevalence of CIED malfunction in the meta-analysis of 22 retrospective studies was 0.41 percent (using a fixed-effects model) and 8.01 percent (using a random-effects model). Moreover, age, pre-existing cardiac conditions, CIED type, lead placement, and medical device interactions all contributed to an increase in the heterogeneity (I2 = 98.90 %) of the risk of CIED malfunction. Conclusion CIED malfunction is common and more likely to occur in elderly individuals and in certain types of CIED. Clinicians should focus on risk factors and closely monitor the patients with higher probability for CIED malfunction with short intervals.

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Section: Resultsmentioning

confidence: 99%

A Systematic Review and Meta-analysis of the Prevalence and Risk Factors in Cardiac Implantable Electronic Device Malfunction

Saeed,

AlShafea,

AlQthami

et al. 2023

Journal of the Saudi Heart Association

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“…40 Most commonly, single chamber leadless pacemakers have been placed in patients with atrial fibrillation with high grade atrioventricular block, as the atrial fibrillation precludes effective dual chamber pacing. 29,41 Single chamber leadless pacemakers are also indicated in certain situations when a dual chamber pacemaker is considered high risk or not clinically necessary. 26,42 A full list of clinical indications for the currently approved leadless pacemaker devices is presented in Table 2.…”

Section: Leadless Pacemaker Overviewmentioning

confidence: 99%

Perioperative Considerations for Modern Leadless Pacemakers

Tanabe,

Gilliland

2024

Semin Cardiothorac Vasc Anesth

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Since their initial approval by the Food and Drug Administration in 2016, leadless pacemakers have become increasingly prevalent. This growth has been driven by an improved adverse effect profile when compared to traditional pacemakers, including lower rates of infection, as well as eliminated risk of pocket hematoma and lead complications. More recently, technology enabling leadless synchronized atrioventricular pacing in patients with atrioventricular block has vastly expanded the indications for these devices. Anesthesiologists will increasingly be relied upon to safely care for patients with leadless pacemakers undergoing non-electrophysiology procedures and surgery. This article provides an overview of the technology, evidence base, current indications, and unique perioperative considerations for leadless pacemakers.

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“…In complex cases in which multiple arteries are inadvertently punctured, vascular ultrasound guidance or micropuncture techniques could be considered to avoid vascular complications [ 50 ]. More than half of the cases of haemostasis following LPM implantation were achieved using figure-of-eight sutures [ 53 ], and the application of pressure alone should be avoided for the 27F introducer sheath [ 29 ]. Surgical isolation of the common femoral vein for the purpose of sheath insertion in patients with severe obesity and vascular haemostasis and suture performed by vascular surgeon were effective and safe in LPM implantation [ 54 ].…”

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

“…Medicine preparation: Almost all the patients in an Italian clinical practice were given a prophylactic dose of antibiotics before the LPM implantation procedure without additional adverse events [ 36 , 53 ]; however, the specific prophylactic antibiotic usage for LPMs in the perioperative setting needs further exploration.…”

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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Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice

Cited by 10 publications

References 38 publications

A Systematic Review and Meta-analysis of the Prevalence and Risk Factors in Cardiac Implantable Electronic Device Malfunction

A Systematic Review and Meta-analysis of the Prevalence and Risk Factors in Cardiac Implantable Electronic Device Malfunction

Perioperative Considerations for Modern Leadless Pacemakers

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

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