Practical considerations, indications, and future perspectives for leadless and extravascular cardiac implantable electronic devices: a position paper by EHRA/HRS/LAHRS/APHRS

Boersma, Lucas V.A.; El‐Chami, Mikhael F.; Steinwender, Clemens; Lambiase, Pier D.; Murgatroyd, Francis; Mela, Theofania; Theuns, Dominic; Khelae, Surinder Kaur; Kalil, Carlos; Zabala, Federico; Stuehlinger, Markus; Lenarczyk, Radosław; Clémenty, Nicolas; Tamirisa, Kamala P.; Rinaldi, Christopher A.; Knops, Reinoud E.; Lau, Chu‐Pak; Crozier, Ian; Boveda, Serge; Defaye, Pascal; Deharo, Jean Claude; Botto, Giovanni Luca; Vassilikos, Vassilios; Oliveira, Mário; Tse, Hung Fat; Figueroa, Jorge; Stambler, Bruce S.; Guerra, José M.; Stiles, Martin K.; Marques, Manlio

doi:10.1093/europace/euac066

Cited by 31 publications

(18 citation statements)

References 70 publications

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“…Thus, it was indicated that leadless pacing could be considered in patients with difficult or impossible upper venous access or who are at a high risk of device infection 4 . A recent position paper that includes most of the variables identified in this research mentions these in an isolated manner 17 . However, this adds validity to our criteria, which also makes it possible to combine the variables according to the individual characteristics of each patient, simulating and facilitating the act of decision‐making.…”

Section: Discussionmentioning

confidence: 93%

“…4 A recent position paper that includes most of the variables identified in this research mentions these in an isolated manner. 17 However, this adds validity to our criteria, which also makes it possible to combine the variables according to the individual characteristics of each patient, simulating and facilitating the act of decision-making. Moreover, this suspicion regarding the relevance of the variables was statistically proven by regression TA B L E 1 Contribution of the scenario variables to the appropriateness of leadless pacemaker implantation in atrial fibrillation and sinus rhythm patients.…”

Section: Discussionmentioning

confidence: 99%

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The VR leadless pacemaker: Results of an expert panel using the RAND/UCLA method

Molina-Linde

Dı́az-Infante

Tercedor-Sánchez

et al. 2023

Pacing Clinical Electrophis

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Background: Leadless pacemakers were developed to reduce complications associated with transvenous pacemaker implantation and long-term follow-up. Existing international guidelines lack detailed instructions on patients suitable for leadless pacemaker implantation. Our aim was to develop a consensus document that provides medical guidance for all health professionals involved in the indication and implantation of Transcatheter Pacing System single-chamber device (VR leadless) pacemakers for patients with atrial fibrillation or in sinus rhythm. Methods: A panel of experts, including interventional and non-interventional cardiologists, used the Research ANd Development/University of California at Los Angeles (RAND/UCLA) method to rate the appropriateness of leadless pacemaker implantation for 64 scenarios in patients with atrial fibrillation and 192 scenarios in sinus rhythm. The scenarios were rated individually and again during a moderated group session. Median ratings and level of agreement were calculated to classify each scenario as appropriate, inappropriate, or questionable. Results: This consensus statement, based on available literature and the experts' opinions, summarizes recommendations for standardizing and optimizing leadless pacemaker implantation. The limitation for vascular access via the superior vena cava was the most influential variable when indicating leadless pacemaker implantation in both patients with atrial fibrillation and patients in sinus rhythm. Conclusions: Life expectancy, risk of infection, prosthetic valve, left ventricular ejection fraction (LVEF), limitation for vascular access via the superior vena cava, and mobility and exercise capacity determine who is advised to undergo VR leadless pacemaker implantation. More prospective studies are needed to optimize existing recommendations.

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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

The VR leadless pacemaker: Results of an expert panel using the RAND/UCLA method

Molina-Linde

Dı́az-Infante

Tercedor-Sánchez

et al. 2023

Pacing Clinical Electrophis

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“…The implantation procedure was performed according to standard practice. 17 Patients were monitored for at least 24 h following the procedure, with continuous telemetry monitoring, and were discharged after clinical verification of the puncture site, electrocardiogram, chest radiography, and after ensuring the absence of pericardial effusion.…”

Section: Implantation Proceduresmentioning

confidence: 99%

Comparison of first‐ and second‐generation leadless pacemakers in patients with sinus rhythm and complete atrioventricular block

Lenormand

Khalil

Bodin

et al. 2023

Cardiovasc electrophysiol

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IntroductionThe efficacy and safety of leadless cardiac pacemakers (LPMs) as an alternative to conventional transvenous cardiac pacing have been largely reported. The first generation of the MicraTM transcatheter pacing system (VR; Medtronic) was able to provide single‐chamber VVI(R) pacing mode only, with a potential risk of pacemaker syndrome in sinus rhythm patients. A second‐generation system (AV) now provides atrioventricular synchrony through atrial mechanical (Am) sensing capability (VDD mode).ObjectiveWe sought to compare VR and AV systems in sinus rhythm patients with chronic ventricular pacing (Vp) for complete atrioventricular block.MethodsAll consecutive patients implanted with an LPM in our department for complete atrioventricular block were retrospectively screened. Patients with atrial fibrillation, sinus dysfunction, or Vp burden <20% at 1 month postimplantation were excluded. Patients were systematically followed with a visit at 1 month, and then at least once a year.ResultsA total of 93 patients—45 VR (2015–2020) and 48 AV (2020–2021)—were included. VR and AV patients had similar baseline characteristics, except for VR patients being older (80 ± 8 vs. 77 ± 9 years, p = 0.049). The mean Vp burden was 77% in the VR and 82% in the AV group (p = 0.38). In AV patients, the median AV synchronous beats rate was 78%, with 65% having a >66% rate. An E/A ratio <1.2 as measured on echocardiography was the only independent predictor of accurate atrial mechanical tracking (p = 0.01). One‐year survival rate was similar in both groups. Five patients in the VR and 0 in the AV group eventually developed pacemaker syndrome within 1 year post‐implantation (p = 0.02).ConclusionIn sinus rhythm patients with chronic Vp for complete atrioventricular block implanted with an LPM, the atrial mechanical sensing algorithm allowed significant atrioventricular synchrony in most patients and was associated with no occurrence of—otherwise rare—pacemaker syndrome.

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“…To prevent lead-related complications, extravascular devices (EVD) have been developed over the past 15 years, such as the subcutaneous implantable cardioverter-defibrillator (S-ICD) and intracardiac leadless pacemaker (LP) [5][6][7][8]. To compare these new technologies with conventional transvenous CIEDs, a randomised controlled trial (RCT) is the preferred study design, but only few RCTs have been performed (PRAETORIAN, ATLAS [5,9]).…”

Section: The Era Of Extravascular Devicesmentioning

confidence: 99%

NL-EVDR: Netherlands—ExtraVascular Device Registry

et al. 2023

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Cardiac implantable electronic device (CIED) therapy is an essential element in treating cardiac arrhythmias. Despite their benefits, conventional transvenous CIEDs are associated with a significant risk of mainly pocket- and lead-related complications. To overcome these complications, extravascular devices (EVDs), such as the subcutaneous implantable cardioverter-defibrillator and intracardiac leadless pacemaker, have been developed. In the near future, several other innovative EVDs will become available. However, it is difficult to evaluate EVDs in large studies because of high costs, lack of long-term follow-up, imprecise data or selected patient populations. To improve evaluation of these technologies, real-world, large-scale, long-term data are of utmost importance. A Dutch registry-based study seems to be a unique possibility for this goal due to early involvement of Dutch hospitals in novel CIEDs and an existing quality control infrastructure, the Netherlands Heart Registration (NHR). Therefore, we will soon start the Netherlands—ExtraVascular Device Registry (NL-EVDR), a Dutch nationwide registry with long-term follow-up of EVDs. The NL-EVDR will be incorporated in NHR’s device registry. Additional EVD-specific variables will be collected both retrospectively and prospectively. Hence, combining Dutch EVD data will provide highly relevant information on safety and efficacy. As a first step, a pilot project has started in selected centres in October 2022 to optimise data collection.

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Practical considerations, indications, and future perspectives for leadless and extravascular cardiac implantable electronic devices: a position paper by EHRA/HRS/LAHRS/APHRS

Cited by 31 publications

References 70 publications

The VR leadless pacemaker: Results of an expert panel using the RAND/UCLA method

The VR leadless pacemaker: Results of an expert panel using the RAND/UCLA method

Comparison of first‐ and second‐generation leadless pacemakers in patients with sinus rhythm and complete atrioventricular block

NL-EVDR: Netherlands—ExtraVascular Device Registry

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