Successful implementation of a totally leadless biventricular pacing approach

Aims Totally leadless cardiac resynchronization therapy (CRT) can be delivered with a combination of Micra and WiSE-CRT systems. We describe the technical feasibility and first insights into the safety and efficacy of this combination in European experience. Methods and results Patients enrolled had indication for both Micra and WiSE-CRT systems because of heart failure related to high burden of pacing by a Micra necessitating system upgrade or inability to implant a conventional CRT system because of infectious or anatomical conditions. The endpoints of the study were technical success of WiSE-CRT implantation with right ventricle-synchonized CRT delivery, acute QRS duration reduction, and freedom from procedure-related major adverse events. All eight WiSE-CRT devices were able to detect the Micra pacing output and to be trained to deliver synchronous LV endocardial pacing. Acute QRS reduction following WiSE-CRT implantation was observed in all eight patients (mean QRS 204.38 ± 30.26 vs. 137.5 ± 24.75 mS, P = 0.012). Seven patients reached 6 months of follow-up. At 6 months after WiSE-CRT implantation, there was a significant increase in LV ejection fraction (28.43 ± 8.01% vs. 39.71 ± 11.89%; P = 0.018) but no evidence of LV reverse remodelling or improvement in New York Heart Association class. Conclusion The Micra and the WiSE-CRT systems can successfully operate together to deliver total leadless CRT to a patient. Moreover, the WiSE-CRT system provides the only means to upgrade the large population of Micra patients to CRT capability without replacing the Micra. The range of application of this combination could broaden in the future with the upcoming developments of leadless cardiac pacing.

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“…Another case was reported by Funasako et al . 11 the same year. More patients have been implanted with these two systems since then.…”

Section: Introductionmentioning

confidence: 92%

European experience with a first totally leadless cardiac resynchronization therapy pacemaker system

et al. 2020

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“…Recently, innovations have been made toward creating a totally leadless CRT system incorporating the WiSE-CRT TM and Micra TM TPS devices, which was described in two published case reports [69, 70]. The implantation procedure for each device is similar to previously described, as both devices are implanted individually.…”

Section: Leadless Cardiac Resynchronization Therapymentioning

confidence: 99%

Emerging Technologies in Electrophysiology: From Single-Chamber to Biventricular Leadless Pacemakers

Gill

2022

Cardiology

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Background: Transvenous pacemakers have been shown to improve quality of life and mortality in patients with bradycardia and cardiac conduction blocks. However, they possess inevitable drawbacks as they have a relatively high incidence of lead and device pocket-related complications. Therefore, leadless pacemakers have emerged as a solution to reduce the complications seen with conventional pacemakers. However, there have been no clinical trials to date comparing transvenous to leadless pacemakers. Summary: Currently, the Micra TPS or AV device has been approved for commercial use worldwide but is limited to single-chamber pacing with single or dual-chamber sensing. Although the leadless pacemaker, Nanostim, was initially promising, it has been recalled due to concerns of battery failures and is no longer approved in Europe. In addition, the lack of defibrillation capabilities with leadless pacemakers has been a limiting factor; therefore, a leadless pacemaker with the already approved subcutaneous cardioverter-defibrillator system is currently being studied in humans. Moreover, the WiSE-CRT device has been approved in Europe, with the capabilities for leadless cardiac resynchronization therapy (CRT), to provide CRT for patients with unsuitable coronary sinus anatomy. Furthermore, retrieval of leadless pacemakers has been an area of concern; however, clinic data has signaled towards safe extraction of these devices with minimal complications. Key messages: This review will encompass the current literature regarding clinical safety and outcomes of these novel leadless pacemakers and discuss the evolving technologies in the field of cardiac pacing.

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“…Current limitations in CRT related to vein morphology and SEAT could be overcome with recent developments of leadless LV pacemaker systems (60)(61)(62). Leadless systems generally have the advantage of nullifying the risk of lead failure and thrombo-fibrotic lead encapsulations (TFLE) or lead infections by minimizing implant size and implant-tissue interface equally.…”

Section: Leadless Pacing In Crtmentioning

confidence: 99%

“…Although leadless biventricular pacing has been shown to be feasible and effective (61,62), it is limited to patients without an implantable cardioverter defibrillator (ICD) since endocardial defibrillation has (currently) no leadless alternative. CRT-D patients, however, constitute ∼70% of all CRT patients and still rely on a subcutaneous pulse generator and transvenous leads.…”

Section: Leadless Pacing In Crtmentioning

confidence: 99%

Morphometric Characterization of Human Coronary Veins and Subvenous Epicardial Adipose Tissue—Implications for Cardiac Resynchronization Therapy Leads

Keiler

Meinel

Ortak

et al. 2020

Front. Cardiovasc. Med.

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Subvenous epicardial fat tissue (SEAT), which acts as an electrical insulation, and the venous diameter (VD) both constitute histomorphological challenges for optimal application and lead design in cardiac synchronization therapy (CRT). In this study, we characterized the morphology of human coronary veins to improve the technical design of future CRT systems and to optimize the application of CRT leads. We retrospectively analyzed data from cardiac computed tomography (CT) of 53 patients and did studies of 14 human hearts using the postmortem freeze section technique and micro CT. Morphometric parameters (tributary distances, offspring angles, luminal VD, and SEAT thickness) were assessed. The left posterior ventricular vein (VVSP) had a mean proximal VD of 4.0 ± 1.4 mm, the left marginal vein (VMS) of 3.2 ± 1.5 mm and the anterior interventricular vein (VIA) of 3.9 ± 1.3 mm. More distally (5 cm), VDs decreased to 2.4 ± 0.6 mm, 2.3 ± 0.7 mm, and 2.4 ± 0.6 mm, respectively. In their proximal portions (15 mm), veins possessed mean SEAT thicknesses of 3.2 ± 2.4 (VVSP), 3.4 ± 2.4 mm (VMS), and 4.2 ± 2.8 mm (VIA), respectively. More distally (20–70 mm), mean SEAT thicknesses decreased to alternating low levels of 1.3 ± 1.1 mm (VVSP), 1.7 ± 1.1 mm (VMS), and 4.3 ± 2.6 mm (VIA), respectively. In contrast to the VD, SEAT thicknesses alternated along the further distal vein course and did not display a continuous decrease. Besides the CRT responsiveness of different areas of the LV myocardium, SEAT is a relevant electrophysiological factor in CRT, potentially interfering with sensing and pacing. A sufficient VD is crucial for successful CRT lead placement. Measurements revealed a trend toward greater SEAT thickness for the VIA compared to VVSP and VMS, suggesting a superior signal-to-noise-ratio in VVSP and VMS.

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Successful implementation of a totally leadless biventricular pacing approach

Cited by 10 publications

References 11 publications

European experience with a first totally leadless cardiac resynchronization therapy pacemaker system

European experience with a first totally leadless cardiac resynchronization therapy pacemaker system

Emerging Technologies in Electrophysiology: From Single-Chamber to Biventricular Leadless Pacemakers

Morphometric Characterization of Human Coronary Veins and Subvenous Epicardial Adipose Tissue—Implications for Cardiac Resynchronization Therapy Leads

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