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

Abstract

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.

Fusion cardiac resynchronization therapy in an left ventricular assist device patient from two devices and crossing leads: a case report

“…Although CRT from two separate devices involving RV endocardial and (hybrid) left ventricular epicardial pacing has been reported previously and is of increasing interest in light of the new leadless pacing modalities, 14 the current case is, to the best of our knowledge, the first one involving entirely transvenous pacing from two separate CIEDs in an LVAD patient. During follow-up, one should be aware of the need for meticulous programming and fine-tuning to obtain the optimal biventricular pacing configuration—modern device algorithms try to automatically optimize the output and biventricular (multipolar) pacing configuration based on individual device programming and intracardiac electrocardiograms; and avoid the potential proarrhythmic effects of epicardial LV trigger pacing.…”

Cardiac Implantable Electronic Devices in Hemodialysis and Chronic Kidney Disease Patients—An Experience-Based Narrative Review

“…Acute QRS reduction following WiSE-CRT implantation was observed in all eight patients. Six months after WiSE-CRT implantation, there was a significant increase in the LV ejection fraction (28.43 ± 8.01% vs. 39.71 ± 1.89%; p = 0.018) [70].…”

“…Montemerlo et al presented a case of fully leadless resynchronization therapy delivered trans-septally with a combination of Micra™ and WiSE-CRT™ systems [69]. Carabelli et al published their experiences in a case series with totally leadless CRT successfully delivered with a similar combination [70]. All eight WiSE-CRT devices could successfully detect the Micra pacing output and be trained to deliver synchronous LV endocardial pacing.…”

The wireless pacemaker is on again; from electro-stimulation to synchronization

“…The first randomized study is currently underway, the Stimulation Of the left Ventricular Endocardium for C(c)ardiac Resynchronization Therapy in Non-Responders and previously Untreatable Patients Study 16 aimed at evaluating the safety and efficacy of the system in a cohort of 350 patients, who after implantation will be randomized to ON or OFF stimulation, in order to evaluate both symptomatic and echocardiographic effects of the method. The WISE-CRT has proven to be compatible with both conventional right ventricular pacing devices and the Micra, 17 and can therefore enable true leadless resynchronization therapy. In one case, 18 the subcutaneous defibrillator was also associated.…”