Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system

Sieniewicz, Benjamin; Betts, Timothy R.; James, Simon; Turley, Andrew; Butter, Christian; Seifert, Martin; Boersma, Lucas V.A.; Riahi, Sam; Neužil, Petr; Biffi, Mauro; Diemberger, Igor; Vergara, Pasquale; Arnold, Martin; Keane, David; Defaye, Pascal; Deharo, Jean Claude; Chow, Anthony; Schilling, Richard J.; Behar, Jonathan M.; Rinaldi, Christopher A.

doi:10.1016/j.hrthm.2020.03.002

Cited by 67 publications

(89 citation statements)

References 14 publications

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“…The LV receiver electrode is fully endothelialized after four weeks, avoiding the need for long-term anticoagulation [67]. In a multicenter registry of 90 patients implanted with the WiSE-CRT system, successful implantation and CRT delivery was achieved in 94.4% of patients, while 70% of patients experienced an improvement in heart failure symptoms [68]. Montemerlo et al presented a case of fully leadless resynchronization therapy delivered trans-septally with a combination of Micra™ and WiSE-CRT™ systems [69].…”

Section: Cieds In a Patient On Hemodialysismentioning

confidence: 99%

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

Nowak

Kusztal

2021

JCM

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Cardiovascular implantable electronic devices (CIEDs) are a standard therapy utilized for different cardiac conditions. They are implanted in a growing number of patients, including those with chronic kidney disease (CKD) and end-stage kidney disease (ESKD). Cardiovascular diseases, including heart failure and malignant arrhythmia, remain the leading cause of mortality among CKD patients, especially in ESKD. CIED implantation procedures are considered minor surgery, typically with transvenous leads inserted via upper central veins, followed by an impulse generator introduced subcutaneously. A decision regarding optimal hemodialysis (HD) modality and the choice of permanent vascular access (VA) could be particularly challenging in CIED recipients. The potential consequences of arteriovenous access on the CIED side are related to (1) venous hypertension from lead-related central vein stenosis and (2) the risk of systemic infection. Therefore, when creating permanent vascular access, the clinical scenario may be complicated by the CIED presence on one side and the lack of suitable vessels for arteriovenous fistula on the contralateral arm. These factors suggest the need for an individualized approach according to different clinical situations: (1) CIED in a CKD patient; (2) CIED in a patient on hemodialysis CIED; and (3) VA in a patient with CIED. This complex clinical conundrum creates the necessity for close cooperation between cardiologists and nephrologists.

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Section: Cieds In a Patient On Hemodialysismentioning

confidence: 99%

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

Nowak

Kusztal

2021

JCM

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“…Rates of successful implantation and effective CRT pacing were high (97.1%), with a substantial improvement (84.8%) in the clinical composite score at 6 months; however, the rate of early serious complications was 31.5% at 1-month postprocedure follow-up (8.6% within 24 hours and 22.9% between 24 hours and 1 month). 49 According to recent data from a Multicenter International Registry of the WiSE-CRT pacing system, 50 implantation of the device was feasible in 94.4% of patients and 70% of those reported improvement in of HF symptoms. Complication rates differed among the centers: 4.4%, 18.8%, and 6.7% within <24 hours, 1-30 days, and 1-6 months, respectively.…”

Section: Wireless Cardiac Resynchronization Therapymentioning

confidence: 99%

“…Complication rates differed among the centers: 4.4%, 18.8%, and 6.7% within <24 hours, 1-30 days, and 1-6 months, respectively. 50 Likewise, the SOLVE-CRT trial 51 is an ongoing RCT assessing the safety and effectiveness of the WiSE-CRT in nonresponders to traditional CRT.…”

Section: Wireless Cardiac Resynchronization Therapymentioning

confidence: 99%

<p>Cardiac Electronic Devices: Future Directions and Challenges</p>

Kotalczyk¹,

Kalarus²,

Wright³

et al. 2020

MDER

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Cardiovascular implantable electronic devices (CIEDs) are essential management options for patients with brady-and tachyarrhythmias or heart failure with concomitant optimal pharmacotherapy. Despite increasing technological advances, there are still gaps in the management of CIED patients, eg, the growing number of lead-and pocket-related longterm complications, including cardiac device-related infective endocarditis, requires the greatest care. Likewise, patients with CIEDs should be monitored remotely as a part of a comprehensive, holistic management approach. In addition, novel technologies used in smartwatches may be a convenient tool for long-term atrial fibrillation (AF) screening, especially in high-risk populations. Early detection of AF may reduce the risk of stroke and other AF-related complications. The objective of this review article was to provide an overview of novel technologies in cardiac rhythm-management devices and future challenges related to CIEDs.

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“…This system still has multiple caveats, including: (1) the need for an endovascular ICD lead; (2) dependence on acoustic window, necessitating alignment of the LV electrode and the subcutaneous transmitter that is not always feasible; (3) long-term use of ultrasound energy which may have unintended adverse effects on myocardial tissue and might be exposed to external interference; and, (4) potential emboli of the LV electrode resulting in stroke. An international registry evaluating the efficacy and safety of the WISE-CRT pacing system was just recently published [ 57 ]. The registry included 90 patients who either failed or could not undergo a conventional trans-venous CRT implant, due to no venous access or anatomic constrains.…”

Section: Multi-component Leadless Cardiac Resynchronization Pacingmentioning

confidence: 99%

“…The registry included 90 patients who either failed or could not undergo a conventional trans-venous CRT implant, due to no venous access or anatomic constrains. The registry revealed high implant success rate (94%), but with a very high six-month complication rate (24%), including: two patients with acute cardiac perforation, two patients with acute lung injury, four deaths of whom three were considered procedure-related, one stroke, three patients with infection, and four patients with arterial bleeding [ 57 ].…”

Section: Multi-component Leadless Cardiac Resynchronization Pacingmentioning

confidence: 99%

Cardiac Implantable Electronic Miniaturized and Micro Devices

Rav

Soifer²,

Hasin

2020

Micromachines

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Advancement in the miniaturization of high-density power sources, electronic circuits, and communication technologies enabled the construction of miniaturized electronic devices, implanted directly in the heart. These include pacing devices to prevent low heart rates or terminate heart rhythm abnormalities (‘arrhythmias’), long-term rhythm monitoring devices for arrhythmia detection in unexplained syncope cases, and heart failure (HF) hemodynamic monitoring devices, enabling the real-time monitoring of cardiac pressures to detect and alert for early fluid overload. These devices were shown to prevent HF hospitalizations and improve HF patients’ life quality. Pacing devices include permanent pacemakers (PPM) that maintain normal heart rates, defibrillators that are capable of fast detection and the termination of life-threatening arrhythmias, and cardiac re-synchronization devices that improve cardiac function and the survival of HF patients. Traditionally, these devices are implanted via the venous system (‘endovascular’) using conductors (‘endovascular leads/electrodes’) that connect the subcutaneous device battery to the appropriate cardiac chamber. These leads are a potential source of multiple problems, including lead-failure and systemic infection resulting from the lifelong exposure of these leads to bacteria within the venous system. One of the important cardiac innovations in the last decade was the development of a leadless PPM functioning without venous leads, thus circumventing most endovascular PPM-related problems. Leadless PPM’s consist of a single device, including a miniaturized power source, electronic chips, and fixating mechanism, directly implanted into the cardiac muscle. Only rare device-related problems and almost no systemic infections occur with these devices. Current leadless PPM’s sense and pace only the ventricle. However, a novel leadless device that is capable of sensing both atrium and ventricle was recently FDA approved and miniaturized devices that are designed to synchronize right and left ventricles, using novel intra-body inner-device communication technologies, are under final experiments. This review will cover these novel implantable miniaturized cardiac devices and the basic algorithms and technologies that underlie their development. Advancement in the miniaturization of high-density power sources, electronic circuits, and communication technologies enabled the construction of miniaturized electronic devices, implanted directly in the heart. These include pacing devices to prevent low heart rates or terminate heart rhythm abnormalities (‘arrhythmias’), long-term rhythm monitoring devices for arrhythmia detection in unexplained syncope cases, and heart failure (HF) hemodynamic monitoring devices, enabling the real-time monitoring of cardiac pressures to detect and alert early fluid overload. These devices were shown to prevent HF hospitalizations and improve HF patients’ life quality. Pacing devices include permanent pacemakers (PPM) that maintain normal heart rates, defibrillators that are capable of fast detection and termination of life-threatening arrhythmias, and cardiac re-synchronization devices that improve cardiac function and survival of HF patients. Traditionally, these devices are implanted via the venous system (‘endovascular’) using conductors (‘endovascular leads/electrodes’) that connect the subcutaneous device battery to the appropriate cardiac chamber. These leads are a potential source of multiple problems, including lead-failure and systemic infection that result from the lifelong exposure of these leads to bacteria within the venous system. The development of a leadless PPM functioning without venous leads was one of the important cardiac innovations in the last decade, thus circumventing most endovascular PPM-related problems. Leadless PPM’s consist of a single device, including a miniaturized power source, electronic chips, and fixating mechanism, implanted directly into the cardiac muscle. Only rare device-related problems and almost no systemic infections occur with these devices. Current leadless PPM’s sense and pace only the ventricle. However, a novel leadless device that is capable of sensing both atrium and ventricle was recently FDA approved and miniaturized devices designed to synchronize right and left ventricles, using novel intra-body inner-device communication technologies, are under final experiments. This review will cover these novel implantable miniaturized cardiac devices and the basic algorithms and technologies that underlie their development.

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Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system

Cited by 67 publications

References 14 publications

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

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

<p>Cardiac Electronic Devices: Future Directions and Challenges</p>

Cardiac Implantable Electronic Miniaturized and Micro Devices

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