Perspectives on the Longevity of Cardiac Rhythm Management Devices

Endoscopy in patients with implanted electronic devices

Practice Advisory for the Perioperative Management of Patients with Cardiac Rhythm Management Devices: Pacemakers and Implantable Cardioverter–Defibrillators

Modern cardiac rhythm management systems have become increasingly complex. The decision on which specific system to implant in a given patient often rests with the implanting physician. We conducted a multiple-choice survey to assess the opinions and preferences of cardiologists and electrophysiologists who implant and follow cardiac rhythm management systems. Reliability and battery longevity were viewed as the most important characteristics in device selection. Patient characteristics which most affected device choice were pacing indication and life expectancy. Remote technology was used in 47% of pacemaker patients, 64% of ICD patients, and 65% of CRT-D patients, with wireless (radiofrequency) remote patient monitoring associated with higher patient compliance rates (74% versus 64%, resp.). Wireless remote patient management with alerts for atrial tachyarrhythmias was felt to be important by 76% of respondents. When choosing an MR-conditional device, physicians deemed patients with prior orthopedic problems, a history of cancer, or neurological disorders to be more likely to require a future MRI. Device longevity and reliability remain the most important factors which influence device selection. Wireless remote patient monitoring with alerts is considered increasingly important when choosing a specific cardiac rhythm management system to implant.

First-in-man implantation of a gold-coated biventricular defibrillator: Difficult differential diagnosis of metal hypersensitivity reaction vs chronic device infection

Infected device explantation is increasingly necessary given the rapid growth in cardiac rhythm management device (CRMD) implantation in China. However, some patients with CRMD infection are unlikely to be capable of paying for a new device. Reassuringly, evidence suggests that reuse of cardiac devices can be safe and feasible. In this study, we evaluated whether explanted cardiac devices, due to infection, can be reimplanted safely within the same individuals. All patients with CRMD infection between 2007 and 2010 were entered into a computer database. From these, patients that had need for CRMD implantation and reimplantation of their infected device were analyzed for safety and complications. Sixty patients had CRMD implantation after the infected device removal, and 44 (73.3 %) patients underwent procedures for reimplantation of their infected device. The mean age of the patients was 64.8 ± 16.5 years, and 32 (72.7 %) were male. Indications for device explantation were: pocket infection (86.6 %) and endocarditis (11.4 %). The average follow-up was 20.4 ± 9.0 months. Endocarditis recurred in one (2.3 %) patient with Brugada syndrome at 17 months after reimplantation of a refurbished implantable cardioverter-defibrillator. There were three deaths during the follow-up period secondary to myocardial infarction and cerebral vascular accident. No early battery depletion or device malfunction was identified during follow-up. Our data emphasize that reimplantation of explanted CRMDs, due to infection, within the same individual is feasible, safe, and effective. Reuse of explanted CRMDs is an alternative choice for people in developing countries.

Atrial fibrillation (AF) is an important prognostic parameter in patients with hypertrophic cardiomyopathy (HCM). Though cardiac rhythm management (CRM) devices (e.g., ICD, pacemaker or implantable loop recorder) can detect subclinical AF, data describing the incidence of AF are rare. We therefore investigated the incidence and clinical impact of de novo and subclinical AF detected by CRM devices in patients with HCM. In our retrospective single-center study, we included patients with HCM and need for CRM devices. The primary endpoint of the study was the incidence of clinical and subclinical de novo AF. During follow-up, patients were screened for adverse events like stroke, ventricular arrhythmia, heart failure, or death. From 192 HCM patients, 44 patients received a CRM device (38 ICDs, 5 pacemakers, 1 implantable loop recorder). In 14 of these patients (32%), AF had been documented before device implantation. Thirty (68%) patients were free from AF at the time of implantation. During a median follow-up of 595 days (interquartile range, 367-890 days), de novo AF was recorded in 16 of these 30 patients (53%). Fourteen (88%) of the 16 patients with de novo AF were free from any clinical symptoms, so these patients were classified to have subclinical AF. In logistic regression analysis, age was the only significant predictor for an increased risk of AF. AF is common in patients with HCM who need a CRM device. More than 50% of these patients develop de novo AF that was predominantly subclinical in our cohort.

Smart wearable device accessories may interfere with implantable cardiac devices

Autonomic regulation therapy via vagus nerve stimulation (VNS) was recently approved as a therapy for chronic heart failure, and will likely be utilized in patients who are also indicated for cardiac rhythm management device implantation. This study is designed to assess the degree to which VNS is likely to cause interference in the cardiac sensing of an implantable cardiac rhythm management device. A VNS stimulation lead and a cardiac sensing lead were placed in a simulated biological medium. A nonconductive carrier frame was used to position the leads at a precise electrode spacing. Stimulation was delivered through the VNS Therapy lead at a maximum output current and a variety of combinations of stimulation frequencies from 5-30 Hz and stimulation pulse widths from 130-1000 μs. The electrode spacing began at 0 cm and was increased in 1 cm increments until the measured signal dropped below the cardiac rhythm management device noise floor for sensing. The test was conducted with both bipolar and unipolar sensing. In the bipolar sensing configuration, the maximum sensed signal amplitude was 687 μV at an electrode separation of 0 cm, signal frequency of 30 Hz, pulse width of 1000 μs, and output current of 3.5 mA. In the unipolar sensing configuration, the maximum amplitude was 406 μV. In both configurations, the measured signal with maximum stimulation intensity decreased significantly with electrode separation, and dropped below the noise floor at an electrode spacing of 3.0 cm. The sensed signal amplitude was further attenuated at lower stimulation amplitudes and pulse widths. Even at maximum neural stimulation intensity of 3.5 mA, at an electrode separation of at least 3.0 cm, neural stimulation did not result in a detectable level of interference with either bipolar or unipolar sensing. Because this separation is significantly smaller than the minimum electrode separation of 15 cm in clinical practice, VNS Therapy is not expected to interfere with the function of implantable cardiac devices.

Safety and efficiency of low-field magnetic resonance imaging in patients with cardiac rhythm management devices

Safety of Computed Tomography in Patients With Cardiac Rhythm Management Devices: Assessment of the U.S. Food and Drug Administration Advisory in Clinical Practice

Intact retrograde ventriculoatrial (VA) conduction in the presence of complete atrioventricular (AV) heart block has been well-documented in the past. We sought to describe the prevalence and clinical significance of intact VA conduction accompanied by complete antegrade AV block in patients with implanted cardiac rhythm management (CRM) devices. During routine follow-up of CRM devices in our device clinic, 42 patients were found to be in a state of complete heart block. All patients presented in sinus rhythm. The patients’ underlying rhythms were tested with the inhibition of pacing and documented AV dissociation. Subsequently, retrograde VA conduction was tested with ventricular pacing. In the 42 patients with complete heart block as the underlying rhythm, five patients demonstrated retrograde VA conduction. In conclusion, the prevalence of intact of VA conduction was 11.9% in our study. The implications of this phenomenon can have noteworthy clinical significance. The occurrence of pacemaker-mediated tachycardia and repetitive nonreentrant VA synchrony are discussed herein. All patients, even those with a device indication of complete heart block, should be tested for retrograde conduction at implantation and during routine follow-up.

The last decade has seen ongoing evolution and use of cardiac rhythm management devices, including pacemakers, cardiac resynchronisation therapy, implantable cardioverter defibrillators and loop recorders. General practitioners are increasingly involved in follow-up and management of patients with these devices. The aim of this article is to provide an overview of different cardiac rhythm management devices, including their role, implant procedure, post-procedural care, potential complications and follow‑up. We also include practical advice for patients regarding driving, exercise, sexual intimacy and precautions with regards to electromagnetic interference. Cardiac rhythm management devices perform many functions, including bradycardia pacing, monitoring for arrhythmias, cardiac resynchronisation for heart failure, defibrillation and anti-tachycardia pacing for tachyarrhythmias. Concerns regarding potential device-related complications should be discussed with the implanting physician. In the post-implant period, patients with cardiac rhythm management devices can expect to lead normal, active lives. However, caution must occasionally be exercised in certain situations, such as near appliances with electromagnetic interference. Future innovations will move away from transvenous leads to leadless designs with combinations of different components on a 'modular' basis according to the function required.

Symptomatic central vein stenosis commonly occurs when cardiac rhythm management device (CRMD) leads are placed via the subclavian vein ipsilateral to arteriovenous (AV) hemodialysis (HD) access. The purposes of this study were to determine the outcomes, complications, and patency following stenting of CRMD lead-associated central vein stenosis or occlusion, and to determine the effect of stents on CRMD function. Fourteen HD patients with AV access and an ipsilateral CRMD were treated with stents for symptomatic central vein stenosis or occlusion following inadequate response to angioplasty from January 2005 to December 2009. Subsequent access interventions, complications, and outcomes were reviewed retrospectively. Cardiology records were examined to assess CRMD function. Treatment of stenosis or occlusion with angioplasty and stenting resulted in 100% procedural success and no complications. At 6 and 12 months, respectively, primary patency rates were 45.5% and 9.0%; primary-assisted patency rates were 90.9% and 80.0%; secondary patency rates were 100% and 90.0%. There were 42 repeat interventions performed in 12 patients; five received additional stents. The mean number of subsequent interventions was 3.2 per patient (2.1 per patient-year). All CRMD testing demonstrated normal function with no device or lead failure. Seven of the 14 subjects died resulting in a 35.3% annual mortality rate. No deaths were attributable to dysrhythmia or CRMD failure and no patient required CRMD removal or exchange. Placement of stents for CRMD lead-associated stenosis or occlusion yields high success and low complication rates with no effect on CRMD function. Patency rates are similar to those reported in other series of central venous stents.

P1467Ambulatory implantation of cardiac rhythm management devices: a retrospective safety and cost-minimization analysis in a developing country

Challenges in activation of remote monitoring in patients with cardiac rhythm devices during the coronavirus (COVID-19) pandemic