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Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially lifesaving treatments for a number of cardiac conditions but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased health care costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well-recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, antibacterial envelopes, prolonged antibiotics post-implantation, and others. When compared with previous guidelines or consensus statements, the present consensus document gives guidance on the use of novel device alternatives, novel oral anticoagulants, antibacterial envelopes, prolonged antibiotics post-implantation, as well as definitions on minimum quality requirements for centres and operators and volumes. The recognition that an international consensus document focused on management of CIED infections is lacking, the dissemination of results from new important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a Novel 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections. [ABSTRACT FROM AUTHOR]

Aims: Lead perforation is a rare, well-known complication of cardiac implantable electronic device (CIED) implants, whose management is mostly not evidence-based. Main management strategies include conservative approach based on clinical and lead function follow-up vs. routine invasive lead revision approach. This study compared the complications of both strategies by composite endpoint, including recurrent perforation-related symptoms, recurrent pericardial effusion (PEf), lead dysfunction, and device infection during 12 month follow-up.Methods and Results: Multicentre retrospective analysis, inquiring data from imaging studies, device interrogation, pericardiocentesis, and clinical charts of patients with suspected perforating leads between 2007 and 2014 in five hospitals. All cases were reviewed by electrophysiologist and defined as definite perforations by suggestive symptoms along with lead perforation on imaging, bloody PEf on pericardiocentesis shortly after implant, or right ventricular (RV) lead non-capture along with diaphragmatic stimulation upon bipolar pacing. Clinical outcomes associated with both management approaches were compared, with respect to the composite endpoint. The study included 48 definitive perforation cases: 22 managed conservatively and 26 via lead revision. Conservative management was associated with an increased composite endpoint compared with lead revision (8/22 vs. 1/26; P = 0.007). The dominant complication among the conservative cohort was appearance of cardiac tamponade during follow-up; 5/6 occurring in cases which presented with no or only mild PEf and were treated by antiplatelets/coagulants during or shortly after CIED implantation.Conclusion: A conservative management of CIED lead perforation is associated with increased complications compared with early lead revision. Lead revision may be the preferred management particularly in patients receiving antiplatelets/coagulants. [ABSTRACT FROM AUTHOR]

The number of implanted cardiovascular implantable electronic devices (CIEDs) has increased significantly in the last 30 years, which has led to an upsurge in CIED complications, such as infection and lead malfunction requiring CIED extraction. The decision-making process of CIED reimplantation requires meticulous planning that includes careful consideration of several aspects: the reason for extraction, the indication for CIED reimplantation, patients' wishes, timing of reimplantation, the need for a bridging device, and the type and location of device to be reimplanted. In this article, the authors review this decision-making process and the necessary steps to achieve optimal patient outcomes. [ABSTRACT FROM AUTHOR]

Background Echocardiographically detected patent foramen ovale (PFO) has been associated with stroke/transient ischemic attack (TIA) in patients with cardiac implantable electronic devices (CIEDs). We sought to evaluate the relationship between echocardiographic characteristics and risk of stroke/TIA and mortality in CIED patients with PFO. Methods In 6,086 device patients, PFO was detected in 319 patients. A baseline echocardiogram was present in 250 patients, with 186 having a follow-up echocardiogram. Results Of 250 patients with a baseline echocardiogram, 9.6% (n = 24) had a stroke/TIA during mean follow-up of 5.3 ± 3.1 years; and 42% (n = 105) died over 7.1 ± 3.7 years. Atrial septal aneurysm, prominent Eustachian valve, visible shunting across PFO, baseline or change in estimated right ventricular systolic pressure (RVSP)/tricuspid regurgitation (TR), or maximum RVSP were not associated with postimplant stroke/TIA (P > 0.05). An exploratory multivariate analysis using time-dependent Cox models showed increased hazard of death in patients with increase in TR ≥2 grades (hazard ratio [HR] 1.780, 95% confidence interval [CI] 1.447-2.189, P < 0.0001), or increase in RVSP by >10 mm Hg (HR 2.018, 95% CI 1.593-2.556, P < 0.0001), or maximum RVSP in follow-up (HR 1.432, 95% CI 1.351-1.516, P < 0.0001). A significant increase (P < 0.001) in TR was also noted during follow-up. Conclusions In patients with CIED and PFO, structural and hemodynamic echocardiographic markers did not predict future stroke/TIA. However, a significantly higher TR or RVSP was associated with higher mortality. [ABSTRACT FROM AUTHOR]

The implantation of cardiac pacemakers has become a well-established therapy for conduction disorders and sinus node dysfunction. In many countries pacemaker registries have been initiated in order to collect information on patient characteristics, trends in numbers and the types of pacemakers used, to identify problematic devices, and for safety monitoring. For this utilisation study the Central Pacemaker Patients Registration (CPPR) from the Netherlands Pacemaker Registry Foundation (CPPR-SPRN) containing data collected for more than 20 years was used. During this period nearly 97,000 first pacemakers were implanted. Analyses show an increase in the rate of implanted devices. The change in pacemaker type from VVI to DDD, followed by biventricular stimulation, is reflected by the number of simultaneously implanted leads, which is partly a consequence of cardiac resynchronisation therapy. Our data demonstrate that indications for implantation and type of pacemaker are comparable with other European countries. [ABSTRACT FROM AUTHOR]

The aim of this survey was to describe the different strategies regarding the management of malfunctioning and recalled pacemaker and defibrillator leads across Europe. A questionnaire has been designed to assess the current practice and physician's approach to the management of leads which are faulty, unnecessary, and/or recalled. Responses to the questionnaire were received from 34 hospitals—members of the European Heart Rhythm Association (EHRA) electrophysiology (EP) research network. The survey involved both very high and low volume implanting centres, with 85% of the responding centres performing lead extraction. The survey provides a panoramic view of operator's decision making in the field of malfunctioning, recalled, and redundant leads and outlines a common point of view on lead abandonment and factors influencing the decision about lead extraction. The main factors strongly influencing the decision making were patient's age (59%), the presence of the damaged leads (44%), and the lead dwelling time (44%). Regarding the lead abandonment, the main concern (61%) was the potential greater difficulty associated with lead extraction in the future. High volume extracting centres showed a greater propensity to removing the malfunctioning or recalled leads compared with low volume or non-extracting centres. This EP Wire survey gives a snapshot of the operators' approaches and options regarding redundant, malfunctioning, and recalled lead management and may form the basis for future prospective research on this topic. [ABSTRACT FROM PUBLISHER]

Implanted cardiac devices, including pacemakers, defibrillators, and resynchronization devices, are known to develop thrombus on their intravascular leads. Patent foramen ovale (PFO) occurs in approximately one-quarter of the adult population. It is unclear whether paradoxical cardioembolism and clinically relevant stroke occur in patients with implanted cardiac leads and PFO. We present a case series of four patients with cardioembolic stroke, presumed to arise from intravascular cardiac leads and associated PFO that required device closure of the PFO. (PACE 2013; 36:50-54) [ABSTRACT FROM AUTHOR]

Copyright of Archives of Cardiovascular Diseases Supplements is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Aims: An estimated 10 000–15 000 pacemaker and implantable cardioverter–defibrillator (ICD) leads are extracted annually worldwide using specialized tools that disrupt encapsulating fibrous tissue. Additional information is needed regarding the safety of the devices that have been approved for lead extraction. The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than published data suggest, and whether procedural safety precautions are effective. [ABSTRACT FROM PUBLISHER]

Introduction: Insulation defects are a leading cause of transvenous lead failure. The purpose of this study was to determine the effects of electrocautery on transvenous lead insulation materials. Methods: A preparation was done to simulate dissection of a transvenous lead from tissues. Radiofrequency energy was delivered using a standard cautery blade at outputs of 10, 20, and 30 W, for 3 and 6 seconds, using parallel and perpendicular blade orientations on leads with outermost insulations of silicone rubber, polyurethane, and silicone–polyurethane copolymer. Damage to each lead segment was classified after visual and microscopic analysis. Results: Significant insulation damage occurred to almost all polyurethane leads. Full insulation breaches were observed with 30 W regardless of application duration with a parallel direction and with all power outputs with a perpendicular direction. Thermal insulation damage to copolymer insulation was similar to that of the polyurethane leads. In contrast, there was no thermal damage to silicone leads, regardless of the power output and duration of power delivery. However, mechanical insulation damage was observed to all silicone leads when at least 20 W was applied in a direction perpendicular to the lead. Conclusions: Polyurethane (PU55D) and copolymer materials have low thermal stability and are highly susceptible to thermal damage during cautery. Implanting physicians should be aware of the lead insulation materials being used during implant procedures and their properties. The use of direct contact cautery on transvenous leads should be minimized to avoid damage to the lead, especially on leads with polyurethane or copolymer outer insulations. [ABSTRACT FROM AUTHOR]

Information about several papers discussed at a conference organized by the International Cardiac Pacing and Electrophysiology Society (ICPES) in December 2007 in Rome, Italy is presented. Topics included those on pacemakers and implantable cardioverters and on how to improve device performance monitoring. It featured several professors including C. P. Lau from Hong Kong, China and M. Santini.

Pericarditis has been noted as a potential complication of pacemaker implantation. This study evaluated the risk of developing pericarditis following pacemaker implantation with active-fixation atrial leads. Included were 1,021 consecutive patients (mean age 73.4 ± 0.4 years, range 16-101 years ;45.2% women ) undergoing new pacemaker system implantation between 1991 and 1999 who were reviewed for the complication of pericarditis. The incidence and outcomes of postimpiantation pericarditis in patients receiving active-fixation atrial leads were compared to those not receiving these leads. Of 79 patients who received active-fixation atrial leads, 4 (5%) developed pericarditis postpacemaker implantation. Of 942 patients with passive-fixation atrial leads or no atrial lead (i.e., a ventricular lead only), none developed pericarditis postoperatively (P < 0.001). Of patients receiving active-fixation ventricular leads only (n = 97), none developed pericarditis. No complications were apparent at the time of implantation in patients who developed pericarditis. Pleuritic chest pain developed between 1 and 28 hours postoperatively. Three patients had pericardial rubs without clinical or echocardiographic evidence of tamponade. They were treated conservatively with acetyisalicylic acid or ibuprofen and their symptoms resolved without sequelae in 1-8 days. One patient (without pericardial rub) died due to cardiac tamponade on postoperative day 6. Postmortem examination revealed hemorrhagic pericarditis with no gross evidence of lead perforation. Pericarditis complicates pacemaker implantation in significantly more patients who receive active-fixation atrial leads. It maybe precipitated by perforation of the atria! lead screw through the thin atrial wall. Patients developing postoperative pericarditis should be followed closely due to the risk of cardiac tamponade. [ABSTRACT FROM AUTHOR]

Background. Indications for extraction of an abandoned pacemaker lead (APL) are controversial. The purpose of this study was to determine whether or not APLs should be extracted in the absence of pacemaker-related problems. Methods and Results. We retrospectively reviewed, from 1977 through 1998, all patients with retained, non-functional leads and identified 433—266 males and 167 females. Mean age at initial pacemaker implantation was 68[emsp4 ]years. These patients received a total of 259 atrial and 948 ventricular leads. Of the total of 1,207 leads, 611 became non-functional. A total of 531 non-functional leads were abandoned, of which 18 were later extracted: one APL in 345 patients, two in 78, and three in 10. Indications for new lead placement when non-functional leads were abandoned included capture and/or sensing failure (243), lead recall (177), lead fracture (86), pacing system replacement to the contralateral side (11), accommodating patient growth (5), pacemaker function upgrade (5), replacement with implantable cardioverter defibrillator (ICD, 2), interference with ICD (1), and unknown (1). Complications that were associated with pacemakers were found in 24 patients (5.5%)—pacemaker system infection (8 patients) and venous occlusion at the time of a subsequent procedure of new lead placement when APLs had already been in place (16) which resulted in APL extraction (7) or transfer of the pacemaker system to the contralateral side (9). Neither venous thrombosis nor other complications were found in the remaining 409 patients (94.5%). The incidence of complications was higher in patients with three APLs than in patients with two or fewer APLs (40% vs. 4.7%, P=1×10−6), in patients with four or more total lead implantations than in patients with three or fewer total lead implantations (26.2% vs. 0.6%, P<1×10−10), and in patients with three or more procedures of new lead placements than in patients with two or fewer procedures of new lead placements (36.4% vs. 3.9%, P=1×10−10). Patients with complications were younger than those without complications both at the time of initial pacemaker implantation (59±16 vs. 68±17[emsp4 ]y, P=0.01) and when non-functional leads were abandoned (63±15 vs. 71±16[emsp4 ]y, P=0.04). Mean numbers of APLs, total leads implanted, and procedures of new lead placement were significantly larger in patients with complications than in those without complications (1.58±0.78 vs. 1.2±0.44, 4.96±1.23 vs. 2.66±0.8, and 2.13±0.85 vs. 1.25±0.53, P=0.03, 4×10−9 and 4×10−5, respectively). Conclusions. 1. With only 5.5% of patients having had pacemaker-related complications, the adverse outcome of APL is small. 2. Clinical clues to the possible occasion for pacemaker-related complications include three or more APLs, four or more total leads, three or more procedures of new lead placement, and a younger age at initial pacemaker implantation. 3. Patients with a large number of APLs, total lead implantations, and procedures of new lead placement should be carefully observed to detect possible pacemaker-associated complications. [ABSTRACT FROM AUTHOR]

A new segmented polyether polyurethane atrial pacemaker lead has been developed and tested acutely and chronically in dogs. This lead was constructed so that its tip could quickly and accurately be positioned in close proximity to the S-A node and provide long-term stability without the use of active fixation devices such as tines or screws. The acute intrinsic P-wave potentials seen at the S-A node area (9.7 ± 4.7 mV) were superior to those detected in the appendage (4.7 ± 2.8 mV) and coronary sinus (6.8 ± 4.1 mV). There were no significant differences in pacing thresholds between sites. In long-term studies, transvenous (jugular) leads maintained their position for over three months without dislodgment in active unrestrained dogs with only a 25% decrease in intrinsic P-wave potentials. The chronic pacing thresholds for this lead were similar, or superior, to those reported for other pacemaker lead placement sites. The polyurethane coating material produces no adverse tissue reaction or thrombosis. [ABSTRACT FROM AUTHOR]

Although several types of commercially available epicardial leads exist, few postimplantation data have been reported. To compare ‘screw-in’ (6917-35) leads with ‘stab-on’ leads (4951-35) from the same manufacturer, we reviewed the records of 80 young patients (age 8 days to 29 years) who underwent ventricular epicardial pacemaker implantation from 1973 to 1986. Follow-up for the 57 patients with the 6917-35 model ranged from 3 months to 17 years (median 6.5 years) and for the 23 patients with the 4952-35 model 9 days to 4.25 years (median 2.0 years). Actuarial life table analysis revealed significantly (P < 0.001) fewer 4951-35 leads were functioning at each of 1–5 years after implant, compared to the 6917-35 leads. Analysis of available threshold pulse width data revealed no difference (P = 0.08) acutely (6 weeks after implant), but a significantly (P = 0.05) higher mean threshold for the 4951-35 leads was found chronically. No significant correlation was found for lead failure with age, underlying heart .disease, lead site (i.e., left or right ventricle), or surgical approach. Using the sutureless, stab-on technique, me 4951-35 lead is associated with higher thresholds and lower survival rate when compared to the 6917-35 lead. [ABSTRACT FROM AUTHOR]

Individuals with permanently implanted pacemakers who have normal sensing and pacing at rest may demonstrate abnormalities, particularly of atrial sensing, with exercise. Exercise is known to cause changes in the surface electrocardiographic voltages. The purpose of this study was to evaluate changes in endocardial and epicardial voltages during exercise in canines with permanently implanted pacing leads similar to those permanently implanted in humans with pacemakers. Six adult mongrel dogs were equipped with transvenous atrial and ventricular endocardial bipolar screw-in leads from a jugular venosection, and with atrial and ventricular bipolar stab-on leads from a left thoracotomy. Exercise was performed at one week following implantation and at weekly intervals for a total of 4 weeks. The animals were studied at rest and at a single workload of 3 miles per hour at a 30% elevation. Unfiltered electrograms were recorded with a VR-12 Electronics-for-Medicine photographic recorder. The mean decreases of electrograms with exercise from resting voltage were: 15% for atrial endocardial unipolar leads; 11% for atrial endocardial bipolar leads; 4% for atrial epicardial unipolar leads; 15% for atrial epicardial bipolar leads; 8% for ventricular endocardial unipolar leads; 18% for ventricular endocardial bipolar leads; 0.1% for ventricular epicardial unipolar leads and 5% for ventricular epicardial bipolar leads. [ABSTRACT FROM AUTHOR]

Copyright of Pacing & Clinical Electrophysiology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Techniques and Technology. The use of magnetic resonance (MR) imaging as a diagnostic technique is rapidly expanding. In parallel, the number of patients with cardiac devices is constantly growing and many of them may be referred for MR examinations. However, implantable cardiac devices are subject to multiple effects from MR, and numerous safety issues need to be considered prior to scanning. In this review, we will summarize our experience with MR imaging of patients with implantable cardiac devices, and outline our safety protocol. (J Cardiovasc Electrophysiol, Vol. 23, pp. 1040-1042, September 2012) [ABSTRACT FROM AUTHOR]

This case reports on an 81-year-old man with implanted dual-chamber pacemaker for binodal disease who required ventricular lead revision due to loss of ventricular capture. Successful placement of a new lead via the subclavian vein despite of high degree stenosis of the medial part of the vein is described using a very thin bipolar ventricular pacing lead. Currently available pacing electrodes for this purpose are reviewed. [ABSTRACT FROM AUTHOR]

We presented a case of a 68-year-old female patient with a device implanted six years ago due to symptomatic sinus pauses. A new device was implanted five years ago due to first pacemaker failure. She was admitted for persistent fever associated with infective endocarditis as a result of pacemaker lead. During the evaluation, two pacemakers pockets with their respective generators were detected. According to the patient, the device had not been removed due to the high risk of the procedure. When making the decision to abandon a pacemaker or implantable cardioverter defibrillator leads, potential future complications should be considered. [ABSTRACT FROM AUTHOR]