Because of concerns regarding the transmission of infectious disease from patient to patient, and because of the lack of data regarding device reliability when used in such a fashion, reuse of explanted CIEDs has not been approved by any governing or regulatory body. However, due to the large numbers of patients in resource-limited settings who have indications for a CIED but are unable to afford the device, there is a potential for compassionate reuse of CIEDs if sterility and reliability can be assured. From a single-center cohort of 81 indigent patients with indications for an ICD who received 106 explanted ICD pulse generators (cleaned and sterilized using a protocol involving hydrogen peroxide, povidone-iodine, and ethylene oxide gas) with a projected battery life of three or more years, the following findings were reported [59]: https://www.uptodate.com/contents/cardiac-implantable-electronic-devices-periprocedural-complications/print 11/21 7/6/23, 10:49 AM Cardiac implantable electronic devices: Periprocedural complications - UpToDate No infectious complications One lead dislodgement and one lead fracture Mean time to subsequent ICD replacement 1287 days Appropriate ICD therapy (shocks or antitachycardia pacing) in 64 out of 106 devices (60 percent) In 2003, the Montreal Heart Institute developed a prospective registry to enroll patients receiving resterilized CIEDs. In 2020, investigators from this group published a case-control study of 1051 patients who had received a reused/resterilized CIED (85 percent PPMs, 15 percent ICDs), who were matched with 3153 matched controls who received their CIED in Canada [60]. Over a follow-up of two years, CIED infection rates were not significantly different between recipients of reused or new CIEDs (2.0 versus 1.2 percent, respectively), with no device-related deaths. While additional data will be helpful in validating this practice on a larger scale and for longer follow-up, reuse of resterilized CIEDs appears safe and feasible, particularly in resource- limited settings. CIED generator changes and revision procedures The risks associated with CIED generator change and/or lead revision are different from those of initial implantation, with the absolute risk differing significantly depending on whether the procedure involves only a generator change or whether lead revision is also involved. If extraction of a chronic lead(s) is performed concurrently, the procedural risk is higher. (See 'Infection' above and "Cardiac implantable electronic device lead removal".) The REPLACE Registry was a prospective multicenter study of patients undergoing CIED reimplantation with two distinct cohorts, patients undergoing generator change only (1031 patients) and patients undergoing generator change plus the placement of at least one additional lead (713 patients), who were followed for six months post-procedure to assess for complications [61]. Major complications occurred in only 41 patients (4 percent) of the generator-only cohort as compared with 109 patients (15 percent) of the generator plus lead cohort. Subsequently, investigators reevaluated the patients from the REPLACE Registry in an effort to identify risk factors related to mortality within the six months post-procedure, ultimately identifying several patient characteristics (admission for heart failure within preceding 12 months, NYHA class III or IV status, antiarrhythmic drug use, chronic kidney disease, cerebrovascular disease, and advancing age) were identified that predicted mortality [30]. PERIPROCEDURAL MONITORING https://www.uptodate.com/contents/cardiac-implantable-electronic-devices-periprocedural-complications/print 12/21 7/6/23, 10:49 AM Cardiac implantable electronic devices: Periprocedural complications - UpToDate All patients who undergo CIED implantation will have the device placed using local anesthesia at the site of the pulse generator insertion, with procedural sedation or higher level of anesthesia provided for patients in whom anxiety or pain control is needed. The monitoring associated with procedural sedation is discussed in detail separately. (See "Procedural sedation in adults: General considerations, preparation, monitoring, and mitigating complications", section on 'Monitoring'.) Following CIED implantation, a posteroanterior (PA) and lateral chest radiograph should be obtained to document the position of the pulse generator and the associated lead(s) and to exclude any apparent complications, including pneumothorax and lead dislodgment [62]. Patients should also have a 12-lead electrocardiogram (ECG) recorded post implant. This is particularly helpful in the case of cardiac resynchronization therapy to verify biventricular capture. Following CIED implantation, patients have traditionally been observed overnight in a hospitalized environment with continuous ECG monitoring, and discharged the following day if doing well without any apparent complications. However, accumulating reports support the feasibility and safety of sending patients home the same day as their implant if there are no apparent early complications [63-65]. SOCIETY GUIDELINE LINKS Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Cardiac implantable electronic devices".) INFORMATION FOR PATIENTS UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." th th The Basics patient education pieces are written in plain language, at the 5 to 6 grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more th th sophisticated, and more detailed. These articles are written at the 10 to 12 grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon. https://www.uptodate.com/contents/cardiac-implantable-electronic-devices-periprocedural-complications/print 13/21 7/6/23, 10:49 AM Cardiac implantable electronic devices: Periprocedural complications - UpToDate Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient info" and the keyword(s) of interest.) Basics topics (see "Patient education: Sudden cardiac arrest (The Basics)" and "Patient education: Pacemakers (The Basics)" and "Patient education: Cardiac resynchronization therapy (The Basics)") Beyond the Basics topics (see "Patient education: Implantable cardioverter-defibrillators (Beyond the Basics)" and "Patient education: Pacemakers (Beyond the Basics)") SUMMARY AND RECOMMENDATIONS Background and incidence There are a variety of potential complications associated with cardiac implantable electronic device (CIED) use, both at and around the time of implantation as well as long-term over the life of the patient and his/her device. Reported implant complication rates range from 2 to 6 percent, although the exact incidence of periprocedural CIED complications is difficult to determine due to inconsistent definitions and the lack of mandatory reporting. (See 'Incidence' above.) Procedural complications Complications associated with transvenous CIED lead implantation include bleeding, infections, lead dislodgement, pneumothorax, cardiac perforation, and rarely death. Perioperative mortality This is rare with transvenous CIED implantation, but it occurs occasionally, with estimates of periprocedural mortality ranging from 0.2 to 0.4 percent. (See 'Mortality' above.) Cardiac perforation At the time of CIED implantation, this is rare, occurring in only 0.1 to 0.2 percent of patients, but it is associated with significant morbidity and mortality. (See 'Cardiac perforation' above.) Bleeding While most patients who undergo transvenous CIED insertion have minimal blood loss or post-operative bleeding, serious bleeding can sometimes occur. To minimize the risk of bleeding, chronic antithrombotic therapy should be discontinued prior to device insertion when reasonable to do so, although this may not be an option for those at the highest risk of thromboembolic events. (See 'Bleeding' above.) Infection An infection of the generator pocket or leads can occur at the time of CIED implantation or at any subsequent time, having been reported in up to 2 percent of https://www.uptodate.com/contents/cardiac-implantable-electronic-devices-periprocedural-complications/print 14/21 7/6/23, 10:49 AM Cardiac implantable electronic devices: Periprocedural complications - UpToDate patients within six months post-procedure. The incidence of early CIED infection is lower with perioperative antibiotics (with the transvenous rather than the epicardial approach) and with pectoral implantation, and higher with increasing number of leads, in replacement versus de novo implants, and in patients on hemodialysis. (See 'Infection' above.) Periprocedural monitoring Following CIED implantation, a posteroanterior (PA) and lateral chest radiograph should be obtained to document the position of the pulse generator and the associated lead(s) and to exclude any apparent complications, including pneumothorax and lead dislodgment. Patients should also have a 12-lead ECG recorded post implant. (See 'Periprocedural monitoring' above.) ACKNOWLEDGMENT The UpToDate editorial staff acknowledges Leonard Ganz, MD, FHRS, FACC, who contributed to an earlier version of this topic review. Use of UpToDate is subject to the Terms of Use. REFERENCES 1. Pfeiffer D, Jung W, Fehske W, et al. Complications of pacemaker-defibrillator devices: diagnosis and management. Am Heart J 1994; 127:1073. 2. Kron J, Herre J, Renfroe EG, et al. Lead- and device-related complications in the antiarrhythmics versus implantable defibrillators trial. Am Heart J 2001; 141:92. 3. DiMarco JP. Implantable cardioverter-defibrillators. N Engl J Med 2003; 349:1836. 4. 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Feasibility and safety of same-day discharge after implantable cardioverter defibrillator placement for primary prevention. Pacing Clin Electrophysiol 2013; 36:885. 65. Archontakis S, Oikonomou E, Sideris K, et al. Safety of same-day discharge versus overnight stay strategy following cardiac device implantations: a high-volume single-centre experience. J Interv Card Electrophysiol 2023; 66:471. Topic 108919 Version 29.0 Contributor Disclosures Kevin F Kwaku, MD, PhD Grant/Research/Clinical Trial Support: Boston Scientific [ICD anti-tachycardia pacing (APPRAISE-ATP) trial]. Other Financial Interest: Medtronic [Travel expenses]. All of the relevant financial relationships listed have been mitigated. Jonathan Piccini, MD, MHS, FACC, FAHA, FHRS Grant/Research/Clinical Trial Support: Abbott [Atrial fibrillation, catheter ablation]; AHA [Atrial fibrillation, cardiovascular disease]; Bayer [Atrial fibrillation]; Boston Scientific [Cardiac mapping, pacemaker/ICD, atrial fibrillation care]; iRhythm [Atrial fibrillation]; NIA [Atrial fibrillation]; Philips [Lead management]. Consultant/Advisory Boards: Abbott [Atrial fibrillation, catheter ablation]; Abbvie [Atrial fibrillation]; Bayer [Atrial fibrillation]; Boston Scientific [Cardiac mapping, atrial fibrillation, pacemaker/ICD]; ElectroPhysiology Frontiers [Atrial fibrillation, catheter ablation]; Element Science [DSMB]; Medtronic [Atrial fibrillation, pacemaker/ICDs]; Milestone [Supraventricular tachycardia]; Pacira [Atrial fibrillation]; Philips https://www.uptodate.com/contents/cardiac-implantable-electronic-devices-periprocedural-complications/print 20/21 7/6/23, 10:49 AM Cardiac implantable electronic devices: Periprocedural complications - UpToDate [Lead extraction]; ReCor [Cardiac arrhythmias]; Sanofi [Atrial fibrillation]. All of the relevant financial relationships listed have been mitigated. Nisha Parikh, MD, MPH No relevant financial relationship(s) with ineligible companies to disclose. Contributor disclosures are reviewed for conflicts of interest by the editorial group. When found, these are addressed by vetting through a multi-level review process, and through requirements for references to be provided to support the content. Appropriately referenced content is required of all authors and must conform to UpToDate standards of evidence. Conflict of interest policy https://www.uptodate.com/contents/cardiac-implantable-electronic-devices-periprocedural-complications/print 21/21