Version May 2024
INTRODUCTION — As more people are living longer with more significant cardiac disease, the number of permanent pacemakers (PPMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in clinical practice continues to increase. Beginning early in the 21st century, there has also been an expansion in the indications for cardiac implantable electronic devices (CIED, a term that includes PPMs, ICDs, insertable [or implantable] cardiac [or loop] monitors [ICMs]) and intravascular devices such as pulmonary artery pressure monitors (eg, Cardiomems), resulting in device therapy becoming more complex and more prolonged over the patient's lifetime. As such, therapy with a CIED frequently involves multiple leads and multiple pulse generators per patient over each patient's lifetime with the device, exposing the patient to greater operative risk as well as ongoing risk related to the CIED.
There are a variety of potential complications associated with 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 [1-3]. Procedural and periprocedural complications associated with CIED implantation will be reviewed here; the focus will be on CIED systems utilizing implantable leads. The long-term complications associated with a CIED, as well as basic principles associated with both PPMs and ICDs, are discussed separately.
●(See "Cardiac implantable electronic devices: Long-term complications".)
●(See "Permanent cardiac pacing: Overview of devices and indications".)
●(See "Implantable cardioverter-defibrillators: Overview of indications, components, and functions".)
INCIDENCE — Overall, reported implant complication rates have ranged from 3 to >10 percent, although the exact incidence of periprocedural CIED complications varies significantly depending upon the type of device (eg, PPM, ICD, CRT) and is difficult to determine due to inconsistent definitions and the lack of mandatory reporting [4-9]. However, following the establishment of the National Cardiovascular Data Registry (NCDR) ICD Registry by the American College of Cardiology, information became available for a majority of ICDs implanted in the United States [10]. Unfortunately, there is no contemporary nationwide registry of pacemaker, CRT, or ICM devices, although some pacemaker complications can be estimated from ICD data, such as pneumothorax rates in single- and dual-lead systems [11-13].
Major complications requiring reoperation or hospitalization were analyzed in a cohort of 114,484 patients aged 65 years or greater (mean age 74.8 years, 72 percent male) who were enrolled in the NCDR ICD registry and received a first ICD between 2006 and 2010 [10]. Within the initial 90 days following implantation, approximately 5.4 percent of patients experience an ICD-related complication requiring hospitalization and/or reoperation.
Most but not all studies have suggested a decline in the overall rate of complications with increasing experience and contemporary devices and practices, although rates remain somewhat higher in elderly populations and female patients [6].
●In an observational study of 367,153 new ICD recipients between April 2006 and March 2010, in-hospital complications and mortality significantly decreased from 3.7 percent during year 1 of the study to 2.8 percent during year 4 (odds ratio [OR] 0.75, 95% CI 0.71-0.79) [5].
●Among a cohort of 83,792 ICD recipients over age 65 who received an initial primary prevention ICD between 2006 and 2009, significantly higher one-year mortality rates were seen among patients with dementia or frailty (27 and 22 percent, respectively, compared with 12 percent in the total cohort) [14].
●In an observational study of 38,912 patients ages 65 years or older who received an ICD for primary prevention between January 2006 and December 2009, 5.4 percent of patients experienced a device-related complication within the first six months [6]. Rates of complications were significantly higher in women (7.2 percent compared with 4.8 percent in men, adjusted OR 1.4, 95% CI 1.3-1.5).
●In an observational cohort study of patients with 11,924 ICDs, 33,519 pacemakers and 4472 CRT devices were implanted (both de novo and replacements) by cardiologists, surgeons, and electrophysiologists across six United States geographical regions within a single integrated healthcare organization between 2007 and 2013 [15]. The 30-day serious complication rate (including tamponade, hematoma, pneumothorax, and deep infection) was 1.23, 1.48, and 1.74 percent for ICDs, pacemakers, and CRT devices, respectively.
●In a retrospective review of more than 3.7 million CIED implantations over the period from 1998 to 2013, a post-procedure pneumothorax developed in 1.3 percent of patients and was more common in patients >80 years old, women, patients with chronic obstructive pulmonary disease, and dual-chamber CIEDs [16]. An earlier systematic review, which included less than 5000 patients, reported a slightly lower incidence of 0.9 percent [17]. The risk of pneumothorax appears dependent on the implant technique used, with a meta-analysis of 23 studies including 35,722 patients finding an increased risk of pneumothorax using a subclavian puncture technique as compared with a cephalic vein cut down (odds ratio 4.88), but this difference disappeared when comparing axillary vein puncture with cephalic vein access [18].
●In a retrospective cohort study (which acquired data from linked administrative databases) of 81,304 adult patients who received their first CIED (81 percent PPMs, 19 percent ICDs) at one of 174 hospitals in Australia or New Zealand between 2010 and 2015, 6664 patients (8.2 percent) experienced a major complication (a composite of death, device-related re-operation, or hospitalization for device-related complication) within the first 90 days [19]. Complication rates were higher with ICDs compared with PPMs (10 versus 7.8 percent), with significant variation from hospital to hospital (complication rates ranging from 5.3 to 14.3 percent).
●In a retrospective cohort study of 14,293 patients who underwent de novo CIED implantation between 2008 and 2021 in Poland, 400 patients aged 60 or older experienced lead dislodgement requiring reoperation [20]. In both women and men, a frailty score was independently predictive of lead dislodgement (odds ratios 2.12 and 1.63, respectively).
Complications can also occur during generator replacement procedures, lead revision procedures (changing or adding a lead), or lead extraction procedures. The rate of complications associated with these procedures, including infections, is an important issue for patients as well as for clinicians and patients considering early generator change due to a device advisory or recall. The reported rates of device failure in the case of an advisory or recall are usually very low, often well under one percent. As an example, in one study of 2915 patients with an ICD subject to an advisory, of whom 533 patients had a device replaced and were followed for an average of 2.7 months, 8 percent of the patients who underwent replacement had a complication, including major complications requiring reoperation in 5 percent [21]. In comparison, during the study period, three of the devices subject to advisories experienced a malfunction (0.1 percent), with none of these malfunctions resulting in adverse clinical sequelae. Thus, even low procedure-related complication rates could outweigh the benefit of changing the device. On the other hand, several studies have shown that proactive management of these advisory components can lead to improved outcomes. As such, these types of decisions are best approached on a case-by-case basis, taking into account the individual patient scenario and the patient's preference [22,23]. (See "Cardiac implantable electronic device lead removal", section on 'Advisory/recall'.)
PROCEDURAL COMPLICATIONS — Implantation of a CIED system involves placement of the lead system and the pulse generator. Both transvenous and epicardial leads are generally attached to a pulse generator in the pectoral region, although some pacemakers and ICDs implanted at the time of surgery are implanted in an abdominal position (with tunneled epicardial leads). Modern CIED lead systems are most commonly placed via the axillary, subclavian, or cephalic vein. Increasingly rarely, permanent pacemaker (PPM) or ICD leads may be placed on the epicardial surface (via thoracotomy).
In addition to transvenous and epicardial systems, a subcutaneous ICD (S-ICD) is also available in which the pulse generator is placed in the mid-axillary region with the lead tunneled subcutaneously and placed along the left parasternal region.
Leadless pacemakers, in which a pulse generator is placed in direct contact with the right ventricular endocardium without external leads, have their own unique risks which are different than standard transvenous devices and are discussed separately. (See "Permanent cardiac pacing: Overview of devices and indications", section on 'Leadless systems'.)
Each option for pulse generator and lead placement carries its own set of unique potential complications. The discussion in this topic will focus on CIED systems with transvenous and epicardial leads, while information on S-ICDs and leadless pacemakers is presented separately. (See "Subcutaneous implantable cardioverter defibrillators", section on 'Complications' and "Permanent cardiac pacing: Overview of devices and indications", section on 'Leadless systems'.)
Given the potential for transvenous lead-related complications, a patient's candidacy for nontraditional devices should be considered at the time of initial implantation.
Operator characteristics — As indications for CIED implantation expand and more patients are receiving CIEDs during their lifetimes, devices are being implanted by increasing numbers of clinicians with a wide range of procedural volumes and with different board certifications. In general, complications and mortality decrease as the implanting provider's volume of implantations increases, regardless of specialty [24].
●In a cohort of 9854 Medicare patients who underwent ICDs implantation by 1672 clinicians, the annual implant volume ranged from 1 to 87 devices (median seven implants per year) [25]. While there was no correlation between operator volume and periprocedural mortality, 90-day rates of mechanical complications (7 versus 4.4 percent) and ICD infection (1.3 versus 0.6 percent) were significantly higher among clinicians in the lowest quartile of implant volume compared with those in the highest. However, once a threshold of 11 implants per year was reached, the overall complication rate was no longer dependent upon volume.
●In a retrospective cohort study using data from a national ICD registry, which included 111,293 patients who underwent initial transvenous ICD placement by 2128 clinicians in 1062 hospitals between January 2006 and June 2007, implanting providers were classified according to one of four categories of board certification: electrophysiologists, non-electrophysiologist cardiologists, thoracic surgeons, and other specialists [26]. Notably, patients were excluded if their clinician submitted fewer than 10 ICD procedures, if they were 18 years old or younger, if they had a prior ICD implantation, or if they had an epicardial lead placed. Clinicians who were board certified in electrophysiology placed 71 percent of ICDs and had the lowest rates of overall and major complications (3.5 and 1.3 percent, respectively), while thoracic surgeons placed 1.7 percent of ICDs and had significantly higher rates of overall and major complications (5.8 and 2.5 percent). Some of the higher rates of complications in the surgical cases may be due to the tendency of surgical cases to be sicker patients. (See "Cardiac resynchronization therapy in heart failure: Indications and choice of system".)
Initial (or de novo) implantation
Transvenous lead systems — Various lead systems approved for use involve one to three transvenous leads [17]. Reported complication rates range from 3 to 6 percent, with up to one-half of these complications considered serious [4-6]. Complications associated with transvenous CIED lead implantation include bleeding, infections, lead dislodgement, pneumothorax, air embolism, cardiac perforation, thrombosis of the implant vein, and rarely death. Most lead dislodgements and infections occur in the first three months, while lead fractures continue to occur during follow-up [17]. The risk of pneumothorax is a function of the venous access method; traditional subclavian access has a higher pneumothorax risk than the extrathoracic axillary vein micropuncture technique or cephalic vein access [18]. The use of periprocedural venography to guide access can reduce the risk of complications.
Mortality — Perioperative mortality with transvenous CIED implantation is rare but does occasionally occur. Estimates of periprocedural mortality have ranged from 0.2 to 0.4 percent [4,11,17,24,27]. Higher in-hospital (rather than periprocedural) mortality rates have been reported:
●In an analysis of over 800,000 patients from the NCDR database who underwent initial CIED implantation procedure between 2010 and 2014, the observed in-hospital mortality rate was 0.9 percent [28].
●In a cohort of 26,887 heart failure patients undergoing ICD and/or cardiac resynchronization therapy (CRT) implantation, complications were more common in older adults with rates ranging from 0.7 to 1.2 to 2.2 percent in patients aged <80, 80 to 85, and >85 years [29]. When compared with those receiving a single-chamber ICD, patients receiving a dual-chamber ICD have a greater risk of complications (3.2 versus 2.1 percent, adjusted odds ratio [OR] 1.40, 95% CI 1.28-1.52) and in-hospital mortality (0.4 versus 0.23 percent, adjusted OR 1.45, 95% CI 1.20-1.74) [27].
Using data from the REPLACE Registry, a prospective multicenter study of patients undergoing CIED reimplantation with two distinct cohorts (patients undergoing generator change only and patients undergoing generator change plus the placement of at least one additional lead), no significant association was identified between the rate of complications and risk of death during the initial six months post-procedure [30]. However, 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. Using these risk markers, the investigators created the REPLACE DARE Mortality Risk Score to predict mortality, with increasingly higher scores associated with greater risk of mortality. It is notable that in the REPLACE registry, replacement of a CRT device was associated with the highest risk of complications (19 percent).
Cardiac perforation — Cardiac perforation at the time of CIED implantation, a rare complication with most estimates ranging between 0.1 and 0.4 percent of CIED procedures, is associated with significant morbidity and mortality [31-33]. Among 440,251 first-time ICD recipients enrolled in the National Cardiovascular Data Registry between January 2006 and September 2011, only 625 cardiac perforations (0.14 percent) were reported [31]. However, patients with cardiac perforation had a significantly greater risk of other major complications (OR 27.5, 95% CI 19.9-38.0) and in-hospital mortality (OR 17.7, 95% CI 12.2-25.6).
Bleeding — While most patients who undergo transvenous CIED insertion have minimal blood loss or postoperative bleeding, serious bleeding can sometimes occur. In addition to the risks associated with a drop in hemoglobin and discomfort associated with a pocket hematoma, patients who develop a significant pocket hematoma are at higher risk of developing device-related infection [34,35]. Reported bleeding rates have varied widely depending on the presence or absence of concomitant antithrombotic therapy [17,36-38]. In patients who are taking dual antiplatelet therapy, bleeding complications are more frequent (between two- and fourfold increase in bleeding compared with those on no antiplatelet therapy) [38-40].
To minimize the risk of bleeding at the time of transvenous CIED insertion, we proceed as follows:
●For patients requiring transvenous CIED insertion who have the highest risk of thromboembolic events (greater than 5 percent per year), in whom the risk of discontinuing antithrombotic therapy is thought to exceed the risks of post-procedural bleeding [41], we recommend continuation of chronic antithrombotic therapy rather than a bridging strategy using heparin.
●For patients with a lower risk of thromboembolic events (5 percent per year or less) who require transvenous CIED insertion, there are no outcomes data to guide the decision to continue or temporarily suspend antithrombotic therapy at the time of the procedure. Our experts typically use the following approach, which is based on individualized assessment of risks and benefits:
•In general, warfarin should be continued, and if it is temporarily stopped in a patient with low risk of thromboembolic complications and/or a high risk of bleeding complications, bridging anticoagulation should not be provided given the increased risk of bleeding and adverse outcomes associated with bridging anticoagulation strategies.
•If the clinical scenario is consistent with a short-term increased risk of thromboembolism (eg, cardioversion as part of the procedure, or performed recently) in a patient who is otherwise not at chronically high risk of thromboembolism, we continue uninterrupted NOAC (or warfarin) therapy.
•If the clinical scenario is not consistent with a short-term increased risk of thromboembolism, or if there is a history of bleeding or frailty, we perform the procedure with interrupted NOAC. The NOAC can be held 24 to 48 hours before and resumed 24 to 48 hours after the procedure if there are no bleeding issues. Given the short half-lives of NOAC agents, there is no rationale for bridging therapy.
●In patients who are taking antiplatelet therapy with either one or two antiplatelet medications, the optimal management strategy is not as clearly defined. In spite of the association of antiplatelet drugs with increased risks of bleeding, many patients are prescribed these drugs for important reasons (eg, prior cerebrovascular events, recent acute coronary syndrome or cardiac stenting procedure, etc) [40]. Additionally, stopping antiplatelet therapy requires five days (for clopidogrel) and seven days (for aspirin) advanced notice, which may make temporarily stopping them impractical. Therefore, we typically continue antiplatelet therapy for CIED procedures, even when prescribed concurrently with antithrombotic medications, unless the indication for therapy is no longer present.
The BRUISE CONTROL investigators performed the largest randomized trial of antithrombotic treatment strategies in patients undergoing transvenous CIED insertion. Among 681 patients with an annualized risk of thromboembolic events of 5 percent or greater and taking long-term warfarin, those randomized to device insertion while on continued warfarin therapy had a significantly lower incidence of the primary outcome (clinically significant pocket hematoma requiring prolonged hospital stay, interruption of anticoagulation therapy, or surgery for hematoma removal) compared with those whose warfarin was stopped and heparin-bridging therapy used (3.5 versus 16 percent, relative risk 0.19, 95% CI 0.10-0.36) [41]. Two subsequent meta-analyses have shown findings consistent with BRUISE CONTROL, including a 2014 meta-analysis that included 3744 patients from 14 studies (including BRUISE CONTROL and four other prospective randomized trials) and found that heparin bridging was associated with a significantly higher risk of bleeding compared with continuation of anticoagulation (hazard ratio 3.1, 95% CI 2.0-4.8) with no significant reduction in thromboembolic events [42,43]. Based on this, we recommend continuation of chronic warfarin therapy rather than a bridging strategy using heparin for patients at high risk of thromboembolic events who undergo transvenous CIED insertion.
Dabigatran, an oral direct thrombin inhibitor, along with apixaban and rivaroxaban, factor Xa inhibitors, have limited data available regarding bleeding risk during transvenous CIED insertion, but the available data does not suggest a higher rate of bleed complications with uninterrupted NOAC therapy [44-47]. The BRUISE CONTROL-2 investigators performed the largest randomized trial of antithrombotic treatment strategies in patients taking an NOAC and undergoing transvenous CIED insertion. Among 662 patients with CHA2DS2-VASc scores ≥2 and taking a NOAC for chronic anticoagulation, those randomized to device insertion while on continued NOAC therapy had no significant difference in the incidence of the primary outcome (clinically significant pocket hematoma requiring prolonged hospital stay, interruption of anticoagulation therapy, or surgery for hematoma removal) compared with those whose NOAC was stopped (2.1 percent in both treatment arms) [47]. While these data are promising that transvenous CIED implantation can be performed with uninterrupted direct thrombin or factor Xa inhibitors, additional studies are needed prior to routinely recommending this in practice.
In a 2019 analysis of the 1343 patients from the two BRUISE CONTROL studies, there was no difference in clinically significant hemorrhage between patients maintained on warfarin compared with NOAC therapy at the time of CIED implantation [40]. However, patients who underwent CIED implantation while on antiplatelet medication had more than twofold greater risk of bleeding (9.8 versus 4.3 percent in patients not taking an antiplatelet agent).
There are limited data evaluating the optimal approach to anticoagulation in patients receiving an S-ICD, but the risk of hematoma appears higher when compared with transvenous insertion. In a single-center retrospective study of 137 patients undergoing S-ICD implantation, 6 of 24 patients maintained on warfarin developed pocket hematoma (25 percent), compared with 2 of 113 patients (2 percent) not taking warfarin [48]. Additional data are needed prior to making recommendations on the management of anticoagulation around the time of S-ICD placement.
Similarly, there are limited data assessing the optimal approach to anticoagulation in patients receiving a leadless pacemaker, but small studies have suggested that the risk of significant bleeding events is small among patients on oral antithrombotic therapy [49]. Additional data are needed prior to making recommendations specific to the management of anticoagulation around the time of leadless pacemaker placement.
Infection — Infection of the generator pocket or leads can occur at the time of CIED implantation or at any subsequent time. Because infection of a CIED can be a life-threatening problem, complete removal of the CIED pulse generator and all leads, along with antibiotic therapy, are strongly recommended for essentially all patients. In very rare instances, a patient may elect to proceed with antibiotic therapy without hardware removal. These issues are discussed in detail separately. (See "Infections involving cardiac implantable electronic devices: Epidemiology, microbiology, clinical manifestations, and diagnosis" and "Cardiac implantable electronic device lead removal".)
In contemporary practice, the rate of infection within one year post-CIED implantation is approximately 1 percent. Among 19,603 patients who underwent CIED implantation between 2012 and 2016, the overall rate of infection was 0.9 percent, with a slightly higher rate (1.1 percent) among "high risk" patients (defined as patients undergoing any repeat procedure or a new CRT implantation) [50]. Among an earlier "real world" cohort of 200,909 patients enrolled in an ICD registry with implant between 2006 and 2009, 1.7 percent (3390 patients) developed an infection within six months post-implantation, with a higher incidence in pulse generator replacements than in initial implantation [51].
The rate of CIED infection appears to be significantly higher among patients on dialysis, estimated at 8 percent of all patients with an indwelling CIED (including pacemakers and ICDs) who were receiving dialysis between 2005 and 2009 [52]. The incidence of early CIED infection appears to be lower with preoperative antibiotic prophylaxis [53], with the transvenous rather than the epicardial approach, and with pectoral implantation rather than abdominal implantation. The use of an antibiotic-impregnated absorbable envelope at the time of CIED implantation has been shown to reduce major CIED infections in certain higher-risk populations [54]. (See "Infections involving cardiac implantable electronic devices: Treatment and prevention", section on 'Use of antibiotic-impregnated envelopes'.)
Lead malposition and lead terminal switches — Unintended cardiac chambers can be sensed and paced in an unintended sequence as a result of lead malposition at initial implant or incorrect connection of the proximal lead terminals to the CIED header at either initial implant or generator replacement. While rare, each of these scenarios can lead to serious consequences if left unrecognized at the time of implant. Ventricular lead placement into the atrial port and vice-versa can lead to pacemaker syndrome and left ventricular systolic dysfunction [55]. A recent systematic review identified 157 cases of inadvertent lead malposition in the left heart [56]. The malposition was not diagnosed until an average of 365 days after CIED implantation; 31 percent had a transient ischemic attack or stroke at time of diagnosis, whereas 15 percent had heart failure. Over a nine-month mean follow-up, four patients experienced transient ischemic attack or stroke (three treated with oral anticoagulants and one following percutaneous lead extraction). Inadvertent lead malposition in the left heart can be avoided (or recognized) intraoperatively by visualizing a guide wire going below the diaphragm, evaluating the paced QRS morphology in V1 or its equivalent, and imaging in both the right and (steep) left anterior oblique projections.
Epicardial lead systems — In the vast majority of patients, transvenous CIED leads can be placed quickly, without general anesthesia, and with relatively little morbidity. Because of this, transvenous lead placement has largely replaced epicardial lead placement, which requires a thoracotomy, general anesthesia, and a longer recovery. However, epicardial leads remain an option for patients with complicated vascular access or active bloodstream infection in which the placement of transvenous leads may be contraindicated. In these patients, nonleaded systems (ie, subcutaneous ICD and leadless pacemaker) should be considered. (See "Permanent cardiac pacing: Overview of devices and indications", section on 'Leadless systems'.)
Given the relative infrequency with which epicardial leads are placed, there are no data available on the frequency of complications from epicardial lead placement with modern devices. Epicardial lead placement is associated with appreciable mortality and with complications that are unique to thoracotomy and epicardial lead systems, such as the postpericardiotomy syndrome (postcardiac injury syndrome), pleural effusion, erosion of epicardial patches, constrictive pericarditis, and atrial arrhythmias [57]. Additionally, epicardial leads do tend to have higher pacing capture thresholds. (See "Post-cardiac injury syndromes" and "Constrictive pericarditis: Diagnostic evaluation".)
Shoulder-related problems — Shoulder-related problems due to pulse generator placement (utilizing either transvenous or epicardial leads) include decreased shoulder motility, pain, reduced function, and insertion tendinitis. These complaints, more common with sub-pectoral CIED placement rather than subcutaneous CIED placement, usually do not require additional intervention or surgical revision and often abate by 12 months after insertion [58]. Furthermore, the smaller size of modern pulse generators has made device-related shoulder problems extremely rare.
Reuse of explanted ICDs — Many CIED pulse generators have useful battery life remaining at the time of a patient's death or when the CIED is explanted due to infection or device upgrade. 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]:
●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 — 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 in the emergency department: 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." The Basics patient education pieces are written in plain language, at the 5th to 6th 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 sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.
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 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.
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