Complications Of Cardiac Implantable Electronic Devices Research Articles

Aging and cardiac implantable electronic device complications: is the procedure safe in older patients?

In this study, we investigated whether there is a higher incidence of cardiac implantable electronic devices (CIED) procedures related complications in older (≥ 75years) than in younger (< 75years) patients. This retrospective cohort study enrolled patients who had undergone CIED procedures (de novo implantation, system upgrade, generator substitution, pocket revision or lead replacement) at two heart centers in Turkey between January 2011 and May 2023. The primary composite endpoint included clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to the device system. Secondary outcomes included each component of the composite end point. The overall sample included 1923 patients (1419 < 75years and 504 aged ≥ 75years). There was no difference between the groups in terms of cumulative events defined as primary outcome (3.5% vs. 4.4%, p = 0.393). Infection related to device system was significantly higher in the ≥ 75 age group (1.8% vs. 3.4%, p = 0.034). There was no significant difference between the groups in terms of clinically significant hematoma and pneumothorax (0.7% vs. 0.4%, p = 0.451, 1.4% vs. 1.0%, p = 0.477, respectively). In multivariate model analysis, no association was found between age ≥ 75years and infection related to the device system. Infection rates were relatively higher in the patient group aged ≥ 75years. This patient group should be evaluated more carefully in terms of infection development before and after the procedure.

Complications related to pacemakers and other cardiac implantable electronic devices: essentials for internists and emergency physicians.

With the aging population, improving technology, and expanding indications for diagnosing and treating arrhythmias and heart failure, many patients are receiving cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators. Consequently, patients with CIEDs are frequently encountered in the emergency department and in the wards. It is imperative that emergency physicians and internists have a strong foundation on CIEDs and their potential complications. This review aims to help physicians develop a framework in approaching CIEDs and to recognize and manage clinical scenarios that may arise from CIED complications.

Surgical Management of Cardiac Implantable Electronic Device Complications in Patients Unsuitable for Transvenous Lead Extraction.

Although surgical approaches for infected or failing cardiac implantable electronic device (CIED) leads are more invasive than transvenous approaches, they are still required for patients considered unsuitable for transvenous procedures. In this study, surgical management with transvenous equipment for CIED complications was examined in patients unsuitable for transvenous lead extraction.Methods and Results: We retrospectively examined 152 consecutive patients who underwent CIED extraction between April 2009 and December 2021 at the Department of Cardiovascular Surgery, Nippon Medical School. Nine patients (5.9%; mean [±SD] age 61.7±16.7 years) who underwent open heart surgery were identified as unsuitable for the isolated transvenous approach. CIED types included 5 pacemakers and 4 implantable cardioverter-defibrillators; the mean [±SD] lead age was 19.5±7.0 years. Indications for surgical management according to Heart Rhythm Society guidelines included failed prior to transvenous CIED extraction (n=6), intracardiac vegetation (n=2), and severe lead adhesion (n=1). Transvenous CIED extraction tools were used in all patients during or before surgery. Additional surgical procedures with CIED extraction included epicardial lead implantation (n=4) and tricuspid valve repair (n=3). All patients were discharged; during the follow-up period (mean 5.7±3.7 years), only 1 patient died (non-cardiac cause). Surgical procedures and transvenous extraction tools were combined in the removal strategy for efficacious surgical management of CIED leads. Intensive surgical procedures were safely performed in patients unsuitable for transvenous extraction.

Incidence of Cardiac Implantable Electronic Device Complications in Patients With Left Ventricular AssistDevices.

The objective of this study was to describe the risk of cardiac implantable electronic devices (CIEDs) complications in patients with left ventricular assist devices (LVADs). Patients with LVADs are predisposed to ventricular arrhythmias and frequently have CIEDs before receiving their LVAD. However, the role of CIED procedures such as generator changes (GC) are unclear in this population, given the potential complications of bleeding and infection. This was a retrospective, multicenter study from January 1, 2012, to September 30, 2018. All patients with LVADs were screened and those who had a CIED GC, implantation, or revision were included in the study and followed until December 31,2018. A total of 179 patients across 6 centers had a CIED procedure after LVAD implantation. The mean age was 59.5 ± 13.4, with the cohort comprising mostly men (78%), destination LVAD therapy (53.8%), and GC (66%). The 30-day primary composite endpoint of hematoma or device infection occurred in 34 (19%) patients. The secondary endpoints of rehospitalization within 30days and appropriate device therapy during follow-up occurred in 40 (22%) and 42 (24%) patients respectively. Of the 126 patients without previous device therapy, 14.3% received appropriate therapy during follow-up. In this large, multicenter cohort, we report the incidence of complications for CIED procedures in theLVAD population; specifically, LVAD patients are at increased risk of pocket hematomas, without downstream riskofinfection, and do experience a high rate of appropriate device therapies.

Avoiding implant complications in cardiac implantable electronic devices: what works?

Nearly one in ten patients experience complications in relation to cardiac implantable electronic device (CIED) implantations. CIED complications have serious implications for the patients and for the healthcare system. In light of the rising rates of new implants and consistent rate of complications, primary prevention remains a major concern. To guide future efforts, we sought to review the evidence base underlying common preventive actions made during a primary CIED implantation.

The Correlation between Common Variable Immunodeficiency and Atrial Fibrillation: Cardiac Implantable Electronic Devices‐associated infection by Stenotrophomonas maltophilia: A case report

BackgroundCommon variable immunodeficiency (CVID) is associated with systemic infections and autoimmune diseases which may elicit and perpetuate atrial fibrillation via inflammatory and oxidative mechanisms. CVID patients with early‐onset atrial fibrillation (AF) and chronic heart failure (CHF) are refractory to standardized cardiac ablation and frequently need sophisticated cardiac resynchronization therapy. Moreover, CVID‐CHF patients with cardiac implantable electronic devices (CIEDs) are vulnerable to opportunistic infection, especially Stenotrophomonas maltophilia bacteremia, which has high resistance to a variety of empirical antibiotics against gram negative bacteremia.Case presentation31 year‐old female with a past medical history of chronic refractory AF, CHF, thyroid cancer, non‐Hodgkin lymphoma, and factor V deficiency presented to the hospital with a fever of 104.0F for 2 days after recent dual‐chamber biventricular defibrillator replacement 2 weeks ago. 2 months ago, the patient was diagnosed with CVID due to recurrent cardiopulmonary infections. Upon this admission, the patient’s blood culture demonstrated S. maltophilia which was likely from the complications of CIEDs placement.ConclusionEarly‐onset Atrial fibrillation in young population may be a feature of CVID. Early recognition of CVID in these patients, especially with comorbidity of CHF, can mitigate the progression of AF with antioxidants as well as promptly identify and manage CIEDs‐associated infections, such as S. maltophilia.Figure 1

Impact on All-Cause and Cardiovascular Mortality of Cardiac Implantable Electronic Device Complications: Results From the POINTED Registry.

This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up. Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality. The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation. During follow-up (median 56.9months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death. All CIED-related complications are associated with an increased risk of cardiovascular mortality, andearly complications are associated with an increased risk of all-cause mortality. These data underline the importanceof specific measures aimed at reducing CIED complications and improving their management.

To abandon or not to abandon: Late consequences of pacing and ICD lead abandonment.

The increasing number of cardiac implantable electronic device complications represents a current problem. Abandoned leads are difficult to manage, even because indications to transvenous lead extraction (TLE) cannot be generalized. The aim of the study was to assess the late consequences of previous abandoned leads. We did a retrospective analysis of clinical data from 3,810 patients undergoing TLE in two high-volume centers (Poland and Italy) in the years 2006-2017. In order to evaluate the effects of lead abandonment, the patients were divided into a group of 582 (15.3%) subjects with abandoned leads (AL) and a group of 3,228 (84.7%) subjects with functional leads (FL). Infective indications to TLE were predominant in the AL group (61.34%vs 43.4%; P<0.001). AL was associated with a higher number of leads per patient, longer lead dwell times, more frequent venous occlusion, higher probability of intracardiac lead abrasion, and tricuspid regurgitation (P<0.001 for all factors). The presence of AL was connected with more frequent technical complications of TLE (odds ratio [OR] 1.617; confidence interval [CI] 1.412-1.852; P=0.000), lower procedural success rate (OR 0.270; CI 0.199-0.363; P=0.000), and with higher mortality rate during 3.518 years of follow-up [hazard ratio 1.286; 95% CI (1.062-1.558), P=0.010]. Presence of previously abandoned leads was associated with the risk of device infections, technical problems during subsequent lead extraction, dysfunction of tricuspid valve, and worse long-term outcomes.

Efficacy and safety of transvenous lead extraction in 108 consecutive patients: a single-centre experience.

The number of cardiac implantable electronic devices is growing worldwide because they play a relevant role in improving the survival rate in patients with specific heart diseases. Cardiac implantable electronic devices complications including infection, dysfunction or venous stenosis increase the need for the least traumatic way to explant leads. Our goal was to report the successes and procedural complication rates of transvenous lead extraction (TLE) in a consecutive series of patients. From 2010 to 2016, 108 patients underwent TLE of 227 leads due to endocarditis (n = 21; 19%), pocket infection (n = 58; 54%) or lead dysfunction (n = 29; 27%). In 98% (n = 106) of the patients, laser-assisted lead extraction was performed. In 2% (n = 2) of the patients, the application of a solitary locking stylet was sufficient. The patient mean age was 68 ± 14 years; 25% of the patients had previous cardiac surgery. TLE was performed a mean of 9 ± 6 years after the implantation of the existing device. Complete procedural success (removal of all lead material from the vascular space) was achieved in 98.7% (n = 224), and clinical success (achievement of all clinical goals associated with the indication for lead removal and absence of major complications) was achieved in 98% (n = 106). In 2 patients the procedure failed due to a vascular tear requiring a thoracotomy. In 1 patient, complete lead extraction was not possible due to heavy calcification (coronary-sinus lead). The 30-day mortality rate was 3.7% (n = 4); the patients died of multiorgan failure (n = 1), cardiac failure (n = 1) and septicaemia (n = 2). The procedure-related major complication rate was 2% (n = 2). Laser-assisted TLE seems to be a safe and effective procedure with an acceptable complication rate.

Use of Administrative Data to Monitor Cardiac Implantable Electronic Device Complications

Cardiac implantable electronic devices (CIEDs) are increasingly used in the Canadian population, because of expanding indications and an aging population. Device-related complications are a source of morbidity and mortality. There is currently no comprehensive monitoring strategy of CIED-related complications in Canada. The objective of this study was to determine the utility of administrative data in tracking CIED complications. This was a retrospective observational study in patients with newly implanted pacemakers, pacemaker system revisions, and implantable cardioverter defibrillators (ICDs) from 2011 to 2014. The study was performed at a single academic centre in Nova Scotia. A comprehensive chart review was used as the gold standard for device-related complications. This was compared with the reporting of complications identified in the Canadian Institute for Health Information Discharge Abstract Database and the National Ambulatory Care Reporting System Database (NACRS). Sensitivity and specificity of Canadian Institute for Health Information/NACRS was reported. There were 1327 patients included in the study (742 pacemakers, 585 ICDs). The rate of complications in the pacemaker population was 8.0%; the sensitivity of Discharge Abstract Database/NACRS for detection of these was 83.1%, and specificity 100%. The rate of complications in the ICD population was 12.0%, with a sensitivity of 92.1%, and specificity 100%. Thirty-day mortality was 1.8% in the pacemaker population, and 0.3% in the ICD population. This study provides feasibility for use of administrative data for detection of device-related complications, showing reasonable sensitivity and excellent specificity. Further work to determine generalizability of these data across Canada is required to ensure accurate monitoring of device-related complications.

P420The cost of virgin cardiac implantable electronic device complications from implant to 1 year

P420The cost of virgin cardiac implantable electronic device complications from implant to 1 year

12 Cardiac implantable electronic devices complications – a single centre experience

Background Indications for cardiac implantable electronic devices including pacemakers, cardiac resynchronization therapy and implantable cardiac defibrillators are increasingly expanding, however complications associated with these devices are associated with increased patient morbidity and healthcare consumption. Population based data from Denmark has shown a higher complication rate (9.5%) than previously identified in clinical trials. 1 Objectives We aimed to assess our departmental complication rate for cardiac implantable electronic devices and conduct a cost analysis of our complications. Methods A retrospective review all patients (n = 397) who underwent new implantation, upgrade or generator change of any cardiac implantable electronic device from January to December 2014 was carried out. Review of out-patient and in-patient records, together with review of Heart Rhythm Ireland data allowed completion of a standardised set of data elements for each patient. Statistical analysis was carried out using SPSS. Results Baseline characteristics for our population are shown in Table 1. Our overall complication rate was 10.83%, which is in keeping with the population based data from the Danish group Table 2. Additional hospital bed days cost €187,962. Conclusion Our complication rate is higher than those reported in clinical trials, however is in keeping with the rates in the large Danish population based study. Cardiac implantable device complications lead to significant cost implications, with our data to date only accounting for the cost of hospital bed nights based on the most recent audited data from our institution. Further work will be carried out to assess the cost of investigations and procedures resulting from our cardiac implantable electronic device complications.

Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark

AimsComplications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality.Methods and resultsPopulation-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1–1.6), underweight (aRR 1.5; 1.1–2.3), implanted in a centre with an annual volume <750 procedures (0–249 procedures: aRR 1.6; 1.1–2.2, 250–499: aRR 2.0; 1.6–2.7, 500–749: aRR 1.5; 1.2–1.8), received a dual-chamber ICD (aRR 2.0; 1.4–2.7) or CRT-D (aRR 2.6; 1.9–3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0–1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4–2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0–2.3).ConclusionCIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment.