Implantable Cardioverter-defibrillator Infection Research Articles

Complications of Implantable Cardioverter Defibrillator and Their Potential Risk Factors in Patients with Hypertrophic Cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) has different complications such as cardiac arrhythmia and sudden cardiac death (SCD). Insertion of an implantable cardioverter defibrillator (ICD) is recommended for HCM patients who are at high risk of SCD and malignant arrhythmias, despite having their own potential complications. Hypothesis. We aimed to investigate the prevalence of different complications of ICD insertion and the impact of the potential influential baseline characteristics in a one-year follow-up period. This was a retrospective study with a total of 71 HCM patients with ICD insertion. We evaluated the prevalence of different complications of ICD implantation and the impact of baseline characteristics on the occurrence of ICD complications using multivariate regression analysis in three 4-month periods. In a one-year follow-up, 13 patients (18.3%) experienced at least one of the complications including pneumothorax, lead failure, ICD infection, inappropriate shocks, perforation, and upper limb deep vein thrombosis (DVT) with no mortality. Inappropriate shocks were reported as the most common (11.3%) complication during this period, with a gradual increase in the second (4.2%) and third (5.6%) follow-up sessions. Among all of the baseline characteristics that were investigated in this study, a positive history of hypertension was the only risk factor with significant impact on the occurrence of complications (P = 0.01). We demonstrated the occurrence of complications during a one-year follow-up as 18.3% in HCM patients with ICD insertion. A positive history of hypertension was the only baseline characteristic affecting the occurrence of complications, and inappropriate shocks were the most common complication.

Subcutaneous versus transvenous implantable cardioverter-defibrillator among drug-induced type-1 ECG pattern Brugada syndrome: a propensity score matching analysis from IBRYD study

No real-world data are available about the complications rate in drug-induced type 1 Brugada Syndrome (BrS) patients with an implantable cardioverter-defibrillator (ICD). Aim of our study is to compare the device-related complications, infections, and inappropriate therapies among drug-induced type 1 BrS patients with transvenous- ICD (TV-ICD) versus subcutaneous-ICD (S-ICD). Data for this study were sourced from the IBRYD (Italian BRugada sYnDrome) registry which includes 619 drug-induced type-1 BrS patients followed at 20 Italian tertiary referral hospitals. For the present analysis, we selected 258 consecutive BrS patients implanted with ICD. 198 patients (76.7%) received a TV-ICD, while 60 a S-ICD (23.4%). And were followed-up for a median time of 84.3 [46.5–147] months. ICD inappropriate therapies were experienced by 16 patients (6.2%). 14 patients (7.1%) in the TVICD group and 2 patients (3.3%) in S-ICD group (log-rank P = 0.64). ICD-related complications occurred in 31 patients (12%); 29 (14.6%) in TV-ICD group and 2 (3.3%) in S-ICD group (log-rank P = 0.41). ICD-related infections occurred in 10 patients (3.88%); 9 (4.5%) in TV-ICD group and 1 (1.8%) in S-ICD group (log-rank P = 0.80). After balancing for potential confounders using the propensity score matching technique, no differences were found in terms of clinical outcomes between the two groups. In a real-world setting of drug-induced type-1 BrS patients with ICD, no significant differences in inappropriate ICD therapies, device-related complications, and infections were shown among S-ICD vs TV-ICD. However, a reduction in lead-related complications was observed in the S-ICD group. In conclusion, our evidence suggests that S-ICD is at least non-inferior to TV-ICD in this population and may also reduce the risk of lead-related complications which can expose the patients to the necessity of lead extractions.

Rate, Time Course, and Predictors of Implantable Cardioverter Defibrillator Infections: An Analysis From the SIMPLE Trial

BackgroundThe number of implantable cardioverter defibrillator (ICD) infections is increasing due to an increased number of ICD implants, higher-risk patients, and more frequent replacement procedures, which carry a higher risk of infection. Reducing the morbidity, mortality, and cost of ICD-related infections requires an understanding of the current rate of this complication and its predictors. MethodsThe Shock Implant Evaluation Trial (SIMPLE) trial randomized 2500 ICD recipients to defibrillation testing or not. Over an average of 3.1 years, patients were seen every 6 months and examined for evidence of ICD infection, which was defined as requiring device removal and/or intravenous antibiotics. ResultsWithin 24 months, 21 patients (0.8%) developed infection. Fourteen patients (67%) with infection presented within 30 days, 20 patients by 12 months, and only 1 patient beyond 12 months. Univariate analysis demonstrated that patients with primary electrical disorders (3 patients, P = 0.009) and those with a secondary prevention indication (13 patients, P = 0.0009) were more likely to develop infection. Among the 2.2% of patients who developed an ICD wound hematoma, 10.4% developed an infection. Among the 8.3% of patients requiring an ICD reintervention, 1.9% developed an infection. ConclusionsThis cohort of ICD recipients at high-volume centres have a low risk of device-related infection. However; strategies to reduce wound hematoma and the need for ICD reintervention could further reduce the rate of infection.

Subcutaneous implantable cardioverter-defibrillator infection affecting deep tissues: is it always mandatory to remove the device?

Subcutaneous implantable cardioverter-defibrillator infection affecting deep tissues: is it always mandatory to remove the device?

INTRAPOCKET APPLICATION OF VANCOMYCIN POWDER IN PREVENTION OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INFECTION

Infection is a serious complication of implantable cardioverter defibrillator (ICD) and is associated with significant morbidity and mortality. In retrospective cohort studies, the rate of ICD infections has ranged from 1.2 to 3.2 percent. We sought to determine the efficacy of intrapocket

The wearable cardioverter defibrillator as a bridge to reimplantation in patients with ICD or CRT-D-related infections

BackgroundThe approach to treat device infection in patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) is a challenging procedure. Optimal treatment is complete extraction of the infected device. To protect these patients from sudden cardiac arrest while waiting for reimplantation and to avoid recurrent infection, a wearable cardioverter defibrillator (WCD) seems to be a valuable solution.Therefore, we investigated the management and outcome of patients with ICD or CRT-D infections using the WCD as a bridge to re-implantation after lead extraction procedures.MethodsWe conducted a retrospective study on consecutive patients who underwent ICD or CRT-D removal due to device-related local or systemic infections. All patients were prescribed a WCD at our center between 01/2012 and 10/2015. All patients returned to our outpatient clinic for regular ICD or CRT-D monitoring initially 1 and 3 months after reimplantation followed by 6-months intervals.ResultsTwenty-one patients (mean age 65.0 ± 8.0 years, male 76.2%) were included in the study. Complete lead extraction was achieved in all patients. While waiting for reimplantation one patient experienced a symptomatic episode of sustained ventricular tachycardia. This episode was converted successfully into sinus rhythm by a single 150 J shock.Mean follow-up time 392 ± 206 days, showing survival rate of 100% and freedom from reinfection in all patients.ConclusionThe WCD seems to be a valuable bridging option for patients with ICD or CRT-D infections, showing no recurrent device infection.

Successful transjugular extraction of a lead in front of the anterior scalene muscle by using snare technique

The incidence of cardiovascular implantable electronic device infection is increasing. We report a case of and successful device removal in a 79-year-old man with implantable cardioverter-defibrillator infection. Right phrenic nerve paralysis was evident on chest radiography. The lead was in front of the anterior scalene muscle, close to the left phrenic nerve. Therefore, extraction carried a risk of bilateral phrenic nerve paralysis. The lead was successfully extracted from the right internal jugular vein by using the snare technique. No complications occurred, and the extraction was successful.

Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry.

The rate of implantable cardioverter-defibrillator (ICD) infections has been increasing faster than that of implantation. We sought to determine the rate and predictors of ICD infection in a large cohort of Medicare patients. Cases submitted to the ICD Registry from 2006 to 2009 were matched to Medicare fee-for-service claims data using indirect patient identifiers. ICD infections occurring within 6 months of hospital discharge after implantation were identified by ICD-9 codes. Logistic regression was used to examine factors associated with risk of ICD infection. Of 200 909 implants, 3390 patients (1.7%) developed an ICD infection. The infection rate was 1.4%, 1.5%, and 2.0% for single, dual, and biventricular ICDs, respectively (P<0.001). Generator replacement had a higher rate compared with initial implant (1.9% versus 1.6%, P<0.001). The factors associated with infection were adverse event during implant requiring reintervention (odds ratio [OR], 2.692; 95% confidence interval [CI], 2.304-3.145), previous valvular surgery (OR, 1.525; 95% CI, 1.375-1.692), reimplantation for device upgrade, malfunction, or manufacturer advisory (OR, 1.354; 95% CI, 1.196-1.533), renal failure on dialysis (OR, 1.342; 95% CI, 1.123-1.604), chronic lung disease (OR, 1.215; 95% CI, 1.125-1.312), cerebrovascular disease (OR, 1.172; 95% CI, 1.076-1.276), and warfarin (OR, 1.155; 95% CI, 1.060-1.257). Patients who developed an ICD infection were more likely to have had peri-ICD implant complications requiring early reintervention, previous valve surgery, device replacement for reasons other than battery depletion, and increased comorbidity burden. Efforts should be made to carefully consider when to reenter the pocket at any time other than battery replacement.

Comparison of Mortality in Women Versus Men With Infections Involving Cardiovascular Implantable Electronic Device

Device infection is a complication of implantable cardioverter-defibrillator (ICD) therapy that significantly increases mortality. Risk factors associated with death and ICD infection are poorly understood. The purpose of this study was to identify patient characteristics associated with death after cardiovascular implantable electronic device (CIED) infection. This is a retrospective cohort study of 64,903 Medicare fee-for-service patients who received an ICD in 2007, including 1,855 with device infection. Long-term survival was significantly reduced with CIED infection (71.6% vs 85.0%, p <0.001). Regression analysis accounting for age, race, gender, and 28 co-morbidities identified only 2 patient characteristics associated with decreased long-term survival with CIED infection: female gender and human immunodeficiency virus/acquired immunodeficiency syndrome. In patients with CIED infection, women had substantially reduced long-term survival compared with men (67.3% vs 72.9%, p <0.02). The risk-adjusted hazard ratio for long-term mortality with device infection in women compared with that in men increased significantly from 0.86 (95% confidence interval [CI] 0.82 to 0.91) to 1.25 (95% CI 1.02 to 1.53), corresponding to a risk increase of >45%. Importantly, a substantial portion of this excess mortality occurred after the index admission for infection, when the hazard ratio for death in women compared with that in men increased from 0.86 (95% CI 0.82 to 0.91) to 1.20 (95% CI 0.96 to 1.51) with CIED infection, despite little gender difference in admission length of stay, disposition, and cost. In conclusion, women are significantly more likely than men to die with CIED infection. A substantial part of this excess mortality occurs after discharge. It will be important to identify and address the cause(s) of this gender difference in mortality.

Erratum to: Risk factors associated with early- versus late-onset implantable cardioverter-defibrillator infections

Erratum to: Risk factors associated with early- versus late-onset implantable cardioverter-defibrillator infections

Risk factors associated with early- versus late-onset implantable cardioverter-defibrillator infections

The infection rates of implantable cardioverter-defibrillators systems (ICDs) are higher than that of permanent pacemaker. Risk factors associated with ICD infection have not been characterized and are the subject of the current investigation. All patients who had an ICD implanted at Mayo Clinic Rochester between 1991 and 2008 were retrospectively reviewed. Each case of ICD infection was matched with two non-infected controls. Cases of ICD infection were further stratified by early- (≤ 6 months) versus late-onset (>6 months) infection. Multivariable analysis was performed to identify significant risk factors for ICD infection. Sixty-eight patients with ICD infection and 136 matched controls met the inclusion criteria. Thirty-five cases presented with early-onset infection and 33 had late-onset device infection. Staphylococcal species were the most common pathogens in both groups of patients. Patients with early-onset infection were more likely to present with generator pocket infection (p = 0.02). Patients with multiple comorbid conditions (high Charlson index) tended to have longer hospital stay during implantation admission (p = 0.009). In a multivariable logistic regression model, the presence of epicardial leads (odds ratio (OR) = 9.7, p = 0.03) and postoperative complications at the generator pocket (OR = 27.2, p < 0.001) were significant risk factors for early-onset ICD infection, whereas longer duration of hospitalization at the time of implantation (2 days versus 1 day: OR = 33.1, p < 0.001; ≥ 3 days versus 1 day: OR = 49.0, p < 0.001) and chronic obstructive pulmonary disease (OR = 9.8, p = 0.02) were associated with late-onset infections. Our study findings suggest that risk factors associated with early- and late-onset ICD infection are different. While circumstances that may increase the chances of pocket contamination in the perioperative period are more likely to be associated with early-onset ICD infection, overall poor health of the host may increase the likelihood of late-onset ICD infection. These factors should be considered when developing strategies to minimize risk of device infection.

Bacteriology of infected extracted pacemaker and ICD leads

Pacemaker and implantable cardioverter defibrillator infections, when not treated, lead to serious consequences. The aim is to identify the prevalent strains of the responsible bacteria to guide an effective therapy. Between May 2003 and April 2008, 118 leads were extracted from 61 patients, with chronic draining sinus, pocket infection, pacemaker endocarditis, or sepsis. Following extraction, samples of the leads underwent cultural and antibiogram examination. Staphylococcus epidermidis was the most frequently isolated bacterial strain (37.7%), followed by Gram-positive flora (16.1%), Staphylococcus aureus (14.3%), Candida parapsilosis (5.4%), Staphylococcus schleiferi (5.4%), Corynebacterium species, and Staphylococcus hominis (3.6%). Cultures were negative in 14.3% of the samples. Retained sensitivity to antibiotics were reported as follows: teicoplanin/vancomycin 100%, doxicyclin 96%, amikacin 94%, piperacillin-tazobactam 58%, cotrimoxazole 78%, gentamycin 65%, quinolones 47%, rifampicin 44%, cephalosporins 25%, and oxacillin 25%. Within staphylococci, involved in about 60% of the infections, S. hominis and S. epidermidis showed the highest antibiotic resistance. In case of sepsis, sensitivity was retained for glycopeptides and amikacin (about 100%), and to a lower degree for doxicyclin (80%). Arbitrarily stratifying into recent (<3 months) and chronic (>3 months) infections, an increase in time prior to referral for lead extraction was associated with a significant increase in antibiotic resistance. Bacteria associated with pacemaker and implantable cardioverter defibrillator-related infections, staphylococci in about 60% of the cases, show poor susceptibility to antibiotics, presenting three out of four methicillin-resistant features. Therefore, systemic antibiotics, mainly glycopeptides, must not be delayed awaiting the complete removal of the implanted system.

Infection after ICD implantation: operating room versus cardiac catheterisation laboratory.

Since the insertion of an implantable cardioverter-defibrillator (ICD) has become technically comparable to pacemaker implantation, these procedures are increasingly being performed in a cardiac catheterisation laboratory (CCL) instead of the operating room (OR). This study aims to describe the relationship between incidence of ICD infection and procedure setting and to describe the characteristics of ICD infection. A retrospective study was performed of first ICD implantation in 677 patients admitted to our hospital between 1996 and 2006. Implantations were performed in the OR until 2003, after 2003 they were carried out in the CCL. The follow-up was censored at one year after implantation. ICD infections were defined as pocket infection or ICD-related endocarditis and a descriptive analysis was performed. Cardiothoracic surgeons implanted 366 ICDs in the OR Electrophysiologists performed 301 implantations in the CCL. Pulse generators were inserted using a pectoral approach with transvenous lead systems. We identified seven ICD infections (incidence rate 1.2/100 person-years), three of which had been implanted in the OR and four in the CCL. In this single-centre study no difference in the incidence of ICD infection was observed between implantation in OR and CCL. However, a larger study will be necessary to rule out a relationship with certainty. (Neth Heart J 2009;17:95-100.).

Infective Endocarditis Complicating Permanent Pacemaker and Implantable Cardioverter-Defibrillator Infection

To describe management of patients with permanent pacemaker (PPM)- and implantable cardioverter-defibrillator (ICD)-related endocarditis. We retrospectively reviewed all cases of infection involving PPMs and ICDs among patients presenting to Mayo Clinic's site in Rochester, MN, between January 1, 1991, and December 31, 2003. Cardiac device-related infective endocarditis (CDIE) was defined as the presence of both vegetation on a device lead or valve and clinical or microbiological evidence of CDIE. Of 189 patients with PPM or ICD infection who were admitted during the study period, 44 met the case definition for CDIE (33 PPM, 11 ICD). The mean +/- SD age of patients was 67 +/- 14 years. Staphylococci (36 [82%]) were the most commonly isolated pathogens. Nearly all patients (43 [98%]) were treated with a combined approach of complete hardware removal and parenteral antibiotics. The median duration of antibiotic treatment after infected device explantation was 28 days (interquartile range, 19-42 days). Device leads were removed percutaneously in 34 cases (77%); only 7 cases (16%) required surgical lead extraction. Percutaneous extraction was uncomplicated in 15 patients with lead vegetation greater than 10 mm in diameter. Six patients (14%) died during hospitalization. Twenty-seven (96%) of 28 patients remained infection free at their last visit (median follow-up, 183 days; intraquartile range, 36-628 days). Prompt hardware removal and prolonged parenteral antibiotic administration decrease mortality among patients with CDIE. The presence of a large (> 10 mm in diameter) vegetation on a lead is not a contraindication for percutaneous lead extraction.

Implantable cardioverter-defibrillator infection due to Scedosporium apiospermum

We report a case of implantable cardioverter-defibrillator infection due to Scedosporium apiospermum. This infection persisted despite systemic antifungal treatment with voriconazole and was controlled after removal of the foreign device and replacement of the involved tricuspid valve. This case underscores the importance of a combined surgical and medical approach for this complicated infection. Scedosporium species should be considered in the differential diagnosis of cardiac or intravascular device-related infections.

Implantable Cardioverter-Defibrillator Infection Due to Brucella melitensis: Case Report and Review of Brucellosis of Cardiac Devices

We report a case of implantable cardioverter-defibrillator infection due to Brucella melitensis and review 5 previously reported cases of Brucella infection of cardiac devices. Device removal, followed by antibiotic therapy for 6 weeks, is probably required for cure. Although rare, reports of Brucella infection of prosthetic implants and devices have increased in the past decade. Brucellosis should be considered in the differential diagnosis of cardiac device infection in patients residing in or traveling to areas of endemicity.

Frequency of Permanent Pacemaker or Implantable Cardioverter-Defibrillator Infection in Patients with Gram-Negative Bacteremia

Despite the frequent occurrence of bacteremia due to gram-negative organisms in patients with underlying permanent pacemakers (PPMs) or implantable cardioverter defibrillators (ICDs), the outcome and treatment of these patients has received scant attention. In patients with PPMs or ICDs who have Staphylococcus aureus bacteremia, 45% have PPM/ICD infection. We conducted a retrospective cohort study over a 7-year period to assess the clinical features and frequency of PPM/ICD infection in patients with gram-negative bacteremia, as well as the incidence of relapse in patients for whom the device was not removed. Forty-nine patients were included in the study; 3 (6%) had either definite (2 patients) or possible (1 patient) PPM/ICD infection. Both patients with definite PPM/ICD infection had clear infection of the generator pocket. None of the other patients with alternate sources of bacteremia developed PPM/ICD infection. Thirty-four patients with retained PPM/ICD were observed for >12 weeks (median time, 759 days), and 2 (6%) developed relapsing bacteremia, although they each had alternative sources of relapse. In sharp contrast to S. aureus infection, PPM/ICD infection in patients with gram-negative bacteremia was rare, and no patients appeared to have secondary PPM/ICD infection due to hematogenous seeding of the system. Despite infrequent system removal in these patients, relapsing bacteremia among patients who survived initial bacteremia was rarely seen. If secondary PPM/ICD infection occurs in patients with gram-negative bacteremia, it is either uncommon or it is cured with antimicrobial therapy despite device retention.

Long-term infection rates associated with the pectoral versus abdominal approach to cardioverter- defibrillator implants

Infection is an uncommon (0% to 6.7%) but serious complication after implantable cardioverter-defibrillator (ICD) implantation. All ICD primary implants, replacements, or revisions performed at the Massachusetts General Hospital between April 1983 and May 1999 were reviewed. A total of 21 ICD-related infections (1.2%) were identified among 1,700 procedures affecting 1.8% of the 1,170 patients who underwent a primary implant, a generator change, or a revision of their systems. The mean follow-up time was 35 ± 33 months. Of the 959 patients with long-term follow-up, 19 of the 584 patients (3.2%) with abdominal and 2 of the 375 patients (0.5%) with pectoral systems developed ICD-related infections (p = 0.03). There was no significant difference between the infection rate among the 959 primary ICD implants and the 447 replacements or system revisions. Only 5 of the patients (24%) had systemic signs of infection, including fever (T>100.5) and elevated white blood count >12,000. Cultures from the wound revealed staphylococcal species in 16 patients (76%). Nineteen patients were treated with removal of the entire ICD system in addition to intravenous antibiotics for 2 to 4 weeks. A decrease in the incidence of ICD-related infection has occurred since the advent of transvenous pectoral systems. The main organism responsible for ICD infection is Staphylococcus. The mainstay of ICD infection management consists of complete removal of the entire implanted system.

Simplified Implantation of Single-Lead Pectoral Cardioverter Defibrillators Using Device-Based Testing

Device-based testing of single-lead pectoral defibrillators (defibrillation efficacy testing without an external defibrillation system after complete implantation of the device) resulted in an adequate defibrillation threshold (< or = 20 J) in 45 of 50 study patients (90%). Mean surgical implantation time (skin to skin) was 62 +/- 29 minutes without perioperative mortality and without implantable cardioverter defibrillator infection during follow-up. Thus, device-based testing appears to be a simple and safe method to test defibrillation efficacy of single-lead pectoral defibrillators.

The treatment of patients with infected implantable cardioverter-defibrillator systems

Objective: The purpose of this study was to evaluate the treatment of patients with infected implantable cardioverter-defibrillator systems. Methods: Retrospective analysis was done of the cases of 21 patients treated for implantable cardioverter-defibrillator infection during an 11-year period. Results: Of 723 cardioverter-defibrillator implantations (550 primary implants, 173 replacements), nine (1.2%) were complicated by early postoperative device-related infections. Late infections developed in two patients 19 and 22 months, respectively, after implantation. Ten other patients were transferred to our institution for treatment of cardioverter-defibrillator infection. The time from implantation to overt infection was 2.2 ± 1.3 months, excluding the two late infections. The responsible organisms were Staphylococcus aureus (9), Staphylococcus epidermidis (6), Streptococcus hemolyticus (1), gram-negative bacteria (3), Candida albicans (1), and Corynebacterium (1). All patients were treated with intravenous antibiotic drugs. Total system removal was done in 15 patients and partial removal in 2; in 4, the cardioverter-defibrillator system was not explanted. There were no perioperative deaths. A new implantable cardioverter-defibrillator system was reimplanted in 7 patients after 2 to 6 weeks of antibiotic therapy. Ten patients were treated without reimplantation (2 arrhythmia operation, 8 antiarrhythmic drugs). Four patients (3 patients without explantation and 1 with partial system removal) were treated with maintenance long-term antibiotic therapy. During a mean follow-up of 21 ± 2.8 months, no patient had clinical recurrence of infection. One patient treated with antiarrhythmic drugs without system reimplantation died suddenly. Conclusions: Infections that involve implantable cardioverter-defibrillator systems can be safely managed by removing the entire system with reimplantation after intravenous antibiotic therapy. In selected patients in whom the risk for system explantation is high and anticipated life expectancy is short, long-term antibiotic therapy to suppress low-virulence infections may represent an acceptable alternative. (J Thorac Cardiovasc Surg 1997;113:121-9)