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Background: Although the subcutaneous ICD (S-ICD®) is an attractive alternative in patients with end-stage renal disease (ESRD), data on S-ICD outcomes in dialysis patients are lacking., Methods: Patients with cardiomyopathy undergoing S-ICD implantation in our center were stratified by need for chronic dialysis at the time of implant. The primary endpoint was incidence of death, heart failure hospitalization or appropriate S-ICD shocks, and secondary endpoints were incidence of inappropriate shocks or implant related complications requiring surgical re-intervention. Mean follow-up was longer in the nondialysis cohort (514 ± 495 vs. 227 ± 233 days, P = 0.006), so all endpoints were analyzed using time-dependent comparisons and reported as annual event rates., Results: Out of 79 S-ICD implants included in this analysis, 27 patients were on dialysis. Dialysis patients were older and more likely to be diabetic. Mean ejection fraction across the entire cohort was 26.9% without significant difference between dialysis and nondialysis groups. Although not significant, the incidence of the primary endpoint was higher in the dialysis cohort (23.8%/year vs. 10.9%/year, P = 0.317), driven primarily by a higher rate of appropriate shocks. The rate of inappropriate shocks was similar between groups (dialysis 6.0%/year vs. nondialysis 6.8%/year, P = 0.509). No patients in the dialysis cohort had complications requiring surgical re-intervention versus 6 patients in the nondialysis cohort (P = 0.086)., Conclusions: Our data suggest that S-ICD implantation in dialysis patients is not associated with an excess risk of implant related complications or inappropriate shocks., (© 2015 Wiley Periodicals, Inc.)

Background: The Sprint Fidelis (SF) and the Riata (RT) implantable cardioverter-defibrillator leads have been recalled for premature failure., Objective: Data on SF and RT extractions are limited; therefore, we performed a pooled analysis to compare the safety and efficacy of lead extraction for the SF and RT lead families., Methods: We retrospectively reviewed consecutive patients undergoing transvenous extraction of SF and RT leads at Emory University and the University of Pittsburgh Medical Center from January 2007 to October 2013. Patients were placed into 2 groups based on the presence of an SF or RT lead. The primary endpoint was a major procedural complication, defined as death, need for urgent cardiac surgery, and hemopericardium or hemothorax that required an intervention., Results: A total of 462 patients underwent extraction of recalled leads (SF, n = 360; RT, n = 102). The mean number of leads extracted in the RT group was higher than in the SF group (1.8 ± 0.9 vs 1.3 ± 0.7, P < .001), and there was a longer implantation time in the RT group (5.5 ± 2.5 vs 4.3 ± 2.0 years, P < .001). Complete procedural success was higher in the SF group (99.4% vs 96.1%, P =.024). Clinical success was similar (SF 99.4% vs RT 97.1%, P = .075). There were 6 major procedural complications in the entire cohort (1.3%). The rate of major complications was not different between the SF and RT groups (SF 1.1% vs RT 2.0%, P = .618). Total mortality was 0.65%, with no difference between the groups, Conclusion: Our data from 2 high-volume centers suggest that extraction of SF and RT leads is associated with excellent clinical success and a similar rate of major procedural complications., (Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The Medtronic Sprint Fidelis defibrillator lead is at an increased risk for failure and was recalled in October 2007. Approximately 268,000 leads were implanted, and more than 100,000 patients still have active Fidelis leads. A number of studies have examined the rate and clinical predictors of lead failure, but none has addressed the effect of an implantable cardioverter-defibrillator generator exchange on subsequent lead failure. Although the manufacturer asserts that "Sprint Fidelis performance after device change-out is similar to lead performance without device change-out," published data are lacking., Objective: To assess the effect of implantable cardioverter-defibrillator generator exchange on the rate of Fidelis lead failure., Methods: A chart review was conducted in patients who underwent implantation of a Fidelis lead. Patients with a functioning Fidelis lead at generator exchange were compared with controls with leads implanted for a comparable amount of time not undergoing ICD replacement., Results: A total of 1366 patients received a Fidelis lead prior to the recall, of which 479 were still actively followed. Seventy-two patients with a functioning lead underwent generator exchange without lead replacement. Following generator replacement, 15 leads failed. Sixty percent of the Fidelis leads failed within 3 months. Generator exchange increased the rate of lead failure compared with matched controls (20.8% vs 2.54%; P < .001)., Conclusions: Generator exchange is associated with a higher than expected rate of Fidelis lead failure, often within 3 months. The risk-benefit ratio of Fidelis lead replacement at the time of generator exchange may be greater than appreciated., (Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Pacemakers and implanted cardioverter defibrillator (ICD) infection rates are rising. Renal insufficiency impairs immune function and is known to increase the risk of infection following implantation of orthopedic hardware. The purpose of the current study is to characterize the risk factors for pacemaker and ICD infection and to evaluate the role of renal insufficiency in this complication., Methods and Results: A large (n = 4,856) single center experience with pacemaker and ICD procedures was reviewed. Of these, 141 were extractions of infected devices and 76 of these patients had been implanted in the Emory system and had preimplant creatinine information available for analysis. These cases were compared to 76 control patients undergoing device implantation matched by date of implant who had no infective complications. Demographic and clinical data from both groups were compared using both univariate and multivariate analysis. The overall rate of infection was 1.5%. Patients with device infection were more likely to have congestive heart failure (CHF), be diabetic, have generator exchanges, and to take warfarin than controls. There was no difference in the prevalence of coronary disease, atrial fibrillation, steroid use, or malignancy between the two groups. Elevated creatinine (Cr > or = 1.5 mg/dL) was much more frequent in patients with infection than in controls (38% vs 12%, odds ratio 4.6, P < 0.001). Moderate to severe renal disease (GFR < or = 60 cc/min/1.73 m2) was the most potent risk factor for infection, with a prevalence of 42% in infected patients versus 13% in controls (odds ratio of 4.8)., Conclusions: Renal insufficiency dramatically increases the risk of infection complicating pacemaker or ICD surgery. This association should be part of the risk-benefit consideration prior to device implantation. Additional study of more extensive perioperative antibiotic therapy in this subset of patients is warranted.

Lead failure places patients with implantable cardioverter defibrillators (ICD) at risk for sudden cardiac death or results in delivery of inappropriate shocks. This study describes a mechanism of lead malfunction occurring at the junction of the terminal ring with the conductor coil of the rate sensing terminal connector in one specific model of a transvenous ICD lead. We detected the problem in a population of 179 patients with a mean age of 61 +/- 10 years and a mean lead implant duration of 16 +/- 11 months. All patients underwent pectoral ICD implantation using a submuscular approach. The implanting physician chose to place the ICD on the left side in 155 patients (87%) and on the right side in 24 patients (13%). Cephalic vein cutdown provided central venous access in 147 patients (82%), and subclavian vein puncture provided access in 32 patients (18%). Follow-up examination detected lead failure in six patients (3.5% over 31 months) due to insulation damage with or without conductor coil fracture at the junction of the terminal ring and conductor coil of the IS-1 rate sense terminal. We detected lead disruption 17 +/- 9 months (range 5-31 months) after implantation. Multiple nonsustained arrhythmia episodes exhibiting nonphysiologic intervals associated with noisy rate sensing electrograms during pocket manipulation led to discovery in three patients. The other three patients presented with inappropriate device discharges confirmed by stored high-energy lead electrograms showing normal rhythm. Pacing lead impedance abnormally dropped in two patients. Impedance remained stable in the other four patients. In conclusion, the generator pocket represents an important site of ICD transvenous lead vulnerability. Lead failure may result from conductor coil and/or insulation disruption at the interface with the rate sensing terminal connector.

Background: The miniaturization of implantable cardioverter defibrillators (ICDs) has made pectoral implantation possible. However, postoperative pain following the procedure has not been systematically studied. The aim of the current study was to prospectively assess patient discomfort and identify factors influencing pain perception during follow-up., Methods: Pain related to device implantation was quantified in 21 consecutive patients (age, 61 +/- 11 years; 17 men and 21 women; 16 of 21 had coronary artery disease; left ventricular ejection fraction, 32% +/- 15%) undergoing pectoral ICD implantation with conscious sedation (fentanyl 118 +/- 72 micrograms midazolam 14 +/- 9 mg). Patients completed the Visual Analogue Scale (VAS, 0-100) and the McGill Pain Questionnaire 24 hours and 1 month postoperatively. Regression analysis was used to define clinical and procedure related variables affecting patient discomfort and frequency of postoperative analgesic use., Results: The mean VAS score was 34 +/- 20 24 hours postoperatively. A single (4.8%) patient described postoperative pain as severe. Pain was reported to be moderate by 10 (47.6%) patients and mild by 10 (47.6%) patients. Intraoperative fentanyl requirement was a predictor of postoperative pain (R = 0.51, P = 0.036), and procedural duration was a strong predictor of postoperative analgesic use (R = 0.75, P < 0.001). Pain at 1 month decreased to a VAS score of 19 +/- 18 (P = 0.002 vs 24 hours) and was rated to be severe, moderate, and mild by 1, 3, and 17 patients, respectively. Late pain was related to a VAS score at 24 hours (R = 0.67, P = 0.004)., Conclusions: (1) Pectoral ICD implantation using conscious sedation is well tolerated. (2) Postoperative discomfort correlates with longer procedural times and larger intraoperative narcotic requirements.

Recent technological advances in implantable defibrillator systems (ICD) have changed implantation approaches. The aim of this study was to investigate the influence of these improvements on procedure times, implant-related charges, patient recovery, and morbidity. Ninety-six consecutive patients undergoing implantation of a nonthoracotomy ICD were studied. Implantation was performed under general anesthesia with the generator placed abdominally in 22 patients (group I) and pectorally in 40 patients (group II). Thirty-four patients underwent pectoral implantation using conscious sedation (group III). Groups were comparable with respect to clinical variables. Implantation duration and total procedure duration were shorter in group III (67 +/- 21 minutes and 117 +/- 30 minutes) when compared with group I (100 +/- 25 minutes and 157 +/- 39 minutes) and group II (86 +/- 24 minutes and 153 +/- 34 minutes, P < 0.05). Patients in group III did not require admission to the Post-Anesthesia Care Unit. In contrast, patients in groups I and II spent 92 +/- 28 minutes and 91 +/- 31 minutes in the Post-Anesthesia Care Unit. Implantation-related charges were reduced in patients having pectoral implantation using conscious sedation ($1451 +/- 217 vs. $2354 +/- 550 and $2796 +/- 384, P < 0.05). Patients in group III had a lower frequency of postoperative oral analgesic use (3.2 +/- 2.7 doses, P < 0.05) and a shortened post-operative length of stay (1.9 +/- 1.6 days, P < 0.05) when compared with groups I (5.7 +/- 4.0 doses and 3.3 +/- 1.4 days) and II (5.2 +/- 3.5 doses and 2.6 +/- 1.1 days). The overall complication rate was low (6.3%), with no differences between groups. Advances in ICD technology have simplified implantation, leading to shorter, less painful, and less expensive procedures.

The objective of this study was to assess the operative risk and efficacy of implantable defibrillators for preventing sudden death in patients with heart failure awaiting transplantation. The average waiting time for elective cardiac transplantation is 6 months to 1 year. Sudden cardiac death is the major source of mortality in outpatients in stable condition awaiting cardiac transplantation. The efficacy of implantable defibrillator therapy in this population is not established. We analyzed the operative risk, time to appropriate shock, and sudden death in 15 patients determined to be at high risk of sudden death who were accepted onto the outpatient cardiac transplant waiting list. Nonfatal postoperative complications occurred in two (13%) subjects with epicardial defibrillating lead systems and in none with transvenous lead systems. Defibrillation energies were 16 +/- 2 J versus 24 +/- 2 J with epicardial and transvenous lead systems, respectively. Sudden death free survival until transplantation was 93%. Most of the patients (60%) had an appropriate shock during a mean follow-up of 11 +/- 12 months. The mean time to an appropriate shock was 3 +/- 3 months. Hospital readmission was required in three (20%) subjects to await transplantation on an urgent basis. However, two of these subjects had received appropriate shocks before readmission. In selected patients at high risk for sudden death while on the outpatient cardiac transplant waiting list, the operative risk is low and adequate defibrillation energies can be obtained to allow implantable defibrillator placement. Most subjects will have an appropriate shock as outpatients before transplantation, and sudden death free survival is excellent.(ABSTRACT TRUNCATED AT 250 WORDS)