Pulmonary, Cardiovascular and Mechanical Complications of Implantable Cardioverter Defibrillators (ICDs) (original) (raw)
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Circulation: Arrhythmia and Electrophysiology, 2011
Background-Complications after implantable cardioverter-defibrillator (ICD) replacement are often clinically devastating, particularly when infection or reoperation occurs. Identifying factors contributing to complications may permit identification of high-risk individuals that warrant incremental monitoring and therapy to attenuate risk. In addition, replacement may be a discretionary decision in the context of an advisory or borderline device performance and patient, device, and implanter factors that predict adverse outcome may assist in clinical decision-making. Methods and Results-In a prospective, multicenter, population-based registry of all ICD patients at 18 centers in Ontario, Canada, we examined 45-day complication and all-cause mortality rates from February 2007 to August 2009 in patients undergoing ICD generator replacement. Complications were determined longitudinally and were categorized as major or minor. ICD replacement was performed in 1081 of 5176 patients (20.8%) undergoing ICD implantation (age, 64.3Ϯ12.7 years; 78.5% men). In patients undergoing ICD replacement, 47 patients (4.3%) had a complication within 45 days, with 47 major complications in 28 patients (2.6%), most commonly infection (nϭ23), lead revision (nϭ35), electrical storm (nϭ14), and pulmonary edema (nϭ13). Minor complications occurred in 2.3% of patients, most commonly incisional infection (nϭ10) and pocket hematoma (nϭ10). On multivariable analysis, risk factors associated with major complications were Canadian Cardiovascular Society angina class (adjusted hazard ratio [HR], 3.70 for class 2 to 4 versus 0 to 1; Pϭ0.027) and multiple previous procedures on the pocket (adjusted HR, 3.35 for Ͼ1 versus 1; Pϭ0.058). Risk factors associated with any complication were the use of antiarrhythmic therapy (adjusted HR, 6.29; Pϭ0.001), implanter volume (adjusted HR 10.4 for Ͻ60/y versus Ͼ120/y, Pϭ0.026), and Canadian Cardiovascular Society angina class (adjusted HR, 3.00 for class 2 to 4 versus 0 to 1; Pϭ0.031). In a Cox model with a time-dependent variable of major complication within 45 days after replacement, major complications after ICD replacement were associated with an increased risk of mortality at 45, 90, and 180 days (adjusted HR, 9.61, 12.69, and 6.41, respectively; Pϭ0.002 to 0.039). Conclusions-Risk factors associated with complications after ICD replacement include the presence of angina, antiarrhythmic therapy, increased number of previous procedures, and low implanter volume. Major complications may be associated with increased risk of subsequent mortality. (Circ Arrhythm Electrophysiol. 2011;4:136-142.) Key Words: implantable defibrillators Ⅲ complications Ⅲ outcomes research Ⅲ mortality Ⅲ quality of care I mplantable cardioverter-defibrillators (ICDs) have been shown to reduce mortality in patients at risk of sudden cardiac death in large randomized trials, both for primary and secondary prevention of sudden death. 1-5 Accordingly, these data have led to changes in ICD guidelines, expanding indications for implantation and increasing implantation rates. 6,7 Device replacement is generally technically less challenging than a new implant but is associated with complications that may place the patient at substantial risk, including system infection requiring complete extraction. 8-12 Factors that may contribute to development of Clinical Perspective on p 142 complications include patient factors, device/system characteristics, and physician factors.
Adverse Events With Transvenous Implantable Cardioverter-Defibrillators
Circulation, 1998
Background —A newly developed classification system relates adverse events to the surgical procedure or the function of the implantable defibrillator. Methods and Results —Adverse events were monitored during prospective clinical evaluation of the Medtronic model 7219 Jewel ICD and were classified according to the definitions of the ISO 14155 standard for device clinical trials into 3 groups: severe and mild device-related and severe non–device-related adverse events. In addition, events were related to the surgical procedure, treatment with the device, or cardiac function. Seven hundred seventy-eight patients were followed up for an average of 4.0 months after ICD implantation. In total, 356 adverse events were observed in 259 patients. At 1, 3, and 12 months after ICD implantation, 99%, 98%, and 97% of the patients, respectively, survived; 95%, 93%, and 92%, respectively, were free of surgical reintervention; and 79%, 68%, and 51%, respectively, were free of any adverse event. Twe...
Circulation, 2011
Background-Patients undergoing implantable cardioverter-defibrillator (ICD) implantation are at risk of postprocedural complications. However, we do not have a risk stratification schema to identify patients at high and low risk of adverse events. Methods and Results-We analyzed data from 268 701 ICD implants submitted to the ICD Registry and developed logistic regression models to identify variables most strongly associated with the risk of acute complications and/or in-hospital death. Overall, 3.2% of the population experienced an adverse event. A simple risk score consisting of 10 readily available variables successfully identified patients at high and low risk of complications. The variables included in the score and assigned points included: age Ն70 years (1 point), female (2 points), New York Heart Association class III (1 point) or IV (3 points), atrial fibrillation (1 point), prior valve surgery (3 points), chronic lung disease (2 points), blood urea nitrogen Ͼ30 (2 points), reimplantation for reasons other than battery change (6 points), ICD type dual chamber (2 points) or biventricular (4 points), and nonelective ICD implant (3 points). The risk of any in-hospital complication increased from 0.6% among patients with a score of Յ5 (8.4% of the population) to 8.4% among patients with Ն19 risk points (3.9% of the population). Conclusions-A simple risk score consisting of readily available clinical variables can identify high-and low-risk subsets of patients undergoing ICD implantation. This information can guide the physician in patient selection and determining the intensity of care required post procedure.
In-hospital complications associated with reoperations of implantable cardioverter defibrillators
The American journal of cardiology, 2014
Repeat implantable cardioverter defibrillator (ICD) procedures are increasing and may be associated with higher risks for complications. To provide more information for clinical decision making, especially in light of recent defibrillator advisories, we examined a large national cohort to characterize repeat ICD procedural outcomes. Using data from the National Cardiovascular Data Registry (ICD Registry), we compared patient characteristics, reasons for ICD implantation, and associated in-hospital adverse events among 92,751 patients receiving their first device and 81,748 patients who underwent repeat procedures with (n = 31,057) and without (n = 50,691) lead involvement. Hierarchical multivariable logistic regression was used to determine the predictors of in-hospital complications. Complication rates were higher in those who underwent repeat ICD procedures with lead involvement (lead implantation or revision), compared with patients who underwent initial implants (3.2% vs 2.6%, p...
The American Journal of Cardiology, 1995
Implantable cardioverter-defibrillators (ICDs) with nonthoracotomy lead systems are widely available, and are implanted either in the electrophysiology laboratory or the operating room. The purpose of this study was to prospectively evaluate the safety and efficacy of nonthoracotomy ICD implantation in an electrophysiology laboratory versus an operating room. During a 7-month period, 62 consecutive ICDs with nonthoracotomy lead systems were implanted in patients in an electrophysiology laboratory. During the next 10 months, 110 consecutive ICDs were implanted in patients in a surgical operating room. All ICD implantations were performed under general anesthesia by electrophysiologists. There were no differences in age (58 +/- 14 vs 62 +/- 12 years, p = 0.06), gender distribution (p = 0.3), frequency of structural heart disease (97% vs 97%, p = 0.9), ejection fraction (0.31 +/- 0.15 vs 0.29 +/- 0.13, p = 0.3), or presentation with cardiac arrest (65% vs 53%, p = 0.2) between patients undergoing ICD implantation in the electrophysiology laboratory and operating room, respectively. The rate of successful implantation and of complications for systems implanted in the electrophysiology laboratory (95% and 13%, respectively) and in the operating room (98% and 14%, respectively) were similar (p = 0.4 and p = 0.8, respectively). Specifically, the rate of infection (0% vs 4%, p = 0.3) and hematoma formation (2% vs 4%, p = 0.8) were not statistically significantly different. Three patients who had undergone ICD implantation in an operating room died within 30 days. ICDs with nonthoracotomy lead systems can be implanted with a similarly high rate of success and acceptable complication rate in the electrophysiology laboratory and in the operating room.
Journal of the American College of Cardiology, 2014
To better inform patients and physicians of the expected risk of adverse events and to assist hospitals' efforts to improve the outcomes of patients undergoing implantable cardioverter-defibrillator (ICD) implantation, we developed and validated a risk model using data from the NCDR (National Cardiovascular Data Registry) ICD Registry. Background ICD prolong life in selected patients, but ICD implantation carries the risk of periprocedural complications. Methods We analyzed data from 240,632 ICD implantation procedures between April 1, 2010, and December 31, 2011 in the registry. The study group was divided into a derivation (70%) and a validation (30%) cohort. Multivariable logistic regression was used to identify factors associated with in-hospital adverse events (complications or mortality). A parsimonious risk score was developed on the basis of beta estimates derived from the logistic model. Hierarchical models were then used to calculate risk-standardized complication rates to account for differences in case mix and procedural volume. Results Overall, 4,388 patients (1.8%) experienced at least 1 in-hospital complication or death. Thirteen factors were independently associated with an increased risk of adverse outcomes. Model performance was similar in the derivation and validation cohorts (C-statistics ¼ 0.724 and 0.719, respectively). The risk score characterized patients into low-and-high risk subgroups for adverse events (10 points, 0.3%; !30 points, 4.2%). The risk-standardized complication rates varied significantly across hospitals (median: 1.77, interquartile range 1.54, 2.14, 5th/95th percentiles: 1.16/3.15). Conclusions We developed a simple model that predicts risk for in-hospital adverse events among patients undergoing ICD placement. This can be used for shared decision making and to benchmark hospital performance.
Pacing and Clinical Electrophysiology, 1994
Third Generation Implantable Defibrillators. Non-thoracotomy implantation 0/implantable cardioverter defibrillators (ICDs) has simplified (he process of device inserfion, promising to decrease associated proceduraJ conipJications whiJe providing sudden death protection at least equal to epicardial systems. This study presents the acute and chronic results 0/110 patients who underwent attempted non-thoracotomy ICD impiuntation wiih the Medtronic Transvene lead system and PCD model 7217 or 7219. Of the no patients attempted, 100 (91 %J had the system successfully implanted without the need for an epicardial patch. One patient died 1 week postoperatively of septic shock related to the implantation (0.9% perioperative mortality). During folloiv-up of 16 ± 11 months, 45% of the patients had an event detected as ventricular tachycardia; 26% of these detections were felt clinically to be due to supraventricular rhythms. Of the remainder, 87% were successfully treated with the first VT therapy, and 98% were terminated by the final therapy; 66% of the patients had at least one episode of ventricular fibrillation, of which 5% were felt to be inappropriate detections; 65% of the appropriate episodes were successfully treated with the first VF therapy, and all were converted by the final therapy. Total mortality at 6, 12, and 24 months was 3%, 11%, and 19% respectively. Only one patient had sudden cardiac death, occurring at 13 months postimplant. Overall, the non-thoracotomy lead system for this ICD displayed infrequent implant complications and proved to be reliable ai terminating arrhythmias and maintaining a low rate 0/sudden cardiac death in this high risk popuiation. fPACE, Vol. 17, March 1994, Part U) implantable defibrillator, non-thoracotomy leads, ventricular tachycardia, ventricular fibrillation Address for reprints: |ohannes Brachmann, M.D.,
The subcutaneous implantable cardioverter-defibrillator: A tertiary center experience
Cardiology Journal
Background: The aim of the study was to evaluate subcutaneous implantable cardioverterdefibrillator (S-ICD) patients with regard to underlying etiology, peri-procedural outcome, appropriate/inappropriate shocks, and complications during follow-up. Methods: All patients who underwent S-ICD implantation from February 2013 to March 2017 at an academic hospital in Vienna were included. Medical records were examined and follow-up interrogations of devices were conducted. Results: A total of 79 S-ICD patients (58.2% males) with a mean age of 44.5 ± 17.2 years were followed for a mean duration of 12.8 ± 13.7 months. A majority of patients (58.2%) had S-ICD for primary prevention of sudden cardiac death. The most common of the 16 underlying etiologies were ischemic cardiomyopathy, non-ischemic cardiomyopathy, and idiopathic ventricular fibrillation. The lead was implanted to the left sternal border in 96.2% of cases, between muscular layers in 72.2%. Mean implant time was 45 min, 3 patients were induced, and all patients except one were programmed to two zones. Six (7.6%) patients experienced at least one appropriate therapy for ventricular arrhythmias and the time to first event ranged from 1 to 52 months. Seven patients experienced inappropriate shocks due to Twave oversensing, atrial tachycardia with rapid atrioventricular conduction, external electromagnetic interference, and/or baseline oversensing due to lead movement. Four patients underwent revision for lead repositioning (n = 1), loose device suture (n = 1), and infection (n = 2). Conclusions: While S-ICDs are a feasible and effective treatment, issues remain with inappropriate shock and infection.
Europace, 2023
A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. Methods and results We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17-0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30-0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50-1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. Conclusion Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks.