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JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016 ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER ISSN 2405-500X/$36.00 http://dx.doi.org/10.1016/j.jacep.2015.09.011 Surgical Management of Implantation-Related Complications of the Subcutaneous Implantable Cardioverter-Defibrillator Tom F. Brouwer, MD,a Antoine H.G. Driessen, MD,b Louise R.A. Olde Nordkamp, MD, PHD,a Kirsten M. Kooiman, CCDS,a Joris R. de Groot, MD, PHD,a Arthur A.M. Wilde, MD, PHD,a Reinoud E. Knops, MDa ABSTRACT OBJECTIVES This study assessed outcomes in patients in whom subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy was continued after implantation-related complications, in order to avoid conversion to transvenous ICD therapy. BACKGROUND Patients at risk for sudden cardiac death benefit from ICD therapy, despite a significant risk for complications. S-ICD has a similar complication rate as transvenous ICD therapy, but the absence of transvenous leads may hold long-term benefits, especially in young ICD patients. METHODS In the largest single-center cohort available to date, S-ICD patients implanted between 2009 and 2015 were included. RESULTS There were 123 patients at a median age of 40 years. During a median follow-up of 2 years, 10 patients (9.4%) suffered implant-related complications. There were 5 infections, 3 erosions, and 2 implant failures for which 21 surgical procedures were needed. In 9 of 10 patients, S-ICD therapy could be continued after intervention. In 6 patients, the period between extraction and reimplantation of the S-ICD system was bridged with a wearable cardioverterdefibrillator (WCD). The pulse generator was reimplanted at the original site in 5 patients and in 3 underneath the serratus anterior muscle. One patient was not reimplanted following extraction due to recurrent infections. Conversion to a transvenous ICD was not needed in any patient. CONCLUSIONS In most patients with a complication, S-ICD therapy could be continued after intervention, avoiding the need to convert to a transvenous system. Bridging to recovery with a WCD and submuscular implantation of the pulse generator are effective treatment strategies to manage S-ICD complications. (J Am Coll Cardiol EP 2016;2:89–96) © 2016 by the American College of Cardiology Foundation. P atients cardiac these complications are related to the use of transve- death benefit from implantable cardioverter- at high nous leads, causing significant morbidity such as defibrillator Conventional thrombotic events, cardiac perforation, and lead transvenous ICDs have been demonstrated to in- endocarditis. Failure of transvenous leads, reported crease survival, despite the fact that approximately to be between 37% and 40% at 8 to 10 years’ follow- 10% to 15% of patients experience implant-related up, results in inappropriate shocks, lead-extraction- or long-term complications (1–5). A proportion of related complications, and failure to effectively detect (ICD) risk of sudden therapy. Listen to this manuscript’s audio summary by JACC: Clinical Electrophysiology Editor-in-Chief Dr. David J. Wilber. From the aDepartment of Clinical and Experimental Cardiology, Heart Center, Amsterdam Medical Center, University of Amsterdam, Amsterdam, the Netherlands; and the bDepartment of Cardiothoracic Surgery, Heart Center, Amsterdam Medical Center, University of Amsterdam, Amsterdam, the Netherlands. Dr. Knops has received an institutional research grant and honoraria from Boston Scientific Inc. Dr. de Groot has received grants from St. Jude Medical, Atricure, Medtronic, and ZonMW/ NWO. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received July 21, 2015; revised manuscript received September 9, 2015, accepted September 24, 2015. 90 Brouwer et al. JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016 FEBRUARY 2016:89–96 Management of S-ICD Complications ABBREVIATIONS and convert ventricular arrhythmias (2,6,7). AND ACRONYMS These are important limitations of transve- 2-incision technique (11). All patients were routinely nous ICD therapy and are particularly relevant evaluated prior to discharge, 2 weeks and 2 months in young ICD patients with a life expectancy of post-implant, and thereafter semi annually in the ICD many decades. clinic. Unscheduled visits were documented and used dCMP = dilated cardiomyopathy DF-test = defibrillation The threshold test subcutaneous implantable cardio- DPP6 = dipeptidyl verter-defibrillator (S-ICD), characterized by aminopeptidase-like protein-6 the extrathoracic position of the lead, was mutation introduced to reduce harm associated with ICD = implantable transvenous leads (8). Young patients are cardioverter-defibrillator overrepresented in S-ICD cohorts because of iCMP = ischemic this presumed benefit, but randomized long- cardiomyopathy term follow-up data are lacking. Drawbacks iVF = idiopathic ventricular of the subcutaneous position are the larger fibrillation size of the device, which is needed to deliver IQR = interquartile range sufficient energy to meet the defibrillation LQTS = long QT-syndrome SAM = serratus anterior muscle S-ICD = subcutaneous requirements; the absence of pacing therapy at low energy levels; and the need for 1 or 2 2010, S-ICD implantations were performed using the for evaluation. ENDPOINTS. Complications in this study are defined as complications related to implantation of the S-ICD system such as infection, hematoma, or skin erosion, requiring surgical intervention such as reposition or device extraction and were retrospectively identified from patient’s medical records. Complications that were adequately and definitively managed without surgical intervention are not reported. The time to complication was defined as interval between implant of the S-ICD and the moment of surgical intervention for the complication. Follow-up data were collected to the last follow-up visit. implantable cardioverter- additional incisions depending on the tech- defibrillator nique used for lead insertion, which might STATISTICAL WCD = wearable cardioverter- increase the infection risk. tested for normality and reported as mean SD or defibrillator ANALYSIS. Continuous data were When device-related complications, such medians with corresponding interquartile ranges as pocket infection or erosion, occur, the treatment (IQR) (25% to 75%). For discrete variables, percent- options for transvenous and S-ICDs are different. ages are calculated. Kaplan-Meier estimates for Transvenous ICDs can be implanted on the contra- complications were calculated and presented with lateral side, which by design is not possible with the corresponding 95% confidence intervals (CIs). All S-ICD. Patients with a complication of the S-ICD are statistical analyses were performed using SPSS often explanted and converted to transvenous ICD version 21 software (IBM, Armonk, New York). therapy, which introduces risk of complications associated with transvenous leads (9). Outcomes of RESULTS patients who have been reimplanted with an S-ICD after a complication have not been reported. We analyzed implant-related complications in pa- PATIENT CHARACTERISTICS. A total of 123 patients (56.9% male) who received an S-ICD were included in tients with an S-ICD in the largest single-center cohort available to date and report the outcome of strategies focused on continuation of S-ICD therapy after a complication. METHODS T A B L E 1 Baseline Characteristics of Patients With an S-ICD (N ¼ 123) Males/females 70/53 (57) Median age, yrs 40 (26-51) Body mass index, kg/m2 24.5 4.8 Prior myocardial infarction 24 (19.5) Diabetes 6 (4.9) single-center cohort study between February 2009 Atrial fibrillation 8 (6.5) and February 2015. All consecutive patients who Previous transvenous implant 16 (13) received implantation with an S-ICD in our hospital Left ventricular ejection fraction 46 14.9 were included, except for patients participating in the ICD indication: primary 80 (65) ongoing PRAETORIAN trial (A PRospective, rAndom- Diagnosis STUDY POPULATION. We conducted a retrospective izEd Comparison of subcutaneous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy) Cardiomyopathy 43 (35.0) Ischemic cardiomyopathy 20 (16.0) Nonischemic cardiomyopathy 23 (18.7) (NCT01296022) (10). The need for informed consent Genetic arrhythmia syndromes 71 (57.7) was waived by the institutional review board. Im- Congenital heart disease 5 (4.1) plantation of the S-ICD was performed under a com- Other* 4 (3.3) bination of local anesthesia, using lidocaine, and conscious sedation in the catheterization laboratory or operating room by 1 implanter (R.K.). From October Values are n (%), median (25%–75%), or mean SD. *Family history of sudden cardiac death and history of nonsustained ventricular tachycardia. Brouwer et al. JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016 FEBRUARY 2016:89–96 Management of S-ICD Complications the current analysis. Table 1 presents the baseline threshold test (DF-test) failure due to malposition of characteristics. The median age at implant was the device 0.9% (95% CI: 0.0% to 2.7%) and 1 case of 40 years old (IQR: 26 to 51 years), and 80 (65%) patients lead displacement 0.9% (95% CI: 0.0% to 2.7%). Of the had a primary prevention indication. The underlying first 31 patients receiving implants with the standard diagnosis was ischemic cardiomyopathy in 16% and implantation technique, 4 patients (12.9%) suffered a nonischemic cardiomyopathy in 19%, genetic arrhy- complication versus 6 of the last 92 (6.5%) who thmia syndromes in 58%, congenital heart disease in received implants using the 2-incision technique, 4%, and a family history of sudden cardiac death and indicating a learning curve with respect to complica- nonsustained ventricular tachycardia in another 3%. tions. The median duration between implant and Of the 123 patients, 92 (75%) received implants using diagnosis of the complication was 24 days (IQR: 9 to the 2-incision technique. The median follow-up was 185 days) and between implant and surgical inter- 27 months (IQR: 9 to 48 months). vention 71 days (IQR: 46 to 274 days), as conservative COMPLICATIONS. The absolute number of patients that encountered a complication related to the implantation of the S-ICD that required surgical intervention was 10. Kaplan-Meier estimates for complication-free survival at 1 and 2 years were 91.8% (95% CI: 86.5% to 97.0%) and 90.6% (95% CI: 84.6% to 96.3%), respectively (Figure 1). There were a total of 8 infectious complications that required surgical intervention: 5 cases of device infection 4.6% (95% CI: 0.6% to 8.5%) and 3 cases of pocket erosion 3.6% (95% CI: 0.0% to 7.6%). All cases had positive biomarkers for infection (elevated Creactive protein or white cell count). Additionally there were 6 patients with presumed infections. Five patients had signs of superficial infection, and 1 had a swollen pocket with elevated infection biomarkers. All 6 patients were successfully managed with conservative antibiotic treatment only. There were 2 acute noninfectious complications requiring intervention: 1 case with defibrillation treatment was attempted in most patients first. Table 2 displays the characteristics of patients with a complication. Complications not related to the implant procedure that were excluded from the analysis consisted of 1 pulse generator malfunction, 1 case of oversensing, and 1 fatal case of lead endocarditis of a concomitant pacemaker in a patient with congenital heart disease, who was deemed inoperable. When these complications were included, the rate at 2-year follow-up was 11.8% (95% CI: 5.2% to 18.0%). MANAGEMENT OF INFECTION-RELATED COMPLICATIONS. All 5 infected S-ICD systems conferred a local infection and were extracted. The period between extraction and reimplantation of the S-ICD at the same site was bridged for between 6 weeks and 3 months with a wearable cardioverter defibrillator (WCD) (LifeVest, Zoll Medical, Chelmsford, Massachusetts). Patient #5 (Table 2) had a history of endocarditis in the presence of a transvenous device and recurrent skin infections due to eczema and chronic Staphylococcus aureus colonization–associated furunculosis. This patient suffered a local infection of the subcutaneous F I G U R E 1 Kaplan-Meier Test for Freedom From Implant- device approximately 2 months post–implant. The Related Complications Requiring Surgical Intervention at S-ICD was permanently extracted, and the patient was 2 Years Post-Implant put on a novel drug regimen to prevent arrhythmias, as the consensus was that recurrent infections imposed a greater risk to this patient than interruption of ICD therapy. The antibiotic regimen consisted of oral flucloxacillin for a median duration of 10 days after extraction of the device, according to local hospital protocol and culture results. Clinical signs of infections and wound healing determined the exact duration of antibiotic treatment. The median duration between termination of antibiotic treatment and reimplantation was 64 days (IQR: 56 to 76 days). There were 3 patients with pocket erosion that required surgical intervention. In all 3 patients, the first step in the management was Two-year freedom of complications is 90.6% (95% confidence repositioning of the can in a deeper subcutaneous interval: 84.6 to 96.3). position under the fibrotic layer of the original pocket. This management proved successful in 1 patient. In 91 92 T A B L E 2 Overview of Implant-Related Complications per Patient, Subsequent Management, and Outcome 1 (43, female) iCMP (1 ) 2 (23, male) Comorbidity Implant Type Days to Complication Acute Management Device Bridging Therapy Reimplantation Course of Follow-Up Follow-Up Since Last Surgical Procedure DM-II, hypertension, obesity De novo Pocket infection WCC 17 CRP 9 -skin flora 12 Extraction day 12 3 months LifeVest Reimplant S-ICD (subcutaneous) Extraction 2nd implant after 998 days. Re-implanted in sub-serratus position after 636 days 4 months DPP6 None De novo Pocket infection WCC 9 CRP 116 -S. aureus 28 Extraction day 28 2 months LifeVest Reimplant S-ICD (subcutaneous) Unremarkable 55 months 3 (22, male) dCMP (1 ) None De novo Pocket infection WCC 12 CRP 80 -S. aureus 14 Extraction day 52 >6 weeks LifeVest Reimplant S-ICD (subcutaneous) Unremarkable 15 months 4 (15, male) iVF (2 ) None De novo Infection of medial incision WCC 10 CRP 54 -S. aureus 20 Extraction at day 72 >6 weeks LifeVest Reimplant S-ICD (subcutaneous) Repositioning pulse generator sub-serratus at 34 days postreimplant due to decubitus 9 months 5 (14, male) LQTS (1 ) None Post-TV-pacemaker (endocarditis) Pocket infection WCC 9 CRP 78 -S. aureus 70 Extraction at day 71 No NA No device follow-up (permanently explanted); conservative medication treatment 6 (21, male) dCMP (2 ) Congenital aortic valve stenosis De novo Pocket erosion WCC 11 CRP 70 -No bacterial growth 437 Deeper subcutaneous positioning pulse generator at 484 days No NA Unremarkable 45 months 7 (48, female) iCMP (2 ) Myocardial infarction Post-TV-ICD (lead dysfunction) Pocket erosion WCC 9 CRP 5 -No bacterial growth 190 1. Pulse generator repositioning at 204 days 2. Extraction at 474 days postrepositioning >3 months LifeVest Reimplant S-ICD (subcutaneous) Unremarkable 16 months 8 (49, male) iCMP (1 ) Myocardial infarction and VT Post TV-ICD (pocket erosion) 1. Pocket erosion WCC 12 CRP 1 2. Infected pocket hematoma -S. lugdunensis 183 1. Pocket revision at 195 days 2. Extraction at 440 days 3 months LifeVest Reimplant S-ICD submusculus serratus anterior Unremarkable 17 months 9 (41, female) DPP6 (1 ) None De novo Undersensing due to improper lead placement 0 Lead replacement at day 56 No NA Unremarkable 71 months 10 (24, male) DPP6 (1 ) None De novo DFT failure -No culture 0 Deeper subcutaneous positioning pulse generator at day 6 No NA Unremarkable 27 months Brouwer et al. Indication (Prevention) Management of S-ICD Complications Patient # (Age [yrs], Sex) Type of Complication Pocket Culture Results NA FEBRUARY 2016:89–96 JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016 dCMP ¼ dilated cardiomyopathy; CRP ¼ C-reactive protein; DFT ¼ defibrillation threshold test; DPP6 ¼ dipeptidyl aminopeptidase-like protein 6 mutation; FU ¼ follow-up duration; iCMP ¼ ischemic cardiomyopathy; iVF ¼ idiopathic ventricular fibrillation; NA = not applicable; LQTS ¼ long QT syndrome; S-ICD ¼ subcutaneous implantable cardioverter-defibrillator; TV-ICD ¼ transvenous implantable cardioverter-defibrillator; WCC ¼ white cell count. Brouwer et al. JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016 FEBRUARY 2016:89–96 Management of S-ICD Complications F I G U R E 2 Lateral Chest Radiograph Showing Failed and Successful Defibrillation Threshold Tests (A) Lateral view shows anterior position of the pulse generator and ventral position of the lead, resulting in a failed defibrillation threshold test. (B) Lateral view now shows repositioned leads and pulse generator. The parasternal lead is positioned directly on the sternum, and the pulse generator is more posterior, resulting in a successful defibrillation test. the other 2 patients, signs of pocket erosion recurred of the tip of the lead to the fascia. The sleeve to at 245 and 270 days after repositioning. In both pa- fixate the lead to the xiphoid, which is currently tients, the system was extracted to allow full recovery, recommended by the manufacturer, had not yet and they were fitted with a WCD for a period of 3 been introduced. The lead was repositioned, which months. After this period, both patients underwent resolved the oversensing. successful reimplantation, one in the same subcu- Patient #10 failed both the periprocedural DF-test taneous position and the other in a deeper sub- and a second DF-test the day after implant at 65 serratus anterior muscle (SAM) position. All 3 joules in standard and reversed polarity. The failed patients were free from complications up to the last DF-test was likely due to an inadequate shock follow-up visit more than 1 year after reimplantation. vector as both the pulse generator and lead were Predictors of infection in transvenous systems positioned too anteriorly and not close enough to were assessed with univariate logistic regression the chest wall fascia (Figure 2A). Both the lead and models, but age, diabetes, concomitant transvenous the pulse generator were repositioned directly on device, infection of previous transvenous device, and the fascia, and the pulse generator was moved in anticoagulation were found not to be significantly the posterior direction. The more posterior position associated with S-ICD infection in this small cohort can result in the pulse generator being partly (data not shown). placed in the natural space between the latissimus MANAGEMENT OF ACUTE NONINFECTIOUS COMPLICATIONS. dorsi and the SAMs, which we do not consider a Patient #9 suffered an inappropriate shock approxi- true submuscular implant of the pulse generator mately 2 months post-implant due to oversensing of (Figure 2B). After repositioning, 2 DF-tests were myopotentials. Chest radiography revealed migration successful at 65 J. of the tip of the lead in the caudal direction and the Entirely submuscular implantation of the pulse proximal part of the coil toward the pulse generator. g e n e r a t o r . In 3 patients who did not tolerate the The lead was implanted using the 3-incision tech- subcutaneous position, the pulse generator was nique, which requires a distal incision and suturing reimplanted directly under the SAM. The 93 94 Brouwer et al. JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016 FEBRUARY 2016:89–96 Management of S-ICD Complications F I G U R E 3 Sub-Serratus Anterior Muscle Implantation of the S-ICD Pulse Generator (A) Lateral view of dissected serratus anterior muscle. Muscle slips are dissected in line with the fiber direction. (B) Pulse generator of the subcutaneous implantable cardioveter-defibrillator (S-ICD) is placed underneath the muscle slips in the submuscular pocket. (C) Slips of the muscle are sutured to close the submuscular pocket. (D) Post-operative view of sub-serratus anterior muscle implantation of S-ICD pulse generator. submuscular implant technique of the pulse gener- as endocarditis, lead failure, and pocket erosion. In the ator was successful in all 3 patients. Implants un- 10th patient, continuation of ICD therapy was deemed derneath the SAM should be performed in the less favorable then a medication-only strategy. operating room in the presence a cardiothoracic surgeon because integrity of the long thoracic nerve is COMPLICATION RATE. Although the sample size of critical for shoulder function and damaging it can this cohort was too small to provide a precise estimate cause a winged scapula. In this implantation tech- of the complications rate, it was similar to the large nique, the pulse generator is positioned underneath S-ICD cohort published study by Burke et al. (12), the sixth and seventh muscle slip (Figures 3A and 3B), which reported 9.6% complications at 2-year follow- and the muscle slips are sutured from lateral to up. No cases of blood-borne infection or endocardi- medial (Figures 3C and 3D). Figure 4 presents an tis were observed. Comparison of complication rates anatomic illustration of the implant position. to transvenous cohorts are impeded by varying patient characteristics, follow-up durations, and DISCUSSION complication definitions. The Danish Pacemaker and ICD registry reported a major complication rate of MAIN FINDINGS. Our study provides several insights 5.8% (95% CI: 5.1% to 6.5%) for new implants at 180 regarding complications of S-ICD therapy. In 9 of the days compared with 7.3% (95% CI: 1.7% to 10.8%) in 10 patients with a complication, S-ICD therapy could this analysis when all complications requiring inter- be continued after intervention. In these 9 patients, vention were considered (13). The Swedish pace- conversion to transvenous ICD therapy was an option maker and ICD registry reported 10.1% complications but not decided. The main reasons to continue S-ICD at 1 year compared with 9.4% (95% CI: 3.0% to 13.5%) therapy were patients’ and physicians’ preferences in this cohort and for infections 3.0% versus 4.6% and prior transvenous ICD–related complications such (95% CI: 0.6% to 8.5%), respectively (14). Brouwer et al. JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016 FEBRUARY 2016:89–96 F I G U R E 4 Submuscular Implantation of the Pulse Generator Management of S-ICD Complications cases of erosion or infection. More important, after this bridging period, reimplantation at the original site of implantation was successful in 5 of 6 patients. This demonstrates that conversion to transvenous ICD therapy in case of an S-ICD complication is not necessary, and transvenous leads can be avoided. In a nationwide cohort, we reported preiously that in S-ICD patients with a device infection, 4 of 7 patients were reimplanted with a transvenous ICD (9). Although no arrhythmia episodes were treated by the WCD, we advocate this management for safety and to avoid prolonged hospitalization. All 3 cases of pocket erosion were initially managed by repositioning the pulse generator in a deeper subcutaneous layer without a bridging period with a WCD, but this strategy proved to be effective in only 1 case. As skin erosion often occurs in the presence of low-grade infection, extraction of the S-ICD system followed by a bridging period with a WCD appears appropriate in these cases. IMPLANT POSITION. Failure of DT-testing in a pa- tient (no. 10) with inappropriate positioning of the S-ICD, underlines the importance of positioning the Anatomical lateral view of the pulse generator positioned underneath the slips of the serratus anterior muscle. pulse generator directly on the fascia of the chest wall centered in the mid-axillary line. Depending on the size and the exact position of the latissimus dorsi muscle, the pulse generator may also be partly placed S-ICD patients, in general and in this cohort, are underneath this muscle to allow a low defibrillation younger than the traditional ICD population, with a threshold and enough tissue to protect the skin from median age of between 40 and 50 years old and with the mechanical stress imposed by the pulse gener- few comorbidities (15–17). Their presumed more ator. In patients who do not tolerate the subcutane- active lifestyle may have caused early post-procedural ous position of the pulse generator, submuscular complications. Previous transvenous ICD studies implantation can be a successful implantation tech- with younger patients between 29 and 48 years of nique. However, the submuscular implantation is age reported complication rates ranging between more invasive and painful, it might therefore not be 17% and 27% during follow-up of 2.5 to 5.0 years, suitable as the default implant technique for de novo which is higher than that in older populations such as implants. SCD-HeFT (14% complications during 3.8 years follow-up) (5,18–21). Many of these complications were related to the transvenous lead failure and dislodgement. A proportion of this cohort consists of patients who participated in the first-in-human study of the S-ICD. In the first 31 patients, the complication rate was twice that of the next 92 patients. Therefore the complication rate is this cohort may be overestimated because of a learning curve effect and this should be taken into account when it is compared with transvenous cohorts with presumably experienced implanters. STUDY LIMITATIONS. First, it is a retrospective cohort study of 123 patients without (randomized) controls. Patients in this cohort do not represent the typical ICD population as they are younger and have less comorbidity. Patients included in the actively recruiting PREATORIAN trial were excluded but are not likely to introduce significant bias because all patients with an ICD indication without need for brady- or antitachycardia pacing indication are eligible for the trial. CONCLUSIONS BRIDGING PERIOD. The use of a WCD for a period of In most patients with a complication, subcutaneous 6 weeks to 3 months allows sufficient time for com- ICD therapy could be continued after intervention, plete recovery of the skin and subcutaneous tissue in avoiding the need to convert to a transvenous system. 95 96 Brouwer et al. JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016 FEBRUARY 2016:89–96 Management of S-ICD Complications The complication rate in this cohort is similar to what has been reported for transvenous ICDs, albeit that the complication rate in this cohort may be overestimated because of a learning curve. Bridging time with a wearable cardioverter-defibrillator allowed reimplantation at the original site of implantation. In patients who do not tolerate subcutaneous placement of the pulse generator, implantation of the pulse generator underneath the SAM can be a viable treatment option. PERSPECTIVES COMPETENCY IN MEDICAL KNOWLEDGE: The complication rate of S-ICDs is similar to that of transvenous ICD therapy. S-ICD therapy can be continued after a complication such as infection or pocket erosion, avoiding the need to convert to transvenous ICD therapy. TRANSLATIONAL OUTLOOK: Additional research REPRINT REQUESTS AND CORRESPONDENCE: Dr. Tom F. Brouwer, Department of Cardiology, Academic Medical Center, P.O. Box 22700, 1100 DE Amsterdam, is needed to evaluate the potential long-term benefits of subcutaneous ICD therapy compared with transvenous ICD therapy. the Netherlands. E-mail: [email protected]. REFERENCES 1. Alter P, Waldhans S, Plachta E, Moosdorf R, Grimm W. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol 2005;28: 926–32. 9. Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, et al. 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