Search

Background: Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. Methods: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. Results: Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow‐up after LP implant was 14.3 (interquartile range [IQR]: 8.4–27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p =.15). Implant‐related adverse events were also similar between heparin bolus and no bolus groups: access‐site hematoma requiring intervention (7 vs. 5, p =.99), pseudoaneurysm (1 vs. 1, p =.99), cardiac perforation (1 vs. 1, p =.99), intraprocedural device thrombus formation (2 vs. 4, p =.41), 30‐day rehospitalization (21 vs. 15, p =.98), and 30‐day all‐cause mortality (16 vs. 14, p =.70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p =.10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p =.52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p =.34). Long‐term device performance was also similar between groups. Conclusion: Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications. [ABSTRACT FROM AUTHOR]

Introduction: Transvenous leads have been implicated in tricuspid valve (TV) dysfunction, but limited data are available regarding the effect of extracting leads across the TV on valve regurgitation. The aim of this study is to quantify tricuspid regurgitation (TR) before and after lead extraction and identify predictors of worsening TR. Methods: We studied 321 patients who had echocardiographic data before and after lead extraction. TR was graded on a scale (0 = none/trivial, 1 = mild, 2 = moderate, 3 = severe). A change of >1 grade following extraction was considered significant. Results: A total of 321 patients underwent extraction of a total of 338 leads across the TV (1.05 ± 0.31 leads across the TV per patient). There was no significant difference on average TR grade pre‐ and postextraction (1.18 ± 0.91 vs. 1.15 ± 0.87; p = 0.79). TR severity increased after extraction in 84 patients, but was classified as significantly worse (i.e., >1 grade change in severity) in only 8 patients (2.5%). Use of laser lead extraction was associated with a higher rate of worsening TR postextraction (44.0% vs. 31.6%, p = 0.04). Conclusion: In our single‐center analysis, extraction of leads across the TV did not significantly affect the extent of TR in most patients. Laser lead extraction was associated with a higher rate of worsening TR after extraction. [ABSTRACT FROM AUTHOR]

Introduction: Permanent pacing indications are common after cardiac surgery and transcatheter structural valve interventions. Leadless pacemakers (LPs) have emerged as a useful alternative to transvenous pacemakers. However, current commercially available LPs are unable to provide atrial pacing or cardiac resynchronization and relatively little is known about LP outcomes after cardiac surgery and transcatheter valve interventions. Methods: This retrospective study included patients who received a Micra VR (MicraTM MC1VR01) or Micra AV (MicraTM MC1AVR1) (Medtronic) leadless pacemaker following cardiac surgery or transcatheter structural valve intervention between September 2014 and September 2022. Device performance and clinical outcomes, including ventricular pacing burden, ejection fraction, and need for conversion to transvenous pacing systems, were evaluated during follow‐up. Results: A total of 78 patients were included, of whom 40 received a Micra VR LP implant, and 38 received a Micra AV LP implant. The mean age of the cohort was 65.9 ± 17.9 years, and 48.1% were females. The follow‐up duration for the entire cohort was 1.3 ± 1.1 years: 1.6 ± 1.3 years for the Micra VR group and 0.8 ± 0.5 years for the Micra AV group. Among the cohort, 50 patients had undergone cardiac surgery and 28 underwent transcatheter structural valve interventions. Device electrical performance was excellent during follow‐up, with a small but clinically insignificant increase in ventricular pacing threshold and a slight decrease in pacing impedance. The mean right ventricle pacing (RVP) burden significantly decreased over time in the entire cohort (74.3% ± 37.2% postprocedure vs. 47.7% ± 40.6% at last follow‐up, p <.001), and left ventricle ejection fraction (LVEF) showed a modest but significant downward trend during follow‐up (55.0% ± 10.6% vs. 51.5% ± 11.2% p <.001). Patients with Micra VR implants had significantly reduced LVEF during follow‐up (54.1% ± 11.9% vs. 48.8% ± 11.9%, p =.003), whereas LVEF appeared stable in the Micra AV group during follow‐up (56.1% ± 9.0% vs. 54.6% ± 9.7%, p =.06). Six patients (7.7%) required conversion to transvenous pacing systems, four who required cardiac resynchronization for drop in LVEF with high RVP burden and two who required dual‐chamber pacemakers for symptomatic sinus node dysfunction. Conclusion: Leadless pacemakers provide a useful alternative to transvenous pacemakers in appropriately selected patients after cardiac surgery and transcatheter structural valve interventions. Device performance is excellent over medium‐term follow‐up. However, a significant minority of patients require conversion to transvenous pacing systems for cardiac resynchronization or atrial pacing support, demonstrating the need for close electrophysiologic follow‐up in this cohort. [ABSTRACT FROM AUTHOR]

Introduction: The Micra Coverage with Evidence Development (CED) Study is a novel comparative analysis of Micra (leadless VVI) and transvenous single‐chamber ventricular pacemakers (transvenous VVI) using administrative claims data. To compare chronic complications, device reinterventions, heart failure hospitalizations, and all‐cause mortality after 3 years of follow‐up. Methods: US Medicare claims data linked to manufacturer device registration information were used to identify Medicare beneficiaries with a de novo implant of either a Micra VR leadless VVI or transvenous VVI pacemaker from March 9, 2017 to December 31, 2018. Unadjusted and propensity score overlap‐weight adjusted Fine‐Gray competing risk models were used to compare outcomes at 3 years. Results: Leadless VVI patients (N = 6219) had a 32% lower rate of chronic complications and a 41% lower rate of reintervention compared with transvenous VVI patients (N = 10 212) (chronic complication hazard ratio [HR] 0.68; 95% confidence interval [CI], 0.59−0.78; reintervention HR 0.59; 95% CI 0.44−0.78). Infections rates were significantly lower among patients with a leadless VVI (<0.2% vs. 0.7%, p <.0001). Patients with a leadless VVI also had slightly lower rates of heart failure hospitalization (HR 0.90; 95% CI 0.84−0.97). There was no difference in the adjusted 3‐year all‐cause mortality rate (HR 0.97; 95% CI, 0.92−1.03). Conclusion: This nationwide comparative evaluation of leadless VVI versus transvenous VVI de novo pacemaker implants demonstrated that the leadless group had significantly fewer complications, reinterventions, heart failure hospitalizations, and infections than the transvenous group at 3 years, confirming that the previously reported shorter‐term advantages associated with leadless pacing persist and continue to accrue in the medium‐to‐long‐term. [ABSTRACT FROM AUTHOR]

Introduction: Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real‐world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed‐ventricular pacing (AM‐VP) percentages in patients with permanent high‐degree AV block and (2) report on the real‐world effectiveness of Micra AV. Methods: The correlation between ECG‐determined AVS in‐clinic and device‐collected %AM‐VP was assessed using data from 40 patients with high‐degree AV block enrolled in the Micra Atrial tRacking using a Ventricular AccELerometer (MARVEL) 2 study. A retrospective analysis to assess continuously‐sampled %AM‐VP since last session, device programming, and electrical parameters was performed using Micra AV transmissions from the Medtronic CareLink database. Patients with transmissions ≥180 days postimplant were included. Results: Among the 40 MARVEL 2 AV block patients with a median %VP of 99.7%, AVS was highly correlated with AM‐VP (median AVS 87.1%, median AM‐VP 79.1%; R2 = 0.764, p <.001). The CareLink cohort included 4384 patients programmed to VDD mode. The mean A4 amplitude was 2.3 ± 1.8 m/s2 at implant and 2.3 ± 1.6 m/s2 at 28 weeks. In patients with %VP >90% (n = 1662), the median %AM‐VP was 74.7%. For the full cohort, median %VP was 65.6% and median projected battery longevity was 10.5 years. Conclusion: In patients with a high pacing burden, %AM‐VP provides a reasonable estimation of AVS. The first large real‐world analysis of Micra AV patients with >90% VP showed stable atrial sensing over time with a median %AM‐VP, a correlate of AVS, of 74.7%. [ABSTRACT FROM AUTHOR]

Background: The feasibility and outcomes of concomitant atrioventricular node ablation (AVNA) and leadless pacemaker implant are not well studied. We report outcomes in patients undergoing Micra implant with concomitant AVNA. Methods: Patients undergoing AVNA at the time of Micra implant from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post‐Approval Registry (PAR) were included in the analysis and compared to Micra patients without AVNA. Baseline characteristics, acute and follow‐up outcomes, and electrical performance were compared between patients with and without AVNA during the follow‐up period. Results: A total of 192 patients (mean age 77.4 ± 8.9 years, 72% female) underwent AVNA at the time of Micra implant and were followed for 20.4 ± 15.6 months. AVNA patients were older, more frequently female, and tended to have more co‐morbid conditions compared with non‐AVNA patients (N = 2616). Implant was successful in 191 of 192 patients (99.5%). The mean pacing threshold at implant was 0.58 ± 0.35 V and remained stable during follow‐up. Major complications within 30 days occurred more frequently in AVNA patients than non‐AVNA patients (7.3% vs. 2.0%, p <.001). The risk of major complications through 36‐months was higher in AVNA patients (hazard ratio: 3.81, 95% confidence interval: 2.33–6.23, p <.001). Intermittent loss of capture occurred in three AVNA patients (1.6%), all were within 30 days of implant and required system revision. There were no device macrodislodgements or unexpected device malfunctions. Conclusion: Concomitant AVN ablation and leadless pacemaker implant is feasible. Pacing thresholds are stable over time. However, patient comorbidities and the risk of major complications are higher in patients undergoing AVNA. [ABSTRACT FROM AUTHOR]

Background: Data on the management of Micra transcatheter pacing system (TPS) at the time of an upgrade or during battery depletion is limited. Objective: We sought to evaluate the management patterns of patients implanted with a Micra TPS during long‐term follow‐up. Methods: We retrospectively identified patients who underwent Micra implantation from April 2014 to November 2019. We identified patients who underwent extraction (n = 11) or had an abandoned Micra (n = 12). Results: We identified 302 patients who received a Micra during the period of the study. Mean age was 72.7 ± 15.4 years, 54.6% were men, and left ventricular ejection fraction was 51.9 ± 5.2%. Mean follow‐up was 1105.5 ± 529.3 days. Procedural complications included pericardial tamponade (n = 1) treated with pericardiocentesis, significant rise in thresholds (n = 6) treated with reimplantation (n = 4), and major groin complications (n = 2). Indications for extraction included an upgrade to cardiac resynchronization therapy (CRT) device (n = 3), bridging after extraction of an infected transvenous system (n = 3), elevated thresholds (n = 3), and non‐Micra‐related bacteremia (n = 2). The median time from implantation to extraction was 78 days (interquartile range: 14–113 days), with the longest extraction occurring at 1442 days. All extractions were successful, with no procedural or long‐term complications. Indications for abandonment included the need for CRT (n = 6), battery depletion (n = 2), increasing thresholds/failure to capture (n = 3), and pacemaker syndrome (n = 1). All procedures were successful, with no procedural or long‐term complications. Conclusion: In this large single‐center study, 6% of patients implanted with a Micra required a system modification during long‐term follow‐up, most commonly due to the requirement for CRT pacing. These patients were managed successfully with extraction or abandonment. [ABSTRACT FROM AUTHOR]

Background: Women undergoing atrial fibrillation catheter ablation (AFCA) have higher rates of vascular complications and major bleeding. However, most studies have been underpowered to detect differences in rarer complications such as stroke/transient ischemic attack (TIA) and procedural mortality. Methods: We performed a systematic review of databases (PubMed, World of Science, and Embase) to identify studies published since 2010 reporting AFCA complications by sex. Six complications of interest were (1) vascular/groin complications; (2) pericardial effusion/tamponade; (3) stroke/TIA; (4) permanent phrenic nerve injury; (5) major bleeding; and (6) procedural mortality. For meta‐analysis, random effects models were used when heterogeneity between studies was ≥50% (vascular complications and major bleeding) and fixed effects models for other endpoints. Results: Of 5716 citations, 19 studies met inclusion criteria, comprising 244,353 patients undergoing AFCA, of whom 33% were women. Women were older (65.3 ± 11.2 vs. 60.4 ± 13.2 years), more likely hypertensive (60.6% vs. 55.5%) and diabetic (18.3% vs. 16.5%), and had higher CHA2DS2‐VASc scores (3.0 ± 1.8 vs. 1.4 ± 1.4) (p <.0001 for all comparisons). The rates of all six complications were significantly higher in women. However, despite statistically significant differences, the overall incidences of major complications were very low in both sexes: stroke/TIA (women 0.51% vs. men 0.39%) and procedural mortality (women 0.25% vs. men 0.19%). Conclusion: Women experience significantly higher rates of AFCA complications. However, the incidence of major procedural complications is very low in both sexes. The higher rate of complications in women may be partially attributable to older age and a higher prevalence of comorbidities at the time of ablation. More detailed studies are needed to better define the mechanisms of increased risk in women and to identify strategies for closing the sex gap. [ABSTRACT FROM AUTHOR]

Introduction: Infections of cardiac implantable electronic devices remain a prevalent health concern necessitating the advent of novel preventative strategies. Based on the observation that bacterial infections of the Micra transcatheter pacemaker device are extremely rare, we examine the effect of parylene coating on bacterial adhesion and growth. Methods: Bacterial growth was compared on polyurethane coated, bare, or parylene coated titanium surfaces. Eight test samples per bacterial species and material combination were incubated with Staphylococcus Aureus or Pseudomonas aeruginosa for 24 hours and then assayed for bacterial growth. The surface contact angle was also characterized by measuring the angle between the tangent to the surface of a liquid droplet made with the surface of the solid sample. Results: The mean bacterial colony counts were significantly reduced for both parylene coated titanium versus bare samples (3.69 ± 0.27 and 4.80 ± 0.48 log[CFU/mL] respectively for S. aureus [P <.001] and 5.51 ± 0.27 and 6.08 ± 0.11 log[CFU/mL] respectively for P. aeruginosa [P <.001]), and for parylene coated titanium versus polyurethane samples (4.27 ± 0.42 and 5.40 ± 0.49 log[CFU/mL] respectively for S. aureus [P <.001] and 4.23 ± 0.42 and 4.84 ± 0.32 log[CFU/mL] respectively for P. aeruginosa [P =.006]). Parylene coated titanium samples had a higher contact angle compared with bare titanium, but lower compared with polyurethane (mean contact angle 87.5 ± 3.1 degrees parylene, 73.3 ± 3.7 degrees titanium [P <.001 vs parylene], and 94.8 ± 3.7 degrees polyurethane [P =.002 vs parylene]). Conclusions: Parylene coating significantly reduced the ability of bacteria to grow in colony count assays suggesting that this could contribute to the reduction of bacterial infections of Micra transcatheter pacemakers. [ABSTRACT FROM AUTHOR]

Introduction: Leadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt. Methods and Results: Patients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT‐D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow‐up duration was 8.5 ± 7.1 months (range 0‐28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1‐7). During follow‐up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection. Conclusion: Implantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction. [ABSTRACT FROM AUTHOR]

Background: Defibrillation threshold (DFT) testing is recommended with the subcutaneous implantable cardioverter defibrillator (SICD).Objective: To describe first shock efficacy for appropriate SICD therapies stratified by the presence of implant DFT testing.Methods: We reviewed all patients receiving SICDs at our institution and stratified them based on whether implant DFT testing was performed. Appropriate shocks were reviewed to see if ventricular tachycardia/ventricular fibrillation (VT/VF) terminated with a single shock. First shock efficacy was stratified by implant DFT status.Results: 178 patients implanted with SICDs and followed in our center were included in this study. Of these, 135 (76%) underwent DFT testing (DFT(+) group). In the DFT(+), 80 appropriate shocks were needed to treat 69 episodes of VT/VF. The first shock was effective in 61 out of 69 episodes (88.4%), whereas multiple shocks were required to terminate VT/VF in the remaining eight episodes. Among 43 patients without implant DFT testing (DFT(-) group), 20 appropriate shocks to treat 17 episodes of VT/VF occurred in seven patients. VT/VF was successfullyterminated with the first shock in 16 out of 17 episodes (first shock efficacy 94.1%). There was no significant difference in first shock effectiveness between those with and without implant DFT testing (P=0.97).Conclusion: A strategy that omits DFT testing at implant did not appear to compromise the effectiveness of the SICD. These data suggest that routine DFT testing at SICD implant might not be necessary. Randomized trials are needed to confirm this finding. [ABSTRACT FROM AUTHOR]

Background New-onset postoperative atrial fibrillation (POAF) occurs in up to 30% of patients undergoing coronary artery bypass grafting (CABG). POAF is associated with short- and long-term mortality. Methods To identify the true incidence and time course of recurrent atrial fibrillation (AF) in patients with POAF, we prospectively assigned 23 patients with POAF to receive an implantable loop recorder (ILR; Medtronic Inc., Minneapolis, MN, USA) for the detection of recurrent AF. Two electrophysiologists independently adjudicated monthly ILR transmissions to classify recurrent AF. We defined AF as any episode lasting ≥6 minutes. Results The cohort included 23 subjects averaging 69.1 ± 7.2 years of age. Their mean CHADS2 score averaged 1.9 ± 0.8. Note that 26.1% underwent direct current cardioversion prior to discharge; 95.7% left the hospital taking amiodarone and 26.1% warfarin. A total of 14 patients (60.9%) experienced recurrent AF. AF first recurred within 3 months in nine patients (39.1%), and in 10 patients AF emerged or continued beyond 3 months. Eight of 17 (47.1%) patients followed for at least 1 year experienced AF recurrence beyond 1 year of CABG. The time from surgery to first AF episode averaged 143 ± 22.5 days. Long-term monitoring shows that 60.9% of patients with POAF develop recurrent AF. Conclusion POAF may represent a propensity for recurrent paroxysmal atrial fibrillation, and not simply a transient consequence of postoperative stress and inflammation. Better detection of recurrent AF might identify patients at risk for stroke who would benefit from continuing anticoagulation. [ABSTRACT FROM AUTHOR]

Background: St. Jude Riata/Riata ST defibrillator leads (St. Jude Medical, Sylmar, CA, USA) were recalled by the Food and Drug Administration in 2011 for an increased rate of failure. More than 227,000 leads were implanted and at least 79,000 patients still have active Riata leads. Studies have examined clinical predictors of lead failure in Riata leads, but none have addressed the effect of implantable cardioverter defibrillator (ICD) generator exchange on lead failure. The purpose of this study is to assess the effect of ICD generator exchange on the rate of electrical failure in the Riata lead at 1 year. Methods: A retrospective chart review was conducted in patients who underwent implantation of a Riata/Riata ST lead at one center. Patients with a functioning Riata lead (with/without externalized conductor) at the time of ICD exchange were compared to controls with Riata leads implanted for a comparable amount of time who did not undergo generator replacement. Results: Riata leads were implanted in 1,042 patients prior to the recall and 153 of these patients underwent generator exchange without lead replacement. Conductor externalization was noted in 21.5% of Riata leads in the ICD exchange cohort, which was not different from the control group (19.2%; P = 0.32). Two leads failed in the first year after generator replacement (1.5%) which did not significantly differ from the control group (2.0%; P = 0.57). At change-out, 54% received a commanded shock (18.6 ± 0.9 J) that did not result in any change in the high-voltage lead impedance (46.1 ± 1.1 ohms). Conclusions: Conductor externalization was seen frequently in our cohort of patients. ICD generator exchange did not accelerate the rate of Riata lead failure at 1 year. Although both the control and the change-out cohorts failed at a rate much greater than nonrecalled leads, generator exchange did not appear to add to the problem. [ABSTRACT FROM AUTHOR]

Background Little data exist on long-term outcomes following extraction of implantable cardioverter defibrillator (ICD) leads, particularly for noninfectious indications. We sought to identify predictors of long-term survival after ICD lead extraction. Methods We retrospectively reviewed ICD lead extractions at our institution (n = 508). Procedural outcomes and long-term survival were ascertained by medical records review. Results Indication for lead extraction was infection in 32.5% and lead failure in 61.8%. Mean dwell time of the oldest extracted lead was 5.1 ± 5.9 years. Complete procedural success was achieved in 96.5% of cases. Major procedure-related complications occurred in 1.6% with six periprocedural deaths. During a mean follow-up of 866 ± 798 days, survival was significantly worse among patients with infection as the indication for extraction. At 1 year after extraction, survival among those with infection was 88.2%, compared to 95.0% in the lead failure cohort (P < 0.001). Procedural failure was a significant predictor of long-term mortality, even after excluding periprocedural deaths. In multivariate models, the presence of chronic kidney disease, increased number of leads requiring extraction, lower ejection fraction, and procedural failure were predictors of mortality. Conclusion Despite high rates of procedural success, infectious indication for ICD lead extraction is associated with increased long-term mortality. In contrast, among patients undergoing extraction for lead failure, long-term survival was excellent. The presence of procedural failure was a significant predictor of long-term mortality. Further studies will be necessary to better understand the mechanisms by which procedural failure may adversely impact long-term outcomes. [ABSTRACT FROM AUTHOR]

Subcutaneous ICD in Dialysis Patients 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. [ABSTRACT FROM AUTHOR]