Marye J. Gleva

Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures Results From the REPLACE Registry

Background— Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates. Methods and Results— We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively. Conclusions— Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00395447.

Poor prognosis for patients with chronic kidney disease despite ICD therapy for the primary prevention of sudden death.

Introduction: Chronic kidney disease (CKD) has been independently associated with increased cardiovascular mortality. Little is known about the benefit of implantable cardioverter defibrillator (ICD) therapy for prevention of sudden death in this large, high‐risk population. We sought to evaluate the impact of CKD on survival in patients who received an ICD for primary prevention of sudden death.

Cardiovascular Implantable Electronic Device Replacement Infections and Prevention: Results from the REPLACE Registry

Background:  Infection following cardiovascular implantable electronic device (CIED) replacement is a serious complication, and rates of infection have increased. Analysis of procedural and clinical data from device replacement procedures collected by the REPLACE Registry may provide insights into infection prevention strategies and outcomes.

Atrial Tachyarrhythmias After the Maze Procedure Incidence and Prognosis

Background—The Maze procedure restores normal sinus rhythm in the majority of patients. However, atrial tachyarrhythmias (ATA) are a common early complication after the operation. The purpose of this study was to define the incidence and natural history of ATA after the Maze procedure. Methods—Complete medical records from 200 patients who underwent the Maze procedures (I, II, and III) from 1987 to 2002 were examined for all episodes of early postoperative ATA that occurred during the first 30 days after the procedure. Two electrophysiologists independently reviewed all postoperative 12-lead electrocardiograms. Results—ATA occurred in 86 patients (43%) after the Maze procedure. Of the patients with ATA, 59% had atrial fibrillation (AF), 14% had atrial flutter (AFL), and 27% had both AF and AFL. Of the patients with AF or AFL, 20% and 5%, respectively, also had episodes of atrial tachycardia and supraventricular tachyarrhythmia. The peak incidence of early postoperative ATA was on postoperative day 8. The average duration of ATA was 5.7±5.0 days. Late recurrence of AF (>1 year postoperatively) occurred in 7.0% of patients who had early postoperative ATA and 8.8% of patients without early postoperative ATA (P=0.8). Conclusions—ATA occurred in 43% of patients after the Maze procedure. The tachyarrhythmias occurred primarily within 8 days after surgery and resolved within 3 weeks in almost all patients. There was no relationship between the incidence of early postoperative ATA and the late recurrence of AF.

Laser-assist during extraction of chronically implanted pacemaker and defibrillator leads

BACKGROUND Extraction of chronically implanted pacing and defibrillator leads has historically been difficult, occasionally requiring open surgical procedures. The purpose of this study was to evaluate the efficacy, safety, and potential need for percutaneous laser-assisted sheath techniques for extraction of chronically implanted leads. METHODS From January 1999 to August 2001, 128 consecutive patients underwent extraction of 229 leads (138 pacing, 91 defibrillator) in the operating room 61 +/- 44 (mean +/- standard deviation) months after implantation. Common indications included erosion or pocket infection (41%), lead dysfunction (30%), and sepsis (13%). RESULTS Laser techniques were used for 56% +/- 4% (104 of 186) of long-term (implanted for more than 1 year) leads, compared with only 16% +/- 6% (7 of 43) of short-term (implanted for less than 1 year) leads (p < 0.001). For infected leads, laser was used in 53% +/- 5% (49 of 92) with erosion or pocket infections, compared with only 3% +/- 4% (1 of 29) with sepsis (p < 0.001). Extraction was complete in 88%, near complete (retained tip) in 10%, and incomplete in 2%. Two patients required a later percutaneous femoral venous approach to remove mobile retained segments, but no patients required cardiac surgery for extraction. Complications included sternotomy for subclavian vein injury (1), chest tube for caval perforation (1), innominate vein thrombosis (1), and partial clavicle removal for subclavian vein repair (2). There were no procedure-related deaths. CONCLUSIONS Laser-assisted lead extraction is safe, but it is best performed in the operating room; it should be available for long-term leads, except when they are grossly infected, producing sepsis. Laser techniques have essentially eliminated the need for open surgical removal of retained leads.

The azygos defibrillator lead for elevated defibrillation thresholds: implant technique, lead stability, and patient series.

Background: Conventional insertion of implantable cardioverter‐defibrillator (ICD) includes an evaluation of the defibrillation threshold (DFT). Implanting an ancillary defibrillation lead in the azygos vein has been introduced as a therapeutic option in patients with “high” DFT. This study reports the efficacy and stability of azygos defibrillation coils implanted for elevated DFTs.

Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia

BACKGROUND Recent advances have enabled noninvasive mapping of cardiac arrhythmias with electrocardiographic imaging and noninvasive delivery of precise ablative radiation with stereotactic body radiation therapy (SBRT). We combined these techniques to perform catheter‐free, electrophysiology‐guided, noninvasive cardiac radioablation for ventricular tachycardia. METHODS We targeted arrhythmogenic scar regions by combining anatomical imaging with noninvasive electrocardiographic imaging during ventricular tachycardia that was induced by means of an implantable cardioverter–defibrillator (ICD). SBRT simulation, planning, and treatments were performed with the use of standard techniques. Patients were treated with a single fraction of 25 Gy while awake. Efficacy was assessed by counting episodes of ventricular tachycardia, as recorded by ICDs. Safety was assessed by means of serial cardiac and thoracic imaging. RESULTS From April through November 2015, five patients with high‐risk, refractory ventricular tachycardia underwent treatment. The mean noninvasive ablation time was 14 minutes (range, 11 to 18). During the 3 months before treatment, the patients had a combined history of 6577 episodes of ventricular tachycardia. During a 6‐week postablation “blanking period” (when arrhythmias may occur owing to postablation inflammation), there were 680 episodes of ventricular tachycardia. After the 6‐week blanking period, there were 4 episodes of ventricular tachycardia over the next 46 patient‐months, for a reduction from baseline of 99.9%. A reduction in episodes of ventricular tachycardia occurred in all five patients. The mean left ventricular ejection fraction did not decrease with treatment. At 3 months, adjacent lung showed opacities consistent with mild inflammatory changes, which had resolved by 1 year. CONCLUSIONS In five patients with refractory ventricular tachycardia, noninvasive treatment with electrophysiology‐guided cardiac radioablation markedly reduced the burden of ventricular tachycardia. (Funded by Barnes–Jewish Hospital Foundation and others.)

Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions

BACKGROUND Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). OBJECTIVE The purpose of the ProMRI/ProMRI AFFIRM Study, which was a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Pacemaker System under specific MRI conditions. METHODS The ProMRI Study (in the United States) and the ProMRI AFFIRM study (outside the United States) with identical design enrolled 272 patients with stable baseline pacing indices implanted with an Entovis or Evia pacemaker (DR-T or SR-T) and Setrox or Safio 53-cm or 60-cm lead. Device interrogation was performed at enrollment, pre-MRI and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects (SADEs) through 1 month post-MRI, (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V), and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. RESULTS Two hundred twenty-six patients completed the MRI and 1-month post-MRI follow-up. No adverse events related to the implanted system and the MRI procedure occurred, resulting in an SADE-free rate of 100.0% (229/229, P <.001). Freedom from atrial and ventricular pacing threshold increase was 99.0% (189/191, P = .003) and 100% (217/217, P <.001), respectively. Freedom from P- and R- wave amplitude attenuation was 99.4% (167/168, P <.001) and 99.5% (193/194, P <.001), respectively. CONCLUSION The results of the ProMRI/ProMRI AFFIRM studies demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to head and lower lumbar MRI conditions.

REPLACE DARE (Death After Replacement Evaluation) Score Determinants of All-Cause Mortality After Implantable Device Replacement or Upgrade From the REPLACE Registry

Background— Identifying factors predictive of mortality may be important to decrease risk associated with cardiac implantable electrical device (CIED) replacement procedures. This study aimed to determine whether clinical factors and complications independently associate with death and to develop a mortality risk prediction tool after CIED replacement. Methods and Results— The prospective REPLACE Registry determined 6-month complication and mortality rates after CIED replacement with or without planned lead addition or revision. Vital status was collected. Kaplan-Meier survival and multivariable Cox proportional hazards regression analyses were performed to identify patient, procedural, or complication variables predictive of death. The REPLACE DARE (Death After Replacement Evaluation) Score was constructed using hazard ratios, reflecting relative risk contributions of each variable, combined into an additive mortality risk score equation. At 6 months, 70 of 1744 (4.0%) patients had died. Cox regression analysis found no significant association between major complications and death. However, recent heart failure admission, New York Heart Association class III/IV, antiarrhythmic drug use, cerebrovascular disease, and chronic kidney disease stage were independently associated with 6-month mortality. The REPLACE DARE Score was 2.0±1.4 in survivors versus 3.5±1.8 in nonsurvivors ( P <0.001), with predictive receiver operating characteristic value=0.758 ( P <0.001). Risk of death was 1.0% for DARE=0 and 55.6% for DARE=7. The hazard ratio was 1.8 for each change of 1 DARE unit. Conclusions— Comorbidities, but not complications, were significantly associated with mortality after CIED replacement. The REPLACE DARE Score is a novel tool that can identify patients with substantial mortality risk. Such patients should have the relative risk and benefit of their procedure considered carefully. Clinical Trial Registration— URL: . Unique identifier: [NCT00395447][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00395447&atom=%2Fcircae%2F7%2F6%2F1048.atomBackground—Identifying factors predictive of mortality may be important to decrease risk associated with cardiac implantable electrical device (CIED) replacement procedures. This study aimed to determine whether clinical factors and complications independently associate with death and to develop a mortality risk prediction tool after CIED replacement. Methods and Results—The prospective REPLACE Registry determined 6-month complication and mortality rates after CIED replacement with or without planned lead addition or revision. Vital status was collected. Kaplan-Meier survival and multivariable Cox proportional hazards regression analyses were performed to identify patient, procedural, or complication variables predictive of death. The REPLACE DARE (Death After Replacement Evaluation) Score was constructed using hazard ratios, reflecting relative risk contributions of each variable, combined into an additive mortality risk score equation. At 6 months, 70 of 1744 (4.0%) patients had died. Cox regression analysis found no significant association between major complications and death. However, recent heart failure admission, New York Heart Association class III/IV, antiarrhythmic drug use, cerebrovascular disease, and chronic kidney disease stage were independently associated with 6-month mortality. The REPLACE DARE Score was 2.0±1.4 in survivors versus 3.5±1.8 in nonsurvivors (P<0.001), with predictive receiver operating characteristic value=0.758 (P<0.001). Risk of death was 1.0% for DARE=0 and 55.6% for DARE=7. The hazard ratio was 1.8 for each change of 1 DARE unit. Conclusions—Comorbidities, but not complications, were significantly associated with mortality after CIED replacement. The REPLACE DARE Score is a novel tool that can identify patients with substantial mortality risk. Such patients should have the relative risk and benefit of their procedure considered carefully. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00395447.

Implant and Clinical Characteristics for Pediatric and Congenital Heart Patients in the National Cardiovascular Data Registry Implantable Cardioverter Defibrillator Registry

Background —In 2010 the NCDR Registry® enhanced pediatric, non-atherosclerotic structural heart disease and congenital heart disease (CHD) data collection. This report characterizes CHD and pediatric patients undergoing implantable cardioverter-defibrillator (ICD) implantation. Methods and Results —ICD procedures (April 2010 - December 2012) in the Registry for two cohorts: 1) all CHD patients (atrial septal defect (ASD), ventricular septal defect (VSD), Tetralogy of Fallot (ToF), Ebstein anomaly, transposition of the great vessels (TGV), and common ventricle (CV)), and 2) patients under 21 years. We evaluated indications and characteristics to include transvenous (TV) and non-TV lead implants, CHD type, and NYHA class. There were 3,139 CHD procedures, 1,601 for patients under 21 years and 126 for CHD under 21 years. ICD indications for CHD patients were primary prevention in 1,943 (61.9%) and secondary prevention in 1,107 (35.2%). Pediatric patients had 935 (58.4%) primary prevention and 588 (36.7%) secondary prevention devices. Primary prevention had higher NYHA class. Non-TV age (35.9 ± 23.2 years vs. 40.1 ± 24.6 years; p= 0.05) and Non-TV height (167.1 ± 18.9 cm; range 53-193 cm; vs. 170.4 ± 13.1 cm; range 61-203 cm; p<0.01) were lower than for TV patients. CHD and pediatrics had similar rates of TV (97%) and non-TV (3%) leads and did not differ from the overall registry. TGV and common ventricle had higher rates of non-TV leads. Conclusions —Primary prevention exceeds secondary prevention for CHD and pediatrics. Non-TV lead patients were younger, with higher rates of TGV and CV patients compared to TV lead patients.Background—In 2010, the National Cardiovascular Data Registry enhanced pediatric, nonatherosclerotic structural heart disease and congenital heart disease (CHD) data collection. This report characterizes CHD and pediatric patients undergoing implantable cardioverter defibrillator implantation. Methods and Results—In this article, we report implantable cardioverter defibrillator procedures (April 2010 to December 2012) in the registry for 2 cohorts: (1) all patients with CHD (atrial septal defect, ventricular septal defect, tetralogy of Fallot, Ebstein anomaly, transposition of the great vessels, and common ventricle) and (2) patients <21 years. We evaluated indications and characteristics to include transvenous and nontransvenous lead implants, CHD type, and New York Heart Association class. There were 3139 CHD procedures, 1601 for patients <21 years and 126 for CHD <21 years. Implantable cardioverter defibrillator indications for patients with CHD were primary prevention in 1943 (61.9%) and secondary prevention in 1107 (35.2%). Pediatric patients had 935 (58.4%) primary prevention and 588 (36.7%) secondary prevention devices. Primary prevention had higher New York Heart Association class. Nontransvenous age (35.9±23.2 versus 40.1±24.6 years; P=0.05) and nontransvenous height (167.1±18.9 cm; range, 53–193 cm versus 170.4±13.1 cm; range, 61–203 cm; P<0.01) were lower than for transvenous patients. CHD and pediatrics had similar rates of transvenous (97%) and nontransvenous (3%) leads and did not differ from the overall registry. Transposition of the great vessels and common ventricle had higher rates of nontransvenous leads. Conclusions—Primary prevention exceeds secondary prevention for CHD and pediatrics. Nontransvenous lead patients were younger, with higher rates of transposition of the great vessels and common ventricle patients compared with transvenous lead patients.