Four-year follow-up of outcomes of the hybrid epicardial-endocardial ablation: A single-center experience.

BACKGROUND: The CONVERGE trial demonstrated that hybrid epicardial and endocardial ablation was more effective than catheter ablation for the treatment of persistent atrial fibrillation (AF) at 1 year. Long-term real-world outcome data are scarce. OBJECTIVE: We described a single-center experience by evaluating the long-term effectiveness and safety of hybrid epicardial-endocardial ablation. METHODS: This is a retrospective single-center study. Patients were followed up to 4 years. The primary end point was the rate of AF recurrence up to 4 years postablation. Secondary end points included reduction in antiarrhythmic therapy use, the effect of the ligament of Marshall removal, epicardial posterior wall, 3-dimensional mapping during epicardial ablation, and left atrial appendage exclusion as adjunct intraoperative interventions for AF recurrence. RESULTS: Of the 170 patients, 86.5% had persistent AF and 13.5% had long-standing persistent AF. AF-free survival was 87.6% at 1 year, 76.9% at 2 years, 70.4% at 3 years, and 59.3% at 4 years. Antiarrhythmic drug use was 87.6% at baseline and reduced to 21%, 20.6%, 18%, and 14.1% at year 1, 2, 3, and 4, respectively (P < .01 for all). Three-dimensional epicardial mapping showed a significant reduction in combined recurrence from 42% to 25% over 4 years of follow-up (P = .023). Ligament of Marshall and left atrial appendage exclusion showed numerical reduction in AF recurrence from 35% to 26% (P = .49) and from 44% to 30% (P = .07). CONCLUSION: The hybrid convergent procedure reduces AF recurrence and the need for antiarrhythmic drugs and, while maintaining a good safety profile, for the treatment of persistent and long-standing persistent AF.

Transvenous Lead Extraction in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy.

OBJECTIVES: This study aimed to evaluate the effectiveness and safety of transvenous lead extraction (TLE) in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC). BACKGROUND: ARVC is an increasingly diagnosed cardiomyopathy that often requires device implantation to prevent sudden death. Little is known about TLE in this setting, which has potential challenges and risks, primarily due to right ventricular (RV) wall thinning and fragility. METHODS: All consecutive patients with ARVC who underwent TLE at our institution between 1996 and 2016 were included. When extraction tools were used, sheaths were advanced to the RV with countertraction at the lead tip. Success and complications were defined in concordance with Heart Rhythm Society guidelines. RESULTS: Twenty-two TLE procedures in patients with ARVC involved extraction of 27 leads (22 defibrillators and 5 pacemakers). TLEs were performed due to evidence of lead malfunction (n = 17; 77%) or device infection (n = 5; 23%). Twenty-four leads (89%) were RV, and 3 leads (11%) were right atrial. The median age of the oldest extracted lead was 1,691 days (interquartile range [IQR]: 1,168 to 2,726 days). Specialized extraction tools were required in 20 procedures (91%). None required the use of a snare or a femoral workstation. The median procedural and fluoroscopic times were 152 min (IQR: 129 to 185 min) and 11 min (IQR: 6 to 18 min), respectively. Complete procedural success with removal of all leads was achieved in all cases. There were no major complications. CONCLUSIONS: In a high-volume center, TLE in patients with ARVC was associated with a high success rate and a low rate of complications when guideline-established techniques and tools were used.

Removal of subcutaneous defibrillator shocking coils: Lessons to learn for future extraction of subcutaneous defibrillator systems.

BACKGROUND: Subcutaneous shocking coils (SQC) have been used to lower defibrillation thresholds in certain patient populations. There are limited data regarding the extraction complexity of these leads. The goal of this study is to describe our SQC extraction experience and identify challenges that may be of importance with the increase in utilization and extraction of fully subcutaneous defibrillator systems. METHODS: We studied consecutive patients who underwent lead removal at our institution during which a Medtronic 6996SQ (Medtronic plc, Minneapolis, MN, USA) was removed RESULTS: Twenty-one patients (54.5 ± 14 years, 85.7% male) underwent procedures where at least one lead removed was a SQC. Mean ejection fraction was 27.7% and 11 patients had prior ventricular arrhythmia. Median SQC age was 177 days and the age of the oldest SQC removed was 3,041 days. Infection was the indication for removal in 14 patients. One removal was performed surgically and 20 were completed percutaneously. Three procedures required additional incisions beyond the device pocket and tie-down sleeve to complete the SQC lead removal due to dense adhesions. One removal procedure required the use of a laser sheath to relieve fibrosis. Complications in this group did not appear related to SQC removal. CONCLUSIONS: Drawing from our SQC removal experience, there may be a need for additional incisions and extra tools to complete removal of older subcutaneous implantable cardioverter defibrillator leads.

Transvenous Lead Extraction in Chronic Kidney Disease and Dialysis Patients With Infected Cardiac Devices.

BACKGROUND: Cardiac implantable electronic device infections have been on the rise. A high-risk population is that with renal disease, especially dialysis. We aimed to assess procedural profiles and clinical outcomes of transvenous lead extraction for cardiac implantable electronic device infection based on renal disease status. METHODS AND RESULTS: In 1420 consecutive patients undergoing transvenous lead extraction of infected cardiac implantable electronic devices (1996-2012), we assessed procedural profiles and clinical outcomes in 3 groups: normal renal function (group 1, n=1159), renal dysfunction not requiring dialysis (group 2, n=163), and dialysis (group 3, n=98). A total of 3182 infected leads were extracted. Dialysis patients had shorter lead dwell times and were less likely to require transvenous lead extraction tools but as likely to require femoral workstations. There were higher overall rates of procedure-related complications in dialysis patients (12% versus ≈6% in nondialysis) with no difference in the major complication rates (P=not significant). Complete procedural success rates were 94%, 96%, and 94% in groups 1, 2, and 3, respectively (P=not significant). There were 4 intraprocedural deaths in group 1 versus none in groups 2 and 3. Mortality rates were significantly higher in dialysis patients both at 1 and 6 months (P<0.0001 for both). In multivariable analyses, dialysis status was independently associated with increased mortality risk at 1 and 6 months. Other factors associated with mortality were lead material retention, functional (New York Heart Association) class, and occurrence of procedural complications. CONCLUSIONS: In patients with cardiac implantable electronic device infection, dialysis status did not seem to add complexity to transvenous lead extraction but was independently associated with increased mortality at 1 and 6 months.

Unrecognized venous injuries after cardiac implantable electronic device transvenous lead extraction.

BACKGROUND: The major complication rate of transvenous lead extraction (TLE) is estimated to be 1%-2%. Laceration of the central veins can be fatal. OBJECTIVES: To define the incidence and extent of venous injuries on a microscopic level after TLE and compare these data with those of clinically documented events of venous laceration. METHODS: We studied all patients who underwent TLE at our tertiary center within 30 months via a variety of techniques. Extracted leads and tissue around them were fixed in formalin. Pathologic examination was standardized to examine the leads identifying the areas covered by tissue cuffs along the length of the lead. The cuffs were removed and sectioned transversely to their longitudinal axis. Microscopic examination was performed using hematoxylin and eosin stains and Movat stains to identify the presence of vein tissue. RESULTS: In all, 861 leads (585 pacemaker and 272 defibrillator leads) were extracted from 461 patients (median age 63 years, standard deviation 15 years), with an average of 1.9 leads per patient and a median lead age of 2546 days. On microscopic review, 80 leads (9.3%) in 72 of 461 patients (15.6%) showed segments of vein, most of which were transmural (venous tissue including adventitia). Despite this finding, only 5 catastrophic complications (1.1%) occurred that required emergent surgical intervention. Risk factors for venous injury included implantable cardioverter defibrillator lead, age of lead, and the use of laser sheath. CONCLUSIONS: Microscopic venous injuries during lead extraction are common but often not recognized clinically.

Cardiac Implantable Electronic Device Infections: Added Complexity and Suboptimal Outcomes With Previously Abandoned Leads.

OBJECTIVES: This study sought to assess the impact of previously abandoned leads on the clinical management of cardiac device infections, notably transvenous lead extraction and subsequent clinical course. BACKGROUND: The population of patients with cardiac implantable electronic devices continues to grow with a disproportionate increase in device infections, which are invariably life threatening. A potentially complicating issue is the widely practiced strategy of device lead abandonment at the time of system revision, change, or upgrade, which is affecting an increasing number of patients. METHODS: The study assessed the impact of previously abandoned leads in a prospectively maintained registry of consecutive patients undergoing percutaneous extraction of infected cardiac devices at the Cleveland Clinic between August 1996 and September 2012. The primary clinical endpoint was complete procedural and clinical success defined as the successful removal of the device and all lead material from the vascular space, in the absence of a major complication. RESULTS: Of 1,386 patients with infected cardiac devices, 323 (23.3%) had previously abandoned leads. Failure to achieve the primary endpoint occurred more frequently in patients with abandoned leads (13.0% vs. 3.7%; p < 0.0001). This was primarily due to retention of lead material (11.5% vs. 2.9%; p < 0.0001), which was associated with poor clinical outcomes including higher rates of 1-month mortality (7.4% vs. 3.5% in those without lead remnants). Lead extraction procedures in patients with previously abandoned leads were longer (p < 0.0001), with longer fluoroscopy times (p < 0.0001), and more likely to require specialized extraction tools (94.4% vs. 81.8%; p < 0.0001) or adjunctive rescue femoral workstations (14.9% vs. 2.9%; p < 0.0001). Procedural complications occurred more frequently in patients with previously abandoned leads (11.5% vs. 5.6%; p = 0.0003), which was true for both major (3.7% vs. 1.4%; p = 0.009) and minor complications (7.7% vs. 4.4%; p = 0.02). CONCLUSIONS: Previously abandoned leads complicate the management of cardiac device infections, leading to worse clinical outcomes.

Microbiology of Cardiac Implantable Electronic Device Infections.

OBJECTIVES: This study reports a high-volume tertiary care center experience with the microbiology of cardiac implantable electronic devices (CIED) infections with assessment of temporal trends and profiles of late versus early infections. BACKGROUND: The rates of CIED infections have been increasing. With changing demographics, patient and device characteristics, prophylactic measures, and the wide use of broad-spectrum antibiotics, there is need for updated contemporary data on the microbiology of CIED infections. METHODS: The study included 816 consecutive patients with confirmed CIED infections who underwent transvenous lead extraction at our institution between the years 2000 and 2011. Blood cultures were obtained in addition of pocket swabs, pocket capsule, and leads. RESULTS: Staphylococcal species remained the most common pathogens in CIED infections (68.4%), especially coagulase-negative species (37.6%). Methicillin-resistant staphylococci were the pathogens in 33.8% of all CIED infections and accounted for 49.4% of all staphylococcal infections. Gram-negative pathogens were identified in 8.9% of cases, whereas 13.2% were with negative cultures. CIED infections related to streptococci (2.5%), enterococci (4.2%), anaerobes (1.6%), fungi (0.9%), and mycobacteria species (0.2%) were less common. Of pocket infections, 49.5% occurred more than 1 year after pocket manipulation, and 53.6% of these were related to coagulase-negative staphylococci. In contrast, most endovascular infections were related to Staphylococcus aureus. The proportions of culture negative infections have increased (p < 0.0001). CONCLUSIONS: The study provides contemporary data on the microbiology of CIED infections. The rates of methicillin resistance seem to be greater than those reported from the preceding decade.

Nomogram for predicting 30-day all-cause mortality after transvenous pacemaker and defibrillator lead extraction.

BACKGROUND: For each clinical circumstance, the benefits of transvenous lead extraction (TLE) need to be weighed against the risks. Clinical decision-making tools for predicting mortality after TLE are lacking. OBJECTIVE: To create a preoperative risk score for prediction of 30-day all-cause mortality after TLE of pacemaker and defibrillator leads. METHODS: Consecutive patients undergoing TLE at the Cleveland Clinic between August 1996 and August 2011 were included in the analysis. A risk nomogram for predicting 30-day all-cause mortality was developed using baseline clinical variables and multivariable logistic regression modeling. Discrimination and calibration were assessed by using bootstrapping for internal validation. Continuous data are presented as median (25th, 75th percentile); categorical data are presented as number (percentage). RESULTS: A total of 5521 (4137 [74.9%] pacemaker and 1384 [25.1%] defibrillator) leads were extracted during 2999 TLE procedures (patient age 67.2 [55.2, 76.2] years, 30.2% female). Lead implant duration was 4.7 (2.4, 8.3) years and 2.0 (1.0, 2.0) leads were extracted per procedure. Sixty-seven patients (2.2%) had died by 30 days after TLE. Variables with the highest predictive value for 30-day all-cause mortality included age, body mass index, hemoglobin, end-stage renal disease, left ventricular ejection fraction, New York Heart Association functional class, extraction for infection, number of prior lead extractions performed by the operator, and extraction of a dual-coil defibrillator lead. These variables were used to create a nomogram with a bootstrap-corrected concordance index value of 0.867. CONCLUSIONS: Thirty-day all-cause mortality after TLE can be assessed with good discriminative power using readily available clinical information.

Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions.

BACKGROUND: It is difficult to predict adverse patient outcomes associated with transvenous lead extraction (TLE) procedures. OBJECTIVE: The purpose of this study was to examine the safety and efficacy of chronic endovascular pacemaker and implantable cardioverter-defibrillator (ICD) lead extraction and risk factors associated with adverse patient outcomes. METHODS: Consecutive patients undergoing TLE at the Cleveland Clinic between August 1996 and August 2011 were included in the analysis. Univariate and multivariable logistic regression analyses were performed to evaluate for associations with outcomes. Continuous data are given as median (25th, 75th percentile). Categorical data are given as number (percentage). RESULTS: In total, 5521 leads (4137 [74.9%] pacemaker, 1384 [25.1%] ICD) were extracted during 2999 TLE procedures (patient age 67.2 [55.2, 76.2] years, 30.2% female). Lead implant duration was 4.7 (2.4, 8.3) years, and 2.0 (1.0, 2.0) leads were extracted per procedure. Powered sheaths were used in 74.9% of procedures. Overall, there was 95.1% complete procedural success, 98.9% clinical success, and 1.1% failure, with 3.6% minor complications and 1.8% major complications. All-cause mortality within 30 days of TLE was 2.2%. Multivariable predictors of major complications included cerebrovascular disease, ejection fraction ≤15%, lower platelet count, international normalized ratio ≥1.2, mechanical sheaths, and powered sheaths. Multivariable predictors of all-cause mortality within 30 days of TLE included body mass index <25 kg/m(2), end-stage renal disease, higher New York Heart Association functional class, lower hemoglobin, higher international normalized ratio, lead extraction for infection, and extraction of a dual-coil ICD lead. CONCLUSION: TLE in this single-center experience was highly successful. Risk factors associated with adverse patient outcomes were identified.

Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction.

BACKGROUND: The outcomes of patients requiring emergent surgical or endovascular intervention during transvenous lead extraction (TLE) have not been well characterized. OBJECTIVES: To evaluate the incidence of catastrophic complications requiring emergent surgical or endovascular intervention during TLE, to describe the injuries, and to review patient management and outcomes. METHODS: Consecutive patients undergoing TLE of pacemaker and implantable cardioverter-defibrillator (ICD) leads at the Cleveland Clinic between August 1996 and September 2012 were included in the analysis. RESULTS: A total of 5973 (4436 [74.3%] pacemaker and 1537 [25.7%] ICD) leads were extracted during 3258 TLE procedures (median [25th, 75th percentile] patient age 67.0 [55.0, 76.1] years; 69.2% men). The median (25th, 75th percentile) lead implant duration was 4.9 (2.4, 8.4) years, and 2.0 (1.0, 2.0) leads were extracted per procedure. Powered sheaths were used in 2369 (72.7%) procedures. Twenty-five (0.8%) patients experienced catastrophic complications requiring emergent surgical or endovascular intervention. Twenty patients (0.6%) required either sternotomy (n = 18) or thoracotomy (n = 2) for superior vena cava laceration (n = 15) and right atrial (n = 2) or ventricular (n = 3) perforation. Two patients required vascular repair at the procedural access site for either subclavian vein or artery laceration. Three patients were managed with an endovascular approach for superior vena cava laceration, left axillary artery laceration, and brachiocephalic vein and artery fistula. In-hospital mortality was 36.0% (6 procedural/operative deaths and 3 deaths during the same hospitalization). CONCLUSIONS: Major vascular injury or cardiac perforation requiring emergent surgical or endovascular intervention during TLE is uncommon but carries significant in-hospital mortality. Despite high mortality, nearly two-thirds of these patients were rescued with immediate response and surgical or endovascular intervention.

Incidence, management, and outcomes of the arteriovenous fistula complicating transvenous lead extraction.

BACKGROUND: An arteriovenous (AV) fistula is an infrequently reported complication of transvenous lead extraction (TLE), but may be under-recognized. OBJECTIVE: To determine the incidence, management, and outcomes of the AV fistula complicating TLE. METHODS: All TLE procedures from July 2001 to December 2012 were reviewed. RESULTS: Of 2471 patients who underwent TLE, the AV fistula occurred in 8 (0.3%; 6 pacemaker and 2 implantable cardioverter-defibrillator) procedures. Patients who developed an AV fistula had longer lead implant duration (11.8 [interquartile range 7.7] vs 5.2 [interquartile range 7.0] years) and were more likely to have required a powered sheath (8 of 8 [100%] vs 1392 of 2463 [56.5%]) compared to those who did not. Other procedural and demographic details did not discriminate. All patients had a continuous bruit along the anterior chest wall. Catheter angiography was more sensitive (100%) than computed tomography (75%) or ultrasound (25%) for confirming the diagnosis and identifying the vessels involved. One fistula closed spontaneously, while others were closed with covered stents (4) or surgical glue (1). One attempt at closure failed, and one was diagnosed postmortem. Mortality related to the AV fistula was 3 of 8 (37.5%). Patients who died all had structural heart disease. In the 5 patients with normal hearts, the AV fistula was well tolerated for up to 2 years. CONCLUSIONS: An AV fistula is an infrequent, though possibly under-recognized, complication of TLE. It requires a high index of suspicion for early diagnosis, may present late, and may be associated with significant morbidity and mortality in patients with structural heart disease.

Transvenous extraction of implantable cardioverter-defibrillator leads under advisory--a comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads.

BACKGROUND: Comparative safety and efficacy associated with transvenous lead extraction (TLE) of recalled and non-recalled implantable cardioverter-defibrillator (ICD) leads has not been well characterized. OBJECTIVES: To compare the indications, techniques, and procedural outcomes of recalled vs non-recalled ICD lead extraction procedures. METHODS: TLE procedures performed at our institution from June 2002 to June 2012 in which Riata, Sprint Fidelis, or non-recalled ICD leads were extracted were included in the analysis. RESULTS: ICD lead extraction procedures were performed in 1079 patients, including 430 patients with recalled leads (121 Riata, 308 Sprint Fidelis, and 1 Riata and Sprint Fidelis) and 649 patients with non-recalled ICD leads. A total of 2056 chronic endovascular leads were extracted, of which 1215 (59.1%) were ICD leads. Overall, there was 96.8% complete procedural success, 99.1% clinical success, and 0.9% failure, with 3.9% minor complications and 1.5% major complications. Procedural outcomes for Riata and Sprint Fidelis TLE procedures were no different. Lead implant duration was significantly less in recalled than in non-recalled ICD lead TLE procedures. Complete procedural success was higher in recalled (424 of 430 [98.6%]) than in non-recalled (621 of 649 [95.7%]; P = .007) ICD lead TLE procedures. Minor complications were lower in recalled (10 of 430 [2.3%]) than in non-recalled (32 of 649 [5.0%]; P = .030) ICD lead TLE procedures. Rates of clinical success, failure, and major complications were no different in the recalled and non-recalled ICD lead TLE procedures. CONCLUSION: In our experience, recalled ICD leads were extracted with safety and efficacy comparable to that of non-recalled ICD leads.

Cardiac venous left ventricular lead removal and reimplantation following device infection: a large single-center experience.

BACKGROUND: Early series of biventricular device removal have contained mostly younger cardiac venous (CV) left ventricular leads and few have reported on rates of successful reimplantation. METHODS AND RESULTS: We performed a retrospective analysis of all patients referred to the Cleveland Clinic between February 2, 2001 and July 27, 2011 for removal of a biventricular device with a CV pacing lead for an infectious indication. A total of 173 patients were included. The median age of the CV leads was 22.3 months (interquartile range: 5.2-46.3 months). The complete procedural success rate for all leads was 97.7%, with the remaining 2.3% clinical successes. A total of 76.9% of CV leads were removed using simple traction alone with the remaining leads requiring the use of a laser-powered sheath. A total of 3.5% of leads required intervention (manual dissection or laser-powered dissection) within the coronary sinus (CS). Major complications occurred in 1.2% of patients. Minor complications occurred in 7.5% of patients, the majority of which were hematomas requiring drainage (6.9%). CV lead reimplantation was attempted in 107 patients of which 88 (82.8%) were successful. CONCLUSION: CV lead removal in patients with an infected biventricular device is associated with an extremely high procedural success rate and a low incidence of major complications. The use of a laser-powered sheath is necessary in roughly one-quarter of cases with a very small percentage requiring intervention within the CS. Reimplantation of CV leads is achievable in roughly 83% of patients, a figure lower than nationally quoted estimates for de novo implantations.

Effect of heparin administration on metabolomic profiles in samples obtained during cardiac catheterization.

BACKGROUND: Metabolic profiling holds promise for early detection of coronary artery disease and assessing risk for ischemic events. Heparin is frequently administered (1) to treat acute coronary syndromes; and (2) during routine cardiac catheterization procedures. Because it stimulates lipolysis, heparin is a potential confounder of metabolic profiling in these populations. METHODS AND RESULTS: Using mass spectrometry and conventional immunoassays, we evaluated how unfractionated heparin administration affected 69 peripheral blood metabolites (acylcarnitines, amino acids, nonesterified fatty acids and their oxidation byproducts, conventional lipids, glucose, and C-reactive protein) in samples obtained pre- and postcardiac catheterization from 19 patients who received heparin and 10 patients who did not. Using unpaired t tests, we compared the changes in mean metabolite levels before and after the procedure between the nonheparin and heparin groups. Clinical characteristics of the nonheparin and heparin groups, indication for cardiac catheterization, procedure performed, and other periprocedural variables were similar. The mean change between pre- and postprocedure ß-hydroxybutyrate (5.43 versus 66.84 µmol/L; P=0.009), ketones (21.17 versus 98.49 µmol/L; P=0.009), nonesterified fatty acids (0.37 versus 1.20 mmol/L; P=0.017), and triglycerides (-9.33 versus -36.50 mg/dL; P=0.007) was significantly different between the nonheparin and heparin groups, respectively. There were no significant differences between groups in the other metabolites measured. CONCLUSIONS: Heparin administration during cardiac catheterization induced changes in peripheral blood metabolites that were consistent with known lipolytic effects of heparin and define a metabolite signature associated with heparin administration. These findings are important for accurate interpretation of future metabolic profiling studies in populations exposed to heparin.