Comparison of outcomes and required tools between transvenous extraction of pacemaker and implantable cardioverter defibrillator leads: Insight from single high-volume center experience.

INTRODUCTION: Reports of comparison with procedural outcomes for implantable cardioverter defibrillator (ICD) and pacemaker (PM) transvenous lead extraction (TLE) are old and limited. We sought to compare the safety, efficacy, and procedural properties of ICD and PM TLE and assess the impact of lead age. METHODS: The study cohort included all consecutive patients with ICD and PM TLE in the Cleveland Clinic Prospective TLE Registry between 2013 and 2022. Extraction success, complications, and failure employed the definitions described in the HRS 2017 TLE guidelines. RESULTS: A total of 885 ICD leads, a median implant duration of 8 (5-11) years in 810 patients, and 1352 PM leads of 7 (3-13) years in 807 patients were included. Procedural success rates in ICD patients were superior to those of PM in >20 years leads but similar in ≤20 years leads. In the PM group, the complete success rate of TLE decreased significantly according to the increase of lead age, but not in the ICD group. ICD TLE required more extraction tools compared with PM TLE but cases with older leads required non-laser sheath extraction tools in both groups. The most common injury site in major complication cases differed between ICD and PM TLE, although major complication rates showed no difference in both groups (2.7% vs. 1.6%, p = .12). CONCLUSION: The procedural success rate by TLE is greater for ICD patients than PM patients with leads >20 years old but requires more extraction tools. Common vascular complication sites and the impact of lead age on procedural outcomes and required tools differed between ICD and PM TLE.

Catheter ablation of atrial fibrillation in elderly and very elderly patients: safety, outcomes, and quality of life.

BACKGROUND: Atrial fibrillation (AF) risk increases with age. We aim to assess the efficacy and safety of catheter ablation in the older population. METHODS: All patients undergoing AF ablation (2013-2021) at our institution were enrolled in a prospectively maintained registry. The primary endpoint was AF recurrence. Patients were divided into 3 groups: non-elderly (< 65 years), elderly (65-75 years), and very elderly (> 75 years). Patient surveys at baseline and during follow-up were used to calculate quality of life (QoL) metrics: the AF severity score as well as the AF burden. RESULTS: A total of 7020 patients were included (42% non-elderly, 42% elderly, and 16% very elderly). Periprocedural major complications were low (< 1.5%) and similar in all groups besides pericardial effusion which was more frequent with older age and similar between the elderly and very elderly. At 3 years, AF recurrence for persistent AF (PersAF) was highest in the very elderly group (48%), followed by the elderly group (42%), and was the lowest in the non-elderly group (36%). In paroxysmal AF (PAF), there was no difference in AF recurrence between the elderly and non-elderly, while the very elderly remained associated with a significantly increased risk. Multivariable Cox analysis confirmed these findings (PersAF; elderly: HR = 1.23, P = 0.003; very elderly: HR = 1.44, P < 0.001) (PAF; elderly: HR = 1.04, P = 0.62; very elderly: HR = 1.30, P = 0.01). Catheter ablation resulted in a significant improvement in quality of life, irrespective of age group. CONCLUSION: Catheter ablation in elderly and very elderly patients is safe, efficacious, and associated with QoL benefits. Overall, major complications were minimal and did not differ significantly between age groups, with the exception of pericardial effusions which were higher in the elderly and very elderly compared to non-elderly adults. Very elderly patients had a higher rate of AF recurrence when compared with elderly or non-elderly patients. Nevertheless, ablation resulted in a remarkable improvement in QoL and a reduction of AF burden and AF symptoms with a similar magnitude, irrespective of age.

Clinical predictors of incomplete coronary sinus lead removal during transvenous lead extraction in patients with cardiac resynchronization therapy.

BACKGROUND: Reports of coronary sinus (CS) lead removal include small studies with short implant durations. Procedural outcomes for mature CS leads removed with long duration implantation are unavailable. OBJECTIVE: The purpose of this study was to examine the safety, efficacy, and clinical predictors of incomplete CS lead removal by transvenous lead extraction (TLE) in a large long implant duration cardiac resynchronization therapy patient cohort. METHODS: Consecutive patients with cardiac resynchronization therapy devices in the Cleveland Clinic Prospective TLE Registry who had TLE between 2013 and 2022 were included in the analysis. RESULTS: CS leads (N = 231; implant duration 6.1 ± 4.0 years) removed from 226 patients were included, using powered sheaths for 137 leads (59.3%). Complete CS lead extraction success was achieved in 95.2% of leads (n = 220) and in 95.6% of patients (n = 216). Major complications occurred in 5 patients (2.2%). Patients who had the CS lead extracted first had significantly higher incomplete removal rates than when the other leads were first removed. Multivariable analysis showed that older CS lead age (odds ratio 1.35; 95% confidence interval 1.01-1.82; P = .03) and removal of the first CS lead (odds ratio 7.48; 95% confidence interval 1.02-54.95; P = .045) were independent predictors of incomplete CS lead removal. CONCLUSION: The complete and safe lead removal rate of long implant duration CS leads by TLE was 95%. However, CS lead age and the order in which leads were extracted were the independent predictors of incomplete CS lead removal. Therefore, before the CS lead is extracted, physicians should first extract the leads from the other chambers and use powered sheaths.

Ablation of Atrial Fibrillation Without Left Atrial Appendage Imaging in Patients Treated With Direct Oral Anticoagulants.

BACKGROUND: Many centers continue to routinely perform transesophageal echocardiograms before atrial fibrillation (AF) ablation procedures in patients treated with direct oral anticoagulants (DOACs). One study suggested that the procedures could be done without transesophageal echocardiogram but used intracardiac echocardiography imaging of the appendage from the right ventricular outflow. This study aimed to assess the safety of ablation for AF without transesophageal echocardiogram screening or intracardiac echocardiography imaging of the appendage in DOAC compliant patients. METHODS: All patients undergoing AF ablation at the Cleveland Clinic (2011-2018) were enrolled in a prospectively maintained data registry. All consecutive patients presenting with AF or atrial flutter on DOAC were included. Periprocedural thromboembolic complications were assessed. RESULTS: A total of 900 patients were included. Their median CHA2DS2-VASc score was 2 (interquartile range 1-3). All were on DOACs (333 rivaroxaban, 285 dabigatran, 281 apixaban, and 1 edoxaban). Thromboembolic complications occurred in 4 patients (0.3%): 2 ischemic strokes, 1 transient ischemic attack without residual deficit, and 1 splenic infarct; all with no further complications. Bleeding complications occurred in 5 patients (0.4%): 2 pericardial effusions (1 intraoperative, 1 after 30 days, both drained), 3 groin hematomas (1 of them due to needing heparin for venous thrombosis, none required interventions). No patients required emergent surgeries. CONCLUSIONS: In DOAC compliant patients who present for ablation in AF/atrial flutter, the procedures could be performed without transesophageal echocardiogram screening or intracardiac echocardiography imaging of the appendage; with low risk of complications.

Clinical Outcomes and Characteristics With Dofetilide in Atrial Fibrillation Patients Considered for Implantable Cardioverter-Defibrillator.

BACKGROUND: Dofetilide is one of the only anti-arrhythmic agents approved for atrial fibrillation (AF) in patients with reduced left ventricular ejection fraction (LVEF). However, postapproval data and safety outcomes are limited. In this study, we assessed the incidence and predictors of LVEF improvement, safety, and outcomes in patients with AF with LVEF ≤35% without prior implantable cardioverter defibrillator, cardiac resynchronization therapy, or AF ablation. METHODS: An analysis of 168 consecutive patients from 2007 to 2016 was performed. Incidences of adverse events, drug continuation, implantable cardioverter defibrillator and cardiac resynchronization therapy implantation, LVEF improvement (>35%) and recovery (≥50%), AF recurrence, and AF ablation were determined. Multivariable regression analysis to identify predictors of LVEF improvement/recovery was performed. RESULTS: The mean age was 64±12 years. Dofetilide was discontinued before hospital discharge in 46 (27%) because of QT prolongation (14%), torsades de pointe or polymorphic ventricular tachycardia/fibrillation (6% [sustained 3%, nonsustained 3%]), ineffectiveness (5%), or other causes (3%). At 1 year, 43% remained on dofetilide. Freedom from AF was 42% at 1 year, and 40% underwent future AF ablation. LVEF recovered (≥50%) in 45% and improved to >35% in 73%. Predictors of LVEF improvement included presence of AF during echocardiogram (odds ratio, 4.22 [95% CI, 1.71-10.4], P=0.002), coronary artery disease (odds ratio, 0.35 [95% CI, 0.16-0.79], P=0.01), left atrial diameter (odds ratio, 0.52 per 1 cm increase [95% CI, 0.30-0.90], P=0.01), and LVEF (odds ratio, per 1% increase, 1.09 [95% CI, 1.02-1.16], P=0.006). The C statistic was 0.78. CONCLUSIONS: In patients with LVEF ≤35%, who are potential implantable cardioverter defibrillator candidates, treated with dofetilide as an initial anti-arrhythmic strategy for AF, drug discontinuation rates were high, and many underwent future AF ablation. However, most patients had improvement in LVEF, obviating the need for primary prevention implantable cardioverter defibrillator.

Transvenous lead extraction in patients with prior extraction procedures: Procedural profiles and outcomes.

BACKGROUND: Subclinical venous injuries are common during transvenous lead extraction (TLE), but their implications for future TLE are unclear. Little is known about whether a prior TLE adds risk or complexity to subsequent extraction procedures. OBJECTIVE: The purpose of this study was to assess procedural profiles and outcomes of TLE based on whether patients had prior extraction procedures. METHODS: All 3258 consecutive patients undergoing TLE at the Cleveland Clinic (1996-2012) were included. Procedural profiles and outcomes were determined. RESULTS: Of 3258 TLEs, 198 had prior TLE. Median number of leads in place was 2 in both groups, but patients with prior TLE were more likely to have defibrillator leads (47% vs 41%; P = .08) and more likely to be pacemaker-dependent (32% vs 25%; P = .02). The age of oldest lead (median 2134 vs 1902 days; P = .4) and combined age of leads (median 2948 vs 2676 days; P = .6) were comparable. Procedures were longer in those with prior TLE (166 ± 79 minutes vs 149 ± 74 minutes; P = .004) with comparable fluoroscopy times (median 13 vs 11 minutes; P = .07), and successful extraction was more likely to require specialized tools (88% vs 81%; P = .006) with higher likelihood of rescue femoral workstation (12% vs 4%; P <.0001). Clinical success rates were comparable in those with prior TLE (99.5% vs 98.9%; P = .8) with similar major (3.0% vs 1.9%; P = .3) and minor (3.0% vs 3.7%; P = .8) complication rates. CONCLUSION: Extraction procedures were more challenging in patients with prior TLE compared to those without prior TLE but with excellent success and low complication rates.

Catheter Ablation in Patients With Cardiogenic Shock and Refractory Ventricular Tachycardia.

BACKGROUND: There is paucity of data regarding radiofrequency ablation for ventricular tachycardia (VT) in patients with cardiogenic shock and concomitant VT refractory to antiarrhythmic drugs on mechanical support. METHODS: Patients undergoing VT ablation at our center were enrolled in a prospectively maintained registry and screened for the current study (2010-2017). RESULTS: All 21 consecutive patients with cardiogenic shock and concomitant refractory ventricular arrhythmia undergoing bailout ablation due to inability to wean off mechanical support were included. Median age was 61 years, 86% were men, median left ventricular ejection fraction was 20%, 81% had ischemic cardiomyopathy, and PAINESD score was 18±5. The type of mechanical support in place before the procedure was intra-aortic balloon pump in 14 patients (67%), Impella CP in 2, extracorporeal membrane oxygenation in 2, extracorporeal membrane oxygenation and intra-aortic balloon pump in 2, and extracorporeal membrane oxygenation and Impella CP in 1. Endocardial voltage maps showed myocardial scar in 19 patients (90%). The clinical VTs were inducible in 13 patients (62%), whereas 6 patients had premature ventricular contraction-induced ventricular fibrillation/VT (29%), and VT could not be induced in 2 patients (9%). Activation mapping was possible in all 13 with inducible clinical VTs. Substrate modification was performed in 15 patients with scar (79%). After ablation and scar modification, the arrhythmia was noninducible in 19 patients (91%). Seventeen (81%) were eventually weaned off mechanical support successfully, but 6 (29%) died during the index admission from persistent cardiogenic shock. Patients who had ventricular arrhythmia and cardiogenic shock on presentation had a trend toward lower in-hospital mortality compared with those who presented with cardiogenic shock and later developed ventricular arrhythmia. CONCLUSIONS: Bailout ablation for refractory ventricular arrhythmia in cardiogenic shock allowed successful weaning from mechanical support in a large proportion of patients. Mortality remains high, but the majority of patients were discharged home and survived beyond 1 year.

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.

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.

Continuous optimization of cardiac resynchronization therapy reduces atrial fibrillation in heart failure patients: Results of the Adaptive Cardiac Resynchronization Therapy Trial.

BACKGROUND: Data from randomized trials have suggested a modest or no effect of conventional cardiac resynchronization therapy (convCRT) on the incidence of atrial fibrillation (AF). AdaptivCRT (aCRT, Medtronic, Mounds View, MN) is a recently described algorithm for synchronized left ventricular (LV) pacing and continuous optimization of cardiac resynchronization therapy (CRT). OBJECTIVE: We compared the long-term effects of aCRT with convCRT pacing on the incidence of AF. METHODS: The Adaptive CRT trial randomized CRT-defibrillator (CRT-D)-indicated patients (2:1) to receive either aCRT or convCRT pacing. The aCRT algorithm evaluates intrinsic conduction every minute, providing LV-only pacing during normal atrioventricular (AV) conduction and AV and ventriculoventricular timing adjustments during prolonged AV conduction. The primary outcome of this subanalysis was an episode of AF >48 consecutive hours as detected by device diagnostics. RESULTS: Over a follow-up period with a mean and standard deviation of 20.2 ± 5.9 months, 8.7% of patients with aCRT and 16.2% with convCRT experienced the primary outcome (hazard ratio [HR] = 0.54; 95% confidence interval [CI] = 0.31-0.93; P = .03). In patients with prolonged baseline AV, the incidence of the primary outcome was 12.8% in patients randomized to aCRT compared with 27.4% in convCRT patients (HR = 0.45; 95% CI = 0.24-0.85; P = .01). Also, patients with AF episodes adjudicated as clinical adverse events were less common with aCRT (4.3%) than with convCRT (12.7%) (HR = 0.39; 95% CI = 0.19-0.79; P = .01). CONCLUSION: Patients receiving aCRT had a reduced risk of AF compared with those receiving convCRT. Most of the reduction in AF occurred in subgroups with prolonged AV conduction at baseline and with significant left atrial reverse remodeling.

Transvenous lead extraction at the time of cardiac implantable electronic device upgrade: Complexity, safety, and outcomes.

BACKGROUND: The practice of lead abandonment at the time of cardiac implantable electronic device upgrade remains a controversial topic but is affecting an increasing number of patients. Inherent risks include high-risk extractions of redundant leads when extraction is required at a later date. OBJECTIVES: We aimed to report our experience with transvenous lead extraction (TLE) at the time of device upgrade. METHODS: All consecutive TLE procedures at the time of device upgrade at the Cleveland Clinic between January 1, 1996 and December 31, 2012 were included (n = 503). Success and complications were defined according to the Heart Rhythm Society consensus document on TLE. RESULTS: There were a total of 984 leads in place, and 719 were targeted with extraction (589 pacer and 130 defibrillator leads, 63 of them being dual-coil leads). In all patients, TLEs aimed to avoid abandoning leads. Concomitant lead management issues included lead malfunction (15%), previously abandoned leads (9%), vascular access occlusion (6%), or leads on advisory (3%). In most procedures (75.4%), special extraction tools were needed. The complete procedural and clinical success rates were 96.6% and 97.2%, respectively. During planned extractions, damage of coexisting leads occurred in 19 patients (3.8%), eventually requiring extraction. The major and minor complication rates were 1% and 1.4%, respectively. CONCLUSION: In a high-volume center, TLEs at the time of device upgrade were successful in the vast majority of patients with a low complication rate.

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.

Randomized Study of Persistent Atrial Fibrillation Ablation: Ablate in Sinus Rhythm Versus Ablate Complex-Fractionated Atrial Electrograms in Atrial Fibrillation.

BACKGROUND: Achieving long-term successful outcomes with ablation of persistent atrial fibrillation (AF) remains a clinical and procedural challenge. We aimed to assess 2 ablation strategies for persistent AF: pulmonary vein antral isolation (PVAI) in sinus rhythm after direct current cardioversion versus PVAI and ablation targeting complex-fractionated atrial electrograms while in AF. METHODS AND RESULTS: Between June 2009 and July 2013, patients with continuous persistent AF for ≥3 months were prospectively randomized to either direct current cardioversion before PVAI and posterior wall/septum ablation while in sinus rhythm (group 1), versus same ablation in group 1 in addition to complex-fractionated atrial electrogram ablation while in AF (group 2). The procedural profiles and clinical outcomes of the 2 strategies were compared. Ninety patients were randomized to group 1 (n=46) or group 2 (n=44). There were no differences in baseline characteristics between groups. Over 365 days of follow-up after the index procedure, 16 patients (35%) in group 1 and 13 patients (30%) in group 2 remained arrhythmia-free off antiarrhythmic medications. Over long-term follow-up (median, 867 days), arrhythmia-free survival off antiarrhythmic medications was more likely in group 1 than in group 2 in Kaplan-Meier analysis (Log Rank P=0.04). Group 1 ablation was associated with significantly shorter procedural duration and fluoroscopy time (231±72 versus 273±76 min; P=0.008 and 54 [Q1-Q3: 46-67] versus 66 (Q1-Q3: 53-83] min; P=0.018, respectively). CONCLUSIONS: In patients with persistent AF, PVAI in sinus rhythm after direct current cardioversion is associated with higher success and shorter procedural and fluoroscopy times compared with PVAI in AF with additional complex-fractionated atrial electrogram ablation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02429648.

Extraction of chronically implanted coronary sinus leads active fixation vs passive fixation leads.

BACKGROUND: The Medtronic model 4195 (StarFix) left ventricular lead is an active fixation lead that provides additional support within the coronary sinus (CS) via deployable lobes. While this lead has been shown to have excellent stability within the CS, concerns about its extractability have been raised. OBJECTIVE: The aim of this study was to compare the safety and efficacy of the extraction of the model 4195 lead vs other Medtronic CS leads in a prospective cohort study. METHODS: Patients undergoing extraction of this and other CS leads for standard indications were prospectively enrolled and studied. The primary outcomes of interest were the removal success rates and associated complication rates. Patients were followed for a month postprocedure. RESULTS: The overall left ventricular lead extraction success rate was 97.6% (n = 205). Among 40 patients with chronic model 4195 leads, there were 37 successful extractions (92.5%) as compared to 98.8% for the 165 non-4195 leads. However, in 2 of the 3 StarFix lead extraction failures, standard extraction techniques were not used. All 10 of the model 4195 leads that had been implanted for less than 6 months were extracted without incident. CONCLUSION: In this largest study of CS lead extractions published to date, the overall success rate of the extraction of chronically implanted CS leads is high and the complication rate is similar in these lead models. The extraction of the model 4195 lead is clearly more challenging, but it can be accomplished in high-volume extraction centers with experienced operators. It is recommended that the model 4195 lead be extracted by experienced operators.

Radiofrequency Ablation of Persistent Atrial Fibrillation: Diagnosis-to-Ablation Time, Markers of Pathways of Atrial Remodeling, and Outcomes.

BACKGROUND: Various ablation strategies of persistent atrial fibrillation (PersAF) have had disappointing outcomes, despite concerted clinical and research efforts, which could reflect progressive atrial fibrillation-related atrial remodeling. METHODS AND RESULTS: Two-year outcomes were assessed in 1241 consecutive patients undergoing first-time ablation of PersAF (2005-2012). The time intervals between the first diagnosis of PersAF and the ablation procedures were determined. Patients had echocardiograms and measures of B-type natriuretic peptide and C-reactive protein before the procedures. The median diagnosis-to-ablation time was 3 years (25th-75th percentiles 1-6.5). With longer diagnosis-to-ablation time (based on quartiles), there was a significant increase in recurrence rates in addition to an increase in B-type natriuretic peptide levels (P=0.01), C-reactive protein levels (P<0.0001), and left atrial size (P=0.03). The arrhythmia recurrence rates over 2 years were 33.6%, 52.6%, 57.1%, and 54.6% in the first, second, third, and fourth quartiles, respectively (P(categorical)<0.0001). In Cox Proportional Hazard analyses, B-type natriuretic peptide levels, C-reactive protein levels, and left atrial size were associated with arrhythmia recurrence. The diagnosis-to-ablation time had the strongest association with the ablation outcomes which persisted in multivariable Cox analyzes (hazard ratio for recurrence per +1Log diagnosis-to-ablation time 1.27, 95% confidence interval 1.14-1.43; P<0.0001; hazard ratio fourth versus first quartile 2.44, 95% confidence interval 1.68-3.65; P(categorical)<0.0001). CONCLUSIONS: In patients with PersAF undergoing ablation, the time interval between the first diagnosis of PersAF and the catheter ablation procedure had a strong association with the ablation outcomes, such as shorter diagnosis-to-ablation times were associated with better outcomes and in direct association with markers of atrial remodeling.

Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial.

OBJECTIVES: This study investigated the impact of the Medtronic AdaptivCRT (aCRT) (Medtronic, Mounds View, Minnesota) algorithm on 30-day readmissions after heart failure (HF) and all-cause index hospitalizations. BACKGROUND: The U.S. Hospital Readmission Reduction Program, which includes a focus on HF, reduces Medicare inpatient payments when readmissions within 30 days of discharge exceed a moving threshold based on national averages and hospital-specific risk adjustments. Internationally, readmissions within 30 days of any discharge may attract reduced or no payment. Recently, cardiac resynchronization therapy (CRT) devices equipped with the aCRT algorithm allowing automated ambulatory device programming were introduced. The Adaptive CRT trial demonstrated the algorithm's safety and comparable outcome against a rigorous echocardiography-based optimization protocol. METHODS: We analyzed data from the Adaptive CRT trial, which randomized patients undergoing CRT defibrillation on a 2:1 basis to aCRT (n = 318) or to CRT with echocardiographic optimization (Echo, n = 160) and followed up these patients for a mean of 20.2 months (range: 0.2 to 31.3 months). Logistic regression with generalized estimating equation methodology was used to compare the proportion of patients hospitalized for HF and for all causes who had a readmission within 30 days. RESULTS: For HF hospitalizations, the 30-day readmission rate was 19.1% (17 of 89) in the aCRT group and 35.7% (15 of 42) in the Echo group (odds ratio: 0.41; 95% confidence interval [CI]: 0.19 to 0.86; p = 0.02). For all-cause hospitalization, the 30-day readmission rate was 14.8% (35 of 237) in the aCRT group compared with 24.8% (39 of 157) in the Echo group (odds ratio: 0.54; 95% CI: 0.31 to 0.94; p = 0.03). The risk of readmission after HF or all-cause index hospitalization with aCRT was also significantly reduced beyond 30 days. CONCLUSIONS: Use of the aCRT algorithm is associated with a significant reduction in the probability of a 30-day readmission after both HF and all-cause hospitalizations. (Adaptive Cardiac Resynchronization Therapy Study [aCRT]; NCT00980057).