Leadless pacemaker implantation after lead extraction for cardiac implanted electronic device infection.

BACKGROUND: Cardiac implanted electronic device (CIED) pocket and systemic infection remain common complications with traditional CIEDs and are associated with high morbidity and mortality. Leadless pacemakers may be an attractive pacing alternative for many patients following complete hardware removal for a CIED infection by eliminating surgical pocket-related complications as well as lower risk of recurrent complications. OBJECTIVE: To describe use and outcomes associated with leadless pacemaker implantation following extraction of a CIED system due to infection. METHODS: Patient characteristics and postprocedural outcomes were described in patients who underwent leadless pacemaker implantation at Duke University Hospital between November 11, 2014 and November 18, 2019, following CIED infection and device extraction. Outcomes of interest included procedural complications, pacemaker syndrome, need for system revision, and recurrent infection. RESULTS: Among 39 patients, the mean age was 71 ± 17 years, 31% were women, and the most frequent primary pacing indication was complete heart block (64.1%) with 9 (23.1%) patients being pacemaker dependent at the time of Micra implantation. The primary organism implicated in the CIED infection was Staphylococcus aureus (43.6%). Nine of the 39 patients had a leadless pacemaker implanted before or on the same day as their extraction procedure, and the remaining 30 patients had a leadless pacemaker implanted after their extraction procedure. During follow-up (mean 24.8 ± 14.7 months) after leadless pacemaker implantation, there were a total of 3 major complications: 1 groin hematoma, 1 femoral arteriovenous fistula, and 1 case of pacemaker syndrome. No patients had evidence of recurrent CIED infection after leadless pacemaker implantation. CONCLUSIONS: Despite a prior CIED infection and an elevated risk of recurrent infection, there was no evidence of CIED infection with a mean follow up of over 2 years following leadless pacemaker implantation at or after CIED system removal. Larger studies with longer follow-up are required to determine if there is a long-term advantage to implanting a leadless pacemaker versus a traditional pacemaker following temporary pacing when needed during the periextraction period in patients with a prior CIED infection.

Safety and efficacy outcomes of left atrial posterior wall isolation compared to pulmonary vein isolation and pulmonary vein isolation with linear ablation for the treatment of persistent atrial fibrillation.

BACKGROUND: Pulmonary wall isolation (PWI) is increasingly used as an adjunctive lesion set to compliment pulmonary vein isolation (PVI), especially in patients with persistent atrial fibrillation (AF). The objective was to compare outcomes of catheter ablation in patients with persistent AF undergoing PVI with and without adjunctive PWI. METHODS: We performed a retrospective study of 558 patients who underwent de novo and repeat ablation for persistent AF. Subjects were matched using propensity score adjustments. Outcomes were freedom from recurrent atrial arrhythmia and adverse events. RESULTS: Among 558 patients who underwent ablation for persistent AF, 78 (14%) underwent PVI + PWI, 255 (46%) underwent PVI, and 225 (40%) underwent PVI + linear ablation. Stratified logistic regression analysis with propensity matching revealed higher odds of recurrent arrhythmia with PVI + PWI when compared to PVI (odds ratio [OR] 2.25, 95% CI 1.08-4.69, P = .030) and when compared to PVI + linear (OR 2.31, 95% CI 1.01-5.28, P = .048). Within the PVI + PWI group, 57.7% of subjects were in normal sinus rhythm at 6 months compared to 73.9% and 72.2% in PVI and PVI + linear groups, respectively. Adverse events were rare, with 19 events total identified across all groups. CONCLUSIONS: PVI + PWI does not appear to be as effective as PVI or PVI + linear ablation in reducing the recurrence of arrhythmia within 6 months of the index procedure in patients with persistent AF. A prospective, randomized controlled trial comparing these ablation techniques is needed to clarify the role of extensive substrate modification for treatment of persistent AF. CONDENSED ABSTRACT: PWI is increasingly used as an adjunctive lesion set to compliment PVI in patients with persistent AF. We performed a retrospective study of 558 patients who underwent de novo and repeat ablation for persistent AF to compare the outcomes between PVI with and without adjunctive PWI. We found an increased incidence in recurrence of AF and other atrial arrhythmias at 6 months in the PVI + PWI cohort compared to PVI with or without additional linear ablation. A prospective, randomized controlled trial comparing these ablation techniques is needed to clarify the role of extensive substrate modification for treatment of persistent AF.

Hands on: How to approach patients undergoing lead extraction.

Due to the growing number of patients treated with cardiac implantable electronic devices (CIEDs) there is an increased need for lead management, evaluation, and extraction. While CIED lead extraction has many indications, a consistent approach to preprocedural planning should be applied in all cases, including a thorough consultation with careful review of the patient's medical and device history, as well as a discussion of informed consent and shared decision-making with the patient and their loved ones. The use of chest X-ray, echocardiography, and computed tomography (CT) scan can further help with risk stratification and procedural planning. Intraprocedural echocardiography (transesophageal or intracardiac) is recommended and allows early recognition of cardiothoracic injury. Establishing an extraction team with cardiology/electrophysiology, anesthesiology, and CT surgery is is crucial to a successful and safe CIED extraction practice, including immediately available surgical backup. This hands-on review will address how to approach patients who are undergoing lead extraction, as well as several innovations in preprocedure and intraprocedural risk assessment.

Preprocedural computed tomography before cardiac implanted electronic device lead extraction: Indication, technique, and approach to interpretation.

Cardiac implantable electronic devices (CIEDs) frequently need to be extracted due to infection, hardware failure, and other causes. The extraction of the CIED is typically performed using percutaneous methods. While these procedures are mostly performed without incident there is a small risk of significant complications. Dedicated imaging pre-CEID removal to include the central veins and heart with multidetector computed tomography (MDCT) can be utilized to evaluate the lead course and termination, the integrity of the central veins and cardiac chambers, and identify potential complications that may alter the lead extraction procedure as well as reimplantation of subsequent leads. Indications for preprocedural imaging, the technique of dedicated preprocedural lead extraction MDCT, and the approach to the interpretation of the images is discussed in this review.

Catheter ablation of atrial fibrillation in cardiac amyloidosis.

BACKGROUND: Cardiac amyloidosis is a progressive infiltrative disease involving deposition of amyloid fibrils in the myocardium and cardiac conduction system that frequently manifests with heart failure (HF) and arrhythmias, most frequently atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT). METHODS: We performed an observational retrospective study of patients with a diagnosis of cardiac amyloid who underwent catheter ablation at our institution between January 1, 2011 and December 1, 2018. Patient demographics, procedural characteristics, and outcomes were determined by manual chart review. RESULTS: A total of 13 catheter ablations were performed over the study period in patients with cardiac amyloidosis, including 10 AT/AF/AFL ablations and three atrioventricular nodal ablations. Left ventricular ejection fraction was lower at the time of AV node ablation than catheter ablation of AT/AF/AFL (23% vs 40%, P = .003). Cardiac amyloid was diagnosed based on the results of preablation cardiac MRI results in the majority of patients (n = 7, 70%). The HV interval was prolonged at 60 ± 15 ms and did not differ significantly between AV nodal ablation patients and AT/AF/AFL ablation patients (69 ± 18 ms vs 57 ± 14 ms, P = .36). The majority of patients undergoing AT/AF/AFL ablation had persistent AF (n = 7, 70%) and NYHA class II (n = 5, 50%) or III (n = 5, 50%) HF symptoms, whereas patients undergoing AV node ablation were more likely to have class IV HF (n = 2, 66%, P = .014). Arrhythmia-free survival in CA patients after catheter ablation of AT/AF/AFL was 40% at 1 year and 20% at 2 years. CONCLUSIONS: Catheter ablation of AT/AF/AFL may be a feasible strategy for appropriately selected patients with early to mid-stage CA, whereas AV node ablation may be more appropriate in patients with advanced-stage CA.

Predicting atrial fibrillation recurrence after ablation in patients with heart failure: Validity of the APPLE and CAAP-AF risk scoring systems.

BACKGROUND: Compared with medical therapy, catheter ablation of atrial fibrillation (AF) in patients with heart failure (HF) improves cardiovascular outcomes. Risk scores (CAAP-AF and APPLE) have been developed to predict the likelihood of AF recurrence after ablation, have not been validated specifically in patients with AF and HF. METHODS: We analyzed baseline characteristics, risk scores, and rates of AF recurrence 12 months postablation in a cohort of 230 consecutive patients with AF and HF undergoing PVI in the Duke Center for Atrial Fibrillation registry from 2009-2013. RESULTS: During a follow-up period of 12 months, 76 of 230 (33%) patients with HF experienced recurrent AF after ablation. The median APPLE and CAAP-AF scores were 1.5 ([Q1, Q3]: [1.0, 2.0]) and 4.0 ([Q1, Q3]: [3.0, 5.0]), respectively and were not different from those patients with and without recurrent AF. Freedom from AF was not different according to APPLE and CAAP-AF scores. Discrimination for recurrent AF with the CAAP-AF score was modest with a C-statistic of 0.60 (95% CI 0.52-0.67). Discrimination with the APPLE score was similarly modest, with a C-statistic of 0.54 (95% CI: 0.47-0.62). CONCLUSIONS: Validated predictive risk scores for recurrent AF after catheter ablation exhibit limited predictive ability in cohorts of AF and HF. Additional tools are needed to facilitate risk stratification and patient selection for AF ablation in patients with concomitant HF.

Outcomes Associated With Extraction Versus Capping and Abandoning Pacing and Defibrillator Leads.

BACKGROUND: Lead management is an increasingly important aspect of care in patients with cardiac implantable electronic devices; however, relatively little is known about long-term outcomes after capping and abandoning leads. METHODS: Using the 5% Medicare sample, we identified patients with de novo cardiac implantable electronic device implantations between January 1, 2000, and December 31, 2013, and with a subsequent lead addition or extraction ≥12 months after the de novo implantation. Patients who underwent extraction for infection were excluded. Using multivariable Cox proportional hazards models, we compared cumulative incidence of all-cause mortality, device-related infection, device revision, and lead extraction at 1 and 5 years for the extraction versus the cap and abandon group. RESULTS: Among 6859 patients, 1113 (16.2%) underwent extraction, whereas 5746 (83.8%) underwent capping and abandonment. Extraction patients tended to be younger (median, 78 versus 79 years; P<0.0001), were less likely to be male (65% versus 68%; P=0.05), and had shorter lead dwell time (median, 3.0 versus 4.0 years; P<0.0001) and fewer comorbidities. Over a median follow-up of 2.4 years (25th, 75th percentiles, 1.0, 4.3 years), the overall 1-year and 5-year cumulative incidence of mortality was 13.5% (95% confidence interval [CI], 12.7-14.4) and 54.3% (95% CI, 52.8-55.8), respectively. Extraction was associated with a lower risk of device infection at 5 years relative to capping (adjusted hazard ratio, 0.78; 95% CI, 0.62-0.97; P=0.027). There was no association between extraction and mortality, lead revision, or lead extraction at 5 years. CONCLUSIONS: Elective lead extraction for noninfectious indications had similar long-term survival to that for capping and abandoning leads in a Medicare population. However, extraction was associated with lower risk of device infections at 5 years.

Clinical outcome as a function of the PR-interval-there is virtue in moderation: data from the Duke Databank for cardiovascular disease.

AIMS: Recently, a U-shaped association between PR-interval and the risk of developing atrial fibrillation was described, with higher risk in patients with long and short PR-intervals. Little is known regarding the association of PR-interval duration and mortality. The objective of the current study was to explore the relationship between PR-interval and major cardiovascular outcomes in patients with known coronary heart disease. METHODS AND RESULTS: Patients in sinus rhythm, undergoing coronary angiography at Duke University Medical Center between 1989 and 2010, who had significant stenosis in at least one native coronary artery, were included. Patients with arrhythmia, second- or third-degree AV-block, QRS > 120 ms were excluded. A total of 9,637 patients were included (median age 63, IQR 55-71 years, 67% men). After adjustment for relevant covariates, the risk of a CV event increased with a decreasing PR-interval (10 ms decrements) for PR-interval values <162 ms (all-cause mortality; HR 1.057, 95% CI 1.019-1.096, P = 0.0030, composite of death or stroke; HR 1.047, 95% CI 1.011-1.085, P = 0.0095 and composite of cardiovascular death or cardiovascular rehospitalization; HR 1.032, 95% CI 1.002-1.063, P = 0.0387). No statistically significant changes in the risk associated with PR-interval for values >162 ms were seen for any of the studied endpoints. CONCLUSION: In patients with coronary heart disease, a prolongation of the PR-interval was not independently associated with poor outcomes, but a PR-interval shorter than normal was associated with increased all-cause mortality and other major cardiovascular events.

Cardiac implantable electronic device removal in patients with left ventricular assist device associated infections.

INTRODUCTION: Heart failure patients with left ventricular assist devices (LVADs) are at risk for infection. Cardiac implantable electronic devices (CIEDs) are commonly present in these patients. The course of infections in patients with an LVAD and a CIED is not well described. METHODS AND RESULTS: We identified 6 patients with a durable LVAD that underwent CIED removal because of an LVAD associated infection (LVADI). Patient and infection characteristics, management strategy, and clinical outcomes are described. All 6 patients were male, and the mean age was 59.6 years (range 43-72). Four of 6 patients had an ischemic cardiomyopathy, and 3 patients were diabetic. The median creatinine clearance for patients was 40.5 mg/dL (range 19-65). Five of 6 patients had a continuous flow LVAD placed as destination therapy. Four of 6 patients had a previous LVADI managed medically before the current infection leading to CIED removal. The indication for CIED removal was a bloodstream infection in 5 of 6 patients. Three of these patients had potential vegetations identified by echocardiography on device leads. The mean implanted age of the removed leads was 62 months (range 1-179), and 1 of the 6 patients experienced a procedural complication (hematoma) from CIED removal. Four of 6 patients that underwent CIED removal for an LVADI had recurrence of infection. Five of 6 patients died during the initial presentation or from repeat presentation for infection. CONCLUSION: Despite CIED removal for an LVADI, recurrent infections are common and mortality remains high.

Preprocedural ECG-gated computed tomography for prevention of complications during lead extraction.

BACKGROUND: Preprocedural multidetector computed tomography (MDCT) may identify patients at risk for mechanical complications during lead extraction. METHODS: To describe the use and feasibility of computed tomography scanning for preprocedural planning of lead extraction, we conducted a retrospective study of high-risk patients, who underwent electrocardiogram (ECG)-gated MDCT before planned lead extraction between January 1, 2012, and March 30, 2013. RESULTS: Among 30 patients the mean age was 63 ± 15 years, 60% were male, and 20% had prior sternotomy. Most devices were left sided (93%) and 24 had implantable defibrillators (80%). Indications for extraction included lead malfunction (n = 15; 50%), class I lead advisories (n = 11; 37%), and infection (n = 10; 33%). Overall, there were 65 leads extracted (mean 2.1 leads per patient). One extraction procedure was deferred due to MDCT evidence of significant myocardial perforation with the lead tip > 1 cm beyond the epicardium (n = 1, 3%). MDCT suggestion of lead adherence to central venous structures (n = 13, 43%) was associated with significantly longer laser times (88 ± 71 seconds vs 30 ± 37 seconds, P = 0.02) and larger sheath size (14.9 ± 1.3 vs 13.5 ± 1.2 French, P = 0.02). MDCT evidence of central venous occlusion or stenosis was not associated with increased laser times. Excluding the patient with MDCT evidence of significant perforation, clinical success was achieved in all patients (n = 29/29). CONCLUSIONS: ECG-gated MDCT scanning before lead extraction may facilitate the identification of significant perforation and patients at high risk for mechanical complication.

Impact of using a telescoping-support catheter system for left ventricular lead placement on implant success and procedure time of cardiac resynchronization therapy.

BACKGROUND: Proper positioning of the left ventricular (LV) lead improves clinical outcomes and survival in patients receiving cardiac resynchronization therapy (CRT). Techniques of LV lead insertion using contrast injection and a telescoping system of delivery catheters to support advancement of the lead into the target branch may allow more efficient, targeted lead placement. We sought to evaluate the impact of an LV lead implant approach using telescoping-support catheters (group TS) on success rate, lead location, and procedural time compared to standard over-the-wire implant techniques (group OTW). METHODS: Four hundred thirty-seven consecutive patients undergoing CRT implantation were divided into group TS (n = 105) or group OTW (n = 332) based upon a review of the operative technique used for LV lead implantation. The primary outcome was success of LV lead implantation at the index procedure. Secondary endpoints included optimal positioning of the LV lead and reduction in procedural fluoroscopy time. RESULTS: Failed LV lead placement was lower (1.9% vs 8.1%, P = 0.02) and optimal lead positioning was achieved more often for group TS than group OTW (87% vs 75%, P = 0.01). In addition, there were significantly shorter fluoroscopy times for group TS versus group OTW (29.6 minutes vs 41.9 minutes, P < 0.01). CONCLUSION: A CRT-implant approach using contrast injection and a telescoping-support catheter system results in fewer failed LV lead implants, improved LV lead location, and shorter procedure times.

Efficacy and Safety of Adjunctive and Primary Use of the TightRail Mechanical Cutting Sheath for Lead Extraction.

BACKGROUND: Rotational cutting tools are increasingly used in transvenous lead extraction. There are limited data on their safety and efficacy, particularly when used adjunctively for stalled progression. The aim of this study was to evaluate the utilization, safety, and effectiveness of mechanical rotational cutting tools for transvenous lead extraction. METHODS: Patients undergoing transvenous lead extraction at a single tertiary center (April 2015 to January 2021, n=586) were included in this retrospective analysis. The study characterized the 251 patients (42.8%) whose cases involved the TightRail mechanical cutting tool. RESULTS: Among 251 patients, 526 leads were extracted and TightRail was used for 70.5%. The TightRail was used adjunctively with the laser for 65.2% of leads, 97.8% of the time as the second tool after stalled progression. Using a multivariable logistic regression model, we found that active-fixation leads (odds ratio, 2.78 [95% CI, 1.62-4.78]; P=0.0002), dual-coil leads (odds ratio, 3.39 [95% CI, 1.87-6.16]; P<0.0001), and lead dwell time (odds ratio, 1.16 [95% CI for 1-year increase, 1.11-1.21]; P<0.0001) were factors independently associated with adjunctive TightRail use. Stalled progression requiring TightRail occurred most often in the innominate vein and superior vena cava (59.3%). The clinical success rate was 96.8%, and the rate of major adverse events was 2.8%. Only 1 major adverse event was observed during TightRail use. CONCLUSIONS: Rotational cutting with TightRail was used in 42.8% of transvenous lead extractions, predominantly in an adjunctive manner after stalled laser progression in the innominate vein and superior vena cava, and more frequently for dual-coil and leads with longer dwell times. Adjunctive TightRail use carries a low risk of major complications.

Lead Extraction and Mortality Among Patients With Cardiac Implanted Electronic Device Infection.

Importance: Complete hardware removal is a class I recommendation for cardiovascular implantable electronic device (CIED) infection, but practice patterns and outcomes remain unknown. Objective: To quantify the number of Medicare patients with CIED infections who underwent implantation from 2006 to 2019 and lead extraction from 2007 to 2019 to analyze the outcomes in these patients in a nationwide clinical practice cohort. Design, Setting, and Participants: This cohort study included fee-for-service Medicare Part D beneficiaries from January 1, 2006, to December 31, 2019, who had a de novo CIED implantation and a CIED infection more than 1 year after implantation. Data were analyzed from January 1, 2005, to December 31, 2019. Exposure: A CIED infection, defined as (1) endocarditis or infection of a device implant and (2) documented antibiotic therapy. Main Outcomes and Measures: The primary outcomes of interest were device infection, device extraction, and all-cause mortality. Time-varying multivariable Cox proportional hazards regression models were used to evaluate the association between extraction and survival. Results: Among 1 065 549 patients (median age, 78.0 years [IQR, 72.0-84.0 years]; 50.9% male), mean (SD) follow-up was 4.6 (2.9) years after implantation. There were 11 304 patients (1.1%) with CIED infection (median age, 75.0 years [IQR, 67.0-82.0 years]); 60.1% were male, and 7724 (68.3%) had diabetes. A total of 2102 patients with CIED infection (18.6%) underwent extraction within 30 days of diagnosis. Infection occurred a mean (SD) of 3.7 (2.4) years after implantation, and 1-year survival was 68.3%. There was evidence of highly selective treatment, as most patients did not have extraction within 30 days of diagnosed infection (9202 [81.4%]), while 1511 (13.4%) had extraction within 6 days of diagnosis and 591 (5.2%) had extraction between days 7 and 30. Any extraction was associated with lower mortality compared with no extraction (adjusted hazard ratio [AHR], 0.82; 95% CI, 0.74-0.90; P < .001). Extraction within 6 days was associated with even lower risk of mortality (AHR, 0.69; 95% CI, 0.61-0.78; P < .001). Conclusions and Relevance: In this study, a minority of patients with CIED infection underwent extraction. Extraction was associated with a lower risk of death compared with no extraction. The findings suggest a need to improve adherence to guideline-directed care among patients with CIED infection.

Cases of Azygous Coil Extraction.

BACKGROUND: Procedural and clinical outcomes of patients undergoing extraction or removal of azygous coils are not well characterized. OBJECTIVE: Evaluate outcomes in patients who undergo device extraction with an azygous coil in situ. METHODS: Patients undergoing extraction with an azygous coil in situ between May 2015 and January 2021 were included in this retrospective single-center analysis. Outcomes included procedural success, use of laser and mechanical cutting tools during the procedure, procedural complications, and mortality. RESULTS: We identified 2 patients undergoing device extraction with an azygous coil in situ with a dwell time greater than 12 months. The patients were male, aged 73 and 83 years. Both had a history of hypertension, atrial fibrillation, heart failure (ejection fractions <15% and 20%), and cardiomyopathy (nonischemic and ischemic), and presented with an infection (case 1 with a single-chamber ICD and Staphylococcus aureus bacteremia, case 2 with a cardiac resynchronization therapy defibrillator pocket infection). The mean dwell time of all 6 leads extracted was 6.43 years (range 1.33-12.63 years), and the 2 azygous coils had dwell times of 1.33 and 6.04 years. In case 1, the azygous coil was inferior to the cardiac silhouette, while in case 2 it was superior. A 14F laser sheath was employed to remove both azygous coils. Both extractions were a complete procedural success in which all leads were removed completely without intraoperative complications. CONCLUSION: These cases demonstrate the variable courses of azygous coils, provide proof of concept that they can be removed safely, and illustrate that azygous coils can be removed with the same techniques that are commonly used to remove other types of leads.

Pulmonary vein contraction before and after radiofrequency ablation for atrial fibrillation.

UNLABELLED: INTRODUCTION: Cardiovascular magnetic resonance imaging (cMRI) may provide a noninvasive method to test for pulmonary vein (PV) isolation after ablation for atrial fibrillation (AF) by detecting changes in PV contraction. METHODS: PV contraction (the maximal percentage change in PV cross-sectional area [CSA] during the cardiac cycle) measured 1 month before and 2 months after PV isolation was compared in 63 PVs from 16 patients with medically refractory AF. Repeat cMRI imaging and invasive catheter mapping was performed prior to repeat PV ablation in 50 PVs from 14 additional patients with recurrent AF. Contraction in PVs with sustained isolation after the initial ablation was compared to contraction in PVs with electrical reconnection to adjacent atrium. Receiver operating characteristic (ROC) curve analysis was performed to determine the optimal cutoff PV contraction value for prediction of PV-atrial reconnection after ablation. The cutoff value was then prospectively tested in 40 PVs from 12 additional patients. RESULTS: PV contraction decreased after AF ablation (22.4 ± 10% variation in CSA before ablation vs 10.1 ± 8% variation in CSA after ablation, P < 0.00001). PVs with sustained isolation on invasive mapping contracted less than PVs with electrical reconnection to adjacent atrium (13.7 ± 10.6% vs 21.4 ± 9.3%, P = 0.021). PV contraction produced a c-index of 0.74 for prediction of PV-atrial reconnection after ablation and >17% variation in PV CSA predicted reconnection with a sensitivity of 84.6% and specificity of 66.7%. CONCLUSION: PV contraction is reduced by ablation. PV contraction measurement may provide a noninvasive method to test for PV isolation after ablation procedures.

Optimizing mechanically sensed atrial tracking in patients with atrioventricular-synchronous leadless pacemakers: A single-center experience.

BACKGROUND: Atrioventricular (AV)-synchronous single-chamber leadless pacing using a mechanical atrial sensing algorithm produced high AV synchrony in clinical trials, but clinical practice experience with these devices has not yet been described. OBJECTIVE: To describe pacing outcomes and programming changes with AV-synchronous leadless pacemakers in clinical practice. METHODS: Consecutive patients without persistent atrial fibrillation who received an AV-synchronous leadless pacemaker and completed follow-up between February 2020 and April 2021 were included. We evaluated tracking index (atrial mechanical sense followed by ventricular pace [AM-VP] divided by total VP), total AV synchrony (sum of AM-ventricular sense [AM-VS], AM-VP, and AV conduction mode switch), use of programming optimization, and improvement in AV synchrony after optimization. RESULTS: Fifty patients met the inclusion criteria. Mean age was 69 ± 16.8 years, 24 (48%) were women, 24 (48%) had complete heart block, and 17 (34%) required ≥50% pacing. Mean tracking index was 41% ± 34%. Thirty-five patients (70%) received ≥1 programming change. In 36 patients with 2 follow-up visits, tracking improved by +9% ± 28% (P value for improvement = .09) and +18% ± 19% (P = .02) among 15 patients with complete heart block. Average total AV synchrony increased from 89% [67%, 99%] to 93% [78%, 100%] in all patients (P = .22), from 86% [52%, 98%] to 97% [82%, 99%] in those with complete heart block (P = .04), and from 73% [52%, 80%] to 78% [70%, 85%] in those with ≥50% pacing (P = .09). CONCLUSION: In patients with AV-synchronous leadless pacemakers, programming changes are frequent and are associated with increased atrial tracking and increased AV synchrony in patients with complete heart block.

Lead Extraction for Cardiovascular Implantable Electronic Device Infection in Patients With Left Ventricular Assist Devices.

OBJECTIVES: The goal of this study was to assess the utility of transvenous lead extraction for cardiovascular implantable electronic device (CIED) infection in patients with a left ventricular assist device (LVAD). BACKGROUND: The use of transvenous lead extraction for the management CIED infection in patients with a durable LVAD has not been well described. METHODS: Clinical and outcomes data were collected retrospectively among patients who underwent lead extraction for CIED infection after LVAD implantation at Duke University Hospital. RESULTS: Overall, 27 patients (n = 6 HVAD; n = 15 HeartMate II; n = 6 Heartmate III) underwent lead extraction for infection. Median (interquartile range) time from LVAD implantation to infection was 6.1 (2.5 to 14.9) months. Indications included endocarditis (n = 16), bacteremia (n = 9), and pocket infection (n = 2). Common pathogens were Staphylococcus aureus (n = 10), coagulase-negative staphylococci (n = 7), and Enterococcus faecalis (n = 3). Sixty-eight leads were removed, with a median lead implant time of 5.7 (3.6 to 9.2) years. Laser sheaths were used in all procedures, with a median laser time of 35.0 s (17.5 to 85.5s). Mechanical cutting tools were required in 11 (40.7%) and femoral snaring in 4 (14.8%). Complete procedural success was achieved in 25 (93.6%) patients and clinical success in 27 (100%). No procedural failures or major adverse events occurred. Twenty-one patients (77.8%) were alive without persistent endovascular infection 1 year after lead extraction. Most were treated with oral suppressive antibiotics after extraction (n = 23 [82.5%]). Persistent infection after extraction occurred in 4 patients and was associated with 50% 1-year mortality. CONCLUSIONS: Transvenous lead extraction for LVAD-associated CIED infection can be performed safely with low rates of persistent infection and 1-year mortality.

Cardiovascular Implantable Electronic Device Surgery Following Left Ventricular Assist Device Implantation.

OBJECTIVES: This study sought to determine the indications, characteristics, and outcomes of cardiovascular implantable electronic device (CIED) surgery in patients with LVAD. BACKGROUND: Many patients with a left ventricular assist device (LVAD) will require implantable cardioverter-defibrillator generator change or device revision or are candidates for de novo implantable cardioverter-defibrillator implantation following LVAD implantation. METHODS: We performed an observational retrospective study of all LVAD recipients who subsequently underwent CIED surgery at Duke University Hospital from 2009 to 2019. RESULTS: A total of 159 patients underwent CIED surgery following LVAD implantation, including generator change (n = 93), device revision (n = 38), and de novo implant (n = 28). The median (interquartile range) time from LVAD implantation to CIED surgery was 18.1 months (5.5 to 35.1 months). Pre-operative risk for infection was elevated in the overall cohort with a median (interquartile range) Prevention of Arrhythmia Device Infection Trial (PADIT) score of 7.0 (5.0 to 9.0). Pocket hematoma occurred in 21 patients (13.2%) following CIED surgery. Antimicrobial envelops were used in 43 patients (27%). Device infection due to CIED surgery occurred in 5 (3.1%) patients and occurred only in patients who developed post-operative pocket hematoma (p < 0.001). Mortality at 1 year following CIED surgery was 20% (n = 32). CONCLUSIONS: CIED surgery following LVAD implantation is associated with an increased risk for pocket hematoma and CIED infection. Further studies are needed to determine the risk-benefit ratio of CIED surgery in patients with LVADs.

Effectiveness of catheter ablation of atrial fibrillation according to heart failure etiology.

BACKGROUND: Catheter ablation is an important rhythm control therapy in patients with atrial fibrillation (AF) with concomitant heart failure (HF). The objective of this study was to assess the comparative efficacy of AF ablation patients with ischemic vs nonischemic heart failure. METHODS: We conducted a retrospective, observational cohort study of patients with HF who underwent AF ablation. Outcomes were compared based on HF etiology and included in-hospital events, symptoms (Mayo AF Symptom Inventory [MAFSI]), and functional status (New York Heart Association class) and freedom from atrial arrhythmias at 12 months. RESULTS: Among 242 patients (n = 70 [29%] ischemic, n = 172 [71%] nonischemic), patients with nonischemic cardiomyopathy were younger (mean age 64 ± 11.5 vs 69 ± 9.1, P = .002), more often female (36% vs 17%, P = .004), and had higher mean left-ventricular ejection fraction (47% vs 42%, P = .0007). There were no significant differences in periprocedural characteristics, including mean procedure time (243 ± 74.2 vs 259 ± 81.8 minutes, P = .1) and nonleft atrial ablation (17% vs 20%, P = .6). All-cause adverse events were similar in each group (15% vs 17%, P = .7). NYHA and MAFSI scores improved significantly at follow-up and did not differ according to HF etiology (P = .5; P = .10-1.00 after Bonferroni correction). There were no significant differences in freedom from recurrent atrial arrhythmia at 12-months between ischemic (74%) and nonischemic patients (78%): adjusted RR 0.63, 95% confidence interval 0.33-1.19. CONCLUSIONS: Catheter ablation in patients with AF and concomitant heart failure leads to significant improvements in functional and symptom status without significant differences between patients with ischemic vs nonischemic HF etiology.

Catheter ablation of atrial fibrillation in patients with diabetes mellitus.

BACKGROUND: Diabetes mellitus (DM) is an independent risk factor for atrial fibrillation (AF). Few studies have compared clinical outcomes after catheter ablation between patients with and those without DM. OBJECTIVE: The purpose of this study was to compare AF ablation outcomes in patients with and those without DM. METHODS: We performed a retrospective analysis of 351 consecutive patients who underwent first-time AF ablation. Clinical outcomes included freedom from recurrent atrial arrhythmia, symptom burden (Mayo AF Symptom Inventory score), cardiovascular and all-cause hospitalizations, and periprocedural complications. RESULTS: Patients with DM (n = 65) were older, had a higher body mass index, more persistent AF, more hypertension, and larger left atrial diameter (P <.05 for all). Median (Q1, Q3) total radiofrequency duration [64.0 (43.6, 81.4) minutes vs 54.3 (39.2, 76.4) minutes; P = .132] and periprocedural complications (P = .868) did not differ between patients with and those without DM. After a median follow-up of 29.5 months, arrhythmia recurrence was significantly higher in the DM group compared to the no-DM group after adjustment for baseline differences (adjusted hazard ratio [HR] 2.24; 95% confidence [CI] 1.42-3.55; P = .001). There was a nonsignificant trend toward higher AF recurrence with worse glycemic levels (HR 1.29; 95% CI 0.99-1.69; P = .064). CONCLUSION: Although safety outcomes associated with AF ablation were similar between patients with and those without DM, arrhythmia-free survival was significantly lower among patients with DM. Poor glycemic control seems to an important risk factor for AF recurrence.