Publications by authors named "Evan Adelstein"

90 Publications

Increased incidence of electrical abnormalities in a pacemaker lead family.

J Cardiovasc Electrophysiol 2021 Apr 24;32(4):1111-1121. Epub 2021 Feb 24.

Department of Medicine, Division of Cardiology, Albany Medical Center, Albany, New York, USA.

Introduction: Several recent studies have raised concern about noise detections on Tendril pacemaker leads, which may represent insulation failure or algorithm-driven overreporting of physiologic signals.

Methods: We identified all pacemaker leads actively followed at Albany Medical Center, of which 1111 leads (262 Abbott Tendril, 576 Medtronic CapSure, 30 Fineline, 195 Ingevity, 48 Dextrus) in 703 patients were included in this observational study. Electrical abnormalities, comprising low-impedance measurements <200 Ω and repeated noise detections, were catalogued, as was initial management and subsequent need for surgical intervention.

Results: During 54 months median follow-up (interquartile range 24-105), 63 leads (5.7%) demonstrated electrical abnormalities, including low impedances in 21 and noise in 59. Tendril leads manifested abnormalities most frequently (n = 50; 19.1%) compared with CapSure (n = 9; 1.6%), Fineline (n = 0), Ingevity (n = 0), and Dextrus (n = 4; 8.3%) leads. The risk of abnormalities was significantly higher in Tendril leads (HR 9.6, 95% CI 5.2-17.6; p < .001). Low impedances were measured on 19 Tendril leads, a significantly higher risk than on other leads (HR 23.8, 95% CI 5.5-102.1; p < .001). Although observation and reprogramming sensitivity were the initial management strategy for 45 and 7 leads, respectively, 18 ultimately required surgical intervention, including 15 Tendrils. No electrical abnormalities were observed in 12 non-Tendril leads attached to Abbott devices compared with 48 of 252 Tendrils attached to Abbott devices (log-rank p = .035).

Conclusion: Tendril leads demonstrate significantly higher risk of repeated low impedances and noise compared to other manufacturers' models, raising concern that these findings reflect early insulation failure. Increased scrutiny is warranted.
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http://dx.doi.org/10.1111/jce.14941DOI Listing
April 2021

Severe chronic kidney disease is associated with poor survival after initial CRT-defibrillator tachyarrhythmia therapy.

Pacing Clin Electrophysiol 2020 01 5;43(1):78-86. Epub 2019 Dec 5.

UPMC Heart and Vascular Institute, Pittsburgh, Pennsylvania.

Background: Implantable cardioverter-defibrillator (ICD) recipients who receive appropriate device therapies have limited survival, and survival benefit in chronic kidney disease (CKD) has been questioned. We examined the association between CKD and survival after cardiac resynchronization therapy (CRT)-defibrillator tachyarrhythmia therapies.

Methods: We compared overall survival after appropriate shocks or anti-tachycardia pacing in 439 CRT-defibrillator recipients with left ventricular ejection fraction (LVEF) ≤35%, non-right bundle-branch block QRS pattern, and QRS duration >130 ms according to glomerular filtration rate (GFR) at implant, including 31 patients with GFR ≤30, 164 patients with GFR 31-60, and 244 patients with GFR >60. At least one shock occurred in 302 patients (24 with GFR ≤30, 102 with GFR 31-60, and 176 with GFR >60). Serial echocardiograms were also compared.

Results: Patients were followed 64 months (interquartile range [IQR]: 29-94) after implant, including 32 months (IQR: 12-61) after first therapy. Time to first therapy or shock was similar across GFR groups. However, survival after first therapy declined directly with declining GFR (P < .001), with median postshock survival of 90 days for GFR ≤30 (95% confidence of interval [CI]: 0-233), 612 days (95% CI: 365-859) for GFR 31-60, and 1672 days (95% CI: 1396-1948) for GFR >60. Declining GFR category, ischemic heart disease, diabetes, and increasing age were independently associated with increased postshock mortality. Echocardiographic response was similar across GFR groups and was not associated with post-therapy survival.

Conclusions: Survival after appropriate tachyarrhythmia therapies, particularly shocks, is attenuated in patients with GFR ≤30. This raises concern over potential lack of survival benefit conferred by CRT-defibrillators versus CRT-pacemakers in this population.
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http://dx.doi.org/10.1111/pace.13823DOI Listing
January 2020

Implications of Neurological Status on Defibrillator Therapy and Long-Term Mortality of Sudden Cardiac Arrest Survivors.

JACC Clin Electrophysiol 2019 07 29;5(7):843-850. Epub 2019 May 29.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address:

Objectives: This study sought to investigate the impact of the neurological status of sudden cardiac arrest (SCA) survivors on implantable cardioverter-defibrillator (ICD) insertion and long-term mortality.

Background: The neurological status of SCA survivors may impact the decision to insert an ICD insertion and influence long-term survival.

Methods: In 1,433 survivors of SCA between 2002 and 2012, we examined the neurological status immediately after the arrest using the Pittsburgh Cardiac Arrest Category (PCAC) and prior to hospital discharge using the cerebral performance category (CPC) score. Patients were followed up to the endpoints of ICD implantation and all-cause mortality.

Results: Over a median follow-up period of 3.6 years, 389 (27%) patients received an ICD, and 674 (47%) died. The PCAC (adjusted hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.69 to 0.90) and CPC (adjusted HR: 0.73; 95% CI: 0.64 to 0.84) scores were highly predictive of the time to ICD insertion and of all-cause mortality (PCAC score, adjusted HR: 1.39; 95% CI: 1.24 to 1.57; CPC score, adjusted HR: 2.03; 95% CI: 1.77 to 2.34). ICD therapy was associated with better survival even after adjusting for neurological status (HR: 0.56; 95% CI: 0.43 to 0.73). A significant proportion of patients in the worse CPC categories had a >1-year survival after the index SCA.

Conclusions: In SCA survivors, worse neurological performance was associated with lower likelihood of ICD insertion and higher mortality. ICD insertion was associated with improved survival even after accounting for neurological performance. ICD discussion should therefore not be omitted in these patients.
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http://dx.doi.org/10.1016/j.jacep.2019.04.003DOI Listing
July 2019

Oral Anticoagulation for Atrial Fibrillation Thromboembolism Prophylaxis in the Chronic Kidney Disease Population: the State of the Art in 2019.

Cardiovasc Drugs Ther 2019 08;33(4):481-488

Division of Cardiology, Albany Medical Center, 47 New Scotland Ave, Albany, NY, 12208, USA.

Atrial fibrillation (AF) is the most common cardiac rhythm disturbance and is associated with increased risk of thromboembolism. Oral anticoagulants are effective at reducing rates of thromboembolism in patients with AF in the general population. Patients with AF and concurrent chronic kidney disease (CKD) have higher risk of thromboembolism and bleeding compared with patients with normal renal function. Among moderate CKD and end-stage renal disease (ESRD) patients on chronic dialysis, the use of oral anticoagulants is controversial. Use of warfarin, while beneficial in non-CKD patients, raises a number of concerns such as increased bleeding risk, labile anticoagulant effect, and calciphylaxis, especially in the ESRD population. The newer direct oral anticoagulant (DOAC) agents have demonstrated comparable efficacy and improved safety profiles compared with coumadin but are not as well studied in the CKD population. This review highlights the efficacy and safety of coumadin and the DOACs for thromboembolism prophylaxis in non-valvular AF patients with CKD.
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http://dx.doi.org/10.1007/s10557-019-06885-xDOI Listing
August 2019

Sex-specific clinical outcomes after cardiac resynchronization therapy in left bundle branch block-associated idiopathic nonischemic cardiomyopathy: A NEOLITH II substudy.

Ann Noninvasive Electrocardiol 2019 07 27;24(4):e12641. Epub 2019 Mar 27.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

Background: Sex differences in clinical outcomes for left bundle branch block (LBBB)-associated idiopathic nonischemic cardiomyopathy (NICM) after cardiac resynchronization therapy (CRT) are not well described.

Methods: A retrospective cohort study at an academic medical center included subjects with LBBB-associated idiopathic NICM who received CRT. Cox regression analyses estimated the hazard ratios (HRs) between sex and clinical outcomes.

Results: In 123 total subjects (mean age 62 years, mean initial left ventricular ejection fraction 22.8%, 76% New York Heart Association class III, and 98% CRT-defibrillators), 55 (45%) were men and 68 (55%) were women. The median follow-up time after CRT was 72.4 months. Similar risk for adverse clinical events (heart failure hospitalization, appropriate implantable cardioverter-defibrillator shock, appropriate antitachycardia pacing therapy, ventricular assist device implantation, heart transplantation, and death) was observed between men and women (HR, 1.20; 95% confidence interval [CI] 0.57-2.51; p = 0.63). This persisted in multivariable analyses. Men and women had similar risk for all-cause mortality in univariable analysis, but men had higher risk in the final multivariable model that adjusted for age at diagnosis, QRS duration, and left ventricular end-diastolic dimension index (HR, 4.55; 95% CI, 1.26-16.39; p = 0.02). The estimated 5-year mortality was 9.5% for men and 6.9% for women.

Conclusions: In LBBB-associated idiopathic NICM, men have higher risk for all-cause mortality after CRT when compared to women.
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http://dx.doi.org/10.1111/anec.12641DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6931705PMC
July 2019

Trends in Hospital Admissions for and Readmissions After Cardiac Implantable Electronic Device Procedures in the United States: An Analysis From 2010 to 2014 Using the National Readmission Database.

Mayo Clin Proc 2019 04 8;94(4):588-598. Epub 2019 Mar 8.

Heart and Vascular Institute, University of Pittsburgh Medical Center, PA.

Objective: To evaluate inpatient trends in de novo complete cardiac implantable electronic device (CIED) procedures and subsequent all-cause 30-day readmissions in the United States.

Patients And Methods: We accessed the National Readmission Database to identify CIED implantation-related hospitalizations between January 1, 2010, and December 31, 2014, using International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes. In-hospital mortality and postprocedure all-cause 30-day readmissions were also analyzed.

Results: During the study period, a total of 800,250 CIED implantation hospitalizations were identified across the United States, with an in-hospital mortality rate of 0.9% (7423 of 800,250) and a 29% decrease in CIED-related index hospitalizations (188,086 in 2010 vs 134,276 in 2014). The all-cause 30-day readmission rate for the entire cohort was 13% (106,505 of 800,250), decreasing from 14% (26,134 of 188,085) in 2010 to only 13% (17,154 of 134,276) by 2014. Dual-chamber pacemakers were the most frequently implanted in-hospital CIEDs (473,615 of 800,250 [59%]). The most common cause for readmission was heart failure exacerbation, which remained unchanged over the study period.

Conclusion: Our data reveal a steady decline in overall in-hospital CIED implantations and only a modest decline in readmission rates. The cause for this decline may be an impact of medical and regulatory changes guiding CIED implantations, but it deserves further investigation.
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http://dx.doi.org/10.1016/j.mayocp.2018.10.028DOI Listing
April 2019

Characterization of pulmonary vein reconnection post Cryoballoon ablation.

Indian Pacing Electrophysiol J 2019 Jul - Aug;19(4):129-133. Epub 2019 Feb 20.

Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. Electronic address:

Background: The Arctic Front Cryoballoon System is a technology in which substrate alterations in patients with atrial fibrillation (AF) recurrence have not been well characterized. In this study, we evaluated sites of pulmonary vein (PV) reconnections and the accuracy of the Achieve™ circular mapping catheter in detecting these reconnections after cryoablation.

Methods: This study included 15 patients undergoing redo AF ablation after a prior single cryoablation procedure. PV reconnection sites were determined by measuring PV signals and high output pacing from 4 vectors of the Achieve catheter. The results were compared with a roving mapping catheter guided by rotational intracardiac echocardiography (ICE) in the left atrium.

Results: All patients had PV reconnections (2.1 ± 0.8 veins/patient). The left superior PV was most commonly reconnected (n = 11), whereas the right inferior PV was least likely (n = 3). Both carinas (left: n = 11; right: n = 7) and left atrial appendage ridge (n = 11) were also frequently reconnected. Mapping with the Achieve catheter showed a positive predictive value (PPV) 100% and negative predictive value (NPV) 96% when compared with ICE guided mapping. In 2 patients, right superior PV reconnection was not identified by the Achieve.

Conclusion: During redo AF ablation after index cryoablation, multiple PVs are usually reconnected, with both carinas and left atrial appendage ridge being common sites of reconnection. The Achieve mapping catheter was able to identify reconnection with high positive and negative predictive values.
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http://dx.doi.org/10.1016/j.ipej.2019.02.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6697463PMC
February 2019

Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Systematic Review and Meta-Analysis.

JACC Clin Electrophysiol 2019 02 30;5(2):152-161. Epub 2019 Jan 30.

Division of Cardiology, Albany Medical College, Albany, New York.

Objectives: This study sought to synthesize the available evidence on the use of the wearable cardioverter-defibrillator (WCD).

Background: Observational WCD studies for the prevention of sudden cardiac death have provided conflicting data. The VEST (Vest Prevention of Early Sudden Death) trial was the first randomized controlled trial (RCT) showing no reduction in sudden cardiac death as compared to medical therapy only.

Methods: We searched PubMed, EMBASE, and Google Scholar for studies reporting on the outcomes of patients wearing WCDs from January 1, 2001, through March 20, 2018. Rates of appropriate and inappropriate WCD therapies were pooled. Estimates were derived using DerSimonian and Laird's method.

Results: Twenty-eight studies were included (N = 33,242; 27 observational, 1 RCT-WCD arm). The incidence of appropriate WCD therapy was 5 per 100 persons over 3 months (95% confidence interval [CI]: 3.0 to 6.0, I = 93%). In studies on ischemic cardiomyopathy, the appropriate WCD therapy incidence was lower in the VEST trial (1 per 100 persons over 3 months; 95% CI: 1.0 to 2.0) as compared with observational studies (11 per 100 persons over 3 months; 95% CI: 11.0 to 20.0; I = 93%). The incidence of inappropriate therapy was 2 per 100 persons over 3 months (95% CI: 1.0 to 3.0; I = 93%). Mortality while wearing WCD was rare at 0.7 per 100 persons over 3 months (95% CI: 0.3 to 1.7; I = 94%).

Conclusions: The rate of appropriately treated WCD patients over 3 months of follow-up was substantial; higher in-observational studies as compared with the VEST trial. There was significant heterogeneity. More RCTs are needed to justify continued use of WCD in primary prevention.
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http://dx.doi.org/10.1016/j.jacep.2018.11.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6383782PMC
February 2019

Amiodarone is associated with adverse outcomes in patients with sustained ventricular arrhythmias upgraded to cardiac resynchronization therapy-defibrillators.

J Cardiovasc Electrophysiol 2019 03 4;30(3):348-356. Epub 2019 Jan 4.

University of Pittsburgh Heart and Vascular Institute, Pittsburgh, Pennsylvania.

Introduction: Amiodarone reduces recurrent ventricular tachyarrhythmias (VTA) but may worsen cardiovascular outcomes in heart failure (HF) patients. Cardiac resynchronization therapy (CRT) may also be antiarrhythmic. When patients with prior sustained VTA are upgraded to CRT defibrillators (CRT-D) from conventional implantable cardioverter-defibrillators (ICDs), should concomitant amiodarone be continued or is CRT's antiarrhythmic potential sufficient?

Methods And Results: We identified 67 patients from a prospective CRT registry with spontaneous sustained VTA, New York Heart Association (NYHA) II-IV HF, and left bundle-branch block (LBBB) who were upgraded to CRT defibrillators from conventional ICDs. We compared changes in QRS duration and left ventricular ejection fraction (LVEF) pre- and post-CRT, time to death, transplant or ventricular assist device (VAD), and time to recurrent VTA therapies between 37 patients continuing amiodarone therapy and 30 amiodarone-naïve patients. Amiodarone-treated patients had worse renal function and a higher prevalence of prior VTA storm compared with amiodarone-naïve patients. After CRT, amiodarone-treated patients demonstrated less QRS narrowing (8 vs 20 ms; P = 0.021) and less LVEF improvement (-2.7 vs +5.2%; P = 0.006). Over 29 months, 31 (47%) patients died and 13 (20%) received transplant or VAD. Risk of death, transplant, or VAD was greater in amiodarone-treated than -naïve patients (corrected hazard ratio [HR], 2.14; 95% confidence interval [CI], 1.12-4.11; P = 0.022). Appropriate CRT-D therapies occurred in 37 (55%) patients; amiodarone use was not associated time to first therapy (HR, 1.13; 95% CI, 0.59-2.16; P = 0.72).

Conclusion: In patients with sustained VTA and LBBB upgraded from conventional ICDs to CRT defibrillators, concomitant amiodarone use is associated with less QRS narrowing, less LVEF improvement, greater risk of death, transplant, or VAD, and similar risk of recurrent VTA.
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http://dx.doi.org/10.1111/jce.13828DOI Listing
March 2019

Improvement in ejection fraction after cryoballoon pulmonary vein isolation for atrial fibrillation in individuals with systolic dysfunction.

J Interv Card Electrophysiol 2019 Apr 17;54(3):225-229. Epub 2018 Oct 17.

Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, 200 Lothrop Street, PUH B-535, Pittsburgh, PA, 15312, USA.

Background: Cryoballoon pulmonary vein isolation (PVI) is commonly used for rhythm control of atrial fibrillation (AF). Data are limited examining the outcomes of cryoballoon PVI in patients with systolic dysfunction. We evaluate the impact of cryoballoon PVI in patients with systolic dysfunction.

Methods: We evaluated a single-center prospective registry of patients undergoing cryoballoon PVI between 8/2011 and 6/2016. Patients with systolic dysfunction (EF < 55%) between the time of AF diagnosis and their cryoballoon PVI procedure were assessed for AF recurrence at 6 months and 1 year post-procedure, with a 3-month blanking period.

Results: Final analysis included 66 patients with systolic dysfunction undergoing cryoballoon PVI. An AF diagnosis for ≥ 1 year prior to PVI was present in 62.1% (n = 41), and 53.0% (n = 35) had systolic dysfunction for ≥ 1 year pre-procedure. The proportion of AF-free patients at 1 year was 51.5%. Of patients with echocardiograms performed at 1 year (n = 43), a greater proportion of individuals without AF recurrence had an improvement in EF of ≥ 10% than in those with AF recurrence (54.2% vs. 25.0%, p = 0.039). Of the patients who had systolic dysfunction at the time of the ablation (EF < 55%), there was a significant increase in EF post-procedure (36.5% pre-procedure vs. 48.3% post-procedure, mean change 11.8%, p < 0.001).

Conclusion: In patients with systolic dysfunction, cryoballoon PVI provides an acceptable AF recurrence-free rate at 1 year. AF recurrence-free individuals were more likely to have improvement in EF. Further evaluation is needed to determine the potential role of early cryoballoon PVI in patients with a new diagnosis of systolic dysfunction and AF.
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http://dx.doi.org/10.1007/s10840-018-0475-3DOI Listing
April 2019

Myocardial recovery after cardiac resynchronization therapy in left bundle branch block-associated idiopathic nonischemic cardiomyopathy: A NEOLITH II substudy.

Ann Noninvasive Electrocardiol 2019 03 28;24(2):e12603. Epub 2018 Sep 28.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

Background: Baseline predictors of myocardial recovery after cardiac resynchronization therapy (CRT) in left bundle branch block (LBBB)-associated idiopathic nonischemic cardiomyopathy (NICM) are unknown.

Methods: A retrospective study included subjects with idiopathic NICM, left ventricular ejection fraction (LVEF) ≤35%, and LBBB. Myocardial recovery was defined as post-CRT LVEF ≥50%. Logistic regression analyses described associations between baseline characteristics and myocardial recovery. Cox regression analyses estimated the hazard ratio (HR) between myocardial recovery status and adverse clinical events.

Results: In 105 subjects (mean age 61 years, 44% male, mean initial LVEF 22.6% ± 6.6%, 81% New York Heart Association class III, and 98% CRT-defibrillators), myocardial recovery after CRT was observed in 56 (54%) subjects. Hypertension, heart rate, and serum blood urea nitrogen (BUN) had negative associations with myocardial recovery in univariable analyses. These associations persisted in multivariable analysis: hypertension (odds ratio (OR), 0.40; 95% confidence interval (CI), 0.17-0.95; p = 0.04), heart rate (OR per 10 bpm, 0.69; 95% CI, 0.48-0.997; p = 0.048), and serum BUN (OR per 1 mg/dl, 0.94; 95% CI, 0.88-0.99; p = 0.04). Subjects with post-CRT LVEF ≥50%, when compared to <50%, had lower risk for adverse clinical events (heart failure hospitalization, appropriate implantable cardioverter-defibrillator shock, appropriate anti-tachycardia pacing therapy, ventricular assist device implantation, heart transplantation, and death) over a median follow-up of 75.9 months (HR, 0.38; 95% CI, 0.16-0.88; p = 0.02).

Conclusion: In LBBB-associated idiopathic NICM, myocardial recovery after CRT was associated with absence of hypertension, lower heart rate, and lower serum BUN. Those with myocardial recovery had fewer adverse clinical events.
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http://dx.doi.org/10.1111/anec.12603DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6931814PMC
March 2019

Implantable cardioverter-defibrillator therapy in device recipients who survived a cardiac arrest associated with a reversible cause.

J Cardiovasc Electrophysiol 2018 10 23;29(10):1413-1417. Epub 2018 Aug 23.

Division of Cardiovascular Diseases, Department of Internal Medicine, Heart & Vascular Institute, University of Pittsburgh, UPMC, Pittsburgh, Pennsylvania.

Background: Guideline recommendations for implantable cardioverter-defibrillators (ICD) for secondary prevention of sudden cardiac arrest (SCA) have excluded patients with reversible causes. We previously demonstrated mortality benefit with the ICD in survivors of SCA associated with reversible causes other than myocardial infarction (MI) or ischemia treated with coronary revascularization. In the current study, we examined the incidence of ICD therapy in patients with SCA related to reversible causes.

Methods: Data were collected for all patients over the age of 18 years who had survived to hospital discharge after SCA between 2002 and 2012. ICD recipients with reversible causes were divided into 2 groups based on their reversible etiology of SCA: MI + ICD (n = 132) and non-MI + ICD (n = 75). Delivered ICD therapy was examined.

Results: Over a follow-up period of 3.8 ± 3.1 years, more patients without MI/ischemia who received an ICD experienced appropriate (adjusted HR, 3.96; 95% CI, 1.32-11.84) but not inappropriate (adjusted HR, 0.65; 95% CI, 0.14-2.97) ICD therapy compared with patients without MI/ischemia. The proportion of patients receiving appropriate (P = 0.012) but not inappropriate (P = 0.80) ICD therapy was also higher in the non-MI + ICD compared with the MI + ICD group.

Conclusion: We show higher rates of appropriate ICD therapy in survivors of SCA associated with reversible causes other than MI/ischemia. This finding, in conjunction with the previously demonstrated lower all-cause mortality noted in the presence of an ICD in SCA survivors with reversible etiology other than MI/ischemia, further supports consideration of ICD implantation in this population.
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http://dx.doi.org/10.1111/jce.13696DOI Listing
October 2018

Scar burden, not intraventricular conduction delay pattern, is associated with outcomes in ischemic cardiomyopathy patients receiving cardiac resynchronization therapy.

Heart Rhythm 2018 11 28;15(11):1664-1672. Epub 2018 May 28.

Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.

Background: Patients with nonspecific intraventricular conduction delay (IVCD) benefit less from cardiac resynchronization therapy (CRT) than patients with left bundle branch block (LBBB).

Objective: The purpose of this study was to determine whether post-CRT outcome differences in patients with ischemic cardiomyopathy (ICM) relate to intrinsic QRS pattern and/or scar burden.

Methods: We analyzed 393 consecutive ICM patients with left ventricular ejection fraction (LVEF) ≤35%, QRS duration >120 ms, and LBBB or nonspecific IVCD who underwent single-photon emission computed tomography myocardial perfusion imaging and CRT-defibrillator implant. We compared scar burden; QRS duration; LVEF change; risk of death, transplant, or ventricular assist device; and risk of appropriate device shocks between LBBB and IVCD patients, using multivariable analyses to determine relative associations between QRS pattern vs scar burden and outcomes.

Results: Nonspecific IVCD is associated with greater scar burden and narrower baseline QRS duration than LBBB. IVCD patients demonstrated less QRS narrowing with CRT than LBBB patients, even when excluding IVCD patients with QRS duration <150 ms. LVEF improved less in patients with IVCD vs LBBB, but only scar burden not QRS morphology or duration was associated with LVEF increase ≥5%. During 39-month follow-up, IVCD was associated with shorter survival free from transplant/ventricular assist device and shorter time to first appropriate device shock. Scar burden but not QRS morphology was independently associated with these outcomes on multivariate analysis.

Conclusion: IVCD is associated with greater scar burden than LBBB in ICM CRT-defibrillator recipients. Scar burden, not QRS pattern, is independently associated with adverse clinical outcomes.
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http://dx.doi.org/10.1016/j.hrthm.2018.05.027DOI Listing
November 2018

Oral anticoagulation and left atrial thrombi resolution in nonrheumatic atrial fibrillation or flutter: A systematic review and meta-analysis.

Pacing Clin Electrophysiol 2018 07 4;41(7):767-774. Epub 2018 Jun 4.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.

Background: Oral anticoagulation (OAC) is prescribed for left atrial thrombi (LAT) in nonrheumatic atrial fibrillation (AF) and/or atrial flutter (AFL). The study objective was to review the existing evidence regarding LAT resolution in nonrheumatic AF and/or AFL with OAC agents.

Methods: Data sources included PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) between January 1, 1991 and February 10, 2017. English-language studies that assessed LAT resolution with OAC agents in subjects with nonrheumatic AF and/or AFL, by serial transesophageal echocardiography, and with follow-up times ≥ 3 weeks and < 1 year, were selected. Study quality was assessed using recommendations adapted from the Agency for Healthcare Research and Quality. Pooled LAT resolution rates were evaluated for vitamin K antagonist (VKA) studies and low risk of bias warfarin studies.

Results: The pooled LAT resolution rate of 619 subjects from 16 VKA studies was 63.7% (95% confidence interval [CI], 53.3%-72.9%). The pooled LAT resolution rate of 94 subjects from four studies that specified warfarin use, exclusion of prior long-term therapeutic OAC, and target international normalized ratio (INR) ≥ 2.0 and/or average achieved INR ≥ 2.0 was 79.3% (95% CI, 69.8%-86.4%). Two studies in direct-acting oral anticoagulants (DOACs) reported LAT resolution rates of 89.5% (17 of 19) for dabigatran and 41.5% (22 of 53) for rivaroxaban.

Conclusions: Warfarin is the most studied initial OAC agent for treating LAT in nonrheumatic AF and/or AFL with a resolution rate of nearly 80%. Further studies in DOACs are warranted.
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http://dx.doi.org/10.1111/pace.13368DOI Listing
July 2018

The Wearable Cardioverter-Defibrillation: An Investment Worth Making or Needing Further Investigation?

JACC Clin Electrophysiol 2018 02 29;4(2):240-242. Epub 2017 Nov 29.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address:

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http://dx.doi.org/10.1016/j.jacep.2017.10.011DOI Listing
February 2018

Implantable Defibrillator Therapy in Cardiac Arrest Survivors With a Reversible Cause.

Circ Arrhythm Electrophysiol 2018 03;11(3):e005940

From the Department of Internal Medicine and the Heart and Vascular Institute, University of Pittsburgh Medical Center, PA (A.L., D.K.P., S.A., A.J., A.F.D., S.P., D.Q., S.A., M.B.M., E.A., S.J., S.S.); Advocate Heart Institute, Advocate Lutheran General Hospital, Park Ridge, IL (S.R.); and Department of Internal Medicine, University of Michigan, Ann Arbor (M.W.).

Background: Current guidelines recommend implantable cardioverter-defibrillator (ICD) therapy in survivors of sudden cardiac arrest (SCA), except in those with completely reversible causes. We sought to examine the impact of ICD therapy on mortality in survivors of SCA associated with reversible causes.

Methods And Results: We evaluated the records of 1433 patients managed at our institution between 2000 and 2012 who were discharged alive after SCA. A reversible and correctable cause was identified in 792 (55%) patients. Reversible SCA cause was defined as significant electrolyte or metabolic abnormality, evidence of acute myocardial infarction or ischemia, recent initiation of antiarrhythmic drug or illicit drug use, or other reversible circumstances. Of the 792 SCA survivors because of a reversible and correctable cause (age 61±15 years, 40% women), 207 (26%) patients received an ICD after their index SCA. During a mean follow-up of 3.8±3.1 years, 319 (40%) patients died. ICD implantation was highly associated with lower all-cause mortality (<0.001) even after correcting for unbalanced baseline characteristics (<0.001). In subgroup analyses, only patients whose SCA was not associated with myocardial infarction extracted benefit from ICD (<0.001).

Conclusions: In survivors of SCA because of a reversible and correctable cause, ICD therapy is associated with lower all-cause mortality except if the SCA was because of myocardial infarction. These data deserve further investigation in a prospective multicenter randomized controlled trial, as they may have important and immediate clinical implications.
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http://dx.doi.org/10.1161/CIRCEP.117.005940DOI Listing
March 2018

Effect of body mass index on survival after sudden cardiac arrest.

Clin Cardiol 2018 Jan 22;41(1):46-50. Epub 2018 Jan 22.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

Background: Although elevated body mass index (BMI) is a risk factor for cardiac disease, patients with elevated BMI have better survival in the context of severe illness, a phenomenon termed the "obesity paradox."

Hypothesis: Higher BMI is associated with lower mortality in sudden cardiac arrest (SCA) survivors.

Methods: Data were collected on 1433 post-SCA patients, discharged alive from the hospitals of the University of Pittsburgh Medical Center between 2002 and 2012. Of those, 1298 patients with documented BMI during the index hospitalization and follow-up data constituted the study cohort.

Results: In the overall cohort, 30 patients were underweight (BMI <18.5 kg/m ), 312 had normal weight (BMI 18.5-24.9 kg/m ), 417 were overweight (BMI 25.0-29.9 kg/m ), and 539 were obese (BMI ≥30 kg/m ). As expected, the prevalence of coronary artery disease, myocardial infarction, diabetes mellitus, and hypertension increased significantly with increasing BMI. Over a median follow-up of 3.6 years, 602 (46%) patients died. Despite higher prevalence of cardiovascular comorbidities in more obese patients, a higher BMI was associated with lower all-cause mortality on univariate analysis (hazard ratio: 0.86 per increase by 1 BMI category, 95% confidence interval: 0.78-0.94, P = 0.002) and multivariate analysis after adjusting for unbalanced baseline comorbidities (hazard ratio: 0.86 per increase by 1 BMI category, 95% confidence interval: 0.77-0.96, P = 0.009).

Conclusions: Higher BMI is associated with lower all-cause mortality in survivors of SCA, suggesting that the obesity paradox applies to the post-arrest population. Further investigation into its mechanisms may inform the management of post-SCA patients.
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http://dx.doi.org/10.1002/clc.22847DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6489713PMC
January 2018

New-onset left bundle branch block-associated idiopathic nonischemic cardiomyopathy and time from diagnosis to cardiac resynchronization therapy: The NEOLITH II study.

Pacing Clin Electrophysiol 2018 02 24;41(2):143-154. Epub 2018 Jan 24.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.

Background: The optimal timing for cardiac resynchronization therapy (CRT) after diagnosis of new-onset left bundle branch block (LBBB)-associated idiopathic nonischemic cardiomyopathy (NICM) and treatment with guideline-directed medical therapy (GDMT) is unknown. The purpose of this study was to describe relationships between time from diagnosis to CRT and outcomes in new-onset LBBB-associated idiopathic NICM with left ventricular ejection fraction (LVEF) ≤35%.

Methods: A retrospective cohort study examined associations between time from diagnosis to CRT (≤9 months vs >9 months) and clinical and echocardiographic outcomes.

Results: In 123 subjects with LBBB-associated idiopathic NICM, time from diagnosis to CRT was ≤9 months in 60 (49%) subjects and 9 months in 63 (51%) subjects. Clinical outcomes were similar for those implanted ≤9 months versus >9 months for adverse clinical events (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.41-1.78; P = 0.67) and all-cause mortality (HR, 0.57; 95% CI, 0.19-1.70; P = 0.31). Multivariable analyses demonstrated similar results. In 105 subjects with post-CRT echocardiograms, LVEF improvement to >35% was more likely in those implanted ≤9 months when compared to >9 months (odds ratio [OR], 3.53; 95% CI, 1.32-9.46; P = 0.01). This association persisted in the final multivariable model adjusted for age at diagnosis, sex, QRS duration, post-GDMT LVEF, and time from CRT to post-CRT echocardiogram (OR, 5.10; 95% CI, 1.71-15.22; P = 0.004).

Conclusion: In LBBB-associated idiopathic NICM, earlier CRT implantation was associated with more favorable cardiac remodeling. Delaying CRT may miss a critical period to halt and reverse progressive myocardial damage.
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http://dx.doi.org/10.1111/pace.13264DOI Listing
February 2018

Impact of 3D mapping on procedural characteristics and outcomes in cryoballoon pulmonary vein isolation for atrial fibrillation.

J Interv Card Electrophysiol 2018 Jan 5;51(1):71-75. Epub 2018 Jan 5.

Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, 200 Lothrop Street, PUH B-535, Pittsburgh, PA, 15213, USA.

Purpose: The use of 3D mapping during cryoballoon pulmonary vein isolation (PVI) is optional with added cost but potential benefit in aiding vein identification, reducing fluoroscopy, and post-ablation testing. Data are limited evaluating procedural characteristics and outcomes in patients undergoing cryoballoon PVI with mapping vs. no mapping. In the present study, we compare procedural characteristics and recurrence-free rates in patients undergoing cryoballoon PVI among patients using CARTO®, NavX™, or no mapping system.

Methods: We evaluated a single center registry of patients undergoing cryoballoon PVI from 2013 to 2016, retrospectively. Patients undergoing a redo procedure or additional RF ablation were excluded. Baseline and procedural characteristics were compared among CARTO, NavX, and no mapping groups. Post-PVI patients were assessed for atrial arrhythmia recurrence after a 3-month blanking period. Recurrence was based on typical symptoms or ECG/event monitor evidence of atrial fibrillation (AF). Kaplan-Meier analysis was used to compare arrhythmia-free survival between groups.

Results: We included 432 patient procedures, 98 using mapping systems (45 NavX, 53 CARTO), and 334 without. When using the CARTO mapping system compared to NavX or no mapping, there were longer procedure times (168 vs.109 vs.115 min, p < 0.001) and LA dwell times (110 vs.81 vs.87 min, p < 0.001). Additionally, both CARTO and NavX, when compared to no mapping, had longer fluoroscopy times (32 vs.31 vs.26 min, p < 0.001). Overall, total ablation time was increased for patients without mapping systems compared to NavX. There were no significant differences in 1-year recurrence-free rates between CARTO, NavX, and no mapping groups (64.9 vs. 65.0 vs. 64.6%, p = 0.278).

Conclusion: Use of CARTO is associated with increased procedure and LA dwell times compared to NavX or no mapping. Mapping system use yielded longer fluoroscopy times without an improvement in atrial fibrillation recurrence. Given the additional cost of mapping, the role for routine use in cryoballoon PVI is unclear.
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http://dx.doi.org/10.1007/s10840-017-0304-0DOI Listing
January 2018

Gender Differences in Cardiac Resynchronization Therapy Device Choice and Outcome in Patients ≥75 Years of Age with Heart Failure.

Am J Cardiol 2017 Dec 19;120(12):2201-2206. Epub 2017 Sep 19.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address:

Cardiac resynchronization therapy (CRT) is an established therapy for heart failure and can be delivered through a CRT pacemaker (CRT-P) or a CRT defibrillator (CRT-D). CRT-P devices are smaller and less expensive, have better battery longevity, and have been subject to fewer recalls and advisories but cannot deliver high-energy shocks to terminate potentially lethal ventricular arrhythmias. As published guidelines do not distinguish between CRT-P and CRT-D indications, we examined the practice of prescribing these devices in older women and men with heart failure. A total of 512 CRT recipients (age ≥75 years, 26% women, 21% CRT-P) were included in this analysis. Baseline characteristics were collected on all patients, and overall survival was compared by gender and type of CRT device implanted. Women were more likely to receive CRT-Ps than men (26% vs 19%). Men with CRT-Ps were significantly older than women with CRT-Ps and both men and women with CRT-Ds (p = 0.04). In addition, women had lower all-cause mortality compared with men (hazard ratio [HR] 0.75, confidence interval [CI] 0.58 to 0.99, p = 0.04), mainly among CRT-P recipients (HR 0.48, CI 0.26 to 0.8, p = 0.02), but this association was attenuated after adjusting for differences in patient characteristics (HR 0.56, CI 0.26 to 1.18, p = 0.13). In conclusion, women are more likely to receive CRT-Ps than men. Whether this difference is driven by patient preference or physician biases remains unclear. Women with CRT, particularly CRT-Ps, have a better overall survival than men. These differences, which may be driven by unbalanced baseline characteristics of patients or by differences in gender response to CRT, deserve further investigation.
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http://dx.doi.org/10.1016/j.amjcard.2017.08.044DOI Listing
December 2017

Implantable cardioverter defibrillator in non-ischemic cardiomyopathy: a meta-analysis of randomized controlled trials.

Cardiovasc Diagn Ther 2017 Aug;7(4):397-404

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.

Background: Sudden cardiac death (SCD) is a significant cause of mortality in patients with non-ischemic cardiomyopathy (NICM). Implantable cardioverter defibrillators (ICDs) are currently indicated for the primary prevention of SCD in these patients. Conflicting results from published randomized controlled trials (RCTs) have recently questioned the protective role of ICD in NICM patients to perform an updated meta-analysis of the effect of ICDs on outcomes of NICM patients.

Methods: We performed a search of PubMed, EMBASE, and Cochrane databases for RCTs comparing ICD to medical therapy in patients with NICM. Outcomes were all-cause mortality, SCD, and cardiac mortality. Mantel-Haenszel (MH) risk ratios (RR) were calculated using random-effects meta-analysis for the outcomes mentioned. Heterogeneity was assessed using I statistics and Q-statistic.

Results: A total of five RCTs met the inclusion criteria, with a total of 1,503 patients in the ICD group and 1,364 patients in the medical therapy. Compared to medical therapy, ICD use resulted in a 24% relative risk reduction (RRR) of all-cause mortality (RR 0.76, 95% CI 0.64-0.91, P=0.002), and 60% RRR of SCD (RR 0.40, 95% CI 0.18-0.90, P=0.03), but was not associated with a statistically significant benefit in the prevention of cardiac mortality (RR 0.75, 95% CI 0.39-1.44, P=0.39). Limiting the analysis to patients who received an ICD only without cardiac resynchronization therapy (CRT) pacemakers (4 trials, 1,825 patients) showed similar all-cause mortality results with 24% RRR in ICD group (RR 0.76, 95% CI 0.61-0.94, P=0.01).

Conclusions: ICD therapy reduces all-cause mortality and SCD in patients with NICM.
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http://dx.doi.org/10.21037/cdt.2017.06.06DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5582055PMC
August 2017

Predictors and implications of early left ventricular ejection fraction improvement in new-onset idiopathic nonischemic cardiomyopathy with narrow QRS complex: A NEOLITH substudy.

Ann Noninvasive Electrocardiol 2017 Nov 12;22(6). Epub 2017 May 12.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.

Background: Predictors and implications of early left ventricular ejection fraction (LVEF) improvement with guideline-directed medical therapy (GDMT) in new-onset idiopathic nonischemic cardiomyopathy (NICM) with narrow QRS complex are not well described. The objectives were to describe predictors of LVEF improvement after 3 months on GDMT and adverse cardiac events based on post-GDMT LVEF status (≤35% vs. >35%).

Methods: A retrospective cohort study was performed in subjects with new-onset NICM, LVEF ≤35%, and narrow QRS complex. Associations for baseline variables with post-GDMT LVEF improvement and absolute change in LVEF (∆LVEF ) were assessed. Cox proportional hazards models assessed associations for post-GDMT LVEF status with adverse cardiac events.

Results: In 70 subjects, 31 (44%) had post-GDMT LVEF ≤35% after a median follow-up time of 97.5 days (interquartile range, 84-121 days). In final multivariable models, severely dilated left ventricular end-diastolic diameter (LVEDD), compared with normal LVEDD, strongly predicted post-GDMT LVEF ≤35% (odds ratio, 7.77; 95% confidence interval [CI], 1.39-43.49; p = .02) and ∆LVEF (β = -15.709; standard error = 4.622; p = .001). Subjects with post-GDMT LVEF ≤35% were more likely to have adverse cardiac events over a median follow-up time of 970.5 days (unadjusted hazard ratio, 2.15; 95% CI, 0.93-4.96; p = .07). In the post-GDMT LVEF ≤35% group, 9 of 26 subjects (35%) had long-term LVEF > 35%.

Conclusion: In new-onset NICM with narrow QRS complex, nondilated LVEDD predicted early LVEF improvement. Those with post-GDMT LVEF ≤35% had higher risk of adverse cardiac events, but a substantial proportion demonstrated continued long-term LVEF improvement.
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http://dx.doi.org/10.1111/anec.12466DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6931791PMC
November 2017

Usefulness of the CHADS-VASc Score to Predict Mortality in Defibrillator Recipients.

Am J Cardiol 2017 07 12;120(1):83-86. Epub 2017 Apr 12.

Department of Medicine, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address:

The CHADS-VAS score is a well-validated stratification tool that predicts the risk of thromboembolism and stroke in patients with nonvalvular atrial fibrillation. Several studies have examined its application as a predictor of mortality in clinical applications other than atrial fibrillation. However, there are current no studies examining its use as an outcome prediction tool in a population of patients with implantable cardiac defibrillators (ICDs). In this study, we examined data from 2,258 patients who underwent ICD device implantation at the hospitals of the University of Pittsburgh Medical Center from February 2002 to April 2014 (median follow-up 5.1 years) and examined the impact of their CHADS-VAS score at the time of device implantation on all-cause mortality. Survival curves based on CHADS-VAS scores were generated using the Kaplan-Meier method and were adjusted for unbalanced covariates using the Cox proportional hazards model. The mean CHADS-VAS score was 3.15 ± 1.52 (range 1 to 8, mode 3). The CHADS-VAS score predicted all-cause mortality in a significant and dose-dependent fashion. Analyzing the population by quartiles revealed increasing all-cause mortality from Q1 to Q4 (p <0.001). Using a Cox multivariate model adjusting for ejection fraction, BMI, serum creatinine, hemoglobin level, and QRS width, the CHADS-VAS score remained a strong predictor of all-cause mortality (hazard ratio 1.26 per 1-point increase, 95% confidence interval 1.20 to 1.32). In conclusion, the CHADS-VAS score is a simple tool that highly predicts all-cause mortality in patients with ICD.
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http://dx.doi.org/10.1016/j.amjcard.2017.03.257DOI Listing
July 2017

Long-term use of the wearable cardioverter-defibrillator: prolonging life or prolonging indecision?

Authors:
Evan Adelstein

J Interv Card Electrophysiol 2017 Jan 26;48(1):9-10. Epub 2016 Nov 26.

University of Pittsburgh, 200 Lothrop Street, PUH B535, Pittsburgh, PA, 15213, USA.

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http://dx.doi.org/10.1007/s10840-016-0212-8DOI Listing
January 2017

Characteristics and Outcomes of Concurrently Diagnosed New Rapid Atrial Fibrillation or Flutter and New Reduced Ejection Fraction.

Pacing Clin Electrophysiol 2016 Dec 22;39(12):1394-1403. Epub 2016 Dec 22.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

Background: Characteristics and outcomes of concurrently diagnosed new rapid atrial fibrillation (AF) or atrial flutter (AFL) and new heart failure with reduced left ventricular ejection fraction (LVEF) are not well described.

Methods: A retrospective cohort study of subjects referred for expedited transesophageal echocardiography-guided rhythm-control strategies for concurrent new rapid AF/AFL and new LVEF ≤ 40% diagnosed during the same admission was analyzed.

Results: Twenty-five subjects (median age 57 years; 96% male; 96% Caucasian; median CHA DS -VASc = 2) presented with new AF (n = 18) or AFL (n = 7) with rapid ventricular rate (median 135 beats/min) and new reduced LVEF (median 27%; range, 10-37.5%). Seven (28%) subjects had left atrial appendage thrombi (LAAT) and five (20%) subjects had heavy or binge alcohol use. Baseline characteristics were similar between those with and without LAAT. Thirteen subjects with AF and without LAAT underwent direct-current cardioversion (DCCV) and 10 (77%) had AF recurrence within 90 days. Improvement of long-term LVEF to >40% was comparable for subjects with and without initial LAAT (83% vs 94%; P = 0.46). Three of four subjects who received primary prophylaxis implantable cardioverter-defibrillators improved their LVEF to >35% after sinus rhythm maintenance. The median long-term follow-up time was 3.0 years.

Conclusions: Subjects with concurrently diagnosed new rapid AF/AFL and new reduced LVEF are characterized by a high prevalence of LAAT and significant alcohol use. AF subjects without initial LAAT who underwent DCCV had a high 90-day AF recurrence rate. The presence of LAAT did not have a prognosticative effect on eventual LVEF improvement, which was observed in almost all subjects.
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http://dx.doi.org/10.1111/pace.12981DOI Listing
December 2016

Left ventricular dimensions predict risk of appropriate shocks but not mortality in cardiac resynchronization therapy-defibrillator recipients with left bundle-branch block and non-ischemic cardiomyopathy.

Europace 2017 Oct;19(10):1689-1694

Heart and Vascular Institute, University of Pittsburgh, 200 Lothrop Str. PUH B535 Pittsburgh, PA, USA.

Aims: Patients with non-ischaemic cardiomyopathy (NICM) and left bundle-branch block (LBBB) often benefit markedly from cardiac resynchronization therapy (CRT). Cardiac resynchronization therapy responders have a lower risk of appropriate device shocks from CRT-defibrillators (CRT-D) than do non-responders. Larger baseline left ventricular (LV) dimensions may be associated with less CRT response and thus greater risk of appropriate shocks.

Methods And Results: We analysed all (n = 249; 55% female) primary prevention CRT-D recipients at our institution with LBBB, NICM, and measured LV dimensions prior to device implant for the outcomes of (i) appropriate shocks, (ii) any appropriate tachyarrhythmia therapies, and (iii) risk of death, transplant, or left ventricular assist device (LVAD). During 59 months (interquartile range 21.5-91.5) follow-up, 19 (8%) patients received ≥1 appropriate shock, and 67 (27%) patients died, received a transplant, or required LVAD. Receiver-operating characteristic analysis of LV end-diastolic diameter (LVEDD) per meter height vs. appropriate shock(s) revealed an area under the curve of 0.75 (95% CI 0.65-0.85; P < 0.001). No patient with indexed LVEDD <3.36 cm/m (n = 76) received a shock. There was no statistically significant difference in risk of death, transplant, or LVAD (corrected HR 1.67, 95% CI 0.90-3.03; P = 0.103) in patients with indexed LVEDD above this cut-off compared to those with smaller dimension. Among 102 patients with paired quantitative echocardiograms, there was no difference in LVEF change between patients with indexed LVEDD <3.36 cm/m (n = 27; median 11%) and larger (n = 75; median 14%).

Conclusion: Patients with LVEDD <3.36 cm/m height prior to CRT-D implant in the setting of NICM and LBBB have minimal risk of appropriate shocks but similar risk of death, transplant- and LVAD and similar extent of LV functional improvement as patients with larger LVEDD. CRT-pacemakers may be appropriate in such patients.
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http://dx.doi.org/10.1093/europace/euw323DOI Listing
October 2017

Incidence and Predictors of Complications During Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation.

J Am Heart Assoc 2016 07 21;5(7). Epub 2016 Jul 21.

Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA

Background: Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency PVI for atrial fibrillation (AF). Data are lacking to define the rates and predictors of complications, particularly phrenic nerve injury (PNI).

Methods And Results: We evaluated a single-center prospective registry of 450 consecutive patients undergoing cryoballoon PVI between 2011 and 2015. Patients were 59±10 years old, 26% were women, 58% had hypertension, their mean CHA2DS2VASc score was 1.7±1.3, 30% had persistent atrial fibrillation, and 92% received a second-generation 28-mm balloon. Predefined major complications were persistent PNI, pericardial effusion, deep vein thrombosis, arteriovenous fistula, atrioesophageal fistula, bleeding requiring transfusion, stroke, and death. PNI was categorized as persistent if it persisted after discharge from the laboratory. Logistic regression was performed to identify predictors of complications and specifically PNI. We identified a major complication in 10 (2.2%) patients. In 49 (10.8%) patients, at least transient PNI was observed; only 5 persisted beyond the procedure (1.1%). All cases of PNI resolved eventually, with the longest time to resolution being 48 days. We also describe 2 cases of PNI manifesting after the index hospitalization. Regression analysis identified 23-mm balloon use (16.3% versus 5.2%, odds ratio 2.94, P=0.011) and increased age (62.8±7.7 versus 58.7±0.12 years, odds ratio 1.058, P=0.014) as independent significant predictors of PNI. There were no significant predictors of major complications.

Conclusions: In a large contemporary cohort, cryoballoon PVI is associated with low procedural risk, including lower rates of PNI than previously reported. Older age and 23-mm balloon use were associated with PNI. Our low rate of PNI may reflect more sensitive detection methods, including compound motor action potential monitoring and forced double-deflation.
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http://dx.doi.org/10.1161/JAHA.116.003724DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5015404PMC
July 2016

Influence of patients' age at implantation on mortality and defibrillator shocks.

Europace 2017 May;19(5):802-807

Boston Scientific Inc., Minneapolis, MN, USA.

Aims: Patients have increasing comorbidities and competing causes of death with advancing age, raising questions about the effectiveness of the implantable cardioverter defibrillators (ICD) in older age. We therefore investigated the effect of patients' age at initial device implantation on all-cause mortality and on the risk of ICD shocks in single-chamber (V-ICD), dual-chamber (D-ICD), and cardiac resynchronization therapy defibrillator (CRT-D) recipients.

Methods And Results: We reviewed de-identified records of 67 128 ICD recipients enrolled in the Boston Scientific ALTITUDE database of remote monitored patients [V-ICD (n = 11 422), D-ICD (n = 23 974), and CRT-D (n = 31 732)]. Over a mean follow-up of 2.3 ± 1.4 years, patients in all ICD groups had increased all-cause mortality but decreased risk of defibrillator shocks and/or anti-tachycardia pacing per 10 year increase in age. Compared with the youngest age group (<50 years), patients in the oldest age group (≥80 years) had a 6.8-fold, 5.9-fold, and 3.4-fold increase in all-cause mortality (P < 0.001 for all comparisons) and a 31, 45, and 53% decrease in the risk of ICD shock (P ≤ 0.002 for all comparisons) for the V-ICD, D-ICD, and CRT-D groups, respectively.

Conclusion: Older recipients of standard and CRT defibrillators have higher mortality but fewer ICD shocks and/or therapies compared with younger patients. These data highly suggest less benefit of ICD therapy with increasing age, presumably because of competing risks of non-arrhythmic mortality. The role of defibrillator therapy in older patients may need to be evaluated with randomized controlled trials.
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http://dx.doi.org/10.1093/europace/euw085DOI Listing
May 2017