Publications by authors named "Raul Weiss"

92 Publications

A 10 J shock impedance in sinus rhythm correlates with a 65 J defibrillation impedance during subcutaneous defibrillator implantation using an inter-muscular technique.

J Cardiovasc Electrophysiol 2021 Sep 23. Epub 2021 Sep 23.

Division of Cardiovascular Medicine, Department of Internal Medicine, the Ohio State University Wexner Medical Center, Columbus, OH, USA.

Introduction: Defibrillation testing (DT) is recommended during the subcutaneous defibrillator (S-ICD) placement. We sought to compare 10 J shock impedance in sinus rhythm (SR) with 65 J defibrillation impedance and evaluate device position on a post-implant chest x-ray (CXR) using an inter-muscular (IM) technique.

Methods: Consecutive S-ICD implantations between 12/2019 and 12/2020 at The Ohio State University were reviewed. All implantations were performed using a 2-incision IM technique. Standard DT with 65 J shock and 10 J shock in SR were performed unless contraindicated. The PRAETORIAN score was calculated based on CXR.

Results: A total of 37 patients (age: 47.2 ± 15.8 years old, male: n=26 [70.3%], body mass index: 30.1 ± 6.7 kg/m ) underwent IM S-ICD implantation, and of those, 27 (73%) underwent both 65 J shock and 10 J shock in SR. The coefficient of determination (R ) between 10 J shock impedance and 65 J shock impedance was 0.84. The mean of an impedance difference was 1.6 ± 4.8 ohms (Minimum - 11, maximum 8). Post-implant CXR was available for 33 out of 37 patients (89.2%). The PRAETORIAN score was < 90 in all patients and the mean score was 32.7 ± 8.8.

Conclusion: We demonstrated that 10 J shock impedance in SR correlated well with 65 J defibrillation impedance during IM S-ICD implantation. An IM implantation technique provides excellent generator location on post-implant CXR. The IM technique combined with 10 J shock in SR may be sufficient to predict and ensure defibrillation efficacy of the S-ICD. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/jce.15249DOI Listing
September 2021

The genomics of heart failure: design and rationale of the HERMES consortium.

ESC Heart Fail 2021 Sep 3. Epub 2021 Sep 3.

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.

Aims: The HERMES (HEart failure Molecular Epidemiology for Therapeutic targetS) consortium aims to identify the genomic and molecular basis of heart failure.

Methods And Results: The consortium currently includes 51 studies from 11 countries, including 68 157 heart failure cases and 949 888 controls, with data on heart failure events and prognosis. All studies collected biological samples and performed genome-wide genotyping of common genetic variants. The enrolment of subjects into participating studies ranged from 1948 to the present day, and the median follow-up following heart failure diagnosis ranged from 2 to 116 months. Forty-nine of 51 individual studies enrolled participants of both sexes; in these studies, participants with heart failure were predominantly male (34-90%). The mean age at diagnosis or ascertainment across all studies ranged from 54 to 84 years. Based on the aggregate sample, we estimated 80% power to genetic variant associations with risk of heart failure with an odds ratio of ≥1.10 for common variants (allele frequency ≥ 0.05) and ≥1.20 for low-frequency variants (allele frequency 0.01-0.05) at P < 5 × 10 under an additive genetic model.

Conclusions: HERMES is a global collaboration aiming to (i) identify the genetic determinants of heart failure; (ii) generate insights into the causal pathways leading to heart failure and enable genetic approaches to target prioritization; and (iii) develop genomic tools for disease stratification and risk prediction.
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http://dx.doi.org/10.1002/ehf2.13517DOI Listing
September 2021

Back to the Future: Defibrillation Energy Requirements, Testing New Technology With Old Concepts.

JACC Clin Electrophysiol 2021 Jun;7(6):777-780

Division of Cardiovascular Medicine, College of Medicine, The Ohio State University, Columbus, Ohio, USA.

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http://dx.doi.org/10.1016/j.jacep.2020.12.007DOI Listing
June 2021

Device-related infection in de novo transvenous implantable cardioverter-defibrillator Medicare patients.

Heart Rhythm 2021 Aug 19;18(8):1301-1309. Epub 2021 Apr 19.

Division of Infectious Diseases, Department of Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota; Department of Cardiovascular Disease, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.

Background: Cardiac device infection is a serious complication of implantable cardioverter-defibrillator (ICD) placement and requires complete device removal with accompanying antimicrobial therapy for durable cure. Recent guidelines have highlighted the need to better identify patients at high risk of infection to assist in device selection.

Objective: To estimate the prevalence of infection in de novo transvenous (TV) ICD implants and assess factors associated with infection risk in a Medicare population.

Methods: A retrospective cohort study was conducted using 100% Medicare administrative and claims data to identify patients who underwent de novo TV-ICD implantation (July 2016-December 2017). Infection within 720 days of implantation was identified using ICD-10 codes. Baseline factors associated with infection were identified by univariable logistic regression analysis of all variables of interest, including conditions in Charlson and Elixhauser comorbidity indices, followed by stepwise selection criteria with a P ≤ .25 for inclusion in a multivariable model and a backwards, stepwise elimination process with P ≤ .1 to remain in the model. A time-to-event analysis was also conducted.

Results: Among 26,742 patients with de novo TV-ICD, 519 (1.9%) developed an infection within 720 days post implant. While more than half (54%) of infections occurred during the first 90 days, 16% of infections occurred after 365 days. Multivariable analysis revealed several significant predictors of infection: age <70 years, renal disease with dialysis, and complicated diabetes mellitus.

Conclusion: The rate of de novo TV-ICD infection was 1.9%, and identified risk factors associated with infection may be useful in device selection.
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http://dx.doi.org/10.1016/j.hrthm.2021.04.014DOI Listing
August 2021

Point/Counterpoint on Halting Implantation of the Subcutaneous ICD.

JACC Clin Electrophysiol 2021 05 12;7(5):685-689. Epub 2021 Mar 12.

Cardiovascular Division, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.

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http://dx.doi.org/10.1016/j.jacep.2021.03.006DOI Listing
May 2021

Esophageal deviation with vacuum suction and mechanical deflection during ablation of atrial fibrillation: First in man evaluation.

J Cardiovasc Electrophysiol 2021 04 2;32(4):1211-1212. Epub 2021 Mar 2.

Division of Cardiology, The Ohio State University, Columbus, Ohio, USA.

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http://dx.doi.org/10.1111/jce.14959DOI Listing
April 2021

Resource Use and Economic Implications of Remote Monitoring With Subcutaneous Cardiac Rhythm Monitors.

JACC Clin Electrophysiol 2021 Jun 27;7(6):745-754. Epub 2021 Jan 27.

Division of Cardiovascular Medicine, Wexner Medical Center at the Ohio State University Medical Center, Columbus, Ohio, USA.

Objectives: This study reports resource use and economic implications of rhythm monitoring with subcutaneous cardiac rhythm monitors (SCRMs).

Background: SCRMs generate a substantial amount of data that requires timely adjudication for appropriate clinical care. Resource use for SCRM monitoring is not known.

Methods: The study included consecutive transmissions during 4 weeks from 1,811 SCRMs. Resource use was quantified by assessment of time commitment of device clinic personnel and electrophysiologists for data adjudication. Incidence and characteristics of false positive (FP) episodes were assessed. Impact of custom programming for arrhythmia detection on incidence of FP episodes and resource use was analyzed.

Results: A total of 1,457 transmissions (alerts = 462; full downloads = 995) were received during study period. Average device clinic personnel time for adjudication of 1 transmission was 15 ± 6 min. This totaled to 364 h spent (2.3 full-time staff) over the 4-week period, which translated into a salary cost of $12,000 U.S. dollars (USD). Average time spent by an electrophysiologist for 1 transmission was 1.5 ± 1 min and totaled to 37 h for 4 weeks, which translated into an estimated cost of $9,600 USD. Of 1,457 total transmissions, 512 (35%) represented multiple transmissions from the same patients, which resulted in no additional reimbursement. Incidence of FP episodes in the entire cohort was 50% and was variable in alert (60%) and full download (49%) (p = 0.04) transmissions. When SCRMs with manufacturer suggested nominal programming and institutional custom programming were compared, there was a reduction in FP episodes (55% vs. 16%; p = 0.01), which translated to a 34% reduction in resource use for data adjudication.

Conclusions: SCRM data adjudication requires significant resources. Custom programming for SCRMs may overcome the data deluge.
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http://dx.doi.org/10.1016/j.jacep.2020.10.014DOI Listing
June 2021

Outcomes of two versus three incision techniques: Results from the subcutaneous ICD post-approval study.

J Cardiovasc Electrophysiol 2021 03 1;32(3):792-801. Epub 2021 Feb 1.

Lexington Cardiology/Baptist Health, Lexington, Kentucky, USA.

Background: Traditionally, implantation of the subcutaneous implantable cardioverter defibrillator (S-ICD) requires incisions near the lateral chest wall, the xyphoid, and the superior sternal region (three-incision technique [3IT]). A two-incision technique (2IT) avoids the superior incision and has been shown to be a viable alternative in small studies with limited follow-up.

Objectives: To report on the long-term safety and efficacy of the 2IT compared to the 3IT procedure in a large patient cohort.

Methods: Patients enrolled in the S-ICD post approval study (PAS) were stratified by procedural technique (2IT vs. 3IT). Baseline demographics, comorbidities and procedural outcomes were collected. Complications and S-ICD effectiveness in treating ventricular arrhythmias through an average 3-year follow-up period were compared.

Results: Of 1637 patients enrolled in the S-ICD PAS, 854 pts (52.2%) were implanted using the 2IT and 782 were implanted using the 3IT (47.8%). The 2IT became more prevalent over time, increasing from 40% to 69% of implants (Q1-Q4). Mean procedure time was shorter with 2IT (69.0 vs. 86.3 min, p < .0001). No other differences in outcomes were observed between the two groups, including rates of infection, electrode migration, inappropriate shocks and first shock efficacy for treating ventricular arrhythmias.

Conclusion: In this large cohort of patients implanted with an S-ICD and followed for 3 years the 2IT was as safe and effective as the 3IT while significantly reducing procedure time.
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http://dx.doi.org/10.1111/jce.14914DOI Listing
March 2021

1-Year Prospective Evaluation of Clinical Outcomes and Shocks: The Subcutaneous ICD Post Approval Study.

JACC Clin Electrophysiol 2020 11 26;6(12):1537-1550. Epub 2020 Aug 26.

Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA. Electronic address:

Objectives: This study evaluated spontaneous arrhythmias and clinical outcomes in the S-ICD System PAS (Subcutaneous Implantable Cardioverter-Defibrillator Post Approval Study) cohort.

Background: The U.S. S-ICD PAS trial patient population more closely resembles transvenous ICD cohorts than earlier studies, which included many patients with little structural heart disease and few comorbidities. Early outcomes and low peri-operative complication rates were demonstrated in the S-ICD PAS cohort, but there are no data detailing spontaneous arrhythmias and clinical outcomes.

Methods: The S-ICD PAS prospective registry included 1,637 de novo patients from 86 U.S. centers. Descriptive statistics, Kaplan-Meier time to event, and multivariate logistic regression were performed using data out to 365 days.

Results: Patients (68.5% men; mean ejection fraction of 32.0%; 42.9% ischemic; 13.4% on dialysis) underwent implantation for primary (76.6%) or secondary prevention indication. The complication-free rate was 92.5%. The appropriate shock (AS) rate was 5.3%. A total of 395 ventricular tachycardia (VT) or fibrillation (VF) episodes were appropriately sensed, with 131 (33.2%) self-terminating. First and final shock efficacy (up to 5 shocks) for the 127 discrete AS episodes were 91.3% and 100.0%, respectively. Discrete AS episodes included 67 monomorphic VT (MVT) and 60 polymorphic VT (PVT)/VF, with first shock efficacy of 95.2% and 86.7%, respectively. There were 19 storm events in 18 subjects, with 84.2% conversion success. Storm episodes were more likely PVT/VF (98 of 137).

Conclusions: In the first year after implantation, a predominantly primary prevention population with low ejection fraction demonstrated a high complication-free rate and spontaneous event shock efficacy for MVT and PVT/VF arrhythmias at rapid ventricular rates. (Subcutaneous Implantable Cardioverter-Defibrillator System Post Approval Study [S-ICD PAS; NCT01736618).
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http://dx.doi.org/10.1016/j.jacep.2020.05.036DOI Listing
November 2020

Incidence of pacing-induced cardiomyopathy in pacemaker-dependent patients is lower with leadless pacemakers compared to transvenous pacemakers.

J Cardiovasc Electrophysiol 2021 02 25;32(2):477-483. Epub 2020 Nov 25.

Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.

Introduction: Frequent right AQ4ventricular pacing (≥40%) with a transvenous pacemaker (TVP) is associated with the risk of pacing-induced cardiomyopathy (PICM). Leadless pacemakers (LPs) have distinct physical and mechanical differences from TVP. The risk of PICM with LP is not known. To identify incidence, predictors, and long-term outcomes of PICM in LP and TVP patients.

Methods: The study comprised all pacemaker-dependent patients with LP or TVP who had left ventricular ejection fraction (LVEF) of ≥50 from 2014 to 2019. The incidence of PICM (≥10% LVEF drop) was assessed with an echocardiogram. Predictors for PICM were identified using multivariate analysis. Long-term outcomes after cardiac resynchronization (CRT) were assessed in both groups.

Results: A total of 131 patients with TVP and 67 with LP comprised the study. All patients in the TVP group and the majority in the LP group underwent atrioventricular node ablation. The mean follow-up duration in TVP and LP groups was 592 ± 549 and 817 ± 600 days, respectively. A total of 18 (13.7%) patients in TVP and 2 (3%) in LP developed PICM after a median duration of 254 (interquartile range: 470) days. The incidence of PICM was significantly higher with TVP compared with LP (p = .02). TVP as pacing modality was a positive (odds ratio [OR]: 1.07) while age was negative (OR: 0.94) predictor for PICM on multivariable analysis. Both patients in LP and all except two in the TVP group responded to CRT.

Conclusion: Incidence of PICM is significantly lower with LP compared with TVP in pacemaker-dependent patients. Age and TVP as pacing modality were predictors for PICM.
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http://dx.doi.org/10.1111/jce.14814DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984287PMC
February 2021

Esophageal deviation with vacuum suction and mechanical deflection during ablation of atrial fibrillation: First in man evaluation.

J Cardiovasc Electrophysiol 2021 01 11;32(1):67-70. Epub 2020 Nov 11.

The Ohio State University, Columbus, Ohio, USA.

Deviation of the esophagus during atrial fibrillation (AF) ablation can reduce esophageal injury. This study reports upon a novel esophageal retractor that utilizes vacuum suction and mechanical deflection to deviate the esophagus. The device was used in seven patients undergoing cryoballoon AF ablation. The esophagus was deviated 31.9 ± 4.4 mm to the right and 28.2 ± 5.9 mm to the left. Endoscopy at 4.4 ± 1.5 days postablation showed no esophageal injury. This study demonstrates the safe and effective deviation of the esophagus without a trailing edge with an esophageal retractor utilizing vacuum suction and mechanical deflection.
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http://dx.doi.org/10.1111/jce.14801DOI Listing
January 2021

Trends in anticoagulation management services following incorporation of direct oral anticoagulants at a large academic medical center.

J Thromb Thrombolysis 2021 May 9;51(4):1050-1058. Epub 2020 Oct 9.

The Ohio State University Wexner Medical Center, Columbus, OH, 43228, USA.

The introduction of direct oral anticoagulants (DOACs) to the market has expanded anticoagulation options for outpatient use. Routine evaluation by health care professionals is recommended as it is with warfarin, therefore requiring adjustments in practices of anticoagulation management services (AMS). This study aims to describe trends that occurred following the incorporation of DOACs into AMS at a large academic medical center. A retrospective chart review of pharmacist-run AMS was used to compare patients on DOAC therapy versus other types of anticoagulation, including warfarin and parenteral agents. Primary outcomes included trends in the number of unique patients, management encounters, and telephone encounters throughout the study period. Secondary outcomes included trends in new encounters, and changes in patient characteristics, resources utilized, and patient satisfaction scores. A total of 2976 unique patients, 74,582 management encounters, and 13,282 telephone encounters were identified. From study beginning to end, results showed stable numbers of unique patients, an increase in management encounters for the DOAC group and decrease in the other anticoagulants group, and stable numbers of telephone encounters. Additionally, the number of new encounters for both groups increased. Throughout the study, pharmacy resources were reallocated within anticoagulation to adapt to the changing trends and patient satisfaction reached targets. Patients' characteristics remained stable, with the DOAC group having fewer comorbid conditions and concomitant medications that could increase bleed risk. This study showed that by reallocating resources within anticoagulation, AMS can maintain stable patient populations while continuing to expand access and satisfy patients following DOAC inclusion.
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http://dx.doi.org/10.1007/s11239-020-02286-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546384PMC
May 2021

Extreme Obesity is Associated with Low Success Rate of Atrial Fibrillation Catheter Ablation.

J Atr Fibrillation 2020 Apr-May;12(6):2242. Epub 2020 Apr 30.

Division of Cardiovascular Medicine, the Ohio State University Wexner Medical Center, Columbus, OH, USA.

Background: Catheter ablation (CA) is an established treatment for patients with symptomatic atrial fibrillation (AF). The purpose of this study was to evaluate the safety and efficacy of single CA in AF patients with extreme obesity (body mass index [BMI] ≥ 40 kg/m2) and its long-term impact on body weight.

Methods: Patients with BMI ≥40 kg/m2 who underwent CA at the Ohio State University between 2012 and 2016 were included. The primary efficacy endpoint was no atrial arrhythmia lasting > 30 seconds without anti-arrhythmic drugs during 1-year follow-up after a single procedure.

Results: Out of 230 AF patients with BMI ≥ 40 kg/m2 undergoing CA, pulmonary vein isolation was achieved in 226 (98%) patients.Seventeen patients (7.4%) experienced acute major complications, including pericardial effusion, vascular complications and respiratory failure. Patient characteristics for 135 patients with complete 1-year follow-up were as follows: mean age 58.6 ± 9.6 years, mean BMI 44.5±4.7 kg/m2, female 63 (47%), non-paroxysmal AF 100 (74%), median CHA2DS2-VASc score 2 (IQR:1-3). In this cohort, the primary efficacy endpoint was achieved in 44 (33%) patients. Paroxysmal AF was associated with higher CA success compared to non-paroxysmal (51 vs. 26% [p < 0.01]).There was no significant weight change even in patients with successful AF CA.

Conclusions: Extreme obesity is associated with low AF CA success, particularly in those with non-paroxysmal AF. Successful AF CA was not associated with long-term weight reduction. A better treatment strategy is needed in this population of AF and extreme obesity.
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http://dx.doi.org/10.4022/jafib.2242DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7533126PMC
April 2020

Perioperative considerations during implantation of the subcutaneous defibrillator: State-of-the-art review.

Pacing Clin Electrophysiol 2020 12 23;43(12):1451-1458. Epub 2020 Sep 23.

Division of Cardiovascular Medicine, Wexner Medical Center, The Ohio State University Medical Center, Columbus, Ohio.

The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an important tool in the armamentarium of an electrophysiologist. Multiple randomized trials over the last decade have shown that S-ICDs are as efficacious as the transvenous ICDs and eliminate complications related to vascular access. In this review, we highlight issues unique to S-ICD implantation, focusing not only on the surgical implantation procedure, but also the pre- and postimplant management of the patient.
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http://dx.doi.org/10.1111/pace.14072DOI Listing
December 2020

How to minimize peri-procedural complications during subcutaneous defibrillator implant?

Expert Rev Cardiovasc Ther 2020 Jul 2;18(7):427-434. Epub 2020 Jul 2.

Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center , Columbus, OH, USA.

Introduction: Subcutaneous defibrillator (S-ICD) is the latest development in the clinically available devices for sudden cardiac death prevention. Experience from pivotal trials and post-marketing studies has proven the feasibility and safety of S-ICD. Extra-cardiac location of S-ICD obviates the need for transvenous leads which translates into lower incidence of lead-related complications and systemic infections. This is a review on peri-procedural interventions to minimize complications associated with S-ICD during implant and follow-up.

Areas Covered: This paper will highlight the results of pertinent studies related to perioperative management of S-ICD and review the approaches to minimize the risk of complications such as hematoma at the pulse generator location, unsuccessful defibrillation due to suboptimal S-ICD lead and generator position, postoperative pain, inappropriate shocks due to T wave oversensing and interaction with concomitant cardiac implantable devices. An extensive literature search was performed to identify the relevant articles.

Expert Commentary: The use of S-ICD is expanding, and the published results suggest a preferential use of such devices for younger patients and those with a potential risk of infection from intravascular devices. The perioperative management of S-ICD has significantly evolved during a decade of experience. Contemporary experience suggests that these procedures are associated with minimal complications.
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http://dx.doi.org/10.1080/14779072.2020.1784006DOI Listing
July 2020

Approaches to Minimizing Periprocedural Complications During Subcutaneous Implantable Cardioverter-defibrillator Placement.

J Innov Card Rhythm Manag 2020 May 15;11(5):4100-4105. Epub 2020 May 15.

Division of Cardiovascular Medicine, Wexner Medical Center, Ohio State University Medical Center, Columbus, OH, USA.

The subcutaneous implantable cardioverter-defibrillator (S-ICD) is the latest option among devices clinically available for the prevention of sudden cardiac death, with experience from previous trials and postmarketing studies supporting the feasibility and safety of this kind of system. The extracardiac positioning of the S-ICD obviates the need for transvenous leads, which translates into lower incidence rates of lead-related complications and systemic infections. This review will highlight the results of pertinent studies related to the perioperative management of S-ICDs and review potential approaches to minimizing the risk of complications such as hematoma at the pulse generator location, unsuccessful defibrillation due to suboptimal S-ICD lead and generator positioning, and postoperative pain. An extensive literature search using PubMed was conducted to identify relevant articles.
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http://dx.doi.org/10.19102/icrm.2020.110504DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7244169PMC
May 2020

Evaluation of a novel esophageal retractor utilizing vacuum suction and mechanical force for deviating the esophagus.

J Cardiovasc Electrophysiol 2020 07 15;31(7):1661-1669. Epub 2020 May 15.

Division of Anesthesiology, Ohio State University Wexner Medical Center, Columbus, Ohio.

Background: Deviation of the esophagus prevents esophageal injury during atrial fibrillation ablation.

Objectives: This study is to evaluate, in animals, safety and effectiveness of a novel esophageal retractor that utilizes vacuum suction and mechanical force to deviate the esophagus.

Methods: Following general anesthesia, a radiopaque ruler was placed behind the animal perpendicular to the esophagus. The esophageal retractor was inserted and esophagram was completed. Suction force (280-300 mm Hg) was applied to the distal aspect of the device that resulted in adherence of the esophagus in a circumferential manner. Then movement of a deflecting arm was used to deviate the esophagus. Four animal studies completed: (a) deviation distance and presence of trailing edge; (b) effect of 1 hour continuous suction and deviation upon esophageal cellular architecture; (c) impact on luminal esophageal temperature (LET) during high power ablation; and (d) compatibility of esophageal retractor with electroanatomic mapping system.

Results: The distance of deviation to the right (26.6 ± 2.5 mm) was higher than to the left (18.7 ± 2.3 mm; P < .01). There was no esophageal trailing edge in 65/68 deviations (96%). With continuous suction for 1 hour, pathology revealed small, <1mm, circular area of hyperemia in the esophageal mucosa. During high power ablation, the maximum increase in LET was 0.2°C. Finally, there was no interference between the device and electro-anatomical mapping system.

Conclusion: In animal models, the esophageal retractor utilizing vacuum suction was successful at deviating the esophagus without significant trailing edge and with minor (1 mm) injury with prolonged continuous suction.
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http://dx.doi.org/10.1111/jce.14529DOI Listing
July 2020

BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study.

BMC Cardiovasc Disord 2020 04 15;20(1):171. Epub 2020 Apr 15.

Cardiology Consultants of East Michigan, Flint, MI, USA.

Background: Insertable cardiac monitors are utilized for the diagnosis of arrhythmias and traditionally have been inserted within hospitals. Recent code updates allow for reimbursement of office-based insertions; however, there is limited information regarding the resources and processes required to support in-office insertions. We sought to determine the safety and feasibility of in-office insertion of the BioMonitor 2 and better understand in-office procedures, including patient selection, pre-insertion protocols, resource availability, and staff support.

Methods: Patients meeting an indication for a rhythm monitor were prospectively enrolled into this single-arm, non-randomized trial. All patients underwent insertion in an office setting. Two follow-up visits at days 7 and 90 were required. Information on adverse events, device performance, office site preparations, and resource utilization were collected.

Results: Eighty-two patients were enrolled at six sites. Insertion was successful in all 77 patients with an attempt. Oral anticoagulation was stopped in 20.8% of patients and continued through insertion in 23.4%, while prophylactic antibiotics were infrequently utilized (37.7% of study participants). On average, the procedure required a surgeon plus two support staff and 35 min in an office room to complete the 8.4 min insertion procedure. The mean R-wave amplitude was 0.77 mV at insertion and 0.67 mV at 90-days with low noise burden (2.7%). There were no procedure related complications. Two adverse events were reported (event rate 2.7% [95% CI 0.3, 9.5%]).

Conclusions: In-office insertion of the BioMonitor 2 is safe and feasible. Devices performed well with high R-wave amplitudes and low noise burden. These results further support shifting cardiac monitor insertions to office-based locations.

Trial Registration: clinicaltrials.gov, NCT02756338. Registered 29 April 2016.
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http://dx.doi.org/10.1186/s12872-020-01439-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7161128PMC
April 2020

Risk Versus Benefit of Combined Aspirin and Warfarin Therapy in Patients With Atrial Fibrillation.

J Pharm Pract 2020 Apr 15:897190020916638. Epub 2020 Apr 15.

Ohio State University Wexner Medical Center, Columbus, OH, USA.

Purpose: Guidelines have differing recommendations for aspirin use in patients with an indication for anticoagulation. The purpose of this study was to evaluate the incidence of major bleeding and thromboembolic events (TEs) in patients with atrial fibrillation (AF) receiving warfarin alone (monotherapy group) versus warfarin plus aspirin (combination therapy group).

Methods: This was a retrospective, cohort study including patients from a pharmacist-run anticoagulation clinic. Inclusion criteria were patients with AF receiving anticoagulation between January 2013 and January 2014 observed over 5 years.

Results: One hundred forty-two patients were included in the combination group versus 89 in monotherapy group. In the combination group, 60 (42.3%) patients were on aspirin for no apparent indication, 19 (13.4%) had stable coronary artery disease and diabetes, and 26 (18.3%) had diabetes alone. Major bleeding occurred in 21 (14.9%) patients in the combination group versus 7 (7.9%) patients in the monotherapy group (odds ratio [OR] = 2.02, 95% confidence interval [CI]: 0.78-5.91; = .17). TE occurred in 10 (7%) patients in the combination group versus 4 (4.5%) in the monotherapy group (OR = 1.61, 95% CI: 0.44-7.24; = .57). There was no significant difference in bleeding ( = .85) or TE ( = .37) rates between aspirin indications in the combination group.

Conclusion: Combination therapy versus monotherapy may increase bleeding risk with little benefit in decreasing AF-related stroke or cardiovascular events.
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http://dx.doi.org/10.1177/0897190020916638DOI Listing
April 2020

Diagnosis and management of subcutaneous implantable cardioverter-defibrillator infections based on process mapping.

Pacing Clin Electrophysiol 2020 09 23;43(9):958-965. Epub 2020 Apr 23.

Center for Heart Rhythm Disorders Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, Illinois.

Background: Infection is a well-recognized complication of cardiovascular implantable electronic device (CIED) implantation, including the more recently available subcutaneous implantable cardioverter-defibrillator (S-ICD). Although the AHA/ACC/HRS guidelines include recommendations for S-ICD use, currently there are no clinical trial data that address the diagnosis and management of S-ICD infections. Therefore, an expert panel was convened to develop consensus on these topics.

Methods: A process mapping methodology was used to achieve a primary goal - the development of consensus on the diagnosis and management of S-ICD infections. Two face-to-face meetings of panel experts were conducted to recommend useful information to clinicians in individual patient management of S-ICD infections.

Results: Panel consensus of a stepwise approach in the diagnosis and management was developed to provide guidance in individual patient management.

Conclusion: Achieving expert panel consensus by process mapping methodology in S-ICD infection diagnosis and management was attainable, and the results should be helpful in individual patient management.
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http://dx.doi.org/10.1111/pace.13902DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607386PMC
September 2020

Genome-wide association and Mendelian randomisation analysis provide insights into the pathogenesis of heart failure.

Nat Commun 2020 01 9;11(1):163. Epub 2020 Jan 9.

Department of Biostatistics, University of Liverpool, Liverpool, UK.

Heart failure (HF) is a leading cause of morbidity and mortality worldwide. A small proportion of HF cases are attributable to monogenic cardiomyopathies and existing genome-wide association studies (GWAS) have yielded only limited insights, leaving the observed heritability of HF largely unexplained. We report results from a GWAS meta-analysis of HF comprising 47,309 cases and 930,014 controls. Twelve independent variants at 11 genomic loci are associated with HF, all of which demonstrate one or more associations with coronary artery disease (CAD), atrial fibrillation, or reduced left ventricular function, suggesting shared genetic aetiology. Functional analysis of non-CAD-associated loci implicate genes involved in cardiac development (MYOZ1, SYNPO2L), protein homoeostasis (BAG3), and cellular senescence (CDKN1A). Mendelian randomisation analysis supports causal roles for several HF risk factors, and demonstrates CAD-independent effects for atrial fibrillation, body mass index, and hypertension. These findings extend our knowledge of the pathways underlying HF and may inform new therapeutic strategies.
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http://dx.doi.org/10.1038/s41467-019-13690-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6952380PMC
January 2020

Feasibility and safety of same day subcutaneous defibrillator implantation and send home (DASH) strategy.

J Interv Card Electrophysiol 2020 Mar 7;57(2):311-318. Epub 2019 Dec 7.

Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

Purpose: To assess the feasibility and safety of same-day discharge after S-ICD implantation by implementing a specific analgesia protocol and phone follow-up.

Methods: Consecutive patients presenting for outpatient S-ICD implantation were enrolled between 1/1/2018 and 4/30/2019. An analgesia protocol included pre-operative acetaminophen and oxycodone, intraoperative local bupivacaine, and limited use of oxycodone-acetaminophen at discharge. The primary outcome was successful same-day discharge. Numerical Pain Rating Scale (NPRS) on postoperative day (POD) 1, 3, 14, and 30 and any unplanned health care visits during the 1-month follow-up period were assessed.

Results: Out of 53 potentially eligible S-ICD patients, 49 patients (92.5%) were enrolled and successfully discharged on the same day. Mean age of these 49 patients was 47 ± 14 years. There were no acute procedural complications. Severe pain (NPRS ≥ 8) on POD 0, 1, and 3 was present in 14.3%, 14.3%, and 8.2% of patients, respectively. The total in-hospital stay was 534 ± 80 min. Four unplanned visits (8%) due to cardiac or device-related issues occurred during 1-month follow-up, including 2 patients with heart failure exacerbation, one patient with an incisional infection, and one patient with inappropriate shocks.

Conclusions: With the appropriate institutional protocol including specific analgesics and phone follow-up, same-day discharge after outpatient S-ICD implantation is feasible and appears safe for most patients.. Device-related pain can be severe in the first 3 days post-implantation and can be successfully treated with limited supply of narcotic medications.
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http://dx.doi.org/10.1007/s10840-019-00673-1DOI Listing
March 2020

Chronic heart failure increases negative chronotropic effects of adenosine in canine sinoatrial cells via A1R stimulation and GIRK-mediated I.

Life Sci 2020 Jan 18;240:117068. Epub 2019 Nov 18.

College of Pharmacy, The Ohio State University, Columbus, OH, USA; Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH, USA. Electronic address:

Aims: Bradycardia contributes to tachy-brady arrhythmias or sinus arrest during heart failure (HF). Sinoatrial node (SAN) adenosine A1 receptors (ADO A1Rs) are upregulated in HF, and adenosine is known to exert negative chronotropic effects on the SAN. Here, we investigated the role of A1R signaling at physiologically relevant ADO concentrations on HF SAN pacemaker cells.

Main Methods: Dogs with tachypacing-induced chronic HF and normal controls (CTL) were studied. SAN tissue was collected for A1R and GIRK mRNA quantification. SAN cells were isolated for perforated patch clamp recordings and firing rate (bpm), slope of slow diastolic depolarization (SDD), and maximum diastolic potential (MDP) were measured. Action potentials (APs) and currents were recorded before and after addition of 1 and 10 μM ADO. To assess contributions of A1R and G protein-coupled Inward Rectifier Potassium Current (GIRK) to ADO effects, APs were measured after the addition of DPCPX (selective A1R antagonist) or TPQ (selective GIRK blocker).

Key Findings: A1R and GIRK mRNA expression were significantly increased in HF. In addition, ADO induced greater rate slowing and membrane hyperpolarization in HF vs CTL (p < 0.05). DPCPX prevented ADO-induced rate slowing in CTL and HF cells. The ADO-induced inward rectifying current, I, was observed significantly more frequently in HF than in CTL. TPQ prevented ADO-induced rate slowing in HF.

Significance: An increase in A1R and GIRK expression enhances I, causing hyperpolarization, and subsequent negative chronotropic effects in canine chronic HF at relevant [ADO]. GIRK blockade may be a useful strategy to mitigate bradycardia in HF.
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http://dx.doi.org/10.1016/j.lfs.2019.117068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294905PMC
January 2020

Implantation of subcutaneous defibrillator is feasible and safe with monitored anesthesia care.

Pacing Clin Electrophysiol 2019 12 18;42(12):1552-1557. Epub 2019 Nov 18.

Division of Anesthesiology, The Ohio State University Wexner Medical Center, Ohio State University Medical Center, Columbus, Ohio.

Background: The perioperative anesthesia care during subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving.

Objective: To assess the feasibility and safety of S-ICD implantation with monitored anesthesia care (MAC) versus general anesthesia (GA) in a tertiary care center.

Methods: This is a single-center retrospective study of patients undergoing S-ICD implantation between October 2012 and May 2019. Patients were categorized into MAC and GA group based on the mode of anesthesia. Procedural success without escalation to GA was the primary endpoint of the study, whereas intraprocedural hemodynamics, need of pharmacological support for hypotension and bradycardia, length of the procedure, stay in the post-anesthesia care unit, and postoperative pain were assessed as secondary endpoints.

Results: The study comprises 287 patients with MAC in 111 and GA in 176 patients. Compared to MAC, patients in GA group were younger and had a higher body mass index. All patients had successful S-ICD implantation. Only one patient (0.9%) in the MAC group was converted to GA. Despite a similar baseline heart rate (HR) and mean arterial blood pressure (MAP) in both groups, patients with GA had significantly lower HR and MAP during the procedure and more frequently required pharmacological hemodynamic support. Length of the procedure, stay in the postanesthesia care unit, and postoperative pain was similar in both groups.

Conclusion: This retrospective experience suggests that implantation of S-ICD is feasible and safe with MAC. Use of GA is associated with more frequent administration of hemodynamic drugs during S-ICD implantation.
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http://dx.doi.org/10.1111/pace.13838DOI Listing
December 2019

RIsk Stratification prior to lead Extraction and impact on major intraprocedural complications (RISE protocol).

J Cardiovasc Electrophysiol 2019 11 23;30(11):2453-2459. Epub 2019 Sep 23.

Department of Internal Medicine, Division of Cardiovascular Medicine, Wexner Medical Center at the Ohio State University Medical Center, Columbus, Ohio.

Background: An internal risk stratification algorithm was developed to decrease the risk of major adverse cardiac events (MACEs) during lead extractions (LEs).

Objective: To report upon the impact of a risk stratification algorithm (RISE [RIsk Stratification prior to lead Extraction] protocol) on outcomes of LEs in a high-volume center.

Methods: A retrospective review of a prospectively maintained LEs database was performed to identify features associated with MACEs. On the basis of the retrospective data, the RISE protocol differentiated LEs procedures into "High" and "Low" risk for occurrence of MACEs. High-risk LEs included dual-coil defibrillator lead (≥3 years), pacemaker and single-coil lead (≥5 years), and any StarFix coronary sinus lead. During the prospective evaluation of the RISE protocol, "High-risk" LEs were performed in an operating room (OR) or hybrid laboratory with the cardiac anesthesiologist, OR nursing team, perfusionist in the room, and a cardiac surgeon on the premises. "Low-risk" LEs were performed in the electrophysiology (EP) laboratory with anesthesia provided by EP nursing team. The preintervention (pre-RISE) and postintervention (post-RISE) group spanned 19 and 40 months and consisted of 449 (632 leads) and 751 patients (1055 leads), respectively. The primary outcome of MACEs in the two groups was compared.

Results: Protocol compliance was 100%. The primary outcome of MACEs occurred in 15 patients (3.34%) before and 12 (1.6%) after implementation of the RISE protocol (P = .04).

Conclusion: RISE identified a low-risk group where minimal resources are needed and allowed for rapid intervention in the high-risk group that reduced the consequences of MACEs.
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http://dx.doi.org/10.1111/jce.14151DOI Listing
November 2019

Type 8 long QT syndrome: pathogenic variants in CACNA1C-encoded Cav1.2 cluster in STAC protein binding site.

Europace 2019 Nov;21(11):1725-1732

Division of Cardiology, University of British Columbia, 1033 Davie St., Rm 211, Vancouver, BC, Canada.

Aims: Pathogenic gain-of-function variants in CACAN1C cause type-8 long QT syndrome (LQT8). We sought to describe the electrocardiographic features in LQT8 and utilize molecular modelling to gain mechanistic insights into its genetic culprits.

Methods And Results: Rare variants in CACNA1C were identified from genetic testing laboratories. Treating physicians provided clinical information. Variant pathogenicity was independently assessed according to recent guidelines. Pathogenic (P) and likely pathogenic (LP) variants were mapped onto a 3D modelled structure of the Cav1.2 protein. Nine P/LP variants, identified in 23 patients from 19 families with non-syndromic LQTS were identified. Six variants, found in 79% of families, clustered to a 4-residue section in the cytosolic II-III loop region which forms a region capable of binding STAC SH3 domains. Therefore, variants may affect binding of SH3-domain containing proteins. Arrhythmic events occurred in similar proportions of patients with II-III loop variants and with other P/LP variants (53% vs. 48%, P = 0.41) despite shorter QTc intervals (477 ± 31 ms vs. 515 ± 37 ms, P = 0.03). A history of sudden death was reported only in families with II-III loop variants (60% vs. 0%, P = 0.03). The predominant T-wave morphology was a late peaking T wave with a steep descending limb. Exercise testing demonstrated QTc prolongation on standing and at 4 min recovery after exercise.

Conclusion: The majority of P/LP variants in patients with CACNA1C-mediated LQT8 cluster in an SH3-binding domain of the cytosolic II-III loop. This represents a 'mutation hotspot' in LQT8. A late-peaking T wave with a steep descending limb and QT prolongation on exercise are commonly seen.
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http://dx.doi.org/10.1093/europace/euz215DOI Listing
November 2019

Incidence of false-positive transmissions during remote rhythm monitoring with implantable loop recorders.

Heart Rhythm 2020 01 16;17(1):75-80. Epub 2019 Jul 16.

Division of Cardiovascular Medicine, Wexner Medical Center at the Ohio State University Medical Center, Columbus, Ohio.

Background: Implantable loop recorder (ILR) is preferred strategy for prolonged rhythm monitoring.

Objective: The purpose of this study was to report the incidence and causes of false-positive (FP) diagnoses during remote monitoring with ILR.

Methods: During a 4-week study period, all consecutive remote transmissions in patients with ILR (Reveal LINQ, Medtronic) implanted for atrial fibrillation (AF) surveillance, cryptogenic stroke (CS), and syncope were reviewed. A nurse specializing in device management and an electrophysiologist adjudicated all transmissions. Primary endpoint of the study was incidence of FP in patients with AF, CS, and syncope.

Results: A total of 695 remote transmissions (scheduled downloads: 414; Alerts: 281) sent from 559 patients were adjudicated. The majority of patients had ILR for AF surveillance (n = 321), followed by CS (n =168) and syncope (n = 70) with nominal programming for rhythm diagnosis. Incidence of FP transmissions during the study period was 46%, 86%, and 71% in patients with AF, CS, and syncope, respectively. Incidence of FP transmissions was higher in patients with CS and syncope than in patients with AF (P <.001). For scheduled transmissions, primary causes of FP were signal dropout and undersensing; for alert transmissions, primary reasons for FP were premature atrial and ventricular ectopy.

Conclusion: Incidence of FP during remote monitoring with nominal settings on this ILR was substantial, ranging from 46% to 86% depending on the indication for implantation. Adjudication of these transmissions required a considerable time commitment from electrophysiologists and device clinic personnel but would be required to avoid misdiagnosis and potential errors in clinical management.
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http://dx.doi.org/10.1016/j.hrthm.2019.07.015DOI Listing
January 2020

Increased risk of hematoma with uninterrupted warfarin in patients undergoing implantation of subcutaneous implantable cardioverter defibrillator.

Pacing Clin Electrophysiol 2019 08 7;42(8):1111-1114. Epub 2019 Jul 7.

Division of Cardiovascular Medicine, Department of Internal Medicine, Electrophysiology Section, Ross Heart Hospital, The Wexner Medical Center at the Ohio State University Medical Center, Columbus, Ohio.

Background: The perioperative management of anticoagulation with the use of subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving.

Objective: The purpose of this study was to assess whether it is safe to perform S-ICD implantation with uninterrupted warfarin.

Methods: This is a multi-center retrospective review of patients undergoing S-ICD implantation between October 1, 2012 and June 30, 2017. Forty-eight patients underwent successful S-ICD implantation during the study period. The most common indication for implantation was primary prevention of sudden cardiac death. In 23 (47.9%) patients, warfarin was continued without any interruption. In 25 (52.1%) patients, warfarin was interrupted prior to implantation. The incidence of clinically significant lateral pocket hematoma was compared in the two groups.

Results: The mean international normalized ratio was 2.0 ± 0.4 in the uninterrupted group and 1.4 ± 0.4 for the interrupted group. A total of seven patients developed a hematoma at the lateral pocket. No patient developed a hematoma at the parasternal pockets. Six patients in the uninterrupted group (26.1%) and one patient in the interrupted group (0.04%) developed a significant lateral pocket hematoma (P = .04). The concomitant use of dual antiplatelet therapy did not increase the risk of hematoma. There was no significant difference between HASBLED and CHA DS VASc scores between the groups. None of the patients with a hematoma developed infection or required hematoma evacuation.

Conclusions: The uninterrupted use of warfarin in the perioperative period of S-ICD implantation is associated with an increased risk of lateral pocket hematoma.
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http://dx.doi.org/10.1111/pace.13754DOI Listing
August 2019

Factors Associated With High-Voltage Impedance and Subcutaneous Implantable Defibrillator Ventricular Fibrillation Conversion Success.

Circ Arrhythm Electrophysiol 2019 04;12(4):e006665

Division of Cardiovascular Medicine, Ohio State University Medical Center, Columbus (M.R.R., R.W.).

Background: The ability to predict defibrillation efficacy at the time of subcutaneous implantable cardioverter-defibrillator implantation without the need to induce ventricular fibrillation might eliminate the need for defibrillation testing. The purpose of this study was to determine the association of high-voltage impedance and system implant position on ventricular fibrillation conversion success with a submaximal 65-J shock.

Methods: In the subcutaneous implantable cardioverter-defibrillator IDE study (Investigational Device Exemption), a successful conversion test required 2 consecutive ventricular fibrillation conversions at 65 J in either shock vector. Chest radiographs were obtained after implantation. Patients with imaging and impedance data were included. Suboptimal device position was defined as an inferior electrode or pulse generator or electrode coil depth >3 mm anterior to the sternum. Absence of suboptimal positional parameters was defined as appropriate position. Conversion success rate was calculated among all 65-J tests.

Results: Of 314 patients who underwent subcutaneous implantable cardioverter-defibrillator implantation, 282 patients were included in this analysis. There were 637 inductions to test defibrillation at 65 J. Sixty-two conversion failures (9.7%) occurred in 42 (14.9%) patients. Lower body mass index and lower shock impedance were associated with higher conversion success rate, whereas white race was associated with lower conversion success rate. Suboptimal position was more common in obese patients. Inferior electrode and greater distance between the lead and sternum were associated with a higher impedance. When appropriate system position was achieved, conversion failure was not associated with high body mass index.

Conclusions: Subcutaneous implantable cardioverter-defibrillator shock efficacy is associated with system position and high-voltage system impedance. A high impedance is associated with inferiorly placed pulse generator and electrode system, inadequate coil depth, and a lower rate of defibrillator success.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01064076.
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http://dx.doi.org/10.1161/CIRCEP.118.006665DOI Listing
April 2019
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