bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical outcomes and programming strategies of implantable cardioverter defibrillator (ICD) devices during childhood in hypertrophic cardiomyopathy: a UK national cohort study
Authors: Norrish G , Chubb H , Field E , McCleod K , Till J , Stuart G , Hares D , Linter K , Bhole V , Bowes M , Uzun O , Sadagopan S , Rosenthal E , Mangat J.P , Kaski J.P 
Published: November 2020

Abstract

Background
Sudden cardiac death (SCD) is the most common mode of death in childhood hypertrophic cardiomyopathy (HCM). ICDs have been shown to be effective at terminating malignant ventricular arrhythmias but at the expense of a high incidence of complications. The optimal device and programming strategies to reduce complications in this patient group are unknown.

Purpose
To describe the programming strategies and clinical outcomes of ICD implantation in childhood HCM.

Methods
Anonymised, non-invasive clinical data were collected from a retrospective, longitudinal multi-centre cohort of children (&lt;16 years) with HCM (n=687) and an ICD in-situ from the United Kingdom.

Results
96 patients (61 male (64%), 6 non-sarcomeric (6%)) underwent ICD implantation at a median age 14yr (IQR 11–16, range 3–16) and weight 52.3 kg (IQR 34.8–63.1). Indication for ICD was primary prevention in 72 (75%). 82 (85%) had an endovascular system, 3 (3%) epicardial and 11 (12%) subcutaneous system. 61 patients (74%) were receiving one or more cardioactive medications at implantation [B blockers n=66, 70%, disopyramide n=14, 15%, amiodarone n=7, 7%, calcium channel blocker n=7, 9%, other n=5, 6%]. Programming practices varied: all had VF therapies activated (median 220bpm, IQR 212–230); 70 (73%) had a VT zone programmed (median rate 187 bpm, SD 20.9), of which 26 (27%) had therapies activated. 50 patients (61%) had antitachycardia pacing (ATP) activated. Over a median follow up of 53.6 months (IQR 27.3,108.4), 4 patients (4.2%) died following arrhythmic events despite a functioning device. 25 patients had 53 appropriate therapies (ICD shock n=47, ATP n=8), incidence rate 5.22 (95% CI 3.5–7.8). On univariable analysis, secondary prevention indication for ICD implantation was the only predictor of therapy [16 (64%) vs 8 (11.3%), p value &lt;0.001]. 8 (8.3%) patients had 9 inappropriate therapies (ICD shock n=4, ATP n=5), incidence rate 1.37 (95% CI 0.65–2.8), caused by T wave oversensing (n=2), lead migration (n=1), supraventricular tachycardia (n=1). Device complications were seen in 30 patients (31%), including lead complications (n=16) and infection (n=10). No clinical characteristics predicted time to inappropriate therapy or lead complication.

Conclusions
In a contemporary cohort of children with HCM, the incidence of inappropriate therapies is lower than previously reported, yet complication rates remain higher than reported in adult patients. No clinical, device or programming strategies were associated with inappropriate therapies or lead complications.

Funding Acknowledgement
Type of funding source: Other. Main funding source(s): British Heart Foundation
Non-invasive electrical synchrony method to guide para-hisian stimulation implant technique
Authors: Logarzo E , Ortega D , Barja L , Paolucci A , Mangani N , Revollo G , Aboy J 
Published: November 2020

Abstract

Introduction
Right ventricular apex stimulation solves electrical disorder but electrical disynchrony can be generated. Left bundle branch block results in heart failure and device upgrade is needed in some cases. Para-hisian stimulation generates a physiological cardiac activation through normal conduction system. Sheaths and special leads are used with current techniques. We developed an implantation technique guided by non-invasive electric synchrony using conventional screw-in leads. Synchromax is a novel device used to evaluate non-invasive cardiac electrical synchrony. It is easy to understand, fast to obtain, non-invasive and reproducible. Synchromax was analyzed in previous studies and correlated with other methods.

Objective
Usefulness and safety of non-invasive cardiac electrical synchrony method using conventional screw-in leads to guide para-hisian device implantation.

Materials and methods
421 patients were evaluated. All patients had indication of ventricular stimulation (pacemaker and ICD). Non-invasive electrical synchrony was performed with Synchromax study during the device implantations in all patients. Synchrony index and curves were analyzed. Type 2 curve and index between 0,1 and 0,4 were considered synchronous. Type 8 curve and index more than 0.7 were considered dyssynchronous. Attempt numbers, thresholds, fluoroscopy time and dislodgments were analyzed.

Results
Mean age 69 years (±8 years). 67,9% males. 421 devices were implanted (334 pacemakes and 87 ICDs). Sick sinus syndrome was the main pacemaker aetiology and dilated cardiomyopathy was in patients with ICD. Conventional screw-in leads were used in all cases. An implant technique was designed. A J-shaped curve with a small perpendicular curve at the tip is performed in the stylet. On average 1,9 attempts were made. Thresholds average 1,2 mV. High thresholds in 4 patients with selective parahisian stimulation. 7 dislodgments was evidenced (1,6%). Fluoroscopy time average 8,4 min. Type 2 curve and index under 0,4 was obtained in 94,5% of cases.

Conclusions
Para-hisian pacemaker implantation guided by Synchromax method using conventional screw-in leads is safe and useful achieving a physiological stimulation. Few attempts were needed with this new technique. Thresholds were similar to those used in conventional technique.

Funding Acknowledgement
Type of funding source: None
His bundle pacing preserves left ventricular ejection fraction in patients with conduction disease and high risk of development pacing induced cardiomyopathy
Authors: Mizner J , Curila K , Stros P , Prochazkova R , Vesela J , Karch J , Herman D , Osmancik P , Widimsky P 
Published: November 2020

Abstract

Background
His bundle pacing (HBP), contrary to right ventricular myocardial pacing (RVP), offers the most physiological activation of both ventricles and may not lead to pacing induced cardiomyopathy. The change in myocardial structure in failing heart due to myocardial pacing should be reflected in plasmatic levels of collagen metabolism biomarkers and inflammation markers.

Purpose
To compare a difference in the left ventricular ejection fraction (LVEF) and levels of selected biomarkers between two groups: HBP and RVP (preferably septal).

Methods
Eighty-six patients with conduction disease indicated to permanent cardiac pacing were randomized to HBP or RVP. Only high-risk patients for pacing induced cardiomyopathy development were included. Blood sampling and echocardiography were performed on the consequent day and 180 days after the pacemaker implantation. The measured biomarkers were: matrix metalloproteinase 9 (MMP-9), tissue inhibitor of metalloproteinase 1 (TIMP-1), galectin-3 (GAL3), ST2/IL-33R (ST2/IL) and TGF-beta 1 (TGFβ1). Statistical analysis included Students t-test, Fishers exact test and Chi-squared test. The p&lt;0.05 was considered to be statistically significant.

Results
First group included 39 patients with HBP (selective or non-selective His bundle capture) and 47 patients with RVP. Both groups were similar with respect to gender, LVEF, QRS duration and the baseline levels of evaluated biomarkers. In both groups, there was a high burden of ventricular pacing after 6 months (above 90%) (p = NS). The ejection fraction of the left ventricle did not change in the HBPgroup (60 vs 60%, p=0,3), but it decreased significantly in the RVP group (59 vs 56%, p=0,004). The decline in the LVEF of at least 5% occurred in 12 patients (26%) from RVP group, compared to 3 patients (8%) in HBP group (p=0,03). The blood levels of dMMP-9 (p=0,02), TIMP-1 (p=0,003), ST2/IL (p=0,003) and TGFβ1 (p=0,021) declined significantly after 180 days in the HBP group, decline of Galectin 3 was nonsignificant. In the RVP group, there was a significant decline in blood levels of MMP-9 (p=0,014), TIMP-1 (p=0,001) and ST2/IL (p= 0,04), decline of Galectin 3 and TGFβ1 was nonsignificant. The biomarker level difference was not statistically significant between the two groups.

Conclusion
His bundle pacing, contrary to right ventricular myocardial pacing, preserves LVEF in patients with high risk of pacing induced cardiomyopathy development.

Funding Acknowledgement
Type of funding source: Public Institution(s). Main funding source(s): Charles University research programme. Q38. UNCE/MED/002
The challenge of education in conduction system pacing: results from single or dual operators
Authors: Zanon F , Marcantoni L , Pastore G , Baracca E , Roncon L 
Published: November 2020

Abstract

Background
The his bundle pacing (HBP) and Left bundle branch pacing (LBBp) techniques are quickly increasing in the cardiovascular interest being the most physiological mode of pacing. Education in these new conduction system pacing (CSP) is mandatory in the modern EP programs. Achieving acceptable implant success rate, together with electrical parameters adequacy is required.

Objective
The aim of the study was to compare clinical and technical outcomes in 2 groups of patients, those implanted by a single operator with large expertise in CSP and those implanted by two operators (one of them during his learning curve).

Methods
Data from 255 consecutive patients (mean age 78±9 years; 186 males) who underwent successful HBP or LBBp implants were collected and analyzed. The operators were classified as expert after performing more than 50 procedures. Baseline caracteristics were not significantly different between the two groups.

Results
After a mean follow-up of 20±10months, we found that there were no differences between patients implanted by 1 single expert operator and 2 operators (1 beginner during his learning cirve supervised by 1 expert operator) in terms of clinical end point (composite of death or heart failure hospitalizations) and technical end point (need for surgical revision of the implant for reason other than battery replacement). Fluoroscopy time (16±17 min vs 9.8±11 min; p 0.004) and procedural time (113±48 min vs 16±17 min; p 0.003) were significantly prolonged when the implant was performed by 2 operators.

Conclusions
Skill acquisition in physiological pacing (both HBP and LBBp) is a nowadays process which cannot put patient's safety at risk. Our experience shows that clinical and technical outcomes were equivalent when the implant was performed by an expert operator or a beginner operator supervised by 1 expert operator. Fluoroscopy time and duration of the procedure were significantly prolonged by the presence of a trainees.
Kaplan Meyer curves

Funding Acknowledgement
Type of funding source: None
Mortality and readmission in non-ischemic compared with ischemic cardiomyopathies after implantable cardioverter-defibrillator implantation
Authors: Freeman J , Bjerre J , Parzynski C , Minges K , Ahmad T , Desai N , Enriquez A , Spatz E , Friedman D , Curtis J , Hlatky M , Higgins A 
Published: November 2020

Abstract

Background/Introduction
Uncertainty remains regarding the benefit of primary prevention ICDs overall in contemporary practice, and particularly in those with NICM compared with ICM.

Purpose
To evaluate the contemporary risk of death and readmission following following implantable cardioverter-defibrillator (ICD) implantation in patients with non-ischemic cardiomyopathies (NICM) compared with ischemic cardiomyopathies (ICM) in a large nationally representative cohort in the United States.

Methods
We used data from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ICD Registry linked with Medicare claims from April 1, 2010 to December 31, 2013 to establish a cohort of NICM and ICM patients with a left ventricular ejection fraction ≤35% who received a de novo, primary prevention ICD. We compared mortality, all-cause readmission, and heart failure readmission using Kaplan-Meier curves and Cox proportional hazard regressions models. We also evaluated temporal trends in mortality.

Results
Among 31,044 NICM and 68,458 ICM patients with a median follow up of 2.4 years, one-year mortality was significantly higher in ICM patients (12.3%) compared with NICM (7.9%, p&lt;0.001). The higher mortality in ICM patients remained significant after adjustment for covariates (hazard ratio (HR) 1.40; 95% confidence interval (CI) 1.36 to 1.45), and was consistent in subgroup analyses. These findings were consistent across the duration of the study. ICM patients were also significantly more likely to be readmitted for all causes (adjusted HR 1.15, CI 1.12 to 1.18) and for heart failure (adjusted HR 1.25, CI 1.21 to 1.31).

Conclusions
The risks of mortality and hospital readmission after primary prevention ICD implantation were significantly higher in patients with ICM compared with NICM, and these findings were consistent across all patient subgroups tested and over the duration of the study.

Funding Acknowledgement
Type of funding source: None
Outcomes of cardiac resynchronization therapy with or without a defibrillator in patients with nonischemic cardiomyopathy in Korea: a nationwide cohort study
Authors: Yang P.S , Kang Y , Park H.D , Sung J.H , Joung B 
Published: November 2020

Abstract

Background
Randomized control trials comparing the effectiveness of cardiac resynchronization therapy devices, with (CRT-D) or without (CRT-P) a defibrillator, are scarce in heart failure patients. Patients with nonischemic dilated cardiomyopathy (NICM) may be at lower risk for ventricular arrhythmias compared with those with ischemic cardiomyopathy. In addition, NICM has been identified as a predictor of positive response to CRT. The aim of this study was to investigate the impact of an additional implantable cardioverter-defibrillator over CRT in Korean patients with NICM.

Methods
During the period from January 1, 2008 to December 31, 2017, 533 NICM patients (mean age, 65.7±12.2 years, male 53.6%) with newly-implanted CRT-P (n=71) or CRT-D (n=462) who were aged 19 years or older were identified by 50-percents random sampling from the Korean National Health Insurance Service database.

Results
Compared with patients receiving CRT-P, those receiving CRT-D were younger (65.3±12.3 vs. 68.3±11.6 years, p=0.038), more likely to be male (56.1% vs. 38.0%, p=0.005), and have an admission history of congestive heart failure (93.9% vs. 87.3%, p=0.041). Over the mean follow-up period of 21 months,114 cases in the CRT-D group and 24 cases in the CRT-P group died, with annualized mortality rates of 14.9 and 17.2 per 100 person-years, respectively. Kaplan-Meier estimates of event-free survival showed that there was no difference in mortality between CRT-D and CRT-P groups (p=0.343). In multivariate analysis, factors associated with mortality were chronic kidney disease, atrial fibrillation, and older age. With regard to death or heart failure hospitalization, heart failure death, and non-cardiac death, there were no difference between the two groups.

Conclusions
Among Asian patients with NICM with indications for CRT, death, death or heart failure hospitalization, heart failure death, and non-cardiac death were not different between CRT-D and CRT-P groups.

Funding Acknowledgement
Type of funding source: None
AV delay optimisation in LV only CRT: constant fusion pacing is easier in patients with first degree AV block
Authors: Vacarescu C , Luca C.T , Petrescu L , Ionac A , Mornos C , Goanta E.V , Crisan S , Lazar M.A , Cozma D 
Published: November 2020

Abstract

Background
LV only pacing is non-inferior to BiV pacing, and recent publications showed that DDD CRT without RV lead is safe in patients with normal atrioventricular (AV) conduction, although there are no device algorithms available for fusion pacing and PR interval variability is understudied in this population.

Purpose
To analyse AV behaviour in patients with DDD CRT and the impact to effective fusion maintenance.

Methods
Consecutive patients with right atrium/left ventricle leads DDD CRT pacing system were included. Prospective data were collected at every 6 months follow-up visits: device interrogation, exercise test (ET), echocardiography. CRT assessment during ET analysed loss of LV capture with special focus on maintaining constant fusion pacing during exercise. We defined 2 groups of patients: longer PR interval patients (200–250 ms) and normal PR interval patients (&lt;200 ms). In case of LV loss of capture or unsatisfactory LV fusion pacing, device reprogramming was performed individualised for each patient and BB/ivabradine dose titration was done to achieve stability of PR spontaneous interval. Patients were rescheduled in no later one month to be reassessed by ET.

Results
55 patients (29 male) aged 62±11 y.o. were included, 36 patients with normal PR and 19 patients with longer PR. During follow-up (45±19 months), a total of 235 ETs were performed with mean exercise load 118±35 watts. In the normal PR group, 14 patients (39%) had inadequate pacing or loss of LV capture during ET due to physiological shortening of PR interval vs. 4 patients (21%) in the longer PR group. Loss of LV capture by exceeding maximum tracking rate (MTR) was noted in 6 patients (17%) with normal PR vs. 2 patients (11%) with long PR. Post ET device optimisation included: reprogramming rate adaptive AV interval (23±8 ms decrease in normal PR patients vs. 12±7 ms in longer PR patients, p&lt;0.0001) and individualised programming of MTR. BB/ivabradine optimisation was performed in 32% of patients with normal PR vs. 13% of patients with longer PR.

Conclusions
A lower rate of optimisations after ET was needed in patients with a slightly longer AV conduction to achieve stability of fusion pacing DDD CRT, without device algorithms. Larger studies are needed to assess AV conduction variability and the benefits of fusion pacing CRT in patients with longer PR interval.

Funding Acknowledgement
Type of funding source: Public Institution(s). Main funding source(s): University of Medicine and Pharmacy “Victor Babes”, Timisoara; Timisoara Institute of Cardiovascular Diseases
Change in QRS area by cardiac resynchronization therapy is associated with clinical outcomes and echocardiographic response
Authors: Ghossein M.A , Van Stipdonk A.M.W , Plesinger F , Kloosterman M , Salden O.A.E , Wouters P , Meine M , Maass A.H , Prinzen F.W , Vernooy K 
Published: November 2020

Abstract

Background
Cardiac Resynchronization Therapy (CRT) is the cornerstone of treatment in patients with dyssynchronous heart failure. Recently, baseline QRS area proved to predict outcomes after CRT better than QRS duration and morphology.

Purpose
It was the aim of the study to investigate whether the change in QRS area (ΔQRS area) by CRT-pacing further improves the prediction of CRT outcomes.

Methods
We conducted a retrospective analysis on 1,299 patients, who were included in a CRT-registry from three Dutch University hospitals with both pre- (baseline) and post-implantation 12-lead ECGs. ΔQRS area and ΔQRS duration were defined as the decrease in their respective values after CRT. Optimal cut offs for ΔQRS area and ΔQRS duration by means of Youden indices were found at 62μVs and −11ms, respectively. Primary endpoint was a combination of all-cause mortality, heart transplantation, and left ventricular assist device implantation. Secondary endpoint was the relative reduction in left ventricular end-systolic volume (LVESV), and echocardiographic response being defined as ≥15% LVESV reduction.

Results
The primary endpoint occurred in 408 patients (31%). ΔQRS area was superior to ΔQRS duration for the primary and secondary endpoints. Primary endpoint analysis showed a lower risk in the ΔQRS area ≥62μVs than in the &lt;62μVs group (HR 0.43; 0.33–0.56, p&lt;0.001). In the multivariable analysis, both baseline QRS area and ΔQRS area remained significantly associated with both primary and secondary endpoints. Clinical outcome (left panel of figure) and echocardiographic response (right panel) were significantly worse in patients with baseline QRS area &lt;109μVs (group 3) than in those with QRS area ≥109μVs. Within the latter group, outcomes were significantly better in patients with ΔQRS area ≥62μVs (group 1) as compared to ΔQRS area &lt;62μVs (group 2) (figure). Baseline QRS duration and ΔQRS duration were not independently associated with both clinical outcome and echocardiographic response.

Conclusion
The combination of baseline QRS area and ΔQRS area has a stronger association with CRT response than baseline QRS area alone, and (Δ)QRS duration. These results suggest that especially in patients with a good electrical substrate (large baseline QRS area) it is worthwhile to adjust CRT to achieve the largest decrease in QRS area.

Funding Acknowledgement
Type of funding source: None
Transvenous lead extraction: procedural outcomes and in-hospital mortality in octogenarian patients
Authors: Giannotti Santoro M , Segreti L , Zucchelli G , Barletta V , Di Cori A , De Lucia R , Fiorentini F , Canu A , Viani S , Bongiorni M.G 
Published: November 2020

Abstract

Background
Managing elderly patients with infection or malfunction deriving from a cardiac implantable electronic device (CIED) may be challenging. The aim of this study was to evaluate safety and efficacy of mechanical transvenous lead extraction (TLE) in elderly patients.

Methods
Patients who had undergone TLE in single tertiary referral center were divided in two groups (Group 1: ≥80 years; group 2:&lt;80 years) and their acute and chronic outcomes were compared. All patients were treated with manual traction or mechanical dilatation.

Results
Our analysis included 1316 patients (group 1: 202, group 2: 1114 patients), with a total of 2513 leads extracted. Group 1 presented more comorbidities and more pacemakers, whereas the dwelling time of the oldest lead was similar, irrespectively of patient's age. In group 1 the radiological success rate for lead was higher (99.0% vs 95.9%; P&lt;0.001) and the fluoroscopy time lower (13.0 vs 15.0 minutes; P=0.04) than in group 2. Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P=0.36). Major complications occurred in 10 patients (0.7%) without significative differences between patients with more or less than 80 years (group 1: 1.5% vs group 2: 0.6%; P=0.24). In the elderly group no in-hospital mortality occurred (0.0% vs 0.5%; P=0.42).

Conclusions
Mechanical TLE in elderly patients is a safe and effective procedure. In the over-80s, a comparable incidence of major complications with younger patients was observed, with at least a similar efficacy of the procedure and no procedural-related deaths.

Funding Acknowledgement
Type of funding source: None