bluuebunny/crossref_metadata_2025_split huggingface dataset:
Two-year outcomes of primary prophylactic use of defibrillators with ischemic and non-ischemic cardiomyopathy: propensity score-matched analysis from NIPPON STORM Study
Authors: Kondo Y , Noda T , Sato Y , Nitta T , Aizwa Y , Ohe T , Kurita T 
Published: November 2023

Abstract

Background
In 2016, the DANISH study showed negative results regarding the efficacy of implantable cardioverter defibrillators (ICDs) for patients with non-ischemic cardiomyopathy (NICM) and reduced left ventricular ejection fraction (LVEF). Thus, the ESC guidelines downgraded the indication for primary ICD prophylaxis for NICM patients with reduced LVEF from Class I to IIa. However, the change might be felt somewhat improper in the real wolrd ICD therapy and decided to use the Nippon storm study, a prospective registry study in Japan, to determine whether the DANISH results are of equal value in the clinical setting.

Objective
To determine the efficacy of ICDs as primary prevention in patients with NICM, the incidence of ICD appropriate therapy in patients with NICM was compared with that in patients with ischemic cardiomyopathy (ICM) for which primary ICD efficacy is generally recognized as a Class I indication.

Methods
We selected 1274 patients with underlying cardiac disease from a total of 1548 patients enrolled in the Nippon storm study. We analyzed data of 451 patients with LVEF ≤35% owing to NICM or ICM who underwent ICD implantation of primary prophylaxis (men, 78%; age, 65±12 years; LVEF, 25±1.4%; cardiac resynchronization therapy, 20%; ICM, 33%). All patients were followed up for at least 2 years. Patient selection was performed by employing the propensity score matching method with a digit-matching algorithm for clinical factors, ie, age, sex, cardiac resynchronization therapy with a defibrillator, LVEF. After all propensity score matches had been performed, we compared baseline covariates between the 2 groups: 132 patients with NICM and 132 with ICM. The cumulative incidences of ICD therapies (including both anti-tachycardia pacing and shock therapies) were calculated using competing risk analysis, because death is a competing risk for loss to follow-up.

Results
In the matched cohort, the 2-year appropriate ICD therapy risks were 27.7% and 12.2% in NICM and ICM groups, respectively (HR = 0.390 [95% CI, 0.218–0.701; P = 0.002) (Figure A). Two-year appropriate ATP therapy risks were 25.5% and 11.4% in NICM and ICM groups, respectively (HR = 0.417 [95% CI, 0.226– 0.776; P = .005]) (Figure B), and appropriate shock therapy risks were 6.3% and 1.6% in NICM and ICM groups, respectively (HR = 0.230 [95% CI, 0.049–1.085; P = .063]) (Figure C).

Conclusion
The present subanalysis of the Nippon Storm Study revealed that the risk for appropriate ICD therapy was significantly higher in the patients with NICM than in those with ICM based on our propensity score–matching method.
Personalized cardiac resynchronization therapy guided by real-time electrocardiographic imaging for non-left bundle branch block patients
Authors: Tam T K , Au A C K , Chan Y S , Chan C P , Cheung L L , Cheng Y W , Yuen S M , Yan B P 
Published: November 2023

Abstract

Background
Heart failure patients with non-left bundle branch block (non-LBBB) QRS pattern have limited response rate to biventricular pacing (BVP).

Objective
A personalized cardiac resynchronization therapy (CRT) implantation approach guided by real-time electrocardiographic imaging (ECGi) was studied.

Methods
Twenty patients with left ventricular ejection fraction (LVEF) ≤35%, QRS duration ≥120ms and non-LBBB (13 right bundle branch block and 7 intraventricular conduction delay) were recruited. During CRT implantation, right atrial, right ventricular, coronary sinus, His-bundle and/or Left-bundle leads were inserted. The total activation time (TAT) with different pacing combinations were measured real-time during implantation by ECGi. The configuration producing shortest TAT would be chosen. Clinical response was defined as ≥1 New York Heart Association (NYHA) class improvement. Echocardiographic response was defined as LV end systolic volume reduction ≥15% and/or LVEF improvement ≥10% at 6-months.

Results
After ECGi guided CRT implantation, LVEF improved from 26±6% to 34±11% (both p&lt;0.01) and NYHA class improved from 3.0±0.5 to 2.0±0.6 (p&lt;0.01). Both clinical and echocardiographic response rates were 70%. ECGi approach resulted in better acute electrical resynchronization over BVP as measured by TAT reduction (40% vs 14%, p&lt;0.01). Percentage of TAT reduction was found to be a strong predicator for echocardiographic response (AUC for ROC curve 0.91, 95% CI 0.78 – 1.00). A strong positive correlation between percentage TAT reduction and percentage LVEF improvement (Pearson R 0.70, p=0.001) was found.

Conclusions
ECGi guided CRT implantation in non-LBBB patients generates superior acute electrical resynchronization compared with BVP and is associated with favorable clinical and echocardiographic outcomes.
Associations of 2013 and 2021 ESC definitions of left bundle-branch block with mechanical dyssynchrony and CRT-induced reverse remodeling
Authors: Beela A , Rijks J , Vernooy K , Prinzen F , Delhaas T , Herbots L , Lumens J 
Published: November 2023

Abstract

Background
In 2021, a new and stricter ECG-based definition of LBBB was proposed and implemented in the European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy (CRT).

Aim
To investigate the association between the 2021 and the 2013 LBBB definitions with CRT-induced left ventricular (LV) reverse remodeling, as well as mechanical dyssynchrony.

Methods
CRT patients (n=191) were retrospectively investigated. Pre-CRT digitally stored ECGs were analyzed and categorized according to the LBBB definition of 2013 (LBBB-2013) and the 2021 (LBBB-2021). Mechanical dyssynchrony (Dyss) was assessed pre-CRT using 2D-echocardiography and was defined as the presence of apical rocking and/or septal flash. CRT-induced LV reverse remodeling was measured as the relative change of left ventricular end systolic volume (LVESV) at 12 ± 6 months after CRT compared to baseline.

Results
Patients’ characteristics were as follows; age 70 ± 10 years, 69% males and NYHA class 2.7 ± 0.5. QRS width was 156 ± 18 ms and LVEF 33 ± 11%, and 52% had ischemic etiology. Dyss was present in 59% of the population.
The percentage of the cohort that was considered to have LBBB was considerably lower according to the LBBB-2021 than according to the LBBB-2013 (18 vs. 57% respectively). Similarly, percentages of patients with LBBB+Dyss were 16 and 46% according to LBBB-2021 and LBBB-2013 respectively, with a respective Kappa coefficient of 0.16 and 0.47 (Figure A).
At CRT follow up, LBBB-2013 patients showed significantly more LV reverse remodeling compared to non-LBBB patients (P &lt; 0.001), while there was no significant difference between patients with LBBB-2021 and non-LBBB (P = 0.09, Figure B).

Conclusion
The LBBB definition proposed in the 2021 ESC guidelines excludes many patients from a class I indication for CRT. It is less associated with mechanical dyssynchrony and with CRT-induced LV reverse remodeling than the 2013 LBBB definition. Therefore, the new LBBB definition appears to be counterproductive with regards to selection of CRT patients.
Cost-effectiveness of remote monitoring for cardiac implantable electronic devices compared with conventional follow-up: a systematic review
Authors: Arcinas L A , Alyosif M , Rennert-May E , Piccini J P , Varma N , Frazier-Mills C , Raj S J , Mark D B , Miller R J H , Chew D S 
Published: November 2023

Abstract

Background
Remote monitoring (RM) of cardiovascular implantable electronic devices (CIEDs) is a form of virtual patient care that involves electronic transmission of CIED diagnostics and remote assessment of this information by clinic staff. Despite expert recommendations advocating its use, adoption remains modest due to inconsistent funding policies across health systems.

Purpose
This study aims to identify and synthesize existing literature in the cost-effectiveness of RM compared with in-person clinic assessments alone in patients with CIEDs.

Methods
We conducted a systematic review of available economic evaluations (including cost-effectiveness, cost-utility, cost-consequence analyses) and costing analyses (which examines costs but not clinical benefits) of RM following CIED implantation compared to in-person clinic follow-up alone. Study outcomes included incremental costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

Results
Of the 1151 unique citations, a total of 27 studies were included. The studies were from Europe (n=20), USA (n=5), or Canada (n=2). Remote transmissions, when detailed in the study, were predominantly patient- and/or physician- triggered, but some also included automatic home monitor transmissions. Fourteen studies (52%) were costing analyses, and the remaining 13 studies were economic evaluations. The majority of studies (78%; n=21) reported cost-savings associated with RM compared to in-clinic follow up alone. Of the 13 economic evaluations, there were 6 cost-utility analyses, which all reported that RM provided additional QALYs for additional costs that met country-specific thresholds for good value in health care. Studies varied greatly in the costs considered, the outcomes measured, and the time horizons used.

Conclusion
Remote monitoring of patients with CIEDs was associated with cost-savings in most studies and across different healthcare systems. RM may be considered cost-effective when conventional thresholds for good value in health care are adopted. Despite heterogeneity in methods of economic evaluation in the studies included, the overall data in this systematic review supports greater implementation of RM technology to improve health system costs and efficiency.
Long-term remote monitoring vs. in-office monitoring of pacemakers: a systematic review and meta-analysis
Authors: Rivera A , Menezes Junior A , Miyawaki I A , Nascimento B N S R 
Published: November 2023

Abstract

Background
Remote monitoring (RM) is increasingly recognised as the standard of care for patients with cardiac implantable electronic devices (CIEDs) according to current practice guidelines, particularly in pacemaker usage which represents the majority of CIEDs. However, there is insufficient evidence to assess the long-term safety of RM compared to in-office (IO) monitoring of pacemakers over extended periods, as well as its effectiveness in reducing in-office visits for device reprogramming.

Purpose
We aimed to perform a meta-analysis to compare RM and IO monitoring of pacemakers with at least 12 months of follow-up.

Methods
We systematically systematic search EMBASE, PubMed/MEDLINE, Cochrane, and ClinicalTrials.gov databases for randomized controlled trials (RCTs) comparing remote monitoring (RM) and in-office (IO) monitoring of pacemakers, with a focus on outcomes related to (1) all-cause mortality, (2) stroke, and (3) hospitalizations due to cardiovascular and device-related adverse events. Heterogeneity was assessed using I² statistics, and outcomes with high heterogeneity were analysed using a random-effects model.

Results
Six RCTs with a total of 3,059 patients were included in the meta-analysis. Of these, 1,495 patients (48.87%) underwent RM. In-office number of follow-ups per year was not significantly different between groups (OR -0.71; 95% CI -1.45 - 0.03; p = 0.06; I² = 99%; Fig. 1a) but tended to favour the RM group. No significant differences were found between RM and IO monitoring in terms of all-cause mortality (OR 1.14; 95% CI 0.83 - 1.55; p = 0.42; I² = 0%; Fig. 1b), stroke (OR 0.82; 95% CI 0.37 - 2.19; p = 0.82; I² = 38%; Fig. 2a), or hospitalizations for cardiovascular or device-related adverse events (OR 0.96; 95% CI 0.72 - 1.28; p = 0.78; I² = 0%. Fig. 2b).

Conclusion
This is the first meta-analysis comparing RM and IO monitoring for long-term pacemaker usage. Our results suggest that the number of follow-ups tended to be fewer in the RM group, and both monitoring methods appear to be similar in terms of all-cause death, stroke, and hospitalizations for cardiovascular or device-related adverse events.
Association between cardiac implantable electronic device infection and mortality: long-term follow up of a complete, state-wide cohort in Australia
Authors: Shawon M , Sotade O , Li J , Hill M , Strachan L , Challis G , King K , Ooi S , Jorm L 
Published: November 2023

Abstract

Introduction
The number of individuals with Cardiac Implantable Electronic Devices (CIEDs) is rising globally, and infection is a serious procedure-related complication. Only a limited number of studies based on population data have quantified the association between CIED infection and mortality, with inconsistent results.

Purpose
To assess the association between CIED infection and all-cause mortality in a large population-wide, contemporary cohort.

Methods
This retrospective cohort study used linked hospital and mortality data for New South Wales (NSW) residents. We studied all patients aged &gt;18 years who underwent a CIED procedure in NSW public or private hospitals between January 2016 and June 2021. CIED infection was defined by the presence of relevant diagnosis codes in any hospitalisation following a CIED procedure. We followed the patients until their death or end of follow-up, whichever occurred first. Adjusted hazard ratios (aHR) with 95% confidence intervals (CIs) for associations of CIED infection with mortality were estimated using Cox regression at 1-year and end of follow-up, with CIED infection as a time-dependent variable.

Results
We followed 37,625 patients with CIED procedures (36% female, mean age (standard deviation [SD]) 75.4 [12.8] years) for an average [SD] of 2.3 [1.5] years. Of these patients, 500 (1.3%) had CIED infection, and 6,224 (16.5%) died during the study period. The overall mortality rate was 24.2% among those with an infection and 16.4% among those without an infection. Compared to other CIED patients, patients with CIED infection had a higher Kaplan-Meier mortality rate (17.0% vs. 7.1%) and adjusted hazard of mortality (aHR 2.43, 95%CI 1.84-3.21) at 12 months post-procedure. These differences were attenuated, but still remained significant at the end of follow-up (mortality rate 43.6% vs. 33.3%; aHR 1.66, 95%CI 1.39-1.99) (Figure 1).

Conclusions
In a complete, state-wide cohort of CIED patients, infection was associated with higher risks of both short- and medium-term mortality.Kaplan-Meier mortality by CIED infection
Prevalence of new-onset tricuspid regurgitation after leadless Micra pacemaker implantation
Authors: La Fazia V , Gianni C , Pierucci N , Della Rocca D G , Mohanty S , Torlapati G , Al-Ahmad A , Bassiouny M , Gallinghouse G J , Horton R , Burkhardt J D , Lakkireddy D , Forleo G B , Di Biase L , Natale A 
Published: November 2023

Abstract

Background
Tricuspid regurgitation (TR) has been reported as a complication of transvenous pacemaker lead implantation. However, the potential risk of TR is not known in case of leadless devices.

Purpose
We describe a case series of moderate to severe TR following implantation of the leadless Micra device.

Methods
We performed a multicenter (n=6) cross-sectional survey across the United States and Italy. Patient data were obtained by chart review and only patients with baseline and follow-up echo Doppler data were included in this analysis. All images were reviewed by the first author.

Results
A total of 158 patients receiving Micra implant were screened of which 6 (3.8%) cases of moderate to severe TR were identified by the Doppler echo. The most common presenting symptom were shortness of breath (6/6, 100%) and fatigue (5/6, 83.3%). Prominent jugular venous pulsation was observed in 1/6 (16.7%) patients indicating severe TR. Median time to development of symptoms and detection of TR was 9±3 months. None of the 6 patients developed symptoms immediately after the procedure.
Figure 1 illustrates severe TR in one of the six patients included in the study (off axis view).

Conclusion
In this small series, we observed new-onset moderate-severe TR following implantation of leadless device in approximately 4% of patients. Whether this is related to the positioning of the device, needs to be ascertained by future studies.Severe TR after Micra implant
Inflammation of conduction tissue is a major determinant of electrical instability in patients with arrhythmic phenotype of myocarditis
Authors: Frustaci A , Magnocavallo M , Rossi P , Bianchi S , Verardo R 
Published: November 2023

Abstract

Background
Arrhythmic presentation of myocarditis can be life-threatening although often associated with a preserved cardiac dimension and function. The involvement of conduction tissue (CT) has been suggested as pro-arrhythmic factor, but its role has not conclusively supported.

Purpose
CT inflammation in myocarditis with arrhythmic presentation.

Methods
We retrospectively enrolled consecutive patients from January 2010 to June 2021 with acute myocarditis (&lt; 1 month from the onset of symptoms). Patients were categorized according to clinical presentation in arrhythmic [frequent premature ventricular beats, non-sustained or sustained ventricular tachycardia (VT) and survivors of ventricular fibrillation, associated to preserved cardiac contractility –LVEF ≥ 50%] (Group A) and cardiomyopathy phenotype (signs and symptoms of heart failure with LVEF≤ 45%) (Group B).
All patients had a normal coronary network at angiography and an unremarkable valvular pattern at 2D-Echo.They all underwent a LV endomyocardial biopsy; sections of CT (Purkinje fibres) were identified by morphologic (Ashoff and Monkeberg criteria) findings and positive immunohistochemistry for HCN4. CT infiltration was demonstrated by the presence of CD45Ro+ T lymphocytes and the necrosis of adjacent small and loosely arranged myocytes. The extent of myocardial fibrosis, the rate of vasculitis and CT inflammation was compared between the two groups.

Results
Among 217 consecutive pts with biopsy-proven diagnosis of myocarditis, 107 (49.3%) had an arrhythmic presentation (Group A). CT was observed in 33 (30.8%) patients in the Group A and 31 (28.2%) of Group B. In patients with biopsy-evidence of CT, no significant difference was reported in the mean age (51.2±16.8 vs 53.7±14.7; p-value: 0.53) . Inflamed CT was documented in 2 (6.5%) cases in Group B and in 33 (100%) in Group A (p-value&lt; 0.001). No statistically difference was observed between Group A and B regarding the presence of vasculitis (4 vs 1; p-value: 0.36) and myocardial fibrosis (8.8±4.2% vs 9.5±4.3%; p-value: 0.50).

Conclusion
CT inflammation is a major determinant of electrical instability in human myocarditis with arrhythmic presentation.
Figure Legend
Sustained ventricular tachycardia (A) associated to severe infiltration by CD45Ro T lymphocytes of CT in an acute myocarditis with arrhythmic presentation.
Prognostic impact of cardiovascular polypharmacy on octogenarians with heart failure with preserved ejection fraction
Authors: Nishino M , Egami Y , Matsunaga-Lee Y , Yano M , Yamada T , Yasumura Y , Seo M , Tamaki S , Hayashi T , Nakagawa A , Nakagawa Y , Sotomi Y , Nakatani D , Hikoso S , Sakata Y 
Published: November 2023

Abstract

Backgrounds
Drug treatments of heart failure with preserved ejection fraction (HFpEF) have a little clinical benefit, but cardiovascular polypharmacy (CP) trend is observed in elderly HFpEF. We investigated the impact of CP on octogenarian with HFpEF.

Methods
We examined 783 consecutive octogenarians (≥80 years) enrolled in the PURSUIT-HFpEF registry. We defined medications for hypertension, dyslipidemia, heart failure (HF), coronary artery disease, stroke, peripheral artery disease, and atrial fibrillation as cardiovascular medications (CM). In this study, we defined CP as ≥5 CM. We investigated whether CP was correlated with the composite end point (CE) of all-cause mortality and HF rehospitalization.

Results
The proportion with CP was 51.9% (n=406). Background characteristics correlated with CP were frailty, history of coronary artery disease, atrial fibrillation and left atrial dimension. Multivariable Cox proportional hazards analysis showed CP was significantly and independently correlated with CE (hazard ratio (HR): 1.31; 95% confidence Interval (CI): 1.01-1.70) in addition to age, clinical frailty scale, history of HF admission and N-terminal pro brain natriuretic peptide (Table). Kaplan-Meier curve analysis showed that, compared with the non-CP group, the CP group had significantly higher risk of CE and HF (HR: 1.27; 95%CI: 1.04-1.56; P=0.02 and HR: 1.46; 95%CI: 1.13-1.88; P&lt;0.01, respectively), but not any-cause death (Figure). In addition, diuretics were correlated with CE (HR: 1.61; 95%CI: 1.17-2.22; P&lt;0.01), but antithrombotic drugs and HFpEF medications were not.

Conclusions
CP at discharge is a prognostic factor driven by HF rehospitalization in octogenarians with HFpEF. In these patients, diuretics may be correlated with the prognosis.
Inter-atrial block and atrial fibrillation predict cardiac adverse events in heart failure with preserved ejection fraction
Authors: Weerts J , Lopez-Martinez H , Mourmans S G J , Barandiaran Aizpurua A , Domingo M , Henkens M T H M , Brunner-La Rocca H P , Knackstedt C , Bayes-Genis A , Van Empel V P M 
Published: November 2023

Abstract

Background
Atrial fibrillation (AF) is a prognostic risk-factor in heart failure with preserved ejection fraction (HFpEF). Earlier stages of atrial dysfunction identified by the ECG, particularly inter-atrial block (IAB), may provide additional risk predictions in HFpEF patients in sinus rhythm.

Purpose
To assess the prevalence of IAB in patients diagnosed with HFpEF compared to non-HFpEF, and to evaluate the prognostic association of IAB and AF in patients diagnosed with HFpEF.

Methods
Consecutive symptomatic patients referred for a systematic diagnostic work-up to rule-in or rule-out HFpEF were included. The diagnosis of HFpEF was based on current guidelines (including HFA-PEFF and H2FPEF algorithms) and confirmed by consensus of multiple experienced HF specialists. Patients in whom HFpEF was ruled-out were included as non-HFpEF. We excluded patients with cardiac valve interventions before or up to 1 year after baseline, or with paced rhythm during IAB assessment. ECGs at baseline were assessed in detail for P-wave duration, morphology, and presence of IAB using digital calipers by investigators blinded to clinical data. IAB was defined based on a P-wave duration of &gt;120ms. Patients with HFpEF and non-HFpEF were grouped into either i) AF based on ECG or medical history, ii) IAB based on ECG, or iii) no IAB or AF based on ECG. Adverse events were evaluated only in HFpEF patients and included HF hospitalization, cardiac or sudden death, and a composite of both.

Results
372 patients with HFpEF and 68 non-HFpEF were included (females: 67.7% vs. 64.7%, p = 0.726; mean age: 75±7 vs. 67±10 years, p&lt;0.001). AF was more common in HFpEF than non-HFpEF (64.8% vs. 23.5%, p&lt;0.001). In sinus rhythm, presence of IAB was comparable between HFpEF and non-HFpEF (87.0% vs. 80.8%). During a mean follow-up of 3.2±1.6 years in HFpEF patients, more adverse cardiac events were observed when AF was present (23.7%, HR 10.6 [95%CI 1.5-1334.4]) compared to IAB (10.5%, HR 4.2 [95%CI 0.56-542.6]) and no IAB (0%), p = 0.0004 (Figure 1). Pairwise comparisons confirmed these observations: AF vs. IAB p = 0.006, AF vs. no IAB p = 0.031. In HFpEF patients with sinus rhythm, a trend was found for more adverse events when IAB was present versus no IAB (p = 0.06).

Conclusion
Patients with HFpEF have a higher prevalence of AF and similar prevalence of IAB compared to symptomatic patients ruled-out for HFpEF. Presence of IAB or AF in HFpEF may predispose to adverse cardiac events in patients without severe valve disease. IAB may enrich cardiac risk stratification in addition to AF in HFpEF.Survival curves for no IAB, IAB, and AF