bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of MADIT II risk stratification score among registry of heart failure patients with primary prevention ICD/CRTD device
Authors: Rav Acha M , Wube O W , Tovia-Brodie O T B , Michowitz Y M , Ilan M A , Ovdat T A , Klempfner R K , Goldenberg I G , Glikson M G 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Current guidelines advocate primary prevention ICD implantation for all symptomatic heart failure (HF) patients with low LVEF. As most patients will not use their device during lifetime, a score delineating subgroups with differential ICD benefit is crucial. The MADIT Risk Stratification Score (MRSS) based on 5 parameters including: age&gt;70, Creatinine &gt;1.4 mg/dl, QRS width &gt;120ms, presence of AF, and NYHA &gt;2, was developed for this purpose.

Objective
Evaluate MRSS among Israeli nationwide registry of HF patients implanted with prophylactic ICD/CRTD. Endpoints included overall mortality, sustained ventricular arrhythmia (VA), and competing risk of arrhythmic (VA-related) versus non-arrhythmic death, a surrogate for potential ICD survival benefit.

Methods
Study based on comprehensive registry of ICD/CRTDs implanted in Israel between 2011-2018. All registry patients were categorized into MRSS-based risk-groups (low-risk- MRSS 0, intermediate-risk- MRSS 1-5, very high-risk (VHR) group defined by Creatinine &gt;2.5mg/dL). Univariate and Kaplan Meier analysis used to evaluate the association of risk groups with study endpoints.

Results
2177 HF patients, implanted with a primary prevention ICD (1255, 58%) or CRTD (922, 42%) were included. There were 189 (8.7%) patients with sustained VA and 316 (14.5%) deaths during median follow-up (F/U) period of 2.5 years. A significant correlation was found between MRSS-based risk subgroups and overall mortality (p 0.001). However, MRSS association with sustained VA was weak (p 0.2). Notably, the MRSS-based very high-risk (VHR) subgroup had an exceptionally high mortality but low VA incidence. Competing risk of arrhythmic versus non-arrhythmic death revealed a large and significant ICD survival benefit among the low and intermediate MRSS-based risk subgroups, with 10.2 and 12.3 months survival gained over 3-year F/U period among these subgroups, respectively (p 0.001). The VHR subgroup in contrast, showed a minimal non-significant ICD survival benefit.

Conclusions
Use of MRSS among a contemporary real-world registry of HF patients revealed subgroups with differing ICD survival benefit, suggesting it as a universal tool to predict ICD survival benefit. MRSS-based VHR subgroup may not gain survival benefit from prophylactic ICD implant.
Cardiac resynchronization therapy via left bundle branch area pacing and a dual-chamber ICD; a CROSS-LEFT substudy
Authors: Clementy N , Bodin A , Ah-Fat V , Babuty D , Bisson A 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Left bundle branch area pacing (LBBAP) has emerged as a promising technique to deliver cardiac resynchronization therapy (CRT).

Purpose
We sought to evaluate the feasibility of a single LBBAP lead connected to a dual-chamber ICD in patients indicated with a CRT-D implantation.

Methods
The CROSS-LEFT study prospectively included consecutive sinus rhythm patients with a reduced ejection fraction and a complete left bundle branch block. A DF-1 lead was implanted at the right ventricular apex, and an LBBAP lead through the interventricular septum. Patients were implanted with a dual-chamber DF-1 defibrillator (ICD) connected to the atrial lead (RA port), the LBBAP lead (RV IS-1 port), and the defibrillation lead (RV DF-1 port), the IS-1 pin being capped. Atrioventricular delay was optimized to ensure fusion between LBBAP and native conduction from the right bundle. Patients were followed during 6 months.

Results
A total of 22 patients were included (median age 68 years, 77% male, 41% ischemic). LBBAP resulted in a significant reduction of median QRS width from 161 to 128ms (p&lt;0.0001). At 6 months, median ventricular sensing was 18mV (range 5–31, IQR 9), and LBBAP threshold 0.5V (range 0.25–0.75, IQR 0). Median LVEF significantly improved from 27 to 45% at 6 months (p&lt;0.0001), with a median reduction of LV end-systolic volume of 32% (p=0.0002), 67% of patients being considered as super-responders.

Conclusion
In patients with a left bundle branch block indicated with a biventricular defibrillator, CRT can be safely and efficiently performed via a single LBBAP lead connected to a dual-chamber ICD, and is associated with significant electromechanical reverse remodeling.
Adaptive CRT algorithm and electrical synchrony
Authors: Bank A , Burns K , Brown C , Walser-Kuntz E , Johnson K 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: Foundation. Main funding source(s): United Hospital Medical Education and Research Committee, United Hospital Foundation.

Background
We have previously shown that optimization of cardiac resynchronization therapy (CRT) nonresponders using a novel electrical dyssynchrony mapping (EDM) system significantly improves electrical dyssynchrony, left ventricle (LV) size and systolic function. Whether this methodology can improve electrical dyssynchrony (and potentially LV function) in nonresponder patients programmed with the adaptive CRT (aCRT) algorithm is not known.

Purpose
To quantify electrical dyssynchrony in CRT nonresponders programmed using aCRT and determine if it can be improved using EDM.

Methods
We studied 97 patients programmed with the aCRT algorithm at multiple device settings with an ECG system of 9 anterior and 9 posterior electrodes. We quantified electrical dyssynchrony using a measure of wavefront fusion, cardiac resynchronization index (CRI), calculated as % change in area under the curve between all combinations of anterior and posterior electrodes as compared to native LBBB (CRT off). CRI results were displayed on an electrical dyssynchrony map (EDM) showing atrial-to-right ventricle-paced intervals (A-RVp) on the y-axis and atrial-to-left ventricle-paced intervals (A-LVp) on the x-axis.

Results
Figure 1 shows an EDM for a typical patient with CRI values marked at different programmed settings. Figure 2 shows CRI for 58 patients programmed LV-only by aCRT at baseline (red bars) and 39 patients programmed biventricular (BiV) by aCRT at baseline (blue bars). CRI at baseline was significantly (p≤0.001) higher in patients programmed LV-only vs. those programmed BiV. In both groups programming to LV-only at the optimal atrial-ventricular delay (AVD) and to sequential BiV pacing at the optimal ventricular-ventricular delay (VVD) produced significantly and markedly better CRI as compared to CRI at aCRT baseline settings. In the patients programmed by aCRT at baseline to LV-only, BiV VV=0 at standard device setting (SAV 120 ms) had significantly worse CRI than baseline.

Conclusions
Electrical dyssynchrony as measured by CRI is better in patients programmed aCRT LV-only than those programmed aCRT BiV. CRI can be improved by 20% or more by using EDM to program patients to LV-only pacing at the optimal AVD or to BiV pacing at the optimal VVD.
EDM technology offers the possibility of substantially improving electrical synchrony in nonresponder patients programmed with aCRT.
Impact of left ventricular scar burden on response to two different modalities of conduction system CRT
Authors: Ali N A D I N E , Arnold A D , Miyazawa A A A , Keene D , Chow J J , Peters N S , Kanagaratnam P , Qureshi N , Ng F S , Lefroy D , Francis D P , Shun-Shin M , Cole G D , Whinnett Z I 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: Foundation. Main funding source(s): British Heart Foundation

Introduction
Cardiac resynchronisation therapy (CRT) in the form of His bundle CRT and left bundle area CRT can be more effective than the gold standard, biventricular pacing (BVP). In BVP scar burden is known to predict response whether this is true for these novel modalities is not known.

Purpose
The purpose of this study was to determine whether left ventricular scar burden assessed using cardiac MRI can be used to predict the electrical and acute haemodynamic response to two novel CRT modalities.

Methods
Patients with standard CRT indications were recruited. They underwent a pre-procedure cardiac MRI, with late gadolinium enhancement (LGE) to quantify scar. His bundle CRT (His CRT) and left bundle area CRT (LBA CRT) were attempted. The electrical response was measured using high precision non-invasive mapping ECGi (CardioInsight, Medtronic). The haemodynamic response was measured with a high precision protocol.
We investigated the impact of scar and baseline electrical characteristic on ECGi and haemodynamic response.

Results
26 patients were recruited (85% male, mean age 69 ± 10, with ischaemic cardiomyopathy in 35%). LGE was observed in 96% of cases and the mean (range 1-39%). We found a significant correlation between scar extent and the electrical response with both modalities. There was a significant correlation between a lower scar burden and better electrical response. For His CRT the reduction in left ventricular activation time was better with lower scar burden (R= 0.77, p &lt; 0.01, Picture 1), for LBA CRT for reduction in left ventricular activation was also better with lower scar burden (R = 0.53, p = 0.05, Picture 2). With His CRT there was also a significant correlation between lower scar extent and better acute haemodynamic response ( R = 0.6, p = 0.002) but this was not observed with LBA CRT (R = 0.07, p = 0.77).

Conclusion
Left ventricular myocardial scar can be used to predict the electrical response to two different conduction system CRT modalities.
Defibrillator capability and all-cause mortality in patients receiving cardiac resynchronization therapy for non-ischemic cardiomyopathy: a Korean nationwide cohort study
Authors: Yang P S , Kang Y H , Park H D , Sung J H , Joung B 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Concerns exist about the benefit of cardiac resynchronization therapy with a defibrillator (CRT-D) compared to those without a defibrillator (CRT-P), especially in patients with non-ischemic cardiomyopathy. We evaluated the association between defibrillator capability and all-cause mortality in patients receiving cardiac resynchronization therapy (CRT) for non-ischemic cardiomyopathy.

Methods
From patients with nationally registered cardiomyopathy in the Korea National Health Insurance Service (KNHIS) database, after the exclusion of those with ischemic heart disease, 1,478 patients with newly-implanted CRT-P (n=258) or CRT-D (n=1220) were identified from 2008 to 2020. The association between defibrillator capability and all-cause mortality was assessed with propensity score (PS) weighting to correct for differences between the groups.

Results
Compared with patients receiving CRT-D, those receiving CRT-P included more subjects older than 75. After PS weighting, over a mean follow-up period of 52.9 months (interquartile interval: 23.5-75.8), CRT-D was associated with a lower rate of mortality (6.5 vs 9.2 per 100 person-years) compared with CRT-P. The weighted risk of all-cause death in patients with CRT-D was lower than those with CRT-P within 1 year (hazard ratio [HR]: 0.70 [95% CI, 0.53–0.91]; p = 0.009) and 5 years (HR: 0.71 [95% CI, 0.61–0.83]; p &lt; 0.001). Results were consistent regardless of subgroups, such as age, sex, year of registration, and comorbidities.

Conclusions
In Korean patients with non-ischemic cardiomyopathy, the defibrillator capability of CRT was associated with reduced 1-year and 5-year all-cause mortality. This association was consistent across all the investigated subgroups.
The tip of the eventberg: incidental rhythm disturbances by remote monitoring following pulmonary vein isolation
Authors: Schlogl S , Schlogl K , Bengel P , Haarmann H , Rasenack E , Busse S , Hasenfuss G , Zabel M , Bergau L 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background/Introduction
Implantable loop recorders (ILR) are increasingly used for continuous rhythm monitoring following pulmonary vein isolation (PVI) for atrial fibrillation (AF). However, the impact of non-AF episodes in this patient population is unknown.

Purpose
Firstly, the aim of our study was to asses the incidence of clinically important non-AF events. Secondly, we wanted to identify possible risk factors leading to incidental non-AF events.

Methods
In this retrospective single center study, all patients implanted with ILR following PVI in our center between 2016 and 2022 were analysed. The indication to ILR implantation and remote monitoring after successful PVI was based on patient preference. Transmissions were carefully reviewed by two independent electrophysiologists. Bradycardic events were defined as documented symptomatic bradycardia, AV-Block II˚, AV-Block III˚ or Sick-Sinus Syndrom. Tachycardic events were defined as documented symptomatic supraventricular tachycardia (non-AF) or ventricular tachycardia &gt;160/min with at least 30 seconds duration.

Results
A total of 219 patients underwent PVI and consequent ILR implantation. We evaluated a mean 2.1±1.1 years of follow up (FU) with a median 68 events/patient (25th–75th IQR: 13-590 events/patient). Overall, 49 patients (22.4%) developed at least one bradycardic event, 6 patients (2.7%) were later implanted with a pacemaker. In univariate logistic regression analysis age, persistent AF, left atrial diameter and prior cardioversion correlated with an increased risk of bradycardic events. Upon a multivariate logistic regression age and prior cardioversion predicted bradycardic events.
At least one tachycardic non-AF event was observed in a total of 9 patients (3.6%). Supraventricular tachycardia was observed by 4 patients (1.8%), one (0.4%) were ablated by an atrioventricular nodal reentry tachycardia (AVNRT), others (1.4%) were ectopic atrial tachycardia treated conservatively. Sustained wide complex tachycardia was recorded in 5 patients (2.2%), thereof two (0.9%) received a secondary prophylactic implantable cardioverter defibrillator (ICD). The multivariate analysis did not show any statistically significant value predicting tachycardic events.

Conclusion
Use of ILR for rhythm monitoring following PVI could increase the early detection of incidental rhythm events, especially bradycardic episodes. However, to asses this possibly beneficial effect further prospective, multicenter studies are needed.
Clinical impact of capsulectomy during cardiac implantable electronic device generator replacement: a prospective randomized trial
Authors: Kim H J , Kim S H , Choi Y , Kim S H , Park S Y , Oh Y S , Jang S W , Hwang Y M , Kim J H , Kim T S , Kim J Y , Kim S H , Lee Y S , Baek J Y 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
The avascular capsule around the generator of cardiac implantable electronic device (CIED) could be susceptible for bacterial colonization and source of infection. Capsulectomy during CIED generator replacement may be beneficial in preventing device infection, but there is a lack of evidence.

Methods
This study was a prospective randomized trial. Patients receiving generator replacement were enrolled from December 2013 to December 2019. A total of 195 patients were 1:1 randomly assigned, for patients in the intervention group (n=97), capsule removal was performed on the floor of the pocket during generator replacement but not for patients in the control group (n=98). In both groups, microbiological culture was performed in the pocket. The primary outcome was the occurrence of device infection requiring pocket revision.

Results
Of the 195 patients included (mean age 70.2 ± 13.6years, 55.4% women), 54 (27.7%) included additional lead revision, 19 (9.7%) had biventricular device. Among 182 patients undergoing microbiological cultures of pockets, 19 (10.4%) were confirmed positive, 4 S. epidermidis (21.1%) and 3 S. aureus (15.8%) were identified most frequently. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (Intervention group 3 (3.1%) vs Control group 1 (1.0%), p=0.606). Hematoma was occurred in 10 patients (Intervention group 3 (3.1%) vs Control group 7 (7.1%), p=0.338), one of them required wound revision. In multivariable analysis, the occurrence of hematoma was the only independent risk factor associated with device infection. (HR 13.6, 95% CI 1.02-181.15, p=0.048).

Conclusion
In this study, capsulectomy during replacement of generator did not reduce the incidence of device infection. There was no association between bacterial colonization in the capsule around the generator and CIED infection.
Electric cars and high power chargers: Are they safe for patients with cardiac implantable electronic devices?
Authors: Lennerz C , O`Connor M , Bock M , Knoll K , Schaarschmidt C , Bahlke F , Storz T , Englert F , Kottmaier M , Reents T , Bourier F , Lengauer S , Schunkert H , Deisenhofer I , Kolb C 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: Public Institution(s). Main funding source(s): Deutsche Stiftung für Herzforschung research grant

Background
Electromagnetic interference (EMI) poses a risk to patients with cardiac implantable devices (CIEDs) and can result in device malfunction including pacing inhibition or inappropriate shock therapy. Such EMI sources are ubiquitous in the modern world. Battery electric vehicles (BEVs) represent such a potential EMI source. We have previously investigated the EMI risk of driving eCars and found that the largest electromagnetic field is located along the charging cable. New high power chargers deliver higher currents (facilitating rapid recharging), potentially associated with greater electromagnetic fields and higher risk for clinically relevant EMI. This present study aims to evaluate this EMI-risk to address this clinically important question.

Methods
A consecutive group of 130 patients with a range of CIEDs were recruited to participate. After a complete device interrogation each had their device programmed to optimise EMI detection with ensured ventricular pacing and ICD therapies were disabled. Under continuous 6-lead ECG monitoring each patient then plugged in and charged four different BEVs (Porsche Taycan Turbo, VW ID3 pro, Tesla Model 3 and Audi e-tron 55 Quattro) in addition to a ‘dummy’ eCar (which permitted the maximal charging power flow of 350kW) with the charging cable placed directly over the device. During charging both the magnetic field and electric field was measured. A further complete device interrogation was then performed to evaluate for spontaneous reprogramming and tachycardia detection.

Results
In total 561 separate charging events were performed by 130 patients with the four eCars and one dummy car. The maximal magnetic field along the charging cable was 38.65µT and at the charging column was 77.9µT. There were no incidences of EMI, specifically there was no pacing inhibition due to oversensing, no spontaneous reprogramming and no tachycardia over-detection. This results in a patient-based risk of 0% (95% CI; 0% - 2.8%) and a charging event-based risk of 0% (95% CI; 0% - 0.6%).

Conclusions and Discussion
We found that there was no EMI induced during the use of high power charger technology for BEV despite device programming and charging cable placement being optimised for a worst-case scenario and maximising the chance of clinical EMI. Our study suggests that there is a very low risk, if any, posed by BEVs and the new high power chargers. CIED patients should reassured that their use is safe. We would still recommend not to place the charging cable directly above the CIED during use to maximise safety of high power charging.
Occlusion balloon during transvenous lead extraction-Lessons learned from a case series
Authors: Hofer D , Grebmer C H , Breitenstein A 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Lead-extraction for infected or dysfunctional electrodes are these days often performed with a high success rate of complete lead removal. The risk for major complications ranges between 1-5 %. The most catastrophic complication is a tear of the superior vena cava with a high mortality despite urgent cardiothoracic surgical intervention. The use of a transvenously placed occlusion balloon has been shown to be associated with a reduced mortality risk in cases where an SVC tear occurred (reference 1). However, there have been reports showing a risk of clot formation on the surface of the occlusion balloon.

Purpose
To investigate the feasibility and safety of an occlusion balloon during lead extraction.

Methods
Prospective case series of 10 patients where the occlusion-balloon during transvenous lead extraction was used prophylactically. Occurrence of clots on the device, complications as a result of the inflated balloon as well as the handling were recorded and documented.

Results
In this prospective analysis, the occlusion-balloon was staged prophylactically in 10 patients undergoing transvenous lead extraction. The device could be placed successfully in all patients without any complications. After correct positioning (figure 1), the balloon was deflated and staged either at the level of the SVC (30 %), within the sheath (40 %) or within the IVC (30%) during lead extraction procedure. The total dwell time was 18.3 10.3 min. After successful extraction of the leads, the balloon could be readvanced over the wire without using fluoroscopy in all cases (final acceptable position was then reconfirmed via fluoroscopy). No clot formation was observed either on TEE during the procedure nor after removal of the balloon as well as no injury to cardiac or venous structures have been found. However, in one patient suffering from severe heart failure, occlusion of the SVC during balloon inflation resulted in a relevant decrease of the cardiac preload and a drop in blood pressure of which the hemodynamic values recovered completely after deflation.

Conclusions
Transvenously positioning of an occlusion balloon is a safe procedure according to this case series. Importantly, no clot formation could have been observed which is most likely due to the much shorter dwelling time compared to previous reports. Furthermore, repositioning of the balloon without fluoroscopy at the same level within the SVC is safe and feasible. In patients with severly impaired cardiac function however, the potential decrease in preload due to the inflated balloon can result in a transient decrease of the cardiac function.