bluuebunny/crossref_metadata_2025 huggingface dataset:
Effectiveness and safety of automatic capture management via remote monitoring system in left bundle branch area pacing
Authors: Yoshimoto D , Sakamoto Y , Yamaguchi R , Naganawa H , Suzuki T
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP) have been popular as physiological pacing procedures and, according to previous reports, both can decrease heart failure admission and preserve left ventricular ejection fraction compared to right ventricular pacing. In general, the physiological pacing has different pacing thresholds (e.g. pacing thresholds of His-bundle or left bundle and myocardium), but automatic capture management cannot diagnose these multiple pacing thresholds and automatic adjustments of ventricular pacing output based on automatic ventricular threshold tests may not achieve the appropriate HBP or LBBAP. Especially in HBP, a fixed pacing output is likely to be recommended to ensure the definite HBP, since HBP thresholds tend to increase over the long term.

Purpose

It has been reported that LBBAP thresholds are maintained lower than HBP thresholds. The aim of this study is to evaluate the safety and appropriateness of automatic capture management via a remote monitoring system in LBBAP patients.

Methods

Patients who underwent LBBAP from July 2019 to July 2022 were enrolled. The ventricular capture management used a 2x safety margin above the automatic ventricular pacing thresholds and a minimum pacing output of 2 V at 0.4 ms. Pacing thresholds were monitored using telemonitoring every month and pacing waveforms were evaluated during outpatient visits.

Results

Ninety patients with successful LBBAP were enrolled. LBBAP thresholds, R-wave amplitudes, and pacing impedances at implantation were 0.71±0.17 V at 0.4 ms, 16.4±6.7 mV, and 568±87.6 Ω, respectively, and the pacing QRS width was 128.8±16.8 ms. There was no significant difference between the pacing thresholds at the time of manual measurement during the outpatient visits and automatic measurement during the telemonitoring immediately before those visits, and all differences in pacing thresholds were less than 0.5 V at 0.4 ms. The median observation period was 481 days (range 215.75-685.5 days), and pacing thresholds, pacing outputs, and pacing QRS width at the last follow-up were 0.87 ± 0.30 V at 0.4 ms, 2.06 ± 0.21 V at 0.4 ms, and 129.3 ± 18.1 ms, respectively. One patient of lead dislodgement was detected 17 months after implantation and lead revision was performed. Another patient had a pacing threshold increase of more than 1V, but the function of automatic pacing output adjustment prevented pacing failure and LBBAP was maintained as well.

Conclusions

Automatic capture managements in LBBAP could be accurately and safety managed with a remote monitoring system.
Validation of a transthoracic impendance sensor for screening of sleep apnea in CIED patients: a pooled analysis of AIRLESS and UPGRADE
Authors: Barbieri F , Adukauskaite A , Spitaler P , Rubatscher A , Senoner T , Jacon P , Venier S , Pfeifer B , Pepin J L , Dichtl W , Defaye P
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Scientific grant support from the Boston Scientific Investigator Sponsored Research (ISR) Committee, Boston Scientific, St. Paul, MN, USA.

Background/Introduction

Cardiac implantable electronic devices and their integrated thoracic impedance sensors, meant to detect sleep apnea, are available for over a decade now. Despite its usage in daily clinical practice, there is only limited data on its diagnostic accuracy.

Purpose

To further validate an apnea sensor by using polysomnography (PSG) and investigate subgroups with potential differences in diagnostic accuracy.

Methods

AIRLESS and UPGRADE were prospective investigator driven trials meant to validate an apnea sensor. Patients, who either fulfilled the criteria for implantation of an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) or upgrading to CRT according to current guidelines were eligible for enrolment. Sleep apnea and its severity, measured by apnea-hypopnea index (AHI), were exclusively assessed by PSG. PSG was conducted in a time interval of 1 to 3 months post implantation of the device. For direct comparison, the apnea sensor derived respiratory disturbance index (RDI) was used from the identical night. Bivariate correlations (spearman coefficient) as well as the Bland-Altmann method were applied to assess diagnostic accuracy of the apnea sensor.

Results

Overall, 80 patients were analysed, out of whom the majority (n = 35, 43.8%) were diagnosed with central sleep apnea. Sixteen (20.0%) patients received a conventional ICD system, whereas 21 (26.3%) were implanted a CRT-P and 43 (53.8%) a CRT-D. Atrial fibrillation was known in 50.0% (n=40) of patients, 45 patients suffered from periodic leg movement syndrome (PLMS, 56.3%). In the overall cohort, the sensor derived RDI correlated significantly with the AHI (r = 0.61, p < 0.001) with a mean difference (MD) of -12.6 (95% CI -38.2 – 13.0). The sensor did specifically perform well in patients without atrial fibrillation (r = 0.80, p < 0.001; MD -9.0, 95% CI -30.4 – 12.5), while the presence of PLMS did not affect the accuracy of measurements (PLMS: r = 0.60, p = 0.007, MD -16.1, 95% CI -43.9 – 11.8 vs. no PLMS: r = 0.62, p = 0.001, MD -9.9, 95% CI -32.8 – 12.9). Furthermore, the RDI was found to correlate well in patients with central sleep apnea (r = 0.61, p = 0.013), although similar overestimation was observed (MD -11.6, 95% CI -35.4 – 12.2) as in other subgroups.

Conclusion

In an exclusive heart failure cohort, the apnea sensor did correlate well with the PSG derived AHI. Although similar correlation is found in most subgroups, there remains to be a decent overestimation of events.
Perioperative and postoperative pain in patients undergoing subcutaneous implantable cardioverter-defibrillator placement
Authors: Bisignani A , Biffi M , Caravati F , La Greca C , Tola G , Palmisano P , D'onofrio A , Nigro G , Sartori P , Notarstefano P , Vicentini A , Valsecchi S , Lovecchio M , Bisignani G
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

The recent Avoiding Transvenous Leads in Appropriate Subjects (ATLAS) Trial demonstrated that the subcutaneous implantable cardioverter–defibrillator (S-ICD) reduces lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain.

Purpose

To assess the perioperative and postoperative pain during S-ICD implantation in current clinical practice and evaluate the influence of implantation techniques.

Methods

We analyzed 255 consecutive patients (84% male, 52±16 years, body mass index 26±4 Kg/m², ejection fraction 42±16%) who had undergone S-ICD implantation from 2017 to 2022. The primary endpoint was pain during S-ICD placement. The secondary outcome measure included static and dynamic pain intensity 6 hours after the end of the procedure. Patients were asked to rate pain intensity on a 10-point visual analogue scale from 0 (no pain) to 10 (worst imaginable pain).

Results

The mean procedure duration was 62±22 minutes. The serratus anterior plane block (SAPB) was performed in 161 (63%) patients for anesthesia/analgesia, and 161 (63%) patients underwent the defibrillation testing. Implantation success was reported in all patients with no operative complications. In the overall group, the pain intensity was 2 [range: 1-8] during the implantation procedure, and 1 [1-7] for both static and dynamic pain, 6 hours after the end of the procedure. Significantly lower values were recorded during implantation in the SAPB group (p=0.010) and among those who did not undergo the defibrillation testing (p=0.008). The adoption of the SAPB (coefficient: -0.54, p=0.047) and the omission of defibrillation testing (coefficient: -0.70, p=0.028) remained associated with less pain during implantation after correction for age, sex, body habitus, ejection fraction. Six hours after the end of the procedure the static and dynamic pain intensity remained lower among those with omitted testing (p=0.018 and 0.004, respectively).

Conclusions

In current clinical practice, S-ICD implantation is associated with very little discomfort. The adoption of novel anesthetic techniques and the omission of defibrillation testing is associated with lower pain levels.
Automatic subcutaneous defibrillator screening in patients with intracardiac devices: comparative study depending on the point of pacing
Authors: Cabrera Borrego E , Molina Lerma M , Rivera Lopez R , Constan De La Revilla E , Alvarez Lopez M
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background/Introduction

Subcutaneous defibrillator (S-ICD) has been shown to be effective in the prevention of sudden cardiac death with the advantage of avoiding intravascular access. Although it should not be indicated when pacing indications exists, the need for pacing may arise in the course of underlying heart disease.

Before implantation, it is necessary to screen the surface electrocardiogram (ECG) to avoid inappropriate shocks due to overdetection. Published studies so far show a drastic reduction in the percentage of patients eligible for screening with conventional pacing techniques (right ventricular apex, right ventricular outflow tract or resynchronisation with coronary sinus pacing).

Purpose

The change in screening signal produced by cardiac pacing during is unknown. So far, no studies have been published comparing the outcome of S-ICD screening between different pacing sites, including conduction system pacing (CSP, his and left bundle branch pacing).

Our aim is to analyse the success rate of screening and its predictors in patients with cardiac pacing according to the pacing point.

Methods

A total of 102 patients were screened for S-ICD and divided into 5 groups according to pacing type: His bundle pacing (HBP), left bundle pacing (LBP), right ventricular apex (RVA), right ventricular outflow tract (RVOT) and biventricular cardiac resynchronisation (CRT). There were no significant differences in any variable between the HBP and LBP group, so they were unified as the CSP group. We used a control group of 10 healthy patients with no implantable devices or ECG abnormalities. All patients underwent automatic screening with paced rhythm using the automatic algorithm (Boston Scientific). We considered a suitable screening when at least one vector (primary, secondary or alternative) was positive in both decubitus and standing position, in left or right parasternal position.

Results

Baseline characteristics by group are summarised in table1. Paced QRS width was lower in the CSP group (135 [120-160] vs 120 [106-120] p=0,001). All healthy controls passed the screening (100%). 39 (97.5%) CSP patients passed the screening, compared to 15 (71.4%) CRT, 14 (70%) RVOT and 4 (19%) RVA. The differences were statistically significant, p < 0.001 (image 1 A & B).

In multivariate analysis, only pacing type was shown to be a predictor of positive screening (p 0.001), independent of paced QRS width.

Conclusions

In our experience, the probability of obtaining a positive screening of the S-ICD is higher with conduction system stimulation than with the other pacing points (AVD, RVOT or CRT).
A manual synchronous low energy shock impedance as a predictor of successful defibrillation testing during subcutaneous icd implantation
Authors: Lopez Perales C , Calvo Galiano N , Oloriz Sanjuan T , Diaz Cortegana F , Jauregui Garrido B , Soto Flores N , Santamaria Luna E , Rodriguez Pradas P , Ortas Nadal M R , Asso Abadia A
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Current guidelines recommend defibrillation testing (DFT) at the time of subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. Implant position, patient characteristics and device factors, such as shock impedance, can influence defibrillation success. In order to evaluate the shock impedance, a manual synchronous 10J shock (LESS) can be delivered, without the need to induce ventricular fibrillation (VF).

Purpose

Our objective was to compare LESS and DFT impedance values and to evaluate the diagnostic performance of LESS impedance for prediction of a successful DFT during S-ICD implantation.

Methods

Consecutive S-ICD implantations were included. Shock impedances were compared by paired t tests. Univariate analysis was performed to investigate factors associated with a successful first shock. A prediction model of successful DFT based on LESS impedance was assessed by logistic regression. Additionally, Receiver Operating Characteristic (ROC) curves and the Hosmer-Lemeshow test were used to evaluate its diagnostic performance.

Results

Sixty patients were included (52 ± 14. years; 69% male). There were no significant differences between LESS and DFT impedance values. Patients with a failed first shock had higher BMI (30±3 vs. 25.7±4.3, p = 0.014), higher mean LESS (120±35Ω vs 86. ± 23Ω, p= 0.0013) and DFT impedance (122±33Ω vs 87±24, p= 0.0013). ROC analysis showed that LESS impedance had a good diagnostic performance in predicting a successful conversion test (AUC 84% [95% CI: 0.72-0.92]) with a cutoff value of <94Ω to identify a successful DFT (sensitivity of 71%, specificity of 73%).

Conclusion

LESS impedance values without the need to induce VF can intraoperatively predict the chance of successful DFT.
Subcutaneous ICD therapy results in a similar quality of life compared with transvenous ICD therapy during both short- and long-term follow-up
Authors: De Veld J A , Delnoy P P H M , Olde Nordkamp L R A , Kuschyk J , Bonnemeier H , Bijsterveld N R , Boersma L V A , El Chami M F , Smeding L , Weger A , Richter S , Betts T R , Wright D J , Wilde A A M , Knops R E
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Boston Scientific

Medical device company St. Paul, Minnesota, USA

Introduction

The PRAETORIAN trial showed that the subcutaneous implantable cardioverter defibrillator (S-ICD) is noninferior to the transvenous ICD (TV-ICD) with respect to device-related complications and inappropriate shocks in a conventional ICD population. It is unknown whether there is a difference in quality of life (QoL) between the two patient groups. The generator size and implant location differ between both devices. This may cause a variation in mental health status and pain perception between treatment arms, in particular in older patients, patients with low BMI, and females.

Purpose

This prespecified analysis of the PRAETORIAN trial compares the impact of the S-ICD and TV-ICD on QoL.

Methods

In the PRAETORIAN trial, 849 patients were randomised to S-ICD (n=426) or TV-ICD (n=423) therapy. QoL was prospectively measured at baseline, discharge and 12 and 30 months after ICD implant, by measuring cardiac-specific physical functioning with the Duke Activity Status Index (DASI) and psychological and physical well-being with the 36-Item Short Form Health Survey (SF-36, divided in 8 subscales). Patients who completed the questionnaires at baseline were included in this analysis. At each time point the mean change in score from baseline was calculated. Subgroups were made based on age (tertiles, < 58, 58-67 and >67 years), BMI categories (<25, 25-30, and ≥30 kg/m2) and sex. In these subgroups, we only looked at differences in pain and mental health between arms. Treatment effects, 95% CIs and interactions were calculated by regression models.

Results

A total of 823/849 patients completed the QoL questionnaires at baseline. Questionnaires were also completed by these patients at discharge (92%), 12 months (85%) and 30 months (69%). There was no difference in QoL between the arms at any time point (p>0.05, figure). Age, BMI and sex were not associated with a difference between the arms in SF-36 subscale bodily pain (p=0.73, 0.72 and 0.92 respectively), or SF-36 subscale mental health (p=0.15, 0.39 and 0.76) at 30 months. Similar results were seen at discharge and 12 months.

Conclusion

There were no differences in QoL between S-ICD and TV-ICD treatment in the first 30 months after implant. In addition, no differences in pain and mental health were seen in older patients, patients with low BMI and females. These results confirm that the S-ICD is a good alternative for the TV-ICD.
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

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>70, Creatinine >1.4 mg/dl, QRS width >120ms, presence of AF, and NYHA >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 >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

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<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<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

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

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 < 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

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 < 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

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 >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

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

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

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.
Impact of right ventricular lead position on the outcomes of transvenous lead extraction
Authors: Miklos M , Zsigmond E J , Benak A , Makai A , Saghy L , Vamos M
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Transvenous lead extraction of apically positioned right ventricular (RV) leads could be more challenging compared to septal leads, however there is no scientific evidence regarding this issue. The aim of this study was to evaluate the impact of the RV lead position on extraction outcomes.

Methods

Data from consecutive patients undergoing transvenous lead extraction between 2014 and 2022 were retrospectively analysed. Extracted RV leads were divided into apical and non-apical groups, according to the preoperative chest X-ray images. Complete success rate of lead extraction was compared between the two groups.

Results

A total of 197 patients (mean age 65±14 years, 73,6% male, mean EF 50%) underwent transvenous lead extraction of 408 leads due to pocket infection (n=132, 67%), endocarditis (n=40, 20%), or non-infectious indications (n=25, 13%). 218/408 (53%) leads were right ventricular, of which 142 (65%) were extracted from an apical and 42 (19%) from a non-apical position, respectively. 34 cases (16%) with RV leads in both locations or RV leads previously pulled back from the right ventricle were excluded. There was no significant difference in the ratio of ICD leads or dual-coils between the two groups, however apical electrodes were older and had more frequently passive fixation compared to non-apical RV leads. Locking stylets, powered sheaths or snare technique were used in 88%, 82% and 30%, respectively, without any significant difference between the two groups.

The complete success rate of lead extraction was higher in the non-apical group compared to apical leads (97,7% vs. 83,2%) (Odds Ratio (OR) 0,12; 95% CI 0,16-0,92; p=0,04). After adjustment for typical risk factors of extraction failure (i.e. age of leads, ICD leads, dual-coils, passive fixation) the difference become non-significant (adjusted OR 0,24; 95% CI 0,03-2,08; p=0,19).

Conclusion

In this single-centre, high-risk patient cohort we found better success rate of RV lead extraction from non-apical positions compared to apical leads, without statistically significant difference on multivariate analysis. Our results are hypothesis generating, and call for further research evaluating the impact of the RV lead position on extraction outcomes with larger patient populations.
Complicated pocket infection in patients undergoing lead extraction - a new entity?
Authors: Milman A , Wieder-Finesod A , Zahavi G , Meitus A , Kariv S , Shafir Y , Glikson M , Luria D , Beinart R , Yahav D , Nof E
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Introduction

Cardiac implantable electronic device (CIED) infection can present with either pocket or systemic manifestations, both necessitating complete device removal and pathogen-directed antimicrobial therapy. However, some may present with both pocket and systemic infection. We aim to characterize those with complicated pocket infection.

Methods

A retrospective analysis of all CIED extraction procedures at our medical center from 07/2010 to 12/2018 was performed. Patients were divided to simple pocket infection, complicated pocket infection and systemic infection groups.

Results

A total of 300 patients were included; 104 (34.7%) had a simple pocket infection, 142 (47.3%) had a systemic infection alone and 54 (18%) presented with a complicated pocket infection. Most were males, with a similar mean age at time of extraction. No differences in comorbidities were observed, except for higher prevalence of diabetes (54.2%) in the systemic infection group (p=0.002).

Patients with a systemic and complicated pocket infection presented more frequently with leukocytosis and fever > 37.8, as opposed to the simple pocket infection group. Staph Aureus was the most common pathogen in the systemic and complicated pocket infection groups (43.7% and 31.5% respectively) while CONS predominated (31.7%) for the simple pocket infection group (10.6%, p<0.001). No differences were observed in procedural success rates or complications of the extraction procedure.

Kaplan Meier survival analysis showed that at 3 years of follow-up the rate of all-cause mortality was significantly higher among patients with systemic infection compared to both pocket infection groups which were similar (p<0.001), with the curves diverging at 30 days. Multivariate analysis demonstrated high creatinine and lower albumin were predictors of 30 days and 1 year mortality while age and the presence of atrial fibrillation were predictors of 1 year mortality only.

Conclusions

We characterize a new entity of a complicated pocket infection. Albeit the similarity to the systemic infection group regarding clinical manifestation, those with complicated pocket infection carry a better prognosis than those with systemic infection alone.
Appropriate therapy for implantable cardioverter defibrillators used as primary versus secondary prophylaxis
Authors: Thuraiaiyah J , Jensen A S , Philbert B T , Sondergaard L , Jons C
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Implantable cardioverter defibrillators (ICD) are used for primary prevention in children highly suspicious of life-threatening arrhythmias due to family history and malignant syncope. This practice might potentially result in a lower incidence of appropriate therapy compared with ICDs implanted for secondary prevention following documented ventricular arrhythmias.

Purpose

We aimed to compare the rate of appropriate therapy after ICD implantation for primary versus secondary prevention in young children.

Method

Using national ICD registry, this retrospective nationawide cohort study included children aged ≤15 years who received their first ICD between 1988 and 2020. Patient characteristics, medical history including mortality, device indication, therapy and complications were retrieved from electronic medical files. The primary endpoint was time to appropriate therapy, defined as shock or anti-tachycardia pacing for ventricular tachycardia or fibrillation.

Results

During the study period, a total of 81 ICDs (39 ICDs pr. million live births) were implanted. Among these, 79 were included in the outcome analysis due to retrievable follow-up data. At baseline, the majority had channelopathies (44%) or structural heart diseases (42%), whereas 25 (32%) and 54 (68%) devices were implanted as primary and secondary prophylaxis, respectively. The median age at primary implantation was 13.9 and 11.6 years (p<0.05), respectively. During a median follow-up of 9.0 (IQR: 4.8–13.9) years, 44 patients experienced appropriate device therapy and 6 died, with no difference for primary and secondary prevention recipients (p=0.34 and p=0.83). The 10-year cumulative incidence of appropriate therapy was 56% for primary prevention recipients and 68% for secondary prevention recipients, whereas 10-year survival probability was 90% (95% CI: 76-100%) and 81 % (95% CI: 63%-99%), respectively. All deaths were of cardiovascular cause. Bleeding occurred in 0 versus 2, infection in 5 versus 4, and inappropriate shock therapy in 2 versus 11 patients, with an overall combined trend towards more events for ICDs implanted as secondary prophylaxis (p=0.08).

Conclusions

ICD implantation in young children was relatively rare. The rate of appropriate therapy was similar among primary and secondary ICD recipients, indicating too restrictive primary prophylaxis implantation, which should be investigated in future studies. The incidence of complications was highest among secondary ICD recipients.