bluuebunny/crossref_metadata_2025_split huggingface dataset:
Preliminary results from a single-center registry of left bundle branch area pacing with the use of classic, non-dedicated electrodes, without the use of additional sheaths
Authors: Ludwik B , Labus M , Spikowski J , Roleder T 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Introduction
In recent years, interest in left bundle branch area pacing (LBBAP) has been growing. The vast majority of reports concern procedures performed with the use of a dedicated set of equipment - a sheath and an electrode.

Purpose
The aim of the study was to assess the possibility of using classical electrodes with active fixation, used for years, for stimulation of the left bundle branch, without the use of dedicated sheaths, which could allow the routine introduction of LBBAP in each patient without the need for preliminary qualification before the procedure.

Methods
These are preliminary results from a single-center, prospective registry of pacemaker, cardioverter-defibrillator and CRT-D implantation procedures from February to November 2022. Routine patients were enrolled in the registry. Abbott's Tendril STS electrodes were used for successful LBBAP. In all procedures only suitably shaped mandrills were used without any additional sheaths.

Results
113 people (age 72.6 ± 13.8, 44 women) were included in the registry in the given period. Successful LBBAP was achieved in 107 (94,7%) patients, including 15 patients initially qualified for CRT-D. LBBAP was abandoned in 6 patients mainly due to problems with finding the optimal implantation site. The average time of mapping and effective fixation of the electrode was 21.7±14.7 minutes, x-ray time (whole procedure): 10:08±5:36 minutes, procedure time: 62,9±21,2 minutes, pacing threshold: 0.57±0.34V/0.4ms, sense: 9.5±4.5mV, resistance: 485±130 Ohms, RWPT: 74±12ms, interpeak (time between peak V6 and V1): 47±15ms. No important adverse events have been observed, nor problems with stimulation in follow-up.

Conclusions
Preliminary results of LBBAP using classic electrodes without the use of dedicated equipment show results comparable to those achieved with dedicated electrodes and sheaths, which may facilitate the use of LBBAP as a routine stimulation method in most patients.
Long-term safety and efficacy of leadless pacemakers in the Dutch cohort
Authors: Breeman K T N , Oosterwerff E F J , De Graaf M A , Juffer A , Saleem-Talib S , Maass A H , Wilde A A M , Boersma L V A , Remanna H , Van Dijk V F , Van Erven L , Delnoy P P H M , Tjong F V Y , Knops R E 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Leadless pacemakers (LPs) were designed to circumvent pocket- and lead-related pacemaker complications. Up to two years after implantation, adequate real-world safety and efficacy have been demonstrated. Because the duration of pacemaker therapy is well over two years, longer-term data is warranted for the net clinical benefit of leadless pacing.

Objective
Our aim was to evaluate the safety and efficacy of LP therapy on the long-term in a real-world cohort.

Methods
In this retrospective cohort study, all consecutive patients were included with a first LP implantation (Nanostim LP or Micra VR LP) from December 21, 2012 to December 13, 2016 in 6 Dutch high-volume centers. The primary safety endpoint was the rate of procedure- or device-related major complications at 5-year follow-up. Analyses were performed with and without the Nanostim battery advisory-related complications. The efficacy is described as pacing threshold, impedance and R-wave amplitude over time; changes in these parameters were assessed using mixed models.

Results
179 patients were included (117 [65%] male, mean age 79±9 years), of whom 93 (52%) with a Nanostim and 86 (48%) with a Micra LP. Mean follow-up duration was 45±25 months. A total of 46 major complications occurred, of which 8 not advisory-related. The 5-year major complication rate without advisory-related complications was 4.5% (Figure, A). Including advisory-related complications, the 5-year major complication rate was 30.5%. Not advisory-related complications included dislocations (n=3, of which 2 periprocedurally), pericardial effusion (n=1), groin bleeding (n=1), loss-of-capture (n=2) and pacemaker syndrome (n=1). Reinterventions were required in 7/8 (88%), only prolonged hospitalization in 1 (12%; the groin bleeding), and surgery in none. All 8 occurred within 90 days after implantation. Pacing threshold was stable over time (p=0.53), R-wave amplitude increased (p=0.002), and impedance decreased (p&lt;0.001) (Figure, B).

Conclusion
The long-term major complication rate excluding advisory-related complications was low. Especially few complications occurred after the acute phase, which may be a specific benefit of LP therapy. The performance was adequate with a stable pacing threshold over time, whereas in transvenous pacemakers usually a gradually increasing threshold is seen. These findings confirm previous safety and efficacy results and are promising for longer-term data on leadless pacing.
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

Abstract

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

Abstract

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 &lt; 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 &lt; 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

Abstract

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

Abstract

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 &lt; 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

Abstract

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 &lt;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

Abstract

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, &lt; 58, 58-67 and &gt;67 years), BMI categories (&lt;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&gt;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.