bluuebunny/crossref_metadata_2025_split huggingface dataset:
Almost zero-fluoroscopy LBBP-procedure using a 3D-mapping system
Authors: Derndorfer M , Puererfellner H , Martinek M R , Kollias G 
Published: October 2022

Abstract

Introduction
Cardiac device therapy has recently been extended by the option of Conduction System Pacing, CSP (HIS Bundle Pacing, HBP; Left Bundle Branch Area Pacing, LBBAP). Similar to cardiac resynchronization therapy (CRT), complex procedures can result in long fluoroscopy-duration and considerable radiation exposure for the patient and the implanting team. According to the principle ALARA (As Low As Reasonably Achievable), measures should be taken to reduce radiation, wherever possible.
We report the almost fluoroscopy-free implantation of a LBBAP-system using a 3D electroanatomical mapping system (EAMS).
The patient was indicated for a pace & ablate concept due to recurrent, highly symptomatic, persistent atrial fibrillation (AF), a history of mitral valve repair and a severely dilated left atrium. ESC guidelines suggest choosing a RV-lead (indication IIa), alternatively either a CRT system or HBP (both IIb). LBBAP as new option for physiological pacing was chosen in this patient because it usually provides excellent stimulation thresholds and the lead – in contrast to HBP – is distant from Koch's triangle, so that AV-nodal-ablation can be performed safely.

Methods
Surgery was performed under deep sedation. After accessing the cephalic vein, a quick 3D map of relevant structures was acquired (right atrium; coronary sinus; HIS; interventricular septum, IVS). Then a preformed sheath and a stylet-driven pacemaker-lead were advanced. The lead-tip was visualized within the EAMS and maneuvered without fluoroscopy. After approaching the proximal IVS, the implantation site was confirmed by unipolar stimulation and the lead was advanced into the IVS under close monitoring of impedance and signals. Final position was confirmed by sheath-angiography [Fig. 1].

Results
During lead fixation, LBBAP-typical ECG-changes (progression to rSR morphology, fixation beats) could be observed. A left bundle branch potential (poLBB) could be documented. The left ventricular activation time (LVAT) as a marker of rapid LV-excitation was shortened from 108 ms to 68 ms. Thresholds for non-selective and selective LBBP were 3 V @ 1 ms and 0.7 V @ 0.4 ms, with a sensing of 8.7 mV, impedance of 643 ohms and a paced QRS-width of 112 ms [Fig. 2]. An atrial lead was added (history of intermittent sinus rhythm) and a dual-chamber pacemaker was connected. Fluoroscopy was required for lead fixation into the IVS, atrial lead placement as well as for sheath angiography and lead length-optimization. Total fluoroscopy time was 1.13 minutes with a radiation dose of 45.04 μGy m2, procedure time 64 minutes. AVN total ablation was performed the following day without complications.

Conclusions
CSP using a 3D mapping system is simple, facilitates understanding of important anatomical structures and helps to reduce the required radiation dose to a necessary minimum. In individual cases, procedures requiring almost zero-fluoroscopy are possible.

Funding Acknowledgement
Type of funding sources: None.
Safety and effectiveness of His-bundle pacing and left bundle branch pacing (conduction system pacing) as a first option for cardiac pacing – results of a single-center
Authors: Slater C , Camanho L E M , Saad E B , Inacio Jr L A O , Dias L C , Santos G V , Mourilhe-Rocha R 
Published: October 2022

Abstract

Background
Conduction system pacing (CSP) (His bundle pacing and left bundle pacing) is a group of techniques intended to achieve cardiac pacing with a narrow QRS complex through a lead directly inserted in conduction system structures. The safety and effectiveness of this technique are not yet fully understood.

Purpose
To describe the short-term implant findings and safety profile of CSP as a first option after 4 years in a single center.

Methods
In a period of 42 months, 214 patients were submitted to CSP as a first strategy to restore AV synchrony (pacemakers for AV block or sinus node dysfunction) or as a resynchronization (CRT) strategy (for patients with heart failure and bundle branch block). CSP lead was implanted in lieu of a conventional right ventricular lead in pacemaker cases, and in addition or in lieu of a coronary sinus lead, in CRT cases, depending on the technical and anatomical possibilities.

Results
The mean age was 76.7±16.4 years, 65% males. 162 patients implanted a CSP lead for a dual-chamber pacemaker, 3 patients for a single chamber pacemaker, 32 patients for CRT-D (CSP lead replacing the coronary sinus lead with a defibrillator), and 13 patients for an optimized CRT (CSP lead plus coronary sinus lead). In 16 patients (7.4%) the technique of choice was His bundle pacing, two of them presented with subacute elevated thresholds, requiring new lead implantation at the moment of generator pulse replacement. One patient submitted to left bundle branch pacing (0.4%) had subacute lead dislodgement, being submitted to lead revision. Four patients intended for CRT (1.8%) didn't meet the criteria for His bundle pacing or left bundle branch pacing, being submitted to conventional coronary sinus lead placement. There were 10 cases (4.6%) of confirmed lead perforation during the lead septum insertion, with prompt repositioning, all uneventful. No pericardium effusion related to lead perforation was observed. One patient (0.4%) had a pneumothorax, requiring chest tube drainage.

Conclusion
Conduction system pacing as a first strategy is a feasible, effective and safe technique, both for pacing and for resynchronization purposes, with a complication rate comparable to conventional implantation.

Funding Acknowledgement
Type of funding sources: None.
Effects of hyperbaric exposure on mechanical and electronic parameters of implantable cardioverter-defibrillators
Authors: Guenneugues R , Henckes A , Mansourati V , Mansourati J 
Published: October 2022

Abstract

Aims
There is currently no adequate assessment of the mechanical and electronic alterations of implantable cardioverter-defibrillators (ICD) in hyperbaric conditions. As a result, many patients eligible for hyperbaric oxygen therapy cannot receive it if they are carrying an ICD, even in emergency situations. Hyperbaric oxygen therapy (HBOT) is the standard adjuvant treatment for life-threatening or disabling pathologies.

Methods
Twenty-two explanted ICDs of various brands and models were randomized in 2 groups: single hyperbaric exposure at an absolute pressure of 4,000 hPa and 30 iterative hyperbaric exposures at an absolute pressure of 4,000 hPa. Mechanical and electronic parameters of these ICDs were blindly assessed before, during and after hyperbaric exposures.

Results
Regardless of the hyperbaric exposure, we could not find any mechanical distorsion, inappropriate occurrence of tachytherapies, dysfunction of tachyarrhythmias therapeutic programming, or dysfunction of programmed parameters.

Conclusion
Dry hyperbaric exposure seems harmless on ICDs tested ex-vivo. This result may lead to a reassessment of the absolute contraindication of emergency HBOT to patients carrying an ICD. A real-life study in patients with ICD receiving HBOT should be performed to assess their tolerance to the treatment.

Funding Acknowledgement
Type of funding sources: None.
Utilization and in-hospital complications associated with implantation of dual versus single chamber implantable cardioverter defibrillator for primary prevention of sudden cardiac death
Authors: Margolis G , Elbaz Greener G , Kazatzker M , Meisel S , Kleiner Shochat M , Heist E K , Ruskin J , Amir O , Roguin A , Rozen G 
Published: October 2022

Abstract

Introduction
Multiple studies showed no clinical benefit in implantation of a dual compared to a single chamber implantable cardioverter defibrillator (dICD vs. sICD) for primary prevention of sudden cardiac death (SCD), in patients with no pacing indication. We aimed to investigate the extent of utilization and complications in sICD vs. dICD implantations in the US, using the National In-Patient Sample (NIS) database.

Methods
Using the NIS database, we identified patients who underwent an elective ICD implantation in the US between 2015 (last quarter)-2019. Patients who had concurrent conduction disorders or indication for atrial pacing were excluded. Baseline demographics, clinical characteristics, cardiomyopathy etiologies as well as outcomes including in-hospital complications, length of stay and mortality were collected. Multivariable logistic regression models were used to identify predictors of complications.

Results and discussion
An estimated total of 15940 patients, who underwent elective ICD implantation for primary prevention of SCD were identified, 8860 (55.6%) of them received a dICD. Forty percent of patients had ischemic cardiomyopathy. The mean age was 64 years and 66% were males. The complication rates documented in the dICD and sICD groups were 13% and 11%, respectively (p&lt;0.001),driven by increased rate of pneumothorax (4.8% vs 3.2%, p&lt;0.001) and lead dislodgement (3.6% vs 2.3%, p&lt;0.001, Table 1). Multivariate analysis confirmed adding an atrial lead as an independent risk factor for “any complication” during ICD implantation [OR 1.13 (1.02–1.25), p=0.022] as well as for pneumo/hemothorax [OR 1.21 (1.03–1.44), p=0.025] and lead dislodgement [OR 1.41 (1.16–1.72), p&lt;0.001].

Conclusion
Despite significant evidence for lack of clinical benefit in adding an atrial lead to a primary prevention ICD implantation, significant proportion of the patients in the US are implanted with a dICD. We show increased risk for complications for dICD compared with sICD implantation in the US in recent years, driven by higher incidence of pneumo/hemothorax and lead dislodgement.

Funding Acknowledgement
Type of funding sources: None.
Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case-control study
Authors: Botto G L , Ziacchi M , Nigro G , D'Onofrio A , Dello Russo A , Francia P , Viani S , Pisano' E , Bisignani G , Caravati F , Migliore F , De Filippo P , Ottaviano L , Valsecchi S , Checchi L 
Published: October 2022

Abstract

Background
A previous randomized study (PRAETORIAN) demonstrated that the subcutaneous implantable cardioverter–defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket.

Purpose
To compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with a SC pocket.

Methods
We analyzed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. SC patients were propensity-matched with patients of the IM group, and their outcomes were compared.

Results
SC implantations were performed in 367 (23%) patients. These patients were propensity-matched with 367 IM patients. Intra-procedural complications were reported in 9 (2.5%) patients in the SC Group and 7 (1.9%) in the IM Group. During a median follow-up of 29 months, device-related complications were reported in 55 (7.5%) patients and inappropriate shocks were reported in 54 (7.4%) patients. The risk of the composite primary endpoint was lower in the matched IM Group than in the SC Group (unadjusted hazard ratio 0.67, 95% CI 0.45–0.99, p=0.042), while the risk of appropriate shocks was similar between groups (unadjusted hazard ratio 0.99, 95% CI 0.60–1.64, p=0.976). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, ejection fraction and generation of the device.

Conclusions
In this experience, IM S-ICD generator positioning was superior to SC positioning in reducing device-related complications and inappropriate shocks.

Funding Acknowledgement
Type of funding sources: None.
Driving restrictions following defibrillator implantation significantly affect recipients' ability to maintain employment
Authors: Bjerre J , Hansen M H , Schou M , Rasmussen T B , Ruwald A C 
Published: October 2022

Abstract

Background
Following defibrillator implantation or in case of ICD therapy, ICD recipients are subject to temporary driving restrictions for private driving. Moreover, the current European recommendations permanently ban professional driving which can significantly alter the recipients' daily life and ability to maintain employment.

Aim and methods
To investigate Danish ICD recipients' perspective on driving restrictions following ICD implantation we distributed a questionnaire to all living ICD patients with a first-time implantation between 2013 and 2016 (n=3913). We linked questionnaire responses with relevant nationwide Danish registers.

Results
Among the 2741 ICD recipients who responded to the questionnaire (response rate 71%, 47% primary prevention, 83% male, median age 67 years), 2513 (92%) held a valid private driver's license at time of implantation and 175 (7%) were actively using a professional driver's license. Almost all (n=2344, 94%) had resumed driving following device implantation. Among those with a driving ban of at least 1 month following either ICD implantation or ICD therapy (n=911), 26% stated the restrictions had severely impeded their daily life, significantly more in the professional drivers group compared with the private drivers (32% vs 24%, p=0.01). Including only patients working prior to implantation (n=465), 27% stated they were very limited and 20% somewhat limited in maintaining employment following implantation due to the driving restrictions. Likewise, 23% were very limited and 19% somewhat limited in getting to their job. Among the active professional drivers (n=175), 58 (33%) stated they had lost their job as a direct consequence of the post-implantation driving restrictions.

Conclusion
Every fourth Danish ICD recipient is severely limited in their daily life due to the driving restrictions. Both professional and private drivers are significantly affected with regards to maintaining employment following implantation, which should be a key focus in rehabilitation programs.

Funding Acknowledgement
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): The Danish Heart Foundation and Arvid Nilssons Fond
Strategic management to optimize response to cardiac resynchronization therapy registry
Authors: Garcia Bolao I , Gras D , D'Onofrio A , Mark G , Nair D , Lellouche N , Novak M , Lo R , Chew E , Wright D , Kaplan A , Veraghtert S , Hu Y , Yong P , Gardner R S 
Published: October 2022

Abstract

Background
Cardiac resynchronization therapy (CRT) is guideline-recommended for the treatment of symptomatic heart failure (HF) in patients (pts) with reduced LVEF and prolonged QRS. Clinical trials report Clinical Composite Score (CCS) response rates from 60 to 75%. However, patients with common comorbidities, such as atrial fibrillation, are often under-represented in clinical trials. The Strategic MAnagement to optimize response to cardiac Resynchronization Therapy (SMART) Registry (NCT03075215) was designed to examine outcomes in CRT patients in the real world.

Methods
The SMART Registry was a global, multicenter, prospective, clinical registry that enrolled subjects undergoing a de novo CRT-D implant or upgrade from pacemaker to CRT-D using a quadripolar LV lead. CCS was assessed at 12 months post-implant.

Results
For study design and CCS outcomes see Figure 1. CCS at 12 months showed that 58.8% of pts improved and 20.1% stabilized. Of the 21.1% of pts that worsened, 8.4% were due to death, 7.8% non-fatal heart failure event, and 5% worsening of NYHA or patient global assessment. Notably, this registry had a high prevalence of pts with NYHA I/II (51%), Non-LBBB (50%), AF (37%), diabetes (35%), and bradycardia (31%) at baseline. Age (&gt;65), diabetes, ischemia, non-LBBB, atrial fibrillation (AF) and renal dysfunction correlated with worsened CCS outcomes. NYHA III/IV patients had significantly higher HF hospitalization (HFH) rates than NYHA I/II (P-value &lt;0.001) (Figure 2a) and patients with AF had higher HFH rates than those without (P-value &lt;0.001) (Figure 2b). Similar effects of NYHA score and AF were seen on mortality. The use of ACE/ARB, or ARNI, and MRA correlated with better outcomes, whereas diuretics and anticoagulants correlated with poorer outcomes.

Conclusions
In this large registry, clinical outcomes across important sub-populations are in line with expectations, with older age, ischemia, renal dysfunction, AF, non-LBBB, and diabetes associated with a lower likelihood of response to CRT. By including these patients, this study provides a clearer picture of the effectiveness of CRT in the real world. Future studies should examine optimization approaches to facilitate CRT effectiveness in these under studied patient populations.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): This registry was funded by Boston Scientific (BSC)
A systematic review and meta-analysis of upgrade to biventricular or conduction system pacing approaches
Authors: Kaza N , Htun V , Miyazawa A , Simader F , Porter B , Howard J P , Arnold A , Francis D P , Whinnett Z I , Shun-Shin M J , Keene D 
Published: October 2022

Abstract

Introduction
Chronic RV pacing has been recognised as being harmful to cardiac function. Patients undergoing a de novo pacemaker implant with even mild LV impairment are recommended to instead receive a physiological pacing strategy (biventricular or conduction system pacing [CSP]). No corresponding guideline recommendation exists for patients who already have a pacemaker.

Methods
We undertook a random-effects meta-analysis of all RCTs and observational studies covering device upgrade to biventricular pacing or conduction system pacing.

Results
6 RCTs assessing effect of upgrade to BiV pacing randomising 161 patients were eligible for analysis. Eligible observational studies included 46 of BiV upgrade and 7 of CSP upgrade totalling 2795 patients.
Mean LVEF improved by +8.3% from 34.4% in BiV upgrade RCTs (p=0.001) and +8.3% from 25.7% in BiV upgrade observational studies (p&lt;0.001).
In observational studies of upgrade to CSP, LVEF increased by +10.1% from 38.4% (p=0.001) despite less severe LV impairment at baseline (p=0.004 vs mean EF in BiV RCTs and p&lt;0.0001 vs mean EF in BiV observational studies).
LVESV decreased significantly by −25.4 ml, −23.7 ml, and −19.8 ml in BiV RCTs, BiV observational studies and CSP observational studies. Significant changes were also seen in NYHA class (decreased by −0.4, −0.8 and −1.0 respectively).
Minnesota Heart Failure Score (−6.9 points) and peak oxygen uptake (+1.1 ml/kg/min) increased significantly in RCTs of BiV upgrade. This was also seen in observational studies of BiV upgrade (−21.0 points and +2.63 ml/kg/min respectively).

Conclusions
RCTs and observational studies of upgrade to BiV pacing show significant physiological and symptomatic benefit. Observational studies of CSP upgrade show similar benefit with significant improvements in LVEF, LVESV and NYHA class in patients with an even milder degree of baseline LV impairment.

Funding Acknowledgement
Type of funding sources: None.
Cardiac implantable electronic device infections: prognostic value of the PADIT score and its cost-utility implications for antimicrobial envelope use in the United Kingdom
Authors: Mahtani K , Maclean E , Honarbakhsh S , Bhuva A , Finlay M , Creta A , Earley M J , Zemrak F , Moore P , Muthumala A , Sporton S , Schilling R J , Hunter R J , Monkhouse C , Chow A 
Published: October 2022

Abstract

Background
The incidence of cardiac implantable electronic device (CIED) infections is rising.

Purpose
We examined the factors associated with CIED infection, assessed the prognostic power of the PADIT risk score, and modelled the cost-utility of selective TYRX antimicrobial envelope use for preventing CIED infections.

Methods
Data were extracted from 2016 to 2019, and included all de novo implants, generator changes and lead interventions for transvenous CIEDs at a high-volume UK centre. CIED infection was defined as hospitalisation for device infection within 12 months of a procedure. Cost-utility analysis was informed by standardised tariffs, and quality adjusted life year (QALY) and efficacy data was extrapolated from analysis of the WRAP-IT trial.

Results
6,035 patients underwent 7,383 procedures; CIED infection occurred in 59 individuals (0.8%). In addition to the constituents of the PADIT score, lead extraction (HR 3.3 (1.9–6.1), p&lt;0.0001), C-reactive protein &gt;50mg/l (HR 3.0 (1.4–6.4), p=0.005), re-intervention within two years (HR 10.1 (5.6–17.9), p&lt;0.0001), and procedure duration over two hours (HR 2.6 (1.6–4.1), p=0.001) were independent predictors of infection. Increased PADIT score was strongly associated with infection (AUC: 0.82, HR per point increase: 1.36 (1.27–1.47), p&lt;0.0001). A cost-utility model assigning TYRX envelopes to patients with PADIT scores ≥6 predicted a reduction in infections (number needed to treat: 72) and a cost per QALY gained within the UK's (NICE) cost-effectiveness threshold (£25,107).

Conclusions
The PADIT score was a powerful predictor of CIED infections in a heterogeneous population,and may facilitate cost-effective TYRX envelope allocation in selected high-risk patients.

Funding Acknowledgement
Type of funding sources: None.
Influence of lead extraction on tricuspid valve function
Authors: Polewczyk A , Jachec W , Nowosielecka D , Tomaszewski A , Brzozowsk W , Szczesniak-Stanczyk D , Duda K , Kutarski A 
Published: October 2022

Abstract

Background
Transvenous lead extraction (TLE) is the main part of contemporaneous lead management strategy. Connecting tissue scar surrounding the lead and binding of it to heart structures creates risk venous or cardiac wall injury with severe bleeding or severe damage of tricuspid valve (TV)

Purpose
The aim of the study was to determine circumstances of appearance and risk factors of TV damages (TVD) and the influence of TVD on long term mortality

Methods
This post-hoc analysis used clinical data of 2693 patients who underwent transvenous lead extraction between 2007and 2021 in three high-volume center. Based on the transthoracic (TTE) and transesophageal echocardiography (TEE), the function of the tricuspid valve before and after TLE was compared, and the potential risk factors for TVD as well as the long-term survival of patients after TLE were assessed

Results
In most procedures (82.0%), TLE had no effect on TV function, in 9.5% different severity of tricuspid regurgitation (TR) was noted, significant deterioration occurred in 2.5% patients. The most important risk factors of TV damage were: young age of patient, long implant duration, multiple leads, abnormal heart lead route and procedure complexity. TVD was often seen in patients with normal left ventricular ejection fraction (LVEF &gt;50% in 73,1% patients), strong adhesion of the lead with the heart structures (46,4%), and abnormal loop of the lead irritated TV (28,8%). The long-term mortality of patients with significant worsening of tricuspid valve function during TLE was comparable to that in patients without TVD (6,0% vs 14,4%; p=0,06).

Conclusions
Significant tricuspid valve dysfunction during TLE is relatively rare in an experienced center. The main echocardiographic predictors of significant TVD during TLE is the presence of intense connective tissue adhesions binding the lead to the heart structures related to long lead dwell tome. Significant TLE related TVD has no clear influence on long-term survival after lead extraction.

Funding Acknowledgement
Type of funding sources: None.