bluuebunny/crossref_metadata_2025_split huggingface dataset:
Leadless or conventional transvenous ventricular permanent pacemakers: a nationwide matched control study
Authors: Bodin AB , Clementy NC , Bisson ABI , Pierre BP , Herbert JH , Babuty DB , Fauchier LF 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.
Introduction / Background
Leadless ventricular permanent pacemakers (leadless VVI, LPM) were designed to reduce lead-related complications of conventional VVI pacemakers (CPM).

Purpose
The aim of our study was to assess and compare real-life clinical outcomes within the first 30 days and during a mid-term follow-up with the two techniques at a nationwide level.

Methods
This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults (age ≥18 years) hospitalized in French hospitals From January 1, 2017 to September 1, 2020, who underwent a first LPM or CPM implantation were included.

Results
Of 42,315 patients included in the cohort, 40,828 patients (96%) had a CPM and 1,487 had a LPM. Using propensity score, 1,344 patients with CPM were adequately matched in a 1:1 fashion with LPM patients.
Clinical outcomes at day 30
In the unmatched population, within the 30 days after implantation, patients with LPM had a lower rate of all-cause mortality (OR: 0.635, 95%CI: 0.527-0.765, p &lt;0.0001) and from a cardiovascular cause (OR: 0.568, 95%CI: 0.405-0.797, p = 0.001). They also had lower rates of major bleeding and need for transfusion. There was no significant difference between groups regarding tamponade, pneumothorax or hemothorax.
In the matched population, LPM implantation was still significantly associated with a lower rate of all-cause death (OR: 0.583, 95%CI: 0.456-0.744, p &lt; 0.0001), cardiovascular death (OR: 0.413, 95%CI: 0.271-0.629, p &lt; 0.0001) or transfusion (OR: 0.481, 95%CI: 0.296-0.780, p &lt; 0.0001). However, tamponade, pneumothorax or hemothorax and major bleeding were not significantly different between the two groups.
Clinical outcomes during mid-term follow-up
In the unmatched patients, mean follow-up was 8.6 ± 10.5 months. Annual incidence of all-cause death was high in both groups, and significantly higher in the LPM group than in CPM group (31%/year vs. 20%/year, p &lt; 0.0001) with a HR of 1.519 (95%CI: 1.296-1.780). Cardiovascular death was not significantly different between groups. Infective endocarditis was higher in the LPM group than in the CPM group with a HR of 2.108 (95%CI: 1.119-3.973). In the matched patients, mean follow-up was 6.2 ± 8.7 months. All-cause death, cardiovascular death and infective endocarditis were not significantly different between groups.

Conclusion
Patients treated with leadless VVI pacemakers had better clinical outcomes in the first month compared to the patients treated with conventional VVI pacing. During a mid-term follow-up, risk of all-cause death, cardiovascular death and endocarditis in patients treated with leadless VVI pacemaker was not statistically different after propensity score matching.
Five year outcomes of the subcutaneous implantable cardioverter-defibrillator EFFORTLESS (evaluation of factors impacting clinical outcome and cost effectiveness of the S-ICD) registry
Authors: Lambiase P , Theuns DAMJ , Murgatroyd FD , Barr CS , Eckardt L , Neuzil P , Scholten MF , Hood MA , Kuschyk J , Brisben A , Carter N , Knops RE , Boersma LVA 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Boston Scientific

OnBehalf
EFFORTLESS Registry

Introduction
Patients (pts) implanted with transvenous (TV) implantable cardioverter-defibrillator (ICD) experience complications (Cx) associated with TV leads and inappropriate shocks (IAS) for atrial fibrillation (AF) or other supraventricular tachycardias (SVT). The EFFORTLESS S-ICD Registry is a 5-year (yr) follow-up (f/u) study of pts implanted with the subcutaneous ICD (S-ICD).

Purpose
To report on the 5-yr outcomes of pts with a wide range of S-ICD indications implanted with early generation devices.

Methods
Pts were enrolled at 43 centers February 2011-December 2014. Kaplan-Meier Cx, appropriate shock (AS), and IAS rates are reported.

Results
994 pts (495 retrospective) were enrolled in the EFFORTLESS study and 984 pts (28% female, 48 ± 17 yrs, BMI 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Mean study f/u was 4.4 ± 1.6 yrs. The pt cohort had diverse etiologies: 31% ischemic heart disease, 19% non-ischemic cardiomyopathy, 11% hypertrophic cardiomyopathy, 17% channelopathies, and 20% of pts miscellaneous. Total system- and procedure-related Cx (table) were 9.4% at 5 yrs. AS and IAS rates at 5 yrs were 15.9% and 16.9%, respectively and the IAS rates for AF/SVT and t wave oversensing were 3.1% and 5.8%, respectively. More pts experienced Cx and IAS in the first yr than in yrs 2-5 altogether (8.7 vs 8.2%), the most common as a result of discomfort/erosion (38%), IAS (26%), system infection (9%), and premature battery depletion (9%). Of these late Cx, 74% were experienced by retrospective pts. Spontaneous conversion efficacy for the first shock and final shocks was 89.7% and 97.7%. Of the 91 (9.2%) deaths reported, none were associated with the S-ICD system or procedure. Cause of death was cardiac for 40 pts, non-cardiac for 40 pts, other for 4 pts, and unknown for 7 pts. Only 20 (2.0%) pts had their S-ICD replaced for a TV device for pacing: 4 bradycardia, 7 anti-tachycardia, and 9 for biventricular pacing.

Conclusions
The EFFORTLESS registry provides 5-year follow-up for a diverse, large, multinational S-ICD registry. Complications primarily occurred in the first year but remained low through 5 years. Inappropriate shock rates were typically observed in older generation devices prior to introduction of the SMART Pass filter. Replacement for TV-ICD due to the need for pacing was rare. Outcome 30 day 1 yr 2 yr 3 yr 4 yr 5yr Annual Complications (Kaplan-Meier) 2.0 5.3 6.8 7.6 8.6 9.4 1.9 IAS, overall (Kaplan-Meier) 1.7 8.7 11.6 13.1 14.6 16.9 3.4 IAS, t wave oversensing 3.4 5.8 1.2
Predictors of success and complications in laser lead extraction
Authors: Madej T , Matschke K , Knaut M 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Extraction of cardiac implantable electronic device (CIED) leads using excimer laser is in use since &gt; 20 years, but the predictors of success, all-cause complications and mortality are not yet sufficiently statistically evaluated.

Method
All consecutive laser extractions performed at our institution between September 2011 and March 2020 with lead age &gt; 12 months were included and retrospectively analysed.
Results
792 leads (mean age 75 months) were extracted during 335 procedures. The indication for extraction was pocket infection in 59%, CIED endocarditis in 25%, lead dysfunction or upgrade in 14% and others in 2%.
94.6% of leads were extracted complete, 4.2% partial (&lt; 4 cm rest) and the extraction failed in 1.3% of the leads (retention of ≥ 4 cm rest).
Multivariable analysis identified lead age &gt; 7.5 years (odds ratio [OR] 6.5; p = 0.0281), broken leads (OR 28.0; p = 0.0009) and implantable cardioverter-defibrillator (ICD) leads (OR 6.5; p = 0.0010) as independent predictors of failed extraction. CIED-endocarditis was independently associated with complete extraction (OR 3.3; p = 0.0218).
Complete procedural success or clinical success was achieved in 330 of 335 procedures (98.6%). The lead extraction failed in five cases (1.5%). Major procedure-associated adverse events (injuries of the great vessels or heart) occurred in four cases (1.2%). Two patients died perioperatively (0.6%). Minor complications occurred in 13 cases (3.9%).
Major adverse events (MAE) causally not related to the procedure occurred in 18 (5.4%) of the patients. The most frequent MAE was postoperative aggravation of the sepsis (10 patients; 3.0%). Independent predictors of major adverse events were CIED-endocarditis (OR 6.0; p = 0.0175), preoperative C-reactive-protein (CRP) &gt; 35 mg/l (OR 3.8; p = 0.0412) and body mass index (BMI) ≥ 25 kg/m2 (OR 5.0; p = 0.0489).
Ten patients (3%) died during the hospital stay. CIED-endocarditis with preoperative CRP &gt; 35 mg/l was independently associated with hospital mortality in multivariable analysis (OR 10.7; p = 0.0020). The Kaplan-Meyer analysis of 30-day mortality showed a significantly worse survival of patients with endocarditis (Log-Rank p = 0.0102).

Conclusion
Leads &gt; 7.5 years, broken leads and ICD leads are independent predictors of failed extraction. CIED endocarditis, CRP &gt; 35 and BMI ≥ 25 are associated with MAE. CIED endocarditis is related to higher short-term mortality despite successful lead extraction. Abstract Figure. Predictors of major adverse events
Rate of device-related infections using an antibacterial envelope in patients undergoing cardiac resynchronisation therapy re-operations
Authors: Frausing M , Nielsen JC , Johansen JB , Joergensen OD , Gerdes C , Olsen T , Kronborg MB 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Karen Elise Jensen Foundation

Background
Cardiac resynchronisation therapy (CRT) re-operations are associated with a particularly high risk of device-related infection (DRI). An antibacterial envelope has been shown to reduce the occurrence of DRIs in a broad population of moderate-to-high risk patients.

Purpose
To investigate the efficacy of an antibacterial envelope in a very high-risk patient population undergoing CRT re-operation.

Methods
In this Danish two-centre, observational cohort study, we included consecutive patients who underwent a CRT pacemaker- or defibrillator re-operation procedure between January 2008 and November 2019. We obtained data from the Danish Pacemaker and ICD Register and through systematic medical chart review. Follow-up was restricted to two years.

Results
A total of 1943 patients were included in the study; 736 (38%) patients received an antibacterial envelope. Envelope patients had more independent risk factors for infection than non-envelope patients. Sixty-seven (3.4%) patients met the primary end point of DRI requiring device system extraction; 50 in the non-envelope group and 17 in the envelope group (4.1% vs. 2.3%, adjusted hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.30-0.90, p = 0.021). This difference persisted in propensity score analysis (HR 0.51 95% CI 0.29-0.90, p = 0.019).

Conclusion
Use of an antibacterial envelope was associated with a clinically and statistically significant reduction in DRIs in patients undergoing CRT re-operations. Our results were comparable to those recently reported from a large randomized controlled trial, which suggests a proportional effect of the envelope even in very high risk patients.
Non-invasive and invasive autonomic tests to facilitate cardioneuroablation and complex indications for transcutaneous lead extraction and discontinuation of permanent pacing
Authors: Wileczek A , Reichert A , Kluk M , Sledz S , Sledz A , Kosior J , Polewczyk A , Kutarski A , Jagielski D , Buchta-Nitecka A , Karbarz D , Stec S 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

OnBehalf
Rare-A-Care registry

Background
Extracardiac vagal nerve stimulation (ECANS) and cardioneuroablation (CNA) are promising methods to cure vagally mediated bradycardia and validate indications for permanent pacing for sinus node dysfunction (SND), atrioventricular blocks (AVB), tachycardia-bradycardia syndrome (TBS) and cardio-inhibitory or mixed reflex syncope (VVS). There are limited information on clinical utility of those procedures in validation of indication for continuation of permanent pacing (PM) and transcutaneous lead extraction (TLE).

Methods
Data were collected from prospective multicentre registry of CNA facilitated by interdisciplinary consultations, state-of-art autonomic tests, atropine/propranolol tests, electrophysiologic study as well as ECANS. Share-decision making were used by EP-HEART-TEAM to developed patient-oriented therapy.

Results
Between June 2018-Jan 2021 the first 102 consecutive patients underwent interdisciplinary approach before invasive EPS and/or invasive ECANS, to consider biatrial, binodal CNA, if possible to cure functional bradycardia. Eleven (10%) patients had implanted permanent PM"s due to SND/AVB/TBS/CI-VVS and were considered for TLE. In 2 out of 11 cases CNA was not performed due to: 1) structural advanced 2nd and 3rd degree AVB with indication for TLE and permanent HBP (no.1), 2) incidental severely symptomatic persistent 3rd degree AVB more than 15 year ago without any further bradycardia episodes (only TLE, no.2). In further 9 of 11 cases with PM CNA was performed, however TLE was not attempted in 2 patients [(SND + PVC ablation + indication for beta-blocker therapy due to IHD in older male. TLE had not yet been attempted to confirm long-term success therapy by patient and/or physician (no.3); two periprocedural successful CNA resulted in disappearance of CI reflex however despite pacing syncopal events persist due to mixed etiology (no.4)]. In further 7/11 cases TLE-s were performed. Three cases had TLE prior to CNA [VVS-CI + advanced functional AVB - prior 3 pacemaker reimplantations and further "rescue" CNA, (no.5); CI-VVS + pacemaker infection (no.6); TLE of PM + TBS no.7]. Finally, in 4 cases TLE was recommended after CNA [CI-VVS (no.8, no.9 and no.10); mixed etiology: TBS + VVS-CI + intermittent, recurrent pericardial efffusion due to lead perforation, PM syndrome, (no. 11)].

Conclusions
Interdisciplinary and comprehensive autonomic approach with ECANS and CNA enable EP-HEART-TEAM to offer patient-oriented therapy with a complex clinical scenarios before final decision about TLE and discontinuation of permanent pacing therapy.
Value of electrocardiographic screening for the early diagnosis of arrhythmic and malignant heart disease in pediatric age
Authors: Leoni L , Elhyka A , Ferretto S , Fumanelli J , Cerutti A , Di Salvo G 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
The 12-lead electrocardiogram (ECG) is an instrument that can identify cardiac conduction system abnormalities that predispose to sudden cardiac death (SCD) in completely asymptomatic subjects.
The rate of sudden cardiac death in pediatric age is estimated to be around 1-1.5 cases per 100.000 individuals, and 10-15% of events occur during physical activity.
We evaluated the importance of the electrocardiogram performed in pediatric age in the early detection of asymptomatic electrocardiographic alterations, suggestive for the presence of electrical or structural heart disease potentially at risk for sudden death.

Materials and Methods
We analyzed 623 patients between 0 and 16 years of age who were sent to the second level pediatric arrhythmology clinic in Padua Hospital between October 2013 and March 2020. The patients were redirected at our clinic after a first finding of electrocardiographic alterations, following ECG performed before the beginning of sport activity, suspected of life-threatening pathologies. The following parameters were evaluated of all patients: clinical suspect of sending the pediatric arrhythmology clinic and electrocardiogram. Then, depending on the type of pathology suspected, the following diagnostic tests were carried out to confirm the clinical suspicion, and if confirmed, to carry out an adequate risk stratification: Holter ECG, ergometric

Results
Among the evaluated population (623 patients), 393 patients (63%) were sent to the pediatric arrhythmology clinic by sports medicine, 179 (29%) were sent by clinical o family pediatrician, and 51 patients (8%) were sent after ECG performed at hospital facilities for familiarity. The majority, 280 patients (45%), were sent for suspected WPW; 124 patients (20%) were sent for BEV and suspected ARVD; 85 patients (14%) for suspected long QT, 31 patients (5%) for suspected Brugada Pattern; 7 patients (1%) suspected CPVT; 8 patients (1%) for electrocardiographic changes with suspected HCM; 1 patient (0.01%) suspected shortened QT, and 88 patients (14%) for other arrhythmic disorders not at risk of sudden death. The diagnosis of WPW was confirmed in 280 patients, LQTS in 45 patients, SQTS in 1 patient, S. di Brugada in 8 patients, CPVT in 5 patients, HCM in 8 patients and ARVD in 6 patients.

Conclusions
Our study shows that the electrocardiographic screening already in pediatric age allows the diagnosis and subsequent early treatment of life-threatening arrhythmic heart diseases.
Routine podiatry assessment as a potential preventive tool for atrial fibrillation screening in diabetics
Authors: Petridou M , Matopoulou E , Kanellos I , Daios S , Patrikios I , Charalampous K , Lampropoulos K , Stefanou A , Skantzis P , Arkouli V , Papaioannou N , Papaioannou G , Kaiafa G , Savopoulos C , Papaioannou S 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.
Background/Introduction
Atrial fibrillation (AF) is a common heart arrhythmia predominantly in advanced age patients and in diabetic’s type II (DMPII). Even if the risk of stroke in AF in DMPII is relative high, 25% of AF patients remains undiagnosed and also cryptogenic AF is very common in the diabetic population. During a 12-month study project, podiatrists and podologists performed foot pulse-checks in their routine podiatry assessment, when encountering visual symptoms that suggest an underlying circulatory disorder in diabetics. This simple non-invasive method aims to increase screening and diagnosis of AF from allied health professionals, in order to reveal patients with previously undiagnosed AF and patients with cryptogenic Af, challenging the potential reduction of AF complications and mainly of stroke.
Purpose
Early detection of AF in diabetics from allied health professionals during routine podiatry assessment. Revealing of previously undiagnosed AF contributes to stroke and other AF complications incidence reduction in the diabetics population.
Methods
During a 12-month study, 2 podiatrists and 6 podologists performed foot pulse-checks on diabetics, during their annual foot screening appointments, since they have been trained from medical doctors to spot rhythm abnormalities during pulse palpation of the foot arteries. They have been also trained to confirm their pulse palpation evidence thought Doppler ultrasound wave assessments during evaluation of arterial blood supply (anterior-posterior tibial arteries and ramifications) of the diabetic foot. During the study 300 diabetics (mean age 60 years old, 180 males, 120 females) had their feet pulse-tested. Spss statistical software had been used.
Results
17% of diabetics during foot pulse-checks presents undiagnosed AF. There was no statistically significant difference (p &lt; 0.05) between sex (males and females AF screening percents were similar).
Conclusion(s)
Early detection and properly managed during AF screening reduces AF complications and specifically stroke incidence. Opportunistic podiatric detection of previously undiagnosed and cryptogenic AF from allied professionals is a non invasive, safe, fast and economic method with potential contributions in this direction. More studies must be designed in order to support the routine podiatry assessment, as a useful Screening diagnostic tool of AF for reducing cardiovascular complications incidence in diabetics but also in the general population.
Advanced practice providers should interpret 12-lead ECGs
Authors: Carey M 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Due to the rapid development of cardiac diagnostic modalities such as imaging techniques, device therapies, invasive procedures and cardiogenomics, many cardiology trainees lack personal interest in clinical electrocardiography (ECG) training. In addition, fewer and fewer practioners are mentoring trainees in this skill. Thus, most ECGs are read by non-cardiologists, including emergency, urgent care and family practice-physicians who do not necessarily have clinical ECG training. Purpose: The purpose of this proposal is to promote the training and certification of Advanced Practice Providers (APPs) to interpret 12-lead ECGs. Rationale. By tradition, as health care tasks increase in complexity, many physician-based tasks are delegated to APPS, especially in the demanding hospital setting. For example, nurses continuously monitor and interpret all bedside ECG arrhythmias and myocardial ischemia. The transition of cardiologist read 12-lead ECGs to APP read 12-lead ECG makes sense in light of the ubiquitous computerization of the ECG which provides high quality waveforms with sophisticated algorithms to help guide in decision making. Despite significant improvements in cardiac technology, the 12-lead ECG remains the classic, non-invasive gold standard for the diagnosis of a myocardial infarction (MI) and it is expected to be interpreted within 10 minutes of chest pain onset. Conclusion: Cardiologists have moved on to utilize new technology for secondary and tertiary evaluations, 12-lead ECGs are the first line diagnostic tool in diagnosis of MI. By training and certifying APPs in ECG interpretation, higher quality, rapid initial diagnosis will be made without delays.
The SCN5A point mutation M1875T, associated with familial atrial fibrillation, causes a gain-of-function effect of the cardiac Nav1.5 channel in atrial cardiomyocytes
Authors: O"reilly M , Sommerfeld L , O"shea C , Broadway-Stringer S , Kabir S , Andaleeb S , Malinova A , Reyat J , Fortmueller L , Pavlovic D , Skryabin BV , Holmes A , Kirchhof P , Fabritz L 
Published: May 2021

Abstract

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

Background
The point mutation M1875T in the SCN5A gene, which encodes the pore-forming α-subunit of the cardiac voltage-gated Na+ channel Nav1.5, has been associated with familial atrial fibrillation (AF), but its effects on atrial cardiomyocyte electrophysiology is unclear.

Aim
To investigate the effect of the point mutation M1875T on atrial electrophysiological parameters.

Methods
In a novel heterozygous knock-in murine model (Scn5a-M1875T+/-), whole-cell patch clamp electrophysiology was used to investigate Na+ currents in left atrial (LA) cardiomyocytes isolated from hearts of young adult mice (10-16 weeks). LA microelectrode and optical mapping recordings were used to study action potential (AP) characteristics. Cardiac size and function were measured by transthoracic echocardiography. Atrial Scn5a gene and Nav1.5 protein expression were assessed by Rt-PCR and Western blot.

Results
The Na+ current was increased in cardiomyocytes isolated from Scn5a-M1875T+/- LA (wildtype (WT) -22.7 ± 0.9 pA/pF (N = 14, n = 115); Scn5a-M1875T+/- -28.3 ± 1.1 pA/pF (N = 15, n = 117)). Scn5a-M1875T+/- intact isolated superfused LA had an elevated AP amplitude (100 ms pacing cycle length (PCL): WT 86.4 ± 0.9 mV (N = 8, n = 24); Scn5a-M1875T+/- 91.2 ± 0.7 mV (N = 8, n = 25)) and a faster peak upstroke velocity (100 ms PCL: WT 127.98 ± 3.28 mV/ms; Scn5a-M1875T+/- 142.80 ± 3.98 mV/ms). AP duration (APD) was not different apart from a small APD shortening at slow rates. Echocardiography revealed no difference in size and function at the age of investigation. Atrial Scn5a gene and Nav1.5 protein expression were comparable. When challenged with flecainide (1 µM), Scn5a-M1875T+/- LA showed less conduction slowing than WT (100 ms PCL: WT -10.43 ± 1.27 cm/s (N = 12); Scn5a-M1875T+/- -6.10 ± 1.34 cm/s (N = 12)). 5 µM flecainide caused significant increase in WT refractoriness (7/12 atria lost 1:1 capture at PCL ≤ 120 ms) compared to Scn5a-M1875T+/- (1/12).
Conclusion(s): SCN5A point mutation M1875T increases the Na+ current in atrial cardiomyocytes and intact atria, leading to a faster AP upstroke and an attenuated response to flecainide. Abstract Figure 1: Current-Voltage relationship