bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of age on patient selection in leadless pacemaker implant: experience with the micra transcatheter pacemaker
Authors: Iacopino S , Roberts P R , Rao A , Johansen J B , Marijon E , Piccini J P , El-Chami M F , Stromberg K , Fagan D , Garweg C
Published: May 2024

Background

The safety and efficacy of the Micra AV leadless pacemaker has been demonstrated in the real-world setting. However, whether the patient profile and outcomes differ based upon patient age is not known.

Purpose

To report age-stratified peri-procedural outcomes and intermediate-term follow-up of patients undergoing Micra implant.

Methods

Patients (n=801) from the Micra AV Post-Approval Registry were included and divided into age groups: ≤40 (n=40), 41-<65 (n=110), 65-80 (n=332), and >80 (n=319). Baseline characteristics were summarized. A Fine-Gray competing risk model was used to compare risk for major complication through 12 months. Pacing burden and projected longevity were summarized.

Results

Among 801 included patients, 40 (5.0%) were ≤40 years of age with a mean age of 29.2 ± 6.6 years (range: 16-40) and 60.0% were female. Among patients ≤40, 20.0% had a prior CIED while 27.5% were precluded from transvenous pacing. Patients ≤40 had lower BMI and lower co-morbidity burden compared with older patients. The most common indication for implant was AV block in all age groups, however 35.0% of patients ≤40 had a syncope indication compared to ≤15.5% for older groups. Micra was successfully implanted in 100% of patients ≤40 years. The major complication rate at 12 months was 2.7% in patients ≤40 and did not significantly differ across age groups (P=0.82, Figure). Median pacing percentage was lowest in the ≤40 group (n=17, median= 1.0%) and was highest in the >80 group (n=127, median 88.0%). Median projected longevity across all patients was 10.9 years and was 14.8 years among patients ≤40 with 82.3% having longevity ≥10 years.

Conclusion

Micra was successfully implanted across a broad range of age groups. Younger patients tended to be healthier and had a low median percentage pacing. The rate of major complications was low and did not differ across age groups.Major complication rate by age subgroup
Leadless pacemaker implantation via the internal jugular vein a promising access for an established intervention
Authors: Molitor N , Breitenstein A
Published: May 2024

Background

Leadless pacemaker therapy was introduced in 2013 to overcome lead- and pocket-related complications in conventional transvenous pacemaker therapy. These leadless devices are self-contained right ventricular single-chamber pacemakers implanted via a femoral percutaneous approach. However, the femoral route is not always possible due to various reasons. The aim of this analysis is to share our first experience using a jugulary approach for the implantation procedure.

Purpose

To evaluate safety and feasibility of leadless pacemaker implantation via the internal jugulary vein.

Methods

The records of the first 34 patients who underwent leadless pacemaker implantation via the right internal jugular venous route at our center were analyzed prospectively. Follow-up period was 3 months. Safety as well as efficacy including electrical parameters of the jugular approach were compared with the data of the first 100 patients who underwent a femoral leadless pacemaker implantation at our center (implanted from 2015-2019).

Results

Thirty-four patients underwent internal jugular vein leadless pacemaker implantation (mean age, 82.37 ± 7.58, 58.8% males). All leadless pacemakers were implanted successfully. The jugular approach was well tolerated by all patients. Mean procedure time was 33.29 ± 8.81 min with a mean fluoroscopy time of 3.66 ± 2.07 min. The device was positioned at the inferior septum in 11 patients, at the high septum in two and midseptal in 21 patients. The mean pacing threshold was 0.52 ± 0.22 V at 0.24 ms pulse width with a sensed amplitude of 9.13 ± 4.08 mV. There were no complications during the procedure as well as during 3-month follow-up. At follow-up, electrical parameters remained stable in all patients.

Conclusion

Implantation of a leadless pacemaker via the right internal jugulary vein is a safe and effective alternative to the femoral approach.Patient demographics/device parameterDevice value development over time.
Accelerated pacing reduces left heart filling pressures: a novel therapy for heart failure with preserved ejection fraction?
Authors: Van Loon T , Wolffs J , Rijks J , Cornelussen R , Van Osta N , Luermans J , Prinzen F , Schotten U , Linz D , Van Empel V , Delhaas T , Vernooy K , Lumens J
Published: May 2024

Background

The recent MyPACE trial demonstrated significant improvement of quality-of-life, physical activity, and atrial fibrillation (AF) burden with accelerated pacing as compared to the standard 60bpm back-up rate setting in patients with heart failure with preserved ejection fraction (HFpEF) and indication for pacemaker therapy. We hypothesized that a potential working mechanism underlying these improved outcomes lies in the reduction of left heart filling pressures during accelerated pacing, reducing congestion and atrial stretch.

Aim

To assess the acute effects of accelerated atrial pacing on left heart filling pressures in consecutive AF patients undergoing catheter ablation.

Methods

Fifty AF patients undergoing catheter ablation were prospectively enrolled for accelerated atrial pacing. As illustrated in Figure 1, pacing was performed proximally in coronary sinus (CS). Pacing rate was increased incrementally from resting heart rate by 10-bpm increments up to Wenckebach rhythm, with 30-sec intervals of pacing on and off for hemodynamic stabilization. Left atrial pressure (LAP) was continuously monitored via a fluid-filled transseptal sheath (SL0 sheath, Abbott). Acute pacing-induced changes in mean LAP and PR-interval were evaluated at each pacing rate and compared between resting heart rate, the patient-specific optimal heart rate (i.e., the rate resulting in the lowest mean LAP), and the maximum pacing rate.

Results

Atrial pacing acutely decreased mean LAP from 14.8[9.8; 18.4] to 12.8[8.5; 15.8]mmHg (median[IQR], p<0.001) as heart rate increased from 51[47; 61] to 90[70; 100]bpm (p<0.001) (Figure 2, resting versus optimal category). Among the 50 patients included, only 4 did not exhibit a decrease in LAP. Further increasing pacing rate to a maximum of 130[100; 140]bpm resulted in an acute LAP increase to 16.2[12.7; 19.9]mmHg (p<0.001) to values above resting mean LAP. Accelerated pacing induced negative AV dromotropy, i.e., lengthening of the PR-interval from 169[150; 185] to 186[164; 209]ms (p=0.003) and 270[217; 310]ms (p<0.001).

Conclusion

Our study demonstrated that moderately accelerated atrial pacing reduced mean LAP in AF patients undergoing catheter ablation. While our primary focus was on acute response in AF patients, the reduction in mean LAP during moderate pacing rates may suggest a promising therapeutic approach for managing HFpEF patients. However, caution is warranted as pacing rates beyond the optimal range led to a marked increase in LAP. Additionally, increasing pacing rates were observed to induce varying degrees of AV-node dromotropy, which potentially modulates therapy response.Fig 1. Overview of clinical protocolFig 2. Response to accelerated pacing
Long-term time-course of atrial sensing and incidence of atrial fibrillation in patients with VDD versus DDD pacemakers
Authors: Quesada Ocete B , Robles Musso M M , Quesada Ocete F J , Robles Musso E , Carrion A , Cardona Mulet S , Luengo S , Jimenez Bello J , Montes Valverde I , Alonso Marin A , Paya Chaume A , Paya Serrano R , Quesada Dorador A
Published: May 2024

Introduction

VDD pacemakers (PM) theoretically have the same advantages with respect to maintaining atrioventricular (AV) synchrony as dual-chamber (DDD) pacemakers, with lower costs and simpler implantation procedure. However, their use is often limited by concerns about the maintenance of atrial sensing (AS) and the occurrence of atrial fibrillation (AF).

Purpose

We aimed to compare long-term atrial sensing stability, the incidence of AF and complications in VDD and DDD systems.

Methods

We retrospectively enrolled patients who underwent VDD or DDD PM implantation for AV block between 2014 and 2021 from 2 centers. Clinical, analytical and electrical variables at implantation, their evolution and events at follow-up (25.2±16.2 months) were collected, comparing the groups by Kaplan-Meier and Cox multivariate analysis.

Results

487 patients who underwent PM implantation were included, 189 (38,8%) received a VDD PM and 298 (61,2%) a DDD PM. Patients with VDD were older and had a higher prevalence of risk factors and lower atrial voltage at implantation (Table). Complications at implantation and early complications were scarce and without significant differences in both groups. During follow-up, there was a reduction in atrial voltage in the VDD group (implant 1.4+0.8 mV; follow-up 1.2+0.9 mV; p<0.01), with stability in the DDD group (3.8+2.1 vs 3.9+2.2 mV). Total percentages of AS loss were 23.2% (VDD) vs 2.3% (DDD); p<0.01) (Figure 1). In the Cox multivariate analysis the risk of late AS loss was higher in the VDD group (HR=7.6; 95% CI 2.86-20.3; p<0.001) together with the AS values at implant (HR=0.72; 95% CI 0.52-1.00; p=0.052). AS loss was corrected with reprogramming in 23 patients, reintervention was needed in 1 (2%) and VVI was abandoned in 27 (53%). The risk of AF occurrence was lower in the VDD group (HR=0.39 CI 95% 0.18-0.87; p=0.021) (Figure 2).

Conclusions

In the long term, AS is significantly reduced in VDD MPs, leading to its loss in a quarter of VDD patients. It is usually correctable with reprogramming, rarely requiring abandonment to VVI. AS at implantation is crucial as it is directed related to the AS during follow-up. DDD PMs were independently associated with a higher incidence of AF, with no differences in the remaining complications.TableFigure
The safety and feasibility of same-day discharge after subcutaneous implantable cardioverter defibrillator implantation
Authors: Toon L T , Elrefai M , Bates A , Patil R , Hudson J , Zubair Z , Roberts P R
Published: May 2024

Introduction

Subcutaneous Implantable cardioverter defibrillators (S-ICDs) are now progressively administered as a day-case procedure. While existing data supports the feasibility and safety of same-day discharge after transvenous ICD implantation, comparable evidence for S-ICDs is not well established. This study addresses this by presenting data from the most extensive population documented in the medical literature. We seek to evaluate the feasibility and safety of same-day discharge after S-ICD implantation.

Purpose

To investigate the feasibility and safety of same-day discharge following S-ICD implantation.

Methods

A retrospective analysis was conducted, encompassing data from all patients who underwent S-ICD implantation at our institution between January 2011 to April 2023 (n=240). The cohort was stratified into two groups: those discharged on the same day of the procedure (SD, n=124) and those subject to at least overnight hospital observation (OD, n=116). The medical records were reviewed during this period aiming to identify potential complications. Complications were categorized as device-related complications or inappropriate shock. Specific events, such as inappropriate shocks; lead revision; infection necessitating lead or generator extraction; pocket hematoma requiring drainage, blood transfusion, or prolongation of hospitalization; and other complications related to the lead or generator prompting medical or surgical intervention were documented. An inappropriate shock was defined as one delivered for any rhythm other than ventricular fibrillation or ventricular tachycardia.

Results

Among the 240 patients included in the study, 123 were scheduled for a day case procedure, while the remaining 117 underwent S-ICD implantation as in-patients. Notably, 112(91%) out of 123 planned-day patients and 12 in-patients (SD, total n=124) were successfully discharged on the same day. A substantial proportion (84%) of SD group had undergone the procedure for primary prevention. Patients with congenital heart disease were predominantly observed overnight.

Defibrillation testing (DFT) is routine in our practice to ensure S-ICD integrity and was conducted in all S-ICD patients unless contraindicated. The success rate of DFT among attempted patients was high, standing at 72% and 78% in the SD and OD groups, respectively.

The incidence of device-related complications was comparable between the two groups. The SD group displayed a slightly higher superficial infection rate but the incidence of inappropriate shocks was lower in the SD groups.

Conclusion

Based on our findings, same-day discharge following S-ICD implantation emerges as an appropriate practice. Our data strongly supports the assertion that same-day discharge in this context is safe and feasible, offering valuable insights into the optimal post-procedural management of S-ICD patients.Table 1ComplicationsTable 2Defibrillation Test
Optimising electrical performance of leadless cardiac resynchronisation therapy and leadless LV septal pacing
Authors: Wijesuriya N , Strocchi M , Mehta V S , Elliott M K , De Vere F , Howell S , Sidhu B , Mannakkara N , Little I , Martic D , Carlisle L , Kwan J , Bosco P , Niederer S A , Rinaldi C A
Published: May 2024

Introduction

Leadless left ventricular (LV) endocardial pacing with the WiSE-CRT System is an emerging form of cardiac resynchronisation therapy (CRT). The system was designed to provide lateral wall LV pacing (LVP) via an endocardial receiver electrode in response to detection of a right ventricular pacing (RVP) stimulus from a co-implanted device, thereby delivering near-simultaneous biventricular pacing (BiVP). However, it is unclear whether BiVP generates the optimal electrical performance in this system, particularly in the context of leadless LV septal pacing, a novel use for leadless CRT.

Aim

We aimed to characterise the acute performance of leadless CRT at different pacing modalities using electrocardiographic imaging (ECGi).

Methods

Patients with the leadless CRT underwent an acute ECGi study. The following pacing modalities were tested: RVP; BiVP; LVP; and LVP with an electrically optimised atrioventricular delay (LV-OPT) in patients with sinus rhythm (SR). Reconstructed epicardial electrograms (Figure 1) were used to calculate BiV activation time (BIVAT-90), LV activation time (LVAT-90), RV activation time (RVAT-90), LV dyssynchrony index (LVDI), and BiV dyssynchrony index (BIVDI). For each metric, the improvement compared to baseline rhythm was calculated, and the optimal pacing modality (OPM) in each patient was determined.

Results

Ten patients were studied, 5 receiving septal LVP, and 5 receiving lateral LVP. The underlying rhythm in 4 patients was SR with left bundle branch block (LBBB), and atrial fibrillation (AF) with complete heart block (CHB) in the remaining 6. BiVP generated a 23.7% improvement in BiVAT-90 compared to baseline (p=0.002). An individualised OPM resulted in a 43.3% BiVAT-90 improvement compared to baseline (p=0.0001), thus a 19.6% improvement compared to BiVP (p=0.02, Figure 2A). Using an OPM, BiVAT-90 was significantly improved in both patients with lateral (43.3%, p=0.0001) and septal LVP (42.4%, p=0.009). The BiVAT-90 OPM varied between patients (Figure 2B). BiVP was the OPM in 4/10 patients, all of whom had AF with CHB. BiVP was the OPM in 1/5 patients receiving LV septal pacing, with LVP or LV-OPT performing best in the remaining 4. In 3/4 patients in SR, LV-OPT was the OPM. Choosing the OPM increased performance primarily through significant improvements in RVAT-90 compared to BiVP (36.5% versus -8.2%, p =0.002).

Conclusion

Leadless CRT, both with lateral and septal LVP, significantly reduces electrical activation times and improves electrical dyssynchrony. Individualised selection of the OPM may be required with leadless CRT to accommodate for varying conduction disease phenotypes and implant locations.
Short-term cost-utility analysis of biventricular cardiac resynchronization therapy in comparison with left bundle branch area pacing cardiac resynchronization therapy
Authors: Sanchez Moreno J , Fernandez Sanchez J A , Garrido-Arroquia Jurado T , Molina Lerma M , Gutierrez Ballesteros G , Frutos Lopez M , Pavon Jimenez R , Jimenez Jaimez J , Garcia Mochon L , Alvarez Lopez M
Published: May 2024

Background

Cardiac resynchronisation therapy (CRT) is a well-established form of treatment for patients with heart failure and cardiac dyssynchrony. Recently, left bundle branch area pacing (LBBAP) has emerged as a more physiological alternative for biventricular pacing (BiVP) cardiac resynchronization therapy (1,2).

Purpose

The purpose of this study was to conduct a cost-utility analysis for LBBAP CRT, compared to BiVP CRT in a cohort of patients with heart failure from the Spanish health system perspective.

Methods

A multicenter prospective quasi-experimental study in which 44 consecutive patients underwent CRT was conducted. According to the study protocol, the four centers would perform their usual clinical practice: two out of them would perform conventional BiVP-CRT while the other half LBBAP-CRT. Intention-to-treat analysis was carried-out. Health outcomes were quality-adjusted life years (QALYs), measured by the EuroQol-5D-5L questionnaire, which the patients were asked to complete at baseline and 12 weeks after the CRT device implantation. The total direct costs include device, leads, guidewires, introducer kits, sheats and operating theater time. The results were expressed as the incremental cost-utility ratio (ICUR). In order to analyze the uncertainty of ICUR results, we performed a non-parametric bootstrapping with 1000 replications.

Results

The LBBAP procedure was attempted for a total of 26 consecutive patients (1 patient underwent rescue BiVP), while BiVP was attempted for 18 patients (2 patients switched to LBBAP). Mean QALYs over 3 months were 0.1914 ± 0.009 in the LBBAP CRT group and 0.1904 ± 0.0112 in the BiVP CRT. Improvements from baseline were greater in the LBBA CRT group but not statistically significant. The total costs at the end of the intervention were 7546.6 €± 602.15€ in the LBBAP CRT group and 16064.56€ ± 723.7€ in the BiVP CRT group. When excluding from the analysis the cases in which ICD was implanted, the mean difference in QALYs is 0.002; 95% confidence interval [95%CI]: -0.03 to 0.036) and the mean saving is -3.510.38 €. The LBBAP CRT leads to cost savings for the health system and similar QALYs outcomes; 95%CI: -6.660 to -360.71. Based on 1000 bootstrapping replication, the cost savings of using LBBAP vs BiVP occur in 99% of the simulations.

Conclusion

LBBAP CRT is an efficient alternative to BiVP CRT for cardiac resynchronization in patients with heart failure with similar results in terms of QALYs but with significant average savings per patient.Cost-utility plane for 1000 bootstrappedBaseline characteristics of patients
Impact of non-typical LBBB on CRT response
Authors: Abrantes A , Joana Brito J B , Beatriz Silva B S , Beatriz Garcia B G , Margarida Martins M M , Miguel Azaredo Raposo M A R , Catarina Gregorio C G , Daniel Cazeiro D C , Diogo Ferreira D F , Pedro Silverio Antonio P S A , Sara Couto Pereira S C P , Ines Ricardo I R , Fausto J Pinto F J P , Joao De Sousa J S , Pedro Marques P M
Published: May 2024

Introduction

Cardiac resynchronization therapy (CRT) benefits have been established in patients with heart failure and reduced left ventricular ejection fraction (HFrEF) who have a broad QRS and remain symptomatic despite optimized medical therapy. Responders typically are female, with LBBB and broader QRS. It remains uncertain to what extent do patients with non-LBBB QRS complex morphology respond to CRT and also if there are differences among various types of intraventricular conduction delays.

Purpose

To evaluate the impact of non-typical left bundle branch block (LBBB) on reverser remodeling and clinical events.

Methods

Single center, observational, retrospective study including patients (pts) who implanted CRT in the context of HFrEF, from 2015 to 2020. Evaluation of QRS morphology analysis was conducted.

CRT response was defined by a reduction of LVESV≥15% or an increase in LVEF≥10%. Predictors of CRT response were evaluated with Chi-square and Mann- Whitney analysis. Impact on reverse remodeling and clinical outcomes was performed with Kaplan-Meyer analysis.

Results

A total of 361 pts were included for analysis, of which 184 had non-typical LBBB. Pts had a mean age of 71±9years old, the majority of pts were female (61%), and almost half were ischemic (47.8%).

EGC evaluation prior to CRT implantation, revealed an atypical LBBB in 83 (45.1%) pts, typical RBBB in 23 (12.5%) pts, atypical RBBB 94.(9%) pts and nonspecific intraventricular conduction delay in 69 (37.5%) pts.

During a mean time of follow-up of 2.9 ±2.4years, 33 pts (18%) had hospitalizations due to HF and 68 (37%) died. In this cohort, 78 pts (42.4%) were deemed as responders, who presented a better clinical outcome when compared to non-responders (p < 0.001, HR 2.629 [95% CI 1.635-4.225].

There was no difference among the four types of intraventricular conduction analyzed in respect to degree of CRT response – figure 1. Regarding clinical events during follow-up, there was once again no significant difference among the different patterns of non-typical LBBB– figure 2.

In this subset population we found no independent predictors of CRT response, although non-responders were significantly older than responders (72±8 vs 69±10 years-old (p=0.016).

Conclusion

Although pts with non-typical LBBB morphology display a lower therapy response to CRT than reported for LBBB pts, the rate of response is not negligible and represents a protective factor for clinical outcomes. Different types of intraventricular conduction delay present no difference regarding long- term prognosis or reverse remodeling.Survival according to CRT response
Predictors of responders to cardiac resynchronization therapy in patients with non-left bundle branch block with mid-wide QRS duration
Authors: Takanashi Y , Kondo Y , Nakano M , Kajiyama T , Ito R , Chiba T , Ryuzaki S , Yoshino Y , Komai Y , Kobayashi Y
Published: May 2024

Background

Cardiac resynchronization therapy (CRT) is useful for patients with severe heart failure with dyssynchrony of left ventricular contraction, significantly reducing total mortality or heart failure rehospitalization. In patient with left bundle branch block (LBBB) or QRS duration (QRSd) ≥ 150 ms, CRT is a well-established therapy at guidelines in Japan and other countries. However, CRT may be more useful and effective in Asian patients with middle range wide QRSd, because of smaller body size than in the West. Few reports have shown the usefulness and efficacy of CRT in patients with non-LBBB and middle range wide QRS duration (mid-wide QRSd).

Purpose

To evaluate the predictors of CRT responders in heart failure patients with non LBBB and mid wide QRSd.

Methods

We retrospectively studied 174 consecutive patients who underwent a denovo CRT device implantation at two institutions between September 2013 and March 2023. Follow up echocardiography examination could be performed after 150 days postoperatively. CRT responders were defined as a decrease in left ventricular end systolic volume ≥15% on echocardiography. We plotted thereceiver operating characteristic (ROC) curve for predicting CRT responders. The area under the curve (AUC) was calculated to determine the best cut off value.

Results

A total of 34 patients with non LBBB and 120≤ QRSd <150 ms were enrolled in this study. Sixteen of 34 (47%) patients were the responders for CRT. There was no significant difference in gender between the responder and non responder groups (p=0.274). Non ischemic cardiomyopathy was more prevalent in the responder group (p=0.046). The ROC curve analysis confirmed that 0.809 was the better optimal cut off value of QRSd/left ventricular end diastolic volume (LVEDV) for predicting CRT responders (AUC = 0.688). The multivariate analysis demonstrated that QRSd/LVEDV was significantly associated with CRT responders [odds ratio (OR) 9.88, 95% confidence interval 1.51 64.90, p = 0.017].

Conclusion

The corrected QRSd for heart size using LVEDV could be the independent predictor of CRT responders in Japanese patients with non LBBB and mid wide QRSd.
Thoracic impedance during national holidays
Authors: Olsson A , Rylance R , Borgqvist R , Erlinge D , Platonov P
Published: May 2024

Background

Several studies have observed increased incidence of myocardial infarctions during Christmas and national holidays. Emotional stress, overindulgence in food and alcohol have been suggested as potential underlying mechanisms. Monitoring of thoracic impedance (TI) by cardiac implantable electronic devices (CIED) has been proposed as a tool for detection of fluid accumulation. We aimed to assess the relationship between TI and national holidays in patients treated with CIED with and without reduced left ventricular ejection fraction (LVEF).

Method

Consecutive patients with CIED capable of TI monitoring enrolled in the remote monitoring program at a tertiary care hospital in Sweden were screened. Full disclosure remote CIED monitoring database containing daily measurements of TI and device therapy delivery was accessed as the source of information for this retrospective cohort study. Patients were included if they had the monitoring data for at least one holiday (Christmas, New Year or Midsummer) between June 2015 and January 2020. TI during the holiday was compared with baseline values, defined as a mean value of three days preceding Christmas Eve and Midsummer. Clinical characteristics, LVEF, medical treatment and possible contact with healthcare during the holidays or the following week were obtained from medical records. A linear mixed model was used since dependent observations existed.

Result

In total, 96 patients (82 % men, age 69±10 years, 92 % ICD, 78 % CRT, 72 % with LVEF<40%) were included, which provided data for 255 patient-holidays. TI decreased by mean 1.3 Ohm (95% CI -1.9 to -0.6, p< 0.001) on the Christmas Day, 0.6 Ohm (95 % CI -1.4 to 0.1, p = 0.08) on New Years Day and 1.0 Ohm (95 %CI -1.7 to -0.3, p=0.005) on Midsummer Day. These TI changes were not related to age and did not differ between men and women. Holiday-related TI drop was observed regardless of LVEF: mean decrease on Christmas Day 1,1 vs 1,4 Ohm, New Years Day 0,2 vs 0,4 Ohm and Midsummer Day 1,2 vs 1,0 Ohm for LVEF <40% and >40% respectively. By the third day after a holiday, TI had reached the baseline level. Only one ventricular tachycardia event requiring shock therapy and hospital admission was documented. No other patients were seeking care during the holidays or the days afterwards.

Conclusion

A significant transient decrease in thoracic impedance was evident during Christmas Day and Midsummer Day in CIED treated patients with reduced and preserved LVEF. These holidays are therefore associated with both decrease in thoracic impedance and incidence of myocardial infarction and it is possible that decrease in thoracic impedance could contribute to the increased incidence of myocardial infarction during holidays.
Incidence of infections related to cardiac implantable electronic devices in Germany
Authors: Baldauf B J , Bode K , Assadian O , Giaccardi M , Cemin R , Chevalier P , Vonthein R , Bonnemeier H
Published: May 2024

Background

Worldwide, the risk of cardiovascular implantable electronic device (CIED) infection is increasing. Publications of contemporary big data regarding CIED infections for Germany are lacking. This investigation is providing rates of CIED, hospital admission for CIED infection and related mortality in Germany.

Methods

Data from the biggest healthcare insurance fund was screened for CIED procedures, including placement, revision with aim to up- or downgrade, generator substitution, early revision and partial or complete extraction using specific procedure codes for reimbursement in Germany during 2015. Among the total population of beneficiaries with CIED placement in that year international Classification of Diseases, 10th revision German modification codes were used to identify CIED infections and lead related endocarditis.

Results

In 2015 altogether 60,296 patients (57.3% male) underwent a CIED procedure. 1129 (1.9%) patients underwent at least one procedure related to CIED infection and 466 (0.77%) participants underwent at least one procedure for treatment of a lead related endocarditis.

CIED infection was associated with a mortality rate of 8.4%. Lead related endocarditis was associated with a mortality rate of 15.4% in 2015.

Patients presenting with CIED infection and lead related endocarditis were younger (69.5 and 67.3 vs 73.5 years) and more often male (69.4 and 70.2 vs 57.3%) 2.22 procedures in case of hospital admission with CIED infection and 1.93 procedures in case of lead related endocarditis were conducted in 2015.

Conclusions

Our observational study shows that the rate of CIED infection is greater than has been reported by large randomised trials. Mortality rates for CIED infection and lead related endocarditis are in line with published rates. Younger age and male gender are host related risk factors for an increased risk for CIED infection and lead related endocarditis.
No lead left behind: procedural outcome of excimer laser powered extractions in patients with abandoned leads - a GALLERY subgroup analysis
Authors: Rexha E , Chung D , Schlichting A , Kaiser L , Hassan K , Gessler N , Reichenspurner H , Willems S , Pecha S , Hakmi S
Published: May 2024

Background

Lead dwell time > 10 years, has been recognized as a predictive factor for procedural failure of transvenous lead extraction (TLE). However, there is a limited information concerning the specific outcomes of TLE for abandoned leads when employing the excimer laser-powered sheath.

Objective

The purpose of this study was to investigate the procedural outcomes of individuals with abandoned leads undergoing TLE with excimer laser-powered sheath as first tool strategy.

Methods

A subgroup analysis of patients with abandoned leads of the GALLERY (GermAn Laser Lead Extraction RegistrY) database was conducted. Patients were categorized into two groups based on the presence of abandoned leads at the time of extraction: Group 1 for those with abandoned leads, and Group 2 for those without abandoned leads.

Results

Among the 2524 patients, 749 individuals (29.7%) had abandoned leads (Group 1) at the time of the procedure. Patients in Group 1 were typically older (69.1±13 vs. 67.6±14.1 years; p=0.026) and 23.5% were female. Leading extraction indication was local infection (37.4% vs. 34.3%, p=0.145), systemic infection (33.2% vs. 26.6%, p=0.001) and lead dysfunction (24.3% vs. 33.5%, p<0.001). Additionally, more patients in Group 1 presented with cardiac resynchronization therapy (CRT) devices (30.4% vs. 22.9%, p<0.001). Significant differences were observed in the mean number of total leads (3.4±1.1 vs. 2.0±0.7, p<0.001), median age of the oldest lead (117 vs. 87 months; p<0.001), and the number of right-sided leads (41.7% vs. 29.5%, p<0.001), all of which were higher in Group 1.

Median hospital stay (10 vs. 9 days; p=0.002), median procedural time (105 vs. 75 minutes; p<0.001) and use of additional tools (11.2% vs. 4.7%, p<0.001) were significantly higher in Group 1. There was no difference regarding clinical success (p=0.32) between the groups. However, complete procedural success was significantly higher in Group 2 (84.9% vs. 94.2%, p<0.001).

All-cause mortality did not differ between the groups (p=0.111) but procedural-related mortality was higher in Group 1 (2.9% vs. 0.6%, p<0.001). The overall complications rate was also significantly higher in Group 1 (5.7% vs. 3.7%, p=0.03).

Conclusion

Patients with abandoned leads presented an increased procedural complexity, less procedural and clinical success despite the use of multiple tools, longer hospital-stay and higher procedure-related mortality rates. Therefore, an extraction strategy should be considered before deciding to abandon non-functional or dysfunctional leads.
Removal of spontaneously fractured leads with their proximal ends in the heart and vasculature -experience among 3847 lead extraction procedures
Authors: Kutarski A , Jachec W , Pietura R , Stefanczyk P , Czajkowski M , Sawonik S , Nowosielecka D , Tulecki L
Published: May 2024

Background

Spontaneous fractures and insulation breaks of the intracardiac leads near their entry into the venous system cause the proximal end of the fractured lead slide into the veins, with potential subsequent looping in the heart and secondary complications. So far, this topic has not been extensively studied. As it is a relatively uncommon finding, it has been described in a few number of case studies only.

The aim of the study was to describe the phenomenon of leads migrated proximal end (LMPEs) into the cardiovascular system and techniques for such leads removal.

Methods

Retrospective analysis of 3847 transvenous lead extractions (TLE).

Results

Over a 17-year period 72 (1.87%) leads with migrated proximal ends (LMPEs) (mean dwell time 148.0 months) were extracted, mainly ventricular leads (56.94%). Overall, 68.06% of MPLEs had their cut proximal ends located in the venous system. Most of them were pacing (95.83%) and passive fixation (98.61%) leads. Independent risk factors for LMPEs included abandoned leads (OR=8.473; p<0.001) and leads on both sides of the chest (2.981; p=0.045). Higher NYHA class lowered the probability of leads with migrated proximal ends (LMPEs) (OR=0.380; p<0.001). Extraction complexity was higher in the MPLE group than in remained patients. Femoral approach was most often used (62.50%), contrary to superior (23.61%) and combined approach (11.11%). Lead dilatation was necessary in 80.56%, and grasping and traction was effective in 18.06%. In 66.7%, the proximal end was strongly attached to the wall and a pulling loop had to be applied. In 15.28% of procedures the lead was wrapped around a pig-tail catheter ("spaghetti twisting technique"), which was sometimes sufficient to free the lead end. This manoeuvre was especially helpful in releasing the leads with their tip in the distal branch of the pulmonary artery. All these manoeuvres were performed from the femoral or superior approach, depending on the anatomical conditions. Extraction of MPLEs did not influence long-term survival. The rate of major complications was 2.78% but it may be attributed to long implant duration (152.2 months) and were not the result of extraction of LMPEs.

Conclusions

1. Extraction of leads with migrated proximal ends (LMPEs) is rare among other TLE procedures (1.9%), 2. Risk factors include abandoned leads and presence of leads on both sides of the chest. 3. Complexity of LMPEs extraction is higher as regards procedure duration, unexpected procedure difficulties, use of advanced tools and techniques but rates of major complications are comparable to other leads but in spite of a high level of procedure complexity its effectiveness is also high (procedural success rate 93.06%) with an acceptable rate of major complications. 4. Extraction of LMPEs did not influence long-term survival.
Severe lead induced tricuspid regurgitation - clinical impact of repair or replacement of tricuspid valve
Authors: Santos A R , Albuquerque F , Castelo A , Ferreira V , Rio P , Timoteo A T , Galrinho A , Branco L , Varela F , Leal A , Santos H , Valente B , Osorio P , Oliveira M , Ferreira R
Published: May 2024

The prevalence of lead-induced tricuspid regurgitation (LITR) ranges between 7 to 45%. The most frequent mechanism of LITR is the impingement of the leaflets, but right ventricle remodelling, pacing-induced cardiomyopathy and tricuspid annular dilatation also can contribute to the severity of tricuspid regurgitation (TR). Different studies concluded that LITR was associated with an increased risk of all-cause mortality and heart failure hospitalizations. Beyond diuretics, patients (P) may be candidates for interventional treatment, including lead extraction, surgery, or percutaneous tricuspid trans-catheter ‘edge-to-edge’ repair (TEER) and heterotopic bicaval devices (HBD). Despite its importance, there is a scarcity of data concerning the management and clinical impact of severe LITR. The purpose of the current analysis is to improve the knowledge regarding the impact of interventional treatment on the outcomes in this population.

Methods

A retrospective, single-centre analysis was made including P with severe LITR referred to evaluation regarding eligibility for tricuspid percutaneous intervention in a tertiary hospital. All P were evaluated using both transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE). Data were collected regarding clinical characterization, management, intervention and follow-up.

Results

From January 2020 to September 2023, of the 97 P referred for tricuspid intervention eligibility, 36 (37%) had LITR, with 14 cases (39%) presenting lead impingement as the TR mechanism. The majority of P were female (58%), with a median age of 78 [IQR 72-83] years. Median Euroscore II was 6 % [IQR 3-9]), with 51% of the P having a previous heart surgery, and 97% presenting atrial fibrillation. Prior to cardiac electronic device (CIED) implantation, 14% already presented TR. When analysing post-CIED TR, 30% increased 1 grade of TR at 1-year follow-up, and 68% increased 2 grades of TR at 5 years. According to TTE, ventricular desynchrony was present in 30% of the P. After evaluation of TR, 30% underwent intervention (22% percutaneous - TEER or HBD - and 8% surgical). All P remained with the previous electrodes. Mortality was 21.1% in the intervention population and 78.9% on the remaining pts (p=0.027). The type of intervention had no statistically significant differences in outcome.

Conclusions

In our study, more than 1/3 of the cases referred due to severe TR presented lead impingement as the mechanism underlying TR. As previously reported, the intervened population had better outcomes than the remaining pts.
Explainable AI for myocardial infarction using the vectorcardiogram
Authors: Ramirez E , Ruiperez S , Castells F , Millet J
Published: May 2024

Background and purpose

Myocardial infarction (MI), a widespread cardiovascular ailment, often lacks immediate patient awareness being early and accurate MI diagnosis crucial for lifesaving interventions. In artificial intelligence studies, ECG signals are extensively explored, while fewer examine the potential of vectorcardiogram (VCG) which offers a three-dimensional cardiac dipole representation. Traditional Machine Learning methods manually extract features; some studies advocate VCG features. Deep Learning, especially Convolutional Neural Networks (CNN), automates feature extraction. Although ECG contains redundant information from the VCG's 12 projections, no studies directly apply CNNs to VCG, nor assess the impact of redundancy on predictive ability. This study aims to bridge this gap by investigating CNNs' diagnostic capabilities with VCG inputs, specifically focusing on improving MI classification.

Methods

The PTB-XL database was used for this study, containing 10-seconds ECG data from various pathologies, including MI. The database encompasses 9,481 records from healthy patients and 4,129 records from patients with MI. Data was divided into 80% for training and 20% for testing. Consequently, the dataset was expanded to have 52% representing MI and 48% representing healthy cases. We designed a 1D-CNN classifier (Figure 1.A) with three convolutional layers. The network was trained using both ECG and VCG reconstruction through the Inverse Dower Transform.

Results

The trained model achieved accuracy values of 0.895 and 0.914 for the test set when utilizing ECG and VCG, respectively. These results underscore how the information condensation in the VCG contributes to an enhanced predictive capacity of the model. In a qualitative analysis, activation maps extracted from the CNN illustrate heightened activation in the QRS complex when the disease is present, contrasting with diminished activation in its absence. These maps depict the weight assigned to each signal segment, enabling the classification of signals into healthy and diseased categories. The presented figure exemplifies a notable activation in the QRS loop in the case of myocardial infarction (MI), aligning with the observed alteration in the cardiac signal associated with this pathology (Figure 1.B).

Conclusion

In this study, an interpretable CNN has been designed for MI detection, with the VCG yielding better results than the ECG for this task due to information compression. This provides a new insight for enhancing classification capability in Deep Learning models, allowing for advancements in the MI detection.
A polygenic risk score predicts future atrial fibrillation-related stroke/systemic embolism
Authors: Park H , Yang P S , Kim D H , Jang E S , Yu H T , Kim T H , Sung J H , Pak H N , Lee M H , Joung B Y
Published: May 2024

Background

Novel strategies to identify patients at risk of stroke/systemic embolism (SSE) earlier before development of clinical atrial fibrillation (AF) might be useful. We examined whether the AF polygenic risk score (PRS) added to a clinical risk model would improve prediction of AF-related SSE in people without prevalent AF.

Methods

A total of 62,145 individuals (≥65 years) without prevalent AF who had additional risk factors for stroke (hypertension, diabetes, heart failure, myocardial infarction, stroke or transient ischemic attack, and peripheral artery disease) were included from the UK Biobank. The primary endpoint was AF-related SSE and the secondary endpoint was incident AF. SSE event was considered AF-related when previously undiagnosed AF was identified at the time of SSE or up to 1-year after the SSE.

Results

For a median of 11.5 (10.6-12.4) years, 334 AF-related SSE and 7,428 incident AF events developed. After adjusting for the clinical risk model, AF-PRS identified a significant gradient for AF-related SSE and incident AF with a 4.59-fold (HR 4.59, 95% CI 3.12-6.75, p<0.001) and 3.14-fold (HR 3.14, 95% CI 2.90-3.40, p<0.001) higher risk in the top quintile of the AF-PRS. The number needed for 5-years of AF screening at the index age of 75 years to find 1 AF-related SSE and incident AF was 91 and 10 for high AF-PRS and 500 and 22 for low AF-PRS, respectively. AF-PRS added to a clinical risk model resulted in a significant improvement in C-statistics for AF-related SSE (C-index; 0.66 to 0.72, p for difference in C-index <0.001) and incident AF (C-index; 0.65 to 0.68, p for difference in C-index <0.001).

Conclusions

AF screening strategy based on AF-PRS added to a clinical risk model might detect and potentially prevent more cases of AF-related SSE.
Results of external validation for anatomical site recognition of ablation sites in atrial fibrillation using the CARTONET R12 model
Authors: Sasaki W , Kudou D , Tanaka N , Naganuma T , Narita M , Matsumoto K , Mori H , Tsutsui K , Ikeda Y , Kato R
Published: May 2024

Background

CARTONET® is a cloud-based management system designed for retrospective analysis of ablation procedures using the CARTO system. Leveraging a proprietary machine learning model, it automates procedural information analysis. However, the efficacy and accuracy of the CARTONET R12 model's automated location identification remain unverified.

Methods

This study involved a total of 396 cases. Pulmonary vein isolation (PVI), including cavo-tricuspid isthmus (CTI) ablation, was performed in 313 patients (PVI group). PVI and additional ablation, such as a Box isolation and superior vena cava isolation (SVCI), was performed in 83 patients (PVI+ group). We compared the automated location identification of R12 model and the location identification of arrhythmia experts.

Results

In this study, 29,422 points were analyzed. The sensitivity of the pulmonary vein carina was low in both PVI group and PVI+ group. Excluding the inferior, anterior, and ridge segmentations, PVI group demonstrated significantly higher sensitivity compared to PVI + group. Regarding the ablation lines for box isolation, both the roof line and post line showed results below 30%. The pulmonary vein carina showed a low PPV in both PVI group and PVI+ group. In segmentations excluding the anterior, PVI group demonstrated significantly higher PPV compared to the group PVI+. Regarding the ablation lines for box isolation, both the roof line and post line showed results below 50%.The R12 model couldn't auto-identify CTI and SVC.

Conclusion

Excluding the carina, it can be said that in cases where PVI was performed, both PPV and sensitivity demonstrate high accuracy. Conversely, in cases where Box isolation was performed, accuracy decreases due to the low discrimination ability between ablation information near the roof, posterior wall, and inferior wall of the pulmonary veins and the ablation lines of Box isolation. Regarding the right atrium, it was found that the R12 model is entirely incapable of discriminating SVC and CTI, indicating a need for revisions in the current model.The segmentation of anatomyResults of the positive predict value
Performance of a vectorcardiographic deep learning algorithm compared to single-lead and 12-lead ECG for atrial flutter detection: implications for wearable devices
Authors: Lampert J , Vajdic B , Shvilkin A , Zimetbaum P , Oguz A , Vaid A , Nadkarni G , Reddy V Y
Published: May 2024

Background

Wearable devices have developed the capacity to offer single-lead ECG analysis and are already widespread in use, particularly for detection of atrial fibrillation (1,2). Vectorcardiography entails the transformation of electrical vectors into X, Y, and Z axes to constitute a vectorcardiogram (VCG) (3). The VCG has diagnostic promise given the capacity to generate it without requiring clinical presentation for standard 12-lead ECG acquisition. Furthermore, a novel credit-card sized device capable of acquiring a VCG has recently been developed – raising the potential for arrhythmia detection and discrimination beyond wearable single-lead ECG systems.

Objective

To assess the performance of a deep learning algorithm trained on single lead and 12-lead ECGs and VCGs for detecting atrial flutter.

Methods

A convolutional neural network (AFL-CNN) was developed on a dataset of 4,000 ECGs and VCGs from a single US academic medical institution (80% training and 20% for testing). Validation was performed on a separate publicly available dataset (2223 ECGs). Model performance was assessed on single lead ECG analysis (lead I, obtained by removing the other leads) and standard 12-lead ECG. The gold standard for AFL diagnosis was physician-confirmed 12-lead ECG diagnoses in the dataset. The VCG was generated from the 12-lead ECG via Kors transformation matrix to which AFL-CNN was also applied. Model performance was assessed with sensitivity, specificity, positive and negative predictive values, accuracy, and F1 statistic.

Results

On single lead ECG analysis, AFL-CNN achieved 71.2% sensitivity and 96.9% specificity with PPV 84.0% and NPV 93.7% and 92.2% accuracy with F1 83.2%. When AFL-CNN was applied to the VCG, performance improved: 91.0% sensitivity and 98.7% specificity, PPV 94.24%, NPV 98.0%, 97.3% accuracy, and F1 95.31%. Lastly, the performance remained high when AFL-CNN was applied to the 12-lead ECG: 95.4% sensitivity, 98.63% specificity, PPV 94.0%, NPV 99.0%, and accuracy of 98.0%, with F1 97.2%.

Conclusion

A deep learning algorithm applied to vectorcardiography for the detection of atrial flutter showed improved performance over single lead analysis and comparable performance to standard 12-lead applications. The finding of improved model performance beyond single lead ECG tracings underscores both the limitations of current wearable technologies in arrhythmia detection beyond atrial fibrillation and the potential for VCG-based algorithm prediction to fill gaps in healthcare inequality when standard 12-lead acquisition is challenging to obtain.