bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of the use of cusp overlap projection technique in the incidence of post-TAVR permanent pacemaker implantation with self-expanding valves
Authors: Moura A , Rodrigues JA , Guerreiro C , Pires-Morais G , Santos L , Melica B , Braga P , Fontes-Carvalho R
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Current rates of new Permanent Pacemaker (PPM) Implantations in the context of Transcatheter Aortic Valve Replacement (TAVR) range from 2-36% and that necessity is related to worse prognosis. The use of self-expanding valves and a lower valve implantation depth are two factors associated with an increased risk of conduction disturbances post-TAVR. Theoretically, cusp overlap implantation technique has the potential to enable a higher valve deployment by eliminating parallax of the delivery catheter.

Aim

To compare the in-hospital incidence of PPM post-TARV using self-expandable valve according to the fluoroscopic guidance technique.

Methods

Retrospective, single-centre study, with evaluation of patients consecutively submitted to TAVR with self-expanding CoreValveTM between July 2020 and December 2021 dichotomized according to the use of cusp overlap implantation technique for fluoroscopic valve implantation guidance.

Results

138 patients were included, predominantly women (57.2%), with a mean age of 78.4±8.0 years old, with severe aortic stenosis of the native valve being the most common indication for TAVI (85.5%). Cusp overlap view technique was applied in 50.7% of the patients (n=70). Frailty and co-morbidities were the most common cause for surgical refusal (54.3%). There was a significantly higher percentage of hypertensive patients (92.9% vs. 77.9%), lower previous aortic valve surgery (2.9% vs. 16.2%) and lower percentage of patients previously medicated with b-blockers in the group of patients in whom was used the cusp overlap technique; there were no other relevant differences related to the baseline characteristics. First degree atrioventricular block was present in 19.6% and complete right bundle block in 13.6% of the patients. Incidence of in-hospital post-TAVR PPM implantation wasn’t significantly different between the two cohorts of patients (cusp overlap vs. standard approach: 24.3% vs. 26.5%, p=0.77) (71.4% implanted in the context of complete heart block). Likewise, there were similar proportions of in-hospital new-onset of complete left bundle branch block (35.8% vs. 37.3%, p=0.86), volume of contrast used (140.6±37.5 mL vs. 145.2±51.5 mL, p=0.12), fluoroscopy time (15.6±8.8 min vs. 19.6±8.9 min, p=0.40) and radiation dose (556.3±320.6 mGy vs. 859.4±531.2 mGy, p=0.06).

Conclusions

This study shows that using the cusp overlap view for self-expanding valve implantation does not seem to achieve a significant reduction in in-hospital PPM implantation rate in comparison with the traditional 3 cusp co-planar fluoroscopic view. A larger and probably randomized clinical trial is needed to confirm these results.
Learning curve of left bundle branch area pacing with standard stylet-driven pacing leads: a single center prospective observational study in Korea
Authors: Yu G , Kim TH , Yu HT , Joung BY , Pak HN , Lee MH
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Although cardiac pacing is an essential therapy for bradycardia, conventional right ventricular pacing (CRVP) can cause electrical-mechanical dyssynchrony. Left Bundle Branch Area Pacing (LBBAP) is a new conduction system pacing strategy that includes a normal conduction system and therefore maintains synchronous ventricular contraction. Most of the experience with LBBAP is done in a lumen-less lead with fixed helix design, and this device is not available in sometimes.

Purpose

This study aimed to evaluate the learning curve of LBBAP using standard stylet-driven lead with extendable helix design.

Methods

This study enrolled patients who underwent permanent cardiac pacemaker implantation at a University Hospital in South Korea from December 2020 to October 2021. LBBAP was performed with a 5.6Fr stylet-driven pacing lead with an extendable helix. The learning curve was assessed by analyzing fluoroscopy time and procedure time.

Results

In 65 patients who underwent LBBAP during the observation period, mean fluoroscopy time and procedural time were 17.1 ± 17.2 minutes and 64.2 ± 33.5 minutes, respectively in this study. The learning curve for achieving LBBAP appears to plateau after around 24th case with a progressive reduction in procedure time. This is a significantly shorter period of time when compared to the previously reported learning curves of his bundle pacing (30-50cases), previously developed conduction system pacing strategy.

Conclusion

During initial experience with LBBAP, fluoroscopy and procedural time continue to improve with operator experience. For physicians who are experienced at cardiac pacemaker implantation, the steepest part of the learning curve of LBBAP appears to be over the first 20-25 cases.
VDD leadless pacemaker: atrioventricular synchrony predictors
Authors: Estevez Paniagua A , Briongos Figuero S , Sanchez Hernandez A , Munoz Aguilera R
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Leadless pacemaker technology has shown a reduction of the complications associated with conventional pacemakers. The development of the VDD mode has allowed us to extend the use of leadless pacemakers to patients in need of pacing due to atrioventricular (AV) block. Maintaining AV synchrony (AVS) in cardiac pacing improves cardiac output and quality of life and reduces the risk of atrial fibrillation (AF) and pacemaker syndrome. In previous analyses, it was observed that the low amplitude of the A4 signal was associated with low AVS.

Methods

Prospective single-center study of consecutive patients who received a VDD leadless pacemaker (Micra AV), and who remained in VDD mode throughout the follow-up. Our purpose was to analyze the possible predictors of A4 signal amplitude and AVS in the first month of follow-up. We tested univariate association with A4 signal and AVS of echocardiographic data, clinical variables, implant parameters, and pacemaker function.

Results

We included data from the first 21 patients who received a VDD leadless pacemaker (Micra AV) between Jun/20 and Apr/21. 18 patients remained in VDD mode after the first month of follow-up. There was no significant association between ventricular filling waves (E and A) and Tissue-Doppler diastolic waves (E ’and A’) with the A4 signal and the percentage of AVS. Only the E / A ratio showed a trend of association with the percentage of AVS, although it did not reach statistical significance (p = 0.09), showing an inverse relationship (Pearson’s correlation coefficient of -0.396). None of the clinical variables analyzed showed an association with the A4 signal or with the percentage of AVS. Only the A4 signal was significantly associated with the percentage of AVS (Pearson´s correlation coefficient of 0.524, p = 0.02). Considering 85% as an adequate discriminator for correct AVS, the mean signal of A4 was significantly lower (p = 0.03) in those with AVS < 85% (2.63 ± 1.73) compared with those with AVS≥85% (4.37± 1.34). Regarding implant factors, there seems to be a tendency to worse AVS with higher number of releases (p = 0.06, Pearson’s correlation coefficient of -0.460), as well as when implanting in positions further away from the atrium (medium interventrcular septum vs. high interventricular septum / proximal right ventricular outflow tract; p = 0.06, Pearson’s correlation coefficient of -0.463).

Conclusions

Although this is a short case series, our results are aligned with the data from the MARVEL2 AVS predictors substudy. It appears that the main predictor of higher AVS is the A4 signal. Device position, as well as the number of releases, could also play a role. Nevertheless, it is necessary to continue the analysis with the data of future patients to corroborate these preliminary findings.
Right ventricular lead sensing latency in pacemaker therapy
Authors: Zagkli F , Kalovrenti N , Patrinos P , Chronopoulos P , Chiladakis J
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Pacemaker’s ventricular sensing function relies on the analysis of the intracardiac electrogram (EGM) including the timing of the intrinsic detection. The phenomenon of ventricular sensing latency refers to the gap of time by which the intrinsic signal gets delayed to be detected compared with the surface electrogram (ECG). A pacing system analyzer (PSA) unit is needed to record the EGM during pacemaker operation, which is expected to correspond to those taken following implantation.

Purpose

We sought to determine the latency period for sensing EGM by the right ventricular (RV) lead, either through the PSA or through the implanted pacemaker on the same patient.

Methods

Patients without significant heart disease and intrinsic atrioventricular conduction underwent conventional dual-chamber Medtronic or Abbott pacemaker implantation with the RV lead positioned on mid-septum. Real time sensing data was obtained through PSA and after pacemaker implantation. The RV lead sensing latency was defined as the time interval Q-VS measured from the beginning of QRS on ECG to the released ventricular sensed (VS) event marker on either device.

Results

Of 157 patients, 105 had narrow QRS (<120 ms) and 52 had wide QRS (≥120 ms) of right bundle branch block (RBBB). Both narrow QRS and RBBB patients had longer sensing latency through PSA (50.9 ± 24.2 ms and 67.8 ± 32.9 ms, respectively) than through pacemaker (18.2 ± 12.8 ms and 31.2 ± 14.8 ms, respectively, both p<0.001). RBBB patients had longer sensing latency compared with narrow QRS patients, either through PSA or through pacemaker (p<0.001). The sensing latency of Medtronic recipients was longer than those of Abbott in narrow QRS, but not in RBBB (p=0.03 and p=0.08, respectively).

Conclusion

We demonstrated longer RV lead sensing latency (1) through PSA than through the implanted pacemaker, (2) in RBBB than in narrow QRS, (3) in Medtronic pacemakers compared with Abbott pacemakers. Knowledge of the RV lead sensing latency helps optimization of atrioventricular delay and reduces unnecessary ventricular pacing.
The subcutaneous ICD replacement in the clinical practice: preliminary observations from the multicentre RHYTHM DETECT
Authors: Bianchi V , Viani S , De Filippo P , Dello Russo A , Checchi L , Biffi M , Caravati F , Giammaria M , Pisano’ E , Papa A , Francia P , Bongiorni M , Valsecchi S , D’onofrio A
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Experience with the subcutaneous implantable cardioverter-defibrillator (S-ICD) is expanding rapidly. However, few data on generator replacement exist.

Purpose

The aim of this analysis was to describe the procedural characteristics of the pulse generator replacement in the current Italian practice and to provide a preliminary insight in the possible acute complications associated with first elective S-ICD generator replacements.

Methods

We analyzed 106 consecutive patients enrolled in the Rhythm Detect registry who underwent elective replacement of the S-ICD generator from September 2019 to July 2021. Procedures were accomplished according to the local clinical practice. A chest X-ray was performed, and the PRAETORIAN score was assessed and compared with the one measured after the first implantation.

Results

All replacements were performed in electrophysiology laboratories, 50% in day-hospital regimen, by 1 or 2 expert operators. Procedures were performed using local (87%) or general anaesthesia (13%). The median procedure duration was 40 (30-45) min. The previous S-ICD generator was in a subcutaneous pocket in 58 (55%) patients, and in an intermuscular pocket in the remaining patients. The PRAETORIAN score of the previous system was low (<90) in 93% of patients and intermediate in 7% of patients. In all patients with the device in an intermuscular pocket, the PRAETORIAN score was <90. During the replacement procedure, 22 S-ICD (3 with PRAETORIAN ≥90 before replacement) were removed from the initial subcutaneous position and placed in an intermuscular pocket. After replacement all patients with intermuscular devices had a score <90, and the overall proportion of patients with low-risk PRAETORIAN score raised to 97%. Defibrillation testing was performed only in 10% of patients, while testing was performed in 77% of patients at the first implantation procedure. No procedure-related complications occurred.

Conclusions

S-ICD replacements seem easy to perform with no peri-procedural complications. The adoption of an intermuscular pocket is associated with optimal positioning according to the PREATORIAN score, and seems preferred also in many cases of generators previously placed subcutaneously. In the Italian clinical practice conversion testing is rarely performed at device replacement.
A multicentric observational study of patients affected by advanced heart failure with implantable cardioverter defibrillator and left ventricular assist devices
Authors: Pignalosa L , Casula M , Rordorf R , Perna E , Baroni M , Garascia A , Guida S , Gazzoli F , Pini D , Cannata F , Pellegrino M , Vergara P , Della Bella P , Gulletta S
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Left ventricular assist device (LVAD) implantation is increasingly used in patients with end-stage heart failure. Most patients already have an implantable defibrillator (ICD) at the time of L-VAD implantation. Studies on this patient population are limited by the small sample size and the short duration of follow-up.

Purpose

The aim of this study was to retrospectively describe the real-world management of patients implanted with both ICD and LVAD. The main objective was to evaluate the incidence and predictors of appropriate and inappropriate therapies of the ICD and the incidence and predictors of ICD related complications.

Methods

212 patients were enrolled in four Centers in the period between July 2006 and November 2020. The inclusion criteria were age> 18 years, advanced heart failure, patients with ICD and concomitant or subsequent continuous flow LVAD implantation. ICD therapy was defined as antitachycardia pacing therapy or shock.

The data available at the last visit with a median follow up of 21 months were analyzed.

Outcome predictors were assessed by univariate logistic regression and the variables of interest included in a multivariate model.

Results

The rate of appropriate ICD therapies was 29.7%, while the incidence of inappropriate therapies was 10.4%; in the multivariate analysis the presence of a zone therapy with low detection rate (VT zone with median detection rate of 164.5 bpm) was found to be an independent predictor of the composite of appropriate and inappropriate therapies (OR = 19.05; CI = 2.19-165.21; p = 0.007). Interference between ICD and LVAD occurred in 7.5% of cases; the incidence of infectious complications related to the ICD was 7.1% and bleeding complications of 5.2%; in the multivariate analysis, ICD generator replacement was an independent predictor of total complications related to the ICD (interference, infectious and bleeding; OR = 4.45; IC = 1.60-12.36; p = 0.004). 103 patients had CRT defibrillator (48,6%). At follow up there was no statistically significant difference in the incidence of appropriate therapies between those who had CRT-on (n=74) and those who had CRT-off (n=29; p = 0.61).

Conclusions

Patients with LVAD implanted with an ICD experience a high rate of appropriate and inappropriate ICD therapies. An active VT zone at low heart rate was found to be an independent predictor of ICD therapies. Of more, ICD generator replacement was found to be an independent predictor of total complications related to the ICD. Our findings suggest the importance of tailoring device programming in order to minimize the incidence of ICD therapies, thus sparing the need for generator replacement in this population.
Comparison between his-bundle pacing and biventricular pacing as cardiac resynchronization therapy for heart failure patients: a systematic review and meta-analysis
Authors: Toding Labi N , Rampengan D , Rampengan S
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Cardiac resynchronization therapy (CRT) has demonstrated significant improvements in cardiovascular outcomes of selected heart failure patients. However, conventional biventricular CRT implantation can be challenging due to unfavorable coronary sinus anatomy, leads to lead instability, poor capture, and insufficient cardiac resynchronization. His-bundle pacing has gained interest as alternative strategy for patients underwent biventricular CRT implantation when coronary sinus lead implantation is unsuccesful or in non-responder cases.

Purpose

This study aims to compare the efficacy of his-bundle pacing and biventricular pacing in improving electrocardiographic, echocardiographic, and clinical parameters of heart failure patients that required resynchronization therapy.

Methods

A search for eligible studies was conducted until August 2021 on three databases (PubMed, ScienceDirect, ProQuest). Included studies were evaluated for risk of bias. Our primary outcomes of interest were mean difference in QRS duration, left ventricular ejection fraction (LVEF), and change in systolic blood pressure (SBP). We also investigated left ventricular activation time, left ventricular dyssynchrony index, left ventricular end-systolic volume (LVESV), New York Heart Association (NYHA) functional class, 6-minute walk test, quality of life, heart failure hospitalization and cardiovascular or all cause death. Review Manager (RevMan) 5.4 was utilized to compute mean differences.

Results

We identified five studies from 2010 to 2019, involving 95 heart failure patients underwent CRT implantation. Pooled analysis showed that his-bundle pacing resulted in significant narrowing of QRS duration compared to biventricular pacing [Mean Difference -23.17 ms (95% CI -36.10, -10.24; p=0.0004; I2=0.63)]. Left ventricular activation time and left ventricular dyssynchrony index were significantly improved in his bundle pacing. There were no significant differences of changes in LVEF, LVESV, and SBP. Clinical parameters such as NYHA functional class, 6-minute walk test, and quality of life were significantly improved in both pacing modality. No significant difference in heart failure hospitalization and cardiovascular or all cause mortality.

Conclusion

His-bundle pacing delivers better decrease of QRS duration, also reduction in left ventricular activation time and left ventricular dyssynchrony index compared to biventricular pacing. These suggests that his-bundle pacing is a reasonable alternative option for cardiac resynchronization therapy.
Feasibility, safety and outcomes of upgrading to left bundle branch pacing in patients with right ventricular pacing induced cardiomyopathy
Authors: Rademakers LMF , Bouwmeester S , Mast TP , Bracke FA
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Right ventricular pacing (RVP) induces abnormal electrical activation and asynchronous ventricular contraction and leads to pacing induced cardiomyopathy (PICM) in 10-20% of patients. Cardiac resynchronization therapy (CRT) utilizing biventricular pacing (BVP) is the recommended treatment. Left bundle branch pacing (LBBP) is a novel physiological pacing technique which may serve as an alternative to CRT. This study assessed feasibility and outcomes of LBBP delivered CRT in patients with PICM.

Methods

Twenty consecutive patients with PICM who received an upgrade of their pacemaker to LBBP were prospectively studied. Acute success rate, complications, functional and echocardiographic response and hospitalization for heart failure within six months from implantation were evaluated.

Results

LBBP was successfully delivered in all patients. Median duration of RVP before upgrade to LBBP was 3.8 years and the RVP percentage was 99. LBBP resulted in significant QRS narrowing (from 192 ± 18 to 131 ± 17 ms (p<0.001)), improvement in LVEF (from 31 ± 6 percent to 44 ± 8 percent (p<0.001)) and NYHA class (from 2.7 ± 0.5 to 1.4 ± 0.5 (p<0.001)) at 6 months. No LBBP-related complications occurred and no hospitalization for heart failure or death occurred.

Conclusion

LBBP is feasible and safe in delivering CRT in PICM. Preliminary analyses demonstrated significant electrical resynchronization and favourable improvement in LV function and NYHA functional class at short term follow-up. Data need to be validated in large randomized controlled trials.
Impact of anticoagulation therapy on outcomes in patients undergoing transvenous lead extraction
Authors: Dias Ferreira Reis JP , Valente B , Portugal G , Lousinha A , Silva Cunha P , Oliveira M , Cruz Ferreira R
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Oral anticoagulation (OAC) is essential for patients (pts) at high risk for thromboembolism. However,uninterrupted anticoagulation and bridging with enoxaparin increases the risk of pocket hematoma (PH) andinfection (I).

Aim

To evaluate the impact of OAC in the rate of PH and outcomes in pts undergoing lead extraction (LE) usingthe Pisa Technique (PT).

Methods

A single centre prospective study of consecutive procedures (Pr) of LE using the PT between February2013 and October 2019. Demographic, clinical, device and procedure related variables, morbidity and mortality(M) data were compared between pts without OAC (O0) and pts with AC (O1).

Results

320 electrodes (E) were removed in a total 171 Pr in 159 pts (mean age - 67.7 years, mean LVEF - 48%,male - 72%). The LE were from the following implanted systems: pacemaker – 110 pts, cardiac resynchronizationtherapy – 29 pts, cardioverter-defibrillator – 20 pts. The radiological success rate was 91.2% and the clinicalsuccess rate was 98.3%. There were 14 cases of PH. During a mean follow-up (FU) of 33 months, 11 pts had toundergo a new Pr, 5 of them due to pocket I. 8 pts (5.0%) died during hospital stay, and 19 pts during the firstyear post-Pr. There were no deaths during the Pr. O1 included 56 pts (35.4%), of which 51.9% were under vitaminK antagonists (AVK) and 48.1% under direct oral anticoagulants (DOAC). 11 pts were receiving OAC due toprosthetic mechanical valve, and the remainder due to atrial fibrillation (AF). Pts in O1 were significantly older(p=0.026), presented a lower LVEF (p=0.001), a higher prevalence of valvular heart disease - VHD -(p=0.002),overt heart failure (p=0.006), AF (p<0.001) and previous cardiac surgery - CS - (p<0.001). OAC was associatedwith a higher rate of PH (OR 2,44, IC 95% 1.02-5,84, p=0.046) and pts with PH presented a significantlyprolonged hospital stay (22.7 vs 9.8 days, p=0.031). These pts also presented a higher hospitalization rate duringthe first year post-Pr (OR 2,48, IC95% 1.27-4.88, p=0.009). There was no difference in all-cause hospital M(p=0.522), all-cause M during first year of follow-up (p=0.551) or need for reintervention (p=0.375). Among pts inO1, pts under AVK presented a significantly higher rate of PH (OR 18,67, IC95% 2,23-156,17, p=0.007).

Conclusion

Pts receiving OAC, particularly pts under AVK, presented a higher rate of PH after LE. PerioperativeOAC management is crucial to reduce the morbidity rate in this population.
Procedural outcome and risk prediction in patients with implantable cardioverter-defibrillator (ICD) undergoing transvenous lead extraction: a GALLERY subgroup analysis
Authors: Chung D , Burger H , Kaiser L , Osswald B , Baersch V , Naegele H , Knaut M , Reichenspurner H , Willems S , Butter C , Pecha S , Hakmi S
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Device complications, such as infection or lead dysfunction necessitating transvenous lead extraction (TLE) are continuously rising amongst patients with indwelling transvenous implantable cardioverter-defibrillator (ICD).

Objectives

Aim of this study was to characterize the procedural outcome and risk factors of patients with indwelling 1- and 2-chamber ICD undergoing TLE.

Methods

We conducted a subgroup analysis of all 1- and 2-chamber ICD patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for procedural failure and all-cause mortality were assessed.

Results

A total of 854 patients with ICD undergoing TLE were identified, who were younger (62.9±13.8 vs. 70.7±13.0 years; p<0.001), less likely to be female (20.8 vs. 27.1%; p<0.001) and had a higher proportion of patients with coronary artery disease (51.5 vs. 38.6%; p<0.001) and highly reduced ejection fraction (32.0 vs. 23.0%; p>0.001), when compared to non-ICD patients. Leading extraction indication was lead dysfunction (48.0 vs. 21.9%; p<0.001), followed by device-related infection (45.6 vs. 73.0%; p<0.001). There were no differences in overall procedural complications (4.3 vs. 4.3%; p=0.980), clinical success rate (97.9 vs. 97.8%; p=0.861) or procedure-related (0.8 vs. 0.5%; p=0.292) and all-cause mortality (3.4 vs. 3.7%; 0.742) between groups. Multivariate analysis revealed lead age≥10 years (OR:5.75, 95%CI:2.0-16.2; p=0.001) as independent predictor for procedural failure. Systemic infection as extraction indication (OR:9.57, 95%CI:2.2-42.4; p=0.003) and procedural complications (OR:8.0, 95%CI:2.8-23.3; p<0.001) were identified as risk factors for all-cause mortality. Predictors for systemic infection in ICD patients were atrial fibrillation (OR: 2.22, 95%CI: 1.51-3.27; p<0.001), diabetes mellitus (OR: 2.28, 95%CI: 1.59-3.25; p<0.001) and chronic kidney disease (OR: 2.0, 95%CI: 1.39-2.89; p<0.001).

Conclusions

Transvenous lead extraction is safe and efficacious in patients with 1- and 2-chamber ICD. Although lead dysfunction is the leading indication for extraction, systemic device-related infection is the main driver of all-cause mortality for ICD patients undergoing TLE.
A head-to-head comparison of the first choice and crossover lead extraction tool: laser vs. mechanical
Authors: Vamos M , Zsigmond EJ , Benak A , Miklos M , Makai A , Hegedus Z , Alacs E , Agocs SZ , Saghy L
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

During transvenous lead extraction (TLE) longer dwelling time often requires the use of powered sheaths.

Purpose

This study aimed to compare outcomes with the laser and mechanical tools.

Methods

Single-center data from consecutive patients undergoing TLE between 2012 and 2021 were retrospectively analyzed. Efficacy and safety of the primary extraction tool were compared. Procedures requiring crossover between powered sheaths were also analyzed. Moreover, we examined the efficacy of each level of the stepwise approach.

Results

Out of 166 patients 142 (age 65.4±13.7 years) underwent TLE requiring advanced techniques with 245 leads (dwelling time 9.4±6.3 years). Laser sheaths were used in 64.9%, mechanical sheaths in 35.1% of the procedures as primary extraction tools. Procedural success rate was 85.5% with laser and 82.5% with mechanical sheaths (p=0.552). Minor and major complications were observed in similar rate. Procedural mortality occurred only in the laser group in case of 3 patients. Crossover was needed in 19.5% after laser and in 12.8% after mechanical extractions (p=0.187). Among crossover procedures only clinical success favored the secondary mechanical arm (87.1% vs. 54.5%, aOR: 0.09, 95%CI: 0.01-0.79, p=0.030). After step-by-step efficacy analysis, procedural success was 64.9% with the first-line extraction tool, 75.1% after crossover, 84.5% with bailout femoral snare, and 91.8% by non-emergency surgery (Figure).

Conclusion

The efficacy and safety of laser and mechanical sheaths were similar in our study, however in the subgroup of crossover procedures mechanical tools had better performance regarding clinical success. Device diversity seems to be indispensable in order to achieve the most optimal outcomes.
Occluded vein as a predictor for complications in non-infectious transvenous lead extraction
Authors: Milman A , Massalha E , Jia K , Meitus A , Kariv S , Shafir Y , Glikson M , Luria D , Sabbag A , Beinart R , Nof E , Leshem E
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Cardiovascular implantable electronic device (CIED) use is steadily increasing, with subsequent need to solve lead failure issues and device upgrades with an occluded vein. Transvenous lead extraction (TLE) has inherent risks that must be carefully weighed. Currently there is lack of conclusive data regarding many non-infectious indications.

Methods

A retrospective study on indications and outcomes of TLE for non-infectious reasons at our medical center, between the years 2011 to 2020 was performed. Occluded vein (OV) presence was compared for characteristics, extraction methods and periprocedural complications and outcomes.

Results

A total of 88 patients underwent TLE for non-infectious reasons. The majority were referred due to lead malfunction (70.5%) and CIED upgrade with an OV (25%), while 4 patients had other TLE indication (intractable pain, heart transplant, severe Tricuspid regurgitation, and irradiation). fourteen patients referred due to lead malfunction had an OV observed during venography.

The OV group (36 patients) were significantly older (65.7±14.1 vs 53.8±15.9 respectively, p=0.001) and had more comorbidities. EF was significantly lower for the OV group (27.5% vs 57.5%, p=0.001) as was longer lead dwell time (3226±2324 vs 2191±1355 days, respectively, p=0.012).

Major complications were exclusive for the OV group (16.7% vs none, p=0.02), and most minor complications occurred in the OV group as well (38.9% vs 4.1% respectively, p<0.001). Laser sheath and Mechanical tools for TLE were frequently used for OV as compared to the non-occluded group (94.4% vs 73.5% respectively, p=0.012). Procedure success was higher in the non-occluded group compared to the OV group (98% vs 83.3%, respectively, p=0.047). Despite these results, peri-procedural mortality was similar between groups.

Conclusions

Among TLE for non-infectious reasons, vein occlusion appears as a major predictor for complex TLE tools use, complications, and procedural success. Venography should be routinely performed prior to non-infectious TLE to identify high-risk patients.
Lead complications after cardiac surgery in danish patients with cardiac implantable electronic devices: a nationwide nested case-control study
Authors: Frausing MHJP , Nielsen JC , Johansen JB , Jorgensen OD , Kristensen J , Olsen T , Gerdes C , Kronborg MB
Published: May 2022

Funding Acknowledgements

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

Background

Manipulation of the heart during cardiac surgery in patients with cardiac implantable electronic devices (CIEDs) may result in lead damage or -displacement, but whether cardiac surgery truly infers an excess risk of lead failure is not known.

Purpose

The objective of this study was to examine risk of lead complications as a result of cardiac surgery in CIED patients.

Methods

We conducted a nationwide nested case-control study. Our source population comprised all patients ≥18 of age who underwent a de novo CIED implantation in Denmark between 1998 and 2017. Only patients who were alive and event-free at six months after implantation were eligible for inclusion in the case-control study. Cases were defined as incident lead complications resulting in a revision procedure, and were matched 1:30 to controls using risk set sampling. We used conditional logistic regression to estimate incidence rate ratios (IRRs) for the association between cardiac surgery and lead complications.

Results

Our population consisted of 61,869 de novo CIED patient. We identified 1324 incident cases of lead complications and 39,708 time-matched controls. 1036 cases and controls underwent cardiac surgery during follow-up; 61 cases (4.5%) and 975 controls (2.5%). Risk of lead-related reoperation was highest within the first six months of cardiac surgery (IRR 10.1, 95% CI 6.5-15.6, adjusted IRR 11.0, 95% CI 7-17.4). At one year, we observed no association between cardiac surgery and lead complications (IRR: 1.0, 95% CI 0.7-1.5 and adjusted IRR: 1.1, 95% CI 0.7-1.6).

Conclusion

Cardiac surgery was associated with a substantial risk of lead complications in patients with de novo CIEDs. Manipulation of the heart including cannulation of the right atrium is a likely explanation for the subsequent lead problems.
Tunnelled dialysis catheter extraction: a cardiology experience
Authors: Akhtar Z , Gallagher MM , Leung LWM , Kontogiannis C , Elbatran AI , Zuberi Z , Sohal M
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Tunnelled dialysis catheters are integral to the management of patients with chronic kidney disease (CKD), providing a means to dialysis. They are prone to blockages necessitating removal. Most catheters are removed with manual traction without any sequalae by renal physicians whilst a small proportion require further intervention which may include interventional radiology or an ‘open’ surgical removal which carries additional risk. Cardiologists versed in transvenous lead extraction (TLE) provide an additional strategy.

Purpose

To evaluate the outcomes of tunnelled dialysis catheter ‘extractions’ performed by cardiologists at a high-volume TLE institute.

Method

All consecutive patients referred to cardiologists (1/10/2016 – 1/10/21) for extraction of tunnelled dialysis catheters following an unsuccessful attempt by the renal physicians and interventional radiology, were included in this series. Data of procedural outcomes was evaluated for safety and efficacy.

Results

Twelve patients (7 male) aged 64.15±15.04 years with a body mass index of 28.3 kg/m2 were referred for tunnelled catheter extraction for non-functioning lines (75%). Of these 12 CKD patients, the aetiology included focal segmental glomerulosclerosis (n=2), hypertension (n=2), diabetes (n=1) and sickle cell disease (n=1). In total, 12 tunnelled catheters (75%; n=9 right side) were completely removed (100%) using local anaesthesia (83.3%) in a procedure lasting 54.7±29.8 minutes and requiring 0.79±1.32 minutes of fluoroscopy. Eleven patients (91.7%) had their catheters successfully extracted with manual traction alone; 3 necessitated the use of a 0.035 stiff J-tip wire whilst one required the use of a rotational dissecting sheath Evolution (Cook Medical, USA). Of the 12 cases, 11 had a failed previous attempt including 1 patient who suffered a ventricular fibrillation cardiac arrest during the procedure and 1 was referred directly without an attempt as there was a concurrent pacemaker situated from the contralateral side; 4 patients had new lines placed and no significant complications occurred. There were no complications or procedural mortality.

Conclusion

Extraction of tunnelled dialysis catheter lines performed by cardiologists is safe and efficacious; experience in TLE is vital. This may provide an additional strategy for removal of these catheters when other percutaneous attempts fail.
Risk factors for gram-negative infection of cardiovascular implantable electronic devices: retrospective multicenter study - CarDINe study
Authors: Pascale R , Abdullah TA , Fabbricatore D , De Potter T , Ripa M , Durante-Mangoni E , Leventopulos G , Domenichini G , Iacopino S , Akova M , Diemberger I , Viale P , Giannella M
Published: May 2022

Funding Acknowledgements

Type of funding sources: Public Institution(s). Main funding source(s): Dr. Fabbricatore is supported by a research grant from the CardioPaTh PhD Program

Background

Gram-negative bacteria (GNB) are unfrequently isolated from patients with cardiac implantable electronic device (CIED) infection. However, data about risk factors for GNB-CIED-infection and associated clinical outcome are missing.

Methods

Multicenter, retrospective case-control-control study. Adult patients undergoing CIED implantation from Jan 2015 to Dec 2019 were included and classified as case (C) if diagnosed of GNB-CIED-infection; control 1 (C1) if diagnosed with Gram positive bacteria (GPB)-CIED infection; and control 2 (C2) if no CIED-infection was diagnosed during the study period. Patients were matched by center and risk period (from CIED implantation to infection diagnosis ±1 month), with a minimum follow-up period after infection diagnosis of 180 days.

Results

Study cohort consisted of 134 patients (33 C, 53 C1 and 42 C2) from 11 centers. Overall, 99 (73.9%) were male, median age 73 (IQR 66-81) years. Cardiac diseases leading to CIED implantation were bradi-arrythmia (48%), hearth failure (23.5), and primary prevention (20.6%). There were not differences for demographic variables and Charlson Index between C, C1 and C2. Time from implantation to infection diagnosis was similar between C and C1 [274 (39-621) vs 220 (58-866) days, p=0.581]. Shariff score was lower in C compared with C1 [1(1-2) vs 2 (1-3); p<0.001]. C reported more frequently than C1 a prior infection (not CIED related) (33% vs 16%, p=0.08). GN and GP causative agents of CIED-infection are depicted in Fig.1. No differences regarding CIED-infection type (pocket site, endocarditis) were observed between C and C1. Interestingly, PET-FDG was more frequently performed in C compared with C1 (41.2% vs 17%, p=0.013), with a trend toward higher yielding (83% vs. 50%, p=0.16). CIED extraction was performed in 79.4% and 92.5% (p=0.07) of C and C1, respectively. Length of stay was similar between groups [17 (7-39) vs23 (12-41) days, p=0.326]. 6-month survival was significantly lower in C compared with C1 and C2 at Kaplan Meier analysis (Fig.2).

Conclusions

GNB-CIED infection is associated with higher 6-month mortality than GPB- or no-CIED infections, prior GNB infection may favor subsequent GNB-CIED infection, the role of PET-FDG in diagnosing GNB-CIED infection seems to be key.
Safety and efficacy of transvenous lead extraction using mechanical (non-laser) extraction tools
Authors: Oconnor M , Schmid P , Knoll K , Schaarschmidt C , Bock M , Bahlke F , Georgi M , Froehlich R , Kottmaier M , Reents T , Bourier F , Hessling G , Deisenhofer I , Kolb C , Lennerz C
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

The rate of transvenous lead extraction (TLE) is increasing with an increasing rate of complex devices being implanted. TLE is now a routine part of cardiac device management and up to date data on the safety and efficacy of TLE with modern tools and techniques is essential to management decisions regarding non-infectious indications for lead extraction.

Purpose

To evaluate the safety and efficacy of TLE in a contemporary cohort using mechanical (non-laser) extraction tools.

Methods

We present a contemporary, prospective review of TLE at our high-volume cardiac centre. All patients undergoing TLE from June 2016 and June 2019 were enrolled in our local database and baseline clinical data, procedural information and outcome data were collected.

Results

In total 561 leads were explanted (n=153) or extracted (n=408) from 341 patients over the study period. Patients were predominantly male (71%) with a mean age of 65 ± 17 years. The most common indication for lead removal was lead failure (45.2%, n=154) followed by infection of the pocket or device (29.3%, n=100). The mean dwell time of the 408 extracted leads was 7.2 years; 35% had a dwell time of 5-10 years, 23% had a dwell time >10 years and 4% had a dwell time >20 years (Figure 1). In total, complete success was achieved in 96.4% (n=541) leads, clinical success in a further 2.1% (n=12) and failure only in 1.4% (n=8). Clinical success was high (93%) even in leads with dwell time >20 years (Figure 2). There was an overall complication rate of 0.9% (3/341) for major complications and 1.5% (5/341) for minor complications. There were no deaths.

Conclusions

Our data would suggest that there are ongoing improvements in the safety profile and success rates of lead extraction undertaken by experienced operators now with a major complication rate of <1%.
Arrhythmia burden, rhythm interventions and outcome in a large Swiss multicenter population of d-TGA patients with atrial switch
Authors: Nozica N , Asatryan B , Aur S , Greutmann M , Schwerzmann M , Bouchardy J , Gass M , Duru F , Pascale P , Reichlin T , Pruvot E , Wolber T , Roten L
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Patients with dextro-transposition of the great arteries (d-TGA) and atrial switch face a high life-time risk of arrhythmias.

Purpose

To describe the incidence of arrhythmias, associated cardiac interventions and outcome in a large Swiss population of patients with d-TGA and atrial switch.

Methods

In this multicenter analysis we included all consecutive patients with d-TGA and atrial switch treated at three Swiss tertiary care hospitals. The primary outcome was survival free from left ventricular assist device (LVAD), heart transplantation (HTx) and death. The secondary outcome was survival free from ventricular tachycardia, ventricular fibrillation and sudden cardiac death.

Results

We identified 207 patients (34% females; median age at last follow-up 35 years) with d-TGA and atrial switch. Arrhythmias occurred in 97 patients (47%) at a median age of 22 years. A pacemaker or an implantable cardioverter/defibrillator was implanted in 39 (19%) and 13 (6%) patients, respectively, and 33 (16%) underwent a total of 51 ablation procedures to target 60 intra-atrial reentry tachycardias, 4 AV nodal reentry tachycardias and one atrial fibrillation (Figure 1). The primary outcome occurred in 21 patients (10%) and the secondary outcome in 18 (9%) (Figure 2). Primary and secondary outcomes were more common in patients with concomitant ventricular septum defect (VSD) than in those without (hazard ratio [HR] 3.06; 95% confidence interval [CI] 1.29-7.27, p=0.011; and HR 3.62; 95% CI 1.43-9.18, p=0.007, respectively).

Conclusions

At a median age of 35 years, arrhythmias occur in almost half of patients with d-TGA and atrial switch and associated rhythm interventions are frequent. One in ten patients does not survive free from LVAD and HTx and outcome is worse in patients with concomitant VSD.
Improvement of a convolutional neural network using synthetic ECGs for the diagnosis of different atrial rhythms
Authors: Alvarez-Acosta L , Rodriguez-Martin N , Ruiz-Hernandez PM , Torres-Gonzalez N , Valdivia-Miranda D , Bermudez-Perez C , Rubio-Sierra D , Hernandez-Afonso J
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

The diagnostic capacity of convolutional neural networks has demonstrated its potential for the diagnosis of different ECG alterations. An important limitation of these networks is that there are classes that are underrepresented in the population, such as the Brugada pattern compared to right bundle branch block or Atrial Flutter (AFL) compared to atrial fibrillation (AF). This asymmetry that exists in any population ECG database is one of the limitations (F1-Score) that could be improved, either with even larger databases (impractical) or by creating synthetic representations of the ECG.

Purpose

Using a tool that allows the drawing of specific electrocardiographic patterns first and subsequently, the random creation of different ECGs based on said pattern, the diagnostic capacity of any unbalanced convolutional network could be improved.

Methods

Initially, a database with 95,000 ECGs from our health area was used. From this data set, 5,810 ECGs were taken that were labeled in three classes (1) Sinus Rhythm (SR), 2) AF and 3) AFL by two arrythmologists, 4,637 for training and 1,173 for validation. It was observed that the network was unbalanced (SR: 81.3% of the total, FA: 16.4% of the total and AFL: 2.2% of the total). After having demonstrated the good capacity of the network for the diagnosis of these three atrial rhythms, it was observed that the diagnostic dispersion matrix erred precisely between the ECGs of AF and AFL (figure 1). Based on this idea, it was decided to create a random pattern-based ECG creation tool. Different atrial flutter patterns were created and 2000 ECGs were synthetically created with variations of the ECG frequency, voltages and morphology. A new neural network was subsequently trained with the addition of these ECGs to the original database and its diagnostic capacity was evaluated on the same initial validation set.

Results

The new network showed a 88,3% sensitivity (vs 82,6%), a 100% specificity (vs 98,5%) and an 92% (vs 87,8%) accuracy. It specially had an improvement in AFL ECGs (70,2% vs 61%) and minor improvements in AF ECGs (90,8% vs 89,4%) and SRs ECGs (100% vs 98,6%) accuracy.

Conclusions

The creation of synthetic ECGs to improve the diagnostic capacity of neural networks for infrequent events is feasible. This application allows the development of networks applicable in real life, in this case, for the diagnosis of atrial arrhythmias.
Mobile app-based symptom-rhythm correlation assessment in patients with persistent atrial fibrillation
Authors: Hermans ANL , Gawalko M , Pluymaekers NAHA , Verhaert DVM , Van Der Velden RMJ , Betz K , Evens S , Luermans JGLM , Den Uijl DW , Baumert M , Vernooy K , Rienstra M , Van Gelder IC , Hendriks JM , Linz D
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

In patients with persistent atrial fibrillation (AF) it is difficult to determine the association between patient self-reported symptoms and the underlying heart rhythm (symptom-rhythm correlation [SRC]). No standardized strategy to assess SRC in AF patients is available.

Purpose

We assessed for the first time SRC in persistent AF patients using a mobile health approach of simultaneous photoplethysmography (PPG)-based rhythm monitoring and active interrogation of patient-reported symptoms, which provides a novel approach to systematically assess SRC in persistent AF.

Methods

Consecutive persistent AF patients planned for electrical cardioversion (ECV) used a mobile app to record a 60-second PPG and report symptoms once daily and in case of symptoms for four weeks prior and three weeks after ECV. Within each patient, SRC was quantified by the SRC-index defined as the sum of symptomatic AF recordings and asymptomatic non-AF recordings divided by the sum of all recordings.

Results

Of 88 patients (33% female, age 68±9 years) included, 78% reported any symptoms during recordings. The overall SRC-index was 0.61 (0.44-0.79). The study population was divided into SRC-index tertiles: low (<0.47), medium (0.47-0.73) and high (≥0.73). Patients within the low (vs high) SRC-index tertile had more often heart failure and diabetes mellitus (both 24.1% vs 6.9%). Extrasystoles occurred in 19% of all symptomatic non-AF PPG recordings. Within each patient, PPG recordings with the highest (vs lowest) tertile of pulse rates conferred an increased risk for symptomatic AF recordings (odds ratio [OR] 1.26, 95% coincidence interval [CI] 1.04-1.52) and symptomatic non-AF recordings (OR 2.93, 95% CI 2.16-3.97). Pulse variability was not associated with reported symptoms.

Conclusion

In persistent AF patients, simultaneous mobile app-based symptom and rhythm monitoring revealed a relatively low overall SRC, suggesting that the majority of patients experienced symptoms irrespective of AF. Extrasystoles can explain a minority of symptomatic non-AF PPG recordings. Pulse rate, but not pulse variability, is the main determinant of reported symptoms during AF and non-AF PPG recordings. Further studies are required to test whether mobile app-based SRC assessment can be implemented in current workflows and integrated into a personalized symptom and rhythm control AF management approach.