bluuebunny/crossref_metadata_2025 huggingface dataset:
CRT with triple fusion: results of the multicentric, randomized, doble-blinded CRUSTY trial
Authors: Francisco Pascual J , Adelino R , Quesada A , Sainz Godoy I , Exposito V , Ferrando J , Fernandez Armenta J , Cabanas P , Perez Rodon J , Santos Ortega A , Villuendas R , Trucco E , Jordan P , Benito B , Rivas Gandara N
Published: May 2024

Background

The possible benefit in terms of cardiac resynchronization therapy (CRT) response using a dynamic automatic algorithm designed to provide triple fusion as compared to conventional optimized biventricular pacing (CBP) is not known.

Methods

In this randomized, doble blinded, multicentric (13 centers) clinical trial we assigned patients with heart failure, reduced left ventricular ejection fraction and left bundle branch block, who underwent CRT implantation to be optimized using the SyncAV dynamic algorithm or through a conventional method. The primary endpoint was the rate of echocardiographic CRT responders at 6-month follow-up defined as a reduction of the left ventricular end diastolic volume (LVEDV) >15%.

Results

The study had to be stopped for slow recruitment in the context of the COVID-19 pandemic after enrolling 56 patients; 54 patients were finally analyzed. Patients’ basal characteristics are shown in TABLE. Patients assigned to the SyncAV group presented a narrowest paced QRS (128±16 ms vs. 145±19 ms; p <0.01) and a greater reduction in QRS duration (FIGURE A). Furthermore, more patients in the SyncAV group achieved a paced QRSd <120 mseg (7% vs 35%, p = 0.02). 21 (81%) patients in the SyncAV group and 19 (68%) in the CBP group were classified as CRT responders (OR = 1.99; 95% CI 0.57–7). While patients in the SyncAV group demonstrated a trend towards superior reverse remodeling across all secondary endpoints, statistical significance was not reached (FIGURE B). In the SyncAV group, 2 (8%) patients were categorized as negative responders, and 4 (16%) in the CBP group. A total of 43% of patients improved by at least one category in the NYHA functional classification, while 2 patients experienced worsening, both in the CBP group (clinical negative responders) (FIGURE C). No adverse events directly associated with device programming or the activation of the SyncAV algorithm were reported.

Conclusions

In this multicenter randomized controlled trial comparing CRT with triple fusion pacing using the SyncAV algorithm to conventional optimized biventricular pacing, there was not reached adequate statistical power to draw a conclusion regarding a potential increase in the CRT response rate. Nevertheless, the use of the SyncAV algorithm resulted in a high proportion of CRT responders. A significant greater reduction of the QRS duration was observed when employing the SyncAV algorithm, leading to a high percentage of cases achieving QRS width normalization. Nonetheless, further investigations are warranted to thoroughly assess the possible clinical benefits associated with triple fusion of LV pacing, RV pacing and intrinsic conduction in HF patients with LBBB.FIGURE
Left bundle branch area pacing optimized cardiac resynchronization therapy (LOT CRT) -comparative results to a CRT implanted patient population
Authors: Ezer P , Vilmanyi G , Szucs K , Lukacs R E K A , Konyi A T T I L A
Published: May 2024

Background

Cardiac resynchronization therapy (CRT) is gold standard treatment option among patients with symptomatic heart failure with reduced left ventricular ejection fraction (LVEF) and intraventricular conduction delay of left bundle branch block (LBBB) morphology.

Purpose

Left bundle branch area pacing optimized cardiac resynchronization therapy (LOT CRT) is a novel and promising approach for CRT candidate patients even in advanced intraventricular conduction delay, however convincing follow-up data regarding this patient group is still lacking.

Methods

In our observational registry 35 LOT CRT vs. 35 conventional CRT patients were consecutively implanted according to current guidelines. All the patients had LBBB morphology QRS width of >150 ms. The two compared patient group did not show significant difference in age, gender, baseline non-ischemic etiology, LVEF, NYHA functional class, LBBB QRS width.

Results

Immediate postoperative results showed significantly increased QRS width reduction (p=.028) and at 6 months of follow-up a significantly greater improvement in LVEF(p=.031), NYHA functional class (p=.04) and Nt-ProBNP levels (p=0.043) were seen in LOT CRT patient group compared to conventional CRT patients.

Conclusion

Our single center observational study showed significant improvement in prompt postoperative QRS width and clinical follow-up parameters in LOT CRT implanted patients compared to conventional CRT implanted patients.LOTCRTvs.CRTQRSwidthreductionLOTCRTXray
Cardiac resynchronization therapy guided by interventricular delay: how to choose between biventricular pacing or conduction system pacing
Authors: Marallo C , Federico Landra F L , Maurizio Collantoni M C , Simone Taddeucci S T , Antonio Pagliaro A P , Stefano Lunghetti S L , Daniele Menci D M , Luca Martini L M , Massimo Fineschi M F , Claudia Baiocchi C B , Amato Santoro A S
Published: May 2024

Background

Biventricular pacing (BIV) is gold standard for cardiac resynchronization therapy (CRT). Thirty % of patients result non responder to CRT. Conduction system pacing (CSP) represents a feasible alternative. Interventricular conduction delay (IVCD), as electrical desynchrony marker, is a CRT response predictor.

The aim of the study was to assess CRT responder’s incidence when it has been achieved choosing best approach between BIV and CSP according to intraoperative IVCD measurement in patients with HFrEF and LBBB.

Methods

Ninety-eight patients have been 1:1 randomized in a standard BIV group (control group, CG) and a group in which CRT approach has been chosen based on IVCD evaluation (study group, SG), as reported in Figure 1. If the right ventricular sensed electrogram (RVs)-left ventricular sensed electrogram (LVs) interval was ≥100 ms, the left ventricular lead was left in its original position; otherwise, the lead was removed and CSP was performed instead, as reported in Figure 2. Clinical, EKG and echocardiographic features have been assessed pre- and 6 months post-implant. Echocardiographic and clinical response have been evaluated.

Results

Twenty-four % of patients in the SG underwent CSP, according to the operative algorithm adopted. CRT responders’ incidence was significantly higher in the SG (echocardiographic criterion: SG 93,9% vs CG 69,8%; clinical criterion SG 87,9% vs CG 62,8%). Patients in SG presented a significant improvement in EF between pre- and post-implant and a significantly reduced End Diastolic Volumes and End Systolic Volumes vs CG. Univariate and multivariate regression analysis showed that enrolment in SG was the only factor consistently associated to CRT response.

Conclusion

Intraoperative evaluation of IVCD may guide the choice of the best resynchronization approach between BIV and CSP, allowing to achieve a significant improvement of CRT responders’ rate.Figure 1Figure 2
Left bundle branch area pacing in the setting of cardiac amyloidosis: a case series
Authors: Mirizzi G , Taddeucci S , Rossi A , Nesti M , Panchetti L , Startari U , Garibaldi S , Piacenti M
Published: May 2024

Background

Cardiac amyloidosis (CA) is a highly prevalent cause of congestive heart failure. It often requires cardiac pacing due atrioventricular conduction (AV) system disorders, often with cardiac resynchronization (CRT) to prevent development/deterioration of left ventricular (LV) dysfunction. Left bundle branch area pacing (LBBAP) is an emerging alternative to CRT, offering a strict physiological LV activation and very limited use of iodinated contrast. The feasibility of LBBAP in CA is considered limited due to the presence of septal pseudohypertrophy which theoretically limits left-sided conduction system engagement.

Purpose

To evaluate the feasibility and effectiveness of LBBAP in cardiac amyloidosis.

Methods

Consecutive patients with CA (both light-chain -AL- or wild-type transtiretin -wtATTr) with a pacing indication for AV conduction disorders were enrolled. Patients underwent baseline echocardiographic examination. LBBAP was achieved by means of stylet-driven leads advanced transeptally (right ventricle (RV) to LV) via dedicated delivery systems, with continuous monitoring of 12-lead electrocardiographic morphology and impedance until a typical QRS morphology in V1 was obtained (usually rSr’ or Sr’). Standard measures for left bundle (LB) capture were used (stimulus to peak R in V6 – S-RV6, V6-V1 interpeak interval, presence of transition in these measures during threshold testing, presence of fascicular signal during spontaneous QRS).

Results

Between January 2022 and June 2023, among 63 patients undergoing LBBAP, 7 patients (11%) had CA, 2 AL (28%) and 5 (72%) wtATTR. Patients were prevalently old (78±7 y) males (6, 85%); LV mean septal thickness was 17±2 mm (min 16, max 20 mm) and mean LV ejection fraction (LVEF) was 45±6%. Indications were PR prolongation in 3, bradycardic atrial fibrillation and LB branch block (LBBB) in 2, primary LBBB in 1 and chronic RV pacing in 1. Baseline QRS duration was 145±47 ms (QRS<120 ms: 97±15 ms, QRS>120 ms: 182±13 ms). LBBAP success was 100%. Fascicular electrograms were observed in ¾ of patients without LBBB; S-RV6 interval was 74 ±11 ms (³70 ms in 3), RV6-RV1 interpeak interval was 47±9 ms (³ 30 ms in 6 patients). DQRS in baseline broad QRS was -52 ms and +32 ms in narrow. No complications were observed. Over a short follow up of 6 months, an increase in average LVEF was observed (LVEF at 6 months: 51±3%, p<0.05).

Conclusions

In patients with CA, LBBAP is easily achievable with stylet-driven systems with frequent selective engagement of conduction system. QRS narrowing in baseline broad QRS is significant while QRS broadening in baseline narrow QRS is limited. Early results regarding follow-up of surrogate endpoint such as LVEF are promising.
QRS narrowing in patients undergoing cardiac resynchronization therapy: LOT-CRT vs. LBBAP
Authors: Ribes F , Perez-Rosello V , Gunturiz-Beltran C , De La Cruz-Cereceda S , Bellver-Navarro A
Published: May 2024

Background

Left bundle branch-optimized cardiac resynchronization therapy (LOT-CRT) is an alternative technique to conventional biventricular pacing (BiVP) and complementary to left bundle branch area pacing (LBBAP). Although it is a more complex technique than LBBAP, it achieves greater QRS narrowing and better resynchronization in most patients.

Purpouse

The aim of this study was to determine the predictors (echocardiographic, ECG and clinical) of greater QRS narrowing with LOT-CRT vs. LBBAP.

Methods

38 consecutive patients with CRT-P indication were included in a period of 1 year. A ventricular lead was implanted in the septum until LBBAP criteria were achieved, evaluated by EGM and electrocardiographic recordings. A lead was subsequently implanted in a subsidiary vein of the coronary sinus (CS). In each patient, the QRS duration was measured during LBBAP and then with the fusion pattern from LBBAP and CS (LOT-CRT). Baseline demographic characteristics, indication for implantation, ECG, echocardiography, and NYHA class were collected in all patients.

Results

The mean age was 77.2 ± 6.9 years (37% women). The most common cardiomyopathy was idiopathic (55.3%) followed by ischemic cardiomyopathy (21.1%). 76.3% were in NYHA class 2 and 23.7% in NYHA class 3, with a mean LVEF of 34.1 ± 8.2%. 86.8% had a LVEDD ≥ 66mm. In 57.9% of patients the indication for implantation was HF in NYHA class ≥ 2, QRS ≥ 130ms with LBBB QRS morphology and LVEF ≤35%, while in the remaining 42.1% it was an LVEF < 50% and stimulation indication. The initial QRS was 180 ± 22 ms, 152 ± 16 ms with LBBAP and 132 ± 16 ms with LOT-CRT, with an additional QRS narrowing of 20 ± 14 ms with LOT-CRT vs. LBBAP (p < 0.001). Predictors of greater QRS narrowing with LOT-CRT vs. LBBAP were the indication for implantation due to HF in NYHA ≥ 2, QRS ≥ 130ms with LBBB QRS morphology and LVEF ≤35% (p 0.01), LVEDD ≥ 66mm (p 0.04) and advanced NYHA class (3 vs. 2) (p 0.019).

Conclusion

LOT-CRT significantly reduces QRS duration compared to LBBAP, favoring better resynchronization. Patients with a classic indication for CRT-P, in advanced stages of HF (NYHA class 3 and or/LVEED ≥ 66mm), are those who present greater QRS narrowing with this technique compared to LBBAP.
Leadless ultrasound-based cardiac resynchronization system in heart failure results from the SOLVE-CRT randomised sub-study and the primary population patient cohort
Authors: Seifert M , Butter C , Rinaldi C A , Sanders P , Kubo S H , James S , Niazi I K , Betts T R , Aziz E , Biffi M , Aurrichio A , Gold M R , Lindenfeld J A , Walsh M N , Singh J P
Published: May 2024

Background

Despite the well-established role of CRT in heart failure, major limitations of CRT include an occasional incidence of unsuccessful coronary sinus (CS) lead placement, one third non-responders in conventional CRT patients and higher complications risk in CRT upgrade procedures. The WiSE® CRT System (EBR Systems, Inc) is designed to overcome these limitations. Prior non-randomized studies with the WiSE System have shown high implant success rates and improvement in LV remodeling and heart failure symptoms.

Objectives

The pivotal SOLVE-CRT study is comprised of two parts: a randomized part and the subsequent single-arm part enrolled during the pandemic. The primary safety endpoint is freedom from Type I (device & procedure-related) complications through 6 months and primary efficacy endpoint is the mean relative (%) change in left ventricular end systolic volume (LVESV) from baseline to 6 months.

Method

Between Jan. 2018 and Mar. 2020 the randomized part enrolled 108 participants for three indications: non-responders (NR), previously untreated, including acute and chronic lead failures (PU), and high-risk upgrades (HRU). All underwent device implantation and were then randomized in 1:1 ratio to Treatment (system turned ON) or Control (system turned OFF) groups. In the single arm, 75 participants had been enrolled within two indications: PU and HRU. The efficacy analysis of the entire randomised cohort included 99 participants (PU, HRU, NR). For the primary indication sub-population, 57 participants (PU, HRU) were analysed.

Results

Randomized Group: Results were available for 91 of the 99 patients. Significant improvements were seen between the Treatment and Control groups with a mean reduction in LVESV (-14.6% vs -5.2%, p=0.005), mean reduction in LVEDV (-8.1% vs -3.0%, p=0.027), mean increase in LVEF (5.4% vs 2.4%, p=0.048) and mean reduction in QRS (-41.9ms vs -1.7ms, p=0.001).

Primary Indication Sub-Population Group: The primary indication sub-population also saw significant improvements between Treatment and Control group with a mean reduction in LVESV (-18.2% vs -3.1%, p=0.002), mean reduction in LVEDV (-11.6% vs -2.1%, p=0.004), mean increase in LVEF (5.7% vs 1.1%, p=0.025) and mean reduction in QRS (-38.0ms vs -3.1ms, p<0.001).

Conclusion

This pivotal SOLVE-CRT trial demonstrates that leadless, ultrasound-based endocardial pacing for heart failure is feasible and efficacious showing evidence of left ventricular remodelling and electrical response after 6 month in the primary population as well as in the sub-study group.

Picture 1: Efficacy entire randomised population

Picture 2: Efficacy primary indications population
Absence of late gadolinium enhancement and outcomes of cardiac resynchronization therapy in non-ischemic dilated cardiomyopathy
Authors: Di Marco A , Faga V , Moreno-Weidmann Z , Santos A , Jimenez-Jaimez J , Jimenez Candil J , Rivas N , Macias R , Hernandez J , Merce J , Rodriguez M , Claver E , Anguera I
Published: May 2024

Background

Among patients with non-ischemic dilated cardiomyopathy (DCM) with indication for cardiac resynchronization therapy (CRT), there are no clear recommendations about who should receive a CRT-defibrillator (CRT-D) and who should have CRT-pacemaker (CRT-P).

Absence of late gadolinium enhancement (LGE) at cardiac magnetic resonance (CMR) has a high negative predictive value for ventricular arrhythmias (VA) and sudden death (SD) in DCM and is a predictor of reverse remodelling in several scenarios.

Purpose

To evaluate the association between absence of LGE and VA/SD or echocardiographic response to CRT in DCM patients treated with CRT.

Methods

Multicenter retrospective observational cohort study including consecutive DCM patients with de-novo CRT implant and with available CMR. The primary endpoints were: 1) a combined arrhythmic endpoint including appropriate defibrillator therapies, sustained VA and sudden death. 2) echocardiographic response to CRT, intended as an increase ≥10% in left ventricular ejection fraction (LVEF).

Results

We included 167 patients, 55% males, with median QRS duration of 160ms and median LVEF of 25%. LGE was present in 46% of cases (LGE+). A CRT-D was implanted in 73% of patients. Median follow-up was 63 months. Of note, among patients without LGE (LGE-) we did not record any event of the combined arrhythmic endpoint. The cumulative incidence of the arrhythmic endpoint was significantly higher in LGE+ than in LGE- patients (25% vs 0%, p<0.001) and LGE was an independent predictor of this endpoint (adjusted HR 42, p<0.001). The proportion of responders to CRT was significantly higher in LGE- than in LGE+ cases (81% vs 53%, p<0.001); absence of LGE was the strongest predictor of echocardiographic response to CRT at multivariate analysis (adjusted OR 4.1, p=0.001). Super-responders (i.e. those with LVEF≥50% at follow-up) were also more frequent among LGE- than LGE+ patients (46% vs 21%, p=0.001) and absence of LGE was an independent predictor of LVEF normalization (HR 2.6, p=0.03).

Conclusions

Among DCM patients who receive CRT, those without LGE have an extremely low (or null in this case) arrhythmic risk and, at the same time, they have a high probability of echocardiographic response to CRT. Thus, LGE- patients could be ideal candidates for CRT-P instead of CRT-D.
Comparative analysis of clinical outcomes in patients undergoing primary CRT implantation versus CRT upgrade: single center experience
Authors: Rocha De Almeida A , Carias De Sousa M , Congo K , Trinca M
Published: May 2024

Background

As heart failure (HF) management evolves, cardiac resynchronization therapy (CRT) has emerged as a cornerstone intervention, improving left ventricular (LV) function and reducing morbidity and mortality. The Budapest trial specifically addressed upgrading from permanent pacemaker (PPM) to CRT, emphasizing the potential for improved clinical outcomes and quality of life in this population. The findings highlighted the impact of CRT upgrade and contribute valuable insights to the cardiac device strategies for HF patients. This study aims to compare clinical outcomes between patients undergoing primary CRT implantation and those undergoing CRT upgrade.

Methods

A retrospective analysis was conducted on a cohort of heart failure patients who received CRT devices between 2015 and 2019. Patients were categorized into two groups: those undergoing primary CRT implantation and those undergoing CRT upgrade. Clinical outcomes, including mortality rate, hospitalization for HF exacerbation, and improvements in left ventricular ejection fraction (LVEF), were assessed and compared between the two groups.

Results

A total of 847 patients were included in the study, with 74,5% (n=631) undergoing primary CRT implantation and 13,5% (n=114) receiving CRT upgrades. The mean age was 72±10 years-old and 57% (n=485) were women, and a mean follow-up time of 23±8 months. 33.7% (n=285) of the total were of ischemic etiology. The primary CRT implantation group demonstrated a mortality of 34% (n=215) and 13% (n=84) of hospitalization due to HF; NYHA functional class improvement in 58% (n=369), and 35,7% (n=225) were CRT responders with a mean LV ejection fraction (EF) improvement of ±10%, while the CRT upgrade group had a 31% (n=36) mortality and 19% (n=22) of hospitalization due to HF; NYHA functional class improvement in 60% (n=68), and 27% (n=31) were CRT responders with a mean LV EF improvement of 8,7%. There were no statistically significant differences regarding each endpoint, namely mortality, HF hospitalizations, NYHA functional class improvement, CRT responders and mean LVEF improvement.

Conclusion

A clear benefit from implantation of a primary CRT device implantation has already been demonstrated. However, recent trials revealed there was also benefit in upgrading from PPM to CRT patients with decrease LVEF, comparing with PPM. This study showed that the benefits from primary CRT were similar to the benefits from upgrading CRT, in terms of mortality reduction, HF hospitalizations, NYHA functional class improvement, CRT responders and mean LVEF improvement. Once again, just like in the most recent trials, this study demonstrates the clear benefit of upgrading from a PPM to CRT in patients with decreased LVEF.
Systematic review and meta-analysis comparing cardiac resynchronization therapy with versus without defibrillation in patients with non-ischemic cardiomyopathy
Authors: Devesa Neto V , Costa G , Santos L F , Costa A , Teixeira R , Goncalves L
Published: May 2024

Background

Cardiac resynchronization therapy (CRT) stands as a notable medical breakthrough for individuals with heart failure and electrical desynchrony. This intervention aims to alleviate symptoms, diminish hospitalization rates, and enhance overall survival, both in conjunction with and without implantable cardioverter-defibrillator (ICD) therapy. Despite these advancements, the role of defibrillator therapy in addition with CRT for patients with non-ischemic cardiomyopathy (NICM) remains a topic of debate.

Objective

To assess and compare the outcomes of individuals diagnosed with NICM who have underwent CRT with implantable cardioverter-defibrillator (CRT-D) against those who received CRT with a pacemaker only (CRT-P).

Methods

We conducted a systematic search of PubMed, Embase and Cochrane database during August 2023 for studies comparing CRT-P and CRT-D in patients with nonischemic cardiomyopathy.

Results

Thirteen studies, including two randomized clinical trials, were incorporated, with a total of 61,326 patients providing 16,446 pooled death events (9,108 in CRT-D and 7,338 in CRT-P). The meta-analysis revealed that CRT-D was associated with a significantly lower risk of all-cause mortality compared to CRT-P (pooled HR 0.74; 95% CI: 0.62-0.88; I2=84%). Subgroup analysis focusing on propensity score-matched studies yielded consistent findings (pooled HR 0.82; 95% CI: 0.77-0.87; I² = 0%, P<0.001). However, subgroup analysis for patients older than 75 years suggested no statistically significant difference in mortality risk within this specific age group (pooled HR 0.96; 95% CI: 0.811-1.15; I² = 39%, P<0.001). Regarding the secondary endpoint of cardiovascular mortality, no significant risk reduction with CRT-D was observed (pooled HR 0.70; 95% CI: 0.49-1.01; I² = 92%), albeit with high heterogeneity.

Conclusion

Our study suggests that the addition of defibrillator therapy significantly reduces all-cause mortality in CRT-eligible patients with NICM, although results were not observed for patients older than 75 years.All-cause MortalityPatients older 75 years old
Predicting the response to cardiac resynchronization therapy using in silico heart models: pilot study of comparison between in silico and real cardiac resynchronization therapy outcomes
Authors: Uhm J S , Hwang M , Shim E B , Kim D , Lee C J , Oh J W , Yu H T , Kim T H , Joung B , Pak H N , Kang S M , Lee M H
Published: May 2024

Background

Cardiac resynchronization therapy (CRT) is treatment for patients with heart failure and left ventricular (LV) dyssynchrony. The objective of this study is to evaluate the feasibility of an in silico electromechanical heart model to predict CRT outcomes.

Methods

The three-dimensional heart geometries of 11 patients (age, 64.0±10.7 years, 4 men) with CRT were constructed from cardiac computed tomography images. We coupled cardiac electrical excitation and mechanical contraction with vascular hemodynamics using a lumped parameter model. We predicted the LV end-diastolic and end-systolic volumes and LV ejection fraction (LVEF) after CRT implantation using the in silico CRT simulation model. We compared the in silico CRT outcomes with the real CRT outcomes.

Results

Two patients were in silico CRT responders, and those 2 patients were also real CRT responders. Nine patients were in silico CRT non-responders, 8 who were real CRT non-responders, and 1 who was a real CRT responder. The in silico CRT outcomes agreed with the real CRT outcomes in 10 of 11 patients. The positive and negative predictive values and accuracy of the in silico CRT model were 100%, 88.9%, and 90.9%, respectively.

Conclusion

The in silico CRT simulation model is feasible for predicting real CRT outcomes.In silico CRT simulation model generatioAn example (patient No. 2) of LV (black
ECG imaging as a real time tool to guide left bundle branch pacing implant in patients with left bundle branch block and resynchronization therapy indication
Authors: Regany M , Pujol-Lopez M , Martinez-Perez M , Pellicer-Sendra B , Molero R , Borras R , R Graterol F , Serrano-Campaner J , Reventos-Presmanes J , Roca-Luque I , Guasch E , Climent A M , Guillem M S , Tolosana J M , Mont L
Published: May 2024

Background

Left bundle branch pacing (LBBP) has emerged as a promising alternative technique for cardiac resynchronization therapy (CRT). ECG imaging (ECGI) may provide an accurate assessment of electrical resynchronization using real-time maps during LBBP implant.

Purpose

To evaluate the usefulness of ECGI to guide LBBP implant, by analyzing the ventricular activation times and the degree of resynchronization at each screwing step during the lead implant.

Methods

Four patients with CRT indication and left bundle branch block (LBBB) referred for LBBP were prospectively enrolled. ECGI was performed during the implant procedure. Cardiac signals were recorded using ECGI and projected into an artificial intelligence-derived geometric model. Thus, generating imageless and non-invasive activation maps at defined stages during lead screwing: basal rhythm (LBBB), right ventricular (RV) septum, mid-septal, deep-septal, and finally pacing from the left bundle branch (according with guidelines ECG criteria).

The following parameters were measured: a) total activation time (TAT); b) left ventricular activation time (LVAT); c) left ventricular dyssynchrony index (LVDI) (as a quantifier of intraventricular dyssynchrony); d) ventricular electrical uncoupling (VEU); and e) histogram overlap between LV and RV distribution (the last 2 markers of interventricular dyssynchrony).

Results

The study cohort comprised men with a median age of 68 [Q1 59- Q3 79], with a median basal LBBB QRS duration of 175 ms [160-188] and a median LVEF of 32% [28-39]. A shortening of the activation times and a decrease in intra and interventricular dyssynchrony was achieved when the final lead position was reached. See the results in Figure 2.

Conclusion

Real-time and imageless ECGI system may offer a novel approach for guiding LBBP and it is useful to ensure left ventricular resynchronization.ECGI to guide LBBP implantActivation and dyssynchrony measurements
Left bundle branch vs biventricular pacing for cardiac resynchronization therapy
Authors: Franco Fernadez I , Razzo O , Rubio Alonso M A , Aroca Peinado A , Merino Llorens J L
Published: May 2024

Background/Introduction

Left bundle branch pacing (LBBP) has emerged as a predominant conduction system pacing technique for reducing QRS duration in patients with intrinsic left bundle branch block (LBBB). It represents a potentially optimal alternative to cardiac resynchronization therapy (CRT) through biventricular pacing (BiVP).

Purpose

This study aims to compare the efficacy of LBBP-CRT with BiVP-CRT in patients experiencing heart failure with reduced left ventricular ejection fraction.

Methods

This single-center prospective study involved patients with heart failure and reduced ventricular ejection fraction, encompassing both ischemic and nonischemic cardiomyopathy. LBBP-CRT was employed when BiVP was unsuccessful for any reason, with LBBP-CRT implanted during the same procedure. After 3 and 6 months of preplanned follow-up, comparisons were made between the New York Heart Association (NYHA) functional class and QRS duration in the BiVP-CRT and LBBP-CRT groups.

Results

Sixty consecutive patients were included in the study (39 males, mean age 64.1 ± 10.6 years, LVEF 29.6% ± 5.6%). All patients completed follow-up, with 32 receiving LBBP-CRT and 28 receiving BiVP-CRT.

All 32 LBBP-CRT patients achieved LBB capture, with 14 undergoing selective LBBP and 18 undergoing nonselective LBBP. The LBBP-CRT group exhibited shorter procedure and x-ray exposure times ((11.95 ± 5.77 vs 18.66 ± 10.12). The LBBP lead demonstrated a lower LBB capture threshold at implantation (0.7 ± 0.26 V vs. 1.1 ± 0.40 V; p= 0.039) compared to the CS LV lead in the BiVP-CRT group. Pacing parameters remained stable at the 6-month follow-up (0.72 ± 0.20 V vs. 1.1 ± 0.57 V; p=0.07). During the 3 and 6-month follow-up, pacing parameters remained stable in both groups. Only one patient in the LBBP-CRT group experienced dislodgment of the CS LV lead two days after the procedure, while no patients in the LBBP-CRT group had lead dislodgment.

QRS duration significantly shortened in LBBP (171.6 ± 14.3 ms to 131.5 ± 12.5 ms; p=0.047) and remained not significantly shortened in BiVP (174.7 ± 14.1 ms to 150.6 ± 12.9 ms; p=0.06).

Both LBBP and BiVP demonstrated improvement in NYHA functional class at the 3 and 6-month follow-up, with statistically significant differences observed between the two groups (change in NYHA functional class from baseline to 6 months -1.2 ± 0.1 vs -0.94 ± 0.11 p=0.047). Throughout the 6-month follow-up, neither the LBBP-CRT nor BiVP-CRT groups experienced rehospitalizations for heart failure, ventricular arrhythmia events, or all-cause death.

Conclusions

In this series, LBBP-CRT exhibited improvements in NYHA functional class and significantly shortened QRS duration when compared to BiVP-CRT in patients with reduced left ventricular ejection fraction and LBBB.
The effect of cardiac resynchronisation therapy upgrade from right ventricular pacing on symptoms and functional clinical outcomes, results from the BUDAPEST-CRT Upgrade trial
Authors: Merkel E D , Hatala R , Szigeti M , Schwertner W R , Lakatos B K , Behon A , Zima E D , Molnar L , Goscinska-Bis K , Solomon S D , Kutyifa V , Kovacs A , Kosztin A , Merkely B K
Published: May 2024

Background

Based on the results of the BUDAPEST-CRT Upgrade trial, in patients with intermittent or permanent right ventricular (RV) pacing and reduced left ventricular ejection fraction (HFrEF) upgrade to cardiac resynchronization therapy (CRT) reduces morbidity and mortality.

Purpose

Whether the substantial treatment effect of the CRT upgrade could also be detected in a better functional and exercise capacity is scarcely investigated. We examined the changes of the prespecified tertiary endpoints such as symptoms, quality of life (QoL), exercise capacity and natriuretic peptide measurement from baseline to 12 months.

Methods

In the BUDAPEST CRT Upgrade trial 360 HFrEF patients with a priorly implanted PM or ICD and >20% of RV pacing burden were randomly assigned to CRT-D upgrade (n=215) or ICD (n=145) in a 3:2 ratio. The prespecified tertiary endpoints were changes in quality of life measured by EQ-5D-3L, New York Heart Association (NYHA) functional class, 6-minute walk test (6-MWT), and NT-proBNP. When data of trial patients were unavailable due to death at 12 months, imputed values were used as 0 (6MWT) and 0 score (EQ-5D-3L) or a 5th grade (NYHA class). Responders were defined as >15% change of left ventricular end-systolic volume at 12 months.

Results

From baseline to 12 months, NYHA functional class improved in the CRT-D upgrade arm compared with the ICD only group [adjusted odds ratio (OR) 0.50; 95% CI 0.32-0.80; P=0.003]. According to the adjusted model there was a statistically significant decrease in the NT-proBNP [adjusted difference -1257 pg/mL; 95% CI -2287 – (-228); P=0.017]. In responders, the changes in NT-proBNP levels were significantly greater than in non-responders [adjusted difference -1635 pg/mL; 95% CI -2811 - (-459); P=0.007]. The progression of worsening of QoL attributed to ageing was moderated only by CRT-D upgrade [EQ-5D-3L difference by age -0.01; 95% CI -0.02 - (-0.003); P=0.004; interaction P=0.003]. 6MWT did not improve significantly in either group.

Conclusions

Patients receiving CRT upgrade showed a substantial improvement in symptoms and a significant decrease in natriuretic peptide levels, as compared to ICD alone, which was more pronounced in responders. Moreover, CRT-D upgrade could moderate the progression of worsening of quality of life attributed to ageing in this vulnerable, older patient population.
Physiologist-led management of heart failure patients using cardiac implantable electronic device diagnostics during COVID-19: a 2-year UK perspective
Authors: Domingos A , Moore L , Cunnington C
Published: May 2024

Background/ Introduction

The COVID-19 pandemic prompted greater use of remote monitoring capabilities of cardiac implantable electronic devices (CIED). The HeartLogic Index incorporated within certain Boston Scientific CIEDs uses device-derived physiological parameters to generate a score which may be predictive of worsening heart failure (HF). We aimed to define the utility of a novel service, led by cardiac physiologists acting autonomously upon HeartLogic Index alerts, to guide HF patient care during the pandemic.

Purpose

To assess the utility of a physiologist-led HF service, using CIED diagnostics combined with clinical assessment, to improve HF management.

Methods

In a single-centre prospective study, 153 Boston Scientific CRT/ICD patients were reviewed over a 2-year period using the integrated HeartLogic algorithm. In response to a HeartLogic alert indicating worsening HF, the patient was contacted by a cardiac physiologist using a structured telephone triage to assess HF symptoms. In those deemed as being at risk of decompensated HF based on clinical assessment, an intervention was made e.g. face-to-face physiologist-led clinical assessment, consultant review, medication optimisation.

Results

During the 2-year audit, 748 alerts were received from 60 patients, the majority of which had a HF implant indication (n=42). Twenty-one patients within the study population required an intervention due to worsening HF. Following intervention, there were no further hospitalisations within this group. Five hospitalisations were documented during the audit, only 3 of which were HF related. Of these HF hospitalisations, one patient denied HF symptoms at the time of telephone contact, one had a HF decompensation due to deteriorating renal failure and the final patient had a disconnected remote monitor. During the 2-year audit, there were a total of 13 deaths, 3 of which were classified as caused by HF.

Conclusion

A physiologist-led service may be of clinical utility within this complex patient population, with the audit results demonstrating favourable outcomes with a low rate of mortality and HF hospitalisations. The addition of this service can act to streamline the time from patient presentation to HF review, and therefore improve patient care.
Heart rate is an important predictor of pacing induced cardiomyopathy in a machine learning analysis
Authors: Britton C , Brown S , Furniss G , Dayer M
Published: May 2024

Background

10-20% of patients who have right ventricular pacing develop pacing induced cardiomyopathy (PICM). Home monitoring (HM) could identify patients developing PICM in real-time and facilitate echocardiographic confirmation, medication optimisation and if necessary cardiac resynchronisation therapy (CRT).

Purpose

To identify predictors of PICM using machine learning models.

Methods

Consecutive cases of patients who developed PICM (12) after dual chamber pacing were identified from our implant database and matched 4:1 with propensity matched controls who underwent pacing but did not develop PICM (48) (Table 1.) HM data from the 6 months prior to echocardiographic diagnosis of PICM was analysed. PICM was defined as (1) a deterioration in left ventricular (LV) ejection fraction (EF) of >10%, (2) to an EF of <45%, (3) with right ventricular (RV) pacing >20% and (4) the exclusion of alternative causes. Three types of ML models were generated (1) random forest, (2) extreme gradient boosted (XGBoost) (3) K-nearest neighbours algorithm (KNN), with 10-fold cross-validation.

Results

HM data were available for 12 PICM cases (75 ± 8 years, 72% male). PICM occurred at 2.0 ± 1.2 years. There was no difference between cases and controls in atrial pacing (8±15% vs 18±22% p=0.14), ventricular pacing (81±29% vs 85±24% p=0.62) or base rate (53±5bpm vs 53±5bpm p=0.80).

Of the 34 RM features analysed, mean ventricular heart rate was identified as the most important predictor of PICM; area under curve with XG Boost 0.95, KNN 0.95, and random forest 0.86. Other RM features failed to add any more predictive power to the models. Mean ventricular rate was significantly higher in cases than controls (80±6 bpm vs 69±9 bpm p<0.001). Sensitivity analysis was performed to assess whether episodes of atrial fibrillation (AF) were responsible for the higher ventricular rates. After days of AF days were excluded, mean ventricular rate was still significantly higher in cases than controls (79± 6vs 69±9bpm p<0.001) (Figure 1). 10/12 patients had a subsequent CRT upgrade. No consistent pattern emerged in heart rate changes in the first 3 months after CRT upgrade.

Conclusion

In a group of patients with normal left ventricular function at implant, remotely monitored heart rate can predict early-onset PICM. Further work is required to understand when these heart rate differences emerge, and whether they improve with positive LV remodelling.Table 1.Figure 1.
Efficacy of a gentamycin-collagen sponge to prevent infection in implantable cardioverter defibrillator patients undergoing revision surgery - results of a monocentric ICD registry observational study
Authors: Kleemann T , Mousavi S B , Kouraki K , Strauss M , Mohammad O , Wenz A , Weisse U , Werling C , Sack F , Zahn R
Published: May 2024

Introduction

Despite the obvious benefits, the use of implantable cardioverter defibrillators (ICDs) is associated with serious complications, including infections. In particular, device replacement or revision procedures are associated with an increased risk of infection. Aim of the study was to compare the cardiac device infection rate with and without the use of the gentamycin-collagen sponge (GCS) in patients undergoing device replacement or revision procedures of implanted ICDs.

Methods

A total of 491 consecutive ICD patients from a prospective single-centre ICD-registry who underwent elective device replacement, system upgrade or lead revision between 2017 and 6/2023 were analyzed. From September 2020 onwards, a GCS was inserted into the device pocket (GCS group, n = 256). These patients were compared to the patients implanted/ revised between 2017 and 8/2020 (control group, n = 235).

Results

The baseline characteristics and the PADIT score were similar in both groups (Table 1). The GCS was well tolerated and there were no complications associated with the GCS. The mean follow-time was 15 + 10 months in the GCS group and 30 + 11 months in the control group. The Kaplan-Meier estimated infection rate after one year was 1.0% in the GCS group and 3.5% in the control group (p = 0.03, Figure 1). Time from revision to infection was 144 + 134 days in the GCS group vs. 362 + 297 days in the control group.

Conclusion

Adjunctive use of a GCS was associated with a lower incidence of device infections than standard-of-care infection-prevention strategies alone.
Feasibility and outcomes of ultrasound-guided transcutaneous access to the axillary vein for implantation, revision, and upgrade of cardiac electronic devices
Authors: Nikorowitsch J , Uectas T , Borof K , Metzner A , Wenzel J P , Winkelmann S J , Pecha S , Reichenspurner H , Kirchhof P , Toennis T , Becher N
Published: May 2024

Background

Implanting leads for cardiac implantable electronic devices (CIED) requires venous access. Venous access is commonly established through the cephalic and subclavian vein. For CIED upgrades or revisions, the preferred cephalic vein access is often not viable. Several reports suggest that fluoroscopy-guided axillary vein puncture may reduce thoracic complications.

Purpose

This study reports on procedural outcomes of ultrasound-guided axillary vein access for CIED implantation, revision, or upgrade in a large tertiary care centre. Outcomes were compared to the traditional subclavian vein approach.

Methods

This retrospective, single-center non-randomized study, conducted from January 2021 to August 2023, analyzed patients undergoing CIED implantation, revision, or upgrade. Axillary access, initially introduced by one operator, was increasingly adapted by additional operators. The axillary access was obtained by ultrasound-guided visualization of the axillary vein at the deltopectoral groove (Figure 1A and B). Subsequently, the wire(s) were transcutaneously inserted. An adjacent skin incision allowed for threading the wire(s) followed by standard lead implantation (Figure 1C). The study evaluated the acute success of each venous access method and the incidence of adverse events. Those were defined as pneumothorax, hemothorax, and pocket hematoma. An intention-to-treat analysis was performed. A p-value assessed the comparative outcomes between the axillary and subclavian access methods.

Results

In this study, 986 patients (mean age 74, IQR 64-82 years, 35% women) underwent CIED implantation, revision, or upgrade with 1636 lead implants. Axillary access was used in 578 patients with 532 (92%) successful implantations. Subclavian access yielded a higher success rate with 394/408 patients (97%) (p=0.003). For device upgrades or revisions specifically, axillary access was successful in 68/79 patients (86%), versus 44/47 patients (94%) with subclavian access (p=0.193). Acute complications were less frequent with axillary access (0.3%, 2/578 patients) and consisting of two cases of pneumothorax requiring intervention. In CIED implantations via subclavian access, complications occurred in 17/408 patients (4.2%) (p<0.001) including pneumothorax in 12 patients (2.9%, with 2% requiring intervention), hemothorax in three patients (0.7%), and pocket hematoma in two patients (0.5%). No additional complications were observed in the axillary group.

Conclusion

The implementation of transcutaneous, ultrasound-guided axillary access for CIED implantations, revisions and upgrades in a major CIED training centre is feasible. Complication rates were low compared to subclavian venous access.Figure 1
Primary vs. secondary wound closure following transvenous system explantation in CIED infection
Authors: Tran Q , Richter U , Bair J , Richter S , Albert A , Gaspar T
Published: May 2024

Background & Introduction

Patients undergoing an explantation of cardiac implantable electronic devices (CIED) receive either a primary or secondary wound closure or open wound treatment depending on departmental practice. To date, there is limited data on whether secondary wound closure or open wound treatment has any benefit in terms of future complications although it requires a more intensive wound care.

Material & Methods

Patients who underwent CIED explantation for system infection at our institution between 2016 and 2022 were retrospectively reviewed. From this cohort, patients diagnosed with pocket infection were isolated and divided into two groups:

(i) Patients who underwent primary wound closure with or without temporary use of a drain (PG), and

(ii) patients who underwent secondary wound closure or open wound management (SG).

Patients were followed up by telephone contact for short and long term complications.

Results

387 patients underwent CIED explantation due to local or system infection at a heart centre. Of this cohort, 205 patients (135 female; 74.4 ±11.4 y.o.) had a pocket infection. In addition to local infection, 25.9% of all patients presented with a pocket perforation. The onset of infection was early (within 28 days) in 16.1%, intermediate (29 days - 1 year) in 50.2% and late (after 1 year) in 33.2%. Wound swabs and blood cultures were positive for pathogens in 61.0% and 14.1% respectively.

136 (65.9%) underwent primary wound closure, 69 (34.1%) underwent secondary wound closure or open wound management. Post-operative (p.o.) hematoma was present in 12.2% of the cases (6.6% of PG and 24.6% of SG). The risk of developing a p.o. hematoma was significantly more likely in the SG (OR=4.61; IC95%: 1.93 − 11.01).

Re-implantation occurred in 70.2%, including 25.7% of leadless pacemakers an 1.5% subcutaneous defibrillators. In 13.7% re-implantation was not indicated, 4.4% refused and 1.0% had contraindications.

Mean length of hospitalization was 12.4 ±8.9 days in the PG and 15.7 ±9.6 days in the SG (ρ = 0.0083). A total of 24 (34.8%) patients were discharged with an open wound with or without vacuum treatment (0.74% of PG; 34.8% of SG).

Mean telephonic follow-up was 27 ±18 months in 147 cases (n1 = 99; n2 = 48). 91.8% of the cases had no pathological findings at follow-up. 2.7% developed a wound healing disorder (WHD) which was treated conservatively, 4.1% required revision, 0.7% explantation and 0.7% endocarditis. No statistical difference of complication risk between both groups was found (OR=1.8; IC95%: 0.51 - 6.17).

Summary & Conclusions

Management of CIED pocket infection with primary wound closure compared to secondary wound closure showed a statistically significant shorter hospital stay and reduced likelihood of post-operative hematoma, with no increase in long-term complication rates.