bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of implantable cardioverter defibrillator intracardiac electrogram morphology changes on hospitalization and life quality
Authors: Ozkahya M , Yilancioglu R Y , Turan O E , Ozcan E E 
Published: May 2024

Abstract

Background
Implantable Cardioverter Defibrillators (ICD) are standard therapy for patients at risk of life-threatening ventricular tachyarrhythmias. ICDs use morphology discrimination to compare ventricular electrogram during tachycardia with reference template during baseline rhythm. Baseline morphology match score (MMS) changes may predict arrhythmic events, but usefulness as a parameter for heart failure (HF) is still unknown.

Methods
The prospective single-center study included consecutive 88 patients undergoing device control at cardiology department from July 2022 to May 2023. Inclusion criteria were patients implanted with ICD or CRT for at least 3 months; the exclusion criteria were defined as communication barriers (n=1), depleted device battery during checks (n=1), total AV block (n=3), and auto-template activation (n=4). The data were analysed for changes in the baseline (MMS) relationship with demographic, clinical characteristics, quality of life (QOL), and hospitalisation with HF.

Results
We analyzed 79 patients with a mean age 64,9 13,6 and an average MMS of 98 1,8 morphology. During follow-up there were 12 (15%) patients hospitalized due to HF. ROC curve analysis showed that a MMS ≤ 97% had 73% sensitivity and 59% specificity for hospitalization (p: 0,033 Area 0.695). No significant differences were observed in demographics between the two groups. Although there was no significant difference in EF and BNP levels, patients with MMS &lt;97% had lower QOL scores and more hospitalizations for heart failure (HF).

Conclusion
EGM baseline MMS changes in ICD were associated with hospitalization for HF and QOL, apart from arrhythmia detection indications. It may be a follow-up parameter for HF, in addition to the current device algorithms.Graphical AbstractTable 1
Substernal lead removal: experience from the EV ICD pivotal study
Authors: Amin A , Crozier I , Murgatroyd F , Boersma L V A , Manlucu J , Knight B P , Leclercq C , Birgersdotter-Green U M , Chan J Y S , Roukoz H , Biffi M , Sagi V , Wiggenhorn C , Friedman P 
Published: May 2024

Abstract

Background
The extravascular implantable cardioverter defibrillator (EV ICD) has recently emerged as a new option for guideline indicated ICD patients. Previous study results from the EV ICD Pilot and Pivotal studies have demonstrated that the device can provide safe and effective therapy through chronic follow up. However, less has been reported regarding EV ICD lead removal.

Purpose
To report on the experience of lead removal in the EV ICD Pivotal Study.

Methods
The EV ICD Pivotal study was an international, prospective, single-arm, premarket clinical study. Patients with a class I or IIa indication for a single-chamber ICD per ESC or ACC/AHA/HRS guidelines were enrolled. Lead removal summary data was reported.

Results
Of 316 patients with an implant attempt, (74.7% male, age 53.8±13.1 years, 82% primary prevention, LVEF of 38.9%±15.4%, and NYHA Class I [23.7%] or II/III [65.5%]) 299 were fully implanted; 17 (5.7%) of which had a lead removal procedure (14–752 days post-implant, at 13 sites) with 3 of them having been implanted for more than 1 year. Reasons for lead removal were lead dislodgement (n=7), infection (n=5), high impedance alert due to lead fracture (n=2), pacing indication (n=1), cardiac transplant (n=1), or scheduled sternotomy (n=1). New EV ICD leads were placed in 7/17 (41.2%) patients. No serious adverse events were adjudicated as related to the explant procedures. There was a single observation of incision site haemorrhage, that was resolved with wound care. Additional details on lead removal will be included at the time of presentation.

Conclusions
The EV ICD lead was successfully removed 14-752 days post implant. Nine patients were re-implanted with either extravascular or transvenous systems. Longer term extraction data collection is ongoing through the EV ICD Pivotal study and through the EV ICD post-approval study and will continue to provide additional insights.Lead removed 24 months post-implant.
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

Abstract

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) &gt;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 &lt;0.01) and a greater reduction in QRS duration (FIGURE A). Furthermore, more patients in the SyncAV group achieved a paced QRSd &lt;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

Abstract

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 &gt;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

Abstract

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

Abstract

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&lt;120 ms: 97±15 ms, QRS&gt;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&lt;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

Abstract

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 &lt; 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 &lt; 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

Abstract

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&lt;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

Abstract

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&lt;0.001) and LGE was an independent predictor of this endpoint (adjusted HR 42, p&lt;0.001). The proportion of responders to CRT was significantly higher in LGE- than in LGE+ cases (81% vs 53%, p&lt;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.