CRT Device Research Articles

Magnetic resonance-conditional cardiac implantable electronic devices: an Italian perspective on the prevalence of mixed-brand systems over time

The historical restriction of magnetic resonance imaging (MRI) for patients with cardiac implantable electronic devices (CIEDs) has been lifted by certified MRI-conditional systems in recent years. Mixed-brand CIED systems consisting of a generator from one manufacturer and at least one lead from another manufacturer are not certified for MRI. We evaluated the temporal trend in the prevalence of mixed-brand systems in the era of MRI-conditional systems. Data were analyzed on 5853 CIEDs implanted de novo between 2012 and 2022 in 81 Italian centers linked to the nationwide Home Monitoring Expert Alliance network. The percentage of mixed-brand implants was calculated by device type (pacemaker, implantable cardioverter-defibrillator [ICD], cardiac resynchronization therapy [CRT] device) and over time. A mixed-brand system was implanted in 4.1% (95% CI, 3.6-4.6%) of analyzed patients or, by device type, in 4.5% (3.5-5.7%) of pacemaker patients, 1.1% (0.7-1.7%) of ICD patients, and 6.8% (5.7-7.9%) of CRT pacemaker/defibrillator patients (p < 0.001). Prevalence of mixed-brand implants exhibited significant temporal fluctuations, first declining from 6.6% (2012–2014) to 1.3% (2019), and then increasing to 5.1% (2022). Temporal changes were statistically significant for pacemakers (p < 0.001) and CRT devices (p = 0.001), but not for ICDs (p = 0.438). In the decade between 2012 and 2022, mixed-brand CIED systems were more prevalent in patients treated with pacemakers and CRT devices than in ICD recipients. A decline in the prevalence of mixed-brand systems was observed after the introduction of MRI-conditional systems, reaching a minimum in 2019, followed by a progressive increase in the subsequent years.

Incidence of Staphylococcus aureus Bacteremia in Patients Following Implantation of Cardiac Implantable Electronic Devices: A Danish Nationwide Cohort Study.

Staphylococcus aureus bacteremia (SAB) is a high-risk condition associated with high morbidity and mortality. In the presence of cardiac implantable electronic devices (CIEDs), SAB may cause or clinically indicate device infection. We aimed to estimate the 10-year absolute risk of SAB in adult Danish first-time CIED carriers. Secondary aims included identification of risk factors associated with SAB. A registry-based study utilizing Danish nationwide registers and including consecutive Danish patients undergoing first CIED implantation between 2000 and 2020 was conducted. The primary outcome was first-time SAB after CIED implantation. A total of 87 257 patients with first CIED implantation in the study period were identified (median age, 75 years; 62.6% were male; median follow-up, 3.8 years). Patients with pacemakers (PMs) were older and with more noncardiovascular comorbidities compared to patients with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with or without defibrillator capacity (CRTs). In total, 1366 patients (1.6%) developed SAB. The 10-year absolute risk (95% confidence interval) of SAB was 2.0% (1.9%-2.1%) for PM, 2.6% (2.2%-3.1%) for ICD, and 3.7% (3.0%-4.5%) for CRT. A multivariable Cox analysis identified hemodialysis (hazard ratio [HR], 8.51), SAB before CIED (HR, 2.76), liver disease (HR, 2.35), and carrying a CRT device (HR, 1.68) among the covariates associated with increased risk of SAB. The absolute risk of SAB in Danish CIED carriers increased with more advanced CIED systems. The risk was highest within the first 3 months after CIED implantation and increased with the presence of certain covariates including renal dialysis, SAB before CIED, male sex, and advancing age.

Optimal timing of of cardiac implantable electronic device reoperation

Abstract Background Early re-intervention may increase the risk of infection of cardiac implantable electronic devices (CIED). Some operators therefore delay lead repositioning in case of dislocation by weeks, however there is no evidence to support this practice. The aim of our study was to evaluate the impact of the timing of re-operation on infection risk. Methods Data from consecutive patients (n=249) receiving lead/generator repositioning in one Hungarian and one German tertiary centre between January 1995 and August 2022 were retrospectively analysed. Relative risk of CIED infection in the first year was compared among patients undergoing early (≤1 week) vs. delayed (from 1 week to 1 year) re-operation. Results Out of 249 patients (mean age 70 ± 13 years, 54% male) requiring CIED re-intervention (30% single-chamber, 48% dual-chamber, and 22% CRT devices), 55 patients underwent right atrial (22%), 145 patients underwent right ventricular (59%), 20 patients underwent coronary sinus (8%), and 28 patients underwent multiple lead (11%) repositioning. Eighty-five patients (34%) went through an early (median 2, interquartile range (IQ): 1-4.5) and 164 (66%) patients had a delayed lead/pocket revision (median 53, IQ 36-209 days). A total of 9 (3,6%) wound/device infections were identified during the first year of follow-up, 1 (1,2%) vs. 8 (4,9%) in the in the early vs delayed groups. The risk of infection was numerically lower in the early vs. the delayed intervention groups yielding no statistically significant difference (OR=0.232; 95% CI 0.029-1.888; p=0.172). After adjustment for typical risk factors for CIED infection (i.e., number of implanted leads, diabetes, heart failure, fever prior to implant, therapy with corticosteroids, anticoagulation or antiplatelet therapy, temporary pacemaker) this difference remained non-significant (adjusted OR=0.266, 95% CI 0.032-2.246, p=0.224). System explantation/extraction was necessary in 7 cases (2,8 %), all being revised in the delayed group (OR early vs. delayed 0.128, 95% CI 0.01-2.273, p=0.161). Conclusion In this bicentric study, delayed re-intervention did not reduce the risk of CIED infection compared to patients undergoing an early (&amp;lt;1 week) re-operation.

THROW YOUR LEAD OVER THE OBSTACLE: A CHALLENGING CRT UPGRADING

Abstract High percentage of right ventricular pacing could lead to pacing induced cardiomyopathy in a non–negligible proportion of patients. Cardiac resynchronization therapy upgrading could represent an option to improve ventricular function, reducing heart failure hospitalizations. A 82 yo male was admitted to hospital with symptomatic heart failure. He had history of complete AV block treated with dual chamber pacemaker implantation five years earlier following coronary artery bypass graft surgery, bioprosthetic aortic valve replacement and septal myectomy. He had also history of cardiac arrest occurred in the context of acute coronary syndrome treated with PCI so that ICD implant was not considered at that time, and two more HF hospitalizations in previous years. Progressive LVEF decline was documented since PM impantation until last echo showed severe left ventricular dysfunction (EF 20% from baseline EF 60%). The ECG showed sinus rhythm and wide paced QRS (206 ms) with 100% pacing percentage. A CRT device upgrading was planned. Baseline venography initially showed pervious axillary–subclavian left axis, but unfortunately the guidewire encountered a complete occlusion before entering the superior vena cava. Nevertheless, dye contrast injection documented the presence of a proximal collateral branch (fig A) having a vertical course in the thorax and reaching the lateral wall of the left ventricle with an extrapericardic course then entering the right heart through inferior vena cava. Using a IM 5Fr sheath (usually used by interventional cardiologists to cannulate internal mammary artery) we could reach this branch, inserting a guidewire and finally advancing a quadripolar lead (Fig B–C) which reached the lateral left ventricular wall. LV capture was confirmed when pacing from the three proximal poles, while the distal one caused phrenic nerve capture. The quadripolar lead was connected to the LV port of a three chamber PM along with previous implanted leads thus obtaining biventricular pacing. QRS paced was 50 ms shorter than baseline. No peri–procedural complications occurred. Lead–related venous occlusion might represent an obstacle to CRT upgrade requiring high technical expertise. The presence of a complete venous occlusion might cause procedural failure, particularly in hospitals without surgical facility. In this case, the presence of a collateral branch reaching the lateral wall of the left ventricle allowed to successfully complete the CRT upgrade.

Feasibility study of wearable capillary refill time measurement device

AbstractCapillary refill time (CRT) is an internationally accepted indicator of peripheral circulation. The CRT is measured by applying compression to the fingernail for a few seconds, releasing it, and observing the process of refilling of blood at the fingertip. The international guidelines for the management of sepsis and septic shock 2021 contains an additional new recommendation for CRT measurement to determine the peripheral circulation statuses of adult patients with septic shock. However, the current CRT measurement method lacks objectivity. Previous studies have reported the development of measurement devices and video analysis systems, which involve complex measurement environment construction and assume only in-hospital measurements. In addition, since medical workers are limited in the number of carrying medical devices, devices that can be used to obtain multiple biometric indicators in a single measurement are needed. Hence, a prototype wearable CRT measurement device was developed in this study, and its feasibility was evaluated by comparing the agreement, intra-class correlation coefficient, and coefficient of variation with those of a CRT measurement device developed in the past. The results indicated that mean CRTs between measurement methods were agreement, with moderate or better intra-rater reliability and no difference in coefficient of variation. Therefore, the results indicate the feasibility of the proposed wearable CRT device.

Clinical utility of QRS duration normalized to left ventricular volume for predicting cardiac resynchronization therapy efficacy in patients with “mid-range” QRS duration

BackgroundCardiac resynchronization therapy (CRT) is effective for patients with heart failure with QRS duration (QRSd) ≥150 ms. However, its beneficial effect seems to be limited for those with “mid-range” QRSd (120–149 ms). Recent studies have demonstrated that modifying QRSd to left ventricular end-diastolic volume (LVEDV)—modified QRSd—improves the prediction of clinical outcomes of CRT. ObjectiveThe purpose of this study was to investigate the clinical impact of the modified QRSd on the efficacy of CRT in patients with “mid-range” QRSd. MethodsWe conducted a retrospective, multicenter, observational study, with heart failure hospitalization (HFH) after CRT as the primary endpoint. Modified QRSd is defined as QRSd divided by LVEDV, determined through the Teichholtz method of echocardiography. ResultsAmong the 506 consecutive patients considered, 119 (mean age 61 ± 15 years; 80% male, QRSd 135 ± 9 ms) with a “mid-range” QRSd who underwent de novo CRT device implantation were included for analysis. During median follow-up of 878 days [interquartile range 381–1663 days], HFH occurred in 45 patients (37%). Fine-Gray analysis revealed modified QRSd was an independent predictor of HFH (hazard ratio [HR] 0.97; 95% confidence interval [CI] 0.96–0.99; P <.01). Receiver operating characteristic curve analysis revealed a cutoff value of 0.65 ms/mL for the modified QRSd in predicting HFH. Patients above the threshold exhibited a significantly lower incidence of HFH than patients below the threshold (HR 0.46; 95% CI 0.25–0.86; P = .01). ConclusionModified QRSd can effectively predict the efficacy of CRT in patients with a “mid-range” QRSd.

CineECG repolarization gradients predict acute hemodynamical response in CRT patients

Abstract Background Cardiac resynchronization therapy (CRT) is widely used for patients with conduction disorders and heart failure. The proportion of the CRT-non-responders can exceed 30%, which warrants search for new approaches to optimize the CRT device implantation and follow-up. CineECG is a novel cardiac anatomy-based ECG modality proposed for better visualization of the myocardial depolarization and repolarization processes. This method yielded promising results in patients with sinus rhythm but has not been tested in ventricular pacing. Purpose The aim of the present study was to evaluate CineECG-derived mean temporo-spatial isochrone (TSI) trajectory in different pacing protocols and test its association with acute hemodynamical responses in CRT patients. Methods CineECG uses a generic heart/torso model to construct the average electrical pathway within the cardiac anatomy from the 12 lead ECG. CineECG and invasive hemodynamical parameters were tested in 15 patients undergoing multisite CRT system implantation. ECG recording and hemodynamical measurements were performed simultaneously, while the patients were undergoing 4-6 biventricular pacing protocols with the same interventricular pacing delay (30 ms) and different left ventricular (LV) lead localizations (apical, basal, multisite). LV dP/dt max was tested for association with the parameters of standard ECG (QRS duration, QT duration, Tpeak-Tend duration) and CineECG pathway parameters. The latter pathway directions were computed for QRS and ST-T intervals for anteroposterior (X), left-to-right (Y), and apicobasal (Z) directions. Results Biventricular protocols did not differ between each other in LV dP/dt. In univariate linear regression analysis, LV dP/dt max was associated with QRS and ST-T pathway directions (Figure 1 - table). The left-to-right (Y) and apicobasal (Z) ST-T pathway directions remained independent predictors of LV dP/dt max in multivariate linear regression analysis with the adjustment for a pacing protocol [regression coefficient 571.6 (319.3 – 823.8), p&amp;lt;0.001; regression coefficient -406.9 (-636.7 – -177.2), p=0.001, respectively]. Optimal repolarization sequences associated with better acute hemodynamic responses assessed by LV dP/dt max were from right to left and from base to apex (Figure 2). Conclusion CineECG repolarization pathway gradients in the left-to-right and apicobasal directions outperform temporal ECG parameters and predict the acute hemodynamical response in biventricular pacing protocols in CRT patients.

Impact of Different Right Ventricular Lead Positions on QRS Complex Duration Post Cardiac Resynchronization Therapy Device Implantation

Abstract Aim and objectives The aim of the study was to evaluate the effect of different RV lead positions on QRS complex duration post CRT device implantation in patients indicated for CRT as a treatment of chronic heart failure based on the recommendations of ESC guidelines for diagnosis and treatment of acute and chronic heart failure published in 2016 and to assess the effect of change of QRS complex duration and morphology according to different RV lead positions on clinical response. Patients and Methods This study included 100 patients (age 60.02 ± 7.18) post CRT device implantation presented for follow up at electrophysiology clinics of the cardiology department of Ain Shams university hospitals at least 3 months post CRT device implantation, during the period form from December 2020 till May 2021. The patients were divided into 2 groups according to the site of RV lead implantation after confirmation of the RV lead position by fluoroscope in Right anterior oblique (RAO) and left anterior oblique (LAO) views, 54 patients had the RV lead implanted in the RV Apex (RVA n = 54) and 46 patients had the RV lead implanted in the RV Septum (RVS n = 46). Results OF the total 100 patients that enrolled in our study the rate of non-responders was 19% of the patients showed no clinical improvement, no improvement of NYHA class by at least one grade, 30% of the patients were non-Echocardiographic responders, no improvement of LVEF (Δ EF) by at least 5% with no decrease of LVES diameter by at least 15%, and 15% of the patient were nonECG responders, delta QRS (ΔQRS) didn`t increase by at least 20%. There was no significant difference between the two groups regarding clinical response (NYHA class) (P-value = 0.583), LVEF (Δ EF 6.26 ± 1.64 in RVS group vs. 6.07 ± 1.67 in RVA group, P-value = 0.575) LVES diameter (47.70 ± 8.03 in RVS group vs. 45.39 ± 7.48 in RVA group, P-value = 0.141) or QRS complex narrowing (ΔQRS 60.93 ± 24.68 in RVS group vs. 54.07 ± 26.12 in RVA group, P-value = 0.182). There was no significant difference in the rate of non-responders between the two groups (clinical non responders in RVS group n = 8 vs. RVA group n = 11, P value = 0.547) (Echo non responders in RVS group n = 13 vs. RVA group n = 17, P value = 0.726) (ECG non responders in RVS group n = 6 vs. RVA group n = 9, P value = 0.613), There was an inverse relationship between ΔQRS and clinical response (NYHA) class post CRT device implantation in both RVS and RVA groups (P value 0.016 in RVS group, P value 0.007 in RVA group). Conclusion The study demonstrates that septal RV pacing in CRT is non-inferior to apical RV pacing regarding the primary objective of the study regarding clinical outcome, narrowing of QRS complex (ΔQRS) or LV reverse remodeling, thus no recommendation for optimal RV lead position can hence be drawn from this study. Also, delta QRS complex duration may be used as indicator for electric remodeling and CRT response.

Clinical outcomes of conduction system pacing versus biventricular pacing for cardiac resynchronization therapy: A systematic review and meta-analysis.

Conduction system pacing (CSP) is observed to produce greater improvements in echocardiographic and hemodynamic parameters as compared to conventional biventricular pacing (BiVP). However, whether these surrogate endpoints directly translate to improvements in hard clinical outcomes such as death and heart failure hospitalization (HFH) with CSP remains uncertain as studies reporting these outcomes are scarce. The aim of this meta-analysis was to analyze the existing data to compare the clinical outcomes of CSP versus BiVP. A systematic search of the Embase and PubMed database was performed for studies comparing CSP and BiVP for patients indicated to receive a CRT device. The coprimary endpoints were all-cause mortality and HFH. Other secondary outcomes included change in left ventricular ejection fraction (LVEF), change in NYHA class, and increase in NYHA class ≥1. A random-effects model was chosen a priori to analyze the composite effects given the anticipated heterogeneity of included trials. Twenty-one studies (4 randomized and 17 observational) were identified reporting either primary outcome and were included in the meta-analysis. In total 1960 patients were assigned to CSP and 2367 to BiVP. Median follow-up time was 10.1 months (ranging 2-33 months). CSP was associated with a significant reduction in all-cause mortality (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.56-0.83) and HFH (OR 0.52, 95% CI: 0.44-0.63). Mean improvement in LVEF was also greater with CSP (mean difference 4.26, 95% CI: 3.19-5.33). Reduction in NYHA class was significantly greater with CSP (mean difference -0.36, 95% CI: -0.49 to -0.22) and the number of patients with an increase in NYHA class ≥1 was significantly greater with CSP (OR 2.02, 95% CI: 1.70-2.40). CSP was associated with a significant reduction in all-cause mortality and HFH when compared to conventional BiVP for CRT. Further large-scale randomized trials are needed to verify these observations.

Acute effects of interruption of cardiac resynchronization therapy on left ventricular morpho-functional parameters as assessed by cardiac magnetic resonance

Abstract Funding Acknowledgements Type of funding sources: None. Background Cardiac resynchronization therapy (CRT) has become a standard treatment for patients with heart failure with reduced ejection fraction (HFrEF) and left ventricular (LV) dyssynchrony. Both immediate and long-term clinical and functional improvement have been reported after CRT implementation, as well as a decrease in the mortality and hospitalization rates. Recently, it has been questioned whether, once LV function has improved and reverse LV remodeling has occurred, ongoing biventricular pacing is still necessary. Purpose To assess by cardiac magnetic resonance (CMR) the acute effect on LV systolic function and dimensions of discontinuing CRT in patients with HFrEF. Methods The study prospectively included a small cohort of patients with HFrEF (7 males and 1 female; mean age 63.7 ± 2.5 years; ischemic etiology in 50%) receiving an MR-conditional CRT device in accordance with the existing guidelines. CMR examinations have been performed before (pre-CRT) and after 6 months after CRT implantation (post-CRT). Each follow-up CMR study included two full sets of cine images for the evaluation of LV systolic function and volumes obtained, respectively, before (post-CRTON) and after (post-CRTOFF) disabling the CRT function on the device. To warrant patient safety, each post-CRT CMR study was performed following institutional protocols based on specific guidelines for patients with MR-conditional cardiac implantable electronic devices (CIEDs). Results No adverse events or significant changes in the CIEDs parameters (including pacing and sensing thresholds and battery level) were recorded during the follow-up CMR studies. At post-CRT evaluation, CMR image quality was judged to be at least sufficient for analysis in all patients. As compared with the basal pre-CRT study, a significant increase in LVEF was detected at the post-CRTON CMR evaluation (28,1 vs 35,0%; p &amp;lt;0,05) (Figure 1), together with a clear trend towards a decrease in LV end-diastolic volume [LVEDV] (118.72 ± 11.00 mL vs. 107.5 ± 13.86 mL; p = n.s) and LV end-systolic volume [LVESV] (87.12 ± 9.40 mL vs. 71.125 ± 11.26 mL; p = n.s.) (Figure 2). No relevant changes were detected when re-assessing the same LV parameters by CMR immediately after switching off the CRT function (post-CRTOFF study), with persisting increase in LVEF (37.9 ± 4.5%; p &amp;lt;0,05 vs. pre-CRT) and tendency towards decreased LVEDV (97.3 ± 12.3 mL; p = n.s. vs. pre-CRT) and LVESV (63.0 ± 11.4 mL; p = n.s. vs. pre-CRT). Conclusion These preliminary findings show that favorable changes induced on LV function and remodeling by prolonged CRT in HFrEF patients are not promptly lost after the interruption of the electrical therapy. Whether a longer CRT interruption would determine more pronounced variations in the LV parameters or if the effects of CTR discontinuation may be related to the effective length of the period of time between implantation and cessation of the therapy deserve further investigation.

Role of RA-LV pacing in patients with symptomatic left bundle branch block with CRT - a single centre experience

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Cardiac Resynchronisation Therapy(CRT) is considered as the cornerstone of treatment for patients with heart failure and left ventricular conduction delay ( left bundle branch block) who remain symptomatic despite optimal medical therapy. However, it has been well documented that the responder and success rates of this therapy are highly variable. Contemporary response rates from clinical trials as well as real world data demonstrate non-response rates of between 30–50%. Suboptimal AV delay timing is the most prevalent modifiable factor on follow up for improving response rates. AV Fusion pacing describes the delivery of CRT pacing with a programming strategy to preserve intrinsic atrioventricular (AV) conduction and ventricular activation via the right bundle branch. This concept is utilised in the RA- LV pacing strategies, which have been described in literature. However, RA-LV only pacing raises certain practical , moral and ethical concerns as it has never been a part of contemporary guidelines nor a part of large randomised control trial. Purpose The purpose of this study was to study the clinical as well as hemodynamic effects of RA-LV pacing in patients with a conventional CRT device with a programmed subthreshold RV lead. Methods All patients with a convention CRT indication ( CRT-P as well as CRT-D), with acceptable intrinsic AV conduction, non pacing dependent and normal Right Ventricular function were enrolled into the study. A total of 60 consecutive patients between 2016-2021 were enlisted from after the implant and followed up in the Device clinic of the institution. The baseline as well as follow-up LV function, Battery life and QRS duration was recorded and analysed. Results Total of 60 patients were enlisted of which 30 were males and 30 females. There were 16 patients were with Ischemic Cardiomyopathy in this group. The average follow-up period was 3 year from implant. The mean baseline Left Ventricular Ejection Fraction was 29% while the mean follow-up Left Ventricular Ejection Fraction was 46.5%. The mean QRS duration at implant was 155msec and the mean follow-up QRS was 123 msec. The subset analysis of ischemic vs the nonischaemic cardiomyopathy groups revealed that both groups had a similar response rates to improvement of clinical as well as Echocardiographic parameters including LVEF. The mean follow up LVEF in the ischemic and nonischaemic groups were 44.5 &amp; 46.5% respectively. This finding suggests that the advantage of AV fusion pacing is not significantly impacted with underlying aetiology of the Cardiomyopathy. Conclusion RA-LV with RV subthreshold CRT is a reasonable strategy for achieving traditional response rates of CRT in patients with a good intrinsic AV conduction. This modality overcomes a large number of procedural as well as ethical roadblocks in the use of fusion pacing for CRT therapy optimisation.

PO-02-158 PACE AND ABLATE IS AN EFFECTIVE MANAGEMENT STRATEGY FOR ATRIAL FIBRILLATION IN PATIENTS WITH HYPERTROPHIC CARDIOMYOPATHY

Atrial fibrillation (AF) is common in patients with hypertrophic cardiomyopathy (HCM). In this cohort, the sequel of rapid ventricular response and symptoms associated with an irregular rhythm can be challenging to manage with medical therapy and catheter ablation (CA). Pace and ablate (PAb) strategy may offer an effective treatment alternative. Assess the efficacy of PAb in patients with HCM who have failed medical therapy and/or catheter ablation for AF. Single centre study with retrospective analysis of a prospectively collated HCM registry. PAb patients were identified. Baseline characteristics, procedural indication and procedural data was collected and symptoms defined by NYHA and EHRA classification plus echocardiographic findings in follow-up assessed. Forty-two patients (17 (40%) male and age 67±11 years) were included (Table 1) of which 18 (43%) patients had undergone previous CA ablation. Indications for PAb: 5 (12%) inappropriate shock, 24 (57%) ineffective rate control and 13 (31%) to regularise rhythm to improve symptoms. Procedural parameters: procedure time 70±12mins and immediate success in 40 patients (95%) with no complications. During a follow-up time of 62±54 months, left ventricular ejection fraction (LVEF) post PAb remained stable (LVEF Pre 52±10%, LVEF Post 50±9%, p=0.6). Those without a CRT also had no change in LV function during follow-up post PAb (LVEF pre 55±8% vs post 51±19%, p=0.21). Thirty-three (83%) patients reported an improvement in symptoms post procedure. In patients with symptom improvement there was no difference in AF type (14/15, 93% paroxysmal vs. 19/25, 76% persistent AF; p=0.22), presence of at least moderate mitral regurgitation (MR) (12/33, 36% moderate MR. 1/7, 14% no moderate MR; p=0.39), LV impairment (10/11, 91% LVEF <50% vs. 23/29, 79% LVEF ≥50%; p=0.65) or CRT device in situ (22/24, 92% CRT vs. 11/16, 69% no CRT; p=0.09). Symptoms improved in 10 (76%) patients who underwent PAb to regularise rhythm. In the majority of patient with HCM and AF, PAb improves symptoms without impacting LV function regardless of AF type, device implanted or the presence of pre-existing LV impairment. PAb was also shown to effectively improve symptoms through regularising the rhythm. Post PAb, LV function remains stable regardless of the type of device implanted. PAb is an effective treatment strategy for AF in patients with HCM.

PO-03-029 LEFT BUNDLE BRANCH AREA PACING LEARNING CURVE AND OUTCOMES IN A BEGINNER IMPLANTER

Left bundle branch area pacing (LBBAP) is a rapidly growing conduction system pacing technique. However, little is known about the learning curve of LBBAP implants in a beginner implanter. We sought to determine acute procedural success rate, implant characteristics, and complications of a single operator implanting LBBA pacing devices in his first year of unsupervised practice. All patients who underwent pacemaker and CRT device implants at our center by a single operator (TC) were reviewed. LBBAP was defined as the presence of R’ in lead V1, and LV activation time (LVAT) <= 80 msec (stim to peak in V6) in the paced QRS complex. Charts were retrospectively reviewed to determine rates of LBBA capture, procedure duration, fluoroscopy time, lead dislodgement, and lead revision rates. LBBA pacing was attempted in 80 patients. Medtronic C315 sheath was used to deliver a Medtronic 3830 lead to the LBBA in all cases. LBBA capture was obtained in 69/80 (86%) patients. Mean paced QRS duration was 131 +/- 13 msec. and mean LVAT was 66 +/- 11 msec. For the first 20 implants, mean procedure duration was 104 +/-32 minutes, and mean fluoroscopy time was 11 +/- 6 minutes. Subsequent 60 implants had significantly lower mean procedure duration (82 +/- 21 mins, p < 0.01) and fluoroscopy time (8 +/- 4 mins, p = 0.01). Overall, mean procedure duration was 88 +/- 26 minutes, and mean fluoroscopy time was 9 +/- 5 minutes. Rate of LBBA capture increased from 70% for the first 20 implants to 92% for the last 60 implants. No significant differences were observed in QRS duration and LVAT time between the first 20 and last 60 implants. Three lead dislodgements occurred, all of which occurred prior to the 15th procedure. One patient required lead revision for increasing pacing thresholds. In this single center, retrospective study of a single operator in his first year of unsupervised practice, LBBA pacing was achieved in majority of patients. Rate of lead dislodgement and need for lead revision were low. Procedural success rate increased while procedure duration, fluoroscopy use, and complications decreased after 20 implants.

Technique of the cardiac resynchronization therapy device implantation

Introduction Cardiac resynchronization therapy has become an established treatment modality for patients with advanced heart failure and left bundle branch block. In 2016 we started the implantation of the CRT devices in Medpark International Hospital and for the first time in The Republic of Moldova. Taking into consideration the lack of the experience we had to face the challenges and quickly implement all the published data. From April 2016 till April 2023 in our center were implanted 49 CRT devices. Objective The purpose of the current article is to describe our technique of CRT implantation and the subsequent follow-up of the patients. Conclusion Cardiac resynchronization therapy is an important tool in heart failure management. The implantation could be a challenging procedure and many complications could arise. Is important to develop a proper strategy to face all the challenges.

Performance of a multisensor implantable defibrillator algorithm for HF monitoring in presence of comorbidities

Abstract Background Cardiovascular and non-cardiovascular comorbidities are common in heart failure (HF) patients and impact disease severity and prognosis. Select modern implantable defibrillators (ICDs) are equipped with multisensor algorithms for HF monitoring. The HeartLogic index combines multiple ICD-based sensor data (heart rate, heart sounds, thoracic impedance, respiration, activity), and the associated alert has proved to be a sensitive and timely predictor of impending HF decompensation in cardiac resynchronization therapy (CRT-D) patients The algorithm was developed using data from CRT-D patients; the performance in non-CRT ICD patients and the impact of selected comorbidities on performance requires further study. Methods The HeartLogic feature was activated in 568 ICD patients (410 with CRT) from 26 centers. The median follow-up was 25 months [25th–75th percentile: 15–35]. Results During follow-up, 97 hospitalizations were reported (53 cardiovascular) and 55 patients died. We recorded 1200 HeartLogic alerts (0.71 alerts/patient-year) in 370 patients. Overall, the time IN the alert state was 13% of the total observation period. The rate of cardiovascular hospitalizations or death was 0.48/patient-year (95% CI: 0.37–0.60) with the HeartLogic IN alert state and 0.04/patient-year (95% CI: 0.03–0.05) OUT of alert state, with an incidence rate ratio of 13.35 (95% CI: 8.83–20.51, p&amp;lt;0.001). Among patient characteristics, atrial fibrillation (AF) at implantation (HR: 1.62, 95% CI: 1.27–2.07, p&amp;lt;0.001) and chronic kidney disease (CKD) (HR: 1.53, 95% CI: 1.21–1.93, p&amp;lt;0.001) independently predicted alerts. HeartLogic alerts were not associated with CRT vs. non-CRT device implantation (HR: 1.03, 95% CI: 0.82–1.30, p=0.775). The comparisons of the clinical event rates in the IN alert state with those in the OUT of alert state yielded incidence rate ratios ranging from 9.72 to 14.54 (all p&amp;lt;0.001) in all groups of patients stratified by: CRT/non-CRT, AF/non-AF, CKD/non-CKD. Indeed, after multivariate correction for CKD and AF at implantation, the time IN the HeartLogic alert state &amp;gt;13% was associated with the occurrence of the combined endpoint of cardiovascular hospitalization or death (HR: 2.54, 95% CI: 1.61–4.01, p&amp;lt;0.001). Conclusions The burden of HeartLogic alerts appears similar between CRT and non-CRT patients, while patients with AF and CKD seem more exposed to alerts. Nonetheless, the ability of the HeartLogic algorithm to identify patients during periods of significantly increased risk of clinical events is confirmed regardless of the type of device, the presence of AF, or CKD. Funding Acknowledgement Type of funding sources: None.

432 SACUBITRIL/VALSARTAN AND RISK OF SUPRAVENTRICULAR ARRHYTHMIAS AS DETECTED BY REMOTE MONITORING IN HEART FAILURE PATIENTS

Abstract Introduction Sacubitril/valsartan (ARNI) has demonstrated a significant benefit compared to angiotensin inhibitor (enalapril) in decreasing both morbidity and mortality in patients with heart failure with reduced ejection fraction (HFrEF). While. recent studies demonstrated that in HFrEF patients, ARNI decreased ventricular arrhythmias no data is available with regards to the supraventricular arrhythmic burden in HFrEF patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy-defibrillator (CRT-D) and remote monitoring. The aim of out study was to assess if ARNI therapy was able to significantly reduce supraventricular arrhythmias. More specifically the primary endpoint was the incidence of AT/AF episodes, as detected by the device. Secondary endpoints included the total burden of AT/AF, the mean number of premature ventricular contractions (PVC) per hour and the percentage of biventricular pacing per day (in patients with CRT-D). Methods We conducted a multicentre, observational, prospective registry : the SAVE THE RHYTHM (SAacubitril Valsartan rEal-world registry evaluating THE arRHYTHMia burden in HFrEF patients with implantable cardioverter defibrillator). We enrolled all patients with HFrEF, ICD or CRT-D actively followed through remote monitoring and starting treatment with sacubitril/valsartan. All patients were followed-up for at least one year. Results At the end of enrollment, 265 patients from 5 centres had at least one sacubitril/valsartan prescription (88% males, age 68±10 years). The annual incidence of AT/AF episodes decreased from 16.6% before sacubitril/valsartan to 12.8%, 6.7% and 0.7% according to the maximum tolerated dose (24/26 mg, 49/51 mg and 97/103 mg, respectively; p=0.026). After treatment with sacubitril/valsartan, patients with at least one episode of AT/AF decreased from 32.6% to 26.5% (24/26 mg), 24.3% (49/51 mg) and 6.9% (97/103 mg); p=.041. A significant decrease in the number of PVC (-28 per hour) and in the rate of appropriate shock (-0.8% per year) were seen in patients with a previous diagnosis of paroxysmal or persistent AF. Patients with permanent AF (n=7) experienced no benefits from sacubitril/valsartan therapy in terms of arrhythmic burden reduction. Patients with a CRT device (41%) experienced a significant increase in biventricular pacing time (+3% per day). Discussion Therapy with sacubitril/valsartan could decrease arrhythmic burden in patients with non-permanent AF and HFrEF and reduce subclinical supraventricular arrhythmias in patients with no history of AF.

281 CARDIAC RESYNCHRONIZATION TERHAPY IN PERSISTENT LEFT SUPERIOR VENA CAVA WITH A BRIDGING INNOMINATE VEIN

Abstract Background The Persistent Left (PL) Superior Vena Cava (SVC) is a congenital malformation of the thoracic venous return that has an incidence of 0.2-3% in the general population and an incidence of about 0.5% in patients undergoing cardiac implantable electronic device. In this case, the placement of the leads, especially for the Right Ventricle (RV) and Left Ventricle (LV) through one of the branches could be challenging. Methods A 66-year-old man with hypertension, diabetes and dyslipidemia, in optimal pharmacologic therapy for congestive heart failure (NYHA II), hospitalized for recurrent syncopal episodes, with extreme sinus bradycardia, first-degree AV block and Left Bundle Branch Block, The patient had a LV hypertrophy and mild global systolic function (LV ejection fraction of 40%) for these we opted for a pacemaker CRT device implantation. Results Isolation of left cephalic vein was used as venous access for right atrium (RA) and RV leads while Seldinger technique via subclavian vein was used as venous access for LV lead. The guidewire through the subclavian vein pointed out the presence of PLSVC. Left subclavian venogram confirmed PLSVC and revealed a bridging innominate vein. To pass through the innominate vein and reach the SVC, a 0.035-inch hydrophilic guidewire was used. A 6Fr-sheath was advanced through the hydrophilic guidewire, subsequently a second metallic guidewire was advanced through the same introducer by removing the dilator. The RV and RA leads were placed respectively on low right interventricular septum and RA appendage passing through bridging innominate vein. Electrical parameters were normal. For the placement of the LV lead a 9.5Fr sheath introducer was advanced over the guidewire through the PLSVC. A venogram showed a lateral and a postero-lateral branch of the coronary sinus with acute angulation. With a 6Fr quadripolar Josephson catheter the postero-lateral branch was entered, eventually a 9Fr peelable outer guide catheter was advanced through the electrophysiology catheter becoming selective with the interested branch. A quadripolar S shaped lead was used, it was advanced into the targeted vein through a 0,014fr hydrophilic guidewire. Adequate electrical parameters and stability were achieved. Conclusion Lead implantation in patient with PLSVC is challenging. Placing the RA and RV leads through SVC ensure a better stability along time. The cannulation of CS is easily achieved by approach via PLSVC while selective vein cannulation can be difficult due to the modified acute angulation.

Abstract 11592: Real-World Performance of Heartlogic Index in Subjects With CRT and ICD Devices

Introduction: The HeartLogic heart failure (HF) diagnostic was developed from data in subjects implanted with CRT-D devices. Diagnostic performance in subjects with ICDs (without CRT) is less well characterized. Objective: Compare HeartLogic performance in ICD and CRT subgroups. Methods: Data from US post-market HeartLogic CRT/ICD devices were directly linked with Medicare claims and subjects with continuous Medicare Part A&amp;B fee-for-service coverage were analyzed. Claims HF events (HFE) were defined using primary HF diagnosis codes (DRG 291-3, I50.xx) and included acute inpatient events, and outpatient events with IV diuretic therapy. Baseline characteristics included patient demographics, implant data, and claims chronic conditions flags (CCFs). Diagnostic performance was defined as the sensitivity to detect HFEs and the false-positive alert rate (FPR), from which a modified receiver operator characteristic (ROC) curve was generated. Continuous variables were expressed as mean±SD and categorical variables as proportions. Two-sided 95% confidence intervals (CI) were calculated for sensitivity (binomial distribution) and FPR (negative binomial model). Results: Out of 4190 subjects,1567 linked subjects were included in the analysis with an average follow-up of 1.4±0.5 years. The CRT group (N=1078, 69%) was more likely to be Caucasian (88% vs 82%), less likely to have de novo devices (62% vs 80%), more likely to have CCFs of AF (43% vs 33%) and congestive HF (89% vs 75%), and a HF hospitalization in the year prior to implant (23% vs 16%). CRT and ICD groups provided 296 and 139 HFEs for performance evaluation. HeartLogic ROCs were similar in both groups with no difference in the nominal sensitivity (83% [CI: 78, 87] vs 80% [72, 86%], p =0.41) or FPR (1.386 [CI: 1.337,1.511] vs 1.322 [1.238,1.488], p =0.41). Conclusions: HeartLogic diagnostic performance determined using real-world claims data was not different in subjects implanted with ICDs and CRT-Ds.

Abstract 10679: Do Hospitals Caring for a High Proportion of Black Adults Deliver Lower Quality Care for Heart Failure? An Analysis of the Get With the Guidelines-Heart Failure Registry

Introduction: Black individuals have higher hospitalization and mortality rates from heart failure (HF). Black adults receive care at a limited set of US hospitals (minority-serving hospitals [MSH]) and understanding quality of care at these sites could inform efforts to improve health equity. Using the Get With The Guidelines (GWTG) - HF Registry, we compared HF care quality and clinical outcomes at MSH vs. non-MSH. Methods: We identified adults ≥18 years hospitalized for HF at GWTG-HF sites. MSH were defined as the top quintile of proportion of hospitalizations for Black adults. We compared performance on GWTG-HF quality measures at MSH vs. non-MSH, adjusting for age, sex, comorbidities, and hospital characteristics, using GEE to account for clustering within sites. After restricting to adults ≥65 years and linking to Medicare FFS claims, we used multivariable Cox proportional hazard models to compare post-discharge outcomes. Results: Study population included 422,483 hospitalizations at 480 hospitals, of which 96 (with &gt;38% Black patients) were MSH. Care quality was similar between MSHs and non-MSHs for 10 of 13 GWTG-HF measures; MSH patients were less likely to be discharged with 7-day follow up, CRT device planning, or aldosterone antagonist (Figure). Overall defect-free care was similar across sites; there were no within-hospital disparities between Black vs. White patients at both MSH and non-MSH. Among 111,930 Medicare beneficiaries, risk-adjusted 30-day readmissions were higher at MSH compared with non-MSH (HR 1.14, 95% CI 1.02-1.26), but risk-adjusted 30-day mortality was similar (HR 0.92, 95% CI 0.84-1.02). Conclusions: Across GWTG-HF-participating hospitals, HF care quality and mortality were similar at MSH vs. non-MSH, but MSH 30-day readmissions were higher. Improving MSH post-discharge follow-up could improve equity in HF outcomes, though additional investigation to address higher MSH readmissions is needed.

Ventricular arrhythmia events in heart failure patients with cardiac resynchronization therapy with or without a defibrillator for primary prevention.

It is uncertain whether cardiac resynchronization therapy with a defibrillator (CRT-D) provides better survival benefits than a CRT-pacemaker (CRT-P) in heart failure patients with a reduced ejection fraction (≦35%, HFrEF) treated with contemporary HF therapy. We retrospectively analyzed the ventricular arrhythmia (VAs; sustained ventricular tachycardia/fibrillation) events in HFrEF patients who underwent CRT without a prior history of VAs or aborted sudden cardiac death before the CRT implantation. Between January/2010 and December/2020, a CRT device was implanted in 79 HFrEF patients (mean age: 69 ± 12 years, male: 57, ischemic cardiomyopathy: 16). CRT-D and CRT-P devices were implanted in 50 and 29 patients, respectively, at each physician's discretion. CRT-Ds were indicated in younger patients than were CRT-Ps (66 ± 12 vs. 73 ± 12 years, p=0.03), but the gender distribution did not differ (female, 24% [12 of 50] vs. 35% [10 of 29], p=0.44). The VA events during a median follow-up of 3.5-years (interquartile range [IQR]:1.6-5.5) and their predictors were analyzed. VA events occurred in 9 patients with CRT-Ds (18%) and one with a CRT-P (3%, p=0.08). The VA event rate was significantly lower in patients without a prior non-sustained ventricular tachycardia (NSVT: ≥3 beats; rate, ≥120 bpm; lasting <30 s, HR 0.05; 95% CI 0.01-0.30; p < 0.01) and females (HR 0.11; 95% CI 0.01-0.93; p=0.04). Of note, no female patients without a prior history of NSVT experienced VA events. HFrEF CRT candidates without a prior history of NSVT and females may obtain less benefit from a primary preventive defibrillator indication.