Cardiac Resynchronization Therapy Pacemaker Research Articles

Abstract 4136884: Incidence and Characteristics of Peri-Procedural Complications of Cardiac Implantable Electrical Devices in Breast Cancer Survivors

Introduction: Breast cancer (BC) is the most common non-cutaneous cancer in women. Several BC treatments increase the risk of conduction abnormalities and heart failure, potentially requiring cardiac implantable electrical devices (CIEDs). Due to vascular access devices, surgical management, and chest wall radiation, these patients are subject to upper extremity vascular alterations. There is limited data regarding CIED use in this population. Research question: Do patients with BC and CIEDs have different procedural approaches or complications compared to the general population? Aims: This study aimed to evaluate CIED placement and periprocedural complications in patients with a history of BC. Methods: This was a retrospective study of CIEDs placed at our institution between 2005 and 2023. Patients with a diagnosis of BC prior to time of placement were included. Complications included those within 30 days of the procedure. Results: We analyzed 109 female patients (median age of 73 years, IQR 66-80) who received pacemaker (PPM, 58.7%), cardiac resynchronization therapy defibrillator (CRT-D, 22%), implantable cardioverter defibrillator (ICD, 16.5%), or cardiac resynchronization therapy pacemaker (CRT-P, 2.8%). The median time from cancer diagnosis to device placement was 13 years (IQR 7-21). Oncologic therapies are included in Figure 1. In patients with unilateral cancer, most devices (78.4%) were placed contralaterally, with 32% of all devices being right sided. Anatomy related to chemotherapy port altered intraoperative approach in 2 cases and bilateral lymph node dissection necessitated subcutaneous ICD in 1 case. Complications were noted in 12 patients (11%) and included hematoma, lead revision, upper extremity DVT, pericardial effusion, stress cardiomyopathy, perforation, site infection, and worsening of chronic lymphedema. Conclusions: BC survivors undergoing CIED placement appear to be at higher risk of periprocedural complications when compared to the general population. They are more likely to undergo right sided device placement to avoid vascular access ipsilateral to prior surgery or radiation. Further studies are required to understand the long-term outcomes of CIED placement in this cohort of patients.

Spanish pacemaker registry. 21st official report of Heart Rhythm Association of the Spanish Society of Cardiology (2023)

IntroductionData on implants of cardiac pacing systems in Spain in 2023 are presented. MethodsThe registry is based on the information provided by centers to the recording platform of the Heart Rhythm Association after device implantations, through Cardiodispositivos, the online platform of the National Registry. Other information sources include: a) data transfers from the manufacturing and marketing industry; b) the European pacemaker patient card; and c) local databases submitted by the implanting centers. ResultsIn 2023, 112 hospitals participated in the registry (30 more than in 2022). A total of 24 343 device implantations were reported (48.1% more than in 2022) compared with 45 120 reported by Eucomed (European Confederation of Medical Suppliers Associations). Of these, 1646 were cardiac resynchronization therapy pacemakers. The devices showing the largest increases were leadless pacemakers, with 963 devices implanted, representing an 18.1% increase over 2022. The most frequent indication was atrioventricular block followed, for the first time, by atrial tachyarrhythmia with slow ventricular response. The number of devices included in remote monitoring also increased (cardiac resynchronization therapy defibrillators, 71%; cardiac resynchronization therapy pacemakers, 63%; and conventional pacemakers, 28%), although more moderately. ConclusionsIn 2023, there was an increase in the number of institutions participating in the registry. The reporting of device implantations rose by 48.1%, and the implantation of leadless pacemakers grew by 18.1%. Remote monitoring also experienced modest growth compared with previous years.

Implantation of CRT pacemaker during pregnancy: estimated fetal radiation dose.

The benefits of a cardiac resynchronization therapy (CRT) implantation are known in severe heart failure and its implantation may also be considered during pregnancy to ensure safe pregnancy and delivery for both the mother and the fetus. This study on a patient case aimed to estimate the absorbed dose (AD) to the fetus during the CRT implantation of 21st week of the pregnant woman. AD measurement was done using anthropomorphic phantom, radiophotoluminescence dosemeters and Monte Carlo simulation utilizing kerma area product (KAP) of the procedures. The measured AD for a phantom's uterus and heart was 0.116 and 14.7mGy with total KAP of 27.9 Gycm2. The estimated actual AD to the fetus and the mother's heart was 0.004 and 1.2mGy, with total KAP of 1.5 Gycm2. The dose to the fetus can be minimized with the optimized procedure.

Registro español de marcapasos. XXI informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2023)

IntroductionData on implants of cardiac pacing systems in Spain in 2023 are presented. MethodsThe registry is based on the information provided by centers to the recording platform of the Heart Rhythm Association after device implantations, through Cardiodispositivos, the online platform of the National Registry. Other information sources include: a) data transfers from the manufacturing and marketing industry; b) the European pacemaker patient card; and c) local databases submitted by the implanting centers. ResultsIn 2023, 112 hospitals participated in the registry (30 more than in 2022). A total of 24 343 device implantations were reported (48.1% more than in 2022) compared with 45 120 reported by Eucomed (European Confederation of Medical Suppliers Associations). Of these, 1646 were cardiac resynchronization therapy pacemakers. The devices showing the largest increases were leadless pacemakers, with 963 devices implanted, representing an 18.1% increase over 2022. The most frequent indication was atrioventricular block followed, for the first time, by atrial tachyarrhythmia with slow ventricular response. The number of devices included in remote monitoring also increased (cardiac resynchronization therapy defibrillators, 71%; cardiac resynchronization therapy pacemakers, 63%; and conventional pacemakers, 28%), although more moderately. ConclusionsIn 2023, there was an increase in the number of institutions participating in the registry. The reporting of device implantations rose by 48.1%, and the implantation of leadless pacemakers grew by 18.1%. Remote monitoring also experienced modest growth compared with previous years.

Minute ventilation sensor-driven rate response as a part of cardiac resynchronization therapy optimization in older patients.

Chronotropic incompetence (CI) is common among elderly cardiac resynchronization therapy pacemaker (CRT-P) patients on optimal medical therapy. This study aimed to evaluate the impact of optimized rate-adaptive pacing utilizing the minute ventilation (MV) sensor on exercise tolerance. In a prospective, multicenter study, older patients (median age 76years) with a guideline-based indication for CRT were evaluated following CRT-P implantation. If there was no documented CI, requiring clinically rate-responsive pacing, the device was programmed DDD at pre-discharge. At 1month, a 6-min walk test (6MWT) was conducted. If the maximum heart rate was < 100bpm or < 80% of the age-predicted maximum, the response was considered CI. Patients with CI were programmed with DDDR. At 3months post-implant, the 6MWT was repeated in the correct respective programming mode. In addition, heart rate score (HRSc, defined as the percentage of all sensed and paced atrial events in the single tallest 10bpm histogram bin) was assessed at 1 and 3months. CI was identified in 46/61 (75%) of patients without prior indication at enrollment. MV sensor-based DDDR mode increased heart rate in CI patients similarly to non-CI patients with intrinsically driven heart rates during 6MWT. Walking distance increased substantially with DDDR (349 ± 132m vs. 376 ± 128m at 1 and 3months, respectively, p < 0.05). Furthermore, DDDR reduced HRSc by 14% (absolute reduction, p < 0.001) in those with more severe CI, i.e., HRSc ≥ 70%. Exercise tolerance in older CRT-P patients can be further improved by the utilization of an MV sensor.

A porcine large animal model of radiofrequency ablation-induced left bundle branch block

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic Background and Objective ECG features of left bundle branch (LBB) block (LBBB) can be observed in up to 20–30 % of patients that suffer from heart failure with reduced ejection fraction. The resulting mechanical intraventricular asynchrony contributes to the worsening of left ventricular hemodynamics and has a relevant impact on the prognosis of the affected patients. The fact that we still cannot accurately predict which LBBB patients will benefit from cardiac resynchronization therapy (CRT) underscores that our understanding of the pathophysiology of LBBB remains incomplete. Here, a translational animal model of LBBB could be a major contributor to improving our knowledge of the molecular and translational pathomechanisms underlying LBBB. Methods A total of 15 male pigs underwent RF catheter ablation of the LBB, guided by fluoroscopy and intracardiac ECG signals. Before LBBB induction and after a follow-up period of one week or three weeks, a thorough clinical characterization was performed including 12-lead ECG, echocardiography, and electroanatomical mapping. To further test the feasibility of cardiac resynchronization in our model, 3 pigs were implanted with a CRT pacemaker on day seven after LBB ablation. Results Upon LBB ablation, 12-lead ECGs displayed typical characteristics of LBBB like a QRS broadening, a QRS slurring in left lateral leads, and a change of the QRS axis. The QRS width was prolonged from 64.2±4.2 ms to 93,4±7.4 ms and the R wave peak time in V6 was extended from 19.3±3.9 ms to 42.7±4.2 ms. Cardiac electromechanical asynchrony was further confirmed by echocardiography, where the appearance of a septal flash, the prolongation of the septal to posterior wall movement delay and extended left ventricular as well as interventricular electromechanical delays were documented. Electroanatomical mapping demonstrated a shift of the left ventricular breakthrough site. After LBBB-induction, left ventricular activation times, defined as the average of the maximum 10 % of activation times minus the average of the minimum 10 % of activation times were significantly prolonged from 36.3±7.1 ms to 60.8±10.2 ms while right ventricular activation times remained unchanged. Finally, RF-induced LBBB persisted over an observation period of three weeks. The pigs that underwent CRT showed a reduction in QRS duration from 99.1±8.2 ms on day seven after LBBB induction to 75.5±8.2 ms and echocardiography provided additional evidence of successful resynchronization. Conclusions In summary, our porcine large animal model accurately recapitulates the electrical and electromechanical phenotype, observed in LBBB patients. This closed-chest model of LBBB therefore provides an experimental platform to study both, molecular and translational characteristics of cardiac electromechanical asynchrony in a reproducible and clinically relevant setting.

Feasibility and effectiveness of left bundle branch area pacing after TAVR: the single center experience

Abstract Introduction Transcatheter aortic valve replacement (TAVR) is a safe alternative to open-heart surgery in patients with symptomatic severe aortic stenosis and high surgical risk due to multiple comorbidities, advanced age, and severe left ventricle dysfunction. Due to anatomical considerations of the atrioventricular node, conduction abnormalities requiring the implantation of a pacemaker are common findings after TAVR. High-grade atrioventricular block and new-onset left bundle branch block (LBBB) are the most commonly reported conduction abnormalities after TAVR. Purpose The aim of our study was to assess the feasibility, success rates, and effectiveness of LBBAP in patients requiring pacing after TAVR. Methods A total of 302 patients underwent the TAVR procedure in our institution in the period from January 2022 to November 2023. In this cohort, 38 patients required ventricular pacing in the postoperative period. 16 patients who underwent permanent pacing using LBBAP were included in this observational study. Patients undergoing traditional right ventricular pacing biventricular pacing or leadless pacemaker implantation were excluded from the study. Results LBBAP was successfully performed in 16 patients (89%). 2 patients underwent conventional CRT implantation (1 cardiac resynchronization therapy pacemaker and 1 cardiac resynchronization therapy defibrillator) in order to severe calcification and presence of fibrotic tissue in the target area. The mean age was 60.5±2.74 years, and 10 patients (62.5%) were women. According to the patient’s medical history, 14 patients (84%) had hypertension; coronary artery disease – 2 (12.5%), 2 (12.5%) patients had atrial fibrillation and atrial flutter, and 7 (43.5%) patients had diabetes mellitus. The mean left ventricle ejection fraction (LVEF) was 46.2±14.7%. Interventricular septal thickness 11.8 ± 1.9 mm. Type of conduction diseases: Infranodal AV block and LBBB were present in 9 (56.5%) patients. 5 (31,25%) patients had persistent complete AV block and 2 (12,25%) had Mobitz II AV block. In 2 patients we observed congestive heart failure combined with LBBB. Pre-TAVR QRS morphology was normal in 15 (93%), and RBBB morphology in 1 (7%). The mean QRS duration at baseline was 105±20 ms. Pre-implant QRS duration 135±52 ms. The single-chamber pacemaker was implanted in 1 patient, dual-chamber pacemaker - 13 patients, and cardiac resynchronization therapy defibrillators in 2 patients. Procedural duration and fluoroscopy times were 105. ± 31.9 min and 18 ± 11 min, respectively. Conclusion Complete AV block and new-onset LBBB after TAVR is still an important issue. LBBB correction using conduction system pacing technology is an effective strategy for this type of patient. LBBAP is one of the most exciting developments in pacing therapy over the last few years. Long-term clinical outcomes and safety of physiological pacing data are limited and require further investigations

Absence of late gadolinium enhancement and outcomes of cardiac resynchronization therapy in non-ischemic dilated cardiomyopathy

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

Bundled Payments for Care Improvement and Quality of Care and Outcomes in Heart Failure

The Centers for Medicare & Medicaid Services (CMS) Bundled Payments for Care Improvement (BPCI) program was launched in 2013 with a goal to improve care quality while lowering costs to Medicare. To compare changes in the quality and outcomes of care for patients hospitalized with heart failure according to hospital participation in the BPCI program. This cross-sectional study used a difference-in-difference approach to evaluate the BPCI program in 18 BPCI hospitals vs 211 same-state non-BPCI hospitals for various process-of-care measures and outcomes using American Heart Association Get With The Guidelines-Heart Failure registry and CMS Medicare claims data from November 1, 2008, to August 31, 2018. Data were analyzed from May 2022 to May 2023. Hospital participation in CMS BPCI Model 2 Heart Failure, which paid hospitals in a fee-for-service process and then shared savings or required reimbursement depending on how the total cost of an episode of care compared with a target price. Primary end points included 7 quality-of-care measures. Secondary end points included 9 outcome measures, including in-hospital mortality and hospital-level risk-adjusted 30-day and 90-day all-cause readmission rate and mortality rate. During the study period, 8721 patients were hospitalized in the 23 BPCI hospitals and 94 530 patients were hospitalized in the 224 same-state non-BPCI hospitals. Less than a third of patients (30 723 patients, 29.8%) were 75 years or younger; 54 629 (52.9%) were female, and 48 622 (47.1%) were male. Hospital participation in BPCI Model 2 was not associated with significant differential changes in the odds of various process-of-care measures, except for a decreased odds of evidence-based β-blocker at discharge (adjusted odds ratio [aOR], 0.63; 95% CI, 0.41-0.98; P = .04). Participation in the BPCI was not associated with a significant differential change in the odds of receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitors at discharge, receiving an aldosterone antagonist at discharge, having a cardiac resynchronization therapy (CRT)-defibrillator or CRT pacemaker placed or prescribed at discharge, having implantable cardioverter-defibrillator (ICD) counseling or an ICD placed or prescribed at discharge, heart failure education being provided among eligible patients, or having a follow-up visit within 7 days or less. Participation in the BPCI was associated with a significant decrease in odds of in-hospital mortality (aOR, 0.67; 95% CI, 0.51-0.86; P = .002). Participation was not associated with a significant differential change in hospital-level risk-adjusted 30-day or 90-day all-cause readmission rate and 30-day or 90-day all-cause mortality rate. In this study, hospital participation in the BPCI Model 2 Heart Failure program was not associated with improvement in process-of-care quality measures or 30-day or 90-day risk-adjusted all-cause mortality and readmission rates.

A porcine large animal model of radiofrequency ablation-induced left bundle branch block.

Electrocardiographic (ECG) features of left bundle branch (LBB) block (LBBB) can be observed in up to 20%-30% of patients suffering from heart failure with reduced ejection fraction. However, predicting which LBBB patients will benefit from cardiac resynchronization therapy (CRT) or conduction system pacing remains challenging. This study aimed to establish a translational model of LBBB to enhance our understanding of its pathophysiology and improve therapeutic approaches. Fourteen male pigs underwent radiofrequency catheter ablation of the proximal LBB under fluoroscopy and ECG guidance. Comprehensive clinical assessments (12-lead ECG, bloodsampling, echocardiography, electroanatomical mapping) were conducted before LBBB induction, after 7, and 21days. Three pigs received CRT pacemakers 7days after LBB ablation to assess resynchronization feasibility. Following proximal LBB ablation, ECGs displayed characteristic LBBB features, including QRS widening, slurring in left lateral leads, and QRS axis changes. QRS duration increased from 64.2 ± 4.2ms to 86.6 ± 12.1ms, and R wave peak time in V6 extended from 21.3 ± 3.6ms to 45.7 ± 12.6ms. Echocardiography confirmed cardiac electromechanical dyssynchrony, with septal flash appearance, prolonged septal-to-posterior-wall motion delay, and extended ventricular electromechanical delays. Electroanatomical mapping revealed a left ventricular breakthrough site shift and significantly prolonged left ventricular activation times. RF-induced LBBB persisted for 3weeks. CRT reduced QRS duration to 75.9 ± 8.6ms, demonstrating successful resynchronization. This porcine model accurately replicates the electrical and electromechanical characteristics of LBBB observed in patients. It provides a practical, cost-effective, and reproducible platform to investigate molecular and translational aspects of cardiac electromechanical dyssynchrony in a controlled and clinically relevant setting.

Cardiac Resynchronization Therapy in Anomalous Coronary Sinus: A Case Report

A 37-year-old man, a known case of Dilated Cardiomyopathy (DCM) with Post PPM (Permanent Pacemaker) status for last 3 years underwent upgrading of PPM to Cardiac Resynchronization Therapy Pacemaker (CRT-P) in a specialized cardiac center. During the implantation procedure, there was anomalous branching of coronary sinus with absence of lateral branch &amp; presence of a highly tortuous posterior branch causing difficulty in lead placement. Finally left ventricular (LV) lead was placed in the tortuous branch using Judkin’s right catheter. Lead position was stable with excellent threshold. The patient has been followed up with improvement of symptoms. Bangladesh Heart Journal 2023; 38(2): 155-157

Mechanocardiography detects improvement of systolic function caused by resynchronization pacing.

Objective.Cardiac resynchronization therapy (CRT) is commonly used to manage heart failure with dyssynchronous ventricular contraction. CRT pacing resynchronizes the ventricular contraction, while AAI (single-chamber atrial) pacing does not affect the dyssynchronous function. This study compared waveform characteristics during CRT and AAI pacing at similar pacing rates using seismocardiogram (SCG) and gyrocardiogram (GCG), collectively known as mechanocardiogram (MCG).Approach.We included 10 patients with heart failure with reduced ejection fraction and previously implanted CRT pacemakers. ECG and MCG recordings were taken during AAI and CRT pacing at a heart rate of 80 bpm. Waveform characteristics, including energy, vertical range (amplitude) during systole and early diastole, electromechanical systole (QS2) and left ventricular ejection time (LVET), were derived by considering 6 MCG axes and 3 MCG vectors across frequency ranges of >1 Hz, 20-90 Hz, 6-90 Hz and 1-20 Hz.Main results.Significant differences were observed between CRT and AAI pacing. CRT pacing consistently exhibited higher energy and vertical range during systole compared to AAI pacing (p< 0.05). However, QS2, LVET and waveform characteristics around aortic valve closure did not differ between the pacing modes. Optimal differences were observed in SCG-Y, GCG-X, and GCG-Y axes within the frequency range of 6-90 Hz.Significance.The results demonstrate significant differences in MCG waveforms, reflecting improved mechanical cardiac function during CRT. This information has potential implications for predicting the clinical response to CRT. Further research is needed to explore the differences in signal characteristics between responders and non-responders to CRT.

Inappropriate shock incidence in patients with subcutaneous implantable cardioverter-defibrillators with concomitant cardiac implantable electronic devices: A single-center cohort study.

Subcutaneous implantable cardioverter defibrillators (S-ICDs) are occasionally used in combination with other cardiac implantable electronic devices (CIEDs). However, whether the incidence of inappropriate shock increases in patients with S-ICDs and concomitant CIEDs remains unclear. This study aimed to investigate the association between the concomitant use of CIEDs and the incidence of inappropriate shock in patients with current-generation S-ICDs. A total of 127 consecutive patients received an S-ICD. Patients were assigned to two groups depending on concomitant use of CIEDs at the time of S-ICD implantation: patients without other CIEDs (non-combined group, 106 patients) and patients with other CIEDs (combined group, 21 patients). CIEDs included pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, and cardiac resynchronization therapy defibrillators. The primary outcome was inappropriate shock, defined as a shock other than ventricular arrhythmia. Hazard ratios and 95% confidence intervals were calculated using a time-varying Cox proportional hazards model which was adjusted for age because age differed between the groups and could be a confounder. During a median follow-up period of 2.2 years (interquartile range, 1.0-3.4 years), inappropriate shock events occurred in 17 (16%) and five (19%) patients of the non-combined and combined groups, respectively. While the age-adjusted hazard ratio for inappropriate shock was 24% higher in the combined than in the non-combined group (hazard ratio=1.24, 95% confidence interval, 0.39-3.97), this difference was insignificant (p=.71). The incidence of inappropriate shock did not differ between patients with and without concomitant use of CIEDs, suggesting that S-ICDs could potentially be combined with other CIEDs without increasing the number of inappropriate shocks. Further studies are warranted to confirm the safety and feasibility of concomitant use of S-ICDs and CIEDs.

Phenogrouping and risk stratification of patients undergoing cardiac resynchronization therapy upgrade using topological data analysis

Choosing the optimal device during cardiac resynchronization therapy (CRT) upgrade can be challenging. Therefore, we sought to provide a solution for identifying patients in whom upgrading to a CRT-defibrillator (CRT-D) is associated with better long-term survival than upgrading to a CRT-pacemaker (CRT-P). To this end, we first applied topological data analysis to create a patient similarity network using 16 clinical features of 326 patients without prior ventricular arrhythmias who underwent CRT upgrade. Then, in the generated circular network, we delineated three phenogroups exhibiting significant differences in clinical characteristics and risk of all-cause mortality. Importantly, only in the high-risk phenogroup was upgrading to a CRT-D associated with better survival than upgrading to a CRT-P (hazard ratio: 0.454 (0.228–0.907), p = 0.025). Finally, we assigned each patient to one of the three phenogroups based on their location in the network and used this labeled data to train multi-class classifiers to enable the risk stratification of new patients. During internal validation, an ensemble of 5 multi-layer perceptrons exhibited the best performance with a balanced accuracy of 0.898 (0.854–0.942) and a micro-averaged area under the receiver operating characteristic curve of 0.983 (0.980–0.986). To allow further validation, we made the proposed model publicly available (https://github.com/tokmarton/crt-upgrade-risk-stratification).

Similar heart failure hospitalization and survival benefits are associated with Sacubitril/Valsartan therapy in CRT non responders and in HFrEF patients with no CRT indication

Abstract Background Sacubitril/Valsartan (S/V) induced reverse remodelling and improved heart failure (HF) hospitalisation and survival in HF with reduced ejection fraction (HFrEF) in recent trials. Data on the clinical effectiveness of S/V in the specific HF patient cohort of CRT non-responders (CRT-NRs) are limited. Aim of the study: Herein, we compared the impact of S/V on hospitalisation and mortality in CRT-NRs and in HFrEF patients with no CRT indication. In addition, we evaluated the outcome in patients with versus without a more marked response to S/V therapy. Methods Database search was performed to identify patients based on the following criteria. Group I: Patients implanted with a CRT pacemaker or ICD who demonstrated a less than 10% increase in left ventricular ejection fraction (LV EF) 6 months after device implantation on optimal medical therapy (CRT-NRs). In addition, these CRT-NRs were initiated on S/V as a replacement of ACEi/ARB therapy at least 6 months after device implantation. Group II: HFrEF patients with no CRT indication initiated on S/V. Patents were on S/V treatment at least for 6 months in both groups. Hospitalization and mortality rates were compared in both groups during follow-up. A subgroup analysis was also performed based on the improvement in LV EF on S/V. Patients with a more than 10% improvement were defined as S/V Super-responders, while those with a less than 10% increase as S/V Moderate responders. Results 70 patients were enrolled in Group I, and 135 in Group II. During a follow-up of 21.9±1.6 no significant differences were detected in the rates of hospitalization (31% vs 28%; p:0.742) and mortality (18.5% vs 17.2%; p = 0.456) in Group I and II, respectively. In group I, 13 (18.5%), and in Group II, 24 (17.7%) patients were identified as SV Super-responders. Rates of hospitalization were similar in S/V Super-responders and in SV Moderate responders in Group I (23.1% vs 31,6%, p = 0.464) as well as in Group II (25% vs 30.7%, p = 0.602). Mortality rates were similar, alike in in S/V Super-responders and in SV Moderate responders in both groups (Group I:15.4% vs 24.6%, p = 0.320, Group II: 20.8% vs 25.3%, p = 0.789). Conclusion Similar hospitalization and mortality rates were demonstrated on S/V in CRT-NR and in HFrEF patients with no CRT indication during a 21-month follow-up. A more than 10% increase of LV EF on S/V treatment did not predict improved hospitalization and survival as compared to a more moderate response in either group.

Trans-oesophageal echocardiography-guided implantation of a cardiac resynchronization therapy pacemaker and successful ablation of the atrioventricular node after TriClip: case report

Abstract Background Edge-to-edge intervention is the most common trans-catheter procedure performed for isolated severe tricuspid regurgitation in high-surgical-risk patients. However, it creates an obstacle for future right ventricular (RV) procedures such as implantation of cardiac implantable electronic devices (CIEDs). Reports of the management of CIED implantation after tricuspid edge-to-edge therapy are scarce. Case summary A 76-year-old woman suffered from severe tricuspid regurgitation with New York Heart Association three symptoms despite optimal medical therapy. After a thorough evaluation, the heart team recommended the TriClip procedure as the treatment of choice. However, 12 months after a successful TriClip procedure, rapid atrial fibrillation needed to be addressed with CIED implantation and atrioventricular (AV) node ablation. Pre-procedural planning included the intended posterior location of the CIED to avoid interference with the implanted clip and future AV node ablation. With an additional left ventricular lead positioned anteriorly to the RV lead, the posterior position of the RV lead was secured. Under peri-procedural trans-oesophageal echocardiography (TEE), the planned procedures were performed successfully. Discussion A blind manoeuvring of the RV lead may damage the edge-to-edge tricuspid device. In addition, friction due to an overly close contract between the RV lead and the edge-to-edge device may damage the RV lead. A successful and safe CIED implantation and atrioventricular node ablation can be performed after tricuspid edge-to-edge therapy with careful planning and its precise execution under TEE surveillance.

Topological data analysis to identify cardiac resynchronization therapy patients exhibiting benefit from an implantable cardioverter-defibrillator

BackgroundCurrent guidelines recommend considering multiple factors while deciding between cardiac resynchronization therapy with a defibrillator (CRT-D) or a pacemaker (CRT-P). Nevertheless, it is still challenging to pinpoint those candidates who will benefit from choosing a CRT-D device in terms of survival.ObjectiveWe aimed to use topological data analysis (TDA) to identify phenogroups of CRT patients in whom CRT-D is associated with better survival than CRT-P.MethodsWe included 2603 patients who underwent CRT-D (54%) or CRT-P (46%) implantation at Semmelweis University between 2000 and 2018. The primary endpoint was all-cause mortality. We applied TDA to create a patient similarity network using 25 clinical features. Then, we identified multiple phenogroups in the generated network and compared the groups’ clinical characteristics and survival.ResultsFive- and 10-year mortality were 43 (40–46)% and 71 (67–74)% in patients with CRT-D and 48 (45–50)% and 71 (68–74)% in those with CRT-P, respectively. TDA created a circular network in which we could delineate five phenogroups showing distinct patterns of clinical characteristics and outcomes. Three phenogroups (1, 2, and 3) included almost exclusively patients with non-ischemic etiology, whereas the other two phenogroups (4 and 5) predominantly comprised ischemic patients. Interestingly, only in phenogroups 2 and 5 were CRT-D associated with better survival than CRT-P (adjusted hazard ratio 0.61 [0.47–0.80], p < 0.001 and adjusted hazard ratio 0.84 [0.71–0.99], p = 0.033, respectively).ConclusionsBy simultaneously evaluating various clinical features, TDA may identify patients with either ischemic or non-ischemic etiology who will most likely benefit from the implantation of a CRT-D instead of a CRT-P.Graphical abstractTopological data analysis to identify phenogroups of CRT patients in whom CRT-D is associated with better survival than CRT-P. AF atrial fibrillation, CRT cardiac resynchronization therapy, CRT-D cardiac resynchronization therapy defibrillator, CRT-P cardiac resynchronization therapy pacemaker, DM diabetes mellitus, HTN hypertension, LBBB left bundle branch block, LVEF left ventricular ejection fraction, MDS multidimensional scaling, MRA mineralocorticoid receptor antagonist, NYHA New York Heart Association

An updated meta-analysis of cardiac resynchronization therapy with or without defibrillation in patients with nonischemic cardiomyopathy.

Cardiac resynchronization therapy (CRT) is a major device therapy used to treat patients suffering from heart failure (HF) and electrical asynchrony. It can improve HF symptoms, reduce HF hospitalization time, and improve long-term survival in HF with and without implantable cardioverter (ICD) therapy. However, the benefit of defibrillator therapy in CRT-eligible patients with nonischemic cardiomyopathy (NICM) remains unknown. As a result, we conducted a systematic review and meta-analysis to compare clinical outcomes in patients with NICM and HF who were treated with implantable CRT defibrillators (CRT-D) vs. a CRT pacemaker (CRT-P) alone. We searched the electronic databases PubMed, Embase, and Cochrane for all studies comparing CRT-D vs. CRT-P treatment in patients with NICM. The time frame was from 1990 to September 2022. All-cause mortality and cardiovascular mortality were the primary clinical outcomes of interest to us. To pool adjusted hazard ratios (HRs) and 95% confidence intervals (CIs), a random-effects model with inverse variance was used. A pooled meta-analysis included two randomized controlled trials (RCTs), each with 1,200 CRT-eligible patients with NICM (592 with CRT-D and 608 with CRT-P) and nine cohort studies representing 27,568 CRT-eligible patients with NICM (16,196 with CRT-D and 11,372 with CRT-P). The adjusted HR for all-cause mortality for CRT-D vs. CRT-P was 0.90 (95% CI, 0.81-0.99). In a subgroup analysis of two RCTs and nine cohort studies, the adjusted HR for all-cause mortality was 0.72 (95% CI, 0.43-1.19) and HR 0.92 (95% CI, 0.83-1.03) for CRT-D vs. CRT-P, respectively. With the addition of defibrillation leads, we found a significantly lower risk of all-cause mortality in patients with NICM, but this association was not found in subgroup analyses of RCTs and observational studies.

Age-stratified comparison of prognosis in cardiac resynchronization therapy with or without prophylactic defibrillator for non-ischemic cardiomyopathy - a nationwide cohort study.

Prior studies have suggested that the benefit from primary preventive defibrillator treatment for patients with non-ischemic cardiomyopathy primarily, treated with cardiac resynchronization therapy, may be age-dependent. We aimed to compare age-stratified mortality rates and mode of death in patients with non-ischemic cardiomyopathy who are treated with either primary preventive Cardiac Resynchronization Therapy-defibrillator (CRT-D) or CRT-pacemaker (CRT-P). All patients with non-ischemic cardiomyopathy and CRT-P or primary preventive CRT-D who were implanted in Sweden during the period 2005-2020 were included. Propensity scoring was used to create a matched cohort. Primary outcome was all-cause mortality within five years. 4027 patients were included, 2334 with CRT-P and 1693 with CRT-D. Crude 5-year mortality was 635 (27%) vs. 246 (15%), p < 0.001. In Cox regression analysis, adjusted for clinically relevant covariables, CRT-D was independently associated with higher five-year survival (0.72 [0.61-0.85], p < 0.001). Cardiovascular mortality was similar between groups (62% vs. 64%, p = 0.64), but death from heart failure was more common in the CRT-D group (46% vs. 36%, p = 0.007). In the matched cohort (n = 2414), five-year mortality was 21% (24% versus 16%, p < 0.001). In age-stratified analyses, CRT-P was associated with higher mortality in age-groups <60 years and 70-79 years, but there was no difference in age groups 60-69 years or 80-89 years. In this nationwide registry-based study, patients with CRT-D have better five-year survival compared to patients with CRT-P. The interaction between age and mortality reduction not consistent, but patients with CRT-D aged <60 years had the largest absolute mortality reduction.

Follow-up of CRT-D patients downgraded to CRT-P at the time of generator exchange.

Some patients with cardiac resynchronisation therapy (CRT) experience super-response (LVEF improvements to ≥50%). At generator exchange (GE), downgrading (DG) from CRT-defibrillator (CRT-D) to CRT-pacemaker (CRT-P) could be an option for these patients on primary prevention ICD indication and no required ICD therapies. Long-term data on arrhythmic events in super-responders is scarce. CRT-D patients with LVEF improvement to ≥50% at GE were identified in four large centres for retrospective analysis. Mortality, significant ventricular tachyarrhythmia and appropriate ICD-therapy were determined, and patient analysis was split into two groups (downgraded to CRT-P or not). Sixty-six patients (53% male, 26% coronary artery disease) on primary prevention were followed for a median of 129 months [IQR: 101-155] after implantation. 27 (41%) patients were downgraded to CRT-P at GE after a median of 68 [IQR: 58-98] months (LVEF 54% ± 4%). The other 39 (59%) continued with CRT-D therapy (LVEF 52% ± 6%). No cardiac death or significant arrhythmia occurred in the CRT-P group (median follow-up (FU) 38 months [IQR: 29-53]). Three appropriate ICD-therapies occurred in the CRT-D group [median FU 70 months (IQR: 39-97)]. Annualized event-rates after DG/GE were 1.5%/year and 1.0%/year in the CRT-D group and the whole cohort, respectively. No significant tachyarrhythmia were detected in the patients downgraded to CRT-P during follow-up. However, three events were observed in the CRT-D group. Whilst downgrading CRT-D patients is an option, a small residual risk for arrhythmic events remains and decisions regarding downgrade should be made on a case-by-case basis.