A network meta-analysis and systematic review of change in QRS duration after left bundle branch pacing, His bundle pacing, biventricular pacing, or right ventricular pacing in patients requiring permanent pacemaker.

Cardiac dyssynchrony is the proposed mechanism for pacemaker-induced cardiomyopathy, which can be prevented by biventricular pacing. Left bundle branch pacing and His bundle pacing are novel interventions that imitate the natural conduction of the heart with, theoretically, less interventricular dyssynchrony. One of the surrogate markers of interventricular synchrony is QRS duration. Our study aimed to compare the change of QRS duration before and after implantation between types of cardiac implantable electronic devices (CIEDs): left bundle branch pacing versus His bundle pacing versus biventricular pacing and conventional right ventricular pacing. A literature search for studies that reported an interval change of QRS duration after CIED implantation was conducted utilizing the MEDLINE, EMBASE, and Cochrane databases. All relevant works from database inception through November 2020 were included in this analysis. A random-effects model, Bayesian network meta-analysis was used to analyze QRS duration changes (eg, electrical cardiac synchronization) across different CIED implantations. The mean study sample size, from 14 included studies, was 185 subjects. The search found 707 articles. After exclusions, 14 articles remained with 2,054 patients. The His bundle pacing intervention resulted in the most dramatic decline in QRS duration (mean difference, - 53 ms; 95% CI - 67, - 39), followed by left bundle branch pacing (mean difference, - 46 ms; 95% CI - 60, - 33), and biventricular pacing (mean difference, - 19 ms; 95% CI - 37, - 1.8), when compared to conventional right ventricle apical pacing. When compared between LBBP and HBP, showed no statistically significant wider QRS duration in LBBP with mean different 6.5 ms. (95% CI - 6.7, 21). Our network meta-analysis found that physiologic pacing has the greatest effect on QRS duration after implantation. Thus, HBP and LBBP showed no significant difference between QRS duration after implantation. Physiologic pacing interventions result in improved electrocardiography markers of cardiac synchrony, narrower QRS duration, and might lower electromechanical dyssynchrony.

Gain in real-world cardiac resynchronization therapy efficacy with SyncAV dynamic optimization: Heart failure hospitalizations and costs.

BACKGROUND: SyncAV, a device-based cardiac resynchronization therapy (CRT) algorithm, promotes electrical optimization by dynamically adjusting atrioventricular intervals. OBJECTIVE: The purpose of this study was to evaluate the impact of SyncAV on heart failure hospitalizations (HFHs) and related costs in a real-world CRT cohort. METHODS: Patients with SyncAV-capable CRT devices followed by remote monitoring and enrolled in Medicare fee-for-service for at least 1 year preimplant and up to 2 years postimplant were studied. Patients with SyncAV OFF were 4:1 matched to those with SyncAV ON on preimplant HFH rate, demographics, comorbidities, disease etiology, and left bundle branch block. HFHs were determined from the primary diagnosis of inpatient hospitalizations, and the cost for each event was the sum of Medicare, supplemental insurance, and patient payment. RESULTS: After 4:1 propensity score matching, 3630 patients were studied (mean age 75 ± 8 years; 1386 [38%] female), including 726 (25%) patients with SyncAV ON. The pre-CRT HFH rate was 0.338 HFH events per patient-year. Overall, CRT diminished the HFH rate to 0.204 events per patient-year (P < .001). SyncAV elicited a larger reduction in HFH rate (SyncAV ON: hazard ratio [HR] 0.52; 95% confidence interval [CI] 0.41-0.66; P < .001 and SyncAV OFF: HR 0.68; 95% CI 0.59-0.77; P < .001). After 2 years, the HFH rate was lower in the SyncAV ON group than in the SyncAV OFF group (0.143 HFHs per patient-year vs 0.193 HFHs per patient-year; HR 0.70; 95% CI 0.55-0.89; P = .003) and fewer HFHs were followed by 30-day HFH readmissions (4.41% vs 7.68%; P = .003) and 30-day all-cause hospital readmissions (7.04% vs 10.01%; P = .010). The total 2-year HFH-associated costs per patient were lower with SyncAV ON (difference $1135; 90% CI $93-$2109; P = .038). CONCLUSION: This large, real-world, propensity score-matched study demonstrates that SyncAV CRT is associated with significantly reduced HFHs and associated costs, incremental to standard CRT.

Safety and Long-term Outcomes of Defibrillator Therapy in Patients With Right-Sided Implantable Cardiac Devices in Adults With Congenital Heart Disease.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) have been proven to prevent sudden cardiac death in adult congenital heart disease (ACHD) patients. Although the left side is chosen by default, implantation from the right side is often required. However, little is known about the efficacy and safety of right-sided ICDs in ACHD patients. METHODS: In this study we reviewed a total of 191 ACHD patients undergoing ICD/cardioverter resynchronisation therapy-defibrillator (CRT-D) implantation at our hospital between 2001 and 2019 (134 men and 57 women; age [mean ± standard deviation], 41.5 ± 14.8 years). RESULTS: Twenty-seven patients (14.1%) had right-sided devices. The most common causes of right-sided implantation were persistent left superior vena cava and vein occlusion (37.0%). Although procedure time (202.8 ± 60.5 minutes vs 143.8 ± 69.1 minutes, P = 0.008) was longer and the procedural success was lower (92.6% vs 99.4%, P = 0.008) for right-sided devices, no difference in R-wave and pacing threshold were noted. Among the 47 patients (24.6%) who underwent defibrillation threshold testing (DFT), no difference in DFT was observed (25.2 ± 5.3 J vs 23.8 ± 4.1 J, P = 0.460). During the median follow-up of 42.4 months, appropriate ICD therapy was observed in 5 (18.5%) and 30 (18.3%) patients for right- and left-sided ICDs/CRTDs, respectively (P = 0.978). No significant difference was seen in complications between them. CONCLUSIONS: Implantation of an ICD on the right side is technically challenging, but it is feasible as an alternative approach for ACHD patients with contraindications to left-sided device implantation.

Current clinical practice of cardiac resynchronization therapy in Turkey: Reflections from Cardiac Resynchronization Therapy Survey-II.

OBJECTIVE: Cardiac resynchronization therapy (CRT) has been shown to reduce mortality in selected patients with heart failure with reduced ejection fraction (HFrEF). CRT Survey-II was a snapshot survey to assess current clinical practice with regard to CRT. Herein, we aimed to compare Turkish data with other countries of European Society of Cardiology (ESC). METHODS: The survey was conducted between October 2015 and December 2016 in 42 ESC member countries. All consecutive patients who underwent a de novo CRT implantation or a CRT upgrade were eligible. RESULTS: A total of 288 centers included 11,088 patients. From Turkey, 16 centers recruited 424 patients representing 12.9% of all implantations. Compared to the entire cohort, Turkish patients were younger with a lower proportion of men and a higher proportion with ischemic etiology. Electrocardiography (ECG) showed sinus rhythm in 81.5%, a QRS duration of <130 ms in 10.1%, and ≥150 ms in 63.8% of patients. Left bundle branch block (LBBB) was more common. Median left ventricular ejection fraction (LVEF) was 25%, lower than in the overall ESC cohort, but NYHA class was more often II. Most common indication for CRT implantation was HF with a wide QRS (70.8%). Almost 98.3% of devices implanted were CRT-D, in contrast to the overall cohort. Fluoroscopy time was longer, but duration of overall procedure was shorter. LV lead implantation was unsuccessful in 2.6% patients. Periprocedural complication rate was 6.3%. The most common complication was bleeding. Remote monitoring was less utilized. CONCLUSION: These are the first observational data reflecting the current CRT practice in Turkey and comparing it with other countries of Europe. Findings of this study may help detect gaps and provide insights for improvement.

Impact of COVID-19 pandemic on the clinical activities related to arrhythmias and electrophysiology in Italy: results of a survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

COVID-19 outbreak had a major impact on the organization of care in Italy, and a survey to evaluate provision of for arrhythmia during COVID-19 outbreak (March-April 2020) was launched. A total of 104 physicians from 84 Italian arrhythmia centres took part in the survey. The vast majority of participating centres (95.2%) reported a significant reduction in the number of elective pacemaker implantations during the outbreak period compared to the corresponding two months of year 2019 (50.0% of centres reported a reduction of > 50%). Similarly, 92.9% of participating centres reported a significant reduction in the number of implantable cardioverter-defibrillator (ICD) implantations for primary prevention, and 72.6% a significant reduction of ICD implantations for secondary prevention (> 50% in 65.5 and 44.0% of the centres, respectively). The majority of participating centres (77.4%) reported a significant reduction in the number of elective ablations (> 50% in 65.5% of the centres). Also the interventional procedures performed in an emergency setting, as well as acute management of atrial fibrillation had a marked reduction, thus leading to the conclusion that the impact of COVID-19 was disrupting the entire organization of health care, with a massive impact on the activities and procedures related to arrhythmia management in Italy.

Left Atrial Function Determined by Cardiac Computed Tomography Predicts Device-Detected Atrial High-Rate Episodes in Patients Treated With Cardiac Resynchronization Therapy.

OBJECTIVE: The objective of this study was to examine whether left atrial (LA) volumes and function were associated with atrial high-rate episodes (AHREs) in patients with cardiac resynchronization therapy (CRT). METHODS: Ninety-two consecutive patients without prior atrial fibrillation underwent clinical evaluation, echocardiograms, and cardiac computed tomography (CT) before CRT implantation and after 6 months. Left atrial volumes and LA emptying fraction (LAEF) were derived by CT images reconstructed at 5% phase increments of the cardiac cycle. Cox regression was used to assess associations between AHRE and LA anatomical and functional variables. RESULTS: Twenty-two patients (24%) developed AHRE during 1.9 years (SD, 1 year) At baseline, higher LAEF was associated with a lower risk of AHRE (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.91-0.98; P = 0.003), and large LA minimal (LAmin) volume was related to higher risk of AHRE (HR, 1.03; 95% CI, 1.00-1.06; P = 0.04). When combining LAEF and LAmin volume, only LAEF remained associated with occurrence of AHRE. Higher passive LAEF was associated with lower risk of AHRE (HR, 0.95; 95% CI, 0.91-0.98; P = 0.003). CONCLUSIONS: In patients with CRT, low preimplant LAEF measured by cardiac CT was independently associated with device-detected AHRE.

Equilibrium radionuclide angiography compared with tissue doppler imaging for detection of right ventricular dyssynchrony and prediction of acute response to cardiac resynchronization therapy.

OBJECTIVE: The aim of this study was to compare tissue doppler imaging (TDI) and equilibrium radionuclide angiography (ERNA) for detection of right ventricular (RV) dyssynchrony and prediction of the acute response to cardiac resynchronization therapy (CRT). METHODS: This study was approved by the local ethics committee of Huai'an First People's Hospital. Patient consent was not provided due to the use of completely anonymous images from which the individual could not be identified in this study. Thirty-three patients with nonischemic dilated cardiomyopathy underwent both TDI and ERNA before and within 48 hour after CRT implantation. RV dyssynchrony was measured with TDI using the difference in time to peak systolic velocity between the RV free wall and ventricular septum (RV-T). With ERNA, the standard of RV mean phase angle and RV phase standard deviation (RVmPA% and RVPSD%) were assessed. RESULTS: Moderate positive correlations were observed among baseline RVmPA%, RVPSD% and RV-T (r = 0.689 and 0.716, P < .001). Twenty patients (61%) with a reduction of at least 15% in LV end-systolic volume were categorized as acute responders after CRT. Responders showed significant reduction in RVmPA% and RVPSD% after CRT (53.60 ±â€Š4.15% to 43.95 ±â€Š6.88% and 14.00 ±â€Š2.41% to 10.40 ±â€Š1.67%, P < .05), whereas RV-T remained unchanged (50.10 ±â€Š10.28 ms to 49.25 ±â€Š13.64ms, NS). Receiver operating characteristic curve showed that the cut-off value of RV-T was 48.5ms, yielding 65% sensitivity and 77% specificity to predict acute respond to CRT. The cut-off value of RVmPA% was 49.5%, yielding 85% sensitivity and 85% specificity and the cut-off value of RVPSD% was 11.5%, yielding 85% sensitivity and 92% specificity. CONCLUSION: ERNA might be an appropriate alternative to TDI for assessment of RV dyssynchrony. Either RVmPA% or RVPSD% was highly predictive for acute response to CRT.

[The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Annual report 2018]. / Registro Italiano Pacemaker e Defibrillatori - Bollettino Periodico 2018. Associazione Italiana di Aritmologia e Cardiostimolazione.

BACKGROUND: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2018 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers. METHODS: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards. RESULTS: PM Registry: data about 23 912 PM implantations were collected (20 084 first implants and 3828 replacements). The number of collaborating centers was 180. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 34.5% of first PM implants, sick sinus syndrome in 18.3%, atrial fibrillation plus bradycardia in 13.0%, other in 34.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (19.2% of first implants). Use of single-chamber PMs was reported in 24.9% of first implants, of dual-chamber PMs in 67.6%, of PMs with cardiac resynchronization therapy (CRT) in 1.6%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 5.9%. ICD Registry: data about 18 353 ICD implantations were collected (13 944 first implants and 4359 replacements). The number of collaborating centers was 433. Median age of treated patients was 71 years (63 quartile I; 78 quartile III). Primary prevention indication was reported in 84.3% of first implants, secondary prevention in 15.7% (cardiac arrest in 5.3%). A single-chamber ICD was used in 27.9% of first implants, dual-chamber ICD in 31.9% and biventricular ICD in 40.2%. CONCLUSIONS: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice. In order to increase and optimize the cooperation of Italian implanting centers, online data entry (http://www.aiac.it/riprid) should be adopted at large scale.

The association between cardiac resynchronization therapy response and sexual activity in patients with heart failure.

BACKGROUND: Sexual activity is an important indicator of quality of life and is significantly impaired in patients with heart failure (HF). Cardiac resynchronization therapy (CRT) has positive effects on cardiac dysfunction and endothelial dysfunction that lead to erectile dysfunction (ED). We aimed to evaluate whether CRT may improve sexual activity in patients with HF. METHODS: In total, 136 patients (mean age 61.8 ± 12.8 years) were evaluated for the study. All patients filled the Sexual Health Inventory for Men (SHIM) questionnaire for evaluation of their erectile functions before CRT device implantation. One hundred eighty days after CRT device implantation, the patients were re-evaluated with SHIM questionnaire. RESULTS: In the whole study population, SHIM test scores were significantly increased after CRT (12.99 ± 3.22 vs. 18.03 ± 5.00; p<0.001). The patients were divided into two groups according to the CRT response. The increase in SHIM test scores was significantly more in the response (+) group than in the response (-) group [response (+) group: 6.94 ± 3.36; p<0.001 vs. response (-) group: 0.81 ± 1.77; p = 0.465]. A positive CRT response was found to be an independent predictor of SHIM score (p<0.001). CONCLUSION: Our study showed that CRT had positive effects on ED of patients with HF.

Impact of defibrillation threshold testing on burden of heart failure hospitalizations.

Background: Defibrillation threshold testing (DT) following implantable cardioverter defibrillator (ICD) implantation has not shown to improve mortality. However, the impact of DT on burden of heart failure (HF) hospitalisations has not been well defined.Methods: We studied retrospectively consecutive patients who underwent ICD implantation or generator change between 2008 and 2014. Primary outcome was burden of HF hospitalisations within 30 days following implantation. Secondary outcomes were mortality, stroke, and ICD shock within 30 days and one-year mortality.Results: Three hundred and eleven of 501 patients (62%) were in DT+ group versus 190 (38%) were in DT- group. The percentage of new implantations was higher in DT+ group than in DT- group (69% vs 39%, p < .001) but the distributions of NYHA function classes were similar between two groups. The burden of HF hospitalisations at 30-days was significantly higher in DT+ group than in DT- group (17.4% vs 4.7%, HR 0.842, 95% CI 0.774-0.915, p < .0001). No difference in mortality, stroke or ICD shocks was found between two groups at 30 days and mortality at 1 year.Conclusions: DT after new ICD or generator replacement was associated with increased HF hospitalisation rates at 30 days after ICD implant in a non-trial HF population. However, there was no association between DT and mortality, stroke and ICD shocks at 30 days or mortality at 1 year. The increased burden of HF hospitalisation in this observational study requires validation by randomised studies.

Clinimetric analysis of heart failure in Mexican patients.

Heart failure (HF) is a syndrome characterized basically by a circulatory deficit to cover the metabolic and energetic demands of the body. This condition has a broad spectrum in its clinical presentation, affects the quality of life significantly, impacts the family/social environment, and generates a great demand for health services. The purpose of this research is to report the situational diagnose of patients with HF in Mexico. We evaluated 292 patients, 70.2% were men. Average age was 56.7 ± 14.3 years. Ischemic heart disease is the main etiology (98 patients, 33.9%) followed by hypertensive (22.6%) and idiopathic (23.3%) heart disease. The associated clinical background was obesity (31.1%), systemic hypertension (36.7%), myocardial infarction (26.4%), and dyslipidemia (15.1%). The most common symptom was stress dyspnea (41.4%) and jugular vein engorgement at physical examination (32.5%). Anemia was observed in 1% of patients. The average left ventricular ejection fraction was 29.2 ± 10.6%. Sinus rhythm was the most frequently detected in 84.9%. 19.9% of patients had an implantable cardioverter-defibrillator or cardiac resynchronization therapy. 13.7% of patients with QRS > 130 ms. In our population, the meta-analysis global group in chronic heart failure risk score calculated was 16.8 ± 5.7 and for EMPHASIS 3.3 ± 1.5. We observed that age at presentation in HF in this analysis is at least 10 years younger than in other reports. The grade of obesity takes relevance in our group. The association of anemia and HF in Mexico is rare.

La insuficiencia cardiaca es un síndrome caracterizado fundamentalmente por un déficit circulatorio para cubrir las demandas metabólicas y energéticas del organismo. Esta entidad tiene un amplio espectro en su presentación clínica, afecta de manera significativa la calidad de vida, impacta en el entorno familiar/social y genera una gran demanda de los servicios de salud. El propósito de esta investigación es reportar el diagnóstico situacional de pacientes con insuficiencia cardiaca (IC) en México. Evaluamos 292 enfermos, 70.2% eran hombres. Con edad promedio 56.7 ± 14.3 años. La principal etiología es la cardiopatía isquémica (33.9%), seguida de la hipertensiva (22.6%) e idiopática (23.3%). Los antecedentes clínicos asociados fueron: obesidad (31.1%), hipertensión arterial sistémica (36.7%), infarto al miocardio (26.4%) y dislipidemia (15.1%). El síntoma con mayor presentación fue la disnea de esfuerzos (41.4%) y a la exploración física la ingurgitación yugular (32.5%). Se observó anemia en 1% de los enfermos. La fracción de expulsión del ventrículo izquierdo (FEVI) promedio fue de 29.2 + 10.6%. El ritmo sinusal fue el más frecuentemente detectado en 84.9%. El 19.9% de los pacientes tenían instalado un desfibrilador automático implantable (DAI) o tratamiento de resincronización cardiaca (TRC). El 13.7% de los enfermos con QRS mayor de 130 ms. El riesgo (MAGGIC) calculado en nuestro grupo poblacional fue de 16.8 ± 5.7 y para EMPHASIS 3.3 ± 1.5. Observamos que la edad de presentación de la IC en el presente análisis es menor por 10 años en comparación con otros reportes. El grado de obesidad toma relevancia en nuestro grupo. La asociación de anemia e IC en México es poco frecuente.

Clinimetric analysis of heart failure in Mexican patients / Análisis clinimétrico de la insuficiencia cardiaca en pacientes mexicanos

Abstract Heart failure (HF) is a syndrome characterized basically by a circulatory deficit to cover the metabolic and energetic demands of the body. This condition has a broad spectrum in its clinical presentation, affects the quality of life significantly, impacts the family/social environment, and generates a great demand for health services. The purpose of this research is to report the situational diagnose of patients with HF in Mexico. We evaluated 292 patients, 70.2% were men. Average age was 56.7 +- 14.3 years. Ischemic heart disease is the main etiology (98 patients, 33.9%) followed by hypertensive (22.6%) and idiopathic (23.3%) heart disease. The associated clinical background was obesity (31.1%), systemic hypertension (36.7%), myocardial infarction (26.4%), and dyslipidemia (15.1%). The most common symptom was stress dyspnea (41.4%) and jugular vein engorgement at physical examination (32.5%). Anemia was observed in 1% of patients. The average left ventricular ejection fraction was 29.2 +- 10.6%. Sinus rhythm was the most frequently detected in 84.9%. 19.9% of patients had an implantable cardioverter-defibrillator or cardiac resynchronization therapy. 13.7% of patients with QRS > 130 ms. In our population, the meta-analysis global group in chronic heart failure risk score calculated was 16.8 +- 5.7 and for EMPHASIS 3.3 +- 1.5. We observed that age at presentation in HF in this analysis is at least 10 years younger than in other reports. The grade of obesity takes relevance in our group. The association of anemia and HF in Mexico is rare.

Resumen La insuficiencia cardiaca es un síndrome caracterizado fundamentalmente por un déficit circulatorio para cubrir las demandas metabólicas y energéticas del organismo. Esta entidad tiene un amplio espectro en su presentación clínica, afecta de manera significativa la calidad de vida, impacta en el entorno familiar/social y genera una gran demanda de los servicios de salud. El propósito de esta investigación es reportar el diagnóstico situacional de pacientes con insuficiencia cardiaca (IC) en México. Evaluamos 292 enfermos, 70.2% eran hombres. Con edad promedio 56.7 +- 14.3 años. La principal etiología es la cardiopatía isquémica (33.9%), seguida de la hipertensiva (22.6%) e idiopática (23.3%). Los antecedentes clínicos asociados fueron: obesidad (31.1%), hipertensión arterial sistémica (36.7%), infarto al miocardio (26.4%) y dislipidemia (15.1%). El síntoma con mayor presentación fue la disnea de esfuerzos (41.4%) y a la exploración física la ingurgitación yugular (32.5%). Se observó anemia en 1% de los enfermos. La fracción de expulsión del ventrículo izquierdo (FEVI) promedio fue de 29.2 + 10.6%. El ritmo sinusal fue el más frecuentemente detectado en 84.9%. El 19.9% de los pacientes tenían instalado un desfibrilador automático implantable (DAI) o tratamiento de resincronización cardiaca (TRC). El 13.7% de los enfermos con QRS mayor de 130 ms. El riesgo (MAGGIC) calculado en nuestro grupo poblacional fue de 16.8 +- 5.7 y para EMPHASIS 3.3 +- 1.5. Observamos que la edad de presentación de la IC en el presente análisis es menor por 10 años en comparación con otros reportes. El grado de obesidad toma relevancia en nuestro grupo. La asociación de anemia e IC en México es poco frecuente.

Cardiac Resynchronization in Women: A Substudy of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial.

OBJECTIVES: This study sought to evaluate the effect of cardiac resynchronization therapy with defibrillator (CRT-D) as compared with implantable cardioverter-defibrillator (ICD) on mortality, heart failure (HF) hospitalization, and ventricular arrhythmia in women versus men. BACKGROUND: CRT-D has demonstrated reduced mortality and HF hospitalizations with greater benefit observed in women compared with men. However, whether CRT-D prevented ventricular arrhythmias in women compared with men was unclear. METHODS: The RAFT (Resynchronization-Defibrillation for Ambulatory Heart Failure Trial) study randomized 1,798 patients to an ICD or CRT-D. In this post hoc analysis, women and men were compared by randomized group. By using a multivariable model, the outcomes of death and HF hospitalization and incidence of ventricular arrhythmia were compared between men and women. RESULTS: There were 1,490 (83%) men (732, ICD; 758, CRT-D) and 308 (17%) women (172, ICD; 136, CRT-D) included in the analysis. Women with CRT-D had a significantly reduced incidence of death and HF hospitalization compared with men with CRT-D (hazard ratio: 0.52; 95% confidence interval: 0.33 to 0.81; p < 0.001) on multivariable analysis. Women with a primary prevention indication and CRT-D had the lowest rate of ventricular arrhythmia compared with men (hazard ratio: 0.59; 95% confidence interval: 0.39 to 0.91; p = 0.016). CONCLUSIONS: Women have improved rates of death and HF hospitalization with CRT-D and were less likely to experience ventricular arrhythmia when compared with men, after adjusting for differences in baseline characteristics over a prolonged follow-up. Whether these improved outcomes reflect inherent sex differences in the underlying myocardial substrate resulting in an enhanced response to CRT-D requires further research.

Sex-Related Procedural Aspects and Complications in CRT Survey II: A Multicenter European Experience in 11,088 Patients.

OBJECTIVES: This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted. BACKGROUND: Sex-related differences in procedural aspects and complications in patients undergoing cardiac resynchronization therapy (CRT) implantation has not been explored in a real-life population. METHODS: A post-hoc analysis of procedural data and complications in different sexes and factors associated with events was performed from data collected in the European Society of Cardiology CRT Survey II. RESULTS: Of all patients (n = 11,088) included, 24.3% were women. The mean age (70 years of age) of male and female recipients was similar. Female patients more frequently had an idiopathic cardiomyopathy (67.4% vs. 44.1%) and fewer comorbidities, including atrial fibrillation (34.8% vs. 42.8%), diabetes (29.1% vs. 32.1%), chronic obstructive lung disease (10.3% vs. 12.6%), and renal failure (28.7% vs. 31.9%), compared with men. More women compared with men had a pacemaker (56.6% vs. 46.3%) and much less often an implantable cardioverter-defibrillator (CRT-D) (19.0% vs. 34.7%) implant. Periprocedural event rate was the highest in women with CRT with defibrillator (7.1% vs. 4.8% in men), followed by women with a CRT with pacing (5.5% vs. 4.4% in men). The higher periprocedural event rate in CRT-D women was attributable primarily to the occurrence of pneumothorax (1.4%), coronary sinus dissection (2.1%), and pericardial tamponade (0.3%). The rate of in-hospital major adverse events (6.0%) and complications necessitating reoperation (4.0%) was not different among sex and device type. CONCLUSIONS: Women are more likely to experience adverse procedure-related events during CRT implantation. Thus, preventive strategies should be employed to minimize complication rate.

Predicting Early Mortality Among Implantable Defibrillator Patients Treated With Cardiac Resynchronization Therapy.

BACKGROUND: The beneficial effects of a cardiac resynchronization defibrillator (CRT-D) in patients with heart failure, low left ventricular ejection fraction (LVEF), and wide QRS have clearly been established. Nevertheless, mortality remains high in some patients. The aim of this study was to develop and validate a risk score to identify patients at high risk for early mortality who are implanted with a CRT-D. METHODS AND RESULTS: For predictive modelling, 1282 consecutive patients from 5 centers (74% male; median age 66 years; median LVEF 25%; New York Heart Association class III-IV 60%; median QRS-width 160 ms) were randomly divided into a derivation and validation cohort. The primary endpoint is mortality at 3 years. Model development was performed using multivariate logistic regression by checking log likelihood, Akaike information criterion, and Bayesian information criterion. Model performance was validated using C statistics and calibration plots. The risk score included 7 independent mortality predictors, including myocardial infarction, LVEF, QRS duration, chronic obstructive pulmonary disease, chronic kidney disease, hyponatremia, and anemia. Calibration-in-the-large was suboptimal, reflected by a lower observed mortality (44%) than predicted (50%). The validated C statistic was 0.71 indicating modest performance. CONCLUSION: A risk score based on routine, readily available clinical variables can assist in identifying patients at high risk for early mortality within 3 years after CRT-D implantation.

Incremental Value of Implantable Cardiac Device Diagnostic Variables Over Clinical Parameters to Predict Mortality in Patients With Mild to Moderate Heart Failure.

Background Heart failure remains a leading cause of morbidity and mortality. Clinical prediction models provide suboptimal estimates of mortality in this population. We sought to determine the incremental value of implantable device diagnostics over clinical prediction models for mortality. Methods and Results RAFT (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial) patients with implanted devices capable of device diagnostic monitoring were included, and demographic and clinical parameters were used to compute Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) heart failure risk scores. Patients were classified according to MAGGIC score into low (0-16), intermediate (17-24), or high (>24) risk groups. Mortality was evaluated from 6 months postimplant in accordance with the RAFT protocol. In a subset of 1036 patients, multivariable analysis revealed that intermediate and high MAGGIC scores, fluid index, atrial fibrillation, and low activity flags were independent predictors of mortality. A device-integrated diagnostic parameter that included a fluid index flag and either a positive atrial fibrillation flag or a positive activity flag was able to significantly differentiate higher from lower risk for mortality in the intermediate MAGGIC cohort. The effect was more pronounced in the high-risk MAGGIC cohort, in which device-integrated diagnostic-positive patients had a shorter time to death than those who were device-integrated diagnostic negative. Conclusions Device diagnostics using a combination of fluid index trends, atrial fibrillation burden, and patient activity provide significant incremental prognostic value over clinical heart failure prediction scores in higher-risk patients. This suggests that combining clinical and device diagnostic parameters may lead to models with better predictive power. Whether this risk is modifiable with early medical intervention would warrant further studies. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT00251251.

Cardiac Resynchronization Defibrillator Therapy for Nonspecific Intraventricular Conduction Delay Versus Right Bundle Branch Block.

BACKGROUND: The benefits of cardiac resynchronization therapy (CRT) in patients with non-left bundle branch block (LBBB) conduction abnormality have not been fully explored. OBJECTIVES: This study sought to evaluate clinical outcomes among Medicare-aged patients with nonspecific intraventricular conduction delay (NICD) versus right bundle branch block (RBBB) in patients eligible for implantation with a CRT with defibrillator (CRT-D). METHODS: Using the National Cardiovascular Data Registry implantable cardioverter-defibrillator (ICD) registry data between 2010 and 2013, the authors compared outcomes in CRT-eligible patients implanted with CRT-D versus ICD-only therapy among patients with NICD and RBBB. Also, among all CRT-D-implanted patients, the authors compared outcomes in those with NICD versus RBBB. Survival curves and multivariable adjusted hazard ratios (HRs) were used to assess outcomes including hospitalization and death. RESULTS: In 11,505 non-LBBB CRT-eligible patients, after multivariable adjustment, among patients with RBBB, CRT-D was not associated with better outcomes, compared with ICD alone, regardless of QRS duration. Among patients with NICD and a QRS ≥150 ms, CRT-D was associated with decreased mortality at 3 years compared with ICD alone (HR: 0.602; 95% confidence interval [CI]: 0.416 to 0.871; p = 0.0071). Among 5,954 CRT-D-implanted patients, after multivariable adjustment NICD compared with RBBB was associated with lower mortality at 3 years in those with a QRS duration of ≥150 ms (HR: 0.757; 95% CI: 0.625 to 0.917; p = 0.0044). CONCLUSIONS: Among non-LBBB CRT-D-eligible patients, CRT-D implantation was associated with better outcomes compared with ICD alone specifically in NICD patients with a QRS duration of ≥150 ms. Careful patient selection should be considered for CRT-D implantation in patients with non-LBBB conduction.

Sex-Based Differences in Heart Failure Across the Ejection Fraction Spectrum: Phenotyping, and Prognostic and Therapeutic Implications.

OBJECTIVES: This study assessed sex-related differences in a large cohort of unselected patients with heart failure (HF) across the ejection fraction (EF) spectrum. BACKGROUND: Females are under-represented in randomized clinical trials. Potential sex-related differences in HF may question the generalizability of trials. METHODS: In the Swedish Heart Failure Registry population multivariate Cox and logistic regression models were fitted to investigate differences in prognosis, prognostic predictors, and treatments across males and females. RESULTS: Of 42,987 patients, 37% were females (55% with HF with preserved EF [HFpEF], 39% with HF with mid-range EF [HFmrEF], and 29% with HF with reduced EF [HFrEF]). Females were older and more symptomatic and more likely to have hypertension and kidney disease but less likely to have diabetes and ischemic heart disease. After adjustments, females were more likely to use beta-blockers and digoxin but less likely to receive HF device therapy. Crude mortality/HF hospitalization rates for HFpEF (hazard ratio [HR]: 1.16) and HFmrEF (HR: 1.14) were significantly higher in females but lower in females with HFrEF (HR: 0.95). After adjustments, the risk was significantly lower in females regardless of EF (HR: 0.80 in HFrEF, HR: 0.91 in HFmrEF, and HR: 0.93 in HFpEF). The main sex-related differences in prognostic predictors concerned diabetes in HFrEF and anemia in HFmrEF. CONCLUSIONS: Males and females with HF showed different characteristics across the EF spectrum. Males reported a lower crude risk of mortality/morbidity in HFpEF and HFmrEF but higher risk of HFrEF, although after adjustments, prognosis was better in females regardless of EF. The observed sex-related differences highlight the need for an adequate representation of females in HF randomized controlled trials to improve generalizability.

Impact of cardiac resynchronisation therapy on burden of hospitalisations and survival: a retrospective observational study in the Northern Region of New Zealand.

OBJECTIVE: Cardiac resynchronisation therapy (CRT) devices have been shown to improve heart failure (HF) symptoms, survival and improve quality of life (QoL). We evaluated the overall impact of CRT on recurrent hospitalisations and survival in real-world patients with HF. DESIGN: Retrospective observational study. SETTING: Northern region of New Zealand. PARTICIPANTS: Patients with HF who underwent CRT device implantation in between 2008 and 2014 were followed up for 1 year. INTERVENTIONS: CRT. PRIMARY AND SECONDARY OUTCOMES MEASURED: Survival, all-cause hospitalisations, length of stay, from which days alive and out of hospital (DAOH) were calculated. RESULTS: 177patients were included, of whom eight died (4.5%) within 1 year of follow-up. Pre-CRT implantation, 83% of all patients had been hospitalised for a total 248 hospitalisation events. Following CRT, 47 patients (27%) were readmitted to hospital within 1 year (total of 98 admissions; p<0.01 compared with pre-device implant). Length of hospital stay was significantly shorter than in the year prior to CRT implantation at a median of 4 (IQR 2-6) vs 7 (IQR 3.5-10.5) days (p=0.03). An increase in the median number of DAOH was observed from 362 (IQR 355-364) to 365 (IQR 364-365) (p<0.01) after CRT implant. The improvement in DAOH was seen regardless of gender and type of CRT devices. Greater DAOH was also seen in those with non-ischaemic cardiomyopathy and Caucasians. CONCLUSION: After CRT implant, patients with HF have greater DAOH with reduction of total hospitalisation and fewer hospital days. These results support CRT devices use as a treatment option for appropriate HF patients. DAOH represents an easily measured, patient-centred endpoint that may reflect effectiveness of interventions in future CRT studies.