Cardiac Resynchronization Therapy Device Research Articles

Association between socioeconomic position and discontinuation of pharmacotherapy for heart failure after cardiac resynchronization therapy.

Pharmacological therapy remains a cornerstone in heart failure (HF) treatment despite implantation of a cardiac resynchronization therapy (CRT) device. The aim of this study was to investigate the association between 1) drug discontinuation, and 2) long-term adherence to HF pharmacotherapy after CRT implantation and socioeconomic position and multimorbidity. We conducted a registry-based cohort study including all patients who underwent a first-time CRT implantation at Aarhus University Hospital from 2000-2017. HF pharmacotherapy included beta blockers (BBs), renin angiotensin system inhibitors (ACEI/ARB), and mineralocorticoid receptor antagonists (MRAs). Patients were identified using the Danish Pacemaker and ICD Registry, and information about medication and comorbidities was obtained through linkage to the Danish health registries. We identified 2,007 patients of whom 1,880 (94%) were eligible for inclusion. The cumulative incidence of drug discontinuation at 10 years was 6% (95% confidence interval [CI] 5-8%) for BB, 10% (95% CI 9-12%) for ACEI/ARB, and 24% (95% CI 20-27%) for MRAs. Living alone was associated with higher BB discontinuation rates (hazard ratio [HR] 1.83, 95%CI 1.20-2.79), whereas patients with multimorbidity were more likely to discontinue ACEI/ARB- (HR 1.92, 95%CI 1.33-2.80) and MRA therapy (HR 1.51, 95% CI 1.10-2.09). Income- and educational level did not influence drug discontinuation rates, and similar adherence patterns were observed across all strata of socioeconomic position and multimorbidity. In patients with CRTs, drug discontinuation rates were low, and adherence to HF pharmacotherapy was comparable regardless of socioeconomic position. Living alone and multimorbidity were associated with discontinuation of specific HF drugs.

Procedural outcome of transvenous lead extraction in patients with right-sided leads - a GALLERY subgroup analysis

Abstract Background Transvenous lead extraction (TLE) in patients with cardiac implantable electronic devices has become a well-established therapy for patients with lead complications. However, there is limited information on specific outcomes for patients with right-sided leads compared to patients with left-sided leads undergoing TLE. Aim The aim of this study was to analyze patient characteristics, procedural outcomes as well as adverse events and mortality of patients with right-sided leads undergoing TLE with the excimer laser sheath as a first line therapy. Methods We performed a subgroup analysis of all reported patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) with unilateral right-sided leads (Group 1) or unilateral left-sided leads (Group 2). Results 2438 patients with unilateral leads were analyzed. 750 patients were in Group 1 and 1688 patients were in Group 2. Patients in Group 1 were older (71.1 ± 13.9 vs. 66.5 ± 13.6; p < 0.001), more patients were female (31.7% vs. 22.1%, p < 0.001), had a lower body-mass-index (26.8 ± 4.5 vs. 27.2 ± 4.7; p=0.03) and more patients were pacemaker dependent (44.9% vs. 25.4%, p< 0.001). The primary indication for TLE was local infection (46.0% vs. 30.6%, p< 0.001) in Group 1 and lead dysfunction (20.0% vs. 36.1%, p< 0.0001) in Group 2. The frequency of TLE for systemic infection was indifferent between groups (28.9% vs. 27.6%, p=0.532). The most common device to be extracted were pacemakers (80.1% vs. 22.7%, p< 0.001) in Group 1 and implantable cardioverter-defibrillators (ICD) (9.7 vs. 45.3%, p< 0.001) and cardiac resynchronization therapy devices (CRT) (9.6 vs. 31.5%); p< 0.001) in Group 2. The mean number of total leads was not different between groups (2.4 ± 0.9 for Group 1 vs. 2.3 ± 1.0 for Group 2; p=0.98), however median lead dwell time (120 vs. 85 months, p< 0.001), patients with abandoned leads (32.0% vs. 25.9%; p=0.0022) and the use of additional extraction tools (8.4% vs. 5.7%, p=0.016) were significantly higher in Group 1. Patients with right-sided leads had a longer median hospital stay (10 vs. 9 [5; 15] p=0.001). Complete procedural success was higher in patients Group 2 (89.1 vs. 93.1%, p=0.001) but there was no difference in clinical success rates (97.7% vs. 98.0%, p=0.74). There was no difference in overall complication rates (4.3% vs. 4.2%, p=0.945). Neither procedure related mortality (0.3% vs. 0.7%, p=0.2940) nor all-cause mortality (3.5% vs. 3.4%, p=0.9101) differed between groups. Conclusion TLE procedures in patients with right-sided leads showed a lower procedural success rate and a higher need of additional tools. This patient group was older, more often pacemaker dependent and had a higher number of abandoned leads. Despite different patient and lead characteristics, there were no differences in clinical success-rates, procedure related complications or all-cause mortality between groups.

Depression and anxiety in Greek heart failure patients who received a cardiac resynchronization therapy device and did not receive shock therapy during a 12-month follow-up

Abstract Background/Introduction Cardiac resynchronization therapy (CRT) represents an effective therapy in selected heart failure with reduced ejection fraction (HFrEF) patients. There are racial, social, geographical, and ethnic differences in the perception of cardiac device therapies as well as in the associated depression and anxiety status. Regarding psychological status indexes in CRT patients, heterogenous results have been reported while data on their variation over time are limited. No relative data regarding Greek patients have been published in the literature. Purpose We aimed to study psychological status and quality of life validated parameters at baseline as well as their variation at 6 and 12 months after implantation of a CRT device in Greek adult patients with HFrEF. Methods We recruited consecutive HFrEF adult patients who were implanted a CRT device (defibrillator or pacemaker). From the present analysis we excluded patients who suffered defibrillator shocks, those with neuropsychiatric disorders, and those with severe chronic medical illnesses or disabilities. Baseline demographic, clinical, laboratory, electrocardiographic, and echocardiographic parameters were carefully recorded. The following scores were assessed at baseline as well as 6 and 12 months after implantation: Minnesota Living with Heart Failure (MLHF), GAD-7 Anxiety, and PHQ-9 Depression. The variation of these scores over time was examined using the non-parametric Friedman’s test. Potential correlations of the baseline scores with other parameters were examined using the Spearman rank test. Comparison of these scores between different groups of patients was examined using the Mann-Whitney U test. Results The initial study population consisted of 105 patients, but after excluding 8 patients who experienced defibrillator shocks, we finally analyzed 97 patients (median age: 72 [64-76.5] years, 76% men). Six patients died during the 12-month follow-up. At baseline the MLHF score was 37 [20 - 56], at 6 months it was 1 [0 – 8], and at 12 months 0.5 [0-10]. The PHQ-9 score for depression at baseline was 9 [3.75 – 14.25], at 6 months it was 0.5 [0 – 2], and at 12 months it was 0.25 [0 – 1.5]; p <0.01. The GAD-7 anxiety score at baseline was 8 [2 – 16], at 6 months it was 0.5 [0 – 2], and at 12 months it was 0.5 [0 – 2.5]; p <0.01. At baseline 29% of patients had PHQ-9 score <5, namely minimal depression; and 35% had GAD-7 score <5, namely minimal anxiety. The baseline PHQ-9 and GAD-7 scores did not correlate to any other parameter while there were no differences between different patient groups. Baseline PHQ-9 and GAD-7 scores demonstrated strong correlation with the baseline MLHF score (p <0.01). Conclusions In Greek patients with HFrEF who were implanted a CRT device, depression was present in 71% and anxiety in 65% of them. The indexes of quality of life, anxiety, and depression were markedly reduced during the 12-month follow-up.

Comparative analysis of clinical outcomes in patients undergoing primary CRT implantation versus CRT upgrade: single center experience

Abstract Background As heart failure (HF) management evolves, cardiac resynchronization therapy (CRT) has emerged as a cornerstone intervention, improving left ventricular (LV) function and reducing morbidity and mortality. The Budapest trial specifically addressed upgrading from permanent pacemaker (PPM) to CRT, emphasizing the potential for improved clinical outcomes and quality of life in this population. The findings highlighted the impact of CRT upgrade and contribute valuable insights to the cardiac device strategies for HF patients. This study aims to compare clinical outcomes between patients undergoing primary CRT implantation and those undergoing CRT upgrade. Methods A retrospective analysis was conducted on a cohort of heart failure patients who received CRT devices between 2015 and 2019. Patients were categorized into two groups: those undergoing primary CRT implantation and those undergoing CRT upgrade. Clinical outcomes, including mortality rate, hospitalization for HF exacerbation, and improvements in left ventricular ejection fraction (LVEF), were assessed and compared between the two groups. Results A total of 847 patients were included in the study, with 74,5% (n=631) undergoing primary CRT implantation and 13,5% (n=114) receiving CRT upgrades. The mean age was 72±10 years-old and 57% (n=485) were women, and a mean follow-up time of 23±8 months. 33.7% (n=285) of the total were of ischemic etiology. The primary CRT implantation group demonstrated a mortality of 34% (n=215) and 13% (n=84) of hospitalization due to HF; NYHA functional class improvement in 58% (n=369), and 35,7% (n=225) were CRT responders with a mean LV ejection fraction (EF) improvement of ±10%, while the CRT upgrade group had a 31% (n=36) mortality and 19% (n=22) of hospitalization due to HF; NYHA functional class improvement in 60% (n=68), and 27% (n=31) were CRT responders with a mean LV EF improvement of 8,7%. There were no statistically significant differences regarding each endpoint, namely mortality, HF hospitalizations, NYHA functional class improvement, CRT responders and mean LVEF improvement. Conclusion A clear benefit from implantation of a primary CRT device implantation has already been demonstrated. However, recent trials revealed there was also benefit in upgrading from PPM to CRT patients with decrease LVEF, comparing with PPM. This study showed that the benefits from primary CRT were similar to the benefits from upgrading CRT, in terms of mortality reduction, HF hospitalizations, NYHA functional class improvement, CRT responders and mean LVEF improvement. Once again, just like in the most recent trials, this study demonstrates the clear benefit of upgrading from a PPM to CRT in patients with decreased LVEF.

Health-related quality of life among patients after cardiac resynchronization therapy: a comparison between biventricular and left bundle branch area pacing

Abstract Background Cardiac resynchronization therapy (CRT) with biventricular pacing (BiVP) has the potential to improve cardiac function in patients with heart failure (HF). However, a portion of patients do not respond to therapy. Recently, left bundle branch area pacing (LBBAP) has emerged as a more physiological alternative for CRT in selected cases (1,2). Quality of life (QoL) tools measures subjective experience and its results are relevant as they may help to assessed the impact that medical interventions have in patient's health. Purpose The authors sought to measure and compare the quality of life in a cohort of patients after the implantation of either a BiVP or a LBBaP CRT device. Methods A multicenter prospective quasi-experimental study in which consecutive patients underwent CRT was conducted. According to the study protocol, the four centers would perform their usual clinical practice: two out of them would perform conventional BiVP-CRT while the other half LBBAP-CRT. The health related QoL was measured by the Spanish version of the EuroQol Group’s five-level EuroQol five-dimensional questionnaire (EQ-5D-5L), which the patients were asked to complete at baseline and 12 weeks after the CRT device implantation. The descriptive system section of the EQ-5D-5L questionnaire produces a 5-digit health state profile that can be converted into a single index value. The EQ-5D-5L Spanish index values range from -0.225 to 1.0 (full health). The EQ-5D visual analogue scale (EQ-VAS) is a vertical scale numbered from 0 to 100 (the worst and the best health you can imagine). Both groups (BiVP and LBBaP) were compared with data from the general population of Spain for the EQ-5D-5L and EQ-VAS (n=20.587) according to the national survey (3). Results The study included 44 consecutive patients (31 males, mean age 66 ± 11 years, LVEF 28.9% ± 6.9%). The LBBAP procedure was finally performed in 27 patients, while BiVP was the therapy performed in the other 17 patients. Crossover rate was less than 12% (1 patient underwent rescue BiVP and 2 patients switched to LBBAP). The basal characteristics of included patients are presented in Table 1. Among the individuals with BiVP the mean EQ-5D-5L index score and the EQ-VAS score were 0.74±0.24 and 65.71±17.90 respectively at baseline while they were 0.83±0.19 [+0.08±0.16, p 0.054, CI 95%] and 76.59±15.76 three months later [+10.80±15.38, p 0.01, CI 95%]. In the LBBAP group, the mean EQ-5D-5L index score and the EQ-VAS score were 0.71±0.25 and 50.04±25.49 respectively at baseline while they were 0.80±0.19 [+0.09±0.22, p 0.044, CI 95%] and 69.30±23.53 [+19.26±22.83, p 0.0001, CI 95%] three months later. Conclusion It was found that the EQ-5D-5L index value and EQ-VAS improved in the LBBAP group. In the BiVP group only EQ-VAS improved although there was also a non-statistically significant trend in EQ-5D-5L index score. The main limitation of the study was the small sample size.Table 1Figure 1

No lead left behind: procedural outcome of excimer laser powered extractions in patients with abandoned leads - a GALLERY subgroup analysis

Abstract Background Lead dwell time > 10 years, has been recognized as a predictive factor for procedural failure of transvenous lead extraction (TLE). However, there is a limited information concerning the specific outcomes of TLE for abandoned leads when employing the excimer laser-powered sheath. Objective The purpose of this study was to investigate the procedural outcomes of individuals with abandoned leads undergoing TLE with excimer laser-powered sheath as first tool strategy. Methods A subgroup analysis of patients with abandoned leads of the GALLERY (GermAn Laser Lead Extraction RegistrY) database was conducted. Patients were categorized into two groups based on the presence of abandoned leads at the time of extraction: Group 1 for those with abandoned leads, and Group 2 for those without abandoned leads. Results Among the 2524 patients, 749 individuals (29.7%) had abandoned leads (Group 1) at the time of the procedure. Patients in Group 1 were typically older (69.1±13 vs. 67.6±14.1 years; p=0.026) and 23.5% were female. Leading extraction indication was local infection (37.4% vs. 34.3%, p=0.145), systemic infection (33.2% vs. 26.6%, p=0.001) and lead dysfunction (24.3% vs. 33.5%, p<0.001). Additionally, more patients in Group 1 presented with cardiac resynchronization therapy (CRT) devices (30.4% vs. 22.9%, p<0.001). Significant differences were observed in the mean number of total leads (3.4±1.1 vs. 2.0±0.7, p<0.001), median age of the oldest lead (117 vs. 87 months; p<0.001), and the number of right-sided leads (41.7% vs. 29.5%, p<0.001), all of which were higher in Group 1. Median hospital stay (10 vs. 9 days; p=0.002), median procedural time (105 vs. 75 minutes; p<0.001) and use of additional tools (11.2% vs. 4.7%, p<0.001) were significantly higher in Group 1. There was no difference regarding clinical success (p=0.32) between the groups. However, complete procedural success was significantly higher in Group 2 (84.9% vs. 94.2%, p<0.001). All-cause mortality did not differ between the groups (p=0.111) but procedural-related mortality was higher in Group 1 (2.9% vs. 0.6%, p<0.001). The overall complications rate was also significantly higher in Group 1 (5.7% vs. 3.7%, p=0.03). Conclusion Patients with abandoned leads presented an increased procedural complexity, less procedural and clinical success despite the use of multiple tools, longer hospital-stay and higher procedure-related mortality rates. Therefore, an extraction strategy should be considered before deciding to abandon non-functional or dysfunctional leads.

Left-ventricular-only cardiac resynchronization therapy with electrocardiographic optimization: 100-day follow-up

Abstract Background LV-only (LVo) cardiac resynchronization therapy (CRT) was recognized in 2013 as a non-inferior alternative to bi-ventricular (biV) CRT [1]. In a triple-chamber device it can extend service life, reduce atrial fibrillation risk. A number of LVo systems have been proposed but have not been shown to be superior to biV [2] due to a lack of individualized optimization of the LV atrio-ventricular delay. Purpose An LVo algorithm with an electrocardiographic optimization for each patient along general principles was developed and successfully implanted in a dozen patients with triple-chamber devices. The algorithm has been reported earlier. Since the RV lead is redundant, a dual chamber CRT (dcCRT) version was developed, with just the RA and LV leads. A preliminary series of 8 dcCRT implants were performed with good results. Methods A 2-week training class on LV lead implantation was held in July 2023. Fourteen dcCRT’s were implanted. Inclusion criteria: CRT indications, Left-bundle-branch block, good A-RV conduction, mostly sinus rhythm. 100-day follow-ups were performed on 15 patients (including 2 earlier patients) and reported here. Results In Fig.1 Implant LVEFs (Simpson): 16% to 38%. At the 100-day follow-ups, the LVEFs range from 24% to 62%. 6 (40%) remained below LVEF 35%, 9 (60%) exceeded the 35% threshold, 3 (20%) exceeded 45%, including 2 (13%) with 56% and 62%. Only 3 patients with small 2-3% LVEF improvements. All others were >5%, up to 29%. Since the devices can measure thoracic impedance, Z, 1024 times/hour, with the hourly average combined for a daily average, the 100-day daily Z trends were analyzed. The implant and 100-day Z’s are plotted in Fig.2. Except for the 2 patients whose Z measurements were left off, the universal upward Z trend is an indication of improved LV blood flow in all patients, helping reduced excessive lung fluid. Z changes range from 14 to 34 Ohms. Of the 2 patients in Fig.1 with only 2% LVEF improvements, their Z improvements were meaningful 23 Ohms increases! The Z and LVEF trends indicate that the therapy had a 100% success. Conclusions The 100-day follow-ups of the ECG optimized LVo CRT of 15 patients with dcCRTs show results superior to what have been reported in previous biV studies, thanks to the ECG optimization. This indicates that this may be a superior alternative to biV CRT. While the study was done with dcCRT, it should be applicable to all triple chamber CRT (-P/-D) devices which can support LVo pacing. Unlike other CRT algorithms, if the device supports LVo, it can be applied. It is safe since the programming can be reverted to biV at any time! This opens the possibility for improving the health of current CRT patients and extending the service lives of their devices, in addition to improved de novo results. The dcCRT is no longer viable since bipolar LV leads have been discontinued in favor of quadripolar leads, but the results apply to all CRT systems.Fig 1. LVEF @ implant & 100 dayFig 2. Thoracic Z @implant & 100 day

Short-term cost-utility analysis of biventricular cardiac resynchronization therapy in comparison with left bundle branch area pacing cardiac resynchronization therapy

Abstract Background Cardiac resynchronisation therapy (CRT) is a well-established form of treatment for patients with heart failure and cardiac dyssynchrony. Recently, left bundle branch area pacing (LBBAP) has emerged as a more physiological alternative for biventricular pacing (BiVP) cardiac resynchronization therapy (1,2). Purpose The purpose of this study was to conduct a cost-utility analysis for LBBAP CRT, compared to BiVP CRT in a cohort of patients with heart failure from the Spanish health system perspective. Methods A multicenter prospective quasi-experimental study in which 44 consecutive patients underwent CRT was conducted. According to the study protocol, the four centers would perform their usual clinical practice: two out of them would perform conventional BiVP-CRT while the other half LBBAP-CRT. Intention-to-treat analysis was carried-out. Health outcomes were quality-adjusted life years (QALYs), measured by the EuroQol-5D-5L questionnaire, which the patients were asked to complete at baseline and 12 weeks after the CRT device implantation. The total direct costs include device, leads, guidewires, introducer kits, sheats and operating theater time. The results were expressed as the incremental cost-utility ratio (ICUR). In order to analyze the uncertainty of ICUR results, we performed a non-parametric bootstrapping with 1000 replications. Results The LBBAP procedure was attempted for a total of 26 consecutive patients (1 patient underwent rescue BiVP), while BiVP was attempted for 18 patients (2 patients switched to LBBAP). Mean QALYs over 3 months were 0.1914 ± 0.009 in the LBBAP CRT group and 0.1904 ± 0.0112 in the BiVP CRT. Improvements from baseline were greater in the LBBA CRT group but not statistically significant. The total costs at the end of the intervention were 7546.6 €± 602.15€ in the LBBAP CRT group and 16064.56€ ± 723.7€ in the BiVP CRT group. When excluding from the analysis the cases in which ICD was implanted, the mean difference in QALYs is 0.002; 95% confidence interval [95%CI]: -0.03 to 0.036) and the mean saving is -3.510.38 €. The LBBAP CRT leads to cost savings for the health system and similar QALYs outcomes; 95%CI: -6.660 to -360.71. Based on 1000 bootstrapping replication, the cost savings of using LBBAP vs BiVP occur in 99% of the simulations. Conclusion LBBAP CRT is an efficient alternative to BiVP CRT for cardiac resynchronization in patients with heart failure with similar results in terms of QALYs but with significant average savings per patient.Cost-utility plane for 1000 bootstrappedBaseline characteristics of patients

Predictors of responders to cardiac resynchronization therapy in patients with non-left bundle branch block with mid-wide QRS duration

Abstract Background Cardiac resynchronization therapy (CRT) is useful for patients with severe heart failure with dyssynchrony of left ventricular contraction, significantly reducing total mortality or heart failure rehospitalization. In patient with left bundle branch block (LBBB) or QRS duration (QRSd) ≥ 150 ms, CRT is a well-established therapy at guidelines in Japan and other countries. However, CRT may be more useful and effective in Asian patients with middle range wide QRSd, because of smaller body size than in the West. Few reports have shown the usefulness and efficacy of CRT in patients with non-LBBB and middle range wide QRS duration (mid-wide QRSd). Purpose To evaluate the predictors of CRT responders in heart failure patients with non LBBB and mid wide QRSd. Methods We retrospectively studied 174 consecutive patients who underwent a denovo CRT device implantation at two institutions between September 2013 and March 2023. Follow up echocardiography examination could be performed after 150 days postoperatively. CRT responders were defined as a decrease in left ventricular end systolic volume ≥15% on echocardiography. We plotted thereceiver operating characteristic (ROC) curve for predicting CRT responders. The area under the curve (AUC) was calculated to determine the best cut off value. Results A total of 34 patients with non LBBB and 120≤ QRSd <150 ms were enrolled in this study. Sixteen of 34 (47%) patients were the responders for CRT. There was no significant difference in gender between the responder and non responder groups (p=0.274). Non ischemic cardiomyopathy was more prevalent in the responder group (p=0.046). The ROC curve analysis confirmed that 0.809 was the better optimal cut off value of QRSd/left ventricular end diastolic volume (LVEDV) for predicting CRT responders (AUC = 0.688). The multivariate analysis demonstrated that QRSd/LVEDV was significantly associated with CRT responders [odds ratio (OR) 9.88, 95% confidence interval 1.51 64.90, p = 0.017]. Conclusion The corrected QRSd for heart size using LVEDV could be the independent predictor of CRT responders in Japanese patients with non LBBB and mid wide QRSd.

QRS INDEX TO PREDICT CARDIAC RESYNCHRONIZATION THERAPY RESPONSE: A TRICENTRIC STUDY

Abstract Background Several studies have evaluated the role of QRS duration (QRSd) or QRS narrowing as a predictor of response to cardiac resynchronization therapy (CRT) to reduce non–responders. Purpose The aim of our study was to determine the correlation between the relative change in QRS narrowing index (QI) compared to clinical outcome and prognosis in patients who underwent CRT implantation. Methods A three–center study involving 398 patients with a CRT device was conducted. Clinical variables, echocardiographic parameters and drug therapies, QRS duration before and after CRT implantation, and QRS index (QI) were measured. Results In a six–month follow–up, a significant improvement in left ventricle ejection fraction (EF), left ventricle end–diastolic and systolic volumes (LVEDV and LVESV) were observed. QI was significantly related to reverse remodelling (r = +0.22; 95% CI: 0.11 to 0.32, p= 0.001) and the cut–off value that best predicted LV reverse remodelling was 12.25% (AUC 0.7, p=0.001). At 24 months, a statistically significant difference was found between patients with a QI < 12.25% and those with a QI > 12.25%, regarding NYHA class worsening (p= 0,04). The mean of the QI of patients who died from cardiovascular causes was lower than patients who died of other causes (p=0,0179). A correlation between pre–CRT QRSd/LVEDV and QI was observed (r = +0.20; 95% CI: 0.09 to 0.30, p=0.0003). A higher QRSd/LVEDV ratio was associated with an improved LVEF, LVEDV, LVESV (p <0.0001) at follow–up. Conclusions QI narrowing after CRT was related to greater echocardiographic reverse remodelling and lower rate of adverse events. The QI can improve adverse events’ prediction in a population with CRT regardless of comorbidities according to the Charlson Comorbidity index. QI could be used to predict CRT response.

Interaction of left ventricular size with the outcome of cardiac resynchronization therapy in Japanese patients.

We analyzed the influence of the QRS duration (QRSd) to LV end-diastolic volume (LVEDV) ratio on cardiac resynchronization therapy (CRT) outcomes in heart failure patients classified as III/IV per the New York Heart Association (NYHA) and with small body size. We proposed the hypothesis that the QRSd/LV size ratio is a better index of the CRT substrate. We enrolled 114 patients with advanced heart failure (NYHA class III/IV, and LV ejection fraction >35%) who received a CRT device, including those with left bundle branch block (LBBB) and QRSd ≥120 milliseconds (n = 60), non-LBBB and QRSd ≥150 milliseconds (n = 30) and non-LBBB and QRSd of 120-149 milliseconds (n = 24). Over a mean follow-up period of 65 ± 58 months, the incidence of the primary endpoint, a composite of all-cause death and hospitalization for heart failure, showed no significant intergroup difference (43.3% vs. 50.0% vs. 37.5%, respectively, p = .72). Similarly, among 104 patients with QRSd/LVEDV ≥ 0.67 (n = 54) and QRSd/LVEDV < 0.67 (n = 52), no significant differences were observed in the incidence of the primary endpoint (35.1% vs. 51.9%, p = .49). Nevertheless, patients with QRSd/LVEDV ≥ 0.67 showed better survival than those with QRSd/LVEDV < 0.67 (14.8% vs. 34.6%, p = .0024). Advanced HF patients with a higher QRSd/LVEDV ratio showed better survival in this small-body-size population. Thus, the risk is concentrated among those with a larger QRSd, and patients with a relatively smaller left ventricular size appeared to benefit from CRT.

Short Registry of Terminal Forms of Chronic Heart Failure in the Samara Region.

To study the clinical characteristics and prognosis of patients with functional class (FC) III-IV chronic heart failure (CHF) who meet the criteria for inclusion in the palliative care program. A short registry of severe CHF forms was conducted at 60 outpatient and inpatient clinics in the Samara region for one month (16.05.2022-15.06.2022). The registry included patients with FC III-IV CHF who sought medical help during that period. Lethal outcomes were assessed at 90 days after the inclusion in the registry using the Mortality Information and Analytics system. 591 patients (median age, 71.0 [64.0; 80.0] years were enrolled, including 339 (57.4%) men, of which 149 (24.1%) were of working age (under 65 years). The main cause of CHF was ischemic heart disease (64.5%). 229 (38.7%) patients had left ventricular ejection fraction &lt;40%. During the past year, 513 (86.8%) patients had at least one hospitalization for decompensated CHF. 45.7% of patients had hydrothorax, and 11.3% of patients had ascites. Low systolic blood pressure was observed in more than 25% of patients; 14.2% required in-hospital inotropic support; and 9.1% received it on the outpatient basis. 4.2% of patients received outpatient oxygen support and 0.8% required the administration of narcotic analgesics. 12 (1.9%) patients were on the waiting list for heart transplantation. In this study, there was an inconsistency in the number of patients with ventricular tachycardia and/or left bundle branch block (LBBB) who were implanted with cardiac resynchronization therapy devices (CRTD) or an implantable cardioverter defibrillator (ICD), a total of 19 patients (11 patients with CRTD and 8 patients with ICD), while 58 (9.8%) patients had indications for CRTD/ICD implantation. Within 90 days from inclusion in the registry, 59 (10.0%) patients died. According to binary logistic regression analysis, the presence of LBBB, hydrothorax, the requirement for outpatient oxygen support, and a history of cardiac surgery were associated with a high risk of death. Patients with severe forms of CHF require not only adequate drug therapy, but also dynamic clinical observation supplemented with palliative care aimed at improving the quality of life, including the ethical principles of shared decision-making and advance care planning to identify the priorities and goals of patients in relation to their care.

Assessment of the Impact of Cardiac Implantable Electronic Devices on Patients' Quality of Life.

Assessing the quality of life serves as a crucial metric during various therapeutic or surgical procedures. The rise in cardiac electronic device implantations in recent years underscores the significance of evaluating the quality of life among such patients. We conducted a study focusing on the quality of life of 438 patients with cardiac implantable electronic devices (cardiac pacemakers, cardioverter-defibrillators, cardiac resynchronization therapy devices). These patients were diagnosed with sick sinus syndrome, high-degree atrioventricular (AV) block, or severe heart failure (New York Heart Association (NYHA) classes III- IV (NYHA III-IV)), with left ventricular ejection fraction (LVEF) ≤ 35%, with/without complete left bundle branch block (QRS ≥ 130 μs), or with a history of ventricular tachycardia/ventricular fibrillation. The study utilized the EuroQol 5-Dimension 5-level (EQ-5D-5L) questionnaire and the EQ visual analog scale, which patients completed both prior to cardiac device implantation and during six post-implantation follow-up visits. The analysis of the research findings was conducted using the IBM SPSS Statistics software program (Armonk, NY). Cardiac pacemaker implantation in patients with sick sinus syndrome and high-grade AV block demonstrated significant and highly reliable positive effects on quality of life concerning mobility, self-care, and usual activity. Similarly, cardiac resynchronization device implantation in individuals with severe heart failure with reduced LVEF and wide QRS showed significant positive effects in these areas. However, cardioverter-defibrillator implantation did not yield positive effects on these modules.Regarding pain/discomfort, neither pacemaker nor cardiac resynchronization device implantation resulted in improved quality of life, while there was a somewhat positive effect observed in the cardioverter-defibrillator group. In terms of anxiety/depression, pacemaker implantation in patients with sick sinus syndrome and high-degree AV block had a significant and highly reliable positive impact on quality of life. Additionally, relatively positive impacts were noted at various periods following cardioverter-defibrillator and cardiac resynchronization device implantations. Cardiac implantable electronic devices play a crucial role not only in saving lives but also in positively impacting the quality of life of patients when appropriately selected.

Association between QRS shortening and mortality after cardiac resynchronization therapy: Results from the DANISH study

BackgroundChanges in QRS duration (∆QRS) are often used in the clinical setting to evaluate the effect of cardiac resynchronization therapy (CRT), although an association between ∆QRS and outcomes is not firmly established. We aimed to assess the association between mortality and ∆QRS after CRT in patients from the DANISH (Danish Study to Assess the Efficacy of ICDs in Patients with Non-Ischemic Systolic Heart Failure on Mortality) study. MethodsWe included all patients from DANISH who received a CRT device and had available QRS duration data before and after implantation. Cox proportional hazards models were used to assess associations between ∆QRS (post-CRT QRS minus pre-CRT QRS) and mortality. ResultsComplete data were available in 572 patients. Median baseline QRS duration was 160 ms (IQR [146;180]). Post-CRT QRS was recorded a median of 48 days (IQR [33;86]) after implantation, and the median ∆QRS was −14 ms (IQR [−38;-3]). During a median follow-up of 4.1 years (IQR [2.5;5.8]), 106 patients died. In crude Cox regression, all-cause mortality was reduced by 6% per 10 ms shortening of QRS (HR 0.94; CI: 0.88–1.00, p = 0.04). The effect did not remain significant after multivariable adjustment (HR 1.01, CI: 0.93–1.10, p = 0.77). Further, no association was found between ∆QRS and improvement of New York Heart Association functional class at 6 months (OR 1.03, CI: 0.96–1.10, p = 0.42). ConclusionIn a large cohort of patients with non-ischemic cardiomyopathy, reduction of QRS duration after CRT was not associated with changes in mortality during long-term follow-up.

Trends in the 30-year span of noninfectious cardiovascular implantable electronic device complications in Olmsted County

Cardiac implantable electronic devices (CIEDs), such as permanent pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, alleviate morbidity and mortality in various diseases. There is a paucity of real-world data on CIED complications and trends. We sought to describe trends in noninfectious CIED complications over the past 3 decades in Olmsted County. The Rochester Epidemiology Project is a medical records linkage system comprising records of over 500,000 residents of Olmsted County from 1966 to present. CIED implantations between 1988 and 2018 were determined. Trends in noninfectious complications within 30 days of implantation were analyzed. A total of 157 (6.2%) of 2536 patients who received CIED experienced device complications. A total of 2.7% of the implants had major complications requiring intervention. Lead dislodgement was the most common (2.8%), followed by hematoma (1.7%). Complications went up from 1988 to 2005, and then showed a downtrend until 2018, driven by a decline in hematomas in the last decade (P < .01). Those with complications were more likely to have prosthetic valves. Obesity appeared to have a protective effect in a multivariate regression model. The mean Charlson comorbidity index has trended up over the 30 years. Our study describes a real-world trend of CIED complications over 3 decades. Lead dislodgements and hematomas were the most common complications. Complications have declined over the last decade due to safer practices and a better understanding of anticoagulant management.

Frailty and long-term survival in patients undergoing cardiac resynchronization therapy

Aim: To access frailty and its impact on 10-year survival in patients with implanted devices for cardiac resynchronization therapy (CRT).Methods: 77 patients with congestive heart failure (74% men, 26% women; mean age of 58.7 ± 10.7 years) with NYHA class II–IV were enrolled. Frailty Index was calculated using 31 parameters (the ability to perform daily activities, clinical status, laboratory markers, comorbidities). Based on the frailty index patients were identified as not frail (&lt; 0.375; n = 41; 53%), and frail (≥ 0.375; n = 36; 47%).Results: The mean follow-up period was 49.0 ± 34.2 months. Survival at 10-year follow-up was 87.5% for non-frail patients, compared to 47.2% for frail patients (log-rank test p &lt; 0.001). In univariate analysis, frailty associated with 10-year mortality (OR 7.824; 95% CI 2.495 – 24.533; p &lt; 0.001). After adjustment for age, gender, rhythm, NYHA class, left ventricular ejection fraction, left bundle branch block, and QRS width, frailty remained a significant prognostic factor associated with 10-year mortality (OR 9.528; 95% CI 2.720 – 33.368; p &lt; 0.001). Also, according to logistic regression, the presence of frailty reduced the chance of superresponse (decrease of left-ventricular end -systolic volume ≥ 30%) to CRT (OR 0.278; 95% CI 0.100–0.770; p = 0.014).Conclusion: Frailty is widespread in patients with heart failure and implanted devices for CRT. In these patients frailty is associated with a more than seven-fold increased risk of death during 10-year follow-up and with a lower chance of superresponse to CRT.

The Psychological, Social, and Quality of Life Outcomes of People with a Cardiac Implantable Electronic Device: An Umbrella Review.

To synthesise the psychological, social, and quality of life outcomes of people with a cardiac implantable electronic device. An umbrella review of systematic reviews that reported the psychological, social, or quality of life outcomes of adults with a cardiac implantable electronic device was conducted. This umbrella review was preregistered with PROSPERO (CRD42023437078) and adhered to JBI and PRISMA guidelines. Seven databases (CINAHL, Cochrane Library, Embase, Emcare, Psycinfo, PubMed, and the Web of Science) were searched alongside citation and bibliographic searches. Methodological quality was assessed using the JBI Checklist of Systematic Reviews and Research Syntheses. Due to the heterogeneity of included reviews, findings were reported narratively. Fourteen systematic reviews met the inclusion criteria; eleven considered quality of life and three considered psychological outcomes. Little difference in quality of life was found between people with an implantable-cardioverter defibrillator and controls, however, a high prevalence of psychological disorders was present. Cardiac resynchronisation therapy devices demonstrated improvements in quality of life compared to control groups, alongside possible cognitive benefits. Quality of life did not differ between subcutaneous and transvenous implantable cardioverter-defibrillators. Pacemakers were associated with improved post-implantation quality of life. Research on the psychosocial and quality of life outcomes of people with a cardiac implantable electronic device is limited and inconsistent. Given the heterogeneity of current research, conclusions are uncertain. Nevertheless, some recipients may experience adverse psychosocial complications. Further research employing rigorous methodologies is needed and healthcare practitioners should provide care that acknowledges the potential for adverse psychosocial experiences. PROSPERO (CRD42023437078).

PP48 Cardiac Implantable Electronic Device (CIED) Infections In New South Wales, Australia: A Non-Interventional Study Utilizing Linked Secondary data

IntroductionCardiac Implantable Electronic Device (CIED) infection is a serious complication associated with morbidity, mortality and high healthcare costs. Internationally, the published rate of CIED infection ranges from 1.0 percent to 1.6 percent. There is a lack of data on CIED infection rates in Australia; the reported range is from less than 1 percent at 30 days to 7 percent over 5 years. Due to the variability within the limited number of studies there is a need for further analyses of CIED infection rates in Australia.MethodsThis was a retrospective cohort study using secondary linked hospital (the NSW Admitted Patient Data Collection) and mortality data for patients who underwent CIED procedures between July 2017 and June 2020 in NSW. Overall and procedure-and patient-specific incidence of infection was calculated.ResultsA total of 23,786 CIED procedures were performed among 22,404 patients and 422 CIED infections were identified, giving an overall infection rate of 1.77 percent. When infections were limited to those following a CIED procedure in the period July 2017-June 2020 (n=309), the procedure-specific CIED infection rate was 1.30 percent, ranging from 1.01 percent for permanent pacemaker (PPM) to 2.71 percent for cardiac resynchronization therapy-defibrillator (CRT-D). The proportion of patients undergoing CIED procedures in this period who had a subsequent CIED infection was 1.29 percent, ranging from 0.97 percent for permanent pacemaker (PPM) to 3.05 percent for cardiac resynchronization therapy defibrillator (CRT-D). Procedure-based infection rate in high-risk patients (generator replacement; system upgrade; revision; or CRT-D procedure) was 1.47 percent and patient-based infection rate was 1.68 percent. Infection rate was highest within the first month following the CIED procedure that dropped significantly over time.ConclusionsRates of infection were highest among patients with cardiac resynchronization therapy (CRT) devices, and those who underwent revision or upgrade procedures. Ongoing monitoring of CIED infection rates and preventative measures are necessary, especially for high-risk patients. This study highlights the important role linked secondary data has in reducing uncertainty and removing the reliance on international estimates by providing targeted, local data for health technology assessment.

Endocardial pacing compared to epicardial left ventricle pacing and right ventricle pacing: A single-center long-term experience in a pediatric population

Background and aimsPediatric pacing is usually performed as epicardial pacing in small children in need of pacemaker therapy. Epicardial pacing compared with transvenous pacing for pediatric complete atrioventricular block (CAVB) has different strengths and weaknesses. The epicardial left ventricular wall position of the lead has been considered superior, in terms of contraction pattern, compared to a transvenous right ventricular stimulation. We aimed to compare QRS duration and cardiac function before and after the switch from epicardial to transvenous pacing in a pediatric population. MethodsPediatric patients with congenital or acquired CAVB, who underwent a switch from epicardial-to transvenous pacing at our center from 2005 to 2021, were identified through the national ICD- and Pacemaker Registry. Data regarding clinical status, ECG, and echocardiography before and after the switch and at last follow-up were collected. ResultsWe included 15 children. The median age at the switch was 6.7 (4.4–11.7) years with a median weight of 21 (15–39) Kg. The median QRS duration with the transvenous systems was 136 (128–152) ms vs. a QRS duration during epicardial stimulation of 150 (144–170) ms with a median difference in QRS duration of 14 (6–20) ms. Children with a post-surgical AV block had a broader QRS duration, both with epicardial and endocardial stimulation. Before the switch, there was one patient with impaired left ventricular function (LVF) but with normal left ventricular end-diastolic diameters. After the switch, one patient developed symptomatic LV dysfunction with the recovery of LVF at the last follow-up after being implanted with a cardiac resynchronization therapy device. ConclusionsOur report of pediatric patients after switching from epicardial to transvenous pacing shows how transvenous pacing is not inferior to epicardial pacing in terms of QRS duration and no significant deterioration of cardiac function was detectable.

Left bundle branch block cardiomyopathy: an intriguing and defiant entity from diagnosis to treatment

Abstract Introduction and objectives Left bundle branch block cardiomyopathy (LBBB-CM) is an increasingly recognized entity, where electromechanical dyssynchrony seems to play a central role in left ventricular dysfunction (LVD) development. This is a challenging and scarcely studied topic, as causality dilemma between LBBB and LVD is still unsolved. Our aim is to increase current evidence on the subject by analyzing a population of idiopathic LBBB patients (pts) who developed, at some point, LVD not explained by other causes. Methods Retrospective study of LBBB adult pts screened from a large tertiary care hospital electrocardiographic database from 2011 to 2017. After careful evaluation, only possible LBBB-CM pts with serial follow-up (FU) echocardiographic and clinical data were included in the analysis. Results 53 pts were identified as possible LBBB-CMP. At baseline, 44% presented left ventricular ejection fraction (LVEF)&amp;gt;50%, while 56% had LVD. 51% were female and mean age at first-ever LBBB report was 59 years-old. All cohort presented echocardiographic mechanical desynchrony, and additional testing to exclude other causes of LVD (non-invasive ischemia testing in 78%; coronariography in 68%; cardiac magnetic resonance in 38%). Median FU time was 10 years. Worst-LVD was reported as severe in 49% of pts, moderate in 23% and mild in 28%. Median time-to-dysfunction in those with initial LVEF&amp;gt;50% was 8 years. 77% of pts presented heart-failure (HF) symptoms. 40% and 42% presented at least 1 CV event and CV hospitalization, respectively. Most events and/or hospitalizations were due to acute decompensated HF. 2 CV deaths were observed. Cardiac resynchronization therapy (CRT) devices were implanted in 47% of pts. All presented clinical improvement after implantation, and LVEF significantly increased (pre-CRT median LVEF of 24% vs 48% post-CRT; p&amp;lt;0.001). When comparing pts with vs without CRT (Figure 1), better LVEF improvements were achieved in CRT group (median LVEF improvement of 27% in CRT vs 11%; p&amp;lt;0.001). Repeating the latter analysis in pts who only presented at least moderate dysfunction, higher LVEF increase was also reported in CRT group (median LVEF improvement of 27% in CRT pts vs 14%; p=0.002), and significantly more CRT pts recovered LV function (50% CRT vs 14% non-CRT; p=0.028). Notably, no differences were found in rates of medical HF therapy between groups (p=1). Conclusion Our data shows LBBB-CM as a diagnosis of exclusion, where careful evaluation of other LVD etiologies should be performed and discarded. We highlight important morbidity rates in this population, namely HF hospitalizations, as well as the apparently critical role of CRT implantation in these pts. All our CRT pts responded excellently to the therapy. Thus, our study raises awareness to the emerging question of whether this entity can be reversed after LBBB correction with CRT and if early intervention would be desirable.Figure 1