Cardiac Resynchronization Therapy Device Research Articles

Dual versus conventional cardiac resynchronization: A pilot study

Background: Systolic heart failure treatment now includes cardiac resynchronization therapy (CRT) as a necessary element. CRT has been shown to have advantageous impacts on mortality, hospitalization rates, and quality of life. Approximately 30% of patients fail to respond to traditional CRT implantation. Aims and Objectives: This study aimed to compare the outcome of dual resynchronization by placing the right ventricular pacing lead at His bundle or left bundle branch area against conventional CRT. Materials and Methods: This longitudinal follow-up study of a total of 35 patients undergoing CRT device placement for assessment of safety, efficacy, and feasibility of the procedure and post-procedural complications and correlation with parameters obtained from electrocardiogram and echocardiography parameters in a tertiary care set up in India. Results: Among this matched population (mean age 64 years) there was a higher responder rate with the newer technique of dual resynchronization compared to conventional CRT (83% vs. 70%). Conclusion: Dual resynchronization therapy is feasible and safe and provides better electrical resynchronization compared to conventional CRT and could be a better alternative, especially when suboptimal electrical resynchronization is obtained.

Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials.

The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.

Tighter is better: Can a simple and cost-free parameter predict response to cardiac synchronization therapy?

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 nonresponders. Our study aimed to determine the correlation between the relative change in QRS index (QI) compared to clinical outcome and prognosis in patients who underwent CRT implantation. A three-centers study involving 398 patients with a CRT device was conducted. Clinical, echocardiographic and pharmacological variables, QRSd before and after CRT implantation and QI were measured. In a 6-month follow-up, a significant improvement in left ventricular ejection fraction (LVEF), left ventricular end-diastolic and systolic volumes (LVEDV and LVESV) were observed. QI was related to reverse remodeling (multiple r-squared: 0.48, adjusted r-squared: 0.43, p=.001), and the cut-off value that best predicted LV reverse remodeling after 6 months of CRT was 12.25% (AUC 0.7, p=.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=.04). The mean of the QI of patients who died from cardiovascular causes was lower than patients who died of other causes (p=.0179). A correlation between pre-CRT QRSd/LVEDV and QI was observed (r=+ 0.20; p=.0003). A higher QRSd/LVEDV ratio was associated with an improved LVEF, LVEDV, and LVESV (p<.0001) at follow-up. QI narrowing after CRT was related to greater echocardiographic reverse remodeling and a lower rate of adverse events (death or cardiovascular hospitalizations). The QI can improve the prediction of adverse events in a population with CRT regardless of comorbidities according to the Charlson Comorbidity Index. QI could be used to predict CRT response.

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 &amp;lt; 0.001), more patients were female (31.7% vs. 22.1%, p &amp;lt; 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&amp;lt; 0.001). The primary indication for TLE was local infection (46.0% vs. 30.6%, p&amp;lt; 0.001) in Group 1 and lead dysfunction (20.0% vs. 36.1%, p&amp;lt; 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&amp;lt; 0.001) in Group 1 and implantable cardioverter-defibrillators (ICD) (9.7 vs. 45.3%, p&amp;lt; 0.001) and cardiac resynchronization therapy devices (CRT) (9.6 vs. 31.5%); p&amp;lt; 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&amp;lt; 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 &amp;lt;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 &amp;lt;0.01. At baseline 29% of patients had PHQ-9 score &amp;lt;5, namely minimal depression; and 35% had GAD-7 score &amp;lt;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 &amp;lt;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 &amp;gt; 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&amp;lt;0.001). Additionally, more patients in Group 1 presented with cardiac resynchronization therapy (CRT) devices (30.4% vs. 22.9%, p&amp;lt;0.001). Significant differences were observed in the mean number of total leads (3.4±1.1 vs. 2.0±0.7, p&amp;lt;0.001), median age of the oldest lead (117 vs. 87 months; p&amp;lt;0.001), and the number of right-sided leads (41.7% vs. 29.5%, p&amp;lt;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&amp;lt;0.001) and use of additional tools (11.2% vs. 4.7%, p&amp;lt;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&amp;lt;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&amp;lt;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 &amp;gt;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 &amp; 100 dayFig 2. Thoracic Z @implant &amp; 100 day

Risk factors for asymptomatic bacterial colonization of cardiac implantable electronic devices

Abstract Introduction With broadening indications and a progressively ageing demographic, incidence of cardiac electronic implantable device (CIED) implantation increased. Despite device infection being rare, it persists as a serious complication concomitant with a high mortality rate. While extensive research on cardiac device infection (CDI) has been conducted, the incidence and clinical significance of asymptomatic bacterial CIED colonisation has not been investigated so far. Purpose Our study aims to elucidate potential risk factors for and investigate the clinical significance of asymptomatic bacterial CIED colonisation. Methods and Results In this prospective single centre study, 345 patients with no clinical signs of CIED infection underwent a generator exchange. In total, 78 pacemakers (PM), 97 implantable cardiac defibrillators (ICD), 67 cardiac resynchronisation therapy devices (CRT), 1 baroreceptor stimulator, as well as 102 implantable loop recorders were sonicated to determine the presence of adherent microorganisms (biofilms). Intraoperative swabs were collected in 329 patients. For statistical analysis, detection of ≥1 colony forming units (CFU) during sonication was considered a significant level of bacterial colonisation. The ≥50 CFU threshold was established in order to examine risk factors relevant for higher levels of bacterial colonization. 88 CIED (25.5%) showed bacterial colonisation ≥1 CFU while 44 CIED (12.8%) were colonised with ≥50 CFU. Multivariate analysis revealed male gender as independent risk factor for both ≥1 CFU (p&amp;lt;0.001; OR 7.73, CI 2.84-21.04) and ≥50 CFU (p&amp;lt;0.001; OR 12.14, CI 2.79-52.78). and immunosuppressive medication (p=0.018; OR 3.31; CI 1.23-8.92) as independent risk factor identified for ≥50 CFU colonisation. For both cutoffs, Cutibacterium acnes emerged as the most frequently detected bacterium during sonication, followed by coagulase negative Staphylococci (CoNS) with Staphylococcus epidermidis being the most common within this CoNS group. During the follow-up (384.5 +/- 480.6 days), 287 patients showed absence of CDI (53 patients lost to follow-up). Of the five patients with CDI, one exhibited concordant results between sonication, swab, and blood culture for Cutibacterium acnes, one presented with partially concordant results, whereas the other three showed varying degrees of disconcordance between index event microbiological results and subsequent CDI pathogens. Conclusion Remarkably, 27.2% of CIEDs with leads (PM, ICD, CRT) exhibited bacterial colonisation. Out of the 5 CDIs identified, 4 were associated with positive sonication results. In addition, our study identifies male gender and immunosuppressive medication as significant risk factors for asymptomatic bacterial CIED colonisation. Thus, in patients with these given risk factors, CIED sonication should be considered for risk stratification with regard to a subsequent CIED infection and possible targeted antimicrobial therapy.Flow Chart

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 &amp;lt;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 &amp;lt; 12.25% and those with a QI &amp;gt; 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 &amp;lt;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.

Effect of adaptive cardiac resynchronization therapy in heart failure patients with pacemaker dependency.

An adaptive cardiac resynchronization therapy (aCRT) algorithm allows continuous adjustments of pacing timings of atrioventricular delays by periodic automatic evaluation of electrical conduction. This applies to patients with an atrioventricular block and is effective in cardiac resynchronization therapy (CRT) devices; however, whether this algorithm benefits patients with pacemaker dependency is uncertain. This study examined the clinical impact of an aCRT algorithm in patients diagnosed with heart failure with reduced ejection fraction and pacemaker dependency. A total of 359 patients underwent CRT between January 2016 and December 2022. Patients undergoing pacemaker-dependent CRT with the aCRT algorithm function were selected. Sixty-four patients with pacemaker dependency (31 with aCRT algorithm and 33 without) were included. Pacemaker dependency was defined as the absence of spontaneous ventricular activity during the sensing test at VVI 30bpm or prolonged atrioventricular delay (> 300 ms). The primary endpoint was the composite clinical outcome of all-cause death or hospitalization for heart failure. No significant differences were observed in baseline characteristics between groups. During a median follow-up of 1,067 days (interquartile range 553-1,776 days), aCRT reduced the risk of composite clinical outcomes in patients with pacemaker dependency (log-rank P = 0.028). In addition, using the aCRT algorithm was an independent predictor of the composite clinical outcomes in the multivariate analysis (hazard ratio 0.34, 95% confidence interval: 0.12-0.94, P = 0.038). The aCRT algorithm significantly reduced the risk of adverse clinical outcomes in patients with pacemaker dependency. This algorithm may be an important tool for managing such patients.

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.

Is CRT Optimization Obsolete? A Referral Center's Experience.

Cardiac resynchronization therapy (CRT) is a well-established therapy for patients with heart failure (HF). However, 30% of HF patients do not show any improvement in clinical status after CRT implantation. In this study, we report our echocardiography-based CRT optimization methodology, in daily practice at our CRT referral center. We included 350 ambulatory patients, who were referred to our center for optimization after CRT implantation. A protocol-driven echocardiographic approach for adjusting mechanical dyssynchrony, whereby adjusting for ventriculoventricular (VV) delays with strain and atrioventricular (AV) delays with Doppler echocardiography was performed. We defined changes in left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) classes as outcome variables in the evaluation of the CRT outcomes. Optimization was obtained in 288 (82%) patients. VV and AV timings were adjusted to 61% and 51%, respectively. In 3%, biventricular pacing was turned off and in 3% left ventricular (LV) only pacing was programmed. The LVEF and NYHA class showed significant improvements in all patients who underwent CRT optimization. CRT optimization remains valuable in improving LVEF and functional status measured using the NYHA class in all patients receiving CRT devices.