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Objectives To evaluate clinical outcomes in patients with diabetes, treated by cardiac resynchronization therapy with a defibrillator (CRT-d), and glucagon-like peptide 1 receptor agonists (GLP-1 RA) in addition to conventional hypoglycemic therapy vs. CRTd patients under conventional hypoglycemic drugs. Background Patients with diabetes treated by CRTd experienced an amelioration of functional New York Association Heart class, reduction of hospital admissions, and mortality, in a percentage about 60%. However, about 40% of CRTd patients with diabetes experience a worse prognosis. Materials and methods We investigated the 12-months prognosis of CRTd patients with diabetes, previously treated with hypoglycemic drugs therapy (n 271) vs. a matched cohort of CRTd patients with diabetes treated with GLP-1 RA in addition to conventional hypoglycemic therapy (n 288). Results At follow up CRTd patients with diabetes treated by GLP-1 RA therapy vs. CRTd patients with diabetes that did not receive GLP-1 RA therapy, experienced a significant reduction of NYHA class (p value < 0.05), associated to higher values of 6 min walking test (p value < 0.05), and higher rate of CRTd responders (p value < 0.05). GLP-1 RA patients vs. controls at follow up end experienced lower AF events (p value < 0.05), lower VT events (p value < 0.05), lower rate of hospitalization for heart failure worsening (p value < 0.05), and higher rate of CRTd responders (p value < 0.05). To date, GLP-1 RA therapy may predict a reduction of AF events (HR 0.603, CI [0.411–0.884]), VT events (HR 0.964, CI [0.963–0.992]), and hospitalization for heart failure worsening (HR 0.119, CI [0.028–0.508]), and a higher CRT responders rate (HR 3.707, CI [1.226–14.570]). Conclusions GLP-1 RA drugs in addition to conventional hypoglycemic therapy may significantly reduce systemic inflammation and circulating BNP levels in CRTd patients with diabetes, leading to a significant improvement of LVEF and of the 6 min walking test, and to a reduction of the arrhythmic burden. Consequently, GLP-1 RA drugs in addition to conventional hypoglycemic therapy may reduce hospital admissions for heart failure worsening, by increasing CRTd responders rate. Trial registration NCT03282136. Registered 9 December 2017 “retrospectively registered”

ObjectiveTo evaluate the cost-effectiveness of implantable cardioverter defibrillators (ICDs), cardiac resynchronisation therapy pacemakers (CRT-Ps) and combination therapy (CRT-D) in patients with heart failure with reduced ejection fraction based on a range of clinical characteristics.MethodsIndividual patient data from 13 randomised trials were used to inform a decision analytical model. A series of regression equations were used to predict baseline all-cause mortality, hospitalisation rates and health-related quality of life and device-related treatment effects. Clinical variables used in these equations were age, QRS duration, New York Heart Association (NYHA) class, ischaemic aetiology and left bundle branch block (LBBB). A UK National Health Service perspective and a lifetime time horizon were used. Benefits were expressed as quality-adjusted life-years (QALYs). Results were reported for 24 subgroups based on LBBB status, QRS duration and NYHA class.ResultsAt a threshold of £30 000 per QALY gained, CRT-D was cost-effective in 10 of the 24 subgroups including all LBBB morphology patients with NYHA I/II/III. ICD is cost-effective for all non-NYHA IV patients with QRS duration <120 ms and for NYHA I/II non-LBBB morphology patients with QRS duration between 120 ms and 149 ms. CRT-P was also cost-effective in all NYHA III/IV patients with QRS duration >120 ms. Device therapy is cost-effective in most patient groups with LBBB at a threshold of £20 000 per QALY gained. Results were robust to altering key model parameters.ConclusionsAt a threshold of £30 000 per QALY gained, CRT-D is cost-effective in a far wider group than previously recommended in the UK. In some subgroups ICD and CRT-P remain the cost-effective choice.

Background Type 2 diabetes mellitus (T2DM) is a multi factorial disease, affecting clinical outcomes in failing heart patients treated by cardiac resynchronization therapy with a defibrillator (CRT-d). Methods One hundred and ninety-five T2DM patients received a CRT-d treatment. Randomly the study population received a CRT-d via multipolar left ventricle (LV) lead pacing (n 99, multipolar group), vs a CRT-d via bipolar LV pacing (n 96, bipolar group). These patients were followed by clinical, and instrumental assessment, and telemetric device control at follow up. In this study we evaluated, in a population of failing heart T2DM patients, cardiac deaths, all cause deaths, arrhythmic events, CRT-d responders rate, hospitalizations for HF worsening, phrenic nerve stimulation (PNS), and LV catheter dislodgment events (and re-intervention for LV catheter re-positioning), comparing multipolar CRT-d vs bipolar CRT-d group of patients at follow up. Results At follow up there was a statistical significant difference about atrial arrhythmic events [7 (7%) vs 16 (16.7%), p value 0.019], hospitalizations for HF worsening [15 (15.2% vs 24 (25%), p value 0.046], LV catheter dislodgments [1 (1%) vs 9 (9.4%), p value 0018], PNS [5 (5%) vs 18 (18.7%), p value 0.007], and LV re-positioning [1 (1%) vs 9 (9.4%), p value 0.018], comparing multipolar CRT-d vs bipolar CRT-d group of patients. Multipolar pacing was an independent predictor of all these events. Conclusions CRT-d pacing via multipolar LV lead vs bipolar LV lead may reduce arrhythmic burden, hospitalization rate, PNS, LV catheters dislodgments, and re-interventions in T2DM failing heart patients. Clinical trial number NCT03095196

Echocardiography-guided left ventricular (LV) lead placement at the site of latest mechanical activation improves heart failure outcomes in patients receiving a cardiac resynchronization therapy defibrillator (CRT-D). In this study, we test the hypothesis that a strategy of echocardiography-guided LV lead placement improves patient survival rate free from appropriate CRT-D therapy for ventricular arrhythmias. Patients enrolled in the prospective, randomized Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial and treated with a CRT-D device (108 with the echo-guided strategy and 75 with the routine strategy) were followed to the end point of death or first appropriate CRT-D therapy. Over a follow-up period of 3.7 ± 2.1 years, 62 patients (33%) died and 40 (22%) received appropriate CRT-D therapy. Compared with the routine group, patients in the echo-guided group had improved CRT-D therapy-free survival rate (hazard ratio = 0.64, 95% confidence interval = 0.42 to 0.98, p = 0.038). Patients randomized to the echo-guided LV lead placement were more likely to resynchronize their LV compared with the routine group (72% vs 48%, respectively, p = 0.006). Patients whose LV did resynchronize after CRT-D had improved therapy-free survival rate compared with those whose LV did not resynchronize (hazard ratio = 0.49, 95% confidence interval = 0.28 to 0.86, p = 0.012). In conclusion, a strategy of echo-guided LV lead placement improved the patient survival rate free from defibrillator therapy in CRT-D recipients.

Objective In MADIT-CRT, patients with non-LBBB (right bundle branch block or nonspecific ventricular conduction delay) and a prolonged PR-interval derived significant clinical benefit from cardiac resynchronization therapy with defibrillator (CRT-D) compared to an implantable cardioverter defibrillator (ICD)-only. We aimed to study the long-term outcome of non-LBBB patients by baseline PR-interval with CRT-D versus ICD-only. Methods Non-LBBB patients ( n  = 534) were dichotomized based on baseline PR-interval: normal PR (PR < 230 ms), and markedly prolonged PR (PR ≥ 230 ms). The primary end point was heart failure (HF) or death. Secondary end points were HF only and all-cause death. Results In patients with a prolonged PR-interval, CRT-D treatment related to a 67 % significant reduction in the risk of HF/death (HR = 0.33, 95 % CI 0.16–0.69, p  = 0.003), 69 % decrease in HF (HR = 0.31, 95 % CI 0.14–0.68, p  = 0.003), and 76 % reduction in the risk of death (HR = 0.24, 95 % CI 0.07–0.80, p  = 0.020) compared to ICD-only (median follow-up 5.8 years). In normal PR-interval patients, CRT-D therapy was associated with a trend towards increased risk of HF/death (HR = 1.49, 95 % CI 0.98–2.25, p  = 0.061), and significantly increased mortality (HR = 2.27, 95 % CI 1.16–4.44, p  = 0.014). Significant statistical interaction with the PR-interval was demonstrated for all end points. Results were consistent for QRS 130–150 ms and QRS > 150 ms. Conclusion In MADIT-CRT, non-LBBB patients with a prolonged PR-interval derive sustained long-term clinical benefit with reductions in heart failure or death from CRT-D implantation, compared to an ICD-only. Our findings support implantation of CRT-D in non-LBBB patients with prolonged PR-interval irrespective of baseline QRS duration.

Soluble ST2 is an established biomarker of heart failure (HF) progression. Data about its prognostic implications in patients with mildly symptomatic HF eligible to receive cardiac resynchronization therapy defibrillators (CRT-D) are limited. In a cohort of 684 patients enrolled in Multicenter Automated Defibrillator Implantation Trial (MADIT)-CRT, levels of soluble ST2 (sST2) were serially assessed at baseline and 1 year (n = 410). In multivariable-adjusted models, elevated baseline sST2 was associated with an increased risk of death, death or HF, and death or ventricular arrhythmia (VA) even when adjusting for baseline brain natriuretic protein (BNP) levels. In addition, patients with lower baseline sST2 levels had greater risk reduction with CRT-D (p = 0.006). Serial assessment revealed increased risk of VA and death or VA (HR per 10 % increase in sST2 1.11 (1.04–1.20), p = 0.004). Among patients with mildly symptomatic HF and eligibility for CRT-D, baseline and serial assessments sST2 may provide important information for risk stratification.

BackgroundThe effects of right ventricular (RV) lead location and the combination of RV and left ventricular (LV) lead locations on long-term outcomes in patients receiving cardiac resynchronization therapy with defibrillator (CRT-D) are not well understood.MethodsOur cohort consisted of 743 CRT-D patients from MADIT-CRT. We evaluated long-term death and combined heart failure or death (HF/death) in patients with non-apical RV vs. apical RV leads. We further assessed these long-term outcomes based on the combination of RV and LV leads, termed “RV-LV lead interaction.” Patients with non-apical RV and apical LV leads and those with apical RV and non-apical LV leads were described to have “discordant RV and LV leads.” Patients with RV and LV leads that were both non-apical or both apical were defined to have “concordant RV and LV leads.”ResultsThere were no differences in death and HF/death between patients with non-apical RV vs. apical RV leads. However, patients with non-apical RV and apical LV leads had higher mortality risk, relative to those with apical RV and non-apical LV leads (HR = 4.06, 95% CI 1.73–9.53, p = 0.001) as well as those with both leads in the non-apical (HR = 3.82, 95% CI 1.33–10.98, p = 0.013) or apical (HR = 3.40, 95% CI 1.24–9.37, p = 0.018) positions. There was no difference in HF/death by RV-LV lead sub-groups.ConclusionAmong CRT-D patients, long-term outcomes were similar for non-apical RV and apical RV leads. However, mortality risk was increased with discordant RV and LV leads, when a non-apical RV lead was combined with an apical LV lead.

Background Cardiac resynchronization therapy (CRT) is an established treatment in heart failure patients. However, a large proportion of patients remain nonresponsive to this pacing strategy. Left ventricular (LV) lead position is one of the main determinants of response to CRT. This study aims to clarify whether multimodality imaging guided LV lead placement improves clinical outcome after CRT. Methods/Design The ImagingCRT study is a prospective, randomized, patient- and assessor-blinded, two-armed trial. The study is designed to investigate the effect of imaging guided left ventricular lead positioning on a clinical composite primary endpoint comprising all-cause mortality, hospitalization for heart failure, or unchanged or worsened functional capacity (no improvement in New York Heart Association class and <10% improvement in six-minute-walk test). Imaging guided LV lead positioning is targeted to the latest activated non-scarred myocardial region by speckle tracking echocardiography, single-photon emission computed tomography, and cardiac computed tomography. Secondary endpoints include changes in LV dimensions, ejection fraction and dyssynchrony. A total of 192 patients are included in the study. Discussion Despite tremendous advances in knowledge with CRT, the proportion of patients not responding to this treatment has remained stable since the introduction of CRT. ImagingCRT is a prospective, randomized study assessing the clinical and echocardiographic effect of multimodality imaging guided LV lead placement in CRT. The results are expected to make an important contribution in the pursuit of increasing response rate to CRT. Trial registration Clinicaltrials.gov identifier NCT01323686 . The trial was registered March 25, 2011 and the first study subject was randomized April 11, 2011.

Background and aims of study Septal flash (SF) describes early inward motion of the ventricular septum in patients with left bundle branch block (LBBB), and correction corresponds to increased response to cardiac resynchronization therapy (CRT). SF has traditionally been assessed by echocardiography. We sought to determine if cardiac magnetic resonance (CMR) imaging could identify SF and if the additional assessment of scar would improve the ability of CMR to predict CRT response. Methods Fifty-two patients with LBBB and heart failure underwent prospective CMR scanning prior to CRT implantation. The presence of SF was assessed visually and by using endocardial contour-tracking software. Presence and extent of myocardial scar was assessed by delayed enhancement imaging during CMR. The association between SF, scar and reverse remodelling (RR) at 6 months was explored. Results RR rate to CRT at 6 months was 52 %. CMR-derived SF was identified in 24 (46 %) patients. RR was seen in more patients with SF than those without (88 % vs 21 %; P  < 0.001). The absence of scar combined with the presence of SF had 96 % specificity for predicting RR. In a multivariate regression model, the presence of SF was the only independent predictor of RR. Conclusion SF can be assessed by CMR and predicts increased response to CRT. The additional value of CMR is the assessment of scar. The presence of SF with no scar is a highly specific predictor of CRT response.

BackgroundCardiac resynchronisation therapy (CRT) is a key treatment for heart failure (HF) in acquired heart disease, but its benefits in adults with congenital heart disease and a systemic right ventricle (sRV) remain unclear. This study aimed to assess whether CRT improves outcomes in patients with sRV.MethodsThis is an international, retrospective study including patients >18 years from 33 centres with transposition of the great arteries (TGA) following atrial switch operation and congenitally corrected TGA. The primary endpoint included overall survival and survival free from HF. The secondary endpoint was a composite of death, hospitalisation for HF, heart transplant, mechanical support and ventricular tachycardia/implantable cardioverter-defibrillator therapies.ResultsWe identified 105 out of 1721 patients (3.5%) who underwent CRT. Median follow-up after CRT implant was 4.6 (1.6–8) years. QRS improvement was limited to those with previous pacing (167±35 vs 154±28 ms; p=0.002). Following CRT, there was no significant change in B-type natriuretic peptide values, peak VO2 and tricuspid regurgitation severity by echocardiography. CRT complications occurred in 10 (9.5%), though they were usually minor. Patients with CRT were propensity-matched to controls according to age, sex, anatomy, presence of complex disease, previous HF and sRV dysfunction at baseline. At univariable analysis, CRT (HR 4.39–95%, CI 1.6 to 11.9; p=0.003), older age and moderate-to-severe sRV dysfunction at baseline were predictive of death, while CRT (HR 3–95%, CI 1.3 to 7; p=0.01) and sRV dysfunction were associated with HF admission. By multivariable analysis, CRT (HR 8.8–95%, CI 2.9 to 26.6; p=0.0001) and age (HR 1.1%–95%, CI 1.01 to 1.15; p<0.0001) were independently associated with poorer outcome.ConclusionIn this retrospective study in the largest population thus far described with an sRV, CRT implant was not associated with improved survival, even after controlling for key confounders.