Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial.

BACKGROUND AND AIMS: De novo implanted cardiac resynchronization therapy with defibrillator (CRT-D) reduces the risk of morbidity and mortality in patients with left bundle branch block, heart failure and reduced ejection fraction (HFrEF). However, among HFrEF patients with right ventricular pacing (RVP), the efficacy of CRT-D upgrade is uncertain. METHODS: In this multicentre, randomized, controlled trial, 360 symptomatic (New York Heart Association Classes II-IVa) HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD), high RVP burden ≥ 20%, and a wide paced QRS complex duration ≥ 150 ms were randomly assigned to receive CRT-D upgrade (n = 215) or ICD (n = 145) in a 3:2 ratio. The primary outcome was the composite of all-cause mortality, heart failure hospitalization, or <15% reduction of left ventricular end-systolic volume assessed at 12 months. Secondary outcomes included all-cause mortality or heart failure hospitalization. RESULTS: Over a median follow-up of 12.4 months, the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm vs. 101/128 (78.9%) in the ICD arm (odds ratio 0.11; 95% confidence interval 0.06-0.19; P < .001). All-cause mortality or heart failure hospitalization occurred in 22/215 (10%) in the CRT-D arm vs. 46/145 (32%) in the ICD arm (hazard ratio 0.27; 95% confidence interval 0.16-0.47; P < .001). The incidence of procedure- or device-related complications was similar between the two arms [CRT-D group 25/211 (12.3%) vs. ICD group 11/142 (7.8%)]. CONCLUSIONS: In pacemaker or ICD patients with significant RVP burden and reduced ejection fraction, upgrade to CRT-D compared with ICD therapy reduced the combined risk of all-cause mortality, heart failure hospitalization, or absence of reverse remodelling.

Baseline clinical characteristics of heart failure patients with reduced ejection fraction enrolled in the BUDAPEST-CRT Upgrade trial.

AIMS: The BUDAPEST-CRT Upgrade study is the first prospective, randomized, multicentre clinical trial investigating the outcomes after cardiac resynchronization therapy (CRT) upgrade in heart failure (HF) patients with intermittent or permanent right ventricular (RV) pacing with wide paced QRS. This report describes the baseline clinical characteristics of the enrolled patients and compares them to cohorts from previous milestone CRT studies. METHODS AND RESULTS: This international multicentre randomized controlled trial investigates 360 patients having a pacemaker (PM) or implantable cardioverter defibrillator (ICD) device for at least 6 months prior to enrolment, reduced left ventricular ejection fraction (LVEF ≤35%), HF symptoms (New York Heart Association [NYHA] functional class II-IVa), wide paced QRS (>150 ms), and ≥20% of RV pacing burden without having a native left bundle branch block. At enrolment, the mean age of the patients was 73 ± 8 years; 89% were male, 97% were in NYHA class II/III functional class, and 56% had atrial fibrillation. Enrolled patients predominantly had conventional PM devices, with a mean RV pacing burden of 86%. Thus, this is a patient cohort with advanced HF, low baseline LVEF (25 ± 7%), high N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (2231 pg/ml [25th-75th percentile 1254-4309 pg/ml]), and frequent HF hospitalizations during the preceding 12 months (50%). CONCLUSION: When compared with prior CRT trial cohorts, the BUDAPEST-CRT Upgrade study includes older patients with a strong male predominance and a high burden of atrial fibrillation and other comorbidities. Moreover, this cohort represents an advanced HF population with low LVEF, high NT-proBNP, and frequent previous HF events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02270840.

Permanent pacemaker implantation after cardiac surgery: Optimization of the decision making process.

BACKGROUND: Conduction disturbances necessitating permanent pacemaker (PPM) implantation after cardiac surgery occur in 1% to 5% of patients. Previous studies have reported a low rate of late PPM dependency, but there is lack of evidence that it might be related to implantation timing. In this study, we sought to determine whether PPM implantation timing and specific conduction disturbances as indications for PPM implantation are associated with late pacemaker dependency and recovery of atrioventricular (AV) conduction. METHODS: Patients with a PPM implanted after cardiac surgery were followed in an outpatient clinic. Two outcomes were assessed: AV conduction recovery and PPM dependency, defined as the absence of intrinsic rhythm on sensing test in VVI mode at 40 bpm. RESULTS: Of 15,092 patients operated between September 2008 and March 2019, 185 (1.2%) underwent PPM implantation. One hundred seventy-seven of these patients met the criteria for inclusion into this study. Follow-up data were available in 145 patients (82%). Implantation was performed at ≤6 days after surgery in 58 patients (40%) and at >6 days after surgery in 87 patients (60%). The median time from implantation to last follow-up was 890 days (range, 416-1998 days). At follow-up, 81 (56%) patients were not PPM dependent. Multivariable analysis showed that PPM implantation at ≤6 days after surgery is a predictor of being not PPM dependent (odds ratio [OR], 5.40; 95% confidence interval [CI], 2.43-12.04; P < .001) and of AV conduction recovery (OR, 4.96; 95% CI, 2.26-10.91; P < .001). Sinus node dysfunction as indication for PPM implantation was predictive of being not PPM dependent (OR, 6.59; 95% CI, 1.67-26.06; P = .007). CONCLUSIONS: We recommend implanting a PPM on postoperative day 7 to prevent unnecessary implantations and avoid prolonged hospitalization.

Factors determining the choice between subcutaneous or transvenous implantable cardioverter-defibrillators in Poland in comparison with other European countries: a sub-study of the European Heart Rhythm Association prospective survey.

BACKGROUND: Subcutaneous implantable cardioverter-defibrillator (S-ICD) may be an alternative to transvenous ICD (TV-ICD). AIM: We sought to evaluate factors determining the choice of S-ICD vs. TV-ICD in Polish patients in comparison to other European countries. METHODS: All consecutive patients who underwent TV-ICD or S-ICD implantation in centres participating in the European Heart Rhythm Association prospective snapshot survey were included. RESULTS: During an eight-week study period, 429 patients were recruited, including 136 (31.7%) ICD patients from Poland (eight with S-ICD). In comparison to other European centres, the proportion of S-ICD implantations in Poland was lower (7% vs. 26%, p < 0.001), whereas the ratio of cardiac resynchronisation therapy defibrillator implantations was higher (43% vs. 26%; p < 0.001). Subjects receiving S-ICD in Poland were more often over 75 years old (25% vs. 0%, p < 0.001), in New York Heart Association class II (87.5% vs. 29.4%, p = 0.001), with chronic kidney disease (37.5% vs. 5.9%, p = 0.003), and with lower left ventricular ejection fraction (32% [14%-50%] vs. 50% [25%-60%], p = 0.04), compared to other European countries. Additionally, in comparison to subjects from other European centres, Polish patients were significantly more often implanted with S-ICD due to prior infection (37.5% vs. 1.5%, p < 0.001) and a lack of venous access (25% vs. 0%, p < 0.001), whereas the largest subset of patients in other European countries were implanted with S-ICD because of young age (50% vs. 25%, p = NS). CONCLUSIONS: The main reasons leading to S-ICD implantations in Polish patients differ from the indications adopted in other European countries. In Poland, patients referred for TV-ICD or S-ICD implantation had more advanced heart failure and more comorbidities in comparison to subjects from other European countries. S-ICD is still underused in Polish patients.

Factors influencing the use of subcutaneous or transvenous implantable cardioverter-defibrillators: results of the European Heart Rhythm Association prospective survey.

The purpose of this European Heart Rhythm Association (EHRA) prospective snapshot survey is to provide an overview of the factors influencing patient selection for the implantation of a particular type of device: subcutaneous implantable cardioverter-defibrillator (S-ICD) or transvenous implantable cardioverter-defibrillator (TV-ICD), across a broad range of tertiary European centres. A specially designed electronic questionnaire was sent via the internet to tertiary reference centres routinely implanting both TV-ICDs and S-ICDs. These centres were asked to prospectively include and fill-in this questionnaire for all consecutive patients implanted with an implantable cardioverter-defibrillator (ICD) (both TV-ICD and S-ICD) during an 8-week period of time. Questions concerned standards of care and policies used for patient management, focusing particularly on the reasons for choosing one or the other type of ICD for each patient. In total 20 centres participated at the survey and entered individual data from a total of 429 consecutive patients (men 76.3%). Indication of implantation was primary prevention for 73% of the patients. Implanted devices were distributed between cardiac resynchronisation therapy (CRT) ones with back-up defibrillators (31.6%), single-chamber TV-ICD (29.5%), S-ICD (19.8%), and dual-chamber TV-ICD (19.1%).The rate of S-ICD shows the current penetration of this treatment in everyday practice. Main reasons favouring the use of an S-ICD were young age (66.7%), anticipated (38.9%) or previous (9.3%) lead-related complications, and elevated risk (18.5%) or previous device infection (7.4%). Importantly, the choice for this device was also based on patient preference (16.7%) or active lifestyle (13%). The three most frequent reasons for the use of a transvenous device were the option of antitachycardia pacing (43.2%), and logically, the current or expected need for CRT (40%) or for permanent pacing (39.6%). This snapshot survey with individual patient data provides a contemporary insight into ICD implantation and management in the European electrophysiology tertiary centres. It also helps to better understand the reasons which condition the choice between a S-ICD and a traditional TV-ICD. Finally, it gives a picture of the distribution of various types of ICD, few years after the introduction of the S-ICD in the Europe.

A study to evaluate the prevalence and determinants of stress coping strategies in heart failure patients in Poland (CAPS-LOCK-HF sub-study).

BACKGROUND AND AIM: We aimed to evaluate the prevalence and determinants of different stress coping strategies in Polish patients suffering from heart failure with reduced ejection fraction (HFREF). METHODS: This manuscript is a sub-study of the CAPS-LOCK-HF multicentre psychological status assessment of patients with HFREF. Patients with > six-month history of HFREF and clinical stability for ≥ three months and left ventricular ejection fraction (LVEF) < 45% were enrolled in the study. Demographic and clinical variables were obtained from medical records, while a standardised Coping Inventory for Stressful Situations (CISS) was applied to all subjects. RESULTS: The study comprised 758 patients (599 men; 79%) with a median age of 64 years (IQR 58-71). Median LVEF was 33% (25-40). Subjects most commonly used task-oriented coping strategies (median CISS score 55 points; IQR 49-61), followed by avoidance (45 points; 39-50) and emotion-oriented coping strategies (41 points; 34-48). Distraction-based avoidance coping strategies (20 points; 16-23) were more pronounced than social diversion strategies (16 points; 14-19). Multiple regression analysis showed that higher New York Heart Association (NYHA) class and lower systolic blood pressure were independent predictors of task-oriented style. Emotion-oriented coping was more common among females and higher NYHA classes, and in patients who did not take angiotensin-converting enzyme inhibitors. Patients who used avoidance-oriented strategies were more frequently those in sinus rhythm on assessment and those who had less history of neoplastic disease. CONCLUSIONS: Patients with HFREF most commonly use favourable task-oriented coping strategies. However, female patients and those with higher NYHA classes tend to use potentially detrimental emotion-oriented coping strategies.

Differences of psychological features in patients with heart failure with regard to gender and aetiology - Results of a CAPS-LOCK-HF (Complex Assessment of Psychological Status Located in Heart Failure) study.

OBJECTIVE: Objective of the study was to assess the psychological state of HF patients with reduced ejection fraction (HFrEF) with regard to gender and aetiology. METHODS: 758 patients with HFrEF (mean age - 64±11years, men - 79%, NYHA class III-IV - 40%, ischemic aetiology - 61%) in a prospective Polish multicenter Caps-Lock-HF study. Scores on five different self-report inventories: CISS, MHLC, GSES, BDI and modified Mini-MAC were compared between the sexes taking into account the aetiology of HFrEF. RESULTS: There were differences in the CISS and BDI score between the genders - women had higher CISS (emotion- and avoidance-oriented) and BDI (general score - 14.2±8.7 vs 12.3±8.6, P<0.05; subscale - somatic score - 7.3±3.7 vs 6.1±3.7, P<0.05). In the ischemic subpopulation, women had higher BDI (general and subscales) than men. In the non-ischemic subpopulation the differences between genders were limited to CISS scale. In a multivariable analysis with demographic and clinical data female sex, NYHA class, atrial fibrillation and diabetes mellitus determined BDI score. Similarly, in the ischemic subpopulation, the female sex, NYHA class and atrial fibrillation determined the BDI, while in the non-ischemic population NYHA class was the only factor that influenced the BDI score. Adding the psychological data made a significant additional contribution to the prediction of depression status. CONCLUSIONS: There are distinct differences in psychological features with regard to gender in patients with HFrEF. Women demonstrate less favourable psychological characteristics. Gender-related differences in BDI score are especially explicit in patients with ischemic aetiology of HF. The BDI score is related to psychological predisposition.

Cardiac resynchronization therapy combined with coronary artery bypass grafting in ischaemic heart failure patients: long-term results of the RESCUE study.

OBJECTIVES: Totally epicardial cardiac resynchronization therapy (CRT) is a novel treatment modality for patients with heart failure (HF) and systolic dyssynchrony undergoing coronary artery bypass grafting (CABG). In this study, we have prospectively evaluated the long-term outcomes of totally epicardial CRT. METHODS: Between September 2007 and June 2009, one hundred and seventy-eight patients were randomly assigned to the CABG alone group (n = 87) and CABG with concomitant epicardial CRT implantation (n = 91). The primary end-point of the study was all-cause mortality in the two groups between the day of surgery and 13 August 2013 (common closing date). The secondary outcomes included mode of death, adverse cardiac events and lead performance. RESULTS: The mean follow-up was 55 ± 10.7 months. According to per-protocol analysis with treatment as a time-dependent variable to account for conversion from CABG to CABG + CRT, there were 24 deaths (35.8%) in the CABG group and 17 deaths (15.3%) in the CABG + CRT group. When compared with CABG alone, concomitant CRT was associated with reduced risk of both all-cause mortality [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.23-0.84, P = 0.012] and cardiac death (HR 0.39, 95% CI 0.21-0.72, P = 0.002). Eleven (12.6%) sudden deaths were observed in the CABG group in comparison with 4 (4.4%) in the CABG + CRT group (P = 0.048). Hospital readmission was required for 9 (9.9%) patients in CABG + CRT group and for 25 (28.7%) patients in the CABG group (P = 0.001). There were 4 (1.5%) epicardial lead failures. CONCLUSIONS: The results of our study suggest that the procedure of CABG and totally epicardial CRT system implantation is safe and significantly improves the survival of patients with HF and dyssynchrony during long-term follow-up. CLINICAL TRIAL REGISTRATION: NCT 00846001 (http://www.clinicaltrials.gov).

Perception of health control and self-efficacy in heart failure.

BACKGROUND: The issue of self-perceived health control and related sense of self-efficacy has not received any attention in patients with heart failure (HF), although these psychological features have been established to determine the patients' approach towards healthcare professionals and their recommendations, which strongly affects compliance. METHODS: A total of 758 patients with systolic HF (age: 64 ± 11 years, men: 79%, NYHA class III­IV: 40%, ischaemic aetiology: 61%) were included in a prospective Polish multicentre Caps-Lock-HF study. A Multidimensional Health Locus of Control (MHLC) scale was used to assess subjective perception of health control in three dimensions (internal control, external control by the others, and by chance); the Generalised Self Efficacy scale (GSES) was used to estimate subjective sense of self-efficacy; and the Beck Depression Inventory (BDI) was used to determine depressive symptoms. RESULTS: The majority of patients perceived the external control (by the others) and internal control of their health as high (77% and 63%, respectively) or moderate (22% and 36%, respectively), whereas self-efficacy was perceived as high or moderate (63% and 27%), which was homogenous across the whole spectrum of the HF cohort, being unrelated to HF severity, HF duration, the presence of co-morbidities, and the applied treatment. The stronger the perception of internal health control, the higher the self-efficacy (p < 0.05); both features were related to less pronounced depressive symptoms (p < 0.05). CONCLUSIONS: The established pattern of self-perceived control of own health and self-efficacy indicates that patients with HF acknowledge the role of others (i.e. healthcare providers) and themselves in the process of the management of HF, and are convinced about the high efficacy of their undertaken efforts. Such evidence supports implementation of a partnership model of specialists' care of patients with HF.

CRT improves LV filling dynamics: insights from echocardiographic particle imaging velocimetry.

Echocardiographic particle imaging velocimetry allows blood flow visualization and characterization of diastolic vortex formation that may play a key role in filling efficiency. We hypothesized that abrupt withdrawal of cardiac resynchronization therapy (CRT) would alter the timing of left ventricular diastolic vortex formation and modify cardiac time intervals. In patients with heart failure (HF) who had chronically implanted CRT devices, the timing of the onset of the diastolic vortex (TDV) from mitral valve opening, transmitral flow, and cardiac time intervals was measured at baseline and after deactivation and reactivation of CRT. Compared with control patients with cardiovascular risk factors but structurally normal hearts, TDV was significantly delayed in patients with HF. Deactivation of CRT resulted in striking delay in TDV due to disorganized flow and reduced flow acceleration, and reactivation reversed these characteristics instantly. In addition, CRT deactivation also prolonged the isovolumic contraction interval, which closely correlated with the changes in the TDV. These data suggest that CRT plays an important role in optimization of left ventricular diastolic filling.

Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study.

AIMS: The long-term clinical value of the optimization of atrioventricular (AVD) and interventricular (VVD) delays in cardiac resynchronization therapy (CRT) remains controversial. We studied retrospectively the association between the frequency of AVD and VVD optimization and 1-year clinical outcomes in the 199 CRT patients who completed the Clinical Evaluation on Advanced Resynchronization study. METHODS AND RESULTS: From the 199 patients assigned to CRT-pacemaker (CRT-P) (New York Heart Association, NYHA, class III/IV, left ventricular ejection fraction <35%), two groups were retrospectively composed a posteriori on the basis of the frequency of their AVD and VVD optimization: Group 1 (n = 66) was composed of patients 'systematically' optimized at implant, at 3 and 6 months; Group 2 (n = 133) was composed of all other patients optimized 'non-systematically' (less than three times) during the 1 year study. The primary endpoint was a composite of all-cause mortality, heart failure-related hospitalization, NYHA functional class, and Quality of Life score, at 1 year. Systematic CRT optimization was associated with a higher percentage of improved patients based on the composite endpoint (85% in Group 1 vs. 61% in Group 2, P < 0.001), with fewer deaths (3% in Group 1 vs. 14% in Group 2, P = 0.014) and fewer hospitalizations (8% in Group 1 vs. 23% in Group 2, P = 0.007), at 1 year. CONCLUSION: These results further suggest that AVD and VVD frequent optimization (at implant, at 3 and 6 months) is associated with improved long-term clinical response in CRT-P patients.

Coronary artery bypass grafting with concomitant cardiac resynchronisation therapy in patients with ischaemic heart failure and left ventricular dyssynchrony.

OBJECTIVE: We have tested the hypothesis that epicardial implantation of cardiac resynchronisation therapy (CRT) system during coronary artery bypass grafting (CABG) may be an additional treatment method, which can decrease the mortality and improve left ventricle (LV) systolic function in patients with ischaemic heart failure (HF) and LV dyssynchrony. METHODS: One hundred and seventy-eight consecutive patients with severe ischaemic HF and LV dyssynchrony were enrolled in two groups: CABG alone (n=87) and epicardial CRT implantation during CABG (n=91). The primary end point of the study was the comparison of mortality between two groups at 18 months of follow-up. RESULTS: Twenty-three patients (26.1%) in the CABG group died at 18 months of follow-up compared with nine (10%) in CABG+CRT group (log-rank test, p=0.006). The Cox regression analysis revealed that LV dyssynchrony (hazard ratio (HR) 2.634 (1.206-5.751), p=0.015) was the independent predictor of all-cause death and HF hospitalisation. LV systolic function, dyssynchrony signs and quality of life did not change significantly post-CABG compared to pre-CABG data in CABG group patients. On the contrary, echocardiography revealed an improved LV ejection fraction (42±1.9 vs 28±2.7; p<0.001), smaller LV end-systolic volume (120±57.5 vs 164±61.4; p=0.04) and improved LV synchrony in the CABG+CRT group compared with the CABG group. In the CABG+CRT group, more patients improved by two NYHA classes (NYHA, New York Heart Association; 49 vs 0; p=0.028), had a longer 6-min-walk test distance (452±65 vs 289±72; p<0.001) and a better quality of life (22.9±5 vs 46.4±11; p<0.001) compared with the CABG group. CONCLUSION: For majority of the patients with ischaemic HF and evidence of LV dyssynchrony, CABG neither eliminates dyssynchrony nor improves systolic function. Epicardial implantation of a CRT system concomitant with CABG facilitates patient management in the early postoperative period, improves LV systolic function and quality of life and is associated with low mortality at 18 months of follow-up.

Low value of simple echocardiographic indices of ventricular dyssynchrony in predicting the response to cardiac resynchronization therapy.

AIMS: A recent study suggested that no single echocardiographic index of cardiac dyssynchrony can reliably identify candidates for cardiac resynchronization therapy (CRT). We examined the value of three simple echocardiographic indices for predicting the 6-month clinical and echocardiographic responses to CRT. METHODS AND RESULTS: We analysed data from 75 CRT-D system recipients. Standard echocardiography was used to measure aortic pre-ejection delay (APED), interventricular mechanical delay (IVMD), and delayed activation of the left ventricular (LV) infero-lateral wall (OVERLAP). Clinical responders were defined as patients who had an improved status, based on rehospitalization for heart failure, NYHA class, and peak oxygen consumption. Echocardiographic responders had a > or =10% decrease in LV end-systolic volume. During the study, one patient died and five were lost to follow-up. Of the remaining 69 analysable patients, 50 (72.5%) were classed as clinical responders and 41 (59.4%) as echocardiographic responders to CRT. Before CRT implantation, APED, IVMD, and OVERLAP were similar in responders and non-responders. The value of these indices of dyssynchrony as single or combined predictors of the clinical or echocardiographic response to CRT was low, with sensitivities ranging between 4 and 63%, and specificities between 37 and 100%. CONCLUSION: Simple echocardiographic indices of dyssynchrony were poor predictors of response to CRT.

Plasma levels of C-reactive protein and interleukin-10 predict late coronary in-stent restenosis 6 months after elective stenting.

BACKGROUND: In-stent restenosis (ISR) is one of the major limitations of percutaneous coronary intervention (PCI). AIM: To evaluate the relationship between the levels of hs-CRP, IL-6, IL-10 and intimal hyperplasia six months after coronary bare metal stent (BMS) implantation. METHODS: The study population consisted of 73 consecutive patients who underwent bare metal stent implantation into narrowed coronary segments. A total of 74 stents were implanted. Angiographic study after six months, together with evaluation of serum level of IL-6 (pg/ml), IL-10 (pg/ml), hs-CRP (microg/ml), fasting insulin (microIU/ml) and glucose (mg%) was performed. Insulin sensitivity was calculated using the HOMA-IR formula. The QCA analysis of stented segments was performed at baseline, after intervention and at six-month follow-up. RESULTS: Restenosis at six months occurred in 10 patients (13.7%). The mean % diameter stenosis at follow-up was 27.8 +/- 19% and late loss was 0.81 +/- 0.6 mm. We found a correlation between late loss and serum hs-CRP, IL-6 and IL-10 concentration. There was no correlation between the lipid profiles, insulin levels and HOMA-IR and re-narrowing of the stented segments. Patients with restenosis were characterised by significantly higher serum concentration of CRP (2.04 +/- 3.4 vs. 10.38 +/- 6.7 microg/ml, p = 0.0036), IL-6 (14.98 +/- 8.3 vs. 5.70 +/- 5.5 pg/ml, p = 00062), and fasting glucose (184.0 +/- 50.5 vs. 107.5 +/- 40.4 mg%, p = 0.0051), as well as lower IL-10 levels (1.25 +/- 0.6 vs. 4.85 +/- 4.9 pg/ml, p = 0.0000). The ROC analysis indicated that CRP (> 2.86 microg/ml), IL-6 (> 6.24 pg/ml) and IL-10 (< 1.7 pg/ml) values predicted the restenosis with reasonable accuracy. A multiple logistic regression model identified CRP and IL-10 levels as independent predictors of restenosis. CONCLUSION: We demonstrated that elevated inflammatory markers 6 months after PCI are associated with late angiographic in-stent restenosis.

Totally epicardial cardiac resynchronization therapy system implantation in patients with heart failure undergoing CABG.

BACKGROUND: Systolic dyssynchrony is present in a considerable number of patients with heart failure (HF) undergoing coronary artery bypass grafting (CABG). Surgical revascularization offers an optimal setting for totally epicardial cardiac resynchronization therapy (CRT) system implantation. AIM: To assess the efficacy of totally epicardial CRT implantation during CABG, in patients with HF. METHODS: Twenty three patients with HF and dyssynchrony underwent totally epicardial CRT system implantation during CABG. This randomised, single-blind, cross-over study compared clinical and echocardiographic parameters during two periods: 3 months of active CRT (CRT+) and 3 months of inactive CRT (CRT-) pacing. RESULTS: Twenty two patients underwent randomisation and completed both study periods. In the CRT+ group more patients improved by two NYHA classes (p=0.028), had a longer 6-minute walk test distance (p=0.047) and better quality of life (p=0.003) compared with the CRT- group. Echocardiography revealed an improved LV ejection fraction (p<0.001), smaller LV end-systolic volume (p=0.04), reduced mitral regurgitation (p=0.026) and improved LV synchrony in the CRT+ group compared with the CRT- group. CONCLUSION: CRT delivered by a totally epicardial system implanted during CABG is associated with additional improvement of clinical and echocardiographic parameters in patients with HF and systolic dyssynchrony.

Mortality in patients with heart failure treated with cardiac resynchronisation therapy. A long-term multi-centre follow-up study.

BACKGROUND: Benefits of cardiac resynchronisation therapy (CRT) for survival in selected congestive heart failure (CHF) patients have been acknowledged by the 2005 ESC guidelines. AIM: To analyse mortality in CRT pacing only (CRT-P) patients during at least one-year follow-up. METHODS: This was a prospective, multi-site, at least one-year observational study on mortality and mode of death in patients who received CRT-P due to commonly accepted indications. One-year follow-up data (or earlier death) were available for 105 patients (19 females, 86 males) aged 60.6+/-9.8 years (35-78). Baseline NYHA class was 3.2+/-0.4 (3-4). Coronary artery disease (CAD) was the underlying aetiology of CHF in 57 (54%) patients and 48 (46%) patients had CHF due to non-coronary factors. RESULTS: Mean follow-up duration was 730 days (360-1780), median 625. There were 21 (20%) deaths: 5 (24%) sudden cardiac deaths (SCD), 13 (62%) deaths due to heart failure (HFD) and 3 (14%) other deaths. Thirteen (62%) patients died within the first year of observation. All SCD occurred in this period. Mean time to death was 303+/-277 days (19-960) to HFD - 339+/-313 days (19-960) and to SCD - 208+/-127 days (31-343). There were no significant differences between survivors and non-survivors with respect to left ventricular ejection fraction (LVEF) (25+/-10 vs. 20+/-8%), 6-minute walk test (6 min WT) (276+/-166 vs. 285+/-163 m) and LV diastolic diameter (LVEDD) (71+/-9 vs. 78+/-10 mm) (all NS). The SCD and HFD patients had similar age (62.0+/-5.4 vs. 56.6+/-13.2 years), gender (80 vs. 83% males), NYHA class (3.1+/-0.2 vs. 3.5+/-0.3), LVEF (22+/-9 vs. 17+/-5%), LVEDD (86+/-10 vs. 79+/-9 mm), 6 min WT (270+/-142 vs. 292+/-188 m) (NS). In 4 patients from the SCD group CHF was of non-coronary aetiology and only in 1 patient from the HFD group (p=0.003). The values of LVEF, LVEDD and NYHA class in HFD patients who died during the first year after implantation, compared with those who died later, were similar. CONCLUSIONS: Sudden cardiac death probability in the studied CRT-P population was the highest during the first year after implantation. Afterwards, the risk of HFD started to increase. Thus, in all patients eligible for CRT prophylactic defibrillation function should be considered.