Effectiveness of cardiac resynchronization therapy in heart failure patients with valvular heart disease: comparison with patients affected by ischaemic heart disease or dilated cardiomyopathy. The InSync/InSync ICD Italian Registry

AimsTo analyse the effectiveness of cardiac resynchronization therapy (CRT) in patients with valvular heart disease (a subset not specifically investigated in randomized controlled trials) in comparison with ischaemic heart disease or dilated cardiomyopathy patients.Methods and resultsPatients enrolled in a national registry were evaluated during a median follow-up of 16 months after CRT implant. Patients with valvular heart disease treated with CRT (n = 108) in comparison with ischaemic heart disease (n = 737) and dilated cardiomyopathy (n = 635) patients presented: (i) a higher prevalence of chronic atrial fibrillation, with atrioventricular node ablation performed in around half of the cases; (ii) a similar clinical and echocardiographic profile at baseline; (iii) a similar improvement of LVEF and a similar reduction in ventricular volumes at 6-12 months; (iv) a favourable clinical response at 12 months with an improvement of the clinical composite score similar to that occurring in patients with dilated cardiomyopathy and more pronounced than that observed in patients with ischaemic heart disease; (v) a long-term outcome, in term of freedom from death or heart transplantation, similar to patients affected by ischaemic heart disease and basically more severe than that of patients affected by dilated cardiomyopathy.ConclusionIn 'real world' clinical practice, CRT appears to be effective also in patients with valvular heart disease. However, in this group of patients the outcome after CRT does not precisely overlap any of the two other groups of patients, for which much more data are currently available

Efficay of cardiac resynchronization therapy in very old patients: the Insync/Insync ICD Italian Registry

Aims: To assess the effects of cardiac resynchronization therapy (CRT) in > or =80-year-old patients vs. patients <80 years, in terms of clinical, functional, and echocardiographic parameters after 12 month of CRT, survival, and incidence of arrhythmic events. Methods and results: The study population consisted of 1181 CRT patients (85 were > or =80 years old). They were enrolled in a national observational registry and underwent baseline evaluation and periodical follow-up visits. In the overall population, New York Heart Association class and ejection fraction (EF) improved and ventricular diameters decreased. Similar changes were observed in the two groups. In the study population, 157 patients died, 144 (13%) in the <80 years group and 13 (15%) in the > or =80 years group. There was a higher all-cause mortality (log-rank test, P = 0.015) among > or =80 years patients, with a trend towards higher sudden cardiac death (SCD) (P = 0.057), but similar non-SCD (P = 0.293). Using the combined endpoint of SCD or appropriate shock from a defibrillator for ventricular fibrillation, no significant differences resulted between groups (P = 0.455). In both groups, lower EF was associated with higher mortality. Conclusion: Cardiac resynchronization therapy demonstrated similar efficacy in patients aged > or =80 years and in those under 80, in terms of clinical and functional parameters and reverse remodelling. Similarly, CRT resulted in comparable effects on death for heart failure and on SCD

Follow-up of CRT-ICD: implications for the use of remote follow-up systems. Data from the InSync ICD italian Registry.

Background: Launch of remote follow-up systems in Europe is currently underway. However, there is insufficient understanding of postimplant practices with respect to device follow-up, reprogramming of device features, and postshock clinic visits. Methods: We analyzed device-stored data from patients implanted with biventricular defibrillators (CRT-ICD) to characterize the management of patients in current clinical practice and the potential impact of remote follow-up systems. Results: Two hundred and seventeen patients were identified, all with complete device-data for at least one year. Over a follow-up period of 570 +/- 158 days, 1,959 device interrogations were performed. Of these, the majority (1,280, 65%) involved the reprogramming of device parameters. The mean time interval between interrogations was 70 +/- 25 days. Overall, a marked reduction of interrogations requiring reprogramming was observed between the first six months of follow-up and subsequent periods (from 3.6 +/- 1.8 to 1.1 +/- 1.0 interrogations/six months). A mean of 6.0 +/- 5.9 device parameters was reprogrammed during the first six months of follow-up, versus 4.4 +/- 5.6 (P = 0.000) during the subsequent period. From multivariate analysis, a higher-than-median number of interrogations was found to be significantly associated with defibrillator shocks (OR:2.51; 95%CI:1.42-4.42). Following a shock, a total of 133 interrogations in 60 patients were performed with 80% of these occurring within five days of the shock, and 49% did not require device reprogramming. Conclusion: Six months after implant, reprogramming of device parameters is significantly less frequent, making the use of remote follow-up systems a practical alternative for patients and physicians. Moreover, a considerable portion of post-shock interrogations does not involve reprogramming and may therefore be performed remotely

Heart rate variability monitored by the implanted device predicts response to CRT and long-term clinical outcome in patients with advanced heart failure

Background: Few data exist on the long-term changes and the prognostic value of heart rate variability (HRV) assessed by implanted devices in heart failure (HF) patients treated with resynchronization therapy (CRT). Aims: To analyze the long-term changes in the standard deviation of 5-minute median atrial-atrial sensed intervals (SDANN), and assess its role in predicting CRT efficacy and major cardiovascular events. Methods and results: We included 509 consecutive patients implanted with CRT devices. At 12-month follow-up, 44 patients had died and 86 patients had at least one HF hospitalisation. A significant increase in SDANN occurred after 4 weeks of CRT (from 69+/-22 ms to 82+/-27 ms, p<0.001). A further increase in SDANN was observed 6 months after implantation. Multivariable analysis identified SDANN as the sole predictor of major cardiovascular events (p=0.03) among several baseline parameters. SDANN< or =65 ms at the first week and SDANN< or =76 ms after 4 weeks of CRT yielded the best prediction of all-cause mortality and urgent heart transplantation on Kaplan-Meier analysis (log-rank test p=0.015 and p=0.011, respectively for week 1 and 4 values). Moreover, relative reduction in LVESV after CRT significantly correlated with SDANN at week 1 (r=-0.596, p=0.012), and week 4 (r=-0.703, p=0.001). Conclusions: Device-monitored HRV is a useful tool to identify, early after implantation, patients with a low likelihood of long-term benefits from CRT and at high risk for cardiovascular events

Impact of mitral regurgitation on the outcome of patients treated with CRT-D: data from the InSync ICD Italian Registry.

Background: We assessed the influence of clinically significant mitral regurgitation (MR) on clinical-echocardiographic response and outcome in heart failure (HF) patients treated with a biventricular defibrillator (cardiac resynchronization therapy defibrillator [CRT-D]). Methods and Results: A total of 659 HF patients underwent successful implantation of CRT-D and were enrolled in a multicenter prospective registry (median follow-up of 15 months). Following baseline echocardiographic evaluation, patients were stratified into two groups according to the severity of MR: 232 patients with more than mild MR (Group MR+: grade 2, 3, and 4 MR) versus 427 patients with mild (grade 1) or no functional MR (Group MR−). On 6- and 12-month echocardiographic evaluation, MR was seen to have improved in the vast majority of MR+ patients, while it remained unchanged in most MR− patients. On 12-month follow-up evaluation, a comparable response to CRT was observed in the two groups, in terms of the extent of left ventricular reverse remodeling and combined clinical and echocardiographic response. During long-term follow-up, event-free survival did not differ between MR+ and MR− patients, even when subpopulations of patients with ischemic heart disease and with dilated cardiomyopathy were analyzed separately. On multivariate analysis, the only independent predictor of death from any cause was the lack of β-blocker use. Conclusions: This observational analysis supports the use of CRT-D in HF patients with clinically significant MR; MR had no major influence on patient outcom