Long-term monitoring of respiratory rate in patients with heart failure: the Multiparametric Heart Failure Evaluation in Implantable Cardioverter-Defibrillator Patients (MULTITUDE-HF) study.

BACKGROUND: Monitoring respiratory rate (RR) is recommended at the time of hospital presentation for acute decompensation in heart failure (HF). Device-based continuous monitoring of RR may be helpful for diagnostic and prognostic stratification after implantable cardioverter-defibrillator (ICD) implantation. This study was undertaken to analyze short- and long-term changes in ICD-measured RR and to relate RR with the patient's clinical status and the occurrence of HF events. METHODS: One hundred twenty-four consecutive HF patients who received ICD endowed with this diagnostic capability (Boston Scientific Inc., Natick, MA, USA) were prospectively enrolled. Patients were followed up for 12 months. RESULTS: At the baseline, the proportion of New York Heart Association (NYHA) class III-IV was higher among patients with daily maximum RR >27 breaths/min (third tertile) than those with <24 breaths/min (first tertile) (43 vs. 23%, p < 0.05). Moreover, the ejection fraction was lower (27 ± 7 vs. 34 ± 8%, p < 0.05). In patients with HF hospitalizations (33 events) and urgent visits for HF (15 events), the weekly average of RR calculated over the 7 days preceding hospital accesses did not differ from values recorded at the baseline and before scheduled follow-up visits. However, the weekly variation in RR (i.e., the difference between maximum and minimum values collected over the week) was significantly higher prior to hospitalization (p < 0.05). A weekly variation >3 breaths/min in maximum RR predicted an impending hospital admission for HF with sensitivity of 73 % and specificity of 57%. CONCLUSIONS: In this study, elevated values of ICD-monitored RR identified patients with worse functional status and lower systolic function. The weekly variation in RR increased before HF exacerbation. This monitoring technology may represent a useful tool in the clinical management of patients with HF.

Clinical characteristics, mortality, cardiac hospitalization, and ventricular arrhythmias in patients undergoing CRT-D implantation: results of the ACTION-HF study.

INTRODUCTION: The characteristics and outcomes of patients who undergo cardiac resynchronization therapy (CRT) device implantation in current clinical practice may differ from those of reference trial populations. Study objectives were to assess 2-year outcomes in a population implanted with a CRT plus defibrillator device in accordance with the standard of care and to evaluate any independent association between clinical variables and outcome. METHODS AND RESULTS: A total of 406 patients enrolled at 35 centers in Italy were followed up prospectively for 2 years. All patient management decisions were left to the treating physician's discretion, in accordance with clinical practice. ACTION-HF patients had a better baseline clinical status than patients enrolled in the COMPANION study: shorter HF history (1 vs 3.5 years, P < 0.01), less advanced NYHA functional class (III-IV: 73% vs 100%, P < 0.01), higher LVEF (26% vs 21%, P < 0.01), higher SBP (122 vs 112 mmHg, P < 0.01), and less diabetes (27% vs 41%, P < 0.01). This status was reflected in lower mortality (11.5% vs 26%) and a lower incidence of appropriate ICD shocks (12.1% vs 19.3%). AF history was an independent predictor of the combination of all-cause mortality and cardiac-cause hospitalization (HR: 3.31; P < 0.001). Recurrent or new atrial arrhythmias were independently associated with the development of ventricular arrhythmias (HR: 3.4; P < 0.001). CONCLUSIONS: This population appears clinically less compromised and had a lower incidence of adverse clinical outcomes than those of reference trials. However, we recorded a substantial burden of atrial arrhythmias, which was independently associated with a higher incidence of ventricular arrhythmias.

Clinical and technical determinants of long-term performance of coronary sinus leads.

OBJECTIVES: Little is known about coronary sinus lead performance in patients with cardiac resynchronization therapy devices. We evaluated the impact of clinical and technical parameters on coronary sinus lead performance over long-term follow-up. METHODS: From February 1999 to July 2004, 235 patients (181 men; mean age, 68 +/- 9 years; mean left ventricular ejection fraction, 26.5 +/- 6.5%; idiopathic dilated cardiomyopathy, 49%; ischemic, 48%; and other cause, 3%) underwent cardiac resynchronization therapy (pacemaker or defibrillator) implantation. RESULTS: On implantation, the only statistically significant difference was observed in mean pacing impedance, which was lower for unipolar leads than for bipolar leads (763 +/- 250 vs. 847 +/- 270 Omega, P = 0.02), and lower in patients with ischemic cardiomyopathy than in those with idiopathic cardiomyopathy (758 +/- 204 vs. 837 +/- 291 Omega, P = 0.03). After a mean follow-up of 41.7 +/- 14.7 months, a significant decrease was observed in mean pacing impedance (from 811 +/- 261 to 717 +/- 284 Omega, P = 0.0026) and mean R-wave amplitude (from 13.2 +/- 6.7 to 10.5 +/- 5.5 mV, P = 0.002), whereas the mean pacing energy threshold increased from 3.6 +/- 10.4 to 9.5 +/- 28 microJ (P = 0.004). On analysis of variance, unipolar lead (P = 0.016) and posterior coronary sinus position (P = 0.049) were related to a greater energy threshold increase. On multivariate analysis (Cox regression), only posterior coronary sinus lead position (P = 0.013) proved to be an independent predictor of long-term significant increase in the stimulation energy threshold. CONCLUSION: Over the long-term follow-up of coronary sinus leads, pacing impedance and R-wave amplitude decreased, whereas the energy threshold increased; unipolar leads and posterior lead location in the coronary sinus were related to a greater energy threshold increase.

Long-term outcomes of CRT-PM versus CRT-D recipients.

OBJECTIVE: To compare the rates of all-cause mortality in recipients of cardiac resynchronization therapy devices without (CRT-PM) versus with defibrillator (CRT-D). METHODS: Between February 1999 and July 2004, 233 patients (mean age = 69 +/- 8 years, 180 men) underwent implantation of CRT-PM or CRT-D devices. New York Heart Association (NYHA) heart failure functional class II was present in 11%, class III in 69%, and class IV in 20% of patients; mean left ventricle ejection fraction (LVEF) was 26.5 +/- 6.5 %, 48% presented with idiopathic dilated cardiomyopathy and 49% with ischemic heart disease. Cox multiple variable regression analysis was performed in search of predictors of death. RESULTS: The clinical characteristics of the 117 CRT-PM and 116 CRT-D recipients were similar, except for LVEF (28.2 +/- 6.2% vs 25.0 +/- 6.5%, respectively; P < 0.001), and ischemic versus nonischemic etiology of heart failure (41% vs 56%, respectively P = 0.02). Over a mean follow-up of 58 +/- 15 months, no significance difference in overall mortality rate was observed between the two study groups. Male sex, NYHA functional class IV, and atrial fibrillation at implant were significant predictors of death. CONCLUSIONS: There was no difference in long-term survival rate among patients with CRT-D versus CRT-PM, although CRT-D more effectively lowered the sudden death rate. Male sex, NYHA functional class IV, and atrial fibrillation predicted the worst prognosis.

Performance of a ventricular automatic-capture algorithm in a wide clinical setting.

BACKGROUND: The optimal programming of a pacemaker (PM) voltage output considers both efficiency (prolonging battery cell longevity) and patient safety (adequate safety margin). Currently, automatic capture (AC) algorithms are designed to ensure safe automatic stimulation threshold determination and pacing with a safety margin. METHODS: The aims of this prospective observational study were (1) to evaluate, over a short-term follow-up, the extent of backup pacing in patients implanted with an AC-featured PM produced by Boston Scientific (Insignia) and a wide range of ventricular leads; (2) to identify patient- or lead-specific predictors of ventricular threshold increase or missed detection of the ventricular pacing threshold; and (3) to analyze day-to-day fluctuations in the ventricular pacing threshold and the relationship between their magnitude, the characteristics of patients, and the system implanted. RESULTS: Five hundred and seventy-nine patients implanted with 89 different leads were followed up for a median of 2.1 months. Five hundred and thirty-six patients (92.5%) never experienced failure of automatic threshold testing; 571 (98.6%) did not experience permanent failure requiring continuous backup pacing at high energy. On multivariate analysis, none of the patient or lead characteristics predicted the occurrence of high-energy backup pacing during the study period. Day-to-day threshold fluctuations were associated only with higher thresholds (>1 V). CONCLUSION: AC algorithm reliably measures ventricular pacing thresholds in most patients: in only 1.4% of patients the system is permanently unable to detect the ventricular threshold. Backup pacing is not dependent on lead or patient characteristics, including lead polarization, polarity, and maturation.

Overdrive versus conventional or closed-loop rate modulation pacing in the prevention of atrial tachyarrhythmias in Brady-Tachy syndrome: on behalf of the Burden II Study Group.

BACKGROUND: Optimizing dual-chamber pacing to prevent recurrences of atrial tachyarrhythmias (AT) in sinus node dysfunction is still debated. Despite the large number of studies, efficacy of sophisticated preventive algorithms has never been proven. It is not clear whether this is due to imperfect study designs or to a substantial inefficacy of pacing therapies. AIM: To intraindividually compare AT burden between an atrial overdrive and two heart rate modulation approaches: a conventional accelerometric-sensor-based DDDR mode and a contractility-driven rate responsive closed loop (CLS) algorithm. METHODS AND RESULTS: Four hundred fifty-one patients with Brady-Tachy syndrome (BTS), severe bradycardia, and a documented episode of atrial fibrillation were enrolled. One month after implant, each pacing therapy was activated for 3 months in random order. A simple log transformation was used to handle large and skew AT burden distributions. Estimates were adjusted for false-positive AT episodes and reported as geometric means (95% confidence interval). A significantly higher AT burden was observed during overdrive, 0.14% (0.09%, 0.23%) (adjusted, 0.12%[0.07%, 0.20%]). Both DDDR and CLS performed better: respectively, 0.11% (0.07%, 0.17%) (adjusted, 0.08%[0.05%, 0.14%]), 0.06% (0.03%, 0.09%) (adjusted, 0.04%[0.03%, 0.07%]). All the comparisons were statistically significant. During overdrive significantly more patients had AT episodes of duration between 1 minute and 1 hour. No significant differences were observed for longer episodes. CONCLUSIONS: Atrial overdrive showed the worst performance in terms of AT burden reduction and should not be preferred to heart rate modulation approaches that still have to be considered as a first-choice pacing mode in BTS.

Atrial tachyarrhythmia burden modelling by some electrophysiological parameters in pacemaker-recipient patients with Brady-Tachy syndrome.

AIMS: (1) To correlate atrial tachyarrhythmia (AT) burden of pacemaker-recipient Brady-Tachy syndrome (BTS) patients with a number of diagnostics-derived parameters after 1 month of DDD pacing; (2) to asses whether the activation of atrial overdrive or conventional rate-responsive pacing may affect relevant variables and their correlation. METHODS AND RESULTS: After 1 month of DDD pacing, rate-responsive function or persistent atrial overdrive was randomly activated for 3 months, in 92 BTS patients. Some pacemaker diagnostics parameters collected at 1- and 4-month follow-ups were included in multiple linear regression models, whose dependent variable was the Log transformation of AT burden and compared. With 1-month data, the only variables significantly correlating with Log AT burden were average (with a regression coefficient estimate of -0.07, P=0.02) and standard deviation (0.10, P=0.007) of atrial rate, mean premature atrial contraction (PAC) coupling interval (CI) (-0.005, P=0.001), frequency of PACs with CI<500 ms (1.30, P<10(-6)). Atrial pacing percentage (APP) and ventricular pacing percentage (VPP), PACs with CI>500 ms did not significantly correlate. Four-month data largely confirmed these results, except that in DDDR atrial rate average and standard deviation no longer correlated. Overdrive significantly increased APP and reduced PACs with CI>500 ms. CONCLUSION: AT burden showed significant dependence in DDD and during overdrive on atrial rate average and standard deviation. Highly premature PACs always significantly correlated with AT burden. Though increasing APP, which unexpectedly never correlated, overdrive could only reduce less premature PACs.