Renato Ricci

Doppler myocardial imaging to evaluate the effectiveness of pacing sites in patients receiving biventricular pacing

OBJECTIVES The goal of this study was to compare the efficacy of biventricular pacing (BIV) at the most delayed wall of the left ventricle (LV) and at other LV walls. BACKGROUND Biventricular pacing could provide additional benefit when it is applied at the most delayed site. METHODS In 31 patients with advanced nonischemic heart failure, the activation delay was defined, in blind before BIV, by regional noninvasive Tissue Doppler Imaging as the time interval between the end of the A-wave (C point) and the beginning of the E-wave (O point) from the basal level of each wall. The left pacing site was considered concordant with the most delayed site when the lead was inserted at the wall with the greatest regional interval between C and O points (CO(R)). After BIV, patients were divided into group A (13/31) (i.e., paced at the most delayed site) and group B (18/31) (i.e., paced at any other site). RESULTS After BIV, in all patients LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes decreased (p = 0.025 and 0.001), LV ejection fraction (LVEF) increased (p = 0.002), QRS narrowed (p = 0.000), New York Heart Association class decreased (p = 0.006), 6-min walked distance (WD) increased (p = 0.046), the interval between closure and opening of mitral valve (CO) and isovolumic contraction time (ICT) decreased (p = 0.001 and 0.000), diastolic time (EA) and Q-P(2) interval increased (p = 0.003 and 0.000), while Q-A(2) interval and mean performance index (MPI) did not change. Group A showed greater improvement over group B in LVESV (p = 0.04), LVEF (p = 0.04), bicycle stress testing work (p = 0.03) and time (p = 0.08) capacity, CO (p = 0.04) and ICT (p = 0.02). CONCLUSIONS After BIV, LV performance improved significantly in all patients; however, the greatest improvement was found in patients paced at the most delayed site.

Prophylactic Implantable Defibrillator in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia and No Prior Ventricular Fibrillation or Sustained Ventricular Tachycardia

Background— The role of implantable cardioverter-defibrillator (ICD) in patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia and no prior ventricular fibrillation (VF) or sustained ventricular tachycardia is an unsolved issue. Methods and Results— We studied 106 consecutive patients (62 men and 44 women; age, 35.6±18 years) with arrhythmogenic right ventricular cardiomyopathy/dysplasia who received an ICD based on 1 or more arrhythmic risk factors such as syncope, nonsustained ventricular tachycardia, familial sudden death, and inducibility at programmed ventricular stimulation. During follow-up of 58±35 months, 25 patients (24%) had appropriate ICD interventions and 17 (16%) had shocks for life-threatening VF or ventricular flutter. At 48 months, the actual survival rate was 100% compared with the VF/ventricular flutter–free survival rate of 77% (log-rank P=0.01). Syncope significantly predicted any appropriate ICD interventions (hazard ratio, 2.94; 95% confidence interval, 1.83 to 4.67; P=0.013) and shocks for VF/ventricular flutter (hazard ratio, 3.16; 95% confidence interval, 1.39 to 5.63; P=0.005). The positive predictive value of programmed ventricular stimulation was 35% for any appropriate ICD intervention and 20% for shocks for VF/ventricular flutter, with a negative predictive value of 70% and 74%. None of the 27 asymptomatic patients with isolated familial sudden death had appropriate ICD therapy. Twenty patients (19%) had inappropriate ICD interventions, and 18 (17%) had device-related complications. Conclusions— One fourth of patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia and no prior sustained ventricular tachycardia or VF had appropriate ICD interventions. Syncope was an important predictor of life-saving ICD intervention and is an indication for ICD. Prophylactic ICD may not be indicated in asymptomatic patients because of their low arrhythmic risk regardless of familial sudden death and programmed ventricular stimulation findings. Programmed ventricular stimulation had a low predictive accuracy for ICD therapy.

Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization

AIMS To evaluate the impact of Home Monitoringtrade mark(HM) remote control on patient medical treatment and on health-care resource utilization. METHODS AND RESULTS One hundred and seventeen patients received HM pacemakers or defibrillators. A pacing expert nurse consulted daily the website and submitted critical cases to physician. During a mean follow-up of 227 +/- 128 days, 25,210 messages were received (23,545 daily messages and 1665 alert events) resulting in 90.7% of HM supervised days. Fifty-nine minutes/week for the nurse and 12 min/week for the physician were spent for HM data analysis during 267 web-connections. The mean connection time per patient was 115 +/- 60 s. The nurse submitted to the physician 133 critical cases in 56 patients. The diagnosis were atrial fibrillation (47%), ventricular tachyarrhythmias (9%), inappropriate implantable cardioverter defibrillator intervention (4%), unsustained ventricular tachycardia (7%), device suboptimal programming (23%), and impending heart failure (10%). Sixty-six unplanned follow-up in 43 patients led to drug therapy change (44%), device reprogramming (18%), diagnosis confirmation without further intervention (24%), no confirmation (6%), further diagnostic tests (9%). CONCLUSION HM technology allowed optimization of medical treatment and device programming with low consumption of health-care resource.

Improving Stroke Risk Stratification Using the CHADS2 and CHA2DS2-VASc Risk Scores in Patients With Paroxysmal Atrial Fibrillation by Continuous Arrhythmia Burden Monitoring

Background and Purpose— In patients with atrial fibrillation (AF), stroke risk stratification schema do not consider AF parameters. The aim of the study is to assess the impact of combining risk factors with continuous AF burden monitoring. Methods— In this retrospective study 568 patients implanted with a DDDR-P pacemaker (AT-500; Medtronic) and a history of AF were continuously monitored for 1 year. Results— During follow-up, 14 patients (2.5%) had a thromboembolic event. Patients were divided into 3 groups: AF burden ⩽5 minutes per day (AF-free; n=223 [39%]), AF burden >5 minutes but <24 hours per day (AF-5 minutes; n=179 [32%]), and AF burden ≥24 hours (AF-24 hours; n=166 [29%]). Patients were also classified according to CHADS2 and CHA2DS2-VASc risk scores. The discrimination ability of each risk score was evaluated performing a logistic regression analysis and calculating the corresponding C-statistic. The addition of AF burden improved C-statistics: for CHADS2 from 0.653 (P=0.051) to 0.713 (P=0.007); for CHA2DS2-VASc, from 0.898 (P<0.0001) to 0.910 (P<0.0001). Conclusions— The CHA2DS2-VASc score had a high sensitivity to predict thromboembolism. Implementation of device data on AF presence/duration/burden has the potential to contribute to improved clinical risk stratification and should be tested prospectively.

Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation.

AIMS To evaluate the impact of Home Monitoring (HM) technology on detection and treatment of atrial fibrillation (AF). METHODS AND RESULTS One hundred and sixty-six patients (mean age 73 +/- 10 years, 112 males) received HM devices [121 pacemakers, 22 implantable cardioverter defibrillators (ICDs), and 23 ICDs combined with cardiac resynchronization therapy]. A nurse consulted the cardioreports on the website and submitted the alerts for AF (new onset AF, persistent AF, and AF burden of >10% for >5 consecutive days) to the physician. During a mean follow-up of 488 +/- 203 days, 42 patients (26%) had alerts for AF. Twenty-two patients had no history of AF before implant. In nine patients, no further action was taken. For the remaining 33 patients, an unscheduled follow-up was performed: in 16, antiarrhythmic drug therapy was introduced/modified; in 15, anticoagulation was started; in 2, antiplatelet drugs were introduced; in 7, an external cardioversion was performed; in 2 patients, the device was reprogrammed to avoid intermittent atrial undersensing during AF; and in 4 patients, no further action was taken. In four cases the arrhythmia was not confirmed (false positive). The median time to the first intervention for AF was 50 days (148 days before the scheduled follow-up). CONCLUSION The HM technology allowed early detection of AF in paced patients and early reaction to optimize medical treatment.

HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices

DavidSlotwiner,MD, FHRS, FACC(Chair),Niraj Varma,MD,PhD, FRCP(Co-chair), JosephG.Akar,MD,PhD, George Annas, JD, MPH, Marianne Beardsall, MN/NP, CCDS, FHRS, Richard I. Fogel, MD, FHRS, Nestor O. Galizio, MD, Taya V. Glotzer, MD, FHRS, FACC, Robin A. Leahy, RN, BSN, CCDS, FHRS, Charles J. Love, MD, CCDS, FHRS, FACC, FAHA, Rhondalyn C. McLean, MD, Suneet Mittal, MD, FHRS, Loredana Morichelli, RN, MSN, Kristen K. Patton, MD, Merritt H. Raitt, MD, FHRS, Renato Pietro Ricci, MD, John Rickard, MD, MPH, Mark H. Schoenfeld, MD, CCDS, FHRS, FACC, FAHA, Gerald A. Serwer, MD, FHRS, FACC, Julie Shea, MS, RNCS, FHRS, CCDS, Paul Varosy, MD, FHRS, FACC, FAHA, Atul Verma, MD, FHRS, FRCPC, Cheuk-Man Yu, MD, FACC, FRCP, FRACP From the Hofstra School of Medicine, North Shore Long Island Jewish Health System, New Hyde Park, New York, Cleveland Clinic, Cleveland, Ohio, Yale University School of Medicine, New Haven, Connecticut, Boston University School of Public Health, Boston, Massachusetts, Southlake Regional Health Centre, Newmarket, Ontario, Canada, St. Vincent Medical Group, Indianapolis, Indiana, Favaloro Foundation University Hospital, Buenos Aires, Argentina, Hackensack University Medical Center, Hackensack, New Jersey, Sanger Heart & Vascular Institute, Carolinas HealthCare System, Charlotte, North Carolina, New York University Langone Medical Center, New York City, New York, University of Pennsylvania Health System, Philadelphia, Pennsylvania, The Arrhythmia Institute at Valley Hospital, New York, New York, Department of Cardiovascular Diseases, San Filippo Neri Hospital, Rome, Italy, University of Washington, Seattle, Washington, VA Portland Health Care System, Oregon Health & Science University, Knight Cardiovascular Institute, Portland, Oregon, Johns Hopkins University, Baltimore, Maryland, Yale University School of Medicine, Yale-New Haven Hospital Saint Raphael Campus, New Haven, Connecticut, University of Michigan Congenital Heart Center, University of Michigan Health Center, Ann Arbor, Michigan, Brigham and Women’s Hospital, Boston, Massachusetts, Veterans Affairs Eastern Colorado Health Care System, University of Colorado, Denver, Colorado, and Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.

Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry.

Aims The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management. Methods and results The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5–86.0%] and 97.4% (CI, 96.5–98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1–14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53–0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0–107.0) min × health personnel/100 patients. Conclusion Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.

Biventricular pacing in heart failure: back to basics in the pathophysiology of left bundle branch block to reduce the number of nonresponders

Cardiac resynchronization therapy is a novel nonpharmacologic approach to treating patients who have advanced heart failure with left bundle branch block (LBBB). Such a therapy is based on the original theory that synchronous biventricular pacing is able to reduce the interventricular delay caused by LBBB in patients with heart failure. Although there is convincing evidence that biventricular pacing increases the left ventricular ejection fraction, decreases mitral regurgitation, and improves symptoms caused by heart failure, the percentage of nonresponders to such therapy has been described as high as about one third of patients with heart failure having LBBB. Factors responsible for this relatively high prevalence are reviewed, the most important of them probably being left intraventricular dyssynchrony, which can persist after biventricular pacing, notwithstanding right and left interventricular resynchronization. Such a dyssynchrony, as evaluated by tissue Doppler imaging, may be because of the discordance between the site of the left ventricular pacing and the site of the left ventricular delay. Therefore, to characterize the pathophysiologic pattern of LBBB, the investigators suggest an assessment of the electromechanical dysfunction with a noninvasive reliable technique, such as tissue Doppler imaging, which can be repeated after biventricular pacing.

Impact of Consistent Atrial Pacing Algorithm on Premature Atrial Complexe Number and Paroxysmal Atrial Fibrillation Recurrences in Brady-Tachy Syndrome: A Randomized Prospective Cross Over Study

AbstractAim of the study: The Consistent Atrial Pacing (CAP) algorithm has been designed to achieve a high percentage of atrial pacing to suppress paroxysmal atrial fibrillation. The aim of our study was to compare the impact of DDDR+CAP versus DDDR pacing on paroxysmal atrial fibrillation recurrences and triggers in patients with Brady-Tachy Syndrome. Methods: 61 patients, 23 M and 38 F, mean age 75±9 y, affected by Brady-Tachy Syndrome, implanted with a DDDR pacemaker, were randomized to DDDR or DDDR+CAP pacing with cross over of pacing modality after 1 month. Results: 78 % of patients in DDDR pacing and 73 % in DDDR+CAP pacing (p=n.s.) were free from symptomatic paroxysmal atrial fibrillation recurrences. During DDDR+CAP pacing, the atrial pacing percentage increased from 77±29 % to 96±7 % (p<0.0001). Automatic mode switch episodes/day were 0.73±1.09 in DDDR and 0.79±1.14 (p=n.s.) in DDDR+CAP. In patients with less than 50 % of atrial pacing during DDDR, automaticmode switch episodes/day decreased during DDDR+CAP from 1.13±1.59 to 0.23±0.32 (p<0.05) and in patients with less than 90 % from 1.23±1.27 to 0.75±1.10 (p<0.001). The number of premature atrial complexes per day decreased during DDDR+CAP from 2665±4468 to 556±704 (p<0.02). Conclusion: CAP algorithm allowed continuous overdrive atrial pacing without major side effects. Triggers of paroxysmal atrial fibrillation induction, such as premature atrial complexes, were critically decreased. Paroxysmal atrial fibrillation episodes were reduced in patients with atrial pacing percentage lower than 90 % during DDDR pacing.

Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial.

AIMS This randomized trial evaluated clinically significant adverse events (CSAEs), in patients implanted with dual-chamber (DC) vs. single-chamber (SC) implantable cardioverter defibrillator (ICD). DC-ICD had atrial tachyarrhythmia (AT) therapy capabilities. Strict programming recommendations were reinforced. METHODS AND RESULTS Patients with conventional SC-ICD indication were randomized to DC-ICD, SC-ICD, or a DC-ICD programmed as an SC-ICD (SC-simulated) and followed for 16 months. Patients in the DC and SC-simulated groups crossed over after 8 months. The primary endpoint was a composite of CSAE: all-cause mortality; invasive intervention; hospitalization (> 24 h) for cardiovascular causes; inappropriate shocks (two or more episodes); and sustained symptomatic AT lasting > 48 h. The outcome variable was a pre-specified score that corrected for clinical severity and follow-up duration. Three hundred and thirty-four patients were analysed (DC-ICD, n = 112; SC-ICD, n = 111; SC-simulated, n = 111). The mean left ventricular ejection fraction was 0.36 +/- 0.13, 69% were in functional class > or = II. CSAE occurred in 65 DC-ICD, 82 SC-ICD, and 84 SC-simulated patients. The outcome variable was 33% lower in the DC-ICD group (OR 0.31; 95% CI 0.14-0.67; P = 0.0028). Mortality was 4% in DC, 9% in SC, and 10% in SC-simulated. CONCLUSION In patients with a standard SC-ICD indication, DC-ICD was associated with less CSAE when compared with SC-ICD.