Alessandro Proclemer

The 11th World Survey of Cardiac Pacing and Implantable Cardioverter-Defibrillators: Calendar Year 2009–A World Society of Arrhythmia's Project

A worldwide cardiac pacing and implantable cardioverter‐defibrillator (ICD) survey was undertaken for calendar year 2009 and compared to a similar survey conducted in 2005. There were contributions from 61 countries: 25 from Europe, 20 from the Asia Pacific region, seven from the Middle East and Africa, and nine from the Americas. The 2009 survey involved 1,002,664 pacemakers, with 737,840 new implants and 264,824 replacements. The United States of America (USA) had the largest number of cardiac pacemaker implants (225,567) and Germany the highest new implants per million population (927). Virtually all countries showed increases in implant numbers over the 4 years between surveys. High‐degree atrioventricular block and sick sinus syndrome remain the major indications for implantation of a cardiac pacemaker. There remains a high percentage of VVI(R) pacing in the developing countries, although compared to the 2005 survey, virtually all countries had increased the percentage of DDDR implants. Pacing leads were predominantly transvenous, bipolar, and active fixation. The survey also involved 328,027 ICDs, with 222,407 new implants and 105,620 replacements. Virtually all countries surveyed showed a significant rise in the use of ICDs with the largest implanter being the USA (133,262) with 434 new implants per million population. This was the largest pacing and ICD survey ever performed, because of mainly a group of loyal enthusiastic survey coordinators. It encompasses more than 80% of all the pacemakers and ICDs implanted worldwide during 2009. (PACE 2011; 34:1013–1027)

Effect of Long-Detection Interval vs Standard-Detection Interval for Implantable Cardioverter-Defibrillators on Antitachycardia Pacing and Shock Delivery: The ADVANCE III Randomized Clinical Trial

IMPORTANCE Using more intervals to detect ventricular tachyarrhythmias has been associated with reducing unnecessary implantable cardioverter-defibrillator (ICD) therapies. OBJECTIVE To determine whether using 30 of 40 intervals to detect ventricular arrhythmias (VT) (long detection) during spontaneous fast VT episodes reduces antitachycardia pacing (ATP) and shock delivery more than 18 of 24 intervals (standard detection). DESIGN, SETTING, AND PARTICIPANTS Randomized, single-blind, parallel-group trial that enrolled 1902 primary and secondary prevention patients (mean [SD] age, 65 [11] years; 84% men; 75% primary prevention ICD) with ischemic and nonischemic etiology undergoing first ICD implant at 1 of 94 international centers (March 2008-December 2010). INTERVENTIONS Patients were randomized 1:1 to programming with long- (n = 948) or standard-detection (n = 954) intervals. MAIN OUTCOMES AND MEASURES Total number of ATPs and shocks delivered for all episodes (primary outcomes) and inappropriate shocks, mortality, and syncopal rate (secondary outcomes). RESULTS During a median follow-up of 12 months (interquartile range, 11-13), long-detection group had 346 delivered therapies (42 therapies per 100 person-years, 95% CI, 38-47) vs 557 in the standard-detection group (67 therapies per 100 person-years [95% CI, 62-73]; incident rate ratio [IRR], 0.63 [95% CI, 0.51-0.78]; P < .001). The long- vs the standard-detection group experienced 23 ATPs per 100 person-years (95% CI, 20-27) vs 37 ATPs per 100 person-years (95% CI, 33-41; IRR, 0.58 [95% CI, 0.47-0.72]; P < .001); 19 shocks per 100 person-years (95% CI, 16-22) vs 30 shocks per 100 person-years (95% CI, 26-34; IRR, 0.77 [95% CI, 0.59-1.01]; P = .06), with a significant difference in the probability of therapy occurrence (P < .001); and a reduction in first occurrence of inappropriate shock (5.1 per 100 patient-years [95% CI, 3.7-6.9] vs 11.6 [95% CI, 9.4-14.1]; IRR, 0.55 [95% CI, 0.36-0.85]; P = .008). Mortality (5.5 [95% CI, 4.0-7.2] vs 6.3 [95% CI, 4.8-8.2] per 100 patient-years; HR, 0.87; P = .50) and arrhythmic syncope rates (3.1 [95% CI, 2.6-4.6] vs 1.9 [95% CI, 1.1-3.1] per 100 patient-years; IRR, 1.60 [95% CI, 0.76-3.41]; P = .22) did not differ significantly between groups. CONCLUSIONS AND RELEVANCE Among patients receiving an ICD, the use of a long- vs standard-detection interval resulted in a lower rate of ATP and shocks, and inappropriate shocks. This programming strategy may be an appropriate alternative. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00617175.

The world survey of cardiac pacing and cardioverter-defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) project.

Background: A worldwide cardiac pacing and implantable cardioverter‐defibrillator (ICD) survey was undertaken for calendar year 2005 and compared to a similar survey conducted in 2001.

A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study

Aims To investigate the efficacy and safety of a cardiac resynchronization therapy with cardioverter–defibrillator (CRT-D) device with simplified ventricular tachycardia management in patients with non-ischaemic heart failure (HF) and primary prevention implantable cardioverter defibrillator (ICD) indication. Methods and results Prospective, controlled, parallel, multicentre, non-randomized study enrolling 324 primary prevention non-ischaemic HF patients implanted with CRT-D devices from 2004 to 2007: Protect group, 164 patients implanted with a Medtronic Insync III Protect device and Control group, 160 patients utilizing other Medtronic CRT-D devices. Efficacy was assessed by computing appropriate and inappropriate detections and therapies during follow-up; safety compared hospitalizations and syncopal events between groups. Ninety per cent of both ventricular and supraventricular tachyarrhythmias terminated within the 13–29 beat detection interval with the Protect algorithm. The Protect group showed a significantly better event-free survival to first delivered therapy for total (P = 0.0001), appropriately treated (P = 0.002), and inappropriately treated episodes (P = 0.017). The total number of delivered shocks was significantly lower in the Protect group (22 vs. 59, P < 0.0001). In the Protect group, a significantly reduced HF hospitalization (hazard ratio 0.38, 95% CI 0.15–0.98, P = 0.044) was observed without any increase of syncope or death. Conclusion A simplified CRT-D device with fixed long detection reduced overall ICD therapy burden and HF hospitalizations without entailing any additional adverse events in primary prevention non-ischaemic HF patients.

Management of patients with syncope referred urgently to general hospitals

OBJECTIVE To evaluate the incidence and the strategy of management of syncope admitted urgently to a general hospital. BACKGROUND The management of patients with syncope is not standardized. METHODS The study was a prospective observational registry from a sample of 28 general hospitals in Italy and enroled all consecutive patients referred to their emergency rooms from November 5th 2001 to December 7th 2001 who were affected by transient loss of consciousness as the principal symptom. RESULTS The incidence of syncope was 0.95% (996 of 105,173 patients attending). Forty-six percent were hospitalized, mostly in the Department of Internal Medicine. The mean in-hospital stay was 8.1+/-5.9 days. A mean of 3.48 tests was performed per patient. A definite diagnosis was made in 80% of cases, neurally-mediated syncope being the most frequent. The findings of each of the 28 hospitals participating in the survey were separately evaluated. We observed great inter-hospital and inter-department heterogeneity regarding the incidence of emergency admission, in-hospital pathways, most of the examinations performed and the final assigned diagnosis. For example, the execution of carotid sinus massage ranged from 0% in one hospital to 58% in another (median 12.5%); tilt testing ranged from 0 to 50% (median 5.8%); the final diagnosis of neurally-mediated syncope ranged from 10 to 78.6% (median 43.3%). CONCLUSION Great inter-hospital and inter-department heterogeneity in the incidence and management of syncope was observed in general hospitals. As a consequence, we were unable to describe a uniform strategy for the management of syncope in everyday practice.

Image integration increases efficacy of paroxysmal atrial fibrillation catheter ablation: Results from the CartoMerge™ italian Registry

AIMS The aim of this study was to investigate whether circumferential pulmonary vein (PV) isolation guided by image integration improves the procedural and clinical outcomes of atrial fibrillation (AF) ablation in comparison with segmental PV isolation and circumferential PV isolation guided by three-dimensional (3D) electroanatomical mapping alone. METHODS AND RESULTS Procedural and clinical outcomes of 573 patients who underwent their first catheter ablation for paroxysmal AF between January 2005 and April 2007 were collected from 12 centres. We evaluated three techniques: segmental ostial PV isolation (SOCA group, 240 patients), circumferential PV isolation guided by electroanatomical mapping (CARTO group, 107 patients), and circumferential PV isolation guided by electroanatomical mapping integrated with magnetic resonance/computed tomographic images of the left atrium (MERGE group, 226 patients). Procedure duration proved to be shorter in MERGE group patients than in CARTO group patients (P < 0.04), but longer than in SOCA group patients (P < 0.0001). During follow-up, atrial tachyarrhythmias relapsed more frequently in SOCA group patients (44.6%) and CARTO group patients (41.7%) than in MERGE group patients (22.6%; P < 0.0001). CONCLUSION In patients with paroxysmal AF, circumferential PV isolation guided by image integration significantly improves clinical outcome in comparison with both circumferential PV isolation guided by 3D mapping alone and with segmental electrophysiologically guided PV isolation.

Risk stratification in individuals with the Brugada type 1 ECG pattern without previous cardiac arrest: usefulness of a combined clinical and electrophysiologic approach

Aims Risk stratification in individuals with type 1 Brugada electrocardiogram (ECG) pattern (type 1 ECG) for primary prevention of sudden death (SD). Methods and results Three hundred and twenty patients (258 males, median age 43 years) with type 1 ECG were enrolled. No patient had previous cardiac arrest. Fifty-four per cent of patients had a spontaneous and 46% a drug-induced type 1 ECG. One-third had syncope, two-thirds were asymptomatic. Two hundred and forty-five patients underwent electrophysiologic study (EPS) and 110 patients received an implantable cardiac defibrillator (ICD). During follow-up [median length 40 months (IQ20-67)], 17 patients had major arrhythmic events (MAE) (14 resuscitated ventricular fibrillation (VF) and three SD). Both a spontaneous type 1 ECG and syncope significantly increased the risk (2.6 and 3.0% event rate per year vs. 0.4 and 0.8%). Major arrhythmic events occurred in 14% of subjects with positive EPS, in no subjects with negative EPS and in 5.3% of subjects without EPS. All MAE occurred in subjects who had at least two potential risk factors (syncope, family history of SD, and positive EPS). Among these patients, those with spontaneous type 1 ECG had a 30% event rate. Conclusion (1) In subjects with the Brugada type 1 ECG, no single clinical risk factor, nor EPS alone, is able to identify subjects at highest risk; (2) a multiparametric approach (including syncope, family history of SD, and positive EPS) helps to identify populations at highest risk; (3) subjects at highest risk are those with a spontaneous type 1 ECG and at least two risk factors; (4) the remainder are at low risk.

Device-detected atrial tachyarrhythmias predict adverse outcome in real-world patients with implantable biventricular defibrillators.

OBJECTIVES The purpose of this analysis was to evaluate the correlation between atrial tachycardia (AT) or atrial fibrillation (AF) and clinical outcomes in heart failure (HF) patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D). BACKGROUND In HF patients, AT and AF have high prevalence and are associated with compromised hemodynamic function. METHODS Forty-four Italian cardiological centers followed up 1,193 patients who received a CRT-D according to current guidelines for advanced HF, New York Heart Association functional class ≥ II, left ventricular ejection fraction ≤ 35%, and QRS complex ≥ 120 ms. All patients were in sinus rhythm at implant. RESULTS During a median follow-up period of 13 months, AT/AF >10 min occurred in 361 of 1,193 (30%) patients. The composite end point (deaths or HF hospitalizations) occurred in 174 of 1,193 (14.6%). Multivariate time-dependent Cox regression analyses showed that composite end point risk was higher among patients with device-detected AT/AF (hazard ratio [HR]: 2.16, p = 0.032), New York Heart Association functional class III or IV compared with II (HR: 2.09, p = 0.002), and absence of beta-blockers (HR: 1.36, p = 0.036). Furthermore, the composite end point risk was inversely associated with left ventricular ejection fraction (HR: 1.04, p = 0.045), increasing by a factor of 4% for each 1% decrease in left ventricular ejection fraction. CONCLUSIONS In HF patients with CRT-D, device-detected AT/AF is associated with a worse prognosis. Continuous device diagnostics monitoring and Web-based alerts may inform the physician of AT/AF occurrences and identify patients at risk of cardiac deterioration or patients with suboptimal rate or rhythm control. (Italian ClinicalService Project; NCT01007474).

Validation of a novel automated border-detection algorithm for rapid and accurate quantitation of left ventricular volumes based on three-dimensional echocardiography

AIMS To assess the accuracy and reproducibility of a novel automated software for left ventricular (LV) volumes and ejection fraction (EF) measurements using real-time three-dimensional echocardiography (3DE). METHODS AND RESULTS A total of 103 patients with a wide range of LV volumes were analyzed with both 4D AutoLVQ and 4D TomTec software. In 23 patients, a side-by-side comparison of LV volume and EF measurements was done between 3DE, 2DE, and cardiac magnetic resonance (CMR). Excellent correlation was found between 4D AutoLVQ and 4D TomTec [r = 0.98 for end-diastolic volume (EDV), 0.99 for end-systolic volume (ESV), and 0.97 for EF, P < 0.0001], with small biases and narrow limits of agreement: EDV 5.2 mL (-14 to 25 mL), ESV 2.9 mL (-10 to 16 mL), EF -0.2% (-7 to 6%). Time of analysis was halved using 4D AutoLVQ with manual correction (1 min 52 s+/- 30 s) in comparison with 4D TomTec software (3 min 46 s +/- 1 min 24 s). Both softwares showed similar accuracy in comparison with CMR (4D AutoLVQ biases -11.0 mL, -9.1 mL, and 2.9%; 4D TomTec biases -8.3 mL, -7.4 mL, and 2.8% for EDV, ESV, and EF, respectively, P = NS for all) and good reproducibility. CONCLUSION Novel 4D AutoLVQ software showed very good agreement with more time-consuming 4D TomTec software, having similar accuracy against CMR.

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.