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Maurizio Lunati

Publications and source records attributed to Maurizio Lunati.

13 recordsLinked to original sources
PubMed2006

Characteristics of ventricular tachyarrhythmias occurring in ischemic versus nonischemic patients implanted with a biventricular cardioverter-defibrillator for primary or secondary prevention of sudden death.

OBJECTIVES: The InSync ICD Registry evaluated patients indicated for cardiac resynchronization therapy with defibrillation. BACKGROUND: Cardiac resynchronization therapy with defibrillation systems are prescribed for both primary and secondary prevention of sudden cardiac death in patients with heart failure with both ischemic and nonischemic etiology. The characterization of ventricular tachyarrhythmias detected by the ICD is not well known in these subpopulations. METHODS: We enrolled 421 patients with symptomatic heart failure despite optimized medical treatment, ventricular dyssynchrony, and primary or secondary ICD indications. An electrophysiologist reviewed all spontaneous episodes. Patients were grouped by etiology and ICD indications. RESULTS: The 421 patients included 292 ischemic (159 primary prevention) and 129 nonischemic (68 primary prevention) patients. In 19 +/- 11 months of follow-up, 110 patients (63 ischemic, 30 primary prevention and 47 nonischemic, 21 primary prevention) presented ventricular tachyarrhythmias, occurring in a ventricular tachycardia (VT) or a ventricular fibrillation zone (1382 and 456 events, respectively). The incidence of overall ventricular tachyarrhythmias in nonischemic patients in secondary prevention (35.7% at 1 year) was higher than in ischemic patients implanted for either indication (16.5% and 22.9% at 1 year, respectively). The incidence of self-terminating ventricular tachyarrhythmias was greater in patients with nonischemic heart disease, regardless of indication. Patients with ischemic heart disease in primary prevention had a lower occurrence of VTs, whereas nonischemic patients in primary prevention had faster VTs. CONCLUSIONS: Both rate of occurrence and characteristics of detected ventricular tachyarrhythmias vary according to underlying etiology and indication. Therefore, different device programming according to patient's profile is advisable to improve ventricular tachyarrhythmias management.

Adult↗
PubMed2006

Comparison of 1-year effects of left ventricular and biventricular pacing in patients with heart failure who have ventricular arrhythmias and left bundle-branch block: the Bi vs Left Ventricular Pacing: an International Pilot Evaluation on Heart Failure Patients with Ventricular Arrhythmias (BELIEVE) multicenter prospective randomized pilot study.

BACKGROUND: Little is known on the chronic effects of left ventricular pacing (LV) in heart failure. METHODS: Seventy-four patients with LBBB, QRS >130 milliseconds, New York Heart Association class (Bradley DJ, Bradley EA, Braughman KL, et al. Cardiac resynchronization and death from progressive heart failure: a meta-analysis of randomized controlled trials. JAMA 2003;289:730-40.) II, LV ejection fraction (LVEF) <35%, and a class I cardioverter/defibrillator indication were implanted with CRT-D devices and were randomized to either LV or biventricular (BiV) pacing. Response (defined as increases of >5 points increase of LVEF and/or > or = 10% 6-minute walking test [6MWT]) between LV and BiV pacing were compared in an attempt to define the number of patients needed to claim noninferiority of LV pacing. In addition, absolute change in LVEF at 12 months in heart failure patients treated with LV pacing was evaluated. The safety of LV pacing was assessed comparing the total number of ventricular arrhythmia episodes, of hospitalizations, and of deaths between the two pacing modes. RESULTS: The percentage of responders was comparable for both groups (LV = 75%, BiV = 70%, P = .788); based on the 95% CI of the difference between the groups, 1100 patients would be needed to claim noninferiority of LV pacing (with a 5% CI lower limit). LV pacing induced siginificant LVEF increase (5.2%, P = .002). These results remained unchanged after performing adjustment analyses. There were no differences in the numbers of ventricular arrhythmias, hospitalizations, and death events between the 2 pacing modes. CONCLUSIONS: At 12 months, percentage of responders to LV pacing was similar to BIV pacing. Furthermore, LV pacing achieved a significant increase of ejection fraction. LV pacing is both safe and feasible.

Aged↗
PubMed2006

Long-term survival in patients treated with cardiac resynchronization therapy: a 3-year follow-up study from the InSync/InSync ICD Italian Registry.

BACKGROUND: Studies reporting the long-term survival of patients treated with cardiac resynchronization therapy (CRT) outside the realm of randomized controlled trials are still lacking. The aim of this study was to quantify the survival of patients treated with CRT in clinical practice and to investigate the long-term effects of CRT on clinical status and echocardiographic parameters. METHODS: The study population consisted of 317 consecutive patients with implanted CRT devices from eight Italian University/Teaching Hospitals. The patients were enrolled in a national observational registry and had a minimum follow-up of 2 years. A visit was performed in surviving patients and mortality data were obtained by hospital file review or direct telephone contact. RESULTS: During the study period, 83 (26%) patients died. The rate of all-cause mortality was significantly higher in ischemic than nonischemic patients (14% vs 8%, P = 0.002). Multivariate analysis showed that ischemic etiology (HR 1.72, CI 1.06-2.79; P = 0.028) and New York Heart Association (NYHA) class IV (HR 2.87, CI 1.24-6.64; P = 0.014) were the strongest predictors of all-cause mortality. The effects of CRT persisted at long-term follow-up (for at least 2 years) in terms of NYHA class improvement, increase of left ventricular ejection fraction, decrease of QRS duration (all P = 0.0001), and reduction of left ventricular end-diastolic and end-systolic diameters (P = 0.024 and P = 0.011, respectively). CONCLUSIONS: During long-term (3 years) follow-up after CRT, total mortality rate was 10%/year. The outcome of ischemic patients was worse mainly due to a higher rate of death from progressive heart failure. Ischemic etiology along with NYHA class IV was identified as predictors of death. Benefits of CRT in terms of clinical function and echocardiographic parameters persisted at the time of long-term follow-up.

Aged↗
PubMed2006

Improvement of quality of life by means of antitachy pacing: from PainFREE to the ADVANCE-D Trial.

BACKGROUND: Implantable cardioverter-defibrillators (ICD) can terminate ventricular tachyarrhythmias with shocks (painful) or antitachycardia pacing (painless). According to the results of the Pacing Fast VT Reduces Shock ThErapies Trials, antitachycardia pacing (ATP) can avoid painful shocks and also increase device longevity. The purpose of the ADVANCE-D (Atp DeliVery for PAiNless ICD ThErapy) study is to determine the most appropriate ventricular tachycardia (VT) therapy, so as to optimize painless therapy for life-threatening arrhythmias. METHODS AND RESULTS: The ADVANCE-D is a prospective, multicenter, parallel, two-arm randomized study designed to evaluate the efficacy of two different sequences of ATP therapies (burst 15 pulses, 88%, vs burst 8 pulses, 88%), during an episode of spontaneous arrhythmia classified as fast VT (FVT) in patients with a Class I or IIA indication for ICD implantation (single and dual chamber devices). The primary endpoint is to compare the efficacy of two ATP therapies for FVT episodes. The study will enroll a minimum of 900 patients within 2 years, followed-up for 12 months. The investigation is expected to be completed in 2007. CONCLUSIONS: The ADVANCE-D trial is the first large randomized clinical investigation aimed to evaluate optimal programming and efficacy of ATP.

Cardiac Pacing, Artificial↗
PubMed2006

Primary prevention of sudden cardiac death: can we afford the cost of cardioverter-defibrillators? Data from the Search-MI Registry-Italian sub-study.

BACKGROUND: Large randomized trials show that in appropriately selected patients with left ventricular dysfunction, implantable cardioverter-defibrillators (ICDs) can improve overall survival at 2-5 years. Since direct implementation of the criteria used in the MADIT II and SCD-HeFT will lead to a marked rise in ICD implants, there is a growing fear that increased use of ICDs may cause a dramatic burden to health care systems. The ICD has traditionally been seen as an expensive form of treatment, which is difficult to accept at the first look. This is mainly due to the nonlinear character of the ICD investment, characterized by high initial expenditure, followed by a deferred pay-off in terms of clinical benefits. Cost-effectiveness analysis may help provide a different perspective on the problem of ICD cost, as may estimation of the daily cost of ICD treatment, assuming a time horizon of 5-7 years--a particularly interesting subject for further registry studies. METHODS AND RESULTS: Based on real expenditure data from 2002 to 2005, as recorded in the Search-MI Registry-Italian Sub-study of patients implanted on MADIT II indications, we estimated the daily costs associated with the device and leads. Over a 5-7 year time horizon, the average daily cost was estimated to be euro 4.60-euro 6.70. Translation of these figures into U.S. market conditions suggests a daily cost of around $7.90-$11.40. CONCLUSIONS: These findings appear useful to help evaluate the affordability of ICD in comparison with other therapeutic options in a context of limited available economic resources.

Aged↗
PubMed2005

Utility of implantable loop recorder (Reveal Plus) in the diagnosis of unexplained syncope.

AIMS: In about 30% of patients with syncope, the responsible mechanisms remain unrecognised. Nevertheless, the possibility of an arrhythmic aetiology remains, however, difficult to rule out. METHODS: We therefore monitored with an implantable loop recorder (ILR, Reveal Plus, Medtronic) 34 subjects (60+/-15 years) with at least two unexplained syncopal episodes and negative neurological and cardiovascular work-up. RESULTS: During a follow-up of 7+/-4 months, syncope occurred in 11 subjects. In nine of them the mechanisms responsible for these events were identified by ILR monitoring: marked bradycardia or asystole (n=6), atrial fibrillation with wide QRS tachycardia (n=1) and sinus rhythm with fine artifacts likely to be due to muscle contractions (n=2). Pre-syncope occurred in seven patients: advanced atrioventricular block (n=3), sinus tachycardia (n=1), and wide QRS tachycardia (n=1) were documented. Thus, when considering all 18 patients with recurrences, a diagnosis was achieved in 53% of subjects. Recognition of the rhythm disorder in seven patients with syncope and four patients with pre-syncope guided patient management. CONCLUSIONS: These data indicate that ILR monitoring facilitates the identification of mechanisms responsible for recurrences and therapeutic management in subjects with syncope or pre-syncope and negative traditional neurological and cardiovascular work-up.

Adult↗
PubMed2005

Surgical ablation of arrhythmias.

The surgical approach was the earliest therapeutic ablation of hyperkinetic arrhythmias. Following the progressive improvements in electrophysiological mapping and operative techniques, new surgical approaches have been developed for the treatment of those arrhythmias related to ectopic phenomena or reentry mechanisms. These procedures have been proven to be highly effective but the associated morbidity and mortality were unacceptably high. More recent and advanced techniques of transcatheter ablation have revolutionized the treatment of these arrhythmias and now represent the treatment of choice in the majority of cases. However, the significant reduction in the operative risk and the improvement in patient outcome with respect to the past, thanks to a better patient selection and to advances in the surgical and myocardial protection techniques, make do that the surgical approach to some forms of arrhythmias is still valid, especially in those cases requiring associated surgery: atrial tachyarrhythmias in patients with congenital heart disease, post-ischemic ventricular tachycardias in patients who necessitate myocardial revascularization, and/or ventricular remodeling and chronic or paroxysmal atrial fibrillation in patients who require cardiac surgery. New techniques such as radiofrequency, microwaves and cryoablation guarantee the creation of linear and transmural lesions with minimum damage to the cardiac structures and appear very interesting as they are surgically simple and associated with shorter procedure times and less complications. The possibility of performing the ablative procedure completely on the epicardial surface may open the way for atrial fibrillation surgery on a totally beating heart and for procedures that are ever less invasive thus enabling treatment of patients without associated surgical indications.

Arrhythmias, Cardiac↗
PubMed2004

Limited thoracotomy as a second choice alternative to transvenous implant for cardiac resynchronisation therapy delivery.

AIMS: Left ventricular (LV) pacing via transvenous implantation has an overall success rate ranging from 88% to 92%. The aim of this study was to assess whether LV pacing via limited thoracotomy would be feasible and safe when used on a routine basis for those cases in which standard transvenous procedures proved to be ineffective or unsatisfactory. METHODS AND RESULTS: We enrolled 33 patients (8 females, 65+/-10 years) who experienced a transvenous implantation failure. All patients underwent a limited thoracotomy and an epicardial lead was implanted. The procedure time was 51+/-28 min. No surgical or post-operative complications occurred and optimal lateral position was achieved for all patients. In the 12 months follow-up period, 5 patients died from refractory heart failure, the remaining patients did not experience complications. At implant, the mean pacing threshold was 1.3+/-0.7 V, bi-ventricular pacing impedance was 476+/-201 Omega and R-wave amplitude was 15.0+/-6.1 mV. No significant differences were found in any of the electrical parameters between baseline and follow-up. Significant improvement was observed in functional and echocardiographic parameters. CONCLUSION: Our results suggest that a combined approach to cardiac resynchronisation therapy delivery, including a transvenous attempt followed by a back up thoracotomic procedure, could potentially guarantee the success.

Aged↗
PubMed2004

Sequential biventricular pacing: evaluation of safety and efficacy.

The study evaluated the clinical safety, performance, and efficacy of sequential biventricular pacing in the InSync III (Model 8042) biventricular stimulator in a multicenter, prospective 3-month study and assessed the proper functioning of features aiming at improving biventricular AV therapy delivery. The system was successfully implanted in 189 (95.9%) of 198 patients with symptomatic systolic heart failure and a prolonged QRS complex duration. Patients significantly improved their 6-minute hall walk distance (baseline 339 +/- 92 vs 3-month 422 +/- 127 meter, P < 0.001) and NYHA class (baseline 3.1 +/- 0.5 vs 3-month 1.9 +/- 0.7, P < 0.001). Echocardiographic optimization of sequential biventricular pacing showed an improvement in stroke volume compared to simultaneous stimulation (sequential 68 +/- 24 mL vs simultaneous 56 +/- 23 mL, P < 0.001) at baseline and at 3 months. In 88% (30/34) of the patients these improvements were seen within a small range of V-V delays of +/-20 ms and in 94% (32/34) within V-V delays of +/-40 ms. In contrast, programming beyond this range reduced stroke volume below that during simultaneous biventricular pacing. The device functioned as expected. LV lead dislodgement was observed in 12 patients and phrenic nerve stimulation required lead repositioning in 2 patients. Eight patients died during the study. Patient survival at 3 and 6 months was 97 +/- 2% and 94 +/- 2%, respectively. Cause of death was cardiac (n = 7), heart failure related (n = 3), arrhythmia related (n = 2), and unknown (n = 2). In conclusion, this sequential biventricular pacemaker was safe and efficacious.

Aged↗
PubMed2003

Cardiac resynchronization and implantable cardioverter defibrillator therapy: preliminary results from the InSync Implantable Cardioverter Defibrillator Italian Registry.

The aim of this study was to evaluate ventricular arrhythmias occurring in recipients of the InSync ICD for the primary and secondary prevention of sudden death. The InSync ICD was implanted in 142 patients (128 men; mean age 65 +/- 10 years) with heart failure (mean NYHA functional Class 3.0 +/- 0.7) and wide QRS (mean 159 +/- 33 ms). The underlying etiology was ischemic in 55%, idiopathic in 33%, and valvular or hypertensive cardiomyopathy in 12% of patients. The numbers of arrhythmic episodes/100 patient-months was computed with their 95% CI, assuming a Poisson distribution. Implants were performed in 48 (34%) patients who did not have an ACC/AHA guidelines Class I indication for ICD therapy. A total of 104 patients were compliant for follow-up visits. During a 9-month median (range 0.1-24) follow-up of 104 compliant patients, 19 experienced a total of 94 ventricular arrhythmias, all successfully interrupted or self-terminated, with a median number of two separate episodes, corresponding to a rate of 10 episodes/100 person-month (95% CI 8-12). A rate of 12 episodes/100 person-months (95% CI 10-15) was measured in the subgroup of patients with ACC/AHA class I indications, versus two episodes/100 person-months (95% CI 1-5) in the remainder of the population. Among 12 deaths, 9 were due to heart failure, 1 to a non-cardiovascular cause, and 2 to unknown causes. The implantation of ICD in heart failure patients has been prominently extended to primary prevention. Patients without standard ICD indications experienced life-threatening arrhythmic events. The impact of ICD combined with cardiac resynchronization therapy on arrhythmic profile, mortality, and costs in this subgroup of patients need to be more precisely studied, with a particular focus on the various types of underlying heart disease.

Adult↗
PubMed2002

Patient selection for biventricular pacing.

INTRODUCTION: Biventricular pacing improves functional status in the majority of patients with drug-refractory heart failure, dilated cardiomyopathy, and interventricular conduction delay. The aim of this study was to analyze the baseline clinical and functional data of a cohort of patients implanted with a biventricular stimulation system in a single-center experience, to verify if the pathophysiologic characteristics of patients affect outcome, and to determine if preliminary identification of the right candidates for the new therapy is possible with noninvasive parameters. METHODS AND RESULTS: Since March 1999, 52 patients with advanced heart failure (idiopathic cardiomyopathy 50%, ischemic cardiomyopathy 35%, other etiology 15%) and left bundle branch block underwent cardiac resynchronization and were followed prospectively. Paired analysis over mean (+/- SD) follow-up of 348 +/- 154 days showed an overall significant decrease of QRS width (baseline 194 +/- 33.2 msec vs follow-up 159.6 +/- 20.1 msec), New York Heart Association (NYHA) functional class (baseline 3.2 +/- 0.5 vs follow-up 2.3 +/- 0.5), quality-of-life score (baseline 54 +/- 25 vs follow-up 25 +/- 16), and increase of maximal VO2 (baseline 12.6 +/- 2.5 mL/kg/min vs follow-up 15.0 +/- 3.3 mL/kg/min). There were 80% responders (documented, persistent decrease > or = 1 NYHA class) and 20% nonresponders (same NYHA class or decline of status; need for heart transplant; death due to progressive pump failure). No significant differences in baseline clinical and functional variables between the two subgroups were observed. In responders, there was a highly significant global improvement of all variables; in nonresponders, no parameters changed between baseline and follow-up. CONCLUSION: These data confirm the role of biventricular pacing in improving the functional status of the great majority of a selected patient population having advanced heart failure and left bundle branch block with wide QRS complex. Basal demographic, clinical, and functional characteristics are not helpful in preliminary selection of responders. Simple evaluation of NYHA class confirms favorable outcome (improvement of functional and hemodynamic status).

Bundle-Branch Block↗