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4. Impact of CRT-D implantation on clinical outcomes and healthcare resource utilization: an Italian cohort study

Author

Landolina, M, Madotto, F, Mantovani, L, Lunati, M, Achilli, F, Curnis, A, Marzegalli, M, Procclemer, A, Fornari, C, Cesana, G, Landolina M, Madotto F, Mantovani LG, Lunati M, Achilli F, Curnis A, Marzegalli M, Procclemer A, Fornari C, Cesana G., Landolina, M, Madotto, F, Mantovani, L, Lunati, M, Achilli, F, Curnis, A, Marzegalli, M, Procclemer, A, Fornari, C, Cesana, G, Landolina M, Madotto F, Mantovani LG, Lunati M, Achilli F, Curnis A, Marzegalli M, Procclemer A, Fornari C, and Cesana G.

Published
2016

5. Impact of ICD/CRT-D implantation on healthcare resources utilization: an Italian cohort study.

Author

Landolina, M, Lunati, M, Madotto, F, Conti, S, Chiodini, V, Mantovani, L, Achilli, F, Curnis, A, Marzegalli, M, Proclemer, A, Fornari, C, Giancarlo, G, Lunati M, Madotto F, Conti S, Chiodini V, Mantovani LG, Achilli F, Curnis A, Marzegalli M, Proclemer A, Fornari C, Giancarlo G.C., Landolina, M, Lunati, M, Madotto, F, Conti, S, Chiodini, V, Mantovani, L, Achilli, F, Curnis, A, Marzegalli, M, Proclemer, A, Fornari, C, Giancarlo, G, Lunati M, Madotto F, Conti S, Chiodini V, Mantovani LG, Achilli F, Curnis A, Marzegalli M, Proclemer A, Fornari C, and Giancarlo G.C.

Published
2016

6. Impact of ICD /CRT-D implantation on healthcare resources utilization: an Italian cohort study

Author

Achilli, F., Madotto, F., Mantovani, L. G., Maurizio Eugenio Landolina, Lunati, M., Curnis, A., Marzegalli, M., Proclemer, A., Fornari, C., Cesana, G., Achilli, F, Madotto, F, Mantovani, L, Landolina, M, Lunati, M, Curnis, A, Marzegalli, M, Proclemer, A, Fornari, C, and Cesana, G

Subjects
MED/42 - IGIENE GENERALE E APPLICATA, CRT-d implantation, healthcare cost
Published
2016

7. Remote monitoring reduces healthcare utilization and improbe quality of care in heart failure patients with implantable defribillators: the EVOLVO (Evolution of Management Strategies of Heart Failure Patients with Implantable Defribillators) Study

Author

Landolina, M, Perego, G, Lunati, M, Curnis, A, Guenzati, G, Vicentini, A, Parati, G, Borghi, G, Zanaboni, P, Valsecchi, S, Marzegalli, M, Perego, GB, Marzegalli, M., PARATI, GIANFRANCO, Landolina, M, Perego, G, Lunati, M, Curnis, A, Guenzati, G, Vicentini, A, Parati, G, Borghi, G, Zanaboni, P, Valsecchi, S, Marzegalli, M, Perego, GB, Marzegalli, M., and PARATI, GIANFRANCO

Abstract

Background—Heart failure patients with implantable cardioverter-defibrillators (ICDs) or an ICD for resynchronization therapy often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. We hypothesized that Internet-based remote interrogation systems could reduce emergency healthcare visits. Methods and Results—This multicenter randomized trial involving 200 patients compared remote monitoring with standard patient management consisting of scheduled visits and patient response to audible ICD alerts. The primary end point was the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related events. Over 16 months, such visits were 35% less frequent in the remote arm (75 versus 117; incidence density, 0.59 versus 0.93 events per year; P 0.005). A 21% difference was observed in the rates of total healthcare visits for heart failure, arrhythmias, or ICD-related events (4.40 versus 5.74 events per year; P 0.001). The time from an ICD alert condition to review of the data was reduced from 24.8 days in the standard arm to 1.4 days in the remote arm (P 0.001). The patients’ clinical status, as measured by the Clinical Composite Score, was similar in the 2 groups, whereas a more favorable change in quality of life (Minnesota Living With Heart Failure Questionnaire) was observed from the baseline to the 16th month in the remote arm (P 0.026). Conclusions—Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare use in patients with ICD or defibrillators for resynchronization therapy. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients.

Published
2012

8. Continuity of care in patients with cardiac failure after acute event [Percorsi e continuità assistenziale nel paziente con scompenso cardiaco dopo evento acuto]

Author

Tridico, C, Fontana, G, Diaco, T, Oliva, F, Giordano, A, Senni, M, Filippi, A, Marzegalli, M, Fiorini, G, Ambrosetti, M, Febo, O, Commissione Cardiocerebrovascolare, Sottocommissione, Tridico C, Fontana G, Diaco T, Oliva F, Giordano A, Senni M, Filippi A, Marzegalli M, Fiorini G, Ambrosetti M, Febo O, Tridico, C, Fontana, G, Diaco, T, Oliva, F, Giordano, A, Senni, M, Filippi, A, Marzegalli, M, Fiorini, G, Ambrosetti, M, Febo, O, Commissione Cardiocerebrovascolare, Sottocommissione, Tridico C, Fontana G, Diaco T, Oliva F, Giordano A, Senni M, Filippi A, Marzegalli M, Fiorini G, Ambrosetti M, and Febo O

Published
2010

10. Continuity of care in patients with cardiac failure after acute event [Percorsi e continuità assistenziale nel paziente con scompenso cardiaco dopo evento acuto]

Author

Tridico C, Fontana G, Diaco T, Oliva F, Giordano A, Senni M, Filippi A, Marzegalli M, Fiorini G, Ambrosetti M, Febo O, Commissione Cardiocerebrovascolare, Sottocommissione, Tridico, C, Fontana, G, Diaco, T, Oliva, F, Giordano, A, Senni, M, Filippi, A, Marzegalli, M, Fiorini, G, Ambrosetti, M, Febo, O, Commissione Cardiocerebrovascolare, and Sottocommissione

Subjects
Heart Failure, Acute Disease, Continuity of Patient Care, Human
Published
2010

12. Il Progetto Criteria: telesorveglianza sanitaria domiciliare ed ospedalizzazione postcardiochirurgica: due modelli assistenziali mediante telemedicina sperimentati su 443 pazienti

Author

Marzegalli, M, Polvani, G, Giordano, A, Scalvini, S, Lombroso, S, Medici, A, Roberto, M, Borghi, G, Luzzi, L, Marzegalli, M, Polvani, G, Giordano, A, Scalvini, S, Lombroso, S, Medici, A, Roberto, M, Borghi, G, and Luzzi, L

Subjects
telesorveglianza sanitaria domiciliare, ospedalizzazione postcardiochirurgica
Published
2006

13. The Economic Impact of The use of Implantable Cardioverter Defibrillator In Primary Prevention

Author

Madotto, F, Conti, S, Chiodini, V, Mantovani, L, Achilli, F, Curnis, A, Landolina, M, Lunati, M, Marzegalli, M, Proclemer, A, Fornari, C, Cesana, G, MADOTTO, FABIANA, CONTI, SARA, MANTOVANI, LORENZO GIOVANNI, FORNARI, CARLA, CESANA, GIANCARLO, Madotto, F, Conti, S, Chiodini, V, Mantovani, L, Achilli, F, Curnis, A, Landolina, M, Lunati, M, Marzegalli, M, Proclemer, A, Fornari, C, Cesana, G, MADOTTO, FABIANA, CONTI, SARA, MANTOVANI, LORENZO GIOVANNI, FORNARI, CARLA, and CESANA, GIANCARLO

Published
2015

18. Impact of mitral regurgitation on the outcome of patients treated with CRT-D: Data from the InSync ICD Italian registry

Author

Giuseppe, Boriani, M. D., H. D., P, Maurizio, Gasparini, † MAURIZIO LANDOLINA, ‡ MAURIZIO LUNATI, MAURO BIFFI, Massimo, Santini, LUIGI PADELETTI, Giulio, Molon, †† GIANLUCA BOTTO, ‡‡ TIZIANA DE SANTO, B. S., and SERGIO VALSECCHI, Gasparini, M., Galimberti, P., Regoli, F., Ceriotti, C., Istituto Clinico Humanitas, Rozzano-, Milano, Lunati, M., Cattafi, G., Magenta, G., Paolucci, M., Vecchi, R., Niguarda, Hospital, Milano, Santini, M., Ricci, R., San Filippo Neri, Roma, Gaita, F., Bocchiardo, M., Didonna, P., Caponi, D., Civile, Hospital, Asti, Tavazzi, L., Landolina, M., Rordorf, R., Petracci, B., Vicentini, A., Savastano, S., Matteo, Pol. S., Pavia, Padeletti, L., Pieragnoli, P., Careggi, Firenze, Vincenti, A., Deceglia, S., Cir ` o, A., Gerardo Dei Tintori, S., Monza(MI), Curnis, A., Mascioli, G., Spedali, Civili, Brescia, Puglisi, A., Bianchi, S., Peraldo, C., Fatebenefratelli, Roma, Sassara, M., Achilli, A., Turreni, F., Rossi, P., Belcolle, Hospital, Viterbo, Perego, Gb., Luca Auxologico, S., Ravazzi, P. A., Diotallevi, P., Antonio e Biagio, Ss., Alessandria, Tritto, M., Mater, Domini, Castellanza, (VA), Carboni, A., Ardissino, D., Gonzi, G., Serra, V., Civile, Parma, Vergara, G., Maria Del Carmine, S., Rovereto, (TN), Boriani, G., Biffi, M., Martignani, C., Diemberger, I., Orsola-Mailpighi, S., Bologna, Luzzi, G., Policlinico, Bari, Laurenzi, F., Camillo, S., Pistis, G., Mauriziano, Torino, Cesario, A., Grassi, G. B., Ostia, (RM), Zanotto, G., Civile, Verona, Orazi, S., Rieti, Ometto, R., Bonanno, C., Bortolo, S., Vicenza, Molon, G., Barbieri, E., Cuore, S., Negrar, (VR), Raviele, A., Gasparini, G., Umbertoi, Mestre, (VE), Botto, G., Luzi, M., Sagone, A., Anna, S., Como, Vado, A., Croce, S., Cuneo, Montenero, A., Multimedica, Giovanni (MI), Sestos., Inama, G., Maggiore, Crema, Sassone, B., Civile, Bentivoglio, (BO), Briedda, M., Zardo, F., Maria, S., Pordenone, E. Bertaglia, Mirano (VE), Proclemer, A., Udine, Zanon, F., Civile, Rovigo, Disertori, M., Gramegna, L., Delgreco, M., Dallafior, D., Chiara, S., Trento, Tomasi, C., Maresta, A., Piancastelli, M., Maria Croci, S., Ravenna, Bridda, A., Martino, S., Belluno, Mantovan, R., C`afoncello, Treviso, Fusco, A., Pederzoli, Peschiera, (VR), Baraldi, P., Agostino, S., Modena, G. Lonardi, Legnago (VR), Rahue, W., Maurizio, S., Bolzano, P. Delise, Conegliano (TV), Menozzi, C., Marianuova, S., Reggioemilia, Babudri, P., Borgoroma, Verona, Marconi, R., Mazzoni, Ascolipiceno, Alfano, G. DeFabrizio F., Moscati, G., Avellino, Barbato, G., Maggiore, Bologna, P. Gelmini, Desenzano (BS), Disabato, Leopoldo, S., Merate, (LC), Ricci, S., Ramazzini, Carpi, (MO), Aulerio, M. D., Biagio, S., Domodossola, (VB), Morgagni, G. L., Latini, R., Macerata, Bardelli, G., Fornaroli, Magenta, (MI), R. Paulichl, F. Tappeiner Merano (BZ), Bernasconi, M., Marzegalli, M., Carlo, S., Neri, G., Montebelluna, Treviso, E. Occhetta, Novara, Bocconcelli, P., Salvatore, S., Pesaro, A. Capucci, Piacenza, Campana, A., Giovanni, S., Salerno, N. Dibelardino, Velletri (RM), Vaglio, A., Giovanni, e Paolo, Venezi, A., Boriani G, Gasparini M, Landolina M, Lunati M, Biffi M, Santini M, Padeletti L, Molon G, Botto G, de Santo T, Valsecchi S, and InSync/InSync ICD Italian Registry Investigators.

Subjects
Male, Mitral Valve Insufficiency, Socio-culturale, heart failure, Comorbidity, CARDIAC RESYNCHRONIZATION THERAPY, mitral regurgitation, Risk Assessment, Survival Analysis, Survival Rate, Treatment Outcome, Italy, Risk Factors, Prevalence, Humans, Female, Registries, Aged
Abstract

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 outcome.

Published
2012

21. BIVentricular versus right ventricular antitachycardia pacing to terminate ventricular tachyarrhythmias in patients receiving cardiac resynchronization therapy: The ADVANCE CRT-D Trial

Author

Gasparini, M, Anselme, F, Clementy, J, Santini, M, Martínez-Ferrer, J, De Santo, T, Santi, E, Schwab, Jo, F, Ricci, R, Kloppe, A, Lunati, M, Proclemer, A, Molon, G, Delache, B, Poschmann, G, Vincenti, A, Hügl, B, Babuty, D, Martinez Ferrer, J, Alzueta Rodriguez, J, Mabo, P, Tritto, M, Bocchiardo, M, Senatore, G, Peinado, R, Tercedor, L, Davy, Jm, Elbaz, N, Glikson, M, Libero, L, Adornato, F, Mantovan, R, Pasquie, Jl, Lavergne, T, Curnis, A, Valle Tudela, V, Schäfer, J, Occhetta, E, Marzegalli, M, Cappato, R, Arenal, A, Barnay, C, Camous, Jp, Durand, P, Mermi, J, Aharon Glick SV, Solimene, F, Botto, G, Ivaldi, M, Zecchi, P, de Sousa AE, Betts, T, Bru, P, Dinanian, S, Deharo, Jc, Leenhardt, A, Sbragia, P, Da Costa, A, Geist, M, Calvi, V, Zardini, M, Orland, M, Ledesma Garcia, J, Martinez, J, Mainardis, M, Cantù, F, Leclercq, Jf, García Robles JA, Wiezcorek, M, Brambilla, R, Hennersdorf, M, Pignalberi, C, Ruiz, A, Rebellato, L, Pedrinazzi, C, Kajackas, A, Burrone, V, Martin, E, Farges, E, Silveira, J, and Pepe, M.

Subjects
Male, Tachycardia, medicine.medical_specialty, Heart Ventricles, medicine.medical_treatment, Population, Electric Countershock, Cardiac resynchronization therapy, Ventricular tachycardia, Disease-Free Survival, Electrocardiography, Internal medicine, Humans, Medicine, Single-Blind Method, Prospective Studies, education, Aged, education.field_of_study, Presyncope, medicine.diagnostic_test, business.industry, Cardiac Pacing, Artificial, medicine.disease, Defibrillators, Implantable, Survival Rate, Treatment Outcome, Anesthesia, Ventricular fibrillation, Tachycardia, Ventricular, Antitachycardia Pacing, Cardiology, Female, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract

Background This multicenter, prospective, randomized, controlled, parallel trial compares the efficacy of biventricular (BIV) versus right ventricular (RV) antitachycardia pacing (ATP) in terminating all kinds of ventricular tachycardia (VT). Methods Five hundred twenty-six patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device were enrolled and randomized 1:1 to either BIV (266) or RV (260) ATP (single burst 8 pulse, 88% coupling interval) and were followed up for 12 months. Results During 12 months' follow-up, 1,077 ventricular episodes in 180 patients were detected and classified: 634 true VTs divided into 69 ventricular fibrillation (VF) (11%), 202 fast ventricular tachycardia (FVT) (32%), and 363 VT (57%). A comparable first ATP efficacy (BIV 65% vs RV 68%, P = .59) was observed in FVT + VT, in VT zone (BIV 62% vs RV 71%, P = .25), and in FVT zone (BIV 71% vs RV 61%, P = .34). A trend toward lower accelerations during ATP applied to FVT was observed in the BIV group (3.5% BIV vs 10.2% RV, P = .163). No syncope/presyncope occurred during ATP for FVT in the BIV group versus 4 events (3.2%) in the RV group ( P = .016). biventricular ATP was more effective in treating FVT in coronary artery disease (CAD) patients ( P = .032), whereas both modalities presented similar efficacy in patients with non-CAD etiology ( P = .549). Conclusions Antitachycardia pacing is effective in patients implanted with a CRT-D device. No significant differences in efficacy emerged between BIV- and RV-delivered ATP in the general population, whereas BIV ATP seems to present a safer profile in ischemic patients.

Published
2010

22. 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

Author

Boriani, G, Gasparini, M, Landolina, M, Lunati, M, Biffi, M, Santini, M, Padeletti, L, Molon, G, Botto, G, De Santo, T, Valsecchi, S, Galimberti, P, Regoli, F, Ceriotti, C, Cattafi, G, Magenta, G, Paolucci, M, Vecchi, R, Ricci, R, Gaita, F, Bocchiardo, M, Didonna, P, Caponi, D, Tavazzi, L, Rordorf, R, Petracci, B, Vicentini, A, Savastano, S, Matteo, Ps, Pieragnoli, P, Vincenti, A, Deceglia, S, Ciró, A, Gerardo Dei Tintori, S, Curnis, A, Mascioli, G, Puglisi, A, Bianchi, S, Peraldo, C, Sassara, M, Achilli, A, Turreni, F, Rossi, P, Perego, Gb, Ravazzi, Pa, Diotallevi, P, Antonio, e Biagio SS, Tritto, M, Carboni, A, Ardissino, D, Gonzi, G, Serra, V, Vergara, G, Maria Del Carmine, S, Martignani, C, Frabetti, L, Orsola-Mailpighi, S, Luzzi, G, Laurenzi, F, Camillo, S, Pistis, G, Cesario, A, Grassi, Gb, Zanotto, G, Orazi, S, Ometto, R, Bonanno, C, Bortolo, S, Barbieri, E, Cuore, S, Raviele, A, Gasparini, G, Luzi, M, Sagone, A, Anna, S, Vado, A, Croce, S, Montenero, A, Giovanni, Ss, Inama, G, Sassone, B, Briedda, M, Zardo, F, Maria, S, Bertaglia, E, Proclemer, A, Zanon, F, Disertori, M, Gramegna, L, Delgreco, M, Dallafior, D, Chiara, S, Tomasi, C, Maresta, A, Piancastelli, M, Maria Croci, S, Bridda, A, Martino, S, Mantovan, R, Fusco, A, Baraldi, P, Agostino, S, Lonardi, G, Rahue, W, Maurizio, S, Delise, P, Menozzi, C, Marianuova, S, Babudri, P, Marconi, R, Defabrizio, G, Alfano, F, Moscati, G, Barbato, G, Gelmini, P, Disabato, Leopoldo, S, Ricci, S, Aulerio, Md, Biagio, S, Morgagni, Gl, Latini, R, Bardelli, G, Paulichl, R, Tappeiner Merano, F, Bernasconi, M, Marzegalli, M, Carlo, S, Neri, G, Occhetta, E, Bocconcelli, P, Salvatore, S, Capucci, A, Campana, A, Giovanni, S, Dibelardino, N, Vaglio, A, Boriani G, Gasparini M, Landolina M, Lunati M, Biffi M, Santini M, Padeletti L, Molon G, Botto G, De Santo T, and Valsecchi S

Subjects
Cardiomyopathy, Dilated, Male, medicine.medical_specialty, Pacemaker, Artificial, medicine.medical_treatment, Cardiac resynchronization therapy, Cardiomyopathy, Heart Valve Diseases, Myocardial Ischemia, Socio-culturale, Heart failure, Aged, Atrial Fibrillation, Defibrillators, Implantable, Female, Heart Failure, Humans, Middle Aged, Registries, Treatment Outcome, Ventricular Remodeling, Cardiac Pacing, Artificial, Clinical Research, Internal medicine, medicine, cardiovascular diseases, Remodelling, Valvular heart disease, Heart transplantation, Ejection fraction, business.industry, valvular heart disease, Atrial fibrillation, Dilated cardiomyopathy, medicine.disease, Cardiology, cardiovascular system, Cardiology and Cardiovascular Medicine, business
Abstract

Aims To 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 results Patients 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. Conclusion In ‘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.

Published
2009

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

Author

Landolina, M, Gasparini, M, Lunati, M, Santini, M, Rodorf, R, Vincenti, A, Montenero AS, Diotallevi P., Bonanno, C, Desanto, T, Valsecchi, S, Padeletti, L, Galimberti, P, Regoli, F, Gronda, E, Cattafi, G, Magenta, G, Paolucci, M, Vecchi, R, Niguarda, Ricci, R, Gaita, F, Bocchiardo, M, Didonna, P, Caponi, D, Tavazzi, L, Rordorf, R, Petracci, B, Vicentini, A, Savastano, S, Pieragnoli, P, Deceglia, S, Cirò, A, Curnis, A, Mascioli, G, Puglisi, A, Bianchi, S, Peraldo, C, Sassara, M, Achilli, A, Turreni, F, Rossi, P, B Perego, G, A Ravazzi, P, Diotallevi, P, Carboni, A, Ardissino, D, Gonzi, G, Serra, V, Boriani, G, Biffi, M, Martignani, C, Frabetti, L, Luzzi, G, Laurenzi, F, Pistis, G, Cesario, A, Zanotto, G, Orazi, S, Ometto, R, Molon, G, Barbieri, E, Raviele, A, Gasparini, G, Botto, G, Luzi, M, Sagone, A, Vado, A, Montenero, A, Inama, G, Sassone, B, Briedda, M, Zardo, F, Bertaglia, E, Proclemer, A, Zanon, F, Disertori, M, Gramegna, L, Delgreco, M, Dallafior, D, Tomasi, C, Maresta, A, Piancastelli, M, Bridda, A, Mantovan, R, Fusco, A, Baraldi, P, Lonardi, G, Rahue, W, Delise, P, Menozzi, C, Babudri, P, Marconi, R, G De Fabrizio, Alfano, F, Barbato, G, Gelmini, P, Disabato, Ricci, S, D Aulerio, M, L Morgagni, G, Latini, R, Bardelli, G, Paulichl, R, Bernasconi, M, Marzegalli, M, Neri, G, Occhetta, E, Bocconcelli, P, Capucci, A, Campana, A, Dibelardino, N, Vaglio, A, Landolina M, Gasparini M, Lunati M, Santini M, Rordorf R, Vincenti A, Diotallevi P, Montenero AS, Bonanno C, De Santo T, Valsecchi S, Padeletti L, and InSync/InSync ICD Italian Registry Investigators [.., Boriani G,..]

Subjects
Male, medicine.medical_specialty, Time Factors, Cardiac pacing, medicine.medical_treatment, Socio-culturale, Heart Rate, Internal medicine, Heart rate variability, Medicine, Humans, In patient, Implanted device, Aged, Monitoring, Physiologic, Retrospective Studies, Heart transplantation, Heart Failure, Ventricular Remodeling, business.industry, Follow up studies, Cardiac Pacing, Artificial, Retrospective cohort study, Equipment Design, medicine.disease, Prognosis, Survival Rate, Heart failure, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract

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

Published
2008

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

Author

Lunati, M, Gasparini, M, Santini, M, Landolina, M, Perego, Gb, Pappone, C, Galimberti, P, Regoli, F, Gronda, E, Cattafi, G, Magenta, G, Paolucci, M, Vecchi, R, Ricci, R, Gaita, F, Bocchiardo, M, Didonna, P, Caponi, D, Tavazzi, L, Rordorf, R, Petracci, B, Vicentini, A, Deceglia, S, Cirò, A, Curnis, A, Mascioli, G, Puglisi, A, Bianchi, S, Sassara, M, Achilli, A, Turreni, F, Rossi, P, B Perego, G, A Ravazzi, P, Diotallevi, P, Tritto, M, Carboni, A, Ardissino, D, Gonzi, G, Serra, V, Vergara, G, Boriani, G, Biffi, M, Martignani, C, Frabetti, L, Orsola, S, Luzzi, G, Laurenzi, F, Pistis, G, Cesario, A, Zanotto, G, Orazi, S, Ometto, R, Bonanno, G, Molon, G, Barbieri, E, Raviele, A, Gasparini, G, Botto, G, Luzi, M, Sagone, A, Vado, A, Montenero, A, Inama, G, Sassone, B, Briedda, M, Zardo, F, Bertaglia, E, Proclemer, A, Zanon, F, Disertori, M, Gramegna, L, Delgreco, M, Dallafior, D, Tomasi, C, Maresta, A, Piancastelli, M, Bridda, A, Mantovan, R, Fusco, A, Baraldi, P, Lonardi, G, Rahue, W, Delise, P, Menozzi, C, Babudri, P, Marconi, R, De Fabrizio, F Alfano, Moscati, G, Barbato, G, Gelmini, P, Disabato, Ricci, S, D Aulerio, M, L Morgagni, G, Latini, R, Bardelli, G, Paulichl, R, Bernasconi, M, Marzegalli, M, Vicedomini, G, Augello, G, Paglino, G, Neri, G, Occhetta, E, Bocconcelli, P, Capucci, A, Campana, A, Dibelardino, N, and Vaglio, A

Subjects
Socio-culturale
Published
2008

29. PREDESTINATION: PRimary vEntricular fibrillation and suDden dEath during a firST myocardIal iNfArcTION: Genetic basis

Author

Grieco, N, Marzegalli, M, Paganoni, AM, De Ferrari, G, De Regibus, V, Gionti, V, Civardi, D, Insolia, R, Pedrazzini, M, Gentilini, D, Di Blasio, A, Crotti, L, Schwartz, P, De Ferrari GM, De Regibus V, Gionti V, Civardi D, Insolia R, Pedrazzini M, Gentilini D, Di Blasio A, Crotti L, Schwartz PJ, Grieco, N, Marzegalli, M, Paganoni, AM, De Ferrari, G, De Regibus, V, Gionti, V, Civardi, D, Insolia, R, Pedrazzini, M, Gentilini, D, Di Blasio, A, Crotti, L, Schwartz, P, De Ferrari GM, De Regibus V, Gionti V, Civardi D, Insolia R, Pedrazzini M, Gentilini D, Di Blasio A, Crotti L, and Schwartz PJ

Abstract

Sudden cardiac death (SCD) is the leading cause of death in the age group 20–65 years, in the western world, with an enormous social and economic impact. The majority of the cases of ventricular fibrillation (VF) occur in patients without a preexisting structural heart disease and represent the first manifestation of coronary artery disease. In most of these cases, VF occurs in the early phase of myocardial infarction (MI) and it is then called primary VF. Although several factors have been associated in various studies with primary VF a recent metaanalysis found no evidence for risk factors other than ST elevation and time from onset of symptoms. In the past several years, few studies have found that a family history of sudden cardiac death (SCD) is a risk factor for primary VF suggesting that this dramatic event may be favored by the genetic background. To explore this possibility we designed the ongoing PREDESTINATION Study, enrolling subjects under 75 years of age with a first MI complicated by primary VF and a control group of subjects with a first uncomplicated MI. Data so far available confirm the association between a family history of SCD and primary VF and suggest that hypokalemia and prolonged QT interval may favor its occurrence. The genetic analysis has already provided some interesting suggestions that will need to be confirmed by the continuation of the enrolment and joint analysis with data deriving from similar patient populations.

Published
2013

31. CV4 Evaluation of Telemonitoring for Heart Failure Patients With Implantable Defibrillators: The Evolvo (Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators) Study

Author

Zanaboni, P., primary, Marzegalli, M., additional, Landolina, M.E., additional, Lunati, M., additional, Perego, G.B., additional, Guenzati, G., additional, Curnis, A., additional, Borghetti, F, additional, Beccagutti, G., additional, Borghi, G., additional, and Masella, C., additional

Published
2012
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32. ITALIAN MULTICENTER CLINICAL-EXPERIENCE WITH ENDOCARDIAL DEFIBRILLATION - ACUTE AND LONG-TERM RESULTS IN 307 PATIENTS

Author

Raviele, A, Gasparini, G, Capestro, F, Renzi, R, Favale, S, Rizzon, P, Capucci, A, Boriani, G, Marchini, A, Verlato, R, Corrado, Domenico, Carli, L, Abbate, M, Calcaterra, V, Leone, G, Paparella, N, Alboni, P, Derosa, F, Plastina, F, Daulerio, M, Tirella, G, Benedini, G, Musso, G, Mureddu, R, Brignole, M, Oddone, D, Arlotti, M, Lotto, A, Lunati, M, Gasparini, M, Marzegalli, M, Bernasconi, M, Vincenti, A, Ciro, A, Musto, B, Donofrio, A, Renzulli, A, Cotrufo, M, Occhetta, E, Plebani, L, Deponti, R, Salerno, Ja, Bongiorni, Mg, Biagini, A, Pulitano, G, Adornato, E, Pennisi, V, Dini, P, Adinolfi, E, Bellocci, F, Zecchi, P, Auricchio, A, Scafuri, A, Potenza, D, Fanelli, R, Fazzari, M, Pistis, G, Libero, L, Giustetto, C, Vergara, G, Furlanello, F, Petz, E, Morgera, T, Proclemer, A, Feruglio, Ga, Onofri, M, Caico, S, Vicentini, A, Peranzoni, G, and Ometto, R.

Subjects
medicine.medical_specialty, Ejection fraction, business.industry, Defibrillation, medicine.medical_treatment, General Medicine, Ventricular tachycardia, medicine.disease, Sudden death, Defibrillation threshold, Internal medicine, Shock (circulatory), Multicenter trial, Ventricular fibrillation, medicine, Cardiology, medicine.symptom, Cardiology and Cardiovascular Medicine, business
Abstract

This study presents the acute and long-term results of 307 patients (267 men, mean age 57.5 years, 205 suffering from coronary artery disease, mean left ventricular ejection fraction 33.3%) with malignant ventricular tachyarrhythmias who underwent attempted transvenous ICD implantation with the CPI Endotak lead system in 37 Italian centers. Transvenous ICD implantation was ultimately accomplished in 306 (99.7%) patients. These included 19 subjects with high (< 10 J below output energy of implanted device) defibrillation threshold (DFT) at implant. One hundred sixty-four patients (53%) were implanted with the endocardial lead alone, while 142 also received an SQ patch or SQ array. The mean DFT (not always step-down DFT) at implant was 16.9 +/- 5.7 joules; 15.3 +/- 5.2 joules with biphasic shock and 19.6 +/- 5.4 joules with monophasic shock; P < 0.0001. A significantly higher percentage of patients tested with a biphasic shock could be implanted with adequate safety margin and without an additional SQ patch or SQ array (98% and 81%, respectively). No perioperative deaths occurred. During the mean follow-up of 14.5 +/- 10.2 months, 140 patients (52%) received at least one appropriate shock. An inappropriate shock was observed in 26% of episodes. The 1- and 3-year actuarial incidence of sudden death was 2% and 4%, respectively, and that of total death was 10% and 20%, respectively. A pocket infection requiring ICD explantation occurred in 4 patients (1.4%) and an endocardial lead dislodgment in 11 patients (3.6%). Two patients (0.3%) showed a sensing pin disconnection and six patients (2.3%) had a lead insulation break. The results of this Italian multicenter trial indicate that the CPI Endotak lead system is a simple, safe, and reliable system for endocardial defibrillation. When compared to epicardial leads, it clearly reduces the perioperative mortality and morbidity, while maintaining a similar efficacy in preventing sudden death and terminating ventricular arrhythmias.

Published
1995

42. Remote monitoring of CRT-ICD: the multicenter Italian carelink evaluation-ease of use, acceptance, and organizational implications.

Author

Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, and Santini M

Abstract

The Medtronic CareLink allows remote implantable device follow-up. In this first European experience with CareLink, we assessed the ease of use of the system, the acceptance, and satisfaction of patients and clinicians. Methods: Patients implanted with biventricular defibrillators for more than 6 months received the CareLink monitor and were trained to perform home device interrogation and transmission. Patient and clinician experience and preference were evaluated through specific questionnaires. Results: Sixty-seven patients were enrolled and were able to perform data transmissions during the 3-month study duration. The overall duration of interrogation procedure was 7 ± 5 minutes, and frequently the procedure did not require the assistance of a caregiver. Patients reported a general preference for remote versus in-clinic follow-up and described a sense of reassurance created by the remote monitoring capability. In the centers, the review procedure was successful; its mean duration was 5 ± 2 minutes per transmission and the users indicated that the access and navigation of the review website were easy. At the end of the evaluation, the data available for remote review were judged complete and adequate to provide almost the same standard of care as that offered in traditional in-clinic visit. In general, the remote monitoring was seen as a potential tool to improve the clinical management of patients with device. Conclusions: The ease of use, satisfaction, and acceptance of the CareLink Network in European clinical practice appears elevated both for patients and for clinicians. [ABSTRACT FROM AUTHOR]

Published
2008
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43. Follow-Up of CRT-ICD: implications for the use of remote follow-up systems. Data from the InSync ICD Italian Registry.

Author

Lunati M, Gasparini M, Santini M, Landolina M, Perego GB, Pappone C, Marzegalli M, Argiolas C, Murthy A, Valsecchi S, and InSync ICD Italian Registry Investigators

Abstract

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. [ABSTRACT FROM AUTHOR]

Published
2008
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50. Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively

Author

Campana Carlo, Guenzati Giuseppe, Pappone Alessia, Perego Giovanni B, Lunati Maurizio, Landolina Maurizio, Marzegalli Maurizio, Frigerio Maria, Parati Gianfranco, Curnis Antonio, Colangelo Irene, and Valsecchi Sergio

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Heart failure patients with implantable defibrillators (ICD) frequently visit the clinic for routine device monitoring. Moreover, in the case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits place a great burden on healthcare providers. Internet-based remote device interrogation systems, which give physicians remote access to patients' data, are being proposed in order to reduce routine and interim visits and to detect and notify alert conditions earlier. Methods The EVOLVO study is a prospective, randomized, parallel, unblinded, multicenter clinical trial designed to compare remote ICD management with the current standard of care, in order to assess its ability to treat and triage patients more effectively. Two-hundred patients implanted with wireless-transmission-enabled ICD will be enrolled and randomized to receive either the Medtronic CareLink® monitor for remote transmission or the conventional method of in-person evaluations. The purpose of this manuscript is to describe the design of the trial. The results, which are to be presented separately, will characterize healthcare utilizations as a result of ICD follow-up by means of remote monitoring instead of conventional in-person evaluations. Trial registration ClinicalTrials.gov: NCT00873899

Published
2009
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