One Hospital ClinicalService Project

One Hospital ClinicalService is a project aiming to provide information and analysis of clinical and device data, back to the treating healthcare providers regarding their own patients, in order to help those healthcare providers improve outcomes and understanding of their patients' care or patients' management.

The mission of the One Hospital ClinicalService Project is to improve outcomes and comprehension of diagnostic and therapeutic strategies applied to patients wearing Medtronic implantable devices or treated by Medtronic therapies. One Hospital ClinicalService provides services to evaluate and improve the quality of clinical care in the International clinical practice.

One Hospital ClinicalService collects acute and chronic patient and device data in a large population during routine usage of the device, without specific study interventions, and always within the approved intended use of the device.

One Hospital ClinicalService uses a core database which can be expanded with specific data sets for particular patient populations, diseases, therapies, devices or features.

One Hospital ClinicalService, with its prospective data collection and its data management infrastructure, forms a data-bank where physicians collect patient data and from which they receive reports about clinical and device diagnostics data. Usage and understanding of diagnostics data may help physicians to optimize tailor device programming and patient therapies. This data-bank, queried by retrospective statistical analyses, may help physicians in quality improvement activities, education, research and scientific activities.

Some examples of scientific focus available through the One Hospital ClinicalService Project include:

* Describing the use of implantable devices, such as cardioverter defibrillator (ICD), pacemakers, implantable loop recorders or others in the Italian clinical practice
* Identifying predictors or clinical variables correlated with clinical outcomes or therapy response
* Evaluating and testing methods to optimize device programming and patient therapy via device diagnostics or patient reports

• Implantable Cardioverter-Defibrillator (ICD) (Device): Medtronic market-released implantable cardioverter-defibrillator
• Implantable Pacemaker Generator (IPG) (Device): Medtronic market-released implantable pacemaker generator
• Implantable Loop Recorder (ILR) (Device): Medtronic market-released implantable loop recorder
• Cardiac Resynchronization Therapy-Defibrillator (CRT-D) (Device): Medtronic market-released cardiac resynchronization therapy defibrillator
• Implantable devices working as neurostimulators, stents, spinal/bone devices or other applications (Device): Medtronic market-released implantable devices used as neurostimulators, stents, spinal/bone devices or for other applications

Primary outcomes

• Mortality [10 years]

Secondary outcomes

• Hospitalizations [10 years]

Other outcomes

• Device interventions [10 years]

Sex: All

Inclusion Criteria:

* Patients wearing a Medtronic market-released device or treated by a Medtronic therapy who have signed a patient data release and informed consent form

Exclusion Criteria:

* Patients unwilling or unable to cooperate or give voluntary consent

• Results publication: Moltrasio M, Iacopino S, Arena G, Pieragnoli P, Molon G, Manfrin M, Verlato R, Ottaviano L, Rovaris G, Catanzariti D, Cipolletta L, Nicolis D, Cattafi G, Tondo C; 1STOP ClinicalService centers. First-line therapy: insights from a real-world analysis of cryoablation in patients with atrial fibrillation. J Cardiovasc Med (Hagerstown). 2021 Aug 1;22(8):618-623. doi: 10.2459/JCM.0000000000001176. PMID 34009837
• Results publication: Giannola G, Torcivia R, Airo Farulla R, Cipolla T. Outsourcing the Remote Management of Cardiac Implantable Electronic Devices: Medical Care Quality Improvement Project. JMIR Cardio. 2019 Dec 18;3(2):e9815. doi: 10.2196/cardio.9815. PMID 31845898
• Results publication: Ricciardi D, Arena G, Verlato R, Iacopino S, Pieragnoli P, Molon G, Manfrin M, Allocca G, Cattafi G, Sirico G, Rovaris G, Sciarra L, Nicolis D, Tondo C. Sex effect on efficacy of pulmonary vein cryoablation in patients with atrial fibrillation: data from the multicenter real-world 1STOP project. J Interv Card Electrophysiol. 2019 Oct;56(1):9-18. doi: 10.1007/s10840-019-00601-3. Epub 2019 Aug 26. PMID 31452001
• Results publication: Perego GB, Iacopino S, Molon G, Arena G, Verlato R, Pieragnoli P, Curnis A, Allocca G, Nicolis D, Sciarra L, Catanzariti D, Senatore G, Rovaris G, Brasca F, Tondo C; ClinicalService 1STOP project i Project Investigators. Cryoablation for paroxysmal and persistent AF in patients with structural heart disease and preserved ejection fraction: Clinical outcomes from 1STOP, a multicenter observational project. J Cardiol. 2019 Jul;74(1):19-26. doi: 10.1016/j.jjcc.2019.02.015. Epub 2019 Apr 1. PMID 30948185
• Results publication: Landolina M, Arena G, Iacopino S, Verlato R, Pieragnoli P, Curnis A, Lunati M, Rauhe W, Senatore G, Sciarra L, Molon G, Agricola PMG, Padeletti L, Tondo C. Center experience does not influence long-term outcome and peri-procedural complications after cryoballoon ablation of paroxysmal atrial fibrillation: Data on 860 patients from the real-world multicenter observational project. Int J Cardiol. 2018 Dec 1;272:130-136. doi: 10.1016/j.ijcard.2018.07.051. Epub 2018 Jul 18. PMID 30045822
• Results publication: Stabile G, Tondo C, Curnis A, Lunati M, Manfrin M, Molon G, Sciarra L, Mantica M, Iacopino S, Arena G, Landolina M, Arestia A, Verlato R. Efficacy of cryoballoon ablation in patients with paroxysmal atrial fibrillation without time to pulmonary vein isolation assessment. Int J Cardiol. 2018 Dec 1;272:118-122. doi: 10.1016/j.ijcard.2018.07.070. Epub 2018 Jul 20. PMID 30037629
• Results publication: Lunati M, Arena G, Iacopino S, Verlato R, Tondo C, Curnis A, Porcellini S, Sciarra L, Molon G, Senatore G, Leoni L, Perego GB, Rauhe W, Pepi P, Landolina M. Is the time between first diagnosis of paroxysmal atrial fibrillation and cryoballoon ablation a predictor of efficacy? J Cardiovasc Med (Hagerstown). 2018 Aug;19(8):446-452. doi: 10.2459/JCM.0000000000000688. PMID 29927782
• Results publication: Gasparini M, Kloppe A, Lunati M, Anselme F, Landolina M, Martinez-Ferrer JB, Proclemer A, Morani G, Biffi M, Ricci R, Rordorf R, Mangoni L, Manotta L, Grammatico A, Leyva F, Boriani G. Atrioventricular junction ablation in patients with atrial fibrillation treated with cardiac resynchronization therapy: positive impact on ventricular arrhythmias, implantable cardioverter-defibrillator therapies and hospitalizations. Eur J Heart Fail. 2018 Oct;20(10):1472-1481. doi: 10.1002/ejhf.1117. Epub 2017 Dec 18. PMID 29251799
• Results publication: Boriani G, Lip GYH, Ricci RP, Proclemer A, Landolina M, Lunati M, Padeletti L, Zanotto G, Molon G, Biffi M, Rordorf R, Quartieri F, Gasparini M. The increased risk of stroke/transient ischemic attack in women with a cardiac implantable electronic device is not associated with a higher atrial fibrillation burden. Europace. 2017 Nov 1;19(11):1767-1775. doi: 10.1093/europace/euw333. PMID 28031277
• Results publication: Padeletti L, Curnis A, Tondo C, Lunati M, Porcellini S, Verlato R, Sciarra L, Senatore G, Catanzariti D, Leoni L, Landolina M, Delise P, Iacopino S, Pieragnoli P, Arena G. Pulmonary Vein Isolation with the Cryoballoon Technique: Feasibility, Procedural Outcomes, and Adoption in the Real World: Data from One Shot Technologies TO Pulmonary Vein Isolation (1STOP) Project. Pacing Clin Electrophysiol. 2017 Jan;40(1):46-56. doi: 10.1111/pace.12975. Epub 2016 Dec 22. PMID 27862043
• Results publication: Zoppo F, Facchin D, Molon G, Zanotto G, Catanzariti D, Rossillo A, Baccillieri MS, Menard C, Comisso J, Gentili A, Grammatico A, Bertaglia E, Proclemer A. Improving atrial fibrillation detection in patients with implantable cardiac devices by means of a remote monitoring and management application. Pacing Clin Electrophysiol. 2014 Dec;37(12):1610-8. doi: 10.1111/pace.12474. Epub 2014 Aug 12. PMID 25113510
• Results publication: Ricci RP, Pignalberi C, Landolina M, Santini M, Lunati M, Boriani G, Proclemer A, Facchin D, Catanzariti D, Morani G, Gulizia M, Mangoni L, Grammatico A, Gasparini M; ClinicalService cardiological centres. Ventricular rate monitoring as a tool to predict and prevent atrial fibrillation-related inappropriate shocks in heart failure patients treated with cardiac resynchronisation therapy defibrillators. Heart. 2014 Jun;100(11):848-54. doi: 10.1136/heartjnl-2013-305259. Epub 2014 Mar 28. PMID 24682569
• Results publication: Verlato R, Facchin D, Catanzariti D, Molon G, Zanotto G, Morani G, Brieda M, Zanon F, Delise P, Leoni L, Comisso J, Campo C. Clinical outcomes in patients with implantable cardioverter defibrillators and Sprint Fidelis leads. Heart. 2013 Jun;99(11):799-804. doi: 10.1136/heartjnl-2012-303259. Epub 2013 Feb 22. PMID 23434626
• Results publication: Boriani G, Santini M, Lunati M, Gasparini M, Proclemer A, Landolina M, Padeletti L, Botto GL, Capucci A, Bianchi S, Biffi M, Ricci RP, Vimercati M, Grammatico A, Lip GY; Italian ClinicalService Project. Improving thromboprophylaxis using atrial fibrillation diagnostic capabilities in implantable cardioverter-defibrillators: the multicentre Italian ANGELS of AF Project. Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):182-8. doi: 10.1161/CIRCOUTCOMES.111.964205. Epub 2012 Feb 28. PMID 22373906
• Results publication: Landolina M, Gasparini M, Lunati M, Iacopino S, Boriani G, Bonanno C, Vado A, Proclemer A, Capucci A, Zucchiatti C, Valsecchi S, Ricci RP, Santini M; Cardiovascular Centers Participating in the ClinicalService Project. Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database. Circulation. 2011 Jun 7;123(22):2526-35. doi: 10.1161/CIRCULATIONAHA.110.015024. Epub 2011 May 16. PMID 21576653
• Results publication: Santini M, Gasparini M, Landolina M, Lunati M, Proclemer A, Padeletti L, Catanzariti D, Molon G, Botto GL, La Rocca L, Grammatico A, Boriani G; cardiological centers participating in ClinicalService Project. Device-detected atrial tachyarrhythmias predict adverse outcome in real-world patients with implantable biventricular defibrillators. J Am Coll Cardiol. 2011 Jan 11;57(2):167-72. doi: 10.1016/j.jacc.2010.08.624. PMID 21211688

• Giuseppe Boriani, MD, Study chair, Cardiology Department, Policlinico di Modena, University of Modena and Reggio Emilia