Clinical trial NCT02076789: DEtect Long-term Complications After icD rEplacement: a Multicenter Italian Registry
Official title: Detect Long-term Complications After ICD Replacement: a Multicenter Italian Registry - DECODE Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Device Replacement
Device Upgrade
Long-term Postoperative Complications
Resource Consumption and Associated Costs After Device Replacement/Upgrade
Keywords: Device Replacement
Device Upgrade
Long-term Postoperative Complications
Resource consumption and associated costs after device replacement/upgrade
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing ICD generator replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies (consecutive patients)

Brief summary: This study has been designed to prospectively estimate long term complication rates (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD) replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies; the study also evaluates the predictors of complications, the patient's management before and during the replacement procedure in clinical practice and the estimated costs related to the use of health care resources.

Detailed description: Based on positive outcomes from numerous randomized, controlled trials, the implantable defibrillators have been included in the current European Society of Cardiology (ESC) and American College of Cardiology / American Heart Associations (ACC/AHA) guidelines as a standard of care in selected patients, and thus ICD use is currently increasing worldwide.

In the years after initial implantation, device replacement may become necessary for battery depletion or for upgrades to more complex multi-lead ICDs. The increase in generator or lead advisories and recalls contributes further to those patients considered for replacement.

The determination of procedural adverse events is complex, and requires monitoring of both short-term complications and long-term patient outcome.

Previous retrospective series have examined complications with ICD replacements. Moreover, the more recent REPLACE registry prospectively collected 6-month complication rates in patients undergoing pacemaker or ICD generator replacement at 72 private practice and academic sites in United States. This study examined a broad range of major and minor complications and found that ICD replacements were associated with a notable complication risk, particularly when a transvenous lead addition or revision was required.

Previous retrospective series have examined complications with ICD implantation in the Italian clinical practice, showing frequent interventions for system revision and demonstrating an association between adverse events and the complexity of the implanted device (i.e. Cardiac Resynchronization Therapy CRT-D versus single- or dual-chamber ICD). Moreover, it was shown that device replacement procedures are associated with significantly higher risk of infections.

Nonetheless, detailed data on the complications of ICD replacement in the current Italian clinical practice are unavailable.

This information would be particularly important because ICD replacement-related events may be associated not only with a worse clinical outcome, but also with incremental costs to the healthcare system.

The analysis of adverse events would permit to study new preventative strategies with significant clinical as well as financial benefits. Moreover, the quantification of the complication rate after ICD replacement would permit to estimate the actual long-term cost of ICD therapy, and to assess the impact of ICD longevity on the cost-effectiveness of the therapy.

This study has been designed to prospectively estimate long term complication rates (at 12-months and 5-years) in patients undergoing ICD generator replacement. The study also evaluates predictors of complications, patient's management before and during the replacement procedure in clinical practice and the estimated costs related to the use of health care resources.

All consecutive patients with standard indications to ICD generator replacement will be enrolled In this study. The decision to perform the generator replacement or to upgrade an existing device will be made according to the investigators' clinical assessment of their patient. The study do not mandate specific surgical or implantation techniques such as venous access, use of temporary pacemakers, or surgical site choices. Any commercially available generator or lead can be included.

Patients will be followed for a 60-month period with periodical in-hospital visits or remote ICD interrogations via remote patient monitoring (RPM) systems, according to the standard hospital practice and the physician's discretion.

Eligibility criteria: Inclusion Criteria:

* Patient implanted with a CardiacResynchronizationTherapy-Defibrillator or single chamber/dual chambers ICD device (any commercially available generator or lead can be included).
* Patient with standard indications to ICD generator replacement according to the investigators' clinical assessment.
* Patient must be able to attend all required follow-up visits at the study center.

Exclusion Criteria:

* Patient is less than 18 years of age.
* Patient is unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
* Patient life expectancy is less than 12 months.
* Patient is participating in another clinical study that may have an impact on the study endpoints.

Primary outcomes:
measure: Rate of complications associated with the ICD replacement / upgrade that occur during a period of 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Baseline patient's characteristics (clinical history and drug therapy) for subjects undergoing ICD replacement/upgrade
timeFrame: 60 months
measure: - Rate of complications associated with the ICD replacement / upgrade that occur during a very long-term period
timeFrame: 60 months
measure: Long-term costs of ICD/upgrade procedure
timeFrame: 60 months
Other outcomes:
Locations:
city: Carbonara di Bari
country: Italy
facility: Ospedale di Venere
state: Bari
city: Bergamo
country: Italy
facility: A.O. "Papa Giovanni XXIII"
state: BG
city: Bentivoglio
country: Italy
facility: Ospedale di Bentivoglio
state: Bologna
city: Cento
country: Italy
facility: Ospedale SS. Annunziata
state: Ferrara
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
state: FG
city: Cesena
country: Italy
facility: Ospedale "Maurizio Bufalini"
state: Forlì
city: Lodi
country: Italy
facility: Ospedale Maggiore
state: LO
city: Baggiovara
country: Italy
facility: Ospedale Civile S.Agostino-Estense
state: Modena
city: Palermo
country: Italy
facility: A.O.U.P. "Paolo Giaccone"
state: PA
city: Rome
country: Italy
facility: Policlinico Universitario "Agostino Gemelli"
state: RM
city: Siena
country: Italy
facility: Ospedale Santa Maria alle Scotte
state: SI
city: Taranto
country: Italy
facility: Casa di Cura "Villa Verde"
state: TA
city: Arezzo
country: Italy
facility: Ospedale "San Donato"
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria , Policlinico Sant'Orsola
city: Campobasso
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Cuneo
country: Italy
facility: Ospedale Cuneo
city: Empoli
country: Italy
facility: Ospedale "San Giuseppe"
city: Ferrara
country: Italy
facility: A.O.S.Anna
city: Forlì
country: Italy
facility: Ospedale "Morgagni-Pierantoni"
city: Genova
country: Italy
facility: Ospedale "Padre Antero Micone" - Sestri Ponente
city: Grosseto
country: Italy
facility: Ospedale della Misericordia
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Napoli
country: Italy
facility: Ospedale Monaldi SUN
city: Perugia
country: Italy
facility: A.O. Santa Maria della Misericordia
city: Pesaro
country: Italy
facility: Azienda Ospedali Riuniti Marche Nord
city: Ravenna
country: Italy
facility: Ospedale "Santa Maria delle Croci"
city: Reggio Emilia
country: Italy
facility: Ospedale Santa Maria Nuova
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Roma
country: Italy
facility: Policlinico Casilino
city: Salerno
country: Italy
facility: A.O. San Giovanni di Dio e Ruggi di Aragona
city: Treviso
country: Italy
facility: Ospedale Santa Maria di Cà Foncello
Study officials:
References:
citation: Zoni-Berisso M, Martignani C, Ammendola E, Narducci ML, Caruso D, Miracapillo G, Notarstefano P, Carinci V, Pierantozzi A, Ciaramitaro G, Calo L, Zennaro M, Infusino T, Ferretti C, Sassone B, Licciardello G, Setti S, Terzaghi C, Malacrida M, Biffi M. Mortality after cardioverter-defibrillator replacement: Results of the DECODE survival score index. Heart Rhythm. 2021 Mar;18(3):411-418. doi: 10.1016/j.hrthm.2020.11.024. Epub 2020 Nov 27.
citation: Biffi M, Ammendola E, Menardi E, Parisi Q, Narducci ML, De Filippo P, Manzo M, Stabile G, Potenza DR, Zanon F, Quartieri F, Rillo M, Saporito D, Zaca V, Berisso MZ, Bertini M, Tumietto F, Malacrida M, Diemberger I. Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry. Europace. 2019 Oct 1;21(10):1527-1536. doi: 10.1093/europace/euz166.
citation: Zanon F, Martignani C, Ammendola E, Menardi E, Narducci ML, DE Filippo P, Santamaria M, Campana A, Stabile G, Potenza DR, Pastore G, Iori M, LA Rosa C, Biffi M. Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement. J Cardiovasc Electrophysiol. 2016 Jul;27(7):840-5. doi: 10.1111/jce.12990. Epub 2016 Jun 17.
citation: Diemberger I, Parisi Q, De Filippo P, Narducci ML, Zanon F, Potenza DR, Ciaramitaro G, Malacrida M, Boriani G, Biffi M. Detect Long-term Complications After ICD Replacement (DECODE): Rationale and Study Design of a Multicenter Italian Registry. Clin Cardiol. 2015 Oct;38(10):577-84. doi: 10.1002/clc.22440. Epub 2015 Aug 18.