DEtect Long-term Complications After icD rEplacement: a Multicenter Italian Registry (DECODE)

Detect Long-term Complications After ICD Replacement: a Multicenter Italian Registry - DECODE Registry

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.

Study Overview

• Status: Unknown
• Conditions: Device Replacement; Device Upgrade; Long-term Postoperative Complications; Resource Consumption and Associated Costs After Device Replacement/Upgrade

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.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Italy
  • Arezzo, Italy, 52100
    • Recruiting
    • Ospedale "San Donato"
  • Bologna, Italy, 40133
    • Recruiting
    • Ospedale Maggiore
    • Principal Investigator: Valeria Carinci
    • Principal Investigator: Francesco Pergolini
  • Bologna, Italy, 40138
    • Recruiting
    • Azienda Ospedaliera Universitaria , Policlinico Sant'Orsola
    • Principal Investigator: Mauro Biffi
  • Campobasso, Italy
    • Recruiting
    • Università Cattolica del Sacro Cuore
    • Principal Investigator: Quintino Parisi
  • Cuneo, Italy, 12100
    • Recruiting
    • Ospedale Cuneo
    • Principal Investigator: Endrj Menardi
  • Empoli, Italy, 50053
    • Recruiting
    • Ospedale "San Giuseppe"
    • Principal Investigator: Attilio Del Rosso
  • Ferrara, Italy, 44124
    • Recruiting
    • A.O.S.Anna
    • Principal Investigator: Tiziano Toselli
    • Principal Investigator: Matteo Bertini
  • Forlì, Italy, 47121
    • Recruiting
    • Ospedale "Morgagni-Pierantoni"
  • Genova, Italy, 16153
    • Recruiting
    • Ospedale "Padre Antero Micone" - Sestri Ponente
    • Principal Investigator: Massimo Zoni Berisso
  • Grosseto, Italy, 58100
    • Recruiting
    • Ospedale della Misericordia
    • Principal Investigator: Gennaro Miracapillo
  • Napoli, Italy, 80122
    • Recruiting
    • Clinica Mediterranea
    • Principal Investigator: Giuseppe Stabile
    • Principal Investigator: Assunta Iuliano
  • Napoli, Italy
    • Recruiting
    • Ospedale Monaldi SUN
    • Principal Investigator: Ernesto Ammendola
    • Principal Investigator: Giuseppe Del Giorno
    • Principal Investigator: Lucio Santangelo
  • Perugia, Italy
    • Recruiting
    • A.O. Santa Maria della Misericordia
    • Principal Investigator: Gianluca Zingarini
  • Pesaro, Italy, 61121
    • Recruiting
    • Azienda Ospedali Riuniti Marche Nord
    • Principal Investigator: Attilio Pierantozzi
  • Ravenna, Italy, 48121
    • Recruiting
    • Ospedale "Santa Maria delle Croci"
  • Reggio Emilia, Italy
    • Recruiting
    • Ospedale Santa Maria Nuova
    • Principal Investigator: Matteo Iori
  • Rimini, Italy, 47900
    • Recruiting
    • Ospedale degli Infermi
  • Roma, Italy, 00169
    • Recruiting
    • Policlinico Casilino
    • Sub-Investigator: Marco Rebecchi
  • Salerno, Italy, 84131
    • Recruiting
    • A.O. San Giovanni di Dio e Ruggi di Aragona
    • Principal Investigator: Andrea Campana
  • Treviso, Italy
    • Recruiting
    • Ospedale Santa Maria di Cà Foncello
    • Principal Investigator: Vittorio Calzolari
  • BG
    • Bergamo, BG, Italy, 24123
      • Recruiting
      • A.O. "Papa Giovanni XXIII"
      • Principal Investigator: Paolo De Filippo
  • Bari
    • Carbonara di Bari, Bari, Italy, 70131
      • Recruiting
      • Ospedale Di Venere
  • Bologna
    • Bentivoglio, Bologna, Italy, 40010
      • Recruiting
      • Ospedale di Bentivoglio
  • FG
    • San Giovanni Rotondo, FG, Italy, 71013
      • Recruiting
      • Ospedale Casa Sollievo della Sofferenza
  • Ferrara
    • Cento, Ferrara, Italy, 44011
      • Recruiting
      • Ospedale SS. Annunziata
  • Forlì
    • Cesena, Forlì, Italy, 47521
      • Recruiting
      • Ospedale "Maurizio Bufalini"
  • LO
    • Lodi, LO, Italy, 26900
      • Recruiting
      • Ospedale Maggiore
      • Principal Investigator: Fabio Lissoni
  • Modena
    • Baggiovara, Modena, Italy
      • Recruiting
      • Ospedale Civile S.Agostino-Estense
      • Principal Investigator: Mauro Zennaro
  • PA
    • Palermo, PA, Italy, 90010
      • Recruiting
      • A.O.U.P. "Paolo Giaccone"
      • Principal Investigator: Gianfranco Ciaramitaro
  • RM
    • Rome, RM, Italy, 00100
      • Recruiting
      • Policlinico Universitario "Agostino Gemelli"
      • Principal Investigator: Maria Lucia Narducci
  • SI
    • Siena, SI, Italy, 53100
      • Recruiting
      • Ospedale Santa Maria alle Scotte
      • Principal Investigator: Valerio Zacà
  • TA
    • Taranto, TA, Italy, 74121
      • Recruiting
      • Casa di Cura "Villa Verde"
      • Principal Investigator: Mariano Rillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICD generator replacement; Patients with standard indications to ICD generator replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complications associated with the ICD replacement / upgrade that occur during a period of 12 months	The primary outcome measure of this study is to estimate, at 12-months follow up, the percentage of subjects undergoing ICD generator replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies, experiencing one of the pre-defined complications.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline patient's characteristics (clinical history and drug therapy) for subjects undergoing ICD replacement/upgrade	This secondary outcome measure of this study is to evaluate baseline patient's characteristics or variables of procedure's management as potential predictors of complications, that will be evaluated at 30 days, at 12 months and 60 months follow up	60 months
- Rate of complications associated with the ICD replacement / upgrade that occur during a very long-term period	This extends to 60 months the results obtained with the primary objective at 12 months	60 months
Long-term costs of ICD/upgrade procedure	This secondary outcome measure of this study is to evaluate resource consumption and associated costs in terms of devices, replacement/upgrade procedures , follow-up, post-replacement/upgrade management of complications and health care resources utilization.	60 months

Collaborators and Investigators

• Sponsor: Mauro Biffi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ANTICIPATED): October 1, 2015
• Study Completion (ANTICIPATED): October 1, 2015

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (ESTIMATE): March 4, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Device Replacement; Device Upgrade; Long-term Postoperative Complications; Resource consumption and associated costs after device replacement/upgrade
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 72/2013/O/Oss