Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Flutter
Conditions
Brief summary
The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable cardioverter defibrillator
Detailed description
The standardized requirements for implantable cardioverter defibrillator (ICD) include defibrillation testing (DT), consisting in induction and termination of ventricular fibrillation (VF). An effective DT has historically been considered part of standard procedures at implant. Nevertheless, implant techniques and technology have evolved during years and nowadays deviations are frequent in clinical practice mainly due to the fact that physicians are seriously concerned about the risk of severe complications related to DT. However, the practice of not performing DT is arbitrary and its safety is yet unproven. This observational study will assess the safety of the two strategies adopted at ICD implant: induction (including patients who undergo DT at implant) and non-induction (including patients who do not undergo DT at implant. No deviation from the centres' current practice in choosing to perform or not perform DT is introduced by this study protocol. The study considers consecutive patients undergoing first implant of ICD
Interventions
Implantable defibrillator to reduce ventricular arrhythmias via shock.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* first implantation of ICD or CRT-D * Patients undergoing upgrade to ICD or CRT-D from pacemaker * Patients undergoing upgrade to CRT-D from CRT * Age 18 or above, or legal age to give written informed consent
Exclusion criteria
* Patients who do not give consent to treat their data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up | 2 years | * Severe implant-related\* complications at ICD implants among the following: * Survival from cardiopulmonary arrest due to VF requiring 3 or more consecutive external shocks for termination or due to electro-mechanical dissociation. * Transient ischemic attack or stroke, * Cardiogenic shock, * Pulmonary edema, * Embolic events, * Anoxic coma * Pericardial tamponade * Death. * Events at follow up: * Sudden cardiac death (defined as witnessed unexpected death occurring \<1 hour from symptoms onset or unwitnessed during sleep) * Resuscitation after ineffective documented appropriate ICD shocks * Implant related events are considered as those listed above, occurring during the implant procedure in the timeframe betweend device poket insertion and patient exit from the cath-lab, as well as those events occurring after the patient exit from the cath-lab that, after review from the event adjudication committee, have been classified as related to the implant procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Intra-operative Complications | Acute (ICD implant) | including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death |
| Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | 2 years | — |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VF Induction Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) | 836 |
| no VF Induction Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) | 1,284 |
| Total | 2,120 |
Baseline characteristics
| Characteristic | VF Induction | no VF Induction | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 12 | 67 years STANDARD_DEVIATION 11 | 66 years STANDARD_DEVIATION 11 |
| Region of Enrollment Italy | 836 participants | 1284 participants | 2120 participants |
| Sex: Female, Male Female | 152 Participants | 268 Participants | 420 Participants |
| Sex: Female, Male Male | 684 Participants | 1016 Participants | 1700 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 108 / 836 | 188 / 1,284 |
| other Total, other adverse events | 120 / 836 | 90 / 1,284 |
| serious Total, serious adverse events | 209 / 836 | 177 / 1,284 |
Outcome results
Primary
Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up
* Severe implant-related\* complications at ICD implants among the following: * Survival from cardiopulmonary arrest due to VF requiring 3 or more consecutive external shocks for termination or due to electro-mechanical dissociation. * Transient ischemic attack or stroke, * Cardiogenic shock, * Pulmonary edema, * Embolic events, * Anoxic coma * Pericardial tamponade * Death. * Events at follow up: * Sudden cardiac death (defined as witnessed unexpected death occurring \<1 hour from symptoms onset or unwitnessed during sleep) * Resuscitation after ineffective documented appropriate ICD shocks * Implant related events are considered as those listed above, occurring during the implant procedure in the timeframe betweend device poket insertion and patient exit from the cath-lab, as well as those events occurring after the patient exit from the cath-lab that, after review from the event adjudication committee, have been classified as related to the implant procedure.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VF Induction | Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up | 18 Participants |
| no VF Induction | Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up | 16 Participants |
Secondary
Severe Intra-operative Complications
including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death
Time frame: Acute (ICD implant)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VF Induction | Severe Intra-operative Complications | 8 Participants |
| no VF Induction | Severe Intra-operative Complications | 4 Participants |
Secondary
Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VF Induction | Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | 10 Participants |
| no VF Induction | Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | 12 Participants |