Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
A chronic total occlusion (CTO) is common in patients with coronary artery disease. CTO
 recanalization has been shown to improve survival in comparison to failed CTO recanalization.
 Whether this is related to ventricular arrhythmias (VA) is unknown. The purpose of this pilot
 study is to evaluate the incidence of VA after successful CTO recanalization, failed CTO
 recanalization and untreated CTO. Patients will be monitored using an insertable cardiac
 monitor.
Rationale: Successful chronic total occlusion (CTO) recanalization has been associated with
 improved long-term survival. Furthermore, CTO is an independent predictor for the occurrence
 of ventricular arrhythmias (VA) in patients with ischemic cardiomyopathy and implantable
 cardioverter defibrillators (ICDs). One may speculate that a successful CTO recanalization
 may provide electrical stability. However, no data are available on the incidence of
 sustained VA in this patient population.

 Objective: The objective of the present pilot study is to assess the incidence of sustained
 VA in 3 CTO groups: patients with successful percutaneous CTO recanalization (group A),
 patients with failed percutaneous CTO recanalization (group B), and patients with untreated
 CTO (group C).

 Study design: Three-arm pilot study of patients with CTO.

 Study population: A total of 90 patients will be enrolled. Intervention: A Medtronic Reveal
 LINQ™ Insertable cardiac monitor (ICM) will be implanted in every patient to continuously
 monitor heart rhythm during the follow-up period.

 Main study parameters/endpoints: To assess the incidence of VA defined as sustained
 ventricular tachycardia >30 s or ventricular fibrillation.
Inclusion criteria:

 1. Presence of CTO defined as complete obstruction of the vessel with Thrombolysis In
 Myocardial Infarction (TIMI) flow grade 0 and an estimated duration of ≥3 months, and
 one of the following:

 1. A successful percutaneous CTO recanalization for stable angina within the
 previous 6 months. A successful CTO recanalization is defined as a final TIMI
 flow grade ≥2 and a residual stenosis ≤30% after stent implantation.

 2. A failed percutaneous CTO recanalization for stable angina within the previous 6
 months. A failed CTO recanalization is defined as not fulfilling the criteria for
 successful CTO recanalization.

 3. Untreated CTO diagnosed in the previous 6 months.

 2. Age ≥18 years.

 3. Written informed consent.

 4. Patient agrees to the follow-up including the implantation of the ICM.

 Exclusion Criteria:

 1. Patients who are potential candidates for an ICD according to the 2015 ESC guidelines.

 2. Patients who have a cardiac implantable electrical device (CIED) (e.g., pacemaker,
 ICD).

 3. Patient has reduced immune function or is otherwise at high risk for infection.

 4. Patient has had a recent (within 30 days) or otherwise unresolved infection.

 5. Known pregnancy at time of inclusion.

 6. Patient has severe co-morbidity that may cause the patient to be non-compliant with
 the protocol, confound the data interpretation or is associated with limited life
 expectancy (i.e., less than one year).