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1 st Bulgarian ICD Registry

1 st Bulgarian ICD Registry. Final Results (3-year Analysis). 1st Bulgarian ICD registry. Sponsor. BIOTRONIK world-wide leader in CRM and VI Donation of up to 50 ICD systems (SC/DC) to Bulgaria Providing scientific and technical support

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1 st Bulgarian ICD Registry

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  1. 1st Bulgarian ICD Registry Final Results(3-year Analysis)

  2. 1st Bulgarian ICD registry Sponsor • BIOTRONIK world-wide leader in CRM and VI • Donation of up to 50 ICD systems (SC/DC) to Bulgaria • Providing scientific and technical support • Under the coordination of the Cardiac Stimulation Society of Bulgaria

  3. 1st Bulgarian ICD registry Organization • 6 implanting Centers • St. Ekaterina Sofia Dr. Svetoslav Jovev • National Heart Center Sofia Dr. Ivaylo Kozhuharov • Tokuda Sofia Dr. Georgi Gurguriev • St. Anna Sofia Dr. Vasil Velchev • St. George Plovdiv Dr. Borislav Borisov • St. Marina Varna Prof. Atanas Penes Dr. Nadya Pancheva

  4. 1st Bulgarian ICD registry Organization • Scientific Committee • Prof. Goran Milasinovic Belgrade • Prof. Tchavdar Shalganov Sofia • Dr. Svetoslav Iovev Sofia • Dr. Borislav Borisov Plovdiv • Clinical Coordinating Investigator • Dr. Svetoslav Iovev Sofia • Clinical Coordinator • Biotronik Representative Vienna • Implant Specialist • Biotronik Representative Berlin • Clinical Monitor • Biotronik Representative Sofia • Logistic • Biotronik Representatives Sofia

  5. Protocol Indication and Objectives • Indication: Secondary Prevention of SCD • Primary Objectives • to promote the use of ICD therapy • to provide reliable data to set on a reimbursement system for ICDs in Bulgaria • Secondary Objectives • Mortality • Morbidity • Effectiveness • Safety • Occupational status

  6. Protocol Endpoints and Additional Outcomes • Primary Endpoint: time to first adequate VT/VF therapy • Secondary Endpoints • all-cause mortality • all-cause hospitalization • type and number of detected episodes (VT/VF) • success rate ICD shocks • success rate ICD ATPs • incidence of Adverse Events (AEs) • occupational status • Additional Outcomes • NYHA class • cardiovascular medications

  7. Protocol Trial Type • Design • Prospective • Multicenter • National • Treatment • Single chamber ICD • Dual chamber ICD • Size • Up to 50 patients

  8. Protocol Inclusion/Exclusion Criteria • Inclusion Criteria • Signed patient informed consent • A) Survivor of cardiac arrest due to VF, orB) hemodynamically unstable sustained VT, orC) structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable, orD) syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study • Age ≥ 18 years

  9. Protocol Inclusion/Exclusion Criteria • Exclusion Criteria • Defibrillator or cardiac assist device already implanted • Planned cardiovascular intervention • Acute coronary syndrome within 40 days prior to enrollment • Cardiac surgery, angioplasty or cerebrovascular accident within 2 months prior to enrollment • Incessant VT or VF which can not be controlled by drugs • Ventricular tachyarrhythmia due to a completely reversible disorder • Enrolled in a drug or device study • Woman currently pregnant or breastfeeding or not using reliable contraconceptives in age of fertility • Mental or physical inability to take part in the registry • Life expectancy ≤ 12 months

  10. Protocol Timeline • Registry duration • Start: end of 2010 • Patients recruitment period: 1st quarter 2011 • Follow-Up: 12, 24 and 36 months • Final data analysis: 2 months • Registry completion: 2nd quarter 2014

  11. Status end of Enrollment Population • From 13.12.2010 till 30.03.2011 40 patients were implanted* • St. Ekaterina 12 • National Heart Center 11 • Tokuda 3 • St. Anna 3 • St. George 4 • St. Marina 7 *all implants were approved by the Scientific Committee

  12. Baseline Characteristics General • Gender (male) 28 (70%) • Age (years) 58,9±10,7 average±SD • NYHA 2,12±0,82 average±SD • Working (yes) 10 (25%)

  13. Baseline Characteristics Etiology • Cardiomyopathy • Ischemic 18 • Dilated 7 • QT Long 6 • None 2 • Other* 7 *HCM, ARVC, Congenital, Brugada, HOCM, ARVD, Valvular

  14. Baseline Characteristics Electrical Disturbances • Atrial Dysfunctions • None 22 • AF 8 • Afl 7 • AT 2 • SSS 1

  15. Baseline Characteristics Electrical Disturbances • AV Dysfunctions • None 25 • AV block I° 7 • LBBB 5 • AV block III° 2 • AV block II° 1

  16. Baseline Characteristics Electrical Disturbances • Ventricular Arrhythmias • Monomorphic VT 32 • VF 5 • Polimorphic VT 2 • V flutter 1

  17. Baseline Characteristics Medical History • Comorbidities • Hypertension 32 • Diabetes 9 • Renal insufficiency 8 • Chronic pulm. dis. 8 • Hepatic disease 1 • Other* 19 *Ca, Dislipedimia, Phlebotrombosis, Glaucoma, Inguinal Hernia, Hypothyroidism, Anemia, Duodenal ulcus, MI, Mitral Valve Regurgitation, Stroke

  18. Baseline Characteristics Therapies • Cardiovascular Medications • Antiarrhythmics 35 • Beta blockers 29 • ACE/ARB 28 • Diuretics 24 • Anticoagulants 18 • Other* 30 *Insulin, Metformin, Costar, Sortis, Zocor, Isodinit, Magnerich, Nitrate, Olicard, Simvacor

  19. Baseline Characteristics Therapies • Implanted Systems • Single chamber 17 • Dual chamber 23

  20. Results Population • Compliant 11 (FU in ± 30 days) • Near-compliant 8 (FU in ± 75 days) • Pre-termination 1 • Death 7 • Lost to FU 13

  21. Results Primary Endpoint • Time to First Adequate VT/VF Therapy • 21 Patients were appropriately and successfully treated by the device

  22. Results Secondary Endpoints • All-cause Mortality • 7 deaths (cardiovascular not sudden) • 5x Worsened Heart Failure • 2x Stroke

  23. Results Secondary Endpoints • 1x Chest pain • 1x Worsened RV sensing/pacing • 1x Persistent tachycardia • 1x Undetected VT • All-cause Hospitalization • 17 admissions • 7x Worsened HF • 4x Stroke • 2x Atrial lead dislocation

  24. Results Secondary Endpoints • Type and Number of Detected Episodes (VT/VF) • 363 VTs in 21 Patients • 78 VFs in 9 Patients • Success Rate ICD shock-therapies • 100% (105/105) • Success Rate ICD ATP-therapies • 70% (182/261)

  25. Results Secondary Endpoints • Incidence of Adverse Events • Total 25 events in 18 Patients • 15 Serious Adverse Events (requiring hospitalization or prolongation of hospitalization) • 8x Worsening of HF • 4x Stroke • 1x Chest pain • 1x Bleeding wound • 1x Persistent Tachycardia • 4 Serious Adverse Device Effect (requiring hospitalization) • RV lead dislodgement • 2 x RA lead dislodgement • Underdetected VT

  26. Results Secondary Endpoints • Incidence of Adverse Events (cont.) • 2 Adverse Events • VF detection because of electrical noise • RV stucked in cardiac tissue • 4 Adverse Device Effects • VT oversensing • RA lead dislodgement • Inadequate VT detection • VT rejected as SVT

  27. Results Secondary Endpoints • Occupational Status (working patients)* • Enrollment 3-year FU 8 10 * Analysis performed on 18 patients who reported occupational status at 36-m FU

  28. Results Additional Outcomes • Class NHYA* • Enrollment 3-year FU • 2,00±0,75 1,84±0,69 (average±SD) *Analysis performed on 18 patients who reported NYHA class at 36-m FU

  29. Results Additional Outcomes • Cardiovascular Medication (n°of Patients)* Enrollment 3-year FU Δ • Antiarrhythmics 15 14 -1 • Beta Blockers 14 15 1 • ACE inhibitors 12 11 -1 • Diuretics 10 8 -2 • Anticoagulants 6 6 0 • Others 16 11 -5 *Analysis performed on 18 patients who reported CV medications at 36-m FU

  30. Results Lost to Follow-up, Drop-out and Near Compliant • Despite several contact’s attempts, 13 patients were lost to follow-up • One Patient withdrew from Study • 3 Patients were upgraded to CRT • 8 Patients underwent 3-year Follow-up within ± 2,5 months window (near compliant)

  31. Conclusions 3-year Results • The donation of the devices has permitted secondary prevention of sudden cardiac death in a large group of patients • 55% of the patients has been successfully treated by the device • All the 7 deaths were not device related • 3 device related hospitalizations required minor surgery • All shock-therapies were successful • Antitachypacing was successful 70% of the times (painless Rx) • Incidence of device related Adverse Events (4) was modest and all events were resolved • Number of working patients, NYHA Class and cardiovascular medications slightly improved • A reimbursement system for ICD therapy has been established in Bulgaria

  32. Conclusions Take home messages • The Bulgarian patient is very sick and mistreated. The late implantation of a devices increases the mortality and Adverse Events rate. • The improper choice of device for the different patients cohorts does not prolong the life of the patients and increases the mortality rate. • Compromise is not an option!

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