1 st Bulgarian ICD Registry
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Transcript of 1 st Bulgarian ICD Registry
1st Bulgarian ICD registry
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
Sponsor
1st Bulgarian ICD registry
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 PenesDr. Nadya Pancheva
Organization
1st Bulgarian ICD registry
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
Organization
Protocol
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
Indication and Objectives
Protocol
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
Endpoints and Additional Outcomes
Protocol
Design
Prospective
Multicenter
National
Treatment
Single chamber ICD
Dual chamber ICD
Size
Up to 50 patients
Trial Type
Protocol
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
Inclusion/Exclusion Criteria
Protocol
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
Inclusion/Exclusion Criteria
Protocol
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
Timeline
Status end of Enrollment
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
Population
Baseline Characteristics
Gender (male) 28 (70%)
Age (years) 58,9±10,7average±SD
NYHA 2,12±0,82 average±SD
Working (yes) 10 (25%)
General
Baseline Characteristics
Cardiomyopathy
Ischemic 18
Dilated 7
QT Long 6
None 2
Other* 7
*HCM, ARVC, Congenital, Brugada, HOCM, ARVD, Valvular
Etiology
Baseline Characteristics
AV Dysfunctions
None 25
AV block I°7
LBBB 5
AV block III° 2
AV block II° 1
Electrical Disturbances
Baseline Characteristics
Ventricular Arrhythmias
Monomorphic VT 32
VF5
Polimorphic VT 2
V flutter 1
Electrical Disturbances
Baseline Characteristics
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
Medical History
80
22,5 20 20
2,5
47,5
0
25
50
75
100
Hypertension Diabetes Renalinsufficiency
CPD Hepatic disease Other
Pts
. [%
]
Baseline Characteristics
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
Therapies
87,5
72,5 70
60
45
75
0
25
50
75
100
Antiarrhythmics Beta blockers ACE/ARB Diuretics Anticoagulants Other
Pts
. [%
]
Sigle chamber43%
Dual chamber57%
Baseline Characteristics
Implanted Systems
Single chamber 17
Dual chamber 23
Therapies
Results
Compliant 11 (FU in ± 30 days)
Near-compliant 8 (FU in ± 75 days)
Pre-termination 1
Death 7
Lost to FU 13
Population
27,5
20
2,5
17,5
32,5
0
25
50
Compliant Near compliant PreTermination Dead Lost to FU
Pts
. [%
]
Results
Time to First Adequate VT/VF Therapy
21 Patients were appropriately and successfully treated by the device
Primary Endpoint
Kaplan-Meier Time to Event Curve
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Days from Implant
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Results
All-cause Mortality
7 deaths (cardiovascular not sudden)
5x Worsened Heart Failure
2x Stroke
Secondary Endpoints
Kaplan-Meier Survival Curve
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Days from implant
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Results
All-cause Hospitalization
17 admissions
7x Worsened HF
4x Stroke
2x Atrial lead dislocation
Secondary Endpoints
1x Chest pain
1x Worsened RV sensing/pacing
1x Persistent tachycardia
1x Undetected VT
Kaplan-Meier Time to Event Curve
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Time
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Results
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)
Secondary Endpoints
Results
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
Secondary Endpoints
Results
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
Secondary Endpoints
Results
Occupational Status (working patients)*
Enrollment 3-year FU
8 10
* Analysis performed on 18 patients who reported occupational status at 36-m FU
Secondary Endpoints
Results
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
Additional Outcomes
Results
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
Additional Outcomes
Results
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)
Lost to Follow-up, Drop-out and Near Compliant
Conclusions
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
3-year Results
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!