Transcript 1st Bulgarian ICD Registry

1st 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
Under the coordination of the Cardiac Stimulation
Society of Bulgaria
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
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
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
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
Protocol
Trial Type
Design
Prospective
Multicenter
National
Treatment
Single chamber ICD
Dual chamber ICD
Size
Up to 50 patients
Protocol
Inclusion/Exclusion Criteria
Inclusion Criteria
Signed patient informed consent
A) Survivor of cardiac arrest due to VF, or
B) hemodynamically unstable sustained VT, or
C) structural heart disease and spontaneous sustained
VT, whether hemodynamically stable or unstable, or
D) syncope of undetermined origin with clinically
relevant, hemodynamically significant sustained VT or
VF induced at electrophysiological study
Age ≥ 18 years
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
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
Status end of Enrollment
Population
From 13.12.2010 till 30.03.2011 40 patients were
implanted*
St. Marina
18%
St. Ekaterina
St. Ekaterina
29%
12
National Heart Center 11
Tokuda
3
St. Anna
3
St. George
4
St. Marina
7
St. George
10%
St. Anna
8%
Tokuda
8%
*all implants were approved by the Scientific Committee
National Heart Center
27%
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%)
Baseline Characteristics
Etiology
Other
18%
Cardiomyopathy
Ischemic
18
Dilated
7
QT Long
6
None
2
Other*
7
None
5%
Ischemic
44%
QT Long
15%
Dilated
18%
*HCM, ARVC, Congenital, Brugada, HOCM, ARVD, Valvular
Baseline Characteristics
Electrical Disturbances
AT
5%
Atrial Dysfunctions
None
22
AF
8
Afl
7
AT
2
SSS
1
SSS
3%
Afl
18%
None
54%
AF
20%
Baseline Characteristics
Electrical Disturbances
AV block II°
3%
AV block III°
5%
AV Dysfunctions
None
25
AV block I°
7
LBBB
5
AV block III°
2
AV block II°
1
LBBB
13%
AV block I°
17%
None
62%
Baseline Characteristics
Electrical Disturbances
Ventricular Arrhythmias
Monomorphic VT
32
VF
5
Polimorphic VT
2
V flutter
1
Polimorphic VT
5%
Vfl
3%
VF
13%
Monomorphic VT
79%
Baseline Characteristics
Medical History
Comorbidities
100
32
Diabetes
9
Renal insufficiency
8
Chronic pulm. dis.
8
Hepatic disease
1
Other*
19
80
75
Pts. [%]
Hypertension
47,5
50
22,5
25
20
20
2,5
0
Hypertension
Diabetes
Renal
insufficiency
CPD
Hepatic disease
*Ca, Dislipedimia, Phlebotrombosis, Glaucoma, Inguinal Hernia, Hypothyroidism,
Anemia, Duodenal ulcus, MI, Mitral Valve Regurgitation, Stroke
Other
Baseline Characteristics
Therapies
Cardiovascular Medications
100
35
Beta blockers
29
ACE/ARB
28
Diuretics
24
Anticoagulants
18
Other*
30
87,5
72,5
75
75
70
60
Pts. [%]
Antiarrhythmics
50
45
25
0
Antiarrhythmics
Beta blockers
ACE/ARB
Diuretics
*Insulin, Metformin, Costar, Sortis, Zocor, Isodinit, Magnerich, Nitrate, Olicard, Simvacor
Anticoagulants
Other
Baseline Characteristics
Therapies
Implanted Systems
Single chamber
17
Dual chamber
23
Sigle chamber
43%
Dual chamber
57%
Results
Population
Compliant
11
(FU in ± 30 days)
Near-compliant
8
(FU in ± 75 days)
Pre-termination
1
Death
7
Lost to FU
13
50
Pts. [%]
32,5
27,5
25
20
17,5
2,5
0
Compliant
Near compliant
PreTermination
Dead
Lost to FU
Results
Primary Endpoint
Time to First Adequate VT/VF Therapy
21 Patients were appropriately and successfully
treated by the device
Kaplan-Meier Time to Event Curve
1
Cumulative Freedom from VT/VF
0,9
0,8
0,7
0,6
0,5
0,4
0,3
0,2
0,1
0
0
365
730
Days from Implant
1095
Results
Secondary Endpoints
All-cause Mortality
7 deaths (cardiovascular not sudden)
5x Worsened Heart Failure
2x Stroke
Kaplan-Meier Survival Curve
1
0,9
Cumulative Survival
0,8
0,7
0,6
0,5
0,4
0,3
0,2
0,1
0
0
365
730
Days from implant
1095
Results
Secondary Endpoints
All-cause Hospitalization
17 admissions
1x Chest pain
7x Worsened HF
1x Worsened RV sensing/pacing
4x Stroke
1x Persistent tachycardia
2x Atrial lead dislocation
1x Undetected VT
Kaplan-Meier Time to Event Curve
1
Cumulative Freedom from
Hospitalization
0,9
0,8
0,7
0,6
0,5
0,4
0,3
0,2
0,1
0
0
365
730
Time
1095
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)
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
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
Results
Secondary Endpoints
Occupational Status (working patients)*
Enrollment
8
3-year FU
10
* Analysis performed on 18 patients who reported occupational status at 36-m FU
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
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
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)
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
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!