1 st Bulgarian ICD Registry

1st Bulgarian ICD Registry

Final Results(3-year Analysis)

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


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


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


Cardiomyopathy

Ischemic 18

Dilated 7

QT Long 6

None 2

Other* 7

*HCM, ARVC, Congenital, Brugada, HOCM, ARVD, Valvular

Etiology


Atrial Dysfunctions

None 22

AF8

Afl7

AT2

SSS 1

Electrical Disturbances


AV Dysfunctions

None 25

AV block I°7

LBBB 5

AV block III° 2

AV block II° 1



Ventricular Arrhythmias

Monomorphic VT 32

VF5

Polimorphic VT 2

V flutter 1



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

. [%

]


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%


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

0

0,1

0,2

0,3

0,4

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0,9

1

0 365 730 1095

Days from Implant

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fro

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T/V

F

Results

All-cause Mortality

7 deaths (cardiovascular not sudden)

5x Worsened Heart Failure

2x Stroke

Secondary Endpoints

Kaplan-Meier Survival Curve

0

0,1

0,2

0,3

0,4

0,5

0,6

0,7

0,8

0,9

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0 365 730 1095

Days from implant

Cu

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urv

ival

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

0

0,1

0,2

0,3

0,4

0,5

0,6

0,7

0,8

0,9

1

0 365 730 1095

Time

Cu

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reed

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fro

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Ho

spit

aliz

atio

n

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!

1 st Bulgarian ICD Registry

Documents

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