Device Registry in Saudi Arabia: What Have We Learned. Ahmad Hersi

Transcription

1 Device Registry in Saudi Arabia: What Have We Learned Ahmad Hersi

2 GULF IMPLANTABLE CARDIOVERTER- DEFIBRILLATOR STUDY (Gulf ICD)

3 Gulf ICD Steering Committee Alawi Alsheikh-Ali (Co-PI) Adel Khalifa [Co-PI] Bahrain Abdulmohsen Al-Musaed KSA Bandar Al-Ghamdi KSA Fayez Bokhari KSA Najib Al-Rawahi Oman Fawziya Al-Kandari Kuwait Salem Alkaabi UAE Hosam Zaky UAE Ahmad Hersi [Co-PI] KSA Ahmad Al-Fagih KSA Faisal Al-Samadi KSA Mohammad Almehairi - UAE Amin Daoulah KSA Nidal Asaad Qatar Omer Elhag UAE Hani Sabbour UAE

4 What we know about ICDs in the Gulf 1. Hersi, A. Implantable Cardioverter Defibrillator Therapy: A single Center Experience in Saudi Arabia. Cardio Med J, 2010, 4, Daoulah A, Alsheikh-Ali AA, Ocheltree A, et. al. Outcome after Implantable Defibrillator in Patients with Brugada Syndrome: The Gulf Brugada Syndrome Registry. Journal of Electrocardiology (3): Alsheikh-Ali AA, Alkaabi S, Elhag O, et. al. The Implantable Cardioverter- Defibrillator in the United Arab Emirates: Preliminary Findings of a National Survey [Abstract]. Circulation (19): P Al Rawahi N, Al Kalbani A. Indications for Cardiac Devices Implantation in Oman [Abstract]. Circulation (19): P518.

5 Gulf ICD in a Nut Shell A prospective observational multi-center multi-national study of the characteristics and outcomes of patients receiving de novo implantable cardioverter-defibrillators (ICD) in the Arabian Gulf region. Original enrolment target = 1,000 patients; extended to 1,500. Data on baseline clinical characteristics, ICD programming parameters, inpatient outcomes, and clinical events such as mortality and ICD discharges over 1 year of follow-up will be collected. Enrolment complete, Follow-up on-going

6 Subject Selection Inclusion Criteria All adult patients 18 years or older, receiving a new ICD implant and willing to sign a consent form will be eligible. Exclusion Criteria Patients < 18 years and those not willing to sign a consent form. Subjects with existing ICDs undergoing pulse generator replacements or system revisions will not be included.

7 Sample Size Considerations We wanted to ensure adequate precision around two key outcomes: all-cause mortality and rate of appropriate ICD discharges at one year. To estimate an event rate of 10% at 1 year with a margin of error of 2% and 95% confidence intervals, a sample size of 829 patients is required. Since there is little guidance in the literature on such event rates among ICD recipients in the Gulf, and to compensate for losses to follow-up, we adjusted our sample size upwards to 1,000 patients. Such a sample size was considered logistically feasible given our experience with ICD implant rates in the Gulf.

8 Sample Size Considerations Sample size would allow for adequate precision (not more than 2% error margin with 95% confidence level) across a wide range of expected event rates

9 Data Variables & Definitions Definitions based on the ACC/AHA/HRS 2006 Key Data Elements and Definitions for Electrophysiological Studies and Procedures and the ACC National Cardiovascular Data Registry (NCDR) ICD Registry data dictionary

10 Timelines 1 st pt. Jan Last pt. July year FU July 2016

11 Gulf ICD Registry Baseline CRF [Page 7/10] F. ICD Programming Cont d Number of Tachy Therapy Zones Zone 1 Rate Cut-Off (bpm) ATP Programmed Yes No Zone 2 Rate Cut-Off (bpm) ATP Programmed Yes No Zone 3 Rate Cut-Off (bpm) ATP Programmed Yes No Ventricular Tachyarrhythmia Detection Criteria Medtronic Device: Initial Beats to Detect. Zone 1 VF 12/16 18/24 24/32 30/40 45/60 60/80 75/100 90/ / /160 Zone 2 FVT Via VF Via VT Zone 3 VT St. Jude Medical Device: Intervals to Detect (enter number). Zone 1 VF Zone 2 VT Zone 3 VT Boston Scientific Device: Time to Detection (enter seconds) Zone 1 VF Zone 2 VT Zone 3 VT Biotronic Device: Detection Counter. Zone 1 VF 6/8 8/12 10/14 12/16 16/20 18/24 20/26 22/30 24/30 Zone 2 VT Zone 3 VT Gulf ICD CRF v

12 Gulf ICD Registry Baseline CRF [Page 8/10] G. ADVERSE EVENTS Adverse Event Yes No Cardiac Arrest Yes No Drug Reaction Yes No Cardiac Perforation Yes No Coronary Sinus Dissection Yes No Pocket Hematoma Yes No If Pocket Hematoma: Requiring Evacuation Requiring Transfusion Lead Dislodgment Yes No TIA Yes No CVA/Stroke Yes No MI Yes No Pericardial Tamponade Yes No If Yes, Complete Below: If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY If Yes, Date: DD MM YYYY Pocket Infection Yes No If Yes, Date: DD MM YYYY Pneumothorax Yes No If Yes, Date: DD MM YYYY Hemothorax Yes No If Yes, Date: DD MM YYYY Yes Yes No No Gulf ICD CRF v

13 Gulf ICD Registry Follow Up CRF [Page 1/1] A. IDENTIFICATION Unique Gulf ICD Number Initials Hospital File Number F M L B. Follow Up Data Follow Up Date DD MM YYYY Follow Up No. Follow Up Type Patient Visit Telephone Call Medical Record Review C. Interim Events Death Yes No Syncope Yes No If Yes, Date: If Yes, Date: Appropriate ICD Discharge Yes No If Yes, Date: If Yes Inappropriate ICD Discharge Yes No If Yes, Date: If Yes VF VT Cycle Length (msec) AF SVT/AT Sinus Tach T-wave oversensing Lead Fracture External Noise Other [ ] ICD Malfunction Yes No If Yes, Date: If Yes Pulse Generator Malfunction Lead Fracture Other [.. ] DD MM YYYY DD MM YYYY DD MM YYYY DD MM YYYY DD MM YYYY Gulf ICD CRF v

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15 Active Centers Saudi Arabia Prince Sultan Cardiac Center Prince Salman Heart Center King Fahad Armed Forces Hospital Jeddah King Khalid University Hospital King Faisal Specialist Hospital and Research Center - Riyadh King Abdulaziz Medical City National Guard King Faisal Specialist Hospital Jeddah UAE Kuwait Sheikh Khalifa Medical City Zayed Military Hospital Dubai Hospital Chest Hospital Kuwait Heart Center Dabbous Cardiac Center 6 Countries 15 Centers Oman Royal Hospital Bahrain Bahrain Defense Force Hospital Qatar Hamad Medical Corporation

16 Site Survey

17 Site Survey 14(93%) 1(7%)

18 Site Survey

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20 Site Survey

21 Enrollment Rate Enrolled Per Month Total Enrollment = 1,545 Monthly enrollment (since launch) = ~ 77 Monthly enrollment (past 12 months) = ~ 88 Cumulative Enrolled # Sites

22 Enrolment by Country & Center (n=1,545) Bahrain Defence Force Hospital Bahrain Gulf ICD Enrolment 3% 3% 5% Hamad Medical Corporation Qatar Royal Hospital Oman Dabbous Cardiac Center Chest Hospital Kuwait % 7% 11% Qatar Bahrain Oman Kuwait UAE KSA Dubai Hospital Zayed Military Hospital SKMC UAE KFSH - Jeddah KFSHRC - Riyadh King Khalid University King Fahad Armed Forces - Jeddah King Abdulaziz Medical City Prince Salman Heart Center Prince Sultan Cardiac Center Saudi Arabia Gulf Population % 4% 3% % 7% 19% Qatar Bahrain Oman Kuwait UAE KSA

23 Baseline Characteristics Variable N = 1,545 Demographics Age (years) 57 ± 14 Age 65 (years) 70% Male 83% Gulf Nationals 71% Insurance Government 89% Private 5% Charity 3% Self Pay 3%

24 Baseline Characteristics Variable N = 1,545 Co-Morbidities LVEF 27 ± 11 LVEF 35 89% Diabetes Mellitus 57% Hypertension 62% CHF 71% Prior MI 40% Atrial Fibrillation 14% Prior Stroke 5% Past Smoker 24% Present Smoker 16%

25 Baseline Characteristics Variable N = 1,545 Implant Characteristics Primary Prevention 80% Elective Admission 55% Pre-implant EPS 3% DFT Testing 4% Single/Dual/CRT-D 47%/20%/33% Single Coil RV Lead 50% Manufacturer Medtronic 66% SJM 15% Boston Scientific 14% Biotronik 5%

26 Baseline Characteristics Variable N = 1,545 In-Hospital Outcomes Complications 1.2% Mortality 0.4%

27 The estimated average national ICD implant rate in the Arabian Gulf region is ~ 40 per million.

28 Adherence to Evidence-Based Criteria for the Implantation of primary Prevention ICD Data from the US suggest that ~ 1 in 4 ICD implants do not meet these evidence-based criteria for implantation 705 receiving ICD 122(17%) did not meet the evidence based criteria In the Gulf-ICD 1 in 6 ICD do not meat the criteria

29 Adherence to Evidence-Based Criteria for the Implantation of primary Prevention ICD Recent diagnosis of heart failure (n=91, 75%) Recent MI (n=26, 21%), NYHA Class IV (n=17, 15%), Recent CABG (n=10, 8%).

30 Concussions Arabian Gulf patients receive ICD at younger age than western counterpart. Low rate of implantation of ICD per 1 M of the population

31 Funding