Utilizing Science & Technology and Innovation for Development Transcatheter Therapies For Congenital & Structural Heart Disease Marriott Hotel- Amman, August 12th, 2015

Project Team

Brief Description 1.Imad Al Haddad, MD 2.Ramzi Tabbalat, MD- 3.Abdel Fatah Abu Haweleh, MD 4.Iyad Al Ammouri, MD

Justifications Scope of the Problem! 1. CHD: Currently, there are more than one million adult patients with congenital heart disease (un-repaired, repaired, and palliated) in the US 2. SHD: AS patients; MR patients; Afib Patients; etc! Millions of patients.

The Team 1. Interventional Adult Cardiologist-Expertise in SHD 2. Interventional Pediatric Cardiologist 3. Cardiac Surgeon-Expertise in CHD & Valve disease 4. Echocardiographer-Expertise in CHD/SHD 5. Anesthesia-Expertise in CHD/SHD 6. Nurses/Techs/Perfusionists/etc

SHD: Based on Anatomy A. Aortic Valve Stenosis B. Mitral Valve Regurgitation/Stenosis C. LAA in Afib Patients D. Pulmonary Valve Regurgitation/Stenosis E. Miscellaneous-Paravalvar leaks, aneurysms, etc

Calcific AS

High Risk Patients

Inoperable Patients

Potential Patients AS Prevalence based on Olmsted county data and US population. More than half of the severe AS are >75 yrs.

Potential Patients in Jordan We need to do a prevalence study in the Kingdom!

At least 30% with severe symptomatic AS are untreated

Other Valves Direct Flow Portico Lotus Others

Objectives 1.Study the prevalence of Aortic Valve Disease in Jordan 2.Determine the number of patients who undergo surgery each year in Jordan for AVR 3.Formulate a Heart Team that can manage all these patients.

Mitral Valve Disease 1.Study the prevalence of Aortic Valve Disease in Jordan 2.Determine the number of patients who undergo surgery each year in Jordan for AVR 3.Formulate a Heart Team that can manage all these patients.

Mitral Regurgitation One of the commonest forms of valvular heart disease Up to 12 % of patients after MI have moderate- to-severe MR 15-20% of patients with heart failure have moderate-to severe mitral valve regurgitation Up to 9.3% of population >75 years old have it.

Mitral Valve Apparatus

Survival After Surgery for MR

MVR-Valves

Results of MVR Substantially improves survival Improves clinical status Improves quality of life Improves exercise tolerance Improves pulmonary hypertension Improves LV end-diastolic volume and mass Contractile function also improves

Major Complications with MVR 3% operative mortality 7.3% prolonged ventilatory support (>24 H) 2.6% acute renal failure 1.4% major stroke 6.3% pre-discharge reoperation 5% thromboembolism within 5 years 2-10% conversion to mitral valve replacement Up to 30% recurrent mitral regurgitation

Surgery for chronic MR Average in-hospital mortality for patients >65 y/o, % Up to 1/3 of patients with severe valvular heart disease never undergo surgery 50% patients with severe symptomatic mitral regurgitation denied surgery

Catheter Based Mitral Valve Repair Provides less invasive alternative to surgical mitral valve repair Avoids the upfront morbidity and mortality of surgical mitral valve Repair Provides treatment option for elderly patients denied conventional surgery Provides alternative therapy for patients with co- morbidities (high risk for conventional surgery)

Objectives 1.Study the prevalence of Mitral Valve Disease in Jordan 2.Determine the number of patients who undergo surgery each year in Jordan for MVR 3.Formulate a Heart Team that can manage all these patients.

Pulmonary Regurgitation

Conduit Types Homograft Cloth tube conduit – porcine valve mounted into polyester tube Medtronic Contegra – bovine jugular vein Conduit/valve stenosis is primary failure mode

Indications For PVR Severe PR in patients with NYHA class II or III symptoms If Asymptomatic: Regurgitant fraction >35%; RVEDV >150 ml/m2; RV EF 180 msec Bonow R et al: ACC/AHA 2006 guidelines for the management of patients with valvular heart disease. JACC 2006;48:e1-e148

The Melody Valve

Bonhoeffer Was the 1st in the world to implant a percutaneous valve in a human! Pediatric Cardiologist!!!! Implanted in >8000 patients in the Pulmonic position. Bovine jugular vein valve sutured onto a platinum iridium stent Using balloon in balloon from NuMED Hand crimping stent onto balloons Requires 22 Fr delivery sheath.

Three bovine pericardial valve leaflets Stainless steel initially, then cobalt chromium stent frame Now available in 20, 23, 26 and 29 mm diameters. Height 14-19mm long E-sheath: Fr The Edwards Sapien THV

Objectives 1.Study the prevalence of patients in Jordan with CHD that require a pulmonic valve 2.Formulate a Heart Team that can manage all these patients.

Other Conditions Atrial Fibrillation & Stroke

LAA

Objectives 1.Study the prevalence of patients in Jordan with Afib 2.Formulate a Heart Team that can manage all these patients.

Scope of work/Duration Estimated Budget Scope of work: 1. Epidemiological studies to determine prevalence of conditions Duration: This will take few years Estimated Budget : 1. Study: Unknown 2. Cost of valves: expensive

Methodology of Implementation ● Determine on a site where all operations should be done ● Formulate the Heart team ● Training of the team ● Work with the industry to provide devices/valves at a reasonable price

Expected output ● Patients in Jordan will benefit from cutting edge technology Length of hospital stay will be reduced Overall resources in Jordan will be saved This will put Jordan on the map in this area.

Impact Reduction of Morbidity & Mortality from open heart surgery

Sustainability With continued financial support and team spirit, this project can last indefinitely.