Utilizing Science & Technology and Innovation for

DevelopmentTranscatheter Therapies For Congenital & Structural Heart Disease

Marriott Hotel- Amman, August 12th , 2015

Project Team

Brief Description

1. Imad Al Haddad, MD2. 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 Team1. Interventional Adult Cardiologist-Expertise in SHD2. Interventional Pediatric Cardiologist3. Cardiac Surgeon-Expertise in CHD & Valve disease4. Echocardiographer-Expertise in CHD/SHD5. Anesthesia-Expertise in CHD/SHD6. Nurses/Techs/Perfusionists/etc

SHD: Based on AnatomyA. Aortic Valve StenosisB. Mitral Valve Regurgitation/StenosisC. LAA in Afib PatientsD. Pulmonary Valve Regurgitation/StenosisE. Miscellaneous-Paravalvar leaks, aneurysms, etc

Calcific AS

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 FlowPorticoLotusOthers

Objectives

1. Study the prevalence of Aortic Valve Disease in Jordan2. Determine the number of patients who undergo surgery

each year in Jordan for AVR3. Formulate a Heart Team that can manage all these

patients.

Mitral Valve Disease

1. Study the prevalence of Aortic Valve Disease in Jordan2. Determine the number of patients who undergo surgery

each year in Jordan for AVR3. Formulate a Heart Team that can manage all these

patients.

Mitral RegurgitationOne of the commonest forms of valvular heart diseaseUp to 12 % of patients after MI have moderate-to-severeMR

15-20% of patients with heart failure have moderate-tosevere 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 survivalImproves clinical statusImproves quality of lifeImproves exercise toleranceImproves pulmonary hypertensionImproves LV end-diastolic volume and massContractile function also improves

Major Complications with MVR

3% operative mortality7.3% prolonged ventilatory support (>24 H)2.6% acute renal failure1.4% major stroke6.3% pre-discharge reoperation5% thromboembolism within 5 years2-10% conversion to mitral valve replacementUp to 30% recurrent mitral regurgitation

Surgery for chronic MR

Average in-hospital mortality for patients >65 y/o, 10.1-20.5%

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 repairAvoids the upfront morbidity and mortality of surgical mitral valveRepairProvides treatment option for elderly patients denied conventional surgeryProvides alternative therapy for patients with co-morbidities (high risk for conventional surgery)

Objectives

1. Study the prevalence of Mitral Valve Disease in Jordan2. Determine the number of patients who undergo surgery

each year in Jordan for MVR3. Formulate a Heart Team that can manage all these

patients.

Pulmonary Regurgitation

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

Indications For PVRSevere PR in patients with NYHA class II or III symptomsIf Asymptomatic: Regurgitant fraction >35%; RVEDV >150 ml/m2; RV EF <40%; QRS duration >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 stentUsing balloon in balloon from NuMEDHand crimping stent onto balloonsRequires 22 Fr delivery sheath.

Three bovine pericardial valve leafletsStainless steel initially, then cobalt chromium stent frameNow available in 20, 23, 26 and 29 mm diameters.Height 14-19mm longE-sheath: 18-20 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

LAA

Objectives

1. Study the prevalence of patients in Jordan with Afib2. Formulate a Heart Team that can manage all these

patients.

Scope of work/DurationEstimated Budget

Scope of work: 1. Epidemiological studies to determine prevalence of conditions

Duration: This will take few years

Estimated Budget : 1. Study: Unknown2. 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 technologyLength of hospital stay will be reducedOverall resources in Jordan will be savedThis 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.