1. MitraClip Mitral Valve Repair System Abbott Vascular MitraClip Mitral Valve Repair System Abbott Vascular Alexandra Camesas & Nathan Kukowski Biomaterials Final Presentation

2. The Heart primary pump of the human body continuous blood circulation through cardiac cycle carries blood & all the vital materials which help our bodies function

3. Mitral Regurgitation Disorder of heart’s mitral valve (bicuspid- between LA and LV) in which valve does not close properly Most common form of valvular heart disease Affects 1 in 10 people over 75 years old During systole, contraction of the LV causes abnormal backflow into LA Initially, heart compensates by increasing size of LV (heart works harder) Eventually dilates and fails

4. 4 Causes Dysfunction in either of 2 leaflets, annulus, papillary muscles, or chordae tendineae Most common cause of MR is Mitral Valve Prolapse (MVP) Myxomatous degeneration- pathological weakening of connective tissue More common in females & with age Ischemic Heart Disease Rheumatic fever Marfan’s syndrome Acute MR caused by endocarditis or papillary muscle rupture

5. 5 Symptoms Shortness of breath Orthopnea Paroxysmal nocturnal dyspnea Pulmonary edema Decreased cardiac output Abnormal heart beat, systolic murmur, tachycardia

6. 6 Pathophysiology Acute Phase: sudden volume overload of both LV and LA Chronic Compensated Phase : can be asymptomatic, develops slowly over time Chronic Decompensated Phase: muscle dysfunction has developed, elevation of LV and LA pressure

7. 7 Alternative Treatments/Therapies Invasive Surgery: Open Heart Surgery Mitral Valve Replacement Mitral Valve Repair Medical Treatment Vasodilators ACE inhibitors

8. 8 Abbott Laboratories MitraClip Device Catheter based therapy aimed to “reduce” MR Patients- deemed "High Risk" by a surgeon Less invasive than open surgical technique Clips together valve leaflets of the MV Important: patients must have CENTRAL MR Leaflets must have a certain “coaptation depth and length,” determined by Echo CE Mark approval in 2008, still investigational in the U.S.

9. 9 3 Major Subsystems Steerable guide catheter: percutaneous Clip delivery system MitraClip device (implant)

10. 10 Biomaterials Similar to other Cardiovascular Implants Metal alloys Nickel, titanium, nitinol Hydrophilic polyester fabric coating

11. 11 Why is MitraClip the Best Choice? For patients who are too high risk for surgery Minimally invasive Rapid recovery No need for any by-pass machine

12. 12 How Much Does it Cost? Proprietary ~$40,000 with associated costs of procedure another~$20,000 Follow-up hospital care less than open heart surgery High risk patients: without treatment, typically get admitted to hospital 2-3 times/year at~$36,000 per visit Mitral valve surgery:~$40,000 but higher for high-risk patients and does not include post-surgical care costs

13. 13 MitraClip Insurance Coverage Not yet approved in the US for commercial use Determined by Medicare as a covered benefit for beneficiaries that participate in a clinical trial Company pays for device but patient responsible for any hospital charges if insurance company does not cover it

14. 14 Therapeutic Procedures Before procedure: Transthoracic/Transesophageal Echocardiagram Determines if their MR is central 1. Guide Catheter through femoral vein to reach the heart 2. MitraClip delivered through catheter to region of the MV 3. Clips the MV to allow it to close better and left on MV while rest of the delivery system/catheter are removed

15. Protocols By protocol: supposed to get 3-4+ MR down to 2+ General anesthesia No heart-lung machine 3-4 hour procedure

16. 16 Mitral Regurgitation vs. MitraClip device implanted

17. 17 Recovery Protocols Recovery is typically 1-3 days Transferred to the cardiac monitoring unit for a day. Reviewed/transferred to regular hospital ward for next 2 days Echocardiogram, blood tests and a chest X-ray. May be given blood thinners: Aspirin and/or Clopidogrel for 6 months Post procedure: Echos at 1 month, 6 months, 1 year

18. 18 Improvements Data Worldwide: more than 8,000 patients treated to date Findings from 351 symptomatic US patients too high risk for open MV surgery 96% implant success rate Acute reduction in MR to 2+ or less in 86% patients 30 day mortality rate of 4.8% vs. 18.2 % open surgery Low rate of adverse events, despite high surgical risk profile of patients Significant improvement in LV size Significant reduced rates of hospitalization for HF 48% reduction from 1 year post discharge vs. year prior to treatment

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20. 20 Potential Complications Clinical like w/ any procedure: infection, bleeding, etc. Clip-related complications: below 5% Trans-septal puncture PM/CRT/ICD lead displacement Clip-related chordal rupture Leaflets degeneration and stress Fatal complications are exceedingly rare Rates of major clinical complications such as stroke, acute renal failure are below 5%

21. 21 MitraClip Procedure http://www.youtube.com/watch?v=jzpUSR5yi-w

22. 22 Works Cited http://www.heart-consult.com/articles/232/evalve-mitraclip http://nhc.health.govt.nz/referrals/referral-templates-received/006-mitral-valve-device http://www.cardiovascmed.ch/docs/2012/10/en/cvm-00103.pdfdocs/2012/10/en/cvm-00103.pdf http://www.abbott.com/press-release/abbotts-minimally-invasive-mitraclip-system-for-mitral- regurgitation-demonstrates-positive.htmelease/abbotts-minimally-invasive-mitraclip-system-for-mi http://www.abbottvascular.com/int/mitraclip.html#learn-more http://www.abbottvascular.com/int/mitraclip.html#overviewlip.html#overview http://www.abbott.com/press-release/fda-advisory-committee-votes-favorably-on-abbotts- minimally-invasive-mitraclip-device-for-patients.htmhttp://www.abbott.com/prerably-on-abbo