Sapien Transcatheter Aortic Valve. Kaitlin Neville Biomedical Engineering University of Rhode Island

Transcription

1 Sapien Transcatheter Aortic Valve Kaitlin Neville Biomedical Engineering University of Rhode Island

2 What is Open Heart Surgery? The simplest definition is that Open-heart surgery is any type of surgery where the chest is cut open and surgery is performed on the muscles, valves, or arteries of the heart When is Open Heart Surgery Needed? Cardiac surgeons may perform open-heart surgery to correct severe disease in the coronary arteries that supply blood to the heart, to fix structural heart defects or to replace or repair heart valves.

3 What is the Sapien Transcatheter Aortic Valve? The Sapien Transcatheter Aortic Valve was originally produced by a company called Edwards Lifesciences in Irvine, CA It is a collapsible artificial aortic heart valve that can be introduced into the body by a catheter-based delivery system The purpose of the valve is to replace the patient's damaged/diseased aortic valve without traditional open heart surgery The valve is implanted while the patient s heart continues to beat normally Image: catheter_aortic_valve_makes_human_debut.html

4 Valve Design - Outer Sealing Skirt - Low Profile Access - Frame design - Low frame height - Valve Tissue

5 What is the surgery like? The surgery is minimally invasive compared to traditional open heart surgery There are two different methods of implanting the Sapien transcatheter Aortic Valve: - Transfemoral Approach - Transapical Approach

6 Transfemoral Approach - The valve itself is placed into a balloon delivery catheter system known as the Retroflex 3 delivery system. - The system is then carefully inserted into the femoral artery located in the upper thigh - The physician then uses echocardiographic and fluoroscopic systems for visualization during valve delivery - The artificial valve is then threaded up to the diseased valve Transapical Approach - The valve itself is places into a different balloon delivery catheter system known as the Ascendra Valve delivery system - The system is then carefully inserted into the apex of the left ventricle, with a small incision in between the ribs - And then the system travels (monitored by the physician) to the diseased valve

7 Transfemoral Approach Transapical Approach

8 pdf RetroFlex 3 Ascendra Valve

9 Who can receive the Sapien Transcatheter Aortic Valve? - The Sapien Transcatheter Aortic Valve is intended for high-risk patients who are unable to receive traditional open heart surgery - There are a few reasons as to why a patient could not receive open heart surgery - Previous medical condition - Deemed unable to fully recover from invasive open heart surgery

10 All about a patient who received the Sapien Transcatheter Aortic Valve Replacement - Maryann Casey (62 years old) was diagnosed with and survived breast cancer 30 years prior to learning that she had severe aortic stenosis which is a potentially fatal heart-valve disease. - The doctors told her that she would probably never recover from invasive open-heart surgery due to severe damage to the tissues and muscles surrounding her heart that had occured when she was undergoing high doses of radiation to eradicate the cancer cells - Her doctors then told her about another option, the Edwards Sapien Transcatheter Aortic Valve replacement, and she decided to receive the surgery - Within 2 days Maryann was out of the hospital with minimal pain - This example is unique because Maryann is not the usual type of person who is eligible to receive the Sapien Transcatheter Aortic Valve, usually patients are in their 80s and 90s

11 Statistics - About 300,000 patients in the United States alone suffer from deterioration of heart valves which have life threatening consequences, oftentime leading to heart failure and eventually death - Every year only about 17% of those suffering from heart valve deterioration (approx 50,000) will receive life saving open-heart surgery - Many other patients are turned away from the invasive surgery, however now there is the option of the Sapien Transcatheter Aortic Valve replacement for those who were onced deemed ineligible for invasive open-heart surgery - Generally those who qualify for this option are weak, elderly people who have no other surgical options - The device manufactured by Edwards Lifesciences was originally approved by the FDA in 2012 but had been used in European countries for years before that - Each valve costs about $33,000

12 ranscatheter-sapien-3 Results Disabling Stroke Results All-Cause Mortality Results

13 Pros and Cons of the Sapien Transcatheter Aortic Valve Replacement and Traditional Open-Heart Surgery Recovery time is extremely limited after receiving the Sapien Transcatheter Replacement mechanical heart valve replacements and replacements made of animal skin have been able to last ten to fifteen years whereas Sapien Transcatheter Replacements have been shown to last up to 5 years There is an increased risk of stroke with the Sapien Transcatheter Replacement

14 Discussion - Edwards Sapien Transcatheter Aortic Valve has been an incredible biomedical breakthrough - This noninvasive procedure is a competitive alternative to open heart surgery. Patients who would have certainly died because they were deemed inoperable are now able to receive a life saving procedure that will dramatically improve their quality of life, offering a shorter recovery time and no damage to the tissues surrounding the heart. - With improvements to make this artificial valve lifespan longer, the Sapien transcatheter aortic valve could eventually be the new and improved open heart surgery that will increase longevity and drastically improve the quality of life for patients.

15 References [1] Alfadhli, Jarrah, et al. "Updates on transcatheter aortic valve replacement: Techniques, complications, outcome, and prognosis." Journal of the Saudi Heart Association 30.4 (2018): [2] Bianchi, Matteo, et al. "Simulation of transcatheter aortic valve replacement in patient-specific aortic roots: effect of crimping and positioning on device performance." Engineering in Medicine and Biology Society (EMBC), th Annual International Conference of the IEEE. IEEE, [3] Gualis, Javier, et al. "Transapical Transcatheter Mitral Valve-In-Valve Implantation Using an Edwards SAPIEN 3 Valve." Heart, Lung and Circulation 27.3 (2018): e23-e24. [4] Huang, Pei-Hsiu, and Andrew C. Eisenhauer. "Transcatheter aortic valve replacement using the Edwards SAPIEN transcatheter heart valves." Cardiology clinics 31.3 (2013): [5] Plessis, Julien, et al. "Edwards SAPIEN transcatheter pulmonary valve implantation: results from a French registry." JACC: Cardiovascular Interventions (2018). [6] Edwards, Edwards Lifesciences, <