Recently, at the East Campus of Qingdao Municipal HospitalDean Yibing ShaoUnder the leadership of, and together with the main hospital areaWang Zhengzhong、Professor Hou Fangjie's Team, East CampusNiu Zhaoduo、Xia Wei、Professor Lin Mingshan`, as well as the Ultrasound Department`Da-Xin He、Chu QiangProfessor. In collaboration with the Department of Anesthesiology, operating room, and multiple other departments, successfully implemented and applied the Mi-thos® Transcatheter Mitral Valve Replacement System ("Mi-thos®") independently developed by Shanghai NewMed Medical Co., Ltd. ("NewMed"), performing a Transcatheter Mitral Valve Replacement (TMVR) on a patient with severe mitral regurgitation and high surgical risk. This marks the first case enrolled in the multi-center confirmatory clinical study of the Mi-thos mitral valve replacement at Qingdao Municipal Hospital.
The patient, a 78-year-old male, was admitted to the hospital due to recurrent episodes of chest tightness and shortness of breath for over four years. Findings include malalignment of the anterior mitral valve leaflet with severe regurgitation, calcification of the aortic valve with mild regurgitation, moderate tricuspid regurgitation, and an EF of 41%. He has heart failure, classified as NYHA Class III, and is considered a high-risk candidate for traditional open-chest surgical procedures.
Assessed by the cardiology team at Qingdao Municipal Hospital as high-risk for surgical procedures, and after simulating the state of artificial valve implantation to confirm no risk of obstruction in the left ventricular outflow tract, it was decided to use the Mi-thos® Transcatheter Mitral Valve Replacement System to perform Transcatheter Mitral Valve Replacement (TMVR) for the patient's treatment. Compared with traditional open-heart surgery, Transcatheter Mitral Valve Replacement has the advantages of minimal trauma, shorter hospital stays, reduced incidence of complications, and enabling patients to return to normal life and work more quickly!
Severe Mitral Regurgitation on Preoperative Echocardiogram
Preoperative CT Evaluation for Simulating Mi-thos® Implantation
The surgery was completed in the hybrid operating room at the main campus of Qingdao Municipal Hospital. It utilized DSA and 3D transesophageal echocardiography monitoring. Through a small incision of approximately 4cm in the patient's left chest, the valve was delivered to the diseased mitral valve position via the apex of the heart. The mitral valve replacement was swiftly performed while the heart was still beating. During the operation, there was almost no bleeding, no conduction block, and no outflow tract obstruction, with both blood pressure and heart rate remaining stable.
Precise Localization of Transcatheter Valve During Surgery
Immediate postoperative transesophageal echocardiography evaluation showed appropriate positioning and intact morphology of the artificial mitral valve, no mitral stenosis, mild mitral regurgitation, effective orifice area of the artificial mitral valve 3.3 cm², and a mean transvalvular pressure gradient of 4 mmHg. The peak velocity of left ventricular outflow tract blood flow was 0.8 m/s, with a mean pressure gradient of 1 mmHg.
Immediate Postoperative Mitral Valve Flow
Immediate Postoperative DSA
Mi-thos® Transcatheter Mitral Valve Replacement System participated in the "13th Five-Year Plan" Key Research and Development Program of the Ministry of Science and Technology of China, and received support from the Shanghai Science and Technology Commission's "Science and Technology Innovation Action Plan" in the biomedical field. Mi-thos® is the first innovative mitral valve replacement product under research in China to enter the FIM clinical trial. This product was independently developed by NewMed, with a total of 34 national patents applied for. It has passed the review of the National Medical Products Administration (NMPA) and has been approved to enter the special review process for innovative medical devices, also known as the "Green Channel," further accelerating its market launch process in China.
Currently, the multi-center confirmatory clinical study of Mi-thos® mitral valve replacement is proceeding steadily to verify the safety and effectiveness of the product, providing more reliable and safe treatment options for Chinese clinicians in the field of mitral valve disease, benefiting a wide range of patients.
Qingdao Municipal Hospital
Chief Physician, Doctoral Supervisor, Vice President of Qingdao Municipal Hospital, Director of the Heart Center, Director of the First Department of Cardiology at the East Campus, Chief Physician (Level III), Postdoctoral Mentor. Member of the Clinical Research Group of the Cardiovascular Branch of the Chinese Medical Doctor Association, Member of the Cardiac Critical Care Professional Committee of the Chinese Medical Doctor Association, Member of the Clinical Research Group of the Cardiovascular Branch of the Chinese Medical Association, Member of the Precision Cardiovascular Group of the Cardiovascular Branch of the Chinese Medical Association, Vice Chairman of the Structural Heart Disease Special Committee of the Shandong Medical Doctor Association, Vice Chairman of the Cardiac Rehabilitation Professional Committee of the Shandong Medical Doctor Association, Vice Chairman of the Interventional Cardiovascular Branch of the Shandong Medical Association, Vice Chairman of the Electrophysiology and Pacing Professional Committee of the Shandong Medical Doctor Association, Chairman of the Cardiovascular Professional Committee of the Qingdao Integrated Traditional Chinese and Western Medicine Association, Chairman of the Cardiovascular Branch of the Qingdao Medical Association. Named "Qingdao Good Doctor" in 2021, and a member of the 13th and 14th Qingdao Municipal Political Consultative Conferences.
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Qingdao Municipal Hospital
Director of the Cardiology Department at the Main Campus of Qingdao Municipal Hospital, Doctor of Medicine, Chief Physician, Master's Supervisor; Vice Chairman of the Qingdao Cardiovascular Disease Branch of the Chinese Medical Association, Vice Chairman of the Qingdao Pacing and Electrophysiology Branch of the Chinese Medical Association, Vice Chairman of the Qingdao Interventional Cardiology Branch of the Chinese Medical Association, Member of the Coronary Artery Group of the Shandong Cardiovascular Disease Branch, Member of the Shandong Pacing and Electrophysiology Branch, Member of the Shandong Physician Association Arrhythmia Branch, Member of the Cardiovascular Disease Branch of the China Geriatric Health Care Medical Research Association, Member of the Clinical Research Branch of the Cardiovascular Division of the Chinese Physician Association; Visiting Scholar in Essen, Germany in 2006; Interventional Training at the Ottawa Heart Institute in Canada from 2013-2015; Recipient of the Outstanding Young Professional Award of Shandong Province and the Outstanding Young Medical Expert of Qingdao City; Proficient in complex coronary intervention techniques, leadless permanent pacemaker implantation, permanent pacemaker implantation including ICD\CRTD and SICD, CCM; routinely performs TAVR and other valve replacement techniques; First author of more than 30 national and provincial articles, 5 SCI papers, and 2 monographs.
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Qingdao Municipal Hospital
M.D., Director of the Cardiac Surgery Department, East Campus of Qingdao Municipal Hospital.
Proficient in surgical treatment of cardiac and major vascular diseases, including critical coronary artery disease, acute aortic dissection, and complex cardiac valve disease. Skilled in off-pump coronary artery bypass surgery, minimally invasive coronary artery bypass surgery, cardiac valve repair or replacement surgery, atrial fibrillation maze radiofrequency ablation surgery, aortic surgeries such as Bentall procedure, total aortic arch replacement, and Sun’s procedure. Also experienced in interventional procedures for cardiovascular diseases, specializing in interventional treatments for valvular heart disease, congenital heart disease, and aortic conditions. Conducts in-depth research on cardiac assist devices and heart transplantation.
Serving as a member of the Shandong Provincial Quality Control Center for Cardiac and Great Vessel Surgery, Secretary of the Cardiovascular Surgery Branch of the Qingdao Medical Association, and a Youth Committee Member of the Cardiac Surgery Branch of the Shandong Medical Association. Published 3 SCI articles, over a dozen core journal articles, won one third prize for Qingdao City's Scientific and Technological Progress, and has multiple ongoing research projects.
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Qingdao Municipal Hospital
PhD, Associate Chief Physician, Deputy Director of the Department, Outstanding Young Talent in Qingdao's Healthcare Industry, Master's Supervisor, Member of the Heart Valve Team.
Working Capability: Skilled in precise coronary interventional procedures guided by intravascular ultrasound and fractional flow reserve, emergency interventional treatment for severe acute coronary syndrome, and transcatheter aortic valve replacement.
Research Capability: Published 9 SCI-indexed papers and led one National Natural Science Foundation of China project.
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Qingdao Municipal Hospital
Deputy Chief of the First Department of Cardiology at the Main Campus of Qingdao Municipal Hospital, Associate Chief Physician, Doctorate, Master's Graduate Supervisor, Outstanding Young Medical Expert of Qingdao City, and the first "Shibei Talent." Areas of expertise: Skilled in precise interventional treatment of coronary heart disease guided by intravascular imaging technologies such as IVUS, OCT, and FFR; minimally invasive surgical treatment for valvular heart disease (TAVR, TEER, TMVR); closure of patent foramen ovale; and permanent pacemaker implantation. Published over 10 SCI papers and more than 10 papers in national core journals. Awarded one Qingdao Science and Technology Award. Professional appointments: Editorial Board Member of the Chinese edition of the European Heart Journal (EHJ), Degree Thesis Review Expert for the Ministry of Education, Member of the Cardiovascular Specialty Committee of the China Association of Geriatric Health Care, Youth Member of the Precision Medicine Expert Committee on Cardiovascular Diseases of the Chinese Society of Gerontology and Geriatrics, Member of the Chronic Disease Prevention and Management Committee of the Chinese Research Hospital Association of Geriatric Health Care Medicine, Member of the Cardiovascular Specialty Branch of Qingdao Medical Association, and Deputy Chairman of the Cardiovascular Specialty Committee of Qingdao Geriatric Medical Association.
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Qingdao Municipal Hospital
Master, Deputy Chief Physician of Cardiothoracic Surgery, Standing Committee Member of the Cardiac and Great Vessels Surgery Branch of the Shandong Research Hospital Association, Member of the Cardiovascular Surgery Branch of the Qingdao Medical Association, Member of the Youth Group of Cardiac and Great Vessels of the Shandong Research Hospital Association.
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Qingdao Municipal Hospital
Associate Chief Physician, Director of the Cardiac Ultrasound Department at Qingdao Municipal Hospital. Member of the Ultrasound Branch of the Qingdao Medical Association, Member of the Cardiac Group of the Ultrasound Branch of the Shandong Medical Association, Director of the Shandong Ultrasound Medicine Engineering Society, Deputy Chairman of Cardiac Ultrasound, Standing Committee Member of the Shandong Hospital Association. Specializes in the ultrasound diagnosis of various complex valvular heart diseases, cardiomyopathy, coronary artery disease, etc., and is proficient in transesophageal echocardiography and intraoperative monitoring for various cardiac interventional procedures.
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Qingdao Municipal Hospital
Deputy Chief Physician at Qingdao Municipal Hospital (East Campus), Master of Medicine, with over a decade of experience in cardiac ultrasound. Published one SCI paper and three papers in domestic journals. Completed a six-month fellowship at Fuwai Cardiovascular Hospital in 2015. Committee member of the Qingdao Medical Association's Ultrasound Branch. Holds an international ultrasound professional development certificate from the Hong Kong Asia Medical Group.
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This article is reprinted from Yanda Medical Network
