(Health Times Reporter Zhengxing Ye) A humanitarian rescue gave a seriously ill elderly woman a new lease of life.
On the afternoon of February 18, 2016, an unusual surgery was performed at St. Paul's Hospital in Vancouver, Canada's largest cardiac surgery center. A local 88-year-old woman suffering from severe heart valve lesions underwent minimally invasive heart valve surgery and was successfully implanted with China's latest self-developed J-Valve heart valve. 3 hours after the surgery, she was already able to joke and eat in her hospital bed and was successfully discharged from the hospital three days later.
"This is arguably the most advanced valve disease treatment technology in the world today, and the product developed by Zhang Ji has solved a difficult problem of concern to the medical community." Professor Wei Lai, deputy director of cardiac surgery at Zhongshan Hospital of Fudan University in Shanghai, had this to say about the J-Valve minimally invasive heart valve technology, which will revolutionize traditional surgery and simplify the heart valve replacement process.
Photo by Dr. Rui-Li Lu, J-Valve inventor and Chairman of Jebsen Medical
Heart valve replacement in 10 minutes
Zhang Ji, the inventor of J-Valve technology, was a cardiac surgeon at Peking University People's Hospital. He compared heart valves to the doors of a room, and when the doors are aging, they either don't open or don't close properly. Only when the door opens and closes smoothly and unobstructed can the heart supply blood healthily and effectively. Once the valve is narrowed or incompletely closed, the heart will be underpowered and cause heart failure.
Statistics show that there are 12 million heart valve patients worldwide, and nearly 1 million people pass away every year due to heart failure. The prevalence is 2% in people over 65 years of age and increases with age, even up to 5% or more. Traditional heart valve surgery requires open-heart and extracorporeal circulation, and the high risk of surgery and the high rate of complications discourage many patients.
In the past, it took several hours or even more than ten hours to perform the difficult and high-risk surgery, but this time it was successfully completed within 10 minutes without opening the chest and without the heart beating.
Wang Wei, director of the Surgical System Management Committee of Fu Wai Cardiovascular Hospital, Chinese Academy of Medical Sciences, revealed that minimally invasive heart valve implantation systems are also being developed in Europe and the United States, but none have comprehensive positioning devices, while the J-Valve heart valve implantation system is the only heart valve replacement system with intelligent three-dimensional positioning that automatically and accurately finds the location of the diseased valve.
"Most of the minimally invasive valve technology was previously used abroad. the success of the J-Valve heart valve clinical trial marks the fact that China has caught up in this field and is on par with the international community." Wang Chunsheng, Director of Cardiac Surgery at Zhongshan Hospital of Fudan University in Shanghai, commented.
"In the J-Valve procedure, the surgeon's judgment is auxiliary. Implanted from 1 to 2 inches below the left nipple, the positioning device looks for the diseased aortic valve, and when it gets to that position, it doesn't pull, and it doesn't need to rely on images to decide where to put it. The valve that is implanted in is in a coaxial orientation with the valve in the body." said J-Valve technology inventor Jie Zhang.
J-Valve heart valves enjoy special access abroad
Previously, heart valve surgery was strictly indicated because the surgery was so traumatic, difficult and risky that many elderly, frail and sick patients could hardly afford it, while the survival time for conservative treatment was only five years.
"Most patients are afraid and would rather die than treat, but not treating is not the same as not spending money, taking medication and hospitalization for a year has a lot of expenses." Zhang Ji introduced, heart valve patients always sleep in a semi-recumbent position, serious even can not lie flat, third or fourth degree heart failure patients, can not walk a few steps, will panic and shortness of breath. Many patients are hospitalized for one month in the first year, three months in the second year, and six months in the third year. With such a patient in the family, the burden of care and medical expenses for the family can be very heavy.
From March 2014 to 2015, West China Hospital of Sichuan University has completed J-Valve heart valve clinical surgery in more than 60 patients cumulatively, all with very good treatment results, "with no case deaths and up to 97% of patients successfully cured." Guo Yingqiang, deputy director of cardiothoracic surgery at West China Hospital of Sichuan University, revealed. These clinical trial cases were eventually published in the world's top academic journal, the Journal of the American College of Cardiology (JACC).
The U.S. FDA has a special clinical approval channel, and pharmaceutical products entering the channel need to meet two conditions: first, there is no effective treatment in the disease area; and second, the disease is life-threatening. "Compared to other minimally invasive heart valve technologies, the J-Valve Valve Replacement System not only treats patients with valve stenosis, but also treats heart valve closure insufficiently well, when the FDA allowed us to go to the U.S. to complete clinical trials and allowed us to skip the initial feasibility clinical trials and go directly to pivotal clinical trials." Zhang Ji said.
Health Canada approved the J-Valve valve as a humane medical device for patients with advanced aortic valves before the FDA did, and has recently continued to approve more procedures, while Italy, Germany, and Singapore have also thrown in the towel on the J-Valve valve.
When will the major breakthrough device land in China?
"After our 40 cases were done, new patients kept coming to me in the clinic. Every day I hear this on the clinic, but all I can tell them is that now that the clinical trial is over, you will have to wait for this product to be officially approved before you can use it." Associate Director Wei Lai said.
Since early 2014, the J-Valve system has been conducting clinical trials of international advanced standards at three large and well-known hospitals in China: the West China Hospital of Sichuan University (West China region), the Zhongshan Hospital of Fudan University in Shanghai (East China region), and the Fu Wai Cardiovascular Hospital of the Chinese Academy of Medical Sciences (North China region). Up to now, more than 100 clinical trials have been successfully completed with remarkable clinical results.
The relevant trial report shows that as of the end of July 2015, J-Valve technology has successfully completed the established number of clinical trial cases, proving that J-Valve is far superior to existing interventional valves at home and abroad, while overcoming the worldwide problem that traditional interventional valve technology cannot treat simple aortic valve closure insufficiency disease; breaking the situation that minimally invasive heart valve replacement surgery is completely monopolized by foreign products.
In the past, family members took care of them, but now they are taking care of their family members. West China Hospital has seen an elderly man with heart failure, post-operative follow-up visits to learn that the body is recovering very well, their own mahjong, speculation can handle, he said recently his partner was hospitalized in a car accident, the previous activity restrictions can not go out of his partner to take care of living, but now he has become busy taking care of his partner.
"We have closely followed more than forty patients who underwent clinical trial surgery at Zhongshan Hospital, the first case was in May 2014, and the latest one is more than a year old. None of the patients had to have a secondary intervention. We were originally worried that the new valve would shift and other problems after a period of use, but none of the bad cases occurred." Professor Wei Lai expressed his hope that the country can appropriately speed up the progress under strict procedures, so that this safe and effective technical product can be approved as soon as possible and widely used in the clinic for the real benefit of heart valve patients in China and the world.
It is reported that J-Valve heart valve technology will be expected to be a representative project of China's science and technology sector to G20 countries for technology exchange as a high technology in the medical field.