Transcatheter valve implantation and repair

  The incidence of right ventricular outflow tract stenosis (pulmonary atresia, pulmonary stenosis, tetralogy of Fallot, double-chambered right ventricle, transposition of great vessels, etc.) is 22%, or about 350,000, of the approximately 1.5 million newborns born worldwide each year with precordial disease. The surgical treatment of these patients requires the implantation of a prosthetic tube in 30% of cases, and reoperation is required on average 10 years after the implantation of the prosthetic tube due to the deterioration of clinical symptoms caused by valve calcification and thrombosis. The mortality rate for reoperation is as high as 7%. The mortality rate is greater than 10% for the second and third reoperations. Therefore, transcatheter implantation is of great importance in the treatment of these patients. Currently, it is mainly used in patients with pulmonary regurgitation or stenosis after implantation of an artificial tube for right ventricular outflow tract lesions: entry criteria for clinical trials 1. weight > 35 kg; 2. implanted tube ≥ 16 mm and ≤ 24 mm at the time of surgery; 3. pulmonary regurgitation determined by ultrasound to be moderate to severe, or regurgitation fraction ≥ 40% as determined by MRI; 4. if there is stenosis of the implanted tube, the mean pressure difference of the right ventricular outflow tract ≥ 35 mmHg; 5, the comprehensive assessment by the treatment specialist is considered feasible.  Currently, there are two types of stents used in clinical practice: balloon-expandable stents with valves and nickel-titanium alloy self-expanding stents with valves. The valve is made of fresh bovine internal jugular vein containing a three- or two-lobed valve, tanned and fixed to the stent. Domestic studies on valve stents, delivery systems and implantation techniques have also been carried out, but have not yet entered clinical use.  The technique has been performed in 95 countries worldwide, treating more than 1,300 patients. The technical success rate is 99%, with a 6-month survival rate of 99%. Patients with successful implantation showed significant improvement in clinical symptoms and cardiac function. This suggests that this technique is safe to apply and has reliable efficacy.  2.Transcatheter aortic valve replacement In 2002, the first percutaneous aortic valve implantation was carried out. There are dozens of valves for animal experiments and clinical applications, and at present, two systems have passed the European CE certification, including the balloon dilatation system and the self-expanding system.  The pathways to deliver the valve are: 1) the cis-approach route via septal puncture; 2) the retrograde route via the artery; and 3) the transapical route via the open chest.  More than 12,000 cases have been completed in more than 50 countries and 170 cardiac centers worldwide. The indications remain those patients who are at high risk of not being able to tolerate surgical treatment with severe aortic valve lesions. In recent years, it has also been applied to patients with aortic bioprosthetic valve failure, i.e., implantation of a valve-in-valve.  3. Atrioventricular valve implantation Experimental animal studies of percutaneous tricuspid valve replacement were reported in 2005, and no clinical applications have been reported. Recently, the application of transcatheter valve implantation has been reported to successfully treat patients with surgically implanted mitral valve bioprosthetic valve failure, which may be a very promising treatment method.  4. Transcatheter mitral valve repair The clinically used percutaneous mitral edge-suture device, which has been used in more than 750 patients, has had good safety and efficacy in patients with functional or degenerative mitral regurgitation. Continuous symptomatic improvement has been achieved up to 2 years. The device received European CE mark approval in 2008. The main complication in all patients with the device was embolism, approximately 9.3%, mainly in the 107 patients initially used and related to operative proficiency. Another mitral valve annular reduction device implanted via the coronary sinus route, a technique mainly performed in Europe, has a success rate between 32% and 80% and can only be used for functional mitral regurgitation with a very low incidence of risk of gyral branch thrombosis leading to acute myocardial infarction.  In conclusion, the interventional treatment of valvular disease has evolved from inaccessible to promising, especially with the development of percutaneous valve implantation and repair technology, which will eventually change the whole concept of valvular disease treatment, so that surgery is no longer the only treatment for certain valvular diseases. However, we must also be aware that there are still many problems with interventional therapy, such as the selection of indications, evaluation of long-term efficacy, and especially the prevention and treatment of late complications, which need to be summarized and further studied.