| BackgroundTricuspid regurgitation(TR)is one of the common heart valve diseases.The symptoms of TR patients are insidious and most patients are under-treated.TR patients are often in the middle to late stages of the disease when they present with clinical symptoms and patients usually have systemic congestion,ascites,hepatic insufficiency,and renal insufficiency.Currently,TR patients show a low rate of surgical treatment and a high surgical mortality,making it an urgent problem to be solved.In the past two decades,the application of transcatheter tricuspid therapies has emerged as a new method to solve heart valve problems.Transcatheter aortic valve replacement devices and transcatheter mitral valve repair devices have been applied to clinical with satisfactory results.Although the development of transcatheter tricuspid valve therapies start late,a variety of transcatheter tricuspid valve devices have been used in clinical in the past years.Some devices have shown satisfactory results in short-term clinical trials.However,the long-term effects remain unclear.There are a few transcatheter tricuspid valve replacement(TTVR)devices used in clinical including Na Vi Gate,EVOQUE system,Cardiovalve,Criovalve,Monar Q,and LuX-Valve.The LuX-Valve is a radial forceindependent device,which was developed in China.The first generation of the LuX-Valve,implanted via a transatrial approach,has been used in a multi-center clinic trial,and oneyear follow-up has been completed.However,the main disadvantages of the LuX-Valve include excessive bleeding of the chest incision and limited application indications.Therefore,based on the LuX-Valve,we have created a transjugular TTVR device,the LuXValve Plus,which is expected to overcome the shortcomings of the first generation.The LuX-Valve Plus is more minimally invasive and will bring hope to more TR patients.ObjectivesThe study aimed to evaluate the feasibility,safety,and efficacy of the LuX-Valve Plus in animal experiment and early clinical trial.Methods1.The development of a transjugular TTVR device-the LuX-Valve Plus.The bioprosthesis of the LuX-Valve Plus system is similar to that of the LuX-Valve system.The bioprosthesis consists of a nitinol stent,a bovine pericardial leaflet,two anterior leafletgraspers,and a ventricular septum anchoring device.The main body of the bioprosthesis is a nickel-titanium alloy stent,which is made through a series of procedures such as cutting,shaping,and polishing.The stent extends to a large atrial disc on the atrial side,which is woven with nickel-titanium alloy wire and sewn with high-temperature-resistant polyester film.The atrial disc can prevent paravalvular leakage effectively.The bovine pericardial is processed with glutaraldehyde and sewn on the nickel-titanium alloy stent.Two anterior leaflet-graspers can be released to capture the anterior leaflet of the tricuspid valve.The ventricular septum anchoring device is shaped like a tongue,which can be fixed on the septum by the anchoring needle.In collaboration with Zhejiang Ningbo Jianshi Biotechnology Co.,Ltd,the delivery system of the LuX-Valve was optimized to make it suitable for the transjugular approach.The design of the delivery system consists of an outer sheath,an inner sheath,and a core.2.Animal experiment of the transjugular transcatheter tricuspid valve replacement device-the LuX-Valve Plus: Eight male sheep received transjugular interventional tricuspid valve replacement using the LuX-Valve Plus under the guidance of digital subtraction angiography(DSA)and transthoracic echocardiography.All animals were euthanized after4-week follow-up.Echocardiographic and hematological tests were collected preoperatively,immediately postoperatively,and at four weeks postoperatively.Gross and pathological structures of the heart,brain,liver,kidney,lung,spleen and jugular vein were observed after euthanasia.3.Early clinical trial of the transjugular transcatheter tricuspid valve replacement device-the LuX-Valve Plus: 15 TR patients with high surgical risk treated with transjugular LuX-Valve Plus implantation under general anesthesia.All patients were followed up for 1month after the procedures.Echocardiographic data and hematological tests were obtained preoperatively,intraoperatively and at 1 month postoperatively in all patients.Results1.The LuX-Valve Plus consists of a bioprosthetic valve and a delivery system.The bioprosthetic valve was made up of a nickel-titanium alloy stent,a bovine pericardial trileaflet,two anterior leaflet-graspers and a ventricular septum anchoring device.The available valve sizes are 28 mm,30 mm,and 32 mm.The diameter of the delivery system was 28 F for animal studies and 34.5 F for clinical trials.The outer sheath of the delivery device can be bent up to 90 degrees.The inner sheath can be extended 3 to 10 cm to adapt to different ventricular septum positions.The delivery device can be adjusted to rotate the valve on its axis to accommodate patients with different ventricular septum positions.The delivery system has a separate channel for the delivery of the anchor needle.After releasing the anchoring needle,the ventricular septum anchoring device can be fixed on the ventricular septum.2.The LuX-Valve Plus was implanted into 8 sheep via the transjugular approach.Six sheep were successfully implanted with the LuX-Valve Plus,and 2 sheep died during the procedure because of valve detachment and ventricular fibrillation,respectively.Intraoperative echocardiography and DSA results showed the suitable position of the anchoring needle in 6 sheep that survived.At the four-week follow-up,echocardiographic results showed that there was no paravalvular leakage or TR in five sheep,whereas 1 sheep had mild paravalvular leakage.The mean tricuspid transvalvular gradient was 1.1 ± 0.9mm Hg.No right ventricular outflow tract obstruction,coronary artery compression,device displacement,pericardial compression,or arrhythmias occurred.3.The LuX-Valve Plus was successfully implanted in 15 severe TR patients who were at high mortality risk for open-heart surgery.No device detachment,atrioventricular block,and/or right ventricular perforation was observed during the operation.Intraoperative transesophageal echocardiography showed no regurgitation in all patients and mild paravalvular leak in 1 patient.During the 1-month follow-up,clinical symptoms improved significantly in 11 patients.The mean 6-minute walk distance significantly increased from baseline to 1-month follow-up(209.8±97.3 m vs.307.9±133.1 m,P = 0.001).Three patients were rehospitalized for renal failure,bleeding from duodenal bulb ulcer,and malnutrition,respectively.Echocardiography showed that there was no regurgitation in all patients.One patient had perivalvular leakage,which was similar to that at discharge.All patients had good valve function with stable hemodynamics except the patient with renal failure.ConclusionsThe transjugular transcatheter tricuspid valve replacement device,the LuX-Valve Plus,is feasible,safe,and effective,which may be an alternative treatment for TR patients at high surgical risk. |
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