❖ TaurusOne® Transcatheter Aortic Valve Replacement (TAVR) System
■ Four-Year Clinical Follow-up Results (PCR-CIT China Chengdu Valves: Prof. Wu Yongjian, Beijing Fuwai Hospital, Chinese Academy of Medical Sciences; ASSA&VMDT 2023: Prof. Peng Yong, West China Hospital of Sichuan University) The product has a 4-year all-cause mortality rate of 16% in long-term follow-up. Its cardiac mortality rate is lower than that of similar products, with only one new case in the last three years. At four years after the procedure, ultrasound assessment shows that the patient’s hemodynamic parameters remained stable, with an effective orifice area (EOA) of 1.85cm2 and a mean pressure gradient (MPG) of 10.82mmHg. The product performed equally well in patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV). Cardiac function and quality of life scores improved with longer follow-up. ❖ TaurusElite® Retrievable TAVR System ■ The Application in Pure Aortic Regurgitation (AR) (PCR-CIT China Chengdu Valves: Prof. Zhang Longyan, Wuhan Asia Heart General Hospital)
For patients with pure AR, both domestic and international consensus suggests that TAVR can be performed in experienced centers for high-risk surgical patients. In cases of open-type outflow tract AR with a large annulus, it is crucial to preoperatively identify the anchoring zone. The fibrous skeleton of the heart, composed of dense connective tissue, serves as the most important anchoring point during the AR procedure. Continuous observation of the valve's morphology and position during the procedure, combined with its waist-like design, allows real-time assessment of the compression at the valve’s base for anchoring evaluation.
■ TaurusElite®-STABLE Technique for Pure AR (2023 Cardiovascular Health Conference: Academician Ge Junbo, Zhongshan Hospital, Fudan University; Prof. Su Xi, Wuhan Asia
Heart General Hospital; Prof. Lu Fanglin, the First People’s Hospital of Shanghai; Prof. Li Hui, the First Affiliated Hospital of Bengbu Medical College; Prof. Pan Wenzhi, Zhongshan Hospital, Fudan University) Peijia Medical interpreted the newly released “China Expert Consensus on TAVR for Pure AR 2023”. It’s feasible to treat patients with AR in use of TaurusElite®-STABLE technique. The major challenge in treating AR lies in the lack of anchoring force in its anatomical structure, leading to potential valve displacement. TaurusElite® Retrievable TAVR system, however, can effectively provide sufficient support to the annulus, while conform to the morphology of the aortic root. With the assistance of a double-layer skirt, TaurusElite® can enhance anchoring force, ensuring the stability of the valve system. ❖ TaurusNXT® Non-glutaraldehyde Crosslinked Dry-tissue TAVR System ■ Single Center Clinical Data of Guangdong Provincial People’s Hospital (ASSA&VMDT 2023: Prof. Luo Songyuan, Guangdong Provincial People's Hospital) The immediate postoperative peak velocity and MPG significantly decreased. During the follow-up period, all 13 patients showed good hemodynamic performance, sustained improvement in cardiac function, and no moderate or severe PVL at six months.
❖ TaurusTrio™ TAVR System ■ Experience for Pure AR (PCR-CIT China Chengdu Valves& ASSA&VMDT 2023: Prof. Song Guangyuan, Beijing Anzhen Hospital, Capital Medical University; PCR-CIT China Chengdu Valves: Prof. Wei Jiafu, West China Hospital of Sichuan University)
All patients presently enrolled had severe AR and were not suitable for routine surgical treatment. The procedure was successful and uneventful, resulting in the disappearance of AR immediately after. The average device time was more than 20 minutes, with the fastest device time being only 10 minutes.
■ One-year Results of the ALIGN-AR Study (2023 PCR London Valves: Dr. Martin B. Leon, MD) The primary safety endpoint at 30 days was 26.7%, and the primary efficacy endpoint at one year was 7.8%. Both the major safety and major efficacy endpoints met the experimentally preset noninferiority expectations (40.5%, 25.0%). Ultrasound follow-up showed favorable EOA and low MPG. The occurrence rate of moderate or greater paravalvular regurgitation at one year was 0%. Patients experienced sustained improvement in cardiac function and quality of life, with significant improvement in ventricular remodeling, including reductions in left ventricular end-systolic diameter (LVESD), left ventricular enddiastolic diameter (LVEDD), and left ventricular mass. As the study progressed and procedural experience accumulated, the incidence of pacemaker implantation in the last third of enrolled patients (patients 121-180) decreased to 14%, compared to 30% in the first third (patients 1-60). These results confirm the excellent clinical performance of Trilogy® TAVR system, a newly designed device optimized for pure AR anatomy. It is expected to facilitate the submission of Trilogy® TAVR system to the FDA for approval. ❖ HighLife® TSMVR System ■ Design Features, Typical Cases, and Advances in Clinical Research (PCR-CIT China Chengdu Valves: Prof. Nicolo Piazza, McGill University Health Centre in Canada; ASSA&VMDT 2023: Prof. Feng Yuan, West China Hospital of Sichuan University)
Prof. Nicolo Piazza from McGill University Health Centre in Canada shared insights into the HighLife® TSMVR system, covering aspects such as design, case studies, and clinical advancements. Results from 52-case clinical feasibility study indicate that, for patients with moderate to severe mitral regurgitation and high procedural risk, HighLife® TSMVR system demonstrates a high rate of procedural success. The 30-day all-cause mortality rate was only 13.5%, and ultrasound results showed no regurgitation rated 2 or higher. These findings further confirm its acceptable primary safety endpoint and superior efficacy endpoint.
■ HighLife® TSMVR System for Large Annulus (2023 PCR London Valves: Thomas E. Waggoner, Tucson Medical Center) Distinguished from the standard valve design, the new Clarity valve incorporates a hollowing of the existing outer fabric in the ventricular segment to reduce unnecessary obstruction of LVOT. Simultaneously, without altering the core design and delivery system, the Clarity valve introduces the LAV Large Annulus Valve, expanding the valve ring applicability from the original 45mm to a further 53mm. The valve update will serve as complementary evidence in the HighFLO study conducted in the United States, demonstrating the feasibility of HighLife® TSMVR system, and is anticipated to extend to global clinical applications in the future, which is to look forward to. ❖ GeminiOne® Transcatheter Edge-To-Edge Repair (TEER) System
■ Clinical Trial Update (PCR-CIT China Chengdu Valves: Prof. Xie Yongquan, Fuwai Hospital, Chinese Academy of Medical Sciences) GeminiOne® TEER system, leveraging its design advantages, has shown promising early clinical results in domestic multicenter clinical trials. All patients maintained regurgitation levels at 1+ or below at 30 days, demonstrating a significant improvement in regurgitation.
❖ MonarQTM Transcatheter Tricuspid Valve Replacement (TTVR) System
■ The Successful First Implantation of MonarQ™ TTVR System at the Rigshospitalet Heart Center, University of Copenhagen, Denmark (2023 PCR London Valves: Prof. Fabien Praz, University Hospital of Bern in Switzerland) One day postoperatively, tricuspid regurgitation (TR) decreased from preoperative turbulent flow grade 4+ to almost none. Ultrasonography and CTA evaluations at 8 months post-implantation revealed virtually no paravalvular leak and TR, with excellent stability in the positioning and structural morphology of the valve.
■ First-in-Man (FIM) Clinical Use in the USA MonarQTM Transcatheter Tricuspid Valve was successfully implanted in a patient suffering from torrential TR and no other available therapy available. The trans-jugular TTVR procedure was performed on December 1, 2023, on compassionate grounds at the UPENN Presbyterian Medical Center. The valve was implanted successfully implanted with a dramatic reduction of torrential TR.
