Clinical results of tricuspid valve replacement—a 21-case report

Objective： To summarize the clinical experiences of 21 patients treated with tricuspid valve replacement （TVR） and investigate the surgical indications and methods. Methods： Data from 21 patients who underwent TVR from December 2002 to March 2009 were retrospectively collected and analyzed. The mean age was 48.86± 15.37 years （range： 20-72 years）. The underlying disease of the patients was classified as rheumatic （n = 10）, congenital （n = 8）, endocarditis （n = 2） or chest trauma （n = 1）. Previous cardiac surgery had been performed in 12 patients （57.14%）. Results： In-hospital death occurred in two patients （9.52%）. Postoperative morbidities included cardiac failure （n = 2）, bleeding related re-operation （n = 1）, and plural effusion （n = 2）. Conclusion： The early outcomes of TVR were acceptable. At the present time TVR can be performed through optimal perioperative management.

Isolated tricuspid valve infective endocarditis in young drug abusers

Isolated tricuspid valve infective endocarditis (TVIE) is a rare clinical condition. Thus, there is no common consensus for the treatment options for TVIE. Vege-tectomy and valvulectomy, valve repair, and valve replacement, which are controversial in regard to hemodynamic consequences in right-sided low-pressure system and long-term prognosis. We present 2 young intravenous drug users with TVIE and our surgical strategy.

Redoing a bioprosthetic tricuspid valve replacement with pacemaker wire through the ruined bioprosthetic valve orifice

Severe tricuspid regurgitation with permanent pacemaker wire passing through the orifice of bioprosthetic tricuspid valve is extremely rare. We present a case of such kind of patient and redid bioprosthetic tricuspid valve replacement. A hawk mouth forceps for bone surgery was used to cut off the mental ring of ruined bioprosthetic tricuspid valve and the ruined valve was removed. A new bioprosthetic tricuspid valve was implanted and the wire of permanent pacemaker was left outside the ring of bioprosthetic tricuspid valve. This method may be helpful for such kind of patient.

Regulatory science promotes the translation of transcatheter tricuspid valve repair/replacement devices

For patients with symptomatic and severe tricuspid regurgitation but inoperable with open surgery,transcatheter tricuspid valve intervention(TTVI)is a procedure of great clinical value.TTVI products include repair and replacement devices.TTVI products are one of the hotspots of investigation now,with different inno-vative biomaterials and structural designs in trials to satisfy di-vergent indications and reduce complications.With the emerging biomaterials,the technical difficulty of structural design will be greatly reduced,spurring further product innovation and devel-opment.The innovativeness and complexity of TTVI products have brought challenges to academia,industry,and regulatory agencies.Regulatory science provides a bridge to address these difficulties and challenges.This perspective article introduces the latest development of the TTVI products.With traditional methods,regulatory agencies face challenges in evaluating the safety and effi-cacy of TTVr/TTVR devices given the uncertainty of clinical use and the diversity of innovative structural design.This perspective article analyzes the regulatory challenges and discusses regulatory science that can be developed to assess the safety,efficacy,quality and performance of such products:including new approaches for innovative devices,pre-review path,computer modeling and simulation,accelerated wear testing methods for transcatheter heart valves and evidence-based research.This article reveals for the first time how to apply regulatory science systematically to TTVI products,which is of great relevance to their development and translation.