Heterotopic transcatheter tricuspid valve implantation: first-in-man application of a novel approach to tricuspid regurgitation

Abstract

AimsTranscatheter treatment of heart valve disease is well established today. However, for the treatment of tricuspid regurgitation (TR), no effective catheter-based approach is available. Herein, we report the first human case description of transcatheter treatment of severe TR in a 79-year-old patient with venous congestion and associated non-cardiac diseases. In this patient, surgical treatment had been declined and pharmacological therapy had been ineffective. After ex vivo and animal studies, the treatment of TR was performed by percutaneous caval valve implantation.Methods and resultsIn a transcatheter approach through the right femoral vein, a custom-made self-expanding heart valve was implanted into the inferior vena cava (IVC). The device was anchored in the IVC at the cavoatrial junction with the level of the valve aligned immediately above the hepatic inflow and protruding into the right atrium. After deployment, excellent valve function was observed resulting in a marked reduction in caval pressure and an abolition of the ventricular wave in the IVC. Sequential echocardiographic exams over a follow-up period of 8 weeks confirmed continuous device function without paravalvular leakage or remaining venous regurgitation. The patient experienced improved physical capacity and was able to resume off-bed activities. There was no recurrence of right heart failure during follow-up and a partial reduction of ascites. The patient was discharged from hospital into a rehabilitation programme.ConclusionTranscatheter treatment of severe TR by caval valve implantation is feasible resulting in an immediate abolition of IVC regurgitation and mid-term clinical improvement. Thus, in selected non-surgical patients, caval valve implantation may become a therapeutic option to treat venous regurgitation and improve associated non-cardiac diseases. Further confirmatory experience with longer follow-up is required to evaluate the long-term clinical benefit of the procedure as well as potential deleterious effects.

Percutaneous Bicaval Valve Implantation for Transcatheter Treatment of Tricuspid Regurgitation

“…Second, the IVC valve was implanted as previously described (see the Data Supplement). 4 After deployment, IVC pressure decreased from 28/19 to 16/14 mm Hg with a reduction of mean pressure from 19 to 14 mm Hg. In the SVC, pressure decreased from 27/14/19 to 21/13/18 mm Hg.…”

“…Hemodynamics, laboratory, and clinical parameters are detailed in the Table. Based on computed tomography-angiographic images, 2 self-expanding percutaneous heart valves were custom-made with 10% to 20% oversizing to fit the anticipated implantation site in the SVC and IVC. 4 The IVC valve was designed with the upper segment protruding into the RA with the biological valve located above the diaphragm to protect the abdominal vasculature from systolic backflow and avoid occlusion of hepatic veins (Figure 1). For the SVC valve, the stent frame was funnel shaped with the upper and lower segments tapered to facilitate sufficient fixation at the cavo-atrial inflow.…”

Trikuspidalklappeninterventionen

“…Nach umfangreicher experimenteller Validierung konnte das Verfahren inzwischen mehrfach am Patienten im Rahmen von Heilversuchen angewandt werden [28]. So wurden unter anderem bei einer 83-jährigen, inoperablen Patientin mit hochgradiger symptomatischer Trikuspidalinsuffizienz und schwerer funktioneller Beeinträchtigung im NYHAStadium IV zwei selbstexpandierbare, aus einer porcinen Perikardklappe und einem Nitinolstent bestehende Klappenprothesen in die obere und untere Hohlvene implantiert [29].…”

“…Bei der tierexperimentellen Evaluation des Verfahrens konnte der hämodynamische Effekt der heterotopen Klappen eindrucksvoll gezeigt werden. Das aufgrund der hochgradigen Trikuspidalinsuffizienz im Tierexperiment reduzierte Herzzeitvolumen stieg nach transvenöser Klappenimplantation signifikant an, gleichzeitig wurde der Rückfluss in die zentralen Venen signifikant reduziert [27].Nach umfangreicher experimenteller Validierung konnte das Verfahren inzwischen mehrfach am Patienten im Rahmen von Heilversuchen angewandt werden [28]. So wurden unter anderem bei einer 83-jährigen, inoperablen Patientin mit hochgradiger symptomatischer Trikuspidalinsuffizienz und schwerer funktioneller Beeinträchtigung im NYHAStadium IV zwei selbstexpandierbare, aus einer porcinen Perikardklappe und einem Nitinolstent bestehende Klappenprothesen in die obere und untere Hohlvene implantiert [29].…”

Special article Transcatheter tricuspid valve implantation

“…W 2. dobie po zabiegu pacjentka opuściła oddział intensywnego nadzoru. W ciągu 8 tygodni po zabiegu obserwowano poprawę tolerancji wysiłku (III klasa wg NYHA), ustąpienie obrzęków i zmniejszenie obwodu brzucha [15].…”