Author + information
- Michael Laule, MD,
- Isabel Mattig, MD,
- Christoph Schöbel, MD,
- Fabian Knebel, MD,
- Alexander Lauten, MD,
- Alexander Lembcke, MD,
- Martin Thoenes, MD,
- Herko Grubitzsch, MD,
- Karl Stangl, MD∗ (, )@ChariteBerlin and
- Henryk Dreger, MD
- ↵∗Medizinische Klinik für Kardiologie und Angiologie, Campus Charité Mitte, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany
Implantation of a transcatheter valve into the inferior vena cava (IVC) (CAVI) has been shown to improve symptoms in patients with severe tricuspid regurgitation (TR) (1,2). To compare the effect of CAVI on exercise capacity and symptom relief with optimal medical therapy (OMT), we conducted the investigator-initiated, randomized TRICAVAL (Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve; NCT02387697) trial. Inclusion criteria comprised New York Heart Association functional class II or greater despite established OMT, age ≥50 years, and high surgical risk. Patients with an IVC diameter >31 mm, left ventricular ejection fraction <30%, chronic kidney disease undergoing regular dialysis, or a serum creatinine concentration >3.0 mg/dl were excluded. The study was approved by the local ethics committee (Landesamt fur Gesundheit und Soziales Berlin), and all patients provided written consent. The primary endpoint was exercise capacity assessed by measuring maximal oxygen uptake by treadmill spiroergometry 3 months after randomization. Secondary endpoints included 6-min walk test, New York Heart Association functional class, N-terminal pro–B-type natriuretic peptide levels, right-sided heart function, hospitalization for heart failure progression, and quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire.
Between January 2015 and November 2017, 28 patients (mean age 75.1 ± 8.5 years; 32% male) were randomized to CAVI (n = 14) or continuation of OMT (n = 14). All implantations were performed through transfemoral venous access, with local anesthesia, and guided by transthoracic echocardiography. After preparation of a landing zone by implantation of a self-expanding stent (sinus-XL, Optimed, Ettlingen, Germany), a Sapien XT transcatheter valve (Edwards Lifesciences, Irvine, California) was implanted into the IVC.
Valve implantations were primarily successful in all patients. Four major complications occurred within 7 to 48 h after implantation and led to open heart surgery (2 cases of cardiac tamponade secondary to stent migration and 2 valve dislocations). After the fourth major complication, recruitment was stopped for safety concerns.
CAVI significantly improved dyspnea, as assessed by a Likert scale (1.5 ± 1.1 vs. −0.2 ± 1.3 under OMT; p = 0.008) and quality of life (Minnesota Living with Heart Failure Questionnaire −19.9 ± 13.1; p = 0.004), but it had no significant effect on exercise capacity at the 3-month follow-up. Comparing both study groups, there were no significant differences regarding the primary and secondary endpoints (Figure 1).
In-hospital mortality after CAVI was 21%: 3 patients died after conversion to surgery of hemorrhagic shock secondary to resuscitation-related splenic rupture after tamponade (post-operative day [POD] 1), acute-on-chronic right-sided heart failure (POD 8), or pneumonia (POD 60). Another 3 CAVI-treated patients died after discharge: 1 patient died of chronic right-sided heart failure (POD 64), and 2 patients died of sepsis (POD 49 and 74) without signs of infective endocarditis of the caval valve. One patient in the OMT group died of chronic right-sided heart failure. No differences in renal failure or heart failure hospitalizations were observed between the 2 groups. Echocardiography confirmed normal valve function in all patients 3 months after implantation. There were no strokes or major vascular complications.
Recently, several approaches have been developed for the interventional treatment of severe TR (3). However, data on the efficacy of these options are mostly limited to nonrandomized case series. Our study represents the first randomized controlled trial evaluating the effect of CAVI on exercise capacity. Compared with OMT, CAVI did not result in a superior functional outcome. Given that the majority of our patients had torrential TR and severe dilatation of the right side of the heart, CAVI may have failed to prove beneficial because of the lack of a potential for reverse remodeling. In addition, our study is limited by the low number of patients as a result of early termination of recruitment. The high number of dislocations—despite multimodal assessment of IVC anatomy by computed tomography and 3-dimensional echocardiography—was an unexpected finding not seen in our compassionate use cases. The smooth inner surface and the fluid load–dependent IVC diameter appear to impair safe anchoring of balloon-expandable transcatheter valves even after preparation of a landing zone by implantation of self-expandable stents.
Additional studies using dedicated devices and focusing on high–surgical risk patients in earlier stages of valvular heart failure may be needed to define the role of caval implants in the treatment of chronic TR.
Please note: The study was financially supported by Edwards Lifesciences. Dr. Laule has received fellowship funding from the Berlin Institute of Health; and has received speaker and proctor fees from Abbott, Edwards Lifesciences, and Medtronic. Dr. Mattig has received a Kaltenbach scholarship from the Deutsche Herzstiftung. Dr. Knebel has received fellowship funding from the Berlin Institute of Health. Dr. Lauten has received speaker and proctor fees from Abbott, Edwards Lifesciences, and Medtronic; and is a consultant for P&F TricValve. Dr. Thoenes is an employee of Edwards Lifesciences. Dr. Stangl has received speaker and proctor fees from Abbott, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- 2019 American College of Cardiology Foundation
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