A novel spacer for transcatheter treatment of tricuspid regurgitation.

Historically considered the 'forgotten valve', there has been increasing attention on the percutaneous transcatheter treatment of tricuspid regurgitation (TR). Prevalence of TR is high in the elderly population and prior studies have shown worse outcomes in patients with severe TR. Advances in transcatheter-based therapies have shed a new light in the treatment of TR and one such treatment option is tricuspid valve replacement with the Cardiovalve system. This device is approved as an early feasibility study in the US and also approved for clinical study in Germany, Italyand Switzerland. The Cardiovalve device is in the early stage of clinical studies and this article reviews the existing clinical data and future studies on percutaneous transcatheter treatment of severe TR.

Caval valve implantation has been suggested for transcatheter treatment of severe tricuspid regurgitation (TR). Combining the interventional technique with the promising surgical experience with decellularized valves, we sought to evaluate the functional and structural outcome of decellularized pericardial tissue valves (dTVs) in the low-pressure venous circulation in a chronic model of TR. Sixteen pericardial tissue valves were heterotopically implanted in the inferior and superior vena cava in a sheep model (54-98 kg; median 74.5 kg, n = 8) of severe TR. The devices were assembled using self-expanding nitinol stents and bovine pericardia decellularized by a detergent-based protocol (group dTV; n = 8). Glutaraldehyde-fixed pericardial tissue valves served as control (GaTV, n = 8). After 6 months, device function and structural maturation were analyzed using echocardiographic, histologic, immunohistologic, and electron microscopic approaches. After implantation, cardiac output increased significantly from 3.7 ± 1.1 l/min to 4.8 ± 1.1 l/min (P < 0.05) and competent valve function was verified by angiography. At 6 months, angiographic and echocardiographic evaluation revealed moderate to severe regurgitation in all GaTV. In contrast, five of the eight dTVs functioned well with only minor regurgitation. In these animals, autopsy revealed preserved valve structure with tender leaflets without signs of thrombosis or calcification. Conversely, GaTV showed severe degeneration with large calcification areas. Microscopic and histologic analysis confirmed endothelial repopulation in both valve types. However, additional interstitial reseeding was observed in decellularized valves. In the venous circulation in severe TR, decellularized valves show superior functional performance compared to Ga-fixed tissue valves. Macroscopic and microscopic analyses suggest preserved structural integrity and advanced endothelial and interstitial repopulation with evidence of less degradation in dTV. © 2014 Wiley Periodicals, Inc.

Transcatheter treatment of tricuspid regurgitation: A state-of-the-art review.

Current surgical and medical treatment options for severe tricuspid regurgitation (TR) are limited, and additional interventional approaches are required. In the present observational study, the safety and feasibility of transcatheter repair of chronic severe TR with the MitraClip system were evaluated. In addition, the effects on clinical symptoms were assessed. Patients with heart failure symptoms and severe TR on optimal medical treatment were treated with the MitraClip system. Safety, defined as periprocedural adverse events such as death, myocardial infarction, stroke, or cardiac tamponade, and feasibility, defined as successful implantation of 1 or more MitraClip devices and reduction of TR by at least 1 grade, were evaluated before discharge and after 30 days. In addition, functional outcome, defined as changes in New York Heart Assocation class and 6-minute walking distance, were assessed. We included 64 consecutive patients (mean age 76.6±10 years) deemed unsuitable for surgery who underwent MitraClip treatment for chronic, severe TR for compassionate use. Functional TR was present in 88%; in addition, 22 patients were also treated with the MitraClip system for mitral regurgitation as a combined procedure. The degree of TR was severe or massive in 88% of patients before the procedure. The MitraClip device was successfully implanted in the tricuspid valve in 97% of the cases. After the procedure, TR was reduced by at least 1 grade in 91% of the patients, thereof 4% that were reduced from massive to severe. In 13% of patients, TR remained severe after the procedure. Significant reductions in effective regurgitant orifice area (0.9±0.3cm2 versus 0.4±0.2cm2; P<0.001), vena contracta width (1.1±0.5 cm versus 0.6±0.3 cm; P=0.001), and regurgitant volume (57.2±12.8 mL/beat versus 30.8±6.9 mL/beat; P<0.001) were observed. No intraprocedural deaths, cardiac tamponade, emergency surgery, stroke, myocardial infarction, or major vascular complications occurred. Three (5%) in-hospital deaths occurred. New York Heart Association class was significantly improved (P<0.001), and 6-minute walking distance increased significantly (165.9±102.5 m versus 193.5±115.9 m; P=0.007). Transcatheter treatment of TR with the MitraClip system seems to be safe and feasible in this cohort of preselected patients. Initial efficacy analysis showed encouraging reduction of TR, which may potentially result in improved clinical outcomes.

Tricuspid regurgitation in patients with left ventricular assist device (LVAD) has a significant impact on prognosis and quality of life, and its effects on liver and renal function could negatively impact planned heart transplantation. The aim of the present case is to report the feasibility and the clinical impact of tricuspid transcatheter edge‐to‐edge repair in LVAD patients as adjunctive bridge to transplantation strategy. A 59‐year‐old female patient previously treated with LVAD implantation (HeartMate III) and tricuspid valve repair with 32 mm rigid ring (Medtronic Contour 3D) as bridge to transplantation developed recurrence of significant tricuspid regurgitation with right ventricular decompensation needing inotropic support. Preoperative echo showed torrential tricuspid valve regurgitation Effective regurgitant orifice area(EROA 1.4 cm2) with suspicious of partial detachment of the prosthetic ring. The patient was successfully treated with transcatheter edge‐to‐edge repair with the MitraClip XTR device. Tricuspid regurgitation was reduced by 50% (postoperative EROA 0.7 cm2). She remained stable under continuous inotropic support with no other episodes of right ventricular decompensation and was successfully transplanted 30 days after the clipping procedure. Transcatheter treatment of tricuspid regurgitation in a patient with LVAD was an effective strategy to gain time and bridge the patient to heart transplantation.

Nowadays, tricuspid regurgitation (TR) is a widespread condition and this has led to a not-unexpected interest in the "forgotten valve". Medical treatment and/or a surgical approach remain the gold standard for this valve disorder, although these approaches are often limited. In the era of transcatheter therapies, the primary interest for less invasive percutaneous approaches targeted to the treatment of TR can thus find a clear rationale for its evolution. The aim of this review is to explore the different transcatheter techniques for TR that are available or under study, and also to report on preliminary clinical results worldwide.

Transcatheter Treatment of Tricuspid Regurgitation Due to Surgical Ring Dehiscence: Combining Intravalvular and Paravalvular Approaches.

Faculty Opinions recommendation of Percutaneous bicaval valve implantation for transcatheter treatment of tricuspid regurgitation: clinical observations and 12-month follow-up.

Diagnosis and transcatheter treatment of tricuspid regurgitation

The aim of this study was to analyse the feasibility, safety and effectiveness of tricuspid valve (TV) repair using the MitraClip system in patients at high surgical risk. Forty-two elderly high-risk patients (76.8±7.3 years, EuroSCORE II 8.1±5.7) with isolated TR or combined TR and mitral regurgitation (MR) underwent edge-to-edge repair of the TV (n=11) or combined edge-to-edge repair of the TV and mitral valve (n=31). Procedural details, success rate, impact on TR severity and predictors of success at 30-day follow-up were analysed. Successful edge-to-edge repair of TR was achieved in 35/42 patients (83%, 68 clips in total, 94% in the anteroseptal commissure, 6% in the posteroseptal commissure). In five patients, grasping of the leaflets was impossible and two patients had no decrease in TR after clipping. In those with procedural success, clipping of the TV led to a reduction in effective regurgitant orifice area by -62.5% (from 0.8±0.4 to 0.3±0.2 cm2; p<0.0001). In both patients with isolated TV and combined procedures, six-minute walking distance improved (from 285±118 to 344±81 m and from 225±113 to 261±130 m, p=0.02 and 0.03, respectively). Predominant anteroseptal or central TR was identified as a predictor of procedural success (p=0.025). Edge-to-edge repair of the TV is feasible with a promising reduction in TR, which could result in clinical improvement.

Transcatheter Treatment of Tricuspid Regurgitation Using Edge-to-Edge Repair: Procedural Results, Clinical Implications and Predictors for Success

Transcatheter tricuspid valve repair: Bringing the forgotten valve into the spotlight

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.

Right-sided heart failure and tricuspid regurgitation are common and strongly associated with poor quality of life and an increased risk of heart failure hospitalizations and death. While medical therapy for right-sided heart failure is limited, treatment options for tricuspid regurgitation include surgery and, based on recent developments, several transcatheter interventions. However, the patients who might benefit from tricuspid valve interventions are yet unknown, as is the ideal time for these treatments given the paucity of clinical evidence. In this context, it is crucial to elucidate aetiology and pathophysiological mechanisms leading to right-sided heart failure and tricuspid regurgitation in order to recognize when tricuspid regurgitation is a mere bystander and when it can cause or contribute to heart failure progression. Notably, early identification of right heart failure and tricuspid regurgitation may be crucial and optimal management requires knowledge about the different mechanisms and causes, clinical course and presentation, as well as possible treatment options. The aim of this clinical consensus statement is to summarize current knowledge about epidemiology, pathophysiology and treatment of tricuspid regurgitation in right-sided heart failure providing practical suggestions for patient identification and management.

Background Due to increased operative mortality in high-risk patients treated for severe tricuspid regurgitation (TR), there is a growing interest in interventional therapy in these patients that are otherwise solely treated with medication. The edge-to edge technique with implantation of one or more MitraClips is an therapeutic interventional option for these patients. So far, data for transcatheter TR treatment are sparse. Purpose The present cohort study investigates safety, feasibility and effectiveness of the edge-to-edge technique treating severe TR after starting a transcatheter TR treatment program at our institution in 2017. Methods A total of 17 high-risk patients (79.18±8.76 years, EUROScore II 9.31±8.23%, table) with symptomatic, severe TR were treated using the MitraClip system from 12/2017 until 12/2018. All patients received pre-interventional clinical, echocardiographic and invasive evaluation and were entered into a database. Safety and feasibility of the procedure, reduction of TR grade and clinical outcomes were collected and analyzed at the day of discharge and at 30-day follow-up. Results MitraClip device was successfully implanted in 16 of 17 patients (94.1%). In one patient grasping of the leaflets was impossible due to bad echo conditions by abdominal air. 76.5% of the patients had severe or massive and 23.5% had a torrential TR (figure). A total of 25 Clips were used (22 in anteroseptal, 3 in posteroseptal commissure). No intraprocedural deaths, emergency surgery or major vascular complications occurred. Postprocedural TR was significantly reduced (TR reduction ≥1 grade) from a mean TR grade of 3.8±0.8 at baseline to 1.74±0.59 postprocedural (p&lt;0.001, table and figure). One patient had device detachment before discharge. There was one death due to progressive cardiogenic shock 4 days after the procedure. However, the procedure was planned as a last therapeutic option in this terminally ill patient. Echocardiography at discharge showed reduction of TR in 82,4% of patients (mean TR grade at discharge 2.21±0.66, p&lt;0.001). At 30 day f/u symptoms were significantly improved from inital mean NYHA class of 3.06±0.56 to a mean NYHA class of 2.55±0.52 (p=0.002) and patients presented with reduced TR (mean TR grade at 30 day f/u 2.58±0.57, p&lt;0.001). Conclusion Interventional treatment of severe TR in high-risk and mostly inoperable patients using the MitraClip technique is safe and effectivly reduces TR grade leading to clinical improvement. However, further investigations are needed to identify clear parameters highly predictive for a favorable acute and midterm procedural success. Also, more data and clinical trials are needed to determine the long-term course in these patients.