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Feasibility Study of a Novel Transcatheter Tricuspid Annuloplasty System in a Porcine Model

ABSTRACT: Visual Abstract Highlights • The K-Clip transcatheter tricuspid annuloplasty system simulates the Kay’s procedure: shortening the distance between anterior leaflet and posterior-septal leaflets and resulting in a functionally bicuspid valve.• The K-Clip system anchors on the annulus tissue using a corkscrew, with no need to cross the valve, and it is easy to adjust the corkscrew position by adjusting the depth and direction of 2 matched deflectable sheaths in the right atrium.• Results from this study indicate that the K-Clip system may be potentially applicable in treatment of severe tricuspid regurgitation in humans. Summary Gradually, more attention has been paid to tricuspid regurgitation. Formerly the “forgotten valvular heart disease,” it has been recognized as having high incidence and adverse prognosis if untreated. However, isolated tricuspid valve surgery carries substantial risk and is thus not recommended. The K-Clip transcatheter tricuspid annuloplasty system has recently emerged as a minimally invasive therapeutic option that may help address these unmet clinical needs. The K-Clip technology simulates the Kay’s procedure, which reduces the dimensions of the tricuspid annulus by folding and clamping the tricuspid annulus issue with a rigid clamping device. The feasibility of the K-Clip technology was investigated in this study, and annulus area reduction and declining tricuspid regurgitation grades were noted following the procedure. The findings of this study suggest that the K-Clip system may potentially be applicable as a novel transcatheter tricuspid annuloplasty device for the treatment of severe tricuspid in humans.

SUBMITTER: Pan W

PROVIDER: S-EPMC9270588 | biostudies-literature |

REPOSITORIES: biostudies-literature

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30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System : A Single-Center, Observational Study

Project description: Not available

| S-EPMC11198610 | biostudies-literature

First-in-human transcatheter pledget-assisted suture tricuspid annuloplasty for severe tricuspid insufficiency.

Project description:ObjectivesWe report the first pledget-assisted suture tricuspid annuloplasty (PASTA) in a patient with torrential tricuspid regurgitation (TR).BackgroundTricuspid valve regurgitation is a common malignant disease with no commercially available transcatheter therapy. PASTA is a "percutaneous surgical" procedure using pledgeted sutures to create a double-orifice tricuspid valve.MethodsAn 83-year-old man had end-stage TR caused by a defibrillator lead. He consented to undergo PASTA on a compassionate basis. A double-orifice valve was created with pledgeted sutures from percutaneous right ventricular apical access.ResultsTR was reduced from torrential to trace. The vena contracta reduced to from 23 to 1 mm and annular area reduced from 1817 to 782 mm2 . However, the annulus dehisced and required closure with a percutaneous nitinol plug. The patient was discharged home and was alive 6 months later but with persistent symptoms.ConclusionsThe anatomy of a double-orifice valve can eliminate TR but a better solution is required to avoid excessive suture tension on annular tissue.

| S-EPMC7648719 | biostudies-literature

Case report: Transcatheter edge-to-edge repair after prior surgical tricuspid annuloplasty

Project description:Residual and recurrent tricuspid regurgitation may occur frequently after surgical tricuspid valve repair. However, reoperation for tricuspid regurgitation is rare, although many patients are again highly symptomatic. Tricuspid transcatheter edge-to-edge repair (TEER) is a promising therapy for severe tricuspid regurgitation. Herein, we report a 77-year-old woman with recurrent symptomatic massive tricuspid regurgitation 2 years after sutured annuloplasty of the tricuspid valve. TEER was successfully performed using the TriClip® device and tricuspid regurgitation was reduced to a mild degree. In conclusion, tricuspid TEER is feasible following surgical suture annuloplasty. TEER is an alternative option for patients with a failed previous annuloplasty repair for tricuspid regurgitation to undergo a less invasive treatment rather than a potentially higher-risk reoperation.

| S-EPMC9650543 | biostudies-literature

Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve.

Project description:OBJECTIVES:Pledget-assisted suture tricuspid valve annuloplasty (PASTA) is a novel technique using marketed equipment to deliver percutaneous trans-annular sutures to create a double-orifice tricuspid valve. BACKGROUND:Tricuspid regurgitation is a malignant disease with high surgical mortality and no commercially available transcatheter solution in the US. METHODS:Two iterations of PASTA were tested using trans-apical or trans-jugular access in swine. Catheters directed paired coronary guidewires to septal and lateral targets on the tricuspid annulus under fluoroscopic and echocardiographic guidance. Guidewires were electrified to traverse the annular targets and exchanged for pledgeted sutures. The sutures were drawn together and knotted, apposing septal and lateral targets, creating a double orifice tricuspid valve. RESULTS:Twenty-two pigs underwent PASTA. Annular and chamber dimensions were reduced (annular area, 10.1?±?0.8 cm2 to 3.8?±?1.5 cm2 (naïve) and 13.1?±?1.5 cm2 to 6.2?±?1.0 cm2 (diseased); septal-lateral diameter, 3.9?±?0.3 mm to 1.4?±?0.6 mm (naïve) and 4.4?±?0.4 mm to 1.7?±?1.0 mm (diseased); and right ventricular end-diastolic volume, 94?±?13 ml to 85?±?14 ml (naïve) and 157?±?25 ml to 143?±?20 ml (diseased)). MRI derived tricuspid regurgitation fraction fell from 32?±?12% to 4?±?5%. Results were sustained at 30 days. Pledget pull-through force was five-fold higher (40.6?±?11.7N vs 8.0?±?2.6N, P?<?.01) using this strategy compared to single puncture techniques used to anchor current investigational devices. Serious complications were related to apical access. CONCLUSIONS:PASTA reduces annular dimensions and tricuspid regurgitation in pigs. It may be cautiously applied to selected patients with severe tricuspid regurgitation and no options. This is the first transcatheter procedure, to our knowledge, to deliver standard pledgeted sutures to repair cardiac pathology.

| S-EPMC6078835 | biostudies-literature

Transatrial intrapericardial tricuspid annuloplasty.

Project description:OBJECTIVES:This study sought to demonstrate transcatheter deployment of a circumferential device within the pericardial space to modify tricuspid annular dimensions interactively and to reduce functional tricuspid regurgitation (TR) in swine. BACKGROUND:Functional TR is common and is associated with increased morbidity and mortality. There are no reported transcatheter tricuspid valve repairs. We describe a transcatheter extracardiac tricuspid annuloplasty device positioned in the pericardial space and delivered by puncture through the right atrial appendage. We demonstrate acute and chronic feasibility in swine. METHODS:Transatrial intrapericardial tricuspid annuloplasty (TRAIPTA) was performed in 16 Yorkshire swine, including 4 with functional TR. Invasive hemodynamics and cardiac magnetic resonance imaging (MRI) were performed at baseline, immediately after annuloplasty and at follow-up. RESULTS:Pericardial access via a right atrial appendage puncture was uncomplicated. In 9 naïve animals, tricuspid septal-lateral and anteroposterior dimensions, the annular area and perimeter, were reduced by 49%, 31%, 59%, and 24% (p < 0.001), respectively. Tricuspid leaflet coaptation length was increased by 53% (p < 0.001). Tricuspid geometric changes were maintained after 9.7 days (range, 7 to 14 days). Small effusions (mean, 46 ml) were observed immediately post-procedure but resolved completely at follow-up. In 4 animals with functional TR, severity of regurgitation by intracardiac echocardiography was reduced. CONCLUSIONS:Transatrial intrapericardial tricuspid annuloplasty is a transcatheter extracardiac tricuspid valve repair performed by exiting the heart from within via a transatrial puncture. The geometry of the tricuspid annulus can interactively be modified to reduce severity of functional TR in an animal model.

| S-EPMC4524739 | biostudies-literature

Tricuspid Valve Annuloplasty Alters Leaflet Mechanics.

Project description:Tricuspid valve regurgitation is associated with significant morbidity and mortality. Its most common treatment option, tricuspid valve annuloplasty, is not optimally effective in the long-term. Toward identifying the causes for annuloplasty's ineffectiveness, we have previously investigated the technique's impact on the tricuspid annulus and the right ventricular epicardium. In our current work, we are extending our analysis to the anterior tricuspid valve leaflet. To this end, we adopted our previous strategy of performing DeVega suture annuloplasty as an experimental methodology that allows us to externally control the degree of cinching during annuloplasty. Thus, in ten sheep we successively cinched the annulus and quantified changes to leaflet motion, dynamics, and strain in the beating heart by combining sonomicrometry with our well-established mechanical framework. We found that successive cinching of the valve enforced earlier coaptation and thus reduced leaflet range of motion. Additionally, leaflet angular velocity during opening and closing decreased. Finally, we found that leaflet strains were also reduced. Specifically, radial and areal strains decreased as a function of annular cinching. Our findings are critical as they suggest that suture annuloplasty alters the mechanics of the tricuspid valve leaflets which may disrupt their resident cells' mechanobiological equilibrium. Long-term, such disruption may stimulate tissue maladaptation which could contribute to annuloplasty's sub-optimal effectiveness. Additionally, our data suggest that the extent to which annuloplasty alters leaflet mechanics can be controlled via degree of cinching. Hence, our data may provide direct surgical guidelines.

| S-EPMC8000450 | biostudies-literature

Novel percutaneous technique for creation of porcine model of tricuspid regurgitation via two routes.

Project description:ObjectiveTo develop an experimental porcine model of tricuspid regurgitation using two induction routes: the inferior vena cava and superior vena cava.MethodsTricuspid regurgitation was generated using the loop wire cutting method. The tricuspid regurgitation jet direction was controlled by accessing the valve through the inferior (n = 7) or superior (n = 6) vena cava. The occurrence, direction, and progression of tricuspid regurgitation were assessed postoperatively, and echocardiography was performed at 4 to 6 weeks. Right heart dilatation was assessed using computed tomography after 6 weeks.ResultsModerate to severe or torrential tricuspid regurgitation occurred immediately after the procedure in 12 of 13 animals. The jet was directed toward the septum in five of seven animals in the inferior vena cava group and toward the posterolateral side in four of six animals in the superior vena cava group. The dimensions of the right heart (right atrium, ventricle, and tricuspid valve annulus) were significantly enlarged at the 4- to 6-week follow-up echocardiographic examination and confirmed to be enlarged by computed tomography, independent of the route used.ConclusionThe loop wire cutting method successfully induced a disease model of tricuspid regurgitation while controlling the regurgitation jet direction via two procedural routes.

| S-EPMC10946071 | biostudies-literature

Transcatheter Tricuspid Valve Implantation of NaviGate Bioprosthesis in a Preclinical Model.

Project description:Patients with isolated functional or recurrent tricuspid regurgitation are often denied surgery because they are considered to be at high risk. Transcatheter valve therapy provides a less invasive alternative for tricuspid regurgitation associated with right heart failure. We have evaluated the feasibility of transcatheter tricuspid valve implantation of the NaviGate valved stent in a long-term swine model. The valved stent was successfully implanted through transjugular and transatrial approaches on the beating heart with excellent hemodynamic and valve performance. No conduction disturbance or coronary obstruction was observed. This technology could provide an alternative treatment for patients who are at high surgical risk with severe tricuspid regurgitation and compromised right ventricular function.

| S-EPMC6058955 | biostudies-literature

First-in-Human Percutaneous Circumferential Annuloplasty for Secondary Tricuspid Regurgitation.

Project description:Transcatheter therapies to treat tricuspid regurgitation are being developed, but few have attempted the gold standard of surgical repair: ring annuloplasty. We describe the first-ever fully percutaneous implantation of a circumferential, semirigid annuloplasty ring to treat massive secondary tricuspid regurgitation. (Level of Difficulty: Advanced.).

| S-EPMC8299844 | biostudies-literature

Hemodynamic outcomes after undersizing ring annuloplasty and focal suture annuloplasty for surgical repair of functional tricuspid regurgitation.

Project description:ObjectiveSurgical annuloplasty for functional tricuspid regurgitation (FTR) is on the rise and can be performed in several ways with varied outcomes. In this study, we sought to compare the hemodynamic outcomes of tricuspid annuloplasty performed with a commercially available annuloplasty ring (tricuspid valve annuloplasty [TVA]) compared with focal suture annuloplasty (Hetzer) in an experimental FTR model.MethodsAn ex vivo FTR model was developed by inducing right ventricular dilatation by acute afterload elevation, causing severe tricuspid valve tethering and annular dilatation, leading to regurgitation. Ten porcine hearts in which FTR was induced underwent TVA with a 26-mm Edwards MC3 ring and Hetzer annuloplasty with a pledgeted suture cinching the anteroposterior and septal annulus. FTR was measured before after each repair, and tenting geometry, valve kinematics, and subvalvular geometry were measured with echocardiography.ResultsAt baseline, none of the hearts had FTR, but upon afterload elevation an FTR volume of 17.7 ± 9.2 mL (26.38 ± 17.47% regurgitant fraction) was measured (P < .0001). TVA reduced regurgitation by 50% and Hetzer annuloplasty by 56% , respectively, but both left persistent FTR. Anteroseptal tenting area was 279.0 ± 158.9 mm2 before repair and decreased significantly to 147.2 ± 134.8 mm2 (P = .0195) with Hetzer but not with TVA. Posteroseptal tenting area was 425.1 ± 169.2 mm2 before repair and was significantly reduced by both techniques (TVA: 200.3 ± 102.9 mm2 [P = .0012]; Hetzer: 237.6 ± 127.6 mm2 [P = .0270]).ConclusionsTricuspid annuloplasty with a ring or a focal suture can reduce FTR but not eliminate it. Annular approaches did not relieve tricuspid valve tethering and reduced leaflet mobility persisted. Either subannular repairs or judicious use of valve replacement may be necessary.

| S-EPMC7921216 | biostudies-literature

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