Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty

Hahn, Rebecca T.; Meduri, Christopher; Davidson, Charles J.; Lim, Scott; Nazif, Tamim; Ricciardi, Mark J.; Rajagopal, Vivek; Ailawadi, Gorav; Vannan, Mani A.; Thomas, James D.; Fowler, Dale; Rich, Stuart; Martin, Ryan C.; Ong, Géraldine; Groothuis, Adam; Kodali, Susheel

doi:10.1016/j.jacc.2017.01.054

Cited by 249 publications

(112 citation statements)

References 53 publications

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“…Nevertheless, recent developments in the field of transcatheter valve interventions have stimulated a renewed interest in the “forgotten” TV 11, 12, 13. Early in‐human experiences demonstrated the feasibility of several transcatheter tricuspid repair and replacement systems in treating TR, but they also highlighted the particularly challenging anatomical features of the TV, subvalvular apparatus, and right ventricle 14, 15, 16, 17, 18, 19, 20, 21. A handful of transcatheter TV therapies are being tested in early feasibility trials (clinicaltrials.gov trial: NCT‐02787408, NCT‐02339974, NCT‐02574650, NCT‐02981953, NCT‐02471807) 13.…”

mentioning

confidence: 99%

Contemporary Trends in the Use and Outcomes of Surgical Treatment of Tricuspid Regurgitation

Alqahtani

Berzingi

Aljohani

et al. 2017

JAHA

162

103

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BackgroundTricuspid regurgitation (TR), if untreated, is associated with an adverse impact on long‐term outcomes. In recent years, there has been an increasing enthusiasm about surgical and transcatheter treatment of patients with severe TR. We aim to evaluate the contemporary trends in the use and outcomes of tricuspid valve (TV) surgery for TR using the National Inpatient Sample.Methods and ResultsBetween January 1, 2003 and December 31, 2014, an estimated 45 477 patients underwent TV surgery for TR in the United States, of whom 15% had isolated TV surgery and 85% had TV surgery concomitant with other cardiac surgery. There was a temporal upward trend to treat sicker patients during the study period. Patients who underwent isolated TV repair or replacement had a distinctly different clinical risk profile than those patients who underwent TV surgery simultaneous with other surgery. Isolated TV replacement was associated with high in‐hospital mortality (10.9%) and high rates of permanent pacemaker implantation (34.1%) and acute kidney injury requiring dialysis (5.5%). Similarly, isolated TV repair was also associated with high in‐hospital mortality (8.1%) and significant rates of permanent pacemaker implantation (10.9%) and new dialysis (4.4%). Isolated TV repair and TV replacement were both associated with protracted hospitalizations and substantial cost.ConclusionsIn contemporary practice, surgical treatment of TR remains underused and is associated with high operative morbidity and mortality, prolonged hospitalizations, and considerable cost.

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mentioning

confidence: 99%

Contemporary Trends in the Use and Outcomes of Surgical Treatment of Tricuspid Regurgitation

Alqahtani

Berzingi

Aljohani

et al. 2017

JAHA

162

103

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“…Among these are the Trialign TM system (Mitralign, Inc.), which will be described in detail below, as well as the Cardioband device (Edwards Lifesciences) and the TriCinch TM system (4Tech Inc), which reduces the septolateral tricuspid annular diameter by implanting a corkscrew anchor in the anteroposterior tricuspid annulus and applying tension on the annulus via a Dacron band fixed to a self-expanding nitinol stent in the inferior vena cava. [22][23][24] The second transcatheter technique currently used to treat functional TR is tricuspid edge-to-edge repair using the…”

Section: Technical Difficulties In the Development Of Transcatheter Tmentioning

confidence: 99%

“…During the Trialign procedure a pair of polyester pledgets are delivered across the tricuspid annulus in proximity to the anteroposterior and septo-posterior commissure, cinched by a polyester suture to obliterate the posterior tricuspid leaflet, and locked on the atrial side (see Figure 4A). 31,35 Access Percutaneous tricuspid valve annuloplasty with the Trialign system requires two 14 F sheaths placed in the ventral and lateral portion of the right internal jugular vein with a distance of approximately 2 cm to avoid bleeding complications. In addition, a guide catheter needs to be placed in the right coronary artery via femoral access because of the close proximity of the right coronary artery to the posterior portion of the tricuspid annulus.…”

Section: Procedural Details On the Trialign Systemmentioning

confidence: 99%

“…As a first step, a dedicated deflectable tricuspid guide catheter (see Figure 4A) is advanced into the right ventricle via jugular access. 31,35 The tricuspid guide catheter is designed to direct all subsequent procedural devices across the tricuspid valve orifice and towards the tricuspid annulus by advancement/retraction, deflection and rotation. Next, a tricuspid wire delivery catheter is advanced to access the ventricular side of the tricuspid annulus at the target location for pledget delivery.…”

Section: Crossing Wire Deliverymentioning

confidence: 99%

“…Afterwards, the pledget delivery catheter is retracted back through the annulus to the atrial side and deploys the proximal portion of the pledget. 31,35 Second Pledget Delivery…”

Section: Pledget Deliverymentioning

confidence: 99%

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Transcatheter Treatment of Functional Tricuspid Regurgitation Using the Trialign Device

Besler¹,

Meduri²,

Lurz³

2017

Interventional Cardiology Review

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Functional tricuspid regurgitation (TR) represents an important unmet need in clinical cardiology given its prevalence, adverse prognostic impact and symptom burden associated with progressive right heart failure. Several transcatheter techniques are currently in early clinical testing to provide alternative treatment options for patients deemed unsuitable for tricuspid valve surgery. Amongst them, the TrialignTM device (Mitralign, Inc.) represents a novel percutaneous tricuspid valve annuloplasty technique, which aims to reduce tricuspid annular dilatation in functional TR by delivering and cinching two pledgeted sutures to the posterior portion of the tricuspid annulus via transjugular access. Early clinical data suggest the Trialign technique is safe and feasible, and associated with an improvement in quality-of-life measures. However, further studies are needed to confirm these data in larger cohorts of patients with longer follow up. In addition, future trials need to address the question whether TR reduction with the Trialign and other devices leads to an improvement in the patient`s functional status and prognosis, over and above medical treatment alone.

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Anatomic Relationship of the Complex Tricuspid Valve, Right Ventricle, and Pulmonary Vasculature

et al. 2019

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Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty

Cited by 249 publications

References 53 publications

Contemporary Trends in the Use and Outcomes of Surgical Treatment of Tricuspid Regurgitation

Contemporary Trends in the Use and Outcomes of Surgical Treatment of Tricuspid Regurgitation

Transcatheter Treatment of Functional Tricuspid Regurgitation Using the Trialign Device

Anatomic Relationship of the Complex Tricuspid Valve, Right Ventricle, and Pulmonary Vasculature

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