Early outcomes of off-label transcatheter tricuspid valve repair/replacement in the STS/ACC TVT registry.

Background Little is known about acute changes in right ventricular (RV) function and geometry following transcatheter tricuspid edge-to-edge repair (T-TEER) or transcatheter tricuspid valve replacement (TTVR). Pressure-strain-volume loop-derived myocardial work metrics showed associations with myocardial energetics and contractility in conditions accompanied by volume overload, suggesting their potential utility in patients with tricuspid regurgitation (TR). Purpose To define acute changes in RV volumes and RV myocardial work following T-TEER and TTVR using conventional and pressure-strain-volume derived RV work metrics. Methods In this multicenter, observational study, 3D echocardiographic datasets and invasively acquired RV pressures were collected before and after transcatheter tricuspid valve procedure. Using dedicated software (ReVISION, Argus Cognitive) 3D RV volumes and strains were quantified and decomposed to longitudinal, radial and anterio-posterior motion. Forward stroke volume (SV) was calculated by subtracting TR volumes from RV 3D end-diastolic volume (EDV) and end-systolic volume (ESV) difference. Three-dimensional pressure-strain-volume loops were constructed and global RV work-index (RV-Wi) was calculated. Changes in RV parameters before and after the intervention were compared using paired-samples t test. Results Of 37 patients included in this study (65% male), 20 underwent T-TEER and 17 underwent TTVR. Compared to T-TEER patients, patients undergoing TTVR had higher prevalence of torrential TR at baseline but also achieved a higher reduction in TR volumes after the intervention (44 ± 11 ml vs 60 ± 16ml; p = 0,001). Following T-TEER there was a significant reduction in RV EDV (240 ± 93 ml vs 200 ± 80 ml; p < 0.001) and increase in SV (55 ± 34 ml vs 68 ± 26 ml; p = 0.036). Following TTVR there was a significant increase in RV ESV (121 ± 46 vs 146 ± 48, p = 0.003) and no significant change in SV (47 ± 24 ml vs 55 ± 20 ml; p = 0.143). There was significant reduction in RV strain and ejection fraction (EF) (all p < 0.001) primarily driven by reduction of radial motion component in both groups. RV-Wi increased in 35% (7/20) of T-TEER patients and in 18% of (3/17) TTVR patients. Conclusion An acute reduction in RV EF was observed in all patients and was mainly caused by decrease in RV EDV in T-TEER patients and increase in RV ESV in TTVR patients. Despite decrease of conventional metrics of RV function in both groups, an increase in RV-Wi was observed in 27% of all patients.Baseline and follow-up characteristicsCentral Figure

Background: TAVR was approved by the US FDA for treatment of severe aortic stenosis (AS) in symptomatic inoperable and high-risk patients. Off-label use of TAVR in the US has not been previously studied. Methods: Patients receiving commercially funded TAVR in the US are included in the Transcatheter Valve Therapy (TVT) Registry. Within this registry, we assessed 23,841 patients from 328 sites receiving TAVR between 11/201-9/2014. We evaluated the frequency and outcomes of off-label TAVR use, defined as TAVR in patients with known bicuspid or unicuspid valve, failing bioprosthetic aortic valve, moderate AS, severe mitral or aortic regurgitation or subaortic stenosis. Data were linked with CMS for 15,394 patients to evaluate 30-day and 1-year outcomes. Results: Off-label TAVR was used in 2682/23841 patients (11.2%); indications noted in the Table 1. Compared to on-label use, off-label use patients were more likely to be younger, male, receive care in urban, teaching hospitals with higher TAVR volume, have higher STS score (median 7.2 vs 6.8, p <0.0001) and less likely to have elective procedures. In CMS-linked data, patients undergoing off-label TAVR had higher 30-day mortality but similar 1 -year mortality compared to on-label TAVR (Table 2). Conclusion: About 1 in 10 patients in the US have received TAVR for an off-label indication. One-year outcomes were similar to on-label indication patients. These results reinforce the urgent need for additional research on the efficacy of TAVR in specific patient cohorts for whom TAVR is being considered in clinical practice.

Commentary: An all-access pass to transcatheter aortic valve replacement

Transcatheter Tricuspid Valve Replacement

Considered initially as a bystander, tricuspid regurgitation has shown to be an important predictor of mortality in patients with left-side valvular or myocardial disease. However, a sizeable number of patients remain untreated until the end stage when cardiac surgery presents a prohibitive risk. The emergent need in finding a treatment for patients with tricuspid regurgitation deemed for surgery options have encouraged the development of transcatheter tricuspid valve interventions. These procedures mimic classical surgery techniques and they are mainly divided in two categories: repair (annuloplasty, coaptation devices, edge-to-edge techniques) and transcatheter tricuspid valve replacement. This review aims to provide an updated overview and a clinical perspective on novel transcatheter tricuspid valve interventions, highlighting potential challenges and future directions.

Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data

Inclusion of Functional Status Measures in the Risk Adjustment of 30-Day Mortality After Transcatheter Aortic Valve Replacement: A Report From the Society of Thoracic Surgeons/American College of Cardiology TVT Registry

Cardiac implantable electronic device implantation and function after transcatheter tricuspid valve replacement.

Patients with severe symptomatic tricuspid regurgitation (TR) are often deemed ineligible for surgical valve repair due to comorbidities. In this setting, transcatheter tricuspid valve replacement (TTVR) is undergoing development, but delivery technique and prosthesis design have yet to be optimized. We sought to assess the challenges of TTVR and the determinants of venous route using computed tomography (CT) analysis. A total of 195 end-diastolic cardiac CT performed prior to surgical correction of a severe TR (n = 38), transcatheter aortic valve replacement (n = 89), or left atrial appendage closure (n = 68) were analyzed. Patients with TR (n = 68; 19 primary and 49 secondary) were compared with patients without (n = 127). Continuous variables with normal and non-normal distributions were compared using Student t test or Mann-Whitney test respectively. The angle from the tricuspid annulus (TA) to the inferior vena cava was tighter (mean = 101 ± 18°) with a broader range of value (44° to 164°) than to the superior vena cava (mean = 143 ± 9°). Patients with TR had rounder TA (eccentricity index of 0.88 ± 0.08, p < 0.001), with a larger area (p < 0.0001), and septolateral (45.3 ± 8.0mm, p < 0.0001) and anteroposterior (44.4 ± 7.4mm, p < 0.0001) diameters than patients without. The distances from the TA to the coronary sinus, the right ventricular outflow tract, and the moderator band were respectively 11.4 ± 3.8mm, 17.2 ± 3.4mm, and 31.0 ± 6.7mm, without differences between groups. The transjugular access for TTVR is straighter and more reproducible than the transfemoral access. Prosthesis development may be challenged by the close position of the coronary sinus, the presence of a moderator band, and the large TA size of patients with severe TR. • The tricuspid annulus is larger in patients with severe tricuspid regurgitation, confirming existing data. • The coronary sinus ostium is close to the tricuspid annulus, requiring a prosthesis with a short atrial length. • The transjugular venous route may be the preferred access to the tricuspid annulus, straighter with less inter-individual variations than the transfemoral route.

Association of Tricuspid Regurgitation With Transcatheter Aortic Valve Replacement Outcomes: A Report From The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

Successful Transcatheter Tricuspid Valve Replacement 30 Years After Heart Transplantation.

Comparison of Outcomes in Patients With and Without Chronic Kidney Disease Undergoing Transcatheter Tricuspid Valve Replacement.

Clinically significant tricuspid regurgitation (TR) has historically been managed with either medical therapy or surgical interventions. More recently, percutaneous trans-catheter tricuspid valve (TV) replacement and tricuspid trans-catheter edge-to-edge repair have emerged as alternative treatment modalities. Patients with cardiac implantable electronic devices (CIEDs) have an increased incidence of TR. Severe TR in this population can occur for multiple reasons but most often results from the interactions between the CIED lead and the TV apparatus. Management decisions in patients with CIED leads and clinically significant TR, who are undergoing evaluation for a percutaneous TV intervention, need careful consideration as a trans-venous lead extraction (TLE) may both worsen and improve TR severity. Furthermore, given the potential risks of ‘jailing’ a CIED lead at the time of a percutaneous TV intervention (lead fracture and risk of subsequent infections), consideration should be given to performing a TLE prior to a percutaneous TV intervention. The purpose of this ‘state-of-the-art’ review is to provide an overview of the causes of TR in patients with CIEDs, discuss the available therapeutic options for patients with TR and CIED leads, and advocate for including a lead management specialist as a member of the ‘heart team’ when making treatment decisions in patients TR and CIED leads.

Comparison of Early Outcomes Following Transjugular Transcatheter Tricuspid Valve Replacement Between Large vs Small Annulus.

Torrential tricuspid regurgitation (TR) in inoperable patients remains a major therapeutic challenge. Transcatheter tricuspid valve replacement (TTVR) is emerging as a definitive option, but many patients fail anatomical screening. To assess through a clinical case the feasibility of transcatheter edge-to-edge repair (TEER) as potential strategy to transform a patient deemed non-candidate to TTVR into a good candidate. We report how a 79-year-old man with torrential TR, chronic kidney disease, permanent atrial fibrillation, prior surgical aortic valve replacement, and a dual-chamber pacemaker who was rejected for TTVR after comprehensive screeningdue to large tricuspid annulus became good candidate to TTVR after TEER. TEER was performed with implantation of two devices and initial symptomatic and hemodynamic improvement. Three weeks later, the patient deteriorated, and detachment of one of the devices from the lateral leaflet was demonstrated with recurrent massive TR. TTVR could be performed thanks to the reduction of the neo-annular size and the anchor in the failing TEER device. This case illustrates both the limits of TEER in end-stage TR and the conceptual role of TEER as a temporizing or remodeling strategy that may, in selected patients, reshape leaflet coaptation and annular geometry sufficiently to enable subsequent TTVR. TEER may serve as a bridge-to-TTVR in anatomically marginal candidates, stabilizing patients clinically and modifying valve geometry to meet device-specific criteria. Prospective evaluation is warranted to define which anatomical substrates can benefit from this staged strategy.