Artificial intelligence-derived risk score for mortality in secondary mitral regurgitation treated by transcatheter edge-to-edge repair: the EuroSMR risk score.

BACKGROUND AND AIMS: Risk stratification for mitral valve transcatheter edge-to-edge repair (M-TEER) is paramount in the decision-making process to appropriately select patients with severe secondary mitral regurgitation (SMR). This study sought to develop and validate an artificial intelligence-derived risk score (EuroSMR score) to predict 1-year outcomes (survival or survival + clinical improvement) in patients with SMR undergoing M-TEER. METHODS: An artificial intelligence-derived risk score was developed from the EuroSMR cohort (4172 and 428 patients treated with M-TEER in the derivation and validation cohorts, respectively). The EuroSMR score was validated and compared with established risk models. RESULTS: The EuroSMR risk score, which is based on 18 clinical, echocardiographic, laboratory, and medication parameters, allowed for an improved discrimination of surviving and non-surviving patients (hazard ratio 4.3, 95% confidence interval 3.7-5.0; P < .001), and outperformed established risk scores in the validation cohort. Prediction for 1-year mortality (area under the curve: 0.789, 95% confidence interval 0.737-0.842) ranged from <5% to >70%, including the identification of an extreme-risk population (2.6% of the entire cohort), which had a very high probability for not surviving beyond 1 year (hazard ratio 6.5, 95% confidence interval 3.0-14; P < .001). The top 5% of patients with the highest EuroSMR risk scores showed event rates of 72.7% for mortality and 83.2% for mortality or lack of clinical improvement at 1-year follow-up. CONCLUSIONS: The EuroSMR risk score may allow for improved prognostication in heart failure patients with severe SMR, who are considered for a M-TEER procedure. The score is expected to facilitate the shared decision-making process with heart team members and patients.

TRI-SCORE and benefit of intervention in patients with severe tricuspid regurgitation.

BACKGROUND AND AIMS: Benefit of tricuspid regurgitation (TR) correction and timing of intervention are unclear. This study aimed to compare survival rates after surgical or transcatheter intervention to conservative management according to a TR clinical stage as assessed using the TRI-SCORE. METHODS: A total of 2,413 patients with severe isolated functional TR were enrolled in TRIGISTRY (1217 conservatively managed, 551 isolated tricuspid valve surgery, and 645 transcatheter valve repair). The primary endpoint was survival at 2 years. RESULTS: The TRI-SCORE was low (≤3) in 32%, intermediate (4-5) in 33%, and high (≥6) in 35%. A successful correction was achieved in 97% and 65% of patients in the surgical and transcatheter groups, respectively. Survival rates decreased with the TRI-SCORE in the three treatment groups (all P < .0001). In the low TRI-SCORE category, survival rates were higher in the surgical and transcatheter groups than in the conservative management group (93%, 87%, and 79%, respectively, P = .0002). In the intermediate category, no significant difference between groups was observed overall (80%, 71%, and 71%, respectively, P = .13) but benefit of the intervention became significant when the analysis was restricted to patients with successful correction (80%, 81%, and 71%, respectively, P = .009). In the high TRI-SCORE category, survival was not different to conservative management in the surgical and successful repair group (61% and 68% vs 58%, P = .26 and P = .18 respectively). CONCLUSIONS: Survival progressively decreased with the TRI-SCORE irrespective of treatment modality. Compared to conservative management, an early and successful surgical or transcatheter intervention improved 2-year survival in patients at low and, to a lower extent, intermediate TRI-SCORE, while no benefit was observed in the high TRI-SCORE category.

Prognostic impact of vasopressor test in transcatheter edge-to-edge repair of secondary mitral regurgitation: The PETIT study.

BACKGROUND: Vasopressor test (VPT) might be useful in patients with functional mitral regurgitation (MR) and left ventricular dysfunction (MITRA-FR-like patients) during transcatheter edge-to-edge repair (TEER). AIMS: We aimed to evaluate the prognostic impact of VPT. METHODS: MR treated with TEER were included in a multicenter prospective registry. VPT was used intraprocedurally in patients with left ventricular dysfunction and/or hypotension. The 1-year echocardiographic and clinical outcomes were compared according to the use of VPT. The primary endpoint was a combination of mortality + heart failure (HF) readmission at 1-year. RESULTS: A total of 1115 patients were included, mean age was 72.8 ± 10.5 years and 30.4% were women. VPT was performed in 128 subjects (11.5%), more often in critically ill patients with biventricular dysfunction. Postprocedurally the VPT group had greater rate of MR ≥ 2+ (46.9% vs. 31.7%, p = 0.003) despite greater number of devices (≥2 clips, 52% vs. 40.6 p = 0.008) and device repositioning or new clip in 12.5%. At 1-year, the primary endpoint occurred more often in the VPT group (27.3% vs. 16.9%, p = 0.002) as well as all-cause mortality (21.9% vs. 8.1%, p ≤ 0.001) but no differences existed in HF readmission rate (14.8% vs. 13.2%, p = 0.610), cardiovascular mortality (4.4% vs. 3.9%, p = 0.713) or residual MR ≥ 2+ (51.1% vs 51.7%, p = 0.371). CONCLUSIONS: Dynamic evaluation of MR during TEER procedure through VPT was performed in patients with worse baseline risk who also presented higher all-cause mortality at 1-year follow-up. However, 1-year residual MR, cardiovascular mortality and HF readmission rate remained comparable suggesting that VPT might help in the management of MITRA-FR-like patients.

Prevalence and prognostic significance of malnutrition in patients with secondary mitral regurgitation undergoing transcatheter edge-to-edge repair.

BACKGROUND: Malnutrition is associated with poor prognosis in several cardiovascular diseases; however, its role in patients with secondary mitral regurgitation (SMR) is poorly known. AIMS: To evaluate the impact of nutritional status, assessed using different scores, on clinical outcomes in patients with SMR undergoing transcatheter edge-to-edge repair (TEER) in a real-world setting. METHODS: A total of 658 patients with SMR and complete nutritional data were identified from the MIVNUT registry. Nutritional status has been assessed using controlling nutritional status index (CONUT), prognostic nutritional index (PNI), and geriatric nutritional risk index (GNRI) scores. Outcomes of interest were all-cause mortality and all-cause mortality or heart failure (HF) hospitalization. RESULTS: Any malnutrition grade was observed in 79.4%, 16.7%, and 47.9% of patients by using CONUT, PNI, and GNRI, respectively, while moderate to severe malnutrition was noted in 24.7%, 16.7%, and 25.6% of patients, respectively. At a median follow-up of 2.2 years, 212 patients (32.2%) died. Moderate-severe malnutrition was associated with a higher rate of all-cause mortality (HR: 2.46 [95% CI: 1.69-3.58], HR: 2.18 [95% CI: 1.46-3.26], HR: 1.97 [95% CI: 1.41-2.74] for CONUT, PNI, and GNRI scores, respectively). The combined secondary endpoint of all-cause mortality and HF rehospitalization occurred in 306 patients (46.5%). Patients with moderate-severe malnutrition had a higher risk of the composite endpoint (HR: 1.56 [95% CI: 1.20-2.28], HR: 1.55 [95% CI: 1.01-2.19], HR: 1.36 [95% CI: 1.02-1.80] for CONUT, PNI, and GNRI scores, respectively). After adjustment for multiple confounders, moderate-severe malnutrition remained independently associated with clinical outcomes. CONCLUSIONS: Moderate-severe malnutrition was common in patients with SMR undergoing TEER. It was independently associated with poor prognosis regardless of the different scores used.

Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation.

AIMS: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone. METHODS AND RESULTS: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03). CONCLUSION: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.

Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction.

AIMS: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. METHODS AND RESULTS: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01). CONCLUSIONS: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

Procedural and clinical outcomes after repeat edge-to-edge transcatheter mitral valve repair.

BACKGROUND AND OBJECTIVES: Evidence regarding redo percutaneous interventions for recurrent mitral regurgitation is scarce. We ought to evaluate procedural and clinical outcomes of repeated edge-to-edge transcatheter mitral valve repair (TMVR) interventions. METHODS: This multicenter study collected individual data from eight high-volume TMVR Centers in Spain. Between 2012 and 2020, all patients undergoing a second edge-to-edge TMVR intervention (Redo) were included in the study. RESULTS: Among a total of 1028 procedures, 31 patients (3%) with residual MR ≥ 3 at follow-up underwent a second procedure (Redo). Redo intervention was mainly conducted between the first and second year after the first procedure. The most common cause of MR progression was partial detachment (46.7%) followed by LV remodeling (35.5%). Procedural success was achieved in 87% of cases. After a mean follow-up of 1.75 ± 1.54 years, all-cause and cardiovascular mortality were 48.1% and 25%, respectively. Nearly half of the patients (48.1%) required at least one hospital admission for CHF within the follow-up period. However, most of the patients presented symptomatic improvement as depicted by an NYHA class ≤2. Elective mitral surgery was conducted in only one patient at follow-up due to insufficient MR reduction. CONCLUSIONS: According to our findings, redo edge-to-edge TMVR interventions were feasible and safe with a high procedural success rate. Clinical and echocardiographic follow-up showed however modest long-term results in this specific setting.

Percutaneous mitral valve repair with MitraClip device in hemodynamically unstable patients: A systematic review.

BACKGROUND: Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip. METHODS: We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included. RESULTS: Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p < .001). The median weaning time from the procedure, to discontinuation of mechanical circulatory or respiratory support, was 2 days (IQR 1-4), with an in-hospital mortality and non-fatal complication rate of 12.6 and 9.1%, respectively. Kaplan-Meier curves estimated an overall mortality rate of 39.1% at 12-month follow-up, with persistent reduction in MR severity for survivors (Grade ≤ 2 in 81.3%) and one case of mitral valve reintervention. CONCLUSIONS: Percutaneous mitral valve repair with MitraClip device is a technically feasible and potentially viable management option in high-risk patients with cardiogenic shock or refractory pulmonary edema and concomitant moderate-severe MR. Prospective trials are required to confirm these findings, and definitively determine the value of MitraClip in hemodynamically unstable patients.

Use of MitraClip for mitral valve repair in patients with acute mitral regurgitation following acute myocardial infarction: Effect of cardiogenic shock on outcomes (IREMMI Registry).

OBJECTIVES: To assess outcomes in patients with acute mitral regurgitation (MR) following acute myocardial infarction (AMI) who received percutaneous mitral valve repair (PMVR) with the MitraClip device and to compare outcomes of patients who developed cardiogenic shock (CS) to those who did not (non-CS). BACKGROUND: Acute MR after AMI may lead to CS and is associated with high mortality. METHODS: This registry analyzed patients with MR after AMI who were treated with MitraClip at 18 centers within eight countries between January 2016 and February 2020. Patients were stratified into CS and non-CS groups. Primary outcomes were mortality and rehospitalization due to heart failure. Secondary outcomes were acute procedural success, functional improvement, and MR reduction. Multivariable Cox regression analysis evaluated association of CS with clinical outcomes. RESULTS: Among 93 patients analyzed (age 70.3 ± 10.2 years), 50 patients (53.8%) experienced CS before PMVR. Mortality at 30 days (10% CS vs. 2.3% non-CS; p = .212) did not differ between groups. After median follow-up of 7 months (IQR 2.5-17 months), the combined event mortality/re-hospitalization was similar (28% CS vs. 25.6% non-CS; p = .793). Likewise, immediate procedural success (90% CS vs. 93% non-CS; p = .793) and need for reintervention (CS 6% vs. non-CS 2.3%, p = .621) or re-admission due to HF (CS 13% vs. NCS 23%, p = .253) at 3 months did not differ. CS was not independently associated with the combined end-point (hazard ratio 1.1; 95% CI, 0.3-4.6; p = .889). CONCLUSIONS: Patients found to have significant MR during their index hospitalization for AMI had similar clinical outcomes with PMVR whether they presented in or out of cardiogenic shock, provided initial hemodynamic stabilization was first achieved before PMVR.

Incidence, predictors, and clinical impact of bleeding recurrence in patients with prior gastrointestinal bleeding undergoing LAAC.

BACKGROUND: Gastrointestinal bleeding (GIB) is associated with a high recurrence rate and a prior GIB episode is common in real-world left atrial appendage closure (LAAC) recipients. The present study sought to evaluate the clinical characteristics and outcomes of patients with prior GIB undergoing LAAC, and to determine the factors associated with and clinical impact of GIB recurrence. METHODS: Multicenter study including 277 consecutive patients who underwent percutaneous LAAC and had prior GIB. All-cause death, all bleeding, GIB recurrence, and clinical ischemic stroke were recorded. RESULTS: After a median follow-up of 17 (interquartile range: 6-37) months post-LAAC, the rates of death, bleeding, GIB recurrence, and ischemic stroke were 14.0 per 100 person-year (PY), 29.3 per 100 PY, 17.7 per 100 PY, and 1.1 per 100 PY, respectively. GIB recurrence occurred within 3 months post-LAAC in 55.8% of patients. A previous lower GIB (vs. upper or unclassified) (HR: 1.76; 95% CI: 1.09-2.82; p = .020) and eGFR < 45 mL/min (HR: 1.70; 95% CI:1.04-2.67; p = .033) determined an increased risk of GIB recurrence. By multivariable analysis, eGFR < 45 mL/min (HR: 2.72; 95% CI: 1.70-4.34; p < .001), GIB recurrence following LAAC (HR: 2.15; 95% CI: 1.33-3.46; p = .002), diabetes mellitus (HR: 1.77; 95% CI: 1.10-2.84; p = .018), and age (HR: 1.06; 95% CI: 1.03-1.10; p < .001) were associated with an increased mortality. CONCLUSIONS: Patients with prior GIB undergoing LAAC exhibited a relatively low rate of GIB recurrence, and prior lower GIB and moderate-to-severe chronic kidney disease determined an increased risk. GIB recurrence was associated with an increased mortality.

Initial Results of Combined MitraClip® Implantation and Left Atrial Appendage Occlusion.

BACKGROUND: Atrial fibrillation is present in 30-50% of patients undergoing percutaneous mitral valve repair. The presence of a formal contraindication to oral anticoagulation is also very common in these patients. In this context, percutaneous left atrial appendage occlusion (LAAO) may be a valid alternative for these patients. The study aim was to assess the feasibility, safety, and technical considerations of the combination of percutaneous mitral valve repair using the MitraClip system and LAAO. The present study describes the multicenter experience of combined MitraClip and LAAO procedures. METHODS: Between April 2012 and April 2016, six patients were successfully treated with the combined procedure. RESULTS: In all patients, mitral valve repair was performed before LAAO. Both procedures were successfully performed in all cases without any relevant procedural complication or mortality. CONCLUSIONS: According to the results of the present study, a combination of both techniques appears to be feasible and safe, with favorable in-hospital outcomes.

Trileaflet Mitral Valve Treated with the MitraClip® System.

A 79-year-old woman with a history of ischemic dilated cardiomyopathy, severely depressed left ventricular ejection fraction and significant mitral regurgitation (MR) was admitted to the authors´ institution for percutaneous mitral valve repair. Transesophageal echocardiography (TEE) revealed the presence of a posterior mitral cleft at the P2 level, causing a trileaflet mitral valve that contributed significantly to the regurgitant jet. The procedure was performed under general anesthesia and guided by real-time three-dimensional TEE. Three MitraClip® devices (Abbott Vascular, Santa Clara, CA, USA) were implanted, which reduced the MR to grade 1+.

Survival Advantage of MitraClip® Over Medical Treatment in Patients with Mitral Regurgitation: A Meta-Analysis.

BACKGROUND: The MitraClip® system is a percutaneous treatment for mitral regurgitation (MR) that has shown promising results in patients who are inoperable or at high risk for mitral surgery. Data on the efficacy of the system over optimal medical therapy, above all in patients with functional MR, are scarce. The study aim was to assess the effect of MitraClip on the survival of patients with moderate/severe or severe MR compared to medical therapy, using meta-analytical techniques. METHODS: Independently, reviewers searched electronically for relevant articles based on predefined criteria and end-points. Only articles with a comparison between MitraClip and conservative therapy were included. Standard meta-analysis techniques were used. The primary outcomes were 30-day and one-year mortalities. RESULTS: Five observational reports were included that enrolled a total of 1,271 patients: 720 patients underwent percutaneous mitral valve repair (PMVR) with the MitraClip device, and 551 were managed conservatively. A total of 49 all-cause mortality events was reported at 30 days: 3.05% (22/720) in the PMVR arm, and 4.90% (27/510) in the conservative group, with no significant differences in all-cause mortality (OR 0.64; 95% CI 0.36-1.14). A total of 269 all-cause mortality events at one year was reported: 15.14% (109/720) in the PMVR arm, and 29.04% (160/551) in the conservative group. A significant difference favoring PMVR with the MitraClip system over medical therapy alone was observed (OR 0.44; 95% CI 0.30-0.64, p <0.0001). Neither significance between study heterogeneity (p = 0.18) nor publication bias was detected (p = 0.3). CONCLUSIONS: PMVR with the MitraClip system may be associated with an improvement in one-year survival compared to stand-alone medical management.

Transapical mitral valve-in-valve ring implantation with the Edwards Sapien 3 prosthesis.

We present the case of a high-risk patient with symptomatic severe mitral regurgitation following a surgical annuloplasty ring. An inverted aortic Edwards Sapien 3 bioprosthesis (Edwards Lifesciences, Irvine, CA) was successfully implanted through a transapical approach inside the previously implanted annuloplasty ring.

Percutaneous Closure of Massive Mitral Paravalvular Leak.

A 59-year-old male with a history of mitral valve replacement several years previously was admitted to the authors' institution with symptoms of advanced heart failure. Echocardiography showed a severe paravalvular dehiscence and surgery was discouraged due to high perioperative risk. A first transcatheter leak closure was unsuccessful despite the correct deployment of various occluding devices. A second percutaneous attempt was carried out with implantation of three Amplatzer Vascular Plug® III devices (five occluders were positioned in total within the oblong defect), leading to a mild residual leakage. Device embolism occurred twice during the procedure but was resolved using adequate catheter retrieval techniques.

A Simple Technique for Aortic Root Dissection and Massive Aortic Regurgitation Repair after Blunt Chest Trauma.

Aortic regurgitation due to valve injury after blunt chest trauma is a rare condition that may be caused by leaflet or commissural rupture, aortic dissection, or a combination of both. The case is presented of a 48-year-old male patient with an aortic dissection and aortic valve commissural detachment and massive aortic regurgitation after a 12-meter vertical free fall and secondary thoracic blunt trauma. The aortic root tear and dissection was repaired with a continuous polypropylene 5/0 suture and subcommissural annuloplasty that restored the aortic valve geometry and resulted in a normally functioning aortic valve.

Insertion of an Edwards Sapien 3 prosthesis as a mitral valve in valve implantation via a transapical approach.

We report a case of transapical mitral valve-in-valve implantation for a deteriorated bioprosthesis using the Edwards Sapien 3 prosthesis via the transapical approach. This case demonstrates the safety and feasibility of using the Edwards Sapien 3 prosthesis in treating degenerated bioprosthetic mitral valves.

Management of Severe Mitral Regurgitation in Patients With Acute Myocardial Infarction: JACC Focus Seminar 2/5.

Severe acute mitral regurgitation after myocardial infarction includes partial and complete papillary muscle rupture or functional mitral regurgitation. Although its incidence is <1%, mitral regurgitation after acute myocardial infarction frequently causes hemodynamic instability, pulmonary edema, and cardiogenic shock. Medical management has the worst prognosis, and mortality has not changed in decades. Surgery represents the gold standard, but it is associated with high rates of morbidity and mortality. Recently, transcatheter interventions have opened a new door for management that may improve survival. Mechanical circulatory support restores vital organ perfusion and offers the opportunity for a steadier surgical repair. This review focuses on the diagnosis and the interventional management, both surgical and transcatheter, with a glance on future perspectives to enhance patient management and eventually decrease mortality.

Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-To-Edge Repair: Observations From the bRIGHT TriClip Study.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR) has experienced fast adoption following commercial approval. Defining the appropriate target population for TEER therapy is important to guide patient selection. The aim of this study was to characterize tricuspid valve anatomy and coaptation gap in subjects receiving TEER for the treatment of TR in a contemporary postmarket setting. METHODS: The bRIGHT study is a prospective, multicenter, single-arm, postmarket study evaluating the safety and effectiveness of the TriClip device. Procedural outcomes included implant success, acute procedural success, TR severity, major adverse events, single-leaflet device attachment, and embolization through 30 postprocedure days. Tricuspid valve characteristics, including morphology, annulus size, and leaflet mobility, were assessed via two-dimensional transesophageal echocardiography from the screening visit by an independent echo core lab to characterize subject variability. Coaptation gap measurements were taken in both the transgastric short-axis (TG SAX) and RV inflow/outflow views. RESULTS: The independent echo core lab performed a detailed assessment of the tricuspid valve on 135 consecutive subjects with available TG SAX views from 24 sites. Tricuspid valve morphologies included 2 to 5 leaflets, with a non-trileaflet valve in 28% of subjects and ≥4 leaflets in 21% of subjects. The etiology of TR was functional in 91% (96/105), mixed in 7% (7/105), and lead induced in 2% (2/105) of subjects. Leaflet mobility was mildly restricted in 69% (78/113) and moderately restricted in 7% (8/113) of subjects. Annulus diameter averaged 4.7 ± 0.7 cm with a range of 2.5 to 6.2 cm. From the TG SAX view, the coaptation gap measured 8.1 ± 3.1 and 5.2 ± 2.3 mm in the central and mid regions of the anterior-septal coaptation line and 6.6 ± 3.2 and 3.8 ± 2.1 mm in the central and mid regions of the septal-posterior coaptation line, respectively. From the right ventricular inflow/outflow view, the coaptation gap measured 4.7 ± 2.4, 5.2 ± 2.4, and 4.6 ± 3.0 mm in the anterior, mid, and posterior regions of the tricuspid valve, respectively. Thirty-day TR reduction (by number of grades) was similar among subjects with coaptation gaps of <7 mm, 7 to 10 mm, and >10 mm. CONCLUSION: A broad range of anatomies was observed in this postmarket population. Characterization of the tricuspid valve and coaptation gap will help to better understand and better define the target patient population for tricuspid TEER therapy.