Concomitant Tricuspid Valve Ring Annuloplasty During Mitral Valve Surgery Versus Mitral Valve Surgery Alone: A Systematic Review and Meta-Analysis.

AIM: Although current guidelines recommend concomitant tricuspid annuloplasty for moderate or greater tricuspid regurgitation (TR) and/or dilated annulus, there remains significant variation in undertaking concomitant tricuspid valve surgery (TVA) across different centres. This meta-analysis aimed to compare the clinical outcomes of concomitant tricuspid valve surgery for patients with moderate or greater TR and/or dilated annulus at the time of mitral valve (MV) surgery. METHOD: A systematic review of the literature using six databases. Eligible studies include comparative studies on TVA concomitant with MV surgery versus MV surgery alone. A meta-analysis was performed on studies reporting outcomes of interest to quantify the effects of concomitant tricuspid ring annuloplasty. RESULTS: Two randomised controlled trials and six cohort studies were included in the analysis. 1,941 patients were included in the analysis, of whom, 1,090 underwent concomitant TVA and 851 underwent MV surgery alone. Pooled analysis demonstrated that there was less progression of moderate/severe TR in the concomitant group (3.0% vs 9.6%; odds ratio [OR] 0.29; 95% confidence interval [CI] 0.13-0.55; p=0.0001). There was no significant difference in in-hospital mortality (3.0% vs 3.8%; OR 0.79; 95% CI 0.47-1.34; p=0.38). The rate of permanent pacemaker implantation was higher in the concomitant group although this did not reach statistical significance (7.6% vs 5.3%; OR 1.30; 95% CI 0.85-1.98; p=0.23). Cardiopulmonary bypass was longer in the concomitant TVA group by 20 minutes (mean difference 13.9-26.0; p<0.00001). CONCLUSIONS: Our study demonstrated that concomitant tricuspid ring annuloplasty at the time of MV surgery is associated with a significantly lower rate of TR progression without increasing the operative mortality. There is a trend towards a higher permanent pacemaker implantation rate although this did not reach statistical significance.

Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study.

BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated. OBJECTIVES: We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting. METHODS: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment. RESULTS: Enrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, P < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, P <0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375). Mortality was not associated with baseline TR grade or with center volume. CONCLUSIONS: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; NCT04483089).

Pacemaker implantation after concomitant tricuspid valve repair in patients undergoing minimally invasive mitral valve surgery: Results from the Mini-Mitral International Registry.

Objective: Randomized evidence suggests a high risk of pacemaker implantation for patients undergoing mitral valve (MV) surgery with concomitant tricuspid valve repair (cTVR). We investigated the impact of cTVR on outcomes in the Mini-Mitral International Registry. Methods: From 2015 to 2021, 7513 patients underwent minimally invasive MV with or without cTVR in 17 international centers (MV: n = 5609, cTVR: n = 1113). Propensity matching generated 1110 well-balanced pairs. Multivariable analysis was applied. Results: Patients with cTVR were older and had more comorbidities. Propensity matching eliminated most differences except for more TR in patients who underwent cTVR (77.2% vs 22.1% MV, P < .001). Mean matched age was 71 years, and 45% were male. European System for Cardiac Operative Risk Evaluation II was still 2.68% (interquartile range [IQR], 0.80-2.63) vs 1.9% (IQR, 1.12-3.9) in matched MV (P < .001). MV replacement (30%) and atrial fibrillation surgery (32%) were similar in both groups. Cardiopulmonary bypass (161 minutes [IQR, 133-203] vs MV: 130 minutes [IQR, 103-166]; P < .001) and crossclamp times (93 minutes [IQR, 66-123] vs MV: 83 minutes [IQR, 64-107]; P < .001) were longer with cTVR. Although in-hospital mortality was similar (cTVR: 3.3% vs MV: 2.2%; P = .5), postoperative pacemaker implantations (9% vs MV: 5.8%; P = .02), low cardiac output syndrome (7.7% vs MV: 4.4%; P = .02), and acute kidney injury (13.8% vs MV: 10%; P = .01) were more frequent with cTVR. cTVR eliminated relevant TR in most patients (greater-than-moderate TR: 6.8%). Multivariable analysis identified MV replacement, atrial fibrillation, and cTVR as risk factors of postoperative pacemaker implantation. Conclusions: cTVR in minimally invasive MV surgery is an independent risk factor for pacemaker implantation in this international registry. It is also associated with more bleeding, low output syndrome, and acute kidney injury. It remains unclear whether technical or patient factors (or both) explain these differences.

Insight into tricuspid transcatheter edge-to-edge repair: no longer the forgotten valve.

INTRODUCTION: Tricuspid regurgitation (TR) is one of the most prevalent types of valvular heart disease linked to poor prognosis in patients with heart failure and is usually ignored. TR has received considerable attention due to the progressive advancements in transcatheter therapies in recent years. AREAS COVERED: With relatively solid data and rapid technological advancements, tricuspid transcatheter edge-to-edge repair (T-TEER) is the most frequently employed in a series of tricuspid transcatheter interventional treatments for TR. However, the efficacy and technical benefits of T-TEER are limited because of the unique anatomical characteristics and pathological mechanisms of the tricuspid valve. The aim of this review is to summarize reported data on current status of T-TEER and to provide an expert opinion regarding the challenges it is now experiencing and future development direction and approach. EXPERT OPINION: T-TEER is a significant treatment for TR, but its effectiveness and technical promotion are limited due to the tricuspid valve unique anatomical characteristics and pathological mechanisms. The selection criteria for suitable patients, the choice of when to intervene, device innovation, the advancement of ultrasound technology, and the volume of evidence in evidence-based medicine all indicate that the disorder of TR will eventually be better treated and understood.

Management of severe tricuspid valve regurgitation due to ruptured papillary muscle in a patient with mediastinitis early after heart transplant.

Objective: Even though severe tricuspid regurgitation is not uncommon after cardiac transplantation, primary severe tricuspid regurgitation is rare. We present such a case with additional complexities. Methods: The patient was 44-year-old man with a HeartWare durable left ventricular assist device (Heartware Inc) who received a temporary right ventricular assist device (RVAD) with a ProtekDuo cannula (LivaNova Inc USA) for refractory ventricular fibrillation and underwent a heart transplant as United Network for Organ Sharing Status 1, in the presence of partially compensated cardiogenic shock, renal failure. Given complex re-operative surgery in a volume-overloaded patient with unknown pulmonary vascular resistance, an RVAD cannula was preserved and re- inserted during cardiac transplant. Postoperatively he required hemodialysis, had severe primary tricuspid regurgitation discovered after RVAD removal and developed Enterobacter mediastinitis. He underwent complex tricuspid valve repair for flail tricuspid leaflet due to ruptured papillary muscle likely due to RVAD cannula injury, after multiple mediastinal washouts and was followed by delayed chest reconstruction. Results: The patient is doing well, 6 months after discharge to home, asymptomatic, without re-admissions, on renal recovery path, with no tricuspid regurgitation and good biventricular function. Conclusions: Replacing the tricuspid valve in presence of hemodialysis catheter, immunosuppression and mediastinitis could be high risk for endocarditis. Even though we have short-term follow-up, tricuspid valve repair can be an effective way of managing primary severe regurgitation especially when there is a desire or need to avoid valve replacement.

First-in-human study of the K-Clip™ transcatheter annular repair system for severe functional tricuspid regurgitation.

BACKGROUND: Severe TR is associated with impaired prognosis while limited interventional options available. The purpose of this observational first-in-human experience with the K-Clip™ transcatheter tricuspid annular reconstruction system is to investigate its feasibility, safety as well as short-term clinical impact on patients with severe functional tricuspid regurgitation (TR). METHODS: In this compassionate-use, prospective, multi-center, single-arm study, 15 patients with severe symptomatic functional TR were treated with the K-Clip™ system and followed up at 30 days after discharge. Feasibility endpoints consisted of safety (major clinical cardiovascular events (MACEs), echocardiographic, clinical and functional endpoints. RESULTS: All the 15 patients (9 males, 72.67 ± 9.42 years of age) successfully received implants and no MACEs were reported throughout the study at 30 days. Between baseline and 30 days, echocardiography showed remarkable reduction of tricuspid annular circumference and area by 14.30% and 25.96%. Improvement of ≥ + 2 grade and ≥ +3 grade TR was presented in 9/15(60.00%) and 4/15(26.67%) respectively while 10/15(66.67%) of patients had ≤ moderate TR. Clinical evaluation indicated that 86.67% of patients were finally in NYHA functional class I or II (p<0.001) and overall Kansas City Cardiomyopathy Questionnaire score improved from 62.28 ± 18.97 to 77.90 ± 11.70 (p = 0.016). CONCLUSION: Our first-in-human results of the transcatheter tricuspid annular reconstruction using the K-Clip™ system demonstrated initial favorable procedural success, acceptable safety and remarkable TR reduction in consistent with significant clinical improvement. Larger-scaled prospective trials with longer follow-up duration are warranted to further determine whether these promising findings could be promoted to a broader population in the long term.

Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice.

BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality. OBJECTIVES: The authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) in a contemporary, real-world setting. METHODS: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device) postapproval study is a prospective, single-arm, open-label, multicenter, postmarket registry conducted at 26 sites in Europe. Echocardiographic assessment was performed at a core laboratory. RESULTS: Enrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days. CONCLUSIONS: Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population. (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device [bRIGHT]; NCT04483089).

Tricuspid repair in mitral regurgitation surgery: a systematic review and meta-analysis.

BACKGROUND: Concomitant tricuspid repair in MR surgery is indicated in patients with severa tricuspid regurgitation, however, concomitant repair in less-than-severe TR patients is still a matter of debate. METHODS: In December 2021, we systematically searched PubMed, Embase and Cochrane databases for randomised control trials (RCTs) comparing isolated MR surgery versus MR surgery with concomitant TR annuloplasty. Four studies were included, resulting in 651 patients (323 in the prophylactic tricuspid intervention group and 328 in the no tricuspid intervention group). RESULTS: Our meta-analysis showed a similar all-cause mortality and perioperative mortality for concomitant prophylactic tricuspid repair when compared with no tricuspid intervention (pooled odds ratio (OR), 0.54; 95% confidence interval (CI): 0.25-1.15, P = 0.11; I2 = 0% and pooled OR, 0.54; 95% CI: 0.25-1.15, P = 0.11; I2 = 0%, respectively) in patients undergoing MV surgery. despite a significantly lower TR progression (pooled OR, 0.06; 95% CI: 0.02-0.24, P < 0.01; I2 = 0%). Additionally, similar New York Heart Association (NYHA) classes III and IV were identified in both concomitant prophylactic tricuspid repair and no tricuspid intervention, despite a lower trend in the tricuspid intervention group (pooled OR, 0.63; 95% CI: 0.38-1.06, P = 0.08; I2 = 0%). CONCLUSIONS: Our pooled analyses suggested that TV repair at the time of MV surgery in patients with moderate or less-than-moderate TR did not impact on perioperative or postoperative all-cause mortality, despite reducing TR severity and TR progression following the intervention.

A robotic-assisted approach to sliding plasty, neochordoplasty, and annuloplasty in a technically complex mitral valve repair.

In experienced hands, complex mitral valve repair can be safely and effectively performed in a totally endoscopic, robotic-assisted manner. We present a technically complex case of a 76-year-old man with severe, symptomatic mitral regurgitation due to Barlow's disease, moderate-to-severe tricuspid regurgitation, and atrial fibrillation.

A rare case of papillary fibroelastoma involving the tricuspid valve. A single center experience over a period of 22 years (1999-2021).

BACKGROUND AND AIM: Papillary fibroelastoma (PFE) represents only 16% of the benign cardiac tumor and approximately 15% of these are located on the tricuspid valve. MATERIALS AND METHODS: Over a period of 22 years (1999-2021) we observed 75 pts with cardiac tumors at our Center over 9650 pts operated on but only one case of a tricuspid valve PFE in a 69-year-old patient. Trans-thoracic echocardiography demonstrated a mobile mass (20 × 10 mm), adhering to the atrial side of the septal leaflet of the tricuspid valve of unknown origin. In consideration of the mobility of the mass and the consequent high embolic risk, surgical removal was made. The patient underwent surgery through a median sternotomy on CPBP. A 'gelatinous' mass adhering to the tricuspid leaflet was found and completely removed. The postoperative course was uneventful. The pathological diagnosis was PFE. CONCLUSIONS: PFEs of the tricuspid valve are rare entities being in most cases found incidentally. In our experience, the incidence of this tumor in this location is 1/10,000 cases of cardiac surgery. Although most patients are asymptomatic, surgical treatment is nevertheless recommended in consideration of the high embolic risk.

Tricuspid Annulus Dilation in Patients With Combined Functional Tricuspid Regurgitation and Left-Heart Valvular Disease: Does Septal Annulus Not Dilate?

Background: This study aimed to investigate the course of tricuspid annulus dilation in functional tricuspid regurgitation with varied severities by direct intraoperative assessment. Methods: A total of 317 patients who underwent left heart surgery and concomitant tricuspid repair were divided into three groups according to the severity of the functional tricuspid regurgitation (mild, moderate and severe). Demographic and echocardiographic data were collected. The length of each tricuspid annulus segment was measured intraoperatively. The risk factors for preoperative severe functional tricuspid regurgitation and its postoperative recurrence were identified, and the impact of each tricuspid annulus segment on postoperative recurrence was compared. Results: In the course of tricuspid annulus dilation, the posterior annulus dilated 17% (group 1: 33.31 ± 6.94 mm vs. group 2: 35.56 ± 7.63 vs. group 3: 38.98 ± 8.70, p < 0.01), the anterior annulus dilated 13.4% (group 1: 36.71 ± 6.30 mm vs. group 2: 38.21 ± 8.35 vs. group 3: 41.63 ± 9.20, p < 0.01), and the septal annulus dilated 11.4% (group 1: 38.11 ± 5.28 mm vs. group 2: 39.76 ± 6.90 vs. group 3: 42.46 ± 7.50, p < 0.01). Tricuspid annulus circumference index (p < 0.01) independently correlated with preoperative severe tricuspid regurgitation and postoperative recurrence. When patients were grouped based on the length of each segment, the septal annulus demonstrated significantly higher sensitivity (p < 0.001) to postoperative recurrence than the anterior (p = 0.085) or posterior annulus (p = 0.262). Conclusions: This study revealed that each segment of tricuspid annulus could dilate in functional tricuspid regurgitation and highlighted the potential benefits of septal annulus plication in tricuspid annuloplasty, which may aid in the development of a methodology for prosthetic ring annuloplasty.

Mid-term outcomes of isolated tricuspid valve surgery according to preoperative clinical and functional staging.

OBJECTIVES: This study aimed at assessing mid-term outcomes of patients undergoing isolated tricuspid valve (TV) surgery based on a preoperative baseline clinical and functional classification. METHODS: All patients treated with isolated TV repair or replacement from March 1997 to May 2020 at a single institution were retrospectively reviewed and assessed for mid-term postoperative outcome according to a novel classification [stages 1-5 related to the absence or presence and extent of right heart failure (RHF)]. Kaplan-Meier survival curves were used to estimate mid-term survival. Competing risk analysis for time to cardiac death and hospitalizations for RHF were also carried out. RESULTS: Among the 172 patients included, 129 (75%) underwent TV replacement and 43 (25%) TV repair. At follow-up (median 4.2 years [2.1-7.5]), there were 23 late deaths. At 5 years, overall survival was 100% in stage 2, 88 ± 4% in stage 3 and 60 ± 8% in stages 4-5 (P = 0.298 and P = 0.001, respectively). Cumulative incidence function of cardiac death at 5 years was 0%, 8.6 ± 3.76% and 13.2 ± 5% for stages 2, 3 and 4 and 5, respectively. At follow-up, cumulative incidence function of re-hospitalizations for RHF was 0% for stage 2, 20 ± 5% for stage 3 and 20 ± 6.7% for stages 4 and 5 (P = 0.118 and P = 0.039, respectively). CONCLUSIONS: Both short- and mid-term outcomes support early referral for surgery in isolated TV disease, with excellent survival at 5 years and no further hospitalizations for RHF.

Impact of inferior vena cava entry characteristics on tricuspid annular access during transcatheter interventions.

OBJECTIVES: The purpose of this study was to characterize the anatomic relationship between the inferior vena cava (IVC) and tricuspid annulus (TA) and its potential impact on the performance of transcatheter TV interventions. BACKGROUND: Transcatheter tricuspid valve (TV) interventions are emerging as a therapeutic alternative for the treatment of severe, symptomatic tricuspid regurgitation (TR). Progression of TR is associated with right heart dilatation. These anatomic changes may distort the IVC-TA relationship and impact successful implantation of transcatheter devices. METHODS: Fifty patients who presented with symptomatic TR for consideration of transcatheter TV therapy with an available CT were included in the study. Comprehensive transesophageal echocardiogram and CT analyses were performed to assess the right-sided cardiac chambers, TA and IVC-TA relationship. RESULTS: The mean age of the study cohort was 78.4 ± 8.9 years. Torrential TR was present in 54% (n = 27). There was considerable variation in the short axis mid-IVC to mid-TA offset (SAXMID 18.2 ± 7.9 mm, range 4.7-42.1 mm). CONCLUSIONS: The IVC-to-TA relationship exhibits significant variability in patients with symptomatic TR. CT analysis of the tricuspid anatomy, including the relationship to the surrounding structures and the IVC, is essential for planning transcatheter TV interventions. Further studies are needed to define whether the IVC-to-TA relationship is a predictor of technical success in the context of specific transcatheter delivery systems.

Functional Tricuspid Regurgitation in Patients With Chronic Mitral Regurgitation: An Evidence-Based Narrative Review.

Chronic mitral regurgitation leads to a series of downstream pathologic changes, including pulmonary hypertension, right ventricular dilation, tricuspid leaflet tethering, and tricuspid annular dilation, which can result in functional tricuspid regurgitation (FTR). The five-year survival rate for patients with severe FTR is reported to be as low as 34%. While FTR was often left uncorrected during left-heart valvular surgery, under the assumption that correction of the left-sided lesion would reverse the right-heart changes that cause FTR, recent data largely have supported concomitant tricuspid valve repair at the time of mitral surgery. In this review, the authors discuss the potentially irreversible nature of the changes leading to FTR, the likelihood of progression of FTR after mitral surgery, and the evidence for and against concomitant tricuspid valve repair at the time of mitral valve intervention. Lastly, this narrative review also examines advances in transcatheter therapies for the tricuspid valve and the evidence behind concomitant transcatheter tricuspid repair at the time of transcatheter mitral repair.

Transcatheter Tricuspid Valve Replacement for Surgical Failures.

Tricuspid valve surgery has high mortality for first-time operations and repeat surgery is fraught with even higher rates. When failed tricuspid surgical prostheses and repairs are present, physicians look toward transcatheter tricuspid valve replacement (TTVR) as a tangible solution. Using balloon-expandable bioprosthetic valves in an off-label fashion, tricuspid valve-in-valve (TViV) procedures can be performed reliably; however, valve-in-ring cases are more nuanced and have higher risks of paravalvular leak and valve malpositioning. TTVR specific issues include THV anchoring, management of preexisting pacing leads, postprocedure thromboembolic prophylaxis, and possible tricuspid reintervention.

Roles of Cardiac Computed Tomography in Guiding Transcatheter Tricuspid Valve Interventions.

PURPOSE OF REVIEW: The field of transcatheter tricuspid valve interventions (TTVI) is rapidly evolving to meet a well-defined but unmet clinical need. Severe tricuspid regurgitation is common and is associated with significant morbidity and mortality. Surgical options are limited and of high risk. The success of TTVI depends on careful procedural planning, and cardiac computed tomography (CCT) plays an emerging key role. RECENT FINDINGS: TTVI technologies have various targets, including the leaflets, annulus, and venae cavae, along with valve replacement. Based on the planned procedure, CCT allows for device sizing, careful assessment of the access route, and comprehensive analysis of relevant adjacent anatomic structures to enhance procedural safety. It can also evaluate right-sided heart function, and its data can be for fusion imaging and 3D printing. Procedural planning is key to TTVI's success and is highly dependent on high-quality CCT data. This review details the comprehensive roles of CCT, specifics of the dedicated TTVI protocol, and its limitations.