Tricuspid Valve Procedures Research Articles

Endovascular Vena Cavae Occlusion Technique in Minimally Invasive Tricuspid Valve Surgery in Patients With Previous Cardiac Surgery

The aim of the present study was to describe a bicaval endovascular occlusion technique in minimally invasive tricuspid valve (TV) surgery in patients with previous cardiac surgery. Case series. Single tertiary university center. The study comprised ten patients. Endovascular occlusion of vena cavae for minimally invasive TV redo surgery. Between 2008 and 2017, ten patients with previous cardiac surgery underwent TV minimally invasive surgery (repair or replacement; isolated or with concomitant procedures) using the Coda balloon catheter (Cook Medical, Bloomington, IN) to occlude both vena cavae. Data were collected retrospectively from electronic medical records. Superior and inferior vena cava occlusion with Coda balloon catheters was successful with no complications. The drainage of the vena cavae was optimal with excellent surgical exposure. Cardiopulmonary bypass time was 131 ± 119 minutes, with 30% of patients undergoing aortic clamping (two with a Chitwood clamp, one with an endoaortic balloon). Intensive care unit length of stay was 3.9 ± 2.7 days, and the in-hospital mortality rate was 30%. Bicaval endovascular occlusion of vena cavae is a feasible and effective technique in patients with previous cardiac surgery who are undergoing a minimally invasive TV procedure. The high mortality rate is associated with the inherent risk of a redo surgery involving the TV.

Abstract 12871: Comparison of Risk Scores at Predicting Mortality and Morbidities After Isolated Tricuspid Valve Surgery

Background: Risk models play important roles in stratification and decision-making towards cardiac surgery. Isolated tricuspid valve surgery (TVR) is a high risk but increasingly performed operation, however the performance of surgical risk models, including the recently developed Society of Thoracic Surgeon’s (STS) TVR score, have not been externally evaluated in these patients. We compared the prognostic utility of contemporary risk scores for isolated TVR. Methods: Consecutive patients undergoing isolated TVR at Cleveland Clinic during 2004-2018 were evaluated. EuroSCORE II and STS-TVR score were retrospectively calculated, and their performance for predicting 30-day mortality, post-operative complications and mortality during follow-up were assessed. Results: Amongst 207 patients studied, mean age was 54.1±17.9 years, 116 (56.0%) were female, 92 (44.4%) had secondary tricuspid regurgitation, and 151 (72.9%) had surgical repair. Mean EuroSCORE II and STS-TVR scores were 6.3±6.6% and 5.5±6.2% respectively. Operative mortality occurred in 10 (4.9%). C-statistics (95% confidence intervals) for 30-day mortality were 0.83 (0.74-0.93) for EuroSCORE II and 0.60 (0.45-0.75) for STS-TVR score (Table), and observed/expected ratios were 0.78 and 0.89 respectively. EuroSCORE II also had higher c-statistics for composite and most post-operative complications. In univariable Cox regression for mortality during follow-up, hazards ratios (95% confidence intervals) were 1.08 (1.05-1.11) for EuroSCORE II and 1.06 (1.02-1.11) for STS-TVR score. Conclusion: EuroSCORE II was superior to STS-TVR score at predicting adverse outcomes after isolated TVR. Although risk scores traditionally under-estimated 30-day mortality after isolated TVR, our excellent surgical results meant that calibration of both scores were satisfactory for our cohort, and provides a benchmark for future studies of isolated surgical and transcatheter tricuspid valve procedures.

Abstract 14107: Early Right Ventricular Reverse Remodeling Predicts Long-term Survival After Isolated Tricuspid Valve Surgery

Introduction: There are limited data on the impact of isolated tricuspid valve (TV) surgery on recovery of right ventricular (RV) function and RV reverse remodeling. Methods: Among 223 patients who had isolated TV procedures between 2001 and 2017, 60 (27%) underwent TV repair and 163 (73%) received TV replacement. RV reverse remodeling was assessed by echocardiography at a median of 11.3 months (IQR 5.9-13.5) post dismissal. Kaplan-Meier analysis and the log-rank test were used to estimate and create survival curves. Cox proportional hazards analysis was performed to study the association of clinical and echocardiographic parameters with mortality. Results: Mean age was 67.3 ± 13.7 years, and 57% were female. Indication for surgery was functional TR in 64% (n=143) patients. Overall 30-day mortality was 2.7%. After a median follow-up period of 9.5 years (IQR 3.6-12.9) there were a total of 122 (54.7%) deaths. Adjusted Cox regression analysis revealed comparable survival for TV repair and replacement and identified older age, and presence of RV dysfunction (HR 1.84, 95% CI 1.14-2.98; P=0.01) as independent predictors of poor survival. Impact of early RV reverse remodeling on survival after TV surgery was evaluated in 90 patients; In 39 RV function and/or RV size recovered, but in 51 RV dysfunction and/or RV enlargement persisted or worsened. Patients who exhibited RV reverse remodeling had significantly improved survival compared to those who did not (Log-Rank P=0.005) and reverse remodeling was independently associated with improved survival (HR 0.42, 95% CI 0.24-0.74; P=0.003). In a multivariable analysis lower preoperative right atrial pressure (OR 0.83, 95% CI 0.73-0.94; P=0.004) was an independent predictor of early right heart reverse remodeling. Conclusions: Isolated TV surgery can be performed with acceptable outcomes, and overall survival is best in patients who receive the operation before developing severe RV systolic dysfunction. Adjusted survival was similar for patients undergoing TV repair or replacement. Reverse remodeling of RV during the first 18 months after surgery appears to provide survival benefit. Preoperative RA pressure is an independent determinant of postoperative RV remodeling.

Tricuspid valve repair in isolated tricuspid pathology: a 12-year single center experience

ObjectivesLong-term data on isolated surgical tricuspid valve procedures is limited. Current guidelines on heart valve disease recommend valve repair over valve replacement. In this study we report our 12-year single-center experience with isolated surgical tricuspid valve repair in patients with various tricuspid valve pathologies.MethodsBetween May 2007 and December 2019, 26 consecutive patients underwent isolated tricuspid valve annuloplasty/repair for various indications. In 18 patients (69.2%) an open ring or band annuloplasty (26.9 and 42.3%, respectively) was performed, 5 patients (19.2%) underwent a tightening of the annulus using the DeVega technique, 5 patients (19.2%) had a leaflet reconstruction with patch or bicuspidalization and in 3 patients (11.5%) a leaflet debridement was performed. In 15.4% of the cohort a combination of the techniques was utilized.ResultsThe mean follow-up time was 2.1 (0.3–5.0) years. Early survival at 30 days after surgery was 84.6%. Mean hospital stay was 11 (6.7–16) days. One-year survival was 73%. No patient required a redo procedure on the tricuspid valve during follow-up.ConclusionTricuspid valve repair is suggested as a treatment of choice according to recent guidelines on heart valve disease. If chosen correctly, various repair techniques provide good long-term results. Tricuspid valve repair may be safely applied in patients undergoing surgical isolated tricuspid valve procedures.

Optimal Tricuspid Annular Size for Tricuspid Annuloplasty in Patients with Less-Than-Moderate Functional Tricuspid Regurgitation.

BackgroundWe evaluated the association between tricuspid annular dilatation and the development of moderate or severe tricuspid regurgitation (TR). Additionally, we determined the optimal tricuspid annular dilatation threshold to use as an indicator for tricuspid annuloplasty in patients with less-than-moderate functional TR (FTR).MethodsBetween August 2007 and December 2014, 227 patients with less-than-moderate TR underwent mitral valve surgery without a tricuspid valve (TV) procedure. The TV annular diameter was measured via transthoracic echocardiography. The TV annular index (TVAI) was calculated as the TV annular diameter divided by the body surface area. The mean duration of echocardiographic follow-up was 42.0 months (interquartile range, 9.3–66.6 months).ResultsEight patients (3.5%) developed moderate or severe TR. The rate of freedom from development of moderate or severe TR at 5 years was 96.2%. TV annular diameter, left atrial diameter, preoperative atrial fibrillation, and TVAI were found to be associated with the development of moderate or severe TR in the univariate analysis. A cut-off TVAI value of 19.8 mm/m2 was found to predict the development of moderate or severe TR, and a significant difference was observed in the development of TR of this severity based on this cut-off (p<0.001).ConclusionThe progression of TR was not infrequent in patients with untreated less- than-moderate FTR. An aggressive treatment approach can be helpful to prevent the progression of FTR for patients with risk factors, especially TVAI greater than 19.8 mm/m2.

Reintervention rates after bioprosthetic pulmonary valve replacement in patients younger than 30 years of age: A multicenter analysis

ObjectivesTo assess the difference in time to and predictors of reintervention according to valve type in surgical bioprosthetic pulmonary valve replacement (PVR) in patients younger than 30 years of age from multiple centers. MethodsData were retrospectively collected for 1278 patients <30 years of age undergoing PVR at 8 centers between 1996 and 2015. ResultsMean age at PVR was 19.3 ± 12.8 years, with 719 (56.3%) patients ≤18 years of age. Diagnosis was tetralogy of Fallot in 626 patients (50.5%) and 165 (12.9%) had previous PVR. Median follow-up was 3.9 years (interquartile range, 1.2, 6.4). Multiple valve types were used, most commonly CE PERIMOUNT, 488 (38.2%), CE Magna/Magna Ease, 361 (28.2%), and Sorin Mitroflow 322 (25.2). Reintervention occurred in 12.7% and was most commonly due to pulmonary stenosis (68.8%), with most reinterventions occurring in children (85.2%) and with smaller valve sizes (P < .001) Among adults aged 18 to 30 years, younger age was not a significant risk factor for reintervention. Surgical indication of isolated pulmonary regurgitation was associated with a lower risk of reintervention (P < .001). Overall, 1-, 3-, 5-, and 10-year freedom from reintervention rates were 99%, 97%, 92%, and 65%. The only independent risk factors for reintervention after controlling for age and valve size were lack of a concomitant tricuspid valve procedure (P = .02) and valve type (P < .001); Sorin and St Jude valves were associated with similar time to reintervention, and deteriorated more rapidly than other valve types. ConclusionsIn this large multicenter study, 8% of patients have undergone reintervention by 5 years. Importantly, independent of age and valve size, reintervention rates vary by valve type.

Survival and long-term outcomes after concomitant mitral and aortic valve replacement in patients with rheumatic heart disease.

IntroductionDouble valve replacement (DVR) with a mechanical prosthesis is associated with a higher risk of mortality. We planned to study the survival rate, early and late mortality and major adverse cardiac and cerebrovascular events (MACCE) in patients undergoing DVR for rheumatic heart disease, with various generations of prosthetic valves ranging from ball in cage to bileaflet prosthesis and tilting disc valves.Materials and methodologyWe followed up 277 patients with rheumatic heart disease who underwent DVR between August 1999 and November 2009, retrospectively, at Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram. Two hundred and fifty-nine patients were followed up for a minimum period of 10 years, and the follow-up period varied between 10 and 20 years. Eighteen patients were lost to follow-up after the surgery and could not be contacted. Their data was included till the time they appeared for follow-up last, for survival analysis. Survival analysis was carried out using the life table method to calculate the freedom from reoperation, survival rates and freedom from MACCE at 1 year, 5 years and 10 years post-DVR.ResultsThe median duration of hospital stay was 8 days. The number of patients with stroke was 11 (4.26%), 21 (8.7%) and 29 (12%) at the end of 1 year, 5 years, and 10 years, respectively. A total of 5 (2%) patients underwent reoperation by the end of 10 years. Seven patients died either in hospital or in the first 30 days following operation, making the early mortality 2.5%. At the end of 1 year, a total of 16 patients (5.8%) died. The mortality at the end of 5 years was 6.8% (19 patients), and at the end of 10 years, it was 7.2% (20 patients). The survival rate of the study population was 94.9%, 93.02% and 93.02% at the completion of 1 year, 5 years and 10 years, respectively. The freedom from MACCE was 93.8%, 88.6% and 85% at 1 year, 5 years and 10 years, respectively. The freedom from re-operation was 98% at 10 years. Kaplan-Meier analysis showed an overall survival time of 226.3 months in the entire study population. The mean survival time in males was 227.5 months and in females was 206.3 months, with no statistically significant difference between the two. Univariate logistic regression analysis revealed an association with mortality when DVR was combined with concomitant tricuspid valve repair procedures, with an odds ratio of 4.5 (p value 0.005). Multivariate logistic regression analysis also showed an association with mortality when tricuspid valve procedures were combined with DVR with an odds ratio of 5.25 (p value 0.003).ConclusionThe operative mortality and morbidity for DVR have been significantly reduced with advancements in operative techniques, myocardial preservation and postoperative care. Patients can have an improved functional status following surgery, with good rates of freedom from re-operation and MACCE.

Contemporary trends in mitral valve surgery in East China: a 10-year experience.

Contemporary nationwide data from mainland China on trends in mitral valve surgery are scarce. The purpose of the present study was to review a single-center experience with mitral valve surgery over a 10-year period in East China. Between July 2009 and June 2019, 3238 consecutive patients who underwent mitral valve surgery in our center were retrospectively reviewed. The patients were evenly divided into three periods: July 2009 to October 2012 (period I), November 2012 to February 2016 (period II), March 2016 to June 2019 (period III). The 3238 patients included 536 (16.6%) who had mitral valve repair and 2702 (83.4%) who had mitral valve replacement. Early mortalities for mitral valve repair and mitral valve replacement were 0.2% and 0.9%, respectively. There were trends towards a higher proportion of degenerative valve lesions (24.6%, 35.8%, 54.7% in periods I, II, and III, respectively) and a lower proportion of rheumatic valve lesions (71.0%, 62.6%, 38.0%) in more recent years. The proportions of minimally invasive surgery (0.7%, 2.1%, 30.2%), mitral valve repair (8.3%, 15.4%, 27.5%), use of a bioprosthesis (10.1%, 17.0%, 23.1%), and concomitant tricuspid valve procedures (13.2%, 28.5%, 46.0%) increased dramatically, while early mortality remained constant during the 10-year period (1.0%, 0.3%, 0.9%). In the past 10 years, the spectrum of mitral valve disease experienced a trend towards more degenerative valve lesions and less rheumatic valve lesions in East China. Mitral valve repair, bioprostheses, tricuspid valve repair, and minimally invasive surgery have been more often applied in recent years.

Permanent pacemaker implantation rates following cardiac surgery in the modern era

AimsThe aim of this study was to evaluate the incidence of permanent pacemaker (PPM) implantation after cardiac surgery in our institution and investigate risk factors for PPM dependency to provide patients with accurate incidence figures at the time of consent for surgery.MethodsData was collected retrospectively from a single tertiary institution from October 2018 to April 2019 inclusive of 403 patients. Incidence of PPM implantation after various cardiac operations was evaluated. A univariate analysis was carried out to identify the independent risk factors related to PPM implantation.ResultsTen patients required a PPM (2.48%). The most common indication for PPM implantation post-cardiac surgery was complete heart block (N = 7, 70%) followed by bradycardia/pauses (N = 2, 20%) and sick sinus syndrome (N = 1, 10%). PPM implantation after coronary artery bypass graft (CABG) surgery was the lowest (0.63%), while combined CABG and valve operations had the highest incidence (5.97%). Independent risk predictors for PPM implantation included female gender (p = 0.03), rheumatic heart disease (p = 0.008), pulmonary hypertension (p = 0.01), redo operations (p = 0.002), mitral valve procedures (p = 0.001), tricuspid valve procedures (p = 0.0003) and combined mitral and tricuspid valve procedures (p = 0.0001). Average length of intensive care unit (ICU)/high-dependency unit (HDU) stay was significantly prolonged for patients who required a PPM post-cardiac surgery.ConclusionAs clinicians, it can be challenging to provide our patients with accurate information on the risk of PPM implantation relative to their operation. A unit-specific data may be a more accurate method of informing our patients on this risk.

Clinical impact of concomitant tricuspid valve procedures during left ventricular assist device implantation

Tricuspid regurgitation (TR) is common in patients with end-stage heart failure receiving left ventricular assist devices (LVADs), but the benefit of concomitant tricuspid valve procedures (TVPs) remains uncertain. This study examined the impact of TVP at the time of LVAD implantation on clinical outcomes and quality of life (QOL) metrics. We included adult patients in the Interagency Registry for Mechanical Circulatory Support database with various degrees of TR who received continuous-flow LVADs from 2008 to 2017. Patients undergoing concomitant TVP were compared with those without the intervention in a stratified analysis. Descriptive analyses, survival analyses, and Andersen‒Gill hazard models were used as appropriate to examine associations with clinical and patient-centered QOL outcomes. Our analysis included 8,263 (53.1%) mild, 4,252 (33.3%) moderate, and 2,100 (13.5%) severe TR cases. TVP rate increased with severity: 8.6% of mild, 18.0% of moderate, and 43.9% of severe cases. TVP was not associated with survival benefit in cases of mild (adjusted hazard ratio [aHR]: 0.97, 95% CI: 0.79-1.19, p = 0.75), moderate (aHR: 1.03, 95% CI: 0.88-1.20, p = 0.72), or severe (aHR: 1.20, 95% CI: 0.98-1.48, p = 0.08) TR. For patients with combined moderate or severe TR, TVP was associated with increased mortality (log-rank p < 0.01, aHR: 1.13, 95% CI: 1.00-1.27, p = 0.04). After adjusting for TR severity, TVP was associated with increased risk of bleeding, arrhythmia, and stroke (p < 0.01 each) and no improvements in QOL (p > 0.05). TVP at the time of LVAD implantation was not associated with either improved survival or QOL, and there were associations with increased risk of adverse events among patients with moderate and severe TR.

4D MDCT in the assessment of the tricuspid valve and its spatial relationship with the right coronary artery: A customized tool based on computed tomography for the planning of percutaneous procedures

Multidetector computed tomography (MDCT) is currently the imaging technique of choice for the assessment of tricuspid valve (TV) annulus geometry and relationship with the right coronary artery (RCA). However, standardized protocols with a full 3D analysis are still lacking to plan percutaneous procedures for functional tricuspid regurgitation (FTR). A novel customized 4-dimensional tool based on MDCT data was developed and provided accurate information on TV annulus morphology (3D-perimeter, 2D-Area, maximum and minimum diameters, eccentricity index), function and distance to the RCA, crucial for patient selection of percutaneous TV procedures.

Questionable Value of Concomitant Tricuspid Valve Procedure with Left Ventricular Assist Device Implantation

Tricuspid regurgitation (TR) is common in end stage heart failure patients receiving left ventricular assist devices (LVADs), but the value of intervention is uncertain. This study examined the impact of tricuspid valve procedures (TVP) at time of LVAD implantation on clinical outcomes and quality of life metrics. We included patients in the INTERMACS database with TR who received continuous-flow LVADs from the 2008 to 2017. TR was stratified by severity. Patients receiving concomitant TVP were compared to those without intervention in a stratified analysis. Survival analyses and Andersen-Gill hazard models were used to examine associations with clinical outcomes. Our analysis included 8263 (53.1%) mild, 4252 (33.3%) moderate, and 2100 (13.5%) severe TR cases. TVP rate increased with severity: 13.0% of mild cases underwent TVP versus 55.2% of severe cases. TVP was not associated with survival difference for mild (median 57.8 months for TVP vs. 55.6 months for non-TVP, P=0.69, HR 1.10 [95%: 0.87-1.50]), moderate (47.5 vs. 51.1 months, P=0.23, HR 1.20 [0.99-1.50]), or severe TR (43.3 vs 46.3 months, P=0.09, HR 1.30 [0.99-1.60]). TVP was associated with increased risk of bleeding, arrhythmia, stroke, renal failure, and respiratory failure (P<0.01 for each) and not with Kansas City Cardiomyopathy Questionnaire (KCCQ) differences at 12- or 24-months follow-up. TVP at time of LVAD implantation was not associated with differences in survival or KCCQ scores. However, there were associations with increased risk of adverse events. Further studies are needed to understand appropriateness criteria for TVP with LVAD implantation.

Tricuspid valve repair in children with hypoplastic left heart syndrome: impact of timing and mechanism on outcome.

Our aim was to evaluate the results of tricuspid valve repair (TVr) in patients with hypoplastic left heart syndrome during staged reconstruction, focussing on the timing of the repair and the mechanisms of tricuspid regurgitation (TR). Records of 44 children with hypoplastic left heart syndrome who underwent a total of 62 tricuspid valve (TV) procedures during staged reconstruction were retrospectively analysed. TVr was performed before stage II in 4 (9%) patients, at stage II in 23 (52%) patients, between stages II and III in 3 (7%) patients and at stage III in 14 (32%) patients. The median age at the first TV procedure was 5 months. At surgery, TR emanated commonly from the anteroseptal commissure in 21 (48%) patients. Anterior leaflet prolapse was observed most frequently (n = 23; 52%), followed by septal leaflet restriction (n = 22; 50%), dilated annulus (n = 21; 48%) and cleft anterior leaflet (n = 9; 21%). Surgical techniques included commissuroplasty in 27 (61.4%) patients, leaflet adaptation in 20 (44%) patients, partial annuloplasty in 11 (25%) patients, chordal reconstruction in 10 (23%) patients and cleft closure in 10 (23%) patients. Among all 44 patients, 27 (61%) patients had preoperative grade III TR and 17 (39%) patients had grade IV; postoperatively, there were no patients with grade IV, 25 patients with grade III (57%), 10 patients with grade II (23%) and 6 patients with grade I (14%). Fifteen patients required redo TV surgeries. Reoperation-free survival was 52% at 5 years. Lower weight at initial TVr predicted mortality [hazard ratio (HR) 0.7, P = 0.044] and reoperation (HR 0.8, P = 0.015). TVr before stage II was a risk for both reoperation (HR 5.5, P = 0.042) and TV replacement (HR 36.9, P = 0.013). Among morphological factors, septal leaflet restriction was a risk for reoperation (HR 4.7, P = 0.017) and anterior (HR 4.7, P = 0.037) and posterior (HR 7.3, P = 0.015) leaflet chordal anomaly for TV replacement. Anterior leaflet prolapse and septal leaflet restriction are the main mechanisms of TR in hypoplastic left heart syndrome. Early-onset TR before stage II predicts worse outcome. Refinements to repair techniques in early infancy, especially for septal leaflet restrictions and chordal anomalies, are mandatory to improve outcomes.

Outcomes in patients who underwent a concomitant tricuspid valve procedure during left ventricular assist device implantation.

Study findings have been inconsistent regarding whether a concomitant tricuspid valve replacement or repair performed concurrently with continuous-flow left ventricular assist device (CF-LVAD) implantation has additive clinical benefit in patients with severe tricuspid valve regurgitation (TR). To determine the effect of performing a concomitant tricuspid valve procedure (TVP) at the time of CF-LVAD implantation on patient outcomes. We retrospectively reviewed our single-institution experience in 526 patients who underwent primary implantation of a CF-LVAD between November 2003 and March 2016. We identified 59 (11.2%) patients who had severe TR at the time of implantation and analyzed the effect of performing a concomitant TVP at the time of CF-LVAD implantation on the rate of survival, incidence of postoperative right heart failure (RHF), recurrence of TR, and incidence of 30-day readmission. We did not observe a significant difference in the overall survival rate (P = .51), incidence of postoperative RHF (P = .26), or recurrence of TR (P = .73) between patients with severe TR who underwent a TVP and those who did not at the time of CF-LVAD implantation. However, the incidence of 30-day readmission was significantly lower in patients who underwent a TVP than in those who did not (P = .002). Performing a concomitant TVP at the time of CF-LVAD implantation did not improve patient outcomes but reduced the incidence of 30-day readmission.

Hemodynamics of concomitant tricuspid valve procedures at LVAD implantation.

Tricuspid regurgitation (TR) is common in patients receiving left ventricular assist device (LVAD) implantation. The current literature is conflicting regarding the effects of concomitant tricuspid valve repair (TVR) at LVAD implantation. We investigated the hemodynamic effects of concomitant TVR at LVAD implantation. Consecutive clinically stable LVAD outpatients who underwent hemodynamic ramp testings were enrolled in this study, and they were stratified by concomitant TVR. Results of hemodynamic ramp tests were compared between the TVR group and the non-TVR group. Among 65 LVAD patients undergoing ramp tests, 34 patients had received TVR, and 31 had not. There were no significant differences in baseline characteristics between two groups except for higher degree of TR and lower pulmonary artery pulsatility index in the TVR group (P < .05 for both). Following LVAD implantation, the degree of TR improved significantly in the TVR group down to the comparable level with the non-TVR group. During ramp tests, the TVR group had steeper cardiac index slope (0.14 ± 0.12 vs 0.07 ± 0.07 L/min/m2 /step, P = .002) and higher cardiac index at set LVAD speed (2.99 ± 0.84 vs 2.52 ± 0.42 L/min/m2 , P = .007). Concomitant TVR improves cardiac output and its response to LVAD speed change following LVAD implantation. Longitudinal clinical implications of such hemodynamic changes are unknown.

Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study

Tricuspid regurgitation is a prevalent disease associated with high morbidity and mortality, with few treatment options. The aim of the TRILUMINATE trial is to evaluate the safety and effectiveness of TriClip, a minimally invasive transcatheter tricuspid valve repair system, for reducing tricuspid regurgitation. The TRILUMINATE trial is a prospective, multicentre, single-arm study in 21 sites in Europe and the USA. Patients with moderate or greater triscuspid regurgitation, New York Heart Association class II or higher, and who were adequately treated per applicable standards were eligible for enrolment. Patients were excluded if they had systolic pulmonary artery pressure of more than 60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. Tricuspid regurgitation was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was a reduction in tricuspid regurgitation severity by at least one grade at 30 days post procedure, with a performance goal of 35%, analysed in all patients who had an attempted tricuspid valve repair procedure upon femoral vein puncture. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups. The trial has completed enrolment and follow-up is ongoing; it is registered with ClinicalTrials.gov, number NCT03227757. Between Aug 1, 2017, and Nov 29, 2018, 85 patients (mean age 77·8 years [SD 7·9]; 56 [66%] women) were enrolled and underwent successful TriClip implantation. Tricuspid regurgitation severity was reduced by at least one grade at 30 days in 71 (86%) of 83 patients who had available echocardiogram data and imaging. The one-sided lower 97·5% confidence limit was 76%, which was greater than the prespecified performance goal of 35% (p<0·0001). One patient withdrew before 6-month follow-up without having had a major adverse event and was excluded from analysis of the primary safety endpoint. At 6 months, three (4%) of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (p<0·0001). Single leaflet attachment occurred in five (7%) of 72 patients. No periprocedural deaths, conversions to surgery, device embolisations, myocardial infarctions, or strokes occurred. At 6 months, all-cause mortality had occurred in four (5%) of 84 patients. The TriClip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post procedure. Abbott.

Mortality after tricuspid valve procedures: A 27-year, single-center experience

ObjectiveTo assess mortality after tricuspid valve (TV) surgery in a large single-center patient cohort. MethodsData from 392 TV procedures performed between 1989 and 2015 in 388 adult patients were retrospectively reviewed. The patients were divided into groups according to the type of concomitant procedure, ie, coronary artery bypass grafting (CABG) (TV + CABG group; n = 87), other valve surgery (TV + valve group; n = 240), or an isolated TV procedure with or without another minor procedure (isolated TV group; n = 65), and the era of the operation, ie, 1989-2005 (n = 173) or 2006-2015 (n = 219). Control groups of patients who underwent other valve procedures and/or CABG during the same time periods were used for comparison. ResultsDuring the most recent era, the annual number of TV procedures increased 2.4-fold, mainly for TV + valve procedures (2.8-fold). Within the TV + valve group, a larger proportion of patients had mild-to-moderate tricuspid regurgitation (grade ≤2) compared with the first-time period (P = .001). The TV + CABG group had significantly greater mortality than both the other groups during both time periods, whereas isolated TV procedure had the lowest mortality rates with the exception of the TV + valve group during the most recent era (P = .41). Survival for patients undergoing TV + valve procedures has improved significantly during the last decade (P = .001) and was comparable with that for other valve operations during this period. ConclusionsIn the last decade, TV repair has been performed more frequently and at lower grades of tricuspid regurgitation compared with previously, and mortality after TV procedures has decreased.

Right ventricular function and residual mitral regurgitation after left ventricular assist device implantation determines the incidence of right heart failure

BackgroundThe effect of significant mitral regurgitation (MR) on outcomes after continuous flow left ventricular assist device (cfLVAD) implantation remains unclear. MethodsWe performed a retrospective review of prospectively collected data from 159 patients with preoperative severe MR who underwent cfLVAD implantation (2003-2017). Two-step cluster analysis using the log-likelihood distance for post-cfLVAD implantation parameters, which included right ventricular (RV) dysfunction, MR severity, and tricuspid regurgitation (TR) severity. Post-cfLVAD implantation echocardiographic parameters were obtained within the first month. ResultsCluster analysis resulted in 3 groups. Group 1 (n = 67) had mild or less MR with moderate-severe RV dysfunction (RVD). Group 2 (n = 43) had moderate-severe MR with moderate-severe RVD. Group 3 (n = 49) had moderate MR with mild RVD. Group 2 had the largest proportion with Interagency Registry for Mechanically Assisted Circulatory Support score of 1 (30.2%) and 2 (41.9%). They were more likely to undergo temporary mechanical circulatory support (18.6%) and tricuspid valve procedure (62.8%). Group 2 had the highest rate of stroke (30.2%; P = .02), hemolysis (39.5%; P = .01), device thrombosis (30%; P = .01), and worst survival (46.5%; P = .01). Survival at 5 years for groups 1, 2, and 3 were 56.0%, 17.6%, and 55.8%. Regression analysis of the entire population showed that greater MR severity after cfLVAD was associated with RV failure (P < .05; odds ratio, 1.6) and RV assist device use (P = .09; odds ratio, 1.6). After excluding tricuspid valve repairs, MR severity had a positive correlation with TR severity (R = 0.33; P < .01). ConclusionsAfter cfLVAD implantation, moderate-severe MR and RVD predicted RV failure. Patients with preoperative moderate-severe MR and TR coupled with moderate-severe RVD might benefit the most from mitral and tricuspid valve intervention.

Longitudinal Trend of Tricuspid Regurgitation Following Left Ventricular Assist Device Implantation

Purpose Although tricuspid regurgitation (TR) following left ventricular assist device (LVAD) implantation is known to be related to unfavorable outcomes, the longitudinal trend of TR during LVAD course remains unknown. The aim of this study is to clarify the longitudinal trend of TR prior to and following LVAD implantation. Methods We retrospectively reviewed patients who received LVAD implantation between 4/2014-8/2018. We evaluated the grade of TR by echocardiography prior to and following LVAD implantation. TR grade was determined based on the color flow jet area. Moderate or severe TR was defined as significant. We compared clinical outcomes of patients with concomitant tricuspid valve (TV) procedure (TVP+) and those without (TVP-). Results Among 199 consecutive patients, 194 patients had at least 2 echocardiographic TR grade assessments. All patients had a test prior to LVAD implantation, and had an average of 6±4 tests after LVAD implantation during a median of 389 (range 8-1540) days of follow-up. Mean age was 57±13 years and 132 patients (68%) were male. 107 (55%) patients were included in TVP+. Prior to LVAD implantation the prevalence of significant TR was higher in TVP+ (51% in TVP+ vs 20% in TVP-, P All-cause mortality and heart failure (HF) readmission-free survival were similar between the groups. In contrast, patients with significant TR in the early period (within 6 months) had lower HF readmission-free survival (at 1 year, 60% in significant TR vs 74% in non-significant TR, P=0.015, Figure 1B). Conclusion Long-term trend of TR and clinical outcomes throughout LVAD course were similar between TVP+ and TVP-. Patients with significant TR had decreased HF-free survival.

Male-female differences in characteristics and early outcomes of patients undergoing tricuspid valve surgery: a national cohort study in the Netherlands.

This study aims to explore male-female differences in baseline and procedural characteristics, and outcomes of patients undergoing isolated or concomitant tricuspid valve (TV) surgery. All TV procedures registered between 2007 and 2016 in the database of the Netherlands Association for Cardio-Thoracic Surgery were analysed. Logistic regression analyses with interaction terms were used to determine whether sex was associated with hospital mortality. Five thousand five hundred and eighty-two patients underwent TV surgery [isolated: N = 685 (49% male), TVrepair: N = 5286 (50% male) and TVreplacement: N = 250 (46% male)]. In the TVrepair group, females were significantly older, had less prior percutaneous/surgical coronary interventions, less extracardiac arteriopathies, a lower prevalence of renal impairment, less endocarditis, a lower prevalence of preoperative critical condition, less recent myocardial infarction, less concomitant coronary artery bypass grafting (CABG) and, in case of concomitant mitral valve surgery, less concomitant mitral valve repair compared to males. In the TVreplacement group, females more often had a history of prior valve surgery and less prior CABG. Hospital mortality for males and females was 7.0% (N = 183) and 6.1% (N = 163), P = 0.241 in the TVrepair group and 2.6% (N = 3) and 8.8% (N = 12), P = 0.074 in the TVreplacement group. Sex was not associated with hospital mortality (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.88-1.48; P = 0.322). Sex demonstrated a significant interaction with the parameter 'critical preoperative condition' (OR 0.44, 95% CI 0.22-0.90; P = 0.026). Substantial differences in patient and procedural characteristics existed between male and female patients undergoing TV surgery, although sex was not a derterminant for hospital mortality. Nevertheless, sex interacted with a critical preoperative condition, indicating the usefulness of separate risk factor models for males and females requiring TV surgery.