Treatment Of Severe Tricuspid Regurgitation Research Articles

Comparison of procedural characteristics of percutaneous annuloplasty and edge-to-edge repair for the treatment of severe tricuspid regurgitation.

In recent years, new interventional therapies for tricuspid regurgitation (TR) demonstrated their effectiveness in reducing TR severity and improving symptoms. Currently, tricuspid transcatheter edge-to-edge repair (T-TEER) and percutaneous annuloplasty are the most widely used techniques in Europe. In this retrospective study, we compared procedural characteristics and learning curves of both TR devices in a real-world cohort. Eligible patients with severe to torrential TR underwent either percutaneous annuloplasty or T-TEER as recommended by the local heart team. Patients with combined mitral and tricuspid interventions were excluded from the analysis. The study focused on procedural characteristics, TR reduction and learning curves. A total of 122 patients underwent either percutaneous annuloplasty (n = 64) or T-TEER (n = 58) with a technical and device success rate of 98% and 97%, respectively. Reasons for technical failure included right coronary artery (RCA) dissection prior to percutaneous annuloplasty, and two single leaflet device attachments (SLDA) during T-TEER implantation. The mean improvement of TR severity was 2.4 ± 0.8 degrees after T-TEER and 2.5 ± 0.8 after percutaneous annuloplasty. T-TEER procedures were shorter in terms of both procedure time and radiation exposure, while percutaneous annuloplasty, although taking longer, showed a significant reduction in procedure time over the course of the analysed period. In summary, both interventional therapies reduce TR severity by approximately two degrees when used in the appropriate anatomy. The learning curve for annuloplasty group showed a significant decrease of procedure times.

Biomechanical performance of the Bicaval Transcatheter System for the treatment of severe tricuspid regurgitation.

Introduction: Tricuspid regurgitation (TR) is a relatively common valvular disease, which can result from structural abnormalities of any anatomic part of the tricuspid valve. Severe TR is linked to congestive heart failure and hemodynamic impairment, resulting in high mortality when repaired by elective surgery. This study was undertaken to quantify the structural and hemodynamic performance of the novel Transcatheter Bicaval Valves System (TricValve) percutaneously implanted in the superior vena cava (SVC) and inferior vena cava (IVC) of two patients with severe TR and venous congestion. Methods: After developing the SVC and IVC device models, the contact pressure exerted on the vena cava wall was obtained by computational analysis. Both smoothed-particle hydrodynamics (SPH) and computational fluid dynamics were carried out to quantify caval reflux in the right atrium and the pressure field of pre- and post-TricValve scenarios, respectively. Results: Analysis of contact pressure highlighted the main anchoring area of the SVC device occurring near the SVC device belly, while the IVC device exerted pronounced forces in the device's proximal and distal parts. SPH-related flow velocities revealed the absence of caval reflux, and a decrease in time-averaged pressure was observed near the SVC and IVC after TricValve implantation. Discussion: Findings demonstrated the potential of computational tools for enhancing our understanding of the biomechanical performance of structural tricuspid valve interventions and improving the way we design next-generation transcatheter therapies to treat the tricuspid valve with heterotopic caval valve implantation.

C15 PERCUTANEOUS EDGE–TO–EDGE REPAIR USING EDWARDS PASCAL SYSTEM FOR SEVERE TRICUSPID REGURGITATION IN CONGENITALLY CORRECTED TRANSPOSITION OF THE GREAT ARTERIES

Abstract Introduction Congenitally corrected transposition of the great arteries (ccTGA) is a rare cardiac malformation characterized by ‘double’ discordance of atrioventricular and ventriculo–arterial connections, resulting in a systemic tricuspid atrioventricular valve and a systemic right ventricle. Clinical case We describe a case report of 54 years–old male patient with ccTGA, diagnosed when he was 3 years–old. Patient performed regular follow–up. Since December 2019, the patient reported onset of effort dyspnoea (NYHA III), fatigue and exercise intolerance. Despite medication optimization, his symptoms persisted. He was referred at our Centre for specialist evaluation. Transthoracic echocardiography showed mild dilatation and dysfunction of right ventricle, massive systemic tricuspid valve regurgitation (EROA 42 mm2), due to multiple jets and systolic pulmonary artery pressure of 45 mmHg. As reported by most recent guidelines, indication was given for surgical replacement of the systemic tricuspid valve. However, the patient refused the cardiac surgery option. Transesophageal echocardiography (TEE) screening showed feasibility of percutaneous approach to tricuspid regurgitation. Being the jet central, the strategy was to place one device implant between the septal and the anterior leaflet (9–3 oriented), as central as possible. Following simultaneous leaflet capture and further optimization of leaflet, the result was excellent. Post–implant deployment TEE revealed only mild–to–moderate residual tricuspid regurgitation, with no tricuspid stenosis (mean gradient 2 mm Hg). The result was a percutaneous bicuspidization of a tricuspid systemic valve. The patient recovered quickly and was discharged to home 2 days after the procedure. Patient experienced significant improvement in functional status (NYHA I), exercise capacity and quality of life at 6 months follow–up. Conclusions In ccTGA patients, treatment of severe tricuspid regurgitation and improvement of the systemic ventricle’s systolic function is critical since progression of dysfunction of the RV and tricuspid regurgitation are considered key determinants for morbidity and mortality in these patients. Based on the results obtained in our case, percutaneous edge–to edge repair seems to be a reasonable alternative to the surgical approach and three–dimensional transesophageal echocardiography is imperative for the proper visualization of the leaflets outcome of the procedure and his durability.

Treatment of severe tricuspid regurgitation induced by permanent pacemaker lead: Transcatheter tricuspid valve replacement with the guidance of 3-dimensional printing.

Lead-induced tricuspid regurgitation is one of the complications after permanent pacemaker implantation (PPI) and refers to tricuspid regurgitation (TR) caused by the lead in the right ventricle (RV). To study the clinical characteristics of severe TR after PPI and the effect of transcatheter tricuspid valve replacement (TTVR) with the guidance of 3-dimensional (3D) printing. This study was a single-center, descriptive study. Six patients with severe TR after PPI were enrolled in Xijing Hospital from January 2020 to May 2020. Before TTVR, the 3D printed tricuspid valve (TV) model was used for evaluation in the bench test. LuX-Valve was implanted under the guidance of TEE and x-ray fluoroscopy, and all patients underwent transatrial access. Six patients' data were collected at baseline, before discharge, and 6 months, 1 year and 2 years after TTVR. The LuX-Valve was successfully implanted in 6 patients, TR was significantly reduced to ≤2+, and no deaths or cardiopulmonary bypass occurred during procedures. Three cases were caused by TV expansion: Patient #4 had TR caused by lead adhesion to TV, Patient #2 had TR caused by lead winding, and Patient #6 had TR caused by lead impingement on TV. During the 2-year follow-up, TTE revealed that 5 patients had no/trace regurgitation, and one patient (Patient #5) had mild regurgitation. All 6 patients (100.0%) reached primary endpoints. TTVR guided by 3D printing is safe and effective in the treatment of severe TR associated with permanent pacemaker lead, providing prospects and possibilities for the precise treatment of TV-related diseases.Clinical Trial Registration: ClinicalTrials.gov Protocol Registration System (NCT02917980).

Delay of surgical treatment of severe tricuspid regurgitation and outcomes in patients with left-sided heart valve disease

Introduction and objectivesThe influence of the delay between diagnosis and surgery in severe tricuspid regurgitation (TR) remains controversial. We aimed to analyze the association between delay to surgery and operative and mid-term mortality in patients with severe TR concomitant to left-valve surgery. MethodsWe conducted an observational retrospective study analyzing risk factors in patients undergoing left-valve surgery concomitant with severe TR. The clinical and demographic variables were prospectively collected. The time of first diagnosis of TR was retrospectively collected. ResultsA total of 253 patients were analyzed. TR was functional in 82.6%. The median latency between diagnosis and surgery was 24 months. Operative mortality was 12.2%. On multivariate analysis, higher operative mortality was associated with older age, worse preoperative NYHA functional class, triple valve surgery, hyponatremia, and anemia. The median follow-up was 35 months. Survival at 1 and 5 years was 85.2% and 73.7%, respectively. Mortality during follow-up was associated with male sex, preoperative massive TR, and longer latency between diagnosis and surgery. ConclusionsThe variables related to worse preoperative functional class were associated with increased operative mortality. Lower mid-term survival was associated with longer latency between diagnosis of severe TR and surgery, massive preoperative TR, and older age.

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry.

Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation. All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry. A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year. The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.

Twelve-month outcomes of the LuX-Valve for transcatheter treatment of severe tricuspid regurgitation.

Severe functional tricuspid regurgitation is associated with adverse clinical outcomes. Conventional surgical risk for patients with advanced tricuspid regurgitation stage is high. Alternative approaches are therefore required. The purpose of this study was to investigate the feasibility, technical details, and midterm outcomes of implantation of a novel radial force-independent orthotopic transcatheter tricuspid valve -the LuX-Valve- in patients with severe functional tricuspid regurgitation. The implantations of the LuX-Valve were performed in six patients with left-sided valvular surgery and secondary massive tricuspid regurgitation. The anatomy of the tricuspid valve and right heart measurements were evaluated by echocardiography and computed tomography in all patients. Conventional right ventricular (RV) function parameters and RV global longitudinal strain were obtained at baseline and 12-month follow-up. LuX-Valve implantation was performed under the guidance of digital subtraction angiography and transoesophageal echocardiography. All patients had successful implantations of LuX-Valves through the right atrium with a substantial reduction in the degree of tricuspid regurgitation. Although one patient with moderate paravalvular leakage died because of right heart failure during three-month follow-up, the five patients who lived had no significant paravalvular leakage, and displayed significant improvements in mean transvalvular gradient, right heart sizes, conventional RV function indices and RV global longitudinal strain, and a reduction in New York Heart Association Functional Class during 12-month follow-up. Transcatheter tricuspid valve replacement with the LuX-Valve was feasible and safe for patients with severe functional tricuspid regurgitation. This strategy seems a promising treatment option for patients at high surgical risk.

MitraClip NTR vs XTR system for transcatheter tricuspid valve repair of tricuspid regurgitation

Abstract Background Transcatheter tricuspid valve repair (TTVr) is a novel modality for treatment of severe tricuspid regurgitation (TR) in patients at high surgical risk. So far, the most frequently used system is the MitraClip® providing two different clip types (NTR vs XTR). Purpose To compare XTR vs NTR clip systems for TTVr regarding safety, feasibility, and effectiveness. Methods 35 consecutive high-risk patients (78.4±7.9 years, EUROScore II 10.7±10.8%, STS Score 7.9±4.1) with symptomatic TR were treated using the MitraClip® system between 2017–2020. with an NTR (N=18, 51.4%) or XTR (N=17, 48.6%) system. The primary outcome was successful TTVr with TR reduction of ≥1 grade with no mortality, single leaflet device attachment (SLDA), or conversion to surgery until hospital discharge. At 30-day follow-up, TR severity grade and NYHA functional class were assessed. Results We found more severe initial TR grades in the XTR group compared to the NTR group expressed with wider TR V. contracta (14.8±4.3 vs 11.1±3.8 mm, p=0.011), larger EROA (0.99±0.4 vs 0.72±0.3 cm2, p=0.032), wider coaptation depth (9.6±2.8 vs 7.3±0.4 mm, p=0.036) and V. cava inferior (30.7±3.6 vs. 25.8±6.4 mm in NTR, p=0.013). 5 patients (29.4%) in the XTR and 3 patients (16.7%) in the NTR group presented initially with torrential TR. No significant differences were observed for clinical characteristics, comorbidities, co-medication, laboratory parameters or initial NYHA functional class (3.0±0.5 in NTR vs 3.2±0.4 in XTR, p=0.45). TTVr was safe with no intraprocedural deaths, emergency surgery or major vascular complications. Duration of the procedure and fluoroscopy did not differ. Both, NTR and XTR system led to procedural success in 72.2% (N=13) and 76.5% (N=13), respectively. At discharge, a significant reduction of initial TR grade was observed in both groups (2.4±0.9 in NTR and 2.3±0.9 in XTR, p&amp;lt;0.001) with a tendency of greater mean reduction in the XTR group (1.9±1.0 vs. 1.3±0.9, p=0.09). All 5 patients with torrential TR in the XTR group (100%) and just 1 patient (33.3%) in the NTR group achieved the primary outcome. At 30-day follow-up, overall SLDA rate was 22% vs 17.6% for NTR and XTR, respectively. However, these cases were attributed to very high risk patients with poor anatomy. Mortality rate was 11.1% in NTR vs 5.9% in XTR group (p=0.59). Achieved reduction of TR was maintained in both groups (2.6±0.9 in NTR and 2.8±0.9 in XTR, p&amp;lt;0.001). Also, improvement of NYHA functional class was seen (2.5±0.5, p=0.001 in NTR and 2.9±0.6, p=0.055 in XTR). Conclusion MitraClip® NTR and XTR systems for TTVr of severe TR in high-risk patients are safe and effective leading to a significant reduction of TR and clinical improvement. The XTR system seems to allow successful treatment of more severe TR stages compared to NTR. Funding Acknowledgement Type of funding sources: None.

Initial Results after the Implementation of an Edge-To-Edge Transcatheter Tricuspid Valve Repair Program.

Transcatheter tricuspid valve repair (TTVr) has emerged as an alternative for the treatment of severe tricuspid regurgitation (TR). We report our initial experience with an edge-to-edge TTVr system in a high-volume institution. Methods: We included consecutive patients who underwent edge-to-edge TTVr systems. The primary efficacy endpoint was a reduction in the TR of at least one grade. The primary safety endpoint was procedure-related clinical serious adverse events. Results: A total of 28 patients underwent TTVr with edge-to-edge systems. All patients presented with at least severe TR with a high impact on quality of life (82% of patients in NYHA class ≥ III). The Triclip system was the most used device (89%). The primary efficacy endpoint was met in all patients. Only one patient experienced a procedural complication (femoral pseudoaneurysm). At three-month follow-up, 83% of patients were in NYHA I or II (18% baseline vs. 83% 3 months follow-up; p < 0.001). Echocardiography follow-up showed residual TR ≤ 2 in 79% of patients (paired p < 0.001). At the maximum follow-up (median follow up = 372 days), no patients had died. Conclusions: Edge-to-edge TTVr systems seem to represent a very valid alternative to prevent morbidity and mortality associated with TR as depicted by the favorable efficacy and safety.

Utility of Intracardiac Echocardiography in the Early Experience of Transcatheter Edge to Edge Tricuspid Valve Repair.

[Figure: see text].

Transcatheter treatment of severe tricuspid regurgitation.

Severe tricuspid regurgitation is a commonly prevalent valvular heart disease that is an independent adverse prognostic marker. However, the majority of patients with tricuspid regurgitation are managed medically; isolated tricuspid valve surgery is rarely performed, partly owing to high associated in-hospital mortality. Therefore, several transcatheter tricuspid valve interventions (TTVIs) that have been developed over the last few years to address this unmet clinical need. The early experience with TTVI has shown that most devices can be safely implanted with excellent rates of technical success and acceptable safety outcomes. Most TTVI recipients have significant improvement in tricuspid regurgitation severity, functional class, and quality of life. Recent retrospective data also suggest mortality benefit of TTVI compared with medical management. There are several issues that need to be addressed prior to widespread adoption of TTVI, including more effective tricuspid regurgitation reduction and need for longer term efficacy data. TTVI has emerged as an attractive treatment option for management of high-risk patients with tricuspid regurgitation. In this review, we will discuss the anatomical considerations specific to tricuspid valve, patient selection, preprocedure planning, and summarize the current evidence and future perspectives on TTVI.

Surgical treatment of severe tricuspid regurgitation.

Severe tricuspid regurgitation is associated with both significant symptoms as well as decreased survival. Surgical correction is possible in most cases but is markedly under used in this population. The purpose of this manuscript is to review the indications for treating severe tricuspid regurgitation and the surgical options available. Surgical correction of isolated severe tricuspid regurgitation has been associated with a high mortality in the surgical literature. This occurs generally from right heart failure associated with the late referral of isolated tricuspid regurgitation for correction. Recent outcomes are improving and tricuspid repair appears to be where mitral valve repair was 30 years ago. Severe tricuspid regurgitation is associated with severe symptoms as well as decreased survival. Tricuspid valve repair (TVr) for severe regurgitation is almost always technically possible. The high mortality thought to be associated with isolated TVr is likely due to late referral when right heart failure is already far advanced. Consideration for earlier referral for isolated severe tricuspid regurgitation should be considered.

Safety and efficacy of transcatheter tricuspid valve replacement with LuX-Valve in patients with severe tricuspid regurgitation

Objectives: To evaluate the safety and efficacy of LuX-Valve on the treatment of severe tricuspid regurgitation (TR). Methods: This is a prospective observational study. From September 2018 to March 2019, 12 patients with severe TR, who were not suitable for surgery, received LuX-Valve implantation in Changhai Hospital. LuX-Valve was implanted under general anesthesia and the guidance of transesophageal echocardiography and X-ray fluoroscopy. Access to the tricuspid valve was achieved via a minimally invasive thoracotomy and transatrial approach. Main endpoints were surgery success and device success. Surgery success was defined as successful implanting the device and withdrawing the delivery system, positioning the valve correctly and stably without severe or life-threatening adverse events. Device success was defined as satisfied valve function (TR severity reduction ≥ 2 grades, tricuspid gradient ≤ 6 mmHg (1 mmHg=0.133 kPa)), absence of malposition, valve failure and reintervention, major adverse events including device related mortality, embolization, conduction system disturbances and new onset shunt across ventricular septum at day 30 post implantation. Results: A total of 12 patients with severe to torrential TR were included in this study. The age was (68.5±6.9) years and 7 were female. All patients had typical right heart failure symptoms. Procedural success was achieved in all cases, there was no intraprocedural mortality or transfer to open surgery. TR significantly improved after LuX-Valve implantation (none/trivial in 8 patients, mild in 3 patients and moderate in 1 patient). The average device time was (9.2±4.2) minutes. Intensive care unit duration was 3.0 (2.0, 4.8) days. One patient died at postoperative day 18 due to non-surgery and device reasons. Transthoracic echocardiography at 30 days after operation showed that TR was significantly reduced (none/trivial in 8 patients, mild in 2 patients and moderate in 1 patient) and device success was achieved in 11 cases. All survived patients experienced a significant improvement in life quality with significantly improvement in New York Heart Association (NYHA) classification (Ⅰ and Ⅱ: 6/11 post operation vs. 0/11 before operation, P=0.012) and there were no device related complications in this patient cohort. Conclusions: LuX-Valve implantation is feasible, safe and effective for the treatment of patients with severe TR.

Outcomes of Isolated Tricuspid Valve Surgery

Isolated tricuspid valve surgery is a rarely performed procedure and traditionally is associated with a bad prognosis, although its clinical outcomes still are little known. The aim of this study was to assess the short- and long-term clinical outcomes obtained at our center after isolated tricuspid valve surgery as treatment for severe tricuspid regurgitation. This retrospective study included 71 consecutive patients with severe tricuspid regurgitation who underwent isolated tricuspid valve surgery between December 1996 and December 2017. Perioperative and long-term mortality, tricuspid valve reoperation, and functional class were analyzed after follow up. Regarding surgery, 7% of patients received a De Vega annuloplasty, 14.1% an annuloplasty ring, 11.3% a mechanical prosthesis, and 67.6% a biological prosthesis. Perioperative mortality was 12.7% and no variable was shown to be predictive of this event. After a median follow up of 45.5 months, long-term mortality was 36.6%, and the multivariate analysis identified atrial fibrillation as the only predictor (Hazard Ratio 3.014, 95% confidence interval 1.06-8.566; P = 0.038). At the end of follow up, 63.6% of survivors had functional class I. Isolated tricuspid valve surgery was infrequent in our center. Perioperative mortality was high, as was long-term mortality. However, a high percentage of survivors were barely symptomatic after follow up.

Transcatheter Tricuspid Valve Intervention: Coaptation Devices

Transcatheter tricuspid valve intervention (TTVI) has recently emerged as an alternative for the treatment of severe tricuspid regurgitation (TR). Multiple percutaneous devices have been developed in the last decade with promising early results. Among them, the coaptation devices are designed to reduce TR severity by valve leaflet plication or occupying the regurgitant orifice with a spacer. To date, the MitraClip/TriClip devices (Abbott, Santa Clara, CA, USA), the PASCAL system (Edwards Lifesciencies, Irvine, CA, USA), and the FORMA device (Edwards Lifesciencies, Irvine, CA, USA) have been used as coaptation devices for treating severe TR. The present document aimed to review the clinical evidence on coaptation devices in the field of TTVI, describing its design characteristics, main procedural steps, and early and mid-term outcomes.

Treatment of Severe TRIcuspid Regurgitation in Patients with Advanced Heart Failure with CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL): a randomised controlled trial.

The aim of our study was to compare the impact of implantation of a balloon-expandable transcatheter valve into the inferior vena cava (CAVI) on exercise capacity with optimal medical therapy (OMT) in patients with severe tricuspid regurgitation (TR) and high surgical risk. Twenty-eight patients were randomised to OMT (n=14) or CAVI (n=14). The primary endpoint was maximal oxygen uptake at the three-month follow-up. Secondary endpoints included six-minute walk test, NYHA class, NT-proBNP levels, right heart function, unscheduled heart failure hospitalisation, and quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Patients underwent follow-up examinations one, three, six, and twelve months after randomisation. Maximal oxygen uptake did not change significantly in either group after three months and there was no difference between the OMT and CAVI groups (-0.1±1.8 ml∙kg-1∙min-1 vs -1.0±1.6 ml∙kg-1∙min-1, p=0.4995). Compared to baseline, CAVI improved NYHA class, dyspnoea, and quality of life after three months. However, there were no statistically significant differences in the secondary endpoints between the groups. Four periprocedural complications occurred after CAVI, resulting in open heart surgery. Four patients in the OMT group and eight patients (including four after conversion to surgery) in the CAVI group died from right heart failure, sepsis or haemorrhage. CAVI did not result in a superior functional outcome compared to OMT. Due to an unexpectedly high rate of valve dislocations, the study was stopped for safety reasons.

Combined Tricuspid and Mitral Versus Isolated Mitral Valve Repair for Severe MR and TR: An Analysis From the TriValve and TRAMI Registries

ObjectivesThe aim of this study was to retrospectively compare the characteristics, procedural courses, and outcomes of patients presenting with concomitant mitral regurgitation (MR) and tricuspid regurgitation (TR) in the TriValve (Transcatheter Tricuspid Valve Therapies) and TRAMI (Transcatheter Mitral Valve Interventions) registries. BackgroundTranscatheter mitral edge-to-edge valve repair (TMVR) has been shown to be successful in patients with severe MR. Lately, edge-to-edge repair has also emerged as a possible treatment for severe TR in patients at high risk for cardiac surgery. In patients with both severe MR and TR, the yield of concomitant transcatheter mitral and tricuspid valve repair (TMTVR) for patients at high surgical risk is unknown. MethodsThe characteristics, procedural data, and 1-year outcomes of all patients in the international multicenter TriValve registry and the German multicenter TRAMI registry, who presented with both severe MR and TR, were retrospectively compared. Patients in TRAMI (n = 106) underwent isolated TMVR, while those in TriValve (n = 122) additionally underwent concurrent TMTVR in compassionate and/or off-label use. ResultsAll 228 patients (mean age 77 ± 8 years, 44.3% women) presented with significant dyspnea at baseline (New York Heart Association functional class III or IV in 93.9%), without any differences in the rates of pulmonary hypertension and chronic pulmonary disease. The proportion of patients with left ventricular ejection fraction <30% was higher in the TMVR group (34.9% vs. 18.0%; p < 0.001), while patients in the TMTVR group had lower glomerular filtration rates. At discharge, MR was comparably reduced in both groups. At 1 year, overall all-cause mortality was 34.0% in the TMVR group and 16.4% in the TMTVR group (p = 0.035, Cox regression). On multivariate analysis, TMTVR was associated with a 2-fold lower mortality rate (hazard ratio: 0.52; p = 0.02). The rate of patients in New York Heart Association functional class ≤II at 1 year did not differ (69.4% vs. 67.0%; p = 0.54). ConclusionsConcurrent TMTVR was associated with a higher 1-year survival rate compared with isolated TMVR in patients with both MR and TR. Further randomized trials are needed to confirm these results.

1637 Percutaneous treatment of severe tricuspid regurgitation in a "bicuspid" tricuspid valve

Abstract A 72 year old female with a past medical history of bicuspid aortic valve with severe aortic regurgitation status post placement of a 21 mm Magna Ease aortic valve replacement on 6/1/16, chronic atrial fibrillation, diabetes mellitus, and severe mitral regurgitation presented with symptoms of dyspnea upon exertion. Transesophageal echocardiogram (TEE) showed normal left ventricular function with severe mitral regurgitation, severe tricuspid regurgitation and severe pulmonary hypertension. Upon close interrogation of the tricuspid valve, there was evidence of fusion with a raphe present between the septal and anterior leaflets ("a bicuspid" tricuspid valve). The patient was referred for surgical evaluation where she was deemed to be at increased surgical risk and referred for percutaneous treatment for both severe mitral and severe tricuspid regurgitation. After an uncomplicated transseptal puncture, she underwent a placement of a single MitraClip XT clip to the A2/P2 portions of the mitral valve leaflets leaving mild residual mitral regurgitation by color Doppler. Attention was then taken towards the tricuspid valve where using TEE guidance, a MitraClip XT was positioned over the central aspect of the "bicuspid" tricuspid valve with the opened clip arms perpendicular leaflet coaptation. The MitraClip XT was advanced into the right ventricle and slowly retracted to grab both TV leaflets. There was mild, residual tricuspid regurgitation by color Doppler. The mean gradient across the tricuspid valve was 1 mmHg obtained at a heart rate of 52 bpm. This case describes the first known percutaneous treatment of severe tricuspid regurgitation from a "bicuspid" tricuspid valve with a MitraClip device. Abstract 1637 Figure.

P917Transcatheter treatment of severe tricuspid regurgitation: first experiences with the edge-to-edge technique using the MitraClip

Abstract Background Due to increased operative mortality in high-risk patients treated for severe tricuspid regurgitation (TR), there is a growing interest in interventional therapy in these patients that are otherwise solely treated with medication. The edge-to edge technique with implantation of one or more MitraClips is an therapeutic interventional option for these patients. So far, data for transcatheter TR treatment are sparse. Purpose The present cohort study investigates safety, feasibility and effectiveness of the edge-to-edge technique treating severe TR after starting a transcatheter TR treatment program at our institution in 2017. Methods A total of 17 high-risk patients (79.18±8.76 years, EUROScore II 9.31±8.23%, table) with symptomatic, severe TR were treated using the MitraClip system from 12/2017 until 12/2018. All patients received pre-interventional clinical, echocardiographic and invasive evaluation and were entered into a database. Safety and feasibility of the procedure, reduction of TR grade and clinical outcomes were collected and analyzed at the day of discharge and at 30-day follow-up. Results MitraClip device was successfully implanted in 16 of 17 patients (94.1%). In one patient grasping of the leaflets was impossible due to bad echo conditions by abdominal air. 76.5% of the patients had severe or massive and 23.5% had a torrential TR (figure). A total of 25 Clips were used (22 in anteroseptal, 3 in posteroseptal commissure). No intraprocedural deaths, emergency surgery or major vascular complications occurred. Postprocedural TR was significantly reduced (TR reduction ≥1 grade) from a mean TR grade of 3.8±0.8 at baseline to 1.74±0.59 postprocedural (p&lt;0.001, table and figure). One patient had device detachment before discharge. There was one death due to progressive cardiogenic shock 4 days after the procedure. However, the procedure was planned as a last therapeutic option in this terminally ill patient. Echocardiography at discharge showed reduction of TR in 82,4% of patients (mean TR grade at discharge 2.21±0.66, p&lt;0.001). At 30 day f/u symptoms were significantly improved from inital mean NYHA class of 3.06±0.56 to a mean NYHA class of 2.55±0.52 (p=0.002) and patients presented with reduced TR (mean TR grade at 30 day f/u 2.58±0.57, p&lt;0.001). Conclusion Interventional treatment of severe TR in high-risk and mostly inoperable patients using the MitraClip technique is safe and effectivly reduces TR grade leading to clinical improvement. However, further investigations are needed to identify clear parameters highly predictive for a favorable acute and midterm procedural success. Also, more data and clinical trials are needed to determine the long-term course in these patients.

Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid Regurgitation: Insights From the First-in-Human Experience

ObjectivesTo evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California). BackgroundScarce data exist on long-term outcomes following TTVr. MethodsThis multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter. ResultsNineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline. ConclusionsTTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years.