Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results.

BACKGROUND: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery. METHODS: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated. RESULTS: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001). CONCLUSION: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

Current devices and interventions in mitral regurgitation.

Mitral regurgitation (MR) is the most common valvular disease. With a rising incidence in older age, the prevalence of relevant comorbidities inevitably increases. Considering the constantly aging population with high surgical risk, transcatheter therapy of MR is gaining increasing importance. Interventional therapy of either primary or secondary MR represents an alternative to pure drug or surgical therapy. With mitral valve transcatheter edge-to-edge repair, a well-established treatment has evolved in the past two decades. In addition, direct or indirect annuloplasty and ultimately transcatheter mitral valve implantation further expand the armamentarium. The current broad spectrum of interventional therapy options allows for patient-oriented therapy individually targeting different MR pathologies. This review discusses the current landscape of transcatheter therapies for relevant MR.

Underweight is associated with inferior short and long-term outcomes after MitraClip implantation: Results from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

BACKGROUND: Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease. AIMS: The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. METHODS AND RESULTS: From August 2010 until July 2013, 799 patients (age 75.3 ±â€¯8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m2 (underweight), BMI 20.0 to <25.0 kg/m2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m2 (overweight) and BMI ≥30 kg/m2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011). CONCLUSIONS: Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team.

Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry.

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?

OBJECTIVES: To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry. BACKGROUND: The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse. METHODS: In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year. RESULTS: Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02). CONCLUSIONS: TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating.

Percutaneous treatment of mitral regurgitation in patients with impaired ventricular function: Impact of intracardiac electronic devices (from the German Transcatheter Mitral Valve Interventions Registry).

OBJECTIVES: To identify prevalence/impact of previous implantation of cardiac electronic devices (CEDs), such as cardioverter defibrillator (ICD) and cardiac resynchronization (CRT), in a group of MitraClip (MC) candidates with LVEF < 30%. BACKGROUND: MC therapy is nowadays often considered in patients with depressed left ventricular ejection fraction (LVEF%) and symptomatic severe secondary MR. METHODS: Data from the German Transcatheter Mitral Valve Interventions (TRAMIs) registry were analyzed. Patients with pre-procedural LVEF <30% were selected and divided according to the presence of CEDs. Pre-procedural, peri-procedural, and 1-year follow-up data were analyzed. RESULTS: Out of 689 MC patients, 235 had LVEF<30%. Of these, 23% (54/235) had CRT, 36.6% (86/235) ICD, and 40.4% (95/235) had no CEDs. Risk profile was similar (median STS score CRT 6.0 (IQR: 3.0-12.0); ICD 7.0 (IQR: 4.0-12.0); No-CED 6.5 (IQR: 2.0-10.0); p = 0.8). No procedural mortality was observed and hospital mortality was 5.6% in CRT, 2.3% in ICD, and 3.2% in No-CED (p = 0.5). At discharge, severe MV regurgitation was reported in 3.8% of CRT, 3.7% of ICD, and 1.1% of No-CED (p = 0.9). One year estimated survival (CRT 75.7%; ICD 75.8%; No-CED 78%; p = 0.94) and freedom from MACCE (CRT 73.6%; ICD 75.8%; No-CED 74.5%; p = 0.88) were similar. CONCLUSIONS: A third of patients have been already submitted to CEDs implantation at time of referral for MC therapy and 40% of those with severely depressed LVEF% arrive to MC therapy before ICD/CRT implantation. The presence of CED does not impair acute MC therapy success. Mid-term follow-up outcomes are similar in patients with and without CEDs.

One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry.

AIMS: The transcatheter mitral valve interventions (TRAMI) registry was established in order to assess safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I 20.0%) between August 2010 and July 2013. We present the 1-year outcome in this MitraClip cohort-which is the largest published to date. METHODS AND RESULTS: Seven forty-nine patients (90.5%) were available for 1-year follow-up and included in the following analyses. Mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes were recorded. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection. The 1-year mortality was 20.3%. At 1 year, 63.3% of TRAMI patients pertained to NYHA functional classes I or II (compared with 11.0% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. Importantly, a significant proportion of patients regained the complete independence in self-care after MitraClip implantation (independence in 74.0 vs. 58.6% at baseline, P = 0.005). Predictors of 1-year mortality were NYHA class IV (hazard ratio, HR 1.62, P = 0.02), anaemia (HR 2.44, P = 0.02), previous aortic valve intervention (HR 2.12, P = 0.002), serum creatinine ≥1.5 mg/dL (HR 1.77, P = 0.002), peripheral artery disease (HR 2.12, P = 0.0003), left ventricular ejection fraction <30% (HR 1.58, P = 0.01), severe tricuspid regurgitation (HR 1.84, P = 0.003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual post-procedural severe mitral regurgitation) (HR 4.36, P < 0.0001). CONCLUSIONS: Treatment of significant MR with MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. In the TRAMI cohort, the failure of procedural success exhibited the highest hazard ratio concerning the prediction of 1-year mortality.

Valve-in-Valve Procedures in Failing Biological Xenografts Using a Novel Balloon-Expandable Device: Experience in Aortic, Mitral, and Tricuspid Positions.

Background Valve-in-valve (ViV) procedures for degenerated bioprostheses are an alternative for the standard of care in an aging population. Several reports showed that the Edwards Sapien XT (Edwards Lifesciences Co., Irvine, California, United States) transcatheter heart valve (THV) can be used in aortic, mitral, and tricuspid position for ViV procedures. No published case series for different valve positions exist regarding suitability of the new Edwards Sapien 3 (Edwards Lifesciences Co.) THV for this purpose. Especially, the increased stent height compared with the XT and the newly added polyethylene terephthalate cuff is of potential concern in ViV interventions. Herein, we report six cases of ViV procedures with the Edwards Sapien 3 THV with a focus on technical considerations. Methods and Results Between October 2013 and November 2014, six ViV procedures with the Edwards Sapien 3 THV were performed. Four implants were done in aortic, one in mitral, and one in tricuspid position. All procedures were performed successfully without any complications. Fluoroscopy and echocardiography confirmed an adequate position and function without any paravalvular or transvalvular leakage or elevated transvalvular gradients in any case. Conclusion Preliminary experience suggests, ViV procedures with the Edwards Sapien 3 THV are safe and reliable. The outer polyethylene terephthalate cuff, for enhanced paravalvular sealing, led to a good outcome, concerning PVL in ViV procedures without resulting in elevated transvalvular gradients. This was even the case in a mildly undersized THV when compared with the internal diameter of the surgical bioprosthesis. The central radiopaque positioning marker and the fine adjustment wheel allow for accurate positioning within degenerated bioprostheses. The increased stent height, compared with the Sapien XT, led to no complications, especially in mitral position. In bioprostheses without any fluoroscopic landmarks, a balloon valvuloplasty may be necessary to identify the appropriate deployment position.

First in human implantation of the mechanical expanding Lotus® valve in degenerated surgical valves in mitral position.

INTRODUCTION: Implantation of transcatheter heart valves (THV) into degenerated surgical valves is an emerging therapy for selected high-risk patients. Although, CE mark of most THV is limited for native aortic valvular stenosis, transcatheter valve implantation into degenerated bioprostheses, even in mitral position is very intriguing. METHODS AND RESULTS: After placement of a cerebral protection device (Claret Sentinel®), three consecutive patients (age, 79.0 ± 6.1; log EuroSCORE I: 33.3 ± 9.2%) with a degenerated mitral bioprosthesis were treated by transapical implantation of the Lotus® valve (Boston Scientific Inc.). In addition, a SwanGanz catheter was introduced in the pulmonary artery for hemodynamic assessments all patients. Procedural success was 100%. Valve implantation was performed without rapid ventricular pacing. Resheating was performed in two patients due to suboptimal initial positioning. Invasive online hemodynamics revealed stable blood pressure in all patients. After Lotus® valve implantation, valvular mitral regurgitation was completely eliminated in all patients. One patient had a mild paravalvular leak of the surgical bioprosthesis, which was present before implantation. Invasive right and left heart hemodynamics showed an immediate improvement after Lotus® valve implantation. Mean mitral surface area (2.1 ± 0.2 cm(2) ) and mean gradient (3.7 ± 2.1 mm Hg) demonstrated satisfactory results. All patients were immediately extubated and discharged from the hospital without any adverse event. CONCLUSIONS: This study demonstrates for the first time the feasibility of transapical Lotus® Valve implantation in degenerated mitral bioprostheses. The controlled mechanical Lotus® valve expansion with remarkably stable hemodynamics throughout the procedure offers a new and valuable treatment option.

Evolution of mitral valve procedural volumes in the advent of endovascular treatment options: Experience at an early-adopting center in Germany.

OBJECTIVES: Our objectives were to assess the evolution of surgical and endovascular mitral valve procedural volumes and to study utilization and reimbursement effects of transcatheter mitral valve repair (TMVR) at our center and to put these in perspective with the corresponding data at the national level. BACKGROUND: TMVR using the MitraClip system has been available in Germany since 2008 as a complementary treatment option for high-risk or inoperable patients. METHODS: Relevant procedure codes were identified for 2006-2012 and yearly utilization volumes obtained from our center's databases and from the national statistics office. Volumes were analyzed in total, and stratified by treatment approach. Procedure reimbursement at our center was determined for years 2007-2012. RESULTS: At our center, 378 MitraClip procedures were performed from 2008 to 2012. During this period, surgical volumes grew at an average of 10.6% annually (2008: 262; 2012: 392; 49.6% total growth rate). Total surgical and TMVR reimbursement increased from EUR 3.8 million (2007) to EUR 7.9 million (2012). By comparison, mitral valve procedural volumes grew by 56.1% from 2006 to 2012 at the national level, with TMVR constituting 9.1% of 20,328 procedures in 2012. Since the introduction of MitraClip, nationwide surgical procedural volumes grew at an average of 6.3% annually (2008: 14,477; 2012: 18,478; 27.6% total growth rate). CONCLUSIONS: Growth in procedural volumes during 2006-2012 reflects an increasing supply and subsequent demand for mitral valve procedures. The introduction of TMVR has contributed to overall growth, and has not reduced continued growth in surgical volumes. Our center-specific analysis suggests a "halo effect" of an integrated approach to mitral valve disease contributing to additional growth in surgical and overall reimbursement volumes.

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

AIMS: To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry. METHODS AND RESULTS: Data of 828 patients (mean age: 76.0 [71-81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 ± 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill pre-interventionally; in-hospital mortality was significantly higher as compared to those without procedural complications. CONCLUSIONS: MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes.

Percutaneous mitral valve repair with the MitraClip system according to the predicted risk by the logistic EuroSCORE: preliminary results from the German Transcatheter Mitral Valve Interventions (TRAMI) Registry.

OBJECTIVE: To evaluate in-hospital and short-term outcomes of percutaneous mitral valve repair according to patients' logistic EuroSCORE (logEuroSCORE) in a multicenter registry BACKGROUND: The logEuroSCORE is an established tool to predict the risk of mortality during cardiac surgery. In high-risk patients percutaneous mitral valve repair with the MitraClip system represents a less-invasive alternative METHODS: Data from 1002 patients, who underwent percutaneous mitral valve repair with the MitraClip system, were analyzed in the German Transcatheter Mitral Valve Interventions (TRAMI) Registry. A logEuroSCORE (mortality risk in %) ≥ 20 was considered high risk RESULTS: Of all patients, 557 (55.6%) had a logEuroSCORE ≥ 20. Implantation of the MitraClip was successful in 95.5 % (942/986) patients. Moderate residual mitral valve regurgitation was more often detected in patients with a logEuroSCORE ≥ 20 (23.8% vs. 17.1%, respectively, P < 0.05). In patients with a logEuroSCORE ≥ 20 the procedural complication rate was 8.9% (vs. 6.4, n.s.) and the in-hospital MACCE rate 4.9% (vs. 1.4% P < 0.01). The in-hospital mortality rate in patients with a logEuroSCORE ≥ 20 and logEuroSCORE < 20 was 4.3 and 1.1%, respectively (P ≤ 0.01) CONCLUSION: Percutaneous mitral valve repair with the MitraClip system is feasible in patients with a logEuroSCORE ≥ 20 with similar procedural results compared to patients with lower predicted risk. Although mortality was four times higher than in patients with logEuroSCORE < 20, mortality in high risk patients was lower than predicted. In those with a logEuroSCORE ≥ 20, moderate residual mitral valve regurgitation was more frequent.

Integrating genome-wide genetic variations and monocyte expression data reveals trans-regulated gene modules in humans.

One major expectation from the transcriptome in humans is to characterize the biological basis of associations identified by genome-wide association studies. So far, few cis expression quantitative trait loci (eQTLs) have been reliably related to disease susceptibility. Trans-regulating mechanisms may play a more prominent role in disease susceptibility. We analyzed 12,808 genes detected in at least 5% of circulating monocyte samples from a population-based sample of 1,490 European unrelated subjects. We applied a method of extraction of expression patterns-independent component analysis-to identify sets of co-regulated genes. These patterns were then related to 675,350 SNPs to identify major trans-acting regulators. We detected three genomic regions significantly associated with co-regulated gene modules. Association of these loci with multiple expression traits was replicated in Cardiogenics, an independent study in which expression profiles of monocytes were available in 758 subjects. The locus 12q13 (lead SNP rs11171739), previously identified as a type 1 diabetes locus, was associated with a pattern including two cis eQTLs, RPS26 and SUOX, and 5 trans eQTLs, one of which (MADCAM1) is a potential candidate for mediating T1D susceptibility. The locus 12q24 (lead SNP rs653178), which has demonstrated extensive disease pleiotropy, including type 1 diabetes, hypertension, and celiac disease, was associated to a pattern strongly correlating to blood pressure level. The strongest trans eQTL in this pattern was CRIP1, a known marker of cellular proliferation in cancer. The locus 12q15 (lead SNP rs11177644) was associated with a pattern driven by two cis eQTLs, LYZ and YEATS4, and including 34 trans eQTLs, several of them tumor-related genes. This study shows that a method exploiting the structure of co-expressions among genes can help identify genomic regions involved in trans regulation of sets of genes and can provide clues for understanding the mechanisms linking genome-wide association loci to disease.

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).

Mitral Valve Transcatheter Edge-to-Edge Repair: 1-Year Outcomes From the MiCLASP Study.

BACKGROUND: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. OBJECTIVES: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. METHODS: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. RESULTS: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline). CONCLUSIONS: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.

Effects of tricuspid transcatheter edge-to-edge repair on tricuspid annulus diameter - Data from the TriValve registry.

AIMS: T-TEER is an effective therapy for the treatment of tricuspid regurgitation (TR). However, the effects of leaflets clipping on tricuspid valve annulus (TA) have not been investigated in detail. The aim of this study is to investigate the effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on TA diameter. METHODS AND RESULTS: The TriValve registry (Transcatheter Tricuspid Valve Therapies, NCT03416166) collected 556 patients from 22 European and North American centres undergoing transcatheter tricuspid valve interventions from 2016 to 2022. Patients undergoing T-TEER with available pre- and post-procedural data on TA diameter measured in the apical 4-chamber view on transthoracic echocardiography were selected for this study. Primary end-point was the reduction of TA diameter after T-TEER. A total of 186 patients were included in the study. In 115 patients (62%) TA diameter was reduced by at least 1 mm as compared to baseline. A significant reduction of TA dimension was observed following T-TEER (mean 2.3 mm [from pre-procedural diameter 46.7 mm to post-procedural diameter 44.4 mm], p < 0.001). In particular, the greatest reduction was observed in those with T-TEER in antero-septal commissure (mean 2.7 mm [from 47.1 mm to 44.4 mm], p < 0.001) as compared to those combining both antero-septal and postero-septal commissures (mean 1.4, from 46.0 mm to 44.6 mm, P = 0.06). A significant reduction of TA dimension was recorded in patients with 1 or 2 clips implanted but not in those patients with ≥3 clips implanted. CONCLUSIONS: In almost two third of patients T-TEER reduces TA diameter in addition to leaflet approximation. CONDENSED ABSTRACT: The effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on tricuspid valve annulus (TA) have not been studied in details. This study investigates TA diameter as measured in apical 4-chamber view on transthoracic echocardiography before and after T-TEER. A total of 186 patients from the TriValve registry were included in the study. The study results show that 62% of patients have a TA reduction after T-TEER, especially in those receiving 1 or 2 clips in the antero-septal commissure. These suggest that T-TEER reduces tricuspid regurgitation not only by approximation of leaflets, but also by TA diameter reduction.

Prognostic Implications of Residual Tricuspid Regurgitation Grading After Transcatheter Tricuspid Valve Repair.

BACKGROUND: The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern. OBJECTIVES: The authors sought to assess the impact of residual TR severity post-TTV repair on survival. METHODS: We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe). RESULTS: Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96). CONCLUSIONS: The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention.

Impact of Intraprocedural Mitral Regurgitation and Gradient Following Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation.

BACKGROUND: The impact of intraprocedural results following transcatheter edge-to-edge repair (TEER) in primary mitral regurgitation (MR) is controversial. OBJECTIVES: This study sought to investigate the prognostic impact of intraprocedural residual mitral regurgitation (rMR) and mean mitral valve gradient (MPG) in patients with primary MR undergoing TEER. METHODS: The PRIME-MR (Outcomes of Patients Treated With Mitral Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation) registry included consecutive patients with primary MR undergoing TEER from 2008 to 2022 at 27 international sites. Clinical outcomes were assessed according to intraprocedural rMR and mean MPG. Patients were categorized according to rMR (optimal result: ≤1+, suboptimal result: ≥2+) and MPG (low gradient: ≤5 mm Hg, high gradient: > 5 mm Hg). The prognostic impact of rMR and MPG was evaluated in a Cox regression analysis. The primary endpoint was 2-year all-cause mortality or heart failure hospitalization. RESULTS: Intraprocedural rMR and mean MPG were available in 1,509 patients (median age = 82 years [Q1-Q3: 76.0-86.0 years], 55.1% male). Kaplan-Meier analysis according to rMR severity showed significant differences for the primary endpoint between rMR ≤1+ (29.1%), 2+ (41.7%), and ≥3+ (58.0%; P < 0.001), whereas there was no difference between patients with a low (32.4%) and high gradient (42.1%; P = 0.12). An optimal result/low gradient was achieved in most patients (n = 1,039). The worst outcomes were observed in patients with a suboptimal result/high gradient. After adjustment, rMR ≥2+ was independently linked to the primary endpoint (HR: 1.87; 95% CI: 1.32-2.65; P < 0.001), whereas MPG >5 mm Hg was not (HR: 0.78; 95% CI: 0.47-1.31; P = 0.35). CONCLUSIONS: Intraprocedural rMR but not MPG independently predicted clinical outcomes following TEER for primary MR. When performing TEER in primary MR, optimal MR reduction seems to outweigh the impact of high transvalvular gradients.

Prediction of Mortality and Heart Failure Hospitalization After Transcatheter Tricuspid Valve Interventions: Validation of TRISCORE.

BACKGROUND: Data on the prognostic role of the TRI-SCORE in patients undergoing transcatheter tricuspid valve intervention (TTVI) are limited. OBJECTIVES: The aim of this study was to evaluate the performance of the TRI-SCORE in predicting outcomes of patients undergoing TTVI. METHODS: TriValve (Transcatheter Tricuspid Valve Therapies) is a large multicenter multinational registry including patients undergoing TTVI. The TRI-SCORE is a risk model recently proposed to predict in-hospital mortality after tricuspid valve surgery. The TriValve population was stratified based on the TRI-SCORE tertiles. The outcomes of interest were all-cause death and all-cause death or heart failure hospitalization. Procedural complications and changes in NYHA functional class were also reported. RESULTS: Among the 634 patients included, 223 patients (35.2%) had a TRI-SCORE between 0 and 5, 221 (34.8%) had 6 or 7, and 190 (30%) had ≥8 points. Postprocedural blood transfusion, acute kidney injury, new atrial fibrillation, and in-hospital mortality were more frequent in the highest TRI-SCORE tertile. Postprocedure length of stay increased with a TRI-SCORE increase. A TRI-SCORE ≥8 was associated with an increased risk of 30-day all-cause mortality and all-cause mortality and the composite endpoint assessed at a median follow-up of 186 days (OR: 3.00; 95% CI: 1.38-6.55; HR: 2.17; 95% CI: 1.78-4.13; HR: 2.08, 95% CI: 1.57-2.74, respectively) even after adjustment for procedural success and EuroSCORE II or Society of Thoracic Surgeons Predicted Risk of Mortality. The NYHA functional class improved across all TRI-SCORE values. CONCLUSIONS: In the TriValve registry, the TRI-SCORE has a suboptimal performance in predicting clinical outcomes. However, a TRISCORE ≥8 is associated with an increased risk of clinical events and a lack of prognostic benefit after successful TTVI.