Iung, Bernard

ABSTRACT Aims The impact of treatment for tricuspid regurgitation (TR) across different levels of left ventricular ejection fraction (LVEF) remains uncertain. This study aimed to compare the outcomes of surgical and transcatheter tricuspid valve interventions (TTVI) to conservative (medical) management across LVEF categories. Methods and results Patients with severe isolated TR from the TRIGISTRY, a multicentre international registry, were categorized based on LVEF (preserved ejection fraction [pEF]: ≥50%, mildly reduced ejection fraction [mrEF]: 41–49%, and reduced ejection fraction [rEF]: ≤40%). We assessed the impact of treatment modality and procedural success (mild-to-moderate or lower residual TR) on 2-year survival within each LVEF category. Among 2384 patients, 1383 had pEF, 400 had mrEF, and 601 had rEF. Compared to conservative management, surgery (p < 0.0005) and TTVI (p < 0.0001) were associated with a survival benefit in patients with pEF. No significant survival advantage was observed in patients with mrEF (p = 0.28 for both), nor in those with rEF (p = 0.76 and p = 0.22, respectively). Similar results were obtained when surgical and transcatheter interventions were grouped (p < 0.0001, p = 0.17 and p = 0.29 in patients with pEF, mrEF and rEF, respectively). Patients with residual TR after TTVI exhibited a trend toward worse survival compared to those managed conservatively across all LVEF categories (p = 0.47, p = 0.33 and p = 0.008 in pEF, mrEF and rEF, respectively). Conclusions Transcatheter tricuspid valve intervention, whether surgical or transcatheter-based, was associated with improved survival in patients with pEF but not in those with mrEF or rEF. Residual TR remained a significant prognostic factor across the entire LVEF spectrum. These findings highlight the need for careful patient selection when considering TTVI in individuals with rEF.

Abstract Background and Aims Severe tricuspid regurgitation is associated with increased mortality rates, but benefit of its correction and ideal timing are not clearly determined. This study aimed to identify patient subsets who might benefit from the surgery. Methods In TRIGISTRY, an international cohort study of consecutive patients with severe isolated functional tricuspid regurgitation (33 centres, 10 countries), survival rates up to 10 years were compared between patients who underwent isolated tricuspid valve surgery (repair or replacement) and those conservatively managed, overall and according to TRI-SCORE category (low: ≤3, intermediate: 4–5, and high: ≥6). Results One thousand and two hundred seventeen were managed conservatively, and 551 underwent isolated tricuspid valve surgery (200 repairs and 351 replacements). TRI-SCORE distribution was 33% low, 32% intermediate, and 35% high. At 10 years, survival rates were similar between surgical and conservative management [41% vs. 36%; hazard ratio (HR) .97; 95% confidence interval (CI) .88–1.08, P = .57]. Surgery improved survival compared with conservative management in the low TRI-SCORE category (72% vs. 44%; HR .27; 95% CI .20–.37, P < .0001), but not in the intermediate (36% vs. 37%; HR 1.17; 95%CI .98–1.40, P = .09) or high categories (20% vs. 24%; HR 1.06; 95% CI .91–1.25, P = .45). Both repair and replacement improved survival in the low TRI-SCORE category (84% and 61% vs. 44%; HR .11; 95% CI .06–.19, P < .0001, and HR .65; 95% CI .47–.90, P = .009). Repair showed benefit in the intermediate category (59% vs. 37%; HR .49; 95% CI .35–.68, P < .0001) while replacement was possibly harmful (25% vs. 37%; HR 1.43; 95% CI 1.18–1.72, P = .0002). Conclusions Higher survival rates were observed with repair than replacement and benefit of intervention declined as TRI-SCORE increased with no benefit of any type of surgery in the high TRI-SCORE category. These results emphasize the importance of timely intervention and patient selection to achieve the best outcomes and the need for randomized controlled trials.

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

Objectives Unbiased information regarding the surgical management of patients with mitral regurgitation (MR) at the nationwide level are scarce and mainly US-based. The Programme de Médicalisation des Systèmes d’Information, a mandatory national database, offers the unique opportunity to assess the presentation and outcomes of all consecutive mitral valve (MV) surgeries performed in France in the contemporary era. Methods We collected all MV surgeries performed for MR in France in 2014–2016. MR aetiology was classified as degenerative (DMR), secondary (SMR) or Other (rheumatic or congenital disease and infective endocarditis). Results During the 3-year period, 18 167 MV surgeries were performed in France (55% repair and 45% replacement; 52% isolated). Age was 66±12 years and 59% were male. Aetiology was DMR in 42%, SMR in 16% and other in 42% including 19% with uncertain aetiologies. Overall, in-hospital mortality was 6.5% and increased with age, female gender, Charlson Comorbidity Index, type of surgery (replacement vs repair), associated surgery (combined vs isolated) and MR aetiology (all p<0.01). In-hospital mortality and rate of death/readmission for heart failure (HF) at 1 year were 3.4% and 13%, respectively for DMR (2.4% and 11% for isolated DMR) and 7.8% and 27%, respectively for SMR (5.5% and 23% for isolated SMR). Repair rate was 55% overall, 68% in DMR and 72% for isolated DMR surgery (70% of all DMR). Repair rates decreased with age, Charlson Comorbidity Index and female sex (all p<0.0001). Conclusion In this cross-sectional contemporary prospective nationwide database, in-hospital mortality and 1 year rate of death and HF readmission were considerable overall and in all subsets. Repair rates were suboptimal overall especially in the elderly and women subsets. These results underline the need to develop strategies to improve management and outcomes of patients with both DMR and SMR.

Background Although US recent data suggest that mitral regurgitation (MR) is severely undertreated and carries a poor outcome, population‐based views on outcome and management are limited. We aimed to define the current treatment standards, clinical outcomes, and costs related to MR at the nationwide level. Methods and Results In total, 107 412 patients with MR were admitted in France in 2014 to 2015. Within 1 year, 8% were operated and 92% were conservatively managed and constituted our study population (68% primary MR and 32% secondary MR). The mean age was 77±15 years; most patients presented with comorbidities. In‐hospital and 1‐year mortality rates were 4.1% and 14.3%, respectively. Readmissions were common (63% at least once and 37% readmitted ≥2 times). Rates of 1‐year mortality or all‐cause readmission and 1‐year mortality or heart failure readmission were 67% and 34%, respectively, and increased with age, Charlson index, heart failure at admission, and secondary MR etiology; however, the event rate remained notably high in the primary MR subset (64% and 28%, respectively). The mean costs of hospital admissions and of readmissions were 5345±6432 and 10 080±10 847 euros, respectively. Conclusions At the nationwide level, MR was a common reason for admission and affected an elderly population with frequent comorbidities. Less than 10% of patients underwent a valve intervention. All subsets of patients who were conservatively managed incurred high mortality and readmissions rates, and MR represented a major societal burden with an extrapolated annual cost of 350 to 550 million euros (390–615 million US dollars). New strategies to improve the management and outcomes of patients with both primary and secondary MR are critical and warranted.

Abstract Background Mitral regurgitation (MR) is the most common heart valve disorder worldwide. The contrast between the large burden of MR and the overall low number of performed mitral valve surgery suggest a marked undertreatment of MR patients. Large and comprehensive contemporary data assessing the management and outcome of patients with MR as well as the societal burden of the disease at the Nationwide level are currently lacking. Methods Based on a French mandatory administrative hospital-discharge database, we collected all admissions in France both in public and private hospitals in 2014 and 2015 with MR as primary or secondary code. Patients with infective endocarditis, congenital or rheumatic disease were excluded. Cost were calculated for patients admitted in public hospitals. Results In 2014–2015, 107,412 patients with MR were admitted in France in 1238 public and private hospitals; 74,098 patients (69%) presented with primary MR (PMR) and 33,314 patients (31%) with secondary MR (SMR). Overall 8,676 patients (8%) were operated on (81% PMR) within 1 year and 98,736 (92%) were conservatively managed and constituted our study population. Mean age was 77±15 years (50% were ≥80 years and 12% ≥90 years) and 53% were female. Most of the patients presented with comorbidities and Charlson Index was ≥2 in 53% of the population. In-hospital and one-year mortality were 4.1% and 14.3% respectively. Readmission were very common and one-year mortality/readmission all cause, and one-year mortality / CHF readmission rates were 67% and 34% respectively and increased with age, Charlson Index, CHF at presentation and SMR etiology but events rate remained notably high in the PMR subset (64% and 28% respectively). The total annual cost in public hospitals (initial hospitalisation and readmissions) was 325,716,311 euros. When only readmissions for heart failure were considered (43% of all readmissions), total annual cost was 202,904,869 euros. Conclusion In this large administrative contemporary nationwide database, 1) MR was a common reason for admission and affected an elderly population with frequent comorbidities, 2) less than 10% of patients were offered any intervention, 3) MR was associated with high mortality and readmissions rates in all subsets; 4) MR represented a major societal burden with an extrapolated annual cost between 250 and 400 million euros. These finding highlight the critical need to develop strategies to improve the overall management and outcomes of patients with both primary and secondary MR. Acknowledgement/Funding Edwards Lifesciences

Abstract Background Contemporary and unbiased information regarding the surgical management of patients with mitral regurgitation (MR) at the Nationwide level are scarce. The PMSI, a mandatory administrative database, offers the unique opportunity to assess the presentation and outcomes of all consecutive mitral valve (MV) surgeries performed in France in the contemporary era. Methods We collected all (isolated or combined) MV surgeries performed for MR in France both in public and private hospitals between 2014 and 2016. Based on an algorithm we developed, MR etiology was classified as degenerative (DMR), secondary (SMR) or OTHER (rheumatic, congenital, infective endocarditis or unknown). Results Between January 2014 and December 2016, 18,167 mitral valve surgeries were performed in France (55% repair and 45% replacement; 52% isolated MV surgery). Mean age was 66±12 years and 59% were male. Etiology was DMR in 42%, SMR in 16% and OTHER in 42%. Among DMR, repair rate was 68% overall and 72% in the subset who underwent an isolated MV surgery (70% of all DMR). Repair rates decreased with age, Charlson index and sex (female) (all P<0.0001). Among SMR, a repair was performed in 39% and a combined surgery in 51%. In-hospital mortality and rate of death / readmission for CHF at one year were 3.4% and 13% respectively for DMR (2.4% and 5.5% respectively for isolated DMR) and 7.8% and 17.8% respectively for SMR (5.5% and 12.4% respectively for isolated SMR). Center volume was associated with a lower in-hospital mortality (p=0.002) but not with higher DMR repair rate (P=0.85). Conclusion In this large administrative contemporary nationwide database, 1) DMR surgery was twice as frequent as SMR and more frequently performed isolated; 2) Repair rates in DMR were suboptimal overall but more critically in the elderly and women subsets. 3) Operative mortality and one-year rate of death and readmission were approximately twice as high in SMR than in DMR and overall considerable even for isolated DMR surgery; and 4) In DMR, center volume had no impact on repair rate but an independent impact on outcome. These results underline the need to develop strategies to improve management and outcomes of patients with both degenerative and secondary MR.