Mitral Transcatheter Edge-to-Edge Repair in Nonagenarians

Outcomes After Transcatheter Mitral Valve Replacement According to Regurgitation Etiology

Outcomes of mitral transcatheter edge to edge repair with MitraClip™ – An Indian single center experience

BackgroundPercutaneous mitral valve leaflet repair can be an effective treatment for primary mitral regurgitation (MR) patients deemed high-risk for surgery. Accurate assessment of cardiac reverse remodelling is essential to optimise...

The PASCAL P10 system for mitral valve transcatheter edge-to-edge repair has undergone iterations, including introduction of the narrower Ace implant and the Precision delivery system. This study sought to evaluate outcomes and the impact of PASCAL mitral valve transcatheter edge-to-edge repair device iterations. The REPAIR (REgistry of PAscal for mltral Regurgitation) study is an investigator-initiated, multicenter registry including consecutive patients with mitral regurgitation (MR) treated from 2019 to 2024. Patients were stratified by device iteration: P10only, P10/AceGen1 (introduction of Ace), and P10/AcePrec (introduction of Precision). The primary endpoint was MR≤1+ at discharge; secondary endpoints included technical success and MR durability (discharge vs 30days, 1 year, and 2 years). A total of 2,165 patients (mean age 78 ± 10 years, 44% female, 85% in NYHA functional class≥III, EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 4.9% [Q1-Q3: 3.0% to 8.1%]) were included: 660 P10only, 945 P10/AceGen1, and 560 P10/AcePrec. Median follow-up was 510days (Q1-Q3: 369-874days). Primary (47% [n=1,019 of 2,142]) and secondary (52% [n=1,123 of 2,142]) MR etiology did not change across device iterations (P=0.547). Technical success was achieved in 97.0% (n=2,099 of 2,165) with similar rates across device iterations (P=0.290). MR≤1+ was achieved in 72% (n=1,397 of 2,085), improving with device iterations (P10only: 66% [n=422 of 638], P10/AceGen1: 73% [n=661 of 906], P10/AcePrec: 77% [n=414 of 541]; P< 0.001). MR grades of≤1+ and≤2+ slightly worsened at 30days, 1 year, and 2 years, primarily in patients with primary MR, with no differences across iterations. Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to≤1+ at discharge, with stable and high technical success rates. A slight deterioration of the initial result warrants further investigation.

475 Larger left ventricle size negatively impacts late postoperative left ventricle function following mitral valve repair

Funding Acknowledgements Type of funding sources: None. Background Percutaneous mitral valve leaflet repair can be an effective treatment for primary mitral regurgitation (MR) patients deemed high-risk for surgery. Accurate assessment of cardiac reverse remodelling is essential to optimise future patient selection. Cardiovascular magnetic resonance (CMR) is the reference standard for cardiac volumetric assessment and compared to transthoracic echocardiography (TTE) provides superior reproducibility in MR quantification. Prior CMR studies have analysed cardiac reverse remodelling following percutaneous intervention in combined cohorts of primary and secondary MR patients. However, as aetiology of MR can significantly impact outcomes, focused studies are warranted. Purpose Assess cardiac reverse remodelling and quantify changes in MR following percutaneous mitral valve leaflet repair for primary MR using the reference standard (CMR). Methods 12 patients with at least moderate-severe MR on TTE were prospectively recruited to undergo CMR imaging and 6-minute walk tests (6MWT) at baseline and 6 months following percutaneous mitral valve leaflet repair (MitraClip). CMR protocol involved: left-ventricular (LV) short axis cines (bSSFP, SENSE-2, 10mm, no gap), transaxial right-ventricular (RV) cines (bSSFP, SENSE-2, 8mm, no gap), two and four chamber cines and aortic through-plane phase contrast imaging, planned at the sino-tubular junction. MR was quantified indirectly using LV and aortic stroke volumes. Results 12 patients underwent percutaneous mitral valve leaflet repair (MitraClip) for posterior mitral valve leaflet prolapse, however 1 patient declined follow up after single-leaflet clip detachment resulting in 11 patients (age 83 ± 5years, 9 male) completing follow up imaging. At 6-months: significant improvements occurred in New York Heart Association functional class (Table 1) and 6MWT distances (223 ± 71m to 281 ± 65m, p = 0.005) and significant reductions occurred in indexed left ventricular end-diastolic volumes (LVEDVi) (118 ± 21ml/m2 to 94 ± 27ml/m2, p = 0.001), indexed left ventricular end-systolic volumes (58 ± 19ml/m2 to 48 ± 21ml/m2, p = 0.007) and quantitated MR volume (55 ± 22ml to 24 ± 12ml, p = 0.003) and MR fraction (49 ± 9.4% to 29 ± 14%, p= &amp;lt;0.001). There were no statistically significant changes in left ventricular ejection fraction (LVEF), right ventricular dimensions/ejection fraction or bi-atrial dimensions (Table 1). All patients demonstrated decreased LVEDVi and quantified MR (Figure 1). Conclusion Successful percutaneous mitral valve leaflet repair for primary MR results in reduction in MR, positive LV reverse remodelling, preservation of LVEF, and functional improvements. Larger CMR studies are now required to further guide optimal patient selection.

To assess, and identify predictors of 2-year adverse outcomes of surgical high-risk patients after successful MitraClip therapy (MC), differentiated by the aetiology of mitral regurgitation (MR). Kaplan-Meier analysis was used to assess survival free from death, heart failure rehospitalization, and reintervention up to 2 years in 202 successfully treated patients [74 ± 9 years, 132 men (65%); secondary MR aetiology in 140 patients, primary MR in 62]. Predictors for study endpoints were determined using Cox regression analyses. Mortality was 20% at 1 year and 33% at 2 years in both primary and secondary MR patients; independent predictors of death were reduced forward stroke volume, impaired LV function, and renal failure in primary MR, yet only an increased logistic EuroSCORE in functional MR patients. The rate of rehospitalizations was not different between the patient subgroups for 6 months, but then diverged significantly in favour of primary MR patients (estimated 2-year incidence, primary MR 40% vs. secondary MR 66%). No predictor was found for primary MR patients, but increased LV end-diastolic volume significantly increased the risk of rehospitalization in functional MR patients. Reinterventions were overall rare (7.4% at 1 year, 9.7% at 2 years); primary MR patients required all except one reintervention within 2 months of MC, with again no predictors found, whereas secondary MR patients (all except one with discharge MR of 2+) exhibited a steadily declining freedom from reintervention curve throughout follow-up. MR aetiology affects rehospitalization and reintervention, but not mortality, differently after successful MC.

Severe mitral regurgitation in nonagenarians: Impact of symptomatic status, frailty and etiology on management and outcomes

Approximately 50% of patients with severe mitral regurgitation (MR) referred for surgery have prohibitive surgical risk. MitraClip (Abbott Vascular) is an alternative therapy option in these patients. The aim of this study is to evaluate mid-term outcome in patients who underwent MitraClip implantation. All consecutive patients with ≥2+ MR and high risk for conventional surgical therapy who underwent MitraClip implantation at our unit were included in the analysis. The primary endpoint was all-cause mortality and secondary endpoint was heart failure rehospitalization. From October 2008 to December 2016, a total of 162 patients underwent MitraClip procedure at our unit. The mean follow-up duration was 819.8 ± 671.1 days. Acute procedural success was achieved in 141 of 162 patients (87.0%) and was not significantly different between primary and secondary MR patients (P=.09). Mortality rates were 14.4%, 28.7%, 38.7%, and 49.3% at 1 year, 2 years, 3 years, and 5 years, respectively. Rehospitalization rates for heart failure were 21.7%, 34.3%, 44.2%, and 56.6% at 1 year, 2 years, 3 years, and 5 years, respectively. At follow-up, patients exhibited significant improvement in New York Heart Association functional classification (P<.001). On multivariate analysis, baseline left ventricular ejection fraction (LVEF) <30% (odds ratio, 6.62) and baseline MR severity (odds ratio, 3.40) were the strongest predictors of mortality. Primary MR (odds ratio, 0.20) was associated with lower risk of mortality compared with secondary MR. Treatment of MR with MitraClip results in significant symptomatic improvement with excellent short-term results. However, 5-year mortality was 49.3%; baseline LVEF <30% and MR severity are the strongest predictors of mortality, while primary MR was a predictor for lower risk of mortality when compared with secondary MR.

Limited data exist regarding the impact of mitral annular calcification (MAC) on outcomes of transcatheter edge-to-edge repair for mitral regurgitation (MR). We retrospectively analyzed 968 individuals (median age, 79 [interquartile range, 70-86] years; 60.0% males; 51.8% with functional MR) who underwent an isolated, first-time intervention. Stratified by MAC extent per baseline transthoracic echocardiogram, the cohort was assessed for residual MR, functional status, all-cause mortality, heart failure hospitalizations, and mitral reinterventions post-procedure. Patients with above-mild MAC (n=101; 10.4%) were older and more likely to be female, exhibited a greater burden of comorbidities, and presented more often with severe, primary MR. Procedural aspects and technical success rate were unaffected by MAC magnitude, as was the significant improvement from baseline in MR severity and functional status along the first postprocedural year. However, the persistence of above-moderate MR or functional classes III and IV at 1 year and the cumulative incidence of reinterventions at 2 years were overall more pronounced within the above-mild MAC group (significant MR or functional impairment, 44.7% versus 29.9%, P=0.060; reinterventions, 11.9% versus 6.2%, P=0.033; log-rank P=0.035). No link was demonstrated between MAC degree and the cumulative incidence or risk of mortality and mortality or heart failure hospitalizations. Differences in outcomes frequencies were mostly confined to the primary MR subgroup, in which patients with above-mild MAC also experienced earlier, more frequent 2-year heart failure hospitalizations (20.8% versus 9.6%; P=0.016; log-rank P=0.020). Mitral transcatheter edge-to-edge repair in patients with and without above-mild MAC is equally feasible and safe; however, its postprocedural course is less favorable among those with primary MR.

Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study

Management of transcatheter aortic valve replacement (TAVR) in aortic stenosis (AS) flow groups-high-gradient (HG-AS), classical low-flow low-gradient (cLFLG-AS), and paradoxical low-flow low-gradient (pLFLG-AS)-is debated. Concomitant mitral regurgitation (MR) worsens outcomes, but the influence of MR aetiology on AS subtypes is unclear. This study aims to evaluate the impact of MR aetiology and severity on outcomes across AS flow groups in TAVR patients. A retrospective analysis was performed on 2658 patients undergoing TAVR (2013-21). MR was categorized as atrial functional (aFMR), ventricular functional (vFMR), or primary MR (PMR). Outcomes included 3-year mortality, MR improvement, and symptomatic benefit. Out of 2658 TAVR patients, 531 (20.0%) showed at least moderate MR (MR ≥ 2+) (50.1% male, median age 83.1 years). The fraction of patients with MR ≥ 2+ was highest among cLFLG-AS patients (34.2%). MR aetiology varied among AS subtypes, with mostly vFMR in cLFLG-AS (83.0%) and highest rates of aFMR (43%) and PMR (45%) in pLFLG-AS patients. Three-year mortality was significantly affected by MR severity [hazard ratio (HR) for MR2+ vs. MR < 2 1.62 (1.38-1.90)]. Differences in 3-year mortality were found in high-gradient (HG)-AS [HR 1.52 (1.16-1.98)] and pLFLG-AS patients [HR 1.73 (1.24-2.40)], but not in cLFLG-AS patients [HR 1.21 (0.93-1.56)]. MR improvement after TAVR was commonly found in HG-AS (67.2%) and least often among pLFLG-AS (48.7%, P = 0.03 compared with HG-AS). While MR improvement was associated with a lower mortality in HG-AS [HR 0.21 (0.10-0.43)] and cLFLG-AS patients [HR 0.48 (0.29-0.79)], this was not the case in pLFLG-AS patients [1.32 (0.67-2.59)]. MR aetiology and severity influence outcomes after TAVR depending on AS flow groups.

Mitral regurgitation (MR) is generally classified as either primary (organic) or secondary (functional). Although patients with atrial fibrillation (AF) often exhibit MR, the relation between the etiology of MR and the outcome of catheter ablation (CA) remains unknown. We conducted this study in order to elucidate this association. Among 1330 consecutive paroxysmal AF patients who underwent initial catheter ablation in our institution, 92 patients (62 men, mean age 65 ± 7years) who had moderate or severe MR were included in this study; 46 were classified to have primary and the remaining 46 to have secondary MR by preoperative echocardiography. These patients were prospectively monitored after the CA. During a mean follow-up period of 27.9 ± 28.8months, AF recurred in 26/46 (56.6%) of primary MR patients and in 15/46 (32.6%) of those with secondary MR (P < 0.02). Although univariate analysis found that diabetes, left atrial volume indexed by body surface area (LAVI), and primary MR were significantly associated with AF recurrence, primary MR (hazard ratio (HR), 2.47; 95% confidence interval (CI), 1.30-4.88; P = 0.006) and LAVI (HR, 1.03/1mL/m(2) increase; 95% CI, 1.00-1.06; P = 0.03) remained significant predictors on multivariate analysis. The AF recurrence-free rate was lower in patients with primary MR after both the initial and final CA. In patients with paroxysmal AF and moderate or severe MR, primary MR may increase the risk of AF recurrence after the initial and final CA.

Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation andItsImpact on Mortality.

Mitral valve reconstruction has become a priority option for mitral regurgitation correction, due to the documented advantages, comparing with valve replacement, in terms of long-term survival, absence of valve-related side effects, and preservation of left ventricle function. Improvement of mitral valve reconstruction techniques has made almost all lesion variants (more than 95 %) suitable for reconstruction, with a 15-year freedom from reoperations in 90 % of all operated patients. Aim. To study clinical manifestations and results of reconstructive surgeries on the mitral valve in patients with primary and secondary mitral regurgitation. Materials and methods. The study is based on the analysis of clinical data of 218 patients with mitral valve insufficiency who were treated in National M. Amosov Institute of Cardiovascular Surgery of the National Academy of Medical Sciences of Ukraine from 01.01.2010 to 01.01.2015. The average age of patients was 52.8 ± 13.0 years (16.0–78.0). The ratio of male to female patients was 151 (69.3 %) and 67 (30.7 %) cases, respectively. Acute occurrence of mitral regurgitation was observed in 10 (4.6 %) cases. Results. According to the clinical and histological causes of mitral regurgitation, we systematized and conducted a comparative analysis between groups of patients with primary (n = 174) and secondary (n = 44) mitral regurgitation. The group with primary mitral regurgitation (n = 174) in the early postoperative period was characterized by averagely shorter duration of the total time of artificial ventilation compared with the secondary genesis of mitral regurgitation. Thus, in the group of patients with secondary mitral regurgitation significantly (P = 0.003) more often there were signs of acute cardiac insufficiency. Hospital mortality for the whole group of patients was 5 (2.3 %) cases. In the group with secondary mitral regurgitation, hospital mortality was significantly higher and amounted to – 6.8 % (3 cases in 44 patients), against 1.2 % (2 cases in 174 patients) in primary mitral regurgitation. Conclusions. Primary mitral regurgitation occurs due to a violation of the anatomy of the valvular apparatus, accompanied by increased mobility of the valves (prolapse) and regurgitation. Hospital mortality in primary mitral regurgitation was 1.2 %. Survival after 6 months and by the end of 1 and 5 years was 98.8 %, 98.2 % and 97.0 %, respectively. Secondary mitral regurgitation is caused by the initial dilatation of the left ventricle with preserved anatomy of the valvular apparatus. Hospital mortality was 6.8 %. Survival rate after 6 months, by the end of 1, 3 and 5 years, was 90.9 %, 86.3 %, 77.9 % and 74.0 % respectively.