Unusual interatrial membrane in the left atrium: A newer obstacle for transseptal-based percutaneous mitral valve repair techniques?

We present a case of a patient with severe mitral regurgitation referred to our Institution for an echocardiographic examination as part of the routine workup to assess the eligibility for mitral valve percutaneous repair with either the MitraClip or Cardioband systems. Echocardiography showed the presence of an unusual interatrial membrane in the left atrium that represented a contraindication for the puncture of the interatrial septum. The patient was finally deferred to percutaneous mitral valve replacement using transapical access.

Percutaneous mitral valve repair with the MitraClip system in the elderly: One-year outcomes from the GRASP registry.

BACKGROUND: Although mitral regurgitation (MR) affects a relevant and increasing number of elderly, an optimal management of this high-risk population is challenging. METHODS AND RESULTS: The aim of this prospective, observational study was to compare one-year outcomes of MitraClip therapy in high surgical risk patients with moderate-to-severe or severe MR between patients aged <75 versus ≥75years. A total of 180 patients were included: 92 were <75years and 88 were ≥75years old. At one-year follow-up the primary efficacy endpoint (composite of death, surgery for mitral valve dysfunction and grade 3+ or 4+ MR) occurred in 41 patients (24.5%), with similar rates between those aged <75years (23.9%) and those ≥75years (25.2%), p=0.912. A total of 21 (12.2%) deaths were observed within 1year after the MitraClip procedure, without significant differences in cumulative mortality rates between elderly and younger patients (10.8% vs. 13.3%, respectively, p=0.574). Compared with baseline, the significant reduction in MR severity achieved after the procedure was sustained at one-year follow-up, in both elderly and younger patients and a significant improvement in NYHA functional class was observed in both groups. A total of 18 (10.0%) patients experienced a re-hospitalization for acute heart failure within one-year after the MitraClip procedure, with no significant differences between elderly and younger. At one-year follow-up both elderly and younger patients showed significant reductions in left ventricular volumes, with changes of similar extent between the two subgroups. CONCLUSIONS: MitraClip therapy can be considered a viable option also among subsets with more advanced age.

Impact of chronic kidney disease on outcomes after percutaneous mitral valve repair with the MitraClip system: insights from the GRASP registry.

AIMS: Our aim was to evaluate the impact of baseline chronic kidney disease (CKD) on clinical outcomes after percutaneous edge-to-edge mitral valve repair (PMVR). METHODS AND RESULTS: Two hundred and fourteen consecutive patients dichotomised by the presence of baseline CKD (n=113) or no-CKD (n=101) had their clinical outcomes compared up to 12-month follow-up. The primary safety endpoint was the incidence of major adverse events and the primary efficacy endpoint was freedom from death, surgery for MV dysfunction, or grade ≥3+ MR. The primary safety endpoint was demonstrated in 12.4% vs. 2.0% in CKD and no-CKD patients, respectively (p=0.003). The primary efficacy endpoint at 12 months was significantly lower in CKD patients (65.8% vs. 84.2%, respectively, log-rank p=0.005). While MR reduction and NYHA functional class improvement were mostly sustained and equivalent up to 12 months in no-CKD patients, they were impaired in CKD patients. Baseline CKD was an independent predictor of the primary efficacy endpoint (adjusted HR 2.48, 95% CI: 1.29 to 4.79, p=0.006) and calcified leaflet predicted grade ≥3+ MR at 12 months (adjusted HR 6.56, 95% CI: 2.71 to 15.88, p<0.001). CONCLUSIONS: CKD patients had worse clinical outcomes compared with no-CKD patients post PMVR. CKD was an independent predictor of the primary efficacy endpoint, whereas calcified leaflet was an independent predictor of grade ≥3+ MR at 12 months.

Gender-related clinical and echocardiographic outcomes at 30-day and 12-month follow up after MitraClip implantation in the GRASP registry.

OBJECTIVES: To assess the influence of patients' gender on the outcomes of percutaneous edge-to-edge mitral valve repair (PMVR) using the MitraClip system. BACKGROUND: Although gender-related differences have been extensively documented in patients who undergo surgery for moderate-to-severe (3+) and severe (4+) mitral regurgitation (MR), studies assessing whether these differences exist after PMVR are lacking. METHODS: Clinical and echocardiographic data through 12-month follow up from 171 consecutive patients whom underwent MitraClip implantation and were dichotomized by the gender (106 males and 65 females) were obtained. The primary safety endpoint was the incidence of major adverse events at 30 days and the primary efficacy endpoint was freedom from death, surgery for mitral valve dysfunction, or grade≥3+ MR at 12-month follow up. RESULTS: The primary safety endpoint was observed in four males (3.8%) and four females (6.2%) (P=0.358). Remarkable reduction in MR postprocedure was revealed in both groups, and these results were mostly sustained. Furthermore, left ventricle reverse remodeling and New York Heart Association (NYHA) functional class improvement were revealed in both groups, but females tended to demonstrate worse results over time (P=0.083). The primary efficacy endpoint obtained by Kaplan-Meier estimates was observed in 76.3 and 70.2%, respectively (log rank P=0.231). CONCLUSIONS: MitraClip implantation in patients with 3+ and 4+ MR is safe and efficacious until mid-term follow up, regardless of patients' gender. Despite improvement in NYHA functional class in both groups, female gender demonstrated a trend toward poorer results. Further validation of our findings is warranted.

Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry.

OBJECTIVES: This study sought to compare, in high-risk patients with 3+ to 4+ mitral regurgitation (MR) dichotomized by baseline echocardiographic features, acute, 30-day, and 12-month outcomes following percutaneous mitral valve repair using the MitraClip. BACKGROUND: The feasibility and mid-term outcomes after MitraClip implantation in patients with echocardiographic features different from the EVEREST (Endovascular Valve Edge-to-Edge Repair) I and II trials have been scarcely studied. METHODS: Clinical and echocardiographic outcomes through 12-month follow-up of consecutive patients who underwent MitraClip implantation were obtained from an ongoing prospective registry. Two different groups, divided according to baseline echocardiographic criteria (investigational group [EVERESTOFF] and control group [EVERESTON]), were compared. RESULTS: Seventy-eight patients were included in EVERESTOFF and 93 patients in EVERESTON groups. Important and comparable acute reductions in MR and no clip-related complications were revealed. The primary safety endpoint at 30 days was comparable between groups (2.6% vs. 6.5%, respectively, p = 0.204); in addition, MR reduction was mostly sustained, whereas equivalent improvement in New York Heart Association functional class were demonstrated. Kaplan-Meier freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 12 months was demonstrated in 71.4% and 76.2%, respectively, in the EVERESTOFF and EVERESTON groups (log rank p = 0.378). Significant improvements in ejection fraction and reduction in left ventricle volumes were demonstrated in both groups over time, but the baseline between-group differences were sustained. CONCLUSIONS: MitraClip implantation in patients with expanded baseline echocardiographic features, compared with the control group, was associated with similar rates of safety and efficacy through 12-month follow-up. Further validation of our findings is warranted.

Association of tricuspid regurgitation with clinical and echocardiographic outcomes after percutaneous mitral valve repair with the MitraClip System: 30-day and 12-month follow-up from the GRASP Registry.

AIM: The aim of this study was to evaluate the association of baseline tricuspid regurgitation (TR) on the outcomes after percutaneous mitral valve repair (PMVR) with the MitraClip system. METHODS AND RESULTS: Data from 146 consecutive patients with functional mitral regurgitation (MR) were obtained. Two different groups, dichotomized according to the degree of pre-procedural TR (moderate/severe, n = 47 and none/mild, n = 99), had their clinical and echocardiographic outcomes through 12-month compared. At 30-day, the primary safety endpoint was significantly higher in moderate/severe TR compared with none/mild TR (10.6 vs. 2.0%, P = 0.035). Marked reduction in MR grades observed post-procedure were maintained through 12 months. Although NYHA functional class significantly improved in both groups compared with baseline, it was impaired in moderate/severe TR compared with the none/mild TR group (NYHA > II at 30 day: 33.3 vs. 9.2%, P < 0.001; at 1 year: 38.5 vs. 12.3%, respectively, P = 0.006). Left ventricle reverse remodelling and ejection fraction improvement were revealed in both groups. The primary efficacy endpoint at 12-month determined by freedom from death, surgery for mitral valve dysfunction, or grade ≥ 3+ MR was comparable between groups, but combined death and re-hospitalization for heart failure rates were higher in the moderate/severe TR group. Multivariable Cox regression analysis demonstrated that baseline moderate/severe TR and chronic kidney disease were independent predictors of this combined endpoint. CONCLUSIONS: Although PMVR with MitraClip led to improvement in MR, TR, and NYHA functional class in patients with baseline moderate/severe TR, the primary safety endpoint at 30-day was impaired, while moderate/severe TR independently predicted death and re-hospitalization for heart failure at 12-month.

One- and twelve-month safety and efficacy outcomes of patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry).

The aim of this study was to report on the 30-day and 1-year outcomes of percutaneous mitral valve repair with the MitraClip technique in patients with grade ≥3+ mitral regurgitation (MR) at high risk for conventional surgical therapy enrolled in the prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry. Acute device success was defined as residual MR ≤2+ after clip implantation. The primary safety end point was the rate of major adverse events at 30 days. The primary efficacy end point was freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 30 days and 1 year. A total of 117 patients were treated. Eighty-nine patients (76%) presented with functional MR and 28 patients (24%) with organic MR. Acute device success was observed in all patients. Device implantation time significantly diminished with experience and varied significantly between cases with 1 versus ≥2 clips. No procedural mortality was recorded. Major adverse events occurred in 4 patients at 30 days (4.3%). Deterioration to MR ≥3+ was recorded in 25% of patients with degenerative MR and 7% of those with functional MR at 1 year. No surgery for mitral valve dysfunction occurred within 1 year. Freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR was 96.4% and 75.8% at 30 days and 1 year, respectively. No significant differences were noted in the primary efficacy end point between patients with degenerative MR and those with functional MR. In conclusion, percutaneous mitral valve repair with the MitraClip technique was shown to be safe and reasonably effective in 117 patients from a real-world setting.