Carmelo Grasso

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.

Long‐term outcomes of bifurcation lesions after implantation of drug‐eluting stents with the “mini‐crush technique”

Objectives: To evaluate clinical and angiographic long‐term outcome of “the mini‐crush” technique for treating bifurcation lesions. Background: Despite proven efficacy of drug‐eluting stent (DES) within most lesions subsets, bifurcation lesions continue to exhibit high restenosis rate using current DES stenting technique. Methods: We report a new stenting technique which was employed in 45 consecutive patients (52 lesions) between April 2004 and July 2005 to treat true bifurcation lesions using DES in both branches. Results: Using this technique procedural success was obtained in 100% of cases, without complications and with excellent angiographic result in 96.1% and 98.1% of main vessel and side branch. Preprocedure reference vessel diameter and minimal lumen diameter (MLD) were 2.68 ± 0.48 and 0.90 ± 0.55 mm for the main branch, respectively and 2.28 ± 0.34 and 1.14 ± 0.47 mm for the side branch, respectively. Postprocedure MLD was 2.56 ± 0.39 mm for the main branch and 2.16 ± 0.29 mm for the side branch. There were no in‐hospital major adverse cardiac events (MACE). At 72 days after procedure there was one case of side branch stent thrombosis (2.2%), which resulted in non Q‐wave MI. Angiographic follow up was obtained in 100% of patients at 7.5 ± 1.3 months. Target lesion revascularization (TLR) was 12.2%; no death and Q‐wave MI were observed; reference vessel diameter and MLD for the main branch were 2.79 ± 0.51 and 1.99 ± 0.65 mm respectively and for the side branch 2.28 ± 0.40 and 1.63 ± 0.48 mm respectively. Restenosis rate in the main branch was 12.2% while in the side branch was 2.0%. Conclusions: In‐hospital outcome indicates that the mini‐crush technique for bifurcation lesions with DES can be easily performed. It provides very low total MACE rate and restenosis at 8‐month follow‐up. These results confirmed the advantage of this specific technique to give complete coverage of the ostium of the side branch using two stents technique.

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.

Predictors of clinical outcomes after edge-to-edge percutaneous mitral valve repair

BACKGROUND There is limited information on the long-term outcomes and prognostic clinical predictors after edge-to-edge transcatheter mitral valve repair with the MitraClip system. METHODS Consecutive patients with mitral regurgitation (MR) undergoing MitraClip therapy between October 2008 and November 2013 in 4 Italian centers were analyzed. The primary end point of interest was all-cause death. The secondary end point was the composite of all-cause death or rehospitalization for heart failure. RESULTS A total of 304 patients were included, of which 79% had functional MR and 17% were in New York Heart Association functional class IV. Acute procedural success was obtained in 92% of cases, with no intraprocedural death. The cumulative incidences of all-cause death were 3.4%, 10.8%, and 18.6% at 30 days, 1 year, and 2 years, respectively. The corresponding incidences of the secondary end point were 4.4%, 22.0%, and 39.7%, respectively. In the Cox multivariate model, New York Heart Association functional class IV at baseline and ischemic MR etiology were found to significantly and independently predict both the primary and the secondary end point. A baseline, left ventricular end-systolic volume >110 mL was found to be an independent predictor of the secondary endpoint. Acute procedural success was independently associated with a lower risk of all-cause death and the combination of all-cause death or rehospitalization for heart failure at long-term follow-up. CONCLUSIONS In a cohort of patients undergoing MitraClip therapy, those presenting at baseline with ischemic functional etiology, severely dilated ventricles, or advanced heart failure and those undergoing unsuccessful procedures carried the worst prognosis.

Percutaneous Mitral Valve Repair With the MitraClip System for Severe Mitral Regurgitation in Patients With Surgical Mitral Valve Repair Failure

To the Editor: Surgical mitral valve repair (SMVR) is the preferred intervention for patients with either symptomatic severe mitral regurgitation (MR) or asymptomatic severe MR and left ventricular dysfunction [(1)][1]. The rate of freedom from severe MR 10 years after SMVR, however, is reported to

Real-world cost effectiveness of MitraClip combined with Medical Therapy Versus Medical therapy alone in patients with moderate or severe mitral regurgitation

BACKGROUND We evaluated the real-world cost-effectiveness of the MitraClip system (Abbott Vascular Inc., Menlo Park, CA) plus medical therapy for patients with moderate/severe mitral regurgitation, as compared with medical therapy (MT) alone. METHODS Clinical records of patients with moderate to severe functional mitral regurgitation treated with MitraClip (N=232) or with MT (N=151) were collected and outcome analyzed with propensity score adjustment to reduce selection bias. Twelve-month outcomes were modeled over a lifetime horizon to conduct a cost-effectiveness analysis, in the payers perspective. Costs and benefits were discounted at an annual rate of 3.5%. RESULTS After propensity score adjustment, the average treatment effect was -9.5% probability of dying at 12months and, following lifetime modeling, 3.35±0.75 incremental life years and 3.01±0.57 incremental quality-adjusted life years. MitraClip contributed to a higher decrease in re-hospitalizations at 12months (difference=-0.54±0.08) and generated a more likely improvement in the New York Heart Association (NYHA) class at 12months versus NYHA at enrollment. Incremental costs, adapted to five possible scenarios, ranged from 14,493 to 29,795 € contributing to an incremental cost-effectiveness ratio ranging from 4796 to 7908 €. CONCLUSIONS Compared to MT alone and given conventional threshold values, MitraClip can be considered a cost-effective procedure. The cost-effectiveness of MitraClip is in line or superior to the one of other non-pharmaceutical strategies for heart failure.

Catheter-based edge-to-edge mitral valve repair after percutaneous mitral valve annuloplasty failure.

A 68-year-old high-risk (STS mortality risk score 15.7%) woman presented with congestive heart failure (New York Heart Association functional class III) and severe mitral regurgitation (MR) (vena contracta 7 mm) 1.5 years after percutaneous implantation, in a different hospital, of the Carillon

Procedural Management of Patients With Advanced Heart Failure Undergoing MitraClip Implantation (From the GRASP Registry).

Cite this article as: Sergio Buccheri, Marco Barbanti, Davide Capodanno, Antonio Popolo Rubbio, Piera Capranzano, Umberto Scaglione, Giuseppe Giuliano, Salvatore Scandura, Sarah Mangiafico, Sebastiano Immé, Silvia Farruggio, Sandra Giaquinta, Carmelo Grasso and Corrado Tamburino, Procedural management of patients with advanced heart failure undergoing MitraClip implantation (from the GRASP registry), Journal of Cardiothoracic and Vascular Anesthesia, http://dx.doi.org/10.1053/j.jvca.2016.09.013

Early results of MitraClip system implantation by real-time three-dimensional speckle-tracking left ventricle analysis.

Aims To appraise the early effect of percutaneous mitral valve repair with the MitraClip system on myocardial function using real-time three-dimensional speckle-tracking echocardiography (3D-STE). Methods Consecutive patients with moderate-to-severe or severe mitral regurgitation, undergoing mitral valve repair with the MitraClip system, were prospectively evaluated during the peri-procedural workout and follow-up. Left ventricular deformation was evaluated by a two-dimensional and 3D speckle-tracking analysis. 3D-STE acquisitions were elaborated obtaining real-time 3D global longitudinal strain evaluation, and by appraising both volumetric and hemodynamic parameters (i.e. left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular ejection fraction, cardiac output, and stroke volume). Results In all, 30 patients were included. At 1-month follow-up, 3D-STE analysis revealed no changes in left ventricular end-diastolic volume (162.6 ± 73.7 ml at baseline vs. 159.8 ± 64.5 ml at 1-month follow-up; P = 0.63) and a downward trend in left ventricular end-systolic volume (104.7 ± 52.0 vs. 100.1 ± 50.4 ml, respectively; P = 0.06). Left ventricular ejection fraction did not significantly increase (38.1 ± 11.3% at baseline vs. 39.4 ± 11.0% at 1-month follow-up; P = 0.20). No significant changes were reported in cardiac output (4.3 ± 2.0 l/min at baseline vs. 4.0 ± 1.5 l/min at follow-up; P = 0.377) and in stroke volume (59.5 ± 25.5 ml at baseline vs. 59.9 ± 20.7 ml at follow-up; P = 0.867). On the contrary, left ventricular deformation capability significantly improved, with the real-time 3D global longitudinal strain value changing from −9.8 ± 4.1% at baseline to −11.0 ± 4.4% at follow-up (P = 0.018). Conclusions Accurately assessing myocardial function by the use of 3D-STE, this study reported irrelevant early changes in left ventricular size, but a positive effect on left ventricular deformation capability following mitral valve repair with the MitraClip system. These preliminary results need to be confirmed in larger series and extended to long-term follow-up.