Margherita Ministeri

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.

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.

Comparison of One-Year Outcomes of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Unprotected Left Main Coronary Artery Disease and Acute Coronary Syndromes (from the CUSTOMIZE Registry)

Uncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p <0.001), driven by a higher rate of target lesion revascularization (8.1% vs 1.7%, p = 0.001). This finding was consistent after statistical adjustment for MACEs (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 5.9, p = 0.01) and target lesion revascularization (adjusted HR 8.0, 95% CI 2.2 to 28.7, p = 0.001). No statistically significant differences between PCI and CABG were noted for death (adjusted HR 1.1, 95% CI 0.4 to 3.0, p = 0.81) and myocardial infarction (adjusted HR 4.8, 95% CI 0.3 to 68.6, p = 0.25). No interaction between clinical presentation (ST-segment elevation myocardial infarction or unstable angina/non-ST-segment elevation myocardial infarction) and treatment (PCI or CABG) was observed (p for interaction = 0.68). In conclusion, in patients with left main coronary artery disease and ACS, PCI is associated with similar safety compared to CABG but higher risk of MACEs driven by increased risk of repeat revascularization.

Objectifying the Impact of Incomplete Revascularization by Repeat Angiographic Risk Assessment With the Residual SYNTAX Score After Left Main Coronary Artery Percutaneous Coronary Intervention

We investigated the prognostic accuracy of a standardized quantification of incomplete revascularization after percutaneous coronary intervention (PCI) of the unprotected left main coronary artery (ULMCA) named residual SYNTAX score (rSS).

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

Volume-to-creatinine clearance ratio in patients undergoing coronary angiography with or without percutaneous coronary intervention: Implications of varying definitions of contrast-induced nephropathy

Whether predicting the risk of early serum creatinine rise using the ratio of the volume of contrast media administered to the estimated creatinine clearance (V/CrCl) is applicable to the broader definition of contrast‐induced nephropathy (CIN) (≥0.5 mg/dL absolute and/or 25% relative increase from baseline serum creatinine) is unknown.

Incorporating Glomerular filtration rate or creatinine clearance by the modification of diet in renal disease equation or the Cockcroft–Gault equations to improve the Global Accuracy of the Age, Creatinine, Ejection Fraction [ACEF] score in patients undergoing percutaneous coronary intervention

BACKGROUND The aim of the present study was to appraise the comparative ability of different ACEF models incorporating glomerular filtration rate or creatinine clearance estimated by the Modification of Diet in Renal Disease [ACEFMDRD] or Cokcroft-Gault [ACEFCG] equations, respectively, over the original ACEF score (ACEFSrCr) in patients undergoing percutaneous coronary intervention (PCI). METHODS A total of 537 patients were analyzed by different measures of discrimination, calibration and net reclassification improvement (NRI). RESULTS A significant gradient in all-cause mortality was consistently seen with all the models at 30 days, 1 year and 5 years. The comparison of the three models showed that the best balance in terms of discrimination and calibration for all-cause mortality was offered by the ACEFCG at 30 days, the ACEFMDRD at 1 year and similarly by the ACEFCG and ACEFMDRD at 5 years. At 30 days, the NRI was +32.9% for ACEFMDRD over ACEFSrCr and +16% for ACEFCG over ACEFSrCr. At 1 year, the NRI was 13.8% for ACEFMDRD over ACEFSrCr and -7.8% for ACEFCG over ACEFSrCr. At 5 years, the NRI was +7.7% for both the ACEFMDRD and the ACEFCG over the ACEFSrCr. CONCLUSIONS In patients undergoing PCI, the ACEF score is associated with satisfactory early-, mid- and long-term discrimination regardless of the definition of renal function. However, incorporating glomerular filtration rate or creatinine clearance by the MDRD or CG formulas in the ACEF score yields superior calibration compared with the original SrCr-based equation, with the ACEFMDRD displaying superior reclassification ability over the ACEFCG and ACEFSrCr at 30 days and 1 year.

EuroSCORE II Versus Additive and Logistic EuroSCORE in Patients Undergoing Percutaneous Coronary Intervention

The aim of the present study was to externally validate the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (ESII) in patients undergoing percutaneous coronary intervention (PCI) and to compare its performance with that of its previously released versions, named additive (addES) and logistic EuroSCORE (logES). A total of 537 patients undergoing PCI were analyzed by different measurements of discrimination, calibration, and global accuracy. A significant gradient in all-cause mortality was seen with all the models at 30 days, 1 year, and 5 years, with the exception of the ESII at 30 days. The ESII had the lowest area under the receiver operating characteristic curve at all time points compared with its previous version, being 0.83 (vs 0.90 for both addES and logES) at 30 days, 0.75 (vs 0.82 for both addES and logES) at 1 year, and 0.69 (vs 0.77 for addES and 0.76 for logES) at 5 years. However, the ESII displayed a better calibration than the logES at 30 days, whereas both scores were miscalibrated at 1 and 5 years. The Brier score displayed similar global accuracy between the ESII and logES. In conclusion, the ESII is better calibrated than the logES at 30 days but does not represent a step forward in discrimination and global accuracy compared with its previous versions for predicting early- and long-term mortality of patients undergoing PCI.

Risk prediction of contrast-induced nephropathy by ACEF score in patients undergoing coronary catheterization.

Aims To explore the ability of the ACEF score to predict the incidence of contrast-induced nephropathy (CIN) in patients undergoing coronary angiography with or without percutaneous coronary intervention. Methods A total of 706 patients undergoing coronary angiography ± percutaneous coronary intervention (PCI) between March 2011 and October 2011 were analyzed. CIN using different definitions was termed as CINnarrow (rise in serum creatinine ≥0.5 mg/dl) and CINbroad (rise in serum creatinine ≥0.5 mg/dl and/or ≥25% increase in baseline serum creatinine). Results The mean ACEF score was 1.5 ± 0.6. Overall incidences of CINnarrow and CINbroad were 5.5% and 13.6%, respectively. There was a significant gradient in the incidence of CINnarrow (2.9%, 3.9%, 10.6% in the I, II, and III tertiles, respectively, P < 0.001) and CINbroad (9.1%, 14.2%, 17.9% in the I, II, and III tertiles, respectively, P = 0.021) across increasing ACEF tertiles. The ACEF score was independently associated with the risk of CINnarrow (adjusted odds ratio [OR] 1.6, 95% confidence interval [CI] 1.0–2.7; P = 0.047). Discrimination was more satisfactory when using the ACEF as a predictor of CINnarrow (c-statistic 0.71, 95% 0.63–0.79). Conclusion The ACEF score is an independent and potentially useful predictor of CIN defined as rise in serum creatinine ≥0.5 mg/dl.