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.

Usefulness of the logistic clinical SYNTAX score for predicting 1-year mortality in patients undergoing percutaneous coronary intervention of the left main coronary artery.

OBJECTIVES: To externally validate the logistic clinical SYNTAX in patients undergoing percutaneous coronary intervention (PCI) of the left main coronary artery (LMCA). BACKGROUND: A novel version of the clinical SYNTAX score (CSS) has been recently introduced to overcome the limitations of categorical risk scores for PCI by the incorporation of clinical variables and the SYNTAX score (SXscore) into a logistic formula for predicting 1-year mortality. METHODS: Core and extended models of the logistic CSS (logCSS(core) and logCSS(ext)) were applied to 400 patients undergoing LMCA PCI, and their performance was compared with those of the standard CSS, SXscore, and age, creatinine, and ejection fraction (ACEF) score by different measures of discrimination and calibration. RESULTS: A significant gradient in the distribution of 1-year mortality was noted with all the models (P < 0.001), with the SYNTAX and ACEF scores showing the lowest (0.64) and the highest (0.75) c-statistic, respectively. Based on Somers' D(xy) rank correlation, discrimination of both the logCSS(core) and the logCSS(ext) was numerically lower than that of the ACEF score. The logCSS(core) was miscalibrated toward underpredicting all-cause mortality in low-predicted probabilities, while the logCSS(ext) tended to underpredict in low-predicted probabilities and overpredict in high-predicted probabilities. Slope and intercept values reflected a better calibration ability of the logCSS(core) compared with the logCSS(ext). The global accuracy of the logCSS(core) was superior to that of the logCSS(ext) (Brier score 0.087 vs. 0.095). CONCLUSIONS: A personalized approach to risk stratification of LMCA PCI with the logistic CSS is feasible and of potential clinical utility. However, in this study, the logistic CSS did not achieve superior discrimination compared with other categorical models, and suffered from mild to moderate miscalibration.

[Clinical decision making in left main coronary artery disease revascularization: the past, present and future]. / Il processo decisionale clinico nella rivascolarizzazione del tronco comune della coronaria sinistra: passato, presente e futuro.

Left main coronary artery disease revascularization is one of the most debated topics in the setting of interventional cardiology. Although the gold standard therapy for left main disease is coronary artery bypass grafting, growing evidences suggest similar outcomes for percutaneous coronary intervention compared to cardiac surgery. The decision-making process aimed at selecting the best treatment option is a complex task requiring advanced expertise, Heart Team discussion, and risk stratification. The aim of this review is to provide an updated overview of treatment options for left main revascularization, highlighting current indications based on the latest international guidelines, reviewing the most important risk stratification systems with a glimpse to further clinical development in the field.

Epidemiology and clinical impact of different anatomical phenotypes of the left main coronary artery.

Several studies have produced estimates of the outcome of percutaneous coronary intervention (PCI) in the field of left main (LM) coronary artery disease, but no research has been found that surveyed the issue of a comprehensive knowledge of LM anatomy and assessed the impact of different anatomic phenotypes on the likelihood of developing complications after LM PCI. We sought to develop a specific investigation on the basis of the regional anatomy and quantitative analysis of a large series of angiograms performed in our institution. We reviewed the baseline selective digital coronary angiographic examinations of 1,000 patients who did not undergo LM PCI and 296 patients with significant LM stenosis who did undergo PCI. All patients in both groups underwent a comprehensive qualitative and quantitative assessment of LM anatomical features according to several parameters. Hierarchical cluster analysis (HCA) was used to identify different anatomic phenotypes of the LM coronary artery. Three different anatomical patterns were identified by HCA. The proportion of patients with LM disease increased across clusters (19% in cluster 1, 27% in cluster 2 and 44% in cluster 3, p < 0.001). No differences were observed in terms of 18-month major adverse cardiac event-free survival among patients with LM disease undergoing PCI stratified by clusters (log rank p = 0.77). In conclusion, LM phenotypes can be identified that are more likely to present with atherosclerotic disease and significant stenosis.

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 ±â€Špercutaneous 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 ±â€Š0.6. 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.

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 ±â€Š73.7 ml at baseline vs. 159.8 ±â€Š64.5 ml at 1-month follow-up; P = 0.63) and a downward trend in left ventricular end-systolic volume (104.7 ±â€Š52.0 vs. 100.1 ±â€Š50.4 ml, respectively; P = 0.06). Left ventricular ejection fraction did not significantly increase (38.1 ±â€Š11.3% at baseline vs. 39.4 ±â€Š11.0% at 1-month follow-up; P = 0.20). No significant changes were reported in cardiac output (4.3 ±â€Š2.0 l/min at baseline vs. 4.0 ±â€Š1.5 l/min at follow-up; P = 0.377) and in stroke volume (59.5 ±â€Š25.5 ml at baseline vs. 59.9 ±â€Š20.7 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 ±â€Š4.1% at baseline to -11.0 ±â€Š4.4% 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.

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.

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.

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.

Three-dimensional echocardiographic and surgical findings in mitral mechanical valve dysfunction.

Periodic echocardiographic evaluation of valve function is recommended in all patients with prosthetic valves. Usually trans-thoracic echocardiography (TTE) is satisfactory to assess prosthetic function. Nevertheless when the TTE is suboptimal or in case of strong clinical doubt of prosthetic valve dysfunction, trans-esophageal echocardiography (TEE) remains the gold standard of imaging. Recent advancements in echocardiography, with the three-dimensional (3D) reconstruction, provide an incremental diagnostic value as compared to two-dimensional TEE. In addition, 3D-TEE gives unique views that add extra morphological and anatomical information, providing a very accurate presurgical evaluation.

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.

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.

Novel drug-eluting stents in the treatment of de novo coronary lesions.

Due to safety concerns in recent years, much effort has been devoted to improving the outcomes associated with drug-eluting stents (DESs). This review summarizes the current status of methodological and technical achievements reported in second-generation DES. Novel stents are described based on the component (the platform, the polymer, and the drug) that has undergone the most significant changes compared to earlier generation DES. An overview of the currently available evidence on the use of novel coronary devices in patients undergoing coronary revascularization is also reviewed.

Global risk classification and clinical SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) score in patients undergoing percutaneous or surgical left main revascularization.

OBJECTIVES: The aim of this study was to investigate the ability to predict cardiac mortality of the Global Risk Classification (GRC) and the Clinical SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) score (CSS) in left main (LM) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). BACKGROUND: There is a renewed interest in combining clinical and angiographic information to define the risk of patients undergoing LM revascularization. METHODS: The GRC and CSS were assessed in patients undergoing LM PCI (n = 400) or CABG (n = 549). Stand-alone clinical (ACEF [age, creatinine, ejection fraction]), EuroSCORE (European System for Cardiac Operative Risk Evaluation) and angiographic (SYNTAX score) risk scores were also investigated. RESULTS: The GRC (Hosmer-Lemeshow statistic 0.357, p = 0.550; area under the curve 0.743) and the ACEF (Hosmer-Lemeshow 0.426, p = 0.514; area under the curve 0.741) showed the most balanced predictive characteristics in the PCI and CABG cohorts, respectively. In PCI patients, the CSS used fewer data to achieve similar discrimination but poorer calibration than the GRC. Propensity-adjusted outcomes were comparable between PCI and CABG patients with low, intermediate, or high EuroSCORE, ACEF, GRC, and CSS and those with low or intermediate SYNTAX score. Conversely, in the group with the highest SYNTAX score, the risk of cardiac mortality was significantly higher in PCI patients (hazard ratio: 2.323, 95% confidence interval: 1.091 to 4.945, p = 0.029). CONCLUSIONS: In LM patients undergoing PCI, combined scores improve the discrimination accuracy of clinical or angiographic stand-alone tools. In LM patients undergoing CABG, the ACEF score has the best prognostic accuracy compared with other stand-alone or combined scores. The good predictive ability for PCI along with the poor predictive ability for CABG make the SYNTAX score the preferable decision-making tool in LM disease.