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Aim: Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge‐to‐edge repair with MitraClip implantation could differ in patients with ischaemic (I‐MR) and non‐ischaemic mitral regurgitation (NI‐MR). Methods and results: PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random‐effects model. Primary endpoint was the composite of all‐cause death and heart failure‐related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re‐intervention. Seven studies enrolling 2501 patients were included. Patients with I‐MR compared with patients with NI‐MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; I2: 0%). The risk of all‐cause death was increased in patients with I‐MR (odds ratio: 1.31; 95% confidence interval: 1.07 to 1.62; I2: 0%), while no differences were observed between the two groups in terms of the other secondary endpoints. Conclusions: The risk of mortality after MitraClip implantation is lower in patients with NI‐MR than in those with I‐MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI).Background: Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor.Methods: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. The primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated.Results: A total of 472 patients (mean age 61 ± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47 ± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients.Conclusions: In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE. [ABSTRACT FROM AUTHOR]

Aims: To explore whether left ventricular reverse remodelling (LVRR) is a predictor of outcomes in patients with functional mitral regurgitation (FMR) undergoing MitraClip procedure.Methods and Results: We analysed 184 consecutive patients with FMR who underwent successful MitraClip procedure. LVRR was defined as a reduction in left ventricular end-systolic volume ≥ 10% from baseline to 6 months. LVRR was observed in 79 (42.9%) patients. Compared with non-LVRR, LVRR patients were more likely to be females, less likely to have an ischaemic aetiology of mitral regurgitation or a prior (<6 months) heart failure (HF) hospitalization, and had smaller left ventricular dimensions. New York Heart Association class improved from baseline up to 1-year follow-up in both groups. Higher rates of overall survival (87.3% vs. 75.2%, P = 0.039), freedom from HF hospitalization (77.2% vs. 60%, P = 0.020), and freedom from the composite endpoint (cardiovascular mortality or HF hospitalization) (74.7% vs. 55.2%; P = 0.012) were observed in LVRR vs. non-LVRR patients at 2-year follow-up. LVRR was associated with a significant reduction of the adjusted relative risk of mortality, HF hospitalization and composite endpoint [hazard ratio (HR) 0.44; 95% confidence interval (CI) 0.20-0.96, P = 0.040; HR 0.55; 95% CI 0.32-0.97, P = 0.038; and HR 0.54; 95% CI 0.32-0.92, P = 0.023, respectively]. Female gender, absence of diabetes, freedom from prior HF hospitalization, non-ischaemic aetiology of mitral regurgitation, and left ventricular end-diastolic diameter < 75 mm were found to be independent predictors of LVRR.Conclusions: Left ventricular reverse remodelling is associated with better long-term outcomes in patients with FMR successfully treated with MitraClip. A careful patient selection may be useful as specific baseline features predict favourable left ventricular remodelling. [Correction added on 17 January 2019, after online publication: the preceding sentence has been changed.]. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study was to investigate the feasibility, safety, and efficacy of Mitraclip therapy in patients with functional mitral regurgitation (MR) and missing leaflet coaptation (MLC).Methods and Results: Out of 62 consecutive patients with functional MR undergoing Mitraclip implantation, 22 had MLC defined as the presence of a 'gap' between two mitral leaflets or insufficient coaptation length (<2 mm), according to the EVEREST II criterion. Compared with the control group, the MLC population had a significantly higher effective regurgitant orifice area (0.67 ± 0.31 vs. 0.41 ± 0.13 cm2 ; P = 0.019) and sphericity index (0.80 ± 0.11 vs. 0.71 ± 0.10; P = 0.003). MLC patients were treated with pharmacological/mechanical support in order to improve leaflet coaptation and to prepare the mitral valve apparatus for grasping. Implantation of >1 clip and device time were comparable in patients with and without MLC (61.9% vs. 47.5%; P = 0.284 and 101 ± 39 vs. 108 ± 69 min; P = 0.646, respectively). No significant differences were observed between the two cohorts in technical success (95.5% vs. 97.5%, P = 0.667), 30-day device success (85.7% vs. 78.9%; P = 0.525), procedural success (81.8% vs. 75%; P = 0.842), and 1-year patient success (52.9% vs. 44.1%; P = 0.261), defined according to the MVARC (Mitral Valve Academic Research Consortium) criteria. The long-term composite endpoint of cardiovascular death and heart failure hospitalization was similar in the two groups (49.9% vs. 44.4%; P = 0.348). A significant improvement of MR and NYHA functional class and a lack of reverse remodelling were observed up to 2 years in both arms.Conclusion: The Mitraclip procedure could be extended to patients with functional MR who do not fulfil the coaptation length EVEREST II criterion and who would otherwise be excluded from this treatment. [ABSTRACT FROM AUTHOR]

Objectives To assess outcomes for MitraClip therapy in patients with refractory heart failure (HF) and mitral regurgitation (MR) ≥3+. Background The beneficial role of Mitraclip also in patients with severe HF has been reported. Methods Out of 45 patients undergoing MitraClip implantation at our institute, 16 were on refractory HF defined as diuretics and/or inotropics infusion and/or IABP dependence (group A) or labile haemodynamic balance (group B). Results Patients were aged 69 ± 13 years and 75% were males. Group A (8 patients) had a mean hospitalization length before MitraClip procedure of 5333 days. Group B (8 patients) had a mean rate of hospitalization, in the last 50 days before procedure, of 254 days. Acute procedural success was observed in 94% of patients. All but one patients of group A were quickly weaned from pharmacologic and/or mechanical supports within 5 ± 3 days from procedure and discharged at 20±10 days. All patients of group B were discharged after 10±8 days from MitraClip. At 1 year: a) cumulative survival rate was 78%; b) all patients were in NYHA functional class ≤ II; c) residual MR ≤ 2 was observed in 90%; d) systolic pulmonary arterial pressure was significantly reduced compared to the baseline (from 5410 to 398; p = 0,008); e) significant reduction of cumulative HF hospitalization days in the post-procedure year (10 days) compared to the pre-implantation year (280 days; p = 0.023) was observed. Conclusions In patients with refractory HF and MR ≥3+, MitraClip implantation resulted in acute and persistent clinical benefit and net reduction of HF re-hospitalization. (J Interven Cardiol 2015;28:61-68) [ABSTRACT FROM AUTHOR]

Objective Aortic valve replacement (AVR) is the standard therapy in patients with symptomatic aortic stenosis (AS). In high surgical risk patients, alternative therapeutic options to medical treatment (MT) such as trans-catheter aortic valve implantation (TAVI) or balloon aortic valvuloplasty (BAV) have been proposed. In this study we evaluated whether treatment assignment influences per se the prognosis of these subjects. Patients and methods Criteria for treatment assignment were based on patient's clinical conditions, Logistic EuroSCORE and other co-morbidities ignored by EuroSCORE. Due to baseline clinical differences between patients with diverse treatment assignment, we used propensity score matching to achieve balance. Results 368 patients were studied: 141 underwent AVR, 127 TAVI, 49 BAV and 51 MT. 84 events (deaths for all causes) occurred during 14 months of follow-up: 11 AVR (8%), 26 TAVI (20%), 18 MT (35%), 29 BAV group (59%). Traditional Cox analysis identified treatment assignment as independent predictor of events (HR 1.82 [CI 1.10-3.25]) together with lower left ventricular ejection fraction, impaired renal function and history of heart failure. Matched Cox analysis by propensity score confirmed treatment assignment as an independent prognosticator of events (HR 1.90 [CI 1.27-2.85]), and showed similar rate events in TAVI and AVR patients, while it was significantly increased in BAV and MT patients. Conclusions Treatment assignment may influence outcome of symptomatic patients with AS. [ABSTRACT FROM AUTHOR]

Objective: Aortic valve replacement (AVR) is the standard therapy in patients with symptomatic aortic stenosis (AS). In high surgical risk patients, alternative therapeutic options to medical treatment (MT) such as trans-catheter aortic valve implantation (TAVI) or balloon aortic valvuloplasty (BAV) have been proposed. In this study we evaluated whether treatment assignment influences per se the prognosis of these subjects. Patients and methods: Criteria for treatment assignment were based on patient’s clinical conditions, Logistic EuroSCORE and other co-morbidities ignored by EuroSCORE. Due to baseline clinical differences between patients with diverse treatment assignment, we used propensity score matching to achieve balance. Results: 368 patients were studied: 141 underwent AVR, 127 TAVI, 49 BAV and 51 MT. 84 events (deaths for all causes) occurred during 14 months of follow-up: 11 AVR (8%), 26 TAVI (20%), 18 MT (35%), 29 BAV group (59%). Traditional Cox analysis identified treatment assignment as independent predictor of events (HR 1.82 [CI 1.10-3.25]) together with lower left ventricular ejection fraction, impaired renal function and history of heart failure. Matched Cox analysis by propensity score confirmed treatment assignment as an independent prognosticator of events (HR 1.90 [CI 1.27-2.85]), and showed similar rate events in TAVI and AVR patients, while it was significantly increased in BAV and MT patients. Conclusions: Treatment assignment may influence outcome of symptomatic patients with AS. [ABSTRACT FROM AUTHOR]

Aims The paucity of evidences about the long-term durability of currently available transcatheter prostheses is one of the main issues of transcatheter aortic valve implantation (TAVI). We sought to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third generation CoreValve prosthesis (Medtronic Incorporation, MN, USA). Methods and results From the Italian CoreValve registry, 181 who underwent TAVI from June 2007 to August 2008 and eligible for 3-year follow-up were analysed. All outcomes were defined according to the Valve Academic Research Consortium. All-cause mortality at 1, 2, and 3 years was 23.6, 30.3, and 34.8%, respectively. Cardiovascular death at 1, 2, and 3 years was 11.2, 12.1, and 13.5%, respectively. The actuarial survival free from a composite of death, major stroke, myocardial infarction, and life-threatening bleeding was 69.6% at 1 year, 63.5% at 2 years, and 59.7% at 3 years. Patients with renal insufficiency had a higher mortality at 3-year follow-up (49.0 vs. 29.2%, P = 0.007); moreover, patients experiencing post-procedural major or life-threatening bleeding had a higher rate of mortality already seen at 30 days (21.6 vs. 2.8%; P < 0.001) and this result was sustained at 3-year follow-up (62.2 vs. 27.7%; P < 0.001). Mean pressure gradients decreased from 52.2 ± 18.1 mmHg (pre-TAVI) to 10.3 ± 3.1 mmHg (1-year post-TAVI) (P < 0.001); aortic valve area increased from 0.6 ± 0.2 cm2 (pre-TAVI) to 1.8 ± 0.4 cm2 (1-year post-TAVI); these results remained stable over the 3 years of follow-up. Paravalvular leak was observed in the majority of patients. There were no cases of progression to moderate or severe regurgitation. No cases of structural valve deterioration were observed. Conclusion This multicentre study demonstrates that TAVI with the 18-Fr CoreValve ReValving System is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic stenosis up to 3-year follow-up. Non-cardiac causes accounted for the majority of deaths at follow-up. [ABSTRACT FROM PUBLISHER]

Eur J Clin Invest 2012; 42 (4): 376-383 Abstract Background Diabetes is associated with increased cardiovascular mortality. The aim of our study was to determine the prognostic factors for mortality in patients with type 2 diabetes (T2DM) and coronary artery disease (CAD) who underwent coronary angiography and percutaneous coronary intervention. Materials and methods Four hundred and forty-five consecutive T2DM patients with significant CAD (≥ 75% stenosis) were included in our analysis. All patients underwent standard clinical examination, laboratory tests and transthoracic echocardiography with measurement of the left ventricular ejection fraction. Severity of CAD at the coronary angiography was evaluated using the Gensini score. Clinical follow-up was completed at 1, 3 and 6 years. Results During a mean follow-up of 73·3 ± 22·1 months, 109 patients died (24·5%). Significant determinants of an increased risk of death at multivariable analysis were age (p < 0·001), serum creatinine (p = 0·001), peripheral vascular disease (p = 0·002), serum glucose (p = 0·004), serum fibrinogen (p = 0·011) and history of heart failure (HF, p = 0·011). When all the variables were entered as categorical variables, with continuous variables split at their median value, only history of HF, estimated glomerular filtration rate, serum glucose, serum fibrinogen (all p < 0·0001) and beta-blocker therapy at discharge (p = 0·027) were selected. Conclusions Our study shows a relatively good prognosis of patients with T2DM. Comorbidities, namely HF and renal impairment, are main determinants of survival. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management. [ABSTRACT FROM AUTHOR]