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AIMS The aim of this study was to evaluate transcatheter aortic valve-in-valve (ViV) implantation performance in rapid deployment (ViVr) vs. conventional (ViVc) surgical heart valves. METHODS AND RESULTS A multicentre registry was developed as part of the VIVID international registry. A total of 30 ViVr patients (Perceval, n=24, ATS 3f Enable™, n=5, and the INTUITY, n=1) were evaluated and compared with 2,288 ViVc patients. Propensity score (PS) matching was performed to adjust further for bias. Compared with ViVc, ViVr patients presented twice as early after surgical heart valve (SHV) implantation (55.2±36.1 vs. 118.4±57.7 months, p

Patients with pulmonary arterial hypertension (PAH) often complain of chest pain or angina pectoris in the absence of coronary artery disease. In this patients’ subgroup, we reported the prevalence of left main coronary artery (LMCA) extrinsic compression by a dilated pulmonary artery occurs in up

Objectives To evaluate the incidence, treatment, and outcomes of acute aortic regurgitation (ARR) complicating BAV. Background In the transcatheter aortic valve implantation (TAVI) era, there is an increase of percutaneous balloon aortic valvuloplasty (BAV) procedures with different indications. Methods From the prospective BAV registry of the University of Bologna, which has enrolled patients between the year 2000 and the present, we selected those who suffered intraprocedural AAR with overt hemodynamic instability. Worsening of baseline aortic insufficiency without hemodynamic collapse, treatment of degenerated biological valve prosthesis, and BAV performed within a planned TAVI procedure were excluded. The main endpoints were in-hospital and 30-day mortality. Results Out of 1517 BAVs, we identified 26 cases of AAR (1.7%). This complication occurred in 80.8% of cases after one or two balloon inflations. Mean transaortic gradient decreased from 50.6 ± 19.3 to 26.0 ± 14.4 mm Hg (p

Objectives To define the incidence of vascular complications (VC) after balloon aortic valvuloplasty (BAV) in recent years, and to compare the performance of two vascular closure devices (VCD). Background VC remain the most frequent drawback of BAV and are associated with adverse clinical outcomes. Methods All BAV procedures performed at 2 high-volume centers over a 6-year period (n = 930) were collected in prospective registries and investigated to assess the incidence of Valve Academic Research Consortium-2 (VARC-2) defined VC. Incidence of life-threatening, major and minor bleeding was also assessed. In-hospital major adverse cardiac and cerebrovascular events (MACCE) rate (composite of in-hospital death, myocardial infarction, TIA/stroke, and life-threatening bleeding) as well as 30-day survival was compared between a suture-mediated closure system and a collagen plug hemostatic device. Results A 9 Fr arterial sheath was used in most of the patients (84.1%). Vascular closure was obtained with the Angio-Seal in 643 patients (69.1%) and the ProGlide in 287 (30.9%). The overall incidence of major VC was 2.7%, and minor VC 6.6%, without significant differences between groups. The Angio-Seal group was associated with a higher rate of small hematomas (6.9% vs. 3.5%, P = 0.042), whilst blood transfusions were more frequent in the ProGlide group (6.6% vs. 3.5%, P = 0.034). Rates of in-hospital MACCE and 30-day survival were similar. Use of either VCD was not independently associated with major VC. Conclusions VC rate after BAV is fairly low in experienced centers without major differences between the 2 most used VCD.

none 12 no Programma di ricerca Regione-Università, RegioneEmilia-Romagna2010-2012 — Area1Innovativeresearch.Title: Technological innovations in the treatment of heart failure ” Objectives: To compare the effectiveness and safety of balloon aortic valvuloplasty (BAV) performed with or without rapid ventricular pacing (RP). Background: BAV technique is poorly standardized. Methods: One hundred consecutive patients were randomly assigned 1:1 between BAV performed with or without RP. Exclusion criteria were an immediate indication for surgical or transcatheter aortic valve replacement, presentation in cardiogenic shock or pulmonary edema refractory to medical stabilization. Results: There were 51 patients in the BAV group performed with RP, 49 in the BAV group without RP (noRP). Procedural success (50% hemodynamic gradient reduction) was achieved in 37.3% and 55.1%, respectively (P=0.16). Fewer people in the noRP group complained of poor tolerance to the procedure (16% vs 41%). The primary efficacy endpoint, a 50% reduction in the mean echocardiographic trans-aortic gradient, was met in 21/49 patients in the noRP group compared to 20/51 in the RP (42.9% vs 39.2%; P=0.84). No significant difference between the groups was observed in the primary safety endpoint, a 30-day composite of death, myocardial infarction, stroke, acute aortic regurgitation, and BARC bleeding ≥3 (8.2% noRP vs 13.7%; P=0.53). The noRP group required fewer bailout temporary pacemakers (P=0.048) and had a lower incidence of moderate/severe renal function worsening (4.1% vs 17.6%; P=0.052). Conclusions: Rapid ventricular pacing did not influence BAV efficacy or safety and tolerance was slightly worse. none Dall'Ara, Gianni; Marzocchi, Antonio; Taglieri, Nevio; Moretti, Carolina; Rodinò², Giulio; Chiarabelli, Matteo; Bottoni, Paolo; Marrozzini, Cinzia; Sabattini, Maria Rita; Bacchi-Reggiani, Maria-Letizia; Rapezzi, Claudio; Saia, Francesco Dall'Ara, Gianni; Marzocchi, Antonio; Taglieri, Nevio; Moretti, Carolina; Rodinò², Giulio; Chiarabelli, Matteo; Bottoni, Paolo; Marrozzini, Cinzia; Sabattini, Maria Rita; Bacchi-Reggiani, Maria-Letizia; Rapezzi, Claudio; Saia, Francesco

Background Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate. Objectives The aim of the Italian Registry of Chronic Total Occlusions (IRCTO) was to provide data on prevalence, characteristics, and outcome of CTO patients according to the management strategy. Methods The IRCTO is a prospective real world multicentre registry enrolling patients showing at least one CTO. Clinical and angiographic data were collected independently from the therapeutic strategy [optimal medical therapy (MT), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)]; a comparative 1-year clinical followup was performed. Results A total of 1777 patients were enrolled for an overall CTO prevalence of 13.3%. The adopted therapeutic strategies were as follows: MT in 826 patients (46.5%), PCI in 776 patients (43.7%), and CABG in the remaining 175 patients (9.8%). At 1-year follow-up, patients undergoing PCI showed lower rate of major adverse cardiac and cerebrovascular events (MACCE) (2.6% vs. 8.2% and vs. 6.9%; P < 0.001 and P < 0.01) and cardiac death (1.4% vs. 4.7% and vs. 6.3%; P < 0.001 and P < 0.001) in comparison with those treated with MT and CABG, respectively. After propensity scorematching analysis, patients treated with PCI showed lower incidence of cardiac death (1.5 vs. 4.4%; P < 0.001), acute myocardial infarction (1.1 vs. 2.9%; P = 0.03), and re-hospitalization (2.3 vs. 4.4% P = 0.04) in comparison with those managed by MT. Conclusions Our data showed how CTO PCI might significantly improve the survival and decrease MACCE occurrence at 1 year follow-up in comparison with MT and/or CABG.

Objectives To compare the outcomes of trans-subclavian (TS) and transapical (TA) access for transcatheter aortic valve implantation (TAVI). Background A considerable proportion of patients undergoing TAVI are not eligible for transfemoral approach. To date, there are few data to guide the choice between alternative vascular access routes. Methods Among 874 consecutive patients who underwent TAVI, 202 procedures were performed through TA (n = 142, 70.3%) or TS (n = 60, 29.7%) access. Medtronic Corevalve (CV, Medtronic, Minneapolis, MN) was implanted in 17.3% of the patients, the Edwards-Sapien (ES, Edwards Lifesciences Inc., Irvine, CA) in 81.2% and other prostheses in 0.1%. In-hospital and long-term outcome were assessed using the Valve Academic Research Consortium (VARC)-2 definitions. Results Mean age was 82 ± 6 years, STS score 9.3 ± 7.9%. The 2 groups showed a relevant imbalance in baseline characteristics. In hospital mortality was 6.4% (1.7% TS vs. 8.4% TA, P = 0.06), stroke 2.0%, acute myocardial infarction 1.0%, acute kidney injury 39.4%, sepsis 4.0% with no significant differences between groups, while bleeding was more frequent in TA patients (53.5% vs. 11.7% TS, P < 0.001). One- and 2-year survival was 85.2% and 73.2% in TS patients, and 83.9% and 74.9% in TA patients (P = ns for both). Access site was not an independent predictor of mortality at multivariable analysis. Conclusion Transapical compared with trans-subclavian access for TAVI was associated with a nonsignificant trend to increased periprocedural events. However, 1- and 2-year survival appears similar. © 2015 Wiley Periodicals, Inc.

AIMS Percutaneous coronary intervention (PCI) and antithrombotic drugs are the standard therapy for patients with acute coronary syndromes (ACS), but their impact on bleeding and mortality in women has not been adequately investigated. METHODS This was a prospective observational cohort study of ACS patients, who were referred to 6 of the 13 centres belonging to the REgistro regionale AngiopLastiche dell'Emilia-Romagna programme in Emilia-Romagna for coronary angiography and PCI between June 2010 and November 2011. The aim of the study was to verify whether the incidence of Global Registry of Acute Coronary Events-defined in-hospital bleeding after an ACS is significantly higher in women than in men, and to evaluate its impact on short and long-term mortality. RESULTS The analysis involved a total of 1686 patients (511 women and 1175 men). The women were older and more frequently affected by hypertension, congestive heart failure and single-vessel disease; however, none of the clinical or procedural variables was significantly different between the sexes after statistical adjustment. There was a significantly higher rate of in-hospital bleeding among the women [8.6 vs. 5.8%; adjusted odds ratio 1.73, 95% confidence interval (CI) 1.19-2.52, P = 0.004], but the adjusted hazard ratio for short and long-term all-cause mortality was not significantly different. After optimal adjustment, bleeding, but not female sex, was identified as a predictor of short-term all-cause mortality (hazard ratio 2.68, 95% CI 1.21-5.93, P = 0.01), but this was not confirmed in the case of long-term mortality (hazard ratio 1.57, 95% CI 0.91-2.71, P = 0.10). CONCLUSION After optimal adjustment for baseline differences, the findings of this contemporary Italian PCI registry study showed that women experience bleeding more frequently, but do not have worse mortality outcomes than men. Bleeding was confirmed as an independent predictor of short-term mortality.

Objectives This study sought to evaluate acute and long-term outcomes of percutaneous paravalvular regurgitation (PVR) closure after transcatheter aortic valve replacement (TAVR). Background Severe symptomatic PVR is a predictor of all-cause mortality after TAVR. The current use of devices for transcatheter closure of PVR has been adapted from other indications without known long-term outcomes. Methods The study population consisted of a series of cases pooled together from an international multicenter experience. Patients underwent transcatheter implantation of a closure device for the treatment of clinically relevant PVR after TAVR with balloon-expandable or self-expandable prostheses. Procedural success was defined by successful deployment of a device with immediate reduction of PVR to a final grade ≤2 as assessed by echocardiography. Results Twenty-seven procedures were performed in 24 patients with clinically relevant PVR after the index TAVR procedure (54.2% Edwards Sapien [Edwards Lifesciences, Irvine, California], 45.8% CoreValve [Medtronic, Minneapolis, Minnesota]). The study population included 75% men with a mean age of 80.6 ± 7.1 years and mean Society of Thoracic Surgeon score of 6.6%. The most frequently used device was Amplatzer Vascular Plug (St. Jude Medical, St. Paul, Minnesota) in 80% of the cases. Overall, 88.9% (24 of 27) of the procedures were technically successful and the results assessed by echocardiography were durable. However, cumulative survival rates at 1, 6, and 12 months were 83.3%, 66.7%, and 61.5%. Most of the deaths (8 of 11) were due to noncardiac causes. Conclusions Transcatheter closure of PVR after TAVR can be performed with a high procedural success rate; however, the long-term mortality remains high mainly due to noncardiac causes.

Aim: To assess the prevalence and postprocedural evolution of cognitive impairment (CI) in patients undergoing transcatheter aortic valve implantation. Methods: 62 patients were enrolled. Mini Mental state examination (MMSE), verbal memory test (VMT), visual search test (VST) and phonemic verbal fluency (PVF) were used to evaluate the cognitive status. CI was considered when a pathological result of MMSE was confirmed by VMT, VST and PVF. Results: A total of 26.2% patients had CI at baseline. MMSE, VMT, VST and PVF were pathologic in 39, 16.1, 8.1 and 22.6% of the patients, respectively. Overall, no significant differences in cognitive function in any dimension were observed from baseline up to 1-year follow-up. Conclusion: CI is frequent in patients undergoing transcatheter aortic valve implantation, though the procedure does not forge cognitive status.

BACKGROUND: An 80-year-old man with symptomatic severe aortic valve stenosis, haemodynamic instability, important comorbidities and a high surgical risk. Following bridgeballoon aortic valvuloplasty to recover from the unstable haemodynamics he was deemed suitable for transcatheter aortic valve implantation (TAVI) via the femoral access route. INVESTIGATION: Fluoroscopy. DIAGNOSIS: During TAVI, while the operators were preparing for prosthesis deployment (Edwards SAPIEN 3), the extra-stiff guidewire was accidentally withdrawn from the left ventricle (LV) to the ascending aorta. MANAGEMENT: Valve orifice was re-crossed from the contralateral access, a snare was introduced through the AL1 catheter and pushed anterogradely through the valve. The extra-stiff wire was then captured in the ascending aorta and pulled back into the LV to complete the procedure.

To assess the accuracy of cardiac magnetic resonance (CMR) for the diagnosis of angiographic stenosis after percutaneous coronary intervention (PCI) of left main coronary artery (LMCA). Patients undergone in the last year PCI of unprotected LMCA and scheduled for conventional X-ray coronary angiography (CXA) were evaluated with stress perfusion CMR within 2 weeks before CXA. Main contraindications to CMR were exclusion criteria. Stress perfusion CMR was performed to follow a bolus of contrast Gadobutrol after 3 min of adenosine infusion. Between the 50 patients enrolled, only 1 did not finish the CMR protocol and 49 patients with median age 71 (65–75) years (38 male, 11 female) were analyzed. Between 784 coronary angiographic segments evaluated we found 75 stenosis or occlusions (prevalence 9.5%), but only 13 stenosis or occlusions in proximal segments (prevalence 6.6%). Patients with coronary stenosis (n = 12, 24%) showed a significantly (p = 0.002) higher prevalence of diabetes (7 of 12, 58%). At CMR examination, late gadolinium enhancement was present in 25 (51%), reversible perfusion defects in 12 (24%), and fixed perfusion defects in 6 subjects (12%). The only patient with LMCA restenosis resulted positive at perfusion CMR. The accuracy of stress perfusion CMR in diagnosis of coronary stenosis was higher when the analysis was performed only in proximal coronary arteries (95%, CI 86–99) compared to overall vessels (84%, CI 70–92). Stress perfusion CMR could strongly reduce the need for elective CXA in follow up of LMCA PCI and should be validated in further multicenter prospective studies.

Background Left main coronary artery (LMCA) compression is increasingly recognized as a cause of angina in pulmonary arterial hypertension (PAH). Objectives This study aimed to evaluate the prevalence of LMCA extrinsic compression from a dilated pulmonary artery (PA) in patients with PAH and angina or angina-like symptoms, determine the usefulness of screening with computed tomography coronary angiography (CTCA), and assess the safety and efficacy of percutaneous coronary interventions (PCIs). Methods All patients with PAH and angina or angina-like symptoms attending the center between May 1, 2008, and December 31, 2013, underwent CTCA. Patients with confirmed LMCA stenosis on selective coronary angiography had PCI. Results Of 765 patients with PAH, 121 had angina or angina-like symptoms. Ninety-four patients had abnormal CTCA based on the relationship between the PA and the LMCA and underwent selective coronary angiography. LMCA stenosis ≥50% was detected in 48 of the 94 patients. Forty-five patients underwent PCI with stenting, of whom 41 had sustained angina symptom relief. The 3 other patients had surgical PA reduction plasty. Nine months after PCI, 5 patients had LMCA restenosis and PCI was successfully repeated. The best predictor of LMCA stenosis ≥50% was a PA diameter ≥40 mm. Rates for death or double-lung transplant and the composite rates for death, double-lung transplant, or restenosis at 36 months were 5% and 30%, respectively. Conclusions The prevalence of LMCA compression in patients with PAH and angina is high. These results suggest that CTCA is indicated in patients with PAH and angina or angina-like symptoms. PCI was well tolerated, improved symptoms, and resulted in favorable long-term outcomes.

The Ross operation is the procedure of choice for aortic valve disease in paediatric patients, because of the potential for growth of the pulmonary autograft and because anticoagulation is not required. However, early and late autograft dilatation and severe aortic regurgitation may occur. Transcatheter aortic valve implantation (TAVI) is an effective procedure for treatment of severe degenerative aortic stenosis in patients deemed inoperable or high surgical risk. Off-label treatment of severe non-calcified aortic regurgitation with transcatheter heart valves has occasionally been reported. We describe the first case of TAVI for severe aortic regurgitation in a young woman 10 years after a Ross operation. The procedure was performed on a compassionate basis after the patient was deemed inoperable because of severe reactive pulmonary hypertension (95/55/68 mmHg; pulmonary resistance 18.3 UR) and haemodynamic compromise. A 29 mm CoreValve™ (Medtronic, Minneapolis, MN, USA) was implanted. A second prosthesis was deployed "valve-in-valve" for residual severe paravalvular leak, caused by the peculiar post-surgical anatomy of the left ventricular outflow tract. The procedure was successful and the in-hospital course was uncomplicated. During follow-up, pulmonary pressure and resistances were significantly lowered and at four years the patient showed markedly improved exercise tolerance.

OBJECTIVES This study investigated coronary artery remodeling patterns associated with clinical outcomes. BACKGROUND In the prospective, multicenter PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree: An Imaging Study in Patients With Unstable Atherosclerotic Lesions) study, reported predictors of nonculprit lesion (NCL) major adverse cardiac events (MACE) were an intravascular ultrasound (IVUS) minimal lumen area (MLA) = 70%, and a IVUS virtual histology (VH) thin-cap fibroatheroma (TCFA), but not lesion site remodeling. METHODS Overall, 697 consecutive patients with an acute coronary syndrome were enrolled and underwent 3-vessel gray-scale and IVUS-VH; 3,223 NCLs were identified by IVUS. The remodeling index (RI) was calculated as the external elastic membrane area at the MLA site divided by the average of the proximal and distal reference external elastic membrane areas. First, one third of the patients were randomly selected to determine RI cutoffs related to NCL MACE (development cohort). Receiver-operating characteristic analysis showed that there were 2 separate cut points that predicted NCL MACE: RI = 0.8789 and RI = 1.0046 (area under the curve = 0.663). These cut points were used to define negative remodeling as an RI 1.00. Second, we used the remaining two-thirds of patients to validate these cut points with respect to lesion morphology and clinical outcomes (validation cohort). RESULTS Kaplan-Meier curve analysis in the validation cohort showed that NCL MACE occurred more frequent (and equally) in negative and positive remodeling lesions compared with intermediate remodeling lesions. In this cohort, negative remodeling lesions had the smallest MLA, positive remodeling lesions had the largest plaque burden, and VH TCFA, especially VH TCFA with multiple necrotic cores, was most common in negatively remodeling lesions. CONCLUSIONS The present study showed the novel concept that positive and negative lesion site remodeling was associated with unanticipated NCL MACE in the PROSPECT study. (PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions [PROSPECT]; NCT00180466) (C) 2014 by the American College of Cardiology Foundation

Background To date, no published data are available regarding long-term follow-up of new generation DES implanted in coronary artery bypass graft (CABG) lesions. Objectives To assess the long-term clinical outcome of patients receiving the new generation Biolimus A9-coated drug-eluting stent (DES) with biodegradable polymer in saphenous vein grafts (SVG). Methods Three thousand sixty-seven patients were included in the NOBORI 2 registry: 71 patients with a total of 117 lesions received at least 1 biolimus A9 DES in SVG lesions and 2,959 patients received percutaneous coronary intervention in other lesions. Clinical follow-up was performed at 1, 6, and 12 months, and annually up to 3 years. Results Compared to the non-CABG group, patients with CABG lesions were older (P

Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p = 0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up.

Background Stroke is a rare but serious adverse event associated with percutaneous coronary intervention (PCI). However, the relative risk of stroke between stable patients undergoing a direct PCI strategy and those undergoing an initial optimal medical therapy (OMT) strategy has not been established yet. This study sought to investigate if, in patients with stable coronary artery disease (SCAD), an initial strategy PCI is associated with a higher risk of stroke than a strategy based on OMT alone. Methods We performed a meta-analysis of 6 contemporary randomized control trials in which 5673 patients with SCAD were randomized to initial PCI or OMT. Only trials with stent utilization more than 50% were included. Study endpoint was the rate of stroke during follow up. Results Mean age of patients ranged from 60 to 65 years and stent utilization ranged from 72% to 100%. Rate of stroke was 2.0% at a weighted mean follow up of 55.3 months. On pooled analysis, the risk of stroke was similar between patients undergoing a PCI plus OMT and those receiving only OMT (2.2% vs. 1.8%, OR on fixed effect = 1.24 95%CI: 0.85–1.79). There was no heterogeneity among the studies (I2 = 0.0%, P = 0.15). On sensitivity analysis after removing each individual study the pooled effect estimate remains unchanged. Conclusions In patients with SCAD an initial strategy based on a direct PCI is not associated with an increased risk of stroke during long-term follow up compared to an initial strategy based on OMT alone.

BACKGROUND: Several factors have been identified as predictors of events after transcatheter aortic valve implantation (TAVI) but the impact of left ventricular ejection fraction (LVEF) and mean transaortic gradient (MTG) is controversial. This multicenter study aimed to clarify the prognostic role of low LVEF and low MTG after TAVI. METHODS: From 2007 to 2012, 764 consecutive patients with severe symptomatic aortic valve stenosis underwent TAVI at participating hospitals. Patients were divided according to LVEF and MTG into four groups. RESULTS: Sixty-four patients had LVEF 40% or less and MTG less than 40?mmHg, 76 had LVEF 40% or less and MTG at least 40?mmHg, 163 had LVEF more than 40% and MTG less than 40?mmHg, 461 had LVEF more than 40% and MTG at least 40?mmHg. Two-year mortality was significantly higher in patients with low LVEF and low MTG, whereas it was similar in patients with low LVEF and high MTG, high LVEF and low MTG, and high LVEF and high MTG (51.3 vs. 22.4 vs. 23.3. vs. 25.5%, respectively; P?=?0.001). These results were confirmed by multivariate analysis, as the combination of low LVEF and low MTG (both less than 40) was identified as the stronger mid-term mortality predictor (hazard ratio 2.4, confidence interval 95% 1.4–3.9; P?=?0.001). CONCLUSION: At least one parameter between LVEF or MTG over 40 predicts a good prognosis for TAVI patients at mid-term follow-up, whereas those with both left ventricular dysfunction and low mean aortic pressure gradient are at high risk of all-cause death after TAVI.

Background— Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets for implantation that would improve hemodynamics after ViV. Methods and Results— Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated postprocedural gradients (mean ≥20 mm Hg). Optimal implantation depths were defined by receiver operating characteristic curve. A total of 292 consecutive patients (age, 78.9±8.7 years; 60.3% male; 157 CoreValve Evolut and 135 Sapien XT) were evaluated. High implantation was associated with significantly lower rates of elevated gradients in comparison with low implantation (CoreValve Evolut, 15% versus 34.2%; P =0.03 and Sapien XT, 18.5% versus 43.5%; P =0.03, respectively). Optimal implantation depths were defined: CoreValve Evolut, 0 to 5 mm; Sapien XT, 0 to 2 mm (0–10% frame height); sensitivities, 91.3% and 88.5%, respectively. The strongest independent correlate for elevated gradients after ViV was device position (high: odds ratio, 0.22; confidence interval, 0.1–0.52; P =0.001), in addition to type of device used (CoreValve Evolut: odds ratio, 0.5; confidence interval, 0.28–0.88; P =0.02) and surgical valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51–6.45; P =0.002). Conclusions— High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self- and balloon-expandable transcatheter valves. These clinical evaluations support specific implantation targets to optimize hemodynamics after ViV.

Degenerative aortic stenosis (AS) is a growing cause of heart failure and death in the elderly. The majority of patients with symptomatic AS are currently treated with surgical or transcatheter aortic valve replacement (TAVR). It was recently suggested [(1)][1] that a share of the sometimes lethal

Italy was one of the first countries in Europe to perform primary percutaneous coronary intervention (p-PCI) and some regions are still a model for the ST-elevation myocardial infarction (STEMI) network organisation. However, in Italy, as in other European countries, some regional disparities have emerged which are related to geographical, economic, organisational and structural issues. Although some regions have excellent STEMI networks, others still have to develop a model which will allow each STEMI patient to receive the best reperfusion treatment. Seven areas where patient clinical needs are not met were identified as primary "Stent for Life" targets in Italy: five main regions in the south of Italy, namely Campania, Sicilia, Puglia, Basilicata and Calabria, and two major areas in the north, the districts of Piemonte and Veneto. In this review we describe socio-political issues and orographic barriers to implementation of STEMI guidelines that have been identified and some hints on what we have done in each target region in order to expand the p-PCI service.

Objectives The goal of this study was to assess the procedural and 2-year results of the subclavian approach for transcatheter aortic valve implantation (TAVI) compared with those of the femoral approach by using propensity-matched analysis. Background The subclavian approach with the CoreValve prosthesis (Medtronic, Inc., Minneapolis, Minnesota) represents an interesting opportunity when the femoral access is unfeasible. Methods All consecutive patients enrolled in the Italian CoreValve Registry who underwent TAVI with the subclavian approach were included. Propensity score analysis was used to identify a matching group of patients undergoing femoral TAVI. Results Subclavian approach was used in 141 patients (61% men; median age 83 years; median logistic European System for Cardiac Operative Risk Evaluation score 23.7%). The femoral group of 141 patients was matched for baseline clinical characteristics, except for peripheral artery disease. The 2 groups showed similar procedural success (97.9% vs. 96.5%; p = 0.47), major vascular complications (5.0% vs. 7.8%; p = 0.33), life-threatening bleeding events (7.8% vs. 5.7%; p = 0.48), and combined safety endpoint (19.9% vs. 25.5%; p = 0.26). The subclavian group showed lower rates of acute kidney injury/stage 3 (4.3% vs. 9.9%; p = 0.02), of minor vascular complications at the 18-F sheath insertion site (2.1% vs. 11.3%; p = 0.003), and of all types of bleeding events related to vascular complications. Survival at 2 years was 74.0 ± 4.0% in the subclavian group compared with 73.7 ± 3.9% in the femoral group (p = 0.78). The 2-year freedom from cardiovascular death was 87.2 ± 3.1% versus 88.7 ± 2.8% in the subclavian versus femoral group, respectively (p = 0.84). Conclusions The subclavian approach for TAVI is safe and feasible, with procedural and medium-term results similar to the femoral approach. Subclavian access should be considered a valid option not only when the femoral approach is impossible but also when it is difficult, albeit feasible.

Current recommendations for the antithrombotic management of patients receiving oral anticoagulation (OAC) who undergo percutaneous coronary intervention with stent implantation (PCI-S) are based on limited and relatively weak data. To broaden and strengthen available evidence, the management and 1-year outcomes of OAC patients who underwent PCI-S and were included in a prospective, multicenter registry from 2003 to 2007 were evaluated. Among the 632 patients receiving OAC, mostly because of atrial fibrillation (58%), who underwent PCI-S, mostly because of acute coronary syndromes (63%), dual-antiplatelet therapy with aspirin and clopidogrel was the most frequently prescribed at discharge (48%), followed by triple therapy with OAC, aspirin, and clopidogrel (32%) and OAC plus aspirin (18%). The choice of antithrombotic therapy largely matched the thromboembolic risk profiles of patients, with the prescription of regimens including OAC predicted by the presence of non-low-risk features. The cumulative 1-year occurrence of major adverse cardiovascular events was as high as 27% and was not significantly different among the 3 treatment groups. Stroke and stent thrombosis were limited to 2% and 3%, respectively, and although no significant differences were found among the 3 groups, stroke was 4 times less frequent when OAC, with either 1 or 2 antiplatelet agents, was administered. Major bleeding was also limited to 3%, with no significant differences among the 3 groups. In conclusion, these findings suggest overall real-world management of OAC patients who undergo PCI-S that is in accordance with their clinical risk profiles and give further support to the reported efficacy and safety of triple therapy for the optimal treatment of these patients.

Objectives This study sought to assess whether transradial intervention, by minimizing access-site bleeding and vascular events, improves outcomes in patients with ST-segment elevation myocardial infarction compared with the transfemoral approach. Background Bleeding and consequent blood product transfusions have been causally associated with a higher mortality rate in patients with myocardial infarction undergoing coronary angioplasty. Methods We identified all adults undergoing percutaneous intervention for acute myocardial infarction in Emilia-Romagna, a region in the north of Italy of 4 million residents, between January 1, 2003, and July 30, 2009, at 12 referral hospitals using a region-mandated database of percutaneous coronary intervention procedures. Differences in the risk of death at 2 years between patients undergoing transfemoral versus transradial intervention, assessed on an intention-to-treat basis, were determined from vital statistics records and compared based on propensity score adjustment and matching. Results A total of 11,068 patients were treated for acute myocardial infarction (8,000 via transfemoral and 3,068 via transradial route). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for the transradial than for the transfemoral group (8.8% vs. 11.4%; p = 0.0250). The rate of vascular complications requiring surgery or need for blood transfusion were also significantly decreased in the transradial group (1.1% vs. 2.5%, p = 0.0052). Conclusions In patients undergoing angioplasty for acute myocardial infarction, transradial treatment is associated with decreased 2-year mortality rates and a reduction in the need for vascular surgery and/or blood transfusion compared with transfemoral intervention.

Objectives: To assess safety and effectiveness of balloon aortic valvuloplasty (BAV) in patients with symptomatic severe aortic stenosis (AS) and significant aortic regurgitation. Background: BAV is a palliative procedure that has possibly been underused in patients with symptomatic AS not suitable for surgical aortic valve replacement or transcatheter aortic valve implantation. Significant aortic regurgitation is commonly perceived as a contraindication to BAV. Methods: Among 416 consecutive patients undergoing BAV at our Institution, 73 patients showed moderate or severe AR before the procedure. Demographics and baseline characteristics, as well as in-hospital clinical outcome, have been prospectively collected in a dedicated database. Transthoracic echocardiography was regularly performed in all patients undergoing BAV before the procedure and at hospital discharge. Results: Patients had a high-risk profile, confirmed by advanced age (77.2 ± 11.8 years) and important comorbidity (logistic Euroscore 26.5 ± 16.3%). Advanced heart failure was present in 73.9%. Indication to BAV was cardiogenic shock in 9.6%, palliation in 31.5%, bridge in 58.9% of the patients. BAV was performed with standard retrograde approach. Aortic valve area increased from 0.62 ± 0.15 cm2 at baseline to 0.83 ± 0.17 cm2 before discharge (P < 0.001). The degree of AR was improved or unchanged in 65 patients (89%). In-hospital mortality was 6.9%, mainly limited to terminal patients. Symptomatic status at discharge was improved in all surviving patients. Acute AR occurred in seven patients; in five of them it was successfully resolved in the catheterization laboratory. Conclusions: When clinically indicated, BAV can be safely performed in patients with combined aortic stenosis and significant aortic regurgitation. © 2011 Wiley Periodicals, Inc.

Aims Many inoperable patients with severe aortic stenosis (AS) are not immediately eligible for transcatheter aortic valve implantation (TAVI). We evaluated the role of percutaneous balloon aortic valvuloplasty (BAV) in this setting. Methods and results Among 210 consecutive patients referred to our institution for BAV, we identified three groups: immediately eligible for TAVI (n=65, 31%), excluded from TAVI (n=67, 32%), BAV as a bridge to TAVI (n=78, 37%). This last group comprised patients with low left ventricular ejection fraction, frailty or enfeebled status, symptoms of uncertain origin, critical conditions, moderate-to-severe mitral valve regurgitation, need of major non-cardiac surgery. Outpatient clinic visit and echocardiography were performed around one month after BAV to decide the final therapeutic strategy. Mean age was 81±8 years and the vast majority of patients had comorbidities and high-risk features. The incidence of periprocedural adverse events was 6.4%: 5.1% death (four patients: one procedural complication, three, natural disease progression), 1.3% minor stroke. After BAV, 46% of these patients were deemed eligible for TAVI, and 28% for cardiac surgery. Patients who underwent TAVI after bridge BAV showed 94% 30-day survival. Conclusions BAV is a safe and effective tool to bridge selected patients to TAVI when indications are not obvious.

Aims: Treatment delay is a powerful predictor of survival in STEMI patients undergoing primary PCI. We investigated the effectiveness of pre-hospital triage with direct referral to PCI, alongside more conventional referral strategies. Methods and results: From January 2003 to December 2007, 1,619 STEMI patients were referred for primary PCI at our cathlab through two main triage groups: i.e., 1) following pre-hospital triage (n=524), 2) via more conventional triages (n=1,095) represented by the S. Orsola-Malpighi hospital emergency department triage (hub hospital) and local hospital triage. Pre-hospital diagnosis was associated with a 76 minute reduction in pain-to-balloon time (143 [107-216] vs. 219 [149-343], p=0.001) allowing mechanical revascularisation within 90 minutes from the first medical contact in the vast majority of the patients (>80%). Clinically, pre-hospital triage showed no significant reductions in terms of adjusted long-term mortality (HR 0.81, 95% CI 0.61-1.08; p=0.16) in the overall population. However, significant adjusted survival benefits were observed in high-risk groups (i.e., cardiogenic shock, TIMI risk score >30, diabetes mellitus). Conclusions: This study shows that pre-hospital diagnosis allows for significant reductions in primary PCI treatment delays and suggests the hypothesis that this referral strategy might provide long-term survival benefits especially in high-risk patients.

Inoperable or high-risk patients with severe aortic stenosis who undergo transcatheter aortic valve implantation (TAVI) have better outcomes compared with those treated with standard medical therapy. As for any other invasive procedure, peri-procedural complications may occur, reducing the procedural success rate and potentially affecting short- and mid-term outcomes. The transfemoral approach prevails over other possible access-site options in most registries. The use of large introducer sheaths and the need for double arterial vascular access can lead to higher rates of vascular complications in this elderly population, with a high prevalence of baseline peripheral artery disease. In this article, we review the results of recent clinical trials and major registries using the two different bioprosthesis currently available for TAVI, focusing on access site-related complications with transfemoral TAVI, their management and relationship with in-hospital and 30-day survival. Awareness of the mechanisms behind these complications might help in their prevention, recognition and management and may ultimately improve the clinical outcome of TAVI procedures.

Background The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear. Methods and results We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002–June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p =0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p =0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group. Conclusions In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory.

Purpose: Recent recommendations of the International Commission on Radiological Protection state that the use of effective dose ( E ) for assessing patient exposure has severe limitations, though it can be kept for dose comparisons. In cardiology procedures, the equivalent dose ( H T ) is one of the most appropriate dose quantity to be evaluated for risk-benefit assessment. In this study, both E and H T values for ten critical organs in coronary angiography (CA) and percutaneous coronary interventions (PCI) were derived from in-the-field dose-area-product (DAP) measurements in order to provide a database for doses in those procedures. Methods: Conversion factors E / DAP calculated by Monte Carlo methods in two different mathematical human phantoms were applied to DAP values measured on 193 patients (118 CA and 75 PCI). Partial DAP values were recorded in-the-field for each projection and for all patients. The partial effective doses of all projections were summed up to calculate the E of the entire procedure. Similarly, equivalent doses for ten critical organs/tissues (bone, colon, heart, liver, lung, esophagus, red bone marrow, skin, stomach, and thyroid) were derived from H T / DAP conversion factors for different projections calculated by Monte Carlo method. Results: All parameters related to the patient dose, i.e., fluoroscopy times, number of images, DAP, effective doses, and equivalent doses, show a wide range of values depending on the complexity of the patient case and the experience of the cardiologist. The mean fluoroscopy time, DAP, and E values for coronary angiography patients were approximately threefold lower than those for PCI patients; the number of images for CA was half that for PCI. The correlation between effective dose and DAP was excellent for both CA and PCI. The equivalent doses values were in good correlations with DAP values in CA examinations, with Pearson’s coefficients ranging from 0.87 (stomach) to 0.99 (skin) and r mean = 0.94 . The same analysis was performed for PCI procedures. In this case, the trends were only slightly worse because “ r ” ranged from 0.70 (stomach) to 0.92 (bone) and r mean = 0.85 . Simple conversion coefficients to estimate equivalent doses to ten critical organs/tissues from DAP values, for both CA and PCI, were provided for avoiding the need to carry out detailed in-the-field analysis for all projections and for all patients. Conclusions: Measurements in-the-field of DAP values were carried out for two common cardiology procedures and effective doses were derived for each technique from detailed analysis of dose and projection data, using conversion factors provided by two different theoretical models. Equivalent doses to organs/tissues were also calculated using conversion factors proposed in the literature for different projections and cumulative conversion factors H T / DAP for ten organs/tissues were estimated.

Objectives We appraised the incidence and clinical outcomes of patients who were treated with the valve-in-valve (ViV) technique for hemodynamically destabilizing paraprosthetic leak (PPL). Background Device malpositioning causing severe PPL after transcatheter aortic valve implantation is not an uncommon finding. It occurs after release of the prosthesis, leading to hemodynamic compromise. It can be managed successfully in selected cases with implantation of a second device inside the malpositioned primary prosthesis (ViV technique). Methods Consecutive patients (n = 663) who underwent transcatheter aortic valve implantation with the 18-F CoreValve ReValving System (Medtronic, Inc., Minneapolis, Minnesota) at 14 centers across Italy were included in this prospective web-based registry. We identified patients treated with the ViV technique for severe PPL and analyzed their clinical and echocardiographic outcomes. Primary end points were major adverse cerebrovascular and cardiac events and prosthesis performance at the 30-day and midterm follow-up. Results Overall procedural success was obtained in 650 patients (98.0%). The ViV technique was used in 24 (3.6%) of 663 patients. The 30-day major adverse cerebrovascular and cardiac event rates were 7.0% and 0% in patients undergoing the standard procedure and ViV technique, respectively (p = 0.185); the mortality rates were 5.6% versus 0% in patients undergoing the standard procedure and ViV technique, respectively (p = 0.238). There was an improvement in the mean transaortic gradient in all patients without significant difference between the 2 groups (from 52.1 ± 17.1 mm Hg and 45.4 ± 14.8 mm Hg [p = 0.060] to 10.1 ± 4.2 mm Hg and 10.5 ± 5.2 mm Hg, respectively [p = 0.838]). At 12 months, the major adverse cerebrovascular and cardiac event rates in the standard procedure and ViV technique groups were 4.5% and 14.1%, respectively (p = 0.158), and the mortality rates were 4.5% versus 13.7%, respectively (p = 0.230). Conclusions This large, multicenter registry provides important information about the feasibility, safety, and efficacy of the ViV technique with the third-generation CoreValve ReValving System. The clinical and echocardiographic end points compare favorably with those of patients undergoing the standard procedure. The ViV technique offers a viable therapeutic option in patients with acute significant PPL without recourse to emergent surgery.

Objectives This study aims to evaluate whether results of “off-hours” and “regular-hours” primary angioplasty (primary percutaneous coronary intervention [pPCI]) are comparable in an unselected population of patients with ST-segment elevation acute myocardial infarction treated within a regional network organization. Background Conflicting results exist on the outcome of off-hours pPCI. Methods We analyzed in-hospital and 1-year cardiac mortality among 3,072 consecutive ST-segment elevation myocardial infarction (STEMI) patients treated with pPCI between January 1, 2004, and June 30, 2006, during regular-hours (weekdays 8:00 am to 8:00 pm ) and off-hours (weekdays 8:01 pm to 7:59 am , weekends, and holidays) within the STEMI Network of the Italian Region Emilia-Romagna (28 hospitals: 19 spoke and 9 hub interventional centers). Results Fifty-three percent of patients were treated off-hours. Baseline findings were comparable, although regular-hours patients were older and had more incidences of multivessel disease. Median pain-to-balloon (195 min, interquartile range [IQR]: 140 to 285 vs. 186 min, IQR: 130 to 280 min; p = 0.03) and door-to-balloon time (88 min, IQR: 60 to 122 vs. 77 min, IQR: 48 to 116 min; p Conclusions When pPCI is performed within an efficient STEMI network focused on reperfusion, the clinical effectiveness of either off-hours or regular-hours pPCI is comparable.

OBJECTIVE To compare the long-term efficacy of cobalt-chromium bare-metal stents (CCSs) with that of first-generation drug-eluting stents (DESs) in patients within a large real-world multicentre registry. METHODS The incidence of major adverse cardiac events [death, acute myocardial infarction, and target-vessel revascularization (TVR)] and angiographic stent thrombosis were assessed in consecutive patients undergoing percutaneous coronary intervention with CCS (n = 1103) or DES (n = 5195) during 2-year follow-up. Propensity score-adjusted outcomes, overall and in patients with low (≤ 10%), intermediate (10-15%), and high (>15%) 1-year restenosis risk, were estimated. RESULTS DES-treated patients had significantly higher rates of diabetes, longer lesions, and smaller vessel diameters than CCS-treated patients (all P < 0.0001). However, CCS patients were older and presented a higher rate of hypertension, previous myocardial infarction, and heart failure (all P < 0.01). At 2 years, adjusted rates of myocardial infarction, death, and cumulative-stent thrombosis were similar for DES and CCS. DES provided statistically significant (P < 0.01) reductions in TVR and adjusted major adverse cardiac event rates (9.7 and 17.2%, respectively) compared with CCS (13.2 and 21.2%, respectively). In patients at highest and intermediate risk of restenosis, adjusted TVR rates were significantly (P < 0.01) lower with DES (12.2 and 8.9%, respectively) than CCS (19.9 and 17.1%, respectively), but rates were similar in low-risk patients. CONCLUSION DESs were more effective than CCSs in lowering TVR rates in patients with an intermediate-high baseline restenosis risk.

Objective We sought to assess what proportion of patients with severe symptomatic aortic stenosis who are excluded from cardiac surgery are eligible for transcatheter aortic valve implantation (TAVI). Methods Between July 2007 and December 2008, 98 patients with severe symptomatic aortic stenosis judged inoperable were referred to our institution for percutaneous aortic balloon valvuloplasty (PABV). They entered a screening for TAVI with the CoreValve Revalving System or the Edwards-Sapien valve, comprising general clinical evaluation, echocardiogram, coronary angiography, angiography and angio-CT scan of thoracic aorta and ilio-femoral axes. Results Mean patients' age was 82 +/- 7 years; the vast majority presented relevant comorbidities. Mortality risk predicted by the logistic European System for Cardiac Operative Risk Evaluation was on average 25.3 +/- 14.5%. Overall, 45 (45.9%) patients met the criteria for TAVI: 29.6% for percutaneous transfemoral access, 6.1% for trans-subclavian and 10.2% for transapical approaches. Reason for exclusion was severe noncardiac comorbidity in around half of the cases. PABV allowed re-classification of several patients with very poor left ejection fraction and severe mitral regurgitation. Among the 39 patients undergoing TAVI after the screening, in-hospital mortality was 3.7% for transfemoral and 0 for trans-subclavian and transapical approaches. Conclusions TAVI represents a viable therapeutic option for elderly patients with severe symptomatic aortic stenosis who are not candidates for surgical aortic valve replacement. However, presently less than half of them actually fulfil the criteria for these procedures.

Background— Transcatheter aortic valve implantation (TAVI) is a new option for patients with severe aortic stenosis at high surgical risk. The standard retrograde approach through the femoral artery is contraindicated in case of unfavorable iliofemoral anatomy or extensive disease. In these patients, a trans-subclavian approach may be feasible. Methods and Results— Between June 2007 and July 2009, TAVI with the CoreValve bioprosthesis (Medtronic, Minneapolis, Minn) was performed in 514 consecutive patients at 13 Italian hospitals, using the subclavian approach in 54 cases. The median logistic EuroSCORE was significantly higher in the subclavian (19.4; interquartile range, 12.5 to 29.8) versus femoral group (25.3; interquartile range, 15.1 to 36.6) ( P =0.03), as well as the rate of comorbidities. Procedural success was obtained in 100% versus 98.4% of the subclavian versus femoral groups, respectively ( P =0.62), with intraprocedural mortality of 0% versus 0.9% ( P =1.00). The most common in-hospital complications were a new left bundle-branch block (22.4%) and the need for pacemaker (16.3%). No specific complications for the subclavian access (vessel rupture, vertebral or internal mammary ischemia) were reported. The learning curve for the subclavian approach led to a wider use of local anesthesia. Thirty-day mortality was 0% versus 6.1% in the subclavian versus femoral groups, respectively ( P =0.13). Six-month mortality rate was 9.4% versus 15.8% ( P =0.44), whereas valve-related adverse events were 13.6% versus 13.9% ( P =0.79). Conclusions— TAVI through the subclavian approach appeared feasible and safe, with excellent procedural success and low in-hospital complication rates. This new technique allows patients with contraindications to the femoral approach to be treated with TAVI.

Background The long-term safety and efficacy of drug eluting stents (DES) implanted during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) is unclear. The purpose of this study was to compare the long-term outcome of STEMI patients undergoing primary PCI with DES vs. bare metal stent (BMS) implantation. Methods In the present analysis 4764 patients were enrolled (706, 15%, received DES). We assessed the cumulative incidence of major adverse cardiac events (MACE) and stent thrombosis (ST). Results Overall, no significant difference emerged for the rates of death and reinfarction. DES implantation was associated to a reduction of target vessel revascularization (TVR) (HR 0.65, 95%CI 0.47–0.91; p =0.01), leading to a MACE reduction (HR 0.7, 95%CI 0.56–0.86; p p p =0.01). On the contrary, during the third year, adverse events tended to be higher in the DES group. ST did not differ between DES and BMS groups ( p =0.6). No differences were observed between sirolimus eluting stents and paclitaxel eluting stents. Conclusions DES implantation during primary PCI is safe and associated with a significant TVR and MACE reduction in the first two years, whereas a trend to have more adverse events in the third year is observed. More data about long-term follow-up are needed to better evaluate both safety and efficacy of DES in the setting of STEMI.

In this study we investigated the impact of acute coronary syndromes (ACSs) on clinical outcomes in patients with unprotected left main coronary artery (ULMCA) stenosis treated with drug-eluting stents (DESs). In this multicenter, retrospective, observational study we enrolled 1,101 patients with ULMCA stenosis treated with DESs. Six hundred eleven patients presented with ACS and 490 had stable coronary artery disease. ACS was defined as the presence of unstable angina or non-ST-segment elevation myocardial infarction (MI). During 2-year follow-up, the adjusted hazard ratio of cardiac mortality and MI of patients with ACS versus stable patients was 2.42 (95% confidence interval 1.37 to 4.28, p = 0.002). We observed a stepwise risk increase, namely patients with stable coronary disease had the lowest risk, patients with unstable angina an intermediate risk, and patients with non-ST-segment elevation MI the highest risk. The increased risk of cardiac mortality and MI of patients with ACS was concentrated in the first year after DES implantation. In conclusion, patients with ULMCA stenosis and ACS treated with DESs have an increased risk of cardiac mortality and MI during the first year after the intervention compared to stable patients.

Objectives The aim of this study was to investigate whether there is a temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI). Background Identifying which periods during follow-up of patients with ULMCA stenosis treated with PCI are associated with higher risk of clinical events might help to improve therapeutic strategies. Methods We analyzed data from 15 centers involved in an observational study conducted by the Italian Society of Invasive Cardiology on patients with ULMCA stenosis treated with PCI. Eight hundred ninety-four patients were enrolled. Results At 30-day follow-up, the rate of cardiac mortality and myocardial infarction (MI) was 5.4%. In patients still taking dual antiplatelet therapy, the adjusted incidence rate ratio/10,000 patient-days of the combination of cardiac mortality and MI in the 31- to 180-day interval compared with the 181- to 360-day interval after PCI was 3.64 (p = 0.035). This risk was particularly high in patients with acute coronary syndromes. After stopping clopidogrel, the adjusted incidence rate ratio of cardiac mortality and MI in the 0- to 90-day interval compared with the 91- to 180-day interval was 4.20 (p = 0.009). Conclusions In patients with ULMCA stenosis taking dual antiplatelet therapy there is an increased hazard of cardiac mortality and MI between 31 and 180 days compared with 181 to 360 days. Furthermore, there is an increased hazard of cardiac mortality and MI in the first 90 days after stopping clopidogrel.

Aims To evaluate the clinical impact of early administration of glycoprotein IIb/IIIa agents (IIb/IIIa agents) in the context of a dedicated hub and spoke network allowing very prompt pharmacological/mechanical interventions. Methods and results Using a prospective database, we conducted a cohort study of ST-elevation myocardial infarction (STEMI) patients ( n = 1124) undergoing primary percutaneous coronary interventions (PPCIs) and IIb/IIIa agents administration (period, 2003–2006). Comparisons were planned between patients receiving early IIb/IIIa agents administration (in hub/spoke centre emergency departments or during ambulance transfer; early group, n = 380) or delayed administration (in the catheterization laboratory; late group, n = 744). The primary outcome measure was long-term overall mortality/re-infarction. Baseline characteristics of the two groups were largely comparable. Angiographically, early group patients more often achieved pre-PPCI TIMI Grade 2–3 and TIMI Grade 3 flow. Clinically, the early administration group experienced lower 2-year risk of unadjusted mortality/re-infarction (17 vs. 23%; P = 0.01). After adjustment for potential confounders, early administration was associated with favourable outcome in the overall population (HR = 0.71, P = 0.03) and in high-risk subgroups (TIMI risk index >25, HR = 0.64, P = 0.02; Killip class >1, HR = 0.54, P = 0.01). Conclusion In patients treated by PPCI within a STEMI network setting, early administration of IIb/IIIa agents may provide long-term clinical benefits. Notably, these results appeared magnified in high-risk patients.

Percutaneous revascularization of saphenous vein grafts (SVGs) remains a challenging task. Drug-eluting stents (DESs) have been shown to decrease the incidence of restenosis in de novo native coronary artery lesions. However, their clinical value in SVGs remains to be established. We compared long-term clinical outcomes of percutaneous coronary intervention with DESs and bare metal stents (BMSs) for de novo lesions in SVGs. In a large prospective, multicenter registry, 360 patients underwent stenting of a de novo lesion in SVGs using BMSs (288 patients) or DESs (72 patients). Incidence of major adverse cardiac events (MACEs), including all-cause mortality, reinfarction, and target vessel revascularization, was recorded at a 12-month follow-up. Compared with the DES group, patients receiving BMSs were more likely to be men, to have chronic renal insufficiency or higher Charlson scores, but less likely to have undergone previous percutaneous coronary intervention. Incidence of MACEs at 12-month follow-up was similar in the 2 groups (17.8% in DES group vs 20.3% in BMS group, respectively, p = 0.460). Cox regression analysis identified age, chronic renal failure, cardiogenic shock at presentation, and ostial location of stenosis as independent predictors of long-term MACEs. In conclusion, our data suggest that rates of 12-month MACEs associated with the use of DESs and BMSs are similar in patients undergoing treatment of de novo lesions in SVGs.

Background— The long-term effectiveness of drug-eluting stents (DES) in unselected diabetics in routine practice is currently unclear. Methods and Results— To evaluate the long-term effectiveness of bare metal stents and DES in a real-world setting of diabetic patients, we analyzed 2-year follow-up data from all diabetic patients with de novo lesions enrolled in a prospective Web-based multicenter registry (Registro Regionale Angioplastiche dell’Emilia-Romagna; study period, 2002 to 2004) comprising all 13 hospitals performing percutaneous coronary interventions in the Emilia-Romagna region of Italy. Among the 1648 eligible patients treated with either bare metal stents alone (n=1089) or DES alone (n=559), 27% were insulin dependent and 83% had multivessel coronary disease. At 2 years, use of DES was associated with lower crude incidence of major adverse cardiac advents (all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization) compared with bare metal stents (22.5% versus 28.1%; P =0.01). After propensity score adjustment, only target vessel revascularization appeared significantly lower in the DES group (11.6% versus 15.0%; hazard ratio, 0.66; 95% confidence interval, 0.46 to 0.96; P =0.041). Two-year angiographic stent thrombosis occurred in 1.5% DES patients and 0.7% of the bare-metal-stents patients ( P =0.18). At Cox regression analysis, predictors of 2-year major adverse cardiac advents were left ventricular ejection fraction Conclusions— In this large, real-world, diabetic population, the use of DES was associated with a moderate reduction in the 2-year risk of target vessel revascularization, a benefit that was limited to non–insulin-dependent diabetic patients. Larger long-term studies are needed to clarify the long-term effectiveness and safety of such devices in diabetic patients.

Drug-eluting stents (DES) in percutaneous coronary interventions significantly reduce rates of restenosis and the need for new revascularizations compared with bare metal stents. However, as the use of DES has increased dramatically, questions have been raised about their long-term safety. Concerns about an increased risk of late stent thrombosis, particularly beyond the first year of treatment, have arisen and have been exacerbated by sparse and conflicting information, and boosted an intense debate between cardiologists. In this article, we reviewed the most recent information to clarify the conundrum of late stent thrombosis and the long-term safety of DES.

Aims To evaluate the predictive value of high sensitivity (hs) C-reactive protein levels on long-term survival in patients with ST-elevation myocardial infarction (STEMI) treated with primary PCI. Methods and results We conducted a retrospective analysis of 758 STEMI patients (from January 2003 to December 2005), with STEMI onset < 12 h and hs-C-reactive protein determination on admission. Patients were classified into four groups [I (hs-C-reactive protein < 0.48 mg/dL), II (hs-C-reactive protein ≥ 0.48 to < 1.2 mg/dL), III (hs-C-reactive protein ≥ 1.2 to < 3.1 mg/dL), IV (hs-C-reactive protein ≥ 3.1 mg/dL)] according to quartiles of hs-C-reactive protein serum level. The IV quartile hs-C-reactive protein group had a higher incidence of in-hospital mortality and cumulative adverse events. At a mean follow-up of 724 ± 376 days (range 0–1393), the IV quartile hs-C-reactive protein group showed lower estimated survival, lower estimated myocardial infarction-free survival and lower estimated event-free survival. At multivariable analysis hs-C-reactive protein appeared to be an independent predictor of long-term mortality (HR: 1.04, 95% CI: 1.01–1.07, P = 0.003), long-term mortality and re-infarction (HR: 1.03, 95% CI: 1.01–1.06, P = 0.008) and adverse events (HR: 1.03, 95% CI: 1.01–1.05, P = 0.03). Conclusion Evaluation of hs-C-reactive protein on admission in STEMI patients undergoing primary PCI allows reliable risk stratification of these patients.

The Italian Society of Interventional Cardiology is aware of the existence of significant local and individual disparities and discordant prescriptions in antiplatelet therapy administered with coronary stents, a critical issue due to the large use of drug-eluting stents (DES), the increasing complexity of percutaneous coronary interventions and the more stringent requirement to avoid stent thrombosis. Current percutaneous coronary intervention is attempting more aggressively to treat difficult lesions and patient cohorts with a high procedural success rate. Double antiplatelet therapy with aspirin (ASA) and thienopyridine is the best current treatment to reduce the risk of coronary stent thrombosis. Due to the lower incidence of side-effects compared to ticlopidine, clopidogrel should be the thienopyridine of choice in association with ASA in the double antiplatelet regimen. However, the combination of delayed healing with DES and the increasing complexity of the stent implantation raises more demanding safety concerns about the dosage and duration of dual antiplatelet therapy.

Background— The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently. Methods and Results— Between July 2002 and June 2005, 10 629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group ( P =0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group ( P =0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group ( P =0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction ( P =0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization ( P P Conclusions— In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.

High residual platelet reactivity (RPR) on clopidogrel treatment has been associated with increased risk for ischemic events during follow-up in patients with acute coronary syndromes. The aim of this study was to assess the incidence, predictors, and clinical consequences of high RPR in a large population of patients with non-ST-segment elevation acute coronary syndromes who underwent percutaneous coronary intervention and stenting. Overall, 833 patients received point-of-care testing of platelet inhibition 30 days after percutaneous coronary intervention. High RPR was diagnosed on the basis of P2Y₁₂ reaction units >230. The incidence and predictors of death, myocardial infarction, stroke, and serious bleeding events were assessed up to 1 year from the day of testing. P2Y₁₂ reaction units were normally distributed, and 264 patients were classified as poor responders (31.7%). Independent predictors of response to clopidogrel were male gender (odds ratio [OR] 1.51), age (OR 0.96), diabetes mellitus (OR 0.51), and use of proton pump inhibitors (OR 0.59). At 1 year, poor responders showed higher rates of death (4.6% vs 1.9%, p = 0.032) and serious bleeding events (4.9% vs 1.8%, p = 0.009) compared with good responders. After adjustment for confounders, high RPR did not emerge as an independent predictor of mortality (OR 0.57, 95% confidence interval [CI] 0.23 to 1.42, p = 0.23) or serious bleeding events (OR 0.61, 95% CI 0.25 to 1.52, p = 0.29). The results did not change using the a cut-off value for P2Y₁₂ reaction units of 208. In conclusion, 1/3 of patients with acute coronary syndromes who underwent percutaneous coronary intervention and stenting showed high on-treatment RPR on bedside monitoring. They had a worse prognosis, but the level of platelet inhibition was not independently associated with the incidence of ischemic or bleeding events.

Background— In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. Methods and Results— In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33–1.03; P =0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37–0.93; P =0.022; interaction P =0.97). Bleeding was significantly lower in the bivalirudin group both in the radial- and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27–0.74; P =0.002). Conclusions— In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01087723.

Background— Epidemiology and consequences of surgery in patients with coronary stents are not clearly defined, as well as the impact of different stent types in relationship with timing of surgery. Methods and Results— Among 39 362 patients with previous coronary stenting enrolled in a multicenter prospective registry and followed for 5 years, 13 128 patients underwent 17 226 surgical procedures. The cumulative incidence of surgery at 30 days, 6 months, 1 year, and 5 years was 3.6%, 9.4%, 14.3%, and 40.0%, respectively, and of cardiac and noncardiac surgery was 0.8%, 2.1%, 2.6%, and 4.0% and 1.3%, 5.1%, 9.1%, and 31.7%, respectively. We assessed the incidence and the predictors of cardiac death, myocardial infarction, and serious bleeding event within 30 days from surgery. Cardiac death occurred in 438 patients (2.5%), myocardial infarction in 256 (1.5%), and serious bleeding event in 1099 (6.4%). Surgery increased 1.58× the risk of cardiac death during follow-up. Along with other risk factors, the interplay between stent type and time from percutaneous coronary intervention to surgery was independently associated with cardiac death/myocardial infarction. In comparison with bare-metal stent implanted >12 months before surgery, old-generation drug-eluting stent was associated with higher risk of events at any time point. Conversely, new-generation drug-eluting stent showed similar safety as bare-metal stent >12 months and between 6 and 12 months and appeared trendly safer between 0 and 6 months. Conclusions— Surgery is frequent in patients with coronary stents and carries a considerable risk of ischemic and bleeding events. Ischemic risk is inversely related with time from percutaneous coronary intervention to surgery and is influenced by stent type.