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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.

OBJECTIVES We compared the clinical outcome of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a real-world scenario. BACKGROUND In selected patients, SES has been associated with lower late luminal loss than PES. Whether this emerging biological difference could translate into different clinical efficacy in daily practice is presently unknown. METHODS This analysis included 1,676 consecutive patients with de novo coronary lesions treated solely with drug-eluting stents (SES = 992; PES = 684). All patients were enrolled in a dynamic prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR) during follow-up. RESULTS Overall, 29% of the patients had diabetes, 23% had prior MI, and 9% had poor left ventricular function. ST-segment elevation MI was diagnosed at admission in 12%. Multivessel intervention was performed in 16%. At 1-year follow-up, SES was associated with a reduced incidence of MACE (9.2% SES vs. 14.1% PES; p = 0.007) and TVR (5.0% SES vs. 10.0% PES; p = 0.0008) compared to PES. A propensity analysis with many clinical and angiographic variables was carried out to adjust for baseline differences. In this analysis, SES was associated with a 44% risk reduction of MACE (hazard ratio 0.56, 95% confidence interval 0.39 to 0.78) and a 55% reduction of TVR (hazard ratio 0.45, 95% confidence interval 0.29 to 0.70). This result was consistent across most subgroups tested. Similar rates of death and MI were observed in the 2 treatment groups. CONCLUSIONS In this large real-world population, SES improved 1-year clinical results as compared to PES.

Although great interest exists in the relative efficacy of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) for the treatment of unprotected left main coronary artery stenosis, data comparing the 2 strategies are scant. Furthermore, no comparison has ever been performed between CABG and drug-eluting stents in this setting. From January 2002 to June 2005, 154 patients with unprotected left main coronary artery stenosis underwent CABG and 157 underwent PCI. Ninety-four patients received a drug-eluting stent in the left main artery. After a median follow-up of 430 days, the rate of mortality, acute myocardial infarction, and target lesion revascularization was 12.3%, 4.5%, and 2.6%, respectively, in the CABG group and 13.4%, 8.3%, and 25.5%, respectively, in the PCI group (death and myocardial infarction p = NS, target lesion revascularization p = 0.0001). Although patients treated with drug-eluting stents had a 25% relative risk reduction in the rate of death, myocardial infarction, and target lesion revascularization compared with patients treated with bare stents, event-free survival was still better for patients treated with CABG. In the multivariate analysis, age >/=70 years, New York Heart Association classes III and IV, acute coronary syndromes, and peripheral vascular disease were the only independent predictors of mortality. In conclusion, our results have indicated that at long-term follow-up no difference exists in the rate of mortality and myocardial infarction between PCI and CABG for the treatment of unprotected left main coronary artery stenosis. However, the rate of target lesion revascularization was higher in the PCI group.

Aims Treatment delay is a powerful predictor of survival in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). We investigated effectiveness of pre-hospital diagnosis of STEMI with direct referral to PCI, alongside more conventional referral strategies. Methods and results From January 2003 to December 2004, 658 STEMI patients were referred for primary PCI at our intervention laboratory. Three predefined referral routes were compared: (1) for patients within 90 min drive of the PCI centre, pre-hospital diagnosis and direct transportation ( n =166), (2) diagnosis at the interventional hospital emergency department ( n =316), (3) diagnosis at local hospitals before transportation ( n =176). Pre-hospital diagnosis was associated with more than 45 min reduction in treatment delay ( P =0.001). No significant difference in in-hospital mortality was apparent in the overall study population. In the cardiogenic shock subgroup ( n =80), pre-hospital diagnosis was associated with a two-thirds reduction in in-hospital mortality ( P =0.019); mortality was only 6.2% in shock patients who underwent PCI in

Rupture of a vulnerable plaque is the main cause of acute coronary syndromes and myocardial infarction. The features of rupture-prone atherosclerotic plaques have been previously described by pathologists. However, identification of vulnerable plaques in vivo is essential to study their natural history and to evaluate potential treatment modalities. Coronary angiography is the gold standard for the diagnosis of coronary artery disease, but it is unable to distinguish between stable and unstable plaques and to accurately predict future cardiac events. This current perspective describes the recently developed invasive imaging techniques to detect atherosclerotic vulnerable plaques in the coronary tree.

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.

Objectives The Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial was a multicenter, randomized, open-label trial comparing the safety and performance of 13- and 17-mm QuaDDS stents (n = 126) (Quanam Medical Corp., Santa Clara, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated control stents (n = 140) in focal, de novo coronary lesions. Background The pioneering drug-delivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 μg of the paclitaxel derivative 7-hexanoyltaxol. Methods Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiography and intravascular ultrasound were performed post procedure and at six-month follow-up. Results In the QuaDDS group, early stent thrombosis and myocardial infarction (MI) rates were significantly higher, leading to premature cessation of enrollment. For the QuaDDS group, the stent thrombosis rate increased from 3.2% to 10.3% between 1 and 12 months, associated with increased non–Q-wave MI and death rates. The angiographic restenosis rate at six months was reduced from 32.7% (control) to 7.4% (p Conclusions Despite angiographic indications of potential anti-restenotic benefit, increased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.

The purpose of this study was to assess the current care of elderly patients with non-ST-elevation acute coronary syndrome (ACS), with particular regard to the rate of use of antiplatelet drugs and the type of strategy, aggressive or conservative, in a population of consecutive patients admitted to 76 Coronary Care Units in Italy.Prospective registry of patients admitted to Coronary Care Units with a diagnosis of non-ST-elevation ACS during a 2-month period. Thirty-day follow-up was available in all patients.Of 1581 patients enrolled in the registry, 564 were 75 years or older. As compared with the 1017 younger patients, elderly patients had a greater prevalence of female sex (42% vs 27%, P.001), hypertension (70% vs 59%, P.001), prior myocardial infarction (MI) (41% vs 29%, P.001), prior angina (18% vs 13%, P.01), prior use of aspirin (49% vs 39%, P.001), ST-segment depression (54% vs 43%, P.001), and troponin positivity (66% vs 59%, P.05). The higher-risk profile of elderly patients was confirmed by the greater number of patients with a high TIMI risk score (37% vs 22%, P.001). GPIIb/IIIa inhibitors were less frequently used in elderly patients (P.05). An aggressive strategy (coronary arteriography within 4 days of admission, followed by revascularization, if feasible) was adopted in 39% elderly patients and in 56% younger patients (P.001). An interventional procedure within 30 days was performed in 30% of elderly patients and 48% of younger patients (P.001). Elderly patients had a more unfavorable 30-day outcome compared with younger ones, as shown by the higher rates of death (6.4% vs 1.7%), acute myocardial infarction (7.1% vs 5%), and stroke (1.3% vs 0.5%). Multivariate analysis of the elderly group identified a conservative strategy (OR, 2.31; 95% CI, 1.20 to 4.48) and a diagnosis of non-Q-wave MI (OR, 2.27; 95% CI, 1.32 to 3.93) as independent predictors of 30-day events.The elderly represent a very high-risk subgroup among patients with non-ST-elevation ACS, with a nearly 4-fold as high 30-day death rate as that of younger patients. These data call for a greater attention to such population, both in terms of an improved representation in clinical research and of the assessment of the outcome of different strategies in appropriately designed randomized trials.

To compare the outcomes of trans-subclavian (TS) and transapical (TA) access for transcatheter aortic valve implantation (TAVI).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.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.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, P0.001). 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.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.

Surgical risk scores fail to accurately predict mortality after transcatheter aortic valve implantation (TAVI). The aim of this study was to develop and validate a dedicated risk score for accurate estimation of mortality risk in these patients. All consecutive patients who underwent TAVI at 6 international institutions were enrolled. Predictors for 1-year all-cause mortality were identified by means of Cox multivariate analysis and incorporated in a prediction score. Accuracy of the score was derived and externally validated for 30-day and 1-year mortality. The net classification improvement compared with the Society of Thoracic Surgeons (STS) score was appraised. A total of 1,064 patients constituted the derivation cohort and 180 patients constituted the external validation cohort. A total of 165 patients (15%) died at 1-year follow-up. Previous stroke (odds ratio [OR] 1.80, 1.4 to 3), inverse of renal clearance (OR 8, 6 to 14), and systolic pulmonary arterial pressure ≥50 mm Hg (OR 2.10, 1.5 to 3) were independently related to 1-year mortality. Area under the curve (AUC) of the survival post TAVI (STT) for 1-year mortality was 0.68 (0.62 to 0.71). At 30 days, 65 patients (7%) had died and the AUC for the STT at this time point was 0.66 (0.64 to 0.75). In the external validation cohorts, the AUC of the STT were 0.66 (0.56 to 0.7) for 30-day and 0.67 (0.62 to 0.71) for 1-year mortality. Net reclassification improvement for STT compared with STS was 31% (p0.001) for 30-day mortality and 14% (p0.001) for 1-year mortality. In conclusion, the STT score represents an easy and accurate tool to assess the risk of short-term and mid-term mortality in patients undergoing TAVI.

This study sought to evaluate acute and long-term outcomes of percutaneous paravalvular regurgitation (PVR) closure after transcatheter aortic valve replacement (TAVR).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.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.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.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.

Background Transcatheter aortic valve replacement (TAVR) is an effective therapeutic option for patients with severe aortic stenosis at high risk for surgery. Identification of causes of death after TAVR may help improve patient selection and outcome. Methods We enrolled 874 consecutive patients who underwent TAVR at 3 centers using all approved bioprostheses and different access routes. Clinical outcomes during follow-up were defined according to the Valve Academic Research Consortium 2 definitions. Causes of deaths were carefully investigated. Results Mean logistic European System for Cardiac Operative Risk Evaluation was 23.5% 15.3%; Society of Thoracic Surgery score, 9.0% +/- 8.2%. The Corevalve (Medtronic, Minneapolis, MN) was used in 41.3%; the Edwards Sapien (Edwards Lifesciences Inc., Irvine, CA) in 57.3%. Vascular access was transfemoral in 75.7%. In-hospital mortality was 5.0%. Cumulative mortality rates at 1 to 3 years were 12.4%, 23.4%, and 31.5%, respectively. Landmark analysis showed a significantly higher incidence of cardiovascular (CV) death in the first 6 months of follow-up and a significantly higher incidence of non-CV death thereafter. At Cox regression analysis, the independent predictors of in-hospital mortality were acute kidney injury grades 2 to 3 (hazard ratio [HR] 3.41) life-threatening bleeding (HR 4.26), major bleeding (HR 4.61), and myocardial infarction (HR 3.89). The independent predictors of postdischarge mortality were chronic obstructive pulmonary disease (HR 1.48), left ventricular ejection fraction at discharge (HR 0.98), and glomerular filtration rate

AIMS: To evaluate the relationship between ECG patterns and infarct related artery (IRA) in an all-comer population with ST-segment elevation myocardial infarction (STEMI) and validate current criteria for identifying IRA (right coronary artery (RCA) versus left circumflex artery (LCA)) in inferior STEMI and for diagnosing left main (LM) or left anterior descendent artery occlusion (LAD) in anterior STEMI.METHODS AND RESULTS: We retrospectively analysed ECGs at presentation and coronary angiogram in 885 consecutive patients undergoing primary percutaneous coronary intervention. Six ECG patterns were identified: anterior-STEMI (n=433; 49.0%), inferior-STEMI (i=365; 43.0%), lateral-STEMI (n=43; 5.0%), left bundle branch block (n=26; 3.0%), posterior-STEMI (n=7; 1.0%) and de Winter sign (n=7; 1.0%). The last two ECG patterns were univocally associated with LCA and proximal LAD occlusion respectively. In patients with inferior STEMI, predefined ECG algorithms showed high sensitivity(>90%) for RCA occlusion and high specificity(>90%) for LCA. The diagnostic performance was mainly determined by RCA dominance. In anterior STEMI the vectorial analysis of ST deviation in both frontal and horizontal planes could identify patients with LM/proximal LAD occlusion (adjusted-odds ratio for in-hospital mortality =2.45, 95% confidence interval: 1.31-4.56, p = 0.005) with low sensitivity (maximum 60%; using ST-depression in lead II, III, aVF + ΣSTE aVR + V1-ST depression V6≥0) and high specificity (maximum 95%; using ST-depression in inferior leads + ST-depression in V6).CONCLUSION: In STEMI undergoing primary percutaneous coronary intervention, six ECG patterns can be identified with a non-univocal relationship to the IRA. In inferior STEMI, vectorial analysis of ST deviation identifies IRA with a high appropriateness only when RCA is the dominant artery. In anterior STEMI, criteria derived from both frontal and horizontal planes identify LM/proximal LAD occlusion with high specificity but low sensitivity.

Several prospective studies have shown that high on-clopidogrel platelet reactivity (HPR) in patients undergoing percutaneous coronary intervention (PCI) is a risk factor for ischemic events. All studies were insufficiently powered to detect differences in stroke between patients with HPR and those without. Therefore, we performed a systematic review and meta-analysis of available publications aimed at determining whether patients undergoing PCI with HPR are also at increased risk of stroke. We searched for prospective studies enrolling patients undergoing PCI and treated with aspirin and clopidogrel that reported on clinical relevance of HPR to adenosine diphosphate. Study end point was the rate of stroke. We also investigated whether there was an interaction on the relative risk of stroke between HPR, clinical presentation, duration of follow-up, or laboratory methods. Fourteen studies including 11,959 patients were deemed eligible. On pooled analysis, the risk of stroke was higher in patients with HPR compared with patients with no HPR (1.2% vs 0.7%, relative risk on fixed effect 1.84, 95% confidence interval 1.21 to 2.80). There was no heterogeneity among the studies (I2 = 0%, p = 0.5). Clinical presentation (p = 0.39 for interaction), duration of follow-up (p = 0.87 for interaction), and laboratory method for detection of HPR (p = 0.99 for interaction) did not affect the relative increase in the risk of stroke in patients with HPR compared with patients with no HPR. In conclusion, in patients with coronary artery disease undergoing PCI, the presence of HPR to adenosine diphosphate is a risk factor for stroke. © 2014 Elsevier Inc. All rights reserved.

Coronary stenting with the half disarticulated Palmaz-Schatz stent is particularly suitable for ostial stenoses, diaphragm stenoses, stenoses distal to tortuous segments or coronary bends and localized dissections after balloon angioplasty. Nevertheless very few data regarding the half stent exist and follow-up data are nonexistent. From January of 1994 to December of 1995 a total of 207 half stents were implanted in 175 patients. Most patients had stable or unstable angina and in the majority of cases the stent was implanted due to localized dissection or to suboptimal result. The procedural success rate was 98%. After stent implantation, 82 patients were treated with acetylsalicylic acid (ASA) and oral anticoagulant (group A), whereas 93 were treated with ASA and ticlopidine (group B). Seven patients had subacute thrombosis (5, group A; 2, group B), and six patients had major bleeding (5, group A; 1, group B). Overall, patients in group A had more cardiovascular complications than patients in group B (10, group A; 3, group B; p = 0.047). After 6-mo follow-up, 1 patient had died and 27 patients had symptoms of angina (16%). Thirteen patients underwent a second PTCA (7%) and four patients (2%) were referred for coronary artery bypass. In conclusion, coronary stenting with half Palmaz-Schatz stent appears to be a safe and effective procedure. In selected cases, the half Palmaz-Schatz stent is easier to handle than the complete stent, it is associated with a low rate of clinical restenosis, and it lowers procedural costs.

To date, no published data are available regarding long-term follow-up of new generation DES implanted in coronary artery bypass graft (CABG) lesions.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).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.Compared to the non-CABG group, patients with CABG lesions were older (P 0.001), had a higher Charlson Comorbidity Index (P = 0.004), and presented more often with acute coronary syndrome (P = 0.02). At 3-year follow-up, cardiac death occurred in 9.7% versus 2.1% (P 0.001), myocardial infarction (MI) in 8.3% versus 3.0% (P = 0.02), target lesion failure in 13.9% versus 6.4% (P = 0.03), and major adverse cardiac event in 18.1% versus 8.6% (P = 0.01). No differences were observed in TV-MI and TLR, nor stent thrombosis (ST) which was generally low in both groups (1.4% vs 0.8%, P = NS).Albeit 3-year outcomes were less favorable in the CABG group, the higher cardiac mortality was apparently not driven by ST, target vessel MI, or TLR, but is likely due to advanced disease and age as well as comorbidity. The low TLR rate as well as the absence of late and very late ST suggest that BES are safe and effective for the treatment of CABG lesions.

Objectives To examine the differences in cardiac outcomes for patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) as a function of whether they underwent culprit-only primary percutaneous coronary intervention (PPCI) or multivessel PCI, either during PPCI or as a staged procedure. Background MVD occurs in about 40% of patients presenting with STEMI, and it has been associated with a worse outcome compared to single-vessel disease. The most favorable PCI strategy for dealing with significant nonculprit lesions has to be established. Methods A total of 2061 STEMI patients with MVD undergoing PPCI, prospectively enrolled in the REAL Registry between July 2002 and December 2010, were considered: 706 underwent culprit-only PPCI; 367 multivessel PCI during the index procedure; 988 had a staged PCI within 60 days. Mortality and outcomes were calculated at 30 days and 2 years. Results At multivariate analysis, culprit-only PPCI was associated with higher rates of cardiac outcomes as compared to staged multivessel PCI, taken as reference [Hazard Ratio (HR): 2.81, 95% confidence interval (CI): 1.34–5.89, P = 0.006 for 30-day mortality, and HR: 1.93, 95% CI: 1.35–2.74, P = 0.0002 for 2-year mortality, respectively]. Short-term mortality rates were higher in multivessel PCI group as compared to staged PCI group (HR: 2.58, 95% CI: 1.06–6.26, P = 0.03); no differences were observed at 2-year follow-up (HR: 1.08, 95% CI: 0.64–1.82, P = 0.76). Conclusions Our findings support the current guidelines recommendation to perform culprit-only PPCI in STEMI patients with MVD without hemodynamic compromise, followed by a staged PCI of noninfarct-related significant lesions. © 2014 Wiley Periodicals, Inc.

This study investigated coronary artery remodeling patterns associated with clinical outcomes.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) ≤4 mm(2), a plaque burden ≥70%, and a IVUS-virtual histology (VH) thin-cap fibroatheroma (TCFA), but not lesion site remodeling.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 RI0.88, intermediate remodeling as an RI of 0.88 to 1.00, and positive remodeling as an RI1.00. Second, we used the remaining two-thirds of patients to validate these cut points with respect to lesion morphology and clinical outcomes (validation cohort).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.The present study showed the novel concept that positive and negative lesion site remodeling was associated with unanticipated NCL MACE in the PROSPECT study. (An Imaging Study in Patients With Unstable Atherosclerotic Lesions [PROSPECT]; NCT00180466).

There is a paucity of epidemiological data on the prevalence of degenerative aortic stenosis (AS) after the recent demographic changes and in the present therapeutic era. We sought to assess the prevalence of AS in an elderly population of an Italian urban area and to derive an epidemiological estimate of AS prevalence on a larger scale.Elderly people (aged 75-95 years) of a 26 000 inhabitants town were clinically screened by general practitioners and classified into four groups: (1) no signs of AS; (2) known AS; (3) suspected AS (on the basis of the presence of a systolic murmur); (4) prior aortic valve replacement (AVR). Group 2 and 3 patients underwent physical examination and transthoracic echocardiography to confirm or rule out the diagnosis of AS, and to assess main comorbidities.Among the eligible patients, 2203 (93.7%) had no sign of AS; 49 (2.1%) had known AS; in 74 (3.1%) there was a systolic murmur suggesting AS, and 26 (1.1%) had previous AVR because of AS. Ten patients refused further screening, therefore 113 patients underwent transthoracic echocardiography. Among them, degenerative aortic disease without stenosis was observed in 22, and 63 had confirmed AS (severe in 21). Important comorbidities were frequently diagnosed in these patients. Including patients with previous AVR, AS was confirmed in 89/2350 patients (3.8%). On a regional scale, based on the demographics of this area, we estimated a prevalence of severe AS of 2248 cases per million inhabitants.The prevalence of AS in a population aged 75-95 years was 3.8%, and it was not previously diagnosed in a sizable proportion. More attention for early diagnosis of AS in the elderly is warranted.

No abstract available

FDG PET/CT was used to assess the extension of the ischemic area and its localization within the mycoardium

AIMS: Non-ST segment elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous syndrome in terms of patho-physiological mechanisms and prognosis. We sought to investigate the clinical features associated with complicated athero-thrombotic (CAT) coronary lesions and their prognostic relevance in NSTE-ACS. METHODS: We enrolled 701 consecutive NSTE-ACS patients without previous coronary bypass undergoing coronary angiography. The study population was divided into two groups according to the presence/absence of angiographic signs of endoluminal thrombi and/or plaque rupture, defined as CAT lesions. Multivariable analyses were used to identify predictors of CAT lesions. Their relation to composite endpoint of death, re-myocardial infarction, and re-unstable angina was investigated with the use of multivariable logistic regression. RESULTS: Patients with CAT lesions (n = 279, 40%) had a higher incidence of the combined endpoint (11.5 vs. 4.3%; P

Background— Little is known of the prognostic significance of mitral regurgitation (MR) on transcatheter aortic valve replacement (TAVR), the impact of TAVR on MR severity, and the variables associated with possible post-TAVR improvement in MR. We evaluated these issues in a multicenter registry of patients undergoing CoreValve Revalving System–TAVR. Methods and Results— Among 1007 consecutive patients, 670 (66.5%), 243 (24.1%), and 94 (9.3%) presented with no/mild, moderate, and severe MR, respectively. At 1 month after TAVR, patients with severe or moderate MR showed comparable mortality rates (odds ratio, 1.1; 95% confidence interval [95% CI], 0.7–1.55; P =0.2), but both were significantly higher compared with patients with mild/no MR (odds ratio, 2.2; 95% CI, 1.78–3.28; P P =0.02, respectively). One-year mortality was also similar between patients with severe and those with moderate MR (hazard ratio, 1.4; 95% CI, 0.94–2.4; P =0.06) and still significantly higher compared with patients with mild/no MR (hazard ratio, 1.7; 95% CI, 1.2–3.41; P P =0.03, respectively). Severe pulmonary hypertension, atrial fibrillation, and MR more than mild, but not an improvement of ≥1 grade in MR severity, were independent predictors of mortality at 1 year. At 1 year, an improved MR was observed in 47% and 35% of patients with severe and moderate MR, respectively. The rate of low implantation was consistent across groups with improved, unchanged, or worsened MR. A functional type of MR and the absence of severe pulmonary hypertension and atrial fibrillation independently predicted the improvement in MR severity. Conclusions— Baseline MR greater than mild is associated with higher mortality after CoreValve Revalving System–TAVR. A significant improvement in MR was more likely in patients with functional MR and without severe pulmonary hypertension or atrial fibrillation. The improvement in MR did not independently predict mortality.

Objectives: To investigate the prognostic significance of baseline white blood cell count (WBCc) in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and its additive predictive value beyond the Global Registry of Acute Coronary Events (GRACE) score. Methods: We included 1,315 consecutive NSTE-ACS patients. Patients were divided in quartiles according to the WBCc (cells per 1 mm3) i.e. Q1 Results: The median age of the study population was 76 years. Overall, 335 patients (25.5%) died with 211 of these (16%) suffering from CVD. Patients in Q4 showed a higher cumulative probability of CVD compared to patients in Q1–Q3. On multivariable analysis, patients in Q4 were at higher risk of CVD [hazard ratio (HR) = 1.47, 95% confidence interval (CI) 1.09–1.98, p = 0.011]. WBCc as a continuous variable was also independently associated with the study end point (HR = 1.043; 95% CI 1.02–1.07; p = 0.001). However, the incorporation of WBCc into the GRACE score did not improve either prediction of risk (C-index = 0.796 for GRACE score with or without WBCc) or classification of risk [relative integrated discrimination improvement = 0.0154, 95% CI) –0.029 to 0.0618; continuous net reclassification improvement = –0.0676, 95% CI –0.2149–0.0738). Conclusions: WBCc was an independent predictor of 3-year CVD in patients with NSTE-ACS. However, it did not add prognostic information beyond the GRACE score.

We appreciate the interest of Prinzen et al about our article,1 but some of their comments need to be addressed. Prinzen et al analyzed a mixed population of patients treated with CoreValve or Edwards Sapien prostheses.2 Of note, their different influence on the cardiac conduction system is well known,3 with the CoreValve being more prone to determine conduction disturbances as a consequence of the larger frame. Accordingly, we decided to specifically focus on the CoreValve, pooling >800 patients, which is more than double the population considered by Prinzen et al. It is clear that the internal and external validity (ie, the extent of systematic biases and the generalizability of the results) are highly affected by the sample size. Prinzen et al excluded patients who underwent pacemaker implantation within 30 days after transcatheter aortic valve replacement, which, in our opinion, makes little …

Transcatheter aortic valve-in-valve (ViV) implantation inside failed bioprostheses is an alternative approach to repeat open heart surgery for those with failed bioprosthetic valves. However, stentless surgical valves lack fluoroscopic markers and provide distinctive challenges. Our objective was to

AIMS To evaluate whether gender differences in terms of up to 4-year outcome still persist within patients with acute myocardial infarction (AMI) who uniformly underwent coronary revascularization, we performed a gender comparison in a large contemporary multicentre percutaneous intervention (PCI) registry. MATERIALS AND METHODS We retrospectively analyzed data from 18,351 patients with AMI, who underwent percutaneous coronary interventions (5093 women and 13,258 men) in the Emilia Romagna region of Italy between July 2002 and December 2007. Median follow-up was 1174 days. RESULTS After propensity score adjustment, differences in gender-related mortality were not temporarily homogeneous: 30-day adjusted mortality was higher in women than in men [hazard ratio (HR): 1.40, P < 0.0001], whereas thereafter female gender showed a significantly lower mortality risk (HR: 0.84, P = 0.01). Notably, younger women (

aortic valve implantation Pedro A. Lemos ⁎, Francesco Saia , Jose Mariani Jr., Cinzia Marrozzini , Antonio Esteves Filho , Luiz J. Kajita , Cristina Ciuca , Nevio Taglieri , Barbara Bordoni , Carolina Moretti , Tullio Palmerini , Marianna D.A. Dracoulakis , Fabio B. Jatene , Roberto Kalil-Filho , Antonio Marzocchi c a Sirio-Libanes Hospital, Sao Paulo, Brazil b Heart Institute, University of Sao Paulo Medical School, Sao Paulo, Brazil c Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy d Irmandade da Santa Casa de Misericordia, Sao Paulo, Brazil

Transcatheter aortic valve implantation (TAVI) represents a promising therapeutic option for patients affected by severe aortic stenosis, but it is currently associated with high costs. Therefore, the assessment of its economic impact becomes urgent to support decision-makers' choices about its use, patient access to treatment and reimbursement mechanisms.A retrospective, observational, single-center (the teaching hospital located in Bologna, Italy) study was conducted. All patients with severe symptomatic aortic stenosis undergoing TAVI during the enrolment period (February 2008-August 2010) were included. The procedures were performed with both bioprostheses approved for clinical use and through different vascular access: CoreValve transfemoral (CV-TF), CoreValve transsubclavian (CV-TS), Edwards Sapien transapical (ES-TA), Edwards Sapien transfemoral (ES-TF). Costs of the whole index hospitalization have been calculated from the hospital perspective. Healthcare resource consumption was measured at patient level and assessed using unit costs (micro-costing approach).Overall, 87 consecutive patients (48 CV-TF, 12 CV-TS, 20 ES-TA, 7 ES-TF) were included in the study. They presented a high-risk profile (age 83.3 ± 5.4 years; logistic EuroSCORE 23.3 ± 12.3%) and important comorbidity. In-hospital mortality was 3.4%. Total cost of hospitalization was, on average, €35.841 (range €27.267-69.744) of which 68% was attributable to the procedure. A huge variation in costs was observed among different treatment groups. Patients treated with transfemoral implant (CV-TF: €33.977; ES-TF: €31.442) were on average less expensive than others (CV-TS: €37.035; ES-TA: €41.139).Our findings show that treating patients with TAVI places a heavy burden on hospital budget. Hence, due to the shortage of financial resources, affordability of TAVI requires further attention.

No abstract available]

OBJECTIVES We sought to compare the 1-year risk of re-hospitalization for acute coronary syndrome (ACS) between patients taking clopidogrel with proton pump inhibitors (PPIs) vs. clopidogrel without PPIs. MATERIALS AND METHODS We conducted a retrospective cohort study among 3896 patients with ACS, at low risk for gastrointestinal bleeding, discharged from all hospitals of the Emilia-Romagna region of Italy during the period January-August 2008. Patients' consumption of clopidogrel and PPIs at hospital discharge and follow-up was based on pharmacy refill data. Of these 3896 patients, 90% (n = 3519) were prescribed PPIs at hospital discharge and/or at some time during follow-up. RESULTS At 1-year follow-up, hospitalization for ACS occurred in 15% of patients taking clopidogrel with PPIs vs. 3.4% of those taking clopidogrel without PPIs (P

not available

During cardiac angiography, hemodynamic alterations and surface electrocardiographic changes are common, predictable and dose-related adverse reactions to radiocontrast media. High osmolality, inadequate sodium content and local transient hypocalcemia are thought to be the main mechanisms responsible for these untoward cardiovascular effects. The purpose of this double-blind, parallel-group trial was to compare the hemodynamic and electrocardiographic responses to cardiac and selective coronary artery injection of iomeprol 400 (400 mgI/ml) and iopamidol 370 (370 mgI/ml). One-hundred consenting adult inpatients were randomised to receive iomeprol 400 (41 males, nine females; mean age, 56.6 years) or iopamidol 370 (46 males, four females; mean age, 57.6 years). Both agents produced minor and transient hemodynamic and electrophysiological effects. Following left ventriculography, iopamidol 370 produced a significantly greater increase in LVEDP than iomeprol 400 (mean increases after first and second left ventriculogram: 2.5 and 4.6 mmHg with iomeprol 400, 3.3 and 9.9 mmHg with iopamidol 370, P = 0.027). The QT-interval was more affected by iopamidol 370 than by iomeprol 400. However, post-contrast prolongation of the QT-interval was not significant with either agent, nor were there any significant T-wave, ST-segment or RR-interval changes associated with the injection of the test compounds. No serious adverse events occurred throughout the study. Mild pain was complained by only one patient, while most patients reported mild to moderate sensation of heat. Image quality of the vast majority of the procedures was rated as good or excellent in both patient groups.(ABSTRACT TRUNCATED AT 250 WORDS)

This work illustrates the joint use of a pilot study and an administrative data base for designing a probabilistic sample for an epidemiological survey. The target is to estimate the prevalence of an asymptomatic disease, the aortic valve stenosis (AS), in the elderly population of the city of Bologna, Italy. The novelty of the study is to reach the target population of elderly patients via a sample of their general practitioners (GPs). The pilot study was conducted in San Giovanni in Persiceto, a town in the province of Bologna. Overall information on patients and their GPs are available in the Azienda Unità Sanitaria Locale di Bologna (AUSL) data sets. Since the disease is asymptomatic, the sampling plan is designed to estimate the number of suspected patients that will be sent to further echocardiographic (ECO) examination. The probabilistic sampling plan aims at controlling the sources of randomness, via an appropriate clustering of the population of GPs. The number of practitioners to sample is fixed in advance. The subpopulations of patients to screen are also defined in advance and assigned to doctors. In this way the potential sources of randomness, due to the individual choices of doctors out of the definition of the experiment, are avoided. The number of elderly patients per doctor has been identified, from the pilot study, as an important factor able to influence the proportion of suspected patients sent to further examination. This feature is the leading factor of the sampling design, together with the clustering of the AUSL Bologna territory in NCPs, which emerges from the AUSL data set.

The implementation of primary percutaneous coronary intervention (PCI) has significantly improved the clinical outcome of patients admitted for ST-segment elevation myocardial infarction (STEMI).1 However, some patients still develop recurrent adverse events, with a negative impact on survival. Accordingly, we analyzed the data from the REAL (Registro Angioplastiche dell’Emilia-Romagna) registry in order to evaluate the 3-year readmission rate for cardiovascular causes and their influence on death. Methods For all patients with STEMI (from January 2003 to June 2009) undergoing primary PCI enrolled in the REAL registry,2-4 we evaluated the incidence of death and hospital readmission due to cardiovascular causes up to 3 years. Particularly, myocardial infarction (MI), coronary revascularization (CR), acute or congestive heart failure (HF), and serious bleeding events […]

In Italy, as in other European countries, public service healthcare presents some disparities that are related to geographical, economic, organizational and structural issues. Although some Italian regions have excellent networks for the treatment of ST-elevation myocardial infarction (STEMI), others still have to develop a model that allows each STEMI patient to receive the best reperfusion treatment. A recent nationwide registry from the Italian Society of Interventional Cardiology (SICI-GISE) showed that efficient STEMI networks cover approximately 50% of the Italian territory. For these reasons, Italy joined the Stent for Life initiative in August 2010 with the primary goal of implementing and defining tailored action programs in order to ensure that the majority of the Italian STEMI population have access to life-saving primary percutaneous coronary intervention.

Background: Limited data exist on renal complications of transcatheter aortic valve implantation (TAVI)within a comprehensive program using different valves with transfemoral, transapical, and trans-subclavian approach. Methods: Prospective single-center registry of 102 consecutive patients undergoing TAVI using both approved bioprostheses and different access routes. The main objective was to assess the incidence, predictors and the clinical impact of acute kidney injury (AKI). AKI was defined according to the valve academic research consortium (VARC) indications. Results: Mean age was 83.7±5.3 years, logistic EuroSCORE 22.6±12.4%, and STS score 8.2±4.1%. Chronic kidney disease at baseline was present in 87.3%. Periprocedural AKI developed in 42 patients (41.7%): 32.4% stage 1, 4.9% stage 2 and 3.9% stage 3. The incidence of AKI was 66.7% in transapical, 30.3% in transfemoral, and 50% in trans-subclavian procedures. The only independent predictor of AKI was transapical access, with a hazard ratio (HR) between 4.57 and 5.18 based on the model used. Cumulative 1-year survival was 88.2%. At Cox regression analysis, the only independent predictor of 30-day mortality was diabetes mellitus (HR 7.05, 95% CI 1.07-46.32; p=0.042), whilst the independent predictors of 1-year death were baseline glomerular filtration rateb30 mL/min (HR 5.74, 95% CI 1.42-23.26; p=0.014) and post-procedural AKI 3 (HR 8.59, 95% CI 1.61-45.86, p=0.012). Conclusions: TAVI is associated with a high incidence of AKI. Although in the majority of the cases AKI is of mild entity and reversible, AKI 3 holds a strong negative impact on 1-year survival. The incidence of AKI is higher with transapical access.

Introduction: We sought to assess the effect of a territorial system of care for ST-elevation myocardial infarction (STEMI) on the outcome of out-of-hospital cardiac arrest (OOHCA). Materials and Methods: We enrolled 720 patients who experienced a witnessed OOHCA of presumed cardiac origin during a four-year period in an area with a STEMI network and for whom resuscitation was attempted. Results: Overall, 242 (33.6%) patients had return of spontaneous circulation (ROSC), 645 (90%) died before discharge. We observed a trend toward decreased overall mortality for OOHCA between the years 2004 and 2007, both in the entire population and in patients with ROSC (2004=94%; 2005=89%; 2006=85%; 2007=89%; P=0.064; 2004=81%; 2005=69%; 2006=65%; 2007=60%; P=0.076, respectively). On multivariable analysis, age, crew-witnessed arrest and presence of shockable rhythm were independent predictors of mortality. Patients who experienced OOHCA in the year 2006 (OR=0.47; 95% CI: 0.21-1.05; P=0.07) and 2007 (OR=0.51; 95% CI: 0.23-1.12; P=0.09) showed a strong trend toward decreased risk of mortality compared to year 2004. In patients with ROSC, the year 2007 was associated with a significant lower risk of mortality compared to year 2004 (OR=0.38; 95% CI: 0.15-0.96; P=0.04). Conclusions: Implementation of a territorial network of care for STEMI appears to be associated with reduced mortality OOHCA patient

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.Bleeding and consequent blood product transfusions have been causally associated with a higher mortality rate in patients with myocardial infarction undergoing coronary angioplasty.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.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).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.

Objective: To ascertain incidence and predictors of new permanent pacemaker (PPM) following transcatheter aortic valve implantation (TAVI) with the self-expanding aortic bioprosthesis. Background: TAVI with the Medtronic Corevalve (MCV) Revalving System (Medtronic, Minneapolis, MN) has been associated with important post-procedural conduction abnormalities and frequent need for PPM. Methods: Overall, 73 consecutive patients with severe symptomatic AS underwent TAVI with the MCV at two institutions; 10 patients with previous pacemaker and 3 patients with previous aortic valve replacement were excluded for this analysis. Clinical, echocardiographic, and procedural data were collected prospectively in a dedicated database. A standard 12-lead ECG was recorded in all patients at baseline, after the procedure and predischarge. Decision to implant PPM was taken according to current guidelines. Logistic multivariable modeling was applied to identify independent predictors of PPM at discharge. Results: Patients exhibited high-risk features as evidenced by advanced age (mean = 82.1 ± 6.2 years) and high surgical scores (logistic EuroSCORE 23.0 ± 12.8%, STS score 9.4 ± 6.9%). The incidence of new PPM was 28.3%. Interventricular septum thickness and logistic Euroscore were the baseline independent predictors of PPM. When procedural variables were included, the independent predictors of PPM were interventricular septum thickness (OR 0.52; 95% CI 0.32–0.85) and the distance between noncoronary cusp and the distal edge of the prosthesis (OR 1.37; 95% CI 1.03–1.83). Conclusions: Conduction abnormalities are frequently observed after TAVI with self-expandable bioprosthesis and definitive pacing is required in about a third of the patients, with a clear association with depth of implant and small interventricular septum thickness. © 2011 Wiley Periodicals, Inc.

INTRODUÇÃO: O implante transcateter de prótese valvular aórtica (ITVA) tem sido utilizado em nosso meio e em diversos países do mundo como alternativa ao tratamento conservador em pacientes com estenose aórtica grave e elevado risco cirúrgico. Objetivou-se descrever o perfil clínico basal e a mortalidade a curto e médio prazos de uma série consecutiva de casos tratados com ITVA em dois centros localizados, respectivamente, na Itália e no Brasil. MÉTODOS: A população de estudo foi composta pelos primeiros 75 pacientes consecutivos com estenose valvar aórtica grave tratados com a prótese Medtronic CoreValveTM Revalving System (MCV - Medtronic, Minneapolis, Estados Unidos). Tipicamente, a indicação para o ITVA foi motivada pelo alto risco cirúrgico. A média de idade era de 82 anos, 55% eram mulheres, um terço apresentava doença pulmonar grave e 95% apresentavam insuficiência cardíaca sintomática. RESULTADOS: Após o ITVA, houve redução significativa do gradiente transvalvar aórtico máximo (basal: 95,8 ± 32,3 mmHg; pós-procedimento: 18,5 ± 6,1 mmHg) e médio (basal: 45,9 ± 16,9 mmHg; pós-procedimento: 10,4 ± 5,2 mmHg) (P < 0,01 para ambos). Insuficiência aórtica moderada ou acentuada foi evidenciada em 7% dos casos após ITVA. A taxa de sobrevida global aos 30 dias foi de 91,6% e aos 12 meses, de 79%. CONCLUSÕES: O ITVA surge como um método terapêutico de grande relevância para portadores de estenose aórtica de alto risco cirúrgico. As taxas de sobrevida precoce e a médio prazo indicam o benefício potencial do novo procedimento também para pacientes tratados no chamado mundo real. BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been used in our country and in several different countries worldwide as an alternative to conservative treatment for patients with severe aortic stenosis and high surgical risk. This paper aimed at describing the baseline clinical profile and the short and medium-term mortality of a consecutive series of cases treated with TAVI in two centers in Italy and Brazil, respectively. METHODS: The study population included the first 75 consecutive patients with severe aortic stenosis treated with the Medtronic CoreValveTM Revalving System (MCV - Medtronic, Minneapolis, USA). Typically, the indication for TAVI was motivated by high surgical risk. Mean age was 82 years, 55% were females, a third had severe lung disease, and 95% had symptomatic heart failure. RESULTS: TAVI was associated with a significant reduction of peak (baseline: 95.8 ± 32.3 mmHg; post-procedure: 18.5 ± 6.1 mmHg) and mean (baseline: 45.9 ± 16.9 mmHg; post-procedure: 10.4 ± 5.2 mmHg) transaortic gradient (P < 0.01 for both). Moderate or severe aortic insufficiency was observed in 7% of the cases. The overall survival rate at 30 days was 91.6% and at 12 months it was 79% CONCLUSIONS: TAVI emerges as an important therapeutic option for high risk patients with aortic stenosis. The short and medium-term survival rates suggest that the new procedure might be of benefit for patients treated in the real world context.

Background— There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis. Methods and Results— A total of 663 consecutive patients (mean age 81.0±7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction Conclusions— Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation ≥2+ mainly impact late outcomes between 30 days and 1 year.