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Aims Recently, the cardiovascular outcomes for people using anticoagulation strategies (COMPASS) trial demonstrated that dual therapy reduced cardiovascular outcomes compared with aspirin alone in patients with stable atherosclerotic disease. Methods and results We sought to assess the proportion of patients eligible for the COMPASS trial and to compare the epidemiology and outcome of these patients with those without COMPASS inclusion or with any exclusion criteria in a contemporary, nationwide cohort of patients with stable coronary artery disease. Among the 4068 patients with detailed information allowing evaluation of eligibility, 1416 (34.8%) did not fulfil the inclusion criteria (COMPASS-Not-Included), 841 (20.7%) had exclusion criteria (COMPASS-Excluded), and the remaining 1811 (44.5%) were classified as COMPASS-Like. At 1 year, the incidence of major adverse cardiovascular event (MACE), a composite of cardiovascular death, myocardial infarction, and stroke, was 0.9% in the COMPASS-Not-Included and 2.0% in the COMPASS-Like (P = 0.01), and 5.0% in the COMPASS-Excluded group (P Conclusion In a contemporary real-world cohort registry of stable coronary artery disease, most patients resulted as eligible for the COMPASS. These patients presented a considerable annual risk of MACE that consistently increases in the presence of multiple risk factors.

Aims We evaluated the 1-year clinical events, pharmacological management, and quality of life in a contemporary cohort of stable coronary artery disease (CAD) patients managed by cardiologists. Methods and results START (STable Coronary Artery Diseases RegisTry) was a prospective, observational, nationwide study that enrolled 5070 stable CAD patients over 3 months in 183 cardiology centres in Italy. At 1 year, 4790 (94.5%) patients had data on vital status. Death occurred in 107 (2.2%) patients and the cause of death was cardiovascular in 41 (38.3%) of cases. Among the 4775 patients with follow-up data on clinical events available, a hospitalization due to cardiovascular and non-cardiovascular causes occurred in 523 (11.0%) and in 231 (4.8%) of cases, respectively. Over 60% of patients reported as ‘no problems’ in all domains (61.4–84.5%) of the EuroQoL quality of life 5D-5L questionnaire. Among the 3239 patients with clinical visit/telephone interview at follow-up, in whom optimal medical therapy (OMT; aspirin or thienopyridine, β-blocker, and statin) was prescribed at enrolment, 2971 (91.7%) were still receiving OMT at follow-up. At multivariable analysis, only increasing age (odds ratio 0.98; 95% confidence interval 0.97–0.99; P = 0.04) resulted as independent negative predictor of OMT persistence at 1 year from enrolment. Conclusion In this large, contemporary registry, stable CAD patients managed by cardiologists presented a high rate of clinical events at 1 year. Nevertheless, the persistence to OMT and quality of life appeared reasonable.

To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) in a real world clinical scenario.Randomized studies suggest that the BES with biodegradable polymer is more effective and safe than early generation coronary stents in patients with STEMI.We included all consecutive STEMI patients undergoing PCI in this prospective, multicenter registry. The primary endpoint of the study was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction and ischemia-driven target vessel revascularization at 1-year follow-up.Between June and December 2012 we enrolled 311 STEMI patients. The primary endpoint occurred in 3.2% (95% confidence interval: 1.6-5.8) of patients: cardiac death, re-infarction, and ischemia-driven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% ± 1.0%.In a real-world cohort of STEMI patients undergoing PCI, the use of BES is associated with good 1-year clinical outcome. These results confirm and expand previous findings showing the efficacy and safety of BES in the setting of randomized trials.

OBJECTIVE - It is still controversial whether sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) are equally effective in patients with diabetes. In these patients, multiple individual variables may be responsible for neointimal hyperplasia, thus making difficult the comparison of the two drug-eluting stents (DES). RESEARCH DESIGN AND METHODS - We designed a prospective, randomized study to compare the efficacy in prevention of restenosis of SES and PES, both implanted in the same diabetic patient with multiple de novo coronary artery lesions undergoing elective percutaneous coronary intervention. We enrolled 60 patients with diabetes with at least two significant de novo angiographic stenoses in different coronary segments. The primary end point was in-stent late luminal loss (LLL) at 8-month angiographic follow-up. RESULTS - A total of 120 lesions were successfully treated with the randomly assigned DES (SES, n=60; PES, n=60). In-stent LLL was lower in the SES than in the PES group (0.26 ± 0.4 vs. 0.50 ± 0.6 mm; P = 0.01). Coronary lesions treated with SES presented a reduced in-stent LLL in 40 (68%) patients, while PES resulted in a lower in-stent LLL in 19 (32%) patients (P = 0.0002). At multivariable analysis, the type of DES implanted was the only independent predictor of in-stent LLL (odds ratio 2.3 [95% CI 1.1-5.0]; P = 0.03). CONCLUSIONS - SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis. © 2008 by the American Diabetes Association.

Aims To analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment. Methods and results Five Italian hospitals enrolled 375 non-diabetic, ischaemic patients without contraindications to dual anti-platelet treatment or corticosteroid therapy in a randomized controlled study. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischaemia needing repeated target vessel revascularization at 1 year, and this was significantly lower in the BMS group (80.8%) compared with the prednisone (88.0%) and DES group (88.8%, P = 0.04 and 0.006, respectively). The long-term analysis of the primary endpoint was a pre-specified aim of the trial, and was performed at 1447 days (median, IQ range = 1210–1641). Patients receiving BMS alone had significantly lower event-free survival (75.3%) compared with 84.1% in the prednisone group (HR: 0.447; 95% CI: 0.25–0.80, P = 0.007) and 80.6% in DES patients (HR: 0.519; 95% CI: 0.29–0.93, P = 0.03). Prednisone-treated patients did not develop new treatment-related clinical problems. Drug-eluting stents patients suffered more very late stent thrombosis as a cause of spontaneous myocardial infarction. The need for target vessel revascularization remained lower in the prednisone and DES groups (13.6 and 15.2%, respectively), compared with BMS (23.2%). Conclusions The clinical benefits of prednisone compared with BMS only persisted almost unchanged at 4 years. Drug-eluting stents performed better than BMS at long-term, although the advantages observed at 1 year were in part attenuated because of the occurrence of very late stent thrombosis and late revascularizations. Clinical Trial NCT 00369356.

Compared with medical therapy alone, coronary artery bypass surgery improves survival in patients with coronary disease and left ventricular dysfunction. Many of these patients have a hibernating myocardium secondary to chronic ischemia with the potential for improvement in left ventricular function and heart failure symptoms following revascularization therapy. Cardiac transplantation remains the treatment of choice for patients with severe congestive heart failure.From January 1992 to June 2000, 351 consecutive patients (318 men, 33 women, mean age 62.8 +/- 8.9 years) with a left ventricular ejection fraction (EF)or = 35% and with multivessel coronary artery disease underwent isolated coronary artery bypass grafting. Preoperatively 226 patients were in CCS class III-IV and 113 in NYHA class III-IV. The mean number of grafts was 3.4 +/- 0.8/patient and complete revascularization was achieved in 98.6% of cases. The internal mammary artery was used in 341 patients (97.2%) and in 328 (96%) as a graft for the left anterior descending artery. Follow-up was obtained in 97% of the patients and on average lasted 42 +/- 28 months.The hospital mortality was 5.9%. At multivariate analysis urgent operation (p0.01) and a lower EF (25.9% in deaths vs 29.1%, p0.05) were predictors of an increased operative mortality. EF (assessed postoperatively at transthoracic echocardiography in survivors) improved from 28.9 +/- 5.7 to 34.4 +/- 7.7% (p0.0001). At 1, 3, 5, 7, and 9 years respectively, the all-cause survival was 93 +/- 1.5, 85 +/- 2.2, 77 +/- 3.1, 69 +/- 4.9, and 60 +/- 7.3% and the freedom from cardiac death was 94 +/- 1.4, 89 +/- 1.9, 88 +/- 2, 80 +/- 4.7, and 76 +/- 5.7% with an improvement in the anginal and congestive heart failure status (p0.0001).In patients with coronary artery disease and severe left ventricular dysfunction, after evaluation of the clinical presentation, of the usefulness of vessels as grafts and of the presence of myocardial viability, 1) coronary artery bypass grafting can be performed with a low mortality and a good mid-term survival, 2) improvement in left ventricular function can be documented after coronary bypass surgery, 3) the internal mammary artery can be safely used as a graft, 4) the quality of life is improved as demonstrated by the improvement in the anginal and congestive heart failure status.

This study reports results of synchronous carotid endarterectomy (CEA) and off-pump coronary artery bypass grafting (CABG) in further support of the hypothesis that carotid and coronary artery revascularization can be safely performed in most patients.The series includes 74 consecutive patients underwent synchronous CEA and off-pump CABG (group A) compared with 50 patients undergoing synchronous CEA and on-pump CABG (group B). Primary endpoint of this study are death, stroke, perioperative myocardial infarction and need for repeated revascularization within 30 days of the procedures. The secondary endpoint includes local and systemic complications.No stroke was observed in group A. Ipsilateral minor stroke occurred in two patients of group B (4%). Two deaths within 30 days were observed in group A (2.7%) compared with 4 deaths in group B (8%). Combined stroke/death rate at 30 days was 2.7% in group A compared with 12% in group B (P0.05). No significant differences in myocardial infarction, local and systemic complications were observed.Synchronous CEA and off-pump CABG may reduce the high surgical risk of patients who actually require combined carotid and coronary revascularization. This opinion has to be substantiated by larger studies and randomized trial.

The organization of a regional system of care (RSC) for ST-elevation myocardial infarction (STEMI) is recommended by the Italian Federation of Cardiology (FIC) and international guidelines in order to increase the number of patients treated with primary coronary angioplasty and, more in general, with reperfusion therapy, speed up the diagnostic and therapeutic processes, and ultimately improve the outcome.The "RETE IMA WEB" survey was launched in 2007 from the Italian Society of Invasive Cardiology (SICI-GISE) in collaboration with the FIC, with the aim of evaluating the current state of RSC for STEMI in Italy. The personnel of the 118 Emergency System participated in the survey. Data collection was made using different electronic forms with access limited by personal passwords. We assessed the organization of the RSC together with local resource availability, with specific attention to the distance from a Hub center.The survey ended in December 31, 2008. We censored 701 hospitals admitting STEMI patients, 157 (22.4%) with uninterrupted access (h24/7 days) to the catheterization laboratory (2.67 per million inhabitants). An operative network was present in 36/103 (35.9%) provinces, with important geographic variability. Among hospitals without a full-time primary angioplasty facility, only 46% was within a RSC. ECG was available in 72% of the national territory, telemedicine in 50%. Prehospital fibrinolysis was available in 16% of the country. Overall, 92.4% of the Italian population resides within 60 min of a Hub center.In 2008, despite an adequate framework, the RSC for STEMI in Italy was heterogeneous and still suboptimal. Healthcare administrators, scientific societies and all operators involved in the process of care for STEMI should make efforts to implement current guidelines.

The significant involvement of proximal left anterior descending (LAD) coronary artery affects patient prognosis and must be treated. Recently, as alternative methods to conventional coronary bypass (CABG), minimally invasive direct coronary artery bypass grafting (MIDCAB) and percutaneous transluminal coronary angioplasty with stent implantation (PTCA/S) have been proposed to reduce costs and patient discomfort. The aim of this study was to obtain early and medium-term results of CABG in patients with complex LAD disease in whom the expected results with PTCA/S or MIDCAB would have been suboptimal.We retrospectively examined one hundred consecutive patients subjected to isolated CABG who received either a single graft to LAD or several grafts to LAD and diagonal branches. The choice of CABG was due to poor expectable results with PTCA/S or MIDCAB because of anatomical characteristics of the lesion, inclusion in ongoing randomized study comparing surgical versus non-surgical revascularization, or preference on the part of the cardiologist or patient.Left internal mammary artery (LIMA) was grafted to LAD in 99 (99%) patients; 65 (65%) patients received at least one saphenous graft to the diagonal branches. No death was observed within 30 days from the operation. One (1%) patient had a perioperative non-Q myocardial infarction (MI). At a mean follow-up time of 38 +/- 16 months (range 2-60), there were no cardiac deaths and no new MI. Six patients complained of recurrent angina: in all cases but one (vein graft failure to a diagonal branch), there were no clinical or diagnostic signs suggesting other graft failures. The probability of freedom from early and late events, including cardiac death, MI and recurrence of angina regardless of site, was 99% at 1 year and 86% at 5 years.At present, conventional CABG seems to be the "gold standard palliation" of LAD disease in most cases. It can be performed safely with excellent early and medium-term results in terms of freedom from cardiac events. Its comparison with percutaneous transluminal techniques and MIDCAB needs to be addressed in further prospective studies.

Optimal hemodynamic performances are of paramount importance when implanting a mechanical valve in patients with a small aortic annulus. A Doppler echocardiographic study was performed to compare the hemodynamic performances of small CarboMedics and St. Jude valves.Twenty-nine patients receiving either a 19 mm (n = 10) or a 21 mm (n = 10) CarboMedics valve or a 19 mm (n = 9) St. Jude Med HP valve were evaluated. A Doppler echocardiographic study was performed at rest and two minutes after treadmill exercise with the Bruce protocol. Peak and mean gradients across the valve were estimated; effective orifice area, performance index and discharge coefficient were calculated. Heart rate, blood pressure and cardiac output were all significantly increased with exercise.Peak and mean gradients at rest were significantly higher (p0.05) in the 19 mm CarboMedics valve (40.2 +/- 15 mmHg and 22.6 +/- 9 mmHg, respectively) when compared either with 21 mm CarboMedics valve (27.6 +/- 6.8 mmHg and 14.2 +/- 3.4 mmHg, respectively) or with the 19 mm St. Jude HP valve (23.6 +/- 10.4 mmHg and 13.6 +/- 5 mmHg, respectively). Peak and mean gradients were not modified with exercise for the 19 mm CarboMedics valve and significantly increased for the 21 mm CarboMedics and the 19 mm St. Jude HP valves. Although these values were still higher in the 19 mm CarboMedics valve, they did not reach the level of statistical significance when compared with the other two valve groups.The 19 mm St. Jude HP valve shows hemodynamic performances at rest that are similar to those of the 21 mm CarboMedics valve and superior to those of the 19 mm CarboMedics valve. With exercise both sizes of the CarboMedics valve show an in vivo discharge coefficient close to one, testifying to a full utilization of the internal orifice area.

Sixty consecutive patients undergoing elective open-heart surgery were prospectively enrolled in a study to compare the efficacy of 3 different antifibrinolytic drugs to reduce postoperative bleeding and to reduce homologous blood requirements in combination with blood-saving techniques and restrictive indications for blood transfusion. The patients were randomized to 1 of 4 intraoperative treatment regimens: 1) control (no antifibrinolytic therapy); 2) epsilon-aminocaproic acid (10 g IV at induction of anesthesia, followed by infusion of 2 g/h for 5 hours); 3) tranexamic acid (10 mg/kg IV within 30 minutes after induction of anesthesia, followed by infusion of 1 mg/kg per hour for 10 hours); or 4) high-dose aprotinin (2 million KIU IV at induction of anesthesia and 2 million KIU added to the extracorporeal circuit, followed by infusion of 500 thousand KIU/h during surgery). Hemoconcentration and reinfusion of blood drained from the operative field and the extracorporeal circuit after operation were used in all patients. Indications for blood transfusion were hypotension, tachycardia, or both, with hemoglobin values < 8.5 g/dL; or severe anemia with hemoglobin values < 7 g/dL. Compared with the blood loss in the control group, patients receiving aprotinin and epsilon-aminocaproic acid showed significantly less postoperative blood loss at 1 hour (control, 128 +/- 94 mL; aprotinin, 54 +/- 47 mL, p = 0.01; and epsilon-aminocaproic acid, 69 +/- 35 mL, p = 0.03); this trend continued at 24 hours after operation (control, 724 +/- 280 mL; aprotinin, 344 +/- 106 mL, p < 0.0001; and epsilon-aminocaproic acid, 509 +/- 148 mL, p = 0.01). Aprotinin was significantly more efficient than epsilon-aminocaproic acid (p=0.002). Tranexamic acid did not have a statistically significant effect on blood loss. Homologous blood requirements were not significantly different among the groups; postoperative hematologic values and coagulation times were also comparable. Despite the efficacy of aprotinin and epsilon-aminocaproic acid shown in the present study, the blood requirements were not significantly different from those that are found when transfusions are restricted, autotransfusions are used, and blood from the operative field and extracorporeal circuit is concentrated and reinfused. Therefore, intraoperative antifibrinolysis may not be indicated in routine cardiac surgery when other blood-saving techniques are adopted.

Transcatheter closure of atrial septal defects with left-to-right shunt induces an abrupt overload of the left ventricle that may cause acute heart failure in patients with left ventricular dysfunction. We report two cases of ostium secundum atrial septal defects associated with left ventricular dysfunction of different etiology. The hemodynamic evaluation of left ventricular function during transient abolition of the shunt with the sizing balloon of the Amplatzer system helped to establish the most correct therapeutic strategy.

The cardioprotective effects afforded by volatile anesthetics, i.e. isoflurane, during heart surgery may be due to preconditioning of the myocardium through the activation of KATP channels. The aims of this study were to establish whether glibenclamide prevents the isoflurane-induced cardioprotection in diabetic patients undergoing coronary surgery (CABG) and whether this cardioprotective effect can be restored by preoperative shift from glibenclamide to insulin therapy.We enrolled 60 patients undergoing CABG. Twenty consecutive non-diabetic patients were randomized to receive conventional anesthesia (CA) or conventional anesthesia plus isoflurane (ISO) (added to the inspired oxygen before starting cardiopulmonary bypass); 40 consecutive diabetic patients in chronic treatment with oral glibenclamide were randomized to conventional anesthesia (G-CA), conventional anesthesia plus isoflurane (G-ISO), conventional anesthesia after shifting to insulin (I-CA) or conventional anesthesia plus isoflurane after shifting to insulin (I-ISO). Serum levels of cardiac troponin I (CTnI) and CK-MB, as markers of ischemic injury, were obtained 1, 24, 48 and 96 hours, postoperatively.Postoperative peak levels of CTnI and CK-MB were lower in ISO than in CA (0.5+/-0.3 vs 2.8+/-2.2 ng/ml, p0.05 and 61+/-27 vs 79+/-28 U/L, p0.05, respectively), as well as in I-CA and I-ISO than G-CA and G-ISO groups (0.5+/-0.7 and 0.7+/-0.9 vs 3.5+/-3 and 2.7+/-2.5 ng/ml, p0.05; 47+/-7 and 41+/-5 vs 85+/-28 and 50+/-23 U/L, p0.05, respectively). No significant differences were detected in postoperative hemodynamic variables or in-hospital outcome.This prospective randomized study shows a cardioprotective effect of preoperative administration of isoflurane during CABG. Such an effect is prevented by glibenclamide, but can be restored in diabetic patients by preoperative shift from glibenclamide to insulin.

Sixty-one consecutive patients with stable effort angina and single vessel disease underwent successful (reduction of coronary stenoses by greater than or equal to 20%) percutaneous transluminal coronary angioplasty (PTCA). Anatomical results were analysed on the basis of functional evaluation obtained by exercise test (ET) 1 week before (pre-PTCA) and within 1 month after (post-PTCA) PTCA. Total exercise duration and maximal double product significantly increased after PTCA (4.5 +/- 1 min vs 6.9 +/- 1.5 min, p less than 0.001 and 14.1 +/- 3.6 x 1000 mmHg x bpm vs 18 +/- 4.2 x 1000 mmHg x bpm, p less than 0.001). Pre-PTCA ET was positive in 43 patients (70%) and post-PTCA ET in 15 (24%). In patients with post-PTCA positive ET, mean stenosis diameter reduction was significantly lower than that obtained in patients with negative post-PTCA ET (29.6 +/- 8.9% vs 61.1 +/- 18.8%, p less than 0.001). In conclusion, PTCA improved exercise tolerance in the majority of patients with myocardial ischemia, however the definition of anatomical success used in this study appears to be poorly correlated with functional improvement as assessed by ET.

Background: Despite the widespread use of transcatheter aortic valve implantation (TAVI), the role of sex on outcome after TAVI or surgical aortic valve replacement (AVR) has been poorly investigated. We investigated the impact of sex on outcome after TAVI or AVR. Methods: There were 2108 patients undergoing TAVI or AVR who were enrolled in the Italian Observational Multicenter Registry (OBSERVANT). Thirty-day mortality, major periprocedural morbidity, and transprosthetic gradients were stratified by sex according to interventions. Results: Female AVR patients showed a worse risk profile compared with male AVR patients, given the higher mean age, prevalence of frailty score of 2 or higher, New York Heart Association class of 3 or higher, lower body weight, and preoperative hemoglobin level (P ≤.02). Similarly, female TAVI patients had a different risk profile than male TAVI patients, given a higher age and a lower body weight and preoperative hemoglobin level (P ≤.005), but with a similar New York Heart Association class, frailty score, EuroSCORE (P = NS), a better left ventricular ejection fraction and a lower prevalence of left ventricular ejection fraction less than 30%, porcelain aorta, renal dysfunction, chronic obstructive pulmonary disease, arteriopathy, and previous cardiovascular surgery or percutaneous coronary intervention (P ≤.01). Women showed a smaller aortic annulus than men in both populations (P

Objectives This study sought to evaluate the 30-day and long-term clinical outcomes of patients with carotid obstructive disease (COD) and concomitant coronary artery disease (CAD) undergoing a combined percutaneous revascularization, in 4 high-volume centers skilled for the treatment of multilevel vascular disease. Background The optimal management of patients with COD and concomitant CAD remains controversial. A variety of therapeutic strategies, including coronary artery bypass grafting, alone or in combination with carotid artery revascularization, have been reported. Methods Between January 2006 and April 2010, 239 consecutive patients with COD (symptomatic carotid stenosis in 20.5%) and concomitant CAD were treated with staged or simultaneous carotid artery stenting and percutaneous coronary intervention, and enrolled in this prospective registry. The primary endpoint was the incidence of major cardiac and cerebrovascular events, including any death, myocardial infarction, or stroke occurring between the first revascularization procedure and 30 days after treatment of the second vascular territory affected. Results The incidence of the primary endpoint at 30 days was 4.2% (95% confidence interval [CI]: 2.02 to 7.56). The rate of death, myocardial infarction, and stroke at long-term follow-up (median 520 days) was 4.2%, 2.1%, and 3.8%, respectively. At long-term follow-up, patients with previous cardiovascular disease had significantly higher rates of major cardiac and cerebrovascular events than did patients with a first clinical episode (17% vs. 6%, hazard ratio: 3.34; 95% CI: 1.46 to 7.63; p = 0.004). Conclusions In patients with COD and concomitant CAD, a combined percutaneous treatment compares favorably with previous surgical or hybrid experiences. Such strategy may be particularly suited to complex patients at high surgical risk.

Controversies still exist over the optimal temperature for blood cardioplegia and systemic perfusion. This study investigates the effect of temperature of blood cardioplegia and systemic perfusion on the release of troponin I and other biochemical markers.One hundred and fifty-four consecutive patients were randomly assigned to one of two cardioplegic and systemic perfusion strategies of cold blood cardioplegia with moderate systemic hypothermia (27 degrees C) or tepid blood cardioplegia with mild systemic hypothermia (33 degrees C). Cardiac troponin I and other biochemical markers were measured at baseline, at the end of surgery, at 12 hours and daily thereafter. A two-way ANCOVA for repeated measure was performed to test the effect of cardioplegia on enzyme release independently of variables that were different between the two groups.The time course of dismission of troponin I, creatine kinase MB, and lactate dehydrogenase were significantly lower with tepid blood cardioplegia and mild systemic perfusion independently of the number of distal anastomoses, CPB time, cross clamp time or total volume of cardioplegia. There were no differences between the two groups in the release of total creatine kinase, aspartate transaminase and alanine transferase.Both strategies of myocardial protection and systemic perfusion guarantee subclinical minor myocardial damage. The strategy of tepid whole blood cardioplegia and mild systemic hypothermia seems to preserve myocardium better than whole blood cold cardioplegia.

The effects of stent carbon coating on the activation of inflammatory and endothelial cells and of coagulation were assessed in patients undergoing coronary artery stent implantation.Forty-four consecutive patients with stable angina and an isolated significant stenosis in a native coronary vessel undergoing stent implantation were randomized to a carbon-coated stent (Carbostent, n = 23) or an uncoated stent with a similar design (Multilink, n = 21). The markers of inflammation, of hemostasis and of platelet and endothelial activation were determined before and 6, 24, 48 and 72 hours after the procedure.Procedural success was achieved in all cases and no patient presented with major in-hospital adverse events. In both the Carbostent and Multilink groups, the median (interquartile range) plasma levels of C-reactive protein significantly increased after the procedure (p0.001 and p = 0.002 vs baseline levels, respectively), reaching a peak at 48 hours, without any difference between groups (p = 0.76). Similarly, in both groups the plasma levels of fibrinogen, thrombin-antithrombin III complexes, prothrombin fragments F1 + 2, plasminogen activator inhibitor-1, soluble E-selectin, soluble P-selectin and von Willebrand factor significantly increased after the procedure (all p0.05 vs baseline values), without any difference between groups (all p = NS).This study confirms that the markers of inflammation, of endothelial and platelet activation and of thrombin generation significantly increase after successful coronary artery stent implantation. More importantly, it demonstrates that carbon coating does not modify the biologic response of the vessel wall to stent implantation.

Secondary prevention after acute coronary syndromes should be aimed at reducing the risk of further adverse cardiovascular events, thereby improving quality of life, and lengthening survival. Despite compelling evidence from large randomized controlled trials, secondary prevention is not fully implemented in most cases after hospitalization for acute coronary syndrome. The Lazio Region (Italy) has about 5.3 million inhabitants (9% of the entire Italian population). Every year about 11 000 patients are admitted for acute coronary syndrome in hospitals of the Lazio Region. Most of these patients receive state-of-the art acute medical and interventional care during hospitalization. However, observational data suggest that after discharge acute coronary syndrome patients are neither properly followed nor receive all evidence-based treatments. This consensus document has been developed by 11 Scientific Societies of Cardiovascular and Internal Medicine in order develop a sustainable and effective clinical approach for secondary cardiovascular prevention after acute coronary syndrome in the local scenario of the Lazio Region. An evidence-based simplified decalogue for secondary cardiovascular prevention is proposed as the cornerstone of clinical intervention, taking into account regional laws and relative shortage of resources. The following appropriate interventions should be consistently applied: smoking cessation, blood pressure control (blood pressure130/80 mmHg), optimal lipid management (LDL cholesterol80 mmHg), weight and diabetes management, promotion of physical activity and rehabilitation, correct use of antiplatelet agents, beta-blockers, renin-angiotensin-aldosterone system blockers.

Non-invasive cardiovascular imaging owns a pivotal role in the preoperative assessment of patient candidates for transcatheter aortic valve implantation (TAVI), providing a wide range of crucial information to select the patients who will benefit the most and have the procedure done safely. This document has been developed by a joined group of experts of the Italian Society of Cardiology and the Italian Society of Medical and Interventional Radiology and aims to produce an updated consensus statement about the pre-procedural imaging assessment in candidate patients for TAVI intervention. The writing committee consisted of members and experts of both societies who worked jointly to develop a more integrated approach in the field of cardiac and vascular radiology. Part 2 of the document will cover CT and MR angiography, standard medical reporting, and future perspectives.

Background: Intravascular lithotripsy (IVL) showed to be effective in dilating heavily calcified de novo coronary lesions but little is known about its performance in under-expanded stents management. Aim of this study was to assess the feasibility, effectiveness and safety of IVL for the treatment of stent underexpansion refractory to balloon dilatation. Methods: A multicentre, retrospective cohort analysis was performed in patients undergoing IVL to treat under-expanded stents following non-compliant balloon expansion failure. Primary endpoint was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase of at least 1 mm2 in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA). Results: Thirty-nine under-expanded stents (34 patients) were included. Two cases (5.1%) of multiple stent layers and one (2.5%) acutely under-expanded stent were treated. The median IVL balloon diameter was 3.1 mm (IQR: 2.5–3.5 mm) while the number of pulses emitted was 56.7 (IQR: 30–80). IVL was successful in 34 cases (87.1%), with significant improvement in MSD (post: 3.23 mm [IQR: 3–3.5 mm] vs. pre: 0.81 mm [IQR: 0.35–1.2], p < 0.00001) and MSA (post: 7.61mm2 [IQR: 6.43–7.79mm2] vs. pre: 3.35 [IQR: 2.8–4 mm2], p < 0.00001). Non-fatal peri-procedural ST-elevation myocardial infarction occurred in one case (2.5%) due to IVL balloon rupture. No cardiac death, target lesion revascularization and stent thrombosis occurred in-hospital and at 30-day follow-up. Conclusions: Bailout IVL was feasible, efficacious and safe to improve refractory stent under-expansion.

Background: The itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety of using cangrelor during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) in the daily practice. Hypothesis: The safety of cangrelor after the transition to oral P2Y12 inhibitors was evaluated as the incidence of bleeding outcomes in the 30 days following PCI according to postauthorization safety study guidelines. Methods: Adults with ACS who were treated with cangrelor in one of the 28 centers involved in the study. Patients who consented to participate were followed in the 30 days following their PCI. Bleedings (Bleeding Academic Research Consortium [BARC] classification), major adverse cardiac events (MACEs), and adverse events were recorded. The interim results at two-thirds of the enrollment period are presented. Results: A total of 17 bleedings were observed in the 320 patients who completed the study at this stage. All bleedings were classified as BARC Type 1–2, except for one case of Type 3a (vessel puncture site hematoma). Four patients experienced MACEs (2 acute myocardial infarctions, 1 sudden cardiac death, 1 noncardiovascular death due to respiratory distress, and multiorgan failure). None of the bleedings was rated as related to cangrelor. Conclusions: The interim results of the ARCANGELO study provide a preliminary confirmation that the use of cangrelor on patients with ACS undergoing PCI is not associated with severe bleedings.

Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI.

Objectives: No standardized algorithm exists to identify patients at risk of bleeding after transcatheter aortic valve replacement (TAVR). The aim of this study was to generate and validate a useful predictive model. Background: Bleeding events after TAVR influence prognosis and quality of life and may be preventable. Methods: Using machine learning and multivariate regression, more than 100 clinical variables from 5,185 consecutive patients undergoing TAVR in the prospective multicenter RISPEVA (Registro Italiano GISE sull'Impianto di Valvola Aortica Percutanea; NCT02713932) registry were analyzed in relation to Valve Academic Research Consortium-2 bleeding episodes at 1 month. The model's performance was externally validated in 5,043 TAVR patients from the prospective multicenter POL-TAVI (Polish Registry of Transcatheter Aortic Valve Implantation) database. Results: Derivation analyses generated a 6-item score (PREDICT-TAVR) comprising blood hemoglobin and serum iron concentrations, oral anticoagulation and dual antiplatelet therapy, common femoral artery diameter, and creatinine clearance. The 30-day area under the receiver-operating characteristic curve (AUC) was 0.80 (95% confidence interval [CI]: 0.75–0.83). Internal validation by optimism bootstrap-corrected AUC was 0.79 (95% CI: 0.75–0.83). Score quartiles were in graded relation to 30-day events (0.8%, 1.1%, 2.5%, and 8.5%; overall p

Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year follow‐up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65–0.99]; P =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58–0.98]; P =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow‐up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72–1.10]; P =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P =0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short‐term, driven by lower bleeding complications. Registration Information URL: clini​caltr​ials.gov ; Unique identifier: NCT02713932.

Background— Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with bare-metal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess. Methods and Results— Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtration rate P P P =0.006). Conclusions— This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design, in patients who have chronic kidney disease with multivessel coronary artery disease. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique identifier: NCT00818792.

Background . Volatile anesthetics enhance postischemic functional recovery in animal models; this effect has not been investigated in man. Methods . Twenty-two patients undergoing coronary surgery were randomized to enflurane administration (0.5% to 2%) for 5 minutes to reduce systolic blood pressure by 20% to 25% immediately before cardioplegic arrest. Left ventricular contractility was assessed by pressure-area relations using echocardiographic automated border detection during inflow occlusion before and after cardiopulmonary bypass. Linear regression analysis in 16 patients with paired data sets assessed changes in contractility. Results . The relation was highly linear ( r = 0.95 ± 0.02). A change of slope versus the change in x intercept was detected in controls (mean difference, 16.1 mm Hg/cm 2 , 95% confidence limits, 5.9 to 26.3; 2.2 cm 2 , 95% confidence limits, −1.1 to 5.5; p = 0.007), which was different from those of treated patients (mean difference, 0.7 mm Hg/cm 2 , 95% confidence limits, −2.2 to 3.7; −0.06 cm 2 , 95% confidence limits, −1.6 to 1.5; p > 0.2). Analysis of covariance in the overall group confirmed a significant effect of treatment ( p = 0.002). Conclusions . Enflurane enhances postischemic functional recovery, possibly through pharmacologic preconditioning of myocardium.

Background . Reinfusion of shed blood after coronary artery bypass grafting might increase the levels of cardiac enzymes with consequent difficulties in the diagnosis of perioperative myocardial infarction. Methods . Thirty consecutive patients undergoing coronary artery bypass grafting who bled at least 400 mL within the first 4 hours after operation underwent reinfusion of shed blood. Thirty consecutive patients who were not autotransfused served as control. All patients underwent enzyme determination (total creatine kinase, MB fraction, lactate dehydrogenase, and troponin I) in the shed blood and in circulating blood preoperatively, at arrival in the intensive care unit, and 6, 24, and 48 hours after operation. Results . The shed blood contained significantly higher concentration of cardiac enzymes than the circulating blood at all time intervals ( p = 0.0001). The levels of creatine kinase, its MB fraction, and lactate dehydrogenase in circulating blood were significantly elevated in patients receiving autotransfusion up to 24 hours after autotransfusion. The blood levels of troponin I were not significantly different between the two group of patients at all time points. The percent fraction of MB did not increase after autotransfusion. Conclusions . The measurement of cardiac troponin I is a useful marker for the diagnosis of perioperative myocardial infarction in patients undergoing transfusion of shed blood after coronary operation.

Objective: Stentless biologic aortic valves are less obstructive than stented biologic or mechanical valves. Their superior hemodynamic performances are expected to reflect in better regression of left ventricular hypertrophy. We compared the regression of left ventricular hypertrophy in 3 groups of patients undergoing aortic valve replacement for severe aortic stenosis. Group I (10 patients) received stentless biologic aortic valves, group II (10 patients) received stented biologic aortic valves, and group III (10 patients) received bileaflet mechanical aortic valves. Methods: Echocardiographic evaluations were performed before the operation and after 1 year, and the results were compared with those of a control group. Left ventricular diameters and function, left ventricular wall thickness, and left ventricular mass were assessed by echocardiography. Results: Group I patients had a significantly lower maximum and mean transprosthetic gradient than the other valve groups (P = .001). One year after operation there was a significant reduction in left ventricular mass for all patient groups (P < .01), but mass did not reach normal values (P = .05). Although the rate of regression in the interventricular septum and posterior wall thickness differed slightly among groups, their values at follow-up were comparable and still higher than control values (P = .002). The ratio between interventricular septum and posterior wall and the ratio between wall thickness and chamber radius did not change significantly at follow-up. Conclusions: Because the number of patients was relatively small, we could not use left ventricular mass regression after 1 year to distinguish among patients undergoing aortic valve replacement for aortic stenosis by means of valve prostheses with different hemodynamic performances. (J Thorac Cardiovasc Surg 1998;116:590-8)

Objective: To assess the extent and pattern of regression of left ventricular hypertrophy after valve replacement for aortic stenosis, we studied 26 patients receiving either 19 or 21 mm CarboMedics valves (group I, 13 patients) or either 23 or 25 mm CarboMedics valves (group II, 13 patients). The studies were done before the operation and after 3 years, and results were compared with those of 10 control patients. Methods: Left ventricular end-diastolic and end-systolic diameters and volumes, ejection fraction and fractional shortening, and interventricular septum and posterior wall thickness were measured. The ratio between interventricular septum and posterior wall thickness, the ratio between left ventricular wall thickness and left ventricular chamber radius, and the left ventricular mass were then calculated. Results: At follow-up there was a significant reduction in the left ventricular mass, interventricular septum, and posterior wall thickness for both patient groups (p < 0.01). However, only the posterior wall thickness reached normal values; the interventricular septum and the left ventricular mass indices were still significantly greater than in the control group (p < 0.01). Because of the incomplete regression of interventricular septal hypertrophy, the ratio between interventricular septum and posterior wall thickness was similar between both patient groups but it was significantly higher than in control subjects (p < 0.01). The ratio between wall thickness and chamber radius did not decrease significantly in group II patients, in whom it remained above the control values. Conclusion: Having a bileaflet aortic prosthesis of one size larger did not seem to significantly influence the pattern and the extent of regression of left ventricular hypertrophy after an intermediate period of follow-up. (J Thorac Cardiovasc Surg 1997;113:901-9)

BACKGROUND Brief episodes of ischemia render the heart more resistant to subsequent ischemia; this phenomenon has been called ischemic preconditioning. In some animal species, myocardial preconditioning appears to be due to activation of ATP-sensitive K+ (KATP) channels. The role played by KATP channels in preconditioning in humans remains unknown. The aim of this study was to establish whether glibenclamide, a selective KATP channel blocker, abolishes the ischemic preconditioning observed in humans during coronary angioplasty following repeated balloon inflations. METHODS AND RESULTS Twenty consecutive patients undergoing one-vessel coronary angioplasty were randomized to receive 10 mg oral glibenclamide or placebo. Sixty minutes after glibenclamide or placebo administration, patients were given an infusion of 10% dextrose (8 mL/min) to correct glucose plasma levels or, respectively, an infusion of saline at the same infusion rate. Thirty minutes after the beginning of the infusion, both patient groups underwent coronary angioplasty. The mean values (+/- 1 SD) of ST-segment shifts on the surface 12-lead ECG and the intracoronary ECG were measured at the end of the first and second balloon inflations, both 2 minutes long. In glibenclamide-treated patients, the mean ST-segment shift during the second balloon inflation was similar to that observed during the first inflation (23 +/- 13 versus 20 +/- 8 mm, P = NS), and the severity of cardiac pain was greater (55 +/- 21 versus 43 +/- 23 mm on a scale of 0 to 100, P < .05). Conversely, in placebo-treated patients the mean ST-segment shift during the second inflation was less than that during the first inflation (9 +/- 5 versus 23 +/- 13 mm, P < .001), as was the severity of cardiac pain (15 +/- 15 versus 42 +/- 19 mm, P < .01). Blood glucose levels were significantly reduced 60 minutes after glibenclamide compared with those at baseline (53 +/- 9 versus 102 +/- 10 mg/100 mL, P < .001) in the glibenclamide group; however, before coronary angioplasty, blood glucose levels increased to 95 +/- 19 mg/100 mL, a value similar to that found in placebo group (96 +/- 11 mg/100 mL, P = NS). CONCLUSIONS In humans, ischemic preconditioning during brief repeated coronary occlusions is completely abolished by pretreatment with glibenclamide, thus suggesting that it is mainly mediated by KATP channels.

Previous studies have assessed the determinants of collateral vessel recruitment during coronary occlusion in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). However, the determinants of severity of myocardial ischemia after sudden coronary occlusion do not necessarily coincide with those responsible for collateral vessel recruitment. The aim of this study was to assess the determinants of severity of myocardial ischemia during balloon inflation by recording surface and intra-coronary electrocardiograms (ECGs). In 62 consecutive patients with 1-vessel disease and without previous myocardial infarction undergoing successful PTCA for stable (n = 33) or unstable (n = 29) angina pectoris, the summation of the absolute values of ST-segment shifts from baseline on the intracoronary and surface ECG at the end of the first 2-minute inflation was obtained as an index of the severity of myocardial ischemia. Stenosis severity before PTCA was measured using computerized coronary angiography, while the grade of collateral filling was scored according to Rentrop's classification. The mean (+/- 1 SD) ST-segment shift at the end of balloon inflation was less in patients with than without collateral vessels (12 +/- 10 vs 23 +/- 15 mm, p0.05). Despite a similar prevalence of collateral vessels (34% vs 24%, p = NS), the mean ST-segment shift was also less in patients with unstable than stable angina (15 +/- 9 vs 24 +/- 17 mm, p0.05). However, the mean ST-segment shift was not associated with the severity of coronary stenosis before PTCA (r = 0.0004, p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)

A 58-year-old woman, referred to our hospital to undergo invasive assessment of mitral valve stenosis, demonstrated prolonged asymptomatic catheter-induced left anterior descending and right coronary artery spasm during coronary arteriography. Coronary spasms were not associated with ECG and arterial blood pressure changes. Intracoronary injection of nitroglycerin (300 and 600 micrograms bolus) did not resolve coronary spasm. Coronary angiography, repeated 24 hours later using the same procedure and materials, did not show any evidence of coronary artery spasm. The present clinical case is interesting for 3 reasons. First, the presence of prolonged proximal double-vessel coronary spasm not associated with symptoms or signs of acute myocardial ischemia; second, the incapacity of high dose of intracoronary nitroglycerin to resolve the coronary spasm; third, the dramatic changes in the sensitivity of coronary artery to mechanical stimulation in different days.

Background: The impairment of flow reserve of the left anterior descending coronary artery in the early postoperative period in patients receiving a left internal thoracic artery graft has been related to the effects of cardiopulmonary bypass. Indeed, the late improvement in flow has been attributed to a late increase in left internal thoracic artery diameter. Methods: We evaluated 12 patients who underwent minimally invasive direct coronary artery bypass surgery with the internal thoracic artery used to graft an occluded left anterior descending artery without extracorporeal circulation. Early and 6 months after the operation, patients underwent a second angiogram of the left internal thoracic artery graft and assessment of coronary flow reserve by use of an intracoronary 0.014-inch Doppler guide wire. Results: At the late study, coronary flow reserve had increased compared with the early postoperative data from 1.8 ± 0.4 (standard deviation) to 2.5 ± 0.6 ( P = .002) because of a significant decrease in baseline averaged peak velocity (32.4 ± 6.2 vs 21.3 ± 6.4 cm/s, P = .002), whereas the hyperemic values were similar (51 ± 6 vs 53.7 ± 21.9 cm/s, P = .6). The diameters of the thoracic artery (2.1 ± 0.3 vs 2.2 ± 0.3 mm, P = .7) and the left anterior descending coronary artery (1.8 ± 0.1 vs 1.8 ± 0.2 mm, P = .5), as well as myocardial oxygen consumption (106 ± 14 vs 101 ± 16 mm Hg · beats/min · 10 –2 , P = .5), were unchanged. Conclusions: Our findings suggest that the late improvement in coronary flow reserve is independent of the diameter of the graft and probably reflects an early distal coronary vessel dysfunction, which normalizes with time. (J Thorac Cardiovasc Surg 1999;118:604-9)