Risk-adjusted early invasive strategy in patients with non-ST-segment elevation acute coronary syndrome in Intensive Cardiac Care Units. / Estrategia invasiva precoz ajustada al riesgo en pacientes con síndrome coronario agudo sin elevación de segmento ST en Unidades de Cuidados Intensivos Cardiológicos.

OBJECTIVE: Current guidelines recommend a risk-adjusted early invasive strategy (EIS) in patients with non-ST-segment elevation acute coronary syndrome (NSTEACS). The present study assesses the application if this strategy, the conditioning factors and prognostic impact upon patients with NSTEACS admitted to Intensive Cardiac Care Units (ICCU). DESIGN: A prospective cohort study was carried out. SETTING: The ICCUs of 8 hospitals in Catalonia (Spain). PATIENTS: Consecutive patients with NSTEACS between October 2017 and March 2018. The risk profile was defined by the European Society of Cardiology criteria. INTERVENTIONS: EIS was defined as the performance of coronary angiography within the first 6hours in patients at very high-risk or within 24hours in high-risk patients. OUTCOME VARIABLES: Mortality or readmission at 6 months. RESULTS: A total of 629 patients were included (mean age 66.6 years), of whom 225 (35.9%) were at very high risk, and 392 (62.6%) at high risk. Most patients (96.2%) underwent an invasive strategy. EIS was performed in 284 patients (45.6%), especially younger patients with fewer comorbidities. These patients had a shorter ICCU and hospital stay, as well as a lesser incidence of ACS, revascularization and death or readmission at 6 months. After adjusting for confounders, the association between EIS and death or readmission at 6 months remained significant (hazard ratio: .66, 95% confidence interval .45-.97; P=.035). CONCLUSIONS: The EIS was performed in a minority of NSTEACS admitted to ICCU, being associated with better outcomes.

The TITAN-AMI multicenter registry evaluating the usage of Titan2 stent in patients with ST segment elevation myocardial infarction. Final result at 12-month follow-up.

AIM: Primary percutaneous coronary intervention with stent implantation is the recommended treatment for patients with ST elevation myocardial infarction (STEMI). Data from randomised trials showed good performance by a titanium-nitric-oxide coated stent in this context. The aim of this study was to confirm these data. METHODS: A multicentre registry was compiled in 23 hospitals in Spain in an all-comers population. We selected patients with STEMI from a global Titan AMI registry that included patients with acute coronary syndrome. Primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, stent thrombosis and target lesion revascularisation, at 12-month follow-up. RESULTS: The study included 893 patients with STEMI. We included all possibilities for PCI: 86.6% primary, 5% facilitated after successful fibrinolysis and 8.4% rescue PCI after failed fibrinolysis. The primary endpoint was reached in 8.4% of the patients: cardiac death 2.7%, reinfarction 3.4%, target lesion revascularisation 3.5% and definite or probable stent thrombosis 2.8%. The majority of stent thromboses presented in the first 30 days after PCI. CONCLUSION: A bioactive stent (titanium-nitric-oxide coated stent) is a possible alternative for the treatment of patients with STEMI. One-year follow-up showed better results than those presented by a regular bare-metal stent or first-generation drug-eluting stent in terms of stent thrombosis.

Rationale and study design of the RESERVOIR trial: a randomized trial comparing reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents with durable polymer in patients with diabetes mellitus.

BACKGROUND: Patients with diabetes mellitus (DM) remain at high risk for stent restenosis and adverse cardiovascular events in the drug-eluting stent era. The amphilimus-eluting stent (AES) is a third generation reservoir-based polymer-free drug-eluting stent that has shown promising preliminary results in patients with DM. It has been suggested that the formulation of the drug with fatty acids could not only modulate the drug release in a timely manner but also achieve convenient levels of drug concentration in diabetic cardiac cells. The aim of this trial is to assess the efficacy of the AES in patients with DM compared with the cobalt chromium everolimus-eluting stent with non-erodible polymer (EES). STUDY DESIGN: This is an investigator-initiated, multicenter, randomized clinical trial, performed in patients with DM. A total of 112 diabetic patients receiving glucose-lowering agents and requiring percutaneous revascularization of a de novo lesion will be randomized in a 1:1 fashion to receive AES or EES. The primary endpoint is the neointimal volume obstruction at 9 months, evaluated by optical coherence tomography. Secondary endpoints will include strut coverage, angiographic in-stent late loss and clinical endpoints such as target vessel revascularization or probable/definite stent thrombosis. This study completed the inclusion in October 2013. CONCLUSIONS: The RESERVOIR trial is an investigator-initiated trial that will evaluate whether the polymer-free AES is not inferior to the EES inhibiting the neointimal hyperplasia in patients with DM. These results are also expected to improve our knowledge of the neointimal healing process in this population (Clinicaltrials.gov number NCT01710748).

Polymer-free amphilimus-eluting stents in patients with diabetes mellitus.

Despite several improvements in drug-eluting stents design, diabetes mellitus (DM) remains an Achilles' heel for percutaneous coronary revascularization at the present time. The Cre8 stent is a third-generation drug-eluting stent devoid of polymer. The drug, which is formulated with an amphiphilic carrier, is eluted from laser-dug wells on the stent's abluminal surface. The Cre8 stent hat has shown promising preliminary results in patients with DM. This review summarizes the mechanisms of DES failure in patients with DM and the potential role of the Cre8 stent in this high-risk population.

Secondary revascularization after coronary surgery.

World population is aging day after day and coronary atherosclerosis disease is becoming a worldwide pandemic disease. Whereas the number of patients with surgical or percutaneous coronary revascularization is increasing, a new revascularization procedure in a previously revascularized patient is a situation that is already being common in cath labs all over the world. Such patients present some special considerations, with a higher risk and worse prognosis than the usual patients and they require to take specific attitudes regarding prognosis, treatment and revascularization technique. At present, much has been achieved in this field, with new devices developed and many randomized clinical trials, but there is still sparse knowledge about this subject and some confusing points. The following article will discuss about the present-day knowledge of secondary coronary revascularization in patients previously operated, focusing in its indications and which are the technical considerations to keep in mind. Special attention will be paid to the percutaneous revascularization of saphenous vein grafts, the most complex and specific situation that we can find in such patients due to its special histopathology and behavior. Moreover, a mention will be made of the new advances that have been made in recent years, about all kind of devices, coronary stents, pharmacological treatment and new emerging revascularization strategies.

Sirolimus in heart transplantation: a single center initial experience.

Sirolimus (SRL) is a potent non-nephrotoxic immunosuppressant. In our unit, SRL was administered to 17 heart transplant (HT) recipients at 1770+/-1234 days' posttransplant surgery, for the following reasons: (1) calcineurin inhibitor (CI) withdrawal due to renal insufficiency (RI; n=6); (2) neurotoxicity (n=1) and pancytopenia (n=1); (3) vascular graft disease (VGD) treatment (n=5); (4) immunosuppression optimization due to lung cancer (n=2); (5) CI use was delayed due to postsurgery RI (n=2). The mean follow-up was 190+/-165 days. Mean SRL doses (mg)/concentrations (ng/mL) at 7 (n=17), 30 (n=14), and 180 (n=8) days were: 1.2+/-0.6/5.9+/-6; 1.6+/-0.8/4.8+/-3.1; and 1.7+/-1.0/5.2+/-3.7. Among group 1, CI patients were discontinued without favorable functional impact. Neurotoxicity and pancytopenia improved, but there were no major clinical events in the VGD group. One "bridge" to CI was successfully performed (postsurgery RI). Total leukocyte count fell while hemoglobin, platelet, and cholesterol profiles were not affected. Ten of 15 patients (67%) were discontinued from CI without rejection and with a dose reduction of mycophenolate mofetil. There were 8 episodes (47%) of SRL-related toxicity, leading to 4 discontinuations (23%); 8 patients (47%) have died during follow-up. This retrospective analysis of outcomes in the context of severe complicated patients suggests that more premature introduction SRL is preferable, particularly in a large patient cohort.

[Endothelial function in coronary segments previously treated with balloon angioplasty]. / Función endotelial en segmentos arteriales previamente sometidos a angioplastia coronaria.

INTRODUCTION AND OBJECTIVES: Coronary angioplasty leads to endothelial disruption and a further rendotelization. The aim of our study was to determine the status of endothelial function in previously dilated coronary segments without restenosis. METHODS: Endothelium-dependent vasomotion was analysed in twelve patients with single vessel coronary disease six month after angioplasty by selective intracoronary doses of acetylcholine (10-6, 10-5, 10-4 M) in the previously treated artery. The control group was made up of seven patients with no evidence of significant coronary stenosis and without risk factors. Vasomotor response at the different doses of acetylcholine was determined by quantitative coronary angiography. RESULTS: Endothelial function showed a global vasodilator response in the dilated segment at the maximum dose of acetylcholine (increase in lumen diameter 3.6 +/- 3.5%), similar to the response observed in the control group (increase of luminal diameter 3 +/- 6%; p = NS). In particular, 8 patients (67%) showed a normal endotelial function, while 4 patients (33%) showed a vasoconstrictor response. A positive correlation was detected between the response to the maximun dose of acetylcholine and the percent of residual stenosis at 6 months of follow-up (r = 0.67; p = 0.02). CONCLUSIONS: In patients treated with coronary angioplasty without restenosis, the dilated segments frequently showed normal endothelial function. Greater residual stenosis at the dilated segment was associated with less impairment in endothelial function.

Predictive factors and long-term evolution of early endothelial dysfunction after cardiac transplantation.

BACKGROUND: Abnormal coronary vasomotion appears to be a common finding after heart transplantation (HTx). However, the pathophysiology and outcome of this functional disturbance remains poorly understood. Aims of the study were to determine the prevalence, predictive factors and long-term evolution of endothelial dysfunction after cardiac transplantation. METHODS: The endothelium-dependent coronary vasomotion of 50 patients, who showed angiographically normal coronary arteries, were studied early (at 3 +/- 1 months) and at follow-up (16 +/- 5 months) after HTx. Endothelial function was studied by selective infusion of serial doses of acetylcholine (ACh) (10(-8), 10(-7)and 10(-6) mol/l) in the left anterior descending coronary artery. Changes in mean luminal diameter after the infusion of each dose were evaluated by quantitative coronary angiography (QCA). RESULTS: At early study, 17 patients (34%) showed a vasoconstriction after maximal dose of ACh (-13.3 +/- 13%) indicative of endothelial dysfunction. Logistic regression analysis identified the following variables as independent predictors of early endothelial dysfunction: donor inotropic support (p = 0.004), female donor (p = 0.04) and rejection at the time of the study (p = 0.01). Forty-one patients were re-studied at follow-up. Nine of them (22%) presented endothelial dysfunction. Early endothelial dysfunction was restored in 6 patients (43%) at follow-up. The number of episodes of rejection was the only variable associated to late endothelial dysfunction. CONCLUSIONS: Endothelial dysfunction is a common finding after cardiac transplantation. The pathogenesis of this functional disturbance appears to be donor-related and immune-mediated. The reversibility of this phenomenon observed at follow-up suggests the episodic nature of the immunologic injury.

Partial improvement in pulmonary function after successful percutaneous balloon mitral valvotomy.

STUDY OBJECTIVES: This study was performed to assess the changes in pulmonary function after a successful percutaneous balloon mitral valvotomy (PBMV) in 23 consecutive patients with symptomatic mitral stenosis. METHODS AND RESULTS: Lung function preprocedure and postprocedure were evaluated by spirometric flow, static pulmonary volumes, and diffusion capacity of the lung for carbon monoxide (DLCO). At baseline, a reduction in small airways flow (maximal expiratory flow at 50% of vital capacity, 70 +/- 29% of predicted value; maximal expiratory flow at 25% of vital capacity, 55 +/- 26% of predicted value) and an increase in DLCO (118 +/- 29%) and Krough Index (KCO; 123 +/- 29% of predicted value) were observed. PBMV caused an improvement in hemodynamic parameters with an increase in mitral valve area (from 1.0 +/- 0.3 to 1.9 +/- 0.5 cm(2); p < 0.001) and a decrease in left atrial pressure (from 17 +/- 3 to 12 +/- 5 mm Hg; p < 0.001). These changes were associated with a significant increase in FVC (from 2.8 +/- 0.84 to 2.9 +/- 0.80 L; p < 0.05) and in FEV(1) (from 2.2 +/- 0.72 to 2.3 +/- 0.68 L; p < 0.05). A decrease in DLCO was observed after PBMV (from 26.7 +/- 7 to 22.5 +/- 5.4 mL/min/mm Hg; p < 0.001; and KCO, from 6.2 +/- 1.4 to 5.2 +/- 1.2 mL/min/mm Hg/L; p < 0.001). No significant changes in small airways flow were detected, suggesting only a partial improvement in pulmonary congestion. CONCLUSION: We conclude that the initial impairment of lung function in patients with symptomatic mitral stenosis is only partially ameliorated by PBMV.

Preserved endothelium-dependent vasodilation in coronary segments previously treated with balloon angioplasty and intracoronary irradiation.

BACKGROUND: Abnormal endothelium-dependent coronary vasomotion has been reported after balloon angioplasty (BA), as well as after intracoronary radiation. However, the long-term effect on coronary vasomotion is not known. The aim of this study was to evaluate the long-term vasomotion of coronary segments treated with BA and brachytherapy. METHODS AND RESULTS: Patients with single de novo lesions treated either with BA followed by intracoronary beta-irradiation (according to the Beta Energy Restenosis Trial-1.5) or with BA alone were eligible. Of these groups, those patients in stable condition who returned for 6-month angiographic follow-up formed the study population (n=19, irradiated group and n=11, control group). Endothelium-dependent coronary vasomotion was assessed by selective infusion of serial doses of acetylcholine (ACh) proximally to the treated area. Mean luminal diameter was calculated by quantitative coronary angiography both in the treated area and in distal segments. Endothelial dysfunction was defined as a vasoconstriction after the maximal dose of ACh (10(-6) mol/L). Seventeen irradiated segments (89.5%) demonstrated normal endothelial function. In contrast, 10 distal nonirradiated segments (53%) and 5 control segments (45%) demonstrated endothelium-dependent vasoconstriction (-19+/-17% and -9.0+/-5%, respectively). Mean percentage of change in mean luminal diameter after ACh was significantly higher in irradiated segments (P=0.01). CONCLUSIONS: Endothelium-dependent vasomotion of coronary segments treated with BA followed by beta-radiation is restored in the majority of stable patients at 6-month follow-up. This functional response appeared to be better than those documented both in the distal segments and in segments treated with BA alone.

[The treatment of intra-stent restenosis. The current situation and future outlook]. / Tratamiento de la reestenosis intra-stent. Situación actual y perspectivas futuras.

In-stent restenosis is an increasing problem due to the frequent use of coronary stent as a form of percutaneous revascularization. The global incidence is near to 28%, and it is well document that a neointimal hyperplasia is its principal mechanism. The most commonly related factors for its appearance are diabetes mellitus, a longer length of the original lesion, a smaller diameter of the reference vessel, the left anterior descending artery location and a smaller luminal diameter at the end of the procedure. Due to a different long term evolution in-stent restenosis has been classified as focal or diffuse, according to the length of the restenotic lesion (focal < 10 mm and diffuse > or = 10 mm). Some strategies have been proven for its treatment, but no randomized-controlled trials have been published comparing these different treatments. In focal in-stent restenosis the practice of a conventional balloon angioplasty is associated with high initial clinical success with a favourable long term evolution (target lesion revascularization between 11-15%). But on the contrary, in diffuse in-stent restenosis, in spite of a high initial success rate, an elevated target lesion revascularization has been detected at the follow-up (up to 43%). Other proved such as atherectomy or excimer laser are associated with a significant procedural non-Q-wave infarction (near to 9%) and a long term target lesion revascularization during follow-up (23-31%). The implantation of an additional stent has been performed with low procedural complications and with a long term target lesion revascularization near to 27%. Patients treated with intracoronary radiation as a complementary technique seem to have a better long term evolution than those having had the other strategies alone. In conclusion, in-stent-restenosis is a new and progressively more frequent problem, requiring complex treatment and of which as been established. Comparative controlled studies need to be performed in order to determine the best treatment for this new entity.

[Intracoronary stents in the treatment of angioplasty complications]. / Stent intracoronario en el tratamiento de las complicaciones de la angioplastia.

Acute or subacute occlusion of the dilated artery is the main cause of complication after percutaneous transluminal coronary angioplasty. The occlusion incidence ranges between 2 and 10% of the procedures and the mechanisms include dissection, subintimal hemorrhage, thrombosis, vasospasm and elastic recoil. Intracoronary stent is a metallic support which may seal dissection due to angioplasty, resists elastic recoil and geometric remodeling and prevents other occlusion mechanisms. Data from recent studies demonstrate the benefit of stenting acute occlusive coronary dissection in a large artery with extensive myocardium at risk. The election of the type of stent in the treatment of the acute coronary occlusion depends on the clinical status, the coronary anatomy and the stent characteristics. The major limitation of stent is the apparition of subacute thrombosis. The mechanisms of stent thrombosis are not well known. However, some factors related to complicated angioplasty, such as the presence of important dissection, intracoronary thrombus and vessels of small diameter have been involved. For this reason, the major incidence of subacute thrombosis is observed in bail-out situations. New techniques using intravascular ultrasound and high pressure dilatation after stent placement and new approaches in antiplatelet treatment have been recently described in order to reduce the incidence of subacute occlusion and the hemorrhagic events associated to previous anticoagulant therapy.

Constrictive pericarditis after heart transplantation: report of two cases.

We report two cases of constrictive pericarditis after heart transplantation. It is noteworthy that constriction developed after a healed intrathoracic infection in the two patients. Unlike previous reported experiences, pericardiectomy was uneventful and successfully performed, although incomplete improvement was achieved in one case.

[The follow-up of transposition of the great arteries corrected by Senning's technic]. / Seguimiento de la transposición de grandes arterias corregida con técnica de Senning.

INTRODUCTION AND OBJECTIVES: The incidence of late complications after a physiological correction of the patients with transposition of the great arteries (D-TGA) is very significant, due to the alternative operation of the arterial switch. METHODS: We studied 125 patients with D-TGA, treated with Senning surgical correction between december of 1978 and november of 1990. Surgery was performed at a mean age of 11.7 months (from 7 days to 11.2 years), and the postoperative mean follow-up was 7.3 years (from 1.4 to 14.3 years). We analyzed their evolutive clinical condition, ECG, Holter and echocardiogram-Doppler. Four groups were defined: A) Simple, 48.8%. B) Associated with ventricular septal defect, 22.4%. C) With pulmonary stenosis, 15.2%. D) Both anomalies, 13.6%. RESULTS: Sixteen children died (12.8%), 11 of them on the postoperative period. The remaining 5 patients died, at a mean time of 34.3 months after surgery, because they were in cardiac failure. All of patients had enlargement of right ventricle and tricuspid regurgitation was observed in 39 children. There were 3 reoperations. Atrioventricular block was observed in 5.7% of the patients, 33.3% were not in sinus rhythm, 6.6% had atrial flutter-fibrillation, sinus node dysfunction was observed in 24.7%, and five permanent pacemakers were implanted (4.7%). CONCLUSIONS: The later mortality is not high, and the clinical outcome is good, but the frequent rhythm disturbances and enlargement of the right ventricle could let us conclude the hypothesis that anatomical correction is an optimal alternative procedure.

[The mechanism producing nausea during ventriculography performed with ioxaglate: the implications of a randomized study]. / Mecanismo de producción de las náuseas durante la ventriculografía realizada con ioxaglato: implicaciones de un estudio randomizado.

INTRODUCTION: The mechanism of ioxaglate-induced nausea has not been fully elucidated. Recent studies have demonstrated that serotonin is one of the principal neurotransmitters of emesis in humans. On the other hand, the greater capacity of ioxaglate to stimulate vomiting has been ascribed to its great ability to inhibit cholinesterase. METHODS: To determine if oral metoclopramide (a serotonin receptor-blocker) is effective in the prophylaxis of ioxaglate-induced nausea during left ventriculography, 637 of 711 consecutive eligible patients were included in a prospective study. Patients were randomized to receive, 60-90 minutes before the procedure, either diazepam 10 mg p.o. (control group [n = 315]) or diazepam 10 mg p.o. plus metoclopramide 10 mg p.o. (metoclopramide group [n = 322]). RESULTS: The two randomized groups were similar in relation to baseline clinical and hemodynamic characteristics. Nausea was documented in 103 patients (16.1%) with similar incidence in the two groups (control group: 16.8%, metoclopramide group: 15.5%; p = NS). Nausea duration was also similar (56 +/- 63 s vs 52 +/- 63 s; p = NS). When patients with and without nausea were compared, the following variables showed a significant difference between the two groups: male gender (86% vs 76%; p < 0.05), age (53 +/- 10 yrs vs 56 +/- 9 yrs; p < 0.05) and body surface area (1.84 +/- 0.2 m2 vs 1.78 +/- 0.1 m2; p < 0.01). Stepwise multiple regression analysis identified low age (p = 0.02) and male gender (p = 0.06) as independent predictors of nausea. The incidence of nausea was 24% in males < or = 45 yrs vs 9% in females > 45 yrs (p < 0.05). CONCLUSIONS: Prophylaxis with oral metoclopramide did not reduce the incidence of ioxaglate-induced nausea during left ventriculography. This data do not support a role of serotonin in the production of nausea by ioxaglate. Low age an male gender are independent predictors of nausea apparition during left ventriculography. A cholinergic mechanism is probably involved in the capacity of ioxaglate to stimulate vomiting.