Guillermo Galeote

Randomized Comparison of Sirolimus-Eluting and Everolimus-Eluting Coronary Stents in the Treatment of Total Coronary Occlusions Results From the Chronic Coronary Occlusion Treated by Everolimus-Eluting Stent Randomized Trial

Background—Patients with coronary total occlusions are at especially high risk for restenosis and new revascularizations. Sirolimus-eluting stents dramatically improved the clinical outcome of this subset of patients in randomized trials, but other drug-eluting stents, mainly the everolimus-eluting stent (currently the most frequently used stent), have not yet been evaluated in patients with coronary total occlusions. The objective was to compare the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent in patients with coronary total occlusions. Methods and Results—A total of 207 patients with coronary total occlusions and estimated time since occlusion >2 weeks were randomized to everolimus- or sirolimus-eluting stent. The primary end point was in-stent late loss at 9-month angiographic follow-up (noninferiority trial). Clinical follow-up was performed at 1 and 12 months. In-stent late loss at 9 months was 0.29±0.60 versus 0.13±0.69 mm in patients allocated to sirolimus- and everolimus-eluting stent, respectively. The observed difference in in-stent late loss between both groups was –0.16 mm (95% confidence interval, 0.04 to –0.36 mm; P for noninferiority <0.01). The rate of binary angiographic restenosis was 10.8% and 9.1% in patients allocated to sirolimus- and everolimus-eluting stent, respectively (P=0.709), whereas the rate of vessel reocclusion was 3.2% and 1.1%, respectively (P=0.339). At 12 months, the rate of major adverse events was 15.9% versus 11.1% with sirolimus- and everolimus-eluting stent, respectively (P=0.335), and probable or definitive stent thrombosis occurred in 3.0% and 0.0% of patients, respectively (P=0.075). Conclusions—In patients with coronary total occlusions, everolimus-eluting stent is as effective as sirolimus-eluting stent. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00793221.

Implantación percutánea de prótesis valvulares aórticas en pacientes con estenosis aórtica severa sintomática rechazados para cirugía de sustitución valvular

La implantacion percutanea de protesis valvulares aorticas ha surgido recientemente como alternativa terapeutica en pacientes con estenosis aortica severa sintomatica rechazados para cirugia. Describimos la experiencia inicial con esta tecnica en nuestro centro. En 4 pacientes con estenosis aortica severa sintomatica rechazados para cirugia (euroSCORE medio, 23%) se realizo implantacion de protesis valvular aortica de Edwards-Sapiens por via transfemoral. En los 4 pacientes, el procedimiento tuvo lugar con exito, con implantacion correcta de la protesis y sin complicaciones. Al mes de seguimiento, no hubo eventos y todos los pacientes habian mejorado en su clase funcional.

Lower levels of in-stent late loss are not associated with the risk of stent thrombosis in patients receiving drug-eluting stents

AIMS The aim of this study was to evaluate whether there is any relationship between in-stent late loss (ISLL) and the risk of stent thrombosis (ST) in patients treated with drug eluting stents (DES). The benefit of DES in reducing binary angiographic restenosis and the need for new revascularisation procedures is due to a reduction on ISLL. It has been hypothesised, however, that neointimal hyperplasia could preclude ST, and thus a very low ISLL could increase the risk of ST. METHODS AND RESULTS We selected 26 randomised clinical trials comparing bare metal stents and DES or different DES types, and including clinical and angiographic follow-up. In order to evaluate the association between risk of ST and ISLL, meta-regression analyses were conducted, weighting for the number of patients of each study. Twenty-six studies were included, retrieving 36 subgroups for analysis and 8,971 patients treated with DES. The incidence for ST and LST was 0.81% and 0.17%. Using meta-regression techniques, neither the risk of ST nor the risk of LST were found to be significantly associated with ISLL, accounting for -0.82 and -0.002 meta-regression estimates respectively (IC 95%: -1.92 to 0.28 for ST and -0.008 to 0.003 for LST). CONCLUSIONS The risk of ST and LST after DES implantation is not related with ISLL values. A very low mean value of ISLL is nor associated with a higher risk of ST.

Immediate and Mid-term Clinical Course After Percutaneous Closure of Paravalvular Leakage

INTRODUCTION AND OBJECTIVES Percutaneous closure of paravalvular leakage is an alternative to surgery in high-risk patients, but its use has been limited by a lack of specific devices. More appropriate devices-like the Amplatzer Vascular Plug III-have recently been developed, but information about their efficacy and safety is still scarce. The objective of the present study was to assess the mid-term results of paravalvular leakage closure with this device. METHODS We analyzed the clinical and echocardiographic course both in-hospital and mid-term (13 [9] months) in a series of 20 consecutive patients (age, 68 years; logistic EuroSCORE, 29) with paravalvular leakage and attempted percutaneous closure. RESULTS Closure was attempted for 23 leaks (17 mitral and 6 aortic) during 22 procedures in 20 patients. Implantation was successful in 87% of the leaks and the procedure was successful in 83%-with success being defined as a reduction in regurgitation of ≥ 1 degree. Survival at 1 year was 64.7% and survival free of the composite event of death/surgery was 58.8%. The degree of residual regurgitation was not associated with mortality but was associated with functional status. Survivors showed significant improvement in functional class. CONCLUSIONS Percutaneous closure of leakage with the Amplatzer Vascular Plug III is safe and efficient in the mid-term. However, mortality among high-risk patients is high independently of the degree of residual regurgitation, indicating that these procedures are performed when heart disease has reached an advanced stage.

Clinical and prognostic implications of atrial fibrillation in patients undergoing transcatheter aortic valve implantation

AIM To study a cohort of consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and compare the outcomes of atrial fibrillation (AF) patients vs patients in sinus rhythm (SR). METHODS All consecutive patients undergoing TAVI in our hospital were included. The AF group comprised patients in AF at the time of TAVI or with history of AF, and were compared with the SR group. Procedural, echocardiographic and follow-up variables were compared. Likewise, the CHA(2)DS(2)-VASC stroke risk score and HAS-BLED bleeding risk score and antithrombotic treatment at discharge in AF patients were compared with that in SR patients. RESULTS From a total of 34 patients undergoing TAVI, 17 (50%) were allocated to the AF group, of whom 15 (88%) were under chronic oral anticoagulation. Patients in the AF group were similar to those in the SR group except for a trend (P = 0.07) for a higher logistic EuroSCORE (28% vs 19%), and a higher prevalence of hypertension (82% vs 53%) and chronic renal failure (17% vs 0%). Risk of both stroke and bleeding was high in the AF group (mean CHA(2)DS(2)-VASC 4.3, mean HAS-BLED 2.9). In the AF group, treatment at discharge included chronic oral anticoagulation in all except one case, and in association with an antiplatelet drug in 57% of patients. During a mean follow-up of 11 mo (maximum 32), there were only two strokes, none of them during the peri-procedural period: one in the AF group at 30 mo and one in the SR group at 3 mo. There were no statistical differences in procedural success, and clinical outcome (survival at 1 year 81% vs 74% in AF and SR groups, respectively, P = NS). CONCLUSION Patients in AF undergoing TAVI show a trend to a higher surgical risk. However, in our cohort, patients in AF did not have a higher stroke rate compared to the SR group, and the prognosis was similar in both groups.

Pharmacological Approach of No-Reflow Phenomenon Related with Percutaneous Coronary Interventions

The no-reflow phenomenon (NRP) is characterized by an inadequate myocardial tissue perfusion in the presence of a patent epicardial coronary artery. It generally occurs after temporary occlusion of the artery causing myocardial ischemia and necrosis that persist after relief of the vessel occlusion, without evidence of epicardial mechanical obstruction. Currently, the main scenario of NRP is the setting of percutaneous coronary interventions (PCI), especially in patients with acute myocardial infarction or saphenous vein graft disease, and its occurrence is associated with adverse clinical outcomes. Pathophysiology of NRP is not fully understood but it seems to be related with microvascular damage. Several mechanisms have been involved, such as distal microembolization, interstitial and intracellular edema, coronary spasm and capillary plugging. Diagnosis of NRP is generally based on clinical and angiographic data. Several methods have been proposed for the assessment of NRP, such as electrocardiography, myocardial contrast echocardiography, contrast-enhanced magnetic resonance imaging, nuclear imaging or positron emission tomography, that have demonstrated additional prognostic value over angiography. There are different pharmacological and mechanical approaches for the prevention of NRP but none of them have demonstrated a clear efficacy. The treatment of established NRP is mainly based on the administration of coronary vasodilators, like adenosine, verapamil or nitroprusside, but clinical results are frequently disappointing. The objective of this review is to describe the state of the art of the pathophysiology, diagnosis and pharmacological management of NRP.

Percutaneous Balloon Pericardiotomy as the Initial and Definitive Treatment for Malignant Pericardial Effusion

INTRODUCTION AND OBJECTIVES Malignant pericardial effusion has a high recurrence rate after pericardiocentesis. We sought to confirm the efficacy of percutaneous balloon pericardiotomy as the initial treatment of choice for these effusions. METHODS Retrospective analysis of the clinical, echocardiographic, and follow-up characteristics of a consecutive series of percutaneous balloon pericardiotomies carried out in a single center in patients with advanced cancer. RESULTS Seventeen percutaneous balloon pericardiotomies were performed in 16 patients with a mean age of 66.2 (15.2) years. Fourteen patients had pathologically confirmed metastatic neoplastic disease, 3 had previously required pericardiocentesis, and in the remaining patients percutaneous balloon pericardiotomy was the first treatment for the effusion. All patients had a severe circumferential effusion, and most presented evidence of hemodynamic compromise on echocardiography. In all cases, the procedure was successful, there were no acute complications, and it was well tolerated at the first attempt. There were no infectious complications during follow-up (median, 44 [interquartile range, 36-225] days). One patient developed a large pleural effusion that did not require treatment. Three patients needed a new pericardial procedure: 2 had elective pericardial window surgeries and 1 had a second percutaneous balloon pericardiotomy. CONCLUSIONS Percutaneous balloon pericardiotomy is a simple, safe technique that can be effective in the prevention of recurrence in many patients with severe malignant pericardial effusion. The characteristics of this procedure make it particularly useful in this group of patients to avoid more aggressive, poorly tolerated approaches.

Implantación de prótesis valvulares aórticas por vía transfemoral. Evaluación de pacientes candidatos al procedimiento

BACKGROUND AND OBJECTIVE In recent years, techniques for implantation of aortic prosthesis via catheter have been developed as a therapeutic alternative in patients with severe aortic stenosis rejected for surgery. The correct selection of candidates is one of the more complex aspects of this treatment. We analyzed the acceptance rate in our environment for transcatheter aortic valve implantation in patients referred to our hospital for evaluation as possible candidates, describing the exclusion reasons. PATIENTS AND METHOD 30 patients with severe aortic stenosis and rejected for surgical aortic valve replacement were referred to our hospital to evaluate transcatheter aortic valve implantation. The patients first underwent clinical evaluation and were studied with echocardiography, angiography and computed tomography. RESULTS Of the 30 patients, 18 were rejected for the procedure (60%): 4 patients with non-severe aortic stenosis, 2 asymptomatic patients, 2 patients who finally underwent surgery because of a low-surgical-risk, 5 patients with contraindications for the procedure, 2 patients who finally did not want to undergo the procedure and 3 patients were further rejected because the vascular access was inappropriate. Of the remaining 12 patients initially accepted, 3 died before the procedure was performed. Finally, only 9 patients (30%) underwent transcatheter aortic valve implantation. CONCLUSIONS Of the patients referred for transcatheter aortic valve implantation, only 40% were accepted. The mortality rate during the evaluation process of this procedure is high, showing that these patients are terminally ill.

Long-term Follow-up After Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis

INTRODUCTION AND OBJECTIVES Transcatheter aortic valve implantation is used as an alternative to surgical valve replacement in patients with severe aortic stenosis who are considered high-surgical-risk or inoperable. Two of the main areas of uncertainty in this field are valve durability and long-term survival. METHODS This prospective single-center registry study from a tertiary hospital included all consecutive patients who underwent percutaneous aortic valve implantation between 2008 and 2012. Clinical follow-up lasted a minimum of 2.5 years and a maximum of 6.5 years. Valve Academic Research Consortium-2 definitions were used. RESULTS Seventy-nine patients were included, with an immediate success rate of 94.9%. The median survival was 47.6 months (95% confidence intervals, 37.4-57.9 months), ie, 4 years. One quarter of deaths occurred in the first month, and most were of cardiovascular cause. After the first month, most deaths were due to noncardiovascular causes. The mean values of valve gradients did not increase during follow-up. The cumulative rate of prosthetic valve dysfunction was 15.3%, with no cases of repeat valve replacement. CONCLUSIONS Half of the patients with aortic stenosis who underwent transcatheter aortic valve implantation were alive 4 years after the procedure. There was a 15.3% prosthetic valve dysfunction rate in cumulative follow-up, with no cases of repeat valve replacement.

A randomised comparison between everolimus-eluting stent and sirolimus-eluting stent in chronic coronary total occlusions. Rationale and design of the CIBELES (non-acute Coronary occlusion treated By EveroLimus-Eluting Stent) trial

Chronic total coronary occlusions constitute a sub-group of lesions at very high risk of restenosis after successful percutaneous coronary intervention. The sirolimus-eluting coronary stent is the only drugeluting stent that has demonstrated to reduce angiographic restenosis and the need for new revascularisation procedures in comparison with bare-metal stents in randomised clinical trials focusing on these lesions. Everolimus-eluting stents have shown to offer optimal angiographic and clinical outcomes in comparison with bare-metal stents and paclitaxel-eluting stents, but no randomised trials have tested the device in chronic total occlusions. The CIBELES (non-acute Coronary occlusIon treated By EveroLimusEluting Stent) will randomise 208 patients with chronic total coronary occlusions in 13 centres from Portugal and Spain to receive everolimus- or sirolimus-eluting coronary stents. The primary endpoint will be angiographic in-stent late loss.