Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol.

BACKGROUND: Cellular therapies have been increasingly applied to diverse human diseases. Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction. However, less information is available about the role of BMMNC therapy for the treatment of dilated myocardiopathies (DCs) of non-ischemic origin. This article presents the methodological description of a study aimed at investigating the efficacy of intracoronary injection of autologous BMMNCs in the improvement of the ventricular function of patients with DC. METHODS: This randomised, placebo-controlled, double-blinded phase IIb clinical trial compares the improvement on ventricular function (measured by the changes on the ejection fraction) of patients receiving the conventional treatment for DC in combination with a single dose of an intracoronary infusion of BMMNCs, with the functional recovery of patients receiving placebo plus conventional treatment. Patients assigned to both treatment groups are monitored for 24 months. This clinical trial is powered enough to detect a change in Left Ventricular Ejection Fraction (LVEF) equal to or greater than 9%, although an interim analysis is planned to re-calculate sample size. DISCUSSION: The study protocol was approved by the Andalusian Coordinating Ethics Committee for Biomedical Research (Comité Coordinador de Ética en Investigación Biomédica de Andalucia), the Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios), and is registered at the EU Clinical Trials Register (EudraCT: 2013-002015-98). The publication of the trial results in scientific journals will be performed in accordance with the applicable regulations and guidelines to clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02033278 (First Posted January 10, 2014): https://clinicaltrials.gov/ct2/show/NCT02033278 ; EudraCT number: 2013-002015-98, EU CT Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002015-98 . Trial results will also be published according to the CONSORT statement at conferences and reported peer-reviewed journals.

Direct bioresorbable vascular scaffold implantation: Feasibility and midterm results.

OBJECTIVES: To analyze the feasibility and safety of direct bioresorbable vascular scaffold (BVS) implantation without previous balloon dilation. BACKGROUND: Lesion preparation through predilation is recommended before BVS implantation. There is no information on the routine use of direct BVS implantation. METHODS AND RESULTS: One hundred fifty-three patients with a total of 200 coronary lesions, were treated with BVS. A baseline intravascular ultrasound study (IVUS) was performed in 171 lesions (86%), and after BVS implantation, the quality of scaffolding was assessed with an additional IVUS (83, 41%) or optical coherence tomography (77, 38%). Elective predilation was conducted in 50 lesions. In 150 lesions, direct BVS implantation was attempted. In 129 lesions (86%), the BVS was implanted successfully, and in the remaining 21 (14%), direct implantation failed. In these cases, the scaffolds were retrieved and successfully implanted after balloon angioplasty. Longer and C-type lesions, and a larger plaque burden, were associated with failure to directly cross the lesion. Balloon postdilation was needed in 34% of the lesions. Ten patients (6.6%) had a periprocedural myocardial infarction. One patient (0.6%) died 60 days after BVS implantation due to thrombosis of the scaffold. At follow-up, target lesion revascularisation was needed in eight patients (5%). After 12 ± 3 months, the remaining patients were symptom-free. CONCLUSIONS: Direct BVS implantation is safe and feasible in most soft coronary plaques.

Clinical features and changes in epidemiology of infective endocarditis on pacemaker devices over a 27-year period (1987-2013).

AIMS: Use of cardiac pacing devices has grown in recent years. Our aim was to evaluate changes in epidemiology and clinical features of infective endocarditis (IE) involving pacemaker devices in a large series of IE over the last 27 years (1987-2013). METHODS AND RESULTS: From 1987 to December 2013, 413 consecutive IE cases were diagnosed in our hospital. During this period, 7424 pacemaker devices were implanted (6917 pacemakers, 239 implantable cardiac defibrillators, 158 resynchronization devices, and 110 resynchronization/defibrillator devices). All consecutive cases of IE on pacemaker devices were included and analysed. Infective endocarditis on pacemaker devices represented 6.1% of all endocarditis cases (25 patients), affecting 3.6/1000 of all implanted pacemakers. Its proportion increased from 1.25% of all endocarditis in 1987-1993 to 4.08% in 1994-2000, 7.69% in 2001-2007 and 9.32% in 2008-2013 (P < 0.01). Its incidence also increased from 1.4/1000 of all pacemaker implants in the period of 1987-1993 to 2.5/1000 in 1994-2000, 3.3/1000 in 2001-2007 and 4.5/1000 implanted devices in 2008-2013 (P < 0.05). Mean age of patients was 68 years, and 80% were male. Causative microorganisms predominantly were Staphylococci (84%: Staphylococcus aureus 48%, Staphylococcus epidermidis 36%). Rate of severe complications was high: persistent sepsis in 60% of cases, heart failure in 20%, and stroke in 12%. Device was removed in 19 patients (76%), mostly by surgery (18 of the 19 cases). Early mortality was 24% (33% of medically, 21% of surgically treated patients, P = 0.82). CONCLUSION: Infective endocarditis on pacemaker devices has shown an increasing incidence during the past decades, representing almost 10% of all IE in the last 6 years. This is a severe disease, with a high rate of severe complications and requiring removal of device in most cases. In spite of therapy, early mortality is high.

Assessment of side branch predilation before a provisional T-stent strategy for bifurcation lesions. A randomized trial.

BACKGROUND: A simple approach is the predominant strategy for the percutaneous coronary intervention of bifurcation lesions. Performing side branch (SB) predilation in this context is currently a matter of controversy. In this study, we assess the efficacy of SB predilatation before a provisional T-stent strategy for bifurcation lesions. METHODS: Between February 2009 and November 2012, 372 patients with true bifurcation lesions were randomized to either predilation of the SB (n = 187) or no predilatation (n = 185) before main branch (MB) stent implantation and a subsequent SB provisional stent strategy. RESULTS: There were no significant differences between the patient groups regarding the baseline characteristics. After MB stent implantation, the TIMI flow of the SB was higher in the patients with SB predilation: TIMI flow 0 to 1; 2 (1%) versus 18 (10%), P < .001; and TIMI flow III; 179 (96%) versus 152 (82%), P < .001. Side branch stenting rates were 4% versus 3%, P = not significant. In addition, 60 patients (32%) from the SB predilation group presented SB residual stenosis by visual inspection <50%, and TIMI flow ≥III did not require any additional treatment. The failure rate of SB rewiring, the time of rewiring, the number of wires used, and the incidence of major events were similar in both groups of patients. CONCLUSIONS: Predilation of the SB resulted in improved TIMI flow after MB stenting and less indication to subsequently treat the SB. If rewiring of the SB is required, predilation did not hinder this maneuver.

[Infective endocarditis in two Spanish university hospitals in different geographical locations with and without a cardiac surgery department]. / Endocarditis infecciosa en 2 hospitales universitarios españoles que difieren en su localización y en la presencia de servicio quirúrgico.

OBJECTIVES: To assess possible differences in clinical presentation, microbiology, morbidity and mortality of infective endocarditis between two Spanish hospitals, one on the mainland that has cardiac surgery and one in the Canary Islands without this service. METHOD: A total of 229patients consecutively diagnosed of endocarditis between 2005 and 2012, including pediatric population, were studied in the Reina Sofía Hospital (Córdoba, n=119) and Nuestra Señora de Candelaria Hospital (Tenerife, n=110). We compared the clinical, microbiological and echocardiographic data and analyzed mortality differences by binary logistic regression analysis. RESULTS: There were no differences in underlying heart disease, proportion of surgery, or the microbiological profile. The proportion of infections attributable to catheter was higher in the Canary Islands hospital (13.6% vs 3.4%). Mortality was also higher (31.8% vs 18.5%, P=.020), although this difference was no longer significant in the multivariate analysis (OR=1.85; 95%CI, 0.70-4.87; P=.213). Age (OR=1.04/year; 95%CI, 1.01-1.07; P=.006), cardiac complications (OR=5.05; 95%CI, 1.78-14.34; P=.002), persistent sepsis (OR=4.89; 95%CI, 2.09-11.46; P<.001), and emergent surgery (OR=4.43, 95%CI, 1.75-11.19; P=.002) were independent predictors of death. Time to surgery, length of stay in the hospital without a surgical service (20 [13-30.5] vs 13 [6-25] days; P=.019) was not associated with outcome. CONCLUSIONS: There are differences in the presentation of endocarditis between two distant hospitals in Spain. The different hospital mortality can not be directly related to the presence of a surgery service.

Ross procedure: valve function, clinical outcomes and predictors after 25 years' follow-up.

OBJECTIVE: To describe long-term outcomes of the Ross procedure in a single center and retrospective series after 25 years follow-up. METHODS: From 1997-2019 we included all consecutive patients who underwent Ross procedure at our center. Clinical and echocardiographic evaluations were performed at least yearly. Echocardiographic valvular impairment was defined as at least moderate autograft or homograft dysfunction. Reintervention outcomes included surgical and percutaneous approach. RESULTS: 151 Ross procedures were performed (mean age 28±12years, 21 %<16years, 70 %male). After 25 years follow-up (median 18 years, interquartile range 9-21, only 3 patients lost) 12 patients died (8 %); Autograft, homograft or any valve dysfunction were present in 38(26 %), 48(32 %) and 75(51 %), respectively; and reintervention in 22(15%), 17(11%) and 38(26 %) respectively. At 20 years of follow-up, probabilities of survival free from autograft, homograft or any valve dysfunction were 63 %, 60 % and 35 %; and from reintervention, 80 %, 85 % and 67 %, respectively. The learning curve period (first 12 cases) was independently associated to autograft dysfunction (HR 2.78, 95 %CI:1.18-6.53, p = 0.02) and reintervention (HR 3.76, 95 %CI: 1.46-9.70, p = 0.006). Larger native pulmonary diameter was also an independent predictor of autograft reintervention (HR 1.22, 95 %CI:1.03-1.45, p = 0.03). Homograft dysfunction was associated with younger age (HR 5.35, 95 %CI: 2.13-13.47, p<0.001) and homograft reintervention, with higher left ventricle ejection fraction (HR 1,10, 95 %CI:1.02-1.19, p<0.02). CONCLUSIONS: In this 25 years' experience after the Ross procedure, global survival was high, although autograft and homograft dysfunction and reintervention rates were not negligible. Clinical and echocardiographic variables can identify patients with higher risk of events in follow up.

Long-term survival in elderly patients with stable coronary disease.

BACKGROUND: This study aimed to assess long-term prognosis of stable coronary artery disease (sCAD) in patients aged ≥ 75 years and to identify clinical predictors of cardiovascular and overall mortality. MATERIALS AND METHODS: From February 2000 to January 2007, 391 outpatients aged ≥ 75 years (median 78 years, interquartile range [IQR] 76-81 years, 66% male) with sCAD were recruited in this prospective cohort study. Associations of baseline variables with long-term cardiovascular and all-cause death were investigated. RESULTS: After up to 11 years of follow-up (median 4 years, IQR 2-6 years), 89 patients died (23%, 5·45%/year), 35 from cardiovascular causes (9%, 2·14%/year). Multivariate analysis identified family history of coronary disease (HR 4·28, 95% CI 1·22-15·02, P = 0·02), baseline atrial fibrillation (HR 3·18, 95% CI 1·37-7·39, P = 0·007), age (HR 1·61 per 5 year increase, 95% CI 1·04-2·50, P = 0·03), resting heart rate (HR 1·26 per 5 bpm increase, 95% CI 1·09-1·47, P = 0·003) and previous revascularization (HR 0·17, 95% CI 0·04-0·77, P = 0·02) as independent predictors of cardiovascular death, and previous acute coronary syndrome (HR 4·93, 95% CI 1·49-16·30, P = 0·009), baseline atrial fibrillation (HR 1·96, 95% CI 1·12-3·43, P = 0·02), tobacco use (HR 1·69, 95% CI 1·00-2·84, P = 0·049 for ex-smoking and HR 6·78, 95% CI 0·89-51·47, P = 0·06 for active smoking), age (HR 1·58 per 5 year increase, 95% CI 1·18-2·11, P = 0·002), resting heart rate (HR 1·10 per 5 bpm increase, 95% CI 1·00-1·22, P = 0·05) and diastolic blood pressure (HR 0·97, 95% CI 0·94-0·99, P = 0·01) as independent predictors of overall mortality. CONCLUSIONS: In this study, 4-years overall mortality was 23% among elderly patients with sCAD. Simple clinical variables can identify patients at higher risk of mortality.

Usefulness of transesophageal echocardiography during implantation of the CoreValve percutaneous aortic prosthesis: influence of the learning curve.

BACKGROUND AND OBJECTIVES: The purpose of this study was to evaluate the usefulness of transesophageal echocardiography during the implantation of the CoreValve percutaneous aortic prosthesis and the influence of the learning curve in its indications. METHODS: From April 2008 to January 2010, 53 patients were treated for symptomatic severe aortic stenosis with a CoreValve percutaneous aortic prosthesis. Transesophageal echocardiography was performed during the procedure for two reasons: if a discrepancy between the measures of the aortic annulus arose before the implantation and to provide visualization if a complication occurred during the procedure. Patients were divided in to two groups based on the learning curve (group I:the first 25 patients, group II: all of the subsequent patients). RESULTS: Thirty-six transesophageal echocardiographies were performed on 28 patients (53%).In 15 cases the indication was to assist us in determining the proper sized prosthesis, and in the other 21 cases it was performed due to a complication during the procedure. The numbers of intraprocedure transesophageal echocardiographies were similar in both learning-curve groups, (64% in group I vs. 71% in group II, P = 0.56) but the proportion of the studies indicated by serious complications was significantly lower in the second period of the learning curve (67% in group I vs. 17% in group II, P < 0.05). CONCLUSIONS: In our experience, transesophageal echocardiography was very useful in more than one-half of the patients during the implantation of the CoreValve percutaneous aortic prosthesis. After overcoming the learning curve, its indication due to serious procedure-related complications decreased significantly.

Randomized study comparing everolimus- and sirolimus-eluting stents in patients with bifurcation lesions treated by provisional side-branch stenting.

OBJECTIVES: To compare the efficacy of sirolimus- and everolimus-eluting stents in patients with bifurcation lesions treated with provisional side-branch stenting. BACKGROUND: The efficacy of everolimus-eluting stents in bifurcation lesions has been poorly tested. METHODS: Patients with all types of Medina bifurcation lesions were randomly assigned to treatment with either a sirolimus- (n = 145) or everolimus-eluting stent (n = 148). We included patients with main vessel diameter over 2.5 mm and side branches over 2.25 mm. Patients with diffuse side-branch stenosis were excluded. RESULTS: There were no significant differences between patients from the sirolimus and everolimus groups in terms of age, risk factors, clinical status, location of the bifurcation lesions or angiographic variables. Immediate results and in-hospital outcome were also similar in both groups of patients. In-hospital death occurred in two patients, one from each group. Target lesion revascularization was required in nine patients: four patients (2.7%) from the sirolimus group and five patients (3.4%) from the everolimus group. Late cardiac mortality occurred in two patients from the sirolimus group and in one patient from the everolimus group. Major cardiac event rates at 1 year were similar in both groups: nine patients (6.2%) in the sirolimus group and nine patients (6.1%) from the everolimus group (p: ns). CONCLUSIONS: In patients with bifurcation lesions, no significant differences in clinical outcome at 1-year follow-up were observed between sirolimus- and everolimus-eluting stent groups.

Etiologic spectrum and clinical features of mitral regurgitation in a Spanish population.

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate the etiologic spectrum of at least moderate mitral regurgitation (MR) in patients at a tertiary care center in a Spanish region. METHODS: All patients referred for echocardiography with moderate or severe MR, assessed according to the guidelines of the American Society of Echocardiography, were included prospectively in the study. RESULTS: Between October 2006 and February 2008, a total of 276 patients (157 females, 119 males; mean age 61 +/- 20 years) were enrolled into the study. At the time of evaluation, 67% of the patients were outpatients and the remainder were hospitalized. The NYHA functional class was III-IV in 31% of patients. The main echocardiographic data were: color flow jet area 11 +/- 5 cm2, vena contracta 6.7 +/- 1.9 mm, effective regurgitant orifice area 0.46 +/- 0.28 cm2, left ventricular diastolic and systolic diameters 58 +/- 10 mm and 39 +/- 12 mm, respectively, left ventricular ejection fraction 0.55 +/- 0.19, and pulmonary artery systolic pressure 39 +/- 16 mmHg. The MR was degenerative in 42% of patients, rheumatic in 22%, functional due to idiopathic dilated cardiomyopathy in 18%, functional due to ischemic cardiomyopathy in 7%, congenital in 7%, and had other causes in 4%. CONCLUSION: Among this Spanish population, the majority of the moderate or severe MR encountered was organic, with degenerative mitral disease as the most common etiology. Functional regurgitation was present in a significant proportion of patients, with idiopathic dilated cardiomyopathy being the most frequent cause.

Monitoring complex secundum atrial septal defects percutaneous closure with real time three-dimensional echocardiography.

BACKGROUND: Atrial septal defect (ASD) is one of the most common congenital heart diseases. Nowadays, percutaneous closure is considered the treatment of choice in most of secundum ASDs. Assessment of the defect and procedure monitoring have been usually performed by angiographic balloon-sizing and/or two-dimensional (2D) transesophageal echocardiography. However, in complex ASDs these techniques might be inaccurate. METHODS: From January 2009 to January 2011 all adult patients with complex ASDs submitted for percutaneous closure were selected. Those defects, where shunts were present through a device previously implanted on the atrial septum or through multiperforated septums, were considered complex ASDs. Two-dimensional transesophageal echocardiography and real time three-dimensional (3D) echocardiography were performed simultaneously during the percutaneous closure procedure. Number of orifices, relationships between the defect, catheter, and device, as well as residual shunt were assessed. RESULTS: Seven patients were included. Five patients had a multiperforated septum and in two cases the defect in the septum was through a previously implanted device. In all cases, 3D echocardiography was superior to 2D echocardiography in relation to the assessment of the relationship between the defect and the catheter or the device. Mechanisms responsible for residual shunts through a device were also better assessed by 3D echocardiography. CONCLUSION: Three-dimensional echocardiography is a safe and useful technique when monitoring percutaneous closure of ASDs, showing relevant advantages over 2D echocardiography.

Oral anticoagulation in nonvalvular atrial fibrillation in clinical practice: impact of CHADS(2) score on outcome.

OBJECTIVES: CHADS(2) score predicts embolic risk in patients with nonvalvular atrial fibrillation (NVAF), but also bleeding risk in patients receiving oral anticoagulation (OAC). Our objective is to analyze the effectiveness and safety of OAC in patients with NVAF in daily clinical practice, according to embolic risk evaluated by means of CHADS(2) score. METHODS: All consecutive outpatients with permanent NVAF seen at 2 cardiology clinics were prospectively followed for embolic events (transient ischemic attack, ischemic stroke, peripheral embolism) and severe bleedings. OAC was prescribed according to the recommendations of scientific associations. CHADS(2) score was obtained for each patient. RESULTS: From February 1, 2000 to July 31, 2003, 796 outpatients fulfilled the inclusion criteria. OAC was prescribed to 564 (71%) patients. After 2.4 +/- 1.9 years of follow-up, the embolic event rates (per 100 patient-years) for each stratum of the CHADS(2 )score for patients with/without OAC were: 1/4.1, p = 0.23 (CHADS(2) = 0); 0.6/7.1, p = 0.0018 (CHADS(2) = 1); 0.5/5.1, p = 0.0014 (CHADS(2) = 2); 2.4/12.5, p = 0.0017 (CHADS(2) = 3) and 2.9/20, p = 0.013 (CHADS(2) >or=4). The severe bleeding rates for the same CHADS(2) score strata were 3/0.8, 0.8/0.7, 1.3/0.7, 0.4/0, and 2.9/5 in patients with/without OAC (n.s.). CONCLUSION: OAC is effective and safe in daily clinical practice in patients with NVAF and CHADS(2) score >or=1.

[Usefulness of brain natriuretic peptide levels, as compared with usual clinical control, for the treatment monitoring of patients with heart failure]. / Utilidad de los valores del péptido natriurético cerebral frente al control clínico habitual para la monitorización del tratamiento en pacientes con insuficiencia cardiaca.

BACKGROUND AND OBJECTIVES: Chronic heart failure continues to have a poor prognosis, in spite of advances made in its therapy. It is uncertain whether symptom-guided therapy optimization is the most effective strategy in this setting. The aim of our study was to evaluate the usefulness of a brain natriuretic peptide (BNP)-guided therapy for the treatment of patients with heart failure. PATIENTS AND METHODS: We carried out a prospective and randomized study including 60 patients consecutively discharged with the diagnosis of heart failure NYHA class III or IV in one cardiology department of a Spanish hospital; 30 patients were randomly assigned to a symptom-guided therapy group based on the clinical Framingham score, and 30 to a BNP-guided therapy group. Therapy was adjusted to obtain a clinical score <2 in the symptom-guided group and BNP levels <100pg/ml in the BNP-guided group. Follow up was 16±4 months. RESULTS: BNP-guided group had lower BNP levels during follow up than had symptom-guided group: 14(20)pg/ml versus 111±71pg/ml at 18 months, p=0.029. Clinical score was similar in both groups: 0.42(0.33) versus 0.39(0.63) at 18 months. Probability of survival (86% in both groups) and probability of being free of readmissions for heart failure (68 versus 66%) at 18 months were similar in both groups. CONCLUSIONS: In our experience, in patients with heart failure, BNP-guided therapy did not improve clinical outcomes compared with symptom-guided therapy.

Drug-eluting stents for the treatment of bifurcation lesions: a randomized comparison between paclitaxel and sirolimus stents.

BACKGROUND: Drug-eluting stents have been shown to reduce restenosis in many types of lesions. The purpose of this article is to assess the efficacy of sirolimus- and paclitaxel-eluting stents in patients with bifurcation lesions. METHODS: Between June 2003 and October 2004, 205 patients were enrolled in a prospective randomized trial; 103 patients were assigned to sirolimus stents and 102 patients to paclitaxel stents. All patients were treated by provisional T-stenting. RESULTS: There were no differences between groups in terms of age, risk factors, clinical condition, location of the bifurcation lesion, or other technical factors. Angiographic data and immediate results were also similar in both groups. Three patients developed inhospital non-Q-wave acute myocardial infarction (2 from the sirolimus group and 1 from the paclitaxel group). Follow-up angiography was obtained in 109 patients (53%). In the sirolimus group, 5 patients developed restenosis (9%): 1 at the main vessel, 2 at the side branch, and 2 in both branches. In contrast, 16 patients from the paclitaxel group had restenosis (29%): 6 at the main vessel, 5 at the side branch, and 5 in both branches. Target lesion revascularization at 24 +/- 5 months post stenting occurred in 4 patients from the sirolimus group (4%) and in 13 from the paclitaxel group (13%) (P < .05). Late loss at the main vessel in the sirolimus group patients was 0.31 +/- 0.59 versus 0.60 +/- 0.77 mm in patients from the paclitaxel group (P < .05). CONCLUSIONS: Patients with bifurcation lesions treated by sirolimus showed significantly lower rates of late loss, restenosis and target lesion revascularization than patients treated with paclitaxel-eluting stents.

Restenosis After Everolimus-eluting Vascular Scaffolding. Angiographic and Optical Coherence Tomography Characterization.

INTRODUCTION AND OBJECTIVES: Coronary restenosis after bioresorbable vascular scaffold (BVS) implantation is infrequent and little information is available on the main characteristics of these lesions. The aim of this study was to assess restenotic lesions by using optical coherence tomography (OCT). METHODS: We studied 330 patients with coronary artery disease who received 398 BVS to treat 380 lesions. These patients were clinically and angiographically evaluated at follow-up and OCT was carried out on detection of restenosis. RESULTS: After a follow-up of 19 ± 10 months, 18 restenotic lesions were detected in 17 patients (5.4%). Depending on the time of presentation, most cases of restenosis were late or very late (9 ± 4 months). The most frequent angiographic pattern was focal restenosis in 12 (67%) patients, which was mainly located at the proximal border in 9 (75%) whether involving the scaffold or not. The homogeneous pattern was infrequent, occurring in 3 (25%) lesions and was only visualized in 3 out of 6 cases of restenosis located at the margin. When the focal restenosis was located in the platform, OCT showed a heterogeneous or layered pattern. Finally, diffuse restenosis was observed in 6 patients (33%). In diffuse restenosis, OCT revealed a lipid-laden or layered tissue structure and the presence of microvessels or microcalcification, potentially suggesting a neoatherosclerotic process. CONCLUSIONS: After a mean follow-up of 19 months, the restenosis rate was 5.4%. Most restenotic lesions were focal, located at the proximal border. Diffuse restenosis mostly occurred late or very late and most showed signs suggestive of neoatherosclerosis.

Pulmonary homograft stenosis in the Ross procedure: Incidence, clinical impact and predictors in long-term follow-up.

BACKGROUND: The Ross procedure is used in the treatment of selected patients with aortic valve disease. Pulmonary graft stenosis can appear in the long-term follow-up after the Ross intervention, but the factors involved and its clinical implications are not fully known. AIM: To describe the incidence, clinical impact and predictors of homograft stenosis and reintervention after the Ross procedure in a prospective series in a tertiary referral hospital. METHODS: From 1997 to 2009, 107 patients underwent the Ross procedure (mean age: 30±11 years; 69% men; 21 aged<18 years), and were followed for echocardiographic homograft stenosis (peak gradient>36mmHg) and surgical or percutaneous homograft reintervention. RESULTS: After 15 years of follow-up (median: 11 years), echocardiographic and clinical data were available in 91 (85%) and 104 (98%) patients, respectively: 26/91 (29%) patients developed homograft stenosis; 10/104 (10%) patients underwent 13 homograft reintervention procedures (three patients underwent surgical replacement, three received a percutaneous pulmonary valve and one needed stent implantation). The other three patients underwent two consecutive procedures in follow-up; one died because of a procedure-related myocardial infarction. Rates of survival free from homograft stenosis and reintervention at 1, 5 and 10 years were 96%, 82% and 75% and 99%, 94% and 91%, respectively. Paediatric patients had worse survival free from homograft stenosis (hazard ratio [HR] 3.50, 95% confidence interval [CI]: 1.56-7.90; P=0.002), although there were no significant differences regarding reintervention (HR: 2.01, 95% CI: 0.52-7.78; P=0.31). Younger age of homograft donor was also a stenosis predictor (HR: 0.97, 95% CI: 0.94-0.99; P=0.046). CONCLUSIONS: The probabilities of homograft stenosis and reintervention 10 years after the Ross procedure were 29% and 10%, respectively; only one patient had a reintervention-related death. Younger donor and recipient age were associated with a higher rate of stenosis.

Five-year results from a prospective multicentre study of percutaneous pulmonary valve implantation demonstrate sustained removal of significant pulmonary regurgitation, improved right ventricular outflow tract obstruction and improved quality of life.

AIMS: Percutaneous pulmonary valve implantation (PPVI) is used to treat patients with dysfunctional pulmonary valve conduits. Short- and longer-term results from multiple trials have outlined haemodynamic improvements. Our aim was to report the long-term results, including quality of life, from a multicentre trial in Europe and Canada. METHODS AND RESULTS: From October 2007 to April 2009, 71 patients (24 female; median age 19.0 [IQR: 14.0 to 25.0] years) were enrolled in a prospective cohort study. PPVI was performed successfully in 63 patients. At five-year follow-up four patients had died. Moderate and severe pulmonary regurgitation were completely resolved in all except one patient, who needed re-PPVI. Outflow tract obstruction improved significantly from a mean pressure gradient of 37.7±12.1 mmHg before PPVI to 17.3±9.7 mmHg at five-year follow-up; however, 11 patients needed treatment for restenosis. The EQ-5D quality of life utility index and visual analogue scale scores were both significantly improved six months post PPVI and remained so at five years. CONCLUSIONS: Five-year results following PPVI demonstrate resolved moderate or severe pulmonary regurgitation, improved right ventricular outflow tract obstruction, and improved quality of life.

Prosthetic Mitral Surgical Valve in Transcatheter Aortic Valve Replacement Recipients: A Multicenter Analysis.

OBJECTIVES: The aim of this study was to determine the prognosis and specific complications of patients with prosthetic mitral valves (PMVs) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is performed relatively often in patients with PMVs, but specific risks are not well described. METHODS: A multicenter analysis was conducted, including patients with severe symptomatic aortic stenosis who underwent TAVR at 10 centers. Patients' clinical characteristics and outcomes were evaluated according to the presence of a PMV. RESULTS: The mean age of the study population (n = 2,414) was 81 ± 8 years, and 48.8% were men. A total of 91 patients (3.77%) had PMVs. They were more commonly women, younger, and had higher surgical risk. PMVs were implanted a median of 14 years before TAVR, and most patients had mechanical prostheses (73.6%). Eighty-six patients (94.5%) were on long-term vitamin K inhibitor therapy, and bridging antithrombotic therapy was administered in 59 (64.8%). TAVR device embolization occurred in 6.7% (vs. 3.3% in the non-PMV group; p = 0.127), in all instances when distance between the PMV and the aortic annulus was <7 mm. Mortality rates did not show a difference, but the rate of bleeding was higher in patients with PMV (24.2% vs. 16.1%; p = 0.041), even in those treated via the transfemoral approach (22.2% vs. 13.9%; p = 0.048). Indeed, bleeding complications, prior atrial fibrillation, chronic obstructive pulmonary disease, surgical risk, and New York Heart Association functional class were independent predictors of mortality. CONCLUSIONS: TAVR presents similar mortality irrespective of the presence of a PMV. However, patients with PMVs had higher bleeding risk that was independently associated with higher mortality. Risk for valve embolization was relatively high, but it occurred only in patients with PMV-to-aortic annulus distances <7 mm.

[Percutaneous transcatheter closure of ventricular septal defects using an Amplatz device]. / Cierre percutáneo de comunicación interventricular congénita mediante el dispositivo de Amplatz.

We carried out an analysis of our initial experience with using an Amplatz device for percutaneous closure of ventricular septal defects in 15 patients. The patient's ages ranged in from 1 to 44 years. Seven were infants with heart failure. In 4 patients, the ventricular septal defect was located in the muscular portion of the ventricular septum; in 11 patients, it was in the perimembraneous portion. The mean size of the Amplatz device selected was 11.2 (3.0) mm. Successful device implantation was achieved in 12 patients. In the other 3, stable occlusion could not be achieved, and the device was retrieved without complications. Immediate complete closure occurred in 11 of the 12 patients who underwent successful implantation. No complications were observed, either immediately or during follow-up. After a mean follow-up period of 9.2 (3.6) months, all patients remained free of symptoms. Follow-up Doppler echocardiography demonstrated complete closure in all patients.

[Heart failure with preserved ejection fraction. Effect of etiology on prognosis]. / Insuficiencia cardiaca con función sistólica conservada. Diferencias pronósticas según la etiología.

INTRODUCTION AND OBJECTIVES: Heart failure with preserved systolic function accounts for almost 40% of heart failure cases. Prognosis is similar to that in patients with a low left ventricular ejection fraction (LVEF). However, it is not clear whether the etiology of heart failure with preserved systolic function has an effect on prognosis. METHODS: We assessed 95 consecutive patients admitted to our hospital with heart failure and a LVEF>45%. Twenty-five (26%) had an ischemic etiology and 70 (74%), a non-ischemic etiology. RESULT: The patients' mean age was 73 (6) years, 60% were female, and their mean LVEF was 61 (7)%. These characteristics were similar in the two etiological groups. After a mean follow-up period of 53 (8) months (4-69 months; median 46 months), mortality was higher in ischemic patients (17.88 vs 2.37/100 patient-years; P<.0001), as was the rate of cardiovascular admissions (24.58 vs 4.14/100 patient-years; P<.0001). The rates of mortality due to heart failure and sudden death were also higher in ischemic patients, at 7.82 vs 0.59/100 patient-years, and 7.82 vs 0.30/100 patient-years, respectively (P<.0001). The higher overall admission rate found in the ischemic group was due to higher rates of admission for heart failure (14.53 vs 0.89/100 patient-years; P<.0001) and acute coronary syndrome (8.94 vs 1.78/100 patient-years; P=.003). CONCLUSIONS: In terms of prognosis, heart failure with preserved systolic function is not a homogeneous disease entity. Morbidity and mortality rates are higher in patients with an ischemic etiology. Moreover, different mechanisms are involved.