Publications by authors named "Garcia Eulogio"

139 Publications

Transcatheter reduction of paravalvular leaks: a systematic review and meta-analysis.

Can J Cardiol 2015 Mar 15;31(3):260-9. Epub 2014 Dec 15.

Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada. Electronic address:

Background: Significant paravalvular leak (PVL) after surgical valve replacement can result in intractable congestive heart failure and hemolytic anemia. Because repeat surgery is performed in only few patients, transcatheter reduction of PVL is emerging as an alternative option, but its safety and efficacy remain uncertain. In this study we sought to assess whether a successful transcatheter PVL reduction is associated with an improvement in clinical outcomes.

Methods: We identified 12 clinical studies that compared successful and failed transcatheter PVL reductions in a total of 362 patients. A Bayesian hierarchical meta-analysis was performed using cardiac mortality as a primary end point. The combined occurrence of improvement in New York Heart Association functional class or hemolytic anemia and the need for repeat surgery, were used as secondary end points.

Results: A successful transcatheter PVL reduction was associated with a lower cardiac mortality rate (odds ratio [OR], 0.08; 95% credible interval [CrI], 0.01-0.90) and with a superior improvement in functional class or hemolytic anemia, compared with a failed intervention (OR, 9.95; 95% CrI, 2.10-66.73). Fewer repeat surgeries were also observed after successful procedures (OR, 0.08; 95% CrI, 0.01-0.40).

Conclusions: A successful transcatheter PVL reduction is associated with reduced all-cause mortality and improved functional class in patients deemed unsuitable for surgical correction.
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http://dx.doi.org/10.1016/j.cjca.2014.12.012DOI Listing
March 2015

Drug-eluting stent thrombosis in the treatment of chronic total coronary occlusions: incidence, presentation and related factors. Data from the CIBELES trial.

Rev Port Cardiol 2015 Mar 14;34(3):193-9. Epub 2015 Feb 14.

Research Manager, School of Biomedical and Health Sciences, Universidad Europea de Madrid, Spain.

Introduction And Objectives: The aim of this study was to analyze the incidence of drug-eluting stent thrombosis (sirolimus or everolimus) in patients with chronic total coronary occlusions (CTO) and to determine its clinical implications and related factors.

Methods: Data from the 12-month follow-up of the 207 patients included in the CIBELES trial with CTO were analyzed.

Results: Stent thrombosis occurred in three patients, two definite and one probable (overall thrombosis rate: 1.4%). However, there were no cases of death or Q-wave myocardial infarction. In univariate analysis, patients with a higher incidence of stent thrombosis were those in whom the target vessel was the left anterior descending, who had single-vessel disease, were assigned to treatment with sirolimus-eluting stents, and those with smaller minimum luminal diameter immediately after the procedure. In multivariate analysis, the only independent predictor of stent thrombosis was minimal luminal diameter immediately after the procedure.

Conclusions: The rate of drug-eluting stent thrombosis in patients with CTO is relatively low (1.4%). The only independent predictor of stent thrombosis in this context was minimal luminal diameter after the procedure and the clinical presentation was in all cases relatively benign.
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http://dx.doi.org/10.1016/j.repc.2014.08.026DOI Listing
March 2015

Late cardiac death in patients undergoing transcatheter aortic valve replacement: incidence and predictors of advanced heart failure and sudden cardiac death.

J Am Coll Cardiol 2015 Feb;65(5):437-48

Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada. Electronic address:

Background: Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valve replacement (TAVR).

Objectives: The purpose of this study was to assess the incidence and predictors of cardiac death from advanced heart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR.

Methods: The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable (43%) valves. Causes of death were defined according to the Valve Academic Research Consortium-2.

Results: At a mean follow-up of 22 ± 18 months, 155 patients had died due to advanced HF (15.2% of total deaths, 46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baseline comorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction ≤40%, lower mean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p < 0.05 for all) and 2 procedural factors (transapical approach, hazard ratio [HR]: 2.38, 95% confidence interval [CI]: 1.60 to 3.54; p < 0.001; presence of moderate or severe aortic regurgitation after TAVR, HR: 2.79, 95% CI: 1.82 to 4.27; p < 0.001) independently predicted death from advanced HF. Left ventricular ejection fraction ≤40% (HR: 1.93, 95% CI: 1.05 to 3.55; p = 0.033) and new-onset persistent left bundle-branch block following TAVR (HR: 2.26, 95% CI: 1.23 to 4.14; p = 0.009) were independently associated with an increased risk of SCD. Patients with new-onset persistent left bundle-branch block and a QRS duration >160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p = 0.006).

Conclusions: Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR. Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future studies should determine whether targeting these factors decreases the risk of cardiac death.
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http://dx.doi.org/10.1016/j.jacc.2014.11.027DOI Listing
February 2015

Percutaneous treatment of a coronary-subclavian steal syndrome.

Rev Esp Cardiol (Engl Ed) 2015 Feb 10;68(2):146. Epub 2014 Jul 10.

Servicio de Cardiología, Hospital Universitario Madrid Norte-Sanchinarro, Madrid, Spain.

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http://dx.doi.org/10.1016/j.rec.2014.02.023DOI Listing
February 2015

Five-year clinical outcome of the Nobori drug-eluting coronary stent system in the treatment of patients with coronary artery disease: final results of the NOBORI 1 trial.

EuroIntervention 2015 Sep;11(5):549-54

Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Massy, France.

Aims: To assess the safety and performance of the Nobori drug-eluting stent with biodegradable polymer versus the TAXUS drug-eluting stent with permanent polymer, in the treatment of patients with de novo coronary artery lesions.

Methods And Results: NOBORI 1 was a multicentre, randomised (2:1), prospective, controlled, clinical trial which enrolled 363 patients (238 Nobori and 125 TAXUS) with up to two de novo lesions in two epicardial vessels. The primary endpoint was in-stent late loss at nine months, while secondary endpoints included safety and efficacy up to five years. At five years, clinical data were available for 350 patients (96%). There were no differences in the composite of death and myocardial infarction (10.9% vs. 11.2%) and target lesion failure (9.2% and 10.4%), while ischaemia- and non-ischaemia-driven target lesion revascularisations were less frequent in the Nobori (6.3%) than in the TAXUS arm (16.0%). The rates of stent thrombosis (definite and probable according to the ARC definitions) were 0.0% and 3.2%, in the Nobori and TAXUS stents, respectively (p=0.014).

Conclusions: Five years after implantation, the Nobori DES resulted in durable treatment effects with very low TLR and no stent thrombosis. The study was not powered to assess the differences in clinical endpoints. These data are hypothesis-generating.
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http://dx.doi.org/10.4244/EIJY14M12_13DOI Listing
September 2015

Initial experience with the low-profile percutaneous aortic valve SAPIEN 3.

Rev Esp Cardiol (Engl Ed) 2014 Nov 27;67(11):953-4. Epub 2014 Sep 27.

Servicio de Cardiología, Hospital Moncloa, Madrid, Spain.

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http://dx.doi.org/10.1016/j.rec.2014.04.014DOI Listing
November 2014

Three-dimensional color Doppler transesophageal echocardiography for mitral paravalvular leak quantification and evaluation of percutaneous closure success.

J Am Soc Echocardiogr 2014 Nov 26;27(11):1153-63. Epub 2014 Sep 26.

Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain.

Background: Three-dimensional (3D) color Doppler transesophageal echocardiography (TEE) enables accurate planimetry of the effective regurgitant orifice (ERO) of a mitral paravalvular leak (PVL). The aim of this study was to evaluate the usefulness of this method to quantify paravalvular regurgitation and to assess percutaneous PVL closure success, compared with 3D planimetry of PVLs without using color-flow images (3D anatomic regurgitant orifice [ARO]).

Methods: Forty-six patients (59 mitral PVLs) who underwent 3D TEE to evaluate the indication of PVL closure procedure were retrospectively included. Receiver operating characteristic curves were compared to identify degree III and IV paravalvular regurgitation of 3D color ERO and 3D ARO measures. Forty patients underwent percutaneous PVL closure procedures; analysis was conducted to determine whether the undersizing of the closure devices according to 3D color ERO and 3D ARO measures was associated with PVL closure failure.

Results: Three-dimensional ERO measures showed better areas under the curve than 3D ARO measures and correlated better with the degree of paravalvular regurgitation. Three-dimensional color ERO major diameter ≥ 0.65 cm showed a positive predictive value of 87.1% and a negative predictive value of 94% to diagnose degree III and IV paravalvular regurgitation. For the 40 patients who underwent PVL closure procedures, the immediate technical success rate was 76.9%, and 1-year estimated survival was 69.5%. Closure device undersizing according to 3D color ERO length, but not other PVL measurements, was significantly associated with PVL closure failure (P = .007).

Conclusion: Three-dimensional ERO was superior to 3D ARO at identifying the presence of degree III and IV paravalvular regurgitation. The undersizing of closure devices according to 3D color ERO length was associated with failed closure procedures. Confirmatory prospective studies are encouraged.
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http://dx.doi.org/10.1016/j.echo.2014.08.019DOI Listing
November 2014

Selected CD133⁺ progenitor cells to promote angiogenesis in patients with refractory angina: final results of the PROGENITOR randomized trial.

Circ Res 2014 Nov 17;115(11):950-60. Epub 2014 Sep 17.

From the Cardiology and Hematology Department, Hospital Clínico San Carlos, IdISSC, Madrid, Spain (P.J.-Q., J.J.G.-F., L.L., E.B., A.O.-P., R.H.-A., F.A., N.G., J.E., C.B., A.F.-O., B.D.N., M.d.T., E.G., C.M.); Cardiology and Hematology Department, Hospital Clinic, IDIBAPS, Barcelona, Spain (M.S., A.R., P.M.); Cardiology Department, Hospital Sant Pau, Barcelona, Spain (X.G.-M.); Department of Radiology and Nuclear Medicine, San Pedro Hospital and Centre for Biomedical Research of La Rioja (CIBIR), Logroño (La Rioja), Spain, and Institute Focuscan, Madrid, Spain (R.D.-B.); Statistic Department, Hospital Clínico San Carlos, Madrid, Spain (C.F.); and Pharmacology Department, Complutense University, Madrid, Spain (T.T., S.R.).

Rationale: Refractory angina constitutes a clinical problem.

Objective: The aim of this study was to assess the safety and the feasibility of transendocardial injection of CD133(+) cells to foster angiogenesis in patients with refractory angina.

Methods And Results: In this randomized, double-blinded, multicenter controlled trial, eligible patients were treated with granulocyte colony-stimulating factor, underwent an apheresis and electromechanical mapping, and were randomized to receive treatment with CD133(+) cells or no treatment. The primary end point was the safety of transendocardial injection of CD133(+) cells, as measured by the occurrence of major adverse cardiac and cerebrovascular event at 6 months. Secondary end points analyzed the efficacy. Twenty-eight patients were included (n=19 treatment; n=9 control). At 6 months, 1 patient in each group had ventricular fibrillation and 1 patient in each group died. One patient (treatment group) had a cardiac tamponade during mapping. There were no significant differences between groups with respect to efficacy parameters; however, the comparison within groups showed a significant improvement in the number of angina episodes per month (median absolute difference, -8.5 [95% confidence interval, -15.0 to -4.0]) and in angina functional class in the treatment arm but not in the control group. At 6 months, only 1 simple-photon emission computed tomography (SPECT) parameter: summed score improved significantly in the treatment group at rest and at stress (median absolute difference, -1.0 [95% confidence interval, -1.9 to -0.1]) but not in the control arm.

Conclusions: Our findings support feasibility and safety of transendocardial injection of CD133(+) cells in patients with refractory angina. The promising clinical results and favorable data observed in SPECT summed score may set up the basis to test the efficacy of cell therapy in a larger randomized trial.
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http://dx.doi.org/10.1161/CIRCRESAHA.115.303463DOI Listing
November 2014

Vascular sealing implications in transfemoral transcatheter aortic valve implantation. Response.

Rev Esp Cardiol (Engl Ed) 2014 Oct 7;67(10):870. Epub 2014 Sep 7.

Servicio de Cardiología, Hospital Universitario Clínico San Carlos, Madrid, Spain.

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http://dx.doi.org/10.1016/j.rec.2014.06.005DOI Listing
October 2014

Successful recanalization of a blind stumpless aorto-ostial left main chronic total occlusion.

Int J Cardiol 2014 Oct 13;176(3):e94-5. Epub 2014 Aug 13.

Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.

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http://dx.doi.org/10.1016/j.ijcard.2014.07.295DOI Listing
October 2014

Direct transfemoral aortic valve implantation in a patient with a mechanical mitral prosthesis.

Rev Esp Cardiol (Engl Ed) 2013 Aug 25;66(8):666-8. Epub 2013 May 25.

Unidad de Hemodinámica y Cardiología Intervencionista, Hospital Universitario Montepríncipe, Madrid, Spain.

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http://dx.doi.org/10.1016/j.rec.2013.02.009DOI Listing
August 2013

Usefulness of placing a wire from the contralateral femoral artery to improve the percutaneous treatment of vascular complications in TAVI.

Rev Esp Cardiol (Engl Ed) 2014 May 22;67(5):410-2. Epub 2014 Mar 22.

Servicio de Anestesia, Hospital Universitario Clínico San Carlos, Madrid, Spain.

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http://dx.doi.org/10.1016/j.rec.2013.10.024DOI Listing
May 2014

In-hospital and mid-term predictors of mortality after transcatheter aortic valve implantation: data from the TAVI National Registry 2010-2011.

Rev Esp Cardiol (Engl Ed) 2013 Dec 4;66(12):949-58. Epub 2013 Oct 4.

Servicio de Cardiología; Unidad de Cardiología Intervencionista y Servicio de Cirugía Cardiaca, Hospital Gregorio Marañón, Madrid, Spain.

Introduction And Objectives: The treatment of severe symptomatic aortic stenosis has been revolutionized by the technique of transcatheter valve replacement. The purpose of this study was to present the outcomes and predictors of mortality in patients enrolled between 2010 and 2011 in the Transcatheter Aortic Valve Replacement National Registry.

Methods: We collected 131 preprocedural, 31 periprocedural, and 76 follow-up variables, and analyzed the immediate implant success rate, the 30-day safety endpoint, and all-cause 30-day and mid-term (mean follow-up, 244 days) mortality.

Results: From January 2010 to December 2011, a total of 1416 patients were included: 806 with Edwards valves and 610 with CoreValves. The implant success and 30-day mortality rates were 94% and 8%, respectively, without differences between types of valves and approaches. The 30-day safety endpoint and mid-term mortality rates were 14% and 16%, respectively, which were also similar between groups. The presence of comorbidities (renal failure, peripheral vascular disease, ejection fraction, and atrial fibrillation), the need for conversion to surgery, and at least moderate aortic regurgitation after transcatheter aortic valve implantation were identified as independent predictors of in-hospital and mid-term mortality.

Conclusions: The prognosis of valve implant patients could be improved by including comorbidities in patient selection and by minimizing the degree of residual aortic regurgitation to optimize the results of the procedure.
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http://dx.doi.org/10.1016/j.rec.2013.07.003DOI Listing
December 2013

Placement of a single Axxess stent as new treatment strategy for Medina 1,0,0 left main stem bifurcation lesion.

J Invasive Cardiol 2014 Apr;26(4):E45-7

Hospital Universitario Madrid Montepríncipe, Madrid, Spain.

A left main stem bifurcation lesion (Medina 1,0,0) treated with a single Axxess stent through radial access is presented. Although the use of this stent in left main stenosis is off label, in selected cases it may simplify the technique, avoiding the use of additional overlapping stents and ensuring the bifurcation coverage with minimal amount of metal at the carina.
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April 2014

Significant mitral regurgitation left untreated at the time of aortic valve replacement: a comprehensive review of a frequent entity in the transcatheter aortic valve replacement era.

J Am Coll Cardiol 2014 Jun 26;63(24):2643-58. Epub 2014 Mar 26.

Quebec Heart & Lung Institute, Quebec City, Quebec, Canada. Electronic address:

Significant mitral regurgitation (MR) is frequent in patients with severe aortic stenosis (AS). In these cases, concomitant mitral valve repair or replacement is usually performed at the time of surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) has recently been considered as an alternative for patients at high or prohibitive surgical risk. However, concomitant significant MR in this setting is typically left untreated. Moderate to severe MR after aortic valve replacement is therefore a relevant entity in the TAVR era. The purpose of this review is to present the current knowledge on the clinical impact and post-procedural evolution of concomitant significant MR in patients with severe AS who have undergone aortic valve replacement (SAVR and TAVR). This information could contribute to improving both the clinical decision-making process in and management of this challenging group of patients.
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http://dx.doi.org/10.1016/j.jacc.2014.02.573DOI Listing
June 2014

Transfemoral implantation of Edwards Sapien XT aortic valve without previous valvuloplasty: role of 2D/3D transesophageal echocardiography.

Catheter Cardiovasc Interv 2014 Nov 21;84(6):868-76. Epub 2014 Feb 21.

Hospital Clínico San Carlos, Avenida de Los Lagos s/n, Madrid, 28040, Spain; Hospital Universitario Madrid Montepríncipe, Madrid, Spain.

Background: Balloon valvuloplasty (BAV) has been considered a mandatory step before TAVI. However, it might be related to cerebrovascular microembolizations, atrioventricular conduction disturbances, and hemodynamic instability. The aim of this study is to describe transesophageal echocardiography characteristics of patients that could benefit from direct transfemoral transcatheter aortic valve implantation (TAVI) of Edwards SAPIEN XT, without previous BAV.

Methods And Results: A total of 16 patients with direct implantation of an Edwards SAPIEN XT valve are included. Preprocedural echocardiographic findings were exhaustively analyzed and described. From 32 patients elected for transfemoral TAVI with an Edwards SAPIEN XT, 16 of them (50%) were selected for direct implantation using the Edwards SAPIEN XT valve of size 23 mm (n = 5), 26 mm (n = 8), or 29 mm (n = 3). Patients selection for direct TAVI presented three echocardiographic conditions: central effective orifice, moderate to severe calcification of the aortic valve apparatus preserving leaflets movement, and symmetric distribution of calcium with absent to moderate central aortic regurgitation. Mean age was 81.4 ± 7.4, 75% female, with a mean logistic Euroscore 18.2 ± 11.2. Preprocedural mean valve gradient was 43.6 ± 16.3. Mean effective orifice area was 0.7 ± 0.2. There was no valve embolization and the success rate was 100%. Postdilation was performed in one patient (6.25%). New permanent pacing was needed in two patients (12.5%).

Conclusions: TAVI without previous BAV is feasible and safe. 2D/3D TEE is an essential tool to select the patients that could benefit from this technique.
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http://dx.doi.org/10.1002/ccd.25417DOI Listing
November 2014

Clinical outcomes after final kissing balloon inflation compared with no final kissing balloon inflation in bifurcation lesions treated with a dedicated coronary bifurcation stent.

Heart 2014 Mar 15;100(6):479-86. Epub 2014 Jan 15.

Department of Cardiology, Academic Medical Center-University of Amsterdam, , Amsterdam, The Netherlands.

Objective: We evaluated differences in clinical outcomes between patients who underwent final kissing balloon inflation (FKBI) and patients who did not undergo FKBI in bifurcation treatment using the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina, USA).

Methods: Clinical outcomes were defined as target vessel failure (composite of cardiac death, any myocardial infarction and clinically indicated target vessel revascularisation), cardiac death, myocardial infarction (MI), clinically indicated target vessel revascularisation and stent thrombosis. Cumulative event rates were estimated using the Kaplan-Meier method. A multivariable logistic regression analysis was performed to evaluate which factors were potentially associated with FKBI performance.

Results: Follow-up data was available in 717 (96%) patients with a median follow-up of 190 days. Cardiac death at 1 year occurred more often in the no-FKBI group (1.7% vs 4.6%, respectively, p=0.017), although this difference was no longer observed after excluding patients presenting with ST segment elevation MI (1.6% vs 3.3%, p=0.133). No significant differences were observed concerning the other clinical outcomes. One-year target vessel failure rates were 10.1% in the no-FKBI group and 9.2% in the FKBI group (p=0.257). Multivariable logistic regression analysis identified renal dysfunction, ST segment elevation MI as percutaneous coronary intervention indication, narrow (<30°) bifurcation angle and certain stent platforms as being independently associated with unsuccessful FKBI.

Conclusions: A lower cardiac death rate was observed in patients in whom FKBI was performed compared with a selection of patients in whom FKBI could not be performed, probably explained by an unbalance in the baseline risk profile of the patients. No differences were observed regarding the other clinical outcomes.
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http://dx.doi.org/10.1136/heartjnl-2013-304912DOI Listing
March 2014

Feasibility and safety of transfemoral implantation of Edwards SAPIEN XT prosthesis without balloon valvuloplasty in severe stenosis of native aortic valve.

Catheter Cardiovasc Interv 2014 Apr 8;83(5):791-5. Epub 2013 Nov 8.

Hospital Clínico San Carlos, Madrid, Spain.

Objectives: Balloon valvuloplasty (BV) before transcatheter aortic implantation has been thought to be mandatory before the valve is implanted. We have explored the feasibility and safety of direct implantation of balloon expandable Edwards SAPIEN XT valve without prior balloon dilatation.

Background: Some complications after transcatheter aortic valve replacement (TAVR) have been associated with unwanted effects of BV, mainly the contribution to stroke and severe aortic regurgitation (AR) before the valve is implanted. Direct implantation with a self-expanding aortic valve has been recently reported.

Methods: From November 2011 to April 2012, ten patients were selected that met the following criteria in the transesophageal echocardiography (TEE): moderate calcification, homogeneous distribution of calcium, symmetrical opening of the valve, and some degree of aortic insufficiency.

Results: All patients had symptomatic aortic stenosis of a native valve and high surgical risk; six patients had the valve mildly calcified, in four patients the degree of calcification was moderate. The native valve was crossed and the prosthetic aortic valve was properly positioned in all cases and implanted in the correct position. No patient underwent post-dilatation and trivial AR was present in four patients. There were no adverse events (death, need for pacemaker, myocardial infarction, or stroke). At 30 days post-procedure, all patients were alive and had significant clinical improvement.

Conclusions: Direct implantation of Edwards SAPIEN XT without prior BV in selected cases is feasible and safe. The number of patients in whom this technique would be applicable, and their impact on reducing complications has to be determined.
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http://dx.doi.org/10.1002/ccd.24766DOI Listing
April 2014

Disturbed coronary hemodynamics in vessels with intermediate stenoses evaluated with fractional flow reserve: a combined analysis of epicardial and microcirculatory involvement in ischemic heart disease.

Circulation 2013 Dec 18;128(24):2557-66. Epub 2013 Oct 18.

Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain (M.E.-P., J.E., E.M., M.M., N.G., P.J.-Q., R.H., R.M. B.I., I.J.N.-G., F.A., C.B., E.G., A.F.-O., C.M.); Centro Nacional de Investigaciónes Cardiovasculares Carlos III (CNIC), Madrid, Spain (M.E.-P., J.E., B.I., A.F.-O.); Imperial College Healthcare and NHS Trust, London, UK (R.P., S.S., J.D.); and Clinical Epidemiology Unit, Hospital Clinico San Carlos, Madrid, Spain (C.F.).

Background: In chronic ischemic heart disease, focal stenosis, diffuse atherosclerotic narrowings, and microcirculatory dysfunction (MCD) contribute to limit myocardial flow. The prevalence of these ischemic heart disease levels in fractional flow reserve (FFR) interrogated vessels remains largely unknown.

Methods And Results: Using intracoronary measurements, 91 coronaries (78 patients) with intermediate stenoses were classified in 4 FFR and coronary flow reserve (CFR) agreement groups, using FFR>0.80 and CFR<2 as cutoffs. Index of microcirculatory resistance (IMR) and atherosclerotic burden (Gensini score) were also assessed. MCD was assumed when IMR≥29.1 (75(th) percentile). Fifty-four (59.3%) vessels had normal FFR, from which only 20 (37%) presented both normal CFR and IMR. Among vessels with FFR>0.80, most (63%) presented disturbed hemodynamics: abnormal CFR in 28 (52%) and MCD in 18 (33%). Vessels with FFR>0.80 presented higher IMR [adjusted mean 27.6 (95% confidence interval, 23.4-31.8)] than those with FFR≤0.80 [17.3 (95% confidence interval, 13.0-21.7), p=0.001]. Atherosclerotic burden was inversely correlated with CFR (r=-0.207, P=0.055), and in vessels with FFR>0.80 and CFR<2 (n=28, 39%), IMR had a wide dispersion (7-72.7 U), suggesting a combination of diffuse atherosclerotic narrowings and MCD. Vessels with FFR≤0.80 and normal CFR presented the lowest IMR, suggesting a preserved microcirculation.

Conclusions: A substantial number of coronary arteries with stenoses showing an FFR>0.80 present disturbed hemodynamics. Integration of FFR, CFR, and IMR supports the existence of differentiated patterns of ischemic heart disease that combine focal and diffuse coronary narrowings with variable degrees of MCD.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.112.001345DOI Listing
December 2013

Long-term clinical performance of paclitaxel-eluting stents coated with a bioactive polymer (P-5) containing a triflusal derivative: results of the REWAC registry.

J Invasive Cardiol 2013 Aug;25(8):391-6

Clinica Moncloa, Madrid, Spain.

Aims: Although drug-eluting stents have dramatically reduced angiographic restenosis and clinical need for repeat revascularization procedures, some adverse effects, such as late stent thrombosis, have been described. We evaluated clinical performance of paclitaxel-eluting stents coated with a new bioactive polymer system (P-5) based on a copolymer of an acrylic derivative of triflusal in patients with coronary artery disease.

Methods And Results: This was a multicenter, observational, prospective study to assess the incidence of target lesion revascularization (TLR) at 6 months and clinical major adverse cardiac events (MACEs) at 1 and 6 months and 1 and 2 years post-stent implantation in 537 patients. After stent implantation, only 1 case of thrombus and acute occlusion was reported in 1 lesion (0.14%). The incidence of new TLR was 0.89% at 6 months, 1.08% at 1 year, and 1.49% at 2 years, with a cumulative incidence of 3.54%. MACEs included cardiac death (0.93%), myocardial infarction (0.37%), and cardiac surgery (0.19%). No cases of late or very late stent thrombosis were recorded.

Conclusion: Under routine clinical practice, the implantation of paclitaxel-eluting stents coated with P-5 is associated with favorable clinical outcomes in both the short and long term (2 years) in patients with coronary artery disease.
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August 2013

Paravalvular leaks: mechanisms, diagnosis and management.

EuroIntervention 2012 Sep;8 Suppl Q:Q41-52

Interventional Cardiology, Cardiac Department, Cardiovascular Institute, San Carlos University Hospital, Madrid, Spain.

Aims: To understand the incidence, aetiology and mechanisms of paravalvular aortic and mitral leaks after valvular surgery; reviewing the best methods for diagnosis, procedural guidance and result assessment of these leaks, as well as describing the different approaches to their treatment.

Methods And Results: A literature search was undertaken as well as an in-depth analysis of our own experience concerning different imaging modalities and various therapeutic strategies for aortic and mitral paravalvular leaks. The majority of patients were diagnosed using two- or three-dimensional transoesophageal echocardiography, useful in both guiding the procedure as well as assessing the procedural results. Haemoglobin, haematocrit, LDH and haptoglobin values were analysed to assess haemolysis. Procedural success for percutaneous closure of paravalvular aortic leaks are around 90% in the different series, with low complication rates. Mitral leaks have been approached by transfemoral and transapical access; the reported success of this procedure ranges from 75% to more than 90% in different reports. Complication rates at 30 days average 10% and mortality related to the procedure is around 1%. Late follow-up results depend on the initial anatomy, baseline clinical class and procedure results.

Conclusions: Paravalvular leaks after surgical valve implantation have a multifactorial aetiology, but are mainly related to specific anatomic characteristics of the valvular ring. Mitral leaks are three times more common than aortic leaks and the incidence increases after reoperation. Different percutaneous techniques with several devices have been explored for leak closure, but we are still lacking devices specifically designed to treat this pathology more effectively.
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http://dx.doi.org/10.4244/EIJV8SQA9DOI Listing
September 2012

Techniques and material used in the percutaneous treatment of chronic coronary occlusions. Data from the CIBELES study.

Rev Port Cardiol 2013 Jul-Aug;32(7-8):593-9. Epub 2013 Jul 27.

Interventional cardiology, University Hospital La Paz, Madrid, Spain.

Introduction: In recent years, various specific techniques and materials have been developed for the treatment of coronary chronic total occlusions (CTO).

Objective: To evaluate the current situation in the treatment of CTO (techniques and material) in our setting.

Methods: We evaluated data on techniques and material used in the CIBELES (ChronIc coronary occlusion treated By EveroLimus Eluting Stent) trial, a randomized comparison of sirolimus- and everolimus-eluting stents in 207 patients with CTO in 13 centers in Spain and Portugal.

Results: A radial approach was used in 23% of patients, and retrograde techniques were used in only 5%. A high number of balloons were used (2.2±0.9 per patient). Microcatheters were used in 33% of patients, and post-dilatation balloons in only 25%. The mean number of stents implanted per patient was 2.1±1.0, with a mean total stent length of 49±24 mm. Other devices and techniques used were: Tornus penetration catheter in 4% of patients, rotational atherectomy in 2%, and cutting balloon in 1%. Intracoronary ultrasound was used in only 6% of patients. In 34% of cases, operators used guidewires that were not specifically for CTO. Considerable variability between centers was detected in the use of different techniques, the highest and lowest variability being observed in the use of intracoronary ultrasound and the use of CTO guidewires, respectively.

Conclusions: In the CIBELES trial, techniques and devices specifically designed for the treatment of CTO were used in a relatively low proportion of patients. Considerable variability between centers was detected.
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http://dx.doi.org/10.1016/j.repc.2012.11.012DOI Listing
August 2014

Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization.

J Am Coll Cardiol 2013 Jul 15;62(3):210-219. Epub 2013 May 15.

Department of Interventional Cardiology at McGill University Health Centre, Montreal, Quebec, Canada; Department of Cardiovascular Surgery, German Heart Center, Munich, Germany. Electronic address:

Objectives: The authors sought to examine the adoption of transcatheter aortic valve replacement (TAVR) in Western Europe and investigate factors that may influence the heterogeneous use of this therapy.

Background: Since its commercialization in 2007, the number of TAVR procedures has grown exponentially.

Methods: The adoption of TAVR was investigated in 11 European countries: Germany, France, Italy, United Kingdom, Spain, the Netherlands, Switzerland, Belgium, Portugal, Denmark, and Ireland. Data were collected from 2 sources: 1) lead physicians submitted nation-specific registry data; and 2) an implantation-based TAVR market tracker. Economic indexes such as healthcare expenditure per capita, sources of healthcare funding, and reimbursement strategies were correlated to TAVR use. Furthermore, we assessed the extent to which TAVR has penetrated its potential patient population.

Results: Between 2007 and 2011, 34,317 patients underwent TAVR. Considerable variation in TAVR use existed across nations. In 2011, the number of TAVR implants per million individuals ranged from 6.1 in Portugal to 88.7 in Germany (33 ± 25). The annual number of TAVR implants performed per center across nations also varied widely (range 10 to 89). The weighted average TAVR penetration rate was low: 17.9%. Significant correlation was found between TAVR use and healthcare spending per capita (r = 0.80; p = 0.005). TAVR-specific reimbursement systems were associated with higher TAVR use than restricted systems (698 ± 232 vs. 213 ± 112 implants/million individuals ≥ 75 years; p = 0.002).

Conclusions: The authors' findings indicate that TAVR is underutilized in high and prohibitive surgical risk patients with severe aortic stenosis. National economic indexes and reimbursement strategies are closely linked with TAVR use and help explain the inequitable adoption of this therapy.
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http://dx.doi.org/10.1016/j.jacc.2013.03.074DOI Listing
July 2013

Safety and efficacy of intense antithrombotic treatment and percutaneous coronary intervention deferral in patients with large intracoronary thrombus.

Am J Cardiol 2013 Jun 22;111(12):1745-50. Epub 2013 Mar 22.

Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain.

The optimal management of a large intracoronary thrombus in patients with acute coronary syndromes without an urgent need of revascularization is unclear. We investigated whether deferring percutaneous coronary intervention (PCI) after a course of intensive antithrombotic therapy (ATT) (glycoprotein IIb/IIIa inhibitors, enoxaparin, aspirin, and clopidogrel) improves the outcomes compared with immediate PCI. We studied 133 stable patients with ACS and a large intracoronary thrombus and without an urgent need for revascularization at angiography. The angiographic and in-hospital outcomes of a prospective cohort of 89 patients who had undergone deferred angiography with or without PCI after ATT (d-PCI) were compared with a historical cohort of 44 patients who had undergone immediate PCI, matched for age, gender, and Thrombolysis In Myocardial Infarction thrombus grade. The absolute thrombus volume was measured before and after ATT using dual quantitative coronary angiography. All d-PCI patients remained stable during ATT (60.0 ± 30.8 hours). A significant reduction in the Thrombolysis In Myocardial Infarction thrombus grade (4, range 4 to 5, vs 3, range 2 to 4; p <0.001), thrombus volume (51.1, range 32.1 to 83, vs 38.1, range 21.7 to 50.7 mm(3); p <0.001), stenosis severity (73.8 ± 25.8% vs 60.3 ± 32.5%; p <0.001) and better Thrombolysis In Myocardial Infarction flow (2, range 0 to 3, vs 3, 1.5 to 3; p <0.001) were noted after ATT. PCI, stenting, and thrombus aspiration were performed less frequently in the d-PCI group (76.4% vs 100%, p <0.001; 70.8% vs 93.2%, p = 0.003; and 21% vs 100%, p <0.001, respectively). However, distal embolization and slow and/or no-reflow were more common during immediate PCI (31.8% vs 9%; p = 0.001). No life-threatening or severe hemorrhagic complications were observed, although the rate of mild and/or moderate bleeding was similar between the 2 groups (6.8% in immediate PCI vs 7.9% in d-PCI; p = 0.829). In conclusion, compared with immediate PCI, d-PCI after ATT in selected, stabilized patients with ACS and a large intracoronary thrombus and without an urgent need for revascularization is probably safe and associated with a reduction in thrombotic burden, angiographic complications, and the need of revascularization. These benefits were observed without an increase in hemorrhagic complications.
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http://dx.doi.org/10.1016/j.amjcard.2013.02.027DOI Listing
June 2013

Safety of lone thrombus aspiration without concomitant coronary stenting in selected patients with acute myocardial infarction.

EuroIntervention 2013 Feb;8(10):1149-56

Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain.

Aims: Although the benefit of concomitant thrombus aspiration (TA) in primary percutaneous coronary intervention (PPCI) treatment of acute ST-segment elevation myocardial infarction (STEMI) has been demonstrated, very little information is available on its safety as a lone revascularisation technique in this setting. We present our experience in a cohort of patients with STEMI treated only with TA, without concomitant interventional devices.

Methods And Results: In 28 patients with STEMI, PPCI was performed using only TA on the grounds of an excellent angiographic result and in order to avoid the potential risks associated with balloon dilatation or stenting. The patients were younger than in the overall PPCI population (n=1,737) at our institution (52±18 vs. 63±14 years, p<0.001), with a history of atrial fibrillation in six (21%), cocaine abuse in three (11%) and mechanical cardiac valves in two (7%). Twenty-eight patients (89%) presented STEMI with Killip class I, two (7%) with cardiogenic shock, and two (7%) with sudden cardiac death. A significant reduction in TIMI thrombus grade (5 [4-5] to 1 [0-1.75], p<0.001) and coronary stenosis percentage (%) (87.2±21.3 to 11.3±0.9, p<0.001) as well as an increase in final TIMI flow (0 [0-2] to 3 [3-3], p<0.001) and minimum luminal diameter (mm) (0.89±1.01 to 2.42±0.70, p<0.001) were noted after TA. Transient no-reflow phenomenon, residual intracoronary thrombus and minor distal thrombus embolisation were observed in two (7.1%), 11 (39.3%) and 10 (25.7%) patients, respectively. All but one patient remained asymptomatic during hospital admission. Scheduled control angiography was performed 6±2 days (min-max, 3-10 days) after PPCI in 11 (39%) patients, demonstrating coronary artery patency and TIMI flow grade 3 in all patients. During clinical follow-up, successfully performed in all patients at 40±23 months (min-max, six to 95 months), there was one sudden cardiac death (4%) and three (11%) non-cardiac deaths. One patient (4%) was admitted with non-STEMI (new coronary angiogram without stenosis) and the remaining 22 (78.5%) remained asymptomatic and free of cardiac events.

Conclusions: Our series suggests that lone TA might be safely performed as a primary revascularisation procedure in STEMI in selected cases. Further information based on additional and larger studies is recommended to confirm our findings.
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http://dx.doi.org/10.4244/EIJV8I10A178DOI Listing
February 2013

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.

Circ Cardiovasc Interv 2013 Feb 12;6(1):21-8. Epub 2013 Feb 12.

Hospital Universitario La Paz, 28046 Madrid, Spain.

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.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.112.000076DOI Listing
February 2013

Double bifurcation lesion treated with double Tryton Sidebranch Stent: first case report.

Catheter Cardiovasc Interv 2013 Oct 8;82(4):E477-81. Epub 2013 Apr 8.

Hospital Universitario Madrid Montepríncipe, Avda. Montepríncipe 25, Boadilla del Monte, Madrid, Spain.

The optimal percutaneous treatment strategy for coronary bifurcation lesions is still unknown. Several dedicated coronary bifurcation stents, such as the Tryton Side Branch Stent™ (Tryton Medical, Durham, NC) have been developed to improve clinical outcomes. We presented a double bifurcation lesion case treated with two Tryton sidebranch stents, with a single drug eluting stent covering the main vessel and both bifurcations.
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http://dx.doi.org/10.1002/ccd.24858DOI Listing
October 2013

Transfemoral Edwards-SAPIEN XT aortic valve implantation without previous valvuloplasty.

Rev Esp Cardiol (Engl Ed) 2013 Feb 15;66(2):150-1. Epub 2012 Sep 15.

Unidad de Hemodinámica, Instituto Cardiovascular, Hospital Clínico San Carlos, Madrid, Spain.

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http://dx.doi.org/10.1016/j.rec.2012.06.015DOI Listing
February 2013