Publications by authors named "Eduard Fernandez Nofrerías"

38 Publications

Effect of COMBinAtion therapy with remote ischemic conditioning and exenatide on the Myocardial Infarct size: a two-by-two factorial randomized trial (COMBAT-MI).

Basic Res Cardiol 2021 Jan 25;116(1). Epub 2021 Jan 25.

Cardiology Department, Vall D'Hebron Institut de Recerca (VHIR), Vall D'Hebron Hospital Universitari, Vall D'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain.

Remote ischemic conditioning (RIC) and the GLP-1 analog exenatide activate different cardioprotective pathways and may have additive effects on infarct size (IS). Here, we aimed to assess the efficacy of RIC as compared with sham procedure, and of exenatide, as compared with placebo, and the interaction between both, to reduce IS in humans. We designed a two-by-two factorial, randomized controlled, blinded, multicenter, clinical trial. Patients with ST-segment elevation myocardial infarction receiving primary percutaneous coronary intervention (PPCI) within 6 h of symptoms were randomized to RIC or sham procedure and exenatide or matching placebo. The primary outcome was IS measured by late gadolinium enhancement in cardiac magnetic resonance performed 3-7 days after PPCI. The secondary outcomes were myocardial salvage index, transmurality index, left ventricular ejection fraction and relative microvascular obstruction volume. A total of 378 patients were randomly allocated, and after applying exclusion criteria, 222 patients were available for analysis. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. IS was similar between groups for the RIC (24 ± 11.8% in the RIC group vs 23.7 ± 10.9% in the sham group, P = 0.827) and the exenatide hypotheses (25.1 ± 11.5% in the exenatide group vs 22.5 ± 10.9% in the placebo group, P = 0.092). There were no effects with either RIC or exenatide on the secondary outcomes. Unexpected adverse events or side effects of RIC and exenatide were not observed. In conclusion, neither RIC nor exenatide, or its combination, were able to reduce IS in STEMI patients when administered as an adjunct to PPCI.
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http://dx.doi.org/10.1007/s00395-021-00842-2DOI Listing
January 2021

Procedural Characteristics and Late Outcomes of Percutaneous Coronary Intervention in the Workup Pre-TAVR.

JACC Cardiovasc Interv 2020 11 14;13(22):2601-2613. Epub 2020 Oct 14.

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

Objectives: This study sought to determine, in patients undergoing percutaneous coronary intervention (PCI) during the work-up pre-transcatheter aortic valve replacement (TAVR): 1) the clinical and peri-procedural PCI characteristics; 2) the long-term outcomes; and 3) the clinical events in those patients with complex coronary features.

Background: A PCI is performed in about 25% of TAVR candidates, but procedural features and late outcomes of pre-TAVR PCI remain largely unknown.

Methods: Multicenter study including 1197 consecutive patients who had PCI in the work-up pre-TAVR. A total of 1,705 lesions (1.5 ± 0.7 lesions per patient) were included. Death, stroke, myocardial infarction, and major adverse cardiovascular and cerebrovascular events (MACCE) were recorded, as well as target lesion failure (TLF) and target vessel failure (TVF).

Results: One-half of patients exhibited a multivessel disease and the mean SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) score was 12.1 ± 9.1. The lesions were of B2/C type, calcified, bifurcation, and ostial in 49.9%, 45.8%, 21.4%, and 19.3% of cases, respectively. After a median follow-up of 2 (interquartile range: 1 to 3) years, a total of 444 (37.1%) patients presented an MACCE. Forty patients exhibited TVF (3.3%), with TLF identified in 32 (2.7%) patients. By multivariable analysis, previous peripheral artery disease (p < 0.001), chronic obstructive pulmonary disease (p = 0.002), atrial fibrillation (p = 0.003), diabetes mellitus (p = 0.012), and incomplete revascularization (p = 0.014) determined an increased risk of MACCE. In patients with unprotected left main or SYNTAX score >32 (n = 128), TLF, TVF, and MACCE rates were 3.9%, 6.3%, and 35.9%, respectively (p = 0.378; p = 0.065, and p = 0.847, respectively, vs. the rest of the population).

Conclusions: Patients undergoing PCI in the work-up pre-TAVR frequently exhibited complex coronary lesions and multivessel disease. PCI was successful in most cases, and TLF and TVF rates at 2-year follow-up were low, also among patients with high-risk coronary features. However, overall MACCE occurred in about one-third of patients, with incomplete revascularization determining an increased risk. These results should inform future studies to better determine the optimal revascularization strategy pre-TAVR.
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http://dx.doi.org/10.1016/j.jcin.2020.07.009DOI Listing
November 2020

Comparison of one year outcomes between the ihtDEStiny BD stent and the durable polymer everolimus and zotarolimus eluting stents. A propensity score matched analysis.

Cardiovasc Revasc Med 2020 Oct 3. Epub 2020 Oct 3.

Clinica Universitaria de Navarra, Madrid, Spain.

Objectives: We sought to evaluate clinical outcomes in patients treated with the drug-eluting stent ihtDEStiny BD.

Background: The ihtDEStiny BD stent is a metallic sirolimus eluting stent with a biodegradable polymer with both drug and polymer coating the abluminal surface of the stent and balloon.

Methods: In this study, the clinical outcomes of a multicenter prospective registry of patients treated with this stent (DEStiny group) were analyzed and compared with those of a control group of patients treated with durable polymer everolimus or zotarolimus eluting stents (CONTROL group) paired by propensity score matching. Primary outcome was the target vessel failure (TVF) at 12 months defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target vessel revascularization (TVR).

Results: A total of 350 patients were included in the DESTtiny group. The control group consisted initially of 1368 patients, but after matching (1:1) 350 patients were selected as CONTROL group. The baseline clinical, angiographic and procedural characteristics were quite comparable in both groups. At 12 months follow up the TVF was 6.6% in DEStiny group and 6.3% in CONTROL group (p = 0.8). No differences were observed for any of the individual components of the primary endpoint: cardiac death 1.1% vs. 1.4%, TV-MI 3.4% vs. 3.7% and TVR 2.6% vs. 2.3% respectively.

Conclusions: The use of ihtDEStiny stent in real practice is associated with a clinical performance at 12 months follow up that appears to be non-inferior to the most widely used and largely evidence supported durable polymer drug eluting stents. A longer follow up is warranted.
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http://dx.doi.org/10.1016/j.carrev.2020.09.046DOI Listing
October 2020

Valve-in-valve transcatheter aortic valve implantation for bioprosthetic aortic sutureless valve failure: a case series.

Rev Esp Cardiol (Engl Ed) 2021 Mar 14;74(3):269-272. Epub 2020 Aug 14.

Servicio de Cardiología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain; Departamento de Medicina, Universidad Autónoma de Barcelona (UAB), Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Barcelona, Spain.

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http://dx.doi.org/10.1016/j.rec.2020.06.020DOI Listing
March 2021

Transradial Crossover Balloon Occlusion Technique for Primary Access Hemostasis During Transcatheter Aortic Valve Replacement: Initial Experience With the Oceanus 140 cm and 200 cm Balloon Catheters.

J Invasive Cardiol 2020 Aug;32(8):283-288

Quebec Heart & Lung Institute, Laval University 2725 Chemin Ste-Foy, G1V 4GS Quebec City, Quebec, Canada.

Objectives: The crossover balloon occlusion technique (CBOT) facilitates primary access hemostasis in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The CBOT is usually performed through the contralateral femoral artery. The aim of this study was to evaluate, in patients undergoing TAVR, the safety and feasibility of transradial CBOT using the new Oceanus balloon dilatation catheter (iVascular).

Methods: This multicenter study included 104 patients (mean age, 81 ± 7 years; 43% women) undergoing transfemoral TAVR. A modified CBOT through the radial artery was performed in all patients with the Oceanus balloon catheter. Data regarding transradial CBOT, balloon performance, vascular complications, and 30-day clinical events were recorded.

Results: Up to 21% of patients had a height >170 cm and 17% presented with severe aortic/iliofemoral tortuosity. The transradial CBOT (left radial 74%, right radial 26%) was performed using either the 140 cm Oceanus (37.5%) or the 200 cm Oceanus (62.5%) balloon catheter. The balloon reached the femoral artery in all patients, and balloon inflation achieved an appropriate vessel closure in 98%. There were no complications related to the balloon catheter, and only 1 patient (1.0%) suffered a minor vascular complication related to the secondary radial access. The 30-day rates of primary access major vascular complications and death were 3.8% and 1.9%, respectively.

Conclusion: In patients undergoing transfemoral TAVR, transradial CBOT with the Oceanus balloon dilatation catheter was feasible and safe. A balloon length up to 200 cm allowed the use of this technique (from right or left radial access) in all patients regardless of patient height or the presence of a challenging vascular anatomy.
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August 2020

Transcatheter aortic valve replacement in patients with paradoxical low-flow, low-gradient aortic stenosis: Incidence and predictors of treatment futility.

Int J Cardiol 2020 10 13;316:57-63. Epub 2020 Apr 13.

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

Background: Few and controversial data exist on the outcomes of patients with paradoxical low-flow, low-gradient aortic stenosis (PLFLG-AS) following transcatheter aortic valve replacement (TAVR). This study aims to better characterize clinical outcomes and predictors of treatment futility in PLFLG-AS patients undergoing TAVR.

Methods: In this multicenter study, 318 patients with PLFLG-AS undergoing TAVR were categorized according to treatment futility, defined as all-cause mortality, poor functional status (NYHA class III-IV) or deterioration in functional class at 1-year follow-up. Clinical outcomes and the factors associated with treatment futility were assessed.

Results: The mean age of the patients was 81.0 ± 8.3 years and 50.3% were women. At 1-year follow-up, 17.6% died and 12.9% had heart failure hospitalization. Residual impaired functional capacity (NYHA ≥ II) was present in 54.4% of patients who were alive at 1-year, and 9.8% remained in NYHA III/IV. The primary endpoint was observed in 103 (32.4%) patients, of which 54% died and 46% had a poor or worsening functional class. Factors independently associated with treatment futility were the presence of atrial fibrillation (AF) (OR:1.79, 95%CI, 1.04-3.10), chronic obstructive pulmonary disease (COPD) (OR:2.66, 95%CI, 1.50-4.74) and a lower SVi (OR per each decrease in 10 ml/m:1.89, 95%CI, 1.06-3.45). The risk of treatment futility of patients with AF, COPD and a SVi < 30 ml/m was 66.38% (95%CI, 54.29%-78.48%).

Conclusion: Close to one-third of patients with PLFLG-AS failed to derive a benefit from TAVR. The presence of AF, COPD and a low SVi were predictors of treatment futility. Being able to identify patients less likely to improve after the procedure may help to guide management and improve outcomes in patients with PLFLG-AS.
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http://dx.doi.org/10.1016/j.ijcard.2020.04.036DOI Listing
October 2020

Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice.

Medicine (Baltimore) 2020 Feb;99(8):e19119

Städtische Kliniken Esslingen, Esslingen, Germany.

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.
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http://dx.doi.org/10.1097/MD.0000000000019119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034709PMC
February 2020

Acute Coronary Syndrome Following Transcatheter Aortic Valve Replacement.

Circ Cardiovasc Interv 2020 02 29;13(2):e008620. Epub 2020 Jan 29.

Quebec Heart and Lung Institute, Laval University, Canada (L.F., D.d.V., T.C., J.R.-C.).

Background: Scarce data exist on coronary events following transcatheter aortic valve replacement (TAVR), and no study has determined the factors associated with poorer outcomes in this setting. This study sought to determine the clinical characteristics, outcomes, and prognostic factors of acute coronary syndrome (ACS) events following TAVR.

Methods: Multicenter cohort study including a total of 270 patients presenting an ACS after a median time of 12 (interquartile range, 5-17) months post-TAVR. Post-ACS death, myocardial infarction, stroke, and overall major adverse cardiovascular or cerebrovascular events were recorded.

Results: The ACS clinical presentation consisted of non-ST-segment-elevation myocardial infarction (STEMI) type 2 (31.9%), non-STEMI type 1 (31.5%), unstable angina (28.5%), and STEMI (8.1%). An invasive strategy was used in 163 patients (60.4%), and a percutaneous coronary intervention was performed in 97 patients (35.9%). Coronary access issues were observed in 2.5% and 2.1% of coronary angiography and percutaneous coronary intervention procedures, respectively. The in-hospital mortality rate was 10.0%, and at a median follow-up of 17 (interquartile range, 5-32) months, the rates of death, stroke, myocardial infarction, and major adverse cardiovascular or cerebrovascular events were 43.0%, 4.1%, 15.2%, and 52.6%, respectively. By multivariable analysis, revascularization at ACS time was associated with a reduction of the risk of all-cause death (hazard ratio, 0.54 [95% CI, 0.36-0.81] =0.003), whereas STEMI increased the risk of all-cause death (hazard ratio, 2.06 [95% CI, 1.05-4.03] =0.036) and major adverse cardiovascular or cerebrovascular events (hazard ratio, 1.97 [95% CI, 1.08-3.57] =0.026).

Conclusions: ACS events in TAVR recipients exhibited specific characteristics (ACS presentation, low use of invasive procedures, coronary access issues) and were associated with a poor prognosis, with a very high in-hospital and late death rate. STEMI and the lack of coronary revascularization determined an increased risk. These results should inform future studies to improve both the prevention and management of ACS post-TAVR.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008620DOI Listing
February 2020

Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes.

PLoS One 2020 13;15(1):e0226606. Epub 2020 Jan 13.

Gachon University Gil Medical Center, Incheon, South Korea.

Background: The objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe.

Methods: Two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months.

Results: Of the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe.

Conclusions: PF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226606PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6957170PMC
April 2020

Distal Bioresorbable Vascular Scaffold Strut Embolization Detected at Late Follow-Up: A New BVS-Related Late Complication.

JACC Cardiovasc Interv 2019 04 13;12(7):e63-e65. Epub 2019 Mar 13.

Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain. Electronic address:

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http://dx.doi.org/10.1016/j.jcin.2019.01.226DOI Listing
April 2019

Trends in prevalence and outcomes of acute coronary syndrome associated with cocaine consumption: The RUTI-cocaine study.

Int J Cardiol 2019 05 10;283:23-27. Epub 2018 Dec 10.

Cardiology Service, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Research Institute Germans Trias i Pujol, Badalona, Spain; CIBERCV, Madrid, Spain; Department of Medicine, Universitat Autònoma de Barcelona, Spain.

Background: The use of cocaine as a recreational drug has increased over recent years. In this study, we aimed to analyze the prevalence, and in-hospital and long-term outcomes of acute coronary syndrome (ACS) associated with cocaine consumption (ACS-ACC).

Methods: A prospective observational registry of young patients hospitalised with ACS from 2001 through 2015, we analysed ACS-ACC temporal trends, clinical characteristics, and major adverse cardiovascular events (MACE) during long-term follow-up.

Results: There were 8153 admissions with ACS, of whom 864 patients were ≤50-years-old; 59 patients (6.8%) presented with ACS-ACC. The prevalence of patients with a history of cocaine consumption increased to maximum of 18% in 2008 with no variations thereafter (r = 0.74, p < 0.001). The ACS-ACC incidence increased over time from 5% to 9% (r = 0.25, p = 0.07). Compared to patients with ACS not associated with cocaine consumption, the ACS-ACC exhibited a higher incidence of in-hospital ventricular tachycardia (16.9% vs 4.7%, p < 0.001) and trends to in-hospital mortality (3.4% vs 1.0%, p = 0.097); during a median follow-up of 5.6 years, ACS-ACC had higher risk of MACE (HR 1.83; 95% CI 1.04-3.25, p = 0.038), higher risk of myocardial infarction (HR 2.39, 95% CI 1.02-5.60, p = 0.045), and higher risk of cardiovascular mortality (HR 6.26; 95% CI 1.67-23.43, p = 0.006).

Conclusion: Young patients with ACS-ACC carry a high risk of short and long-term major adverse cardiovascular events. Over the 15-year study period, we observed an increasing prevalence of this entity. This trend and its outcomes underscore the need for increased awareness and improved management strategies.
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http://dx.doi.org/10.1016/j.ijcard.2018.12.026DOI Listing
May 2019

Primary Ventricular Fibrillation in the Primary Percutaneous Coronary Intervention ST-Segment Elevation Myocardial Infarction Era (from the "Codi IAM" Multicenter Registry).

Am J Cardiol 2018 08 27;122(4):529-536. Epub 2018 Jun 27.

Heart Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; CIBER Enfermedades Cardiovasculares (CIBERCV), Barcelona, Spain; Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain.

Primary ventricular fibrillation (PVF) is a dreadful complication of ST segment elevation myocardial infarction (STEMI). Scarce data are available regarding PVF prognosis since primary percutaneous coronary intervention (PPCI) became routine practice in STEMI. Our aim was to compare 30-day and 1-year mortality for patients with and without PVF (including out-of-hospital and in-hospital PVF) within a regional registry of PPCI-treated STEMI patients. This prospective multicenter registry included all consecutive STEMI patients treated with PPCI from January 2010 to December 2014. Patients were classified as non-PVF or PVF, with further subdivision into out-of-hospital and in-hospital PVF. We analyzed 30-day and 1-year all-cause mortality in groups. The registry included 10,965 patients. PVF occurred in 949 patients (8.65%), including 74.2% out-of-hospital and 25.8% in-hospital PVF. Compared with the non-PVF group, PVF patients were younger; less commonly diabetic; more frequently had anterior wall STEMI, higher Killip-Kimball class, and left main disease; and showed significantly higher 24-hour (5.1% vs 1.1%), 30-day (18.5% vs 4.7%), and 1-year mortality (23.2% vs 7.9%) (all p <0.001). Mortality did not differ in out-of-hospital versus in-hospital PVF. After multivariable adjustment, PVF remained associated with all-cause 30-day (2.32, 95% CI: 1.91 to 2.82, p <0.001) and 1-year (HR: 1.59, 95% CI: 1.13 to 2.24, p = 0.008) mortality. In conclusion, we present the largest registry of PVF patients in the era of routine PPCI in STEMI. Although overall STEMI mortality has declined, PVF emerged as a predictor of both 30-day and 1-year mortality. These data warrant prospective validation and proper identification and protection of high-risk patients.
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http://dx.doi.org/10.1016/j.amjcard.2018.04.054DOI Listing
August 2018

Impact of a 'stent for life' initiative on post-ST elevation myocardial infarction heart failure: a 15 year heart failure clinic experience.

ESC Heart Fail 2018 02 29;5(1):101-105. Epub 2017 Dec 29.

Heart Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.

Aims: Multidisciplinary heart failure (HF) clinics are a cornerstone of contemporary HF management. The stent-for-life (SFL) initiative improves mortality after ST elevation myocardial infarction (STEMI), but its impact in post-STEMI HF is not well characterized. Here we assessed the impact of SFL among patients referred to a multidisciplinary HF clinic over a 15 year time period.

Methods And Results: Between 2001 and 2015, 1921 patients were admitted to our HF clinic. In 2009, Catalonia established the Codi IAM network, a regional STEMI network that prioritizes primary percutaneous coronary intervention in STEMI. Patients admitted during the study period were divided into two groups based on admission date: pre-SFL (2001-June 2009; n = 1031) and post-SFL (July 2009-2015; n = 890). Compared with those in the pre-SFL group, patients admitted in the post-SFL period had better New York Heart Association (NYHA) functional class (22.1 vs. 38.7 NYHA classes III-IV; P < 0.001) and higher left ventricular ejection fraction (LVEF) (36.1 ± 19.6 vs. 32.6 ± 13.4; P < 0.001). Among STEMI survivors, 101 (6.7%) pre-SFL patients and 40 (2%) post-SFL patients (P < 0.001) fulfilled the criteria for HF clinic referral (Killip-Kimball class ≥ 2 during index admission and/or LVEF of <40%). Furthermore, among patients admitted to the HF clinic, post-STEMI HF with reduced ejection fraction patients comprised 8.9% of the pre-SFL group and only 4.2% of the post-SFL group (P < 0.001).

Conclusions: Among patients treated at our multidisciplinary HF clinic, the adoption of an SFL network has decreased the prevalence of post-STEMI HF with reduced ejection fraction.
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http://dx.doi.org/10.1002/ehf2.12245DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5793981PMC
February 2018

IVUS Findings in Late and Very Late Stent Thrombosis. A Comparison Between Bare-metal and Drug-eluting Stents.

Rev Esp Cardiol (Engl Ed) 2018 May 1;71(5):335-343. Epub 2017 Sep 1.

Departamento de Cardiología Intervencionista, Hospital Universitari de Bellvitge, Institut d' Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.

Introduction And Objectives: Stent thrombosis (ST) is a life-threatening complication after stent implantation. Intravascular ultrasound is able to discern most causes of ST. The aim of this study was to compare intravascular ultrasound findings between bare-metal stents (BMS) and drug-eluting stents (DES) in patients with late (31 days to 1 year) or very late ST (> 1 year).

Methods: Of 250 consecutive patients with late or very late ST in 7 Spanish institutions, 114 patients (45.5% BMS and 54.5% DES) were imaged with intravascular ultrasound. Off-line intravascular ultrasound analysis was performed to assess malapposition, underexpansion, and neoatherosclerosis.

Results: The median time from stent implantation to ST was 4.0 years with BMS and 3.4 years with DES (P = .04). Isolated malapposition was similarly observed in both groups (36.5% vs 46.8%; P = .18) but was numerically lower with BMS (26.6% vs 48.0%; P = .07) in patients with very late ST. Isolated underexpansion was similarly observed in both groups (13.5% vs 11.3%; P = .47). Isolated neoatherosclerosis occurred only in patients with very late ST and was more prevalent with BMS (22.9%) than with DES (6.0%); P = .02. At 2.9 years' follow-up, there were 0% and 6.9% cardiac deaths, respectively (P = .06) and recurrent ST occurred in 4.0% and 5.2% of patients, respectively (P = .60).

Conclusions: Malapposition was the most common finding in patients with late and very late ST and is more prevalent with DES in very late ST. In contrast, neoatherosclerosis was exclusively observed in patients with very late ST and mainly with BMS.
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http://dx.doi.org/10.1016/j.rec.2017.08.001DOI Listing
May 2018

Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry).

Am J Cardiol 2016 Aug 29;118(4):578-84. Epub 2016 May 29.

Cardiology Department, Fundación Jiménez-Díaz, Madrid, Spain.

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.
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http://dx.doi.org/10.1016/j.amjcard.2016.05.054DOI Listing
August 2016

IVUS-guided treatment strategies for definite late and very late stent thrombosis.

EuroIntervention 2016 Dec 10;12(11):e1355-e1365. Epub 2016 Dec 10.

Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, L'Hospitalet de Llobregat, Spain.

Aims: Our aim was to describe the intravascular ultrasound (IVUS) findings of patients with late stent thrombosis (ST) undergoing percutaneous intervention, and to compare the pre- and post-intervention IVUS findings of patients treated with balloon angioplasty (BA) vs. additional stent implantation (ASI).

Methods And Results: A total of 117 patients with late ST imaged with IVUS were included (51.2% had drug-eluting stent ST). Treatment was left to the operator's discretion: BA was performed in 53.8% and ASI in 46.2%. Pre-intervention, incomplete stent apposition (ISA) was observed in 69.8% vs. 63.0% (p=0.43), underexpansion in 33.3% vs. 18.5% (p=0.07) and restenosis in 15.9% vs. 27.8% (p=0.12), respectively. Post-intervention, persistent ISA was observed in 37.2% vs. 60.9% (p=0.03) and malapposition volume decreased by 43.6% vs. 2.6% (p=0.03). Persistent underexpansion was observed in 9.3% vs. 17.4% (p=0.26); however, the stent expansion index was largely increased with BA (from 0.75 to 0.88) compared to ASI (from 0.80 to 0.82); p=0.046. At two years, recurrent ST was observed in one (1.7%) vs. four (7.7%) patients, respectively; p=0.09.

Conclusions: Non-optimal IVUS criteria of stent implantation are often observed in patients with late ST. Treatment of late ST with BA leads to a larger reduction of malapposition and underexpansion with respect to ASI and is associated with favourable outcomes.
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http://dx.doi.org/10.4244/EIJY15M12_08DOI Listing
December 2016

Early ST elevation myocardial infarction in non-capable percutaneous coronary intervention centres: in situ fibrinolysis vs. percutaneous coronary intervention transfer.

Eur Heart J 2016 Apr 18;37(13):1034-40. Epub 2015 Nov 18.

Cardiology Department, H. U. Germans Trias i Pujol, Carretera de Canyet SN. 08916, Badalona, Spain Department of Medicine, Universitat Autonoma de Barcelona, Barcelona, Spain.

Aims: The preferred reperfusion strategy for early ST elevation myocardial infarction (STEMI, defined as time from symptoms onset ≤120 min) in non-capable percutaneous coronary intervention (PCI) centres remains controversial. We sought to compare mortality of in situ fibrinolysis vs. PCI transfer in a real-life consecutive cohort of early STEMI.

Methods And Results: Prospective multicentre STEMI registry (Catalonia 'Codi IAM' network) of all-comers in a non-capable PCI centre with symptom onset to first medical contact (FMC) <120 min. Two groups were identified: in situ fibrinolysis and transfer to a PCI-capable centre. Primary endpoint was 30-day mortality. We included 2470 patients, of whom 2227 (90.2%) and 243 (9.8%) comprised the transfer and fibrinolysis groups, respectively. In the fibrinolysis group, diagnostic and system delays were shorter (24 vs. 31 min, P < 0.001; 45 vs. 119 min, P < 0.001, respectively). Thirty-day mortality was 7.7 and 5.1% in fibrinolysis and transfer groups, respectively (P = 0.09). However, patients in the transfer group whose time FMC-device was achieved within 140 min were associated with significantly lower mortality (2.0% for FMC-device <99 min, and 4.6% for FMC-device 99-140 min; P < 0.01 and P = 0.03, respectively vs. fibrinolysis). In multivariable logistic regression analysis, reperfusion with fibrinolysis was an independent 30-day mortality predictive factor (odds ratio: 1.91, 95% confidence interval: 1.01-3.50; P = 0.04), together with age and Killip-Kimball class (both P < 0.001).

Conclusions: In early STEMI patients assisted in non-capable PCI centres, in situ fibrinolysis had worse prognosis than patient transfer. Transfer to a PCI-capable centre seems recommended in patients with FMC-device delay <140 min.
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http://dx.doi.org/10.1093/eurheartj/ehv619DOI Listing
April 2016

Time-dependent effects of unfractionated heparin in patients with ST-elevation myocardial infarction transferred for primary angioplasty.

Int J Cardiol 2015 Nov 24;198:70-4. Epub 2015 Jun 24.

Servei de Cardiologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Departament de Medicina, Universitat Autonoma de Barcelona, Barcelona, Spain.

Aims: Initial thrombolysis in myocardial infarction (TIMI) flow and mortality are related in ST-elevation myocardial infarction (STEMI) patients treated with primary angioplasty (PPCI). It is unclear whether early adjunctive treatment with unfractionated heparin (UFH) is beneficial for coronary patency. We investigated the effect of UFH administered before transfer versus in the catheterization laboratory (CathLab) on initial patency of the infarct related artery (IRA) in transferred STEMI patients treated with PPCI.

Methods And Results: Consecutive STEMI patients (n=1326, February 2007-December 2013) were allocated in two groups relative to UFH administration: pre-transfer group - administration by ambulance crew or physician-in-charge at the non-PPCI centre, 758 patients (57%); post-transfer group - administration in the CathLab, 568 patients (43%). The time range between symptom onset (SO) and UFH administration (SO-UFH) was assessed and the 1-year mortality prediction was analysed by logistic regression. Initial IRA TIMI 2-3 flow was 30.3% in pre-transfer group vs. 21.2% in post-transfer group (p<0.001). A time-dependent association was found between SO-UFH and initial TIMI 2-3 in pre- vs. post-transfer groups [<120 min: 33.2% vs. 18%, p<0.001; 120-240 min: 29.2% vs. 22.8%, p=0.18; >240 min: 25% vs. 28%, p=0.57]. No differences in major bleeding were found between groups. UFH administration before transfer remained an independent predictor for initial TIMI 2-3 flow (OR 1.60 CI 95% 1.22-2.11, p=0.01) and for 1-year mortality (OR 0.51 CI 95% 0.29-0.91, p=0.02).

Conclusions: Early UFH administration in STEMI patients transferred for PPCI results in higher IRA initial patency in a time-dependent manner and improves clinical outcomes.
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http://dx.doi.org/10.1016/j.ijcard.2015.06.009DOI Listing
November 2015

Dyspnea in a pneumonectomized patient.

Arch Bronconeumol 2015 Oct 14;51(10):524-5. Epub 2015 Jan 14.

Servicio de Neumología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España.

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http://dx.doi.org/10.1016/j.arbres.2014.11.011DOI Listing
October 2015

Impassable brachiocephalic tortuosity in right transradial access: overcoming the curves with the pigtail catheter.

Int J Cardiol 2015 Feb 26;180:76-7. Epub 2014 Nov 26.

Cardiology Department, University Hospital Germans Trias i Pujol, Spain; Medicine Department, Universitat Autònoma de Barcelona, Spain.

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http://dx.doi.org/10.1016/j.ijcard.2014.11.185DOI Listing
February 2015

Is cocaine-associated acute myocardial infarction the same as myocardial infarction associated with recent cocaine consumption?

Rev Esp Cardiol (Engl Ed) 2014 Nov 11;67(11):964-5. Epub 2014 Sep 11.

Servicio de Cardiología, Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain; Departamento de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.

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http://dx.doi.org/10.1016/j.rec.2014.06.007DOI Listing
November 2014

Thrombus age, clinical presentation, and reperfusion grade in myocardial infarction.

Cardiovasc Pathol 2014 May-Jun;23(3):126-30. Epub 2014 Jan 23.

Cardiology Service, Hospital Universitari Germans Trias i Pujol, Badalona.

Introduction: Autopsy studies show that dynamic coronary thrombosis leads to infarction. We studied intracoronary thrombus age in ST-segment elevation myocardial infarction (STEMI) and its relationship with clinical presentation and epicardial reperfusion grade.

Methods And Results: Intracoronary thrombectomy was performed in 131 STEMI patients within 24 h after symptom onset, and material sufficient for pathological analysis was retrieved from 81 patients. Thrombus age was classified as fresh (<1day), lytic (1 to 5 days), or organized (>5days). A fresh thrombus was found in 48 patients (60%), whereas the thrombus showed lytic or organized changes in 33 patients (40%). Both thrombus and plaque material were aspirated in 40% of cases. Lytic or organized thrombi were aspirated in one third of the cases early (<12h) after symptom onset, and fresh thrombi were also aspirated in one third of STEMI of>12h evolution. In multivariable analysis, fresh thrombus was associated with both persistent ST-segment elevation (even after 12 h of onset) during percutaneous coronary intervention [odds ratio (OR) 4.23, 95% confidence interval (CI) 1.05-17.42, P=.042) and a previous history of ischemic heart disease (OR 4.54, 95% CI 1.41-14.64, P=.011). There were no associations between thrombus composition and epicardial reperfusion grade or the presence of the no-reflow phenomenon. Plaque components were found in all cases of distal embolization (5%).

Conclusion: Intracoronary thrombi aspirated in STEMI frequently show more than one stage of maturation. Fresh thrombi predominate in patients with known ischemic heart disease or persistent ST-segment elevation.

Summary: In STEMI, thromboaspiration revealed thrombi at different stages of maturation, supporting a dynamic process of rupture and repair of the atherosclerotic plaque. Fresh thrombi were present more frequently within 12 h of infarction onset but also in patients with symptoms beyond 12 h. When containing plaque material, thrombi were often associated with macroscopic distal embolization during angioplasty.
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http://dx.doi.org/10.1016/j.carpath.2014.01.007DOI Listing
December 2014

Results of primary percutaneous coronary intervention in patients ≥75 years treated by the transradial approach.

Am J Cardiol 2014 Feb 9;113(3):452-6. Epub 2013 Nov 9.

Servei de Cardiologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain; Institut per la Recerca Germans Trias i Pujol, Badalona, Spain.

Previous trials in elderly patients with ST-elevation myocardial infarction (STEMI) have not shown a definitive benefit of primary percutaneous coronary intervention (PPCI) by transfemoral approach over thrombolysis. The transradial approach (TRA) is associated with a significant decrease in mortality, MACE (Major Adverse Cardiac Event), and serious access site complications compared with the transfemoral approach. We have evaluated clinical outcomes in a cohort of real-life unselected ≥75-year-old patients with STEMI treated by TRA-PPCI. This is a single-center prospective, observational registry of consecutive patients with STEMI who underwent PPCI between February 2007 and February 2013. MACE was defined as death, reinfarction, or stroke. A total of 307 patients were treated by PPCI, 293 (95.1%) with TRA-PPCI (mean age 80 ± 2 years, 42% women). Patients had high co-morbidity levels (cardiogenic shock on admission 8.5%, previous myocardial infarction 11.6%, diabetes 30.4%, previous renal failure 25.6%, previous PCI 9.6%, and peripheral arterial disease 14.3%); IIbIIIa inhibitors were used in 45.1% of patients. Severe bleeding and need for transfusion were recorded for 6.5% and 9.9% of patients, respectively. In-hospital mortality, 1-year mortality, and 1-year MACE were 11.9%, 17.4%, and 22.2%, respectively. Excluding 25 patients with cardiogenic shock on admission, the in-hospital mortality, 1-year mortality, and 1-year MACE were 7.8%, 13.1%, and 17.9%, respectively. In conclusion, TRA-PPCI was feasible in the vast majority of elderly patients with STEMI. In-hospital mortality, 1-year mortality, and 1-year MACE were lower than reported for transfemoral access, suggesting a benefit of the TRA in these patients.
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http://dx.doi.org/10.1016/j.amjcard.2013.10.030DOI Listing
February 2014

The utility of stent enhancement to guide percutaneous coronary intervention for bifurcation lesions.

EuroIntervention 2013 Dec;9(8):968-74

Cardiovascular Intervention Unit, Cardiology Department, University Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain.

Aims: Percutaneous coronary intervention (PCI) of bifurcation lesions is complex and is technically very demanding. Coronary angiography is considered the gold standard method to guide PCI but has several limitations. The purpose of this study was to determine the utility of stent enhancement with StentBoost® (StB), a novel fluoroscopic imaging technique, and its potential role during bifurcation PCI.

Methods And Results: This prospective study included 97 patients who underwent bifurcation PCI (98 bifurcations), using StB. Bifurcation lesions were classified according to the modified Medina classification. StB was performed in all patients to obtain improved stent visualisation and to detect optimal release and deployment. Therefore, three groups were formed, according to the quality of image: optimal visualisation, suboptimal visualisation and poor visualisation. Most of the bifurcation disease involved the main vessel (99%) and in 80 patients (81.6%) there was side branch involvement. Most bifurcations had both main vessel and side branch lesions (Medina 1,1,1) (70 patients, 71.4%). StB image quality was good in 79.6% of the cases (optimal visualisation of the stent and guidewire), was suboptimal in 19.4%, and poor in 1% (overlapping of structures or devices). In three cases, StB enabled the identification of the guidewire and angioplasty balloon passing outside stent borders during rewiring of the side branch.

Conclusions: Imaging techniques have a primary role during bifurcation PCI. StentBoost is a simple and quick method that offers several advantages, enabling improved stent visualisation, appropriate rewiring of the side branch, adequate stent expansion and optimal apposition of the struts to the wall.
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http://dx.doi.org/10.4244/EIJV9I8A162DOI Listing
December 2013

Integration of a local into a regional primary angioplasty action plan (the Catalan Codi Infart network) reduces time to reperfusion.

Int J Cardiol 2013 Oct 6;168(4):4354-7. Epub 2013 Jun 6.

Cardiology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Departament de Medicina, Universitat Autònoma de Barcelona, Spain. Electronic address:

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http://dx.doi.org/10.1016/j.ijcard.2013.05.071DOI Listing
October 2013

Transradial percutaneous coronary intervention in cardiogenic shock: a single-center experience.

Am Heart J 2013 Mar;165(3):280-5

Servei de Cardiologia, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.

Background: Use of the transradial approach (TRA) in percutaneous coronary intervention (PCI) has increased in recent years. TRA has a lower mortality rate than the transfemoral approach (TFA) in patients with acute coronary syndrome. Comparative studies have systematically excluded patients with cardiogenic shock (CS).

Methods: We performed a prospective, observational registry study of consecutive patients undergoing emergent revascularization between February 2007 and January 2012. An analysis of the clinical evolution of patients with CS during hospitalization was performed.

Results: Of 1,400 emergency procedures, 122 had CS, of which 80 underwent PCI by TRA (65.6%) and 42 underwent PCI by TFA (34.3%). The main reason for choosing TFA was the absence of radial pulse (54.9%). Mortality (64.3% vs 32.5%, P = .001), serious access site complications (11.9% vs 2.5%, P = .03), access site complications requiring blood transfusion (7.1% vs 0%, P = .04), and major adverse cardiac events (death, infarction, stroke, serious bleeding, and postanoxic encephalopathy) (73.8% vs 43.8%, P = .001) were greater in patients treated by TFA. In the multivariate analysis, TRA was a predictor of mortality (odds ratio [OR] 0.39 [0.15-0.97]); other predictive factors were age ≥75 years (3.47 [1.35-8.92]), previous treatment with diuretics (3.67 [1.21-11.12]), and success of the procedure (0.07 [0.02-0.24]).

Conclusions: Transradial approach for PCI is possible and safe in up to two-thirds of patients with CS. Absence of radial pulse was the main factor preventing use of TRA. In multivariate analysis, TRA was associated with a lower risk of mortality.
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http://dx.doi.org/10.1016/j.ahj.2012.08.011DOI Listing
March 2013

Safety and efficacy of transradial access in coronary angiography: 8-year experience.

J Invasive Cardiol 2012 Jul;24(7):346-51

Cardiology Service, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.

Aims: The transradial approach (TRA) in coronary angiography is used less frequently than the transfemoral approach; the learning curve and transradial failure (TRF) have slowed its widespread use. We evaluate the incidence, causes, and predictors of TRF in TRA coronary angiographies in an unselected population.

Methods And Results: All elective coronary angiographies using TRA from January 2002 to December 2009 were analyzed in this single-center, prospective, observational study. TRF occurred in 465/8463 procedures (5.5%). The main causes of TRF were puncture failure in 48.3% and tortuous brachiocephalic arteries in 22.8% of cases. The annual TRF percentage decreased from 9.1% in 2002 to 4.1% in 2009 (P<.001). In a multivariable regression model, the independent factors associated with TRF included use of >3 catheters (odds ratio [OR], 3.973; confidence interval [CI], 3.198-4.937), abnormal Allen test (OR, 3.231; CI, 1.839-5.676), radial spasm (OR, 3.896; CI, 2.903-5.229), peripheral vascular disease (OR, 1.900; CI, 1.426-2.532), female sex (OR, 1.451; CI, 1.094-1.925), and age >80 years (OR, 1.441; CI, 1.020-2.036). Intra-arterial administration of verapamil (OR, 0.137; CI, 0.098-0.190) and nitroglycerin (OR, 0.455; CI, 0.317-0.653), and height (OR, 0.974; CI, 0.959-0.990) reduced the risk of TRF.

Conclusions: Experience with TRA was associated with a low incidence of TRF. Independent factors associated with TRF were identified.
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July 2012

Changes in radial artery volume assessed using intravascular ultrasound: a comparison of two vasodilator regimens in transradial coronary interventions.

J Invasive Cardiol 2011 Oct;23(10):401-4

Cardiology Service, Hospital Universitari Germans Trias i Pujol, Barcelona.

Objectives: This study used intravascular ultrasound (IVUS) to evaluate radial artery volume changes after intraarterial administration of nitroglycerin and/or verapamil.

Background: Radial artery spasm, which is associated with radial artery size, is the main limitation of the transradial approach in percutaneous coronary interventions (PCI).

Methods: This prospective, randomized study compared the effect of two intra-arterial vasodilator regimens on radial artery volume: 0.2 mg of nitroglycerin plus 2.5 mg of verapamil (Group 1; n = 15) versus 2.5 mg of verapamil alone (Group 2; n = 15). Radial artery lumen volume was assessed using IVUS at two time points: at baseline (5 minutes after sheath insertion) and post-vasodilator (1 minute after drug administration). The luminal volume of the radial artery was computed using ECOC Random Fields (ECOC-RF), a technique used for automatic segmentation of luminal borders in longitudinal cut images from IVUS sequences.

Results: There was a significant increase in arterial lumen volume in both groups, with an increase from 451 ± 177 mm³ to 508 ± 192 mm³ (p = 0.001) in Group 1 and from 456 ± 188 mm³ to 509 ± 170 mm³ (p = 0.001) in Group 2. There were no significant differences between the groups in terms of absolute volume increase (58 mm³ versus 53 mm³, respectively; p = 0.65) or in relative volume increase (14% versus 20%, respectively; p = 0.69).

Conclusions: Administration of nitroglycerin plus verapamil or verapamil alone to the radial artery resulted in similar increases in arterial lumen volume according to ECOC-RF IVUS measurements.
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October 2011

Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study.

J Am Coll Cardiol 2011 Jul;58(4):351-8

Hospital Marques de Valdecilla, IFIMAV, Santander, Spain.

Objectives: This study is a prospective validation of 6 mm(2) as a minimum lumen area (MLA) cutoff value for revascularization of left main coronary artery (LMCA) lesions.

Background: Lesions involving the LMCA are prognostically relevant. Angiography has important limitations in the evaluation of LMCA lesions with intermediate severity. An MLA of 6 mm(2) assessed by intravascular ultrasound has been proposed as a cutoff value to determine lesion severity, but there are no large studies evaluating the prospective application and safety of this approach.

Methods: We have designed a multicenter, prospective study. Consecutive patients with intermediate lesions in unprotected LMCA were evaluated with intravascular ultrasound. An MLA <6 mm(2) was used as criterion for revascularization.

Results: A total of 354 patients were included in 22 centers. LMCA revascularization was performed in 90.5% (152 of 168) of patients with an MLA <6 mm(2) and was deferred in 96% (179 of 186) of patients with an MLA of 6 mm(2) or more. A large scatter was observed between both groups regarding angiographic parameters. In a 2-year follow-up period, cardiac death-free survival was 97.7% in the deferred group versus 94.5% in the revascularized group (p = 0.5), and event-free survival was 87.3% versus 80.6%, respectively (p = 0.3). In the 2-year period, only 8 (4.4%) patients in the deferred group required subsequent LMCA revascularization, none with an infarction.

Conclusions: Angiographic measurements are not reliable in the assessment of intermediate LMCA lesions. An MLA of 6 mm(2) or more is a safe value for deferring revascularization of the LMCA, given the application of the clinical and angiographic inclusion criteria used in this study.
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http://dx.doi.org/10.1016/j.jacc.2011.02.064DOI Listing
July 2011

Drug-eluting stents for off-label indications in real clinical world: evidence based or 'intuition' based clinical practice?

Int J Cardiol 2013 Mar 13;164(1):116-22. Epub 2011 Jul 13.

Cardiology Department, Àrea del Cor. University Hospital Vall d'Hebron Barcelona, Spain.

Background: The use of drug-eluting stents (DES) is an example of the disparity between recommendations given by regulatory agencies and the real clinical world. Such disparity might lead cardiologists to adopt different routines in the use of DES. We aimed to assess variability of off-label DES use between hospitals and to what extent it can be explained by differences in patient or hospital characteristics.

Methods: Characteristics of consecutive patients receiving DES in 29 hospitals were recorded. Individual and hospital determinants of receiving DES for off-label indications were assessed by multilevel logistic regression.

Results: 1903 patients were recruited and 1188 (62.4%) received DES for off-label indications. Individual variables associated with off-label use were age (OR 1.01 (1-1.02)), previous percutaneous (OR 2.24 (1.68-2.97)) or surgical (2.41 (1.52-3.84)) revascularization, repeated procedure at the same admission (OR 4.66 (2.7-8.05)), receiving two (OR 4.17 (3.24-5.37)) or three or more DES (OR 14.12 (9.08-21.96)) vs one. Adjusting for individual variables, the Odds of receiving DES for off-label indication was higher in public funding hospitals with surgery availability vs private hospitals: 1.49 (0.86-2.6), and in public hospitals without surgery vs public with surgery availability: OR 1.76 (1.02-3.03). Interhospital variability reminded significant after adjustment for individual and contextual variables.

Conclusion: Off-label DES use is highly variable between centers. Although this variability is partially determined by hospital type of funding and cardiac surgery availability, the substantial interhospital variability after multilevel adjustment suggests heterogeneity in the process of care.
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http://dx.doi.org/10.1016/j.ijcard.2011.06.096DOI Listing
March 2013