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1.
Eur Heart J ; 43(13): 1320-1330, 2022 03 31.
Artículo en Inglés | MEDLINE | ID: mdl-34735004

RESUMEN

AIM: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. METHODS AND RESULTS: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. CONCLUSION: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03321032.


Asunto(s)
Enfermedad de la Arteria Coronaria , Diabetes Mellitus , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/terapia , Humanos , Intervención Coronaria Percutánea/métodos , Diseño de Prótesis , Sirolimus/análogos & derivados , Sirolimus/uso terapéutico , Resultado del Tratamiento
2.
Cardiol J ; 2023 Oct 19.
Artículo en Inglés | MEDLINE | ID: mdl-37853825

RESUMEN

BACKGROUND: Stent underexpansion is a challenge in interventional cardiology. Some off-label treatments, such as rotational atherectomy, intravascular lithotripsy (IVL) and coronary lasing, have been used to overcome the problem. The purpose of this study is to evaluate the safety and efficacy of coronary laser atherectomy with simultaneous contrast injection and subsequent balloon dilation to optimize stent expansion. METHODS: Coronary laser atherectomy with simultaneous contrast injection was used. After lasing, non-compliant balloon dilation at high pressure was performed to overcome the underexpanded point. The average increase in the minimum stent area (MSA) was measured by intravascular ultrasound (IVUS), and any complication related to the technique was evaluated. Additionally, major adverse cardiovascular events (MACE), consisting of death from any cause, new myocardial infarction (MI) and target lesion revascularization (TLR), were scrutinized in a long-term follow-up. RESULTS: Sixteen underexpanded stents were treated with laser between August 2017 and November 2022. In all cases but one, IVUS was used to evaluate the MSA before and after lasing. The MSA showed an average increase of 2.34 ± 1.57 mm² (95% confidence interval [CI]: 1.47-3.21; p < 0.001) after laser application and balloon inflation. No complication related to the technique was detected. During a follow-up period of a median (interquartile range) of 457 (50-973) days, the combined MACE assessed by Kaplan-Meier estimator showed an event-free rate of 0.82 (95% CI: 0.59-1). CONCLUSIONS: Coronary laser with simultaneous contrast injection is a safe method to optimize a stent underexpansion, with an acceptable event-free rate in long-term follow-up.

3.
Cardiol J ; 30(1): 59-67, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-34125431

RESUMEN

BACKGROUND: Several scoring systems have been described to assess the level of difficulty and to predict the probability of success of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). The J-CTO score was initially developed to correlate CTO complexity with guidewire time crossing through the lesion within 30 min. Moreover, almost all scoring systems represent procedures performed by seasoned operators. Herein, this study sought to evaluate the predictive capacity of J-CTO for PCI success in a European single-center cohort with growing experience in the approach of CTO. METHODS: Five hundred twenty-six procedures were performed between 2007 and 2020 mainly by a single operator. The predictive power of J-CTO score was assessed by area under the receiver-operator characteristic curve (ROC) in the entire cohort and additionally in two separate periods. The goodnessof- fit of the model was evaluated by the Hosmer and Lemeshow statistic. RESULTS: Successful procedure in first-attempt PCI was 79.5% and the overall success including 47 repeated procedures was achieved in 85.8%. The retrograde approach was attempted in 14.4%. The score was inversely associated with procedural success with lower success rate in more difficult CTOs (p < 0.001). ROC curve for the entire cohort, and first block (case 1-200) and second block (case 201-526) was 0.696, 0.661 and 0.748, respectively. The model showed good calibration for the entire cohort (X2 = 1.7; p = 0.43). CONCLUSIONS: J-CTO score showed an acceptable predictive power for procedural success in this cohort although its discriminatory power is better as the level of experience is improved.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Resultado del Tratamiento , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Oclusión Coronaria/diagnóstico , Oclusión Coronaria/cirugía , Angiografía Coronaria/métodos , Enfermedad Crónica , Sistema de Registros , Factores de Riesgo
4.
Cardiol J ; 30(4): 506-515, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-34581426

RESUMEN

BACKGROUND: Several scoring systems have been developed in order to predict percutaneous coronary intervention (PCI) result of chronic total occlusion (CTO). The scores principally include anatomic and clinical variables. Operator experience is a decisive factor for achieving successful result. We sought to assess the real impact of operator growing experience on CTO-PCI success. METHODS: The angiographic and clinical variables of CTO-PCIs performed in our center between May 2007 and April 2021 were collected, and variables with potential association with procedural result were thoroughly reviewed. The influence of operator experience based on the number of previous CTO-PCIs was statistically assessed. A scoring system with combination of anatomic variables and operator experience was devised. RESULTS: A total of 540 PCIs in 457 patients were performed in our institution. The scoring model was developed from the derivation set (2/3 of the cohort). The final variables in logistic regression model were CTO length ≥ 20 mm, blunt stump, vessel tortuosity > 45o and operator experience < 100 PCIs. The model showed good performance in the derivation set (area under curve [AUC]: 0.768; confidence interval [CI]: 0706-0.830; p < 0.001) with no significant shrinkage in the validation set (AUC: 0.704; CI: 0.613-0.796; p < 0.001). CONCLUSIONS: This new score (E-CTO score) adequately predict the probability of CTO-PCI failure. The model includes a variable representing operator experience along with other anatomic variables.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/cirugía , Angiografía Coronaria , Resultado del Tratamiento , Valor Predictivo de las Pruebas , Enfermedad Crónica , Sistema de Registros , Factores de Riesgo
5.
Rev Esp Cardiol (Engl Ed) ; 76(7): 503-510, 2023 Jul.
Artículo en Inglés, Español | MEDLINE | ID: mdl-35934294

RESUMEN

INTRODUCTION AND OBJECTIVES: Transthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA. METHODS: Comparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis of CA. RESULTS: We studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA2DS2-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P=.283), hemorrhagic stroke (2.5% and 0.8% in the control group; P=.284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P <.001) but this difference was unrelated to hemorrhagic complications or ischemic stroke. CONCLUSIONS: LAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile.


Asunto(s)
Amiloidosis , Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Hemorragia/complicaciones , Fibrilación Atrial/complicaciones , Fibrilación Atrial/cirugía , Fibrilación Atrial/diagnóstico , Amiloidosis/complicaciones , Amiloidosis/diagnóstico , Resultado del Tratamiento
6.
Minerva Cardiol Angiol ; 71(3): 284-293, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35420282

RESUMEN

BACKGROUND: It is unknown whether the availability of long drug-eluting stents modify the PCI strategy of long CTO. To describe the contemporary PCI strategy of long chronic total occlusions (CTO) using overlapping (OS) or single long stents (SS) and to analyze its results. METHODS: 2842 consecutive CTO PCIs were included. Those with an occlusion length ≥20 mm in which ≥1 drug eluting stent (DES) was implanted were analyzed. We compared procedural characteristics and clinical outcomes of CTO treated with OS or SS. RESULTS: 1088 CTO PCIs were analyzed (79.9% males; 64.7±10.6 years). Mean J-score was 2.8±0.9. A SS was used in 38.5% of cases and OS in 61.5%. Total stent length was 64.1±29.9 mm; it was higher in the OS group (OS: 79.9±25.5 mm vs. SS: 38.3±14.7 mm; P<0.0001). Mean number of stents in the OS group was 2.3±1. Very long stents (≥40 mm) were used in 27.4% of cases, more frequently in the OS group (OS:32.4% vs. SS:19.3%; P<0.0001). After a mean follow-up of 19±15.9 months, the rate of adverse events (MACE) was 2% (cardiac death: 1.6%, myocardial infarction: 1.6%, target lesion revascularization: 1.9% and stent thrombosis: 0.18%) with no significant differences between both groups. Overlapping was not an independent predictor of MACE. CONCLUSIONS: In long CTO PCIs, OS is more frequently used than single stenting, especially in more complex procedures. Clinical outcomes at a mid-term follow-up are favorable. Using newer generation DES, overlapping was not an independent predictor of MACE; however, a trend toward a higher event rate was observed in the OS group.


Asunto(s)
Oclusión Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Masculino , Humanos , Femenino , Oclusión Coronaria/cirugía , Oclusión Coronaria/etiología , Stents Liberadores de Fármacos/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Enfermedad Crónica , Stents , Sistema de Registros
7.
Rev Esp Cardiol (Engl Ed) ; 76(4): 253-260, 2023 Apr.
Artículo en Inglés, Español | MEDLINE | ID: mdl-35691552

RESUMEN

INTRODUCTION AND OBJECTIVES: Transfemoral access is the most frequently used vascular approach in chronic total occlusion percutaneous coronary interventions (CTO-PCI). The aim of this study was to evaluate the safety and feasibility of a transradial access CTO-PCI program and its impact on angiographic and clinical results and length of hospital stay. METHODS: Retrospective multicenter cohort study including 2550 consecutive CTO-PCI procedures included in a multicenter registry with accurate information on vascular access. A total of 896 procedures were performed as radial-only access while 1654 were performed through at least 1 femoral puncture. Clinical and angiographic data were collected. RESULTS: The mean age was 66.3± 11.4 years. The mean Japan-chronic total occlusion score (2.7±0.3) was similar in the 2 groups. Successful revascularization was achieved in 2009 (79.6%) cases, 78.2% and 82.1% in the femoral and radial access cohorts, respectively (P=.002). Periprocedural in-hospital complications were observed in 5.1% and 2.3% (P=.02), with fewer access site-dependant vascular complications in the transradial cohort (2.3% vs 0.2%; P=.009). The mean length of hospital stay was significantly shorter in the transradial access group (0.89±1.4 vs 2.2±3.2 days, P<.001). CONCLUSIONS: A transradial program for CTO-PCI is safe and effective in most CTO lesions. The transradial strategy has fewer vascular complications and shorter length of hospital stay without compromising the success rate.


Asunto(s)
Enfermedades Cardiovasculares , Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Persona de Mediana Edad , Anciano , Intervención Coronaria Percutánea/métodos , Oclusión Coronaria/diagnóstico , Oclusión Coronaria/cirugía , Estudios de Factibilidad , Estudios de Cohortes , Arteria Radial/cirugía , Arteria Femoral/cirugía , Resultado del Tratamiento , Angiografía Coronaria , Sistema de Registros , Enfermedad Crónica
8.
Cardiovasc Revasc Med ; 51: 55-64, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36822975

RESUMEN

BACKGROUND: Intracoronary pressure wire is useful to guide revascularization in patients with coronary artery disease. AIMS: To evaluate changes in diagnosis (coronary artery disease extent), treatment strategy and clinical results after intracoronary pressure wire study in real-life patients with intermediate coronary artery stenosis. METHODS: Observational, prospective and multicenter registry of patients in whom pressure wire was performed. The extent of coronary artery disease and the treatment strategy based on clinical and angiographic criteria were recorded before and after intracoronary pressure wire guidance. 12-month incidence of MACE (cardiovascular death, non-fatal myocardial infarction or new revascularization of the target lesion) was assessed. RESULTS: 1414 patients with 1781 lesions were included. Complications related to the procedure were reported in 42 patients (3.0 %). The extent of coronary artery disease changed in 771 patients (54.5 %). There was a change in treatment strategy in 779 patients (55.1 %) (18.0 % if medical treatment; 68.8 % if PCI; 58.9 % if surgery (p < 0.001 for PCI vs medical treatment; p = 0.041 for PCI vs CABG; p < 0.001 for medical treatment vs CABG)). In patients with PCI as the initial strategy, the change in strategy was associated with a lower rate of MACE (4.6 % vs 8.2 %, p = 0.034). CONCLUSIONS: The use of intracoronary pressure wire was safe and led to the reclassification of the extent of coronary disease and change in the treatment strategy in more than half of the cases, especially in patients with PCI as initial treatment.


Asunto(s)
Enfermedad de la Arteria Coronaria , Estenosis Coronaria , Intervención Coronaria Percutánea , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/terapia , Sistema de Registros , Resultado del Tratamiento , Angiografía Coronaria
9.
Rev Esp Cardiol (Engl Ed) ; 76(12): 1021-1031, 2023 Dec.
Artículo en Inglés, Español | MEDLINE | ID: mdl-37863184

RESUMEN

INTRODUCTION AND OBJECTIVES: This article presents the annual activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) for the year 2022. METHODS: All Spanish centers with catheterization laboratories were invited to participate. Data were collected online and were analyzed by an external company in collaboration with the members of the board of the ACI-SEC. RESULTS: A total of 111 centers participated. The number of diagnostic studies increased by 4.8% compared with 2021, while that of percutaneous coronary interventions (PCI) remained stable. PCIs on the left main coronary artery increased by 22%. The radial approach continued to be preferred for PCI (94.9%). There was an upsurge in the use of drug-eluting balloons, as well as in intracoronary imaging techniques, which were used in 14.7% of PCIs. The use of pressure wires also increased (6.3% vs 2021) as did plaque modification techniques. Primary PCI continued to grow and was the most frequent treatment (97%) in ST-segment elevation myocardial infarction. Most noncoronary procedures maintained their upward trend, particularly percutaneous aortic valve implantation, atrial appendage closure, mitral/tricuspid edge-to-edge therapy, renal denervation, and percutaneous treatment of pulmonary arterial disease. CONCLUSIONS: The Spanish cardiac catheterization and coronary intervention registry for 2022 reveals a rise in the complexity of coronary disease, along with a notable growth in procedures for valvular and nonvalvular structural heart disease.


Asunto(s)
Cardiología , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Cateterismo Cardíaco , Sistema de Registros
10.
J Clin Med ; 11(4)2022 Feb 18.
Artículo en Inglés | MEDLINE | ID: mdl-35207370

RESUMEN

The diagnosis of ischemic cardiomyopathy is not well established. Our objective is to determine predictive variables of coronary disease in unselected patients with ventricular dysfunction. This study is a retrospective cohort study of consecutive patients with left ventricular dysfunction and no known history of ischemic heart disease. We analyse the demographic variables, clinical data, electrocardiogram, and echocardiogram that are associated with the presence of coronary stenosis on coronary angiography. A total of 536 patients with left ventricular dysfunction were studied, with 135 (25.2%) of them having significant coronary lesions. In the multivariate logistic regression analysis, age ≤ 50 years, female gender, and the presence of atrial fibrillation on the electrocardiogram (ECG) were predictors of the absence of coronary lesions. Diabetes, hypercholesterolemia, the existence of Q waves in the ECG, and segmental alterations in contractility in the echocardiogram were predictors of coronary heart disease (C-Statistics 0.771, 95% CI 0.727 to 0.814). The information obtained from the clinical history, the ECG, and the echocardiogram of patients with ventricular dysfunction allows us to select subjects in whom coronary angiography has shown poor performance in diagnosing coronary disease.

11.
J Invasive Cardiol ; 34(10): E701-E708, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-36075883

RESUMEN

OBJECTIVES: Coronary lithotripsy (CL) works by fracturing the calcified plaque, allowing mean area gain, enhancing vessel compliance, and facilitating stent deployment. This study reports the safety, effectiveness, and durability of the clinical benefit of CL at long-term follow-up of a real-world multicenter registry. METHODS: This was a prospective, multicenter, single-arm study that included consecutive patients with calcified lesions undergoing CL from August, 2018 to October, 2020 with a clinical follow-up of 20 months (interquartile range, 14.5-25). Exclusion criteria were a target lesion located in a vessel <2.5 mm and/or the presence of dissection prior to CL. The primary endpoint was the rate of major adverse cardiovascular event (MACE, defined as death or target-lesion revascularization [TLR] or myocardial infarction [MI]) at follow-up. RESULTS: This registry included 109 patients (128 lesions). The population was elderly (mean age, 74 years old), with high rates of diabetic patients (58%), renal insufficiency (32%), and multivessel disease (76%). Most of the lesions were predilated with semicompliant/noncompliant balloons (25 with cutting balloon). Rotational atherectomy was used in 20 lesions. On average, CL required the use of 1 balloon delivering a mean of 60 pulses. Twelve patients presented with ST-segment-elevation MI and a culprit calcified coronary lesion undergoing CL. Successful CL was achieved in 99% of cases. There were few procedural complications, with 30-day freedom from MACE rate of 98%. The MACE rate at long-term follow-up was 5.6%. CONCLUSION: This is the first real-world, multicenter registry that confirms the safety and long-term efficacy of percutaneous coronary intervention for calcified lesions using CL in an unselected and high-risk population with a low long-term follow-up MACE rate.


Asunto(s)
Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Litotricia , Intervención Coronaria Percutánea , Calcificación Vascular , Anciano , Aterectomía Coronaria/efectos adversos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Estudios de Seguimiento , Humanos , Litotricia/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Sistema de Registros , Resultado del Tratamiento , Calcificación Vascular/diagnóstico , Calcificación Vascular/terapia
12.
Rev Esp Cardiol (Engl Ed) ; 75(3): 213-222, 2022 Mar.
Artículo en Inglés, Español | MEDLINE | ID: mdl-34301507

RESUMEN

INTRODUCTION AND OBJECTIVES: Severe calcification is present in> 50% of coronary chronic total occlusions (CTOs) undergoing percutaneous intervention. We aimed to describe the contemporary use and outcomes of plaque modification devices (PMDs) in this context. METHODS: Patients were included in the prospective, consecutive Iberian CTO registry (32 centers in Spain and Portugal), from 2015 to 2020. Comparison was performed according to the use of PMDs. RESULTS: Among 2235 patients, wire crossing was achieved in 1900 patients and PMDs were used in 134 patients (7%), requiring more than 1 PMD in 24 patients (1%). The selected PMDs were rotational atherectomy (35.1%), lithotripsy (5.2%), laser (11.2%), cutting/scoring balloons (27.6%), OPN balloons (2.9%), or a combination of PMDs (18%). PMDs were used in older patients, with greater cardiovascular burden, and higher Syntax and J-CTO scores. This greater complexity was associated with longer procedural time but similar total stent length (52 vs 57mm; P=.105). If the wire crossed, the procedural success rate was 87.2% but increased to 96.3% when PMDs were used (P=.001). Conversely, PMDs were not associated with a higher rate of procedural complications (3.7 vs 3.2%; P=.615). Despite the worse baseline profile, at 2 years of follow-up there were no differences in the survival rate (PMDs: 94.3% vs no-PMDs: 94.3%, respectively; P=.967). CONCLUSIONS: Following successful wire crossing in CTOs, PMDs were used in 7% of the lesions with an increased success rate. Mid-term outcomes were comparable despite their worse baseline profile, suggesting that broader use of PMDs in this setting might have potential technical and prognostic benefits.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Anciano , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/diagnóstico , Oclusión Coronaria/cirugía , Humanos , Estudios Prospectivos , Resultado del Tratamiento
13.
Int J Cardiol Heart Vasc ; 38: 100941, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-35024431

RESUMEN

BACKGROUND: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. METHODS: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. RESULTS: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centers previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. CONCLUSIONS: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operators experience with its previous device iteration or the number of Watchman FLX devices implanted.

14.
J Clin Med ; 10(23)2021 Nov 30.
Artículo en Inglés | MEDLINE | ID: mdl-34884362

RESUMEN

This study aimed to analyze angiographic characteristics of new attempted percutaneous coronary intervention (PCI) on chronic total occlusion (CTO) compared to first attempt group. The cohort of 527 CTO-PCIs was divided into first-attempt and re-attempt groups, and angiographic characteristics, level of complexity, and contributing factors to failure were analyzed. Between-group success rate difference and potential angiographic and technical aspects contributing to the success in new attempts were scrutinized. A total of 47 new PCIs in 39 patients were performed. The reattempt group showed higher J-CTO score compared to the first-attempt group (2.4 ± 1.06 vs. 1.2 ± 1.06; p < 0.001). The use of more complex techniques and devices such as retrograde approach (29.8% vs. 12.9%) and IVUS (48.9 vs. 27.3%; p: 0.002) were more frequent in the reattempt group. Both procedural and fluoroscopy time were higher in the reattempt group (197 ± 83.9 vs. 150.1 ± 72.3 and 97.7 ± 55.4 vs. 68.7 ± 43, respectively; p < 0.001). There was no between-group difference in terms of technical success (79.8 vs. 76.6% for first attempt vs. reattempt group, respectively; p: 0.6). The overall success rate increased by 6.1%, achieving 85.9% in the entire cohort. Reattempted CTO-PCIs required more complex techniques and had comparable technical success rate with regard to the first-attempt group.

15.
Coron Artery Dis ; 32(3): 241-246, 2021 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-33186144

RESUMEN

BACKGROUND: Coronary laser is a long-established coadjuvant therapy in interventional cardiology. This study aimed to present our experience regarding the safety and efficacy of laser assistance to percutaneous coronary intervention (PCI) in different scenarios of coronary artery disease. METHODS: We used coronary laser as an adjunctive therapy for PCI between May 2014 and March 2020. The safety of laser ablation was evaluated by studying any complication associated with the laser application. Besides, the laser contribution to PCI and 1 year of follow-up for adverse cardiac events was studied. RESULTS: Coronary laser was performed in 81 lesions and 75 patients in different scenarios to assist PCI. The average age was 66 ± 11.7 years and 72 (88.9%) were men. Coronary laser was used in 30 (37%) cases for in-stent-material debulking; 26 (32.1%) in primary angioplasty, 19 (23.4%) in chronic total occlusion and 5 (6.2%) in saphenous vein grafts. Procedural success was achieved in 77 (95.1%) with 1 (1.2%) type III coronary perforation. One year of follow-up for combined adverse cardiac events consisting of death due to any cause, myocardial infarction or target vessel failure showed an event-free rate of 0.82 (95% confidence interval, 0.72-0.91). CONCLUSIONS: Our preliminary experience reveals the safety and efficacy of the current modality of coronary laser as a coadjuvant therapy in PCI with a low rate of adverse cardiac events in 1-year of follow-up. Further studies are needed to establish more precisely the contribution of laser application in different contexts of coronary artery disease.


Asunto(s)
Enfermedad de la Arteria Coronaria/cirugía , Terapia por Láser , Intervención Coronaria Percutánea , Anciano , Angioplastia Coronaria con Balón , Angiografía Coronaria , Femenino , Humanos , Masculino , Vena Safena/trasplante , Stents
16.
PLoS One ; 16(4): e0245898, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33798205

RESUMEN

BACKGROUND: We aimed to compare the performance of the recent CASTLE score to J-CTO, CL and PROGRESS CTO scores in a comprehensive database of percutaneous coronary intervention of chronic total occlusion procedures. METHODS: Scores were calculated using raw data from 1,342 chronic total occlusion procedures included in REBECO Registry that includes learning and expert operators. Calibration, discrimination and reclassification were evaluated and compared. RESULTS: Mean score values were: CASTLE 1.60±1.10, J-CTO 2.15±1.24, PROGRESS 1.68±0.94 and CL 2.52±1.52 points. The overall percutaneous coronary intervention success rate was 77.8%. Calibration was good for CASTLE and CL, but not for J-CTO or PROGRESS scores. Discrimination: the area under the curve (AUC) of CASTLE (0.633) was significantly higher than PROGRESS (0.557) and similar to J-CTO (0.628) and CL (0.652). Reclassification: CASTLE, as assessed by integrated discrimination improvement, was superior to PROGRESS (integrated discrimination improvement +0.036, p<0.001), similar to J-CTO and slightly inferior to CL score (- 0.011, p = 0.004). Regarding net reclassification improvement, CASTLE reclassified better than PROGRESS (overall continuous net reclassification improvement 0.379, p<0.001) in roughly 20% of cases. CONCLUSION: Procedural percutaneous coronary intervention difficulty is not consistently depicted by available chronic total occlusion scores and is influenced by the characteristics of each chronic total occlusion cohort. In our study population, including expert and learning operators, the CASTLE score had slightly better overall performance along with CL score. However, we found only intermediate performance in the c-statistic predicting chronic total occlusion success among all scores.


Asunto(s)
Oclusión Coronaria/cirugía , Intervención Coronaria Percutánea , Anciano , Área Bajo la Curva , Oclusión Coronaria/diagnóstico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Medición de Riesgo , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
17.
Cardiovasc Revasc Med ; 21(5): 657-660, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-31477446

RESUMEN

Device uncrossable lesions are a challenge in interventional cardiology and despite improvements in balloon and microcatheter profile, rotational atherectomy is necessary in some circumstances in order to ablate and traverse the lesion. Nevertheless, the application of rotational atherectomy requires utilization of a specific wire, Rotawire, which is not always so easily navigable. Debulking of device uncrossable lesions can be performed by coronary laser over any kind of angioplasty guidewire. We present a series of six patients with chronic total (100%) and functional occlusions (99% stenosis) in whom after successful wire crossing, microcatheter failed to traverse the lesion. After coronary laser performance, 5 out of 6 lesions were successfully dilated, achieving a successful final angiographic result of 83.3%.


Asunto(s)
Angioplastia Coronaria con Balón , Aterectomía Coronaria/instrumentación , Oclusión Coronaria/terapia , Láseres de Excímeros/uso terapéutico , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/efectos adversos , Aterectomía Coronaria/efectos adversos , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/fisiopatología , Femenino , Humanos , Láseres de Excímeros/efectos adversos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Grado de Desobstrucción Vascular
18.
Rev Esp Cardiol (Engl Ed) ; 73(12): 1003-1010, 2020 Dec.
Artículo en Inglés, Español | MEDLINE | ID: mdl-32430261

RESUMEN

INTRODUCTION AND OBJECTIVES: Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population. METHODS: This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory. RESULTS: This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization. CONCLUSIONS: This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results.


Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Litotricia , Intervención Coronaria Percutánea , Calcificación Vascular , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Estudios Prospectivos , Sistema de Registros , Resultado del Tratamiento , Calcificación Vascular/diagnóstico , Calcificación Vascular/cirugía
19.
Rev Esp Cardiol (Engl Ed) ; 72(5): 373-382, 2019 May.
Artículo en Inglés, Español | MEDLINE | ID: mdl-29954721

RESUMEN

INTRODUCTION AND OBJECTIVES: There is current controversy regarding the benefits of percutaneous recanalization (PCI) of chronic total coronary occlusions (CTO). Our aim was to determine acute and follow-up outcomes in our setting. METHODS: Two-year prospective registry of consecutive patients undergoing PCI of CTO in 24 centers. RESULTS: A total of 1000 PCIs of CTO were performed in 952 patients. Most were symptomatic (81.5%), with chronic ischemic heart disease (59.2%). Previous recanalization attempts had been made in 15%. The mean SYNTAX score was 19.5 ± 10.6 and J-score was > 2 in 17.3%. A retrograde procedure was performed in 92 patients (9.2%). The success rate was 74.9% and was higher in patients without previous attempts (82.2% vs 75.2%; P = .001), those with a J-score ≤ 2 (80.5% vs 69.5%; P = .002), and in intravascular ultrasound-guided PCI (89.9% vs 76.2%, P = .001), which was an independent predictor of success. In contrast, severe calcification, length > 20mm, and blunt proximal cap were independent predictors of failed recanalization. The rate of procedural complications was 7.1%, including perforation (3%), myocardial infarction (1.3%), and death (0.5%). At 1-year of follow-up, 88.2% of successfully revascularized patients showed clinical improvement (vs 34.8%, P < .001), which was associated with lower mortality. At 1-year of follow-up, the mortality rate was 1.5%. CONCLUSIONS: Compared with other national registries, patients in the Iberian registry undergoing PCI of a CTO showed similar complexity, success rate, and complications. Successful recanalization was strongly associated with functional improvement, which was related to lower mortality.


Asunto(s)
Oclusión Coronaria/cirugía , Revascularización Miocárdica/métodos , Anciano , Enfermedad Crónica , Oclusión Coronaria/mortalidad , Femenino , Humanos , Masculino , Isquemia Miocárdica/etiología , Isquemia Miocárdica/mortalidad , Isquemia Miocárdica/cirugía , Revascularización Miocárdica/estadística & datos numéricos , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/estadística & datos numéricos , Portugal/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Estudios Prospectivos , Sistema de Registros , Reoperación/estadística & datos numéricos , España/epidemiología , Cirugía Asistida por Computador/métodos , Resultado del Tratamiento , Ultrasonografía Intervencional/métodos
20.
Cardiovasc Revasc Med ; 19(3 Pt A): 292-297, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29174825

RESUMEN

Percutaneous coronary intervention of chronic total occlusion is a particular interventional area which requires high level of operator's experience and the support of additional tools based on intracoronary image such as intravascular ultrasound in many cases to clarify difficulties during procedures and to increase success rate. Implantation of long stents in many cases, the presence of stump ambiguity, and the use of specific techniques in this kind of interventions, such as reverse controlled antegrade and retrograde subintimal tracking (CART) and reverse CART make necessary in many cases the use of intravascular ultrasound for a better understanding of the situation, for reducing eventual complications and increasing procedural success rate. We made a review of literature related to most challenging situations in which the use of intravascular ultrasound during chronic total occlusion percutaneous coronary intervention becomes rather indispensable to safely continue and finish the procedure. Besides, two complex percutaneous coronary interventions of chronic total occlusion with unfavourable anatomic features in which intravascular ultrasound was crucial for the procedural success are presented in this manuscript along with support of the literature.


Asunto(s)
Oclusión Coronaria/cirugía , Intervención Coronaria Percutánea , Ultrasonografía Intervencional , Anciano , Catéteres Cardíacos , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/diagnóstico por imagen , Stents Liberadores de Fármacos , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Resultado del Tratamiento
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