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The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI..
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Consenso , Hemorragia , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Fatores de Risco , Hemorragia/etiologia , Medição de Risco , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgiaRESUMO
Left atrium appendage closure is a safe and effective therapy for patients with atrial fibrillation and high thromboembolic and hemorrhagic risks. Prosthesis embolization is a potential major complication with an incidence of 0.07%. We report a case of migration of an Amplatzer Amulet (Abbott) device that was successfully retrieved in an innovative way (4).
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Apêndice Atrial , Fibrilação Atrial , Cateterismo Cardíaco , Cateteres Cardíacos , Remoção de Dispositivo , Migração de Corpo Estranho , Dispositivo para Oclusão Septal , Humanos , Migração de Corpo Estranho/etiologia , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/terapia , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/fisiopatologia , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/efeitos adversos , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/terapia , Fibrilação Atrial/diagnóstico , Resultado do Tratamento , Ventrículos do Coração/diagnóstico por imagem , Masculino , Idoso , Desenho de Equipamento , FemininoRESUMO
BACKGROUND AND AIMS: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing transcatheter aortic valve intervention (TAVI). METHODS: We followed the European Society of Cardiology (ESC) methodology for the development of QIs. Key domains were identified by constructing a conceptual framework for the delivery of TAVI care. A list of candidate QIs were developed by conducting a systematic review of the literature. A modified Delphi method was then used to select the final set of QIs. Finally, we mapped the QIs to the EuroHeart Data Standards for TAVI to ascertain the extent to which the EuroHeart TAVI registry captures information to calculate the QIs. RESULTS: We formed an international group of experts in quality improvement and TAVI, including representatives from the European Association of Percutaneous Cardiovascular Interventions, the European Association of Cardiovascular Imaging and the Association of Cardiovascular Nursing & Allied Professions. In total, 27 QIs were selected across eight domains of TAVI care, comprising 22 main (81%) and five secondary (19%) QIs. Of these, 19/27 (70%) are now being utilised in the EuroHeart TAVI registry. CONCLUSION: We present the 2023 ESC QIs for TAVI, developed using a standard methodology and in collaboration with ESC Associations. The EuroHeart TAVI registry allows calculation of the majority of the QIs, which may be used for benchmarking care and quality improvement initiatives.
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Background: The DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function. Methods: This international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747). Findings: 445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), pnon-inferiority < 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI: -3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09 mm [SD 0.34] versus 0.25 mm [SD 0.39], p = 0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p < 0.001). Interpretation: This is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function. Funding: The study was funded by Elixir Medical.
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Introducción y objetivos: Las oclusiones coronarias crónicas totales (OCT) que afectan a lesiones en bifurcación representan un subconjunto de lesiones difíciles de tratar y poco estudiadas en la literatura. Este estudio analiza la incidencia, la estrategia de tratamiento, los resultados hospitalarios y las complicaciones de la intervención coronaria percutánea (ICP) de las OCT en bifurcación (OCT-BIF). Métodos: Se evaluaron los datos de 607 pacientes consecutivos con OCT tratados en el Institut Cardiovasculaire Paris Sud (ICPS), Massy, Francia, entre enero de 2015 y febrero de 2020. Se compararon 2 subgrupos de pacientes (OCT-BIF, n=245; OCT-no BIF, n=362) en cuanto a estrategia de procedimiento, resultado hospitalario y tasa de complicaciones. Resultados: La media de edad de los pacientes fue 63,2±10,6 años; el 79,6% eran varones. Las lesiones en bifurcación estuvieron implicadas en el 40,4% de los procedimientos. La complejidad general de la lesión fue alta (valores medios de las puntuaciones J-CTO, 2,30 ± 1,16, y PROGRESS CTO, 1,37±0,94). El stent condicional fue la estrategia preferida para el tratamiento de las lesiones en bifurcación (93,5%). Los pacientes OCT-BIF presentaban una mayor complejidad de la lesión según la puntuación J-CTO (2,42±1,02 frente a 2,21±1,23 de los pacientes OCT-no BIF; p=0,025) y la puntuación PROGRESS CTO (1,60±0,95 frente a 1,22±0,90 de los pacientes OCT-no BIF; p<0,001). El éxito de la intervención fue del 78,9% y no se vio afectado por la presencia de bifurcación (el 80,4% en el grupo de OCT-BIF y el 77,8% en el grupo de OCT-no BIF; p=0,447) ni por el lugar de la bifurcación (OCT-BIF en segmento proximal, el 76,9%; OCT-no BIF en segmento medio, el 83,8%; OCT-BIF en segmento distal, el 85%; p=0,204). Las tasas de complicaciones fueron similares en ambos grupos...(AU)
Introduction and objectives: Coronary chronic total occlusions (CTO) involving bifurcation lesions are a challenging lesion subset that is understudied in the literature. This study analyzed the incidence, procedural strategy, in-hospital outcomes and complications of percutaneous coronary interventions (PCI) for bifurcation-CTO (BIF-CTO). Methods: We assessed data from 607 consecutive CTO patients treated at the Institut Cardiovasculaire Paris Sud (ICPS), Massy, France between January 2015 and February 2020. Procedural strategy, in-hospital outcomes and complication rates were compared between 2 patient subgroups: BIF-CTO (n=245=and nonBIF-CTO (n=362). Results: The mean patient age was 63.2±10.6 years; 79.6% were men. Bifurcation lesions were involved in 40.4% of the procedures. Overall lesion complexity was high (mean J-CTO score 2.30±1.16, mean PROGRESS-CTO score 1.37±0.94). The preferred bifurcation treatment strategy was a provisional approach (93.5%). BIF-CTO patients presented with higher lesion complexity, as assessed by J-CTO score (2.42±1.02 vs 2.21±1.23 in the nonBIF-CTO patients, P=.025) and PROGRESS-CTO score (1.60±0.95 vs 1.22±0.90 in the nonBIF-CTO patients, P<.001). Procedural success was 78.9% and was not affected by the presence of bifurcation lesions (80.4% in the BIF-CTO group, 77.8% in the nonBIF-CTO-CTO group, P=.447) or the bifurcation site (proximal BIF-CTO 76.9%, midBIF-CTO 83.8%, distal BIF-CTO 85%, P=.204). Complication rates were similar in BIF-CTO and nonBIF-CTO. Conclusions: The incidence of bifurcation lesions is high in contemporary CTO PCI. Patients with BIF-CTO present with higher lesion complexity, with no impact on procedural success or complication rates when the predominant strategy is provisional stenting.(AU)
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Humanos , Masculino , Feminino , Oclusão Coronária/complicações , Resultado do Tratamento , Incidência , Intervenção Coronária Percutânea/estatística & dados numéricos , Stents , Doenças Cardiovasculares , França/epidemiologia , Estudos Retrospectivos , Oclusão Coronária/terapiaRESUMO
Background: A steep rise in the use of transcatheter aortic valve implantation (TAVI) for the management of symptomatic severe aortic stenosis occurred. Minimalist TAVI procedures and streamlined patient pathways within experienced Heart Valve Centres are designed to overcome the challenges of ever-increasing procedural volume. Aims: The 2022 European TAVI Pathway Survey aims to describe contemporary TAVI practice across Europe. Materials and methods: Between October and December 2022, TAVI operators from 32 European countries were invited to complete an online questionnaire regarding their current practice. Results: Responses were available from 147 TAVI centres in 26 countries. In 2021, the participating centres performed a total number of 27,223 TAVI procedures, with a mean of 185 TAVI cases per centre (median 138; IQR 77-194). Treatment strategies are usually (87%) discussed at a dedicated Heart Team meeting. Transfemoral TAVI is performed with local anaesthesia only (33%), with associated conscious sedation (60%), or under general anaesthesia (7%). Primary vascular access is percutaneous transfemoral (99%) with secondary radial access (52%). After uncomplicated TAVI, patients are transferred to a high-, medium-, or low-care unit in 28%, 52%, and 20% of cases, respectively. Time to discharge is day 1 (12%), day 2 (31%), day 3 (29%), or day 4 or more (28%). Conclusion: Reported adoption of minimalist TAVI techniques is common among European TAVI centres, but rates of next-day discharge remain low. This survey highlights the significant progress made in refining TAVI treatment and pathways in recent years and identifies possible areas for further improvement.
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INTRODUCTION AND OBJECTIVES: Coronary chronic total occlusions (CTO) involving bifurcation lesions are a challenging lesion subset that is understudied in the literature. This study analyzed the incidence, procedural strategy, in-hospital outcomes and complications of percutaneous coronary interventions (PCI) for bifurcation-CTO (BIF-CTO). METHODS: We assessed data from 607 consecutive CTO patients treated at the Institut Cardiovasculaire Paris Sud (ICPS), Massy, France between January 2015 and February 2020. Procedural strategy, in-hospital outcomes and complication rates were compared between 2 patient subgroups: BIF-CTO (n=245=and non-BIF-CTO (n=362). RESULTS: The mean patient age was 63.2±10.6 years; 79.6% were men. Bifurcation lesions were involved in 40.4% of the procedures. Overall lesion complexity was high (mean J-CTO score 2.30±1.16, mean PROGRESS-CTO score 1.37±0.94). The preferred bifurcation treatment strategy was a provisional approach (93.5%). BIF-CTO patients presented with higher lesion complexity, as assessed by J-CTO score (2.42±1.02 vs 2.21±1.23 in the non-BIF-CTO patients, P=.025) and PROGRESS-CTO score (1.60±0.95 vs 1.22±0.90 in the non-BIF-CTO patients, P<.001). Procedural success was 78.9% and was not affected by the presence of bifurcation lesions (80.4% in the BIF-CTO group, 77.8% in the non-BIF-CTO-CTO group, P=.447) or the bifurcation site (proximal BIF-CTO 76.9%, mid-BIF-CTO 83.8%, distal BIF-CTO 85%, P=.204). Complication rates were similar in BIF-CTO and non-BIF-CTO. CONCLUSIONS: The incidence of bifurcation lesions is high in contemporary CTO PCI. Patients with BIF-CTO present with higher lesion complexity, with no impact on procedural success or complication rates when the predominant strategy is provisional stenting.
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Oclusão Coronária , Intervenção Coronária Percutânea , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Feminino , Intervenção Coronária Percutânea/métodos , Resultado do Tratamento , Oclusão Coronária/diagnóstico , Oclusão Coronária/epidemiologia , Oclusão Coronária/cirurgia , Incidência , Stents , Doença Crônica , Angiografia Coronária/métodos , Fatores de Risco , Sistema de RegistrosRESUMO
The European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Heart Rhythm Association (EHRA), the European Association of Cardiovascular Imaging (EACVI), the European Society of Cardiology (ESC) Regulatory Affairs Committee and Women as One support continuous review and improvement, not only in the practice of assuring patients a high quality of care but also in providing health professionals with support documents to help them in their career and enhance gender equity. Recent surveys have revealed that radiation exposure is commonly reported as the primary barrier for women pursuing a career in interventional cardiology or cardiac electrophysiology (EP). The fear of foetal exposure to radiation during pregnancy may lead to a prolonged interruption in their career. Accordingly, this joint statement aims to provide a clear statement on radiation risk and the existing data on the experience of radiation-exposed cardiologists who continue to work in catheterisation laboratories (cath labs) throughout their pregnancies. In order to reduce the barrier preventing women from accessing these careers, increased knowledge in the community is warranted. Finally, by going beyond simple observations and review of the literature, our document suggests proposals for improving workplace safety and for encouraging equity.
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Cardiologia , Proteção Radiológica , Gravidez , Humanos , Feminino , Laboratórios , Cateterismo , Atenção à SaúdeRESUMO
BACKGROUND/PURPOSE: Conventional stents "cage" the coronary arteries, impairing vascular function and physiology. The DynamX Bioadaptor is a cobaltchromium platform with uncaging elements, designed to improve arterial pulsatility, vasomotion, compliance, and positive adaptive remodelling which may attenuate late clinical events associated with the caging of arteries through conventional stents. We present the first 24-month outcomes of this device. METHODS/MATERIALS: This European multicenter study enrolled 50 patients with 50 de novo lesions treated with the DynamX Bioadaptor. Clinical follow-up is scheduled until 36 months and imaging follow-up was performed at 9-12 months. RESULTS: 24-month endpoints were target lesion failure (2 cardiac deaths), myocardial infarction (1 non-target vessel myocardial infarction), target vessel revascularisation (n = 0), and definite or probable device thrombosis (n = 0). No endpoint events occurred beyond 9 months. Paired intravascular ultrasound analysis of 18 patients from a single center revealed a 0.22 mm2 increase in device cross-sectional area at 9-12 months. Pulsatility analysis showed an increase of in-device lumen area change by 46 % compared to the caged post-procedural configuration, reducing the compliance mismatch between the treated and not-treated vessel segments (segmental compliance). Likewise, vasomotion in response to nitroglycerin improved from 0.03mm2 post-procedure to 0.17mm2 at follow-up. CONCLUSIONS: 24-month clinical data demonstrate promising safety and efficacy of the DynamX Bioadaptor. Imaging data confirmed its unique capacity to improve arterial pulsatility, vasomotion, compliance and positive adaptive remodelling after "uncaging" which might have led to the promising clinical outcomes that need to be confirmed in larger studies.
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Doença da Artéria Coronariana , Infarto do Miocárdio , Intervenção Coronária Percutânea , Trombose , Humanos , Seguimentos , Implantes Absorvíveis , Resultado do Tratamento , Infarto do Miocárdio/etiologia , Trombose/etiologia , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/efeitos adversosAssuntos
Injúria Renal Aguda , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/diagnóstico , Cateterismo Cardíaco/efeitos adversos , Humanos , Resultado do Tratamento , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/cirurgiaRESUMO
BACKGROUND: Noninvasive functional imaging is often performed in patients with obstructive coronary artery disease (CAD) on coronary computed tomography angiography (CTA). However, the prognostic value of stress cardiac magnetic resonance (CMR) is unknown in patients with coronary stenosis of unknown significance on coronary CTA. OBJECTIVES: This study assessed the prognostic value of stress CMR in symptomatic patients with obstructive CAD of unknown significance on coronary CTA. METHODS: Between 2008 and 2020, consecutive symptomatic patients without known CAD referred for coronary CTA were screened. Patients with obstructive CAD (at least 1 ≥50% stenosis on coronary CTA) were further referred for stress CMR and followed for the occurrence of major adverse cardiovascular events (MACEs), defined as cardiovascular death or nonfatal myocardial infarction. RESULTS: Of 2,210 patients who completed CMR, 2,038 (46.5% men; mean age 69.8 ± 12.2 years) completed follow-up (median 6.8 years; IQR: 5.9-9.2 years); 281 experienced a MACE (13.8%). Inducible ischemia and late gadolinium enhancement (LGE) were significantly associated with MACEs (HR: 4.51 [95% CI: 3.55-5.74], and HR: 3.32 [95% CI: 2.55-4.32], respectively; P < 0.001). In multivariable Cox regression, the number of segments with >70% stenosis, with noncalcified plaques and the number of vessels with obstructive CAD were prognosticators (P < 0.001). The presence of inducible ischemia and LGE were independent predictors of MACEs (HR: 3.97 [95% CI: 3.43-5.13]; HR: 2.30 [95% CI: 1.52-3.33]; P < 0.001). After adjustment, stress CMR showed the best improvement in model discrimination and reclassification above traditional risk factors and coronary CTA (C-statistic improvement: 0.04; net reclassification improvement = 0.421; integrative discrimination index = 0.047). CONCLUSIONS: In symptomatic patients with obstructive CAD of unknown significance on coronary CTA, stress CMR had incremental prognostic value to predict MACEs.
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Doença da Artéria Coronariana , Estenose Coronária , Idoso , Idoso de 80 Anos ou mais , Constrição Patológica/complicações , Meios de Contraste , Angiografia Coronária/métodos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/patologia , Estenose Coronária/complicações , Estenose Coronária/diagnóstico por imagem , Feminino , Gadolínio , Humanos , Espectroscopia de Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Medição de Risco , Fatores de RiscoRESUMO
INTRODUCTION: Long drug-eluting stents may limit the issue of overlapping multiple stents when treating long coronary lesions. AIM: The aim of the study was to assess the safety and efficacy of the 48 mm Xience Xpedition everolimus-eluting stent (48mm-EES) for the treatment of long coronary lesions, in an all-comer population. METHODS: Patients receiving at least one 48mm-EES were prospectively included from March 2014 to December 2018. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 1 year. The main secondary endpoint was the patient-oriented composite endpoint (POCE) defined as a composite of death, stroke, myocardial infarction, and reintervention. RESULTS: A total of 268 patients with 276 long coronary lesions, including 94 chronic total occlusions (CTO), were successfully treated using at least one 48mm-EES. The total stent length per lesion was 66 ± 22 mm. A single 48mm-EES was suitable to successfully treat the target lesion in 48% of cases (60% for non-CTO lesions). One-year follow-up rate was 96.3%. TLF occurred in 13 patients (5.3%), mainly driven by TLR (4.1%). Two cardiac death occurred (0.7%). POCE occurred in 30 patients (11.6%) mainly driven by repeat revascularization (9.7%). Definite stent thrombosis was observed in two patients (0.7%). No difference was observed in one-year outcomes between single 48mm-EES and multiple stents implantation as well as between CTO and non-CTO lesions. CONCLUSION: The 48mm-EES is safe and effective to treat long coronary lesions, including CTOs, and provides attractive cost-effectiveness by limiting multiple stenting.
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Fármacos Cardiovasculares , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Fármacos Cardiovasculares/efeitos adversos , Morte , Everolimo/efeitos adversos , Humanos , Estimativa de Kaplan-Meier , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Fatores de Risco , Sirolimo , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The Academic Research Consortium - High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding. AIMS: We sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR). METHODS: Patients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients. RESULTS: Of 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: -2.72 to 6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications. CONCLUSIONS: The ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.
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Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Medição de Risco , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to identify independent angiographic predictors of collateral channel (CC) tracking success, microcatheter tracking failure, and complications in chronic total occlusion (CTO) retrograde approach. We also developed a "crossability score," comparing its predictive performance with pre-existing scores. BACKGROUND: The retrograde approach was introduced for recanalization of challenging CTOs. The passage of guidewires through CCs is a key step of the procedure. Two scoring systems have been recently developed to predict CC tracking success. METHODS: A total of 180 patients and 297 CCs were retrospectively analyzed in an unselected retrograde CTO population. RESULTS: Guidewire crossing was successful in 203 collaterals (68.3%). The only independent predictor of successful CC tracking was Werner score 2. Conversely, Werner score 0, severe tortuosity (>180°), acute exit angle (<90°), and length of collateral were independently associated with tracking failure. We assigned a score to each "significant" variable to create a model that showed a greater accuracy than pre-existing scores (area under the receiver-operator characteristics curve, 0.72 vs 0.65 and 0.69). Moreover, CC length was also associated with microcatheter tracking failure and complications. CONCLUSIONS: Werner score 0, tortuosity, acute exit angle, and CC length were independently associated with CC tracking failure, whereas Werner score 2 was a predictor of crossing success. Length of CC is associated with a higher rate of microcatheter crossing failure and complications. We combined these findings into the R-ICPS score, which showed an adequate accuracy for collateral crossing prediction.
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Oclusão Coronária , Intervenção Coronária Percutânea , Circulação Colateral , Angiografia Coronária/métodos , Oclusão Coronária/diagnóstico , Oclusão Coronária/cirurgia , Humanos , Intervenção Coronária Percutânea/métodos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Background: Epidemiological characteristics and prognostic profiles of patients with newly diagnosed coronary artery disease (CAD) are heterogeneous. Therefore, providing individualized cardiovascular (CV) risk stratification and tailored prevention is crucial. Objective: Phenotypic unsupervised clustering integrating clinical, coronary computed tomography angiography (CCTA), and cardiac magnetic resonance (CMR) data were used to unveil pathophysiological differences between subgroups of patients with newly diagnosed CAD. Materials and Methods: Between 2008 and 2020, consecutive patients with newly diagnosed obstructive CAD on CCTA and further referred for vasodilator stress CMR were followed for the occurrence of major adverse cardiovascular events (MACE), defined by cardiovascular death or non-fatal myocardial infarction. For this exploratory work, a cluster analysis was performed on clinical, CCTA, and CMR variables, and associations between phenogroups and outcomes were assessed. Results: Among 2,210 patients who underwent both CCTA and CMR, 2,015 (46% men, mean 70 ± 12 years) completed follow-up [median 6.8 (IQR 5.9-9.2) years], in which 277 experienced a MACE (13.7%). Three mutually exclusive and clinically distinct phenogroups (PG) were identified based upon unsupervised hierarchical clustering of principal components: (PG1) CAD in elderly patients with few traditional risk factors; (PG2) women with metabolic syndrome, calcified plaques on CCTA, and preserved left ventricular ejection fraction (LVEF); (PG3) younger men smokers with proximal non-calcified plaques on CCTA, myocardial scar, and reduced LVEF. Using survival analysis, the occurrence of MACE, cardiovascular mortality, and all-cause mortality (all p < 0.001) differed among the three PG, in which PG3 had the worse prognosis. In each PG, inducible ischemia was associated with MACE [PG1, Hazards Ratio (HR) = 3.09, 95% CI, 1.70-5.62; PG2, HR = 3.62, 95% CI, 2.31-5.7; PG3, HR = 3.55, 95% CI, 2.3-5.49; all p < 0.001]. The study presented some key limitations that may impact generalizability. Conclusions: Cluster analysis of clinical, CCTA, and CMR variables identified three phenogroups of patients with newly diagnosed CAD that were associated with distinct clinical and prognostic profiles. Inducible ischemia assessed by stress CMR remained associated with the occurrence of MACE within each phenogroup. Whether automated unsupervised phenogrouping of CAD patients may improve clinical decision-making should be further explored in prospective studies.
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BACKGROUND: Vasospastic angina is an infrequent underlying cause of angina and is under-diagnosed. Ergonovine provocation tests can be performed via intravenous or intracoronary injections. Although the safety profile of intracoronary injection has been well documented, no study has yet compared the intracoronary and intravenous injections regarding the positivity rate of the test. AIMS: This study sought to compare the positivity rate of intravenous versus intracoronary injection of ergonovine in the diagnosis of vasospastic angina. METHODS: Between January 2010 and February 2018, 427 patients with suspected vasospastic angina underwent an ergonovine provocation test in 2 tertiary hospitals in France and were retrospectively included in this study. Injection was performed via the intravenous or the intracoronary route. The primary endpoint was the positivity rate of the test. Propensity score matching was used to account for confounding factors. RESULTS: 427 patients were included in the study. Mean age was 60.3 (+/- 12.4) years. There were 247 (58%) females and 97 (23%) smokers. The intracoronary route was used in 199 (47%) patients. The indication for the test was acute coronary syndrome for 121 (28%). No rhythmic complications or deaths were reported. After propensity-matching, the baseline characteristics of the 2 groups (148 patients in each) were comparable. The positivity rate was 24% in the intracoronary group and 9% in the intravenous group (OR [95%CI]: 3.2 [1.6, 6.4]). CONCLUSIONS: Intracoronary injection of ergonovine is safe and associated with a positivity rate of the test three times higher compared to intravenous injection.
Assuntos
Vasoespasmo Coronário , Metilergonovina , Angiografia Coronária , Vasos Coronários/diagnóstico por imagem , Ergonovina , Feminino , Humanos , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
OBJECTIVES: The aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO). BACKGROUND: CAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication. METHODS: In the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR. RESULTS: To date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p < 0.01), cardiogenic shock (52.0% vs. 2.9%; p < 0.01), and resuscitation (44.0% vs. 2.9%; p < 0.01) all occurred more frequently in patients with established CAO compared with those with impending CAO. The absence of upfront coronary protection was the sole independent risk factor for the combined endpoint of death, cardiogenic shock, or myocardial infarction. During a median follow-up time of 612 days (interquartile range: 405 to 842 days), 2 cases of stent failure were reported (1 in-stent restenosis, 1 possible late stent thrombosis) after 157 and 374 days. CONCLUSIONS: Chimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection.
Assuntos
Valva Aórtica/cirurgia , Oclusão Coronária/terapia , Próteses Valvulares Cardíacas , Intervenção Coronária Percutânea/instrumentação , Stents , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/etiologia , Oclusão Coronária/mortalidade , Reestenose Coronária/etiologia , Trombose Coronária/etiologia , Europa (Continente) , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Oriente Médio , América do Norte , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
OBJECTIVES: The United Kingdom and Ireland Implanters' registry is a multicenter registry which reports on real-world experience with new transcatheter heart valves. BACKGROUND: The Evolut PRO (Medtronic, Minneapolis, MN) transcatheter aortic valve is a self-expanding transcatheter aortic valve with an outer pericardial wrap, designed to minimize paravalvular regurgitation. METHODS: Between July 2017 and December 2018, clinical, procedural, and 30-day outcome data were prospectively collected from all patients receiving the Evolut PRO valve across nine participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2 (VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 317 patients underwent implantation. Mean age was 81.8 ± 6.4 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.5 ± 1.8%. Iliofemoral access was used in 99.1% of patients. Device success was 91.2%. Mean gradient was 7.6 ± 4.7 mmHg and effective orifice area 1.9 ± 0.7 cm2 . The incidence of moderate paravalvular regurgitation was 1.7% and there was no severe paravalvular regurgitation. A new permanent pacemaker was implanted in 17.8% of patients without a pacemaker at baseline. Early safety was demonstrated in 92.7%. At 30 days, all-cause mortality was 0.6%, stroke 3.8%, and major vascular complication 2.8%. CONCLUSIONS: Real-world experience of the Evolut PRO transcatheter aortic valve demonstrated favorable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Próteses Valvulares Cardíacas , Pericárdio/transplante , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Feminino , Humanos , Irlanda , Masculino , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Reino UnidoRESUMO
OBJECTIVES: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. BACKGROUND: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. METHODS: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. RESULTS: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. CONCLUSIONS: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.