RESUMO
BACKGROUND: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. METHODS: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. RESULTS: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). CONCLUSIONS: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01070771.
Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Estenose Coronária/diagnóstico , Humanos , Qualidade de Vida , Medicina Estatal , Resultado do TratamentoRESUMO
BACKGROUND: Patients with prior coronary artery bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported. METHODS: PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI >48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale). CONCLUSION: PROCTOR is the first randomized trial comparing an invasive strategy of native coronary artery PCI with SVG PCI in post-CABG patients presenting with SVG failure.
Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Estudos Prospectivos , Intervenção Coronária Percutânea/efeitos adversos , Veia Safena/transplante , Qualidade de Vida , Resultado do Tratamento , Stents Farmacológicos/efeitos adversos , Canadá , Ponte de Artéria Coronária/efeitos adversos , Infarto do Miocárdio/etiologiaRESUMO
AIMS: To describe the utility and safety of intravascular lithotripsy (IVL) in the setting of primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). METHODS AND RESULTS: We performed a retrospective analysis, across six UK sites of all patients in whom IVL was used for coronary calcium modification of the culprit lesion during primary PCI for STEMI. The 72 patients were included. IVL was used in de-novo culprit lesions in 57 (79%) of cases and culprit in-stent restenoses in 11 (15%) of cases. In four cases (6%) it was used in a newly deployed stent when this was under-expanded due to inadequate calcium modification. Of the 30 cases in which intracoronary imaging was available for stent analysis, the average stent expansion was 104%. Intra-procedural stent thrombosis occurred in one case (1%), and no-reflow in three cases (4%). The 30 day MACE rates were 18%. CONCLUSION: IVL appears to be feasible and safe for use in the treatment of calcific coronary artery disease in the setting of STEMI.
Assuntos
Litotripsia , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Calcificação Vascular , Humanos , Litotripsia/efeitos adversos , Litotripsia/métodos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapiaRESUMO
Improved technical equipment, dissemination of best practices, and the importance of complete coronary revascularization have led to a renewed interest in coronary chronic total occlusion (CTO) PCI. In particular, the hybrid algorithm has been associated with increasing procedural success rates in the US. However, the hybrid algorithm only covers overarching strategies in the overall approach to these lesions. Several technical challenges can occur during execution of these approaches, each of which has several potential solutions. A systematic or algorithmic approach to dealing with these challenges could contribute to improved procedural efficiency and higher procedural success. While there have been isolated attempts in the past to codify approaches to each of these situations, there has not been a contemporary, comprehensive review of the potential solutions to these problems. We present 10 common problems encountered during CTO PCI and a consensus hierarchical approach to them.
Assuntos
Algoritmos , Oclusão Coronária/terapia , Procedimentos Clínicos , Intervenção Coronária Percutânea/efeitos adversos , Doença Crônica , Tomada de Decisão Clínica , Consenso , Angiografia Coronária , Oclusão Coronária/diagnóstico por imagem , Humanos , Intervenção Coronária Percutânea/instrumentação , Resultado do TratamentoRESUMO
BACKGROUND: The benefits of chronic coronary total occlusion (CTO) percutaneous coronary intervention (PCI) are being questioned. The aim of this study was to assess the effects of CTO PCI on absolute myocardial perfusion, as compared with PCI of hemodynamically significant non-CTO lesions. METHODS: Consecutive patients with a preserved left ventricular ejection fraction (≥50%) and a CTO or non-CTO lesion, in whom [15 O]H2 O positron emission tomography was performed prior and after successful PCI, were included. Change in quantitative (hyperemic) myocardial blood flow (MBF), coronary flow reserve (CFR) and perfusion defect size (in myocardial segments) were compared between CTOs and non-CTO lesions. RESULTS: In total 92 patients with a CTO and 31 patients with a non-CTO lesion were included. CTOs induced larger perfusion defect sizes (4.51 ± 1.69 vs. 3.23 ± 2.38 segments, P < 0.01) with lower hyperemic MBF (1.30 ± 0.37 vs. 1.58 ± 0.62 mL·min-1 ·g-1 , P < 0.01) and similarly impaired CFR (1.66 ± 0.75 vs. 1.89 ± 0.77, P = 0.17) compared with non-CTO lesions. After PCI both hyperemic MBF and CFR increased similarly between groups (P = 0.57 and 0.35) to normal ranges with higher hyperemic MBF values in non-CTO compared with CTO (2.89 ± 0.94 vs. 2.48 ± 0.73 mL·min-1 ·g-1 , P = 0.03). Perfusion defect sizes decreased similarly after CTO PCI and non-CTO PCI (P = 0.14), leading to small residual defect sizes in both groups (1.15 ± 1.44 vs. 0.61 ± 1.45 segments, P = 0.054). CONCLUSIONS: Myocardial perfusion findings are slightly more hampered in patients with a CTO before and after PCI. Percutaneous revascularization of CTOs, however, improves absolute myocardial perfusion similarly to PCI of hemodynamically significant non-CTO lesions, leading to satisfying results.
Assuntos
Oclusão Coronária/terapia , Vasos Coronários/diagnóstico por imagem , Reserva Fracionada de Fluxo Miocárdico , Hemodinâmica , Imagem de Perfusão do Miocárdio , Intervenção Coronária Percutânea , Tomografia por Emissão de Pósitrons , Idoso , Doença Crônica , Angiografia Coronária , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/fisiopatologia , Vasos Coronários/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Estudos Prospectivos , Recuperação de Função Fisiológica , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: A retrospective study was performed to investigate if the generation of X-ray system used was an independent factor for radiation dose in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: PCI procedures for CTOs are known to be associated with higher doses of radiation. The authors suspected progressive reductions in radiation doses for CTO PCI as newer X-ray systems were introduced into clinical practice. METHODS: Procedures performed over a five-year period by three interventional cardiologists were retrospectively reviewed. Five different X-ray systems were used across three hospital sites. These included: Axiom Artis and Coroskop HIP (both Siemens), Innova (GE), Allura Xper FD 10, and Allura Clarity FD 10 (both Philips). Procedural and demographic data including body mass index (BMI; kg/m2 ), fluoroscopy time (min), and dose area product (DAP; cGycm2 ) were collated for each procedure. Statistical analysis was performed to compare the influence each X-ray system would have on DAP values after BMI and fluoroscopy time were controlled for. RESULTS: In total, 860 procedures were analyzed. Mean fluoroscopy time was 40.00 ± 19.99 min, mean BMI was 29.90 ± 5.13 kg/m2 , mean DAP 11,980 ± 7,947 cGycm2 . Log values of DAP were used to normalize results in a general linear model. A significant statistical difference in DAP between X-ray systems was demonstrated after fluoroscopy time and BMI were controlled for (P ≤ 0.001). CONCLUSION: There is a significant impact on DAP values resulting from the generation of X-ray system used, measured during PCI for CTOs, with the most modern systems producing the lowest radiation doses.
Assuntos
Cateterismo Cardíaco/instrumentação , Angiografia Coronária/instrumentação , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/terapia , Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea/instrumentação , Doses de Radiação , Exposição à Radiação , Radiografia Intervencionista/instrumentação , Cateterismo Cardíaco/efeitos adversos , Doença Crônica , Angiografia Coronária/efeitos adversos , Desenho de Equipamento , Humanos , Irlanda do Norte , Intervenção Coronária Percutânea/efeitos adversos , Exposição à Radiação/efeitos adversos , Exposição à Radiação/prevenção & controle , Radiografia Intervencionista/efeitos adversos , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Escócia , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of the Hybrid Video Registry (HVR) is to assess the acute safety and efficacy of the Hybrid Approach in comparison to other contemporary methods of CTO-PCI. BACKGROUND: Recently, multiple techniques in Percutaneous Coronary Intervention (PCI) for coronary Chronic Total Occlusions (CTO) have been synthesized into a method referred to as the "Hybrid Approach". METHODS: About 194 video-taped timed live cases from CTO-PCI training workshops were analyzed by independent data abstractors and compared to three contemporary CTO-PCI registries stratified by case complexity based on the J-CTO score. RESULTS: Overall procedural success was 95% of all cases attempted with an excellent safety profile. In the most complex lesion subset, which made up 45% of all HVR cases, success was 92.8%, which was significantly higher than either the Royal Bromptom (78.9%), or Japanese-CTO (73.3%) registries, P = 0.04 Hybrid vs. Royal Brompton, P = 0.006 Hybrid vs. Japanese-CTO). The Hybrid Approach was also associated with shorter procedure times and lower contrast utilization. CONCLUSIONS: In a real world angiographic registry of complex CTOs, the Hybrid Approach to CTO-PCI is safe, and may be superior to other contemporary approaches to CTO intervention with respect to procedural success and efficiency among a diverse group of operators and lesion complexity. © 2017 Wiley Periodicals, Inc.
Assuntos
Oclusão Coronária/cirurgia , Intervenção Coronária Percutânea/métodos , Gravação em Vídeo , Angiografia Coronária , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/fisiopatologia , Humanos , Japão , Duração da Cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Complicações Pós-Operatórias/etiologia , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Reino Unido , Estados UnidosRESUMO
BACKGROUND: Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease. METHODS: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651. FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke. INTERPRETATION: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease. FUNDING: Biosensors, Aarhus University Hospital, and participating sites.
Assuntos
Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea/métodos , Idoso , Doença da Artéria Coronariana/mortalidade , Stents Farmacológicos/normas , Europa (Continente) , Feminino , Humanos , Masculino , Infarto do Miocárdio , Acidente Vascular Cerebral , Resultado do TratamentoRESUMO
BACKGROUND: Chronic total occlusion (CTO) revascularisation has a crucial role in contemporary percutaneous coronary intervention (PCI). Procedural success is influenced by disease complexity, calcific burden and patient characteristics but has substantially improved with the implementation of novel hybrid strategies. However, vascular-access related complications remain a cause of morbidity and mortality. This study aimed to assess the effectiveness of fluoroscopic-guided femoral arterial puncture to minimise this risk during CTO PCI. METHODS: Standardised data were retrospectively collected from four high-volume UK CTO centres between September 2011 and November 2013. Demographic, clinical and procedural data (vascular access site, sheath size, anticoagulation use) was collated. The anatomical location of the femoral puncture in relation to the femoral bifurcation, femoral head position and inferior epigastric artery were recorded. Adverse events related to vascular access were documented. RESULTS: A total of 528 patients were included (676 femoral punctures) with the majority being male (n=432, 81.8%). Large sheaths (8F) were used in 81.2% of cases. Fluoroscopy-enabled punctures were made in the 'safe zone' in over > 93% of cases. Vascular closure devices (VCD) were used in 88.3% of cases. The adverse event rate per puncture was 0.89%. CONCLUSIONS: This study demonstrates an extremely low incidence of vascular-access complications in CTO PCI when fluoroscopic guidance is used to obtain femoral arterial access by default radial operators.
Assuntos
Artéria Femoral , Punções/efeitos adversos , Punções/métodos , Adulto , Assistência ao Convalescente , Idoso , Idoso de 80 Anos ou mais , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Fluoroscopia , Fidelidade a Diretrizes , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Reino UnidoRESUMO
OBJECTIVES: To investigate the outcomes of a cohort of acute and elective percutaneous coronary intervention (PCI) patients who were discharged home 6 hours postprocedure. BACKGROUND: Contemporary PCI is safe with a low rate of acute complications. It is well established as a day procedure in elective cases; however, data are lacking in acute cases. METHODS: We describe a prospective observational audit of routine clinical practice in the 3 PCI centers in Northern Ireland. Patients were selected for same-day discharge after 6 hours of post-PCI observation. Both elective and acute coronary syndrome (ACS) cases were included. Criteria for same-day discharge were based on the technical result of the procedure rather than lesion complexity or clinical presentation. Radial access was preferred but not mandatory. Patients were contacted directly to assess for 30-day major adverse cardiovascular events (MACE). Reported events were corroborated with the general practitioner or hospital notes. RESULTS: A total of 1,059 patients were selected for same-day discharge with 30-day follow-up available for all cases. Of these, 766 (72.3%) were elective and 293 (27.7%) were ACS patients. Radial access was almost universal (98%). A total of 1,224 lesions were stented, of which 432 (40.8%) were high risk (highest risk lesion in each case by AHA/ACC classification). MACE rate at 30 days was 0.85% with a sub-acute stent thrombosis rate of 0.4%. There were no MACE events from discharge to 24 hours. CONCLUSIONS: Selected acute and elective patients with a range of lesion complexity and risk can be discharged safely home early after PCI.
Assuntos
Síndrome Coronariana Aguda/cirurgia , Tempo de Internação , Auditoria Médica , Intervenção Coronária Percutânea , Adulto , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
PURPOSE: The aim of this study was to provide 2-year clinical outcomes for patients with Medina 1,1,1 bifurcation lesions treated with a culotte technique, comparing Synergy and Xience drug eluting stent (DES) platforms. A sub-group analysis of 9-month Optical Coherence Tomography (OCT) was performed to assess stent healing. METHODS: A total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurcations were carried out on OCT images taken at 9-month follow-up. RESULTS: After 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all patients by 2 years. OCT analysis found smaller stent and lumen areas in patients treated with Synergy stents. There was a higher proportion of malapposed struts in patients treated with Xience stents. CONCLUSIONS: The first report of the CELTIC bifurcation study demonstrated a low MACCE rate after 9 months. There was little accrual of events after this timepoint. There was no difference in clinical outcomes between the platforms tested. OCT analysis demonstrated excellent healing of both platforms.
Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Everolimo/efeitos adversos , Seguimentos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Desenho de Prótese , Sirolimo/efeitos adversos , Stents , Tomografia de Coerência Óptica , Resultado do TratamentoRESUMO
BACKGROUND: Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). AIMS: The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. METHODS: This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. RESULTS: Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). CONCLUSIONS: In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.
Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Implantes Absorvíveis , Cromo , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Everolimo/uso terapêutico , Humanos , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Platina , Polímeros , Resultado do TratamentoRESUMO
A 46-year-old man with type 1 diabetes underwent percutaneous coronary intervention with bioresorbable scaffold implantation for a long segment of physiologically significant left anterior descending coronary artery disease. The procedure was complicated by longitudinal stent deformation (LSD). The images carry several important educational messages for clinicians. First, as with all stents, LSD is possible in extreme circumstances. Second, as the device is not seen angiographically, it is imperative that optical coherence tomography be performed to confirm LSD. When recognized and treated, the procedural and long-term outcomes are good for this complication.
Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Stents Farmacológicos/efeitos adversos , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Tomografia de Coerência Óptica , Resultado do TratamentoRESUMO
AIMS: Coronary intravascular lithotripsy (IVL) is a novel approach to vascular calcium modification that restores vessel compliance allowing effective lesion expansion. In this study we report the capacity for coronary IVL to precipitate ventricular ectopics ("shocktopics") and asynchronous cardiac pacing. METHODS AND RESULTS: This was a retrospective review of all cases of coronary IVL (n=54) undertaken in the Royal Victoria Hospital, Belfast, between September 2018 and March 2019. The indication for PCI was chronic stable angina in 46.1% (n=26), non-ST-elevation acute coronary syndrome (NSTEACS) in 33.3% (n=18) and ST-elevation myocardial infarction (STEMI) in 18.5% (n=10) of patients. The incidence of coronary IVL-provoked ventricular capture was 77.8% (n=42). Multivariable logistic regression analysis identified heart rate as the only independent predictor of an increased risk of IVL-induced ventricular capture. Patients with a heart rate <65 bpm prior to IVL were sixteen-fold more likely (OR 16.3 [2.4-110.8], p=0.004) to experience events compared to patients with a heart rate ≥65 bpm. "Shocktopic" beat morphology was largely uniform in each patient and appeared dependent on the target lesion location, in keeping with mechano-electric coupling through activation of local stretch-activated cardiomyocyte channels. No adverse clinical events occurred as a result of coronary IVL-induced capture. CONCLUSIONS: Coronary IVL with the Shockwave Medical system is associated with a high incidence of "shocktopics" and asynchronous cardiac pacing that is largely dependent on the resting heart rate. There have been no clinical events associated with this phenomenon, but further systematic evaluation is warranted.
Assuntos
Angina Estável , Litotripsia/métodos , Infarto do Miocárdio sem Supradesnível do Segmento ST , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Idoso , Idoso de 80 Anos ou mais , Angina Estável/diagnóstico , Angina Estável/epidemiologia , Angina Estável/cirurgia , Estudos de Coortes , Comorbidade , Frequência Cardíaca/fisiologia , Humanos , Incidência , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/epidemiologia , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/estatística & dados numéricos , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Resultado do Tratamento , Reino Unido/epidemiologiaRESUMO
BACKGROUND: The aim of this study was to evaluate the safety and efficacy of the novel NovaCross microcatheter system in patients with ischemic heart disease due to coronary chronic total occlusions (CTO). METHODS: A total of 191 subjects between the ages of 25-80 years were recruited in 10 investigational sites. Each subject underwent a percutaneous coronary intervention (PCI) of a CTO lesion using the NovaCross microcatheter, equipped with expandable nitinol scaffolds to enhance guidewire penetration and crossing of the CTO lesion. The primary safety endpoint was procedural major adverse cardiac events [composite of death, myocardial infarction (MI), or urgent target vessel revascularization]. The primary efficacy endpoint was to assess the ability of the NovaCross microcatheter to successfully facilitate the placement of a guidewire beyond a native coronary CTO in the true vessel lumen. After the PCI, subjects remained in hospital until a 12-lead ECG and blood tests for cardiac biomarkers were taken at 3-6 h and 8-16 h post-procedure. RESULTS: No deaths, urgent revascularization, or urgent coronary artery bypass surgery were reported. The reported MI rate according to the protocol definition was 12.3%, and technical success was achieved in 75.3% of the subjects regardless of CTO procedure technique. In 89.2% of the subjects, the NovaCross succeeded in penetrating the proximal CTO cap, and in 25.8% of the subjects, the extendable portion of the NovaCross crossed the full length of the CTO lesion. CONCLUSIONS: The NovaCross met both the primary safety endpoint and the primary efficacy endpoint. We, therefore, conclude that the device is well tolerated, effective, and could be easily adopted by interventional cardiologists.
Assuntos
Ligas/farmacologia , Cateteres Cardíacos , Oclusão Coronária/cirurgia , Vasos Coronários , Intervenção Coronária Percutânea , Materiais Biocompatíveis/farmacologia , Cateteres Cardíacos/efeitos adversos , Cateteres Cardíacos/normas , Angiografia Coronária/métodos , Oclusão Coronária/diagnóstico , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Desenho de Equipamento , Feminino , Humanos , Masculino , Teste de Materiais/métodos , Pessoa de Meia-Idade , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/etiologia , Isquemia Miocárdica/prevenção & controle , Avaliação de Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Stents , Alicerces TeciduaisRESUMO
AIMS: We aimed to investigate the association between the use and findings of IVUS with clinical outcomes in the PCI arm of a randomised trial of LMS PCI. METHODS AND RESULTS: The NOBLE trial randomised patients with LMS disease to treatment by PCI or CABG. Of 603 patients treated by PCI, 435 (72%) underwent post-PCI IVUS assessment, 224 of which were analysed in a core laboratory. At five years, the composite of MACCE was 18.9% if post-PCI IVUS was performed versus 25.0% if it was not performed (p=0.45, after adjustment). Overall repeat revascularisation was not reduced (10.6% vs 16.5%, p=0.11); however, LMS TLR was (5.1% vs 11.6%, p=0.01) if IVUS was used. For comparison of stent expansion, LMS MSA was split into tertiles. We found no significant difference in MACCE, death, myocardial infarction or stent thrombosis between tertiles. There was a significant difference between the lower and upper tertiles for repeat revascularisation (17.6% vs 5.2%, p=0.02) and LMS TLR (12.2% vs 0%, p=0.002). CONCLUSIONS: Post-PCI IVUS assessment and adequate stent expansion are not associated with reduced MACCE; however, there is an association with reduced LMS TLR. The use of intracoronary imaging to prevent stent underexpansion in LMS PCI is likely to improve outcomes.
Assuntos
Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Ultrassonografia de Intervenção/métodos , Vasos Coronários/patologia , Stents Farmacológicos/normas , Humanos , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to assess angiographic, imaging, and clinical outcomes following chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with dissection and re-entry techniques (DART) and subintimal (SI) stenting compared with intimal techniques. BACKGROUND: Reliable procedural success and safety in CTO PCI require the use of DART to treat the most complex patients. Potential concerns regarding the durability of DART with SI stenting still need to be addressed. METHODS: This was a prospective, multicenter, single-arm trial of patients with appropriate indications for CTO PCI. RESULTS: Successful CTO PCI was performed in 210 of 231 patients (91% success). At 1 year, the primary endpoint of target vessel failure (cardiac death, myocardial infarction related to the target vessel, or any ischemia-driven revascularization) occurred in 5.7% of patients, meeting the pre-set performance goal. Major adverse cardiovascular events (all-cause mortality, myocardial infarction, or target vessel revascularization) occurred in 10% at 1 year and 17% by 2 years and was not influenced by DART. Quality-of-life measures significantly improved from baseline to 12 months. There was no difference in intravascular healing assessed using optical coherence tomography at 12 months for patients treated with DART and SI stenting compared with intimal strategies. CONCLUSIONS: Contemporary CTO PCI is associated with medium-term clinical outcomes comparable with those achieved in other complex PCI cohorts and significant improvements in quality of life. The use of DART with SI stenting does not adversely affect intravascular healing at 12 months or medium-term major adverse cardiovascular events. (Consistent CTO Trial; NCT02227771).
Assuntos
Oclusão Coronária/terapia , Vasos Coronários/fisiopatologia , Intervenção Coronária Percutânea , Cicatrização , Implantes Absorvíveis , Doença Crônica , Angiografia Coronária , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/mortalidade , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Qualidade de Vida , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de Intervenção , Reino UnidoRESUMO
[This corrects the article DOI: 10.15420/icr.2018.10.2.].