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Background: While not available for clinical use in the United States, dedicated drug-coated balloons (DCB) are currently under investigation for the management of coronary in-stent restenosis (ISR). Peripheral drug-coated balloons (P-DCB) have been used off-label for coronary ISR. Further data regarding this practice are needed. We aimed to describe outcomes in patients who underwent off-label P-DCB angioplasty for coronary ISR. Methods: We analyzed data on P-DCB angioplasty for coronary ISR at a single high-volume center between April 1, 2015, and December 30, 2017. Demographic and procedural details were collected, with systematic follow-up as clinically indicated. Results: Data from 31 patients treated with P-DCB angioplasty (mean age 68.0 ± 10.7 years) with coronary ISR (17 recurrent and 14 first time) were analyzed. Most patients presented with high-grade angina (81%) or myocardial infarction (13%). Treated ISR lesions were in native coronary arteries (68%), saphenous vein grafts (SVG, 23%), and the left internal mammary artery (10%). Diffuse intrastent ISR was common (69%) with a mean lesion length of 21.7 ± 12.4 mm. No postprocedural myocardial infarction occurred and 1 nonprocedural mortality occurred during index admission. At follow-up (median: 283, interquartile range [IQR]: 354 days), repeat angiography was performed in 19 patients (median: 212, IQR: 188 days), and 11 patients had target lesion recurrent ISR (Kaplan-Meier event-free survival estimate: 44.7%, 95% CI, 26.1%-76.5%). Conclusions: In the absence of availability of dedicated coronary DCB, treatment of coronary ISR using P-DCB angioplasty was feasible, although follow-up demonstrated continued risk for recurrent ISR in this high-risk population.
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BACKGROUND: Cardiorenal syndrome (CRS) complicates 33% of acute decompensated heart failure (ADHF) admissions, and patients with persistent congestion at discharge have high 30-day event rates. OBJECTIVES: The purpose of this study was to evaluate a novel catheter-deployed intra-aortic entrainment pump (IAEP) in patients with ADHF with CRS and persistent congestion. METHODS: A multicenter (n = 14), nonrandomized, single-arm, safety and feasibility study of IAEP therapy was conducted. Within patient changes (post-pre IAEP therapy) in fluid loss, hemodynamics, patient-reported dyspnea, and serum biomarkers were assessed using Wilcoxon signed-rank testing. RESULTS: Of 21 enrolled patients, 18 received Aortix therapy. Mean ± SD patient age was 60.3 ± 7.9 years. The median left ventricular ejection fraction was 22.5% (25th-75th percentile: 10.0%-53.5%); 27.8% had a left ventricular ejection fraction ≥50%. Pre-therapy, patients received 8.7 ± 4.1 days of loop diuretic agents and 44% were on inotropes. Pump therapy averaged 4.6 ± 1.6 days, yielding net fluid losses of 10.7 ± 6.5 L (P < 0.001) and significant (P < 0.01) reductions in central venous pressure (change from baseline: -8.5 mm Hg [25th-75th percentile: -3.5 to -10.0 mm Hg]), pulmonary capillary wedge pressure (-11.0 mm Hg [25th-75th percentile: -5.0 to -14.0 mm Hg]), and serum creatinine (-0.2 mg/dL [25th-75th percentile: -0.1 to -0.5 mg/dL]) with improved estimated glomerular filtration rate (+5.0 mL/min/1.73 m2 [25th-75th percentile: 2.0-9.0 mL/min/1.73 m2]) and patient-reported dyspnea score (+16 [25th-75th percentile: 3-37]). Dyspnea scores, natriuretic peptides, and renal function improvements persisted through 30 days. CONCLUSIONS: This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion using IAEP therapy. These initial promising results provide the basis for future randomized clinical trials of this novel pump. (An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome [The Aortix CRS Pilot Study]; NCT04145635).
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Síndrome Cardiorrenal , Insuficiência Cardíaca , Idoso , Humanos , Pessoa de Meia-Idade , Dispneia/etiologia , Projetos Piloto , Volume Sistólico , Função Ventricular Esquerda , Estudos de ViabilidadeRESUMO
BACKGROUND: Patients with congenitally corrected transposition of the great arteries (ccTGA) often develop tricuspid valve (systemic atrioventricular valve) dysfunction due to right ventricular overload and dilatation, but isolated mitral valve (MV) disease is rarely found. Isolated mitral (subpulmonic atrioventricular valve) interventions, specifically catheter-directed, have not been reported up to date. CASE SUMMARY: A man with ccTGA is evaluated for dyspnoea. Multimodality imaging assessment confirmed severe right-sided MV regurgitation due to prolapse. In light of high surgical risk, a minimally invasive transcatheter MitraClip procedure was pursued. DISCUSSION: To our knowledge, this is the first case of successful MV repair via percutaneous approach using MitraClip in a patient with ccTGA and biventricular failure. Our case illustrates the safety and feasibility of the edge-to-edge procedure in such a rare instance, but also the importance of multimodality imaging (both invasive and non-invasive) and the Heart Team approach when caring for these complex patients.
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BACKGROUND: Connecting the antegrade wire (AW) and the retrograde wire (RW) is a goal of chronic total occlusion (CTO) treatment, but angiographic guidewire location is sometimes misleading. AIMS: The aim of this study was to evaluate the association between intravascular ultrasound (IVUS)-defined AW and RW position and procedural outcomes when treating CTO lesions using the retrograde approach. METHODS: Overall, 191 CTO lesions treated using an IVUS-guided retrograde approach at three centres in Japan, China, and the USA were included. RESULTS: When the AW and RW angiographically overlapped, four wire positions were seen on IVUS: (i) AW within the plaque (AW-intraplaque) and RW-intraplaque in 34%; (ii) AW-intraplaque and RW in the subintimal space (RW-subintima) in 28%; (iii) AW-subintima and RW-subintima in 22%; or (iv) AW-subintima and RW-intraplaque in 16%. The procedure succeeded without repositioning the wire in 89% of AW-intraplaque/RW-intraplaque, 61% of AW-intraplaque/RW-subintima and 57% of AW-subintima/RW-subintima, but only one (3%) AW-subintima/RW-intraplaque. Lesion and procedure complexity and failure/complications were greatest in AW-subintima/RW-intraplaque. CONCLUSIONS: IVUS-identified vascular compartment concordance versus IVUS-identified vascular compartment mismatch leads to higher success rates irrespective of intraplaque or subintimal passage. AW-subintima/RW-intraplaque was associated with the most complex CTO morphology and procedure, and repositioning the wire was almost always necessary. Visual summary. When the antegrade wire is in the subintimal space and the retrograde wire is in the intraplaque, re-wiring is almost always necessary.
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Oclusão Coronária , Placa Aterosclerótica , Doença Crônica , Angiografia Coronária , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/cirurgia , Humanos , Japão , Placa Aterosclerótica/diagnóstico por imagem , Placa Aterosclerótica/cirurgia , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
OBJECTIVES: We sought to assess in-hospital and long-term outcomes of retrograde compared with antegrade-only percutaneous coronary intervention for chronic total occlusion (CTO PCI). BACKGROUND: Procedural and clinical outcomes following retrograde compared with antegrade-only CTO PCI remain unknown. METHODS: Using the core-lab adjudicated OPEN-CTO registry, we compared the outcomes of retrograde to antegrade-only CTO PCI. Primary endpoints included were in-hospital major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, stroke, myocardial infarction [MI], emergency cardiac surgery, or clinically significant perforation) and MACCE at 1-year (all-cause death, MI, stroke, target lesion revascularization, or target vessel reocclusion). RESULTS: Among 885 single CTO procedures from the OPEN-CTO registry, 454 were retrograde and 431 were antegrade-only. Lesion complexity was higher (J-CTO score: 2.7 vs. 1.9; p < .001) and technical success lower (82.4 vs. 94.2%; p < .001) in retrograde compared with antegrade-only procedures. All-cause death was higher in the retrograde group in-hospital (2 vs. 0%; p = .003), but not at 1-year (4.9 vs. 3.3%; p = .29). Compared with antegrade-only procedures, in-hospital MACCE rates (composite of all-cause death, stroke, MI, emergency cardiac surgery, and clinically significant perforation) were higher in the retrograde group (10.8 vs. 3.3%; p < .001) and at 1-year (19.5 vs. 13.9%; p = .03). In sensitivity analyses landmarked at discharge, there was no difference in MACCE rates at 1 year following retrograde versus antegrade-only CTO PCI. Improvements in Seattle Angina Questionnaire Quality of Life scores at 1-year were similar between the retrograde and antegrade-only groups (29.9 vs 30.4; p = .58). CONCLUSIONS: In the OPEN-CTO registry, retrograde CTO procedures were associated with higher rates of in-hospital MACCE compared with antegrade-only; however, post-discharge outcomes, including quality of life improvements, were similar between technical modalities.
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Oclusão Coronária , Intervenção Coronária Percutânea , Assistência ao Convalescente , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/cirurgia , Humanos , Alta do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Qualidade de Vida , Sistema de Registros , Resultado do TratamentoRESUMO
Patients with structural heart disease are at increased risk of adverse outcomes from the coronavirus disease-2019 (COVID-19) due to advanced age and comorbidity. In the midst of a global pandemic of a novel infectious disease, reality-based considerations comprise an important starting point for formulating clinical management pathways. The aims of these "crisis-driven" recommendations are: 1) to ensure appropriate and timely treatment of structural heart disease patients; 2) to minimize the risk of COVID-19 exposure to patients and health care workers; and 3) to limit resource utilization under conditions of constraint. Although the degree of disruption to usual practice will vary across the United States and elsewhere, we hope that early experiences from a heart team operating in the current global epicenter of COVID-19 may prove useful for others adapting their practice in advance of local surges of COVID-19.
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Infecções por Coronavirus , Procedimentos Clínicos , Cardiopatias , Controle de Infecções/métodos , Pandemias , Pneumonia Viral , Betacoronavirus/isolamento & purificação , COVID-19 , Comorbidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Procedimentos Clínicos/organização & administração , Procedimentos Clínicos/tendências , Cardiopatias/epidemiologia , Cardiopatias/cirurgia , Humanos , Inovação Organizacional , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , SARS-CoV-2RESUMO
BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has significantly evolved in recent years. METHODS: We compared the clinical, angiographic, and technical characteristics, as well as procedural outcomes of CTO-PCIs in a multicenter registry between the "early era" (2012-2016) and the "current era" (2017-2019). RESULTS: Current era patients more often had stage III or IV angina compared with early era patients (71% vs 66%, respectively; P=.03) and were less likely to undergo ad hoc CTO-PCI (13% vs 16%, respectively; P=.04). The J-CTO score was slightly lower in the current era patients vs the early era patients (2.3 ± 1.4 vs 2.5 ± 1.3, respectively; P=.04). Use of antegrade wire escalation increased in the current era (92% vs 83% in the early era patients; P<.001) whereas use of retrograde crossing decreased (29% vs 39% in the early era; P<.001) and antegrade/ dissection re-entry decreased (23% vs 32% in the early era; P<.001). Technical success rates (85% in the current era vs 86% in the early era; P=.69) and procedural success rates (83% in the current era vs 85% in the early era; P=.15) were similar, whereas the incidence of in-hospital major cardiovascular events decreased in the current era (2% vs 3% in the early era; P=.04). CONCLUSIONS: During recent years, ad hoc CTO-PCI decreased along with decreasing use of retrograde crossing and antegrade dissection and re-entry. Technical and procedural success rates remained stable, whereas the incidence of in-hospital MACE decreased.
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Oclusão Coronária , Intervenção Coronária Percutânea , Angina Pectoris , Doença Crônica , Angiografia Coronária , Oclusão Coronária/diagnóstico , Oclusão Coronária/epidemiologia , Oclusão Coronária/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Sistema de Registros , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: The introduction of quadripolar (QP) cardiac resynchronization therapy (CRT) leads aimed to improve procedural and clinical outcomes. OBJECTIVE: The National Cardiovascular Data Registry was analyzed to characterize the use as well as the procedural and clinical outcomes of QP leads in comparison with unipolar and bipolar (BP) leads. METHODS: We evaluated data on 175,684 procedures reported between September 1, 2010, and December 31, 2015. Clinical outcomes were analyzed using Centers for Medicare & Medicaid Services claims data. RESULTS: Among all CRT device implants, there was a drop in reported lead placement failure from 6.04% to 5.21% (P < .0001 for trend) and a drop in the reported diaphragmatic stimulation rates from 0.07% to 0.01% (P < .007 for trend) between the last quarters of 2010 and 2015. No significant difference in procedural complication rates between QP and BP leads occurred (1.34% and 1.39%, respectively; P = .50). Among patients linked to Centers for Medicare & Medicaid Services claims data, no statistically significant difference in the combined primary outcome of death, congestive heart failure admission, device malfunction, and reoperation between BP and QP leads was observed (34.15 and 34.19 events per 100 patient-years, respectively; P = .89). CONCLUSION: Since the introduction of QP leads, there was a reduction in CRT lead placement failure rates and a reduction in diaphragmatic stimulation rates. However, no statistically significant difference in long-term clinical outcomes between BP and QP leads was observed in elderly patients undergoing CRT implantation.
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Terapia de Ressincronização Cardíaca/métodos , Eletrodos Implantados , Insuficiência Cardíaca/terapia , Sistema de Registros , Idoso , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Left main coronary artery (LMCA) chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We reviewed 4436 CTO-PCIs performed in 4340 patients between 2012 and 2018 at 25 sites. LMCA-CTO-PCI was performed in 20 cases (0.45%). We examined the clinical and angiographic characteristics and procedural outcomes of these cases. RESULTS: Mean patient age was 68 ± 11 years and 65% were men. Most patients (85%) had undergone prior coronary artery bypass graft surgery and had a protected left main. Mean J-CTO score was 2.7 ± 1.3, mean PROGRESS-CTO score was 1.3 ± 1.1, and mean PROGRESS-CTO Complications score was 3.8 ± 1.9. Antegrade-wire escalation was the most common successful crossing strategy (50%), followed by retrograde crossing (30%) and antegrade dissection/re-entry (10%). Technical and procedural success rates were both 85%. One patient with failed LMCA-CTO-PCI had periprocedural myocardial infarction. Median procedure time was 178 minutes (interquartile range [IQR], 123-250 minutes), median contrast volume was 190 mL (IQR, 133-339 mL), and patient air kerma radiation dose was 2.6 Gray (IQR, 1.3-3.9 Gray). CONCLUSIONS: LMCA-CTO-PCI is infrequent, is performed mostly in patients with prior coronary artery bypass graft surgery, and is associated with good procedural outcomes.
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Angiografia Coronária/métodos , Oclusão Coronária/cirurgia , Vasos Coronários/cirurgia , Intervenção Coronária Percutânea/métodos , Idoso , Oclusão Coronária/diagnóstico , Vasos Coronários/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: In patients with acute pulmonary embolism (PE), detectable levels of cardiac troponin I (cTnI) using a highly sensitive assay have been associated with increased in-hospital mortality. We sought to investigate the impact of detectable cTnI on long-term survival following acute PE. HYPOTHESIS: Detectable cTnI levels in patients presenting with acute PE predict increased long-term mortality following hospital discharge. METHODS: In a retrospective cohort study, we analyzed consecutive patients with confirmed acute PE and cTnI assay available from the index hospitalization. The detectable cTnI level was ≥0.012 ng/mL. Patients were classified into low and high clinical risk groups according to the Pulmonary Embolism Severity Index (PESI) at presentation. Subjects were followed for all-cause mortality subsequent to hospital discharge using chart review and Social Security Death Index. RESULTS: A cohort of 289 acute PE patients (mean age 56 years, 51% men), of whom 152 (53%) had a detectable cTnI, was followed for a mean of 3.1 ± 1.8 years after hospital discharge. A total of 71 deaths were observed; 44 (29%) and 27 (20%) in the detectable and undetectable cTnI groups, respectively (P = 0.05). Detectable cTnI was predictive of long-term survival among low-risk (P = 0.009) but not high-risk patients (P = 0.78) who had high mortality rates irrespective of cTnI status. CONCLUSIONS: In patients with acute PE, detectable cTnI is predictive of long-term mortality, particularly among patients who were identified as low risk according to PESI score.
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Embolia Pulmonar/sangue , Medição de Risco , Troponina I/sangue , Doença Aguda , Angiografia por Tomografia Computadorizada , Ecocardiografia , Eletrocardiografia , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Hospitalização/tendências , Humanos , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidade , Estudos Retrospectivos , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Fatores de Tempo , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Elevated cardiac troponin levels have been shown to be associated with adverse outcomes in patients with acute pulmonary embolism (PE). However, few data address the management implications of undetectable cardiac troponin I (cTnI) using a highly sensitive assay. We hypothesized that undetectable cTnI predicts very low in-hospital adverse event rates. METHODS: In a retrospective cohort study, we classified patients with confirmed acute PE according to cTnI detectability into cTnI+ (≥ 0.012 ng/mL) and cTnI- (< 0.012 ng/mL) groups. The Pulmonary Embolism Severity Index (PESI) was used for clinical risk determination. The primary outcome was a composite of hard events defined as in-hospital death, CPR, or thrombolytic therapy. The secondary outcome was a composite of soft events defined as ICU admission or inferior vena cava filter placement. RESULTS: Among 298 consecutive patients with confirmed acute PE, 161 (55%) were cTnI+ and 137 (45%) cTnI-. No deaths occurred in the cTnI- group vs nine (6%) in the cTnI+ group (P = .004). No hard events were observed in the cTnI- group vs 15 (9%) in the cTnI+ group (P < .001). Soft events were observed at a lower rate in the cTnI- group (21[15%] vs 69 [43%], P < .001). Patients in the cTnI- group had a higher survival rate free of hard (P = .001) or soft (P < .001) events, irrespective of clinical risk. Furthermore, cTnI provided incremental prognostic value beyond clinical, ECG, and imaging data (P < .001). CONCLUSIONS: Highly sensitive cTnI assay provides an excellent prognostic negative predictive value; thus, it plays a role in identifying candidates for out-of-hospital treatment of acute PE.