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The optimal treatment strategy for coronary bifurcation lesions by percutaneous coronary intervention (PCI) is complex and remains a subject of debate. Current guidelines advise a stepwise provisional approach with optional two-stent strategy. However, a two-stent strategy, both upfront and stepwise provisional, is technically demanding. Therefore, there is increasing interest in the use of drug-eluting balloons (DEB) in bifurcation lesions, mainly after a provisional approach with unsatisfactory result of the side branch. Some small pilot studies already showed that the use of DEB in bifurcation lesions is safe and feasible. However, a randomized comparison of this hybrid DEB strategy with a two-stent strategy is currently lacking. TRIAL DESIGN: The Hybrid DEB study is a prospective, multicenter, randomized controlled trial investigating noninferiority of a hybrid DEB approach, using a combination of a drug-eluting stent (DES) in the main vessel and DEB in the side branch, compared to stepwise provisional two-stent strategy in patients with true bifurcation lesions. A total of 500 patients with de novo true coronary bifurcation lesions, treated with a stepwise provisional approach and an unsatisfactory result of the side branch after main vessel stenting (≥ 70% stenosis and/or < thrombolysis in myocardial infarction III flow), will be randomized in a 1:1 ratio to receive either treatment with a DEB or with a DES in the side branch. The primary endpoint is a composite endpoint of the occurrence of all-cause death, periprocedural or spontaneous myocardial infarction and/or target vessel revascularization at the anticipated median 2-year follow-up. CONCLUSION: The Hybrid DEB study will compare in a multicenter, randomized fashion a hybrid DEB approach with a stepwise provisional two-stent strategy in patients with true bifurcation lesions. TRIAL REGISTRATION: ClinicalTrials.gov no. NCT05731687.
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Angioplastia Coronária com Balão , Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Stents Farmacológicos/efeitos adversos , Angioplastia Coronária com Balão/efeitos adversos , Estudos Prospectivos , Angiografia Coronária/efeitos adversos , Stents/efeitos adversos , Infarto do Miocárdio/etiologia , Resultado do Tratamento , Doença da Artéria Coronariana/complicaçõesRESUMO
BACKGROUND: Ischemic heart disease is a major cause of out-of-hospital cardiac arrest. The role of immediate coronary angiography and percutaneous coronary intervention (PCI) in the treatment of patients who have been successfully resuscitated after cardiac arrest in the absence of ST-segment elevation myocardial infarction (STEMI) remains uncertain. METHODS: In this multicenter trial, we randomly assigned 552 patients who had cardiac arrest without signs of STEMI to undergo immediate coronary angiography or coronary angiography that was delayed until after neurologic recovery. All patients underwent PCI if indicated. The primary end point was survival at 90 days. Secondary end points included survival at 90 days with good cerebral performance or mild or moderate disability, myocardial injury, duration of catecholamine support, markers of shock, recurrence of ventricular tachycardia, duration of mechanical ventilation, major bleeding, occurrence of acute kidney injury, need for renal-replacement therapy, time to target temperature, and neurologic status at discharge from the intensive care unit. RESULTS: At 90 days, 176 of 273 patients (64.5%) in the immediate angiography group and 178 of 265 patients (67.2%) in the delayed angiography group were alive (odds ratio, 0.89; 95% confidence interval [CI], 0.62 to 1.27; P = 0.51). The median time to target temperature was 5.4 hours in the immediate angiography group and 4.7 hours in the delayed angiography group (ratio of geometric means, 1.19; 95% CI, 1.04 to 1.36). No significant differences between the groups were found in the remaining secondary end points. CONCLUSIONS: Among patients who had been successfully resuscitated after out-of-hospital cardiac arrest and had no signs of STEMI, a strategy of immediate angiography was not found to be better than a strategy of delayed angiography with respect to overall survival at 90 days. (Funded by the Netherlands Heart Institute and others; COACT Netherlands Trial Register number, NTR4973.).
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Angiografia Coronária , Eletrocardiografia , Cardiopatias/diagnóstico por imagem , Parada Cardíaca Extra-Hospitalar/diagnóstico por imagem , Intervenção Coronária Percutânea , Tempo para o Tratamento , Idoso , Feminino , Cardiopatias/complicações , Cardiopatias/terapia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Parada Cardíaca Extra-Hospitalar/mortalidade , Parada Cardíaca Extra-Hospitalar/terapiaRESUMO
OBJECTIVES: The optimal targeted temperature in patients with shockable rhythm is unclear, and current guidelines recommend targeted temperature management with a correspondingly wide range between 32°C and 36°C. Our aim was to study survival and neurologic outcome associated with targeted temperature management strategy in postarrest patients with initial shockable rhythm. DESIGN: Observational substudy of the Coronary Angiography after Cardiac Arrest without ST-segment Elevation trial. SETTING: Nineteen hospitals in The Netherlands. PATIENTS: The Coronary Angiography after Cardiac Arrest trial randomized successfully resuscitated patients with shockable rhythm and absence of ST-segment elevation to a strategy of immediate or delayed coronary angiography. In this substudy, 459 patients treated with mild therapeutic hypothermia (32.0-34.0°C) or targeted normothermia (36.0-37.0°C) were included. Allocation to targeted temperature management strategy was at the discretion of the physician. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: After 90 days, 171 patients (63.6%) in the mild therapeutic hypothermia group and 129 (67.9%) in the targeted normothermia group were alive (hazard ratio, 0.86 [95% CI, 0.62-1.18]; log-rank p = 0.35; adjusted odds ratio, 0.89; 95% CI, 0.45-1.72). Patients in the mild therapeutic hypothermia group had longer ICU stay (4 d [3-7 d] vs 3 d [2-5 d]; ratio of geometric means, 1.32; 95% CI, 1.15-1.51), lower blood pressures, higher lactate levels, and increased need for inotropic support. Cerebral Performance Category scores at ICU discharge and 90-day follow-up and patient-reported Mental and Physical Health Scores at 1 year were similar in the two groups. CONCLUSIONS: In the context of out-of-hospital cardiac arrest with shockable rhythm and no ST-elevation, treatment with mild therapeutic hypothermia was not associated with improved 90-day survival compared with targeted normothermia. Neurologic outcomes at 90 days as well as patient-reported Mental and Physical Health Scores at 1 year did not differ between the groups.
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Angiografia Coronária/métodos , Cardioversão Elétrica/estatística & dados numéricos , Hipotermia Induzida/normas , Parada Cardíaca Extra-Hospitalar/terapia , Idoso , Angiografia Coronária/estatística & dados numéricos , Feminino , Humanos , Hipotermia Induzida/métodos , Hipotermia Induzida/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Países Baixos , Parada Cardíaca Extra-Hospitalar/epidemiologia , Ressuscitação/métodos , Ressuscitação/estatística & dados numéricos , Resultado do TratamentoRESUMO
Background: Personalized prognosis plays a vital role in deciding between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD). The aim of this study is to compare the modality of revascularization chosen by the local heart team to that recommended by using individualized predictions of medium, and long-term all-cause mortality amongst patients with 3VD screened in the Multivessel TALENT trial. Methods: The SYNTAX score II (SS-II) and SS-2020 were evaluated in 200 consecutive patients by a core laboratory and compared to the decision of the "on site" heart team. Results: According to the SS-II, CABG was the recommended treatment in 51 patients (25.5%) however 34 (66.6%) of them received PCI. According to SS-2020 the predicted absolute risk differences (ARD) between PCI and CABG were significantly higher in patients receiving CABG compared to those treated by PCI for major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, stroke or myocardial infarction at 5-years (8.8 ± 4.6% vs 6.0 ± 4.0%, p < 0.001) and all-cause mortality at 5- (5.2 ± 3.5% vs 3.7 ± 3.0%, p = 0.008) and 10-years (9.3 ± 4.8% vs 6.2 ± 4.2%, p < 0.001). Based on the novel threshold of equipoise (individual absolute risk differences [ARD] < 4.5%), 133 patients were eligible for PCI however 23 of them underwent CABG; conversely, amongst the 67 patients where CABG was recommendation (individual ARD > 4.5%), only 19 received it. Conclusions: Despite the robustness of the risk models proposed for screening, several deviations from the recommended mode of revascularization were observed by the core laboratory among the first 200 patients with 3VD screened in the Multivessel TALENT trial. Clinical Trial Registration: ClinicalTrials.gov reference: NCT04390672.
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AIMS: The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. METHODS AND RESULTS: COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001). CONCLUSIONS: Among DM patients with ≥1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients.
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Doença da Artéria Coronariana , Diabetes Mellitus , Reserva Fracionada de Fluxo Miocárdico , Placa Aterosclerótica , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Humanos , Placa Aterosclerótica/diagnóstico por imagem , Valor Preditivo dos Testes , Estudos Prospectivos , Tomografia de Coerência ÓpticaRESUMO
Interrupting myocardial reperfusion with intermittent episodes of ischemia (i.e., postconditioning) during primary percutaneous coronary intervention (PPCI) has been suggested to protect myocardium in ST-segment elevation myocardial infarction (STEMI). Nevertheless, trials provide inconsistent results and any advantage in long-term outcomes remains elusive. Using a retrospective study design, we evaluated the impact of balloon inflations during PPCI on enzymatic infarct size (IS) and long-term outcomes. We included 634 first-time STEMI patients undergoing PPCI with an occluded infarct-related artery and adequate reperfusion thereafter and divided these into: patients receiving 1-3 inflations in the infarct-related artery [considered minimum for patency/stent placement (controls); n = 398] versus ≥4 [average cycles in clinical protocols (postconditioning analogue); n = 236]. IS, assessed by peak creatine kinase, was lower in the postconditioning analogue group compared with controls [median (interquartile range) 1,287 (770-2,498) vs. 1,626 (811-3,057) UI/L; p = 0.02], corresponding to a 21 % IS reduction. This effect may be more pronounced in women, patients without diabetes/hypercholesterolemia, patients presenting within 3-6 h or with first balloon re-occlusion ≤1 min. No differences were observed in 4-year mortality or MACCE between groups. Four or more inflations during PPCI reduced enzymatic IS in STEMI patients under well-defined conditions, but did not translate into improved long-term outcomes in the present study. Large-scale randomized trials following strict postconditioning protocols are needed to clarify this effect.
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Angioplastia Coronária com Balão/métodos , Pós-Condicionamento Isquêmico/métodos , Infarto do Miocárdio/terapia , Traumatismo por Reperfusão Miocárdica/terapia , Idoso , Eletrocardiografia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/fisiopatologia , Traumatismo por Reperfusão Miocárdica/diagnóstico , Traumatismo por Reperfusão Miocárdica/fisiopatologia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND: iMAP is a new intravascular ultrasound (IVUS) derived technique for tissue characterization using spectral analysis. Since there is a need for reproducibility data to design longitudinal studies, we sought to assess the in vivo reproducibility of this imaging technique. METHODS: iMAP (40 MHz, Boston Scientific Corporation) was performed in patients referred for elective percutaneous intervention and in whom a nonintervened vessel was judged suitable for a safe IVUS analysis. Overall 20 patients with 20 non-angiographically significant lesions were assessed by two independent observers. Five of these 20 patients received an additional iMAP analysis using a new IVUS catheter and using the same catheter after its engagement and reengagement. RESULTS: The interobserver relative difference in plaque area was 2.5%. Limits of agreement for lumen, vessel, and plaque area measurements were 1.62, -2.47 mm(2) ; 2.09, -3.71 mm(2) ; 2.80, -3.72 mm(2) ; respectively. Limits of agreement for fibrotic, lipidic, necrotic, and calcified measurements were 1.32, -1.44 mm(2) ; 0.24, -0.36 mm(2) ; 1.50, -2.26 mm(2) ; 0.09, -0.11 mm(2) ; respectively. The intercatheter and intracatheter relative difference in plaque area were 0.9% and 4.1%, respectively. Although the variability for compositional measurements increased using two different catheters or using the same catheter twice, the variability for compositional measurements keeps always below 10%. CONCLUSIONS: Our analysis demonstrates that the geometrical and compositional iMAP analysis is acceptably reproducible.
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Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Placa Aterosclerótica/diagnóstico por imagem , Ultrassonografia de Intervenção/métodos , Idoso , Vasos Coronários/cirurgia , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Curva ROC , Reprodutibilidade dos Testes , Resultado do TratamentoRESUMO
BACKGROUND: We examined the risk of psychosocial distress, including Type D personality, depressive symptoms, anxiety, positive mood, hostility, and health status fatigue and disease specific and generic quality of life for MACE in patients with non-obstructive coronary artery disease (NOCAD). METHODS: In the Tweesteden mild stenosis (TWIST) study, 546 patients with NOCAD were followed for 10 years to examine the occurrence of cardiac mortality, a major cardiac event, or non-cardiac mortality in the absence of a cardiac event. Cox proportional hazard models were used to examine the impact of psychosocial distress and health status on the occurrence of MACE while adjusting for age, sex, disease severity, and lifestyle covariates. RESULTS: In total 19% of the patients (mean age baseline = 61, SD 9 years; 52% women) experienced MACE, with a lower risk for women compared to men. Positive mood (HR 0.97, 95%CI 0.95-1.00), fatigue (HR 1.03, 95%CI 1.00-1.06), and physical limitation (HR 0.99, 95%CI 0.98-1.00) were associated with MACE in adjusted models. No significant interactions between sex and psychosocial factors were present. Depressive symptoms were predictive of MACE, but no longer after adjustment. CONCLUSIONS: In patients with NOCAD fatigue, low positive mood, and a lower physical limitation score were associated with MACE, without marked sex differences. Type D personality, psychosocial factors, and health status were not predictive of adverse outcomes. Reducing psychosocial distress is a valid intervention goal by itself, though it is less likely to affect MACE in patients with NOCAD.
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Doença da Artéria Coronariana , Nível de Saúde , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Doença da Artéria Coronariana/psicologia , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/epidemiologia , Idoso , Fatores de Risco , Seguimentos , Angústia Psicológica , Qualidade de Vida/psicologia , Estresse Psicológico/psicologia , Estresse Psicológico/epidemiologia , Fatores de Tempo , Estudos ProspectivosRESUMO
The optimal antithrombotic management of atrial fibrillation (AF) patients who require oral anticoagulation (OAC) undergoing percutaneous coronary intervention (PCI) remains unclear. Current guidelines recommend dual antithrombotic therapy (DAT; OAC plus P2Y12 inhibitor - preferably clopidogrel) after a short course of triple antithrombotic therapy (TAT; DAT plus aspirin). Although DAT reduces bleeding risk compared to TAT, this is counterbalanced by an increase in ischaemic events. Aspirin provides early ischaemic benefit, but TAT is associated with an increased haemorrhagic burden; therefore, we propose a 30-day dual antiplatelet therapy (DAPT; aspirin plus P2Y12 inhibitor) strategy post-PCI, temporarily omitting OAC. The study aims to compare bleeding and ischaemic risk between a 30-day DAPT strategy following PCI and a guideline-directed therapy in AF patients requiring OAC. WOEST-3 (ClinicalTrials.gov: NCT04436978) is an investigator-initiated, international, open-label, randomised controlled trial (RCT). AF patients requiring OAC who have undergone successful PCI will be randomised within 72 hours after PCI to guideline-directed therapy (edoxaban plus P2Y12 inhibitor plus limited duration of aspirin) or a 30-day DAPT strategy (P2Y12 inhibitor plus aspirin, immediately discontinuing OAC) followed by DAT (edoxaban plus P2Y12 inhibitor). With a sample size of 2,000 patients, this trial is powered to assess both superiority for major or clinically relevant non-major bleeding and non-inferiority for a composite of all-cause death, myocardial infarction, stroke, systemic embolism or stent thrombosis. In summary, the WOEST-3 trial is the first RCT temporarily omitting OAC in AF patients, comparing a 30-day DAPT strategy with guideline-directed therapy post-PCI to reduce bleeding events without hampering efficacy.
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Anticoagulantes , Fibrilação Atrial , Hemorragia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Anticoagulantes/efeitos adversos , Administração Oral , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Agregação Plaquetária/efeitos adversos , Hemorragia/induzido quimicamente , Aspirina/uso terapêutico , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Terapia Antiplaquetária Dupla/métodos , Masculino , Feminino , Idoso , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Resultado do Tratamento , Pessoa de Meia-IdadeRESUMO
Background: In out-of-hospital cardiac arrest (OHCA) without ST-elevation, predictive markers that can identify those with a high risk of acute coronary syndrome are lacking. Methods: In this post hoc analysis of the Coronary Angiography after Cardiac Arrest (COACT) trial, the baseline, median, peak, and time-concentration curves of troponin-T (cTnT) (T-AUC) in OHCA patients without ST-elevation were studied. cTnT values were obtained at predefined time points at 0, 3, 6, 12, 24, 36, 28, and 72 hours after admission. All patients who died within the measurement period were not included. The primary outcome was the association between cTnT and 90-day survival. Secondary outcomes included the association of cTnT and acute thrombotic occlusions, acute unstable lesions, and left ventricular function. Results: In total, 352 patients were included in the analysis. The mean age was 64 ± 13 years (80.4% men). All cTnT measures were independent prognostic factors for mortality after adjustment for potential confounders age, sex, history of coronary artery disease, witnessed arrest, time to BLS, and time to return of spontaneous circulation (eg, for T-AUC: hazard ratio, 1.44; 95% CI, 1.06-1.94; P = .02; P value for all variables ≤.02). Median cTnT (odds ratio [OR], 1.58; 95% CI, 1.18-2.12; P = .002) and T-AUC (OR, 2.03; 95% CI, 1.25-3.29; P = .004) were independent predictors for acute unstable lesions. Median cTnT (OR, 1.62; 95% CI, 1.17-2.23; P = .003) and T-AUC (OR, 2.16; 95% CI, 1.27-3.68; P = .004) were independent predictors for acute thrombotic occlusions. CTnT values were not associated with the left ventricular function (eg, for T-AUC: OR, 2.01; 95% CI, 0.65-6.19; P = .22; P value for all variables ≥.14). Conclusion: In OHCA patients without ST-segment elevation, cTnT release during the first 72 hours after return of spontaneous circulation was associated with clinical outcomes.
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BACKGROUND: Early-generation drug-eluting stents releasing sirolimus (SES) or paclitaxel (PES) are associated with increased risk of very late stent thrombosis occurring >1 year after stent implantation. It is unknown whether the risk of very late stent thrombosis persists with newer-generation everolimus-eluting stents (EES). METHODS AND RESULTS: We assessed the risk of stent thrombosis in a cohort of 12 339 patients with unrestricted use of drug-eluting stents (3819 SES, 4308 PES, 4212 EES). Results are incidence rates per 100 person-years after inverse probability of treatment weighting to adjust for group differences. During follow-up of up to 4 years, the overall incidence rate of definite stent thrombosis was lower with EES (1.4 per 100 person-years) compared with SES (2.9; hazard ratio, 0.41; 95% confidence interval, 0.27-0.62; P<0.0001) and PES (4.4; hazard ratio, 0.33; 95% confidence interval, 0.23-0.48; P<0.0001). The incidence rate per 100 person-years of early (0-30 days), late (31 days-1 year), and very late stent thrombosis amounted to 0.6, 0.1, and 0.6 among EES-treated patients; 1.0, 0.3, and 1.6 among SES-treated patients; and 1.3, 0.7, and 2.4 among PES-treated patients. Differences in favor of EES were most pronounced beyond 1 year, with a hazard ratio of 0.33 (EES versus SES; P=0.006) and 0.34 (EES versus PES; P<0.0001). There was a lower risk of cardiac death or myocardial with EES compared with PES (hazard ratio, 0.65; 95% confidence interval, 0.56-0.75; P<0.0001), which was directly related to the lower risk of stent thrombosis-associated events (EES versus PES: hazard ratio, 0.36; 95% confidence interval, 0.23-0.57). CONCLUSION: Current treatment with EES is associated with a lower risk of very late stent thrombosis compared with early-generation drug-eluting stents.
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Angioplastia Coronária com Balão/mortalidade , Trombose Coronária/etiologia , Trombose Coronária/mortalidade , Stents Farmacológicos/efeitos adversos , Stents Farmacológicos/estatística & dados numéricos , Idoso , Angioplastia Coronária com Balão/estatística & dados numéricos , Estudos de Coortes , Everolimo , Feminino , Seguimentos , Humanos , Imunossupressores/administração & dosagem , Incidência , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Readmissão do Paciente/estatística & dados numéricos , Estudos Prospectivos , Sistema de Registros/estatística & dados numéricos , Fatores de Risco , Sirolimo/administração & dosagem , Sirolimo/análogos & derivados , Análise de Sobrevida , Fatores de Tempo , Moduladores de Tubulina/administração & dosagemRESUMO
Background: Surgical Site Infections (SSI) are one of the most common complications after a caesarean with significant morbidity. Evidence suggests that SSI rates can be reduced post caesarean by using a Leukomed® Sorbact® (Essity) bacteria binding wound dressing, thereby reducing bacterial wound colonisation. Barking, Havering & Redbridge University Hospitals NHS Trust, London, UK (BHRUT) maternity unit sought change their clinical practice by using Leukomed Sorbact and evaluate if this reduced their SSI rate, SSI readmission rate, antibiotic usage and evaluate any associated cost savings. Methods: From January 1st 2022, Mepore® (Molnlycke) wound dressings were replaced with Leukomed Sorbact for all caesareans. Retrospective and prospective audits were undertaken to compare SSI incidence pre- and post- implementation of the dressing. No changes were made to wound cleaning products, prophylactic antibiotic use or surgical technique. Wound closure technique remained the choice of the individual surgeon. Results: Prior to this practice change, the baseline SSI rate between January-December 2021 was 6.1% and the SSI readmission rate was 1.27%. Comparative data for January-December 2022 showed a 38% reduction in SSI rates (overall SSI rate = 3.8%), a 31% reduction in readmission rate for SSI (overall rate = 0.88%), a 38% reduction in readmission bed days and a 30% reduction in antibiotic use. There was a reduction in SSI rates in all body mass index (BMI) categories. Total savings due to the reduction in SSI rates over twelve months were £234,784. The cost savings to BHRUT solely attributable to the reduction in readmissions was £49,750 or £21 per Caesarean, which will be an ongoing saving. Conclusion: The use of Leukomed Sorbact dressings after Caesarean resulted in improved clinical outcomes with reduced SSI and readmission rates. Investment in the new dressing was cost effective when considering bed days freed, the reduction in antibiotic usage, reduced morbidity and improved patient experience.
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Placenta accreta spectrum (PAS) disorder is one of the most dangerous conditions that can affect pregnancy and its incidence is increasing secondary to rising cesarean section rates worldwide. The standard treatment is frequently elective hysterectomy at the time of cesarean delivery; however, uterine and fertility preserving surgery is becoming more common. In the pursuit of a reduction in blood loss and associated maternal morbidity, occlusive vascular balloons are increasingly used at the time of surgery, usually placed with fluoroscopic guidance. Occlusive balloons placed in the infrarenal aorta have been shown in the literature to be superior in terms of blood loss and hysterectomy rates than those placed more distally, such as within iliac or uterine arteries. We present the first five cases performed in Europe of ultrasound-guided infrarenal aortic balloon placement before cesarean for PAS disorder, and describe the technique we used, which provided reduced blood loss, a clearer operating field and avoided fetal and maternal exposure to radiation and intravenous contrast.
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Study objective: Ischemia with non-obstructive coronary arteries (INOCA) is caused by vascular dysfunctions and predominantly seen in women. For better recognition and prevention more insight is needed on risk factors and well-being. We aimed to explore differences in psychological distress, quality of life, risk factors, and medication use between women with INOCA and obstructive coronary artery disease (CAD). Methods: Patients from two separate studies (n = 373, 57 % women) completed a questionnaire assessing psychological and clinical factors. Analyses were performed for women only who were categorized into three groups: non-ischemic chest pain (n = 115), INOCA (n = 68), and obstructive CAD (n = 30). Secondary analyses were performed for men only, and sex differences within INOCA patients were explored. Results and conclusion: Compared to obstructive CAD patients, INOCA patients reported better physical functioning (p = 0.041). Furthermore, INOCA patients had less often hypercholesterolemia (p < 0.001), were less often active smokers (p = 0.062), had a lower mean BMI (p = 0.022), and reported more often a familial history of CAD (p = 0.004). Patients with INOCA used antithrombotic, cholesterol lowering medications, and beta-blockers less often than patients with obstructive CAD. No differences between patients with INOCA and obstructive CAD were found for psychological distress, well-being, and for women-specific risk factors. The results suggest that women with INOCA experience similar levels of psychological distress and seem to have different risk factor profiles and are less optimally treated as compared to obstructive CAD patients. Further research on risk factors is needed for better prevention and treatment.
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BACKGROUND: The long-term prognostic implications of fractional flow reserve (FFR)-negative lesions hosting vulnerable plaques remain unsettled. AIMS: The aim of this study was to evaluate the association of non-ischaemic lesions hosting optical coherence tomography (OCT)-detected thin-cap fibroatheromas (TCFA) with first and recurrent cardiovascular events during follow-up up to 5 years in a diabetes mellitus (DM) patient population. METHODS: COMBINE OCT-FFR is a prospective, international, double-blind, natural history study. Patients with DM and with ≥1 FFR-negative lesion were classified into 2 groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint (PE) is a composite of cardiac mortality, target vessel-related myocardial infarction (TV-MI), clinically driven target lesion revascularisation (TLR), or unstable angina (UA) requiring hospitalisation during follow-up up to 5 years. RESULTS: Among 390 DM patients (age 67.5±9 years; 37% female) with ≥1 FFR-negative lesion, 292 (74.9%) were TCFA-negative while 98 (25.1%) were TCFA-positive. The PE occurred more frequently in TCFA-positive than in TCFA-negative patients (21.4% vs 8.2%, hazard ratio [HR] 2.89, 95% confidence interval [CI]: 1.61-5.20; p<0.001; 6.42 vs 2.46 events per 100 patient-years, rate ratio [RR] 2.61, 95% CI: 1.38-4.90; p=0.002). Furthermore, when TV-MI, TLR, and UA were treated as recurrent components of the PE, TCFA-positive patients experienced a higher risk of recurrent events (HR 2.89, 95% CI; 1.74-4.80; p<0.001; 13.45 vs 2.87 events per 100 patient-years, RR 4.69, 95% CI: 2.86-7.83; p<0.001). A multivariable analysis identified the presence of TCFA as an independent predictor of the PE (HR 2.76, 95% CI: 1.53-4.97; p<0.001). CONCLUSIONS: OCT-detected TCFA-positive lesions, although not ischaemia-generating, are associated with an increased risk of adverse events during long-term follow-up. CLINICALTRIALS: gov: NCT02989740.
Assuntos
Doença da Artéria Coronariana , Diabetes Mellitus , Reserva Fracionada de Fluxo Miocárdico , Infarto do Miocárdio , Placa Aterosclerótica , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Placa Aterosclerótica/diagnóstico por imagem , Placa Aterosclerótica/patologia , Estudos Prospectivos , Infarto do Miocárdio/terapia , Prognóstico , Angina Instável , Tomografia de Coerência Óptica/métodos , Doença da Artéria Coronariana/terapia , Valor Preditivo dos Testes , Angiografia Coronária/métodosRESUMO
AIMS: To study if any qualitative or quantitative optical coherence tomography (OCT) variables in combination with thin cap fibroatheroma (TCFA) patients could improve the identification of lesions at risk for future major adverse cardiac events (MACEs). METHODS AND RESULTS: From the combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) trial database (NCT02989740), we performed a detailed assessment OCT qualitative and quantitative variables in TCFA carrying diabetes mellitus (DM) patients with vs. without MACE during follow-up. MACEs were defined as a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, and hospitalization for unstable angina. From the 390 fractional flow reserve (FFR)-negative DM patients, 98 (25.2%) had ≥1 OCT-detected TCFA, of which 13 (13.3%) had MACE and 85 (86.7%) were event-free (non-MACE). The baseline characteristics were similar between both groups; however, a smaller minimal lumen area (MLA) and lower mean FFR value were observed in MACE group (1.80 vs. 2.50 mm2, P = 0.01, and 0.85 vs. 0.89, P = 0.02, respectively). Prevalence of healed plaque (HP) was higher in the MACE group (53.85 vs. 21.18%, P = 0.01). TCFA were predominantly located proximal to the MLA. TCFA area was smaller in the MACE group, while no difference was observed regarding the lesion area. CONCLUSION: Within TCFA carrying patients, a smaller MLA, lower FFR values, and TCFA location adjacent to a HP were associated with future MACE. Carpet-like measured lesion area surface was similar, while the TCFA area was smaller in the MACE arm, and predominantly located proximal to the MLA.
Assuntos
Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Infarto do Miocárdio , Placa Aterosclerótica , Humanos , Placa Aterosclerótica/patologia , Tomografia de Coerência Óptica/métodos , Angina Instável , Vasos Coronários/patologia , Doença da Artéria Coronariana/patologia , Valor Preditivo dos Testes , Angiografia CoronáriaRESUMO
BACKGROUND: There is few information on the long-term efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared to bare metal stents (BMS) in all-comer percutaneous coronary intervention (PCI)-patients complicated by renal insufficiency (RI). OBJECTIVE: Our aim was to assess the 6-year clinical outcome of PCI-patients with RI treated exclusively with BMS, SES, or PES in our academic hospital. METHODS: A total of 1382 patients, included in three cohorts of consecutive PCI-patients (BMS = 392; SES = 498; PES = 492), were categorized by creatinine clearance calculated by the Cockroft-Gault formula (normal kidney function ≥ 90; mild RI = 60-89; moderate RI < 60) and systematically followed for the occurrence of major adverse cardiac events (MACE). RESULTS: Mortality rates were significantly higher for patients with moderate RI compared to mild RI and normal kidney function at 6 years (Kaplan-Meier estimate: moderate RI (34%) vs. mild RI (12%), P < 0.001; moderate RI (34%) vs. normal kidney function (8%), P < 0.001). After multivariate Cox-regression analysis, SES and PES decreased the occurrence of target-vessel revascularization (TVR) and MACE at 6 years in patients with a normal creatinine clearance compared to BMS [adjusted hazard ratio (aHR) = 0.48, 95% CI: 0.28-0.84; aHR = 0.75, 95% CI: 0.57-0.97, respectively] with no significant effect on mortality. Safety- and efficacy end points were comparable for the three stent types in patients with mild- and moderate renal function. CONCLUSION: Patients with a normal creatinine clearance had significant improvement in TVR and MACE rates after SES- or PES implantation compared to BMS at 6 years. However, there was no superiority of both drug-eluting stents over BMS in safety and efficacy end points for patients with impaired renal function.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Rim/fisiopatologia , Metais , Insuficiência Renal/complicações , Stents , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Biomarcadores/sangue , Fármacos Cardiovasculares/administração & dosagem , Distribuição de Qui-Quadrado , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/mortalidade , Creatinina/sangue , Feminino , Taxa de Filtração Glomerular , Humanos , Estimativa de Kaplan-Meier , Rim/metabolismo , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Países Baixos , Paclitaxel/administração & dosagem , Segurança do Paciente , Modelos de Riscos Proporcionais , Desenho de Prótese , Sistema de Registros , Insuficiência Renal/sangue , Insuficiência Renal/mortalidade , Insuficiência Renal/fisiopatologia , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Sirolimo/administração & dosagem , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aim was to investigate the 7-year clinical outcomes of patients treated with either drug-eluting stents (DES) or bare-metal stents (BMS) for saphenous vein graft disease (SVG). BACKGROUND: Atherosclerotic disease in SVG has several peculiarities which make it difficult to extrapolate outcomes of the use of DES as compared to BMS, from outcomes observed in native coronary arteries. To date no long-term safety and efficacy results for DES in SVG have been published. METHODS: Between January, 2000 and December, 2005 a total of 250 consecutive patients with saphenous vein graft disease were sequentially treated with DES (either sirolimus- or paclitaxel-eluting stents) or with BMS. Yearly follow-up was performed. RESULTS: At 87 months (7.25 years), a total of 101 patients died (58 [46%] in the BMS group and 43 [42%] in the DES group, P-value= 0.4). There was no significant difference in the combined endpoint mortality or myocardial infarction. Cumulative target vessel revascularisation (TVR) was higher in the BMS group compared to the DES group (41% vs. 29%, respectively; adjusted hazard ratio [HR] 0.63, 95% confidence interval [CI]: 0.39-1.0). The cumulative incidence of major adverse cardiac events was 73% vs. 68% in the BMS and DES groups, respectively (adjusted HR 0.93, 95% CI: 0.67-1.3). CONCLUSIONS: In the present study, the unrestricted use of DES for SVG lesions appeared safe and effective up to 7.25 years- and the use of DES resulted in a clinically relevant lower rate of TVR.