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1.
Int J Artif Organs ; : 391398820975408, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33259258

RESUMO

BACKGROUND: Venovenous extracorporeal membrane oxygenation (VV ECMO) has gained popularity for the treatment of refractory respiratory failure during and after the 2009 influenza pandemic, and still represents a precious therapeutic resource for severe novel coronavirus 2019 infection. However, most of the published studies are small case series, and only two randomized trials exist in literature. AIM: Aim of this systematic review is to describe trends in VV ECMO treatment outcomes according to large studies only. METHODS: We searched and included studies with more than 100 VV ECMO cases dated up to August 1st, 2019. RESULTS: Thirty-three studies published in the period 2011-2019 met inclusion criteria, for a total of 12,860 patients (age 46.3 ± 17.4 years). ARDS was mainly by pneumonia, in 3126 (37%) cases; further 401(7%) patients had H1N1 Influenza A infection. Cannulation-related complications occurred in 502 (7%) cases. Weighted mean (95% confidence interval) of VV ECMO duration was 8.9 (8.7-9.1) days, and ICU stay was 23.6 (22.4-24.8) days. Mortality at the longest follow up available was 40%. Data collection in 70% of the studies had a duration of >5 years. CONCLUSION: This study reveals the characteristics of large case VV ECMO studies.

2.
Blood Purif ; : 1-8, 2020 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-32659757

RESUMO

BACKGROUND: There is no information on acute kidney injury (AKI) and continuous renal replacement therapy (CRRT) among invasively ventilated coronavirus disease 2019 (COVID-19) patients in Western healthcare systems. OBJECTIVE: To study the prevalence, characteristics, risk factors and outcome of AKI and CRRT among invasively ventilated COVID-19 patients. METHODS: Observational study in a tertiary care hospital in Milan, Italy. RESULTS: Among 99 patients, 72 (75.0%) developed AKI and 17 (17.7%) received CRRT. Most of the patients developed stage 1 AKI (33 [45.8%]), while 15 (20.8%) developed stage 2 AKI and 24 (33.4%) a stage 3 AKI. Patients who developed AKI or needed CRRT at latest follow-up were older, and among CRRT treated patients a greater proportion had preexisting CKD. Hospital mortality was 38.9% for AKI and 52.9% for CRRT patients. CONCLUSIONS: Among invasively ventilated COVID-19 patients, AKI is very common and CRRT use is common. Both carry a high risk of in-hospital mortality.

3.
Int J Cardiol ; 316: 26-30, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-32473286

RESUMO

Background Bedside insertion of Impella percutaneous ventricular assistant device (pVAD) (Abiomed, Danvers, MA) under transesophageal echocardiographic (TEE) guidance is an attractive strategy enabling lifesaving treatment in patients with cardiogenic shock and who cannot to be transported promptly to the catheterization laboratory (Cathlab). Methods In this retrospective, single-center study, we reviewed all consecutive patients supported with Impella pVAD for CS. We compared the characteristics and outcomes of those who underwent Impella pVAD insertion under fluoroscopic guidance (Fluoro group) in the Cathlab with those who underwent insertion under TEE guidance at bedside (TEE group). Results: Between February 2013 and April 2018, a total of 150 consecutive patients with CS were supported with Impella. Fifty-five (38%) were in TEE group and 95 (62%) in Fluoro group. Impella insertion was successful in all the patients. At the time of Impella insertion patients among the TEE group had higher incidence of refractory hemodynamic collapse (87% vs 53%; p < 0.001) and venoarterial extracorporeal membrane oxygenation (62% vs 35%, p=0.002). In-hospital mortality was significantly higher in the TEE group (55% vs. 31%, p=0.04). Rates of Impella-related complications were not different between the two groups, except for higher requirement for renal replacement therapy in the TEE group (35% vs 17%; p = 0.004). Conclusions Emergent Impella insertion with TEE guidance is feasible, safe and effective in critically ill patients with cardiogenic shock.

5.
ASAIO J ; 66(4): 415-422, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31453830

RESUMO

We characterized the biologic background of prothrombotic platelet function in the setting of durable left ventricular assist devices (LVADs) evaluating the role of different antithrombotic regimens. Platelet-mediated thrombin generation was quantified using the Platelet Activity State (PAS) Assay and the Thrombin Generation Test (TGT) in 78 patients implanted with the HeartMate II (n = 10, 13%), the HeartMate 3 (HM3) (n = 30, 38%), or the HVAD (n = 38, 49%) and managed with oral anticoagulation plus aspirin (n = 46, 59%) or anticoagulation alone (n = 32, 41%). Coagulation parameters (platelet count, International Normalized Ratio (INR), activated Partial Thromboplastin Time, Fibrinogen and D-Dimer levels) and hemolysis (lactate dehydrogenase levels [LDH]) were also recorded to comprehensively characterize the hemostatic profile in the two groups. In patients without aspirin, the PAS assay revealed low-intensity increase in platelet prothrombinase activity (1.11-fold, p = 0.03). Similarly the TGT revealed moderate higher platelet reactivity when compared with patients receiving aspirin, consistent with reduction in lag time (0.87-fold, p < 0.001), increase in peak of thrombin generation (1.5-fold, p = 0.002) and thrombin generation rate (2-fold, p = 0.02), but comparable endogenous thrombin potential (p = 0.50). Coagulation parameters and LDH were comparable in the two groups (p > 0.05). Moreover, no differences were noted in platelet prothrombinase activity of patients implanted with the HM3 or HVAD. Our results suggest that, in the setting of durable LVADs, aspirin minimally modulates the biochemical pathway of platelet-mediated thrombin generation. Accordingly, re-evaluation of current antithrombotic management criteria in patients stratified according to bleeding/thromboembolic risk might be safe and beneficial to prevent adverse events.

6.
J Cardiothorac Vasc Anesth ; 34(6): 1641-1654, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31668634

RESUMO

BACKGROUND: Delirium after cardiac surgery is associated with adverse outcomes, including prolonged hospital stay, prolonged intensive care unit stay, and increased mortality. Effective preventive interventions and treatments still are largely unknown. AIM: This systematic review aimed to gather and summarize the existing evidence from randomized trials concerning interventions studied in the prevention or treatment of delirium in adult patients undergoing cardiac surgery. METHODS: A systematic review of the literature using a key word strategy and Boolean operators was performed. PubMed and the Cochrane and Scopus databases were searched for pertinent studies until July 2018 (no inception limit). RESULTS: Of 2,556 articles identified, 56 studies met the inclusion criteria and were included in the review-39 addressed pharmacologic strategies and 17 nonpharmacologic interventions. Interestingly, 51 (91%) trials focused on delirium prevention and only 5 (9%) on delirium treatment. Most of the analyzed studies were recent double-blind, single-center trials conducted in Europe or North America, with a low risk of bias. Overall, 38 different interventions were identified: 15 (26%) interventions were performed before surgery, 20 (36%) in the operating room, and 21 (38%) after surgery. The most frequently analyzed strategies were the administration of dexmedetomidine, ketamine, antipsychotics, glucocorticoids, propofol, opioids, volatile anesthetics, local anesthetics, and remote ischemic preconditioning. The analyzed strategies were extremely heterogenous, and dexmedetomidine was the most promising measure able to prevent the development of postoperative delirium. CONCLUSIONS: In the present systematic review of 56 randomized controlled trials that examined 38 interventions, the authors found that dexmedetomidine was the most frequently studied agent and that it might reduce the occurrence of delirium after cardiac surgery.

7.
Ann Card Anaesth ; 22(4): 400-406, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31621676

RESUMO

Background: Percutaneous left atrial appendage occlusion (LAAO) is indicated in subjects with atrial fibrillation who cannot receive oral anticoagulants. This procedure requires transesophageal echocardiography guidance and is usually performed under general anesthesia. The Janus Mask is a new device designed to allow upper endoscopic procedures during noninvasive ventilation (NIV). Aims: This study aims to assess the possibility of performing LAAO under sedation and NIV. Setting: Cardiac electrophysiology laboratory. Design: Case-control study. Materials and Methods: Data from 11 subjects undergoing LAAO under sedation and NIV with the Janus Mask were retrospectively collected. Procedure duration, outcomes, and physicians' satisfaction were compared with those of 11 subjects who underwent LAAO under general anesthesia in the same period. Statistical Analysis: Univariate analysis and analysis of variance for between-groups comparison. Results: The 11 subjects treated with sedation experienced a good outcome, with a high degree of satisfaction from the medical team. An increase in arterial partial pressure of carbon dioxide in the Janus group (45 [43-62] mmHg vs. 33 [30-35] mmHg in the general anesthesia group, P < 0.001) led to a transient pH decrease 45 min after the beginning of the procedure (7.30 [7.18-7.36] vs. 7.40 [7.39-7.46], P = 0.014). No differences in arterial partial pressure of oxygen, FiO2, and hemodynamic parameters were observed. The subjects' conditions at discharge from the recovery room were comparable. No difference in procedure duration was registered. Conclusions: LAAO procedure under sedation and NIV through the Janus Mask is safe and feasible. This strategy might represent a valuable alternative to manage such a compromised and fragile population.

9.
J Cardiothorac Vasc Anesth ; 33(10): 2685-2694, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31064730

RESUMO

OBJECTIVE: Reducing mortality is a key target in critical care and perioperative medicine. The authors aimed to identify all nonsurgical interventions (drugs, techniques, strategies) shown by randomized trials to increase mortality in these clinical settings. DESIGN: A systematic review of the literature followed by a consensus-based voting process. SETTING: A web-based international consensus conference. PARTICIPANTS: Two hundred fifty-one physicians from 46 countries. INTERVENTIONS: The authors performed a systematic literature search and identified all randomized controlled trials (RCTs) showing a significant increase in unadjusted landmark mortality among surgical or critically ill patients. The authors reviewed such studies during a meeting by a core group of experts. Studies selected after such review advanced to web-based voting by clinicians in relation to agreement, clinical practice, and willingness to include each intervention in international guidelines. MEASUREMENTS AND MAIN RESULTS: The authors selected 12 RCTs dealing with 12 interventions increasing mortality: diaspirin-crosslinked hemoglobin (92% of agreement among web voters), overfeeding, nitric oxide synthase inhibitor in septic shock, human growth hormone, thyroxin in acute kidney injury, intravenous salbutamol in acute respiratory distress syndrome, plasma-derived protein C concentrate, aprotinin in high-risk cardiac surgery, cysteine prodrug, hypothermia in meningitis, methylprednisolone in traumatic brain injury, and albumin in traumatic brain injury (72% of agreement). Overall, a high consistency (ranging from 80% to 90%) between agreement and clinical practice was observed. CONCLUSION: The authors identified 12 clinical interventions showing increased mortality supported by randomized controlled trials with nonconflicting evidence, and wide agreement upon clinicians on a global scale.

10.
N Engl J Med ; 380(13): 1214-1225, 2019 03 28.
Artigo em Inglês | MEDLINE | ID: mdl-30888743

RESUMO

BACKGROUND: Volatile (inhaled) anesthetic agents have cardioprotective effects, which might improve clinical outcomes in patients undergoing coronary-artery bypass grafting (CABG). METHODS: We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year. RESULTS: A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P = 0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction. CONCLUSIONS: Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).


Assuntos
Anestesia Intravenosa , Anestésicos Gerais/farmacologia , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Administração por Inalação , Idoso , Anestesia Geral , Anestésicos Intravenosos , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/fisiopatologia , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Mortalidade , Método Simples-Cego , Volume Sistólico
11.
J Cardiothorac Vasc Anesth ; 33(5): 1430-1439, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30600204

RESUMO

The authors aimed to identify interventions documented by randomized controlled trials (RCTs) that reduce mortality in adult critically ill and perioperative patients, followed by a survey of clinicians' opinions and routine practices to understand the clinicians' response to such evidence. The authors performed a comprehensive literature review to identify all topics reported to reduce mortality in perioperative and critical care settings according to at least 2 RCTs or to a multicenter RCT or to a single-center RCT plus guidelines. The authors generated position statements that were voted on online by physicians worldwide for agreement, use, and willingness to include in international guidelines. From 262 RCT manuscripts reporting mortality differences in the perioperative and critically ill settings, the authors selected 27 drugs, techniques, and strategies (66 RCTs, most frequently published by the New England Journal of Medicine [13 papers], Lancet [7], and Journal of the American Medical Association [5]) with an agreement ≥67% from over 250 physicians (46 countries). Noninvasive ventilation was the intervention supported by the largest number of RCTs (n = 13). The concordance between agreement and use (a positive answer both to "do you agree" and "do you use") showed differences between Western and other countries and between anesthesiologists and intensive care unit physicians. The authors identified 27 clinical interventions with randomized evidence of survival benefit and strong clinician support in support of their potential life-saving properties in perioperative and critically ill patients with noninvasive ventilation having the highest level of support. However, clinician views appear affected by specialty and geographical location.


Assuntos
Cuidados Críticos/métodos , Estado Terminal/mortalidade , Internet , Médicos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Inquéritos e Questionários , Cuidados Críticos/tendências , Estado Terminal/terapia , Humanos , Unidades de Terapia Intensiva/tendências , Internet/tendências , Mortalidade/tendências , Médicos/tendências
12.
ASAIO J ; 65(4): e33-e35, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-29952802

RESUMO

We present a time-series analysis of shear-mediated platelet activation (SMPA) in a patient supported by a Left Ventricular Assist Device (LVAD) who developed recurrent thromboembolic events over the course of support. The patient showed marked alterations of SMPA as quantified via the Platelet Activity State (PAS) assay. At the time of a first pump thrombosis, PAS was equal to 16.2 ± 2.1%, indicating a significant level of SMPA. A moderate decrease of PAS was observed 30 days after pump exchange (PAS = 9.5 ± 1.0%). A sudden PAS increase was recorded after 60 days (PAS = 60.5 ± 4.3%), and an ischemic stroke with hemorrhagic transformation was subsequently diagnosed at 120 days after pump exchange (PAS = 86.9 ± 7.5%); high PAS values did not recover over time likely because of sustained platelet activation from the inflammatory milieu caused by a driveline infection occurred at 240 days of support (PAS = 84.4 ± 7.3%). PAS values were completely reversed after heart transplantation (PAS = 0.6 ± 0.1%), demonstrating resolution of SMPA. This study provides further insight into our understanding of the pathogenesis of LVAD thrombosis, addressing SMPA as a relevant key factor associated with thrombotic complications. With the PAS assay, we have identified a reliable biomarker to promote tailored pharmacological therapy for the prevention of thromboembolic events in patients with LVADs.


Assuntos
Transplante de Coração , Coração Auxiliar/efeitos adversos , Ativação Plaquetária/fisiologia , Tromboembolia/etiologia , Plaquetas/patologia , Plaquetas/fisiologia , Feminino , Insuficiência Cardíaca/terapia , Humanos , Pessoa de Meia-Idade , Estresse Mecânico , Trombose/etiologia , Fatores de Tempo
13.
Eur J Vasc Endovasc Surg ; 57(3): 360-367, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30385186

RESUMO

OBJECTIVE: Epidural analgesia improves pain control and outcomes of abdominal aortic aneurysm procedures, while the effect of thoracic epidural analgesia on thoraco-abdominal aortic aneurysm (TAAA) repair is unknown. The aim of the study was to evaluate thoracic epidural analgesia effects in patients undergoing open TAAA repair in terms of pain control and clinically relevant outcomes. METHODS: This was a retrospective study of a prospectively collected database. Patients undergoing open TAAA repair between January 2009 and December 2016. RESULTS: Four hundred and fifty-nine consecutive patients were included. Thoracic epidural analgesia was used in 409 (89%) of cases. On multivariable analysis, patients who received thoracic epidural analgesia experienced reduced post-operative pain (odds ratio [OR] 0.003, 95% confidence interval [CI] 0.0007-0.009; p < .001), a lower rate of acute kidney injury (AKI; OR 0.39, 95% CI 0.21-0.71 [p = .002]), atrial fibrillation (OR 0.47, 95% CI 0.23-0.95; p = .04), acute myocardial infarction (AMI; OR 0.189, 95% CI 0.05-0.64; p = .008), and paraplegia (OR 0.31, 95% CI 0.157-0.615; p = .001) compared with the conventional analgesia (CA) group. After propensity score matching, 43 patients in the CA group were compared with 43 in thoracic epidural analgesia group. On case match analysis thoracic epidural analgesia showed a significant reduction in post-operative pain (p < .001) and no differences in the incidence of AKI, atrial fibrillation, AMI, and paraplegia. In the thoracic epidural analgesia group there were no epidural haematomas. CONCLUSION: Thoracic epidural analgesia was effective in reducing post-operative pain with no effect on major post-operative complications. The use of thoracic epidural analgesia, if not contraindicated, might be considered in clinical practice, even in patients undergoing open TAAA repair. Whether a better post-operative management enhances patient's recovery in this setting remains to be tested.


Assuntos
Analgesia Epidural/métodos , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/efeitos adversos , Dor Pós-Operatória/prevenção & controle , Idoso , Analgesia Epidural/efeitos adversos , Analgesia Epidural/mortalidade , Aneurisma da Aorta Torácica/diagnóstico , Aneurisma da Aorta Torácica/mortalidade , Implante de Prótese Vascular/mortalidade , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/mortalidade , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
J Heart Lung Transplant ; 38(4): 440-448, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30503053

RESUMO

BACKGROUND: In this retrospective analysis we evaluated a standardized echocardiographic assessment and an invasive technique for patient selection for successful continuous-flow left ventricular assist device (CF-LVAD) explantation. METHODS: Inclusion criteria for LVAD recovery assessment were: clinically stable condition; LVAD support for >6 months; physical activity; normal echocardiography findings; and no more than mild valvular disease and aortic valve opening. In a second step, echocardiography was performed under CF-LVAD reduction and stop conditions (PStopE). In the third step, patients who presented with stable parameters underwent right heart catheterization under CF-LVAD stoppage and occlusion of the outflow graft with a balloon catheter. Criteria for explantation were normal pulmonary artery pressure and pulmonary capillary wedge pressure <16 mmHg. RESULTS: Thirty-three of 424 patients entered the second step of evaluation and 20 entered the third step. Fourteen presented positive results and the pump was successfully explanted. The PCWP at baseline was 8.5 (2.8) mmHg in the explantation group and 10.6 (2.8) mmHg in the non-explantation group (p = 0.105). It increased to 10.9 (3.0) mmHg vs 20.8 (4.9) mmHg under outflow graft occlusion. The wedge pressure was significantly higher in the non-explantation group (p < 0.001). Median duration of follow-up after explantation was 9.74 (interquartile range 4.3 to 20.60) months, with survival of 93%. CONCLUSIONS: The protocol presented is feasible and safe. The criteria applied provide good patient selection for sustained mid-term myocardial recovery after LVAD explantation.

15.
J Cardiothorac Vasc Anesth ; 33(7): 1883-1889, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30581110

RESUMO

OBJECTIVE: Patients undergoing transapical cardiac procedure are a minority of cardiac surgery patients but represent a challenge for cardiac anesthesiologists because they generally are older and have more comorbidities than do open heart cardiac surgery patients. The aims of this study were to describe the anesthetic experience with transapical procedures in a single high-volume center and to analyze the most critical aspects for anesthetic management. DESIGN: Retrospective study. SETTING: IRCCS San Raffaele Scientific Institute, Milan, Italy. PARTICIPANTS: All patients undergoing a cardiac transapical procedure from January 2009 to April 2018 were included in this case series. INTERVENTIONS: Patients were managed by a multidisciplinary heart team. The perioperative anesthetic approach and hemodynamic management were consistent and performed by a group of trained cardiac anesthesiologists. MEASUREMENTS AND MAIN RESULTS: The study population comprised 143 patients: 81 (57%) underwent an aortic valve procedure, 60 (42%) a mitral valve intervention, 1 patient underwent a procedure involving both the aortic and mitral valves, and 1 patient underwent correction of a congenital heart defect. A major intraoperative complication occurred in 5 (3.5%) patients, the procedure was not technically feasible because of unsuitable anatomy in 3 patients, and conversion to open heart surgery was needed in 2 patients. All patients were admitted to the intensive care unit. Intensive care unit stay was 1 (1-3) days, and hospital stay was 6 (5-8) days. Hospital survival was 94%. CONCLUSIONS: Patients undergoing transapical cardiac procedures are a minority of cardiac surgery patients, but represent a high-risk population. A patient-tailored anesthetic approach, in the context of the therapeutic strategy shared by the heart team, is crucial to improve outcomes.


Assuntos
Anestesia em Procedimentos Cardíacos/métodos , Procedimentos Cirúrgicos Cardíacos/métodos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Procedimentos Cirúrgicos Cardíacos/mortalidade , Feminino , Implante de Prótese de Valva Cardíaca/métodos , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/cirurgia , Estudos Retrospectivos
16.
Minerva Anestesiol ; 85(2): 194-200, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30394068

RESUMO

It is a common observation that many multicenter randomized controlled trials (mRCT) performed in critically ill patients do not achieve the positive findings often seen in single center studies (sRCT). This has, of course, relevant consequences for clinical practice, as mRCTs have higher scientific validity compared to sRCTs. The aim of this manuscript was to review and discuss the several potential causes of this phenomenon and to relate them to the future of mRCTs in critical care medicine. Overall, this seems to recall the old mythologic story of Achilles and the tortoise: although mRCTs (i.e. Achilles) are much more powerful, indeed, they always arrive later in time compared to the sRCTs (i.e. the tortoise) from which they were powered. However, sRCTs are more prone to several bias compared to mRCTs, such as local effect bias, selection and performance bias, detection and reporting bias, analysis and attrition bias, concomitant therapy bias, low fragility index and publication bias. In this sense, it is high time the critical care community should see the positive findings of sRTCs with a very high level of scientific caution, unless they are confirmed by mRCTs. MRCTs represent the final step of the process of evidence-based medicine and in the end (however slowly and painfully) such evidence catches up with sRCT and truly helps changes practice worldwide.


Assuntos
Estudos Multicêntricos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Cuidados Críticos , Estado Terminal/terapia , Humanos , Projetos de Pesquisa
17.
Circulation ; 139(10): 1249-1258, 2019 03 05.
Artigo em Inglês | MEDLINE | ID: mdl-30586755

RESUMO

BACKGROUND: Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS. METHODS: Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality. RESULTS: In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%, P<0.01) and peripheral vascular complications (9.8% versus 3.8%, P=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results. CONCLUSIONS: In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03313687.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Coração Auxiliar , Balão Intra-Aórtico , Infarto do Miocárdio/terapia , Revascularização Miocárdica , Choque Cardiogênico/terapia , Idoso , Fármacos Cardiovasculares/efeitos adversos , Europa (Continente) , Feminino , Coração Auxiliar/efeitos adversos , Humanos , Balão Intra-Aórtico/efeitos adversos , Balão Intra-Aórtico/mortalidade , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Revascularização Miocárdica/efeitos adversos , Revascularização Miocárdica/mortalidade , Desenho de Prótese , Recuperação de Função Fisiológica , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidade , Choque Cardiogênico/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
18.
J Interv Cardiol ; 31(6): 717-724, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30460719

RESUMO

OBJECTIVES: Aim of the study was to assess in-hospital survival rate and the degree of myocardial recovery after MCS treatment (IABP or IMPELLA) at discharge and at 6 months in patients with AMI-CS and planned early percutaneous revascularization. BACKGROUND: All studies on MCS for acute myocardial infarction related cardiogenic shock (AMI-CS) focused on its impact on in-hospital mortality; however, few data about its role on myocardial recovery are available. METHODS: Retrospective study on 64 patients: 36 patients (56%) received IABP and 28 (44%) Impella 2.5/CP. RESULTS: Patients treated with Impella were sicker compared to those treated with IABP as shown by a higher need of catecholamines (93% Impella vs 57% IABP, P = 0.002) and higher inotropic score before procedure: 8 (5-15) versus 4.5 (0-9), P = 0.02. In-hospital survival and MCS-related complications were comparable; hemolysis was more frequent in the Impella group (32% vs 0%, P < 0.0001). Myocardial damage was lower in those patients who were implanted with IMPELLA before PCI: lower troponin peak [3831 ng/dL (1441-8436) vs 16 581 (7802-23 675), P = 0.004] and lower CPK peak [893 UI/L (584-4082) vs 5797 (2483-9292) P = 0.04]. Impella patients had higher LVEF at 6 months [45 (38-52) vs 40 (33-45)%, P = 0.04]. LVEF increase at 6 months was statistically significant in both groups (P < 0.0001), with higher myocardial recovery in patients supported with Impella (absolute delta-LVEF increase 20% vs 10% P = 0.005). CONCLUSIONS: Cardiac unloading with IMPELLA in ACS-CS, especially if implanted before PCI, might provide lower myocardial damage and improved myocardial recovery which translates into significantly higher LVEF at 6 months.


Assuntos
Coração Auxiliar/estatística & dados numéricos , Infarto do Miocárdio/terapia , Choque Cardiogênico/terapia , Idoso , Cardiotônicos/administração & dosagem , Feminino , Coração Auxiliar/efeitos adversos , Mortalidade Hospitalar , Humanos , Balão Intra-Aórtico/efeitos adversos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidade , Taxa de Sobrevida , Resultado do Tratamento
19.
J Cardiothorac Vasc Anesth ; 32(5): 2339-2343, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30093192

RESUMO

Temporary mechanical circulatory support devices for the treatment of acute right ventricular failure represent crucial tools for clinical practice. Right ventricular failure presents specific treatment issues, and dedicated percutaneous devices are less in number compared to the left ventricle. Current data and insights on mechanical circulatory support for the right ventricle come mostly from the context of cardiac surgery, predominantly the setting of acute right ventricular failure after left ventricular assist device implantation. The Impella RP (Abiomed, Danvers, MA) is a minimally invasive temporary device that has gained application for the percutaneous treatment of right ventricular failure with positive clinical results. Even though treatment indications are clear, technical and management issues still are relevant because of the limited scientific data available. Appropriate positioning and repositioning, interaction with right ventricular valvular apparatus, anticoagulation management, weaning, and patient mobilization are examples of the open challenges. In line with the positive initial experience with this device, future research efforts should be focused on the improvement of device limitations and on providing additional data that might drive optimal clinical management.


Assuntos
Insuficiência Cardíaca/terapia , Coração Auxiliar , Disfunção Ventricular Direita/terapia , Função Ventricular Direita/fisiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Desenho de Prótese , Disfunção Ventricular Direita/fisiopatologia
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