Short-term dual antiplatelet therapy in diabetic patients admitted for acute coronary syndrome treated with a new-generation drug-eluting stent.

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug-eluting stent (DES) remains unclear. This is a prespecified sub-study from the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short-term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent. METHODS: In this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow-up. RESULTS: A total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow-up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all-cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups. CONCLUSIONS: This sub-analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high-risk patients.

Point-of-Care Measurement of Kaolin Activated Clotting Time during Cardiopulmonary Bypass: A Single Sample Comparison between ACT Plus and i-STAT.

Heparin anticoagulation monitoring by point-of-care activated clotting time (ACT) is essential for cardiopulmonary bypass (CPB) initiation, maintenance, and anticoagulant reversal. Concerns exist regarding the comparability of kaolin activated ACT devices. The current study, therefore, evaluated the agreement of ACT assays using parallel measurements performed on two commonly used devices. Measurements were conducted in a split-sample fashion on both the ACT Plus (Medtronic, Minneapolis, MN) and i-STAT (Abbott Point of Care, Princeton, NJ) analyzers. Blood samples from 100 adult patients undergoing elective cardiac surgery with CPB were assayed at specified time points: before heparinization, following systemic heparinization, after CPB initiation, every 30 minutes during CPB, and following protamine administration. A cutoff value of 400 seconds (s) was used as part of the local protocol. Measurements were compared using t tests or Wilcoxon signed-rank tests, linear regression, and Bland-Altman analyses. Parallel ACT measurements demonstrated a good linear correlation (r = .831, p < .001). The overall median difference between both measurements was significantly different from zero, amounting to 87 (14-189) (p < .001), with limits of agreement of -124 and 333s. The i-STAT-derived ACT values were systematically lower than the ACT Plus values, which was more pronounced during CPB. Fourteen patients received additional heparin during CPB at a median ACT Plus value of 414s, with a concomitant median i-STAT value of 316s. Assuming 308s as the theoretical i-STAT cutoff value based on the linear regression equation and an ACT Plus threshold of 400s, 29 patients would have received additional heparin. Based on these results, kaolin point-of-care ACT devices cannot be used interchangeably. Device-specific predefined target values are warranted to avert heparin overdosing during CPB.

Cerebral and Limb Tissue Oxygenation During Peripheral Venoarterial Extracorporeal Life Support.

Femoral access in extracorporeal life support (ECLS) has been associated with regional variations in arterial oxygen saturation, potentially predisposing the patient to ischemic tissue damage. Current monitoring techniques, however, are limited to intermittent bedside evaluation of capillary refill among other factors. The aim of this study was to assess whether cerebral and limb regional tissue oxygen saturation (rSO2) values reflect changes in various patient-related parameters during venoarterial ECLS (VA-ECLS). This retrospective observational study included adults assisted by femorofemoral VA-ECLS. Bifrontal cerebral and bilateral limb tissue oximetry was performed for the entire duration of support. Hemodynamic data were analyzed parallel to cerebral and limb rSO2. A total of 23 patients were included with a median ECLS duration of 5 [1-20] days. Cardiac arrhythmias were observed in 12 patients, which was associated with a decreased mean rSO2 from 61%±11% to 51%±10% during atrial fibrillation and 67%±9% to 58%±10% during ventricular fibrillation (P<0.001 for both). A presumably sudden increase in cardiac output due to myocardial recovery (n=8) resulted in a significant decrease in mean cerebral rSO2 from 73%±7% to 54%±6% and from 69%±9% to 53%±8% for the left and right cerebral hemisphere, respectively (P=0.012 for both hemispheres). Also, right radial artery partial gas pressure for oxygen decreased from 15.6±2.8 to 8.3±1.9 kPa (P=0.028). No differences were found in cerebral desaturation episodes between patients with and without neurologic complications. In six patients, limb rSO2 increased from on average 29.3±2.7 to 64.0±5.1 following insertion of a distal cannula in the femoral artery (P=0.027). Likewise, restoration of flow in a clotted distal cannula inserted in the femoral artery was necessary in four cases and resulted in increased limb rSO2 from 31.3±0.8 to 79.5±9.0; P=0.068. Non-invasive tissue oximetry adequately reflects events influencing cerebral and limb perfusion and can aid in monitoring tissue perfusion in patients assisted by ECLS.

Economic Analysis of Noninvasive Tissue Oximetry for Postoperative Monitoring of Deep Inferior Epigastric Perforator Flap Breast Reconstruction: A Review.

Background. Postoperative monitoring of deep inferior epigastric perforator (DIEP) flaps for breast reconstruction using noninvasive tissue oximetry enables timely recognition of vascular compromise. This may limit ischemic tissue damage, minimizing postoperative morbidity and healthcare costs. The aim of this review was to provide an economic analysis of tissue oximetry for postoperative monitoring of DIEP flap breast reconstruction. Methods. A systematic literature search was conducted utilizing PubMed and Embase. Articles reporting costs related to tissue oximetry following DIEP flap breast reconstruction, costs directly related to DIEP flap surgical procedure, and costs associated with postoperative complications were included. Risk of bias was assessed using different tools depending on study type. Results. Six articles were included. Four studies provided an overview of total costs associated with DIEP flap breast reconstruction; two studies focused on whether tissue oximetry could facilitate a decrease in hospital costs. Average overall costs for DIEP flap procedure were estimated at $28 000, with additional costs up to $37 530 in case of total flap failure. Tissue oximetry to monitor DIEP flaps could potentially save up to $1667 per procedure. Moreover, it might eliminate the need for specialized postoperative care. Conclusion. Tissue oximetry following DIEP flap breast reconstruction can potentially facilitate a decrease in hospital costs since its readings enable physicians to intervene in an early stage of tissue malperfusion, contributing to minimizing complications. Tissue oximetry may eliminate the need for specialized postoperative care. However, based on the current literature, no firm conclusions can yet be drawn regarding cost-effectiveness of standard implementation.

Non-Invasive Tissue Oximetry-An Integral Puzzle Piece.

Non-invasive tissue oximetry is a monitoring method for continuous assessment of tissue oxygenation, which may aid in detection of hemodynamic instability and otherwise unnoticed hypoxia. Numerous studies focused on using non-invasive tissue oximetry intraoperatively, proposing its predictive value in relation to clinical outcome. Tissue oximetry may be part of standard monitoring practice for brain monitoring during cardiac surgery in many clinical centers; however, the monitoring method can be deployed in numerous clinical settings. This succinct overview aims to determine the role of non-invasive tissue oximetry in current clinical practice.

Cerebral Oximetry and Autoregulation during Cardiopulmonary Bypass: A Review.

Postoperative neurological complications (PNCs) following cardiac surgery with cardiopulmonary bypass (CPB) is a detrimental complication, contributing to increased mortality rates and health care costs. To prevent intraoperative cerebral desaturations associated with PNC, continuous brain monitoring using near-infrared spectroscopy has been advocated. However, clear evidence for a defined desaturation threshold requiring intervention during CPB is still lacking. Since cerebral oximetry readings are nonspecific, cerebral tissue oxygenation values need to be interpreted with caution and in the context of all available clinical information. Therefore, maintaining an intact autoregulatory activity during CPB rather than solely focusing on regional cerebral oxygen saturation measurements will collectively contribute to optimization of patient care during CPB.

Vascular Occlusion Test to Dynamically Assess Microcirculation During Normothermic Pulsatile Cardiopulmonary Bypass.

OBJECTIVE: To evaluate parameters of the vascular occlusion test (VOT) before, during, and after pulsatile cardiopulmonary bypass (CPB). DESIGN: Prospective, observational study. SETTING: Single-center university hospital. PARTICIPANTS: Adult patients undergoing elective cardiac surgery with pulsatile CPB. INTERVENTIONS: An oximeter sensor and adult-sized pneumatic tourniquet were positioned at the right forearm. A VOT with a predefined ischemic time of 3 minutes was performed before, during, and after CPB. Changes in tissue oxygen saturation were recorded. MEASUREMENTS AND MAIN RESULTS: Thirty-four patients who underwent cardiac surgery were enrolled in the study. The lowest tissue oxygen saturation measured during the ischemic challenge differed among all 3 stages of surgery, with median values of 62.9% before, 57.5% during, and 59.3% after perfusion (p<0.05). Both occlusion (p<0.001) and reperfusion (p<0.05) slopes were steeper after bypass compared with before initiating bypass, whereas the reperfusion time remained constant among the different time points. CONCLUSIONS: The microcirculatory function as demonstrated by changes in VOT parameters was enhanced during and after normothermic pulsatile CPB. Clinical relevance, however, needs to be further explored.

Hemodilution Combined With Hypercapnia Impairs Cerebral Autoregulation During Normothermic Cardiopulmonary Bypass.

OBJECTIVE: To investigate the influence of hemodilution and arterial pCO2 on cerebral autoregulation and cerebral vascular CO2 reactivity. DESIGN: Prospective interventional study. SETTING: University hospital-based single-center study. PARTICIPANTS: Forty adult patients undergoing elective cardiac surgery using normothermic cardiopulmonary bypass. INTERVENTIONS: Blood pressure variations induced by 6/minute metronome-triggered breathing (baseline) and cyclic 6/min changes of indexed pump flow at 3 levels of arterial pCO2. MEASUREMENTS AND MAIN RESULTS: Based on median hematocrit on bypass, patients were assigned to either a group of a hematocrit ≥28% or<28%. The autoregulation index was calculated from cerebral blood flow velocity and mean arterial blood pressure using transfer function analysis. Cerebral vascular CO2 reactivity was calculated using cerebral tissue oximetry data. Cerebral autoregulation as reflected by autoregulation index (baseline 7.5) was significantly affected by arterial pCO2 (median autoregulation index amounted to 5.7, 4.8, and 2.8 for arterial pCO2 of 4.0, 5.3, and 6.6 kPa, p≤0.002) respectively. Hemodilution resulted in a decreased autoregulation index; however, during hypocapnia and normocapnia, there were no significant differences between the two hematocrit groups. Moreover, the autoregulation index was lowest during hypercapnia when hematocrit was<28% (autoregulation index 3.3 versus 2.6 for hematocrit ≥28% and<28%, respectively, p = 0.014). Cerebral vascular CO2 reactivity during hypocapnia was significantly lower when perioperative hematocrit was<28% (p = 0.018). CONCLUSIONS: Hemodilution down to a hematocrit of<28% combined with hypercapnia negatively affects dynamic cerebral autoregulation, which underlines the importance of tight control of both hematocrit and paCO2 during CPB.

Impact of Intraoperative Events on Cerebral Tissue Oximetry in Patients Undergoing Cardiopulmonary Bypass.

Previous studies showed that decreased cerebral saturation during cardiac surgery is related to adverse postoperative outcome. Therefore, we investigated the influence of intraoperative events on cerebral tissue saturation in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). A total of 52 adult patients who underwent cardiac surgery using pulsatile CPB were included in this prospective explorative study. Cerebral tissue oxygen saturation (SctO2) was measured in both the left and right cerebral hemisphere. Intraoperative events, involving interventions performed by anesthesiologist, surgeon, and clinical perfusionist, were documented. Simultaneously, in-line hemodynamic parameters (partial oxygen pressure, partial carbon dioxide pressure, hematocrit, arterial blood pressure, and CPB flow rates) were recorded. Cerebral tissue saturation was affected by anesthetic induction (p < .001), placement of the sternal retractor (p < .001), and initiation (p < .001) as well as termination of CPB (p < .001). Placement (p < .001) and removal of the aortic cross-clamp (p = .026 for left hemisphere, p = .048 for right hemisphere) led to changes in cerebral tissue saturation. In addition, when placing the aortic crossclamp, hematocrit (p < .001) as well as arterial (p = .007) and venous (p < .001) partial oxygen pressures changed. Cerebral tissue oximetry effectively identifies changes related to surgical events or vulnerable periods during cardiac surgery. Future studies are needed to identify methods of mitigating periods of reduced cerebral saturation.

Unraveling the Multitude of Etiologies in Myocardial Infarction With Nonobstructive Coronary Arteries.

Although recent studies revealed suboptimal outcomes in patients with myocardial infarction with nonobstructive coronary arteries (MINOCAs), the underlying etiology remains unknown in most patients. Therefore, adequate treatment modalities have not yet been established. We aimed to assess demographics, treatment strategies, and long-term clinical outcome in MINOCA subgroups. We retrospectively analyzed data from a large, prospective observational study of patients with acute coronary syndrome admitted to the Isala hospital in Zwolle, The Netherlands between 2006 and 2014. Patients with MINOCA were divided into subgroups based on the underlying cause of the event. From 7,693 patients, 402 patients (5%) concerned MINOCA. After the exclusion of missing cases (n = 47), 5 subgroups were distinguished: "true" acute myocardial infarction (10%), perimyocarditis (13%), cardiomyopathy (including Takotsubo cardiomyopathy) (19%), miscellaneous causes (21%), and an indeterminate group (38%). Patients with cardiomyopathy were predominantly women (78%) and showed the highest incidence of major adverse cardiovascular events at 30 days follow-up (7%; p = 0.012), 1 year (19%; p = 0.004), and mortality at long-term follow-up (27%; p = 0.010) compared with any other MINOCA subgroup. The cardiomyopathy group was followed by the indeterminate group, with major adverse cardiovascular events rates of 1% and 5%, respectively, and 17% long-term all-cause mortality. In conclusion, long-term prognosis in MINOCA depends on the underlying etiology. Prognosis is worst in the cardiomyopathy group followed by the indeterminate group. This underlines the importance of revealing the diagnosis to ultimately optimize treatment.

Prevalence of a History of Metabolic or Hypertensive Pregnancy Disorder in Patients With Myocardial Infarction and Non-obstructive Coronary Arteries: An Observational Cohort Study.

Introduction: Myocardial infarction with non-obstructive coronary arteries (MINOCA) predominantly affects younger females. Women with a history of gestational hypertension (GH), preeclampsia (PE), and gestational diabetes mellitus (GDM) are subjected to an elevated lifetime risk of cardiovascular disease. However, data on the potential association between these obstetric complications and MINOCA is lacking. Therefore, the current study aimed to provide insight in the prevalence of metabolic and hypertensive pregnancy disorders (MHPD) in MINOCA patients and their clinical characteristics. Methods: In this observational cohort study conducted at the Zuyderland Medical Center and Maastricht University Medical Center in the Netherlands, patients were enrolled if they were identified as having MINOCA. Data on individual patient characteristics, laboratory results, electrocardiography as well as (non-)invasive imaging procedures were derived from the electronic health record system. Patients were asked to complete a questionnaire about prior MHPD including GDM, GH, and PE. Patients were grouped into those with MHPD and those with prior uncomplicated normotensive pregnancy (or pregnancies; NP). Results: After excluding patients without 1-year follow-up (n = 53), 86 female MINOCA patients remained eligible for analysis. Of the total female population, 25 (29.1%) patients had MHPD, including GH (n = 19; 22.1%), PE (n = 4; 4.7%), and GDM (n = 7; 8.1%). The MHPD patients showed higher rates of chronic hypertension (84.0 vs. 55.7%; p = 0.013), hypercholesterolemia (64.0 vs. 34.4%; p = 0.012), a family history of CVD (84.0 vs. 45.9%; p = 0.001), gout or rheumatic arthritis (16.0 vs. 1.6%; p = 0.024), and were more often non-smokers (45.8 vs. 78.3%; p = 0.004), compared to the NP patients. Moreover, MHPD patients were more likely to use cardiovascular medications at baseline. A trend toward no specific cause found for the MINOCA event was observed in MHPD patients compared to the NP group (64.0 vs. 42.6%, p = 0.072). Conclusion: A history of metabolic and hypertensive pregnancy disorders occurred in one-third of female MINOCA patients. In these patients, conventional cardiovascular risk factors were more prevalent compared to NP patients. In most MHPD patients, the specific cause for MINOCA remained unclear.

MINOCA: The caveat of absence of coronary obstruction in myocardial infarction.

AIMS: Whether patients with MINOCA (myocardial infarction with non-obstructive coronary arteries) have better outcomes than patients with obstructive coronary artery disease remains contradictory. The current study focussed on the clinical profile and prognosis of MINOCA patients. METHODS AND RESULTS: We performed a retrospective analysis of patients with acute coronary syndrome (ACS) admitted to the Isala hospital in Zwolle, the Netherlands, between 2006 and 2014. A total of 7693 patients were categorized into three groups: MINOCA, single-vessel obstructive ACS (SV-ACS), and multi-vessel obstructive ACS (MV-ACS). MINOCA patients (5.2% of the total population) were more likely to be female (51.5% vs. 30.3% and 26.0% in SV-ACS and MV-ACS, respectively, p < 0.001 for both). The prevalence of risk factors in the MINOCA group was in between the SV-ACS and MV-ACS groups. Logistic regression revealed a lower odds of dying in SV-ACS (odds ratio (OR) = 0.70 (p = 0.04)) and a similar odds in MV-ACS (OR = 0.88, p = 0.45) compared to MINOCA. CONCLUSIONS: Patients with MINOCA show an 'intermediate' risk profile with mortality rates in between those of both ACS groups. Hence, MINOCA should be recognised as a potential risk factor for mortality, requiring adequate treatment and follow-up.

The role of patient's profile and allogeneic blood transfusion in development of post-cardiac surgery infections: a retrospective study.

OBJECTIVES: We aimed to investigate the association of patient characteristics and allogeneic blood transfusion products in development of post-cardiac surgery nosocomial infections. METHODS: This retrospective study was conducted in 7888 patients undergoing cardiac surgery with median sternotomy and cardiopulmonary bypass. Multivariable logistic regression analysis was used for independent effect of variables on infections. RESULTS: A total of 970 (12.3%) patients developed one or several types of postoperative infections. Urinary (n = 351, 4.4%) and pulmonary tract infections (n = 478, 6.1%) occurred more frequently than sternal wound infections (superficial: n = 102, 1.3%, deep: n = 72, 0.9%) and donor site infections (n = 61, 0.8%). Interventions, including valve replacement (P = 0.002) and coronary artery bypass grafting combined with valve replacement (P = 0.012), were associated with increased risk of several types of postoperative infections. Patients' profiles changed substantially over the years; morbid obesity (P = 0.019), smoking (P = 0.001) and diabetes mellitus (P = 0.001) occur more frequently nowadays. Furthermore, surgical site infections showed to be related to morbid obesity (P < 0.001) and higher risk stratification (P = 0.031). Smoking (P < 0.001) and chronic obstructive pulmonary disease (P < 0.001) were related to pulmonary tract infections. In addition, diabetic patients developed more sepsis (P = 0.003) and advanced age was associated with development of urinary tract infections (P < 0.001). Even after correcting for other factors, blood transfusion was associated with all types of postoperative infection (P < 0.001). This effect remained present in both leucocyte-depleted and non-leucocyte-depleted transfusion. CONCLUSIONS: Our data showed that post-cardiac surgery infections occur more frequently in patients with predetermined risk factors. The amount of blood transfusions was integrally related to every type of postoperative infection.