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1.

Background

Surgery for pancreatic cancer yields significant morbidity and mortality risks and survival is limited. Therefore, the influence of complications on quality of life (QoL) after pancreatic surgery is important. This study compares QoL in patients with and without severe complications after surgery for pancreatic (pre-)malignancy.

Methods

This prospective cohort study scored complications after pancreatic surgery according to the Clavien–Dindo system and the definitions of the International Study Group of Pancreatic Surgery. QoL was measured by the RAND36 questionnaire, the European Organization for Research and Treatment of Cancer core questionnaire (QLQ-C30) and the pancreas specific QLQ-PAN26. QoL in patients with severe complications was compared with QoL in patients with no or mild complications over a period of 12 months. Analysis was performed with linear mixed models for repeated measurements.

Results

Between March 2012 and July 2016, 137 patients were included. Sixty-eight patients (50%) had at least 1 severe complication. There were no statistically significant and clinically relevant differences between both groups in QoL up to 12 months after surgery.

Conclusion

In this study, no differences in QoL between patients with and without severe postoperative complications were encountered during the first 12 months after surgery for pancreatic (pre-)malignancy.

Trial registration

http://www.clinicaltrials.gov Identifier: NCT02175992.  相似文献   

2.

Background

Neoadjuvant treatment of colorectal liver metastases has become increasingly common, and while effective, often renders small metastases difficult to visualize on intraoperative US. The objective of this study was to determine the utility of a 3D image-guidance system in patients with intraoperative sonographically-occult CRLM.

Methods

50 patients with at least one CRLM ≤ 1.5 cm were enrolled in this prospective trial of an FDA-approved Explorer image-guidance system. If the tumor(s) seen on preoperative imaging were not identified with intraoperative US, Explorer was used to target the US examination to the involved area for a more focused assessment. The primary endpoint was the proportion of cases with sonographically-occult metastases identified using Explorer.

Results

Forty-eight patients with preoperative scans within eight weeks of surgery were included for analysis. Forty-six patients were treated with preoperative chemotherapy (median 4 months, range 2–24 months). Overall, 22 sonographically-occult tumors in 14 patients were interrogated by Explorer, of which 15 tumors in 10 patients were located with image-guidance assistance. The only difference between patients with tumors not identified on US and those who did was the number of tumors (median 3 vs. 2, p = 0.018).

Conclusion

3D image-guidance can assist in identifying small CRLM, particularly after treatment with chemotherapy.

Trial registration

ClinicalTrials.gov, NCT02806037, https://clinicaltrials.gov/ct2/show/NCT02806037.  相似文献   

3.

Background

Western guidelines recommend resection for hepatocellular carcinoma (HCC) in so-called ideal cirrhotic patients with a Barcelona Clinic Liver Cancer (BCLC) stage 0-A tumour. This study compares short-term outcomes following resection between patients defined as ideal and nonideal according to the BCLC guidelines.

Methods

This prospective single-centre open study (ClinicalTrials.govNCT02145013) included all cirrhotic patients with HCC referred for resection from 2014 to 2016. Mortality, morbidity, unresolved liver decompensation, and readmission were measured.

Results

The study population included 65 consecutive patients: 32 (49%) ideal and 33 (51%) nonideal. Ideal and nonideal groups did not differ in mortality (3% vs. 6%; p = 0.57), morbidity (53% vs. 73%; p = 0.10), or unresolved liver decompensation (6% vs. 15%; p = 0.23) at 90 days. The readmission rate was higher in the nonideal (21%) than in the ideal group (3%; p = 0.02).

Conclusion

Straying from the current guidelines for resection in a selected subset of nonideal patients doubled the number of resections performed for treating HCC, with satisfactory short-term outcomes. These results argue for the expansion of the acknowledged BCLC guidelines.  相似文献   

4.

Background

Peripheral artery disease (PAD), a diffuse manifestation of atherothrombosis, is a major cardiovascular threat. Although platelets are primary mediators of atherothrombosis, their role in the pathogenesis of PAD remains unclear.

Objectives

The authors sought to investigate the role of platelets in a cohort of symptomatic PAD.

Methods

The authors profiled platelet activity, mRNA, and effector roles in patients with symptomatic PAD and in healthy controls. Patients with PAD and carotid artery stenosis were recruited into ongoing studies (NCT02106429 and NCT01897103) investigating platelet activity, platelet RNA, and cardiovascular disease.

Results

Platelet RNA sequence profiling mapped a robust up-regulation of myeloid-related protein (MRP)-14 mRNA, a potent calcium binding protein heterodimer, in PAD. Circulating activated platelets were enriched with MRP-14 protein, which augmented the expression of the adhesion mediator, P-selectin, thereby promoting monocyte–platelet aggregates. Electron microscopy confirmed the firm interaction of platelets with monocytes in vitro and colocalization of macrophages with MRP-14 confirmed their cross talk in atherosclerotic manifestations of PAD in vivo. Platelet-derived MRP-14 was channeled to monocytes, thereby fueling their expression of key PAD lesional hallmarks and increasing their directed locomotion, which were both suppressed in the presence of antibody-mediated blockade. Circulating MRP-14 was heightened in the setting of PAD, significantly correlated with PAD severity, and was associated with incident limb events.

Conclusions

The authors identified a heightened platelet activity profile and unraveled a novel immunomodulatory effector role of platelet-derived MRP-14 in reprograming monocyte activation in symptomatic PAD. (Platelet Activity in Vascular Surgery and Cardiovascular Events [PACE]; NCT02106429; and Platelet Activity in Vascular Surgery for Thrombosis and Bleeding [PIVOTAL]; NCT01897103)  相似文献   

5.

Objective

This was a systematic review and meta-analysis to compare outcomes between patients undergoing simultaneous or delayed hepatectomy for synchronous colorectal liver metastases.

Background

The optimal strategy for treating liver disease among patients with resectable synchronous colorectal liver metastases (CRLM) is unclear. Simultaneous resection of primary tumour and liver metastases may improve patient experience by reducing the number of interventions. However, there are concerns of increased morbidity compared to delayed resections.

Methods

A systematic literature search was performed using EMBASE, Medline, Cochrane library and Google scholar databases. Meta-analyses were performed using both random-effects and fixed-effect models. Publication and patient selection bias were assessed with funnel plots and sensitivity analysis.

Results

Thirty studies including 5300 patients were identified. There were no statistically significant differences in parameters relating to safety and efficacy between the simultaneous and delayed hepatectomy cohorts. Patients undergoing delayed surgery were more likely to have bilobar disease or undergo major hepatectomy. The average length of hospital stay was six days shorter with simultaneous approach [MD = ?6.27 (95% CI: ?8.20, ?4.34), p < 0.001]. Long term survival was similar for the two approaches [HR = 0.97 (95%CI: 0.88, 1.08), p = 0.601].

Conclusion

In selected patients, simultaneous resection of liver metastases with colorectal resection is associated with shorter hospital stay compared to delayed resections, without adversely affecting perioperative morbidity or long-term survival.  相似文献   

6.

Objectives

The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort.

Background

The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization.

Methods

The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF.

Results

A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF.

Conclusions

In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)  相似文献   

7.

Objectives

This study sought to perform a prospective head-to-head comparison of the predictive value of clinical risk factors and a variety of cardiac imaging modalities including coronary artery calcium score (CACS), coronary computed tomography angiography (CTA), single-photon emission computed tomography (SPECT), and invasive coronary angiography (ICA) on major adverse cardiac events (MACE) and all-cause mortality in kidney transplantation candidates.

Background

Current guidelines recommend screening for coronary artery disease in kidney transplantation candidates. Furthermore, noninvasive stress imaging is recommended in current guidelines, despite its low diagnostic accuracy and uncertain prognostic value.

Methods

The study prospectively evaluated 154 patients referred for kidney transplantation. All patients underwent CACS, coronary CTA, SPECT, and ICA testing. The clinical endpoints were extracted from patients’ interviews, patients’ records, and registries.

Results

The mean follow-up time was 3.7 years. In total, 27 (17.5%) patients experienced MACE, and 31 (20.1%) patients died during follow-up. In a time-to-event analysis, both risk factors and CACS significantly predicted death, but only CACS predicted MACE. Combining risk factors with CACS identified a very-low-risk cohort with a MACE event rate of 2.1%, and a 1.0% mortality rate per year. Of the diagnostic modalities, coronary CTA and ICA significantly predicted MACE, but only coronary CTA predicted death. In contrast, SPECT predicted neither MACE nor death.

Conclusions

Compared with traditional risk factors and other cardiac imaging modalities, CACS and coronary CTA seem superior for risk stratification in kidney transplant candidates. Applying a combination of risk factors and CACS and subsequently coronary CTA seems to be the most appropriate strategy. (Angiographic CT of Renal Transplantation Candidate Study [ACToR]; NCT01344434)  相似文献   

8.

Background

Delayed cholecystectomy is associated with increased risk of biliary events. The objectives of the study were to confirm the superiority of index cholecystectomy over delayed operation in mild gallstone pancreatitis.

Methods

Patients with mild gallstone pancreatitis were randomized into index–or delayed cholecystectomy (IC vs. DC). IC was performed within 48 h from randomization provided a stable or improved clinical condition. The primary outcome was gallstone-related events. Secondary outcomes were rates of cholecystectomy complications, common bile duct stones (CBDS) detected at cholecystectomy and patient reported quality-of-life and pain.

Results

Sixty-six patients were randomized into IC (n = 32) or DC (n = 34) between May 2009 and July 2017. There were significantly higher rates of gallstone-related events in the DC compared with the IC group (nine patients vs. one patient, p = 0.013). No statistically significant differences could be demonstrated in cholecystectomy complications (p = 0.605) and CBDS discovered during cholecystectomy (p = 0.302) between the groups. Pain and emotional well-being measured by SF-36 were improved significantly in the IC group at follow-up.

Conclusions

Delayed cholecystectomy in mild gallstone pancreatitis can no longer be recommended since it is associated with an increased risk for recurrent gallstone-related events and impaired patient's reported outcomes.Trial registration number:clinicaltrials.gov (ID: NCT02630433).  相似文献   

9.

Objectives

In 13,038 patients with non–ST-segment elevation acute coronary syndrome undergoing index percutaneous coronary intervention (PCI) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) and TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trials, the relationship between PCI-related myocardial infarction (MI) and 1-year mortality was assessed.

Background

The definition of PCI-related MI is controversial. The third universal definition of PCI-related MI requires cardiac troponin >5 times the 99th percentile of the normal reference limit from a stable or falling baseline and PCI-related clinical or angiographic complications. The definition from the Society for Cardiovascular Angiography and Interventions (SCAI) requires creatine kinase–MB elevation >10 times the upper limit of normal (or 5 times if new electrocardiographic Q waves are present). Implications of these definitions on prognosis, prevalence, and implementation are not established.

Methods

In our cohort of patients undergoing PCI, PCI-related MIs were classified using the third universal type 4a MI definition and SCAI criteria. In the subgroup of patients included in the angiographic core laboratory (ACL) substudy of EARLY ACS (n = 1,401) local investigator– versus ACL-reported angiographic complications were compared.

Results

Altogether, 2.0% of patients met third universal definition of PCI-related MI criteria, and 1.2% met SCAI criteria. One-year mortality was 3.3% with the third universal definition (hazard ratio: 1.96; 95% confidence interval: 1.24 to 3.10) and 5.3% with SCAI criteria (hazard ratio: 2.79; 95% confidence interval: 1.69 to 4.58; p < 0.001). Agreement between ACL and local investigators in detecting angiographic complications during PCI was overall moderate (κ = 0.53).

Conclusions

The third universal definition of MI and the SCAI definition were both associated with significant risk for mortality at 1 year. Suboptimal concordance was observed between ACL and local investigators in identifying patients with PCI complications detected on angiography. (Trial to Assess the Effects of Vorapaxar [SCH 530348; MK-5348] in Preventing Heart Attack and Stroke in Participants With Acute Coronary Syndrome [TRA·CER] [Study P04736]; NCT00527943; EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome [Study P03684AM2]; NCT00089895)  相似文献   

10.

Background

Preoperative skeletal muscle depletion or sarcopenia has been suggested to predict worse outcome after resection of colorectal liver metastases. The aim of the present study was to investigate the impact of neoadjuvant chemotherapy on preoperative skeletal muscle mass prior to liver resection.

Methods

Patients operated with liver resection for colorectal liver metastases between 2010 and 2014 were retrospectively reviewed. Muscle mass was evaluated by measuring muscle area on a cross-sectional computed tomography image at the level of the third lumbar vertebra, and normalized for patient height, presenting a skeletal muscle index.

Results

Preoperative skeletal muscle mass was analysed in 225 patients, of whom 97 underwent neoadjuvant chemotherapy. In total 147 patients (65%) were categorized as sarcopenic preoperatively. Patients receiving neoadjuvant chemotherapy decreased in skeletal muscle mass (decrease by 5.5 (?1.1 to 11) % in skeletal muscle index, p < 0.001). Patients with muscle loss >5% during neoadjuvant chemotherapy were less likely to undergo adjuvant chemotherapy than others (68% vs 85%, p = 0.048). A >5% muscle loss did not result in worse overall (p = 0.131) or recurrence-free survival (p = 0.105).

Conclusion

Skeletal muscle mass decreases during neoadjuvant chemotherapy. Skeletal muscle loss during neoadjuvant chemotherapy impairs the conditions for adjuvant chemotherapy.  相似文献   

11.
12.

Background and aims

Both aerobic (AER) and resistance (RES) training improve metabolic control in patients with type 2 diabetes (T2DM). However, information on the effects of these training modalities on cardiovascular autonomic control is limited. Our aim was to compare the effects of AER and RES training on cardiovascular autonomic function in these subjects.

Methods and results

Cardiovascular autonomic control was assessed by Power Spectral Analysis (PSA) of Heart Rate Variability (HRV) and baroreceptors function indexes in 30 subjects with T2DM, randomly assigned to aerobic or resistance training for 4 months. In particular, PSA of HRV measured the Low Frequency (LF) and High Frequency (HF) bands of RR variations, expression of prevalent sympathetic and parasympathetic drive, respectively. Furthermore, we measured the correlation occurring between systolic blood pressure and heart rate during a standardized Valsalva maneuver using two indexes, b2 and b4, considered an expression of baroreceptor sensitivity and peripheral vasoactive adaptations during predominant sympathetic and parasympathetic drive, respectively.After training, the LF/HF ratio, which summarizes the sympatho-vagal balance in HRV control, was similarly decreased in the AER and RES groups. After AER, b2 and b4 significantly improved. After RES, changes of b2 were of borderline significance, whereas changes of b4 did not reach statistical significance. However, comparison of changes in baroreceptor sensitivity indexes between groups did not show statistically significant differences.

Conclusion

Both aerobic and resistance training improve several indices of the autonomic control of the cardiovascular system in patients with T2DM. Although these improvements seem to occur to a similar extent in both training modalities, some differences cannot be ruled out.

Clinical trial registration number

NCT01182948, clinicaltrials.gov.  相似文献   

13.

Background

Patients with synchronous colorectal liver metastases (sCRLM) are increasingly operated with liver resection before resection of the primary cancer. The aim of this study was to compare outcomes in patients following the liver-first strategy and the classical strategy (resection of the bowel first) using prospectively registered data from two nationwide registries.

Methods

Clinical, pathological and survival outcomes were compared between the liver-first strategy and the classical strategy (2008–2015). Overall survival was calculated.

Results

A total of 623 patients were identified, of which 246 were treated with the liver-first strategy and 377 with the classical strategy. The median follow-up was 40 months. Patients chosen for the classical strategy more often had T4 primary tumours (23% vs 14%, P = 0.012) and node-positive primaries (70 vs 61%, P = 0.015). The liver-first patients had a higher liver tumour burden score (4.1 (2.5–6.3) vs 3.6 (2.2–5.1), P = 0.003). No difference was seen in five-year overall survival between the groups (54% vs 49%, P = 0.344). A majority (59%) of patients with rectal cancer were treated with the liver-first strategy.

Conclusion

The liver-first strategy is currently the dominant strategy for sCRLM in patients with rectal cancer in Sweden. No difference in overall survival was noted between strategies.  相似文献   

14.

Background

Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.

Objectives

The authors report their early experience with TMVR using a new valve system.

Methods

The valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (United States, Australia, and Europe).

Results

Fifty consecutively enrolled patients (mean age: 73 ± 9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean Society for Thoracic Surgery score was 6.4 ± 5.5%; 86% of patients were New York Heart Association functional class III or IV, and the mean left ventricular ejection fraction was 43 ± 12%. Device implant was successful in 48 patients with a median deployment time of 14 min (interquartile range: 12 to 17 min). The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173 days (interquartile range: 54 to 342 days). At latest follow-up, echocardiography confirmed mild or no residual MR in all patients who received implants. Improvements in symptom class (79% in New York Heart Association functional class I or II at follow-up; p < 0.0001 vs. baseline) and Minnesota Heart Failure Questionnaire scores (56.2 ± 26.8 vs. 31.7 ± 22.1; p = 0.011) were observed.

Conclusions

TMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement. These results inform trial design of TMVR in lower-risk patients with severe mitral valve regurgitation (Evaluation of the Safety and Performance of the Twelve Intrepid Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation – The Twelve Intrepid TMVR Pilot Study; NCT02322840)  相似文献   

15.

Background

Recent studies have suggested that the difficulty of laparoscopic liver resections are related to both patient and tumour factors, however the available difficulty scoring systems only incorporate tumour factors. The aim of this study was to assess the opinion of laparoscopic liver surgeons regarding the factors that affect the perceived difficulty of laparoscopic liver resections.

Method

Using a Visual Analogue Scale an international survey of laparoscopic liver surgeons was undertaken to assess the perceived difficulty of 26 factors previously demonstrated to affect the difficulty of a laparoscopic liver resection.

Results

80 surgeons with a combined experience of over 7000 laparoscopic liver resections responded to the survey. The difficulty of laparoscopic liver surgery was suggested to be increased by a BMI > 35 by 89% of respondents; neo-adjuvant chemotherapy by 79%; repeated liver resection by 99% and concurrent procedures by 59% however these factors have not been included in the previous difficulty scoring systems.

Conclusion

The results suggests that the difficulty of laparoscopic liver surgery is not fully assessed by the available difficulty scoring systems and prompts the development of a new difficulty score that incorporates all factors believed to increase difficulty.  相似文献   

16.

Background

Levels of faecal elastase-1 (FE-1), a marker of exocrine pancreatic function, are lower in patients with type 2 diabetes than without diabetes. We aimed to investigate the association between FE-1 and nutritional status, gastrointestinal symptoms, and lipid absorption.

Methods

This randomized, open-label, crossover study included 315 patients with type 2 diabetes aged 18–70 years treated with oral antidiabetics, with HbA1c 6.5–9.0% and BMI 18–40?kg/m2. Assessments included levels of FE-1 and blood biomarkers of nutrition, and Bristol Stool Scale and Gastrointestinal Symptom Rating Scale (GSRS) scores. Plasma exposure of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) after oral administration of free omega-3 carboxylic acids or ethyl esters with breakfast was investigated in patients with low, intermediate, and normal FE-1 levels.

Results

The prevalence of low and intermediate FE-1 levels was 5.2% and 4.9%, respectively. Bristol Stool Scale scores and mean values of GSRS Diarrhoea and Indigestion domain symptoms were similar across groups, but patients with low FE-1 were heavier and reported lower stool frequency. FE-1 levels correlated positively with plasma levels of amylase, lipase, 25-hydroxy vitamin D, and albumin. Mean EPA + DHA exposure was similarly higher after intake of free vs. esterified omega-3 fatty acids in all FE-1 groups.

Conclusions

The prevalence of low FE-1 (<100?μg/g) as a measure of pancreatic exocrine insufficiency was infrequent in type 2 diabetes. Except for low plasma concentrations of EPA and 25-hydroxy vitamin D, type 2 diabetes patients with low FE-1 had no other signs of malabsorption or gastrointestinal disorders. Plasma levels of EPA and DHA after the intake of esterified versus free EPA and DHA did not correlate with FE-1 levels.

Trial registration

ClinicalTrials.gov NCT02370537.  相似文献   

17.

Background

Liver surgery for colorectal metastases (CLM) is moving toward parenchyma-sparing approaches. The authors reported the technical feasibility of parenchyma-sparing hepatectomy for deeply located tumors, but its impact on daily practice and long-term outcomes remain unclear.

Methods

The patients undergoing liver resection (LR) for CLM with vascular contact (first-/second-order pedicle or hepatic vein (HV) trunk) were considered. Those undergoing major hepatectomy were excluded. The authors' technique included tumor–vessel detachment, partial resection of marginally infiltrated HVs, and detection of communicating vessels (CVs) among HVs to preserve outflow after HV resection.

Results

Among 169 patients with major vascular contact, parenchyma-sparing LR was feasible in 146 (86%). Twenty-eight SERPS, 13 transversal hepatectomies, 6 mini-mesohepatectomies, and 4 liver tunnels were performed. Sixty-six (45%) patients underwent CLM–vessel detachment, 25 (17%) underwent partial HV resection, and 30 (21%) achieved outflow preservation by CV identification. The mortality and severe morbidity rates were 1.4% and 8.2%, respectively. The 5-year survival rate was 30.7%. The parenchyma-sparing strategy failed in 14 (7%) patients because of recurrence in the spared parenchyma or cut edge; 13 were radically retreated.

Conclusion

Ultrasound-guided parenchyma-sparing surgery is feasible in most patients with ill-located CLMs. This procedure is safe and achieves adequate oncologic outcomes.  相似文献   

18.

Background

Intravascular volume expansion plays a major role in the prevention of contrast-induced acute kidney injury (CI-AKI). Recommended standard amounts of fluid infusion before procedures do not produce homogeneous responses in subjects with different initial hydration status.

Objectives

The goal of this study was to compare the effect of standard and double intravenous (IV) infusion volumes in patients with low body fluid level, assessed by using bioimpedance vector analysis (BIVA), on the incidence of CI-AKI after elective coronary angiographic procedures.

Methods

A total of 303 patients with low BIVA level on admission were randomized to receive standard volume saline (1 ml/kg/h for 12 h before and after the procedure) or double volume saline (2 ml/kg/h). Patients (n = 715) with an optimal BIVA level received standard volume saline and were included in a prospective registry. The saline infusion was halved in all patients with an ejection fraction <40%. BIVA was repeated immediately before the angiographic procedure in all patients. CI-AKI was defined as an increase in levels of cystatin C ≥10% above baseline at 24 h after contrast administration.

Results

The incidence of CI-AKI was significantly lower (11.5% vs. 22.3%; p = 0.015) in patients receiving double volume saline than in those receiving standard volume saline, respectively. Before the angiographic procedure, 50% of the double volume patients achieved the optimal BIVA level compared with only 27.7% in the standard group (p = 0.0001). The findings were consistent in all the pre-specified subgroups excluding patients with a left ventricular ejection fraction <40% (p for interaction = 0.01).

Conclusions

Evaluation of BIVA levels on admission in patients with stable coronary artery disease allows adjustment of intravascular volume expansion, resulting in lower CI-AKI occurrence after angiographic procedures. (Personalized Versus Standard Hydration for Prevention of CI-AKI: A Randomized Trial With Bioimpedance Analysis; NCT02225431)  相似文献   

19.

Background

Prior studies found patients treated with sodium-glucose co-transporter-2 inhibitors (SGLT-2i) had lower rates of death and heart failure (HF). Whether the benefits of SGLT-2i vary based upon the presence of cardiovascular disease (CVD) is unknown.

Objectives

This study sought to determine the association between initiation of SGLT-2i therapy and HF or death in patients with and without CVD.

Methods

The CVD-REAL (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors) study was a multinational, observational study in which adults with type 2 diabetes were identified. Patients prescribed an SGLT-2i or other glucose-lowering drugs (GLDs) were matched based on a propensity score for initiation of an SGLT-2i. Hazard ratios (HRs) for the risk of death, HF, and HF or death in patients with and without established CVD were estimated for each country and pooled.

Results

After propensity score matching, 153,078 patients were included in each group. At baseline, 13% had established CVD. Compared with therapy using other GLDs, initiation of an SGLT-2i was associated with lower risk of death in patients with and without CVD (HR: 0.56; 95% confidence interval [CI]: 0.44 to 0.70; and HR: 0.56; 95% CI: 0.50 to 0.63, respectively). There were also associations between SGLT-2i and lower risk of HF (HR: 0.72; 95% CI: 0.63 to 0.82; and HR: 0.61; 95% CI: 0.48 to 0.78, respectively) and the composite of HF or death (HR: 0.63; 95% CI: 0.57 to 0.70; and HR: 0.56; 95% CI: 0.50 to 0.62, respectively) observed in patients with and without established CVD.

Conclusions

In this large, multinational, observational study, initiation of SGLT-2i was associated with lower risk of death and HF regardless of pre-existing CVD. Ongoing clinical trials will provide further evidence regarding the benefit of SGLT-2i in patients without established CVD. (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors [CVD-REAL]; NCT02993614)  相似文献   

20.

Background

The role of platelets and important effect modifiers on the risk of first stroke is unknown.

Objectives

This study examined whether low platelet count (PLT) and elevated total homocysteine (tHcy) levels jointly increase the risk of first stroke, and, if so, whether folic acid treatment is particularly effective in stroke prevention in such a setting.

Methods

A total of 10,789 Chinese hypertensive adults (mean age 59.5 years; 38% male, with no history of stroke and myocardial infarction) were analyzed from the China Stroke Primary Prevention Trial, where participants were randomly assigned to daily treatments of 10 mg enalapril and 0.8 mg folic acid (n = 5,408) or 10 mg enalapril alone (n = 5,381). The primary endpoint was first stroke.

Results

During 4.2 years of follow-up, a total of 371 first strokes occurred. In the enalapril-alone group, the lowest rate of first stroke (3.3%) was found in patients with high PLT (quartiles 2 to 4) and low tHcy (<15 μmol/l); and the highest rate (5.6%) was in patients with low PLT (quartile 1) and high tHcy (≥15 μmol/l) levels. Following folic acid treatment, the high-risk group had a 73% reduction in stroke (hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.64; p = 0.003), whereas there was no significant effect among the low-risk group.

Conclusions

Among Chinese hypertensive adults, the subgroup with low PLT and high tHcy had the highest risk of first stroke, and this risk was reduced by 73% with folic acid treatment. If confirmed, PLT and tHcy could serve as biomarkers to identify high-risk individuals who would particularly benefit from folic acid treatment. (China Stroke Primary Prevention Trial [CSPPT]; NCT00794885)  相似文献   

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