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1.

Background

While post-hepatectomy liver failure (PHLF) accurately predicts short-term mortality, its role in prognosticating long-term overall survival (OS) remains unclear.

Methods

Patients who underwent hepatectomy for colorectal liver metastases (CRLM) after portal vein embolization during 1999–2015 were evaluated retrospectively. PHLF was defined per International Study Group of Liver Surgery (ISGLS) criteria and as PeakBil >7 mg/dl. Survival was analyzed using log-rank statistic and Cox regression; patient mortality within 90 days was excluded.

Results

Of 175 patients, 68 (39%) had PHLF according to ISGLS criteria, including 40 (23%) with ISGLS grade B/C, and 14 (8%) had PeakBil >7 mg/dl. Patients with PeakBil >7 mg/dl had significantly worse OS than patients without PHLF (median OS, 16 vs 58 months, p = 0.001). Patients with ISGLS defined PHLF (p = 0.251) and patients with ISGLS grade B/C PHLF (p = 0.220) did not have worse OS than patients without PHLF.

Conclusion

Peak bilirubin >7 mg/dl impacts on long-term survival after hepatectomy for CRLM and is a better predictor of long-term survival than ISGLS-defined PHLF.  相似文献   

2.

Background

Liver steatosis is associated with poor outcome after liver transplantation and liver resection. There is a need for an accurate and reliable intraoperative tool to identify and quantify steatosis. This study aimed to investigate whether surface diffuse reflectance spectroscopy (DRS) measurements could detect liver steatosis on humans during liver surgery.

Methods

The DRS instrumentation setup consists of a computer, a high-power tungsten halogen light source and two spectrometers, connected through a trifurcated optical fiber to a hand-held probe. Patients scheduled for open resection for liver tumors were considered for inclusion. Multiple DRS measurements were performed on the liver surface after mobilization.

Results

In total, 1210 DRS spectra originated from 38 patients, were analyzed. When applying the data to an analytical model the volumetric absorption ratio factor of fat and water specified an explicit distinction between mild to moderate, and moderate to severe steatosis (p < 0.001). There were significant differences between none-to-mild and moderate-to-severe steatosis grade for the following parameters: reduced scattering coefficient (p < 0.001), Mie to total scattering fraction (p < 0.001), Mie slope (p = 0.003), lipid/(lipid + water) (p < 0.001), blood volume (p = 0.044) and bile volume (p < 0.001).

Conclusion

This study shows that it is possible to evaluate steatosis grades with hepatic surface diffuse reflectance spectroscopy measurements.  相似文献   

3.

Background

Surgical site infections (SSIs) are a major cause of morbidity, mortality, and healthcare costs, and patients undergoing simultaneous colorectal/liver resections are at an especially high SSI risk.

Methods

Data were collected on all patients undergoing synchronous colorectal/liver resection from 2011 to 2016 (n = 424). The intervention, implemented in 2013, included 13 multidisciplinary perioperative components. The primary endpoints were superficial/deep and organ space SSIs. Secondary endpoints were hospital length of stay (LOS) and 30-day readmission rate. To control for changes in SSI rates independent of the intervention, interrupted time series analysis was conducted.

Results

Overall, superficial/deep, and organ space SSIs decreased by 60.5% (p < 0.001), 80.6% (p < 0.001), and 47.6% (p = 0.008), respectively. In the pre-intervention cohort (n = 231), there were 79 (34.2%), 31 (13.4%), and 48 (20.8%) total, superficial/deep, and organs space SSIs, respectively. In the post-intervention cohort (n = 193), there were 26 (13.5%), 5 (2.6%), and 21 (10.9%) total, superficial/deep, and organs space SSIs, respectively. Median LOS decreased from 9 to 8 days (p < 0.001). Readmission rates did not change (p = 0.6). Interrupted time series analysis found no significant trends in SSI rate within the pre-intervention (p = 0.35) and post-intervention (p = 0.55) periods.

Conclusion

In combined colorectal/liver resection patients, implementation of a multidisciplinary care bundle was associated with a 61% reduction in SSIs, with the greatest impact on superficial/deep SSI, and modest reduction in LOS. The absence of trends within each time period indicated that the intervention was likely responsible for SSI reduction. Future efforts should target further reduction in organ space SSI.  相似文献   

4.

Background

Perihilar cholangiocarcinoma (PHC) often requires extensive surgery which is associated with substantial morbidity and mortality. This study aimed to compare an Eastern and Western PHC cohort in terms of patient characteristics, treatment strategies and outcomes including a propensity score matched analysis.

Methods

All consecutive patients who underwent combined biliary and liver resection for PHC between 2005 and 2016 at two Western and one Eastern center were included. The overall perioperative and long-term outcomes of the cohorts were compared and a propensity score matched analysis was performed to compare perioperative outcomes.

Results

A total of 210 Western patients were compared to 164 Eastern patients. Western patients had inferior survival compared to the East (hazard-ratio 1.72 (1-23-2.40) P < 0.001) corrected for age, ASA score, tumor stage and margin status. After propensity score matching, liver failure rate, morbidity, and mortality were similar. There was more biliary leakage (38% versus 13%, p = 0.015) in the West.

Conclusion

There were major differences in patient characteristics, treatment strategies, perioperative outcomes and survival between Eastern and Western PHC cohorts. Future studies should focus whether these findings are due to the differences in the treatment or the disease itself.  相似文献   

5.

Background

Lymph node metastasis (LNM)has widely been recognized as a poor prognostic indicator for hepatocellular carcinoma (HCC) patients. Preoperative prediction of LNM is important for clinicians to decide on treatment. This study was designed to develop a simple and convenient system to predict LNM.

Methods

Consecutive HCC patients who were suspected to have LNM were divided into a training, an internal validation and an external validation cohort. The receiver operating characteristic (ROC) analysis was used to determine the threshold value of the preoperative serological variables. A nomogram visualization system model was then established.

Result

Of the 287 patients, there were 31 patients who had LNM (10.8%), and 21 of 203 patients (10.3%) were in the training cohort and 10 of 84 patients (11.9%) in the internal validation cohort. Sixteen of 176 patients (9.1%) in the external validation cohort had LNM. The serological indices including neutrophil/lymphocyte rate, age, platelet, prothrombin time, and total protein, were included in the nomogram. The areas of the ROC curve were 0.846, 0.679 and 0.738 in predicting LNM in the training cohort, the internal validation cohort and the external validation cohort, respectively.

Conclusion

The scoring system constructed using the preoperative serological variables predicted LNM in HCC patients.  相似文献   

6.

Background

Bile leak following liver resection can be associated with significant morbidity. This systematic review and meta-analysis aims to evaluate the effect of intraoperative bile leak testing on postoperative bile leak rate and other complications after liver resection without biliary reconstruction for any cause.

Methods

PubMed, MEDLINE, Embase, Cochrane Library and grey literature databases were searched for articles between 1960 and 2017 comparing bile leak rates with or without bile leak testing. Standard meta-analysis methods were used. The primary outcome was bile leak rate, and secondary outcomes were overall morbidity, reintervention rate and length of stay.

Results

8 articles met inclusion criteria. Intraoperative bile leak testing after resection was associated with lower postoperative bile leak rate (4.1% vs 12.3%, OR 0.36, 95% CI 0.23–0.55, p < 0.001), overall morbidity (OR 0.67, 95% CI 0.47–0.96, p = 0.030), need for reintervention (OR 0.11, 95% CI 0.03–0.36, p < 0.001) and a shorter duration of hospital stay (2.21 days, 95% CI 0.69–3.73, p = 0.004).

Conclusion

The routine use of intraoperative bile leak testing during liver resection results in a significant reduction in postoperative bile leak rate, overall morbidity, length of hospital stay and need for re-intervention. Bile leak testing should be performed after liver resection without biliary reconstruction.  相似文献   

7.

Background

Microvascular invasion (MVI) is a powerful predictor of recurrence in patients who undergo liver resection for hepatocellular carcinoma (HCC). This study aimed to evaluate the efficacy of postoperative adjuvant transarterial chemoembolization (PA-TACE) in HCC patients with MVI, and further select potential patients benefitting from PA-TACE.

Methods

Patients who had HCC with MVI and underwent liver resection between September 2004 and December 2015 were identified for further analysis. Overall survival (OS) and disease-free survival (DFS) were compared between patients treated with and without PA-TACE. Propensity score matching analysis was used to minimize inter-group differences.

Results

A total of 176 patients with HCC and MVI were included. In both the entire and propensity-matched cohorts, OS and DFS were higher in PA-TACE group than non-TACE group (all P < 0.05). In subgroup analyses, PA-TACE showed efficacy in improving OS and DFS in HCC patients at early stage beyond Milan criteria and intermediate stage, but not in patients within Milan criteria. Multivariable analysis identified PA-TACE as a significantly favorable factor of OS and DFS for patients beyond Milan criteria, but not for those within Milan criteria.

Conclusion

PA-TACE could be beneficial for patients who have HCC with MVI beyond Milan criteria, but not for those within Milan criteria.  相似文献   

8.

Background

Pancreatoduodenectomy is associated with a high risk of complications. The aim was to identify preoperative risk factors for major intraoperative bleeding.

Methods

Patients registered for pancreatoduodenectomy in the Swedish National Pancreatic and Periampullary Cancer Registry, 2011 to 2016, were included. Major intraoperative bleeding was defined as ≥1000 ml. Univariable and multivariable analysis of preoperative parameters were performed.

Results

In total, 1864 patients were included. The median blood loss was 600 ml, and 502 patients (27%) had registered bleeding of ≥1000 ml. Preoperative independent risk factors associated with major bleeding were male sex (p < 0.001), body mass index (BMI) ≥25 kg/m2 (p < 0.001), preoperative biliary drainage (PBD) (p < 0.001), C-reactive protein (CRP) ≥12 mg/L (p = 0.006) and neo-adjuvant chemotherapy treatment (NAT) (p = 0.002). Postoperative intensive care (p < 0.001), reoperation (p = 0.035), surgical infections (p = 0.036), and bile leakage (p = 0.045) were more common in the group with major bleeding, and the 30-day mortality was higher (4.9% vs 1.6%; p < 0.001).

Conclusion

Most predictive parameters for major intraoperative bleeding are not modifiable. PBD is an independent predictor for major intraoperative bleeding and to reduce the risk, patients with resectable periampullary tumors should, if possible, be subject to surgery without preoperative biliary drainage.  相似文献   

9.

Background

The aim of this retrospective review was to evaluate the long-term survival benefits of thermal ablation versus wedge or segmental resection in solitary HCC lesions using tumor size and clinical factors.

Methods

Survival analysis was performed on 43,601 patients from 2004 to 2015 in the National Cancer Database with solitary HCC lesions ≤5 cm with further stratification by tumor size, fibrosis score, and type of resection.

Results

In patients with moderate fibrosis or less, survival benefit was seen with one-segment resection over ablation in tumors 1.1–3 cm (HR 0.54, p = 0.03) while tumors of 3.1–5 cm received survival benefit from wedge (HR 0.44, p = 0.04), one (HR 0.28, p = 0.001) and two-segment (HR 0.20, p = 0.001) resections over ablation. In patients with severe fibrosis to cirrhosis, wedge resection demonstrated survival benefit over ablation in patients with tumors 1.1–3 cm (HR 0.48, p = 0.01) with no survival benefit of any resection type in patients with tumors of 3.1–5 cm.

Conclusion

These findings suggest that the decision to utilize thermal ablation versus resection to extend survival in solitary HCC lesions should include tumor size, fibrosis score, and type of resection.  相似文献   

10.

Background

The outcomes of living donor liver transplantation (LDLT) versus deceased donor liver transplantation (DDLT) for HCC patients were not well defined and it was necessary to reassess.

Methods

A comprehensive literature search was conducted in PubMed, Embase, Cochrane Library, Google Scholar and WanFang database for eligible studies. Perioperative and survival outcomes of HCC patients underwent LDLT were pooled and compared to those underwent DDLT.

Results

Twenty-nine studies with 5376 HCC patients were included. For HCC patients underwent LDLT and DDLT, there were comparable rates of overall survival (OS) (1-year, RR = 1.04, 95%CI = 1.00–1.09, P = 0.03; 3-year, RR = 1.03, 95%CI = 0.96–1.11, P = 0.39; 5-year, RR = 1.04, 95%CI = 0.95–1.13, P = 0.43), disease free survival (DFS) (1-year, RR = 1.00, 95%CI = 0.95–1.05, P = 0.99; 3-year, RR = 1.00, 95%CI = 0.94–1.08, P = 0.89; 5-year, RR = 1.01, 95%CI = 0.93–1.09, P = 0.85), recurrence (1-year, RR = 1.41, 95%CI = 0.72–2.77, P = 0.32; 3-year, RR = 0.89, 95%CI = 0.57–1.39, P = 0.60; and 5-year, RR = 0.85, 95%CI = 0.56–1.31, P = 0.47), perioperative mortality within 3 months (RR = 0.89, 95%CI = 0.50–1.59, p = 0.70) and postoperative complication (RR = 0.99, 95%CI = 0.70–1.39, P = 0.94). LDLT was associated with better 5-year intention-to-treat patient survival (ITT-OS) than DDLT (RR = 1.11, 95% CI = 1.01–1.22, P = 0.04).

Conclusion

This meta-analysis suggested that LDLT was not inferior to DDLT in consideration of comparable perioperative and survival outcomes. However, in terms of 5-year ITT-OS, LDLT was a possibly better choice for HCC patients.  相似文献   

11.

Background

The microvascular effects occurring after unilateral preoperative portal vein embolization (PVE) are poorly understood. The aim of this study was to assess the microvascular changes in the embolized and the non-embolized lobes after right PVE.

Methods

Videos of the hepatic microcirculation in patients undergoing right hemihepatectomy following PVE were recorded using a handheld vital microscope (Cytocam) based on incident dark field imaging. Hepatic microcirculation was measured in the embolized and the non-embolized lobes at laparotomy, 3–6 weeks after PVE. The following microcirculatory parameters were assessed: total vessel density (TVD), microcirculatory flow index (MFI), proportion of perfused vessel (PPV), perfused vessel density (PVD), sinusoidal diameter (SinD) and the absolute red blood cell velocity (RBCv).

Results

16 patients after major liver resection were included, 8 with and 8 without preoperative PVE. Microvascular density parameters were higher in the non-embolized lobes when compared to the embolized lobes (TVD: 40.3 ± 8.9 vs. 26.8 ± 4.6 mm/mm2 (p < 0.003), PVD: 40.3 ± 8.8 vs. 26.7 ± 4.7 mm/mm2 (p < 0.002), SinD: 9.2 ± 1.7 vs. 6.3 ± 0.8 μm (p < 0.040)). RBCv, PPV and the MFI were not significantly different.

Conclusion

The non-embolized lobe has a significantly higher microvascular density, however without differences in microvascular flow. These findings indicate increased angiogenesis in the hypertrophic lobe.  相似文献   

12.

Background

This retrospective UNOS database evaluation analyzes the prevalence of preoperative portal vein thromboses (PVT), and postoperative thromboses leading to graft failure in pediatric patients undergoing liver transplantation (LT).

Methods

The evaluation was performed in three age groups: I (0–5), II (6–11), III (12–18) years old. Factors predictive of pre- and postoperative thromboses were analyzed.

Results

Between 2000 and 2015, 8982 pediatric LT were performed in the US. Of those, 390 patients had preoperative PVT (4.3%), and 396 (4.4%) had postoperative thromboses. The prevalence of both types of thromboses was less in Group III than in the other two groups (3.20% vs 4.65%, p = 0.007 and 1.73% vs. 5.13%, p < 0.001, respectively). The prevalence of postoperative thromboses was significantly higher in Group I than in the other two groups (5.49% vs. 2.51%, p < 0.001). Preoperative PVT was independently associated with postoperative thromboses (OR = 1.7, p = 0.02). Children less than 5 years of age were more likely to develop postoperative thromboses leading to graft failure (OR = 2.9, p < 0.001).

Conclusion

Younger children undergoing LT are prone to pre-and postoperative thrombotic complications. Preoperative PVT at the time of transplantation was independently associated with postoperative thromboses. Perioperative antithrombotic therapy should be considered in pediatric patients undergoing LT.  相似文献   

13.

Background

The benefit of performing major hepatic resection (MHR) for hepatocellular carcinoma (HCC) in patients with cirrhosis remains controversial because of its high risk of posthepatectomy liver failure (PHLF). This study was conducted to assess the risk of MHR for HCC in patients with cirrhosis.

Methods

Patients with Child-Pugh A or B cirrhosis and HCC who underwent MHR from January 2000 to June 2014 were retrospectively identified. Risk factors for postoperative morbidity and mortality using univariate and multivariate analyses were evaluated.

Results

Seventy patients with Child-Pugh A (93%) and 5 (7%) with Child-Pugh B cirrhosis underwent MHR for HCC. Thirteen (17%) had Barcelona Clinic Liver Cancer (BCLC) stage A, 39 (50%) had BCLC B, and 23 (32%) had BCLC C disease. A perioperative blood transfusion was performed in 18 patients (24%). Ninety-day postoperative mortality was 9% (n=7). Major complications occurred in 16 patients (21%), including PHLF in 9 patients (12%). A multivariate analysis showed that perioperative blood transfusion was the main independent factor associated with mortality (OR= 6.5) and major morbidity (OR=10).

Conclusion

In selected patients with HCC and cirrhosis, MHR is feasible and has acceptable mortality, but careful perioperative management and limiting blood loss are required.  相似文献   

14.

Objectives

This study sought to define the relationship between functional tricuspid regurgitation (TR) and mortality in patients with heart failure with reduced ejection fraction (HFrEF); and to establish the prognostic value of quantitative measures of TR severity (i.e., effective regurgitant orifice area [EROA] and regurgitant volume).

Background

The significance of TR in chronic heart failure is controversial. Earlier studies have shown an independent impact of TR on mortality, whereas more recent evidence suggests myocardial impairment to be the driving force of mortality rather than TR itself. Earlier studies have used qualitative measures of TR severity, hence the prognostic value of more quantitative measures of TR severity (i.e., EROA and regurgitant volumes) remains unclear.

Methods

We enrolled 382 patients with HFrEF on guideline-directed medical therapy and assessed TR EROA and regurgitant volume by Doppler/2-dimensional echocardiography. All-cause mortality was defined as the primary study endpoint.

Results

TR severity was associated with the HFrEF phenotype with more symptoms (p = 0.004), higher neurohumoral activation (p < 0.001), progressive right-ventricular dilatation (p < 0.001), and impaired function (p < 0.001). Cox regression showed a strong association between quantitative measures of TR with mortality (all p < 0.001). Quantitative metrics of TR severity were consistently associated with mortality with a hazard ratio of 1.009 (95% confidence interval: 1.004 to 1.013; p < 0.001) per 0.01 cm2 increase of the EROA and of 1.013 (95% confidence interval: 1.007 to 1.020; p < 0.001) per 1-ml increase in regurgitant volume. Results remained unchanged after bootstrap- or clinical confounder-based adjustment. A spline curve pattern illustrates the association with mortality with thresholds for the EROA ≥0.2 cm2, and the regurgitant volume ≥20 ml with sustained excess mortality thereafter.

Conclusions

This large-scale outcome study demonstrates the prognostic value of quantitative Doppler-echocardiographic measures of TR severity in HFrEF. The thresholds for EROA and TR regurgitant volume associated with mortality in our study fall within current ranges defining nonsevere TR. This may potentially impact therapeutic decision making, particularly timing of intervention.  相似文献   

15.

Background

Limited data are currently available to address the safety and efficacy of combined resection of the liver and inferior vena cava (IVC) for hepatic malignancies.

Methods

A systematic review was performed to identify relevant studies. Pooled individual data were examined for the clinical outcome of combined resection of the liver and IVC for hepatic malignancies.

Results

A total of 258 patients were described in 38 articles eligible for inclusion. Resections were performed for colorectal liver metastasis (CLM) [n = 128 (50%)], intrahepatic cholangiocarcinoma (ICC) [n = 51 (20%)], hepatocellular carcinoma (HCC) [n = 48 (19%)], and other pathologies [n = 31 (11%)]. There were 14 (5%) perioperative deaths. The median survival duration was 34 months, and the 1-, 3- and 5-year overall survival (OS) rate was 79%, 46% and 33%, respectively. The 5-year OS rate was 26% for CLM, 37% for ICC, and 30% for HCC.

Conclusion

Combined resection of the liver and IVC for hepatic malignancies is safe and applicable, and offers acceptable survival outcomes.  相似文献   

16.

Background

To compare the presentations and outcomes of anti-HBc seropositive Hepatocellular Carcinoma (HBc-HCC) with anti-HBc seronegative (NHBc-HCC) patients in HBsAg negative Non-HBV Non-HCV (NBNC-HCC) HCC population.

Methods

515 newly diagnosed HCC patients from January 2011 to September 2016 were retrospectively reviewed. 145 (66.5%) NHBc-HCC and 73 (33.5%) HBc-HCC patients were identified. Patient demographics, disease characteristics, details of treatments, recurrence and survival outcomes were analysed.

Results

A significantly lower proportion of HBc-HCC patients were diagnosed through surveillence (6.8% vs 26.2%, p = 0.001). HBc-HCC patients were less likely cirrhotic (p < 0.001), portal hypertensive (p < 0.001), ascitic (p = 0.008) and thrombocytopenic (p = 0.003). A higher proportion of HBc-HCC patients had treatment with curative intent (46.6% vs 30.3%, p = 0.018) and surgery (39.7% vs 16.6%, p < 0.001). Although HBc-HCC patients had larger median tumor size (74.0 mm vs 55.0 mm, p = 0.016) with a greater proportion of patients having tumors ≥5 cm, there was no difference in the overall median survival (19.0 months vs 22.0 months, p = 0.919) and recurrence rates (38.2% vs 40.9%).

Conclusion

Isolated anti-HBc seropositivity in HbsAg negative patients tend to present incidentally with delayed diagnoses resulting in larger tumors, but their long-term survival remain comparable.  相似文献   

17.

Background

Centralization of pancreatic resections is advocated due to a volume-outcome association. Pancreatic surgery is in Norway currently performed only in five teaching hospitals. The aim was to describe the short-term outcomes after pancreatoduodenectomy (PD) within the current organizational model and to assess for regional disparities.

Methods

All patients who underwent PD in Norway between 2012 and 2016 were identified. Mortality (90 days) and relaparotomy (30 days) were assessed for predictors including demographic data and multi-visceral or vascular resection. Aggregated length-of-stay and national and regional incidences of the procedure were also analysed.

Results

A total of 930 patients underwent PD during the study period. In-hospital mortality occurred in 20 patients (2%) and 34 patients (4%) died within 90 days. Male gender, age, multi-visceral resection and relaparotomy were independent predictors of 90-day mortality. Some 131 patients (14%) had a relaparotomy, with male gender and multi-visceral resection as independent predictors. There was no difference between regions in procedure incidence or 90-day mortality. There was a disparity within the regions in the use of vascular resection (p = 0.021).

Conclusion

The short-term outcomes after PD in Norway are acceptable and the 90-day mortality rate is low. The outcomes may reflect centralization of pancreatic surgery.  相似文献   

18.

Background

There are conflicting data regarding the relative effectiveness of renal sympathetic denervation (RSD) in patients with hypertension.

Objectives

The purpose of this study was to evaluate the blood pressure (BP) response after RSD in sham-controlled randomized trials.

Methods

Databases were searched through June 30, 2018. Randomized trials (RCTs) with ≥50 patients comparing catheter-based RSD with a sham control were included. The authors calculated summary treatment estimates as weighted mean differences (WMD) with 95% confidence intervals (CIs) using random-effects meta-analysis.

Results

The analysis included 977 patients from 6 trials. The reduction in 24-h ambulatory systolic blood pressure (ASBP) was significantly greater for patients treated with RSD than sham procedure (WMD ?3.65 mm Hg, 95% CI: ?5.33 to ?1.98; p < 0.001). Compared with sham, RSD was also associated with a significant decrease in daytime ASBP (WMD ?4.07 mm Hg, 95% CI: ?6.46 to ?1.68; p < 0.001), office systolic BP (WMD ?5.53 mm Hg, 95% CI: ?8.18 to ?2.87; p < 0.001), 24-h ambulatory diastolic BP (WMD ?1.71 mm Hg, 95% CI: ?3.06 to ?0.35; p = 0.01), daytime ambulatory diastolic BP (WMD ?1.57 mm Hg, 95% CI: ?2.73 to ?0.42; p = 0.008), and office diastolic BP (WMD ?3.37 mm Hg, 95% CI: ?4.86 to ?1.88; p < 0.001). Compared with first-generation trials, a significantly greater reduction in daytime ASBP was observed with RSD in second-generation trials (6.12 mm Hg vs. 2.14 mm Hg; p interaction = 0.04); however, this interaction was not significant for 24-h ASBP (4.85 mm Hg vs. 2.23 mm Hg; p interaction = 0.13).

Conclusions

RSD significantly reduced blood pressure compared with sham control. Results of this meta-analysis should inform the design of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with hypertension.  相似文献   

19.

Objectives

The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label.

Background

Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known.

Methods

The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT).

Results

100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury.

Conclusions

Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824)  相似文献   

20.

Objectives

The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial.

Background

There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV.

Methods

Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach.

Results

A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: ?8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths.

Conclusions

Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927)  相似文献   

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