Assessment of Quality Outcomes and Learning Curve for Robot-Assisted Minimally Invasive McKeown Esophagectomy.

BACKGROUND: This study aimed to identify the results of the quality assessment and the learning curve of robot-assisted minimally invasive McKeown esophagectomy (RAMIE-MK). METHODS: The study retrospectively reviewed the data of 400 consecutive patients with esophageal cancer who underwent RAMIE-MK by a single surgeon from November 2015 to March 2019. Cumulative summation analysis of the learning curve was performed. The patients were divided into decile cohorts of 40 cases to minimize demographic deviations and to maximize the power of detecting statistically significant changes in performance. RESULTS: The 90-day mortality rate for all the patients was 0.5% (2 cases). The authors' experience was divided into the ascending phase (40 cases), the plateau phase (175 cases), and the descending phase (185 cases). After 40 cases, significant improvements in operative time (328 vs. 251 min; P = 0.019), estimated blood loss (350 vs. 200 ml; P = 0.031), and conversion rates (12.5% vs. 2.5%; P < 0.001) were observed. After 80 cases, a decrease in the rates of anastomotic leakage (22.5% vs. 8.1%; P = 0.001) and vocal cord palsy (31.3% vs. 18.4%; P = 0.024) was observed. The number of harvested lymph nodes increased after 40 cases (13 vs. 23; P < 0.001), especially for lymph nodes along the recurrent laryngeal nerve (3.0 vs. 6.0; P < 0.001). CONCLUSIONS: The learning phase of RAMIE-MK consists of 40 cases, and quality outcomes can be improved after 80 procedures. Several turning points related to the optimization of surgical outcomes can be used as benchmarks for surgeons performing RAMIE-MK.

Robotic thoracic surgery: lessons learned from the first 1,000 procedures.

Introduction: The aim of this study was to evaluate the impact of the thoracic robotic approach in a high-volume center regarding procedures and clinical outcomes after 1,000 procedures. Methods: In a single-center subset of the Epithor® database, a prospective cohort database of French thoracic surgery, we analyzed procedural characteristics and clinical outcomes from February 2014 to April 2023. A surgical technique for lung surgery was conducted with a four-arm closed chest with the port access approach and vascular sewing and knotting were preferred over stapling. Statistical analysis was performed using the Chi-2 test for discontinuous variables and the Mann-Whitney-Wilcoxon test for continuous variables. Tests were considered significant for a p-value <0.05. Results: Robotic thoracic surgery was used in anatomical lung resection in 85% of the cases. Over the study period, 1,067 patients underwent robotic surgery, of which 509 had lobectomies and 391 segmentectomies. In the segmentectomy group vs. lobectomy group we observed a shorter length of stay (9 ± 7 vs. 7 ± 5.6 days, p < 0.001), a shorter surgery time (99 ± 24 vs. 116 ± 38 min, p < 0.001) a lower conversion rate (n = 2 vs. n = 17, p = 0.004), and a lower complication rate (28% vs. 40%, p = 0.009, mainly Clavien-Dindo II, 18% and 28%, respectively). For cancer treatment surgery, we found more previous cancer in the segmentectomy group (48% vs. 26%, p < 0.001). We also observed a progressive change of lobectomy vs. segmentectomy from 80%/20% to 30%/70% over the 9 years. Discussion: A robotic platform is an appropriate tool to perform anatomical lung resection and especially to develop a safe and systematic approach to lung-sparing sub-lobar resection.

Impact of robotic access on outcomes after lung cancer surgery in France: Analysis from the Epithor database.

Introduction: We aimed to compare postoperative outcomes after pulmonary resection for lung cancer after open thoracotomy (OT), video-assisted (VATS), and robotic-assisted (RA) thoracic surgery using a propensity score analysis. Methods: From 2010 to 2020, 38,423 patients underwent resection for lung cancer. In total, 58.05% (n = 22,306) were operated by thoracotomy, 35.35% (n = 13,581) by VATS, and 6.6% (n = 2536) by RA. A propensity score was used to create balanced groups with weighting. End points were in-hospital mortality, postoperative complications, and length of hospital stay, reported by odds ratios (ORs) and 95% confidence intervals (CIs). Results: VATS decreased in-hospital mortality compared with OT (OR, 0.64; 95% CI, 0.58-0.79; P < .0001) but not compared with RA (OR, 1.09; 95% CI, 0.77-1.52; P = .61). VATS reduced major postoperative complications compared with OT (OR, 0.83; 95% CI, 0.76-0.92; P < .0001) but not RA (OR, 1.01; 95% CI, 0.84-1.21; P = .17). VATS reduced prolonged air leaks rate compared with OT (OR, 0.9; 95% CI, 0.84-0.98; P = .015) but not RA (OR, 1.02; 95% CI, 0.88-1.18; P = .77). As compared with OT, VATS and RA decreased the incidence of atelectasis (respectively: OR, 0.57; 95% CI, 0.50-0.65; P < .0001 and OR, 0.75; 95% CI, 0.60-0.95; P = .016); the incidence of pneumonia (OR, 0.75; 95% CI, 0.67-0.83; P < .0001 and OR, 0.62; 95% CI, 0.50-0.78; P < .0001); and the number of postoperative arrhythmias (OR, 0.69; 95% CI, 0.61-0.78; P < .0001 and OR, 0.75; 95% CI, 0.59-0.96; P = .024). Both VATS and RA resulted in shorter hospital stays (-1.91 days [-2.24; -1.58]; P < .0001 and -2.73 days [-3.1; -2.36]; P < .0001, respectively). Conclusions: RA appeared to decrease postoperative pulmonary complications as well as VATS compared with OT. VATS decreased postoperative mortality as compared with RA and OT.

Deep learning-assisted development and validation of an algorithm for predicting the growth of persistent pure ground-glass nodules.

Background: The prediction of the persistent pure ground-glass nodule (pGGN) growth is challenging and limited by subjective assessment and variation across radiologists. A chest computed tomography (CT) image-based deep learning classification model (DLCM) may provide a more accurate growth prediction. Methods: This retrospective study enrolled consecutive patients with pGGNs from January 2010 to December 2020 from two independent medical institutions. Four DLCM algorithms were built to predict the growth of pGGNs, which were extracted from the nodule areas of chest CT images annotated by two radiologists. All nodules were assigned to either the study, the inner validation, or the external validation cohort. Accuracy, sensitivity, specificity, receiver operating characteristic (ROC) curves, and areas under the ROC curve (AUROCs) were analyzed to evaluate our models. Results: A total of 286 patients were included, with 419 pGGN. In total, 197 (68.9%) of the patients were female and the average age was 59.5±12.0 years. The number of pGGN assigned to the study, the inner validation, and the external validation cohort were 193, 130, and 96, respectively. The follow-up time of stable pGGNs for the primary and external validation cohorts were 3.66 (range, 2.01-10.08) and 4.63 (range, 2.00-9.91) years, respectively. Growth of the pGGN occurred in 166 nodules [83 (43%), 39 (30%), and 44 (45%) in the study, inner and external validation cohorts respectively]. The best-performing DLCM algorithm was DenseNet_DR, which achieved AUROCs of 0.79 [95% confidence interval (CI): 0.70, 0.86] in predicting pGGN growth in the inner validation cohort and 0.70 (95% CI: 0.60, 0.79) in the external validation cohort. Conclusions: DLCM algorithms that use chest CT images can help predict the growth of pGGNs.

Effects of a ground-glass opacity component on the recurrence and survival of pathological stage IA3 lung adenocarcinoma: a multi-institutional retrospective study.

Background: This study aimed to evaluate the effect of the presence of a radiographically manifested ground-glass opacity (GGO) component on the prognosis of patients with pathological stage IA3 lung adenocarcinoma. Methods: Patients diagnosed with pathological stage IA3 lung adenocarcinoma who underwent radical surgery at two medical institutions in China between July 2012 and July 2020 were enrolled. The cumulative incidence of recurrence (CIR) and cumulative incidence of death (CID) in patients with and without a GGO component were compared. Risk curves for the recurrence and tumor-related death overtime were analyzed between the two groups according to life table. In order to validate the prognostic value of GGO components, the recurrence-free survival (RFS) and cancer-specific survival (CSS) were estimated. Decision curve analysis (DCA) was performed to evaluate the clinical benefit rate of different models. Results: Among the 352 included patients, the presence of a GGO component was radiographically shown in 166 (47.2%) patients, while 186 (52.8%) displayed solid nodules. Patients exhibiting the absence of a GGO component had higher incidences of total recurrence (17.2% vs. 3.0%, P<0.001), local-regional recurrence (LRR) (5.4% vs. 0.6%, P=0.010), distant metastasis (DM) (8.1% vs. 1.8%, P=0.008), and multiple recurrences (4.3% vs. 0.6%, P=0.028) than the presence-GGO component group. The 5-year CIR and CID were 7.5% and 7.4% in the presence-GGO component group, and 24.5% and 17.0% in the absence-GGO component group, respectively, with statistically significant differences between the two groups (P<0.05). The risk of recurrence in patients with the presence of GGO components showed a single peak at 3 years postoperatively, while patients with the absence of GGO components showed a double peak at 1 and 5 years after surgery, respectively. However, the risk of tumor-related death peaked in both groups at 3 and 6 years postoperatively. Multivariate Cox analysis showed that the presence of a GGO component was a favorable independent risk factor for pathological stage IA3 lung adenocarcinoma patients (P<0.05). Conclusions: Pathological stage IA3 lung adenocarcinoma with or without GGO components are two types of tumors with different invasive abilities. In clinical practice, we should develop different treatment and follow-up strategies.

Evaluation of prothrombin complex concentrate and recombinant activated factor VII to reverse rivaroxaban in a rabbit model.

BACKGROUND: As a potent anticoagulant agent, rivaroxaban exposes a risk of bleeding. An effective way to reverse its effects is needed. Objectives were to study efficacy and safety of recombinant activated factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to reverse the anticoagulant effect of an overdose of rivaroxaban in a rabbit model of bleeding and thrombosis. METHODS: First, a dose-ranging study assessed the minimal rivaroxaban dose that increased bleeding. Then, 48 anesthetized and ventilated rabbits were randomized into four groups: control (saline), rivaroxaban (rivaroxaban and saline), rFVIIa (rivaroxaban and rFVIIa), and PCC (rivaroxaban and PCC). The Folts model was applied: a stenosis and an injury were carried out on the carotid artery, inducing thrombosis, detected as cyclic flow reductions, which were recorded over 20 min. Then the following were measured: ear immersion bleeding time, clotting times, anti-Xa activity, thrombelastometric parameters, and thrombin generation test. Ultimately, a hepatosplenic section was performed and the total amount of blood loss after 15 min was evaluated as primary endpoint. RESULTS: Rivaroxaban increased blood loss (17 g [8-32] vs. 7 g [5-18] for control (median [range]), P = 0.0004), ear bleeding time, clotting times, thrombelastographic clotting time, and decreased thrombin generation. In contrast, rFVIIa decreased ear bleeding time (92 s [65-115] vs. 140 s [75-190], P < 0.02), but without efficacy on blood loss. PCC and rFVIIa decreased activated partial thromboplastin time as well as thrombelastographic clotting time. Regarding safety, neither rFVIIa nor PCC increased cyclic flow reductions. CONCLUSION: rFVIIa and PCC partially improved laboratory parameters, but did not reverse rivaroxaban induced-bleeding.

Recombinant activated factor VII attenuates major arterial bleeding in noncoagulopathic rabbits.

BACKGROUND AND OBJECTIVE: Recombinant activated factor VII (rFVIIa), which is used off-label as an adjuvant therapy for uncontrolled and life-threatening bleeding, might also attenuate intractable bleeding related to macrovascular arterial lesions. Here we evaluated the efficacy of rFVIIa in sealing a large arterial wound in haemostatically competent rabbits. METHODS: Sixty male New Zealand rabbits were randomly divided into vehicle control and 80 and 200 µg kg⁻¹ rFVIIa groups (n = 20 animals each). A standardized wound of the isolated right carotid artery was made in all rabbits with an 18-G catheter. Bleeding, which was limited by mild compression, was assessed every minute. At 5 min, an intravenous bolus of vehicle or human rFVIIa was given and the animals were further observed for 1 h. Efficacy was assessed from the bleeding duration and blood mass lost. Statistical significance was defined as P less than 0.05. All investigators were blinded to the treatment the animals received. RESULTS: The bleeding duration and blood mass lost were significantly reduced in both rFVIIa dosage groups as compared with the vehicle control group. For the vehicle, 80 and 200 µg kg⁻¹ rFVIIa groups, the median bleeding durations were 56 min (range 7-60 min), 15 min (range 5-60 min) and 10 min (range 5-60 min), respectively; and the median blood mass losses were 22.5 g (range 1-58 g), 12 g (range 0-36 g) and 5 g (range 0-31 g), respectively. The prothrombin time was shorter in the rFVIIa groups. Visual inspection of the carotid artery and microscopic analysis of the liver and kidney revealed neither gross thrombi nor entrapped microthrombi in any rabbit. CONCLUSION: Recombinant FVIIa at 80 or 200 µg kg⁻¹ promoted the sealing of a large and slightly compressed arterial wound in rabbits. These results suggest a potential role for the drug in the management of massive bleeds due to an arterial lesion when surgical intervention is not immediately and readily available. Safety should remain a matter of concern.

Comparative study on the diagnostic value of intravenous/peritumoral injection of indocyanine green for metastatic lymph node location in patients with head and neck squamous cell carcinoma (HNSCC).

BACKGROUND: Accurate assessment of regional lymph node (LN) status is essential for the treatment of head and neck squamous cell carcinoma (HNSCC) patients. In this study, we aimed to compare the difference between intravenous injection of indocyanine green (ICG) and peritumoral injection of ICG in the location of metastatic LNs. METHODS: Twenty-nine patients were enrolled in this study with 13 patients receiving intravenous injection of ICG and 16 patients receiving peritumoral injection of ICG. During the surgery, the fluorescence-positive LNs in vivo were sent to undergo frozen section after fluorescence intensity was recorded. After the cervical LN dissection, all LNs were sorted by region, and the fluorescence intensity was recorded before the LNs were sent for paraffin section. RESULTS: During the surgery, both intravenous or peritumoral injections with near-infrared (NIR) fluorescence imaging of ICG had their respective pros and cons in vivo, with the sensitivity and specificity being 62.5%/75% and 98.1%/89.1% respectively. After the surgery, both methods could reduce the pathological workload by preselecting the LNs at-risk in the premise of accurate assessing the cervical LN stage. However, intravenous ICG administration was more valuable in determining all types of LN status according to the fluorescence intensity [area under the curve (AUC): 0.91 vs. 0.78, P<0.001]. CONCLUSIONS: With the assistance of NIR fluorescence imaging using ICG, both administration methods could reduce the postoperative complication and the pathological workload, whereas the intravenous mode of ICG administration is superior in application value.

Robotic lobectomy in children with severe bronchiectasis: A worthwhile new technology.

BACKGROUND/PURPOSE: Lobectomy is required in children affected by non-responsive, symptomatic, localized bronchiectasis, but inflammation makes thoracoscopy challenging. We present the first published series of robotic-assisted pulmonary lobectomy in children with bronchiectasis. METHODS: Retrospective analysis of all consecutive patients who underwent pulmonary lobectomy for severe localized bronchiectasis (2014-2019) via thoracoscopic versus robotic lobectomy. Four 5 mm ports were used for thoracoscopy; a four-arm approach was used for robotic surgery (Da Vinci Surgical Xi System, Intuitive Surgical, California). RESULTS: Eighteen children were operated (robotic resection, n = 7; thoracoscopy, n = 11) with infected congenital pulmonary malformation, primary ciliary dyskinesia, and post-viral infection. There were no conversions to open surgery with robotic surgery, but five with thoracoscopy. Total operative time was significantly longer with robotic versus thoracoscopic surgery (mean 247 ± 50 versus 152 ± 57 min, p = 0.008). There were no significant differences in perioperative complications, length of thoracic drainage, or total length of stay (mean 7 ± 2 versus 8 ± 3 days, respectively). No blood transfusions were required. Two thoracoscopic patients had a type-3 postoperative complication. CONCLUSIONS: Pediatric robotic lung lobectomy is feasible and safe, with excellent visualization and bi-manual hand-wrist dissection - useful properties in difficult cases of infectious pathologies. However, instrumentation dimensions limit use in smaller thoraxes.

Four-arm robotic lung resection versus muscle-sparing mini-thoracotomy: retrospective experience.

BACKGROUND: Robotic surgery was introduced in the early 2000s but its use remains limited, particularly in thoracic surgery. Here we compare the first consecutive 185 four-arm robotic procedures carried out in our institution vs. muscle-sparing video-assisted mini-thoracotomy (MSMT), our previous minimally invasive approach for anatomical lung resection. METHODS: One hundred and eighty-five consecutive patients undergoing surgery using the four-arm robotic technique between February 2014 and December 2016 were compared to a control historical series of 136 consecutive patients undergoing surgery by MSMT in the same institution. The same senior surgeon performed all surgical procedures. Comparisons between the two groups were performed using the Chi2 test for qualitative data and the Wilcoxon, Mann-Whitney or Student's t-test for quantitative data. RESULTS: The demographic and clinical characteristics of the patients were similar in the two groups. In the robotic group, median (min-max) length of hospital stay (LOS) was significantly shorter (by 2 days) than in the MSMT group {7 days [3-63] vs. 9 days [5-63], respectively; P<0.0001}. The rate of complications was similar in the two groups, but the complications appeared to be less severe in patients undergoing robotic surgery (switch from Clavien-Dindo grade III and IV to grade II) although further studies are required to confirm this due to the large number of missing data. CONCLUSIONS: In a senior thoracic surgery practice, the switch from a minimally invasive technique to robotic surgery was safe and beneficial in patients undergoing anatomical lung resection in terms of LOS and possible complication severity.

Forced vital capacity assessment for risk stratification of blunt chest trauma patients in emergency settings: A preliminary study.

OBJECTIVE: The aim of this study was to assess the performance of Forced Vital Capacity (FVC) for prediction of secondary respiratory complications in blunt chest trauma patients. METHODS: During a 15-month period, all consecutive blunt chest trauma patients admitted in our emergency intensive care unit with more than 3 rib fractures were eligible, unless they required mechanical ventilation in the prehospital or emergency settings. FVC was measured at admission and at emergency discharge after therapeutic interventions. The main outcome was the occurrence of secondary respiratory complications defined by hospital-acquired pulmonary infection, secondary admission in the intensive care unit or mechanical ventilation for respiratory failure or death. The performance of FVC for prediction of secondary respiratory complications was assessed by receiver operating characteristic (ROC) curve and multivariate analysis after logistic regression. RESULTS: Sixty-two consecutive patients were included and 13 (21%) presented secondary respiratory complications. Only FVC measured at emergency discharge - not FCV at admission - was significantly lower in patients who developed secondary respiratory complications (44±15 vs. 61±20%, P=0.002). The area under the ROC curves for FCV in predicting secondary pulmonary complications was 0.79 [95% CI: 0.66-0.88], P=0.0001. An FVC at discharge≤50% was independently associated with the occurrence of secondary complications with an OR at 7.9 [1.9-42.1], P=0.004. CONCLUSION: The non-improvement of FVC≤50% at emergency discharge is associated with secondary respiratory complications and should prevent the under-triage of patients with no sign of respiratory failure at admission.

Should a reimplantation valve sparing procedure be done systematically in type A aortic dissection?

OBJECTIVE: To evaluate the risks and benefits of a systematic reimplantation valve sparing procedure in the surgical treatment of type A aortic dissection (TAAD). PATIENTS AND METHODS: From February December 2005, 15 consecutive patients (mean age 61+/-12 years) who underwent surgery for TAAD were analyzed prospectively. Eleven had a preoperative CT-scan and all had an echography. Eight patients presented with a preoperative aortic insufficiency>2/4 and seven had an ascending aortic aneurysm over 50mm. In 11 cases, arterial cannulation was performed directly into the ascending aorta. Surgical technique included complete resection and replacement of the ascending aorta using a reimplantation valve sparing technique (David), associated in 12 patients with an arch replacement, under mild (29.7+/-3.0 degrees C) hypothermia and cerebral selective antegrade perfusion. RESULTS: Aortic clamping, cerebral perfusion and cardiopulmonary bypass (CPB) times were respectively 93+/-29, 18+/-9, and 131+/-38min. Mean bleeding at 24h was 1165+/-846ml. Troponin I level at 24h was 21+/-30 microg/l. One patient had a right coronary artery bypass for a chronically occluded coronary. Another had a triple arterial revascularisation for pre-existing coronary dissection. One patient presented with a postoperative regressive right hemiparesia (normal CT-scan). Two patients underwent revision for bleeding (one was undergoing treatment by clopidogrel). One patient had at day 7 an implantation of a covered stentgraft on the descending aorta for a concomitant penetrating aortic ulcer. One patient died suddenly on POD 7 during a tracheal aspiration. Intubation and ICU times were respectively 9.5+/-16.3 and 16.2+/-20.9 days. Four patients with severe preoperative co morbidities had long intubations. Echographic and CT-scan control, done in postoperative and after a mean follow up of 11.0+/-4.8 months, did not show any residual aortic insufficiency (actuarial survival rate at 2 years of 93.3%). CONCLUSION: A reimplantation valve sparing procedure in the TAAD seems to be reliable and should be proposed systematically without emphasizing perioperative morbidity.

Longitudinal displacement of the carotid wall and cardiovascular risk factors: associations with aging, adiposity, blood pressure and periodontal disease independent of cross-sectional distensibility and intima-media thickness.

The recently discovered longitudinal displacement of the common carotid arterial wall (i.e., the motion along the same plane as the blood flow), may be associated with incident cardiovascular events and represents a novel and relevant clinical information. At present, there have only been a few studies that have been conducted to investigate this longitudinal movement. We propose here a method to assess noninvasively the wall bi-dimensional (two-dimensional [2-D], cross-sectional and longitudinal) motion and present an original approach that combines a robust speckle tracking scheme to guidance by minimal path contours segmentation. Our method is well suited to large clinical population studies as it does not necessitate strong imaging prerequisites. The aim of this study is to describe the association between the longitudinal displacement of the carotid arterial wall and cardiovascular risk factors, among which periodontal disease. Some 126 Indigenous Australians with periodontal disease, an emerging risk factor, and 27 healthy age- and sex-matched non-indigenous control subjects had high-resolution ultrasound scans of the common carotid artery. Carotid intima-media thickness and arterial wall 2-D motion were then assessed using our method in ultrasound B-mode sequences. Carotid longitudinal displacement was markedly lower in the periodontal disease group than the control group (geometric mean (IQR): 0.15 mm (0.13) vs. 0.42 mm (0.30), respectively; p < 0.0001), independent of cardiovascular risk factors, cross-sectional distensibility and carotid intima-media thickness (p < 0.0001). A multivariable model indicated that the strongest correlates of carotid longitudinal displacement in adults with periodontal disease were age (ß-coefficient = -.235, p = .03), waist (ß-coefficient = -.357, p = 0.001), and pulse pressure (ß-coefficient = .175, p = 0.07), independent of other cardiovascular risk factors, cross-sectional distensibility and pulse wave velocity. Carotid longitudinal displacement, estimated with our approach, is impaired in the periodontal disease group, independent of established cardiovascular risk factors and other noninvasive measures of arterial stiffness, and may represent an important marker of cardiovascular risk.

Large thoracomyoplasty and negative pressure therapy for late postpneumonectomy empyema with a retrosternal abscess: a modern version of the Clagett procedure.

A 63-year-old male with a history of cancer, and who had undergone a left pneumonectomy seven years before, presented with deterioration in his general status and recent dyspnea [stage III (New York Heart Association) NYHA]. Imaging revealed a contralateral mediastinal shift and cardiac compression caused by pneumonectomy cavity enlargement and a retrosternal liquid mass. Late empyema associated with a retrosternal abscess caused by Propionibacterium acnes was diagnosed after thoracoscopy and an anterior mediastinotomy. Surgical treatment included an axillary open-window thoracostomy associated with negative pressure therapy (NPT), followed by a large thoracomyoplasty where part of the latissimus dorsi was harvested, and then guided healing. The chest was closed after eight months. This case is an unusual observation of a late post-pneumonectomy empyema with Propionibacterium acnes presenting like recurring cancer, but that was treated effectively using traditional (Clagett procedure) and newer (NPT) strategies.

Efficacy of prothrombin complex concentrate to reverse the anticoagulant effect of the pentasaccharide fondaparinux in a rabbit model.

As a potent anticoagulant agent, fondaparinux exposes a risk of bleeding. An effective way to reverse its effects is needed. It was the objective to study efficacy and safety of prothrombin complex concentrate (PCC) to reverse the anticoagulant effect of fondaparinux in a rabbit model of bleeding and thrombosis. In anaesthetised and ventilated rabbits, the Folts model was applied: a stenosis (75%) and an injury were carried out on the carotid artery, inducing thrombosis. Blood flow decreased as thrombus size increased until the pressure gradient was such that the thrombus was released and local blood flow was suddenly restored. This is known as a cyclic flow reduction (CFR). After the first CFR, rabbits were randomised into three groups: control (saline and saline after 1 minute), fondaparinux (fondaparinux [3 mg.kg-1] and saline), PCC (fondaparinux and PCC [40 UI.kg-1]). Then CFRs were recorded over 20 minutes. The following were measured: ear immersion bleeding time (BT), haemoglobin blood level (Hb1) and thrombelastometric parameters (ROTEM®). Finally, a hepatosplenic section was performed; 15 minutes later, the amount of blood loss was recorded as primary endpoint and Hb2 was measured. Blood loss was increased with fondaparinux and normalised with PCC. Regarding ROTEM® INTEM, fondaparinux increased clotting time and clotting formation time. PCC normalised these parameters. EXTEM and FIBTEM tests were not modified. Regarding safety, PCC did not increase CFRs. PCC reduced bleeding without increasing thrombosis and was effective to reverse the haemorrhagic effect of fondaparinux in this rabbit model.

Off-label use of recombinant activated factor VII in intractable haemorrhage after cardiovascular surgery: an observational study of practices in 23 French cardiac centres (2005-7).

OBJECTIVES: The study aimed to describe French off-label use of rFVIIa for intractable bleeding in major cardiovascular surgery. METHODS: Retrospective observational analysis of data from 2005 to October 2007 (no formal guidelines were available) was employed. The collect request form was elaborated by a multidisciplinary committee. RESULTS: Data on 109 patients--37 mechanical cardiac assist devices--were collected, with repeated injection for 24%. Bleeding stopped, decreased or continued in 43%, 37% and 20% of the cases, respectively. For patients treated in the intensive care unit (ICU), hourly bleeding decreased from 365 ± 212 to 115 ± 106 ml h(-1) (p<0.001). The median number of transfused products was 25 (2-90) before and 6 (0-48) after rFVIIa (p<0.001). Most patients had been well compensated with fibrinogen (>1g.l(-1)) and platelets (>50 G.l(-1)) before rFVIIa. The bleeding outcome (cessation, decrease or no change) was associated with the infused dose (81 ± 31, 71 ± 24, 64 ± 23 µg.kg(-1); p = 0.044) and did not differ whether rFVIIa was administered in the operating room (49%) or ICU (51%). Thrombotic events occurred in 13% of patients without assist devices and in 27% of those with them (but without obvious intra-device clotting). The overall 28-day survival rate was 60% and associated with bleeding outcome (p = 0.002). CONCLUSIONS: rFVIIa rescue therapy was followed by control of bleeding in a substantial number of the patients with seemingly acceptable safety; however, thrombotic risk remains a matter of concern. Our observational study suggests that the dose to be tested prospectively is at least 80 µg.kg(-1).

Measurement of two-dimensional movement parameters of the carotid artery wall for early detection of arteriosclerosis: a preliminary clinical study.

The aim of this study was to clinically investigate the association between the risk factors of early-stage atherosclerosis and the two-dimensional (2-D) movement of the artery wall. To meet this objective, a speckle tracking approach for the estimation of the 2-D trajectory of the vessel wall was proposed and applied to B-mode ultrasound (US) sequences of the left common carotid artery (CCA). A deformable skeleton model was also introduced in the block matching scheme. Finally, the 2-D movements of both proximal and distal walls were investigated in three different local regions, with 1.5 × 0.3 mm(2) kernel blocks. A clinical study was conducted in which two different populations (26 young healthy volunteers and 26 older diabetic patients) were studied. The results show that the mean amplitude value of the diameter change ΔD, of the longitudinal displacement of the proximal wall ΔX(p) and of the longitudinal displacement of the distal wall ΔX(d) were 0.65 ± 0.17 vs. 0.41 ± 0.12 mm (p < 0.001), 0.48 ± 0.21 vs. 0.26 ± 0.18 mm (p < 0.001) and 0.48 ± 0.20 vs. 0.35 ± 0.23 mm (p = 0.006) for the young healthy volunteers and the older diabetic patients, respectively. The results of the three dynamic parameters ΔD, ΔX(p) and ΔX(d) were systematically and significantly lower for the diabetic subjects, respectively 37%, 46% and 27%. The method introduced in this feasibility study might constitute a pertinent approach to assess the presence of early-stage arteriosclerosis by the noninvasive estimation of the 2-D motion of the intima-media complex in the CCA.