Predictive Factors for Sustained Pain after (sub)acute Osteoporotic Vertebral Fractures. Combined Results from the VERTOS II and VERTOS IV Trial.

PURPOSE: Osteoporotic vertebral compression fractures are treated conservatively or in selected cases with percutaneous vertebroplasty (PV). The purpose of this retrospective analysis is to determine predictive factors for a high visual analogue scale (VAS) pain score after conservative, sham or PV and is based on previously published randomized trials. METHODS: The VERTOS II compared conservative versus PV, and VERTOS IV compared sham versus PV treatment. The conservative group received pain medication. The sham and PV group received subcutaneous lidocaine/bupivacaine. In addition, the PV group received cementation, which was simulated in the sham group. Nineteen different predictors of high (≥ 5) versus low (< 5) VAS pain score at 12 months were investigated. RESULTS: 20.7% of patients in the PV group demonstrated a VAS ≥ 5 at the 12-month, compared to 40.1% in the conservative or sham group, with a significant difference (χ2(1) = 15.26, p < 0.0001, OR = 2.57, 95% CI = 1.59 to 4.15). In the subgroup analysis, we detected five predictors for the risk of high pain scores (VAS ≥ 5 after 12 months follow-up), namely: female, baseline VAS > 8, long-term baseline pain, mild/severe Genant and new fractures. CONCLUSIONS: Statistically significant more patients had a high pain score at 12 months in the sham and conservative group when compared with the PV group. Five predictors were identified for sustained high local back pain, regardless of the received treatment. Patients with moderate fracture deformity were less likely to have high pain scores at 12 months if they received PV than if they had sham or conservative therapy.

Stentless Root Replacement versus Tissue Valves in Infective Endocarditis - A Propensity-Score Matched Study.

INTRODUCTION: People with aortic/prosthetic valve endocarditis are a high-risk cohort of patients who present a challenge for all medically involved disciplines and who can be treated by various surgical techniques. METHODS: We analyzed the results of treatment of root endocarditis with Medtronic Freestyle® in full-root technique over 19 years (1999-2018) and compared them against treatment with other tissue valves. Comparison was made with propensity score matching, using the nearest neighbor method. Various tests were performed as suited for adequate analyses. RESULTS: Fifty-four patients in the Medtronic Freestyle group (FS group) were matched against 54 complex root endocarditis patients treated with other tissue valves (Tissue group). Hospital mortality was 9/54 (16.7%) in the FS group vs. 14/54 (25.6%) in the Tissue group (P=0.24). Cox regression performed for early results demonstrated coronary heart disease (P=0.004, odds ratio 2.3), among others, influencing early mortality. Recurrent infection was low (1.8% for FS and Tissue patients) and freedom from reoperation was 97.2% at a total of 367 patient-years of follow-up (median of 2.7 years). CONCLUSION: The stentless xenograft is a viable alternative for treatment of valve/root/prosthetic endocarditis, demonstrating a low rate of reinfection. The design of the bioroot allows for complex reconstructive procedures at the outflow tract and the annular level with at an acceptable operative risk. Endocarditis patients can be treated excluding infective tissue from the bloodstream, possibly with benefits, concerning bacteremia and recurrent infection. Furthermore, the use of the stentless bioroot offers varying treatment options in case of future valve degeneration.

Stentless root replacement versus tissue valves in infective endocarditis - a propensity-score matched study

Abstract Introduction: People with aortic/prosthetic valve endocarditis are a high-risk cohort of patients who present a challenge for all medically involved disciplines and who can be treated by various surgical techniques. Methods: We analyzed the results of treatment of root endocarditis with Medtronic Freestyle® in full-root technique over 19 years (1999-2018) and compared them against treatment with other tissue valves. Comparison was made with propensity score matching, using the nearest neighbor method. Various tests were performed as suited for adequate analyses. Results: Fifty-four patients in the Medtronic Freestyle group (FS group) were matched against 54 complex root endocarditis patients treated with other tissue valves (Tissue group). Hospital mortality was 9/54 (16.7%) in the FS group vs. 14/54 (25.6%) in the Tissue group (P=0.24). Cox regression performed for early results demonstrated coronary heart disease (P=0.004, odds ratio 2.3), among others, influencing early mortality. Recurrent infection was low (1.8% for FS and Tissue patients) and freedom from reoperation was 97.2% at a total of 367 patient-years of follow-up (median of 2.7 years). Conclusion: The stentless xenograft is a viable alternative for treatment of valve/root/prosthetic endocarditis, demonstrating a low rate of reinfection. The design of the bioroot allows for complex reconstructive procedures at the outflow tract and the annular level with at an acceptable operative risk. Endocarditis patients can be treated excluding infective tissue from the bloodstream, possibly with benefits, concerning bacteremia and recurrent infection. Furthermore, the use of the stentless bioroot offers varying treatment options in case of future valve degeneration.

Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPOCH): study protocol of a randomised controlled, multicentre, superiority trial.

INTRODUCTION: Surgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI. METHODS AND ANALYSIS: EPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmoll-1) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis. ETHICS AND DISSEMINATION: Ethics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results. TRIAL REGISTRATION NUMBER: Registered in the Dutch Trial Register: NL5572.

Use of the Medtronic Freestyle for aortic valve infection: A retrospective propensity score matched analysis.

BACKGROUNDS: Aortic valve and prosthetic valve endocarditis present a challenging subgroup of patients at high risk. We analyzed our experience using the Medtronic Freestyle in full root technique for the treatment of these cases over 18-year time period. METHODS: We investigated the endocarditis subgroup from our cohort of 971 patients and compared results against other valve types with propensity score matching implementing nearest neighbor method. T-test, χ2 test, logistic regression, and Cox regression were performed. RESULTS: Fifty-four patients from the Freestyle group (FS) were matched against 54 patients from a cohort of 376 aortic valve/root endocarditis patients treated by other valve types (non-FS). Hospital mortality was 9/54 (16.7%) in the FS vs 13/54 (24.1%) in the non-FS group (P = .33). Variables age (P = .003) and renal impairment (P = .026) had an impact on mortality according to Cox regression analysis for early results. Variables with significant risk for long-term mortality included postoperative renal impairment (P = .0001) and multiorgan failure (P = .0001). Recurrent infection was low (1.8% for FS and 3.7% for non-FS group), and freedom from reoperation was 97.2%. Use of the Medtronic Freestyle was no significant risk factor for long-term mortality. CONCLUSION: The Freestyle stentless xenograft is a viable alternative for treatment of valve/root and prosthetic endocarditis. In our experience, it showed good postoperative performance with low rate of reinfection while having an acceptable operative risk-profile for this high-risk cohort.

Infection of Previously Closed Urachus Mimicking Malignancy: A Case Report and Literature Review of Radiological Findings to the Diagnosis.

The urachus is a vestigial structure of the allantois and cloaca. It involutes as fetal development progresses to become a fibrous cord, which courses between the umbilicus and bladder dome within the retropubic space. Infection occasionally occurs in patients with congenital patent urachus. Here, we report a patient with infection of a previously closed urachal tract presenting as an abdominal mass. This has rarely been described in the literature. Current knowledge on imaging findings to the diagnosis is discussed.

Hospital Results of a Single Center Database for Stentless Xenograft Use in a Full Root Technique in Over 970 Patients.

Our aim was to analyse the hospital outcome for the worldwide largest series of stentless bioroot xenografts (Medtronic Freestyle) as full root replacement in a single centre over a period of 18 years. Retrospective data analysis was performed for the entire cohort of patients undergoing aortic root surgery with the Medtronic Freestyle valve prosthesis. Logistic regression analysis was performed to analyse predictors of in-hospital mortality. 971 patients underwent aortic full root replacement with the Medtronic Freestyle valve in the period from 1999-2017, with an average age of 68.8 ± 10.3y and gender distribution of 608:363 (male:female). Concomitant surgery was performed in 693 patients (71.4%). In-hospital all-comers mortality was 9.8% (95 patients), with the respective highest risk profiles including dissections (6.4%), endocarditis (5.6%) and re-do procedures (12.5%). In-hospital mortality for elective patients was 7.6% while isolated aortic root replacement demonstrated a mortality of 3.6%. Logistic regression analysis demonstrated age (OR 1.05, p = 0.005), dissection (OR 5.78, p < 0.001) and concomitant bypass surgery (OR 2.68, p < 0.001) as preoperative risk factors for the entire cohort. Postoperative analysis demonstrated myocardial infarction (OR 48.6, p < 0.001) and acute kidney injury (OR 20.2, p < 0.001) to be independent risk factors influencing mortality. This analysis presents a work-through of all patients with stentless bioroot treatment without positive selection in a high-volume clinical center with the largest experience world-wide for this form of complex surgery. Isolated aortic root replacement could be performed at acceptable operative risk for this technically-challenging procedure.

Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial.

OBJECTIVE: To assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body. DESIGN: Randomised, double blind, sham controlled clinical trial. SETTING: Four community hospitals in the Netherlands, 2011-15. PARTICIPANTS: 180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89). INTERVENTIONS: Participants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group. MAIN OUTCOME MEASURES: Main outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months' follow-up. RESULTS: The mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval -0.53 to 0.94) at baseline, -0.43 (-1.17 to 0.31) at one day, -0.11 (-0.85 to 0.63) at one week, 0.41 (-0.33 to 1.15) at one month, 0.21 (-0.54 to 0.96) at three months, 0.39 (-0.37 to 1.15) at six months, and 0.45 (-0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months' follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction. CONCLUSIONS: Percutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months' follow-up among patients with acute osteoporotic vertebral compression fractures. TRIAL REGISTRATION: ClinicalTrials.gov NCT01200277.

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches.

OBJECTIVE: To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement. METHODS: A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach. RESULTS: No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed tomographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs. CONCLUSIONS: Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.

First-in-Man Transcervical Surgical Aortic Valve Replacement Using the CoreVista System.

OBJECTIVE: This study aimed to evaluate a novel device system for surgical aortic valve replacement (SAVR) using a unique new less invasive access approach. The hypothesis is that SAVR can be performed through a short transverse incision in the neck, similar to that used for transcervical thymectomy avoiding chest disruption. METHODS: A new device system was developed to provide retraction, step-by-step illumination, and on-screen visualization for the new approach. Preliminary feasibility studies were performed in cadavers. Comprehensive risk analysis was performed, and training was implemented in Thiel preserved cadavers. For the first-in-man clinical case, a 63-year-old woman with symptomatic critical aortic stenosis (The Society of Thoracic Surgeons risk, 11%) and heavily calcified aortic valve was selected. A short transverse incision was made in the neck; the device was introduced, and the sternum was elevated; femorofemoral cardiopulmonary bypass was established; substernal dissection was guided by the sequenced illumination, and high-definition visualization was provided by the device, allowing for optimal exposition of the aorta and aortic valve; and a 23-mm Medtronic ENABLE sutureless valve prosthesis was implanted. Procedure success was evaluated according to the standardized composite end point definition of "device success" proposed by the Valve Academic Research Consortium. RESULTS: Access, delivery, and deployment of the valve prosthesis were successful. The correct position and intended performance of the valve were demonstrated (mean gradient, 6 mm Hg; aortic valve area, 2.5 cm) with the absence of moderate or severe prosthetic aortic regurgitation. Only one valve prosthesis was used. CONCLUSIONS: Transcervical SAVR with sutureless valve is feasible using this novel access system. The new approach has potential to offer patients substantially shorter stay and fewer, less serious complications, as has been observed in transcervical thymectomy. Further studies are merited.

Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel.

OBJECTIVES: After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS: Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS: Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION: The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.

Sutureless aortic valve replacement: a systematic review and meta-analysis.

BACKGROUND: Sutureless aortic valve replacement (SU-AVR) has emerged as an innovative alternative for treatment of aortic stenosis. By avoiding the placement of sutures, this approach aims to reduce cross-clamp and cardiopulmonary bypass (CPB) duration and thereby improve surgical outcomes and facilitate a minimally invasive approach suitable for higher risk patients. The present systematic review and meta-analysis aims to assess the safety and efficacy of SU-AVR approach in the current literature. METHODS: Electronic searches were performed using six databases from their inception to January 2014. Relevant studies utilizing sutureless valves for aortic valve implantation were identified. Data were extracted and analyzed according to predefined clinical endpoints. RESULTS: Twelve studies were identified for inclusion of qualitative and quantitative analyses, all of which were observational reports. The minimally invasive approach was used in 40.4% of included patients, while 22.8% underwent concomitant coronary bypass surgery. Pooled cross-clamp and CPB duration for isolated AVR was 56.7 and 46.5 minutes, respectively. Pooled 30-day and 1-year mortality rates were 2.1% and 4.9%, respectively, while the incidences of strokes (1.5%), valve degenerations (0.4%) and paravalvular leaks (PVL) (3.0%) were acceptable. CONCLUSIONS: The evaluation of current observational evidence suggests that sutureless aortic valve implantation is a safe procedure associated with shorter cross-clamp and CPB duration, and comparable complication rates to the conventional approach in the short-term.

Sutureless Aortic Valve Replacement International Registry (SU-AVR-IR): design and rationale from the International Valvular Surgery Study Group (IVSSG).

BACKGROUND: Sutureless aortic valve replacement (SU-AVR) is an innovative approach which shortens cardiopulmonary bypass and cross-clamp durations and may facilitate minimally invasive approach. Evidence outlining its safety, efficacy, hemodynamic profile and potential complications is replete with small-volume observational studies and few comparative publications. METHODS: Minimally invasive aortic valve surgery and high-volume SU-AVR replacement centers were contacted for recruitment into a global collaborative coalition dedicated to sutureless valve research. A Research Steering Committee was formulated to direct research and support the mission of providing registry evidence warranted for SU-AVR. RESULTS: The International Valvular Surgery Study Group (IVSSG) was formed under the auspices of the Research Steering Committee, comprised of 36 expert valvular surgeons from 27 major centers across the globe. IVSSG Sutureless Projects currently proceeding include the Retrospective and Prospective Phases of the SU-AVR International Registry (SU-AVR-IR). CONCLUSIONS: The global pooling of data by the IVSSG Sutureless Projects will provide required robust clinical evidence on the safety, efficacy and hemodynamic outcomes of SU-AVR.

Early single-center experience in sutureless aortic valve implantation in 120 patients.

OBJECTIVE: The study objective was to evaluate the safety and efficacy of sutureless self-expanding nitinol stent-frame aortic valve prostheses made of equine pericardium implanted in patients with symptomatic aortic valve disease. METHODS: We performed a retrospective analysis of 120 patients (mean age, 76.7 ± 5.9 years) who underwent isolated aortic valve replacement or in combination with other cardiovascular procedures. Preoperatively, Society of Thoracic Surgeons score was determined. Transthoracic echocardiography and clinical outcome evaluation were performed at the time of discharge and at 6, 12, and 18 months follow-up, respectively. RESULTS: A total of 71 of 120 patients underwent isolated sutureless aortic valve replacement (mean aortic crossclamp time, 37 ± 11 minutes; mean bypass time, 62 ± 18 minutes). Coronary bypass grafting was performed in 30 patients. Overall mean Society of Thoracic Surgeons score was 14.8% ± 10%. Thirty-day mortality rate was 6.7% overall and 1.4% in stand-alone procedures. During a mean follow-up of 313 days, 3 more deaths occurred. The reoperation rate was 4.2%. Mean and peak transvalvular pressure gradients were 9 mm Hg (4-13 mm Hg) and 14 mm Hg (8-22 mm Hg) at discharge, respectively. In 8 patients (6.7%), permanent pacemaker implantation was necessary. No thromboembolic events or bleedings related to the bioprosthesis were observed. CONCLUSIONS: In this large single-center experience with sutureless aortic valve replacement, the surgical procedure is shown to be safe and time-saving. In view of the excellent hemodynamic results and shortening of aortic crossclamp and bypass times, we notice advantages especially in high-risk patients. Minimally invasive access seems to be facilitated. The long-term durability of this prosthesis has yet to be determined.

WDR19: an ancient, retrograde, intraflagellar ciliary protein is mutated in autosomal recessive retinitis pigmentosa and in Senior-Loken syndrome.

Autosomal recessive retinitis pigmentosa (arRP) is a clinically and genetically heterogeneous retinal disease that causes blindness. Our purpose was to identify the causal gene, describe the phenotype and delineate the mutation spectrum in a consanguineous Quebec arRP family. We performed Arrayed Primer Extension (APEX) technology to exclude ∼500 arRP mutations in ∼20 genes. Homozygosity mapping [single nucleotide polymorphism (SNP) genotyping] identified 10 novel significant homozygous regions. We performed next generation sequencing and whole exome capture. Sanger sequencing provided cosegregation. We screened another 150 retinitis pigmentosa (RP) and 200 patients with Senior-Løken Syndrome (SLS). We identified a novel missense mutation in WDR19, c.2129T>C which lead to a p.Leu710Ser. We found the same mutation in a second Quebec arRP family. Interestingly, two of seven affected members of the original family developed 'sub-clinical' renal cysts. We hypothesized that more severe WDR19 mutations may lead to severe ciliopathies and found seven WDR19 mutations in five SLS families. We identified a new gene for both arRP and SLS. WDR19 is a ciliary protein associated with the intraflagellar transport machinery. We are currently investigating the full extent of the mutation spectrum. Our findings are crucial in expanding the understanding of childhood blindness and identifying new genes.

Assessment of the effect on blood loss and transfusion requirements when adding a polyethylene glycol sealant to the anastomotic closure of aortic procedures: a case-control analysis of 102 patients undergoing Bentall procedures.

BACKGROUND: The use of CoSeal(®), a polyethylene glycol sealant, in cardiac and vascular surgery for prevention of anastomotic bleeding has been subject to prior investigations. We analysed our perioperative data to determine the clinical benefit of using polyethylene glycol sealant to inhibit suture line bleeding in aortic surgery. METHODS: From January 2004 to June 2006, 124 patients underwent aortic surgical procedures such as full root replacements, reconstruction and/or replacement of ascending aorta and aortic arch procedures. A Bentall procedure was employed in 102 of these patients. In 48 of these, a polyethylene glycol sealant was added to the anastomotic closure of the aortic procedure (sealant group) and the other 54 patients did not have this additive treatment to the suture line (control group). RESULTS: There were no significant between-group differences in the demographic characteristics of the patients undergoing Bentall procedures. Mean EuroSCORES (European System for Cardiac Operative Risk Evaluation) were 13.7 ± 7.7 (sealant group) and 14.4 ± 6.2 (control group), p = NS. The polyethylene glycol sealant group had reduced intraoperative and postoperative transfusion requirements (red blood cells: 761 ± 863 versus 1248 ± 1206 ml, p = 0.02; fresh frozen plasma: 413 ± 532 versus 779 ± 834 ml, p = 0.009); and less postoperative drainage loss (985 ± 972 versus 1709 ± 1302 ml, p = 0.002). A trend towards a lower rate of rethoracotomy was observed in the sealant group (1/48 versus 6/54, p = 0.07) and there was significantly less time spent in the intensive care unit or hospital (both p = 0.03). Based on hypothesis-generating calculations, the resulting economic benefit conferred by shorter intensive care unit and hospital stays, reduced transfusion requirements and a potentially lower rethoracotomy rate is estimated at €1,943 per patient in this data analysis. CONCLUSIONS: The use of this polymeric surgical sealant demonstrated improved intraoperative and postoperative management of anastomotic bleeding in Bentall procedures, leading to reduced postoperative drainage loss, less transfusion requirements, and a trend towards a lower rate of rethoracotomy. Hypothesis-generating calculations indicate that the use of this sealant translates to cost savings. Further studies are warranted to investigate the clinical and economic benefits of CoSeal in a prospective manner.

Influence of operative strategy for the aortic arch in DeBakey type I aortic dissection: analysis of the German Registry for Acute Aortic Dissection Type A.

OBJECTIVE: Patients treated with an extensive approach including total aortic arch replacement for acute aortic dissection type A may have a favorable long-term prognosis by treating the residual false lumen. Our goal was to analyze the operative strategy for treatment of type I DeBakey aortic dissection from the German Registry for Acute Aortic Dissection Type A (GERAADA) data. METHODS: A total of 658 patients with type I DeBakey aortic dissection and entry only in the ascending aorta were identified in the GERAADA. Patients in group A underwent replacement of the ascending aorta with hemiarch replacement. Patients in group B received extensive treatment with total arch replacement or conventional or frozen elephant trunk. RESULTS: A total of 518 patients in group A and 140 patients in group B were treated. There was an overall 30-day mortality of 20.2% (n = 133). Group A had a slightly lower rate of mortality with 18.7% (n = 97) compared with 25.7% for group B (n = 36), but with no statistical significant difference (P = .067). The onset of new neurologic deficit (13.6% in group vs 12.5% in group B, P = .78) and new malperfusion deficit (8.4% in group A vs 10.7% in group B, P = .53) showed no statistical difference. CONCLUSIONS: On analysis of the GERAADA data, it seems that a more aggressive approach of aortic arch treatment can be applied without higher perioperative risk even in the onset of acute aortic dissection type A. Long-term follow-up data analysis will be necessary to offer the optimal surgical strategy for different patient groups.

Nomogram for suboptimal cytoreduction at primary surgery for advanced stage ovarian cancer.

AIM: Maximal cytoreduction to minimal residual tumor is the most important determinant of prognosis in patients with advanced stage epithelial ovarian cancer (EOC). Preoperative prediction of suboptimal cytoreduction, defined as residual tumor >1 cm, could guide treatment decisions and improve counseling. The objective of this study was to identify predictive computed tomographic (CT) scan and clinical parameters for suboptimal cytoreduction at primary cytoreductive surgery for advanced stage EOC and to generate a nomogram with the identified parameters, which would be easy to use in daily clinical practice. MATERIALS AND METHODS: Between October 2005 and December 2008, all patients with primary surgery for suspected advanced stage EOC at six participating teaching hospitals in the South Western part of the Netherlands entered the study protocol. To investigate independent predictors of suboptimal cytoreduction, a Cox proportional hazard model with backward stepwise elimination was utilized. RESULTS: One hundred and fifteen patients with FIGO stage III/IV EOC entered the study protocol. Optimal cytoreduction was achieved in 52 (45%) patients. A suboptimal cytoreduction was predicted by preoperative blood platelet count (p=0.1990; odds ratio (OR)=1.002), diffuse peritoneal thickening (DPT) (p=0.0074; OR=3.021), and presence of ascites on at least two thirds of CT scan slices (p=0.0385; OR=2.294) with a for-optimism corrected c-statistic of 0.67. CONCLUSION: Suboptimal cytoreduction was predicted by preoperative platelet count, DPT and presence of ascites. The generated nomogram can, after external validation, be used to estimate surgical outcome and to identify those patients, who might benefit from alternative treatment approaches.

Iatrogenic subtotal stenosis of the right subclavian artery treated with percutaneous transluminal angioplasty.

This report describes a rare vascular complication of surgical placement of a marking clip and a possible approach to problem solving. A 55-year-old patient presented with loss of sensation in the fingers and loss of peripheral pulsations in the right arm 4 days after right upper lobectomy for a pT2N1 moderately differentiated adenocarcinoma of the lung. Duplex examination and computed tomography were performed the same day and showed a subtotal stenosis of the right subclavian artery, which was caused by the surgical placement of a metal clip to mark the surgical boundary. Selective angiography was subsequently performed. Percutaneous transluminal angioplasty (PTA) successfully dilated the stenosis and pushed the clip off. Flow in the right subclavian artery (RSA) was completely restored as were neurology and peripheral pulses. In conclusion, arterial stenosis by a surgical (marking) clip may be feasibly treated with PTA.