Early and Midterm Outcomes of Endovascular Aortic Arch Repair Using In Situ Laser Fenestration.

INTRODUCTION: The aim of this study is to present single-center outcomes in patients treated with in situ laser fenestration thoracic endovascular aortic repair (LFTEVAR) for various aortic arch pathologies and assess the impact of increasing experience. METHODS: The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was followed. A retrospective analysis of prospectively collected single aortic center data was conducted, including baseline information and peri- and post-operative outcomes of consecutive patients managed with LFTEVAR for aortic arch pathologies. Patients were enrolled from April 1, 2017 to January 31, 2023. The cohort was dichotomized to compare early (2017-2019) and late experience (2020-2023). Primary outcomes were peri-operative mortality and cerebrovascular morbidity. RESULTS: Thirty patients were included (63.3% males, mean age 69.8±9.6 years); 21.4% presented with aortic ruptures. Aortic aneurysm involving the aortic arch was the most frequent pathology (53.3%). Forty target vessels (TVs) were revascularized, including 19 left subclavian arteries (47.5%) and 17 left common carotid arteries (42.5%). Double fenestrations were performed in 10 patients. The proximal landing zone was Ishimaru zone 0 in 5 patients (16.7%) and zone 1 in 13 patients (43.3%). Technical success was 93%. No spinal cord ischemia was recorded, and 3 patients (10%) suffered a post-operative stroke, of which 1 was major (3.3%). The median follow-up was 12 months (range=1-48 months). Thirty-day and follow-up mortality rates were 13.5% and 15.3%, respectively. Target vessel instability was 10%, of which 3.8% required reintervention. There was no statistically significant difference in outcomes between the early and late experience groups. CONCLUSIONS: Laser fenestration thoracic endovascular aortic repair of the aortic arch performed in experienced aortic centers is associated with low early mortality and stroke rates. It is a safe and effective therapeutic option in patients considered unfit for open repair. CLINICAL IMPACT: Custom-made devices for arch pathologies requiring urgent repair are not an option because of manufacturing delays. Off-the-shelf devices with single branch arch prostheses, and outside IFU techniques such as parallel-grafts and surgeon-modified endografts have been proposed in this setting. Another off-the-shelf alternative is in situ laser fenestration thoracic endovascular repair (LFTEVAR), which addresses many limitations of the other off-the-shelf options. Our study reports the outcomes of 30 patients treated with LFTEVAR, showing that it is a viable therapeutic option in patients considered unfit for open repair acknowledging that sufficient experience with complex endovascular aortic repair is mandatory to achieve acceptable outcomes in these high-risk patients with challenging aortic anatomies.

The Elevator Technique: A New Bailout Maneuver to Achieve Target Vessel Patency During Challenging BEVAR.

PURPOSE: The purpose of the study is to describe a new bailout maneuver for use during branched endovascular thoracoabdominal aneurysm repair (BEVAR) while dealing with challenging target vessel cannulation. TECHNIQUE: A 54-year-old woman underwent urgent BEVAR with a low-profile T-branch device to exclude a type 2 thoracoabdominal aneurysm (TAAA). The endovascular procedure was challenging because the left renal artery ostium was covered by the endograft fabric, compounded by diseased target vessels. A novel bailout maneuver is described. After angioplasty of the left renal artery (LRA), the LRA remained precannulated and a low-profile T-branch was implanted. The 3 proximal branches (superior mesenteric artery, inferior mesenteric artery, and the right renal artery) were connected to their respective target vessels swiftly with a steerable sheath from a femoral approach. Access to the left renal artery was not achieved because it was obstructed by the fully deployed endograft. We subsequently stented the LRA over the "pre-positioned buddy wire," using a balloon-expandable covered stent protruding inside the aneurysm lumen. The proximal stent was then flared and lifted upward using an 8.5 Fr steerable sheath, which made cannulation and stenting of the LRA through the side-branch from above finally achievable. CONCLUSION: The elevator technique described in this article will help achieve technical success in challenging BEVAR cases. CLINICAL IMPACT: We describe in this technical note the "elevator technique" that will complement the "Snare-Ride" and "Balloon Anchoring" techniques over a buddy wire positioned in a target vessel, to provide successful bailout options for challenging TV cannulations during BEVAR.After failed access to the renal artery through the renal branch, a covered stent was implanted in the renal artery over the buddy wire with 10 mm protruding into the aortic lumen. This stent was then flared, prior to advancing a curved steerable sheath into the stent, which shaped it with a superior-facing funneled aortic segment. This maneuver resulted in the renal stent facing its corresponding branch, finally easy to access from the endograft lumen.

Cerebral oximetry monitoring by means of INVOS-4100 as a predictor of ischemic events during carotid endarterectomy.

Background: Several methods have been proposed to monitor cerebral perfusion during carotid endarterectomy (CEA), with the purpose of minimizing the risk of perioperative stroke. The INVOS-4100 is able to detect cerebral oxygen saturation providing an intraoperative real-time monitoring system of cerebral oximetry. The aim of this study was to evaluate the performance of the INVOS-4100 in predicting cerebral ischemia during CEA. Methods: Between January 2020 and May 2022, 68 consecutive patients were scheduled for CEA either under general anesthesia or regional anesthesia with deep and superficial cervical block. Vascular oxygen saturation was recorded continually through INVOS before and during clamping of the ICA. Awake testing was performed in the group of patients undergoing CEA under regional anesthesia. Results: Sixty-eight patients were included; 43 were males (63.2%). Severe stenosis of the artery was present in 92%. Forty-one (60.3%) patients were monitored by INVOS, while 22 (39.7%) underwent awake testing. Mean clamping time was 20 ± 6.6 min. Patients undergoing awake testing had a lower hospital stay and ICU stay during admission (p = 0.011 and p = 0.007 respectively). Comorbidities correlated with a higher ICU stay (p < 0.05). The INVOS monitoring was able to predict ischemic events with a sensitivity of 98% (AUC = 0.976). Conclusions: The present study demonstrates that cerebral oximetry monitoring was a strong predictor of cerebral ischemia, although it was not possible to determine the non-inferiority of cerebral oximetry compared to awake testing. Nonetheless, the use of cerebral oximetry evaluates only perfusion in the superficial brain tissue and an absolute rSO2 value corresponding to significant cerebral ischemia has not been established. Therefore, larger prospective studies that correlate cerebral oximetry with neurologic outcomes are needed.

Systematic Review on In Situ Laser Fenestrated Repair for the Endovascular Management of Aortic Arch Pathologies.

BACKGROUND: In situ laser-fenestrated thoracic aortic endovascular repair (FTEVAR) has emerged as a valuable alternative for aortic arch management. This review assessed the early and follow-up outcomes of in situ laser-FTEVAR in aortic arch pathologies. METHODS: The PRISMA statement was followed. The English literature was searched, via Ovid, until 15 October 2022. Observational studies, published after 2000, reporting on early and follow-up outcomes for the in situ laser-FTEVAR were eligible. The Newcastle-Ottawa Scale was used to assess the risk of bias. Primary outcomes were the technical success, stroke, and mortality at 30-days, and the secondary were the mortality and reintervention during follow-up. RESULTS: Six retrospective studies from 591 and 247 patients were included. Fifty-nine (23.9%) patients were managed for aortic arch aneurysms and 146 (59.1%) for dissections; 22.6% of them for type A. Technical success was at 98% (range 90-100%). Eight patients died (3.2%) and 11 cases presented any type of stroke (4.5%) during the 30-day follow-up. The mean follow-up was 15 months (1-40 months). Ten deaths were reported (4.2%); one was aortic-related (10%). Thirteen re-interventions (6.0%) were performed. CONCLUSIONS: In situ laser-FTEVAR for aortic arch repair may be performed with high technical success and low 30-day and midterm follow-up mortality, stroke, and re-intervention rates when applied in well selected patients and performed by experienced teams.

Midterm Outcomes of Antegrade In Situ Laser Fenestration of Polyester Endografts for Urgent Treatment of Aortic Pathologies Involving the Visceral and Renal Arteries.

OBJECTIVE: Aortic endografting and antegrade in situ laser fenestration of visceral arteries (LFEVAR) may be considered as an alternative to open surgery for the emergency repair of complex abdominal aortic aneurysms (AAA) in fragile patients. The aim of this article was to evaluate the midterm results of LFEVAR performed with polyester endografts. METHODS: From August 2015 to December 2020, all consecutive LFEVAR performed for non-deferrable treatment of complex AAA were analysed. Polyester endografts were deployed and subsequently fenestrated using an atherectomy laser probe; the fenestrations were enlarged using cutting and semicompliant balloons before implantation of balloon expandable bridging stents into the target vessels. Prospectively collected midterm survival, patency, and re-intervention rates were analysed. RESULTS: Forty four procedures were performed for 11 type 1a endoleaks, five thoraco-abdominal aneurysms, 20 pararenal aneurysms, four segmental renal artery (RA) preservations, three anastomotic aneurysms, and one aortic dissection. One hundred and eight laser fenestrations were performed (26 for the superior mesenteric artery [SMA], 13 for the coeliac trunk, 33 and 31 for the right and left RA, respectively). The median ischaemia duration was 7, 48, 48, and 45 minutes, respectively. The technical success rate was 97%, with no open surgical conversions. The 30 day mortality was 4.5% (n = 2). No spinal cord ischaemia events were observed nor early stent related complications. Kaplan-Meier overall survival at two years was 73%, the aortic related re-intervention free survival was 70%, and the stent related re-intervention free survival was 90.6%. Four target vessel thromboses were detected, of which three were rescued. Three type IIIc endoleaks, one RA false aneurysm, and one SMA stenosis, required re-intervention during a median follow up of 24.7 months. CONCLUSION: Antegrade LFEVAR is feasible, safe, and provides satisfactory early and midterm outcomes for non-deferrable treatment of aortic pathologies involving the visceral segment. Long term data are mandatory to confirm the usefulness of this promising off label technique.

Comparison of surgical versus percutaneously created arteriovenous hemodialysis fistulas.

OBJECTIVE: The aim of the present study was to compare the results between percutaneous arteriovenous fistulas (p-AVFs) created with the Ellipsys device (Ellipsys Vascular Access System; Avenu Medical, San Juan Capistrano, Calif) and surgical arteriovenous fistulas (s-AVFs). METHODS: A single-center retrospective comparative study of the first 107 patients who had undergone p-AVF creation with the Ellipsys system from May 2017 to May 2018 with an equal number of consecutive patients who had undergone s-AVF creation in our center during the same period. The primary endpoints included the maturation and patency rates. The secondary endpoints were reintervention, risk of infection, and the incidence of steal syndrome and aneurysm formation. RESULTS: The demographic, hypertension, and diabetes data were similar for both groups. The only difference between the two groups was that more p-AVF patients had already been receiving hemodialysis (61% vs 47%; P < .05). The p-AVFs showed superior maturation rates at 6 weeks (65% vs 50%; P = .01). The primary patency rates were greater for the s-AVFs at 12 months (86% vs 61%; P < .01). However, primary patency was comparable between the two groups at 24 months (52% vs 55%; P = .48). No significant difference was found in the secondary patency rates at 12 (90% vs 91%) and 24 (88% vs 91%) months. At the 2-year follow-up point, the rate of percutaneous reintervention was similar; however, the s-AVFs had required more frequent surgical revision (36% vs 17%; P = .01). Issues with wound healing and infection were also more frequent with s-AVFs (9% vs 0.9%; P < .01). CONCLUSIONS: Fistulas created percutaneously with the Ellipsys system showed superior maturation rates and similar patency with s-AVFs created in an experienced high-volume vascular surgery practice. p-AVFs had a lower risk of wound healing issues, infection, and surgical revision. Larger, prospective, randomized multicenter studies are needed to confirm these findings.

KRAS and NRAS mutation detection in circulating DNA from patients with metastatic colorectal cancer using BEAMing assay: Concordance with standard biopsy and clinical evaluation.

Patients with metastatic colorectal cancer (mCRC) are routinely screened for either K- and N-RAS to select the appropriate treatment. The present study aimed to evaluate the concordance between K- and NRAS status in the tissue (either primary tumor or metastasis) and the plasma of patients with mCRC and to identify the associations between K- and NRAS mutations in ctDNA and the clinicopathological parameters. Samples from a total of 31 patients with mCRC with measurable disease according to the Response Evaluation Criteria in Solid Tumors were analyzed. For all patients, K- and NRAS status was determined in the tissue by matrix-assisted laser desorption/ionization time of flight mass spectrometry. For the detection of RAS mutations in cell-free tumor DNA also defined as circulating tumor DNA (ctDNA), the OncoBEAM® RAS CRC kit (Sysmex Inostics) was used. A total of 6/31 tissue samples expressed wild-type KRAS, whereas 25/31 presented mutations. In addition, 7/31 plasma samples expressed wild-type KRAS, mutations were detected in 22/31 patients, and for 2/31 patients, the test did not provide a conclusive result. A total of 24/31 patients expressed wild-type NRAS, 6/31 had mutations and 1/21 was not informative. For the KRAS mutational status, a moderate concordance (agreement, 85.18%; Cohen's k, 0.513) between the tissue and plasma analysis was observed; for NRAS, a fair agreement (agreement, 83.33%; Cohen's k, 0.242) was obtained. In conclusion, both tissue and plasma analyses should be performed for the management of patients with mCRC. To better exploit the beads, emulsions, amplification, magnetics (BEAMing) technique in the clinical setting, studies aimed at determining the RAS status to monitor therapy and during follow-up are warranted.

Patient associations and clinical oncology research: how much does a patient's voice really matter?

Background: New trends are emerging in clinical research, such as patient empowerment and an active role in influencing health and research ethics. Patients' involvement is considered pivotal by stakeholders and institutions because they can channel the voice of those they represent, empowering their starring role in the different research activities.Objectives: To obtain an overview of the real involvement of Italian patient associations in clinical research.Methods: In January 2019, the Working Group 'Clinical Research Coordinators' of the Italian Association of Medical Oncology spread an online questionnaire consisting of 16 questions on the active involvement of patient associations in clinical research.Results: The involvement in clinical research working groups, in the organization and implementation of specific activities and training initiatives is very limited (21.7% in both cases), as well as the active involvement in the conduct and/or definition of clinical trials (0.3%). Moreover, few associations (15.2%) have joined projects on patient involvement in clinical research in collaboration with other associations.Discussion: Although the current involvement of the associations may have been somewhat underestimated, there is no doubt that much more can be done in terms of training and identification of common objectives between patients and professionals.

Midterm results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System, technical recommendations, and an algorithm for maintenance.

OBJECTIVE: The aim of this study was to report our midterm results of percutaneous arteriovenous fistula (pAVF) creation using the Ellipsys (Avenu Medical, San Juan Capistrano, Calif) device and to present technical recommendations and our algorithm of pAVF maintenance. METHODS: A single-center comprehensive database of all consecutive predialysis and end-stage renal disease patients who had a pAVF creation with the Ellipsys device was reviewed retrospectively. Study end points included technical success, maturation, functional patency, and required interventions. RESULTS: Between May 2017 and July 2019, there were 234 patients (mean age, 64 years; 148 male [63%]) who had a pAVF created. Technical success was achieved in 232 individuals (99%), and average duration of the procedure was 15 minutes (7-35 minutes). Average follow-up was 252 days (range, 83-696 days). The 1-year primary, primary assisted, and secondary patency rates were 54%, 85%, and 96%, respectively. Average pAVF flow was 923 mL/min (range, 425-1440 mL/min). There were no significant adverse events related to the procedure. Only three patients (1%) required a later conversion of the pAVF anastomosis to a surgical fistula. Twenty-four (10%) patients required superficialization of deep outflow veins because of difficult cannulation. Average maturation time was 4 weeks (range, 1-12 weeks). Fourteen patients (6%) had early (<2 weeks after creation) cannulation of the pAVF. CONCLUSIONS: The Ellipsys pAVF device allows the rapid and safe creation of a reliable autogenous access. Rates of technical success, patency, and maturation were excellent. For patients unsuited for a distal radiocephalic arteriovenous fistula, it should be considered the next preferred access option.

Covered Stent Implantation for Treatment of Iliac Vein Rupture During Percutaneous Left Atrial Appendage Occlusion.

An 82-year-old woman who experienced an iatrogenic external iliac vein perforation during a left atrial appendage occlusion procedure was successfully treated by endovascular graft implantation. We report the short- and long-term outcomes of the procedure. (Level of Difficulty: Advanced.).

Phase I studies: a test bench for Italian clinical research.

BACKGROUND: The Agenzia Italiana del Farmaco (AIFA) Determination 809/2015 sets all the requirements that clinical units and laboratories must meet in order to conduct phase I studies. Requirements include buildings, equipment, personnel, emergency management, as well as quality requirements defined in a set of standard operating procedures. METHODS: In September 2018, the Italian Association of Medical Oncology working group, Clinical Research Coordinator, created an anonymous survey addressed to 51 medical directors of oncologic/hematologic clinical phase I units and all medical directors of generic and transversal units located in Italy and listed at the AIFA website. RESULTS: Questionnaires from 24 institutions were collected, 9 previously inspected by competent authorities. All surveyed structures are certified to conduct profit studies and 1 is authorized to include healthy volunteers; 15 units implemented a Clinical Trial Quality Team in order to conduct nonprofit studies. At the time of data collection, a total of 398 proposals for phase I trials have been received, more than 50% coming from 3 institutes. A total of 144 phase I studies were active, with a median of 2.5 (Q1-Q3=0-6) studies for each center and asymmetric distribution of proposals. CONCLUSION: The considerable number of proposals received from the interviewed centers indicates that Italy plays an important role in the international pharmaceutical scene, despite bureaucratic procedures that threaten exclusion from decision-making. The AIFA Determination will be an important opportunity to acquire a competitive working approach.

Robotic Resection of a Left Brachiocephalic Vein Aneurysm Mimicking Thymoma.

A 70-year-old man was scheduled for the robotic resection of a 21×16 × 30 mm thymic nodule incidentally detected by a computed tomography scan (CT) for thoracic trauma after a domestic accident. Positron emission tomography (PET) scan confirmed a low [18F]-FDG uptake (SUVmax = 1,9). During the surgery, the mass showed to be a saccular aneurysm of the left brachiocephalic vein (LBCV). A complete tangential resection of the aneurysm, with the use of EndoGIA stapler (Covidien® Endo GIA™) at its origin, was performed. The patient's recovery was uneventful, and postoperative CT with contrast administration confirmed the patency of the vein.

Percutaneous arteriovenous fistulae: Technique, feasibility and results

Patients with end-stage renal disease that require chronic haemodialysis need a reliable vascular access. Unanimously, native arteriovenous fistulae are considered to be the most reliable access for patients with reasonable life expectancy. For the last 60 years arteriovenous fistulae have been created surgically at the wrist or the elbow with variable rates of success, maturation problems, reinterventions and complications, making this field of surgery particularly challenging and full of scientific controversies. The recent addition of the technical ability to create arteriovenous fistulae percutaneously comes to add one more option for the patients and one more source of controversy for the experts.

Upper arm basilic vein elevation as a solution for forearm ulnar-basilic arteriovenous fistulae with cannulation problems.

BACKGROUND: Ulnar-basilic arteriovenous fistula is an alternative option when a radiocephalic arteriovenous fistula is not feasible. We review our technique of basilic vein transposition in the upper arm for difficult to puncture forearm ulnar-basilic non-transposed arteriovenous fistulae. TECHNICAL NOTE: Three patients were referred for forearm ulnar-basilic arteriovenous fistulae with difficult cannulation where the forearm basilic vein was left in situ (non-transposed). Surgeon performed ultrasound examination confirmed a patent arteriovenous fistula with adequate diameter and flow, draining to the basilic vein in the forearm and into the upper arm. Recurrent new and resolving hematomas were present surrounding the forearm basilic vein resulting from difficult cannulation issues and problems maintaining needle position due the posterior-medial ulnar-basilic arteriovenous fistula position and mobility of the non-transposed forearm basilic vein. A basilic vein transposition elevation procedure was performed in the upper arm starting at the level of the elbow to a few centimeters below the axilla. Branches of the dilated basilic vein were ligated, the median cutaneous nerve was preserved, and the vein was elevated from its native position to a superficial and anterior location. Although difficult, dialysis access had been continued in the forearm during a brief period and none required catheter placement. Reliable dialysis access was successfully initiated using the newly transposed basilic vein in the upper arm 3-4 weeks after the procedure, maintaining arterial inflow based on the original ulnar-basilic arteriovenous fistula anastomosis at the wrist. None of the patients required further interventions with follow-up of 8, 15, and 22 months.

Early results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System.

OBJECTIVE: We reviewed our initial experience creating a percutaneous arteriovenous fistula (pAVF) using a thermal resistance anastomosis device with proximal radial artery inflow. METHODS: A retrospective review was conducted of all patients who underwent a pAVF creation procedure between May 2017 and October 2017. Primary end points of the study were technical success, patency by Doppler ultrasound examination or angiography, flow levels achieved, time to first use, and pAVF-related complications. RESULTS: A pAVF was attempted in 34 patients with technical success in 33 individuals (97%). Patency of the pAVF was 94%. Mean access flow was 946 mL/min (brachial artery measurement) at the latest follow-up visit (53-229 days; average, 141 days). At 6 weeks, all fistulas have been used or were ready for dialysis by clinical examination or ultrasound examination. Only one patient required superficialization of the upper arm cephalic vein by lipectomy. There were no adverse events related to the pAVF creation or use, nor was there need for further interventions. CONCLUSIONS: Successful pAVFs with proximal radial artery inflow were created with excellent initial results regarding technical success, patency, and safety. Advantages include avoidance of a surgical incision, short procedure times, good acceptance by patients, prompt access maturation, moderate flow, and low-pressure access, with possible reduction of risk for ischemic complications. Avoidance of vessel manipulation and side branch ligation might reduce risk of thrombosis and improve long-term patency and reduce need for further interventions. These early findings need to be confirmed in larger and longer follow-up studies.

Resection of puncture site necrosis over an arteriovenous fistula: Endoclamp use for preservation of cannulation sites.

Skin necrosis overlying an arteriovenous fistula at the cannulation site is a common and potentially life-threatening problem, often associated with underlying aneurysm formation. Arteriovenous fistula-skin necrosis generally requires resection of surrounding skin margins and the underlying aneurysmal vessel wall, allowing repair with healthy tissue of the arteriovenous fistula in addition to closure of soft tissue and skin. In patients with insufficient fistula length, salvage of these arteriovenous fistulas may result in difficult or insurmountable cannulation issues leading to attempts at one-needle cannulation dialysis or, most often, catheter placement. Pre-existing stents or extensive calcification may add to the technical challenge of gaining proximal and/or distal control. We describe our technique for dealing with such arteriovenous fistula-skin necrosis lesions utilizing endo-occlusion with an angioplasty balloon for vascular control, allowing a limited incision and tissue resection with preservation of arteriovenous fistula cannulation length.

Pseudo-aneurysm caused from banding failure.

BACKGROUND: To present a case of banding failure with vessel wall erosion and pseudo-aneurysm creation caused by the suture. CASE REPORT: A 75-year-old male patient was operated for a high-flow fistula (>2 L/min). This was overall the third time that the patient was operated for the same indication since he started dialysis 5 years ago. Standard banding technique with perioperative flow measurements was used, and three separate Prolene sutures tied over 5 and 4.5 mm probes to achieve flow reduction. The operation was successful and first few weeks were uneventful. However, 5-6 weeks postoperatively, the patient felt locally an acute pain that lasted only few seconds and a voluminous aneurysm occurred progressively within the next few weeks. He was observed 2 months after the first operation where a recurrent high-flow fistula was diagnosed and ultrasound examination revealed that the sutures used for banding were into the vessel lumen while a pseudo-aneurysm had occurred at the same level. The patient was re-operated for excision of the aneurysm and flow reduction with tapering of the anastomosis. CONCLUSION: Under certain conditions, the suture used for banding may erode through the vessel wall and get into the lumen. This will result in recurrence of a high-flow fistula. While this has been previously described, the phenomenon was otherwise uneventful. In contrary, in the case presented herein, a potentially threatening pseudo-aneurysm has occurred.

Effect of Contract Research Organization Bureaucracy in Clinical Trial Management: A Model From Lung Cancer.

INTRODUCTION: Contract research organization (CRO) support is largely included in clinical trial management, although its effect in terms of time savings and benefit has not yet been quantified. We performed a retrospective multicenter analysis of lung cancer trials to explore differences in term of trial activation timelines and accrual for studies with and without CRO involvement. MATERIALS AND METHODS: Results regarding study timelines from feasibility data to first patient enrollment were collected from 7 Italian thoracic oncology departments. The final accruals (screened/enrolled patients) are reported. We considered CRO/sponsor-administered and CRO-free trials according to who was responsible for the management of the crucial setup phases. RESULTS: Of 113 trials, 62 (54.9%) were CRO-administered, 34 (30.1%) were sponsor-administered, and 17 (15.0%) were CRO-free. The median time from feasibility invitation to documentation obtainment was 151 days in the CRO-administered trials versus 128 in the sponsor-administered and 120 in the CRO-free trials. The time from document submission to contract signature was 142 days in the CRO-administered versus 128 in the sponsor-administered and 132 in the CRO-free trials. The time from global accrual opening to first patient enrollment was 247 days for the CRO-administered versus 194 in the sponsor-administered and 151 in the CRO-free trials. No significant differences were observed in terms of the median overall timeline: 21 months in the CRO-administered, 15 in the sponsor-administered, and 18 months in the CRO-free studies (P = .29). CONCLUSION: Although no statistically significant differences were identified, the results of our analysis support the idea that bureaucratic procedures might require more time in CRO-administered trials than in sponsor-administered and CRO-free studies. This bureaucratic delay could negatively affect Italian patients' screening and enrollment compared with other countries.

Drug eluting balloon angioplasty for assisted maturation of failing fistulae.

OBJECTIVE: To present our experience of balloon-assisted maturation with drug-eluting balloon dilation in patients with recurrent failing arteriovenous fistulae. CASE SERIES: Three patients (all males, mean age 71 years) with a complex history of failed attempts at native fistula creation underwent surgical creation of arteriovenous fistulae. Two patients had a two-stage brachio-brachial fistula and 1 had a brachio-cephalic fistula that also required subsequent elevation. After a few weeks of preserved patency with a thrill detected clinically, all patients had a gradual deterioration of flow manifested with loss of thrill and multiple severely stenotic lesions of neo-intimal hyperplasia seen on duplex ultrasound. All 3 non-maturing native arteriovenous fistulae had 1 or more angioplasties with regular balloons that were initially successful; however, they rapidly deteriorated with a loss of thrill and a recurrence of multiple stenosis. Drug-eluting balloon dilation was used subsequently as a last resort to save these failing fistulae. All procedures were successful with the preservation of patency and adequate fistula flow (>600 mL/min) during the follow-up period (4-8 months, mean 6 months), and all patients received successful dialysis with 2-needle cannulation of their fistulae. There were no adverse events during the study period. CONCLUSIONS: Drug-eluting balloon angioplasty was to salvage nonmaturing fistulae with durable results in complex patients where conventional treatment had previously failed. Drug-eluting balloons may provide a useful treatment option for patients prone to multiple access failures due accelerated neo-intimal hyperplasia.

CT-guided radiofrequency ablation of osteoid osteoma using a multi-tined expandable electrode system.

BACKGROUND AND AIM OF THE WORK: Radiofrequency ablation (RFA) is the gold standard for the treatment of symptomatic osteoid osteoma (OO) as RFA yields both a high success and low complication rate. It has been widely utilized over the years, but recurrences of OO after this treatment have been documented. These recurrences may be the result of various factors, including incomplete tumor ablation, and are significantly higher in lesions greater than 10 mm. Thus, the need to induce thermal ablation in a wider area led us to use a Multi-Tined Expandable Electrode System (MTEES). In this study we examined the efficacy and safety of RFA using a MTEES in symptomatic OO. METHODS: Between January 2005 and June 2007, 16 patients with symptomatic OO were treated by CT-guided percutaneous RFA using a MTEES. The diameter of OO ranged from 6 to 15 mm (mean 10±2.6 mm). Patients were evaluated for clinical outcomes, complications and recurrence. Pain evaluation was assessed preoperatively, 2 weeks postoperatively and at last follow-up. RESULTS: Clinical follow-up was available for all patients at a mean of 84.3 months (range 73-96 months). Mean preoperative VAS score was 7.4 (range 5-9), two weeks after the procedure mean VAS score was 0.3 (range 0-1) with a mean change of -7.06 points (p<0.0001). At the last follow-up a complete relief from pain has been observed in all patients. No major and minor complications were observed nor recurrences. CONCLUSIONS: RFA using a MTEES has been effective, safe and reliable for the treatment of OOs. This system, by increasing the size of the necrosis, could be a viable alternative to the single needle electrode in lesions larger than 10 mm, reducing the risk of recurrence.