Multicenter Prospective Pilot Research Articles

Sacral neuromodulation in endometriosis - A promising treatment option for chronic pelvic pain.

Chronic pelvic pain (CPP) affects over one fifth of women worldwide, and endometriosis is one of the most common causes. In the present study, we examined whether sacral neuromodulation (SNM) is effective in the treatment of refractory chronic pelvic pain in women with endometriosis. This multicenter prospective pilot study was started in 2017 and includes patients with chronic pelvic pain with no other obvious pathology than endometriosis. Other treatment options have been tried or they are unsuitable. Patients underwent SNM implantation. The main outcome was postoperative pain reduction and secondary outcome was quality of life. The following questionnaires were used to assess the outcomes: Brief pain inventory (BPI), clinical global impression - improvement (CGI-I), 15D-measure of health-related quality of life, and Biberoglu and Behrman (B&B) score. A total of 35 patients underwent the SNM procedure and, at the time of analysis, 15 patients had returned one-year questionnaires. The patients had a history of endometriosis for a median of 5.5 (interquartile range 2-9) years, with no correlation between the severity of symptoms and the duration of the disease (p = 0.158). A total of 31 patients (89%) were implanted with the internal pulse generator. There were statistically significant changes in BPI pain-related items. Worst experienced daily pain decreased among those who returned 12-month questionnaires from median 9 to 5 (p = 0.006), average daily pain from 6 to 3.5 (p = 0.004), and least daily pain from 3 to 1 (p = 0.004). Based on the CGI questionnaire (n = 14), at 12 months nine patients (60%) experienced great improvement in their symptoms, three patients (20%) much improvement and two patients (13%) minimal improvement. None of the patients experienced worsening of their symptoms. There was a statistically significant change in overall 15D score at 1 month (p < 0.001), 6 months (p = 0.001) and 12 months (p = 0.018), when the results were compared to baseline values. Median B&B score also improved significantly and decreased from a baseline value of 8 (4-12) to 4.5 (0-6), p = 0.002. Based on the preliminary findings of our study, SNM might be a promising treatment of CPP in endometriosis patients.

Drained versus non-drained inflatable penile prosthesis implantation: A multicenter prospective pilot study

Drained versus non-drained inflatable penile prosthesis implantation: A multicenter prospective pilot study

Letter to The Editor Regarding Article “Mindfulness Training for Young Neurosurgeons: A Virtual Multicenter Prospective Pilot Study”

Letter to The Editor Regarding Article “Mindfulness Training for Young Neurosurgeons: A Virtual Multicenter Prospective Pilot Study”

In Reply to Letter to the Editor Regarding “Mindfulness Training for Young Neurosurgeons: A Virtual Multicenter Prospective Pilot Study”

In Reply to Letter to the Editor Regarding “Mindfulness Training for Young Neurosurgeons: A Virtual Multicenter Prospective Pilot Study”

Step down to 6 months of prophylactic‐dose low molecular weight heparin after initial full‐dose anticoagulation for the treatment of cancer‐associated thrombosis (STEP‐CAT): A pilot study

BackgroundPatients with cancer‐associated thrombosis (CAT) are treated with full‐dose anticoagulation for at least 3 months, but optimal dosing thereafter is unknown. AimWe explored the feasibility of extended prophylactic‐dose low molecular weight heparin (LMWH) treatment following a minimum of 3 months of full‐dose LMWH. MethodsWe conducted a multicenter prospective pilot study of patients with CAT who completed at least 3 months of therapeutic‐dose LMWH. Patients received 6 months of prophylactic‐dose subcutaneous enoxaparin (40 mg once daily). The primary outcome was recurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE), and secondary outcomes included major, clinically relevant non‐major (CRNM), and minor bleeding. ResultsFrom August 2016 to May 2019, 52 patients with a mean age of 64.1 years were included. The study was stopped early because of poor recruitment. Breast (23.1%) and colorectal (19.2%) were the most common cancers, and 61.0% had stage IV malignancy. Index CAT consisted of DVT alone in 57.7% of patients and pulmonary embolism (PE) with or without DVT in 42.3%. Patients received a mean of 7.6 months of weight‐adjusted LMWH before enrollment. During a mean follow‐up of 5.6 months, one patient was diagnosed with recurrent incidental PE (0.0035 events/subject‐month). There were no major bleeding events, one CRNM, and one minor bleeding event. Eight (15.4%) patients died; six from cancer and two from respiratory disease unrelated to PE. ConclusionsThese results, in part, provide support for trials of extended reduced‐dose anticoagulation for the secondary prevention of CAT. (ClinicalTrials.gov: NCT02752607)

Mindfulness Training for Young Neurosurgeons: A Virtual Multicenter Prospective Pilot Study

Burnout is prevalent among neurosurgeons and can negatively impact both technical and nontechnical skills and subsequent patient care. Mindfulness training has previously been shown to ameliorate the effects of burnout and improve performance in health care workers and high-stress occupations, but no such evaluation has been formally conducted for neurosurgeons. We aimed to determine the effectiveness and feasibility of a virtual mindfulness-based intervention (MBI) in neurosurgeons. A prospective trial of an MBI was implemented and hosted from our tertiary academic unit, running virtually from October to December 2020. Practicing neurosurgeons of all grades were recruited from 9 neurosurgical centers. Participants underwent 8 weeks of 90-minute MBI classes and suggested daily practice. Psychometric measures related to burnout, stress, wellbeing, and mindfulness competencies were assessed at baseline and on course completion. Twenty-one neurosurgeons participated in the study (attendings= 2, residents= 18, interns= 1, mean age= 30.3 [standard deviation 3.9] years). Significant improvements after intervention were present in perceived stress (Z= -2.54, P= 0.04) and emotional exhaustion (Z= -2.41, P= 0.04). Mindfulness trainingwas associated with improved mindfulness skills(Z = -2.58, P= 0.006), self-compassion (t= -4.4, P= 0.002), resilience (Z= -3.18, P= 0.004), and choice response times (Z= -2.13, P= 0.03). All neurosurgeons who completed the postintervention assessment stated they would recommend the course and agreed that it was relevant to their surgical practice. Preliminary evidence from this trial cautiously supports the effectiveness and feasibility of a virtual MBI for dealing with stress, burnout, and improving dexterity among young neurosurgeons. Further research is warranted to validate these findings.

Transesophageal echocardiography for cardiovascular risk estimation in patients with sepsis and new-onset atrial fibrillation: a multicenter prospective pilot study

BackgroundEchocardiographic parameters have been poorly investigated for estimating cardiovascular risk in patients with sepsis and new-onset atrial fibrillation. We aim to assess the prevalence of transesophageal echocardiographic abnormalities and their relationship with cardiovascular events in mechanically ventilated patients with sepsis and new-onset atrial fibrillation.MethodsIn this prospective multicenter pilot study, left atrial/left atrial appendage (LA/LAA) dysfunction, severe aortic atheroma, and left ventricular systolic dysfunction were assessed using an initial transesophageal echocardiographic study, which was repeated after 48–72 h to detect LA/LAA thrombus formation. The study outcome was a composite of cardiovascular events at day 28, including arterial thromboembolic events (ischemic stroke, non-cerebrovascular arterial thromboembolism, LA/LAA thrombus), major bleeding, and all-cause death.ResultsThe study population comprised 94 patients (septic shock 63%; 35% women; median age 69 years). LA/LAA dysfunction, severe aortic atheroma, and left ventricular systolic dysfunction were detected in 17 (19%), 22 (24%), and 27 (29%) patients, respectively. At day 28, the incidence of cardiovascular events was 46% (95% confidence interval [CI]: 35 to 56). Arterial thromboembolic events and major bleeding occurred in 7 (7%) patients (5 ischemic strokes, 1 non-cerebrovascular arterial thromboembolism, 2 left atrial appendage thrombi) and 18 (19%) patients, respectively. At day 28, 27 patients (29%) died. Septic shock (hazard ratio [HR]: 2.36; 95% CI 1.06 to 5.29) and left ventricular systolic dysfunction (HR: 2.06; 95% CI 1.05 to 4.05) were independently associated with cardiovascular events.ConclusionsTransesophageal echocardiographic abnormalities are common in mechanically ventilated patients with sepsis and new-onset atrial fibrillation, but only left ventricular systolic dysfunction was associated with cardiovascular events at day 28.

Diagnostics of Pulmonary Aspergillosis in Critically Ill Hematological and Non-Hematological Patients in the Intensive Care Unit By Combined Use of Galactomannan, 1-3-Beta-D-Glucan, Aspergillus Specific PCR and Conventional Culture in Concurrent Blood and Bronchoalveolar Lavage Samples — Results of a Multicenter Prospective Pilot Study

Invasive pulmonary aspergillosis (IPA) is a life-threatening infectious complication mainly affecting immunocompromised hematological patients. Therapeutic success requires early and precise diagnostics. Few data are available on the performance of current diagnostic tests in patients admitted to the intensive care unit (ICU) as the majority of diagnostic studies is conducted in hematological patients and results cannot readily be transferred to patients in the ICU setting.In a prospective multicenter study, we evaluated concurrent bronchoalveolar lavage (BAL) samples and concurrent blood samples from 44 patients admitted to the ICU who required mechanical ventilation and therefore underwent a diagnostic work-up including chest CT scan and BAL (NCT01695499). The subsequent diagnostic work-up comprised of conventional methods for direct detection of Aspergillus spp. as well as biomarkers such as galactomannan (GM) and 1-3-beta-D-glucan (BDG) and an Aspergillus specific nested polymerase chain reaction (PCR).14 patients (32%) suffered from a hematological/hematooncological disease, of which 7 had received allogeneic stem cell transplantation. 6 patients (14%) had a solid tumor requiring chemotherapy. The remaining 24 patients (54%) had no hematological or oncological disease. 11 patients were neutropenic with ANC <1.0/nl (10 belonged to the hematooncological group). According to AspICU classification (Blot et al., Am J Respir Crit Care Med 2012) 9 patients (20%) had putative IPA (3 patients with hematological malignancy). Other invasive fungal diseases (IFD) besides IPA were observed: positive growth of Rhizopus microsporus in BAL was seen in one patient. Furthermore, two cases of disseminated candidiasis with positive growth in blood culture (C.albicans, C.krusei) and one case with positive growth in ascites (C.albicans). Additionally, two cases of Pneumocystis jirovecii pneumonia (PcP) were diagnosed.Diagnostic performance of each single test and of test combinations was analyzed. GM and PCR showed superior performance in BAL (sensitivity/specificity of 56%/94% (GM) and 44%/94% (PCR) compared to 33%/97% and 11%/94% in serum). Despite a better sensitivity of 89%, BDG showed a specificity of only 31% in BAL and 26% in serum, reducing the diagnostic odds ratio (DOR) to 3.7 and 2.8, respectively. For hematological patients the mean GM optical density index (ODI) in BAL was 0.97 and in serum 0.58 compared to 0.59 and 0.16 in non-hematological patients. The strength of agreement between GM in BAL and GM in serum as calculated by Cohen's kappa intertest coherence analysis was 0.62 [0.29-0.95], which is considered to be good. BDG levels and performance of the PCR assay did not differ between hematological and non-hematological patients. The combined use of biomarkers in BAL showed a diagnostic performance of sensitivity/specificity/PPV/NPV and DOR of 89%/31%/25%/92% and 3.67. Testing of GM and BDG solely in serum resulted in a combined test performance of 89%/26%/ 24%/ 90% and 2.77. GM (BAL) combined with BDG (serum) showed high joint sensitivity of 100% with specificity of 25% (DOR 6.81). Using PCR instead of GM dropped sensitivity to 89% (specificity 23%, DOR 2.37). Diagnostic performance of combined GM and PCR testing in BAL showed sensitivity/specificity/PPV/NPV and DOR 67%/89%/60%/91% and 15.0. Cohen's kappa for PCR (BAL) vs. GM (BAL) was 0.49 [0.145 to 0.840], which is considered to be moderate. If a diagnostic algorithm defines BDG (serum) as an initial test that is, in case of a positive result, followed by a confirming test combination from BAL with strong or even exclusive specificity for Aspergillus spp. (GM, PCR and culture) a diagnostic performance is achieved with sensitivity/specificity/positive predictive value/negative predictive value of 88%/97%/88%/97% and DOR >100.This study intended as a pilot study underscores the concept of combined testing in serum and BAL for optimized detection of IPA and provides valuable data for the emerging cohort of critically ill patients, both hematological and non-hematological. Further studies with hematological ICU patients in larger cohorts are planned. DisclosuresBoch:Pfizer research grant (WS 2274964): Research Funding. Buchheidt:Pfizer research grant (WS 2274964): Research Funding.

Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study

The effectiveness of amblyopia therapy can be limited by poor adherence. Dichoptic therapies are a new approach, but recent trials have demonstrated difficulty maintaining high adherence over extended periods of at-home treatment. We evaluated the efficacy and adherence of Luminopia One-a dichoptic treatment that applies therapeutic modifications to streaming content chosen by the patient. This single-arm, multicenter prospective pilot study enrolled children aged 4-12 with anisometropic, strabismic, or mixed amblyopia at 10 pediatric ophthalmic and optometric practices across the United States. The therapeutic was prescribed for 1hour/day, 6days/week for 12weeks of at-home use. The primary endpoint was best-corrected visual acuity (BCVA) at the 12-week follow-up visit. In total, 90 participants (mean age, 6.7±2.0years) were enrolled, and 73/90 participants (81%) had prior treatment beyond refractive correction. For those who completed the 12-week visit, mean amblyopic eye BCVA improved from 0.50 logMAR to 0.35 logMAR (1.5 logMAR lines; 95% CI, 1.2-1.8 lines; P<0.0001). Mean stereoacuity improved by 0.28 log arcsec (95% CI, 0.14-0.42 log arcsec; P<0.0001). Median adherence was 86% (interquartile range, 70%-97%). In our study cohort, adherence over the 12-week study period was high, and participants demonstrated clinically and statistically significant improvements in visual acuity and stereoacuity.

Multicenter Prospective Pilot and Feasibility Study of a Novel Robotic System for Laparoscopic Transvaginal Hysterectomy

Study Objective When feasible, vaginal hysterectomy has been shown to be the safest and most cost-effective route to remove the uterus compared to abdominal, laparoscopic or robotic techniques. However, in the US, vaginal hysterectomy is performed in only 20% of cases. This study evaluates the safety and feasibility of a novel humanoid shaped robot assisted surgical system for transvaginal laparoscopic hysterectomy. Design A multi-center, single arm, prospective study of robotic transvaginal laparoscopic hysterectomy in women with nonmalignant indications. Setting The surgical-gynecologic services of participating hospitals. Patients or Participants 30 eligible female patients aged was 57.2 years, BMI 18 to 40 kg/m2. Interventions Total transvaginal laparoscopic hysterectomy with salpingectomy or salpingo-oophorectomy performed with a novel robotic system. Measurements and Main Results The transvaginal robotic system performed as intended and all procedures were completed successfully with no conversions to open or laparoscopic surgery. No intraoperative complications, transfusion, bladder or rectal injuries were observed and no robotic system malfunctions or other device-related deficiencies were reported. The procedures had an average time of 57 minutes (range: 24 to 88 min) with the estimated blood loss for 80% of subjects less than 100ml (24/30), 13% between 100-200ml (4/30) and 7% at 400ml (2/30). All patients’ vaginal cuff and point of entry healed as expected at the six weeks follow up visit. Conclusion The positive results of this clinical series show this new approach using a humanoid shaped robot assisted surgical system to be both a safe and effective tool for laparoscopic transvaginal hysterectomy. When feasible, vaginal hysterectomy has been shown to be the safest and most cost-effective route to remove the uterus compared to abdominal, laparoscopic or robotic techniques. However, in the US, vaginal hysterectomy is performed in only 20% of cases. This study evaluates the safety and feasibility of a novel humanoid shaped robot assisted surgical system for transvaginal laparoscopic hysterectomy. A multi-center, single arm, prospective study of robotic transvaginal laparoscopic hysterectomy in women with nonmalignant indications. The surgical-gynecologic services of participating hospitals. 30 eligible female patients aged was 57.2 years, BMI 18 to 40 kg/m2. Total transvaginal laparoscopic hysterectomy with salpingectomy or salpingo-oophorectomy performed with a novel robotic system. The transvaginal robotic system performed as intended and all procedures were completed successfully with no conversions to open or laparoscopic surgery. No intraoperative complications, transfusion, bladder or rectal injuries were observed and no robotic system malfunctions or other device-related deficiencies were reported. The procedures had an average time of 57 minutes (range: 24 to 88 min) with the estimated blood loss for 80% of subjects less than 100ml (24/30), 13% between 100-200ml (4/30) and 7% at 400ml (2/30). All patients’ vaginal cuff and point of entry healed as expected at the six weeks follow up visit. The positive results of this clinical series show this new approach using a humanoid shaped robot assisted surgical system to be both a safe and effective tool for laparoscopic transvaginal hysterectomy.

Implementing an Emergency Department Telephone Follow-Up Program for Suicidal Patients: Successes and Challenges

Many emergency department (ED) patients are at risk of suicide, and the ED is a key setting for suicide prevention. Although ED interventions are associated with reduced suicide attempts and societal costs, most EDs do not have follow-up programs. This pilot investigated the feasibility and implementation process of a statewide program. This multicenter prospective pilot program included all patients evaluated for suicidal behavior in, and discharged home from, participating EDs across Colorado. Suicidal ED patients were offered crisis hotline follow-up calls that focused on continued support and connection to outpatient care. Data collection at EDs focused on implementation issues and referral and participation rates; the crisis line collected patient information and call statistics. From July 1, 2015, to October 31, 2017, the program expanded to 15 EDs covering almost a quarter of ED visits in a large, high-burden state. Some sites achieved 100% referral rates, suggesting that referral became routine, and the mean referral rate was 76%. High referral rates were associated with an ED champion, record system enhancements, repeated training, and regular communication. Of 5,620 visits with referral, 2,737 resulted in participation (48.7%). Although the program was free for patients, half declined it. The call center made 15,414 calls, ultimately reaching all but 9.8% of participants. Few participants reported repeat ED visits or suicide attempts. This project demonstrated the feasibility of using a state crisis hotline to provide postdischarge follow-up for suicidal ED patients. Continued investigation into sustainable implementation and outcomes of such programs is warranted.

Forewarning of hypotensive events using a Bayesian artificial neural network in neurocritical care.

Traumatically brain injured (TBI) patients are at risk from secondary insults. Arterial hypotension, critically low blood pressure, is one of the most dangerous secondary insults and is related to poor outcome in patients. The overall aim of this study was to get proof of the concept that advanced statistical techniques (machine learning) are methods that are able to provide early warning of impending hypotensive events before they occur during neuro-critical care. A Bayesian artificial neural network (BANN) model predicting episodes of hypotension was developed using data from 104 patients selected from the BrainIT multi-center database. Arterial hypotension events were recorded and defined using the Edinburgh University Secondary Insult Grades (EUSIG) physiological adverse event scoring system. The BANN was trained on a random selection of 50% of the available patients (n = 52) and validated on the remaining cohort. A multi-center prospective pilot study (Phase 1, n = 30) was then conducted with the system running live in the clinical environment, followed by a second validation pilot study (Phase 2, n = 49). From these prospectively collected data, a final evaluation study was done on 69 of these patients with 10 patients excluded from the Phase 2 study because of insufficient or invalid data. Each data collection phase was a prospective non-interventional observational study conducted in a live clinical setting to test the data collection systems and the model performance. No prediction information was available to the clinical teams during a patient's stay in the ICU. The final cohort (n = 69), using a decision threshold of 0.4, and including false positive checks, gave a sensitivity of 39.3% (95% CI 32.9-46.1) and a specificity of 91.5% (95% CI 89.0-93.7). Using a decision threshold of 0.3, and false positive correction, gave a sensitivity of 46.6% (95% CI 40.1-53.2) and specificity of 85.6% (95% CI 82.3-88.8). With a decision threshold of 0.3, > 15min warning of patient instability can be achieved. We have shown, using advanced machine learning techniques running in a live neuro-critical care environment, that it would be possible to give neurointensive teams early warning of potential hypotensive events before they emerge, allowing closer monitoring and earlier clinical assessment in an attempt to prevent the onset of hypotension. The multi-centre clinical infrastructure developed to support the clinical studies provides a solid base for further collaborative research on data quality, false positive correction and the display of early warning data in a clinical setting.

Initial Experience With Real-Time Continuous Physical Activity Monitoring in Patients Undergoing Spine Surgery.

Multicenter prospective pilot study. To evaluate if continuous physical activity monitoring by a personal electronic 3-dimensional accelerometer device is feasible and can provide objective data that correlates with patient-reported outcomes following spine surgery. Self-reported health-related quality-of-life (HRQOL) metrics are inherently limited by being very subjective, having a low frequency of data collection, and inconsistent follow-up. Inclusion criteria: adults (18+), thoracolumbar deformity or degenerative disease, and regular access to a computer with internet connection. Physical activity parameters included: number of daily steps, maximum hourly steps, and activity intensity. Patients completed the Oswestry Disability Index (ODI), the Short-Form Health Survey 36 (SF-36), and the Scoliosis Research Society-22r (SRS22) preoperatively and postoperatively at 6 weeks, 3 months, and 6 months. Thirty-two patients were enrolled, 8 (25%) withdrew, 1 (3.1%) died, and 1 (3.1%) did not end up undergoing surgery resulting in 22 (68.8%) available patients. Mean preoperative and postoperative step ranges were 1278±767 to 17,800±6464 and 891±587 to 12,655±7038, respectively. Eleven patients improved in mean total daily steps at the final postoperative month with 2 having significant improvements (P<0.05). Five patients did not significantly change (P>0.05) and 6 patients had significantly lower mean total daily steps at 6 months (P<0.05). The entire cohort significantly improved in ODI, SF-36 Physical Component Summary, SRS Activity, SRS Appearance, SRS Mental, SRS Satisfaction, and SRS Total score at 6 months postoperative (P<0.05 for all). Both ODI and Physical Component Summary were significantly correlated with preoperative average total daily steps (r=-0.61, P=0.0058 and r=0.60, P=0.0114, respectively). No other HRQOL metrics were significantly correlated at baseline or at 6 months postoperative (P>0.05). A prospective pilot study for continuous real-time physical activity monitoring was successfully completed. This is the first study of its kind and demonstrates a foundation to continuous physical activity monitoring following spine surgery. A larger and longer prospective study is needed to confirm long-term results and its relationship with HRQOL scores.

The accuracy of transcranial Doppler in excluding intracranial hypertension following acute brain injury: a multicenter prospective pilot study

BackgroundUntimely diagnosis of intracranial hypertension may lead to delays in therapy and worsening of outcome. Transcranial Doppler (TCD) detects variations in cerebral blood flow velocity which may correlate with intracranial pressure (ICP). We investigated if intracranial hypertension can be accurately excluded through use of TCD.MethodThis was a multicenter prospective pilot study in patients with acute brain injury requiring invasive ICP (ICPi) monitoring. ICP estimated with TCD (ICPtcd) was compared with ICPi in three separate time frames: immediately before ICPi placement, immediately after ICPi placement, and 3 hours following ICPi positioning. Sensitivity and specificity, and concordance correlation coefficient between ICPi and ICPtcd were calculated. Receiver operating curve (ROC) and the area under the curve (AUC) analyses were estimated after measurement averaging over time.ResultsA total of 38 patients were enrolled, and of these 12 (31.6%) had at least one episode of intracranial hypertension. One hundred fourteen paired measurements of ICPi and ICPtcd were gathered for analysis. With dichotomized ICPi (≤20 mmHg vs >20 mmHg), the sensitivity of ICPtcd was 100%; all measurements with high ICPi (>20 mmHg) also had a high ICPtcd values.Bland-Altman plot showed an overestimation of 6.2 mmHg (95% CI 5.08–7.30 mmHg) for ICPtcd compared to ICPi. AUC was 96.0% (95% CI 89.8–100%) and the estimated best threshold was at ICPi of 24.8 mmHg corresponding to a sensitivity 100% and a specificity of 91.2%.ConclusionsThis study provides preliminary evidence that ICPtcd may accurately exclude intracranial hypertension in patients with acute brain injury. Future studies with adequate power are needed to confirm this result.

EUS-guided rendezvous for difficult biliary cannulation using a standardized algorithm: a multicenter prospective pilot study (with videos)

Biliary cannulation is necessary in therapeutic ERCP for biliary disorders. EUS-guided rendezvous (EUS-RV) can salvage failed cannulation. Our aim was to determine the safety and efficacy of EUS-RV by using a standardized algorithm with regard to the endoscope position in a prospective study. EUS-RV was attempted after failed cannulation in 20 patients. In a standardized approach, extrahepatic bile duct (EHBD) cannulation was preferentially attempted from the second portion of the duodenum (D2) followed by additional approaches to the EHBD from the duodenal bulb (D1) or to the intrahepatic bile duct from the stomach, if necessary. A guidewire was placed in an antegrade fashion into the duodenum. After the guidewire was placed, the endoscope was exchanged for a duodenoscope to complete the cannulation. The bile duct was accessed from the D2 in 10 patients, but from the D1 in 5 patients and the stomach in 4 patients because of no dilation or tumor invasion at the distal EHBD. In the remaining patient, biliary puncture was not attempted due to the presence of collateral vessels. The guidewire was successfully manipulated in 80% of patients: 100% (10/10) with the D2 approach and 66.7% (6/9) with other approaches. The overall success rate was 80% (16/20). Failed EUS-RV was salvaged with a percutaneous approach in 2 patients, repeat ERCP in 1 patient, and conservative management in 1 patient. Minor adverse events occurred in 15% of patients (3/20). EUS-RV is a safe and effective salvage method. Using EUS-RV to approach the EHBD from the D2 may improve success rates.

Mo1446 Endoscopic Ultrasound-Guided Rendezvous for Difficult Biliary Cannulation: a Multicenter Prospective Pilot Study

Biliary cannulation is indispensable step in therapeutic ERCP for biliary disorder. Although the reported success rate of biliary cannulation is high, there are still cases with difficult biliary cannulation. EUS guided rendezvous (EUS-RV) can salvage failed cannulation. Aims: To determine the safety and efficacy of EUS-RV with a standardized algorithm in terms of a scope position in a prospective cohort undergoing therapeutic ERCP.

Sutureless Perceval Aortic Valve Replacement in Aortic Homograft

We report a case of aortic valve replacement with a sutureless valve in a degenerated aortic homograft. This technique allows rapid aortic valve replacement in a heavily calcified aortic root. It avoids the problems of postoperative prosthetic disinsertion frequently encountered after aortic valve replacement in a calcified annulus. It is particularly suitable in redo procedures for homograft degeneration. It avoids performing a redo Bentall operation with its known morbidity.

Prospective Comparison of the Use of Sirolimus and Cyclosporine in Recipients of a Kidney From an Expanded Criteria Donor

A 6-month, open-label, multicenter prospective pilot study was conducted to evaluate the effects of sirolimus (SRL) versus cyclosporine (CsA) in recipients of kidneys from expanded criteria donors. All patients also received antithymocyte globulins induction, mycophenolate mofetil, and steroids. Sixty-nine patients (33 SRL, 36 CsA) were randomized. More patient were withdrawn in the SRL group (16 vs. 6, P<0.01), because of delayed graft function and surgical complications. Delayed graft function tended to be more frequent with SRL than with CsA (45.4% vs. 30.6%, P=0.22). Graft survival was numerically lower in the SRL group (87.5% vs. 97%, P=0.19). At 6 months, there were no significant differences in biopsy-proven acute rejection or calculated creatinine clearance (SRL 12.1% vs. CsA 8.3%; P=0.7 and 44.7+/-16.6 vs. 41.9+/-15.2 mL/min; P=0.54 respectively). These results do not support the use of SRL immediately after transplantation in expanded criteria donor recipients.