Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial.

INTRODUCTION: Focal therapy (FT) targets individual areas of cancer within the prostate, providing oncological control with minimal side-effects. Early evidence demonstrates encouraging short-medium-term outcomes. With no randomized controlled trials (RCT) comparing FT to radical therapies, Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (CHRONOS) will compare the cancer control of these two strategies. PATIENTS AND METHODS: CHRONOS is a parallel phase II RCT for patients with clinically significant non-metastatic prostate cancer, dependent upon clinician/patient decision, patients will enrol into either CHRONOS-A or CHRONOS-B. CHRONOS-A will randomize patients to either radical treatment or FT. CHRONOS-B is a multi-arm, multistage RCT comparing focal therapy alone to FT with neoadjuvant agents that might improve the current focal therapy outcomes. An internal pilot will determine the feasibility of, and compliance to, randomization. The proposed definitive study plans to recruit and randomize 1190 patients into CHRONOS-A and 1260 patients into CHRONOS-B. RESULTS: Primary outcome in CHRONOS-A is progression-free survival (transition to salvage local or systemic therapy, development of metastases or prostate-cancer-related mortality) and in CHRONOS-B is failure-free survival (includes the above definition and recurrence of clinically significant prostate cancer after initial FT). Secondary outcomes include adverse events, health economics and functional outcomes measured using validated questionnaires. CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B. CONCLUSION: CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.

Development of a Model for Training and Assessing Open Image-Guided Liver Tumor Ablation.

BACKGROUND: Image-guided microwave ablation (MWA) is a technically demanding procedure, involving advanced visual-spatial perception skills. This study sought to create and evaluate a low-cost model and training curriculum for open ultrasound-guided liver tumor MWA. METHODS: Simulated tumors were created, implanted into bovine livers, and visualized by ultrasound. A high-fidelity abdominal model was constructed, with a total cost of $30. Experienced physicians in MWA performed simulated ablations and evaluated the model. Expert performance metrics were established and served as targets for our training curriculum. These included time, number of passes, number of repositionings, and percentage of tumor ablated. Next, 8 novice trainees completed our deliberate practice curriculum. Participants' performances were recorded throughout. RESULTS: Physicians completed a structured feedback questionnaire rating the model's realism and training utility at 8/10 and 10/10, respectively. Tumors appeared hyperechoic and were clearly visualized on ultrasound. Trainees performed a total of 32 ablations. Our trainees' performance improved significantly in all outcomes of interest in the postcurriculum ablations compared to precurriculum ablations. CONCLUSION: We have created a cost-effective, high-fidelity model of MWA, with a deliberate practice curriculum. Trainees can practice to proficiency with clear target metrics prior to participating in clinical cas.

A novel 3-dimensional electromagnetic guidance system increases intraoperative microwave antenna placement accuracy.

BACKGROUND: Failure to locate lesions and accurately place microwave antennas can lead to incomplete tumor ablation. The Emprint™ SX Ablation Platform employs real-time 3D-electromagnetic spatial antenna tracking to generate intraoperative laparoscopic antenna guidance. We sought to determine whether Emprint™ SX affected time/accuracy of antenna-placement in a laparoscopic training model. METHODS: Targets (7-10 mm) were set in agar within a laparoscopic training device. Novices (no surgical experience), intermediates (surgical residents), and experts (HPB-surgeons) were asked to locate and hit targets using a MWA antenna (10-ultrasound only, 10-Emprint™ SX). Time to locate target, number of attempts to hit the target, first-time hit rate, and time from initiating antenna advance to hitting the target were measured. RESULTS: Participants located 100% of targets using ultrasound, with experts taking significantly less time than novices and intermediates. Using ultrasound only, successful hit-rates were 70% for novices and 90% for intermediates and experts. Using Emprint™ SX, successful hit rates for all 3-groups were 100%, with significantly increased first-time hit-rates and reduced time required to hit targets compared to ultrasound only. DISCUSSION: Emprint™ SX significantly improved accuracy and speed of antenna-placement independent of experience, and was particularly beneficial for novice users.

Predictive factors for successful renal denervation: should we use them in clinical trials?

Renal denervation (RDN) is facing various challenges to its initial claimed value in hypertension treatment. Major concerns are the choice of the patients and the technical efficacy of the RDN. Different factors have been described as predicting the capacity of RDN to decrease blood pressure. These factors are related to the patients, the procedure and the tools to confirm successful neural ablation. Their use in future trials should help to improve RDN trials understanding and outcomes. This review summarizes the different predictive factors available and their potential benefits in patient selection and in procedure guidance.

How to learn pulmonary vein isolation with a novel ablation device: learning curve effects using the endoscopic ablation system.

INTRODUCTION: Novel ablation devices for pulmonary vein isolation (PVI) need a careful evaluation of its efficacy and safety beyond clinical studies in a real world situation. The endoscopic ablation system (EAS) was recently approved for PVI in Europe. We sought to determine the safety, efficacy, and learning curve effects of EAS-PVI in a large volume single center. METHODS AND RESULTS: Between June 2010 and March 2013, all EAS guided PVI procedures were analyzed and 150 consecutive patients were divided in tertiles (T). Clinical follow-up of 12 months assessed freedom from atrial fibrillation (AF) using 72 hour-Holter ECG recordings. In total, 497 of 583 PVs (85%) were isolated by visual guidance only. In T 2 and T 3, visually guided PVI rates increased from 73% to 91% (P < 0.001). After gap mapping, 96% and 99% of all PVs were isolated in T 1-3, respectively (P = 0.018). Total procedure and fluoroscopy time significantly declined over time. All major periprocedural complications occurred in the first T. In 3 patients (2 in 1st and 1 in 2nd T), phrenic nerve palsy was observed (2%). At 12-months follow-up, 103 of 133 patients (77%) remained in stable sinus rhythm without significant differences between Ts. CONCLUSION: With EAS even first time users may achieve acute PVI in a high number of patients with favorable clinical outcomes after 1 year. Yet, acute procedural efficacy and safety are further improved after passing a learning curve of 50 patients.

Development and evaluation of a novel cadaveric model for performance of image-guided percutaneous renal tumor ablation.

INTRODUCTION: Thermal ablation is a well established treatment option for the management small renal masses. Increasingly, renal ablation is performed via a percutaneous approach. However, most urologists are not formally trained in image-based deployment of ablation needles. To address this need, we created a novel training model to teach urologists to perform precise and accurate percutaneous needle placement. This teaching model was implemented as part of a recent training course on tissue ablation organized by the American Urological Association. METHODS: Two fresh frozen human cadavers (Anatomic Gifts Registry, Hanover, Maryland) were used in the model. Plumber's Putty (Oatey, Cleveland, Ohio) and nonpitted olives soaked in Isovue (Bracco Dianostics, Inc, New York, New York) were used to create ablation targets. Course participants underwent a tutorial on the computed tomography (CT)-guided deployment of a 19-gauge Yueh Needle (Cook Medical, Bloomington, Indiana) or Cool-tip radio-frequency ablation (RFA) probe (Covidien, Inc, Boulder, Colorado). After each needle placement, a CT scan was performed to assess successful deployment. Participants were then queried regarding their experience. RESULTS: A total of 18 urologists performed needle or radio-frequency ablation probe placement on 2 cadavers. A mean of 3.39 (range 2-5) attempts was required to hit targets. Subjectively, participants noted an increase in confidence performing percutaneous needle deployment. The cadaver laboratory exposed participants to pretreatment planning, tactile feel of needle placement, needle readjustment, and 3-D spatial relationships of a percutaneous approach. CONCLUSIONS: The presented cadaveric model is an effective tool for teaching percutaneous needle placement. All urologists evaluated noted increased confidence in this technique after training on the model.

Current minimally invasive practice patterns among postgraduate urologists.

PURPOSE: To determine laparoscopic and robotic surgical practice patterns among current postgraduate urologists. MATERIALS AND METHODS: There were 9,095 electronic surveys sent to practicing urologists with e-mail addresses registered with the American Urological Association. RESULTS: Responses were received from 864 (9.5%) urologists; 84% report that laparoscopic or robotic procedures are performed in their practice. The highest training obtained by the primary laparoscopist was fellowship (31%), residency (23%), or 2- to 3-day courses (22%). Eighty-six percent report performance of laparoscopic nephrectomy in their practice, and 71% consider it the standard of care. Sixty-six percent of practices have access to at least one robotic unit, and 9% plan on purchasing one within a year. Attitudes toward robotics are favorable, with 80% indicating that it will increase in volume and potential procedures. Thirty-one percent state that robot-assisted prostatectomy is standard of care, while 50% believe this procedure looks promising. Respondents think that optimal training in minimally invasive techniques is fellowships (23%), minifellowships (23%), or hands-on courses (23%). Twenty-nine percent think that they were trained adequately in laparoscopy and robotics from residency, and 62% believe residents should be able to perform most laparoscopic procedures on completion of residency. CONCLUSIONS: The practice and availability of laparoscopic and robotic procedures have increased since previous evaluations. Opinions regarding these techniques are favorable and optimistic. As the field of urology continues to see a growing demand for minimally invasive procedures, training of postgraduate urologists and residents remains essential.

Are urology residents adequately exposed to conservative therapies for managing small renal masses?

PURPOSE: Increasing diagnosis of small renal masses (SRMs) necessitates trainees to be familiar with available therapies. We hypothesized that involvement in conservative treatments (ablation and/or active surveillance) occurs infrequently. Therefore, we evaluated resident exposure and participation in treatments as well as proposed management for SRMs. METHODS: A survey was distributed to residents of the American Urologic Association and queried exposure to ablation and surveillance for SRMs. Three case scenarios (SRM in a healthy 55-year-old, healthy 75-year-old, and comorbid 75-year-old patient) were presented for management. RESULTS: Two hundred fifty-seven residents responded to the survey. Two hundred thirty-four (91%) reported ablation was offered at their institution, although only 140 (54%) ever participated in this procedure. Of these, 80 (57%) were involved in fewer than five procedures. Experience with ablation did not increase at higher levels of training (U3-61%, U4-66%, and U5-63%). Two hundred twenty-four (87%) residents noted exposure to surveillance for managing SRMs, increasing from 70% in U1 to 94% in U5. When considering case scenarios, management strategy shifted significantly from extirpation to ablation or surveillance as patient age and comorbidity profile increased. In particular, almost 50% of respondents advocated ablation for SRMs in a comorbid 75-year-old patient. CONCLUSIONS: Although most residents are adequately exposed to surveillance strategies for SRMs, only 54% participated in an ablative procedure. Nonetheless, almost 50% of residents recommended ablation to manage SRMs in the aging, comorbid patient. This suggests a disconnect between training and future practice pattern.