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BMJ Surgery, Interventions, & Health Technologies
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  This is an Open Access Journal Open Access journal
ISSN (Online) 2631-4940
Published by BMJ Publishing Group Homepage  [68 journals]
  • Generating evidence for new high-risk medical devices

    • Authors: Campbell, B; Wilkinson, J, Marlow, M, Sheldon, M.
      Keywords: Open access
      PubDate: 2019-09-04T23:46:51-07:00
      DOI: 10.1136/bmjsit-2019-000022
      Issue No: Vol. 1, No. 1 (2019)
  • Race and prostate imaging: implications for targeted biopsy and
           image-based prostate cancer interventions

    • Authors: Gross, M. D; Al Hussein Al Awamlh, B, Shoag, J. E, Mauer, E, Banerjee, S, Margolis, D. J, Mosquera, J. M, Hamilton, A. S, Schumura, M. J, Hu, J. C.
      Abstract: PurposeFor men with an elevated prostate-specific antigen (PSA), there is a strong evidence for prostate MRI to assess the risk of clinically significant prostate cancer (CSPC) and guide targeted-biopsy interventions. Prostate MRI is assessed using the Prostate Imaging-Reporting and Data System (PI-RADS), which is scored from 1 to 5. Equivocal or suspicious findings (PI-RADS 3–5) are recommended for subsequent targeted biopsy, for which the risk of infection and sepsis is increasing. However, PI-RADS was developed primarily in men of European descent. We sought to elucidate PI-RADS and MRI-targeted biopsy outcomes in Asian men, a rapidly growing population in the USA, Europe, Australia and internationally.Materials and methodsA prospective cohort of 544 men with elevated PSA without a diagnosis of prostate cancer who underwent MRI-targeted biopsy at our institution from January 2012 to December 2018 was analyzed. We categorized the cohort by self-designated race then used a validated algorithm which uses surname lists to identify a total of 78 (14%) Asian-Americans. The primary outcome was the likelihood of diagnosing CSPC (Gleason grade group >1) in Asian-Americans versus non-Asian-Americans. Multivariable logistic regression was used to determine the association of demographic and other characteristics with CSPC.ResultsOverall, MRI-targeted biopsy identified CSPC in 17% of Asian-American men versus 39% of non-Asian-American men (p
      Keywords: Open access
      PubDate: 2019-08-24T02:17:32-07:00
      DOI: 10.1136/bmjsit-2019-000010
      Issue No: Vol. 1, No. 1 (2019)
  • Correction: Evolution of transanal total mesorectal excision according to
           the IDEAL framework

    • Keywords: Open access
      PubDate: 2019-08-20T22:23:44-07:00
      DOI: 10.1136/bmjsit-2019-000004corr1
      Issue No: Vol. 1, No. 1 (2019)
  • The Precision Prostatectomy: an IDEAL Stage 0, 1 and 2a Study

    • Authors: Sood, A; Jeong, W, Taneja, K, Abdollah, F, Palma-Zamora, I, Arora, S, Gupta, N, Menon, M.
      Abstract: ObjectiveThis study aimed to develop a preclinical model of prostate cancer (CaP) for studying focal/hemiablation of the prostate (IDEAL stage 0), and to use the information from the stage 0 investigation to design a novel focal surgical treatment approach—the precision prostatectomy (IDEAL stage 1/2a).MethodsThe IDEAL stage 0 study included simulation of focal/hemiablation in whole-mount prostate specimens obtained from 100 men who had undergone radical prostatectomies, but met the criteria for focal/hemiablation. The IDEAL stage 1/2a was a prospective, single-arm, Institutional Review Board-approved study of precision prostatectomy undertaken in eight men, who met the predetermined criteria. Criteria for both stages included (1) prostate-specific antigen (PSA) ≤15 ng/mL, (2) stage ≤cT2, (3) dominant unilateral lesion with Gleason ≤4+3 with any number of cores or % cores involved ipsilaterally on transrectal biopsy, (4) no primary Gleason ≥4 contralaterally on transrectal biopsy, and (5) preoperative erectile function score (International Index of Erectile Function (IIEF)-5) of ≥17 (out of 25) without PDE-5i (applicable only to the stage 1/2a study participants). Feasibility and safety of the precision prostatectomy technique, and short-term urinary, sexual and oncological outcomes were studied.ResultsAnalysis of whole-mount specimens in the 100 men showed an index lesion (>1 cm in diameter) in all. Ninety-eight men had satellite lesions smaller than 0.5 cm3 in volume—46 on the side of the dominant lesions and 52 in the contralateral lobe. If the men in this modeling cohort had undergone focal ablation with a 5–10 mm untreated margin, all except one would have had at least Gleason 6 residual cancer. If they had undergone hemiablation with no untreated tissue on the ablated side, 56 men would have had residual cancer on the contralateral side, of whom 21 would have had clinically significant cancer (Gleason 7 or higher). If these men had undergone precision prostatectomy, with preservation of 5–10 mm of tissue on the non-dominant side, 10% and 4% would have had Gleason 3+4 and Gleason 4+3 disease left behind, respectively. For the stage 1/2a study, the median (IQR) age, PSA and IIEF-5 scores at the time of surgery were 54 (52–57) years, 4.4 (3.8–6.1) ng/mL and 24 (23-25), respectively. All eight patients were continent and sexually active at 12 months with a median IIEF-5 score of 21 (out of 25). At 24–30 months from surgery, the median PSA was 0.2 (range 0.1–0.7) ng/mL. Six men had undergone follow-up protocol biopsies, two, with undetectable PSA, had refused. Two men had residual Gleason 3+3 cancer, with PSA of 0.7 and 0.4 ng/mL, and remain on active surveillance. No man has undergone secondary whole-gland therapy.ConclusionsExamination of whole-mount radical prostatectomy specimens in men who fit the conventional criteria of focal/hemiablation showed that approximately 21%–68% of men would have clinically significant CaP in the untreated tissue. In a small development cohort, precision prostatectomy was technically feasible, with excellent postoperative functional recovery. At 30 months of follow-up, no patient had clinically significant residual cancer or required secondary treatment. Pending long-term follow-up, a risk-stratified surgical approach may avoid whole-gland therapy and preserve erectile function in the majority of men with intermediate-risk CaP.
      Keywords: Open access
      PubDate: 2019-08-19T03:14:39-07:00
      DOI: 10.1136/bmjsit-2019-000002
      Issue No: Vol. 1, No. 1 (2019)
  • Precision prostatectomy: reconciling functional and oncological outcomes

    • Authors: Neal; D.
      Keywords: Open access
      PubDate: 2019-08-19T03:14:39-07:00
      DOI: 10.1136/bmjsit-2019-000015
      Issue No: Vol. 1, No. 1 (2019)
  • Innovation in surgery

    • Authors: McCulloch; P.
      Keywords: Open access
      PubDate: 2019-08-19T03:14:39-07:00
      DOI: 10.1136/bmjsit-2019-000021
      Issue No: Vol. 1, No. 1 (2019)
  • Recent progress to shorten premarket evaluation and improve patient access
           to medical devices by the Pharmaceuticals and Medical Devices Agency of

    • Authors: Handa, N; Takae, S, Ishii, K.
      Keywords: Open access
      PubDate: 2019-08-15T19:20:58-07:00
      DOI: 10.1136/bmjsit-2019-000014
      Issue No: Vol. 1, No. 1 (2019)
  • Active surveillance for implanted devices: strength in numbers

    • Authors: Resnic, F; Majithia, A.
      Keywords: Open access
      PubDate: 2019-07-31T21:14:12-07:00
      DOI: 10.1136/bmjsit-2019-000017
      Issue No: Vol. 1, No. 1 (2019)
  • Evolution of transanal total mesorectal excision according to the IDEAL

    • Authors: Roodbeen, S. X; lo Conte, A, Hirst, A, Penna, M, Bemelman, W. A, Tanis, P. J, Hompes, R.
      Abstract: Tremendous innovations have taken place in surgical procedures, but contrary to drug development, this process has been unregulated in the past. IDEAL promotes a structured framework for the safe implementation and assessment of a new surgical technique or intervention, by describing five stages for evaluating and reporting of innovations: Idea, Development, Exploration, Assessment and Long term. Transanal total mesorectal excision (TaTME) is a relatively new technique in rectal cancer surgery that has attracted huge interest and increasing adoption worldwide. This review article aims to provide an overview of the evolution of TaTME, according to the IDEAL framework, which guides us in the difficult yet exciting process of surgical innovation.
      Keywords: Open access
      PubDate: 2019-07-24T02:01:07-07:00
      DOI: 10.1136/bmjsit-2019-000004
      Issue No: Vol. 1, No. 1 (2019)
  • Determining value of Coordinated Registry Networks (CRNs): a case of
           transcatheter valve therapies

    • Authors: Pappas, G; Berlin, J, Avila-Tang, E, Carroll, J, Drozda, J, Dumont, D, Gross, T, Hewitt, K, Kirtane, A, Kong, D, Krucoff, M, Lashinger, J, Lew, N, Mack, M, Masoudi, F, Marinac-Dabic, D, Mehran, R, Normand, S.-L, Quin, E, Resnic, F, Sedrakyan, A, Waksman, R, Wood, L, Wu, C, Ziegler, T.
      Abstract: BackgroundThe Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs.ObjectivesWe aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies.MethodsFor both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers.ResultsWe identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years.ConclusionsThe CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method.
      Keywords: Open access
      PubDate: 2019-07-04T23:24:17-07:00
      DOI: 10.1136/bmjsit-2019-000003
      Issue No: Vol. 1, No. 1 (2019)
  • Long-term active surveillance of implantable medical devices: an analysis
           of factors determining whether current registries are adequate to expose
           safety and efficacy problems

    • Authors: Banerjee, S; Campbell, B, Rising, J, Coukell, A, Sedrakyan, A.
      Keywords: Open access
      PubDate: 2019-07-03T02:14:24-07:00
      DOI: 10.1136/bmjsit-2019-000011
      Issue No: Vol. 1, No. 1 (2019)
  • Lighting a candle

    • Authors: Sedrakyan, A; McCulloch, P.
      Keywords: Open access
      PubDate: 2019-05-08T00:00:00-07:00
      DOI: 10.1136/bmjsit-2019-000008
      Issue No: Vol. 1, No. 1 (2019)
School of Mathematical and Computer Sciences
Heriot-Watt University
Edinburgh, EH14 4AS, UK
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