Expert Review of Medical Devices最新文献_第5页

Sex differences in ¹²³I-mIBG scintigraphy imaging techniques in patients with heart failure. 心力衰竭患者123I-mIBG闪烁成像技术的性别差异。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-07-24 DOI: 10.1080/17434440.2023.2239139

Miriam Conte, Maria Silvia De Feo, Viviana Frantellizzi, Arianna Di Rocco, Alessio Farcomeni, Flaminia De Cristofaro, Ricci Maria, Antonio Rosario Pisani, Giuseppe Rubini, Giuseppe De Vincentis

{"title":"Sex differences in 123I-mIBG scintigraphy imaging techniques in patients with heart failure.","authors":"Miriam Conte, Maria Silvia De Feo, Viviana Frantellizzi, Arianna Di Rocco, Alessio Farcomeni, Flaminia De Cristofaro, Ricci Maria, Antonio Rosario Pisani, Giuseppe Rubini, Giuseppe De Vincentis","doi":"10.1080/17434440.2023.2239139","DOIUrl":"10.1080/17434440.2023.2239139","url":null,"abstract":"Background: 123I-mIBG-scintigraphy could be a useful stratifying tool for patients with heart failure (HF). The purpose of this retrospective study is to evaluate whether there are differences between men and women with HF in terms of the prediction of cardiac arrhythmic events (AE).Research and methods: A total of 306 patients, before implantable-cardioverter-defibrillator (ICD) implantation, were evaluated. They underwent 123I-mIBG-scintigraphy and an evaluation of the results was performed after 85 months of follow-up. Early and late planar and SPECT cardiac images were acquired. Heart-to-mediastinum ratio (HM) for planar images and the sum of the segmental scores (SS) for SPECT were calculated.Results: In the general population, age, early SS (ESS), late SS (LSS), and ejection fraction (EF) were statistically significant for the prediction of AE at Cox regression, while early and late HM (eHM,lHM) were not significative for the prediction of AE. Population was divided into females and males and univariate analysis was conducted separately for the two cohorts: no significant variables for prediction of AE were found in females. For males, ESS, LSS, EF, and late HM were statistically significant predictors of AE. The overall survival was similar in males and females, but the risk of AE is lower in males than in females.Conclusions: 123I-mIBG represents a more effective tool for the prediction of AE in male patients than in women.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 9","pages":"769-778"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10472340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A contemporary systematic review of the complications associated with SURGICEL. 外科手术并发症的当代系统综述。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-08-04 DOI: 10.1080/17434440.2023.2242776

Matthew Masoudi, Jacob Wiseman, Sam M Wiseman

{"title":"A contemporary systematic review of the complications associated with SURGICEL.","authors":"Matthew Masoudi, Jacob Wiseman, Sam M Wiseman","doi":"10.1080/17434440.2023.2242776","DOIUrl":"10.1080/17434440.2023.2242776","url":null,"abstract":"Background: This review aims to summarize the findings from recent literature (2010-2022) reporting on complications that resulted from the surgical use of SURGICEL for intraoperative hemostasis.Methods: A literature search was conducted using the MEDLINE (OVID), Embase, and Cochrane Central Register of Controlled Trials - CENTRAL (OVID) databases. The studies were sorted into case reports and other study types for data extraction. Covidence was used for data extraction and statistics were descriptive.Results: Of the total 560 articles screened, 73 papers were selected for a full-text review and 70 studies were included in this review. A total of 7,242 participants were included in the studies (case studies n = 93, others n = 7149). 67/70 of the included studies reported complications when SURGICEL was used intraoperatively. Reported complications included: SURGICEL induced masses (granulomas, abscesses, hematomas, cysts) (n = 25), hemorrhagic complications (n = 12), masses misdiagnosed as tumors, cardiovascular, nervous system, and hepatobiliary complications, pain, and infections. Other complications included: fistulas, erectile dysfunction, chorioamnionitis, swelling, urinary leak, renal failure, and anaphylaxis.Conclusions: Publications reporting on complications associated with the use of SURGICEL intraoperatively have continued to emerge. Future studies should compare how the types and rates of complications compare between SURGICEL and alternative hemostatic agents.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 9","pages":"741-752"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10472855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement. 兰花安全释放阀的装置外形，用于防止导管意外脱位。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 DOI: 10.1080/17434440.2023.2216383

Nancy Moureau

{"title":"Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement.","authors":"Nancy Moureau","doi":"10.1080/17434440.2023.2216383","DOIUrl":"https://doi.org/10.1080/17434440.2023.2216383","url":null,"abstract":"Introduction: More than 4 out of 5 patients in acute care require intravenous catheters. Complications of catheter dislodgement and failure are commonly reported at rates of 15-69% causing interrupted treatment and greater resource consumption when catheter replacement is required.Areas covered: This manuscript outlines unmet needs in the prevention of catheter dislodgement and how a novel safety release device (Orchid SRV™, Linear Health Sciences) might address these gaps based on available evidence.Expert opinion: Healthcare initiatives focus on reducing complications and associated costs with the delivery of intravenous treatments. Tension-activated safety release valve devices, attached to intravenous tubing, are a new feature that adds a level of safety to intravenous catheters to reduce mechanical catheter dislodgement when a pull force of greater than 3 pounds is applied. Incorporating a tension-activated accessory into and between existing intravenous tubing and the catheter and extension set protects the catheter from dislodgement. Flow continues until excessive pull force separates and closes the flow pathway in both directions, while the SRV provides a quick replacement to reestablish flow. The safety release valve is used to prevent accidental catheter dislodgement, limit tubing contamination, and avoid more serious complications while maintaining a functional catheter.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 7","pages":"529-536"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9637793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

inHEART Models software - novel 3D cardiac modeling solution. inHEART Models软件-新颖的三维心脏建模解决方案。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-08-18 DOI: 10.1080/17434440.2023.2247983

Leah A John, Brett Tomashitis, Zain Gowani, Dan Levin, Chau Vo, Ian John, Jeffrey R Winterfield

{"title":"inHEART Models software - novel 3D cardiac modeling solution.","authors":"Leah A John, Brett Tomashitis, Zain Gowani, Dan Levin, Chau Vo, Ian John, Jeffrey R Winterfield","doi":"10.1080/17434440.2023.2247983","DOIUrl":"10.1080/17434440.2023.2247983","url":null,"abstract":"Introduction: Advanced cardiac imaging is an important component in pre-procedural planning for ventricular tachycardia (VT) ablations. inHEART's proprietary software, inHEART Models, and its academic version, Multimodality Platform for Specific Imaging in Cardiology (MUSIC), provide detailed characterization of anatomical structures and scars.Areas covered: This review highlights the current overview of the market and offers insight into inHEART Models and MUSIC and its application during VT ablations with supporting case examples. An overview of the clinical profile and regulatory status of inHEART Models, and other competing technologies, such as Automatic Detection of Arrhythmia Substrate (ADAS) 3D software and Catheter Precision's View into Ventricular Onset (VIVO), are also discussed.Expert opinion: inHEART and MUSIC utilization has increased over the last few years and continues to establish its presence as an important aspect of VT ablations. Its unique proprietary software sets itself apart from others in the field. The introduction of dual source-photon counting detector computed tomography (PCD-CT) is expected to make significant advancements in the field and take imaging to a new level. inHEART's continued research in cardiac imaging and digital technology is expected to increase as is its global presence in the electrophysiology (EP) community.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":" ","pages":"797-803"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10019866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices. 心血管植入式电子设备中汽车无源无钥匙进入的电磁干扰。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-09-05 DOI: 10.1080/17434440.2023.2255126

Narawudt Prasertwitayakij, Taradol Komolmis, Siriluck Gunaparn, Cheeranun Pisespongsa, Arintaya Phrommintikul, Wanwarang Wongcharoen, Teerapat Nantsupawat

{"title":"Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices.","authors":"Narawudt Prasertwitayakij, Taradol Komolmis, Siriluck Gunaparn, Cheeranun Pisespongsa, Arintaya Phrommintikul, Wanwarang Wongcharoen, Teerapat Nantsupawat","doi":"10.1080/17434440.2023.2255126","DOIUrl":"10.1080/17434440.2023.2255126","url":null,"abstract":"Introduction: The automobile passive keyless entry (PKE) system is a potential source of electromagnetic interference (EMI). We aim to determine the incidence and significance of EMI from automobile PKE system in cardiovascular implantable electronic device (CIED) patients.Methods: This was a single-center cross-sectional study conducted at Maharaj Nakorn Chiang Mai hospital, Thailand. Patients with CIED were instructed to lock and unlock two automobiles using the PKE system. Any EMI or arrhythmias were detected by CIED interrogation and single-lead electrocardiogram event recorder. We also used a spectrum analyzer to identify the automobiles working frequency bandwidth.Results: There was a total of 102 CIED patients. Device types included 48.0% defibrillators, 37.3% permanent pacemakers, and 14.7% cardiac resynchronization therapy device. Both interrogated data from device and event monitor revealed no incidence of EMI during the PKE activation. We failed to identify the working frequency bandwidth of the two studied cars due to very low signal strength, thus blended in with the background noise.Conclusions: Automobile PKE systems transmitted very low power signals. Therefore, under normal circumstances, CIED patients can use automobile PKE system safely without any EMI regardless of key fob positions in relation to the CIED pulse generator.Trial registration: The study was registered at ClinicalTrials.gov (https://clinicaltrials.gov), and the identification number is NCT03016390.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":" ","pages":"973-977"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10155810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The current state, challenges, and future directions of deep brain stimulation for obsessive compulsive disorder. 强迫症脑深部刺激的现状、挑战和未来方向。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-09-07 DOI: 10.1080/17434440.2023.2252732

Lauren Fanty, Jun Yu, Nita Chen, Drew Fletcher, Grace Hey, Michael Okun, Josh Wong

{"title":"The current state, challenges, and future directions of deep brain stimulation for obsessive compulsive disorder.","authors":"Lauren Fanty, Jun Yu, Nita Chen, Drew Fletcher, Grace Hey, Michael Okun, Josh Wong","doi":"10.1080/17434440.2023.2252732","DOIUrl":"10.1080/17434440.2023.2252732","url":null,"abstract":"Introduction: Obsessive-compulsive disorder (OCD) is clinically and pathologically heterogenous, with symptoms often refractory to first-line treatments. Deep brain stimulation (DBS) for the treatment of refractory OCD provides an opportunity to adjust and individualize neuromodulation targeting aberrant circuitry underlying OCD. The tailoring of DBS therapy may allow precision in symptom control based on patient-specific pathology. Progress has been made in understanding the potential targets for DBS intervention; however, a consensus on an optimal target has not been agreed upon.Areas covered: A literature review of DBS for OCD was performed by querying the PubMed database. The following topics were covered: the evolution of DBS targeting in OCD, the concept of an underlying unified connectomic network, current DBS targets, challenges facing the field, and future directions which could advance personalized DBS in this challenging population.Expert opinion: To continue the increasing efficacy of DBS for OCD, we must further explore the optimal DBS response across clinical profiles and neuropsychiatric domains of OCD as well as how interventions targeting multiple points in an aberrant circuit, multiple aberrant circuits, or a connectivity hub impact clinical response. Additionally, biomarkers would be invaluable in programming adjustments and creating a closed-loop paradigm to address symptom fluctuation in daily life.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":" ","pages":"829-842"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10159124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Histological examination of tooth-derived biomaterials obtained from different devices. 从不同设备获得的牙齿衍生生物材料的组织学检查。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-08-28 DOI: 10.1080/17434440.2023.2251891

Robert Dłucik, Bogusława Orzechowska-Wylęgała, Daniel Dłucik, Katarzyna Bogus

{"title":"Histological examination of tooth-derived biomaterials obtained from different devices.","authors":"Robert Dłucik, Bogusława Orzechowska-Wylęgała, Daniel Dłucik, Katarzyna Bogus","doi":"10.1080/17434440.2023.2251891","DOIUrl":"10.1080/17434440.2023.2251891","url":null,"abstract":"Aim: The aim of the present study was to investigate the histological differences between samples processed by different devices and to confirm safe clinical application of different dentin matrix obtained from three devices: BonMaker, Tooth Transformer, and Smart Dentin Grinder in regeneration of maxillary defects.Research design: The study involved 39 patients with two-wall or three-wall defects who underwent bone augmentation procedures in the maxilla using dentin matrix grafts from the BonMaker, Tooth Transformer, and Smart Dentin Grinder devices. Histological examination was conducted on samples obtained from patients who received each device. In this article, histological samples have been selected and are presented.Results: In all patients, bone defects were successfully augmented with ground dentin matrix. The histological examination revealed no inflammation and a good connection between the bone and dentin matrix and clinically all patients were qualified for implant placement.Conclusions: After comparing the BonMaker, Tooth Transformer, and Smart Dentin Grinder devices in our practice, we concluded that all these systems have the potential for obtaining regenerative material from the patient's teeth.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":" ","pages":"979-988"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10229916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

HOPE for a better selection of patients for cardiac contractility modulation. 希望能更好地选择心脏收缩力调节的患者。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 DOI: 10.1080/17434440.2023.2217329

Daniele Masarone, Ishu Rao, Giuseppe Pacileo

{"title":"HOPE for a better selection of patients for cardiac contractility modulation.","authors":"Daniele Masarone, Ishu Rao, Giuseppe Pacileo","doi":"10.1080/17434440.2023.2217329","DOIUrl":"https://doi.org/10.1080/17434440.2023.2217329","url":null,"abstract":"Cardiac contractility modulation (CCM) is an innovative devicebased therapy for the treatment of patients with heart failure (HF) with mildly reduced ejection fraction (HFmrEF) and reduced ejection fraction (HFrEF) with a narrow QRS complex (and therefore with no indication for cardiac resynchronization therapy). The CCM therapy is based on the delivery, by an impulse pocket generator (Optimizer Smart®), of high-voltage (≈7.5 V) and long-duration (≈20 ms) biphasic electrical signals to the septal wall of the right ventricle during the absolute refractory period of the myocardium [1]. Therefore, these signals do not cause a novel myocardial contraction, but induce an improvement in calcium handling and, consequently, an increase in myocardial contractility [2]. Besides improving calcium handling, CCM therapy induces several positive effects (Table 1) that affects the entire biology of the failing myocardium [3–5]. In randomized controlled trials, CCM therapy improves functional capacity (i.e. VO2 peak at cardiopulmonary exercise test) [6]; also, in a real-world registry, CCM therapy is associated with a lower rate of HF-related hospitalizations [7]. In addition, CCM therapy induces both left and right ventricular reverse remodeling [8–10]. Based on the results of these randomized clinical trials, the Optimizer Smart® system has been approved in countries covered by CE markings since October 2016 and granted United States Food and Drug Administration (FDA) approval in March 2019. As with all device-based therapies for HF, appropriate patient selection is crucial for increasing the possibility of clinical and echocardiographic response. Because no practical guidance on proper patient selection for CCM therapy is currently provided by the European Society of Cardiology and the American College of Cardiology/American Heart Association guidelines [11,12], we proposed the HOPE algorithm as a simple tool for screening and selecting outpatients with HFrEF/HFmrEF in which CCM therapy is more likely to be effective (Figure 1).","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 7","pages":"525-528"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10064566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Readmission rate and healthcare utilization outcomes of computer-assisted fluoroscopy-based hip navigation versus manual total hip arthroplasty. 基于计算机辅助荧光透视的髋关节导航与人工全髋关节置换术的再移植率和医疗保健利用结果。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-07-25 DOI: 10.1080/17434440.2023.2238609

William G Hamilton, Robert A Sershon, Anshu Gupta, Laura Goldstein, Mina Kabiri, Chantal E Holy, Rodrigo Diaz

{"title":"Readmission rate and healthcare utilization outcomes of computer-assisted fluoroscopy-based hip navigation versus manual total hip arthroplasty.","authors":"William G Hamilton, Robert A Sershon, Anshu Gupta, Laura Goldstein, Mina Kabiri, Chantal E Holy, Rodrigo Diaz","doi":"10.1080/17434440.2023.2238609","DOIUrl":"10.1080/17434440.2023.2238609","url":null,"abstract":"Introduction: The study evaluates the technology of fluoroscopy-based hip navigation that has shown to improve implant positioning in total hip arthroplasty (THA).Methods: Premier Healthcare data for patients undergoing manual THA or fluoroscopy-based hip navigation THA between 1 January 2016-30 September 2021, were analyzed 90- and 365-day post-THA. The primary outcome was inpatient readmission. Secondary outcomes were operating room (OR) time, length of stay, discharge status, and hospital costs. Baseline covariate differences were balanced using fine stratification and analyzed using generalized linear models.Results: Among 4,080 fluoroscopy-based hip navigation THA and 429,533 manual THA balanced patients, hip-related readmission rates were statistically significantly lower for the fluoroscopy-based hip navigation THA cohort vs. manual THA for both 90-day (odd ratio [95% CI]: 0.69 [0.52 to 0.91] and 365-day (0.63 [0.49 to 0.81] follow-up. OR time was higher with fluoroscopy-based hip navigation THA vs. manual THA (134.65 vs. 132.04 minutes); however, fluoroscopy-based hip navigation THA patients were more likely to be discharged to home (93.73% vs. 90.11%) vs. manual THA. Hospital costs were not different between cohorts at 90- and 365-day post-operative.Conclusions: Fluoroscopy-based hip navigation THA resulted in fewer readmissions, greater discharge to home, and similar hospital costs compared to manual THA.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 9","pages":"779-789"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10116668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Learning curve and factors influencing successful robot-assisted bilateral sentinel lymph node mapping in early-stage cervical cancer: an observational cohort study. 早期宫颈癌机器人辅助双侧前哨淋巴结定位成功的学习曲线和影响因素:一项观察性队列研究。

IF 3.1 3区医学

Expert Review of Medical Devices Pub Date : 2023-07-01 DOI: 10.1080/17434440.2023.2212157

Ilse G T Baeten, Jacob P Hoogendam, Arthur J A T Braat, Bart de Keizer, Cornelis G Gerestein, Ronald P Zweemer

{"title":"Learning curve and factors influencing successful robot-assisted bilateral sentinel lymph node mapping in early-stage cervical cancer: an observational cohort study.","authors":"Ilse G T Baeten, Jacob P Hoogendam, Arthur J A T Braat, Bart de Keizer, Cornelis G Gerestein, Ronald P Zweemer","doi":"10.1080/17434440.2023.2212157","DOIUrl":"https://doi.org/10.1080/17434440.2023.2212157","url":null,"abstract":"Objectives: To evaluate whether a learning curve affects the bilateral sentinel lymph node (SLN) detection in early-stage cervical cancer.Methods: All patients with FIGO (2018) stage IA1-IB2 or IIA1 cervical cancer who had undergone robot-assisted SLN mapping performed with a combination of preoperative technetium-99m nanocolloids (including preoperative imaging) and intraoperative blue dye were retrospectively included. Risk-adjusted cumulative sum (RA-CUSUM) analysis was used to determine if a learning curve based on bilateral SLN detection existed in this cohort.Results: A total of 227 cervical cancer patients were included. In 98.2% of patients (223/227) at least one SLN was detected. The bilateral SLN detection rate was 87.2% (198/227). Except for age (OR 1.06 per year, 95%CI 1.02-1.09), no significant risk factors for non-bilateral SLN detection were found (e.g., prior conization, BMI or FIGO stage). The RA-CUSUM analysis showed no clear learning phase during the first procedures and cumulative bilateral detection rate remained at least 80% during the entire inclusion period.Conclusions: In this single-institution experience, we observed no learning curve affecting robot-assisted SLN mapping using a radiotracer and blue dye in early-stage cervical cancer patients, with stable bilateral detection rates of at least 80% when adhering to a standardized methodology.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 7","pages":"589-596"},"PeriodicalIF":3.1,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9637536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0