UNASSIGNED: To demonstrate the use of the Data Extraction and Longitudinal Trend Analysis (DELTA) system in the National Evaluation System for health Technology\'s (NEST) medical device surveillance cloud environment by analyzing coronary stent safety using real world clinical data and comparing results to clinical trial findings.
UNASSIGNED: Electronic health record (EHR) data from two health systems, the Social Security Death Master File, and device databases were ingested into the NEST cloud, and safety analyses of two stents were performed using DELTA.
UNASSIGNED: This is an observational study of patients receiving zotarolimus drug-eluting coronary stents (ZES) or everolimus eluting coronary stents (EES) between July 1, 2015 and December 31, 2017.
UNASSIGNED: After exclusions, 3334 patients receiving EES and 1002 receiving ZES were available for study. Analysis using inverse probability weighting showed no significant difference in one-year mortality or major adverse cardiac events (MACE) for EES compared to ZES [Mortality Odds Ratio 0.94 (95% CI 0.81-1.175); p = 0.780] [MACE Odds Ratio 1.04 (95% CI 0.92-1.16; p = 0.551]). Analysis using propensity matching showed no significant difference in EES one-year mortality (547 of 992 alive and available after censoring) compared to ZES (546 of 992) [Log-Rank statistic 0.3348 (p = 0.563)].
UNASSIGNED: Automated cloud-based medical device safety surveillance using EHR data is feasible and was efficiently performed using DELTA. No statistically significant differences in 1-year safety outcomes between ZES and EES were identified using two statistical approaches, consistent with randomized trial findings.

暂无摘要。

BACKGROUND: We previously proposed a novel method for detecting a rupture of a breast implant using high-resolution ultrasound (HRUS). We therefore conducted this retrospective, observational study to describe its feasibility in making a preoperative diagnosis of rupture of the device in patients receiving an implant-based augmentation mammaplasty.
METHODS: We initially evaluated the medical records of the patients who had received primary or secondary augmentation mammaplasty using a breast implant at other hospitals for aesthetic or reconstructive purposes between August 31, 2017, and August 31, 2020. The patients underwent breast US using the Aplio i600 (Canon Medical System, Otawara, Tochigi, Japan) system with a 7-18 MHz linear transducer. Through a retrospective review of the patients\' medical records, we analyzed their baseline and clinical characteristics. Then, we compared an agreement between preoperative diagnosis of rupture on HRUS and findings at reoperation.
RESULTS: A total of 29 patients with rupture (55 breasts) were evaluated for the performance of ultrasound in making a diagnosis of rupture. This showed that they were unaware of rupture but they were diagnosed with it on ultrasound. Preoperatively, there were no cases of rupture in 110 left breasts (80.9%) and 107 right breasts (78.7%), which exactly matched to the number of breasts without rupture on HRUS. Moreover, preoperatively, there were 26 (19.1%) and 29 cases (21.3%) of rupture in the left and right breast, respectively, which exactly matched to the number of breasts with rupture on HRUS.
CONCLUSIONS: In conclusion, patients who are suspected of having rupture of a breast implant should be stringently evaluated for presence of rupture and, if any, its scope using HRUS. Moreover, we propose that surgeons consider using HRUS in making a preoperative diagnosis of rupture of a breast implant.
METHODS: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

BACKGROUND: We conducted this study to describe the feasibility of high-resolution ultrasound (HRUS) in characterizing a breast implant in patients receiving an implant-based augmentation mammaplasty.
METHODS: The current study was conducted in a total of 612 patients (n =6 12) receiving an implant-based augmentation mammaplasty at other hospitals between August 31, 2017 and August 31, 2020. Of these, 136 patients (n = 136; 272 breasts) receiving reoperation were included in the current study. We compared between the patients\' subjective awareness of a breast implant and its HRUS findings and an agreement between HRUS findings of a breast implant and its findings at reoperation.
RESULTS: The proportion of the patients receiving a silicone gel-filled breast implant was increased from 65.44% (89/136) to 81.61% (111/136) on HRUS. Moreover, HRUS was effective in identifying a manufacturer of the device.
CONCLUSIONS: In conclusion, our results indicate that HRUS is feasible in characterizing a breast implant in patients receiving an implant-based augmentation mammaplasty. But further prospective, large-scale studies are warranted to corroborate our results.
METHODS: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors. www.springer.com/00266 .

暂无摘要。

OBJECTIVE: Pelvic organ prolapse (POP) is a common condition and there is a plethora of surgical techniques available to address this problem. We present a review of biologic grafts, including the latest literature to help guide a surgeon\'s choice on the type of biologic materials to augment repairs.
RESULTS: Since the 2019 Food and Drug Administration (FDA) ban on mesh, including xenograft, there is a sparsity of biologic graft products available for POP repairs. This has led to a significant decrease in surgical application. Surgeons must be familiar with the biochemical properties, processing, and clinical application of biologic grafts prior to use. They should also be familiar with alternative operative techniques that utilize autografts, although there is limited outcome data on these techniques. With heightened awareness of mesh and its complications, biologic grafts have made a resurgence. Surgeons must be well versed on their available options. Current literature is limited, and studies have not demonstrated superiority of biologic graft over native tissue repairs for prolapse. Nevertheless, there is a role for these types of biologic graft material in specific patient populations. Future studies are warranted.

暂无摘要。

Left ventricular assist devices (LVADs) are being increasingly implanted given the increasing prevalence of patients with advanced heart failure stages. However, they are not exempt from device malfunctions. A PubMed search for the key words (left ventricular assist device malfunction) (ventricular assist system malfunction) was performed. We identified 28 publications in the US Food and Drug Administration (FDA) website database that addressed LVAD malfunction. Twenty-nine FDA recalls were identified regarding LVAD malfunctions: 17 regarding HeartWare ventricular assist device, six for HeartMate II, three for HeartMate 3, and three for total artificial heart. Mechanisms involved in LVAD malfunction include battery malfunction, loose driveline connector, malfunction of the system controller, loose power supply connector ports, malfunction of the driveline splice kit, problems with the percutaneous lead connection, disconnection of the bend relief and outflow graft and outflow graft occlusion among others. Multiple mechanisms could be linked to LVAD malfunction. However, multiple device modifications have been developed over the past decade to avoid recurrent malfunctions. Constant improvements and research in biotechnology are needed to prevent these complications. It remains to be seen if newer generation devices will lead to improved patient outcomes over the long term.

Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair.
Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI.
A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results.
Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.

暂无摘要。