Adverse events with orbital atherectomy: an analytic review of the MAUDE database

Khalid, Nauman; Javed, Hasan; Rogers, Toby; Shlofmitz, Evan; Wermers, Jason P.; Chen, Yuefeng; Musallam, Anees; Khan, Jaffar; Torguson, Rebecca; Bernardo, Nelson L.; Waksman, Ron

doi:10.4244/eij-d-19-00295

Cited by 16 publications

(7 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although pharmacotherapy, particularly with regard to dual antiplatelet therapy (DAPT), was not fully in line with the latest ESC/ESH guidelines [ 34 ], it must be emphasized that our data come from a real-life registry, and in the general population, deviations from the latest recommendations for antiplatelet therapy are common findings [ 35 , 36 , 37 ]. Similar results were obtained in other small-number trials [ 38 , 39 , 40 , 41 , 42 , 43 ]. The results obtained suggest a relatively low rate of adverse outcomes compared to previously published data on alternative treatment strategies.…”

Section: Discussionsupporting

confidence: 90%

Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR)

Rola,

Włodarczak,

Barycki

et al. 2023

JCM

View full text Add to dashboard Cite

Background: Coronary calcifications represent a challenging subset for the interventional cardiologist performing percutaneous coronary intervention (PCI) and are well-established risk factors for adverse outcomes. Adequate plaque modification prior to stent implantation is critical to achieve an optimal outcome following PCI. Recently, a novel orbital atherectomy device has been introduced into clinical practice to modify calcified plaques. We evaluated the mid-term safety and efficacy of OA in a high-risk “all-comers” population. Methods: We evaluated 96 consecutive patients with severely calcified coronary lesions who underwent PCI facilitated by the orbital atherectomy device. Results: In-hospital MACCE was 5.2% without target lesion revascularization. At 6-month follow-up, the MACCE rate was 10.4% with a concomitant TLR rate of 1%. Conclusions: Our mid-term data showed good safety and efficacy of orbital atherectomy as a plaque-modifying tool in an all-comers cohort with severely calcified coronary lesions.

show abstract

Section: Discussionsupporting

confidence: 90%

Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR)

Rola,

Włodarczak,

Barycki

et al. 2023

JCM

View full text Add to dashboard Cite

show abstract

“…The events are typically divided into the following four categories: death, injury, malfunction, or other. The MAUDE database serves as a safety monitoring tool for FDA‐approved medical devices 11‐15 . The FDA may issue a warning or recall if a device does not work or is a health risk to patients 16 …”

Section: Methodsmentioning

confidence: 99%

“…The MAUDE database serves as a safety monitoring tool for FDA-approved medical devices. [11][12][13][14][15] The FDA may issue a warning or recall if a device does not work or is a health risk to patients. 16…”

Section: Maude Databasementioning

confidence: 99%

Real‐world experience of suture‐based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience

Case

Kumar

Yerasi

et al. 2021

Cathet Cardio Intervent

Self Cite

View full text Add to dashboard Cite

Objectives: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) -Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). Background: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. Methods: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports.Results: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group.Conclusions: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

show abstract

“…[72] The Feasibility of Orbital Atherectomy System in Calcified Bifurcation Lesion (ORBID-OA) study is an on-going US observational study in which 30 patients will be assessed with frequency domain OCT.[73] While waiting for the results of these trials, new data have emerged from the Manufacturer and User Facility Device Experience (MAUDE) database of a not negligible number of cases of perforations attributed primarily to excessive straightening from the Viper wire and prompting changes in technique. [74]…”

Section: Percutaneous Coronary Intervention Of Complex Calcified Coromentioning

confidence: 99%

Contemporary Approach to Heavily Calcified Coronary Lesions

et al. 2019

View full text Add to dashboard Cite

Percutaneous treatment of heavily calcified coronary lesions still represents a challenge for interventional cardiology, with higher risk of immediate complications, late failure due to stent underexpansion and malapposition, and consequently poor clinical outcome. Good characterisation of calcium distribution with multimodal imaging is important to improve the successful treatment of these lesions. The use of traditional or new dedicated devices for the treatment of calcified lesions allows better lesion preparation; therefore, it is important that we know the different mechanisms and technical features of these devices.

show abstract

Adverse events with orbital atherectomy: an analytic review of the MAUDE database

Cited by 16 publications

References 3 publications

Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR)

Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR)

Real‐world experience of suture‐based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience

Contemporary Approach to Heavily Calcified Coronary Lesions

Contact Info

Product

Resources

About