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IP179. Society for Vascular Surgery YouTube Channel: Who Is Delivering the Message?
Journal of Vascular Surgery
Abstracts
103S
Volume 65, Number 6S
IP177. Drug-Coated Balloon Catheters: What Is Being Reported in the MAUDE Database? Michael F. Amendola, Ifechukwude Ikem, Gi-Ann Acosta. Virginia Commonwealth University Objectives: The Manufacturer and User Facility Device Experience (MAUDE) Database was established by the United States Food and Drug Administration (FDA) to allow for voluntarily reporting of adverse outcomes with medical devices. There are two commercially available drug-coated balloons: IN.PACT Admiral (I-DCB; Medtronic, Inc; release date 1/5/2015) and Lutonix (L-DCB; C.R. Bard, Inc; release date 10/9/2014). We sought to examine MAUDE reporting of these two systems. Methods: The MAUDE database was accessed from October 1, 2014, to December 1, 2016, at a single time point for entries related to I-DCB and LDCB. The time to report from index event, adverse event (restenosis, thrombosis or embolization), off indication for use vessel treated, and percentage of devices returned to the manufacturer. Results: A total of 532 entries were found for the time period examined. I-DCB and L-DCB accounted for 66% and 33% of the reports, respectively. Adjusting the total reports per total time that each product has been on the market, the I-DCB had 0.5 reports/day compared to 0.22 reports/day for L-DCB. The two systems are compared in the Table. Conclusions: In our examination of the MAUDE database, we find similar reporting times and overall adverse events reported for each of the DCB type. Interestingly, <5% of the devices listed were stated to be in an off-label usage. The I-DCB accounted for more total reports to the MAUDE compared to L-DCB. Additionally, the I-DCB had almost twice as many devices returned. These data should be used to inform the vascular surgery community at large that equal rates of adverse events are being reported to the MAUDE despite one system having almost double of the reports and devices returned.
Table. Comparison of the two systems Variable
I-DCB (n ¼ 351)
L-DCB (n ¼ 181)
Reporting time (days 6 SD)
165 6 237
164 6 184
P value .98a
Adverse event (%)
53
58
.27b
Devices returned (%)
31
18
.018b
Off IFU vessel treated (%)
2.3
2.2
1.000b
I-DCB, IN.PACT drug-coated balloon; L-DCB, Lutonix drug-coated balloon; IFU, instructions for use; SD, standard deviation. a Two-tail t-test. b Fisher exact test. Author Disclosures: G. Acosta: Nothing to disclose; M. F. Amendola: Nothing to disclose; I. Ikem: Nothing to disclose.
IP179. Society for Vascular Surgery YouTube Channel: Who Is Delivering the Message? Michael F. Amendola, Brian Kaplan, Luke G. Wolfe. Virginia Commonwealth University, Richmond, Va Objectives: Medical professionals and the lay pubic are turning to the Internet and, in particular, YouTube for information about their providers, disease states, and potential interventions. The Society for Vascular Surgery (SVS) has sponsored a YouTube Channel as part of its branding campaign for vascular surgery. We set forth to analyze the SVS YouTube Channel results to gain insight on what users are seeing from this national vascular society. Methods: The SVS YouTube Channel (www.youtube.com/user/ SVSChannel) Web site was accessed three different times in September 2015 with a cleared cached Web browser. All videos were examined for subject type, time of creation, and total views. Four major categories were examined: (1) disease state, (2) procedures, (3) vascular surgery career options, and (4) other (education, history, systems based practice and society advertising). Gender of the video presenter was also captured.
Results: A total of 156 videos were examined on the SVS YouTube Channel. One-way analysis of variance analysis indicates that the vascular disease state videos had significantly more views (mean 4379.2 6 6256.2; P ¼ .003) and shorter durations (4.02 6 1.03; P ¼ .0002). Female presenters were in the minority in all categories, with career videos having the most representation. Conclusions: Disease state videos from the SVS YouTube were the most viewed with the shortest duration. Male speakers predominated in all categories (Fig). These data should inform future branding efforts in terms of vascular surgery.
Fig. Author Disclosures: M. F. Amendola: Nothing to disclose; B. Kaplan: Nothing to disclose; L. G. Wolfe: Nothing to disclose.
IP181. Hemophilic Pseudotumor: Feasibility and Value of Open Surgical Resection Birute Vaisnyte,1 Aiste Gulla,2 Lina Kryzauskaite,3 Darius Palionis,4 Daiva Nevidomskyte5. 1Department of Vascular and Endovascular Surgery, Santariskiu Clinics, Vilnius University, Vilnius, Lithuania; 2 Department of Vascular and Endovascular Surgery, Vilnius University, Vilnius, Lithuania; 3Department of Hematology, Oncology and Transfusiology Department, Vilnius University Hospital, Santariskiu Clinics, Vilnius University, Vilnius, Lithuania; 4Department of Radiology, Duke University Medical Center, Durham, NC; 5Duke University Medical Center, Vilnius University, Vilnius, Lithuania Objectives: Hemophilic pseudotumor is a rare complication of hemophilia that results from repetitive bleeding leading to an encapsulated, slowly expanding hematoma and necrosis of the surrounding tissues. The aim of this study was to present the clinical case and literature review examining the feasibility and clinical value of surgical resection in patients with hemophilic pseudotumors. Methods: A total of 31 studies, published in the last 5 years, were identified by systemically searching PubMed, Embase, and Cochrane electronic databases. Patient population, treatment strategies, and results were reviewed. Our clinical case is described separately and includes patient’s demographics, clinical data, radiological imaging, and surgical outcome. Results: The literature review identified a total of 31 retrospective case reports. In these studies, all patients were male and diagnosed with hemophilia A (factor VIII; 4.6%). The average age was 24.1 6 15.3 years, and 10 of 31 (32%) had a history of trauma. For 23 of 31 patients (74%), the removal of the tumor was a definitive treatment choice. Of the 31 patients, 20 (64%) had excision, 1 (3%) underwent a hybrid procedure, and 2 (6.4%) required limb amputation. Meanwhile, six of 31 (19%) had factor VIII replacement therapy, and two of 31 (13%) refused treatment. All patients (23 of 31) who underwent surgical resection were reported to have excellent clinical outcomes. Our case features a 54-year-old man with hemophilia A (factor VIII, 4%) and hepatitis C with a history of multiple episodes of blunt trauma, most recently 3 years ago while biking. The patient presented with swelling and pain at the anterior surface of the left thigh. Laboratory studies, including coagulation factors and ultrasound and magnetic resonance imaging of the left lower extremity, were performed. Magnetic resonance imaging findings revealed a multicavernous, nonhomogenic cystic conglomerate mass in the left posterior thigh
Abstracts
103S
Volume 65, Number 6S
IP177. Drug-Coated Balloon Catheters: What Is Being Reported in the MAUDE Database? Michael F. Amendola, Ifechukwude Ikem, Gi-Ann Acosta. Virginia Commonwealth University Objectives: The Manufacturer and User Facility Device Experience (MAUDE) Database was established by the United States Food and Drug Administration (FDA) to allow for voluntarily reporting of adverse outcomes with medical devices. There are two commercially available drug-coated balloons: IN.PACT Admiral (I-DCB; Medtronic, Inc; release date 1/5/2015) and Lutonix (L-DCB; C.R. Bard, Inc; release date 10/9/2014). We sought to examine MAUDE reporting of these two systems. Methods: The MAUDE database was accessed from October 1, 2014, to December 1, 2016, at a single time point for entries related to I-DCB and LDCB. The time to report from index event, adverse event (restenosis, thrombosis or embolization), off indication for use vessel treated, and percentage of devices returned to the manufacturer. Results: A total of 532 entries were found for the time period examined. I-DCB and L-DCB accounted for 66% and 33% of the reports, respectively. Adjusting the total reports per total time that each product has been on the market, the I-DCB had 0.5 reports/day compared to 0.22 reports/day for L-DCB. The two systems are compared in the Table. Conclusions: In our examination of the MAUDE database, we find similar reporting times and overall adverse events reported for each of the DCB type. Interestingly, <5% of the devices listed were stated to be in an off-label usage. The I-DCB accounted for more total reports to the MAUDE compared to L-DCB. Additionally, the I-DCB had almost twice as many devices returned. These data should be used to inform the vascular surgery community at large that equal rates of adverse events are being reported to the MAUDE despite one system having almost double of the reports and devices returned.
Table. Comparison of the two systems Variable
I-DCB (n ¼ 351)
L-DCB (n ¼ 181)
Reporting time (days 6 SD)
165 6 237
164 6 184
P value .98a
Adverse event (%)
53
58
.27b
Devices returned (%)
31
18
.018b
Off IFU vessel treated (%)
2.3
2.2
1.000b
I-DCB, IN.PACT drug-coated balloon; L-DCB, Lutonix drug-coated balloon; IFU, instructions for use; SD, standard deviation. a Two-tail t-test. b Fisher exact test. Author Disclosures: G. Acosta: Nothing to disclose; M. F. Amendola: Nothing to disclose; I. Ikem: Nothing to disclose.
IP179. Society for Vascular Surgery YouTube Channel: Who Is Delivering the Message? Michael F. Amendola, Brian Kaplan, Luke G. Wolfe. Virginia Commonwealth University, Richmond, Va Objectives: Medical professionals and the lay pubic are turning to the Internet and, in particular, YouTube for information about their providers, disease states, and potential interventions. The Society for Vascular Surgery (SVS) has sponsored a YouTube Channel as part of its branding campaign for vascular surgery. We set forth to analyze the SVS YouTube Channel results to gain insight on what users are seeing from this national vascular society. Methods: The SVS YouTube Channel (www.youtube.com/user/ SVSChannel) Web site was accessed three different times in September 2015 with a cleared cached Web browser. All videos were examined for subject type, time of creation, and total views. Four major categories were examined: (1) disease state, (2) procedures, (3) vascular surgery career options, and (4) other (education, history, systems based practice and society advertising). Gender of the video presenter was also captured.
Results: A total of 156 videos were examined on the SVS YouTube Channel. One-way analysis of variance analysis indicates that the vascular disease state videos had significantly more views (mean 4379.2 6 6256.2; P ¼ .003) and shorter durations (4.02 6 1.03; P ¼ .0002). Female presenters were in the minority in all categories, with career videos having the most representation. Conclusions: Disease state videos from the SVS YouTube were the most viewed with the shortest duration. Male speakers predominated in all categories (Fig). These data should inform future branding efforts in terms of vascular surgery.
Fig. Author Disclosures: M. F. Amendola: Nothing to disclose; B. Kaplan: Nothing to disclose; L. G. Wolfe: Nothing to disclose.
IP181. Hemophilic Pseudotumor: Feasibility and Value of Open Surgical Resection Birute Vaisnyte,1 Aiste Gulla,2 Lina Kryzauskaite,3 Darius Palionis,4 Daiva Nevidomskyte5. 1Department of Vascular and Endovascular Surgery, Santariskiu Clinics, Vilnius University, Vilnius, Lithuania; 2 Department of Vascular and Endovascular Surgery, Vilnius University, Vilnius, Lithuania; 3Department of Hematology, Oncology and Transfusiology Department, Vilnius University Hospital, Santariskiu Clinics, Vilnius University, Vilnius, Lithuania; 4Department of Radiology, Duke University Medical Center, Durham, NC; 5Duke University Medical Center, Vilnius University, Vilnius, Lithuania Objectives: Hemophilic pseudotumor is a rare complication of hemophilia that results from repetitive bleeding leading to an encapsulated, slowly expanding hematoma and necrosis of the surrounding tissues. The aim of this study was to present the clinical case and literature review examining the feasibility and clinical value of surgical resection in patients with hemophilic pseudotumors. Methods: A total of 31 studies, published in the last 5 years, were identified by systemically searching PubMed, Embase, and Cochrane electronic databases. Patient population, treatment strategies, and results were reviewed. Our clinical case is described separately and includes patient’s demographics, clinical data, radiological imaging, and surgical outcome. Results: The literature review identified a total of 31 retrospective case reports. In these studies, all patients were male and diagnosed with hemophilia A (factor VIII; 4.6%). The average age was 24.1 6 15.3 years, and 10 of 31 (32%) had a history of trauma. For 23 of 31 patients (74%), the removal of the tumor was a definitive treatment choice. Of the 31 patients, 20 (64%) had excision, 1 (3%) underwent a hybrid procedure, and 2 (6.4%) required limb amputation. Meanwhile, six of 31 (19%) had factor VIII replacement therapy, and two of 31 (13%) refused treatment. All patients (23 of 31) who underwent surgical resection were reported to have excellent clinical outcomes. Our case features a 54-year-old man with hemophilia A (factor VIII, 4%) and hepatitis C with a history of multiple episodes of blunt trauma, most recently 3 years ago while biking. The patient presented with swelling and pain at the anterior surface of the left thigh. Laboratory studies, including coagulation factors and ultrasound and magnetic resonance imaging of the left lower extremity, were performed. Magnetic resonance imaging findings revealed a multicavernous, nonhomogenic cystic conglomerate mass in the left posterior thigh