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Article ; Online: Data Requirement for Animal-Derived Wound Care Devices: Limitations of the 510(k) Regulatory Pathway.

DeLong, Michael R / Wells, Michael W / Chang, Irene A / Vardanian, Andrew J / Harris, Hobart

Journal of the American College of Surgeons

2023 Volume 238, Issue 2, Page(s) 218–224

Abstract: Background: Device classification and preclinical data requirements for animal-derived wound care products were recently reviewed by the FDA. Given the possible performance differences for these products, we evaluated the FDA data requirements as well ... ...

Abstract	Background: Device classification and preclinical data requirements for animal-derived wound care products were recently reviewed by the FDA. Given the possible performance differences for these products, we evaluated the FDA data requirements as well as the published literature for all animal-derived wound care products ever cleared through the FDA. Study design: The publicly available online database was queried for all animal-derived wound products; premarket data requirements for each product were recorded. A PubMed search was conducted to determine the number of published clinical studies for each product, and manufacturer websites were accessed to obtain the price for each product. Results: A total of 132 animal-derived wound products have been cleared by the FDA since the Center for Devices and Radiological Health was established in 1976. Of these, 114 had a publicly available clearance statement online. Preclinical biocompatibility testing was performed in 85 products (74.6%) and referenced in 10 (8.8%). Preclinical animal wound healing testing took place in 17 (14.9%). Only 9 products (7.9%) had clinical safety testing, and no products had clinical effectiveness data. We found no published peer-reviewed clinical data for 97 products (73%). Cost was infrequently available but ranged from $4.79 to $2,178 per unit. Conclusions: Although the current pathway is appropriate for efficiently clearing new wound care products, clinical effectiveness is not included in the regulatory review process. Wound care products are primarily evaluated by the FDA for safety and biocompatibility. Thus, any claims of clinical effectiveness require independent validation, which is often lacking.
MeSH term(s)	Animals ; United States ; Device Approval ; United States Food and Drug Administration ; Treatment Outcome ; Databases, Factual
Language	English
Publishing date	2023-10-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	1181115-8
ISSN	1879-1190 ; 1072-7515
ISSN (online)	1879-1190
ISSN	1072-7515
DOI	10.1097/XCS.0000000000000884
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Article ; Online: Evaluation of the Risk of Hypertrophic Scarring and Keloid Following Eyelid Procedures: A Systematic Review.

Anderson, Lexy / Vankawala, Jay / Gupta, Nisha / Dorfman, Robert / Pflibsen, Lacey / Vardanian, Andrew / Delong, Michael

Aesthetic surgery journal

2023 Volume 43, Issue 8, Page(s) 820–829

MeSH term(s)	Humans ; Cicatrix, Hypertrophic/etiology ; Keloid/etiology ; Keloid/surgery ; Eyelids/pathology ; Blepharoplasty/adverse effects
Language	English
Publishing date	2023-02-16
Publishing country	England
Document type	Systematic Review ; Journal Article
ZDB-ID	2087022-X
ISSN	1527-330X ; 1090-820X ; 1084-0761
ISSN (online)	1527-330X
ISSN	1090-820X ; 1084-0761
DOI	10.1093/asj/sjad034
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Article ; Online: Reply: Comparison of immediate implant-based versus staged tissue expander breast reconstruction technique.

Vardanian, Andrew J / Crisera, Christopher A

Plastic and reconstructive surgery

2013 Volume 131, Issue 3, Page(s) 440e

MeSH term(s)	Breast Implants ; Female ; Humans ; Mammaplasty/methods ; Surgical Flaps ; Tissue Expansion/methods
Language	English
Publishing date	2013-02-01
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	208012-6
ISSN	1529-4242 ; 0032-1052 ; 0096-8501
ISSN (online)	1529-4242
ISSN	0032-1052 ; 0096-8501
DOI	10.1097/PRS.0b013e31827c714d
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Article: Light-assisted stab phlebectomy: report of a technique for removal of lower extremity varicose veins.

Lawrence, Peter F / Vardanian, Andrew J

Journal of vascular surgery

2007 Volume 46, Issue 5, Page(s) 1052–1054

Abstract: We report a new technique to remove varicose veins and reduce recurrence from missed veins. A rigid cannula with a light source injects tumescent solution and transilluminates under veins. Varicose veins are removed with stab phlebectomy using a modified ...

Abstract	We report a new technique to remove varicose veins and reduce recurrence from missed veins. A rigid cannula with a light source injects tumescent solution and transilluminates under veins. Varicose veins are removed with stab phlebectomy using a modified crochet hook and mosquito clamp. Additional tumescent solution flushes hematomas and compresses empty vein channels, resulting in less pain, bleeding, and pigmentation. More than 200 patients have undergone light-assisted stab phlebectomy at the Gonda Vascular Center, with high patient and surgeon satisfaction. This sutureless technique allows complete and rapid varicose branch vein removal with few missed varicose veins, little bruising, and an excellent cosmetic result.
MeSH term(s)	Hemostasis, Surgical ; Humans ; Transillumination ; Varicose Veins/surgery ; Vascular Surgical Procedures/instrumentation ; Vascular Surgical Procedures/methods
Language	English
Publishing date	2007-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	605700-7
ISSN	1097-6809 ; 0741-5214
ISSN (online)	1097-6809
ISSN	0741-5214
DOI	10.1016/j.jvs.2007.08.029
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Article ; Online: Social media use and impact on plastic surgery practice.

Vardanian, Andrew J / Kusnezov, Nicholas / Im, Daniel D / Lee, James C / Jarrahy, Reza

Plastic and reconstructive surgery

2013 Volume 131, Issue 5, Page(s) 1184–1193

Abstract: Background: Social media platforms have revolutionized the way human beings communicate, yet there is little evidence describing how the plastic surgery community has adopted social media. In this article, the authors evaluate current trends in social ... ...

Abstract	Background: Social media platforms have revolutionized the way human beings communicate, yet there is little evidence describing how the plastic surgery community has adopted social media. In this article, the authors evaluate current trends in social media use by practicing plastic surgeons. Methods: An anonymous survey on the use of social media was distributed to members of the American Society of Plastic Surgeons. Prevalent patterns of social media implementation were elucidated. Results: One-half of respondents were regular social media users. Reasons for using social media included the beliefs that incorporation of social media into medical practice is inevitable (56.7 percent), that they are an effective marketing tool (52.1 percent), and that they provide a forum for patient education (49 percent). Surgeons with a primarily aesthetic surgery practice were more likely to use social media. Most respondents (64.6 percent) stated that social media had no effect on their practice, whereas 33.8 percent reported a positive impact and 1.5 percent reported a negative impact. Conclusions: This study depicts current patterns of social media use by plastic surgeons, including motivations driving its implementation and impressions on its impact. Many feel that social media are an effective marketing tool that generates increased exposure and referrals. A small number of surgeons have experienced negative repercussions from social media involvement. Our study reveals the presence of a void. There is a definite interest among those surveyed in developing best practice standards and oversight to ensure ethical use of social media platforms throughout the plastic surgery community. Continuing discussion regarding these matters should be ongoing as our experience with social media in plastic surgery evolves.
MeSH term(s)	Academic Medical Centers/statistics & numerical data ; Adult ; Data Collection ; Humans ; Marketing of Health Services/statistics & numerical data ; Middle Aged ; Physicians/statistics & numerical data ; Practice Patterns, Physicians'/statistics & numerical data ; Private Practice/statistics & numerical data ; Referral and Consultation/statistics & numerical data ; Social Media/statistics & numerical data ; Surgery, Plastic/statistics & numerical data ; United States
Language	English
Publishing date	2013-02-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	208012-6
ISSN	1529-4242 ; 0032-1052 ; 0096-8501
ISSN (online)	1529-4242
ISSN	0032-1052 ; 0096-8501
DOI	10.1097/PRS.0b013e318287a072
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Uk I Zs.142: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 293: Show issues

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Article: Light-assisted stab phlebectomy: early postoperative experience.

Vardanian, Andrew J / Cao, Huynh L / Lawrence, Peter F

The American surgeon

2007 Volume 73, Issue 10, Page(s) 1067–1070

Abstract: Light-assisted stab phlebectomy (LASP) is a technique that we have developed for treatment of lower extremity varicose veins. It combines powered and stab phlebectomy with minimally invasive surgical instruments to optimize intraoperative visualization ... ...

Abstract	Light-assisted stab phlebectomy (LASP) is a technique that we have developed for treatment of lower extremity varicose veins. It combines powered and stab phlebectomy with minimally invasive surgical instruments to optimize intraoperative visualization of varicose veins and to remove branch veins with minimal bruising, hematoma, or pain. The early experience with this technique has not been reported. We conducted a retrospective review of all patients who underwent LASP to characterize the associated perioperative experience and to identify postoperative factors that indicated a successful outcome. From 2004 to 2006, LASP was performed on 268 limbs to remove lower extremity branch veins. The majority of patients were women (75%), and the mean age was 52 years. A group of 184 patients underwent LASP in combination with another procedure, and 49 patients underwent LASP alone. Nearly all patients had conscious sedation for anesthesia (99%); operating room time averaged 44 minutes, and blood loss averaged 88 cc. Immediate postoperative complications were infrequent, occurring in 10 per cent of patients, and included unresected or missed veins, hematoma, and cellulitis. LASP provides improved visualization of branch veins and allows varicose veins to be removed with a short operating room time and minor postoperative complications.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Blood Loss, Surgical/statistics & numerical data ; Conscious Sedation ; Female ; Humans ; Male ; Middle Aged ; Postoperative Complications/epidemiology ; Varicose Veins/surgery ; Vascular Surgical Procedures/adverse effects ; Vascular Surgical Procedures/methods
Language	English
Publishing date	2007-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	202465-2
ISSN	1555-9823 ; 0003-1348
ISSN (online)	1555-9823
ISSN	0003-1348
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Arterial allograft allows in-line reconstruction of prosthetic graft infection with low recurrence rate and mortality.

Vardanian, Andrew J / Chau, Anthony / Quinones-Baldrich, William / Lawrence, Peter E

The American surgeon

2009 Volume 75, Issue 10, Page(s) 1000–1003

Abstract: Surgical management of infected prosthetic vascular grafts is associated with a significant risk of recurrent infection, limb loss, and mortality. Treatment options include graft excision with extra-anatomic bypass and in-line repair with prosthetic ... ...

Abstract	Surgical management of infected prosthetic vascular grafts is associated with a significant risk of recurrent infection, limb loss, and mortality. Treatment options include graft excision with extra-anatomic bypass and in-line repair with prosthetic graft, vein, or artery. We hypothesized that in-line reconstruction using cryopreserved arterial allografts would be associated with a lower recurrent infection rate, limb loss, and mortality than other alternatives. We reviewed all cases where adults underwent surgical management of infected prosthetic aortic, iliac, or femoral bypass grafts with cryopreserved arterial allograft at our medical center from 2001 to 2008. Cryopreserved arterial allografts were used in 21 patients. There were nearly equal number of men (n = 11, 52%) and women (n = 10, 48%). The median age was 63 years and median time since cryoartery repair was 4 years. There have been no deaths in the follow-up period. Complications (19%) included colon perforation (n = 1), lower extremity compartment syndrome (n = 1), limb ischemia (n = 1), and reinfection with pseudoaneurysm and subsequent limb amputation (n = 1). These positive findings of low morbidity and absence of mortality in high risk patients have resulted in a shift at our institution to the preferential use of cryopreserved arterial allograft with in-line reconstruction for infected prosthetic grafts.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Arteries/transplantation ; Blood Vessel Prosthesis/adverse effects ; Cohort Studies ; Cryopreservation ; Female ; Gram-Negative Bacterial Infections/etiology ; Gram-Negative Bacterial Infections/mortality ; Gram-Negative Bacterial Infections/surgery ; Gram-Positive Bacterial Infections/etiology ; Gram-Positive Bacterial Infections/mortality ; Gram-Positive Bacterial Infections/surgery ; Humans ; Male ; Middle Aged ; Prosthesis-Related Infections/etiology ; Prosthesis-Related Infections/mortality ; Prosthesis-Related Infections/surgery ; Recurrence ; Retrospective Studies ; Treatment Outcome
Language	English
Publishing date	2009-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	202465-2
ISSN	1555-9823 ; 0003-1348
ISSN (online)	1555-9823
ISSN	0003-1348
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Article: Patient rankings: why patient feedback should affect our delivery of care but not our pay.

Li, Andrew / Yoon, Alfred / Vardanian, Andrew / Nguyen, Phuong / Sacks, Justin / Gordon, Chad / Jarrahy, Reza

Bulletin of the American College of Surgeons

2013 Volume 98, Issue 11, Page(s) 22–23

MeSH term(s)	Feedback ; General Surgery/economics ; General Surgery/standards ; Humans ; Patient Satisfaction ; Quality of Health Care ; Salaries and Fringe Benefits ; United States
Language	English
Publishing date	2013-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	390409-x
ISSN	0002-8045
ISSN	0002-8045
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Article ; Online: Urban Telemedicine: The Applicability of Teleburns in the Rehabilitative Phase.

Liu, Yuk Ming / Mathews, Katie / Vardanian, Andrew / Bozkurt, Taylan / Schneider, Jeffrey C / Hefner, Jaye / Schulz, John T / Fagan, Shawn P / Goverman, Jeremy

Journal of burn care & research : official publication of the American Burn Association

2016 Volume 38, Issue 1, Page(s) e235–e239

Abstract: Telemedicine has been successfully used in many areas of medicine, including triage and evaluation of the acute burn patient. The utility of telemedicine during the rehabilitative phase of burn care has yet to be evaluated; therefore, we expanded our ... ...

Abstract	Telemedicine has been successfully used in many areas of medicine, including triage and evaluation of the acute burn patient. The utility of telemedicine during the rehabilitative phase of burn care has yet to be evaluated; therefore, we expanded our telemedicine program to link our burn center with a rehabilitation facility. The goal of this project was to demonstrate cost-effective improvements in the transition and quality of care. A retrospective review was performed on all patients enrolled in our telemedicine/rehabilitation program between March 2013 and March 2014. Data collected included total number of encounters, visits, type of visit, physician time, and readmissions. Transportation costs were based on local ambulance rates between the two facilities. The impact of telemedicine was evaluated with respect to the time saved for the physician, burn center, and burn clinic, as well as rehabilitative days saved. A patient satisfaction survey was also administered. A total of 29 patients participated in 73 virtual visits through the telemedicine project. Virtual visits included new consults, preoperative evaluations, and postoperative follow-ups. A total of 146 ambulance transports were averted during the study period, totaling $101,110. Virtual visits saved 6.8 outpatient burn clinic days, or 73 clinic appointments of 30-min duration. The ability to perform more outpatient surgery resulted in 80 inpatient bed days saved at the burn hospital. The rehabilitation hospital saved an average of 2 to 3 patient days secondary to unnecessary travel. Satisfaction surveys demonstrated patient satisfaction with the encounters, primarily related to time saved. The decrease in travel time for the patient from the rehabilitation hospital to outpatient burn clinic improved adherence to the rehabilitation care plan and resulted in increased throughput at the rehabilitation facility. Videoconferencing between a burn center and rehabilitation hospital streamlined patient care and reduced health care costs, while maintaining quality of care and patient satisfaction. This program has improved inpatient burn rehabilitation by maximizing time spent in therapy and avoiding unnecessary patient travel to offsite appointments.
MeSH term(s)	Adult ; Burn Units ; Burns/diagnosis ; Burns/rehabilitation ; Continuity of Patient Care ; Cost-Benefit Analysis ; Female ; Health Care Costs ; Humans ; Injury Severity Score ; Male ; Middle Aged ; Patient Satisfaction/statistics & numerical data ; Rehabilitation Centers ; Retrospective Studies ; Telemedicine/economics ; Telemedicine/organization & administration ; United States ; Urban Health Services/organization & administration ; Wound Healing/physiology
Language	English
Publishing date	2016-08-22
Publishing country	England
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2224246-6
ISSN	1559-0488 ; 1559-047X
ISSN (online)	1559-0488
ISSN	1559-047X
DOI	10.1097/BCR.0000000000000360
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Article: Incidentally discovered tumors of the endocrine glands.

Vardanian, Andrew J / Hines, O Joe / Farrell, James J / Yeh, Michael W

Future oncology (London, England)

2007 Volume 3, Issue 4, Page(s) 463–474

Abstract: Clinically inapparent masses, or 'incidentalomas' of the endocrine glands are increasingly common owing to continued advancements in medical imaging. Incidentalomas of the adrenal glands have received substantial attention in the literature, whereas ... ...

Abstract	Clinically inapparent masses, or 'incidentalomas' of the endocrine glands are increasingly common owing to continued advancements in medical imaging. Incidentalomas of the adrenal glands have received substantial attention in the literature, whereas lesions of the thyroid and endocrine pancreas, though frequently encountered in the clinic, have received relatively little attention. We review the detection and subsequent management of incidentalomas of the thyroid, adrenal and pancreas, with specific attention paid to the mode of detection and risk stratification of lesions.
MeSH term(s)	Adrenal Gland Neoplasms/diagnostic imaging ; Biomarkers, Tumor ; Diagnosis, Differential ; Endocrine Gland Neoplasms/diagnosis ; Endocrine Gland Neoplasms/diagnostic imaging ; Humans ; Pancreatic Neoplasms/diagnostic imaging ; Positron-Emission Tomography ; Thyroid Neoplasms/diagnostic imaging ; Tomography, X-Ray Computed ; Ultrasonography
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2007-08
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2274956-1
ISSN	1479-6694
ISSN	1479-6694
DOI	10.2217/14796694.3.4.463
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