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A review of the available information was performed.Per the reply to the editor, ¿is biologic glue the inexperienced surgeon¿s best friend?¿, bo yang states that ¿a single article reported no adverse effects; this was the article cited by lee and choi to support their use of bioglue.In that study, however, most of the patients had aortic aneurysms, and only 49 patients (21%) had ataad; 1 patient with ataad had an anastomotic pseudoaneurysm develop 3 years postoperatively.Personally, in the past 5 years, i have reoperated on a handful of patients with proximal aortic anastomotic pseudoaneurysms resulting from biologic glue used in the initial repair of ataad at other hospitals.Every patient had severe inflammation and tissue necrosis related to bioglue, and extensive adhesions as a result of polytetrafluoroethylene felt¿.The following information is unknown: the condition of the native tissue before surgery, how much bioglue was used in the procedures, whether used as an adjunct to sutures, or if the syringe was primed and de-aired.Pseudoaneurysm: per kitamura et al, pseudoaneurysm formation ¿is not a rare late complication late after repair of acute aortic dissection (mohammadi, s et al).The underlying mechanism of pseudoaneurysm formation is considered to be associated with tissue cutting due to the fragility of the dissected aortic wall at the anastomosis and from the chemical reaction to the aldehyde contained in the glue material (bingley, ja et al).¿ if bioglue was applied to fragile tissue, this would raise the question of whether attempted salvage of the native aorta was an appropriate surgical decision.Perhaps the native tissue was too damaged to be repaired and an aortic replacement with a synthetic graft should have been considered.Furthermore, while surgical glue is helpful in surgery for acute type a aortic dissection, it may also cause late pseudoaneurysm formation or valve deterioration when not used properly (kitamura et al).Dr.Fehrenbacher et al.Performed a retrospective review of 92 consecutive patients who underwent complex operation in which bioglue was used.Postoperative pseudoaneurysm formation occurred in 3.3% of the patients (fehrenbacher 2006).Weiner et al.Presented at 15th world congress of heart disease in vancouver, canada in july 2010 they identified 97consecutive patients in whom bioglue was used to reinforce thoracic aortic suture lines.During follow-up 2 patients were identified as having a pseudoaneurysm, the control group, without bioglue use, had similar incidences of pseudoaneurysm formation (weiner 2010).Ma et al.Reviewed 233 patients with a mean follow-up time of 2.4 years post-operation; a pseudoaneurysm was detected in only 1 patient (0.6%).The authors concluded, ¿the use of bioglue in thoracic aortic surgery was not associated with excess incidence of anastomotic pseudoaneurysm formation following surgical repair of thoracic aortic disease.¿ (ma 2017) inflammation: in the bioglue ifu it warns ¿bioglue should be applied in a thin layer as an adjunct to sutures or staples, and in amounts sufficient to seal the area.Bioglue should not be applied in excess.¿ also, it states, apply an even coating of bioglue to target area.The ifu lists ¿inflammatory reaction¿ as an observed adverse event.Foreign body reactions have been reported with the use of bioglue.Hewitt et al.Performed an animal study where bioglue was applied to a sheep¿s aorta; histopathologically, bioglue generate only a minimal inflammatory response (hewitt et al 2001).When used properly, histopathological observations with bioglue are consistent with a normal foreign body reaction.Coselli et al.Found 2.6% of bioglue patients developed inflammatory, immune systemic allergic reaction (coselli 2003).The exact amount of bioglue used is unknown; however, if a large amount was utilized it could result in an enhanced or prolonged inflammatory reaction.Necrosis: the images in figure 2 within the publication would need to be confirmed with histologic examination.Tissue necrosis due to the use of bioglue cannot be ruled out.Tissue necrosis is listed as a potential adverse event that may occur from the use of bioglue.There is insufficient information to determine if there is an association between the use of bioglue and the pseudoaneurysms formed.Pseudoaneurysm formation is a known complication in standard surgical repair of aortic dissections.The condition of the native aortic tissue at the time of initial surgery is unknown in these cases.Pre-existing conditions such as medial necrosis or other intrinsic aortic disease may have contributed to further complications.Foreign-body type inflammatory reactions and local tissue necrosis are known complications of bioglue use.Adequate precautions and warnings are provided in the instructions for use.Root cause for this event is unknown.No further action required.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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