The Effect of the Suspension of the License for Aprotinin on the Care of Patients Undergoing Cardiac Surgery: A Survey of Cardiac Anesthesiologists' and Surgeons' Opinions in the United Kingdom

McMullan, Victoria; Alston, R. Peter

doi:10.1053/j.jvca.2009.10.028

Cited by 17 publications

(12 citation statements)

References 4 publications

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“…They feel that much harm is being done by not being able to use aprotinin. [60,61] Several databases, both clinical and administrative revealed extremely divergent results. Even as some [62][63][64] found poor outcome with aprotinin, others [65][66][67][68] did not find any adverse effects of aprotinin.…”

Section: Post Aprotinin Dilemmamentioning

confidence: 99%

Antifibrinolytics in cardiac surgery

Dhir

2013

Ann Card Anaesth

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Cardiac surgery exerts a significant strain on the blood bank services and is a model example in which a multi-modal blood-conservation strategy is recommended. Significant bleeding during cardiac surgery, enough to cause re-exploration and/or blood transfusion, increases morbidity and mortality. Hyper-fibrinolysis is one of the important contributors to increased bleeding. This knowledge has led to the use of anti-fibrinolytic agents especially in procedures performed under cardiopulmonary bypass. Nothing has been more controversial in recent times than the aprotinin controversy. Since the withdrawal of aprotinin from the world market, the choice of antifibrinolytic agents has been limited to lysine analogues either tranexamic acid (TA) or epsilon amino caproic acid (EACA). While proponents of aprotinin still argue against its non-availability. Health Canada has approved its use, albeit under very strict regulations. Antifibrinolytic agents are not without side effects and act like double-edged swords, the stronger the anti-fibrinolytic activity, the more serious the side effects. Aprotinin is the strongest in reducing blood loss, blood transfusion, and possibly, return to the operating room after cardiac surgery. EACA is the least effective, while TA is somewhere in between. Additionally, aprotinin has been implicated in increased mortality and maximum side effects. TA has been shown to increase seizure activity, whereas, EACA seems to have the least side effects. Apparently, these agents do not differentiate between pathological and physiological fibrinolysis and prevent all forms of fibrinolysis leading to possible thrombotic side effects. It would seem prudent to select the right agent knowing its risk-benefit profile for a given patient, under the given circumstances.

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Section: Post Aprotinin Dilemmamentioning

confidence: 99%

Antifibrinolytics in cardiac surgery

Dhir

2013

Ann Card Anaesth

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“…In Italy, where aprotinin has not been commercially available since 1998, Ranucci et al reported PRBC, FFP, and platelet transfusion rates of 40.4, 12.9, and 2.6 %, respectively [14], which are comparable to transfusion rates during the aprotinin utilization era. In a survey of cardiac anesthesiologists and surgeons from Great Britain, the question of aprotinin withdrawal was raised and their opinions were sought [15] felt it had no effect, 29 % believed it had a detrimental effect, and 2 % felt the effect was extremely detrimental. Two thirds felt there was no change in the utilization of blood, while one third felt there was increased utilization [15].…”

Section: Discussionmentioning

confidence: 99%

“…In a survey of cardiac anesthesiologists and surgeons from Great Britain, the question of aprotinin withdrawal was raised and their opinions were sought [15] felt it had no effect, 29 % believed it had a detrimental effect, and 2 % felt the effect was extremely detrimental. Two thirds felt there was no change in the utilization of blood, while one third felt there was increased utilization [15]. As stated by B. D. Spiess, MD, FAHA, BIt can only be concluded from all the papers together that the usage of transfusion and the usage of aprotinin are closely intertwined, meaning that the ability to separate them as true cause and effect by retrospective analysis is at best a statistical three-ringed circus^ [16].…”

Section: Discussionmentioning

confidence: 99%

Adult cardiac surgery blood/blood product utilization in the post aprotinin era: an 855 patient, community hospital, retrospective experience

Sharma

Al-Achi

Behrend

et al. 2016

Indian J Thorac Cardiovasc Surg

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Background and objectives Prior to 2008, when it was withdrawn, aprotinin use in cardiac surgery patients was associated with reduced bleeding and blood utilization, but studies linked its administration to increased patient mortality. We investigated (a) blood/blood product utilization between 2008 and 2013 at our community hospital heart center according to the type of surgery performed following the withdrawal of aprotinin and (b) clinical variables associated with increased patient blood utilization. Materials and methods Seven hundred nine patients were retrospectively investigated for blood/blood product utilization. Variables examined were patient age, body surface area (BSA), gender, preoperative creatinine level, hematocrit level, total cell saved blood (CSB) administered, cardiopulmonary bypass (CPB) time, type of surgical procedure performed, and preoperative clopidogrel usage. Variables (categorical and continuous) were placed into a forward stepwise regression model for the continuous outcome, packed red blood cell (PRBC) utilization. The stepwise function utilized a P value threshold of 0.25 for entering the model and 0.1 for leaving the model. Results For coronary artery bypass graft (CABG) surgery, use of PRBC was 29.26 % (0.75/1.44), of platelets was 14.18 % (0.24/0.72), of fresh frozen plasma (FFP) was 7.34 % (0.19/ 0.78), and of cryoprecipitate was 10.63 % (0.23/0.97) among our patient sample. [Data expressed as percent patient utilization, mean/S.D. in units transfused]. Increased age, smaller BSA, higher preoperative creatinine level, lower preoperative hematocrit level, longer CPB time, and increased CSB administration was associated with increased PRBC administration (P < 0.0001). Conclusion At our community heart surgery center, with a multidisciplinary blood conservation program in place, expected increase in blood/blood product utilization following aprotinin withdrawal was not experienced.

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“…Notably, not a single physician had remarked that the withdrawal of the drug had made their patients better. 39 In a large series from China comparing 1700 patients before the cessation and 2200 patients after the cessation of aprotinin availability, the use of blood products increased significantly. 40 For patients undergoing coronary artery bypass grafting, the same group showed no effect of aprotinin on mortality (P ¼ .45), long-term mortality (P ¼ .21), or major adverse cardiac/cerebrovascular events (P ¼ .82).…”

Section: Abbreviations and Acronymsmentioning

confidence: 99%

Aprotinin revisited

DeAnda

Spiess

2012

The Journal of Thoracic and Cardiovascular Surgery

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In 2008, we saw the withdrawal of aprotinin from the US markets after preliminary results from a large, randomized clinical trial in Canada. This drug, a potent antifibrinolytic, was used primarily in complex and/or redo cardiac surgery as an adjunct to decrease postoperative bleeding and complications. The Canadian study raised questions previously brought up in similar studies-does aprotinin increase the risk of mortality and renal failure after cardiac surgery? Recently, a re-review of the Canadian data noted flaws in the study, as well as in the interpretation of the results. The present review revisits the aprotinin controversy.

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The Effect of the Suspension of the License for Aprotinin on the Care of Patients Undergoing Cardiac Surgery: A Survey of Cardiac Anesthesiologists' and Surgeons' Opinions in the United Kingdom

Cited by 17 publications

References 4 publications

Antifibrinolytics in cardiac surgery

Antifibrinolytics in cardiac surgery

Adult cardiac surgery blood/blood product utilization in the post aprotinin era: an 855 patient, community hospital, retrospective experience

Aprotinin revisited

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