Comparison Between Perfadex and Locally Manufactured Low-Potassium Dextran Solution for Pulmonary Preservation in an Ex Vivo Isolated Lung Perfusion Model

Soares, Paula Roberta Otaviano; Braga, Karina Andrighetti de Oliveira; Nepomuceno, Natalia Aparecida; Pazetti, Rogério; Correia, Aristides Tadeu; Cardoso, Paulo Francisco Guerreiro; BiscegliJatene, Fábio; Pêgo-Fernandes, Paulo Manuel

doi:10.1016/j.transproceed.2010.12.005

Cited by 13 publications

(17 citation statements)

References 24 publications

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“…Researchers have investigated whether the quality of nonacceptable lungs can be adequately improved during EVLP before LTx by direct pharmacologic intervention with the graft via an endotracheal or intravascular route. 10 Our group has conducted several studies of lung preservation using a rat model of ex vivo lung perfusion, 11,12 and about 2 years ago, we initiated a study with ex vivo evaluation and reconditioning of human lungs. 13 In our study, lungs from 13 donors (81.2%) were refused due to poor gas exchange.…”

Section: Discussionmentioning

confidence: 99%

Histologic and functional evaluation of lungs reconditioned by ex vivo lung perfusion

Medeiros¹,

Pêgo-Fernandes²,

Mariani³

et al. 2012

The Journal of Heart and Lung Transplantation

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Section: Discussionmentioning

confidence: 99%

Histologic and functional evaluation of lungs reconditioned by ex vivo lung perfusion

Medeiros¹,

Pêgo-Fernandes²,

Mariani³

et al. 2012

The Journal of Heart and Lung Transplantation

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“…The ex vivo lung perfusion system has the advantage of serving as a screening method for new lung preservation strategies and has an excellent cost-benefit ratio. (8,9,11) Another group of authors used the same system in order to test preservation solutions and administer PGI 2 parenterally. (10) The same authors recently demonstrated that the functional performance of transplanted lungs in pigs was better in the animals receiving PGI 2 by inhalation than in those receiving PGI 2 parenterally.…”

Section: Discussionmentioning

confidence: 99%

“…(27) Our choice of a 6-h ischemia period was based on a previous study, in which we demonstrated that this duration of ischemia results in a larger number of viable lungs during perfusion. (11) Our decision to use a dose of 10 µg/kg when administering PGI 2 parenterally was based on the dose used in another study (a mean of 10 µg every 3 min).…”

Section: Discussionmentioning

confidence: 99%

“…We corrected blood perfusate pH by adding sodium bicarbonate to the system (0.3 mEq • L −1 • dose −1 ) in order to maintain arterial pH within the 7.1-7.4 range. (11) After perfusion, the heart-lung block was removed, and the left lung was weighed and stored at 70°C for 72 h, after which it was weighed again in order to determine the wet/dry lung weight ratio.…”

Section: Methodsmentioning

confidence: 99%

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Modelo experimental de perfusão pulmonar ex vivo em ratos: avaliação de desempenho de pulmões submetidos à administração de prostaciclina inalada versus parenteral

et al. 2011

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Objective: To present a model of prostaglandin I 2 (PGI 2 ) administration (inhaled vs. parenteral) and to assess the functional performance of the lungs in an ex vivo lung perfusion system. Methods: Forty Wistar rats were anesthetized and placed on mechanical ventilation followed by median sterno-laparotomy and anticoagulation. The main pulmonary artery was cannulated. All animals were maintained on mechanical ventilation and were randomized into four groups (10 rats/group): inhaled saline (IS); parenteral saline (PS); inhaled PGI 2 (IPGI 2 ); and parenteral PGI 2 (PPGI 2 ). The dose of PGI 2 used in the IPGI 2 and PPGI 2 groups was 20 and 10 µg/kg, respectively. The heart-lung blocks were submitted to antegrade perfusion with a low potassium and dextran solution via the pulmonary artery, followed by en bloc extraction and storage at 4°C for 6 h. The heart-lung blocks were then ventilated and perfused in an ex vivo lung perfusion system for 50 min. Respiratory mechanics, hemodynamics, and gas exchange were assessed. Results: Mean pulmonary artery pressure following nebulization decreased in all groups (p < 0.001), with no significant differences among the groups. During the ex vivo perfusion, respiratory mechanics did not differ among the groups, although relative oxygenation capacity decreased significantly in the IS and PS groups (p = 0.04), whereas mean pulmonary artery pressure increased significantly in the IS group. Conclusions: The experimental model of inhaled PGI 2 administration during lung extraction is feasible and reliable. During reperfusion, hemodynamics and gas exchange trended toward better performance with the use of PGI 2 than that with the use of saline.Keywords: Prostaglandins; Lung transplantation; Reperfusion; Models, animal; Rats. ResumoObjetivo: Apresentar um modelo experimental de administração de prostaglandina I 2 (PGI 2 ) por via inalatória vs. parenteral e avaliar o desempenho funcional dos pulmões em um sistema de perfusão pulmonar ex vivo. Métodos: Quarenta ratos Wistar foram anestesiados, ventilados, submetidos a laparotomia com ressecção do esterno e anticoagulados. O tronco da artéria pulmonar foi canulado. Todos os animais foram submetidos a ventilação mecânica. Os animais foram randomizados em quatro grupos (10 ratos/grupo): salina nebulizada (SN); salina parenteral (SP); PGI 2 nebulizada (PGI 2 N); e PGI 2 parenteral (PGI 2 P). A dose de PGI 2 nos grupos PGI 2 N e PGI 2 P foi de 20 e 10 µg/kg, respectivamente. Os blocos cardiopulmonares foram submetidos in situ a perfusão anterógrada com solução de baixo potássio e dextrana a 4°C via artéria pulmonar, extraídos em bloco e armazenados a 4°C por 6 h. Os blocos foram ventilados e perfundidos em um sistema ex vivo por 50 min, sendo obtidas medidas de mecânica ventilatória, hemodinâmica e trocas gasosas. Resultados: Houve redução da pressão arterial pulmonar média após a nebulização em todos os grupos (p < 0,001), sem diferença entre os grupos. Na perfusão ex vivo, a mecânica ventilatória não diferiu entre os grupos. Hou...

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“…4 You follow the PICOT format, which serves as the starting point for identification of important key words used in the search process: 5 • Population: heart transplant patients • Intervention: heart transplantation with ex-vivo perfusion • Comparison: heart transplantation with cold storage • Outcome: patient survival and graft survival • Time horizon: 30 days after transplant You then conduct a literature search in PubMed Clinical Queries using the search terms "heart transplantation" AND "ex-vivo perfusion" AND "cold storage," using the "Therapy" and "Broad" filters. You identify 10 articles: 7 ex-vivo human/animal studies, [6][7][8][9][10][11][12] 1 nonrandomized clinical study, 13 1 review 14 and 1 RCT. 15 The RCT addresses your research question and has the benefit of being level-I evidence.…”

Section: Finding the Evidencementioning

confidence: 99%

Users’ guide to the surgical literature: how to assess a noninferiority trial

Thoma

Farrokhyar

Waltho

et al. 2017

CJS

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DISCUSSIONS IN SURGERY • DISCUSSIONS EN CHIRURGIEUsers' guide to the surgical literature: how to assess a noninferiority trial A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect).1,2 Let's consider a hypothetical RCT that compares laparoscopic to open appendectomy and the outcome meas ured is a pain score based on a Likert scale from 0 to 10. Suppose it was found that the mean pain score following laparoscopic appendectomy was 7 points and that following open appendectomy was 8 points, and that this 1-point difference was statistically significant. Such a result would be uncommon because it would require a large sample size, but let's accept this for now. Although statistically the result is significant, we do not consider this 1-point difference to have clinical relevance. This type of thinking addresses the concept of minimum clinically important difference (MCID), which describes a threshold that might persuade us to change our surgical practice. The meaningful MCID is usually based on the available best evidence derived from previous systematic reviews, pilot/feasibility studies or clinical judgment based on discussion with experts in the field.In another hypothetical RCT, the length of stay (LOS) after laparoscopic appendectomy was observed to be 24 hours versus 30 hours after open appendectomy, with a p < 0.05. It would be meaningless to conclude that the observed difference of 6 hours is the truth without reporting a confidence interval (CI), as a p value alone does not provide information on the degree of uncertainty (variation) applied in measuring the difference in hospital stay. Briefly, a CI provides information regarding the degree of uncertainty associated with the observed difference of 6 hours in hospital stay. It is within the CI that the true difference will likely lie. Let's say that in our hypothetical example the 95% CI for hospitalization time difference of 6 hours was 1-11 hours in favour of the laparoscopic approach. This means we are 95% confident that the true difference lies somewhere between 1 and 11 hours, A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect). A noninferiority RCT design seeks to determine whether a new intervention is not worse than a prevailing (standard) one within an acceptable margin of risk or benefit, referred to as the "noninferiority margin...

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Comparison Between Perfadex and Locally Manufactured Low-Potassium Dextran Solution for Pulmonary Preservation in an Ex Vivo Isolated Lung Perfusion Model

Cited by 13 publications

References 24 publications

Histologic and functional evaluation of lungs reconditioned by ex vivo lung perfusion

Histologic and functional evaluation of lungs reconditioned by ex vivo lung perfusion

Modelo experimental de perfusão pulmonar ex vivo em ratos: avaliação de desempenho de pulmões submetidos à administração de prostaciclina inalada versus parenteral

Users’ guide to the surgical literature: how to assess a noninferiority trial

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