Evaluation of the safety and feasibility of resuscitative endovascular balloon occlusion of the aorta

Saito, Nobuyuki; Matsumoto, Hisashi; Yagi, Takanori; Hara, Yoshiaki; Hayashida, Kazuyuki; Motomura, Tomokazu; Mashiko, Kunihiro; Iida, Hiroaki; Yokota, Hiroyuki; Wagatsuma, Yukiko

doi:10.1097/ta.0000000000000614

Cited by 209 publications

(187 citation statements)

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“…The main predictors of mortality in REBOA are the severity of injury and the duration of occlusion (16,20,31,34), which are not independent of each other. Patients in poor conditions are likely to present higher resuscitation requirements, being occluded earlier.…”

Section: Outcomes Features and Keys For Successmentioning

confidence: 98%

“…Survival rates of trauma patients undergoing REBOA from available studies (USA, Japan and Europe) range from 13% to 67% (14)(15)(16)18,20,27,(29)(30)(31)(32)(33)(34). Unfortunately, there are huge discrepancies in methodology, inclusion criteria and interventions.…”

Section: Outcomes Features and Keys For Successmentioning

confidence: 99%

“…There is good evidence from animal models that prolonged aortic occlusion of greater than 60 minutes will have a substantial systemic effect on cord perfusion and a poor outcome (17,21,23,25) Further work is, however, required to translate these finding into the clinical setting, but it appears that 40 minutes maybe an appropriate cut off time Systemic complications have been reported and include multisystem organ failure, acute kidney injury and ARDS (15,31). However, it is impossible to assess the contribution of REBOA and or trauma to the development of these complications.…”

Section: Outcomes Features and Keys For Successmentioning

confidence: 99%

“…However, it is impossible to assess the contribution of REBOA and or trauma to the development of these complications. REBOA is directly associated with femoral artery injury (with or without ischemia and amputation), embolism, device malposition (catheter exiting through an aortic lesion or placed in a non-desired position) and cord lesion; these globally ranging from 2% to 13% (15,30,31).…”

Section: Outcomes Features and Keys For Successmentioning

confidence: 99%

“…Morphometric studies have proven the association of external corporal measurements, and other parameters, with the depth of insertion needed to deploy the balloon at the target site (32,33) This supports the feasibility of an accurate deploy of the balloon by the only means of physical exam. Most studies do not to use any imaging (16,18,20,31,34) and as such does not require either a vascular surgeon or interventional radiologist.…”

Section: Outcomes Features and Keys For Successmentioning

confidence: 99%

See 4 more Smart Citations

Resuscitative endovascular balloon occlusion of the aorta (REBOA): What have we learned?

Andrés

Scott²,

Giannoudis

2016

Injury

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Section: Outcomes Features and Keys For Successmentioning

confidence: 98%

Section: Outcomes Features and Keys For Successmentioning

confidence: 99%

Section: Outcomes Features and Keys For Successmentioning

confidence: 99%

Section: Outcomes Features and Keys For Successmentioning

confidence: 99%

Section: Outcomes Features and Keys For Successmentioning

confidence: 99%

See 3 more Smart Citations

Resuscitative endovascular balloon occlusion of the aorta (REBOA): What have we learned?

Andrés

Scott²,

Giannoudis

2016

Injury

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Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage

Jansen,

Hudson,

Cochran

et al. 2023

JAMA

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ImportanceBleeding is the most common cause of preventable death after trauma.ObjectiveTo determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage.Design, Setting, and ParticipantsPragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days.InterventionPatients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44).Main Outcomes and MeasuresThe primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death.ResultsOf the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR &gt;1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours.Conclusions and RelevanceIn trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone.Trial Registrationisrctn.org Identifier: ISRCTN16184981

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Resuscitative Endovascular Balloon Occlusion of the Aorta in Patients With Exsanguinating Hemorrhage

Tingerides,

Walker

2024

JAMA

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patent to estimate the maximum added exclusivity the REMS patents could provide.For each drug, we identified the number of REMS patents the generic manufacturers challenged and the outcome of the challenges. Analyses were performed using Excel, version 16 (Microsoft).Results | Of 24 novel small-molecule drugs covered by active, non-class-wide REMS, 5 (21%) had Orange Book-listed REMS patents: alvimopan (Entereg), lenalidomide (Revlimid), pomalidomide (Pomalyst), sodium oxybate (Xyrem), and thalidomide (Thalomid). There was a median of 10 (range, 2-14) REMS patents per drug, comprising a median of 33% (range, 32%-70%) of all patents per drug, which was higher than the median number of active ingredient (1 [range, 0-2]; 5% [range, 0%-17%]), formulation (3 [range, 1-6]; 17% [range, 5%-30%]), or method-of-use (5 [range, 2-15]; 33% [range, 20%-50%]) patents per drug (Table ).Generic entry had occurred for 2 drugs by 2022. For lenalidomide, the date of first generic marketing was 16 months after expiration of the last-expiring REMS patent and 28 months after expiration of the closest expired non-REMS patent. For alvimopan, the date of first generic marketing was more than 9 years before expiration of the last-expiring REMS patent and 3 days after expiration of the first method-of-use patent (Figure). Among drugs with no generic entry, only pomalidomide had an active ingredient patent, which expired 12 months before the last expiring REMS patent. Generic manufacturers challenged 10 lenalidomide, 10 pomalidomide, 7 sodium oxybate, and 14 thalidomide REMS patents, leading to invalidation of 6 sodium oxybate REMS patents and 2 REMS patents each for lenalidomide, pomalidomide, and thalidomide. Discussion | REMS patenting was observed for one-fifth of REMScovered small-molecule drugs and constituted one-third to three-fourths of their patent portfolios. Generic entry occurred after expiration of the last expiring REMS patent for lenalidomide but a decade beforehand for alvimopan. REMS patents for alvimopan were not subject to challenges, while most REMS patents for lenalidomide, pomalidomide, sodium oxybate, and thalidomide were, with a few invalidations. Thus, the association of REMS patents with delaying generic entry has been variable.Study limitations included not being able to evaluate biologics since they do not have the same system of listing their patents with the FDA. 5 REMS can also complicate generic entry in other ways, such as when negotiations are needed to set up shared REMS between brand-name and generic manufacturers. 6 Since some REMS patents may contribute to delays in generic marketing for emerging REMS-covered drugs, to the detriment of patients and the health care system, Congress should consider shielding generic manufacturers from REMS patent infringement claims.

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Evaluation of the safety and feasibility of resuscitative endovascular balloon occlusion of the aorta

Abstract: Therapeutic/care management, level V.

Cited by 209 publications

References 0 publications

Resuscitative endovascular balloon occlusion of the aorta (REBOA): What have we learned?

Resuscitative endovascular balloon occlusion of the aorta (REBOA): What have we learned?

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage

Resuscitative Endovascular Balloon Occlusion of the Aorta in Patients With Exsanguinating Hemorrhage

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