Treatment of Cardiogenic Shock in Severe Aortic Stenosis With the Edwards INTUITY Valve

Martinelli, Gian Luca; Braccio, Maurizio; Cotroneo, Attilio; Labriola, Cataldo; Cassese, Mauro

doi:10.1016/j.athoracsur.2014.07.084

Cited by 4 publications

(4 citation statements)

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“…Reports on the safety, efficacy and immediate complications in a real-world setting are key [3][4][5]. Recent reports communicate excellent outcomes in terms of durability, safety and hemodynamic performance.…”

Section: Introductionmentioning

confidence: 99%

Risk Factors for Postoperative Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement: Results from the RADAR Registry

et al. 2021

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Introduction: Rapid deployment aortic valve replacement has been recently introduced in clinical practice. Different studies have reported a significant reduction in surgical times with excellent hemodynamic profiles and short-term results. However, an increase in permanent pacemaker requirements compared with conventional aortic valve replacement has been described. Nevertheless, risk factors for postoperative pacemaker implantation are not well known. The aim of this study is to report our early outcomes with rapid deployment aortic valve replacement within the RADAR Registry, especially focusing on risk factors for postoperative pacemaker implantation. Methods: Between April 2012 and January 2016, 164 patients undergoing isolated or combined aortic valve replacement with Edwards INTUITY Elite (Edwards Lifesciences, Irvine, CA, USA) were included in the RADAR Registry. Pre-, intra-and postoperative clinical data results and complications were recorded, especially focusing on risk factors for the development of postoperative complete or high-grade AV block requiring pacemaker implantation. Patients were followed up for up

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Section: Introductionmentioning

confidence: 99%

Risk Factors for Postoperative Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement: Results from the RADAR Registry

et al. 2021

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“…As for AVR, three cases been reported of successful surgical aortic valve replacement in patients presenting in cardiogenic shock with severe AS, all alive after six months [16].…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, with the introduction of transcatheter aortic valve implantation (TAVI) in 2002, which conferred long-lasting results comparable to those of surgical replacement of the aortic valve, in low to high surgical risk individuals, BAV feels out of use [12-14]. However, TAVI requires a larger sheath size than that for BAV, takes longer, and requires accurate imaging for successful implantation, features that may preclude its use in emergent settings [15-16]. Its associated costs should also be considered.…”

Section: Introductionmentioning

confidence: 99%

Balloon Aortic Valvuloplasty in Patients Admitted for Cardiogenic Shock with Severe Aortic Stenosis: A Retrospective Analysis of 14 Cases

Varela

Teixeira

Ponte

et al. 2019

Cureus

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IntroductionBalloon aortic valvuloplasty (BAV), introduced in 1986, quickly lost its wide adoption due to the high incidence of restenosis after the procedure and due to improved skills in transcatheter aortic valve implantation (TAVI). It has seen a re-emergence in the last few years as bailout therapy in critical care patients presenting with cardiogenic shock (CS) and severe aortic stenosis (AS), who are temporarily unable to tolerate such a procedure as TAVI or surgery for valve replacement.MethodsWe did a retrospective analysis of every BAV performed between January 1, 2008, and November 11, 2018, in our hospital and identified those admitted to the cardiac intensive care unit (CICU) due to cardiogenic shock with severe aortic stenosis, as defined in the European Society of Cardiology Guidelines. Procedures were categorized as emergent (within 24h after the decision to intervene) and urgent (24h after the decision was made but before discharge).ResultsDuring this period, of 98 BAV performed, 14 were performed on patients with CS with severe AS, nine of them being emergent. The patients’ mean age was 76.2±7.2 years, with 6 (43%) of them being female.On the day of BAV, the mean Euroscore II and sequential organ failure (SOFA) were, respectively, 19±7% and 8.0±2.4 in emergent cases and 11±5% and 4.8±2.9 in urgent cases. In patients deemed emergent, there was a tendency for a decrease in SOFA in the days following the procedure, although not statistically significant (p>0.05). Clinically significant aortic regurgitation did not occur in any patient, neither were there any major post-procedure complications. Thirty-day mortality was 33% in emergent cases and 0% in urgent cases.In emergent cases, four were later submitted to TAVI and one had surgery for aortic valve replacement surgery. Only one patient in the urgent group was regarded as a candidate for TAVI.Discussion and conclusionEmergent cases presented with higher scores of severity and procedure risk and had greater mortality. In this group, a greater proportion of survivors was later deemed fit for definite procedures. This highlights that presenting status does not seem to influence the prognosis of those extremely high-risk patients once the acute event is promptly treated. Nevertheless, the low sample size precludes generalization of the findings.BAV as bailout treatment may be safe in patients presenting with CS and severe AS, allowing patient survival for elective definitive treatment.

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“…Some other studies have initially reported on RDV regarding: potential benefits of this technology in patients with a small aortic annulus;27 technical issues when severe calcification of the sinotubular junction is present28 and application to patients having surgery under emergency cardiogenic shock 29. However, those and other pending issues may be answered by prospective registries.…”

Section: Discussionmentioning

confidence: 99%

Rapid Deployment Aortic Replacement (RADAR) Registry in Spain: a protocol

et al. 2017

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IntroductionRapid deployment valves (RDV) represent a newly introduced approach to aortic valve replacement which facilitates surgical implantation and minimally invasive techniques, shortens surgical times and shows excellent haemodynamic performance. However, evidence on their safety, efficacy and potential complications is mostly fitted with small-volume and retrospective studies. Moreover, no current guidelines exist. To improve our knowledge on this technology, The Rapid Deployment Aortic Replacement (RADAR) Registry will be established across Spain with the aim of assessing RDV outcomes in the real-world setting.Methods and analysisThe RADAR Registry is designed as a product registry that would provide information on its use and outcomes in clinical practice. This multicentre, prospective, national effort will initially involve 4 centres in Spain. Any patient undergoing cardiac surgery for aortic valve replacement and receiving an RDV as an isolated operation or in combination with other cardiac procedures may be included. Participation is voluntary. Data collection is equal to information obtained during standard care and is prospectively entered by the participating physicians perioperatively and during subsequent follow-up visits. The primary outcome assessed is in-hospital and up to 5 years of follow-up, prosthetic valve functioning and clinical status. Secondary outcomes are to perform subgroup analysis, to compare outcomes with other existing approaches and to develop future clinical guidelines. The follow-up assessments are timed with routine clinical appointments. Dissociated data will be extracted and collectively analysed. Initial target sample size for the registry is 500 participants entered with complete follow-up information. Different substudies will be implemented within the registry to investigate specific populations undergoing aortic valve replacement.Ethics and disseminationThe protocol is approved by all local institutional ethics committees. Findings will be shared by the participant hospitals, policymakers and the academic community to promote quality monitoring and efficient use of this technology.

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Treatment of Cardiogenic Shock in Severe Aortic Stenosis With the Edwards INTUITY Valve

Cited by 4 publications

References 8 publications

Risk Factors for Postoperative Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement: Results from the RADAR Registry

Risk Factors for Postoperative Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement: Results from the RADAR Registry

Balloon Aortic Valvuloplasty in Patients Admitted for Cardiogenic Shock with Severe Aortic Stenosis: A Retrospective Analysis of 14 Cases

Rapid Deployment Aortic Replacement (RADAR) Registry in Spain: a protocol

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