Comparison of transcatheter versus surgical aortic valve implantation in high-risk patients: A nationwide study in France

Armoiry, Xavier; Obadia, Jean‐François; Pascal, Léa; Polazzi, Stéphanie; Duclos, Antoine

doi:10.1016/j.jtcvs.2018.02.092

Cited by 33 publications

(18 citation statements)

References 32 publications

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“…Thus, the results observed here may not be reproducible within the scope of a randomized controlled trial (RCT). More broadly, observational studies and RCT can generate heterogenous or even conflicting results [35]. Given this limitation, our findings should be viewed cautiously and call for future clinical research using a more robust design.…”

Section: Limitationsmentioning

confidence: 91%

Can levosimendan reduce ECMO weaning failure in cardiogenic shock?: a cohort study with propensity score analysis

et al. 2020

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Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been increasingly used over the last decade in patients with refractory cardiogenic shock. ECMO weaning can, however, be challenging and lead to circulatory failure and death. Recent data suggest a potential benefit of levosimendan for ECMO weaning. We sought to further investigate whether the use of levosimendan could decrease the rate of ECMO weaning failure in adult patients with refractory cardiogenic shock. Methods: We performed an observational single-center cohort study. All patients undergoing VA-ECMO from January 2012 to December 2018 were eligible and divided into two groups: group levosimendan and group control (without levosimendan). The primary endpoint was VA-ECMO weaning failure defined as death during VA-ECMO treatment or within 24 h after VA-ECMO removal. Secondary outcomes were mortality at day 28 and at 6 months. The two groups were compared after propensity score matching. P < 0.05 was considered statistically significant. Results: Two hundred patients were analyzed (levosimendan group: n = 53 and control group: n = 147). No significant difference was found between groups on baseline characteristics except for ECMO duration, which was longer in the levosimendan group (10.6 ± 4.8 vs. 6.5 ± 4.7 days, p < 0.001). Levosimendan administration started 6.6 ± 5.4 days on average following ECMO implantation. After matching of 48 levosimendan patients to 78 control patients, the duration of ECMO was similar in both groups. The rate of weaning failure was 29.1% and 35.4% in levosimendan and control groups, respectively (OR: 0.69, 95%CI: 0.25-1.88). No significant difference was found between groups for all secondary outcomes. Conclusion: Levosimendan did not improve the rate of successful VA-ECMO weaning in patients with refractory cardiogenic shock. Trial registration: ClinicalTrials.gov, NCT04323709.

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Section: Limitationsmentioning

confidence: 91%

Can levosimendan reduce ECMO weaning failure in cardiogenic shock?: a cohort study with propensity score analysis

et al. 2020

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“…While durability of tissue valves may be one explanation for this possible difference at 5 years, one summary of the available information 41 and one outcome study of the NOTION trial illustrated that signs for structural valve deterioration were even lower in the TAVI population, although the rates of valve failure were low and the same in both groups. 42 Thus, the differences in mortality observed in several studies 39,40,43,44 may not be explained by differences in midterm durability.…”

Section: The Role Of Medical Therapy In Cabg Patientsmentioning

confidence: 94%

Cardiac Surgery 2019 Reviewed

Doenst

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Kirov

et al. 2020

Thorac Cardiovasc Surg

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For the year 2019, almost 25,000 published references can be found in PubMed when entering the search term “cardiac surgery.” We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses approach for article selection and reviewed the main fields of adult cardiac surgery (i.e., coronary, valve, aortic, and heart failure surgery). The past decade has experienced an enormous development of interventional techniques that compete more and more with classic surgery. This contest was broadly visible in 2019. It peaked over the interpretation of the EXCEL trial data, where percutaneous coronary intervention and coronary artery bypass grafting (CABG) for left main disease were compared. A novel pathomechanism for CABG was proposed, potentially answering open questions in the field. In aortic valve surgery, two low-risk trials comparing transcatheter aortic valve implantation (TAVI) to classic aortic valve replacement (surgical aortic valve replacement) received attention for showing equal or superior short-term outcomes for TAVI. Longer follow-up information from recent trials became available presenting results emphasizing the need for joint decision making. While publications addressing surgery on the aorta and the mitral and tricuspid valves were less abundant, there was substantial activity regarding left ventricular assist device support and heart transplantation. This article attempts to summarize the most pertinent publications. It does not expect to be complete and cannot be free of individual interpretation. We aimed to provide a condensed summary of 2019s publications with a stimulus for in-depth reading and a basis supporting patient information.

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“…In high‐risk surgical patients, the clinical benefit of TAVI over SAVR is less clear. In fact, several studies describe an increase in long‐term mortality with TAVI, as well as an increase in long‐term complications such as stroke, MI, and requirement of pacemaker implantation . Although it is argued that TAVI may be a reasonable alternative treatment to SAVR in some high‐risk patients, especially those with advanced age, severe COPD, and ascending aortic calcification the lack of studies showing a statistically significant difference in complication rates and survival outcomes demonstrates that caution should be taken before expanding the indications of TAVI to noninoperable patients, especially younger patients given the unknown durability of TAVI…”

Section: Savr In Patients With Aortic Stenosis?mentioning

confidence: 99%

TAVI and the future of aortic valve replacement

et al. 2019

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Aortic valve stenosis (AS) is the most common valvular pathology and has traditionally been managed using surgical aortic valve replacement (SAVR). A large proportion of affected patient demographics, however, are unfit to undergo major surgery given underlying comorbidities. Since its introduction in 2002, transcatheter aortic valve implantation (TAVI) has gained popularity and transformed the care available to different-risk group patients with severe symptomatic AS. Specific qualifying criteria and refinement of TAVI techniques are fundamental in determining successful outcomes for intervention. Given the successful applicability in high-risk patients, TAVI has been further developed and trialed in intermediate and low-risk patients. Within intermediate-risk patient groups, TAVI was shown to be noninferior to SAVR evaluating 30-d mortality and secondary endpoints such as the risk of bleeding, development of acute kidney injury, and length of admission. The feasibility of expanding TAVI procedures into low-risk patients is still a controversial topic in the literature. A number of trials have recently been published which demonstrate TAVI as noninferior and even superior over SAVR for primary study endpoints. K E Y W O R D S aortic valve, surgery, TAVI, valve replacement 1 | INTRODUCTION Aortic valve stenosis (AS) is the most common valvular pathology, with between 2% and 4% of patients over the age of 75 years bring affected. 1 For decades, surgical aortic valve replacement (SAVR) has been considered the class I recommendation in the management of AS. 2 However, given that advanced age, frailty, and significant comorbidities are increasingly prevalent in affected patients; more than one-third of high-risk and severe symptomatic AS patients were not considered physiologically fit enough for major surgical intervention. 2,3 This merited the development of TAVI, an intervention suitable for high-risk patients and those deemed unfit for surgery. With a shift in clinical paradigm toward minimally invasive procedures, the development of TAVI has revolutionized clinical outcomes in AS, particularly in those once considered inoperable. 4 The decision to use TAVI vs SAVR for aortic valve replacement (AVR) is determined by clinical, anatomical, and technical considerations. Since its introduction in 2002, 5 TAVI has increasingly replaced SAVR, the once considered gold standard treatment, in aortic valve diseases. 6-10 More recently, trials such as the Placement of Aortic Trans-Catheter Valve II (PARTNER II) and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) 11,12 have further established the use of TAVI in intermediate-risk patients as well. Given this validation of TAVI within high-and intermediate-risk patients, a need has now developed to evaluate the clinical efficacy of TAVI within low-risk surgical candidates. 13Selective candidate criteria, as well as advances in operative techniques within TAVI, are mainstay contributors to successful outcomes. Fundamentally, there exist both retrogr...

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Comparison of transcatheter versus surgical aortic valve implantation in high-risk patients: A nationwide study in France

Abstract: In our study, high-risk patients harbored a greater risk of mortality and morbidity at 5 years after TAVI compared with those who underwent SAVR and higher hospitalizations costs. Those results should encourage caution before expanding the indications of TAVI.

Cited by 33 publications

References 32 publications

Can levosimendan reduce ECMO weaning failure in cardiogenic shock?: a cohort study with propensity score analysis

Can levosimendan reduce ECMO weaning failure in cardiogenic shock?: a cohort study with propensity score analysis

Cardiac Surgery 2019 Reviewed

TAVI and the future of aortic valve replacement

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