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      Management of elective aortic valve replacement over the long term in the era of COVID-19

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          Abstract

          As numerous patients await elective aortic valve intervention for aortic stenosis (AS) during this unprecedented outbreak of severe acute respiratory syndrome coronavirus 2 in 2019 (COVID-19), there is serious concern for the possibility of morbidity and mortality during prolonged wait-times. During this time period, the American College of Surgeons and Center for Disease Control released their recommendation to reschedule elective surgeries and to shift elective inpatient diagnostic and surgical procedures to the outpatient setting [1]. Accordingly, the Centers for Medicare & Medicaid Services provided a framework to further group elective surgeries into levels of urgency [2]. A tiered framework ensures that we are providing surgical services and procedures to those patients in whom the risk of delaying a procedure may lead to significant morbidity or mortality. As cardiovascular healthcare providers caring for patients with AS, we must now differentiate cases at a higher tier of urgency from the rest. Current guidelines suggest treatment of severe AS when symptomatic (angina, heart failure and/or syncope), and there is now growing data to support intervention even before symptom onset [3]. Though most hospitals are equipped for urgent/emergency cases, the majority of aortic interventions are done on an elective basis, and therefore have been postponed due to the COVID-19 outbreak. However, there is a significant relationship between aortic valve replacement (AVR) wait-time and mortality as well as hospital readmission [4, 5]. Delaying AVR has been associated with poor operative outcomes and risk of mortality during the waiting period [6, 7]. Additionally, hospitalizations during wait-time and urgent/emergency AVR have been associated with worse short- and long-term outcomes [8]. It is, therefore, essential that our established multi-disciplinary heart team carefully reviews each patient individually, and determines who would likely benefit from an ‘early elective’ strategy. Timing of intervention when balanced with healthcare resources has not been a major focus among our academic community until now. We are compelled to generate algorithms to help balance the risk of a procedure during this critical time versus the risk of waiting for a therapy, both having potentially life-altering consequences to patient and family. Symptom severity is generally the largest driver for an earlier AVR strategy. Patients with New York Heart Association (NYHA) IV symptoms and/or syncope clearly portend a worse prognosis than less symptomatic patients [9]. These patients should, therefore, be treated in a timely manner. The presence of angina is always concerning, although the natural history of patients with severe AS suggests that angina is not as ominous a sign as syncope. Yet, since the prevalence of concomitant coronary artery disease is as much as 50%, earlier strategies in patients with severe or unstable angina should be strongly considered [10]. There is a paucity of literature addressing clinical risks (i.e. non-invasive data, comorbidities and demographics) that are associated with higher clinical events during wait-time. Factoring in the severity of AS into our equation is important, as we know that patients who meet these criteria are at higher risk. Asymptomatic patients with indexed aortic valve area <0.4 cm2 have a higher risk of events prior to intervention, and a peak jet velocity >5 m/s is an independent predictor of mortality [11, 12]. Another important echocardiographic finding is impaired ejection fraction (EF). Patients managed conservatively with an impaired EF (EF < 60%) have been independently associated with poorer long-term outcomes, whilst an earlier AVR strategy has improved outcomes [13]. In these patients with less cardiac reserve, it is imperative to negate the effects of AS before an event. Furthermore, the decision for type of intervention may also have significant impact. Transcatheter AVR (TAVR) indications have been expanded to include patients who are at low risk for surgical AVR complications. Strategies involving shared-decision-making with patients have been applied, particularly to patients <70 years old, remembering that the average age in the low-risk trials was 73 ± 6 years old. From these trials, TAVR did result in a shorter index hospitalization compared to surgical AVR (3 vs 7 days) [14]. Understanding the dynamic constraints on healthcare systems, minimalist TAVR can potentially help to further reduce post-care utilization of resources and allow early patient recover at home [13]. Balloon aortic valvuloplasty as a bridge to TAVR has also shown an improved safety profile in the contemporary era of TAVR [15]. Its role as a bridge for patients with anatomical challenges for TAVR, whether non-transfemoral or requiring adjunctive techniques (such as coronary protection with snorkel stenting or leaflet laceration, etc.) may be more important now than ever. As the treatment for aortic intervention continues to improve both from surgical techniques to transcatheter technology, we need more focus on the timing and application of our interventions. For now, symptoms and echocardiographic criteria can drive how we deliver therapy (Fig. 1), but we also need to factor in other clinical information. Many questions remain; should baseline comorbidities such as chronic lung disease, renal impairment and Society of Thoracic Surgery PROM score push us to act more quickly, whereas other factors (i.e. immunocompromised patients) push us to delay? Do NYHA IIIb symptoms herald worse outcomes during waiting than NYHA IIIa? Should patients with NYHA III symptoms receive an ‘early elective’ strategy versus a patient with NYHA II symptoms? Do we need to factor in other non-invasive data such as degree of left ventricular hypertrophy, and biomarkers (including elevated natriuretic peptide) which may portend a higher rate of events during wait time? [16] Should discussions with the multi-disciplinary team increase considerations for utilizing TAVR in the very low-risk AS patient and balloon aortic valvuloplasty as a bridge to TAVR in efforts to decrease length of stay, hospital resource utilization and patient/family exposure COVID-19? Further investigation is clearly needed, and we must work on developing a risk stratification system for suggested wait-times. Until then, we must balance the risk of delaying therapy against the availability of hospital resources and potential exposure of COVID-19 on a case-by-case basis. Figure 1: Algorithm for managing elective AVR over the long term in the era of COVID-19. *Aortic valve area indexed <0.4, peak jet velocity >5 m/s. AVR: aortic valve replacement (transcatheter or surgical); EF: ejection fraction; NYHA: New York Heart Association; SAVR: surgical aortic valve replacement; TAVR: transcatheter aortic valve replacement. Conflict of interest: Dr Chad A. Kliger is a consultant and receives speaking honoraria from Edwards Lifescience and Medtronic. All other authors declare no conflict of interest.

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          Most cited references 11

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          Temporal Trends and Clinical Consequences of Wait-Times for Trans-Catheter Aortic Valve Replacement: A Population Based Study.

          Background -Trans-catheter aortic valve replacement (TAVR) represents a paradigm shift in the therapeutic options for patients with severe aortic stenosis. However, rapid and exponential growth in TAVR demand may overwhelm capacity, translating to inadequate access and prolonged wait-times. Our objective was to evaluate temporal trends in TAVR wait-times and the associated clinical consequences. Methods -In this population-based study in Ontario, Canada, we identified all TAVR referrals from April 1st, 2010 to March 31st, 2016. The primary outcome was the median total wait-time from referral to procedure. Piecewise regression analyses were performed to assess temporal trends in TAVR wait-times, before and after provincial reimbursement in September 2012. Clinical outcomes included all-cause death and heart failure hospitalizations while on the wait-list. Results -The study cohort included 4,461 referrals, of which 50% led to a TAVR, 39% were off-listed for other reasons and 11% remained on the wait-list at the conclusion of the study. For patients who underwent a TAVR, the estimated median wait-time in the post-reimbursement period stabilized at 80 days and has remained unchanged. The cumulative probability of wait-list mortality and heart failure hospitalization at 80 days was approximately 2% and 12% respectively, with a relatively constant increase in events with increased wait-times. Conclusions -Post-reimbursement wait-time has remained unchanged for patients undergoing a TAVR procedure, suggesting the increase in capacity has kept pace with the increase in demand. The current wait-time of almost 3 months is associated with important morbidity and mortality, suggesting a need for greater capacity and access.
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            Prognostic Impact of Left Ventricular Ejection Fraction in Patients With Severe Aortic Stenosis

            The aim of this study was to evaluate the prognostic impact of left ventricular ejection fraction (LVEF) in patients with severe aortic stenosis (AS).
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              Coronary Artery Disease and Transcatheter Aortic Valve Replacement

              About one-half of transcatheter aortic valve replacement (TAVR) candidates have coronary artery disease (CAD), and controversial results have been reported regarding the effect of the presence and severity of CAD on clinical outcomes post-TAVR. In addition to coronary angiography, promising data has been recently reported on both the use of computed tomography angiography and the functional invasive assessment of coronary lesions in the work-up pre-TAVR. While waiting for the results of ongoing randomized trials, percutaneous revascularization of significant coronary lesions has been the routine strategy in TAVR candidates with CAD. Also, scarce data exists on the incidence, characteristics, and management of coronary events post-TAVR, and increasing interest exist on potential coronary access challenges in patients requiring coronary angiography/intervention post-TAVR. This review provides an updated overview of the current landscape of CAD in TAVR recipients, focusing on its prevalence, clinical impact, pre- and post-procedural evaluation and management, unresolved issues and future perspectives.
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                Author and article information

                Journal
                Eur J Cardiothorac Surg
                Eur J Cardiothorac Surg
                ejcts
                European Journal of Cardio-Thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery
                Oxford University Press
                1010-7940
                1873-734X
                17 April 2020
                17 April 2020
                Affiliations
                Department of Cardiothoracic Surgery, Lenox Hill Hospital Heart & Lung, Northwell Health System , New York, NY, USA
                Author notes
                Corresponding author. Department of Cardiovascular and Thoracic Surgery, Lenox Hill Hospital/Northwell Health, 130 East 77th Street, 4th Floor, New York, NY 10075, USA. Tel: +1-212-4343000; fax: +1-212-4344559; e-mail: cbasman@ 123456northwell.edu (C. Basman).
                Article
                ezaa152
                10.1093/ejcts/ezaa152
                7184510
                32301976
                © The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

                This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model ( https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

                This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

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