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Impact of COVID-19 on TAVI and the management of patients with severe symptomatic aortic stenosis

Aortic stenosis and a backlog of care

COVID‐19 has had an unprecedented impact on the management of patients with aortic valve disease since non-urgent cardiovascular diagnostics and interventions were deferred.1–3 Delays in treatment are leading to a growing number of patients waiting for treatment with longer wait times.2,4 The consequences of such delays include death within the perioperative period and poor operative outcomes.1,4–7 It is estimated that as much as 50% of cancelled or delayed procedures may result in significant harm;6 therefore, delays in elective procedures to treat severe symptomatic aortic stenosis (ssAS) contribute to a hidden mortality rate of COVID-19.8 This is creating a wave of pressure on healthcare resources and personnel;4 reconsideration of these patients for transcatheter aortic valve implantation (TAVI) may help to prevent such complications as well as offering patient and organisational benefits1

Diverting ssAS patients to TAVI during COVID-19

COVID-19 has had a significant impact on therapeutic options for ssAS patients undergoing aortic valve replacement (AVR).3

During the pandemic, hospitals have initiated protocols that favour management options that minimise the use of (a) anaesthesiologists, (b) ventilators, (c) operating rooms, and (d) intensive care unit beds. While  surgical AVR (SAVR) require all these elements, TAVI does not1,6—using widely described ‘minimalist’ methodology.6,9–11 Guidelines for ssAS patients during the COVID-19 pandemic have, therefore, included the principle that patients who may have been accepted for sAVR could be ‘diverted’ to TAVI under the guidance of the Heart Team.1,2 SAVR has been the treatment choice in AS for decades, nevertheless, TAVI and especially TAVI with transfemoral access, has become a reliable and effective treatment option.1 This has formed a cornerstone of recommendations for TAVI practice during COVID-19.12

The adoption of a minimalist TAVI approach as the preferred default strategy is an imperative to promote access to care in the ‘new normal’ as COVID-19 continues to dictate the priorities of care.4 Perek et al. report that, from their hospital experience, in the years preceding the pandemic (2018 and 2019), approximately 50% of patients underwent SAVR; this rate dropped to 34% during COVID-19 (2020), demonstrating a shift in procedure from SAVR to minimally invasive TAVI.3 Alongside this shift, Joseph et al. report that there was a significant increase in the proportion of SAPIEN 3™ valves inserted (34 vs 68%, p = 0.001).12 During 2020, patients with AS were younger and had a lower calcification burden compared with pre-pandemic practice, making these patients more suitable for the SAPIEN 3™ valve, accounting for the increase in the use of the SAPIEN 3™ valve.12

Improved organisational and patient benefits of TAVI during COVID-19

COVID-19 cardiology guidelines were based on the accumulation of scientific evidence from clinical trials evidencing that minimally invasive TAVI is a safe and efficacious procedure with low complication rates, shorter length of hospital stay, reduced mortality and minimal stroke rate at 30 days, compared with SAVR.3,9–11 TAVI enables patients to rapidly derive significantly improved quantity and quality of life, regardless of surgical risk profile.2,4 From the patient’s standpoint, TAVI is preferable to SAVR, given shorter hospitalisation and consequent exposure of patients to COVID-19 in hospital and rehabilitation centers.8 This is also true from an organisational viewpoint, undoubtedly conserving resources relative to SAVR.8

Joseph et al. report that TAVI can be undertaken safely during the COVID-19 pandemic with 30-day event rates similar with published clinical trials and international registries.12 No statistically significant difference was noted in peri-procedural complications and 30-day outcomes, while post-operative length of stay was significantly reduced (2 vs 3 days, p < 0.0001) when compared with pre-COVID-19 practice.12

COVID-19 expedited a trend that is expected to continue

The rapid onset of halting referrals and procedures to create capacity to manage the COVID-19 pandemic will be followed by the resumption of access to care under drastically different circumstances, as the world emerges from the pandemic into a ‘new normal’.4 Addressing the escalating needs of patients with cardiovascular disease who are awaiting treatment presents the next challenge for healthcare systems across regions.4 Along with an understanding of the dynamic constraints on healthcare systems, minimalist TAVI can potentially help to further reduce post-care utilisation of resources and allow early patient recovery at home.5

The COVID-19 pandemic has acted as a catalyst for change in healthcare systems worldwide. Resulting adaptations ought to be perceived as opportunities for sustained change and not as temporary disruptions to an often empirically derived TAVI service framework.12 For patients with severe aortic stenosis, efforts to bring treatment to patients amid this pandemic might lead to favoured use of catheter-based management using minimalist techniques.6 As the pandemic abates, TAVI programmes cannot expect a ‘flipping of the switch’ back to pre-pandemic status.4 TAVI programmes must facilitate access to care without compromising patient safety, enable hospitals to manage the competing demands created by COVID-19 and establish new processes to support patients living with valvular heart disease.4

Cost remains a significant barrier to the widespread adoption of TAVI by publicly-funded services outside the pandemic setting; however, incorporating minimalist TAVI has the potential to further improve the cost-effectiveness of a TAVI service.12 There is a compelling need to facilitate the rapid adoption of best practices adapted to the unique demands created by COVID-19 and leverage existing evidence to minimise healthcare resources, facilitate accelerated treatment of AS without compromising patient safety and ensure that patients return home to enjoy the benefits that TAVI affords.4


References

  1. Harky A, Seyedzenouzi G, Sanghavi R, et al. COVID‐19 and its implications on patient selection for TAVI and SAVR: Are we heading into a new era? J Card Surg 2021;36:265-267.
  2. Khialani B, MacCarthy P. Transcatheter management of severe aortic stenosis during the COVID-19 pandemic. Heart 2020;106:1183-1190.
  3. Perek B, Olasinska-Wisniewska A, Misterski M, et al. How the COVID-19 pandemic changed treatment of severe aortic stenosis: a single cardiac center experience. J Thorac Dis 2021;13:906-917.
  4. Lauck S, Forman J, Borregaard B, et al. Facilitating transcatheter aortic valve implantation in the era of COVID-19: Recommendations for programmes. European Journal of Cardiovascular Nursing 2020;19:537-544.
  5. Basman C, Kliger CA, Pirelli L, et al. Management of elective aortic valve replacement over the long term in the era of COVID-19. European Journal of Cardio-Thoracic Surgery 2020;57:1029-1031.
  6. Mehta JJ, Patel J, Ayoub B, et al. Caution regarding potential changes in AVR practices during the COVID‐19 pandemic. J Card Surg 2020;35:1168-1169.
  7. Ro R, Khera S, Tang GHL, et al. Characteristics and Outcomes of Patients Deferred for Transcatheter Aortic Valve Replacement Because of COVID-19. JAMA Netw Open 2020;3:e2019801.
  8. Sundt TM. Managing Aortic Stenosis in the Age of COVID-19: Preparing for the Second Wave. JAMA Netw Open 2020;3:e2020368.
  9. Wood D. The Vancouver 3M (multidisciplinary, multimodality but minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers. JACC: Cardiovascular Interventions 2019;12:459-69.
  10. Barbanti M, van Mourik MS, Spence MS, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention 2019;15:147-154.
  11. Lauck SB, Wood DA, Baumbusch J, et al. Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway: Minimalist Approach, Standardized Care, and Discharge Criteria to Reduce Length of Stay. Circ Cardiovasc Qual Outcomes 2016;9:312-321.
  12. Joseph J, Kotronias RA, Estrin-Serlui T, et al. Safety and operational efficiency of restructuring and redeploying a transcatheter aortic valve replacement service during the COVID-19 pandemic: The Oxford experience. Cardiovascular Revascularization Medicine 2020:S1553838920307855.

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