Mitral valve: New guidelines – what is missing?
Prof. Nikolaos Bonaros
Be courageous, be experienced, be ethical … according to the Guidelines!
Mr. Steve Livesey
Be courageous, be experienced, be ethical … according to the Guidelines!
With the publication of the 2021 update to ESC/EACTS guidelines for the management of valvular heart disease, new guidance should be considered when caring for patients with severe aortic stenosis.1
Three key recommendations stand out:
Early intervention is recommended for asymptomatic patients with a LVEF below 55% without another cause
An emphasis on Heart Team collaboration to provide the optimal treatment while informing and involving patients in their decision-making
A clear age delineation that patients younger than 75 years of age with severe aortic stenosis receive SAVR, and patients older receive TAVI
It is established that the durability of modern surgical bioprosthetic valves is over 10 years,2 and in recent years there has been a trend towards a greater use of bioprosthetic valves.3 On the other hand, mechanical valves continue to be associated with bleeding risks because of the need for lifelong anticoagulation therapy, leading to lifestyle changes.4-6
Several large, long-term studies have demonstrated up to 20-year durability for the bioprosthetic Carpentier-Edwards PERIMOUNT
aortic valve.2,7,8
Carpentier-Edwards PERIMOUNT valve
Two ongoing trials, COMMENCE and EU Feasibility, are evaluating the longevity of bioprosthetic aortic valves with novel RESILIA tissue after five-year implantation. Five-year results from these studies have demonstrated a favourable safety profile and good haemodynamic performance.9,10
INSPIRIS RESILIA aortic valve
Another study found that the INSPIRIS RESILIA valve reduced the length of hospital stay compared with mechanical valves (6.6 days versus 10.3 days).11 Selecting the right treatment for the patient requires many considerations, most importantly the desire of the informed patient.
Additionally, the Heart Team needs to consider the age, estimated life expectancy, comorbidities, and anatomical and procedural characteristics of the patient; relative risks and long-term outcomes associated with SAVR or TAVI; prosthetic heart valve durability; feasibility of transfemoral TAVI; and local experience and outcome data to achieve optimal outcomes for patients.1
Recommended resources
References
1. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2021: doi:10.1093/eurheartj/ehab395.
2. Johnston DR, Soltesz EG, Vakil N et al. Long-term durability of bioprosthetic aortic valves: Implications from 12,569 implants. Ann Thorac Surg. 2015; 99: 1239–47
3. Bartus K, Sadowski J, Litwinowicz R et al. Changing trends in aortic valve procedures over the past ten years—from mechanical prosthesis via stented bioprosthesis to TAVI procedures—analysis of 50,846 aortic valve cases based on a Polish National Cardiac Surgery Database. J Thorac Dis. 2019; 11: 2340–9.
4. Head SJ, Çelik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017; 38: 2183–91.
5. Reul RM, Ramchandani MK, Reardon MJ. Transcatheter aortic valve-in-valve procedure in patients with bioprosthetic structural valve deterioration. Methodist DeBakey Cardiovasc J. 2017; 13: 132.
6. Swinkels B, Ten Berg J, Kelder J et al. What can we learn from the past by means of very long-term follow-up after aortic valve replacement? J Clin Med. 2021; 10: 3925.
7. Bourguignon T, Bouquiaux-Stablo A-L, Candolfi P et al.Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg. 2015; 99: 831–7.
8. Forcillo J, Pellerin M, Perrault LP et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013; 96: 486–93.
9. Bartus K, Litwinowicz R, Bilewska A et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardio-Thorac Surg. 2021; 59: 434–41.
10. Bavaria J, Griffith B, Heimansohn DA et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. Presented at the Society of Thoracic Surgeons (STS) Annual Meeting 2021.
11. Meuris B. Innovation in anticalcification technology in heart valves leads to lower hospital stay in adults undergoing aortic valve replacement. Oral Presentation at HTAi 2021 virtual congress.
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
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A key focus of the new ESC/EACTS guidelines is the instrumental role of the Heart Team in decisions concerning intervention and treatment, and the importance of collaborative decision making, taking both the Heart Team’s expert guidance and the wishes of the patient into consideration.
Key points include:
Heart Team recommendations must be discussed with patient and family to allow informed treatment choice
Heart Valve Centres are a key component of the Heart Team approach
Early Heart Team referral encouraged if patient’s symptoms develop/worsen before next planned visit
All patients with severe aortic stenosis must be referred through the Heart Team
Joint decision making gets the right treatment to each patient
ESC/EACTS guidelines now recommend that an active and collaborative Heart Team make decisions about intervention and treatment.
Your expertise means you are best placed to recommend the optimal valve procedure for the patient, in collaboration with the other specialists and dedicated personnel of the Heart Team.
Class I recommendations for a collaborative Heart Team approach
The choice between a surgical or transcatheter approach will depend on evaluation of the clinical, anatomical and procedural factors by the Heart Team, considering the risks and benefits for each individual patient.
Interventions should be performed in Heart Valve Centres, using a structured and collaborative Heart Team approach.
All procedural decisions should be patient-centred, giving consideration to age, operative risk, the patient’s life expectancy, lifestyle and environmental factors, their potential for reintervention and any co-morbidities. The final recommendation should also consider the desires of the patient. Ensure you meet your patients’ high expectations by offering them the best valve technologies. Early referral is encouraged if a patient’s symptoms develop/worsen before the next planned visit.
All procedural decisions should be patient-centred, giving consideration to age, operative risk, the patient’s life expectancy, lifestyle and environmental factors, their potential for reintervention and any co-morbidities. The final recommendation should also consider the desires of the patient. Ensure you meet your patients’ high expectations by offering them the best valve technologies. Early referral is encouraged if a patient’s symptoms develop/worsen before the next planned visit.
Interested in finding out more
The upcoming EACTS Annual Meeting has several sessions relevant for these changes:
- Meet the people behind the guidelines in 2021 EACTS/ESC Guidelines for the management of valvular heart disease: Meet the task force members in room 111, at 12:30 on Saturday 16 October
- Join Drs Bonaros and Bourguignon for Problems and concerns related to the choice of an optimal aortic valve substitute in room 111 on Thursday 14 October at 14:15
- Challenging decisions and long-term outcomes in tricuspid and mitral disease with Professor Folliguet is one to attend in room 115 at 16:15 on Friday 15 October
Check out the Edwards congress hub for more information about their upcoming symposia, or meet them onsite at the booth.
You can also read more practical information about the ESC/EACTS guidelines
- Check out Professor Michael Borger’s recent presentation on what’s missing from the new ESC/EACTS guidelines
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Dr. Marco Di Eusanio
Introduction
With almost 380,000 deaths to date and just over 6 million confirmed cases, coronavirus disease 2019 (COVID-19) continues its global spread. In many countries, the first peak in cases has been reached or surpassed, and governments around the world are taking their first tentative steps towards easing lockdown restrictions as they attempt to find the difficult balance between public health and economic priorities.
The scientific effort to tackle the pandemic has brought new insights into the epidemiology and course of the disease, including several new reports detailing the link between COVID-19 and cardiac disease. Multiple studies have been initiated in the search for a vaccine and at least 15 clinical trials are already entering Phase I/II. Additionally, the antiviral remdesivir has become the first drug approved by the FDA for the treatment of COVID-19. Here, we summarise the latest use of cutting-edge science in the fight against COVID-19.
COVID-19 Strategies for impact reduction summary
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Edwards Lifesciences• Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
The global spread of coronavirus disease 2019 (COVID-19) persists. With over 3 million infections and more than 210,000 deaths to date, the pandemic continues to present significant challenges to health systems around the world, and across all branches of medicine.
In response to the COVID-19 pandemic, the scientific community has united to tackle the disease, with many studies initiated to understand its mechanism and treatment options. Scientific societies have provided guidance for the treatment of patients with comorbidities, and journals have provided open access to scientific literature in an attempt to disseminate knowledge and contribute to better outcomes.
Here, we focus on the implications of the COVID-19 pandemic for cardiovascular medicine. Emerging studies address how COVID-19 impacts the cardiovascular system, the status of prospective treatment approaches, and the importance of safety for healthcare providers on the frontline. The information included acknowledges the significant contribution of researchers, scientific societies and publishers, and does not necessarily reflect a position of Edwards Lifesciences in relation to individual studies.
For professional use.
Edwards Lifesciences, the stylized E logo, are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.
© 2020 Edwards Lifesciences Corporation. All rights reserved. PP–EU-0209 v1.0
Edwards Lifesciences• Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Introduction
During the ongoing COVID-19 pandemic, it is important for healthcare workers to understand the implications of COVID-19 for the safe provision of cardiac surgery.
Here, Edwards Lifesciences provides a selection of publications that may be of interest to healthcare workers involved in cardiac surgery at this time. The publications highlight key learnings from prior pandemics, techniques that have been used to support patients with respiratory distress and implications for cardiac surgery. For convenience, a short summary of each publication is provided. Please refer to the full publication for detailed information on the techniques used and the outcomes achieved.
We are learning more about COVID-19 every day. Therefore, it is important to acknowledge that insights from previous pandemics might not be directly applicable to the situation we presently face, and that treatment for critical COVID-19 patients may differ from previous pandemics.
Section 1: Cardiac surgery during the COVID-19 pandemic: Recent learnings
Cardiac surgery and the COVID-19 outbreak: What does it mean?
Matt P & Maisano F. PCR Online, March 2020.
Acknowledging that cardiac surgery is not on the front line of patient care in the COVID-19 outbreak, it is important to understand the impact the pandemic may have on cardiac surgery, both for healthcare workers and for their patients. The authors highlight the importance of strategic decision-making by cardiac surgeons in planning essential operations, while also minimising the burden of these procedures on healthcare systems during the pandemic. Surgeons need to assess the risks associated with delaying surgical care against the risks of exposing patients to SARS-CoV-2 within the hospital environment. Additional challenges are also discussed, such as limited ICU beds and ventilation facilities, the consequences of postponing surgeries and the protection of healthcare workers. This article, with its accompanying references and the articles summarised below may prove useful in developing or improving treatment algorithms for currently overwhelmed healthcare systems around the world.
- Zheng YY et al. Nat Rev Cardiol. 2020; Mar 5. https://go.nature.com/2R3huNf
- Adams JG & Walls RM. JAMA 2020; Mar 12. https://bit.ly/3aBGDX1
- Romaguera R et al. REC Interv Cardiol. 2020; Mar 20. https://bit.ly/3aBonNJ
- Ong SWX et al. JAMA 2020; Mar 4. https://bit.ly/3aAe789
Access details about ongoing COVID-19 trials on ClinicalTrials.gov: https://clinicaltrials.gov/ct2/results?cond=COVID-19
Association of coronavirus disease 2019 (COVID-19) with myocardial injury and mortality
Bonow RO et al. JAMA Cardiol. 2020; March 27: e1–3.
In this editorial, Bonow and colleagues discuss the paucity of information regarding risks of COVID-19 for individuals with underlying cardiovascular disease. They highlight the insufficient attention given thus far to understanding the effects of COVID-19 infection in causing or exacerbating cardiovascular injury. The authors discuss early data from several recent publications that aim to help fill this knowledge gap, acknowledging that patients with long-term coronary artery disease and/or those with risk factors for atherosclerotic cardiovascular disease, prevalent in the elderly, have an increased risk of developing acute coronary syndrome upon COVID-19 infections. Such acute infections can place a high demand on myocardial tissue, which would make these patients more susceptible to adverse outcomes and death. Severe inflammatory stress and haemodynamic decompensation result in an increase in circulating cytokines. This can also increase disease severity and mortality risk. This publication highlights many coordinated efforts by the scientific community in understanding the relationship between COVID-19 infection and cardiovascular disease.
Association of cardiac injury with mortality in hospitalized patients with COVID-19 in Wuhan, China
Shi S et al. JAMA Cardiol. 2020; March 25: e1–8.
Presenting data collected during January and February this year from a single hospital in Wuhan, China, Shi and colleagues demonstrate a statistically significant association between cardiac injury and mortality in hospitalised COVID-19 patients. To compare outcomes of patients with and without cardiac injury, the authors analysed clinical, radiological and treatment data. The paper acknowledges that, due to the logistical constraints of collecting data from patients in ICU and isolation, measures of echocardiography, electrocardiography and cytokine levels were lacking. This limits the determination of potential mechanisms of cardiac injury. Another limitation is that, for many patients, clinical endpoints had not been reached as these individuals were still under clinical observation. The authors point to the need for data from larger populations and multiple centres to further understand and manage the outcomes of cardiac injury in COVID-19.
Section 2: Learnings from previous pandemics
The 1918 influenza pandemic: Lessons for 2009 and the future
Morens DM et al. Crit Care Med. 2010; 38: e10–20.
This paper provides a history of the
1918–1919 H1N1 influenza pandemic and discusses whether knowledge of its
characteristics, epidemiology and spread can help us to predict and manage
other respiratory pandemics. The paper explains how, in the case of similar
outbreaks, a strategic combination of pharmaceuticals, technology and treatment
algorithms can identify and/or treat high-risk or severely ill patients. This
strategy may include rapid antigen testing and timely availability of imaging
and laboratory data to allow healthcare workers to assess a patient’s risk of
complications. Mechanical ventilation methods, such as ECMO, are also useful to
support the most severely ill. The 1918 influenza pandemic has provided a
wealth of information, and the authors recommend using this knowledge to
prepare for future pandemics by doing targeted research in prevention,
containment and treatment.
Extracorporeal membrane oxygenation in pandemic flu: Insufficient evidence or worth the effort?
Dalton HJ & MacLaren G. Crit Care Med. 2010; 38: 1484–1485.
During the 2009–2010 H1N1 influenza pandemic, patients with severe influenza required mechanical ventilation to prevent organ failure. In some severely ill patients, early antiviral treatment and intensive care failed in stopping ongoing organ failure and ineffective gas exchange. In these cases, rescue therapies were employed to save lives. Dalton and MacLaren summarise the use of ECMO, one of several rescue therapies employed by clinicians across the world during the pandemic. The authors cite several case series, review articles and a systematic review of the evidence for ECMO use in adult patients. They highlight technological advances that have helped clinicians use ECMO across all patients. The authors also recommend using a framework to coordinate ECMO use by clinicians around the world.
Section 3: Technical manuscripts on the use of ECCO2R and ECMO
Daily use of extracorporeal CO2 removal in a critical care unit: Indications and results
Winiszewski H et al. J Intensive Care 2018; 6: 36.
Highlighting the potential of ECCO2R for patients with ARDS and COPD in critical care settings, the authors of this retrospective study found that ECCO2R was associated with decreased tidal volume and driving pressure in patients with ARDS. ECCO2R use in patients with COPD improved minute ventilation, PaCO2 and pH normalisation. Although the authors recommend caution for potential anticoagulation events, they found that ECCO2R was well-tolerated.
Extracorporeal membrane oxygenation for acute respiratory distress syndrome
Aokage T et al. J Intensive Care 2015; 3: 17.
In this review, the authors discuss the potential of ECMO as a lifesaving therapy for patients with refractory severe respiratory failure or cardiac failure. In recent years, use of ECMO for respiratory failure has been increasing. ECMO may reduce the high mortality rate associated with severe ARDS, with advantages including the stabilisation of gas exchange and haemodynamic compromise, thereby preventing additional hypoxic organ damage. This study highlights the potential benefit of using ECMO in adult patients with ARDS, when adequate oxygenation cannot be maintained using conventional methods. The authors also highlight, however, that ECMO is a complicated and high-risk therapy that can only be administered by adequately trained medical staff.
Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome: The SUPERNOVA study
Combes A et al. Intensive Care Med 2019; 45: 592–600.
This study presents results from SUPERNOVA, a prospective Phase 2 trial. The trial assessed the feasibility and safety of ECCO2R to facilitate ultra-protective ventilation in 95 patients with moderate ARDS. In this study, 82% of patients achieved ultra-protective ventilation at 24 hours. ECCO2R was maintained for 3–8 days, with 78% patient survival at day 28. The authors highly recommend a randomised clinical trial to fully assess the risks and benefits of ECCO2R in patients with moderate ARDS. This study demonstrates that ECCO2R is a feasible intervention in moderate ARDS patients, whose potential must be further explored.
Extracorporeal membrane oxygenation in acute respiratory distress syndrome due to influenza A (H1N1) pdm09 pneumonia. A single-center experience during the 2013-2014 season
Menon N et al. Rev Bras Ter Intensiva 2017; 29: 271–278.
This study of 10 patients with severe H1N1-associated ARDS observed favourable outcomes with ECMO intervention. The median age of patients was 40 years. Typically, patients received mechanical ventilation for 22 days and spent 29.1 days in hospital (with 27 days in intensive care). Six patients experienced minor bleeding as a complication. Eight patients survived and were discharged with good functional status. The authors demonstrate that ECMO may result in excellent outcomes by helping a vulnerable but relatively young patient population to achieve good functional status.
Interstitial pneumonia with autoimmune features: An additional risk factor for ARDS?
Grasselli G et al. Ann Intensive Care 2017; 7: 98.
A recently recognised autoimmune syndrome, IPAF is characterised by the presence of interstitial lung disease and autoantibodies, but absence of a specific connective tissue disease or alternative aetiology. In this study, patients with IPAF in the ICU had comparable survival compared to patients with ARDS who had a known risk factor. All patients required prolonged mechanical ventilation ranging from 10 to 88 days (median 49 days), 4 received ECMO and 1 received ECCO2R. The study demonstrates that a diagnosis of IPAF should be considered in any critically ill patient with interstitial lung disease of unknown origin. This diagnosis leads to the interventions recommended, helping these patients achieve survival rates comparable to ARDS patients with a known clinical insult.
Simulation-based training of extracorporeal membrane oxygenation during H1N1 influenza pandemic: The Italian experience
Brazzi L et al. Sim Healthcare 2012; 7: 32–34.
Simulation-based training shows potential for the identification and treatment of complex clinical problems, enabling immediate feedback, remote collaborations and training in a controlled and safe environment. During the 2009 H1N1 outbreak, the Italian health authorities instigated a network of ICU centres in preparation for the treatment of the sickest H1N1 patients by means of ECMO. Two major urgencies were identified: the absolute imperative of having all necessary equipment needed to support the provision of ECMO, and the importance of comprehensive training for all physicians working within the ICU on the correct use of ECMO. Using simulation technology, physicians were upskilled and prepared as demonstrated by the resultant survival data. This paper clearly shows the benefits of simulation-based training for quickly and comprehensively preparing ICU personnel in the use of ECMO.
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