4 Takeaways from the 2021 ESC/EACTS Guideline for Valvular Heart Disease

New updates include timing of intervention, TAVR vs. SAVR selection criteria, surgery priority over TEER for MR, and anticoagulation strategies for VHD subgroups

Earlier intervention is better for patients with valvular heart disease (VHD), even those who are asymptomatic, according to key updates from the 2021 European guideline for managing VHD.

European heart specialists presented highlights from the 2021 joint guideline by the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) for managing VHD at ESC Congress 2021.

The 72-page text1 was simultaneously published in the European Heart Journal on Aug. 28.

Compared to the prior 2017 ESC/EACTS VHD guideline, this year¡¯s update stressed early intervention and hashed out details for which patients should get a surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) based on recent randomized trials.

Early intervention is preferable, but only if expert heart teams can deliver very high-quality treatment at specialized heart valve centers.

Friedhelm Beyersdorf, MD

The emphasis on early intervention was coupled with the underscoring of heart valve centers. Panelists noted that heart teams should work together for all patients, ranging from the asymptomatic to the high-risk groups.

Updates also included more nuanced definitions for mitral regurgitation (MR) based on refined etiology. Surgical repair got priority over transcatheter edge-to-edge repair (TEER) for severe MR. However, TEER got a boost from a Class IIb to a Class IIa recommendation for patients unsuitable for surgery with symptomatic secondary MR without coronary artery disease (CAD).

A critical section on VHD patient management featured anticoagulation strategies for patient subgroups, such as atrial fibrillation (AF) patients with native VHD and post-SAVR/TAVR populations.

Here are four takeaways from the 2021 ESC/EACTS Guideline on VHD.

1. The earlier the intervention, the better – even for asymptomatic VHD

One key feature included expanded indications for early intervention to patients with low operative risk.

Patient-centered evaluations by an expert heart team also gained prominence for weighing the risks and benefits of early intervention in asymptomatic patients with severe VHD.

¡°Timing of intervention is crucial. Proper evaluation of patient¡¯s disease severity and comorbidities can influence the timing for intervention,¡± said Victoria Delgado, MD, PhD (Leiden University Medical Center, Leiden, Netherlands) at ESC Congress 2021. ¡°It¡¯s crucial to weigh the risk of complications with TAVR/SAVR versus potentially irreversible damage in the left atrium.¡±

Accordingly, Delgado pointed out that surgery recommendations were bumped up for select patients with severe aortic regurgitation (AR). SAVR was also recommended based on the severity of systolic left ventricle (LV) dysfunction.

Recommendation Class/LoE
For severe aortic regurgitation (AR):
(Merged) Surgery recommended in asymptomatic patients with LVESD >50 mm (or LVESD >25 mm/m2 in patients with small body size) or resting LVEF ¡Â50% Class I/B
Surgery may be considered in asymptomatic patients with LVESD >20 mm/m2 (esp. for small body size) or resting LVEF ¡Â55% if low surgical risk Class IIb/C
For severe aortic stenosis (AS):
Intervention recommended in asymptomatic patients with severe AS and systolic LV dysfunction (LVEF <50%) without another cause Class I/B
Intervention recommended in asymptomatic patients with severe AS and demonstrable symptoms on exercise testing Class I/C
(New) Intervention should be considered in asymptomatic patients with severe AS and systolic LV dysfunction (LVEF <55%) without another cause Class IIa/B
(New) Intervention should be considered in asymptomatic patients with severe AS and a sustained fall in BP (¡Ã20 mmHg) during exercise testing Class IIa/C
(New) Intervention should be considered in asymptomatic patients with LVEF >55% and a normal exercise test if the procedural risk is low and one of the following parameters is present:
1) very severe AS (mean gradient ¡Ã60 mmHg or Vmax>5m/s)
2) severe valve calcification and Vmax progression ¡Ã0.3m/s/year
3) markedly elevated BNP levels (>3x age- and sex-corrected normal range) confirmed by repeated measurements and without other explanation
Class IIa/B

The last two new recommendations, Delgado said, were based on a recent trial by Duk-hyun Kang, MD (Asan Medical Center, Seoul, South Korea) and colleagues last year2, which found better outcomes with early surgical intervention than conservative care for asymptomatic patients with very severe AS.

Updates were also made for patients with MR, mitral stenosis, and asymptomatic severe tricuspid regurgitation (TR) - with focus on early signs of hemodynamic consequences.

¡°The early intervention is what struck me as an important new addition. The concept applied to all cases, even in the asymptomatic VHD population,¡± said Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York, USA) who served as a panelist.

Friedhelm Beyersdorf, MD (University Heart Center Freiburg, Freiburg, Germany) who was surgical EACTS Chairperson of the joint guideline¡¯s task force clarified: ¡°Early intervention is preferable, but only if it can be delivered at very high quality. Because of the risks of early intervention, high-quality repair requires expertise and specialized heart valve centers that accommodate a wide spectrum of treatment.¡±

Alec Vahanian (University Paris-Descartes, Paris, France), ESC Chairperson of the guideline task force, added: ¡°Heart valve clinics are essential for early diagnosis and follow-up because we¡¯ve seen better outcomes in these centers. Optimal medical therapy comes first, but it¡¯s important to evaluate patients quickly to avoid keeping them too long after initial contact. Diagnosis is the start of everything, followed by medical treatment and the expertise of everyone.¡±

Faiez Zannad, MD, PhD (University of Lorraine, Nancy, France) said: ¡°The heart failure team should be put in early but the issue is referral for most tertiary hospitals, so we need clear guidance on how early referral should be done.¡±

2. Age cut-off for TAVR or SAVR in aortic stenosis set to 75

For severe AS patients indicated for intervention, surgery was recommended for all patients under 75 years of age and at low surgical risk (STS-PROM/EuroScore II <4%) and for those unsuitable for TAVR but surgically operable (Class I; LoE: B)

For all other patients, SAVR and TAVR were both named as viable options (Class I; LoE: B).

TAVR was recommended for patients over 75 years or for those either unsuitable or at high surgical risk (STS-PROM/EuroScore II >8%) and suitable for TAVR (Class I; LoE: A).

¡°Both SAVR and TAVR are excellent treatment options for AS, and their complementary use has led to a 94% increase in patients receiving any form of aortic valve replacement globally in the past decade,¡± said Bernard Prendergast, MD (St. Thomas¡¯ Hospital and Cleveland Clinic, London, UK).

¡°The choice between the two interventions for all patients should be based on evaluations by a heart team,¡± Prendergast said. ¡°Basic recommendations delineate younger patients (<75 years) at low surgical risk, unsuitable for TAVR, and operable should get SAVR. Patients who are older (>75 years), inoperable, or at high surgical risk should get TAVR.¡±

¡°For the remaining patients, it¡¯s important to take account of clinical, anatomical, and procedural factors beyond age and sex,¡± he added. ¡°Heart teams must note factors such as surgical risk, previous cardiac surgery, severe frailty, and active/suspected endocarditis.¡±

Clinical characteristics favoring TAVR or SAVR
Favors TAVR Favors SAVR
  • Higher surgical risk
  • Older age
  • Previous cardiac surgery
  • Severe frailty
  • Lower surgical risk
  • Younger age
  • Active or suspected endocarditis
Anatomical and procedural factors favoring TAVR or SAVR
Favors TAVR Favors SAVR
  • TAVR feasible via transfemoral approach
  • Transfemoral access challenging or impossible and SAVR inadvisable
  • Sequelae of chest radiation
  • Porcelain aorta
  • High likelihood of severe patient-prothesis mismatch (AVA <0.65 cm2/m2 BSA)
  • Severe chest deformation or scoliosis
  • Transfemoral access challenging or impossible and SAVR feasible
  • Aortic annular dimensions unsuitable for available TAVR devices
  • Bicuspid aortic valve
  • Thrombosis in aorta or LV
  • Valve morphology unfavorable for TAVR (e.g., high risk of coronary obstruction due to low coronary ostia/heavy leaflet/LVOT calcification
Concomitant cardiac conditions requiring intervention favoring TAVR or SAVR
Favors TAVR
  • Significant multi-vessel CAD requiring surgical revascularization
  • Severe primary mitral valve disease
  • Severe tricuspid valve disease
  • Significant dilation/aneurysm of the aortic root and/or ascending aorta
  • Septal hypertrophy requiring myectomy

The updated recommendations on TAVR/SAVR incorporated the ¡°closing of a major gap¡± in the evidence on patients of low surgical risk with the PARTNER 33 and EVOLUT Low Risk4 trials.

The PARTNER 3 and EVOLUT Low Risk studies favored TAVR for the primary endpoint outcomes of death, stroke, or rehospitalization. However, several limitations such as a highly selective cohort (high flow AS, low risk of STS=2, younger age) and exclusion of ¡°high risk¡± TAVR/SAVR anatomy restricted application of its positive findings to a wider clinical setting.

Coupled with ongoing TAVR uncertainties in bicuspid aortic valves, long-term consequences such as pacemakers and future coronary access confined indications for transcatheter intervention to older patients.

¡°Long-term durability of transcatheter heart valves (THV) may not be important for an 80-year-old with a life expectancy of five years, but it is fundamentally important for younger patients who may have a life expectancy of 25 years. We have to recognize the limited evidence regarding the long-term durability of THV with TAVR and the limited data on subgroups,¡± Prendergast said.

¡°Heart teams with expertise in evaluating all clinical, anatomical, and procedural factors as well as diagnosis and intervention are crucial to mitigate the challenging and complicated decision-making process for intervention strategy. The significant life-threatening complications associated with both surgical and transcatheter interventions mandate that they are performed in a heart valve center with on-site cardiac facilities.¡±

3. Surgical repair endorsed over TEER for severe MR; MR etiology gets down to nitty-gritty

The new guideline also reinforced the role of surgical repair for primary MR ¡°whenever possible¡± with concomitant correction of secondary MR.

TEER was recommended for select patients not suitable for surgery and when anatomically suitable, suggesting an increased probability of subgroups deriving a symptomatic benefit from TEER, Fabien Praz, MD (Bern University Hospital, Bern, Switzerland) said.

Also highlighted was the importance of concomitant treatment of TR with a Class I recommendation for surgery in severe TR and in mild or moderate cases with tricuspid annulus dilation.

Overall, experts stressed the heart team should first identify symptoms and evaluate the operative risk to choose the mode of intervention.

Recommendation Class/LoE
For severe primary mitral regurgitation (MR):
Mitral valve repair is the recommended surgical technique when the results are expected to be durable Class I/B
Surgery is recommended in symptomatic patients who are operable and not high risk. Class I/B
Surgery is recommended in asymptomatic patients with LV dysfunction (LVESD ¡Ã40 mm and/or LVEF ¡Â60%). Class I/B
Surgery should be considered in asymptomatic patients with preserved LV function (LVESD <40 mm and LVEF >60%) and AF secondary to mitral regurgitation or pulmonary hypertension (SPAP at rest >50 mmHg). Class IIa/B
Surgical mitral valve repair should be considered in low-risk asymptomatic patients with LVEF >60%, LVESD <40 mmd and significant LA dilatation (volume index ¡Ã60 mL/m2 or diameter ¡Ã55 mm) when performed in a Heart Valve Center and a durable repair is likely. Class IIa/B
TEER may be considered in symptomatic patients who fulfill the echocardiographic criteria of eligibility, are judged inoperable or at high surgical risk by the Heart Team and for whom the procedure is not considered futile. Class IIb/B
For chronic severe secondary MR:
Valve surgery/intervention is recommended only in patients with severe SMR who remain symptomatic despite GDMT (including CRT if indicated) and has to be decided by a structured collaborative Heart Team. Class I/B
Patients with concomitant coronary artery/other cardiac disease requiring treatment
Valve surgery is recommended in patients undergoing CABG or other cardiac surgery. Class I/B
In symptomatic patients, who are judged not appropriate for surgery by the Heart Team on the basis of their individual characteristics, PCI (and/or TAVI) possibly followed by TEER (in cases of persisting severe SMR) should be considered. Class IIa/C
Patients without concomitant coronary artery/other cardiac disease requiring treatment
TEER should be considered in selected symptomatic patients, not eligible for surgery and fulfilling criteria suggesting an increased chance of responding to the treatment Class IIa/B
Valve surgery may be considered in symptomatic patients judged appropriate for surgery by the Heart Team Class IIb/C
In high-risk symptomatic patients not eligible for surgery and not fulfilling the criteria suggesting an increased chance of responding to TEER, the Heart Team may consider in selected cases a TEER procedure or other transcatheter valve therapy if applicable, after careful evaluation for ventricular assist device or heart transplant Class IIb/C

The two main etiologies of primary and secondary MR were broken down into new subgroups to aid diagnosis and intervention outcomes.

¡°MR etiology is important to determine the mode of intervention and subsequent long-term prognosis since differences exist not only between primary and secondary MR but also between subgroups of the two broad categories,¡± Praz said. ¡°We need precise assessment of MR with 3D echocardiograms and imaging techniques to determine the source lesion.¡±

This ¡°precise assessment¡± calls for a multidisciplinary strategy for secondary MR, especially considering the recent MITRA-FR and COAPT trials produced different outcomes in the same target population, as previously reported by SummitMD5,. The contrasting study outcomes, Praz explained, arose mainly due to the different patient inclusion and exclusion criteria that led to different baseline characteristics.

¡°All these factors call for multidisciplinary treatment of secondary MR that includes an HF specialist for GDMT, an EP specialist for CRT, a cardiac surgeon for CABG/MR repair/LVAD/heart transplantation, and an invasive cardiologist for PCI/TEER and other transcatheter interventions.¡±

4. Stroke prevention in AF-VHD, post-SAVR/TAVR patients

NOACs were endorsed over VKAs for stroke prevention in AF patients with native VHD (i.e., AS, AR, MR).

Surgical left atrial appendage (LAA) occlusion also got a boost to a Class IIa recommendation for reducing thromboembolic risk in AF patients with a CHA2DS2VASc score ¡Ã2 and undergoing valve surgery, based on the LAAOS III trial published in June in the New England Journal of Medicine6.

For patients with surgical bioprosthetic aortic valves not indicated for oral anticoagulation, the guideline ¡°did not take a position¡± regarding aspirin or VKA (Class IIa; LoE: B) for the first three months post-intervention, according to Davide Capodanno, MD, PhD (Ferrarotto Hospital, Catania, Italy).

The recommendation was based on the ¡°largest¡± randomized trial published in Thrombosis Research7 on warfarin versus aspirin after bioprosthetic aortic valve implementation. .Results showed no significant difference between warfarin or aspirin for thromboembolic complications (6.6% vs. 7.5%, difference 0.9%, P=0.83) and major bleeding (5.4% vs. 1.3%).

However, Capodanno noted that the RIVER trial8, which examined rivaroxaban versus warfarin, showed some promise for DOACs in AF patients with bioprosthetic mitral valves after it showed no significant difference between mean time to death, MACE, and major bleeding (347.5 days vs. 340.1 days) or major bleeding events (1.4% vs. 2.6%).

After TAVR, OAC was recommended lifelong for patients who had an OAC indication (Class I; LoE: B) and lifelong single antiplatelet therapy (SAPT) was recommended for those without a baseline OAC indication (Class I; LoE: A). Routine use of OAC was not recommended post-TAVR for patients without baseline OAC indication (Class III; LoE: B). The three new recommendations on post-TAVR management were based on the cohort A9 and cohort B10 of the POPular TAVI study and the GALILEO trial11.

A new, albeit weak, recommendation (Class IIa, LoE: B) endorsed anticoagulation for patients with leaflet thickening and reduced leaflet motion that leads to elevated gradients (at least until resolution) based on the GALILEO-4D trial12. Although GALILEO-4D showed a rivaroxaban-based antithrombotic strategy was better for preventing subclinical leaflet-motion abnormalities than aspirin, Capodanno cautioned that anticoagulation to reduce the endpoint is not recommended in most cases.


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