Table 3. What is new.
| New or Revised | Recommendations in 2017 version | Class | Recommendations in 2021 version | Class |
|---|---|---|---|---|
| Section 3. Management of atrial fibrillation in patients with native VHD | ||||
| Revised | Surgical excision or external clipping of the LAA may be considered in patients undergoing valve surgery. | IIb | LAA occlusion should be considered to reduce the thromboembolic risk in patients with AF and a CHA2DS2VASc score ≥2 undergoing valve surgery. | IIa |
| Revised | NOACs should be considered as an alternative to VKAs in patients with aortic stenosis, aortic regurgitation and mitral regurgitation presenting with AF. | IIa | For stroke prevention in AF patients who are eligible for OAC, NOACs are recommended in preference to VKAs in patients with aortic stenosis, aortic and mitral regurgitation. | I |
| Section 4. Recommendations on indications for surgery in severe aortic regurgitation | ||||
| Revised | Surgery is indicated in asymptomatic patients with resting ejection fraction ≤50%. | I | Surgery is recommended in asymptomatic patients with LVESD >50 mm or LVESD >25 mm/m2 BSA (in patients with small body size) or resting LVEF ≤50%. | I |
| Surgery should be considered in asymptomatic patients with resting ejection fraction >50% with severe LV dilatation: LVEDD >70 mm or LVESD >50 mm (or LVESD >25 mm/m2 BSA in patients with small body size). | IIa | |||
| New | Surgery may be considered in asymptomatic patients with LVESD >20 mm/m2 BSA (especially in patients with small body size) or resting LVEF ≤55%, if surgery at low-risk. | IIb | ||
| Revised | Heart Team discussion is recommended in selected patients in whom aortic valve repair may be a feasible alternative to valve replacement. | I | Aortic valve repair may be considered in selected patients at experienced centres when durable results are expected. | IIb |
| Section 4. Recommendations on indications for surgery in aortic root or tubular ascending aortic aneurysm (irrespective of the severity of aortic regurgitation) | ||||
| Revised | Aortic valve repair, using the reimplantation or remodelling with aortic annuloplasty technique, is recommended in young patients with aortic root dilation and tricuspid aortic valves, when performed by experienced surgeons. | I | Valve-sparing aortic root replacement is recommended in young patients with aortic root dilation, if performed in experienced centres and durable results are expected. | I |
| Section 5. Recommendations on indications for intervention in symptomatic and asymptomatic aortic stenosis | ||||
| Symptomatic aortic stenosis | ||||
| Revised | Intervention is indicated in symptomatic patients with severe, high-gradient aortic stenosis (mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s). | I | Intervention is recommended in symptomatic patients with severe, high-gradient aortic stenosis [mean gradient ≥40 mmHg, peak velocity ≥4.0 m/s and valve area ≤1.0 cm2 (or ≤0.6 cm2/m2)]. | I |
| Asymptomatic patients with severe aortic stenosis | ||||
| New | Intervention should be considered in asymptomatic patients with severe aortic stenosis and systolic LV dysfunction (LVEF <55%) without another cause. | IIa | ||
| Revised | SAVR should be considered in asymptomatic patients with normal ejection fraction and none of the above-mentioned exercise test abnormalities if the surgical risk is low and one of the following findings is present: • Very severe aortic stenosis defined by a Vmax >5.5 m/s. • Severe valve calcification and a rate of Vmax progression ≥0.3 m/s/year. • Markedly elevated BNP levels (>3x age- and sex-corrected normal range) confirmed by repeated measurements without other explanations. • Severe pulmonary hypertension (systolic pulmonary artery pressure at rest >60 mmHg confirmed by invasive measurement) without other explanation. |
IIa | 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: • Very severe aortic stenosis (mean gradient ≥60 mmHg or Vmax ≥5 m/s). • Severe valve calcification (ideally assessed by CCT) and Vmax progression ≥0.3 m/s/year. • Markedly elevated BNP levels (>3x age- and sex-corrected normal range) confirmed by repeated measurements and without other explanation. |
IIa |
| Section 5. Recommended mode of intervention in patients with aortic stenosis | ||||
| Revised | The choice for intervention must be based on careful individual evaluation of technical suitability and weighing of risks and benefits of each modality. In addition, the local expertise and outcomes data for the given intervention must be taken into account. | I | The choice between surgical and transcatheter intervention must be based upon careful evaluation of clinical, anatomical and procedural factors by the Heart Team, weighing the risks and benefits of each approach for an individual patient. The Heart Team recommendation should be discussed with the patient who can then make an informed treatment choice. | I |
| Revised | SAVR is recommended in patients at low surgical risk (STS or EuroSCORE II <4% or logistic EuroSCORE I <10%, and no other risk factors not included in these scores, such as frailty, porcelain aorta, sequelae of chest radiation). | I | SAVR is recommended in younger patients who are low risk for surgery (<75 years and STS-PROM/ EuroSCORE II <4%) or in patients who are operable and unsuitable for transfemoral TAVI. | I |
| Revised | TAVI is recommended in patients who are not suitable for SAVR as assessed by the Heart Team. | I | TAVI is recommended in older patients (≥75 years), or in those who are high-risk (STS-PROM/ EuroSCORE II >8%) or unsuitable for surgery. | I |
| Revised | In patients who are at increased surgical risk (STS or EuroSCORE II ≥4% or logistic EuroSCORE I ≥10%, or other risk factors not included in these scores such as frailty, porcelain aorta, sequelae of chest radiation), the decision between SAVR and TAVI should be made by the Heart Team according to the individual patient characteristics, with TAVI being favoured in elderly patients suitable for transfemoral access. | I | SAVR or TAVI are recommended for remaining patients according to individual clinical, anatomical and procedural characteristics. | I |
| New | Non-transfemoral TAVI may be considered in patients who are inoperable for SAVR and unsuitable for transfemoral TAVI. | IIb | ||
| Section 6. Indications for intervention in severe primary mitral regurgitation | ||||
| Revised | Surgery is indicated in asymptomatic patients with LV dysfunction (LVESD ≥45 mm and/or LVEF ≤60%). | I | Surgery is recommended in asymptomatic patients with LV dysfunction (LVESD ≥40 mm and/or LVEF ≤60%). | I |
| Revised | Surgery should be considered in asymptomatic patients with preserved LV function (LVESD <45 mm and LVEF >60%) and AF secondary to mitral regurgitation or pulmonary hypertension (SPAP at rest >50 mmHg). | IIa | 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). | IIa |
| Revised | Surgery should be considered in asymptomatic patients with preserved LVEF (>60%) and LVESD 40-44 mm when a durable repair is likely, surgical risk is low, the repair is performed in a Heart Valve Centre and at least one of the following findings is present: • flail leaflet or; • presence of significant LA dilatation (volume index ≥60 mL/m2 BSA) in sinus rhythm. |
IIa | Surgical mitral valve repair should be considered in low-risk asymptomatic patients with LVEF >60%, LVESD <40 mm and significant LA dilatation (volume index ≥60 mL/m2 or diameter ≥55 mm) when performed in a Heart Valve Centre and a durable repair is likely. | IIa |
| Section 6. Indications for mitral valve intervention in chronic severe secondary mitral regurgitation | ||||
| New | 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. | I | ||
| Patients with concomitant coronary artery or other cardiac disease requiring treatment | ||||
| New | 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 case of persisting severe SMR) should be considered. | IIa | ||
| Revised | Surgery is indicated in patients with severe SMR undergoing CABG and LVEF >30%. | I | Valve surgery is recommended in patients under- going CABG or other cardiac surgery. |
I |
| Patients without concomitant coronary artery or other cardiac disease requiring treatment | ||||
| Revised | When revascularization is not indicated and surgical risk is not low, a percutaneous edge-to-edge procedure may be considered in patients with severe secondary mitral regurgitation and LVEF >30% who remain symptomatic despite optimal medical management (including CRT if indicated) and who have a suitable valve morphology by echocardiography, avoiding futility. | IIb | TEER should be considered in selected symptomatic patients, not eligible for surgery and fulfilling criteria suggesting an increased chance of responding to the therapy. | IIa |
| Revised | In patients with severe SMR and LVEF <30% who remain symptomatic despite optimal medical management (including CRT if indicated) and who have no option for revascularization, the Heart Team may consider a percutaneous edge-to-edge procedure or valve surgery after careful evaluation for a ventricular assist device or heart transplant according to individual patient characteristics. | IIb | 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 trans-catheter valve therapy if applicable, after careful evaluation for ventricular assist device or heart transplant. | IIb |
| Section 8. Indications for intervention in primary tricuspid regurgitation | ||||
| Revised | Surgery should be considered in asymptomatic or mildly symptomatic patients with severe isolated primary tricuspid regurgitation and progressive RV dilatation or deterioration of RV function. | IIa | Surgery should be considered in asymptomatic or mildly symptomatic patients with isolated severe primary tricuspid regurgitation and RV dilatation who are appropriate for surgery. | IIa |
| Revised | After previous left-sided surgery and in absence of recurrent left-sided valve dysfunction, surgery should be considered in patients with severe tricuspid regurgitation who are symptomatic or have progressive RV dilatation/dysfunction, in the absence of severe RV or LV dysfunction and severe pulmonary vascular disease/hypertension. | IIa | Surgery should be considered in patients with severe secondary tricuspid regurgitation (with or without previous left-sided surgery) who are symptomatic or have RV dilatation, in the absence of severe RV or LV dysfunction and severe pulmonary vascular disease/hypertension. | IIa |
| New | Transcatheter treatment of symptomatic secondary severe tricuspid regurgitation may be considered in inoperable patients at a Heart Valve Centre with expertise in the treatment of tricuspid valve disease. | IIb | ||
| Section 11. Recommendations for prosthetic valve selection | ||||
| New | A bioprosthesis may be considered in patients already on long-term NOACs due to the high risk for thromboembolism. | IIb | ||
| Revised | A bioprosthesis should be considered in those (patients) whose life expectancy is lower than the presumed durability of the bioprosthesis. | IIa | A bioprosthesis is recommended when good-quality anticoagulation is unlikely (adherence problems, not readily available), contraindicated because of high bleeding risk (previous major bleed, comorbidities, unwillingness, adherence problems, life-style, occupation) and in those patients whose life expectancy is lower than the presumed durability of the bioprosthesis. | I |
| Section 11. Recommendations for perioperative and postoperative antithrombotic management of valve replacement or repair | ||||
| Management of antithrombotic therapy in the perioperative period | ||||
| New | Bridging of OAC, when interruption is needed, is recommended in patients with any of the following indication: • Mechanical prosthetic heart valve. • AF with significant mitral stenosis. • AF with a CHA2DS2-VASc score ≥3 for women or 2 for men. • Acute thrombotic event within the previous 4 weeks. • High acute thromboembolic risk. |
I | ||
| New | It is recommended that VKAs are timely discontinued prior to elective surgery to aim for an INR <1.5. | I | ||
| New | In patients undergoing surgery, it is recommended that aspirin therapy, if indicated, is maintained during the periprocedural period. | I | ||
| New | In patients who have undergone valve surgery with an indication for postoperative therapeutic bridging, it is recommended to start either UFH or LMWH 12-24 hours after surgery. | I | ||
| New | In patients with MHVs, it is recommended to (re)-initiate VKAs on the first postoperative day. | I | ||
| New | In patients treated with DAPT after recent PCI (within 1 month) who need to undergo heart valve surgery, in the absence of an indication for OAC, it is recommended to resume the P2Y12 inhibitor postoperatively, as soon as there is no concern over bleeding. | I | ||
| New | In patients treated with DAPT after recent PCI (within 1 month) who need to undergo heart valve surgery, in the absence of an indication for OAC, bridging P2Y12 inhibitors with glycoprotein IIb/IIIa inhibitors or cangrelor may be considered. | IIb | ||
| Patients with an indication to concomitant antiplatelet therapy | ||||
| Revised | In patients undergoing an uncomplicated PCI dual therapy comprising VKA and clopidogrel (75 mg/day) should be considered as an alternative to 1-month triple antithrombotic therapy in patients in whom the bleeding risk outweighs the ischaemic risk. | IIa | After uncomplicated PCI or ACS in patients requiring long -term OAC, early cessation (≤1 week) of aspirin and continuation of dual therapy with OAC and a P2Y12 inhibitor (preferably clopidogrel) for up to 6 months (or up to 12 months in ACS) is recommended if the risk of stent thrombosis is low or if concerns about bleeding risk prevail over concerns about risk of stent thrombosis, irrespective of the type of stent used. | I |
| New | Discontinuation of antiplatelet treatment in patients treated with an OAC is recommended after 12 months. | I | ||
| New | In patients treated with a VKA (e.g. MHVs), clopidogrel alone should be considered in selected patients (e.g. HAS-BLED ≥3 or ARC-HBR met and low risk of stent thrombosis) for up to 12 months. | IIa | ||
| New | In patients requiring aspirin and/or clopidogrel in addition to VKA, the dose intensity of VKA should be considered and carefully regulated with a target INR in the lower part of the recommended target range and a time in the therapeutic range >65-70%. | IIa | ||
| New | After uncomplicated PCI or ACS in patients requiring both OAC and antiplatelet therapy, triple therapy with aspirin, clopidogrel and OAC for longer than 1 week should be considered when the risk of stent thrombosis outweighs the risk of bleeding, with a total duration (≤1 month) decided according to assessment of these risks and clearly specified at hospital discharge. | IIa | ||
| Surgical valve replacement | ||||
| New | NOACs should be considered over VKA after 3 months following surgical implantation of a BHV, in patients with AF. | IIa | ||
| New | In patients with no baseline indications for OAC, low-dose aspirin (75-100 mg/day) or OAC using a VKA should be considered for the first 3 months after surgical implantation of an aortic BHV. | IIa | ||
| New | NOACs may be considered over VKA within 3 months following surgical implantation of a BHV in mitral position in patients with AF. | IIb | ||
| Transcatheter Aortic Valve Implantation | ||||
| New | OAC is recommended lifelong for TAVI patients who have other indications for OAC. | I | ||
| Revised | SAPT may be considered after TAVI in the case of high bleeding risk. | IIb | Lifelong SAPT is recommended after TAVI in patients with no baseline indication for OAC. | I |
| New | Routine use of OAC is not recommended after TAVI in patients with no baseline indication for OAC. | III | ||
| Section 11. Recommendations on management of prosthetic valve dysfunction | ||||
| Haemolysis and paravalvular leak | ||||
| New | Decision on transcatheter or surgical closure of clinically significant paravalvular leaks should be considered based on patient risk status, leak morphology, and local expertise. | IIa | ||
| Bioprosthetic thrombosis | ||||
| New | Anticoagulation should be considered in patients with leaflet thickening and reduced leaflet motion leading to elevated gradients, at least until resolution. | IIa | ||
| Bioprosthetic failure | ||||
| New | Transcatheter valve-in-valve implantation in the mitral and tricuspid position may be considered in selected patients at high-risk for surgical re-intervention. | IIb | ||
| ACS: acute coronary syndrome; AF: atrial fibrillation; ARC-HBR: Academic Research Consortium - high bleeding risk; BHV: biological heart valve; BNP: B-type natriuretic peptide; BSA: body surface area; CABG: Coronary artery bypass grafting; CCT: cardiac computed tomography; CRT: cardiac resynchronization therapy; DAPT: dual anti-platelet therapy; EuroSCORE: European System for Cardiac Operative Risk Evaluation; GDMT: guideline-directed medical therapy; INR: international normalized ratio; LA: left atrium/left atrial; LAA: left atrial appendage; LMWH: low-molecular-weight heparin; LV: left ventricle/left ventricular; LVEDD: left ventricular end-diastolic diameter; LVEF: left ventricular ejection fraction; LVESD: Left ventricular end-systolic diameter; MHV: mechanical heart valve; NOAC: non-vitamin K antagonist oral anticoagulant; OAC: oral anticoagulation; PCI: percutaneous coronary intervention; RV: right ventricle/right ventricular; SAPT: single antiplatelet therapy; SAVR: surgical aortic valve replacement; SMR: secondary mitral regurgitation; SPAP: systolic pulmonary arterial pressure; STS-PROM: Society of Thoracic Surgeons - predicted risk of mortality; TAVI: transcatheter aortic valve implantation; TEER: transcatheter edge-to-edge repair; UFH: unfractionated heparin; VHD: valvular heart disease; VKA: vitamin K antagonist; Vmax: peak transvalvular velocity. | ||||