Two in ten severe MR patients can die within 1 year without intervention.5
Treatment options
The main treatment options for patients with mitral regurgitation (MR) are guideline-directed medical therapy (GDMT), surgical intervention and transcatheter treatment. Treatment options vary depending on the type of MR: degenerative mitral regurgitation (DMR) or functional mitral regurgitation (FMR).1
DMR
Despite millions of cases in an aging population, DMR is still substantially undertreated.2
Only 15% of patients aged 80 years or older, diagnosed with moderate or severe MR (DMR/FMR), underwent valve surgery.2
Surgery saves lives, but many patients do not meet the criteria.2,4
96.3 1-year survival rates for patients with severe symptomatic MR who received surgical intervention.4
49% of patients with symptomatic MR are denied surgery, influenced by older age, comorbidities and impaired left ventricular ejection fraction (LVEF).4,5
A less invasive option is needed for patients at high surgical risk.6
A patient with severe heart failure, for them undergoing open heart surgery is a huge strain.*
-Dr.med. Leonhard Schneider
University Heart Centre Ulm, Ulm, Germany
*Expert opinions, advice and all other information expressed represent contributors' views and not necessarily those of Edwards Lifesciences.
Transcatheter edge-to-edge repair (TEER) has shown significant and sustained MR reduction and durable patient benefits7
From the 2-year outcomes of the CLASP IID trial, TEER has shown significant and sustained MR reduction in patients with severe, symptomatic DMR at prohibitive surgical risk at 2 years.7
79% of patients achieved significant and sustained MR reduction (MR ≤1+)*
88% of patients achieved NYHA class I/II
89% freedom from cardiovascular mortality
+17 points KCCQ-OS improvement
*Data from unpaired analysis. The presented MR reduction was achieved using the PASCAL system.
KCCQ-OS: Kansas City Cardiomyopathy Questionnaire Overall Summary Score; MR: mitral regurgitation; NYHA: New York Heart Association.
FMR
Severe FMR is seen in about 25% of heart failure (HF) with reduced ejection fraction (HFrEF) patients.8 Four drug classes are proving to reduce morbidity and mortality in patients with chronic HFrEF.9
The conventional approach to the implementation of the core pharmacological treatments for HFrEF may not be optimal, and alternative approaches, such as rapid sequencing, could lead to a substantial reduction in lives lost and hospitalisations for worsening HF.10
The 2021 update to the European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic HF introduces a simplified treatment algorithm for HFrEF, as well as a new algorithm tailored to specific HFrEF phenotypes.11
Convention: Sequential approach9
Initiation of all four foundation drug classes one after the other; up-titration to target dose at each step.
New: Rapid sequencing9
Initiation of all four foundation drug classes within 4 weeks; up-titration to target doses after all steps.
Could improve the implementation of treatments that reduce morbidity and mortality.
ACE-I: angiotensin-converting-enzyme inhibitors; ARB: angiotensin receptor blocker; ARNI: angiotensin receptor neprilysin inhibitor; MRA: mineralocorticoid receptor antagonist; SGLT2i: sodium–glucose co-transporter 2.
All foundation drug classes are Class I recommendations.
Barriers to GDMT implementation12
In a real-world setting, up to 42% of HFrEF patients are not optimally managed on GDMT.13
29% increased risk of mortality for every year of inadequate GDMT.13
When symptoms of severe FMR persist despite GDMT and surgery isn't an option, minimally invasive treatments are available.
2021 ESC Heart Failure guidelines support TEER for patients with severe FMR with the following recommendations:11
The following patients should be considered for TEER:
- Ineligible for surgery
- Symptomatic despite GDMT*
- Don’t need coronary revascularisation
- And who fulfil criteria for reducing HF hospitalisations†
The following patients may be considered for TEER:
- Ineligible for surgery
- Symptomatic despite GDMT*
- Don’t need coronary revascularisation
- And who DON’T fulfil criteria for reducing HF hospitalisations
*Patients with advanced HF should be re-evaluated every 3–6 months; †All of the following criteria must be fulfilled: LVEF 20–50%, LVESD <70 mm, systolic pulmonary pressure <70 mmHg, absence of moderate or severe right ventricular dysfunction or severe TR, absence of haemodynamic instability.
HF: heart failure; LVESD: left ventricular end systolic diameter; TR: tricuspid regurgitation.
Help your patients start a new chapter with TEER
References
- Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2022;43(7):561–632. doi:10.1093/eurheartj/ehab395.
- Taramasso M, Gaemperli O, Maisano F. Treatment of degenerative mitral regurgitation in elderly patients. Nat Rev Cardiol. 2015;12(3):177–183. doi:10.1038/nrcardio.2014.210.
- Dziadzko V, Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: A community cohort study. Lancet. 2018;391(10124):960–969. doi:10.1016/s0140-6736(18)30473-2.
- Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358–1365. doi:10.1093/eurheartj/ehm001.
- Welman MJM, Streukens SAF, Mephtah A, et al. Outcomes of mitral valve regurgitation management after Expert Multidisciplinary Valve Team evaluation. J Clin Med. 2024;13(15):4487. doi:10.3390/jcm13154487.
- Iung B, Urena M. New insights into transcatheter edge-to-edge repair: Filling a gap for undertreatment of primary mitral regurgitation in the elderly? Eur Heart J. 2022. doi:10.1093/eurheartj/ehac039.
- Makkar R. CLASP IID randomised trial and registry: Two-year outcomes of transcatheter edge-to-edge repair for degenerative mitral regurgitation. PCR London Valves; 24–26 November 2024, London, UK.
- Bartko PE, Heitzinger G, Pavo N, et al. Burden, treatment use, and outcome of secondary mitral regurgitation across the spectrum of heart failure: observational cohort study. BMJ. 2021;373:n1421. doi:10.1136/bmj.n1421.
- Packer M, McMurray JJV. Rapid evidence-based sequencing of foundational drugs for heart failure and a reduced ejection fraction. Eur J Heart Fail. 2021;23(6):882–894. doi:10.1002/ejhf.2149.
- Shen L, Jhund PS, Docherty KF, et al. Accelerated and personalized therapy for heart failure with reduced ejection fraction. Eur Heart J. 2022;43(27):2573–2587. doi:10.1093/eurheartj/ehac210.
- McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2021;42(36):3599–3726. doi:10.1093/eurheartj/ehab368.
- Malgie J, Clephas PRD, Brunner-La Rocca HP. Guideline-directed medical therapy for HFrEF: Sequencing strategies and barriers for life-saving drug therapy. Heart Fail Rev. 2023;28(5):1221–1234. doi:10.1007/s10741-023-10325-2.
- McCullough PA, Mehta HS, Barker CM, et al. Mortality and guideline-directed medical therapy in real-world heart failure patients with reduced ejection fraction. Clin Cardiol. 2021;44(9):1192–1198. doi:10.1002/clc.23664.
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Medical device for professional use.
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