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STANDARD MEDICAL THERAPY* 20% ABSOLUTE REDUCTION in all-cause mortality at one year22 Balloon-expandable Transcatheter Aortic Valve Implantation (TAVI) Aortic Stenosis A brief summary of prevalence, guidelines, new treatment options, and current data New Options for Aortic Valve Replacement Epidemiological studies have determined that more than one in eight people aged 75 and older have moderate or severe aortic stenosis (AS).1 Multiple surveys have shown that many patients with severe AS are not referred to a heart team for valve replacement evaluation.2 Surgical aortic valve replacement (SAVR) is the gold standard for treatment of severe AS and transcatheter aortic valve implantation (TAVI) offers a new treatment option for patients considered high risk for surgery. Here is how you can help. A o r t i c Va lv e D i s e a s e I s C o m m o n i n E l d e r ly P a t i e n t s “Valvular heart diseases represent an under appreciated yet serious and growing public health problem that should be addressed.” —V.T. Nkomo, Mayo Clinic, USA3 Prevalence of Valvular Heart Disease by Age 3 As the chart illustrates, aortic valve disease is common and its prevalence increases with age. For people over the age of 75 years, the prevalence of aortic stenosis is 5%.4 More than one in eight people over the age of 75 have moderate or severe valve disease.1 As the population ages, this condition becomes an important public health problem.3 P R EVA LE NCE O F MO DE RATE O R SE VE R E VALVE DISE ASE 14% All valve disease Mitral valve disease Aortic valve disease 12% 10% 8% 6% 4% 2% 0 45 45-54 55-64 A GE (YEARS) 2 65-74 >75 Aortic Stenosis I s L i f e - T h r e at e n i n g “Unless investigation and surgery can be performed very quickly, death, whether sudden or not, is still unacceptably common in severe aortic stenosis.” —J.B. Chambers & P. Das, Guy’s and St. Thomas’ Hospitals, London25 Progression of Aortic Stenosis 6 Onset Severe Symptoms 100 S URVIVAL % Latent Period (Increasing Obstruction, Myocardial Overload) 80% 60% ANGINA SYNCOPE FAILURE 0 2 4 6 AV ER AGE SURV IVAL (Y EARS) 40% 20% 0 40 80 A G E ( YE AR S ) Valvular aortic stenosis is progressive and life-threatening. Once symptoms appear, untreated patients have a poor prognosis; they will experience worsening symptoms, eventually leading to death. After the onset of symptoms, average survival is 50% at two years and 20% at five years.7 3 A ORTIC STENOSIS T r e at m e n t G u i d e l i n e s “Surgical intervention should be performed promptly once even minor symptoms occur.” —C.M. Otto, University of Washington School of Medicine, Seattle, Washington6 ESC/EACTS AS Treatment Guidelines 8 Severe AS Symptoms No Yes LVEF < 50% No Contraindication for AVR Yes Physically active No Yes No Yes High risk for AVR Short life expectancy Exercise test No Symptoms or fall in blood pressure below baseline No Yes Yes TAVI Med Rx Yes Presence of risk factor and low/intermediate individual surgical risk No No Yes AVR AVR or TAVI Re-evaluate in 6 months According to the ESC Guidelines, severe AS is defined by these characteristics: • Aortic valve area: < 1cm2 • Jet Velocity: > 4.0m/sec • Mean transvalvular pressure: > 40mmHg The 2012 ESC/EACTS guidelines for AS recommend valve replacement for Class I patients, i.e. those with severe AS and symptoms 8. TAVI is indicated in patients with severe symptomatic AS who are not suitable for AVR as assessed by a “heart team” and should be considered in high risk patients who may still be suitable for surgery, but in whom TAVI is favoured by a “heart team” based on the individual risk profile.8 4 2 T r e at m e n t I s U r g e n t a n d A o r t i c Va lv e R e p l a c e m e n t i s E f f e c t i v e Patient Survival 1 0 100 90 % Survival 80 70 60 50 40 AV AV No No 30 20 10 0 0 1 2 3 4 5 AVR, Asymptomatic AVR, Symptomatic No AVR, Asymptomatic No AVR, Symptomatic 13 14 15 6 7 8 9 10 11 12 13 14 15 YEARS There are no medications to reverse or slow the progression of AS. AVR is the standard of care. Because of the risk of sudden death, AVR should be performed promptly after the onset of symptoms.9 Without timely aortic valve replacement, patients with severe AS and symptoms have high mortality: mortality is 3% to 4% soon after symptoms appear and 7% among patients on a waiting list for AVR. In contrast, mortality in a fit patient is 1% to 2% after AVR.5 In recent decades, surgical AVR has consistently produced outstanding results in prolonging life and improving quality of life.8,11,12,13 Even among patients over the age of 80 years, functional outcomes have been excellent in patients after AVR.13 Survival is good, with 60% to 65% of patients who underwent AVR alive five years later,11,12 with improved quality of life.8 AVR takes patients out of full-time care or sedentary lifestyles, enabling a return to independence. 5 Ma n y A o r t i c S t e n o s i s P a t i e n t s A r e N o t T r e at e d “Too many patients with severe symptomatic valve disease are denied surgery.” —B. Iung, Bichat Hospital, Paris2 Surgery vs No Surgery in AS Pati ents 1 4 Guidelines are not consistently followed. In actual practice, more than one third of patients eligible for AVR are not referred for evaluation. As the chart illustrates, five different surveys identified 30% to 60% of patients not referred for surgery. Additionally, the Euro Heart Survey of 5000 patients from 92 centers in 25 European countries determined that 32.3% of patients over the age of 75 were denied surgery.2 100% 41 80% 33 30 100% 80% 41 33 30 60 48 50 67 70 40 52 Pellikka17 2005 Charlson18 2006 Bach19 2007 60% 40% 20% 0 60 Bouma15 1999 Iung16 2005 No Surgery 48 Surgery 60% R e a s o n s m a n y a o r t i c s t e n o s i s pa t i e n t s d50o n ’ t67 g e t70 n e e 40d e d 52t r e a t m e n t 40% 20% 0 14 Reasons for AVR Non-Referral Charlson Bach Iung Pellikka Bouma15 1999 16 2005 18 17 2005 Patient Preference 12% 2006 19 2007 High Risk 45% AS Not Severe 18% Mild Symptoms 25% 6 Treatment decisions for older patients with severe AS are challenging due to comorbidity; they have a higher operative risk and have reduced life expectancy. In addition, their risk is increased by comorbidities such as heart disease and other conditions that are often present in this age group.8 No S T r a n s c at h e t e r t r e at m e n t o p t i o n add r e s s e s a n u n m e t n e e d “Today, TAVI allows patients who are at very high surgical risk or with contraindications to surgical AVR to benefit from an effective treatment of AS.” —D. Himbert, Bichat-Claude Bernard Hospital, Paris20 Transcatheter Aortic Valve Implantation Transaortic Valve Implantation Transfemoral Valve Implantation Transapical Valve Implantation A new option for patients with severe AS considered to be high risk for surgical AVR is transcatheter aortic valve implantation, or TAVI. In this procedure, the valve is delivered via transfemoral, transapical or transaortic access without open-heart surgery. TAVI received the CE mark in 2007. 7 t h e pa r t n e r t r i a l The PAR TNER Trial Protocol 2 2 Symptomatic Severe Aortic Stenosis ASSESSMENT Operability Yes No Cohort A Cohort B C o h o rt B p o p u l at i o n p r o f i l e Mean age n = 358 n = 700 Yes ASSESSMENT Transfemoral Access No NYHA Class III-IV 93% COPD, O 2 dependent 23% PVD 28% Porcelain aorta 15% Chest wall deformity 1:1 Randomization Transfemoral VS Standard Therapy Not in Study 83 y 7% CAD 71% Frail 23% CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; NYHA, New York Heart Association; PVD, peripheral vascular disease; BAV, balloon aortic valvuloplasty. The PARTNER (Placement of AoRtic TraNscathetER Valves) trial represents a paradigm shift in clinical investigation and interpretability. As the world’s first prospective, randomized, and controlled trial for transcatheter heart valves, the PARTNER trial sets new standards in site selection, case screening, study management, multidisciplinary teamwork, and patient follow-up.22 The PARTNER Trial consists of two individually powered patient cohorts. • In Cohort A, the safety and effectiveness of the Edwards SAPIEN transcatheter heart valve (THV) was compared to surgical aortic valve replacement (sAVR) in high-risk patients with severe aortic stenosis. The results of Cohort A were published in 2011.22 • In Cohort B, the safety and effectiveness of the Edwards SAPIEN THV was compared to best medical management (standard therapy) in inoperable patients with severe aortic stenosis. Patient selection required at least two cardiothoracic surgeons and an interventional cardiologist to agree that patients were not suitable candidates for surgery.22 8 T h e Ed w a r d s S A P IEN TH V S i g n i f i c a n t ly I m p r o v e s S u r v i va l Co-Primary Endpoint: All-Cause Mort ality 2 2 All-Cause Mortality, % 100 P < .001 ∆ at 1 y = 20.0% NNT = 5.0 pts 80 “On the basis of a rate of death from any cause at 1 year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery.” Standard Medical Therapy* 50.7% 60 Edwards THV 40 30.7% 20 0 0 6 12 18 24 Months —The Partner trial Investigators21 * P a t i e n t s i n co n tro l arm recei ved bes t m edic a l ma na ge me nt whic h f requ en tl y (7 8 .2 %) i n cl u ded bal l o o n aortic va lvulop la sty. T h e Ed w a r d s S A P IEN TH V S i g n i f i c a n t ly I m p r o v e s P a t i e n t Symptoms and Quality of Life —David J. Cohen, St Luke’s Mid-America Heart and Vascular Institute, Kansas City, Missouri23 Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores Over T ime 2 1 MCID = 5 pts 70 6070 5060 KCCQ Score KCCQ Score “The dramatic improvement in quality of life scores in the Edwards SAPIEN THV group is equivalent to a 10-year reduction in age.” MCID = 5 pts 4050 3040 ∆ = 13.9 P < .001 ∆ = 13.9 P < .001 2030 1020 010 0 0 2 0 4 2 ∆ = 20.7 P < .001 ∆ = 20.7 P < .001 6 8 4Months 6 ∆ = 24.5 P < .001 ∆ = 24.5 P < .001 10 8 12 10 12 Months Edwards THV Edwards THV Control* Control* *Pa tie nts in c ontrol a rm re c e ive d b e st me d ic a l ma na ge me nt whi ch fre q ue ntly (78.2%) inc lud e d b a lloon a ortic va lvulop la sty. 9 R e f e r S y m p t o m at i c A o r t i c s t e n o s i s Pat i e n t s t o a H e a r t T e a m Heart Team Evaluation Patient is referred to a heart team Low Risk Surgical AVR High Risk Transcatheter Valve Implantation Balloon Aortic Valvuloplasty Medical Management An increasing number of heart centers offer all of the available AS solutions. Referral to such a center offers the most options for your patients. A multidisciplinary approach is necessary in order to direct each patient toward the best therapeutic option. The team will evaluate patients for surgical AVR, balloon valvuloplasty, TAVI, or medical management. 10 N e w T r e a t m e n t Op t i o n s L e ad t o Increased Referral, awareness, a n d p r o p e r t r e at m e n t “A significant population of patients with AS are still treated medically.” —S.C. Malaisrie, Bluhm Cardiovascular Institute, Northwestern University Memorial Hospital, Chicago, Illinois24 Impact of TAVI on Referrals 2 4 80% 70% 60% 50% 40% 30% 20% (A) Unoperated AS (Pre-TAVI vs. Post-TAVI, p=.002) 10% (B) Referral for Surgery (Pre-TAVI vs. Post-TAVI, p=.003) 0 2006 (N=179) 2007 (N=183) 2008 (N=214) Pre-TAVI 2009 (N=265) Post-TAVI YEAR A retrospective study determined that the introduction of TAVI was associated with an increase in aortic valve replacement referrals and a decrease in the rate of unoperated AS. This positive impact was due to increases in both TAVI and AVR volume. Increased volume was not associated with worse patient survival.24 11 Want to Know More? You can access more information on both surgical AVR and TAVI on the Edwards Lifesciences’ web site Edwards.com/eu. The site will also help you to locate a heart center and to identify specialists near you who are trained in the TAVI procedure. References 1. National Heart Lung and Blood Institute, U.S. National Institutes of Health. Heart Valve Disease. Accessed at www.nhlbi.nih.gov/health/dci/Diseases/hvd/hvd_whatis.html. November 12, 2010. 2. lung B, Baron G, Tornos P, et al. Valvular heart disease in the community: a European experience. Curr Probl Cardiol 2007; 32:609-61. 3. Nkomo VT, Gardin JM, Skelton TN et al. Burden of valvular heart diseases: a population-based study. Lancet 2006; 368:1005-11. 4. Lindroos M et al. Epidemiological studies estimate the prevalence of aortic stenosis at 5% in subjects over the age of 75 years. J Am Coll Cardiol 1993; 21:1220-5. 5. Chambers JB. Aortic stenosis. Eur J Echocardiography 2009; 10:111-19. 6. Otto M. Valve disease: timing of aortic valve surgery. Heart 200 Chart. In: Ross J Jr, Braunwald E. Aortic Stenosis. Circulation 1968; 38(suppl 1):61-7. 7. Lester SJ, Heilbron B, Gin K, et al. The natural history and rate of progression of aortic stenosis. Chest 1998; 113:1109-14. 8. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease. Eur Ht J 2012. Aug 24. Epub ahead of print. 9. Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA 2006 Guidelines for the management of patients with valvular heart disease. Circulation 2006 Aug 1; 111(5):e84-231. 10. Brown ML, Pellikka PA, Schaff HV, et al. The benefits of early valve replacement in asymptomatic patients with severe aortic stenosis. J Thorac Cardiovasc Surg 2008; 135(2): 308-15. 11. Conti V, Lick SD. Cardiac surgery in the elderly: indications and management options to optimize outcomes. Clin Geriatr Med 2006; 22:559-74. 12. Chiappini B, Camurri N, Loforte A, et al. Outcome after aortic valve replacement in octogenarians. Ann Thorac Surg 2004; 78:85-9. 13. Sundt TM, Bailey MS, Moon MR, et al. Quality of life after aortic valve replacement at the age of >80 years. Circulation 2000; 102[suppl III]:III-70-111-74. 14. van Geldorp MW, van Gameren M, Kappetein AP, et al. Therapeutic decisions for patients with symptomatic severe aortic stenosis: room for improvement? Eur J Cardiothorac Surg 2009; 35:953-7. 15. Bouma BJ, van Den Brink RB, van Der Meulen JH, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999; 82:143-8. 16. Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 2005; 26:2714-20. 17. Pellikka PA, Sarano ME, Nishimura RA, et al. Outcome of 622 adults with asymptomatic, hemodynamically significant aortic stenosis during prolonged follow-up. Circulation 2005; 111:3290-5. 18. Charlson E, Legedza AT, Hamel MB. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis 2006; 15:312-21. 19. Bach DS, Cimino N, Deeb GM. Unoperated patients with severe aortic stenosis. J Am Coll Cardiol 2007; 50:2018-9. 20. Himbert D, Descoutures F, Al-Attar N, et al. Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis. J Am Coll Cardiol 2009; 54:303-11. 21. Reynolds MR et al; PARTNER Trial Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation 2011; 124(18):1964-1972. 22. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363:1597-1607. 23. Cohen DJ. Health-related quality of life after transcatheter aortic valve implantation vs non-surgical therapy among inoperable patients with severe aortic stenosis. Results from the PARTNER trial. Presented at the American Heart Association’s Scientific Sessions, Chicago, IL, November 2010. 24. Malaisrie SC, Tuday E, Lapin B, et al. Transcather aortic valve implantation decreases the rate of unoperated aortic stenosis. Eur J Cardiotherac Surg; e-pub Jan 11, 2011. 25. Chambers JB, Das P. Treadmill exercise in apparently asymptomatic aortic stenosis. Heart 2001; 86:361-362. *Patients in control arm received best medical management which frequently (78.2%) included balloon aortic valvuloplasty For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/ECC bear the CE marking of conformity. Any quotes used in this material are taken from independent third-party publications and are not intended to imply that such third party reviewed or endorsed any of the products of Edwards Lifesciences. Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation. © 2012 Edwards Lifesciences Corporation. All rights reserved. E3154/08-12/THV Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com