Dr.ssa Loredana Iannetta. Centro Cardiologico Monzino

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1 Dr.ssa Loredana Iannetta Centro Cardiologico Monzino

2 Bicuspid aortic valve BAV is the most common congenital cardiac anomaly. Estimated incidence is 2% in general population. 4:1 male predominance. Frequency of BAV in TAVI and AVR cohorts. Zhao ZG, et al. Nat Rev Cardiol

3 TAVI in BAV from 33 centers vs. tricuspid from 12 centers starting in 2013 Supplemental Table 1. Baseline Characteristics Unadjusted cohort Bicuspid AS Tricuspid AS (n = 561) (n = 4546) p value Age, years 76.5 ± ± 7.3 < Male 352 (62.7) 2323 (51.1) < NYHA functional class III or IV 454 (80.9) 3598 (81.1) 0.90 Logistic EuroSCORE, % 14.8 ± ± STS score, % 5.0 ± ± 8.8 < Hypertension 387 (69.0) 3608 (79.4) < Diabetes mellitus 131 (23.4) 1303 (28.7) Creatinine, mg/dl 1.2 ± ± Peripheral vascular disease 85 (15.2) 1031 (22.7) < Prior cerebrovascular accident 84 (15.0) 618 (13.6) 0.37 Chronic lung disease 101 (18.0) 1045 (23.0) Prior PCI 119 (21.2) 1254 (27.6) Prior CABG 57 (10.2) 815 (17.9) < Echocardiographic findings Mean gradient, mm Hg 49.8 ± ± 16.2 < Aortic valve area, cm ± ± LVEF, % 51.2 ± ± 13.8 < Procedural data Yoon SH et al. J Am Coll Cardiol 2017

4 TAVI in BAV It is well known that bicuspid valve stenosis can be treated with TAVI even if specific issues can cause problems: dilatation of ascending aorta possible aorthopathy eccentricity of the valve calcium distribution in leaflets and in commissures Our BAV classification: TYPE 0 2 cusps and no raphe TYPE 1 2 cusps and one or more raphes

5 Bicuspid aortic valves Sievers HH, Schmidtke C. A classification sys- tem for the bicuspid aortic valve from 304 surgical specimens. J Thorac Cardiovasc Surg 2007;133:

6 AORTIC DISSECTION Aortic dissection incidence in bicuspid valve: 3.1/ pts/year,in bicuspid TAVI 2%. Aortic dissection incidence in general population: / pts/year, in tricuspid TAVI 0,38.

7 AORTIC DISSECTION: main causes Balloon expandable valves. Aorthopaty. Increased diameters of thoracic aorta.

8 TAVI: coronary ostia

9 Bicuspid aortic valves Type 0 Purely bicuspid valve 2 cusps and no raphe Type 1 1 or more raphe corresponding to one or more commissures, underdeveloped and obliterated For the procedure outcomes what is important? Is the truly bicuspid shape

10 At anular level the radial force is high in order to assume a circular shape. But if elliptical shape is achieved at anular level, being the level of functioning valve high, it remains round and not deformed. Images courtesy of Drs. De Jaegere and Schultz, Erasmus MC, Rotterdam, The Netherlands CoreValve and Evolut R Systems Overview Medtronic - Confidential 11

11 Difference between tricuspid and bicuspid aortic valve. Review of 17 studies (series and case report) Bicuspid Aortic Valve n=152 Tricuspid Aortic Valve n=3318 Age (yy) <0.001 Ascending aortic size (mm) <0.001 Post TAVI moderate-severe AR 12.9 % 8.3 % 0.06 Post TAVI mean aortic gradient (mmhg) <0.001 Aortic dissection 2.0 % 0.4 % day survival 91% 90% ns FU survival 81% 80% ns Nature Reviews-Cardiology p

12 Aims of the study The aim of the present study is to compare the results of two types of valve (CoreValve from 2009 to 2016 and Lotus valve from 2014 to 2017) in a consecutive series of BAV patients treated in 2 Italian centers. A total of 30 patients with BAV undergone TAVI from September 2009 to March 2017.

13 Baseline characteristics Patient baseline characteristics TOTAL (n=30) CoreValve (n=16) Lotus (n=14) p-value Age 77.6± ± ± Male 60% (18) 56.3%(9) 64.3% (9) NYHA III 74.1% (20) 69.2%(9) 78.6%(11) NYHA IV 3.7%(1) 7.7%(1) 0.0%(0) Log Euroscore 24.67± 24.7± ±5.8 <0.001 Hypertension 75.9%(22) 86.7%(13) 64.3%(9) Diabetes 27.6%(8) 13.3%(2) 42.9%(6) Current smoker 6.9%(2) 6.7%(1) 7.1%(1) BMI 25.1± ± ± Creatinine (mg/dl) 1.1± ± ± Peripheral vasculopathy 8.3%(2) 10.0%(1) 7.1%(1) Previous stroke or TIA 7.1%(2) 7.1%(1) 7.1%(1) Previous PCI/CABG 20%(6) 25.0%(4) 14.3%(2) Mean gradient 59.3± ± ± AVA (mm 2 ) 0.6± ± ± LVEF (%) 50.8± ± ± Pre procedural Aortic regurgitation 26.7%(8) 25%(4) 29%(4) Valve area CT (mm 2 ) 254.6± ± ± Ascending aorta (mm) 40.3± ± ±

14 Baseline characteristics Procedural characteristics TOTAL (n=30) CoreValve (n=16) Lotus (n=14) P-value Trans-femoral access 100%(30) 100%(16) 100%(14) Size (mm) 26.7± ± ±1.2 <0.001 BAV type %(9) 35.7%(5) 28.6%(4) BAV type %(19) 64.3%(9) 71.4%(10) Post-dilatation 23.3%(7) 43.8%(7) 0.0% (0) Device size in group1 was more often bigger than in group 2 (p<0.001)

15 Periprocedural outcomes Periprocedural outcomes TOTAL (n=30) CoreValve (n=16) Lotus (n=14) P-value Procedure-related death 0.0% 0.0% 0.0% --- Conversion to surgery 0.0% 0.0% 0.0% --- Coronary obstruction 0.0% 0.0% 0.0% --- Aortic root injury 0.0% 0.0% 0.0% --- Implantation of 2 valves 3.3%(1) 6.2%(1) 0.0%(0) 1.00 Angio AR post %(16) 57,1%(8) 57.1%(8) Angio AR post %(4) 28.6%(4) 0%(0) 0.05 New permenent pacemaker 37.9%(11) 40.0%(6) 35.7%(5) Creatinine peak post 1.1± ± ± LVEF post 49.6± ± ± AR post 1/2 7.7%(2) 0.0%(0) 14.3%(2) AR post %(5) 41.7%(5) 0%(0) 0.035

16 Periprocedural outcomes Group 1 had a significant more frequent aortic regurgitation 2 assessed with angiography (28.6% vs 0%; p= 0.05). A non-statistically significant higher rate of second valve implantation (6.2% vs 0%; p=0.157) was also observed. New permanent pacemaker implantation (40.0% vs 35.7%; p= 0.812) was equal in both valves.

17 Procedural outcomes with new generation devices Yoon SH et al. JACC 2016 and 2017

18 Biscuspid TAVI tips and tricks To undersize the balloon used for pre-implantation BAV Higher implantation Valve-in-valve implantation if severe regurgitation is present 2 1

19 Bicuspid aortic valve in pregnancy Pregnant women with a severely stenotic BAV may experience cardiovascular deterioration % of pregnant severely stenotic BAV patients experience complications. High therapeutic abortion rate. Complication Report, n (%) Case, n (%) Aortic stenosis 9 (37.5) 18 (52.9) Aortic dissection 10 (41.7) 11 (32.4) Infective endocarditis 3 (12.5) 3 (8.8) Aortic regurgitation 2 (8.3) 2 (5.9) Yuan SM. Bicuspid aortic valve in pregnancy. Taiwan J Obstet Gynecol. 2014; 53(4):

20 Hemodinamic changes in pregnancy Decreased cardiac output Congestive heart failure (42%) During preconceptional evaluation a woman with severe aortic stenosis should be discouraged from becoming pregnant, particularly if functional heart capacity is reduced. Increased heart rate Myocardial ischemia

21 Bicuspid aortic valve in pregnancy The transvalvular pressure gradients and calculated aortic valve areas in 18 pregnant patients with stenotic BAVs were collected from nine reports Yuan SM. Bicuspid aortic valve in pregnancy. Taiwan J Obstet Gynecol. 2014; 53(4):

22 BAV in pregnancy: current treatment strategies Clinical status Mild AS with normal LVEF before pregnancy Treatment Manage conservatively throughout pregnancy with medical supervision and close monitoring. Severe AS before pregnancy Treat AS before pregnancy and counseling regarding pregnancy Symptomatic AS before the end of 1st trimester MTP strongly recommended/percutaneous BAV Severe AS with CHF in 2nd trimester Symptomatic AS with CHF and viable fetus (>28 wks) Symptomatic AS at term pregnancy (3rd trimester) Asymptomatic severe AS with pregnancy and viable fetus AS with high risk of AVR with pregnancy BAV or AVR followed by vaginal/cesarean delivery at term[9,20] BAV/AVR as life saving procedures LSCS combined with AVR BAV/AVR before labor and delivery. Conservative treatment (bed rest, beta blockers, oxygen therapy) - Vaginal/ LSCS delivery as per obstetric indication,[12,17] AVR after three months. BAV as a bridge to surgery Datt V et al. Anesthetic management for emergency cesarean section and aortic valve replacement in a parturient with severe bicuspid aortic valve stenosis and congestive heart failure. Ann Card Anaesth 2010;13(1):64-8

23 BAV in pregnancy: anatomic issues BAV is associated with dilatation of the ascending aorta in 30% to 50% of patients. Awareness of the association between BAV and aortopathy. Pregnancy as a risk factor for dissection is longstanding but weak.

24 BAV in pregnancy: anatomic issues The incidence of aortic dissection in women with aortopathies is already increased in BAV patients with Turner syndrome, Marfan syndrome. Aortic diameter is a predictor of dissection in patients with BAV. Wanga Set al. Pregnancy and Thoracic Aortic Disease: Managing the Risks. Can J Cardiol Jan;32(1):78-85.

25 BAV in pregnancy: anatomic issues 88 women with congenital BAV residing in Olmsted County were identified McKellar SH, et al. Frequency of cardiovascular events in women with a congenitally bicuspid aortic valve in a single community and effect of pregnancy on events. Am J Cardiol 2011; 107(1):96-9.

26 Guidelines ESC 2014 ACC/AHA 2014

27 BAV in pregnancy What about TAVI in pregnant patiants with severely stenosed BAV?

28 Conclusions TAVI in BAV patients with severe stenosis is feasible and safe even if specific issues are still present: POST-PROCEDURAL AORTIC REGURGITATION Lotus valve, with a higher radial force put in a small annuls seems associated to better procedural outcomes in this subset of patients.

29 Conclusions Can TAVI be a feasible and safe alternative to balloon valvuloplasty and AVR during pregnancy?

Andrzej Ochala, MD Medical University of Silesia, Katowice, Poland

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