1. Balloon Aortic Valvuloplasty AATS Sept. 2005 Peter C. Block M.D. Andreas Gruentzig Cardiovascular Center Emory University

2. “When it is considered how narrow the opening is, which these constrictions leave, it is difficult to conceive how such an organic derangement can continue for years. It is evident, if such an obstacle to the circulation were suddenly introduced into a healthy subject, death would immediately follow: but as these obstacles are slowly formed, the circulation is gradually impeded and nature seems in some measure to be habituated to such a perversion of her laws.” J. N. Corvisart 1803

3. ACC Guidelines Aortic Stenosis “In the vast majority of adults, AVR is the only effective treatment for severe AS……. Although there is some lack of agreement about optimal timing of surgery, particularly in asymptomatic patients…….” »Bonow et al. ACC/AHA task Force Report

4. Balloon Valvuloplasty: The History 1950’s Intraoperative dilatation for valve conservation 1982Pulmonary Valve in Children - Kan - Pepine 1983 Hypoplastic PV and PA’s – Lock Coarctation – Lock 1984 Aortic stenosis in Children – Lababidi 1983 Mitral stenosis Inoue 1985 Acquired Aortic stenosis in 3 pts– Cribier 1987 Aortic stenosis in Children - Choy 1987 Cribier - 92pts and Block - 55pts 1986 Mansfield Registry 1987 NHLBI Registry

5. What is the role of Balloon Aortic Valvuloplasty in 2005? 1)Neonatal, childhood and adolescent applications are well established. 2) Fetal application remains experimental. 3) The rare adult with AS

6. Aortic Valve Replacement New York State 2002 77,075 Heart Operations 19,057 Valve operations –4943 Isolated Aortic Valve Replacements Mortality 3.54% –4704 Aortic Valve Replacement with CABG Mortality 6.27%

7. Survival without Intervention Aortic Stenosis Survival without Intervention Ross J. Circ 1968; 37, Suppl V O’Keefe et el. 1987. Carabello, B. A. N Engl J Med 2002;346:677-682

8. So… what about valvuloplasty?

9. Balloon Aortic Valvuloplasty Major Series Mansfield Scientific Registry, n = 492 NHLBI Registry, n = 674 Cribier (French Registry), n = 406 Block, n = 375 Safian, n = 170 Lieberman, n = 165 Lewin, n = 125 Ferguson, n = 73

10. Balloon Aortic Valvuloplasty Acute Outcome “Success” ? –Mansfield Registry 87% Success - i.e. alive, no AVR, a significant Δ AVA –NHLBI 95% –Kuntz et al 93% “In absence of data correlating final AVA to clinical response, and in the difficulty in estimating AVA …… Any definition of success is … arbitary” - Bashore et al

11. Balloon Aortic Valvuloplasty Hemodynamic results

12. Balloon Aortic Valvuloplasty Acute Hemodynamic Results 44% M; 56%F; 78 ±9 yrsBeforeAfter BAVp Valve Gradient, mmHg Mean Peak to peak 55 ±21 65 ±28 29 ±13 31 ±18 <0.0001 Valve Area, cm 2 0.5 ±0.20.8 ±0.3<0.0001 Cardiac output, L/min4.0 ±1.24.1 ±1.3<0.0001 Aortic Pressure, mmHg87 ±1690 ±17<0.0001 LV systolic Pressure, mmHg196 ±39172 ±32<0.0001 LVEDP, mmHg22 ±919 ±9<0.0001 PA Pressure, mmHg31 ±1330 ±12<0.0001 674 pts in NHLBI Registry Circ 1991;84:2383-2397

13. Valve Area Balloon Aortic Valvuloplasty Acute Hemodynamic Results Valve Area AVA increased 0.5 ±0.2 to 0.8 ±0.3 cm 2 Range 0.1 – 1.4 to 0.1 – 3.4 cm 2 –77% Δ AVA < 0.4 cm 2 –13% Δ AVA 0 cm 2 –AVA F ≥ 1cm 2 in only 29% “Start with AS and end with AS” Circ 1991;84:2383-2397 NHLBI. n = 674

14. Balloon Aortic Valvuloplasty Effect of Procedural variables Mansfield Registry 1 v 2 Balloon Balloon Size  Inflat ns Largest B Inflation Time Total # Inflations Balloon Exchanges Final Valve Areans 0.008ns Δ Valve Area ns Final Gradient ns 0.0030.001 Δ Gradient 0.009ns 0.0060.02 McKay 1991 JACC “..the optimal technique.... not yet defined” n = 492;  20mm 30 sec

15. 30 Day Functional Status Balloon Aortic Valvuloplasty 30 Day Functional Status NYHA Functional Class (364 improved) Functional Class Score (257 improved) 484 Survivors from NHLBI Registry

16. Balloon Aortic Valvuloplasty Hemodynamic Follow-up Mansfield Registry AVA Baseline - cm 2 Post BAV6 month f/u * Bashore JACC 1991:1188 n = 95 6.2 ±3.3 mnths

17. Balloon Aortic Valvuloplasty Hemodynamic Follow-up Pre BAVPost BAV6m f/u AVA cm 2 0.560.870.63 m AVG mmHg 723555 P-P AVG mmHg 593251 LV EF % 4953 LVeDP mmHg 191619 Bashore JACC 1991:1188 6.2 ±3.3 mnths n = 95 Mansfield Registry

18. Balloon Aortic Valvuloplasty Complications - % DeathCVAPerf n MIARVasc Mansfield. Registry (492) 7.52.21.80.21.011 NHLBI (674) 3.04.611127 Cribier (334) 4.51.40.60.3013.1 Safian (225) 3.00.41.20.50.87.5 Block (308) 5.02.00.30.509.0 Lewin (125) 10.43.201.6 9.6

19. Balloon Aortic Valvuloplasty Arteriotomy management Manual, C-clamp or Femostop Suture closure –Post procedure with 10F sheath –Preclose with 6 or 8F devices Feldman,Michaels, Marchant & Solomon: successful closure with no complications

20. Balloon Aortic Valvuloplasty Mortality - % n In Hospital 30 Day 6 Month 1 year2 year3 year NHLBI6743*14456577 Mansfield4927.514366577 Safian17026 Kuntz2054.42540 Cribier3344.42434 Block908.830 Ferguson73017 Lewin12510.41238 * Procedural

21. Balloon Aortic Valvuloplasty Predictors of 30 day Mortality NHLBILewinFergusonLiebermanKuntz n = 674n = 125n = 73n = 165n = 205 ♂ & older ageOlder age Prior MI CO <3.0L/min  C.O. BUN >30 CHF ShockSBP <110  LV EF PCWP >25 CAD <AVA / ΔAVAΔ AVA Variables identified in multivariate analysis

22. Balloon Aortic Valvuloplasty Clinical Follow-up Pre (%)6m f/u (%)p CHF5449ns Fatigue5961ns Dyspnoea8771ns NYHA III/IV7157<0.05 Angina5333<0.05 Syncope2312<0.05 Bashore JACC 1991:1188 6.2 ±3.3 mnths n = 95 Mansfield Registry Data

23. Balloon Aortic Valvuloplasty Long Term Follow up Kuntz R NEJM 1991;325:17 Months

24. Balloon Aortic Valvuloplasty Why such poor outcomes ? The patient Medical Co-morbidities Coronary Artery Disease – ≥50% of patients Inadequate residual valve area – < 1 cm 2 in most patients post procedure The procedure Fracture of calcific nodules Commissural splitting Annular stretching

25. Aortic Stenosis Recommendations for Aortic Balloon Valvotomy in Adults With Aortic Stenosis IndicationClass I A bridge to surgery in hemodynamically unstable patients who are at high risk for AVR IIa Palliation in patients with serious comorbid conditions IIb Patients who require urgent noncardiac surgeryIIb As an alternative to AVRIII Bonow et al. 1998 ACC/AHA Task Force

26. Balloon Aortic Valvuloplasty ? BenefitsBenefits –Yes, but transient RisksRisks –Yes AlternativesAlternatives –AVR Alters natural history but also carries risk –Percutaneous AVR ? The future? The only role for BAV ?

27. Balloon Aortic Valvuloplasty Balloon Aortic Valvuloplasty (may) will be necessary again….. as a preliminary to Perc. AVR But wait……

28. BAV in autopsied heart. Note cracks in Ca++ nodules

29. X-ray of BAV in autopsied heart (note splits in Ca++ nodules

30. Take home messages: BAV may hold some valuable lessons for the future of Rx of aortic stenosis BAV may still be needed to help rearrange/split/move Ca++ BAV may be needed to allow passage of PAVR devices In the desperately ill pt. BAV may be lifesaving and allow further therapeutic options

31. 1.BAV may hold some valuable lessons