balloon aortic valvuloplasty

Balloon Aortic Valvuloplasty

AATS Sept. 2005

Peter C. Block M.D.Andreas Gruentzig Cardiovascular CenterEmory University

“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 wouldimmediately 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

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

Balloon Valvuloplasty:The History

• 1950’s Intraoperative dilatation for valve conservation• 1982 Pulmonary 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

What is the role of Balloon Aortic What is the role of Balloon Aortic Valvuloplasty in 2005?Valvuloplasty in 2005?

1) Neonatal, childhood and adolescent applications are well established.

2) Fetal application remains experimental.

3) The rare adult with AS

Aortic Valve ReplacementNew 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%

Aortic StenosisSurvival Survival without without

InterventionIntervention

0102030405060708090

100

Act

uari

al

surv

ival

- %

1 2 3 years

ASControl

Ross J. Circ 1968; 37, Suppl V

O’Keefe et el. 1987.

Carabello, B. A. N Engl J Med 2002;346:677-682

So… what about valvuloplasty?

Balloon Aortic ValvuloplastyMajor 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


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

Balloon Aortic ValvuloplastyHemodynamic results

0

0.2

0.4

0.6

0.8

1

valv

e ar

ea

- cm

2

Pre

Post


Acute Hemodynamic Results

44% M; 56%F; 78 ±9 yrs Before After BAV p

Valve Gradient, mmHg

Mean

Peak to peak

55 ±21

65 ±28

29 ±13

31 ±18

<0.0001

Valve Area, cm2 0.5 ±0.2 0.8 ±0.3 <0.0001

Cardiac output, L/min 4.0 ±1.2 4.1 ±1.3 <0.0001

Aortic Pressure, mmHg 87 ±16 90 ±17 <0.0001

LV systolic Pressure, mmHg 196 ±39 172 ±32 <0.0001

LVEDP, mmHg 22 ±9 19 ±9 <0.0001

PA Pressure, mmHg 31 ±13 30 ±12 <0.0001

674 pts in NHLBI Registry

Circ 1991;84:2383-2397

Balloon Aortic ValvuloplastyAcute Hemodynamic Results

Valve AreaValve Area

AVA increased 0.5 ±0.2 to 0.8 ±0.3 cm2

Range 0.1 – 1.4 to 0.1 – 3.4 cm2

– 77% Δ AVA < 0.4 cm2

– 13% Δ AVA 0 cm2

– AVAF ≥ 1cm2 in only 29%

“Start with AS and end with AS”

Circ 1991;84:2383-2397

NHLBI. n = 674


Effect of Procedural variables

Mansfield Registry

1 v 2

Balloon

Balloon Size

Inflatns

Largest B

Inflation

Time Total #

Inflations

Balloon

Exchanges

Final

Valve Area ns ns ns 0.008 ns ns

Δ Valve Area ns ns ns ns ns ns

Final Gradient ns ns ns ns 0.003 0.001

Δ Gradient 0.009 ns ns ns 0.006 0.02

McKay 1991 JACC

“..the optimal technique . . . . not yet defined”

n = 492; < or > 20mm

< or > 30 sec

Balloon Aortic Valvuloplasty30 Day Functional Status30 Day Functional Status

0%

25%

50%

75%

100%

Pre Post

IVIIIIII

0%

25%

50%

75%

100%

Pre Post

25-050-2675-51100-76

NYHA Functional Class

(364 improved)

Functional Class Score

(257 improved)484 Survivors from NHLBI Registry


Hemodynamic Follow-upMansfield Registry

00.20.40.60.8

11.21.41.61.8

2

0 0.5 1 1.5 2

00.20.40.60.8

11.21.41.61.8

2

0 0.5 1 1.5 2

AVA Baseline - cm2

AVA Baseline - cm2

Post BAV

6 month f/u *

Bashore JACC 1991:1188

n = 95 n = 95

6.2 ±3.3 mnths


Hemodynamic Follow-up

Pre BAV Post BAV 6m f/u

AVA cm2 0.56 0.87 0.63

m AVG mmHg 72 35 55

P-P AVG mmHg 59 32 51

LV EF % 49 53

LVeDP mmHg 19 16 19


6.2 ±3.3 mnths

n = 95 Mansfield Registry


Complications - %

Death CVA Perfn MI AR Vasc

Mansfield .

Registry (492)

7.5 2.2 1.8 0.2 1.0 11

NHLBI (674) 3.0 4.6 1 1 1 27

Cribier (334) 4.5 1.4 0.6 0.3 0 13.1

Safian (225) 3.0 0.4 1.2 0.5 0.8 7.5

Block (308) 5.0 2.0 0.3 0.5 0 9.0

Lewin (125) 10.4 3.2 0 1.6 1.6 9.6

Balloon Aortic ValvuloplastyArteriotomy 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


Mortality - %

nIn

Hospital30

Day6

Month

1 year 2 year 3 year

NHLBI 674 3* 14 45 65 77

Mansfield

492 7.5 14 36 65 77

Safian 170 26

Kuntz 205 4.4 25 40

Cribier 334 4.4 24 34

Block 90 8.8 30

Ferguson

73 0 17

Lewin 125 10.4 12 38

* Procedural

Balloon Aortic ValvuloplastyPredictors of 30 day Mortality

NHLBI Lewin Ferguson Lieberman Kuntz

n = 674 n = 125 n = 73 n = 165 n = 205

♂ & older age Older age

Prior MI

CO <3.0L/min C.O.

BUN >30

CHF CHF

Shock SBP <110

LV EF LV EF LV EF PCWP >25

CAD CAD

<AVA / ΔAVA Δ AVA

Variables identified in multivariate analysis


Clinical Follow-up

Pre (%) 6m f/u (%) p

CHF 54 49 ns

Fatigue 59 61 ns

Dyspnoea 87 71 ns

NYHA III/IV 71 57 <0.05

Angina 53 33 <0.05

Syncope 23 12 <0.05


6.2 ±3.3 mnths

n = 95

Mansfield Registry Data

Balloon Aortic ValvuloplastyLong Term Follow up

0

50

100

150

200

250

0 6 12 18 24 30 36 42

Event FreeSurvival

Kuntz R NEJM 1991;325:17

Months

Balloon Aortic Valvuloplasty Why such poor outcomes ?

The patient•Medical Co-morbidities•Coronary Artery Disease

– ≥50% of patients•Inadequate residual valve area

– < 1 cm2 in most patients post procedure

The procedure

•Fracture of calcific nodules

•Commissural splitting

•Annular stretching

Aortic Stenosis

Recommendations for Aortic Balloon Valvotomy Recommendations for Aortic Balloon Valvotomy in Adults With Aortic Stenosisin Adults With Aortic Stenosis

Indication Class

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 surgery

IIb

As an alternative to AVR IIIBonow et al. 1998 ACC/AHA Task Force

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 ?

Balloon Aortic ValvuloplastyBalloon Aortic Valvuloplasty (may) will be necessary again…..

as a preliminary to Perc. AVR

But wait……

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

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

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

1. BAV may hold some valuable lessons

balloon aortic valvuloplasty

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