Device Closure of Paravalvular Leak: Imaging in Patient Selection and Device Placement

Brian Griffin MD FACC

Section of Cardiovascular Imaging

Cleveland Clinic

Paravalvular Leak

• Usually at a valve replacement – mechanical or bioprosthetic, also at a ring in repair

• Mitral (7-17%) > aortic (2-10%)

• Most asymptomatic

• Major underlying cause – Technical failure – early – inadequate suturing

– Endocarditis – early or late, often in setting of preexisting infection

– Absence of adequate secure material to sew into

– Calcification of annulus – early or late

– Excess stress at sewing ring – anterolateral mitral annulus

– Percutaneous valve insertion – calcification, incorrect size

Mild Residual Paravalvular AR post TAVR

Excellent

symptomatic

result

2 years out

Paravalvular Leak: Major Sequelae • Often occult - exam, echocardiography

• 1-3% require reoperation or intervention

• Hemodynamic – severe regurgitation,

– low cardiac output,

– pulmonary hypertension with MR

• Hemolysis – due to red blood cell destruction – Jet hitting solid surface – rapid deceleration

– Anemia and frequent transfusion

– Jaundice, gallstones, high LDH, fragmentation of RBC

• Consequences of infection when present

• Usually progression – Eventual dehiscence

– Hemodynamic collapse

Paravalvular Leak: Evaluation • Usually CHF only (16%), Hemolysis only (14%) or

combination (70%)

• Symptomatic deterioration without obvious cause

• Unexpected anemia

• New pulmonary hypertension

• THINK paravalvular leak

• Blood – LDH, fragmentation, haptoglobin

• Echocardiography – If not obvious – always TEE

• Exclude infection – Blood cultures

Paravalvular Leak: Evaluation with

Echocardiography - TEE

• Determine severity of regurgitation – Quantify if possible

• Assess site of regurgitation – Often multiple leaks

– 3D imaging essential

• Exclude infection – Look for evidence of vegetation, abscess

• Determine whether prosthetic occluder/leaflets normal – Assess gradients

– Thrombus

• Is the valve dehiscing? – Valve rocking

– Extent of leak (s)

Paravalvular Leak: Decision to

Intervene

Surgical

• Infection present

• Dehiscence

• Leaflet problem

• Lower risk

• Percutaneous failure

Percutaneous

• Multiple prior surgery

• Mortality for reoperation

13% 1ST, 15% 2nd, 37% 3rd

• Localized site(s)

• High surgical risk

• Significant impairment

Amplatzer Devices used in Paravalvular

Leak repair

Percutaneous Closure of Paravalvular Leak

Sorajja et al Cath Cardiovasc Intervent 2007; 70:815-23

Occluder Deployed

Sorajja et al Cath Cardiovasc Intervent 2007; 70:815-23

Reduction in MR

N=16

14 mitral

81% success

No serious

sequelae

Sorajja et al Cath Cardiovasc Intervent 2007; 70:815-23

Recent Results of Paravalvular

Leak Closure

• N = 43 (57 procedures)

• 67% male

• Age 69 + 12 years

• 35% two prosthetic valves

• Attempted leaks 65% bioprosthetic, 35% mechanical

• Two procedures (n=10), Three procedures (n=2)

• Mitral (n=38, 26 one leak, 6 two leaks); aortic n=11

• One patient both aortic and mitral at 1 procedure

Ruiz et al JACC 2011; 58:2210-7

Recent Results of Paravalvular

Leak Closure: Procedural Success • Successful deployment 86% leaks and patients

• 12 failures

– 8 due to inability to cross defect

– 3 due to device interference with function of prosthesis

– 1 due to wire entrapment in defect at AVR

• Amplatzer duct occluder 69%, Amplatzer muscular VSD occluder 19%, Vascular Plug II 8%, Septal occluder in 4%

• Mitral 89% success, 4 % required additional procedure

• Aortic 73% success, 27% required second procedure

• 89% clinical success

• NYHA Class improved by 1(n=18), by 2 (n=8), by 3 (n=2), no improvement in 7 but 5 no longer needed transfusion

Ruiz et al JACC 2011; 58:2210-7

Recent Results of Paravalvular

Leak Closure: Complications • 6 complications

• 2 device embolization, both successfully closed, 1 device retrieved, the other remains in position

• 1 entrapped wire – surgical removal

• 1 iliac artery dissection, managed conservatively

• 2 cardiac perforations, pericardial effusion without tamponade, managed conservatively

• I death from PEA

• Prior reports suggest 33% have worse hemolysis, 10 % have new hemolysis – may require another procedure

• Transfusion need fell from 56% to 5% post procedure

• Survival was 92%, 89%, 87% at 6, 12, 18 months

Ruiz et al JACC 2011; 58:2210-7

78 yo Woman with Severe Hemolytic

Anemia:Guidance with RT3DTEE

• 15 years s/p St. Jude MVR

• Progressive hemolytic anemia over 2 years, now requiring 2 units/month

• Severe COPD (FEV1 0.7 liter)

• Hct 26, LDH 3000

• Not considered surgical candidate

Percutaneous Closure of Paravalvular MVR

5 mm hole

Percutaneous Closure of Paravalvular MVR

Direct visualization of paravalular leak

Percutaneous Closure of Paravalvular MVR

Direct visualization of both jets

Percutaneous Closure of Paravalvular MVR

Transseptal puncture

Percutaneous Closure of Paravalvular MVR

Passing retrograde wire

Percutaneous Closure of Paravalvular MVR

Retrograde wire with balloon occluder

Percutaneous Closure of Paravalvular MVR

Transseptal lasso catheter capturing

retrograde wire through leak

Percutaneous Closure of Paravalvular MVR

Transseptal lasso catheter capturing

retrograde wire through leak

Percutaneous Closure of Paravalvular MVR

Deployment of first occluder

Percutaneous Closure of Paravalvular MVR

Second retrograde wire in place

Percutaneous Closure of Paravalvular MVR

Second retrograde wire in place

Percutaneous Closure of Paravalvular MVR

Second deployment

Percutaneous Closure of Paravalvular MVR

Two closure plugs in place

Post Closure Images

Much less MR

78 yo Woman with Severe Hemolytic Anemia

Guidance with RT3DTEE

• Severity of regurgitation reduced to ~2+

• Hemolytic indices persisted but blood requirements reduced from 2 units/month to a few units/year

• Quality of life improved, within limits of severe COPD

75 year old man with 2 prior valve surgeries

Has severe shortness of breath

Mitral and aortic bioprosthesis with severe annular calcification and severe perivalvular MR

Now severe CHF

Has had endocarditis x 2 – staph epi and strep bovis

Culture negative

Moderate hemolysis LDH 800

Has colon cancer in right hemicolon

Now culture negative but increasing MR

Does not want another operation

TEE

TEE

3D TEE

75 year old man with Paravalvular Leak

• Given mobile structures and large area of

dehiscence, decision made to reoperate

• Operation performed on 2 successive days due to

bleeding

• AVR and MVR replaced – extensive calcification

and infection

• Excellent result – long hospitalization

• Colon cancer successfully removed – early stage

• No recurrence of paravalvular leak 3 months later

45 year old Man with Paravalvular

Leak and Hemolysis

• Mitral mechanical prosthesis

• Two prior surgeries

• Considered high risk operation

• Sizeable area of leakage, 2 closure devices

used

• Paravalvular occlusion attempted

• Improvement in transfusion requirements

and improved symptoms

Severe Paravalvular MR

3D Echo

Residual MR – improvement in hemolysis

45 year old Man with Paravalvular

Leak and Hemolysis

• He developed marked hemolysis after 1

year

• No CHF symptoms

• TEE performed

Hemolysis 1 year later

Recurrent hemolysis 1 year later

TEE

45 year old Man with Paravalvular

Leak and Hemolysis

• TEE confirms device movement and

rocking motion

• Underwent successful reoperation

• No recurrent leak