Percutaneous Reduction of Periprosthetic Leaks: An Attractive Alternative to Repeat Surgery

1
Percutaneous Reduction of Periprosthetic Leaks
An Attractive Alternative to Repeat Surgery

• Jeannot Potvin MD, Stéphane Noble MD, Arsène-J.
  Basmadjian MD, Jacques Crépeau MD, Reda Ibrahim MD

2
Disclosures

• I wish I had some

3
Clinical Case

• 55 M
• Open mitral valve commissurotomy for
  rheumatic mitral valve disease
• Mechanical mitral valve replacement for
  recurrent stenosis
• Right-sided heart failure with severe
  pulmonary hypertension (PAP 80/24 at
  catheterization) poor response to medical
  treatment
• Acute pulmonary edema significant
  periprosthetic leak (PPL) discovered at TEE

1979
2000
OPTIONS ?
2004
2006
4
Background

• Gold standard repeat surgery
• significant morbidity and mortality
• Prevalence of PPL
• CHF symptoms or hemolysis difficult to control
  medically
• Attractive non-invasive alternative with
  percutaneous approach
• Reported technical and clinical results variable

up to 10
5
Hypothesis

• Transcatheter reduction of PPL
• Technically achievable goal
• Clinically improves CHF symptoms and/or hemolysis
• in poor surgical candidates

6
Methods

• From June 2001 to December 2007
• 38 patients (all attempts)
• 42 procedures
• Retrospective collection of procedural and
  clinical data from records telephone follow-up
• Latest clinical status
• Identify clinical events not recorded in local
  file

7
Methods

• Retrograde approach

8
Methods

• Anterograde approach

9
Methods

• Arterio-venous circuit

10
RESULTS

11
TABLE I. Baseline Characteristics (n 38
patients) Age

64 12

Gender (malefemale)

2117 Valve -Mitral Aortic

308

-Mechanical Bioprosthetic

353 Median number of previous open heart
surgeries (range) 2
(1-5) Indication for intervention
-Congestive heart failure ()
26 (68)
-CHF Transfusion-dependant Hemolysis ()
8 (21) Median
NYHA functional class (range)
3 (2-4) -Transfusion-dependant
Hemolysis ()
4 (11)
71 2
89
87 3-4
12
TABLE I. Baseline Characteristics (n 38
patients)


Euroscore

19.9 14.7 Parsonnet

23.7 8.0 Comorbidities
-Systolic pulmonary artery pressure (mean)
58.2 16.9 -AF ()

30 (79)
-Hypertension ()
20
(53) -Chronic renal failure ()
18
(47) -Dyslipidemia ()

16 (42) -CAD ()

10 (26) -Stroke/Transient ischemic
attack ()
6 (16) -LVEF 40 ()

5 (13) -Diabetes mellitus ()

4 (11) -Peripheral vascular disease ()
3
(8)

• Euroscore in-hospital mortality post-cardiac
  surgery
• Roques et al, Eur Jour
  Cardiovasc Thor Surg. 199923598-602
• Parsonnet 30-day mortality post-cardiac surgery
• 
  Parsonnet et al,
  Circulation. 198979I3-I12

13
TABLE 2. Interventional data (n 42
procedures) Procedural time (minutes) 125
42 Contrast use -With, n (mean quantity,
cc)
24 (59 75)
-Without, n

15 Type of device used
-Amplatzer Duct Occluder ()
16 (51)
-Amplatzer mVSD ()
15 (49)
14
TABLE 2. Interventional data (n 42
procedures) Device implantation achieved ()

31 (74) Device could not be positioned ()
11
(26) -Unable to cross defect

6 -Unable to size defect

2 -Defect not found during procedure
1
-Valve obstruction by device
2 Immediate
reduction of 1 grade of regurgitation (TEE or
angio) 28 (90)
Technical success

• Complex, crescent-shaped defects complete
  closure difficult Necessary???
• Further improvement in degree of regurgitation
  following endothelialisation?

• Entire cohort 28/42 ? 67 technical success
• When device implanted 28/31 ? 90 technical
  success

15
TABLE 2. Interventional data (n 42 procedures)
Acute complications -Death (due to device
embolization)
1 -Hemothorax

1
-Inguinal hematoma
1
-Perforation

0 -Arrhythmias

0 -Thromboembolic event

0
16
TABLE 3. Follow-up data (n )





At 6 months () At 1 year ()
Follow-up completed

Survival -Overall

-Free from
re-hospitalisation for CHF or HL 17 (65)
NYHA functional class
-Improvement of 1 grade ()
-Number
with NYHA 2 () 17
(65) 8 (40)
28 patients
26 (93)
20 (71)
23 (88)
16 (80)
11 (50)
15 (58)
7 (33)

• Device embolization (day 2)
• F 82, new HL, renal hematoma heparin? (day14)
• History of 5 open-heart surg, recurrent CHF (5
  months)

17
TABLE 3. Follow-up data (n 28 patients)





At 6 months () At 1 year ()
Follow-up completed

Survival -Overall

-Free from
re-hospitalisation for CHF or HL 17 (65)
NYHA functional class
-Improvement of 1 grade ()
-Number
with NYHA 2 ()

26 (93)
20 (71)
23 (88)
16 (80)
11 (50)
15 (58)
7 (33)
17 (65)
8 (40)
18
TABLE 3. Follow-up data (n 28 patients)



Hemolysis
-Present before intervention
7 Resolved
temporarily
1 Resolved permanently
1
Unchanged
5
-Appeared post-intervention
3

• Mechanical effect of occluder?
• Smaller leak(s)?

19
TABLE 4. Comparison between mitral and aortic
PPLs reduction





Mitral Aortic Device implantation
achieved ()
25 6 Immediate reduction of
1 leaking grade (TEE or angio) 24
4 Improvement of 1 grade NYHA -At 6
months ()
13 (65) 2 (33)
-At 1 year ()
7 (44)
0 Subsequent surgical repair ()
2 (9)
3 (50) Hemolysis -Present before
intervention ()
7 (32) 0 -Appeared
post-intervention ()
1 (5) 2 (33)
(76)
(67)
(96)
(67)
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Key points

• Technically demanding but feasible
• Safe

1Akins et al, J Heart Valve Dis. 200514793
21
Key points

• Reduction of leakage achievable and sufficient
• Selection criteria
• Peri-mitral leaks
• CHF symptoms

Hemolysis alone? Peri-aortic leaks?
22
Study limitations

• Small number of patients
• Technically no routine TEE or angio for
  long-term outcome of regurgitation
• Clinically no pre/post objective assessment of
  functionnal capacity

23
Conclusions

• Additional new therapeutic option when
• Surgery risk ???
• Failure of medical treatment

24
Hypothesis

• Transcatheter reduction of PPL
• Technically
• Improve CHF symptoms and/or hemolysis
• in surgical candidates

achievable goal
demanding but
actual
poor
?

• Stepwise approach?
• Definitive therapy?

25
Thank you!
26
Special thanks to

• Dr. Réda Ibrahim
• Dr. Arsène Basmadjian
• Dr. Stéphane Noble
• Dr. Donald Palisaitis
• Dre. Lise-Andrée Mercier

27
TABLE 2. Interventional data (n 42
procedures) Valve -Mitral ()

33 (79)
-Aortic ()

9 (21) Procedural time (minutes)
-Total (mean)
125
42 -Fluoroscopy (mean)
48
21 Contrast use -With, n (mean quantity,
cc)
24 (59 75)
-Without, n

15 Transoesophageal
echocardiography guidance ()
32 (76) General anesthesia ()

30 (71) Device implantation possible ()

31 (74) Immediate reduction of 1 leaking
grade (TEE or angio) 28 (90)
Device could not be positioned ()
11 (26)
-Defect not found during procedure ()
1 (2) -Unable to
cross defect ()
6 (14) -Unable to
size defect ()
2 (5) -Valve
obstruction by device ()
2 (5)
28
TABLE 2. Interventional data (n 42 procedures)
continued
Device used -Amplatzer Duct Occluder ()

16 (51) -Amplatzer mVSD ()

15 (49) Acute complications
-Death ()

1 (3) -Device embolisation ()

1 (3) -Valve obstruction by device
()
2 (5) Device immediately
retrieved ()
2 (100) -Pneumothorax/Hemothora
x ()
1 (3) -Inguinal hematoma ()

1 (3) -Perforation ()

0 (0)
-Arrhythmias ()

0 (0) -Thromboembolic event ()

0 (0) Length of hospitalisation in days after
intervention mean/median (range)7.8/4(1-59)
29
TABLE 3. Follow-up data




At 6
months () At 1 year () Follow-up completed

Survival -Overall


-Free from re-hospitalisation for CHF or HL
17 (65) NYHA functional class
-Improvement of 1 grade ()

-Number with NYHA 2 ()
17 (65) 8 (40)

Number ()
Hemolysis -Present before intervention
7 (25)
Resolved temporarily
1 (14)
Resolved permanently
1 (14)
Unchanged
5 (72)
-Appeared post-intervention
3 (11) Subsequent
surgical repair
5 (18) -Within 1 year

3 (60) -After 2 years

2 (40)
26 (93)
20 (71)
23 (88)
16 (80)
11 (50)
15 (58)
7 (33)
30
TABLE 4. Comparison between mitral and aortic
PPLs reduction





Mitral Aortic Device implantation
possible ()
25 6 Immediate reduction of
1 leaking grade (TEE or angio) 24
4 Overall survival -At 6 months ()

17 (85) 6 (100) -At 1 year
()
11 (73) 5
(100) Survival free from re-hospitalisation for
CHF or HL -At 6 months ()
13 (62)
4 (67) -At 1 year ()

9 (50) 2 (40) Improvement of 1
grade NYHA -At 6 months ()
13
(65) 2 (33) -At 1 year ()

7 (44) 0 Hemolysis
-Present before intervention ()
7 (32) 0
-Appeared post-intervention ()
1 (5) 2 (33)
Subsequent surgical repair ()
2 (9)
3 (50)
(76)
(67)
(96)
(67)
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Literature

• 10 patients, 14 procedures
• 2 technical failures
• 8 patients with device followed over 1 year

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Literature

• 11 patients procedures
• 1 technical failure
• 10 patients with device followed over 2-36 months

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Literature

• 21 patients procedures
• 1 technical failure
• 20 patients with device followed over 14 /- 12
  months

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Literature

• 35 patients procedures
• 12 technical failures
• 23 patients with device followed over 3 months

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Literature

• 38 patients, 42 procedures
• 11 technical failures
• 28 patients with device followed over 6-12 months

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• Retrospective Jan 86-Dec 01
• Primary or secondary repair
• F/U 75 /- 50 months

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1 2
50
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• In-hospital evolution

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• Long-term evolution

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