1. Paravalvular Leaks Post-Transcatheter Aortic Valve Replacement
Philippe Généreux, MD
Director, Angiographic Core Laboratory
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY
Assistant Professor of Medicine, Interventional Cardiologist,
Director, Transcatheter Aortic Valve Implantation program
Hôpital du Sacré-Coeur de Montréal, Québec, Canada

2. Disclosure Statement of Financial Interest
I, Philippe Généreux, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. Disclosure Statement of Financial Interest
Susheel Kodali has received consulting fees from Edwards Lifesciences and St-Jude. Pieter Kappetein is member of steering committee of the SURTAVI trial sponsored by Medtronic. Martin B. Leon is a nonpaid member of the Scientific Advisory Board of Edwards Lifesciences. The other authors report no conflicts.

4. Généreux et al. J Am Coll Cardiol 2013
Paravalvular Leak (PVL) after Transcatheter Aortic Valve Replacement (TAVR): The new Achilles’ heel? A Comprehensive Review of the literature.  
Philippe Généreux, MD1,2,3 *, Stuart J. Head, MSc4 *, Rebecca Hahn, MD1,2, Benoit Daneault, MD1,2,, Susheel Kodali, MD1,2, Mathew R. Williams, MD1,2, Nicolas M. van Mieghem, MD5, Maria C. Alu, MM1, Patrick W. Serruys, MD, PhD5, A. Pieter Kappetein, MD, PhD4, Martin B. Leon, MD1,2.
1. Columbia University Medical Center/New York Presbyterian Hospital, New York, NY, USA; 2. The Cardiovascular Research Foundation, New York, NY, USA; 3. Hôpital du Sacré-Coeur de Montréal, Montréal, Canada, 4.Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands, 5. Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands
Généreux et al. J Am Coll Cardiol 2013

5. Introduction-1
Transcatheter aortic valve replacement (TAVR) has become the treatment of choice for inoperable patients with severe aortic stenosis and is comparable to surgical aortic valve replacement (SAVR) for patients at high-risk.
However, when compared to conventional SAVR, paravalvular leak (PVL) is more frequently seen after TAVR and its potential association with mortality has raised concerns.
Moreover, recent reports suggested that PVL could negatively impact mid- and long-term prognosis following TAVR

6. Introduction-2
While concerning, the lack of standardized quantitative and qualitative methods to assess and categorize PVL, and the heterogeneity in the timing of post-procedural assessment of PVL warrant caution in interpretation of these data.
Therefore, we sought to perform a systematic review of the current literature to better define the rate, the progression over time, the predictors, and the consequences of PVL after TAVR.

7. Incidence of PVL

8. Incidence of PVL Significant heterogeneity exists among studies:
Imaging modalities (TTE vs. TEE vs. Angio)
Timing of assessment (immediately post-implantation, before discharge, 30-day),
THV system used (Edward vs. CoreValve)
Grading scale
Adjudication of events vs. site reported

9. Incidence of PVL before discharge
Site reported:
PVL present: 41%-94%
PVL moderate-severe: 0%-24%

10. Leon et al. J Am Coll Cardiol 2011;57:253–69
Kappetein et al. J Am Coll Cardiol 2012;60:1438–54

11. PARTNER Grading Criteria for PVL
Circumference = 6″
AR = = 0.45″
Ratio = 8% Severity = Mild
Circumference = 6″
AR = = 1.0″
Ratio = 17% Severity = Moderate (Trans AR also present)
One of the most important aspects of this trial was the core lab analysis of the echocardiographic data. These allowed for a rigorous and blinded assessment of the echo findings. Paravalvular leak was assessed in a semi-quantitative manner incorporating multiple factors. One of the key components was circumferential extent of AR. Jets that occupied less than 10% was classified as mild, 10-20% as moderate and >20% as severe. These criteria have since been adopted by the ASE.
Circumference = 6″
AR = = 1.7″
Ratio = 28% Severity = Severe

12. Semi-quantitative Parameters Quantitative Parameters
VARC II recommendations for the evaluation of aortic and/or PVL after TAVR.
Mild
Moderate
Severe
Semi-quantitative Parameters
Diastolic flow reversal in the
descending aorta
Absent or brief
early diastolic
Intermediate
Prominent holodiastolic
Circumferential extent of prosthetic valve paravalvular regurgitation (%)*
<10
10-29
≥30
Quantitative Parameters
Regurgitant volume (ml/beat)
<30
30-59
≥60
Regurgitant fraction (%)
30-49
≥50
EROA (cm2)
0.10
≥0.30
Kappetein et al. J Am Coll Cardiol 2012;60:1438–54

13. Smith et al. N Engl J Med 2011;364:2187-98.
PVL Severity
30 days
(n=287)
6 months
(n=240)
1-Year
(n=222)
None
22.6%
26.3%
32.9%
Trace-Mild
65.2%
62.5%
60.4%
Moderate-Severe
12.2%
11.3%
6.8%
Smith et al. N Engl J Med 2011;364:

14. PVL Edwards PARTNER A trial (AT)
Paravalvular regurgitation was more frequent in the TAVR group with ~40% of patients having mild AR and ~10% with moderate to severe. Over the course of follow-up there was no significant change in the severity of AR in either group.
N = 277
N = 226
N = 230
N = 172
N = 216
N = 155
N = 145
N = 112

15. Edwards vs. Corevalve?

16. Edwards vs. CoreValve
No prospective-randomized trials data comparing directly both devices
Patients population and devices are different
Moderate-Severe:
Edwards: 6 to 13.9%
CoreValve: 9 to 21%
Généreux et al. J Am Coll Cardiol 2013

17. No central independent
FRANCE-2
Major Limitations:
No central independent
Echo Core Laboratory
All
(N=3195) TF
(N = 2361) TA
(N = 567) SC
(N = 184)
Grade 0
37.8%
34.1%
51.8%
33.0%
Grade 1
45.7%
47.3%
39.2%
51.9%
Grade 2
15.7%
17.7%
9.0%
13.4%
Grade 3
0.8%
0.9% 0%
1.8%
Edwards SAPIEN
(N = 2107)
Medtronic CoreValve
(N=1043)
Grade 0
41.0%
31.6%
Grade 1
45.1%
46.9%
Grade 2
13.5%
19.9%
Grade 3
0.4%
1.6%
Δ 7.6%
Gilard et al. N Engl J Med 2012;366:

18. Chieffo et al. J Am Coll Cardiol 2013;61:830–6

19. No central independent
Pragmatic
Major Limitations:
No central independent
Echo Core Laboratory
Chieffo et al. J Am Coll Cardiol 2013;61:830–6

20. Progression through time

21. PVL through time Author, year No. of patients Significant
post-procedural
Significant at
6 months
1 year
2 years
3 years
Webb,
2009,
168
30 days
2+ = 37%
3+ = 5% …
“Stable”
Muñoz-Garcia, 2011
144
72 hours
mild = 40%
moderate = 23%
mild = 47%
moderate = 19%
Ussia,
2012
181
Post-procedure
mild = 53%
moderate = 15%
mild = 48%
moderate = 18%
mild = 50%
moderate = 17%
moderate = 10%
Ye,
2010 71
mild = 26%
moderate = 5%
“Remained unchanged and clinically insignificant during follow-up”
Takagi,
2011 79
1+ = 51%
2+ = 20%
3+ = 3%
1+ = 49%
2+ = 27%
3+ = 0%
Ewe,
107
1+ = 58%
2+ = 16%
≥6 months
2+ = 31%
Godino,
137
1+ ≈ 60%
2+ ≈ 12%
3+ = 4%
4+ = 2%
1+ ≈ 65%
2+ ≈ 9%
3+ ≈ 5%
4+ = 0%
Généreux et al. J Am Coll Cardiol 2013

22. Echo Analysis PV Leak Changes Post Procedure Compared to 2 Years
Patients With Data at Both Time Points
2 Year
30 Day
None
Trace
Mild
Moderate
Severe 17 8 6 1 24 12 11 3 10 34 5 2
26/61 improved
25/61 unchanged
10/61 progressed
53 died
Of the 144 patients alive with data at 2 years:
31.9% Improved
38.9% Unchanged
22.2% Progressed

23. CoreValve ADVANCE Paravalvular Leak

24. Impact on mortality

25. Outcomes associated with aortic and/or PVL
Author, year
No. of patients
Variable
Outcome
Univariate Analysis
Multivariate Analysis
Abdel-Wahab, 2011
690
AR ≥2
In-hospital mortality
OR = 2.50 [ ]
OR = 2.43 [ ]
Gotzmann, 2011
122
6-month mortality
No clinical improvement …
OR = 4.26 [ ]
OR = 10.1 [ ]
Takagi, 2011 41
12.2% vs. 25.0%, p=0.25
Hayashida, 2012
260
median 217 days [IQR ]
HR = 1.97 [ ]
Leber, 2011 69
AR >2
1-year mortality
9% vs. 37.5%, p=0.07
Moat, 2011
870
HR = 1.49 [ ]
HR = 1.66 [ ]
Sinning, 2012
152
PVL ≥2
HR = 4.0 [ ]
HR = 4.9 [ ]
Tamburino, 2011
663
Late mortality
HR = 3.79 [ ]
146
Moderate/severe PVL
1-year survival
HR = 3.9 [ ]
HR = 2.4 [ ]
Unbehaun, 2012
358
None vs. trace vs. mild AR
2-year survival
66% vs. 72% vs. 67%, p=0.77
Kodali, 2012
158
Mild to severe AR
HR = 1.75 [ ]
Not significant
Mild to severe PVL
HR = 2.11 [ ]
Généreux et al. J Am Coll Cardiol 2013

26. Impact of PVL Mild PVL or worse associated with 1-year mortality
FRANCE 2 registry
HR 2.49 (95% CI, )
PARTNER cohort A
HR 2.11 (95% CI, 1.43–3.10) (unadjusted)
No Echo Core Lab
Gilard M et al. N Engl J Med:2012;266:
Kodali S et al. N Engl J Med:2012;266:

27. Kodali S et al. N Engl J Med:2012;266,1686-95

28. Total AR and Mortality TAVR Patients (AT)
HR [95% CI] = 1.66 [1.13, 2.44]
p (log rank) =
None - Trace
Mild - Moderate - Severe
36.3%
Mortality
27.8%
26.3%
12.7%
Months Post Procedure
Numbers at Risk
None-Tr
135
125
115
101 68 31 11
Mild-Mod-Sev
199
164
143
130 86 39 18

29. Total AR and Mortality TAVR Patients (AT)
None - Trace
Mild
Moderate - Severe
p (log rank) < 0.001
50.7%
35.3%
33.4%
Mortality
26.2%
26.3%
Separating these curves in three categories (none-tr vs. mild vs. mod-severe) shows an interesting stepwise increase in mortality with worsening AR.
12.7%
Months Post Procedure
Numbers at Risk
None-Tr
135
125
115
101 68 31 11
Mild
165
139
121
111 71 33 16
Mod-Sev 34 25 22 19 15 6 2

30. Paravalvular AR and Mortality TAVR Patients (AT)
None - Trace
Mild - Moderate - Severe
HR [95% CI] = 2.01 [1.38, 2.92]
p (log rank) =
39.5%
Mortality
29.5%
24.8%
14.5%
We sought to look at the impact of paravalvular AR on mortality. This KM curve reveals mortality is significantly higher in patients with mild-moderate-severe AR with a hazard ratio of The KM estimates for mortality at one year were doubled and at two years the mortality with mild-mod-severe Paravalvular AR was 39.5% vs. 24.8% in those with none-trace paravalvular AR.
Months Post Procedure
Numbers at Risk
None-Tr
167
149
140
126 87 41 16
Mild-Mod-Sev
160
134
112
101 64 26 12

31. Paravalvular AR and Mortality TAVR Patients (AT)
p (log rank) < 0.001
None - Trace
Mild
Moderate - Severe
41.7%
Mortality
39.2%
29.5%
29.2%
24.8%
14.5%
When you separate the groups further, it is clear that mortality is being driven by patients with mild AR who have higher mortalities. These curves start to separate in the first year.
Months Post Procedure
Numbers at Risk
None-Tr
167
149
140
126 87 41 16
Mild
136
115 95 86 51 21 10
Mod-Sev 24 19 17 15 13 5 2

32. Impact of mild to severe PVL
Kodali. TVT 2012

33. Are the patients with paravalvular regurgitation different?
Baseline Characteristics of TAVR patients with Paravalvular Regurgitation
Echocardiographic Parameter (Baseline)
None/Trace
≥ Mild
p-value
Annular Diameter (mm)
21.3 ± 1.8
21.7 ± 1.7
0.04
LVDV (mL)
115 ± 46
132 ± 50
0.02
LV Mass (gm)
269 ± 85
299 ± 82
0.003
Ejection fraction (%)
54 ± 13
51 ± 14
0.03
Low Doppler Stroke Volume
43%
57%
0.01
Total AR
1.5 ± 0.8
1.6 ± 0.8
0.4
There were significant differences in baseline parameters for the patient with none/trace paravalvular regurgitation versus those with >= mild paravalvular regurgitation.
Are the patients with paravalvular regurgitation different?

34. CoreValve ADVANCE | Survival by AR

35. Chieffo et al. J Am Coll Cardiol 2013;61:830–6

36. Moderate-Severe AR impacted
mortality at 1-year
Chieffo et al. J Am Coll Cardiol 2013;61:830–6

37. Predictors

38. Delgado V, et al. Eur Heart J. 2010;31(7):849-56.
Detaint D, et al. JACC Cardiovasc Interv. 2009;2(9):821-7.
Jabbor A, et al. J Am Coll Cardiol. 2011;58(21):
Jilaihawi et al. J Am Coll Cardiol. 2012;59(14):Article-in-press.
John D, et al. JACC Cardiovasc Interv. 2010;3(2):
Koos R, et al. Int J Cardiol. 2011;150(2):142-5.
Schultz CJ, et al. Catheter Cardiovasc Interv. 2011;78(3):
Wilson AB, et al. J Am Coll Cardiol. 2012; 59(14):Article-in-press.

39. Predictors: Key concepts
Incomplete prosthesis apposition
Patterns or extent of calcification
Annular eccentricity
Undersizing of the device
Depth of implantation (malpositioning)

40. Mechanisms of PVR Shallow implantation Deep implantation
Prosthesis-annulus size mismatch
Sinning JM et al., JACC 2012

41. Paravalvular AR after TAVR
THV Too High or Too Low
CoreValve Self-Expanding TAVR
Edwards Balloon-Expandable TAVR
The “SEAL” Zone

42. John D, et al; JACC Intv 2010;3:23-43
PVL after TAVR
Methods
100 pts with CoreValve TAVR
MSCT with and without contrast to assess calcium load in valve and adjacent LVOT estimated by Agaston Score (AgS) and the amount and distribution of calcium at the device landing zone (DLZ-CS) by semi-quantitative scoring (grade 1-4)
Calcium levels correlated with PVL by angio and TTE (2 weeks later)
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John D, et al; JACC Intv 2010;3:23-43 43

43. Para-valvular Regurgitation after TAVR
grade 1
grade 2
RESULTS:
Strong correlation betw AgS and DLZ-CS (r=0.86, P<0.001)
Both AgS and DLZ-CS were correlated with PVL (angio and TTE)
Angio PVL: AgS r=0.25, P=0.011; DLZ-CS r=0.24, P=0.016
TTE PVL: AgS r=0.34, P=0.001; DLZ-CS r=0.30, P=0.002
grade 3
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grade 4
John D, et al; JACC Intv 2010;3:23-43 44

44. Para-valvular Regurgitation after TAVR
Methods:
79 pts with Edwards TAVR (TF or TA); aqe 80 yo, 49% male
MSCT assessment with aortic valve calcium scoring for severity and location; TEE determination of PVL (severity and location) after TAVR
Results:
PVL associated with both severity of Ca++ and specific location
ROC curves for predicting PVL > 1+; calcium in aortic wall significant cw valve edge or body (AUC 0.93, P<0.001), calcium at commissures significant cw valve edges (AUC 0.94 vs. 0.71)
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Ewe SH, et al. Amer J Cardiol 2011;108: 45

45. Para-valvular Regurgitation after TAVR
Comprehensive Assessment of Aortic Valve Calcium (Severity and Location)
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Ewe SH, et al. Amer J Cardiol 2011;108: 46

46. Para-valvular Regurgitation after TAVR
Scoring system to
assess location of
calcium in aortic valve (aortic wall, commissures, valve edge or valve body
Aortic wall
Commissures
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ROC curves for
calcium location
as a predictor
for TAVR PVL
Ewe SH, et al. Amer J Cardiol 2011;108: 47

47. Para-valvular Regurgitation after TAVR
Methods:
70 pts with TAVR (Edwards).
Assess congruence betw annulus and device size by analyzing the COVER INDEX: 100X prosthesis (D) – TEE annulus D/prosthesis D
RESULTS:
Predictors of PVL ≥ 2/4 were increased pt height, larger annulus, and a cover index < 8%
PVL ≥ 2/4 was never seen if annulus was < 22mm or the cover index was > 8%
CONCLUSION
Prosthesis/annulus “discongruence” is a strong predictor of post-TAVR ≥ 2/4 PVL
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Detaint, et al; JACC Intv 2009;2:821-7 48

48. Para-valvular Regurgitation after TAVR
Relationship of Cover Index to PVL
AR <2/4
AR >2/4
25%
20%
15%
Population Proportion
10% 5%
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Prosthesis-Annulus Cover Index, %
Detaint, et al; JACC Intv 2009;2:821-7 49

49. Paravalvular Leak by Cover Index
< 8%
≥ 8%
p = 0.02
None-Trace
Mild-Severe
Cover index = 100X [(valve diameter - annulus diameter) ÷ valve diameter]

50. Willson et al. J Am Coll Cardiol 2012; 59
CTA Imaging and PVL
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Conclusion:
MSCT derived 3D-annular measurements predicts mod-severe PVL after TAVR; 35.3% cases undersized valve based on MSCT
Oversizing THV size using 3D-MSCT will reduce mod-severe PVL
Willson et al. J Am Coll Cardiol 2012; 59 51

51. Comparison Studies: 3D vs. 3D
There was high agreement between 3D TEE and DCST
Coronal diameters (23.60 ± 1.89 vs ± 2.07 mm)
Sagittal diameters (22.19 ± 1.96 vs ± 2.01 mm)
There was a high correlation between DSCT and 3D TEE
Coronal aortic annulus diameters (r=0.88, SEE=0.89 mm)
Sagittal aortic annulus diameters (r=0.77, SEE=1.26 mm).
Correlation of 3D TEE (13.47 ± 1.67 mm) and DSCT (13.64 ± 1.82 mm) in the analysis of the distance between aortic annulus and left main coronary artery ostium was better (r=0.54, SEE=1.55 mm) than between angiography (14.85 ± 3.84 mm) and DSCT (r=0.35, SEE=1.77 mm).
DSCT = Dual Source CT
Altiok E. et al. Heart 2011;97:

52. How to avoid PVL

53. Preventing Para-Valvular AR The “Art” of Valve Sizing
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% undersizing
10-15%
% oversizing
Adapted from Thierry Lefevre; London Valves, 2012 54

54. Imaging: Planning/Sizing/Positioning
Willson et al. J Am Coll Cardiol 2012;59
Jilaihawi et al. J Am Coll Cardiol 2012;59:1275–86
Jilaihawi et al. J Am Coll Cardiol 2013;61:908–16

55. CTA Imaging and PVL METHODS:
Comparison of cross-sectional 3D-MSCT vs. 2D-TEE to measure aortic annular for THV sizing
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RESULTS:
3D-MSCT highest discriminatory value for predicting PVL
Prospective 3D-MSCT (cw 2D-TEE) valve sizing reduced post- TAVR mod-severe PVL (7.5% vs. 21.9%, p=0.045)
Jilaihawi et al. J Am Coll Cardiol 2012;59:1275–86 56

56. How to manage PVL

57. Management of PVL TAVR Treatment Depends on Etiology
Malposition (too high or too low)
consider valve-in-valve
Severe calcification
consider post-dilatation
consider PVL occluder (usually staged)
Under-sizing
consider post-dilatation a/o PVL occluder
consider surgical AVR

58. Valve-in-Valve

59. 2.8% (21) THV-in-THV implant due severe AR
760 consecutive TAVRs
2.8% (21) THV-in-THV implant due severe AR
Malposition: 10 Too high, 8 Too low, 3 correct position
Technically successful in 19 patients (90%)
Unsuccessful in 2 patients (10%)
2/21 (9.5%) PMP; 1/21 (4.7%) Stroke
Toggweiler et al. J Am Coll Cardiol Intv 2012;5:571–7

60. Toggweiler et al. J Am Coll Cardiol Intv 2012;5:571–7

61. Toggweiler et al. J Am Coll Cardiol Intv 2012;5:571–7

62. 663 consecutives TAVR in 14 centers in Italy ViV used in 24 pts (3.6%)
No Coronary impairment
PMP ViV 33.3% vs. 14.5% no ViV, p=0.02
Ussia et al. J Am Coll Cardiol 2011;57:1062–8

63. No difference in major outcomes
Ussia et al. J Am Coll Cardiol 2011;57:1062–8

64. Post dilatation 211 TAVI with Balloon Expandable valve
BPD performed in 28% of pts for PVL ≥2
Nombela-Franco L et al. J Am Coll Cardiol Intv 2012;5:

65. Baseline characteristics
Post dilatation
N = 59
No Post dilatation
N =152
P value
Male gender
50.9%
36.8%
0.086
Mean aortic gradient
45 ± 16
38 ± 16
0.006
Calcium volume, mm3
3,369 (2,250-4,665)
1,822 (1,260-2,749)
<0.0001
TF approach
44.1%
25.7%
0.013
Ratio diameter THV/diameter aortic annulus
1.15 ( )
1.15 ( )
0.211
Nombela-Franco L et al. J Am Coll Cardiol Intv 2012;5:

66. Effect of post-dilation on AR
Percentage
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Nombela-Franco L et al. J Am Coll Cardiol Intv 2012;5: 67

67. Nombela-Franco L et al. J Am Coll Cardiol Intv 2012;5:499-512
PD and CV events ≤24 hours
P =0.007
Percentage
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Nombela-Franco L et al. J Am Coll Cardiol Intv 2012;5: 68

68. Nombela-Franco L et al. J Am Coll Cardiol Intv 2012;5:499-512
Calcification
Predictor of need for post-dilation
Amount of calcification and TF access
Predictor of non-response to PD
Greater amount of calcification
Predictor of CV events
Amount of calcification and PD
Nombela-Franco L et al. J Am Coll Cardiol Intv 2012;5:

69. CUMC experience N=259 consecutive pts PVL Decreased by Post-Dilatation
Daneault et al. Circulation Cardiovasc Intervention 2013

70. Daneault et al. Circulation Cardiovasc Intervention 2013
CUMC experience
Post dilatation
N = 106
No Post dilatation
N =153
OR (95%CI)
P value
30-day mortality
2 (1.9%)
11 (7.2%)
0.25 ( )
0.06
30-day cardiac mortality
1 (0.9%)
6 (3.9%)
0.23 ( )
0.25
In-hospital cerebrovascular
events
All stroke or TIA
5 (4.7%)
2 (1.3%)
3.74 ( )
0.13
All stroke
4 (3.8%)
1 (0.7%)
5.96 ( )
0.16
Aortic dissection
1.45 ( )
1.00
Aortic wall hematoma
3 (2.0%)
0.48 ( )
0.65
PPM implantation during index hospitalization
6 (5.7%)
13 (8.5%)
0.65 ( )
0.39
Daneault et al. Circulation Cardiovasc Intervention 2013

71. The Future is promising for TAVR…

72. Emerging devices with reduced rate of PVL
Généreux et al. J Am Coll Cardiol 2013

73. Conclusions
Post-procedural PVL is common after TAVR and did not change significantly during follow-up
Moderate-Severe post-procedural AR (PVL and total AR) was associated with increased mortality; Mild AR also seems to be clinically important
Valve in valve is a potential treatment option for AR due to malpositioning
Balloon post-dilatation improves regurgitant volume but may result in increased neurologic events
Improved imaging modalities and upcoming imaging technologies are promising for singnificanty decrease rate of PVL