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TAVR in Native AI/AR; TAVR in Homograft: Future and Now

David R. Holmes, Jr, MD

Rocky Mountain Valve SymposiumJuly 19, 2019

The following relationships exist related to this presentation:

None

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FUTURE

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TAVR for Pure Native ARIssues

• Lack of calcific landing zone

• Suboptimal fixation

• Residual AR

• Ascending aortic dilatation

• Dilatation of aortic anulus

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TAVI for pure ARSTS/ACC TVT Registry

Carroll J et al. JACC 2017;70:29-41

274 cases primary AR (0.58%)

• Unclear landmarks

• Poor valve anchoring

• Valve embolisation

• Residual AR

• Large annulus

• Aortic root dilatation

• Dilatation asc Ao

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TAVI for pure AR

Anwaruddin S

Jan 14 – Sept 15

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TAVI for pure AR

Anwaruddin S

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5 Meta Analyses

Takagi 2019 911 patients 11 studies

Wernly 2019 640 patients 12 studies

Rawasia 2019 998 patients 19 studies

Haddad 2019 638 patients 12 studies

Jiang 2018 266 patients 10 studies

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5 StudiesHisato Takagi, MD

Meta-Analysis and Meta-Regression of Transcatheter Aortic Valve Implantation for Pure Native Aortic RegurgitationTakagai et al. Heart, Lung Circ, 2019, https://doi.org/10/1016/j.hlc.2019.04.012

Bernhard Wernly, MD

Transcatheter Aortic Valve Replacement for pure aortic valve regurgitation: “on-label” versus “off-label” use of TAVR devicesWernly et al. Clinc Research in Card 2019

Wasiq Faraz Rawasia, MD

Safety and efficacy of transcatheter aortic valve replacement for native aortic valve regurgitation: A systematic review and meta-analysisRawasia et al. Catheter Cardiovasc Interv. 2019;93:345-353

Abdullah Haddad, MD

Transcatheter aortic valve replacement in patients with pure native aortic valve regurgitation: A systematic review and meta-analysisHaddad et al. Clinical Cardiology. 2019;42:159-166

Jubo Jiang, MD

Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: A Systematic review

Jiang et al. Cardiology 2018;141:132-140

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Crucial Issues

• All cause 30 day mortality

• Procedural success

• Residual paravalvular leak

• Second valve needed

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TAVR for PARAll Cause Mortality (%)30 Days

Takagi 9.5 (2.3-23.1)

Wernly 10.4 (95% CI 7.1-14.2)

Rawasia 11.4 (9.4-14.7)

Haddad 11 (95% CI 7-16)

Jiang 9 (0-30)

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TAVR for PAROverall procedural success (%)

Takagi 80.4 (72.2-88.6%)

Wernly 89.9 (95% CI 81.1-96.1%)

Rawasia 86.2 (54-100%)

Haddad 84.0 (95% CI 75-91%)

Jiang 88.3 (72-100%)

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TAVR for PAROverall Residual Paravalvular LeakModerate-Severe (5)

Takagi 7.4

Wernly NR

Rawasia 9.2

Haddad 14.0

Jiang 15.0

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TAVR for PARSecond Valve Needed (%)

Takagi 10.5 (4.9-16.2)

Wernly 7.0 (95% CI 2.3-13.3)

Rawasia NR NR

Haddad NR NR

Jiang NR NR

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All animals are created equal but some are more equal than others

All TAVR valves are created equal but some are much more equal than others

Holmes

Orwell

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TAVR for PARApproaches

• Larger stent frames

• Optimized radial force

• Potential to reposition

Wernly et al. Clinc Research in Card 2019

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TAVR for PARSecond generation valves

• J valve, JenaValve, Acurate TA, DirectFlow, Evolut R, Lotus, Engager, Portico, Sapien 3

Wernly et al. Clinc Research in Card 2019

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TAVR for PARAll cause mortality (%)30 days

Takagi 6.1 14.7

Wernly 7.1 15.6

Rawasia 8.2 13.0

Haddad 7.0 15.0

Jiang 7.0 12.0

New

generation

device

Early

generation

device

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TAVR for PARProcedural Success (%)

Takagi 90.2 67.2

Wernly 92.9 68.4

Rawasia 96.3 75.2

Haddad 92.0 68.0

Jiang 95.0 71.0

New

generation

device

Early

generation

device

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TAVR for PARResidual Paravalvular LeakModerate-Severe (%)

Takagi 3.4 17.3

Wernly NR

Rawasia 3.3 20.1

Haddad 3.0 19.0

Jiang 0 28.0

New

generation

device

Early

generation

device

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TAVR for PARWhat can we say

• We have no randomized data

• Newer devices have improved outcome

• Success rates with newer generation devices are improving

• 30 day mortality rates still higher than with AS

• Paravalvular leak rates substantially improved with newer devices

• We still worry about fixation, aortic annular diameter, dilatation of the ascending aorta

Wernly et al. Clinc Research in Card 2019

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FUTURE

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Fresh Aortic Homografts and AVR

• 655 patients undergoing aortic homograft with AVR1980-2002

• 30-day overall hospital mortality 2.87%

• Mean durability for all grafts 12.4 +/– 4.5 years

• Freedom from reoperation

• 5 years 94%

• 10 years 87.9%

• 15 years 76.6%

• 20 years 49.55%

Sadowski: Eur J CV Surg 23:996-1000, 2003

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Sadowski: Eur J CV Surg 23:996-1000, 2003

Fresh Aortic Homografts and AVRIndication for Reoperation

79.8

62.5

17.5

0

20

40

60

80

100

Graft degeneration Aortic regurgitation Predominant AS

%

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The CombinationAortic Valve Disease and Failing Homografts

• Repeat SAVR technically challenging

• Homograft often calcified

• Sternal entry injury – excess blood loss

• Substantial risk of morbidity, mortality

• Patient comorbidities common

• Need for additional procedures

• Relatively limited clinical data

Sedeek AF et al: J Thoracic & CV Surg 1-8, 2019

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Aortic Valve Disease and Failing Homografts

• Single center clinical experience

• 51 patients with failing homografts undergoing repeat AV replacement (2000-2018)

• SAVR in 40, TAVR in 11

• SAVR cases 30/40 repeat composite AV/Root

Sedeek AF et al: J Thoracic & CV Surg 1-8, 2019

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Aortic Valve Disease and Failing Homografts

TAVR SAVR

Age, years 75 (52-79) 58 (47-63)

EF, % 54 (49-59) 57 (50-66)

Time to repeat AVR, yrs 15 10

NYHA Fc III/IV, % 64 40

AV stenosis, % 100 50

AI moderate/severe, % 100 90

Sedeek AF et al: J Thoracic & CV Surg 1-8, 2019

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Sedeek AF et al (in press)

Aortic valve annulus area512 mm2 (435-630)

LV outflow tract area677 mm2 (490-780)

TAVR in Homograft

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Aortic Valve Disease and Failing HomograftsClinical Outcome

TAVR

11

SAVR

40

No. % No. %

Major/life threatening

bleed0 – 23 58

Atrial fib 1 9 12 30

Vasc injury 4 36 6 15

Op death 1 9 3 8

Stroke 0 – 1 3

LOS (days) 2 – 7 –

Sedeek AF et al: J Thoracic & CV Surg 1-8, 2019

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Aortic Valve Disease and Failing HomograftsPost-op Echo

TAVR SAVR P

EF, % 55 53 –

Mean gradient (mm) 12 19 0.085

>20 mm Hg, no. (%) 1 (9) 15 (38) 0.080

AR, no. (%)

None 5 (45) 32 (82) –

Trivial 5 (45) 7 (18) –

Moderate 1 (9) – –

Sedeek AF et al: J Thoracic & CV Surg 1-8, 2019

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Estimates of Mortality in TAVR and SAVR Groups

0.0

0.2

0.4

0.6

0.8

1.0

0 5 10

Years

Dea

thTAVR

Sedeek AF et al (in press)

SAVR

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TAVR in Failing HomograftsProcedural Performance

• Valve size: 29 (5 pts); 26 (5 pts); 23 (1 pt)

• Annulus geometric oversize: 6%

• LVOT geometric oversize: –17%

Sedeek AF et al: J Thoracic & CV Surg 1-8, 2019

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Conclusions: Repeat aortic valve replacement for failing

aortic root homograft is associated with notable risk of

morbidity and mortality regardless of replacement

technique. Avoidance of vascular injury could lead to

improved outcomes in the transcatheter aortic valve

replacement group.

Sedeek AF et al: J Thoracic & CV Surg 1-8, 2019

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The CombinationAortic Valve Disease and Failing Homografts? Role TAVR

• Sizing of the valve annulus

• Angulation and distortion of aortic root

• Level of implant of homograft

• Access

• Dimension of LVOT, annulus, and root

• Really limited data

Sedeek AF et al: J Thoracic & CV Surg 1-8, 2019

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Aortic Valve Disease and Failing GraftsIssues

• Preservation of the initial homograft?

• Failure to treat concomitant disease

• Difficult removing the calcified annulus

• Undersized annulus

• Coronary occlusion

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EW

• 75 year old male

• 1999 Bicuspid aortic valve – AVR with homograft, subsequent AR, severe cerebrovascular disease, TIA –2017

• 27 mm aortic homograft, 8 cm long extending to just proximal to innominate

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EW

• 2-14-2018:

• Severe LV enlargement

• Severe AR, gradient 10 mm

• ASC aorta 50 mm

• CT

• Calcified homograft

• Aortic annulus 27 x 26; area 5.12 cm2

• LVOT 7.7 cm2 (4 mm below annulus)

• Coronary height 11 LMCA; 12 RCA

• Mediolateral 9 mm LMCA

• Virtual cage 8 mm RCA

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EW

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TAVR in Failing HomograftsIssues

• Concern about sizing

• Aortic root homograft annulus

• Represents homograft native annulus

• Suture lines

• Options

1. Oversize annulus; undersized LVOT

2. Optimize annulus; really undersize LVOT

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Questions & Discussion