In hospital mortality after TAVR: Common and Uncommon

Causes

Susheel Kodali, MD

Director, Structural Heart and Valve Center

Avanessians Associate Professor of Cardiology

Columbia University Medical Center

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

• Consultant

• SAB

• Claret Medical, Abbott Vascular, Merrill Lifesciences, Admedus

• Thubrikar Aortic Valve, Inc, Dura Biotech, Biotrace Medical, MID

Affiliation/Financial Relationship Company

Disclosure Statement of Financial Interest

Susheel K. Kodali, MD

Mortality post TAVR

0%

1%

2%

3%

4%

5%

6%

7%

8%

9%

PARTNER ICohort B

CoreValveExtreme Risk

PARTNER ICohort A

CoreValveHigh Risk

PARTNER IIA SURTAVI PARTNER III CoreValveLow Risk

Mo

rtal

ity

30 Day Mortality

Reasons for Improvement

• Device iteration

• Increased operator experience resulting in fewer complications

• Refinement in procedural technique

• Lower risk population

Causes of In-hospital Mortality

• Acute procedural catastrophe (LV perforation, annular rupture, aortic dissection, coronary occlusion, etc)

– Must be prepared to handle complications

– Despite successful rescue, it may still lead to poor outcome depending on patient protoplasm

• 93 yo female with severe aortic

stenosis and NYHA III CHF

• Echo: EF 55%, AVA 0.8 cm2

• STS score 8.4%, inoperable

due to porcelain aorta

Aortic Root RuptureCase Example

Severe

Calcification

extending in

LVOT

Aortic Root RuptureCase Example

Aortic Annulus by

3D TEE 478 mm2

Acute Hypotension Immediately Post Valve Deployment

Aortic Root RuptureCase Example

Emergent pericardiocentesis performed and a 2nd

26 mm Sapien THV placed to seal the annular rupture

Aortic Root RuptureCase Example

Aortogram And Echo After Pericardiocentesis And Second Valve

Deployment

Aortic Root RuptureCase Example

Type 1 bicuspid, large sinusesAnnulus Area 554, perimeter 84

Unusual Coronary Occlusion

BAV Sizing and TAVR

26 mm balloon 26 mm SAPIEN 3

Resuscitation and Urgent Assessment

• Severe, refractory hypotension

• Wall motion abnormality

• Ventricular tachycardia -> fibrillation

• Cardiopulmonary resuscitation

Stabilization with ECMO and

attempted PCI

JL 3.5 Guide Occlusion of LM / sinus

White line sign

Final Result

• Weaned off ECMO and extubated in room

• Discharged home on POD4

• 30 day follow-up with no significant CV symptoms

Coronary Occlusion: What Happened?

Right-Non Fusion

26mm S3

Coronary leaflet to sinus curved length ratio >1

CL SCL

Coronary Occlusion: What Happened?

Asymmetric Sinus Height

Causes of In-hospital Mortality

• Acute procedural catastrophe (LV perforation, annular rupture, aortic dissection, coronary occlusion, etc)

– Must be prepared to handle complications

– Despite successful rescue, it may still lead to poor outcome depending on patient protoplasm

• Anything that extends hospitalization…

Complications Impact Outcomes

14.0%11.2%

36.2%

21.7%

4.1%2.6%

19.0%

6.9%

0

0.05

0.1

0.15

0.2

0.25

0.3

0.35

0.4

All mortality CV mortality All mortality CV mortality

Fre

qu

en

cy

≥ 1 complication (n=514)

No complications(n=2005)

p < 0.0001

p < 0.0001

p < 0.0001

p < 0.0001

30 days 1 year

PARTNER Trial

Complications Post TAVR

➢Stroke

• 82 year old independent female with htn, atrial fibrillation (STS – 4) undergoes TAVR

• Acute procedural result excellent No hemodynamic issues during the case

• Upon extubation, patient noted to have dense left hemiparesis

• Patient underwent urgent angiography to identify and remove clot

• Minimal improvement over first 48 hours• After nearly 4 week course in the hospital,

patient dies from respiratory failure after nosocomial pneumonia

Case Example

Strokes and TAVR

Eggebrecht et al.; EuroIntervention 2012;8:129-38

METHODS:• Meta-analysis from 53 studies in 10,037 pts treated with TAVI (TA, TF, or

TS) published from Jan, 2004 to Nov, 2011• Mean age 81.5 ± 1.8 yrs and mean logES 24.8 ± 5.6%

RESULTS:• Procedural stroke (< 24 hrs) 1.5 ± 1.4%; 30-day stroke/TIA 3.3 ± 1.8%,

most major strokes 2.9 ± 1.8%; 1-year stroke/TIA increased to 5.2 ± 3.4%• Different stroke rates with different approaches and valve prostheses;

lowest with TA-ES 2.7±1.4% vs. TF-ES 4.4±2.2% (30-day stroke/TIA)• Mortality at 30 days + stroke = 25.5% vs. - stroke = 6.9% (> 3.5X)

8.1%

25.5%

6.9%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

All patients

Patients with stroke

Patients withoutstroke

30-day mortality

Neurologic Event Rates Decreasing

SAPIEN SAPIEN XT SAPIEN 3

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

P1B (TF) P1A (All) P2B (TF) P2B XT (TF) S3HR (All) S3i (All) P3

179 344 276 284 583 1076 496

30 Days

US TVT Registry Stroke Rate

2.6 2.6 2.62.4

0

0.5

1

1.5

2

2.5

3

2012 2013 2014 2015

% 30 Day Stroke

TVT RegistryExperience and Risk of Stroke

Carroll J, et al. ACC 2016

• Over 53,000 US TAVR patients from >350 US centers

• No significant decline in stroke rate as centers gain experience

• Self-reported rates without prospective neurologist exams pre and post-procedure likely underestimate true rates

Reducing Risk of Stroke

• Embolic Protection

• Antithrombotic and Anticoagulation Regimens

• Avoiding hypotension

• Valve choice?

Complications Post TAVR

➢Stroke

➢Vascular and Bleeding Complications

All Bleeding is Not the Same

Keys to minimizing impact of vascular complications• Early identification and appropriate management to

minimize impact on recovery (i.e. – limit blood loss)• Percutaneous treatment of vascular injury if feasible

Smaller Sheath Size Results in Lower Complications

EdwardsSAPIEN THV

EdwardsSAPIEN XT THV

EdwardsSAPIEN 3 THV

22F16F

14F

30-day major vascular complications by platform

From PARTNER 2B and S3 HR

15.9%

11.3%

5.3%

0%

5%

10%

15%

20%

SAPIEN SAPIEN XT SAPIEN 3

Nuis et al. Circ Cardiovasc Interv. 2012;5(5):680-8

Nombela-Franco et al, JACC Intv 2015

Piccolo et al, JACC Intv 2017

• Registry of 926 patients undergoing TAVR• Bleeding adjudicated based on VARC 2

criteria• Bleeding rate – 30.7%• All access related bleeds occurred within 30

days whereas 40% of non-access related bleeding events occurred after 30 days

• Bleeding events significantly increased mortality

Impact of non-access site bleeding more significant than access site bleeding after

transfemoral TAVR

Piccolo et al, JACC Intv 2017

Complications Post TAVR

➢Stroke

➢Vascular and Bleeding Complications

➢Renal Insufficiency

Impact of Baseline Renal Function on Post-TAVR Outcomes

CoreValve High Risk Trial

Boehar et al

One-year all-cause mortality Placement of Aortic Transcatheter Valves (PARTNER) 1 cohorts A and B

The Annals of Thoracic Surgery 2016 102, 1172-1180DOI: (10.1016/j.athoracsur.2016.07.001)

Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions

Mitigating Risk of Renal Failure

• Space out contrast requiring procedures

• Minimize contrast load in patients with renal insufficiency– Avoid preop CTA – use non-con CT to assess

vasculature

– Skip coronary angiography or perform very limited pictures

– Perform TAVR under GA with TEE guidance

• Optimize hemodynamics both pre, during and post TAVR to avoid hypotension

Complications Post TAVR

➢Stroke

➢Vascular and Bleeding Complications

➢Renal Insufficiency

➢Infection

Another Deadly WeaponFoley catheter

placed

Male patient with BPH

Hematuria Urinary Retention

Urinary Tract Infection

27.8%

15.2%

3.9%

0.5%

11.5%

8.4%

16.0%

34.1%

19.6%

8.3%

2.8%

21.5%

5.8%

19.0%

30.7%

17.2%

5.9%

1.6%

16.1%

7.2%

17.2%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

UAE UrinaryRetention

Reinsertionof IUC

Dischargedwith IUC

Hematuria* UTI AKI

Inci

de

nce

of

Co

mp

licat

ion

s

Women (n=382) Men (n=326) Total (n=708)

p=0.07

p=0.13

p=0.06

p=0.2

p<0.01

p=0.24

p=0.32

In-Hospital Urologic Adverse Events in Patients Undergoing TAVR with in-dwelling catheter

Impact of UAE on 30 day mortality post TAVR

Strategies to Mitigate Risk

• Avoid Foley catheters even in general anesthesia cases

• If Foley is required, consider urologic consult in complex anatomies to avoid further complications

• Consider pre-treatment with alpha blockers such as FloMax

• Avoid anti-cholinergic drugs• If Foley is required, consider removal as soon as

possible

• Elderly patient with multiple co-morbidities has less reserve

• Ability to tolerate complication reduced

• More prone to infection

Risk Profile Impacts Outcomes

Low

RiskIntermediate

Risk

Fu

tile

Too

Sick

High

Risk

Who does poorly with

surgery?

Who does well with

TAVR?

Who Not to Treat?

p= 0.043p= 0.046 p< 0.0001p= 0.13 p= 0.0002p= 0.13

100%

75%

25%

0%

50%

p= 0.0004 p< 0.0001 p< 0.0001

O2-dep COPD patients had the worst functional status in follow-up

No COPD

COPDnon-O2 dep.

COPDO2 dep.

No COPD COPDnon-O2 dep.

COPDO2 dep.

No COPD COPDnon-O2 dep.

COPDO2 dep.

Baseline 30 Days 1 Year

Impact of COPD on Outcomes

Dead

NYHA IV

NYHA III

NYHA II

NYHA I

45% 44%

Dvir et al, TCT 2012

Decreased mobility is a poor prognostic sign

Death (%) Non-cardiovascular death (%)

6 minute walk test (meters)

p = 0.02 p < 0.001

6 minute walk test (meters)

0

5

10

15

20

25

<50 50 - 100 100 - 200 > 2000

2

4

6

8

10

12

14

16

<50 50 - 100 100 - 200 > 200

Dvir et al, TCT 2012

Learning Who Not to Treat

Patients in whom the presence of multiple comorbidities, especially frailty, overwhelm the likelihood of functional recovery despite

successful TAVR

53

TAVR Medical therapy

Porcelain aorta

Hostile chest

RIMA/LIMA anatomy

Severe frailtySevere COPD

Liver cirrhosis

Dementia

Dea

th In

cid

ence

(%

)

Months

0%

20%

40%

60%

80%

100%

0 6 12 18 24

STS 5-14.9

Numbers at Risk

STS <5

Months

0%

20%

40%

60%

80%

100%

0 6 12 18 24

28 26 25 24 16

12 8 7 6 5

Standard Rx TAVR

STS ≥15

0%

20%

40%

60%

80%

100%

0 6 12 18 24

Months

43 32 23 19 15

47 29 19 14 8

108 80 76 67 52

119 84 59 42 29

PARTNER – Cohort BMortality Stratified by STS Score (ITT)

Close Calls

Balloon Aortic valvuloplasty was performed with a 26mm True

Flow balloon

Not All Embolic Events Cause a Stroke

• Following valvulopasty, denuded endothelium was seen protruding/floating into the aorta (center and right images)

• The fragment was attached to the upper aortic root, adjacent to the sino-tubular junction

▪ Decision was made to proceed with TAVR - 29mm Sapien 3 valve was successfully deployed.

▪ After deployment, TEE didn`t show the piece of endothelium in the aorta anymore… it was found protruding into the LM coronary artery.

LMAo

LM tissue flap protrusion - stenting

▪ A 4.0 x 28 mm Synergy stent was deployed in the LM, and post dilated with a 5.0 NC balloon under IVUS guidance.

Complication only identified because case performed under TEE. Otherwise this could have

led to event later

Distal Embolization• Uneventful TAVR performed

under TEE and general anesthesia due to borderline vascular access

• Patient extubated but over next 24-48 hours complains of abdominal pain

• Lactate rises and kidneys shut down

• Acute abdomen noted and general surgery called

• CT consistent with dead bowel

• Family elected for palliative care and patient expired

Could it have been prevented?

• 82 year female underwent successful TAVR with Sapien 3 valve.

• No immediate issues identified.• Baseline ECG reveals Afib with RBBB• Patient ambulating next day with no

change in ECG• Planned for discharge and send for echo

Case Example – Conduction Abnormalities

Be cautious about aggressive early discharge protocols in patients with

baseline conduction abnormalities

• 78 year male underwent successful TAVR with Sapien 3 valve.

• Due to new LBBB and 1o AVB, 5F balloon tipped pacer left in place in LFV

• ECG returned to normal later in day and pacer pulled

• ~1 hour later patient noted to be hypotensive• Echo performed – Pericardial effusion• Successfully drained and patient eventually

discharged home

Case Example – Late Effusion

Reducing Risk of TAVR

• Careful review of CTA to understand high risk anatomic features

• Optimized patient prior to procedure – If possible avoid urgent in-hospital cases

• Minimize contrast, avoid neck lines, avoid foley

• Early mobilization

Thank you!

skodali@columbia.edu