Interventional Cardiology
Board Review 2014
Samin K. Sharma, MD, FACC
Director, Clinical and Interventional Cardiology
President Mount Sinai Heart Network
Professor of Medicine
Cardiovascular Institute
Mount Sinai Hospital , New York
2002- 71%
2003- 75%
2004- 78%
2005- 83%
2006- 85%
2007- 84%
2008- 85%
2009- 86%
2010- 88%
2011- 90%
2012- 88%
2013- 86%
ACC/AHA Guidelines
Customary ACC/AHA Classification
Class
I
IIA
Characteristics
Evidence & general agreement
for usefulness/efficacy
Level of
evidence
• A (highest rank)
Evidence in favor of
usefulness/efficacy
IIB
Evidence is controversial,
usefulness/efficacy less well
established
III
Not useful/effective, & in some
cases may be harmful
Characteristics
Data derived from multiple
randomized trials
involving large numbers of
patients
Data derived from limited
randomized trials
• B (intermediate)
involving small numbers of
patients or from
careful analysis of nonrandomized studies
• C (low rank)
Expert consensus
PCI Indications and Outcomes According to
Clinical Presentation
For every 100 pts treated with primary angioplasty rather
then thrombolytic therapy, primary angioplasty (when
performed without significant delays) saves approximately
how many lives?
a.
b.
c.
d.
e.
<1
2-3
4-6
6-7
>7
B
Thrombolysis Vs. PCI for STEMI
30-Day Event Rate in 21 Randomized Trials
Thrombolysis
PCI
20
15
%
10
An additional
21 lives saved
/1000 treated
0
OR:
95% CI:
p<0.001
11.9
p=0.02
7.2
6.5
5
NNT=?
4.4
p=0.007
5.3
2.9
Mortality
0.66
0.46-0.94
Non-fatal MI
0.53
0.34-0.
2
Mortality/re-MI
0.58
0.44-0.76
0.7
Stroke
0.35
0.14-0.77
Weaver et al. JAMA 1997;278:2093
NNT=100/Absolute risk reduction
Question
RRR= Absolute difference/Occurrence in non-treatment arm x100
A randomized study of 1000 pts indicated a 13.5% event rate with treatment A vs.
a 16.0% event rate with placebo; p = 0.08. Another study in a similar patient
population indicated a 14.5% event rate with treatment B compared to 16.0% with
placebo; p = 0.02. Which of the following is true?
a. The absolute risk reduction is 2.5% with A and 1.5% with B compared to
placebo; this means that A is superior to B
b. Treatment B is superior to placebo, while A is not; this means that B is
superior to A
c. The number of patients needed to treat with B in order to prevent 1 event
that would have occurred with placebo is 67
d. The number of patients needed to treat with B in order to prevent 1 event
that would have occurred with placebo is 11
e. The number of patients needed to treat with A in order to prevent 1 event
that would have occurred with placebo is 6
C
Thrombolysis Vs. PCI for STEMI
30-Day Event Rate in 21 Randomized Trials
Thrombolysis
PCI
20
15
%
10
An additional
21 lives saved
/1000 treated
0
OR:
95% CI:
p<0.001
11.9
p=0.02
7.2
6.5
5
NNT=48
4.4
p=0.007
5.3
2.9
Mortality
0.66
0.46-0.94
Non-fatal MI
0.53
0.34-0.80
2
Mortality/re-MI
0.58
0.44-0.76
0.7
Stroke
0.35
0.14-0.77
Weaver et al. JAMA 1997;278:2093
A patient develops sudden slow
flow after PCI of the LAD without
dissection. The next step is:
•
•
•
•
•
A Stent
B Nitroglycerin 200mcg
C Nipride 50 mcg
D Verapamil 50mcg
E TPA
C
Nipride 50mcg, Adenosine 80-120mcg, Verapamil 250500mcg, Cardizem 250-500 mcg.
Which of the following is not true regarding
abciximab and stents
A. Reduces 1 year mortality
B. Reduces TVR in diabetics at 6 months.
C. Reduces TVR at 6 months.
D. No effect on stent thrombosis
C
EPISTENT Trial: One-year
Outcome
Stent + placebo (173 DM / 635 no DM)
30
p=0.035
Stent + abciximab (162 DM / 632 no DM)
PTCA + abciximab (154 DM / 640 no DM)
25.3
25
22.4
p=0.01
18.7
20
p=NS
%
15.6
p=0.005
15
11.1
13.7
13.7
p=0.002
p=NS
10
8.7
8.4
p=NS
5
2.6
1.9
1.2
0
Death
MI
TVR
Diabetic patients (n=489)
Topol et al. Lancet 1999;354:2019
6
p=NS
4.3
4.1
1
p=NS
4.4
2
Death
MI
TVR
Non-diabetic patients (n=1907)
The REPLACE 2 Trial showed a
major bleed rate of
A. 4.1 v 2.4
B. 3.0 v 2.0
C. 5.2 v 3.1
D. 6.1 v 4.2
A
DANAMI 2 Showed a Reduction of the
Primary endpoint of Death, MI, CVA
from:
A. 20 to 10%
B. 14 to 8%
C. 15 to 9%
D. 9 to 5%
B
No difference in mortality
In a patient undergoing PCI on
bivalirudin with CrCL< 30 ml/Min
A. The bolus should be reduced to 0.5
mg/Kg
B. The infusion should be reduced to 1.0
mg/Kg/Hr
C. The infusion should be reduced to 0.25
mg/Kg/Hr
D. The infusion should remain 1.75
mg/Kg/Hr
B
You are about to perform PCI of a 70%
lesion of the LAD with heparin and
eptifibatide when you are informed that
the ACT is 170. The correct next step is:
A. Give another 50U/ Kg IV bolus and check an ACT
B. Give another 25U/Kg IV bolus and check an ACT
C. Give another 70U/KG IV bolus and check an ACT
D. Give another 60U/KG IV bolus and check an ACT
B
GP IIb/IIIa Inhibitors
Major differences in pharmacodynamics / pharmacokinetic
Abciximab
Tirofiban
Eptifibatide
Long
(hours)
Short
(seconds)
Short
(seconds)
Short
(minutes)
Long
(1.8 hr)
Long
(2.5 hr)
Drug to receptor ratio
1.5-2.0
>250
250-2500
% of dose in bolus
75%
<2-5%
<2-16%
Platelet-bound half-life
Plasma half-life
A patient is undergoing rotational
atherectomy on heparin and abciximab when
there is a perforation. What is the next step?
A. Order a platelet transfusion
B. Check an ACT
C. Check the level of platelet inhibition (PAU)
D. The drug will reverse on its own.
A
A 60 year old patient is started on enoxaparin
for ACS with aspirin and clopidogrel. The last
dose of enoxaparin was 7 hours prior to PCI.
Your best option is:
A. PCI without any extra anticoagulation
B. Add a IIB/IIIA inhibitor and proceed with PCI
C. Add a IIB/IIIA inhibitor and heparin 50U/KG
and proceed to PCI
D. Add enoxaparin 30mg IV and proceed to PCI
A
(1/3rd after 8-12 Hrs)
Question
A 65-year-old woman with recent non-Q-wave MI is scheduled to undergo coronary
intervention. Diagnostic angiography performed 2 days ago revealed complex 20 mm long
lesion of the proximal RCA. She has been on chronic therapy with ASA and has received
Plavix 600mg loading and 75 mg daily for the past two days. She has also been treated
with IV unfractionated heparin infusion, which is interrupted at the time of sheath
insertion. Her weight is 80 kg and her height is 165 cm. Use of weight-adjusted dose of
abciximab has been opted. Which of the following statements regarding the appropriate
next step for this patient’s management is correct?
a. Abciximab plus 7,000 units of IV heparin should be administered
immediately after insertion of the femoral sheaths
b. 10,000 units of IV heparin should be administered immediately after
insertion of the femoral sheaths; abciximab should be administered when
the activated clotting time value is 200-300 seconds
c. Abciximab plus 5,600 units of IV heparin should be administered
immediately after insertion of the femoral sheaths
d. 5,600 units of IV heparin should be administered immediately after insertion
of the femoral sheath & abciximab should be administered when ACT is 200300 seconds
e. None of the above
Question
A 65-year-old woman with recent non-Q-wave MI is scheduled to undergo coronary
intervention. Diagnostic angiography performed 2 days ago revealed complex 20 mm long
lesion of the proximal RCA. She has been on chronic therapy with ASA and has received
Plavix 600mg loading and 75 mg daily for the past two days. She has also been treated
with IV unfractionated heparin infusion, which is interrupted at the time of sheath
insertion. Her weight is 80 kg and her height is 165 cm. Use of weight-adjusted dose of
abciximab has been opted. Which of the following statements regarding the appropriate
next step for this patient’s management is correct?
a. Abciximab plus 7,000 units of IV heparin should be administered
immediately after insertion of the femoral sheaths
b. 10,000 units of IV heparin should be administered immediately after
insertion of the femoral sheaths; abciximab should be administered when
the activated clotting time value is 200-300 seconds
c. Abciximab plus 5,600 units of IV heparin should be administered
immediately after insertion of the femoral sheaths
d. 5,600 units of IV heparin should be administered immediately after insertion
of the femoral sheath & abciximab should be administered when ACT is 200300 seconds
e. None of the above. B/c ACT has to be measured first before any
heparin is given
E
An invasive strategy with adjunctive
glycoprotein IIb/IIIa inhibition compared with a
conservative strategy has been shown to:
a. Have a higher mortality
b. Have a lower mortality
c. To reduce death or MI
d. To increase death or MI
C
PCI Indications and Outcomes According to
Clinical Presentation
The mortality/morbidity of NSTEMI as compared to STEMI
is:
a.
b.
c.
d.
e.
Similar in-hospital and at 6 months
Lower in-hospital and higher at 6 months
4-6%
6-7%
>7%
B
Prognostic Value of the Admission ECG in
Acute Coronary Syndromes: GUSTO Trials
Kaplan-Meier Estimates of Probability of Death
30-Day Mortality (%)
6-Month Mortality
&
Re-MI (%)
6.6%
9.1% 8.9%
ST  and 
ST  and 
ST 
5.1%
5.1%
ST 
ST 
ST 
1.7%
Isolated T wave inversion
Days from randomization
8.9% 9.2%
6.8%
6.8%
3.4%
5.4%
Isolated T wave inversion
Days from randomization
Savonitto et al. JAMA 1999;281:707
PCI Indications and Outcomes According to
Clinical Presentation
Which of the following trials found no major benefits of
routine early invasive strategy compared to conservative
treatment in ACS?
a.
b.
c.
d.
e.
COURAGE
ICTUS
ACUITY
TACTICS-TIMI 18
FRISC II
B
Recent Randomized Trials of ACS
Primary Endpoints: Death, Re-MI, & ReConservative hospitalization
%
Early Intervention
30
p=0.33
25
p=0.025
p=0.32
19.4
20
15.9
21.2
19.5
16.2
13.5
15
22.7
p=0.001
13.5
p=0.04
25%
NNT=25
P=0.001
18.6
11.6
14.6
10
5.9
5
0
TACTICS*
(n=2210)
INTERACT** RITA-3*** ISAR-COOL** ICTUS***
(n=746)
(n=1810)
(n=410) (n=1200)
*At 6 mths, ** At 30-days, ***At 1-year
Cons. Inter.
All Combined
PCI Indications and Outcomes According
to Clinical Presentation
A 64 yrs old man has been treated with ASA, a statin, nitrates and a betablocker for stable angina, hypertension and hyperlipidemia. He successfully
controls his DM with diet alone. He recently had somewhat more frequent
angina, and a Thallium stress test revealed a reversible anterior perfusion
defect. Coronary angiography showed an 80% prox-LAD lesion, 40% circumflex
and 40% RCA; LVEF is 55%. Which of the following options is correct?
a.
b.
c.
d.
Surgical therapy offers a survival advantage over medical therapy
Both PCI and surgery offer a survival advantage over medical therapy
Strict HTN control is not necessary after successful revascularization
According to the BARI trial, surgery should offer a survival advantage
over PCI in this pt
e. None of the above
E
TIMI Risk Score for UA / Non-STEMI
%
Rate of
composite endpoint
Death, MI, UA requiring revasc.
• Age 65 years
50
40.9
40
19.9
20
0
• ST segment deviation
13.2
4.7
• 3 risk factors for CAD
• Significant coronary lesion
26.6
30
10
Characteristics for
development of
TIMI risk score:
• Severe anginal symptoms
8.3
• Use of aspirin in last 7 days
0/1
2
3
4
5
6/7
Low Risk No.
Intermed
of risk factors
risk High risk
Test cohort:
No. 85
339
% 4.3
17.3
627
32.0
573
29.3
267
13.6
66
3.4
•  serum cardiac markers
Antman et al. JAMA 2000;284:835
Pathophysiology of ACS: Platelet Activation
Vessel wall
One-Month & One-Year Composite Endpoint*
CREDO Trial
40
%
PCI-CURE Trial
(*Death, MI, or stroke)
(*Death, MI, or urgent TVR)
Clopidogrel (n=1053)
Placebo (n=1063)
Clopidogrel (n=1313)
Placebo (n=1345)
 16%
p=0.03
30
20
 27%
p=0.02
 19%
p=NS
10
5.5
0
11.5
18.3
 30%
p=0.03
8.5
6.9
At 28 days
21.7
4.5
At 1 year
Steinhubl et al. JAMA 2002;288:2411
At 30 days
6.4
At 1 year
Mehta et al. Lancet 2001;358:527
CURRENT OASIS 7 Trial: A 2x2 Randomized Trial of Optimal
Clopidogrel and ASA Dosing in Pts with ACS Undergoing an Early Invasive
Strategy with Intent for PCI
Study Design, Flow and Compliance
25,087 ACS Patients (UA/NSTEMI 70.8%, STEMI 29.2%)
Planned Early (<24 h) Invasive Management with intended PCI
Ischemic ECG Δ (80.8%) or ↑cardiac biomarker (42%)
Randomized to receive (2 X 2 factorial):
CLOPIDOGREL: Double-dose (600 mg then150 mg/dx7d then 75 mg/d) vs Standard dose (300 mg then 75 mg/d)
ASA: High Dose (300-325 mg/d) vs Low dose (75-100 mg/d)
Angio 24,769
(99%)
No PCI 7,855
(30%)
PCI 17,232
(70%)
No Sig. CAD 3,616
Clop in 1st 7d (median) 7d
Efficacy Outcomes:
Safety Outcomes:
Key Subgroup:
7d
CV Death, MI or stroke at day 30
Stent Thrombosis at day 30
Bleeding (CURRENT defined Major/Severe and TIMI Major)
PCI v No PCI
CABG 1,809
2d
CAD 2,430
7d
Complete
Follow-up
99.8%
CURRENT OASIS 7: Randomized Trial of Optimal
Clopidogrel and ASA Dosing in Pts with ACS
Clopidogrel Double vs. Standard Dose – Major Efficacy
Outcomes in PCI Patients
Clopidogrel Standard Dose (n= 8684)
Clopidogrel Double Dose (n= 8548)
10
8
P = 0.036
6
%
P = 0.002
4
3.9
P = 0.68
2.6
2.3
2
4.5
P = 0.012
1.6
2.0
1.9
1.9
P = 1.00
2.3
2.3
P = 0.59
0.4
0.4
0
Stent thrombosis
MI
Death
Stroke
Death/MI/Stroke
Major Bleed
Yusuf et al. NEJM 2010;363:930.
New Players in the Antiplatelet Therapy Field
Biotransformation and Mode of Action of Clopidogrel, Prasugrel, and Ticagrelor
Ticagrelor
Clopidogrel
Prasugrel
No in vivo
biotransformation
CYP-dependent
oxidation
Ticagrelor
Prasugrel
Hydrolysis
by esterase
CYP3A4/5
CYP2B6
CYP2C19
CYP2C9
CYP2D6
Binding
Platelet
P2Y12
Clopidogrel
CYP-dependent
oxidation
Active compound
Intermediate metabolite
Prodrug
CYP1A2
CYP2B6
CYP2C19
CYP-dependent
oxidation
CYP2C19
CYP3A4/5
CYP2B6
Ticagrelor, a cyclopentyl
triazolopyrimidine, is
rapidly absorbed in the
intestine and does not
require further
biotransformation for
activation. It directly and
reversibly binds to the
platelet adenosine
diphosphate (ADP) receptor
P2Y12. The half-life of
ticagrelor is 7 to 8 hours.
The thienopyridines
prasugrel and clopidogrel
are prodrugs. Their active
metabolites irreversibly
bind to P2Y12 for the
platelet's life span. After
intestinal absorption of
clopidogrel, it requires two
cytochrome P-450 (CYP)–
dependent oxidation steps
to generate its active
compound. After intestinal
absorption of prasugrel, it is
rapidly hydrolyzed, by
means of esterases, to an
intermediate metabolite and
requires one further CYPdependent oxidation step to
generate its active
compound.
TRITON-TIMI 38 Trial
Study Design
ACS (STEMI or UA/NSTEMI) and Planned PCI
ASA
N = 13,600
Double-blind
Clopidogrel
Prasugrel
300 mg LD/ 75 mg MD
60 mg LD/ 10 mg MD
Median duration of therapy – 12 months
Primary end point: CV death, MI, Stroke
Secondary end points: CV death, MI, Stroke, Recurrent Ischemia
CV death, MI, UTVR
Stent thrombosis
Safety endpoints: TIMI major bleeds, life-threatening bleeds
Key sub studies: Pharmacokinetic, Genomic
Wiviott S et al. NEJM 2007;357:2001
Prasugrel versus Clopidogrel in Patients with
Acute Coronary Syndromes: TRITON Trial
Cumulative Kaplan–Meier Estimates of Primary Efficacy End Point (death from
CV causes, MI or stroke) and Key Safety End Point (TIMI major bleeding)
15
Primary Efficacy End Points
12.1
Clopidogrel
138 events
10
9.9
P <0.001
Prasugrel
%
5
0
1.8
0
Number at risk
Clopidogrel
Prasugrel
2.4
Key Safety End Points
6795
6813
30
90
180
270
Days after Randomization
6169
6305
6036
6177
5835
5951
5043
5119
360
4369
4445
35 events
P = 0.03
450
3017
3085
Wiviott et al. N Engl J Med 2007;357:2001
TRITON Trial: Stent Thrombosis in
DES and BMS
%
Wiviott et al. Lancet 2008;371:1353
TRITON Trial: Greater Clinical Benefit of More Intensive
Oral Antiplatelet Therapy With Prasugrel in Pts With DM
Kaplan–Meier curves for Prasugrel vs. Clopidogrel stratified
by DM status
Efficacy end point (death/ MI/ stroke)
TIMI major bleeding non-CABG
1.
Wiviott et al, Circulation 2008;118:1626
TRITON-TIMI 38 Trial: Net Clinical Benefit
Bleeding Risk Subgroups – Therapeutic Consideration
Reduced MD
guided by PK
Age 75 or Wt
<60 Kg
Avoid Prasugrel
4% Prior CVA/TIA
16%
Subgroups with +Benefit:
- STEMI
- Diabetes
- Stent thrombosis on plavix
Significant Net Clinical
Benefit with Prasugrel
80%
MD 10 mg
- Clopidogrel Non-responders
- Complex High Risk Lesions
Wiviott S et al. Circulation 2007;116:2923
Ticagrelor Compared with Clopidogrel in Pts
with ACS: PLATO trial
Study Design
NSTE-ACS (moderate-to-high risk) STEMI (if primary PCI)
Clopidogrel-treated or -naive; randomised within 24 hours of index event
(N=18,624)
Clopidogrel
If pre-treated, no additional loading dose;
if naive, standard 300 mg loading dose,
then 75 mg qd maintenance;
(additional 300 mg allowed pre PCI)
Ticagrelor
180 mg loading dose, then
90 mg bid maintenance;
(additional 90 mg pre-PCI)
6–12-month exposure
Primary endpoint: CV death + MI + Stroke
Primary safety endpint: Total major bleeding
PCI = percutaneous coronary intervention; ASA = acetylsalicylic acid;
CV = cardiovascular; TIA = transient ischaemic attack
1.
Wallentin L et al, N Engl J Med 2009;361:1045
PLATO Trial
Cumulative incidence (%)
K-M estimate of time to first primary efficacy event
(composite of CV death, MI or stroke)
13
12
11
10
9
8
7
6
5
4
3
2
1
0
9.8
Ticagrelor
HR 0.84 (95% CI 0.77–0.92), p=0.0003
0
60
9,333
8,628
8,460
8,219
Clopidogrel 9,291
8,521
8,362
8,124
No. at risk
Ticagrelor
11.7
Clopidogrel
120
180
240
Days after randomisation
300
360
6,743
5,161
4,147
6,743
5,096
4,047
K-M = Kaplan-Meier; HR = hazard ratio; CI = confidence interval
1.
Wallentin L et al, N Engl J Med 2009;361:1045
PLATO Trial
K-M estimate of primary efficacy (composite of CV death,
MI or stroke) & Bleeding
P <0.001
15
Ticagrelor (n= 5640)
Clopidogrel (n= 5649)
11.7
12
P = 0.005
P = 0.43
11.6 11.2
9.8
P = 0.001
9
%
6
6.9
5.8
P = 0.009
3
1.3
0
5.1
P = 0.22
4.0
1.9
Stent
Thrombosis
1.5
MI
Death
1.3
Stroke
1.
Death/MI/
Stroke
TIMI major
Bleeding
Wallentin L et al, N Engl J Med 2009;361:1045
Fondaparinux Vs. Enoxaparin in ACS:
OASIS-5 Trial
Death Rates and Events at 180-Days Follow-Up
P = 0.06
6.5%
P = 0.05
0.06
5.8%
Enoxaparin
15
13.2
12.3
Fondaparinux
0.04
P <0.001
10
mm
%
5.8
0.02
4.3
5
0.00
0
30
Fondaparinux
90
120
150
180
Follow-up period (Days)
No. at risk
Enoxaparin
60
10021
10057
9673
9762
9574
9664
9495
9585
8594
8611
8506
8549
8321
8386
0
Death/MI/Refractory
Ischemia
Major
Bleeding
Enoxaparin (n = 10021)
Fondaparinux (n = 10057)
Issue was catheter induced thrombus in PCI pts
OASIS-5 Trial, N Engl J Med 2006;354:1464
ACUITY Trial: MACE and Major Bleeding after PCI
Heparin*+ IIb/IIIa vs. Bivalirudin + IIb/IIIa vs. Bivalirudin Alone:
30-Day Events
Heparin+GPI (N=2561)
15
Bivalirudin+GPI (N=2609)
Bivalirudin alone (N=2619)
12
P = 0.16
9.3
9
8.2
8.8
P = 0.32
P = 0.16
7.5
%
6.8
6.6 6.5
5.6
6
P = 0.31
3.2
3.7
3.2
P < 0.001
3.5
P = 0.37
3
0.9 1.1 1.1
0
Composite ischemia
Death
*Heparin=unfractionated or enoxaparin
MI
urgent
Major bleeding
Revascularization
Stone GW et al. NEJM. 2006;355:2203
Prasugrel versus Clopidogrel for ACS without
Revascularization: TRILOGY Trial @ 30 months Follow up
Prasugrel (N = 4663)
25
20
Clopidogrel (N = 4663)
P = 0.45
18.7
20.3
P = 0.38
15
P = 0.58
%
12.3
9.9
10.2
10.7
10
P = 0.52
5
2.2
2.6
0
CV death / MI / Stroke
CV death
MI
Stroke
Roe et al. NEJM 2012;367:1297
Question
Following are the PCI versus CABG trials for multivessel disease,
except:
A. EAST
B. BARI
C. CABRI
D. ERACI
E. CASS
E
Revascularization Trials for Angina
Old:
Medicine vs. Surgery – VA, ECSS, CASS
New: Single vessel disease:
Medicine vs. Angioplasty – ACME
Angioplasty vs. CABG – GOY
Medicine, Angioplasty vs. CABG – MASS
Multivessel disease:
PTCA vs. CABG – ERACI, RITA, CABRI,
GABI, EAST, BARI
Medicine vs. PTCA – RITA II
Recent Trials:
Stent vs. Surgery – SOS, ARTS, ERACI II
CABG Vs. Medical Therapy Trials
VACS, ECSS, CASS – Results
CABG is superior to medical therapy:
• Left main disease >70% (VACS, ECSS)
• 3-vessel disease (ECSS, VACS)
• 3-vessel disease with mild LV dysfunction (CASS, VACS)
• 2-vessel disease with one being prox LAD (ECSS)
• 2 or 3-vessel disease with high-risk features
- ST segment depression
- Early positive ETT
- Old age or LVH
No difference in Q-wave MI and return to work.
PTCA Vs. Medical (CABG) Therapy Trials
ACME, MAAS, GUY Trials – Results
PTCA is superior to medical therapy:
• Improvement in symptoms
• Better exercise duration
• Less angina & anti-anginals drugs
• Better quality of life
But:
• Higher initial cost and cardiac procedures
No difference in MI, death or long-term revascularization.
PTCA Versus CABG Trials
Results
• In-hospital mortality:
Slightly higher in CABG
• Out of hospital mortality:
Slightly higher in PTCA
• Overall long-term mortality:
Equal, except in diabetics
• Incidence of MI:
Equal
• Repeat revascularization:
Significantly lower in CABG
• Angina class & anti-anginals use:
Significantly lower in CABG
• Return to work:
Earlier in PTCA
• Cumulative cost:
Slightly lower in PTCA
• QOL indicator
Better in CABG
Question
Which of the following statements regarding the trials
of PCI versus CABG is true:
A. Diabetics did better with PCI than with CABG
B. CABG has lower MI versus PCI
C. CABG has higher restenosis versus PCI
D. PCI is cheaper than CABG
D
Diabetes and Coronary
Revascularization: BARI Investigators
• 343 patients in BARI had treated diabetes at study entry and
were followed for 5.4 years.
Total mortality (%)
Cardiac mortality
(%)
ARI Investigators. Circulation 1997
PTCA
CABG
n=170
34.7
n=173
19.1
0.003
20.6
5.8
0.0003
IMA graft
n=140
2.9
p
SVG only
n=33
18.2%
p<0.005
Bypass Angioplasty Revascularization
Investigation: BARI Registry Vs. Trial
Seven-year mortality
p<0.05
p=0.001
50
40
46.3
p=NS
%
p=NS
30
26
23.6
p=NS
26
20
10
0
BARI Registry (n=1814)
BARI Trial (n=1476)
CABG
n=202
n=173
PTCA
Diabetics
p=NS
p=NS
15.6
13.9
14.2
n=106 n=180
p<0.01
n=625
n=734
CABG
19.1
n=1189 n=742
PTCA
Overall
Feit et al. Circulation 2000;101:2795
Which of the following is true regarding distal
protection devices (balloon occlusion vs filter wire)
for saphenous vein graft intervention:
a. Restenosis rates are improved compared to
no distal protection
b. Balloon occlusion systems are more
protective than filter wires
c. Filter wires are preferred to balloon
occlusion systems because of increased
crossability
d. Both systems are equally effective in
preventing non Q-wave MI
D
Adverse Events in Coronary Interventions
Pathophysiology of “No-reflow” & Treatments
Ca++ blockers
Adenosine
SNP
Vasospasm
Nitro
GP IIb/IIIa blockade
Thrombus removal
Thrombolytics
Thrombosis ASA+Clopidigrel
Plaque
embolism
Direct stenting
Covered stent grafts
Distal protection devices
The SAFER Trial
Results: Primary Endpoint
GuardWire
(n=406)
All MI (%)
No GuardWire
(n=395)
p
8.6
14.7
- Q-wave MI (%)
1.2
1.3
- Non Q-wave MI (%)
7.4
13.7
1.0
2.3
0.17
0
0.5
0.24
0.5
0.8
0.34
Death (%)
Emergent CABG (%)
TLR (%)
MACE @ Index Hospitalization 8.8%
16.3%
0.008
0.001
Baim et al. Circulation 2002;105:1285.
The SAFER Trial
Results: MACE
20
16.3
15
10
16.5
46%
(p<0.001)
8.8
42%
(p<0.001)
9.6
5
0
Baim et al. Circulation 2002;105:1285.
The FIRE Trial
Results: Primary Endpoint
FilterWire Ex
(n=304)
All MI (%)
GuardWire +
(n=283)
p
8.6
9.9
- Q-wave MI (%)
0.7
0.7
- Non Q-wave MI (%)
7.9
9.2
Death (%)
1.0
0.7
0.77
Emergent CABG (%)
0
0.0
0.94
0.7
1.4
0.84
TLR (%)
MACE @ 30-days
9.5%
11.0%
0.28
0.51
A 58 y/o female, typical angina, positive exercise test,
undergoes stenting of a severe left circumflex
stenosis. There is an additional smooth 50%
stenosis in the mid RCA. How do you proceed with
this RCA:
a. No further treatment, just treat medically
b. Just stent without further exam
c. Send the pt to the ward for mibi-spect
d. Measure fractional flow reserve (FFR)
e. Measure coronary flow reserve (CFR)
D
In a symptomatic pt with angiographic 3-vessel disease (90%
stenosis in mid-LAD, 70% in obtuse marginal branch, 70% in
mid-RCA), fractional flow is measured and the values are 0.45,
0.89 and 0.65, respectively. Based upon these findings, you
have to consider the following possibilities.
Which of the following possibilities would you choose?
a. The pt qualifies for bypass surgery anyway
b. It is safe to perform stenting of the LAD and the RCA
to relieve the symptoms. Further stenting of the
obtuse marginal branch can be safely deferred
c. The pt’s prognosis is improved by stenting all 3
lesions
d. It is sufficient to stent the LAD stenosis
e. Medical treatment in this pt is as good as
interventional treatment
B
Which of the following statements regarding the
randomized control trials of CABG vs. medical therapy
are correct?
a. Survival differences in favor of CABG are
noted in all subgroups
b. The incidence of MI is reduced by CABG
c. Relief of angina is better with CABG
d. Pts with LV dysfunction do better with medical
therapy
e. The use of “statins” improved outcomes in
both groups.
C
In regard to the randomized control trials of CABG vs. PCI in pts
with multivessel disease, please answer TRUE or FALSE:
a. The majority of pts had preserved LV function - True
b. Triple vessel disease was present in the majority False
c. Repeat revascularization rates are higher after PCI True
d. The majority of pts undergoing PCI were treated with
stents - False
e. In diabetics with single-vessel disease, the mortality
was reduced by CABG - False
Which of the following statements about PCI for AMI is
true?
a. The routine use of intra-aortic balloon pump to
reduce reinfarction and reocclusion after primary
PTCA is not recommended
b. Intracoronary stenting is indicated (ACC/AHA) for
routine use during primary acute MI intervention
c. Rotational atherectomy is recommended for the
treatment of calcified lesions in acute MI
d. A platelet IIb/IIIa inhibitor is indicated (ACC/AHA) for
routine use during AMI intervention
e. The combination of stenting and platelet IIb/IIIa
inhibitor provides survival benefit at 1-year followup after primary AMI intervention.
A
Question
Match the following:
1. Modest  in coronary blood flow (CBF) and  of myocardial energy
metabolism (MEM) in a steady state that may last months.
2. Transient  in CBF followed by normal or high CBF and
normal/excessive MEM, lasting hours or days.
3. Severely  CBF and increasingly  MEM lasting minutes to hours.
4. Multiple short attacks of  CBF followed by complete reperfusion.
With:
A. Preconditioning - 4
B. True ischemia - 3
C. Stunning - 2
D. Hibernation - 1
Question
All except one trial evaluated the role of abciximab plus
stenting/PTCA in acute MI or elective PCI?
A. CADILLAC
B. EPILOG
C. ESPRIT
D. ADMIRAL
E. RAPPORT
C
ADMIRAL & CADILLAC Trials
6-Month MACE: Death, Repeat MI, TVR, Stroke
20
16
%
ADMIRAL
CADILLAC
15.9
p=NS
p=0.02
12
10.4
9.5
7.4
8
4
0
N:
Stent
151
Stent+
Abciximab
149
Montalescot et al. NEJM 2001;344:1895
Stent
512
Stent +
Abciximab
525
Stone et al. NEJM 2002;346:957
ADMIRAL & CADILLAC Trials
6-Month Mortality
-53%
p=0.13
10
8
%
No abciximab
Abciximab
7.3
-14%
p=0.32
6
4
3.4
3.5
3
2
0
ADMIRAL
Montalescot et al. NEJM 2001;344:1895
CADILLAC
Stone et al. ACC 2001;102:II-664
Question
All of the following are predictors of restenosis after stent
implantation, except:
A. Not using IVUS
B. Diabetes mellitus
C. Multiple stents
D. Minimal lumen diameter immediately post stenting
E. Aorto-ostial lesions
A
Question
Of the following statements regarding arterial remodeling
after PCI, all are true, except:
A. Restenosis after PTCA is a balance between intimal neoformation
and arterial remodeling.
B. Arterial remodeling is described in de novo atherosclerosis as
well as post angioplasty.
C. Arterial remodeling is defined as constriction or “shrinkage” of
the vessel with loss in coronary diameter after PCI.
D. Coated stents basically eliminate arterial remodeling.
A
Mechanisms of Restenosis
L
EEM
Balloon/Atherectomy
L
L
 EEM ± P+M
= restenosis
L
 P+M, but
no  EEM
= restenosis
Stent
P+M
EEM = external elastic membrane
P = plaque
M = media
L = lumen
 EEM ±  P+M
= no restenosis
Of the following statements regarding late lumen loss, all are
true, except:
A. It represents the difference between the lumen diameter after
PCI and at 6 months F/U
B. It reflects the net effects of intimal hyperplasia, elastic recoil,
and vascular remodeling
C. Late loss averages 0.5 mm for PTCA and 0.9 mm for stents
D. The relationship between acute gain and late loss is constant
among devices
D
MLD
(mm)
4
Calculate the following:
2.8
3
A. Acute gain
2
1.9
C. Net gain
1
0.5
0
B. Late loss
Pre-PCI
D. Loss index
Post-PCI
F/U
4
Acute Gain, Late Loss & Other
Parameters
2.8
3
MLD
(mm)
2
1
0
Late
loss
Acute
gain
1.9
0.5
Pre-PCI
Post-PCI
Late loss
Loss index =
Acute gain
F/U
Net
gain
Intervention leads to MLD 0.30mm to
2.20mm ref 2.75mm. F/up angiogram
MLD 1.80mm ref 2.82mm. Late Loss is:
•
•
•
•
A. 0.07mm
B. 0.40mm
C. 1.50mm
D. 1.02mm
B
Question
The following rotational atherectomy techniques have shown
to improve procedural outcome, except:
A. Decelerations <5000 rpm
B. Rota-flush
C. Short runs
D. Burr-to-artery ratio >0.9
E. Slow pecking motion
F. Low-speed (140,000 rpm)
D
Question
A 50-year old construction worker underwent PTCA and stent of a 95% prox RCA
lesion 6 months ago. He calls to arrange a diagnostic cath and he is very adamant
about his request, which was prompted by one of his colleagues who had
crescendo angina culminating with admission to the hospital last week, almost 5
months after a PTCA to RCA. Which of the following statements is true?
A. 75% of patients with angiographic restenosis develop symptoms.
B. The stent restenosis rate is reduced by 60% compared to PTCA.
C. The prognosis of asymptomatic stent restenosis is excellent.
D. Repeat PCI of asymptomatic restenotic lesion is indicated to decrease the
future risk of anginal symptoms.
Answer
A 50-year old construction worker underwent PTCA and stent of a 95% prox RCA
lesion 6 months ago. He calls to arrange a diagnostic cath and he is very adamant
about his request, which was prompted by one of his colleagues who had crescendo
angina culminating with admission to the hospital last week, almost 5 months after
a PTCA to RCA. Which of the following statements is true?
A.
75% of patients with angiographic restenosis develop symptoms. = NO, ONLY 50%
B.
The stent restenosis rate is reduced by 60% compared to PTCA. = NO, ONLY 30%
C.
The prognosis of asymptomatic stent restenosis is excellent. = YES
D.
Repeat PCI of asymptomatic restenotic lesion is indicated to decrease the
future risk of anginal symptoms. = NO
A 67 yrs-old man undergoes bypass surgery for severe
three-vessel coronary disease. Approximately 12 hrs after
the surgery he becomes short of breath and has 3 mm ST
elevation in the inferolateral leads. The best management
strategy at this time is:
a. Conservative management without coronary angiography
b. Coronary angiography followed by catheter-based treatment
strategy with subsequent PCI
c. Coronary angiography followed by surgical-based treatment
strategy readmitting patients to emergency redo-CABG
d. Coronary angiography followed by conservative treatment
B
Chronic total occlusions are most prevalent in which
vessel?
a. Left anterior descending artery
b. Left circumflex artery
c. Right coronary artery
d. Left main artery
C
Least Lcx
Which of the following statements is true regarding
the influence of lesion length on the AHA/ACC
classification of lesion type?
a. A lesion <10 mm in length represents an
AHA/ACC type A lesion
b. A lesion > 2 cm in length represents an AHA/ACC
type B1 lesion
c. A lesion > 2 cm in length represents an AHA/ACC
type B2 lesion
d. A lesion 10 to 20 mm in length represents an
AHA/ACC type C lesion
A
The importance of the evaluation of hemodynamic waveforms during coronary
intervention cannot be overemphasized. Many young operators tend to focus
on the angiographic image and ignore the hemodynamic clues of pressure
tracing. The pressure waveforms can alert the interventionalist to catheter
position (e.g., migration to the ventricle during difficult RCA interventions),
dangerous anatomy (e.g., left main stenosis) and unstable hemodynamics
(e.g., hypotension and hypertension). Match the following waveforms with the
correct answer:
1
Catheter kinking
2
Damping
3
Normal aortic waveform
4
Normal ventricular waveform
5
Ventricularization
A
B
D
C
E
1C
2B
3D
4E
5A
A 45-year old with diabetes who was hypercholesterolemic, hypertensive and a
heavy (two packs a day) smoker, underwent a successful angioplasty and stent
placement to mid-LAD lesion. Before angioplasty, the patient received ASA 325 and
GP IIb/IIIa inhibitor treatment. The angioplasty procedure was uneventful. The
Xience 3.0 x 28 mm stent was deployed at 16 atm. The final angiogram showed a
well-expanded vessel with thrombolysis in myocardial infarction (TIMI) 3 flow. The
following morning, a routine troponin was 1.5 ng/ml. The patient remained
asymptomatic and his cardiac examination was normal. His electrocardiogram
(EKG) showed non-specific ST-T wave changes, which were unchanged from the
admitting EKG. The best course of action for this patient now is as follows:
A.
Discharge the patient immediately with beta-blockers, nitrates, statin, ASA, Plavix
and an angiotensin-converting enzyme (ACE) inhibitor
B.
Bring the patient back to the catheterization laboratory for a repeat angiogram
C.
Transfer the patient to a coronary care unit (CCU)
D.
Continue to monitor the patient in telemetry for 48 hrs
E.
Check another set of troponin in 6-8 hrs. If the trend is down, then discharge him
on Plavix, beta-blockers, statins and an ACE-inhibitor.
E
Mitral Stenosis
Mitral valve area: Normal 4-6 cm2
MS: - mild 1.5-2 cm2
- moderate 1.0-1.5 cm2
- severe <1 cm2
Etiology:
- rheumatic
- congenital
- calcification
- infiltration
- drugs
Echocardiographic Score
1
Rigidity
Mobile
valve
Thickening Thin
Calcium
No bright
echos
Subvalvular Sparse
apparatus echos
2
3
4
Immobile
valve
Severely
thickened
Multiple right
echo areas
Multiple thick
chordae seen
Echocardiographic Score
Influence on outcome after BMV
Pre-BMV
Post-BMV
4
100
3
MVA
(cm2)
%
75
good
results
2
50
1
25
0
0
Echo score: 4
5
6
7
8
9
10
11
12
Block et al. In Topol Interventional Cardiology 1990;831
Balloon Mitral Valvuloplasty
Long-term follow-up results
Good results: MVA >2.0 cm2; CI >2.5
5-7 yrs event-free survival >90%
Suboptimal results: MVA 1.5 cm2; CI <2.0
5 yrs event-free survival 50%
Predictors of restenosis:
Echo score
Pre-BMV valve area
Post-BMV valve area
Atrial fibrillation
Age
Palacios et al. Circulation 1989;79:573 NYHA class
Herrmann et al. JACC 1990;15:1221
Chen et al. Cath Cardiovasc Diagn 1998;43:132
BMV Hemodynamic Results in a
Patient with Mitral Stenosis
Pre-dilatation
Post-dilatation
Pressure
(mmHg)
Mean mitral gradient (mmHg) 17
Cardiac output (L/min) 5.0
Mitral valve area (cm2) 1.0
Mean mitral gradient (mmHg) 3
Cardiac output (L/min) 5.9
Mitral valve area (cm2) 3.2
Stepwise Dilatation Technique for BMV
Commissure split
Increase in mitral regurgitation
Non / minimal
Mild
2 mm
larger
1 mm
larger
1 mm
larger
Stop
2 mm
larger
1 mm
larger
1 mm
larger
Stop
Moderate/severe
Bilateral split
Uni-lateral split
Non-split
Use catheter one size
smaller and inflate to
maximal diameter
Stop
Stop
Balloon Mitral Valvuloplasty
(BMV)
Percutaneous Mitral Commissurotomy
(PMC)
Procedural success
Post-procedure MVA >1.5 cm2 with 2+ MR
BMV vs. Open Surgical Commissurotomy
Baseline and follow-up results
Mitral Valve Area
BMV
Surgery
3
p<0.001
2.5
p=NS
30
p=0.03
25
p=NS
MVA
2
(cm2)
1.5
Hemodynamics
20
15
p=NS
1
10
0.5
5
0
0
Baseline
p=NS
1 week
Reyes et al. NEJM 1994;331:961
6 months
3 years
p=NS
Wedge
pressure
(mmHg)
Gradient
(mmHg)
Exercise
duration
(min)
Balloon Valvuloplasty in Mitral Stenosis
Indication
• Class II-IV, MVA <1.5 cm2, favorable morphology, no
LA clot, no moderate to severe MR
Class
I
• Asymptomatic, MVA <1.5 cm2, PASP >50 mm at rest or
60 mm with exercise
IIa
• Class III-IV, MVA <1.5 cm2, calcified valve, high risk
for MVR
IIa
• Asymptomatic, MVA <1.5 cm2, new atrial fibrillation
IIb
• Class III-IV, MVA <1.5 cm2, calcified valve, low surgical
risk
IIb
• Mild MS
III
All of the following are used to
calculate the echo score in BMV
except
A. Leaflet mobility
B. Leaflet thickening
C. Extent of subvalvular disease
D. Calcification
E. Degree of MR
E
Complications of BMV include all
of the following except
A. Femoral Artery pseudoaneurysm
B. CVA
C. MR
D. Tamponade
E. Left to Right shunt
A
Restenosis after BMV at 5 yrs
occurs in:
A. <5%
B. 5-10%
C. 10-25%
D. >25%
C
Question
A young woman is found to have mitral stenosis with MVA 1.3 cm2. She is
asymptomatic, she has mild mitral and tricuspid regurgitation; pulmonary artery
systolic pressure is estimated to be 48 mm Hg by Doppler interrogation. Mitral
valve score by echo is 6. You recommend:
a. Afterload reduction with ACE-inhibitors and repeat echo in 1-2 years
b. Balloon mitral valvotomy if the exercise pulmonary artery systolic pressure
is >50 mmHg
c. If the exercise pulmonary artery systolic pressure is >60 mmHg she should
undergo surgical mitral valve replacement because the echo score is >5
and there is mild mitral regurgitation
d. Balloon mitral valvotomy if the exercise pulmonary artery systolic pressure
is >60 mmHg
e. Balloon mitral valvotomy at this point, before the echo score deteriorates
with time
D
Aortic Stenosis
Aortic valve area: Normal 3-4 cm2
AS: - mild >1.5 cm2
- moderate 1.0-1.5 cm2
- severe <1.0 cm2
Etiology:
Congenital:unicuspid
bicuspid
tricuspid
Acquired: rheumatic
calcific
cholesterolemia
rheumatoid
Balloon Aortic Valvuloplasty in
Adults
Indications
1. Severe LV dysfunction
Safian et al. Circulation 1988;78:1181
2. Low gradient, low output state
Nishimura. BAV Registry JACC 1991;17:828
3. Cardiogenic shock
Morena & Palacios. JACC 1994;23:1071
4. Pre-op before non-cardiac surgery
Roth & Palacios. JACC 1989;13:1039
Balloon Valvuloplasty in Adults with
Aortic Stenosis
Indication
Class
• Bridge to surgery in hemodynamically unstable
high risk patients for AVR
IIa
• Palliation in patients with serious comorbid
conditions
IIb
• Prior to urgent non-cardiac surgery
IIb
• Alternative to AVR
III
Transcatheter Aortic Valve
Replacement and Aortic
Valvuloplasty
Case #1
• An 87-year-old male with a history of
moderate COPD presents to the
emergency department in pulmonary
edema with a NSTEMI.
• His previous medical history includes
hypertension, diabetes, and renal
impairment.
• Echocardiography performed in the ER
reveals severe aortic stenosis with
systolic dysfunction, LVEF 30%. The mean
aortic gradient is 40mmHg with a
calculated valve area of 0.6cm2.
• Coronary angiography demonstrates
normal coronary arteries and a porcelain
aorta.
Question:
Which of the following factors would make this
patient inoperable?
a) Age
b) Renal impairment
c) Porcelain aorta
d) Left ventricular systolic dysfunction
What defines “Inoperable”?
• Clinical decision best made by a multidisciplinary team
• In the TAVI trials defined as:
 “ those who were not considered to be suitable candidates
for surgery because they had coexisting conditions that
would be associated with a predicted probability of 50% or
more of either death by 30 days after surgery or a serious
irreversible condition.”
 At least two surgeon investigators had to agree that the
patient was not a suitable candidate for surgery.
What defines “Inoperable”?
• Additional criteria for inoperability include serious
comorbidities as described in the early CoreValve
experience
 Cirrhosis of liver, pulmonary insufficiency (forced expiratory
volume in one second <1L ), previous cardiac surgery,
pulmonary hypertension >60 mm Hg, porcelain aorta,
recurrent pulmonary embolus, right ventricular insufficiency,
thoracic burning sequelae with contraindication for open
chest surgery, history of mediastinum radiotherapy, severe
connective tissue disease with contraindication for surgery,
or cachexia (body mass index <18 kg/m2), frailty
Question:
Which of the following factors would make this
patient inoperable?
a) Age
b) Renal impairment
c) Porcelain aorta
d) Left ventricular systolic dysfunction
Question:
Which of the following factors would add the most
risk to the patient’s risk profile for surgical aortic
valve replacement?
a) Age
b) Renal Impairment
c) Left Ventricular systolic dysfunction
d) All of the above
What defines “High Risk”?
• Clinical decision best made by a multidisciplinary team
• Relies heavily on the use of risk scores such as STS
• Defined in clinical trials (PARTNER A) as:
 “as defined by a Society of Thoracic Surgeons (STS) risk
score of 10% or higher (on a scale of 0% to 100%, with
higher scores indicating greater surgical risk) or by the
presence of coexisting conditions that would be
associated with a predicted risk of death by 30 days after
surgery of 15% or higher”
STS Score
• For our patient:
 Age 87
 Moderate COPD
 Diabetes
 LVEF 30%
 NSTEMI with normal
coronary arteries
 Urgent intervention
Now let’s assume he is on
hemodialysis….
Now the predicted mortality goes up to almost 30%.....
www.riskcalc.sts.org
Question:
Which of the following factors would add the most
risk to the patient’s risk profile for surgical aortic
valve replacement?
a) Age
b) Renal Impairment
c) Left Ventricular systolic dysfunction
d) All of the above
STS Score
• For our patient:
 Age 87
 Moderate COPD
 Diabetes
What is the impact of a
 Creatinine 1.6mg/dl
previous cardiac
 LVEF 30%
surgery for bypass
 NSTEMI with normal coronary
grafts?
arteries
 Urgent intervention
 = Predicted mortality of 16%
www.riskcalc.sts.org
STS Score
• For our patient:
• Age 87
• Moderate COPD
• Diabetes
• Creatinine 1.6mg/dl
• LVEF 30%
• NSTEMI with normal
coronary arteries
• Urgent intervention
Predicted operative risk increases to 20%
if the patient has had previous CABG.
Case #2
• An 80-year old female with
severe symptomatic aortic
stenosis is referred for
TAVI due to surgical high
risk.
• Preliminary investigations
demonstrate friable
atheroma in the aorta on
TEE and CT imaging.
Question:
Which of the following has been demonstrated to
be a significant early complication of TAVR?
a) Iliac artery rupture
b) Coronary artery obstruction
c) Stroke
d) All of the above
Retrograde Trans-femoral Edwards Aortic
Valve Deployment
Complications post-TAVR (PARTNER B)
Leon et al, N Engl J Med 2010;363:1597
Stroke and TAVR (PARTNER A)
• Major strokes were observed more
frequently in the TAVI group than in
the standard-therapy group at 30
days (5.0% vs. 1.1%, P = 0.06) and
at 1 year (7.8% vs. 3.9%, P = 0.18).
• However, the rate of the composite
of major stroke or death from any
cause (Kaplan–Meier analysis) was
still significantly lower in the TAVI
group than in the standard-therapy
group (33.0% vs. 51.3% at 1 year;
hazard ratio, 0.58; 95% CI, 0.43 to
0.78; P<0.001).
Question:
Which of the following has been demonstrated to
be a significant early complication of TAVR?
a) Iliac artery rupture
b) Coronary artery obstruction
c) Stroke
d) All of the above
Case #3
• An 89 year old female with severe aortic stenosis, peripheral
vascular disease and congestive heart failure presents to the
emergency department with chest pain.
• Her past medical history is notable for the following:
 Previous pulmonary embolism
 Severe pulmonary hypertension
 Frailty
 Cachexia
• Patient is assessed and refused by cardiac surgery for surgical
AVR
• Due to progressive
hemodynamic
instability, decision is
made for balloon aortic
valvuloplasty.
• Balloon aortic
valvuloplasty is
performed using a
balloon with rapid
pacing with reduction in
aortic valve gradient.
Question:
This patient was an appropriate candidate for
percutaneous balloon valvuloplasty:
a) As a bridge to aortic valve replacement
b) As a bridge to TAVR
c) As an alternative to aortic valve replacement
d) All of the above
INDICATIONS for PBAV
• Class IIb
 Aortic balloon valvotomy might be reasonable as a bridge to
surgery in hemodynamically unstable adult patients with AS
who are high risk for AVR (Level of Evidence C)
 Aortic balloon valvotomy might be reasonable for palliation in
adult patients with AS in whom AVR cannot be performed
because of serious comorbid condition (Level of Evidence C)
• Class III
 Aortic balloon valvotomy is not recommended as an
alternative to AVR in adult patients with AS
Bono et al., J Am Coll Cardiol 2006;48:e1
INDICATIONS for PBAV….cont.
• This patient meets criteria for
inoperability: her STS score would
be increased by age, peripheral
vascular disease, cachexia, heart
failure, hemodynamic instability, and
emergent nature of the procedure. If
her hemodynamics improve with
balloon valvuloplasty, and her
symptoms improve to class II, her
STS score would still be high (~12)
and a bridge to AVR is unlikely to be
the best choice.
Bono et al., J Am Coll Cardiol 2006;48:e1
Question:
This patient was an appropriate candidate for
percutaneous balloon valvuloplasty:
a) As a bridge to aortic valve replacement
b) As a bridge to TAVR
c) As an alternative to aortic valve replacement
d) All of the above
Question:
The most likely potential complication in this patient
might be:
a) Major or minor vascular complication
b) Stroke
c) Death
d) Renal failure (50% increase in creatinine)
Complications of BAV
Univ Bologna
Wash Hosp Center
N
415
434
Death (%)
5.1 (in hospital)
2.5 (intraprocedure)
Stroke (%)
0.5
2.3
Major + Minor Vascular
Complication (%)
5.6%
5.7 (major only)
Renal failure (VARC 1)
18.5
9.6
No MI rates reported
Saia et al., Eurointervention 2013;8:1388
Ben-Dor et al., Cath Cardiovasc Intervent 2013;82:632
Question:
The most likely potential complication in this patient
might be:
a) Major or minor vascular complication
b) Stroke
c) Death
d) Renal failure (50% increase in creatinine)
Question:
An 85 year old man was in previously good health. He has a 20 pack
year smoking history, feels well, takes long walks but notices some
fatigue and minimal dyspnea after walking a mile up hill. Aortic valve
area by echo is 0.8, peak systolic velocity is 4.5 m/sec and his mean
gradient is 45 mm Hg. Left ventricular ejection fraction is 55%. The
appropriate diagnostic procedure for him is:
1.
2.
3.
4.
Cardiac cath to assess coronaries and severity of aortic
stenosis
Dobutamine echo
Transesophageal echo
Stress test
Management Strategy for Patients with Severe
Aortic Stenosis
BP 
ST
Symptoms
Arrhythmia
Bonow et al., J Am Coll Cardiol 2008;52:e1
Question:
1. Cardiac cath to assess coronaries and severity of
aortic stenosis
2. Dobutamine echo
3. Transesophageal echo
4. Stress test
This patient meets all criteria for severe aortic stenosis.
Coronary angiography is appropriate but cardiac cath to assess
hemodynamics is inappropriate (Class III) given unequivocal
severity of AS.
Dobutamine echo would not be indicated given normal LV function
and gradient that meets severity guidelines.
There is no indication for TEE in this patient.
Because the symptoms are equivocal, a stress test is appropriate.
Question:
A 65 year old man has had a heart murmur since childhood.
He now presents with classic symptoms and physical exam
findings of aortic stenosis. His mean gradient is 55 mm Hg.
He had extensive mantle radiation for a lymphoma in his 30s.
The procedure of choice for him is likely to be:
•
•
•
•
TAVR
Surgical aortic valve replacement
Mini-AVR
Obtain another diagnostic test
Question:
•
•
•
•
TAVR
Surgical aortic valve replacement
Mini-AVR
Obtain another diagnostic test
This patient has hemodynamic criteria for aortic stenosis and is symptomatic.
Aortic valve replacement has a Class I indication.
The presence of high dose mantle radiation may make him a high risk or
inoperable candidate for thoracotomy. TAVR would ordinarily be indicated.
However the murmur since childhood and his relatively young age increase the
possibility for his having a bicuspid aortic valve, classically considered a
relative contraindication for TAVR.
Question:
A 90 year old patient with severe aortic stenosis needs to have
a total hip replacement. He is frail and has declined both AVR
and TAVR. Prior to PBAV you explain to his referring doctor
that:
1. The risk of acute PBAV mortality and major
morbidity is > 10%
2. The results are not as good as TAVR or AVR, but
he will have an improved quality of life and 18
month survival.
3. The procedure is typically effective because it
splits open the commissures
4. All of the above
Aortic Valvuloplasty –Mechanisms
+ Commissural
stretching
- Commissural
splitting
+ Calcification
cracking
Balloon Valvuloplasty
(PBAV)
• > 10% risk of serious complication (death [3%], CVA,
aortic rupture, AR, vascular injury)
• 14% 30 day mortality
• 60% 18 month mortality (similar to those not
undergoing PBAV)
• 20% event-free 2 year survival
Question:
1. The risk of acute PBAV mortality and major
morbidity is > 10%
2. The results are not as good as TAVR or AVR, but
he will have an improved quality of life and 18
month survival.
3. The procedure is typically effective because it
splits open the commissures
4. All of the above
Question:
An 88 year old patient with a cardiomyopathy and aortic stenosis is
referred to you for consideration of TAVR. His LV ejection fraction is
25%, mean gradient 20 mm Hg. It rises to 28 mm Hg with 40
mcg/kg/min of dobutamine. Valve area is reported as 0.9. He is
symptomatic with minimal exertion. Based on which one of the
following would you decide to have him undergo transapical TAVR:
1.
2.
3.
4.
He has severe mitral regurgitation
He has concentric calcification in the ascending aorta.
His iliac arteries have a minimal diameter of 5 mm
bilaterally.
You elect not to have him undergo TAVR.
Low gradient Aortic Stenosis
• Group 1 - Severe AS with resultant severe
LV dysfunction and inability to generate
gradient
• Group 2 - Moderate aortic stenosis and
underlying cardiomyopathy
Differentiating severity of stenosis
low gradient patients
• Increase transvalvular flow
– Dobutamine, nitroprusside, isoproterenol,
exercise
– In patients with severe stenosis 
disproportionate rise in gradient
0.6
2.0
– Minimal change in valve area if orifice size fixed
How dobutamine stress echocardiography can help in
decision-making in patients with low-flow aortic
stenosis
Pibarot etn al., J Am Coll Cardiol 2012;60:1845
Multivariable Predictors of Mortality
Kodali et al., N Engl J Med 2012;366:1686
Question:
1.
2.
3.
4.
He has severe mitral regurgitation
He has concentric calcification in the ascending aorta.
His iliac arteries have a minimal diameter of 5 mm bilaterally.
You elect not to have him undergo TAVR.
The key to this question is the very modest rise in gradient despite
dobutamine. Thus this is likely a cardiomyopathy with moderate aortic
stenosis. A concentrically calcified ascending aorta is a contraindication to
aortic cross-clamping and surgical aortic valve replacement. 5 mm femoral
arteries are too small to accommodate the 22 and 24F sheaths used in
transfemoral TAVR, but not to transapical TAVR. Severe mitral insufficiency
raises the overall risk of aortic valve replacement, more so with AVR than
TAVR. However, this patient does not meet criteria for either TAVR or aortic
valve replacement based on his hemodynamic assessment.
Question:
A 80 year old patient undergoes TAVR and has an
excellent result except for a mild paravalvular leak.
When speaking with the family afterward:
1. You mention the leak and reassure them that it is mild.
2. You do not mention the leak since it is present in almost all
TAVRs
3. You explain that the leak is potentially important and may be
associated with lower overall survival than patients with trace
or no paravalvular leak
4. You explain that you will do percutaneous closure of the
paravalvular leak as indicated by the guidelines
Severity of Paravalvular Leak:
None or Trace vs. Mild to Severe
Kodali et al, N Engl J Med 2012;366:1686
Question:
1. You mention the leak and reassure them that it is mild.
2. You do not mention the leak since it is present in almost all
TAVRs
3. You explain that the leak is potentially important and may be
associated with lower overall survival than patients with trace
or no paravalvular leak
4. You explain that you will do percutaneous closure of the
paravalvular leak as indicated by the guidelines
Paravalvular leak is typically the result of undersizing of the aortic prosthesis.
Other causes relate to the placement of a circular object in a non-circular and
frequently irregular calcified orifice. The three year results of PARTNER IA
show a higher mortality in patients with even mild paravalvular leak than
those with trace or none. There is limited experience with percutaneous
paravalvular leak closure in this setting – hence no guidelines.
Complex Coronary Lesions
Question:
• PCI is planned on a 67 year old man with ESRD
and left main with triple vessel coronary
disease. Syntax score is calculated at 30 and
left ventricular systolic function is markedly
depressed. Compared with support using an
IABP, the use of an Impella device would be
associated with
a.
b.
c.
d.
Lower mortality
Lower myocardial infarction
Lower repeat revascularization
Higher stroke rate
Complex Coronary Lesions
The PROTECT II Trial: Impella 2.5 vs. IABP in High
Risk PCI
Complex Coronary Lesions
In- and Out-of-Hospital Hierarchical Outcomes
Intent-to-Treat Population
O’Neill et al., Circulation 2012;126:1717
Complex Coronary Lesions
Question:
• PCI is planned on a 67 year old man with ESRD
and left main with triple vessel coronary
disease. Syntax score is calculated at 30 and
left ventricular systolic function is markedly
depressed. Compared with support using an
IABP, the use of an Impella device would be
associated with
a.
b.
c.
d.
Lower mortality
Lower myocardial infarction
Lower repeat revascularization
Higher stroke rate