Based on the results of this study, the authors recommend starting anticoagulation immediately after any episode of new-onset atrial fibrillation following transcatheter aortic valve implantation, regardless of the duration of the atrial fibrillation, in order to reduce the risk of late stroke and other thromboembolic complications.

1. Michael G. Katz, MD
Fellow in Cardiovascular Disease
University of Rochester
February 2, 2012

2.  Frst successful surgical replacements of
diseased human heart valves were
reported in 1960
• Outcomes were so vastly improved over medical
therapy that RCTs were considered unethical
• Exposing lower risk AS patients to RCTs was also
avoided
 Consequently, the majority of data
regarding AVR has been observational

3.  Since the introduction of transcatheter
aortic valve implantation (TAVI) in 2002,
there has been a drive to develop bench-
to-bedside endpoints to drive evidence
based trials.
J Am Coll Cardiol
2011;57:253–69

4.  http://youtu.be/1VwlEXhQKao

6.  Aortic Valvular Complex
• anterior mitral valve leaflet,
• intervalvular fibrosa,
• aortic annulus,
• ventricular septum,
• aortic sinuses and root,
• coronary arteries, and
• cardiac conduction system

7.  Following surgical AVR:
• new-onset bundle branch
block 16% to 32% of
patients
• permanent pacemakers in
3% to 8% of patients
 Early experiences with
TAVI:
• new-onset bundle branch
block has occurred in up to
45% of patients
• need for permanent
pacemakers 4% to 33%

8.  1) What is the epidemiology?
 2) What is the pathophysiology?
 2) What is the clinical impact?

9.  Conventional AVR:
• 20% to 30%
• Generally interpreted as a consequence of perioperative
systemic and local inflammatory reaction and/or changes in
beta-adrenergic tone
• (So we should see less AF with TAVI, right?)
 AF is associated with an increased long-term risk of
stroke,HF, and all-cause mortality, especially among
women.
 On the other hand: AF is not included in the guidelines
for reporting mortality and morbidity after cardiac
valve interventions.

10. Symptomatic Severe Aortic Stenosis
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
3,105 Total Patients Screened
Total = 1,057 patients
N = 699 High
High Inoperable
Inoperable N = 358
Risk
Risk 2 Parallel Trials:
Individually Powered
ASSESSMENT:
ASSESSMENT: ASSESSMENT:
ASSESSMENT:
Yes
Yes Transfemoral No
No Transfemoral
Transfemoral Transfemoral
Access
Access Access
Access
Transfemoral (TF)
Transfemoral (TF) Transapical (TA)
Transapical (TA) Yes No
Yes No
1:1 Randomization
1:1 Randomization 1:1 Randomization
1:1 Randomization 1:1 Randomization
1:1 Randomization Not In Study
Not In Study
N = 244 N = 248 N = 104 N = 103 N = 179 N = 179
TA
TA Standard
Standard
TF TAVR
TF TAVR AVR
AVR AVR
AVR TF TAVR
TF TAVR
TAVR
TAVR Therapy
Therapy
VS VS VS
Primary Endpoint: All-Cause Mortality at 11 yr Primary Endpoint: All-Cause Mortality
Primary Endpoint: All-Cause Mortality
Primary Endpoint: All-Cause Mortality at yr Over Length of Trial (Superiority)
(Non-inferiority)
(Non-inferiority) Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality
Co-Primary Endpoint: Composite of All-Cause Mortality
and Repeat Hospitalization (Superiority)
and Repeat Hospitalization (Superiority)

11. PARTNER A PARTNER B
Stroke Surg. TAVI P Stroke Med TAVI P
AVR value mab. value
30 Day 2.4% 5.5% 0.04 30 Day 1.7% 6.7% 0.03
1 Year 4.3% 8.3% 0.04 1 Year 4.5% 10.6% 0.04
AF Surg. TAVI P AF Med TAVI P
AVR value man. value
30 Day 16% 8.6% 0.006 30 Day 1.1% 0.6% 1.0
1 Year 17.1% 12.1% 0.07 1 Year 1.7% 0.6% 0.62

12.  Although about one-third of
cerebrovascular events occur during the
TAVI procedure, 50% of them occur
several days after TAVI

14.  To determine the incidence and
predictive factors of NOAF in patients
with no history of chronic/paroxysmal
atrial fibrillation (AF) undergoing TAVI,
and to evaluate the prognostic value of
NOAF as a complication of TAVI, with
special attention to cardioembolic
events.

15.  138 consecutive patients with severe
symptomatic aortic stenosis underwent
TAVI with a balloon-expandable valve
(Edwards SAPIEN)
• 57 with known prior AF were excluded

17. This study PARTNER A
TAVR (N = AVR (N = p-
Characteristic
348) 351) value
Age (yr) 83.6 ± 6.8 84.5 ± 6.4 0.07
Male sex - % 57.8 56.7 0.82
STS Score 11.8 ± 3.3 11.7 ± 3.5 0.61
Logistic EuroSCORE 29.3 ± 16.5 29.2 ± 15.6 0.93
NYHA
II - %
III or IV - % 94.3 94.0 0.79
CAD - % 74.9 76.9 0.59
Previous MI - % 26.8 30.0 0.40
Prior CV Intervention - % 72.1 71.6 0.93
Prior CABG - % 42.6 44.2 0.70
Prior PCI - % 34.0 32.5 0.68
Prior BAV - % 13.4 10.2 0.24
29.3 27.4 0.60

18. Left atrial size was defined as the anteroposterior diameter
measured during systole in the parasternal long-axis view by M-
mode echocardiography using the leading edge of the posterior
aortic wall to the leading edge of the posterior atrial wall.

19.  Selection of transapical
approach was based on the
following criteria:
• small diameter of the iliofemoral
arteries, significant peripheral
vascular disease, severely
calcified or porcelain aorta, and
horizontal ascending aorta
 full-dose heparin (100 U/kg,
adjusted for an activated
clothing time 250 s) during
the procedure
 aspirin (80 mg/day) and
clopidogrel (75 mg/day) were
administered following the
procedure.

20. THIS STUDY PARTNER A
Transfemoral 27.5% Transfemoral 70.1%
Transapical 72.5% Transapical 29.8%

21.  Continuous telemtry during hospitalization
 Episodes > 30 secs
 Duration of the NOAF episode was classified as follows:
<1min,1min to1h, 1to12h, 12 to 24 h, 24 to 48 h, or >48 h
 Tx:
• Anticoagulation was started, unless contraindicated, immediately after
the diagnosis of NOAF and continued for at least 1 month.
• In case of short episodes (<12 h) of AF, the potential risks/bene fits of
anticoagulation were evaluated in each patient, and the decision was
finally made by the physician responsible for the patient
• In patients with an epidural catheter for pain relief after transapical
TAVI, anticoagulation was delayed 24 h after the removal of the
catheter following the criteria of the American Association of Regional
Anesthesia and Pain Medicine

23. 31.9%

32. No differences in global and cardiac mortality between patients
with and without NOAF.

33.  “All patients with a late (>24 h) stroke following TAVI had at least 1 episode of AF,
compared with only 25% of the patients who complicated with a procedural stroke.
• Indeed, a plausible temporal relationship between NOAF and stroke was found in 4 of the 5 patients with late stroke and also in
the patient who suffered a systemic embolism.
 Importantly, anticoagulation treatment was not optimal in 3 of the 5 patients with
late stroke, either because the episode of AF was considered too short to start
anticoagulant therapy (2 patients) or for safety reasons due to the presence of an
epidural catheter for pain relief after a transapical procedure (1 patient).
 The risk of a cardioembolic event was as high as 40% in those patients who had
NOAF and did not receive anticoagulant therapy, even if AF episodes were of short
(<12 h) duration.
 These results strongly suggest that anticoagulation therapy should have been
started immediately after diagnosis of the AF episode and continued for
several months.”