CARDIOVASCULAR JOURNAL OF AFRICA • Vol 24, No 4, May 2013
AFRICA
109
Most safety events occurred during the first three implant
procedures (12.3 vs 5.9% subsequently). These safety events
have been further significantly reduced in the subsequent 460
patients enrolled in the Continued Access Patient Registry to
3.7%, most likely due to increasing operator experience.
20
The ACP is used extensively in Europe and Asia as an
alternative to the Watchman device due to it’s perceived
superiority in sealing the LAA orifice (Figs 1, 2). The Watchman
device consists of a parachute-shaped nitonol frame which plugs
the LAA orifice while the ACP consists of two parts; one, the
lobe, fixes the device into the left atrial appendage and second,
the disc, which seals off the LAA orifice. The incidence of leaks
into the LAA on follow-up TEE is approximately 30% with the
Watchman device and just over 1% with the ACP.
19
The European Prospective Observational Study (
n
=
204)
using the ACP in patients with AF who have contra-indications
for oral anticoagulant therapy had a 96.6% implantation success
rate with a total safety event rate of 2.9% (serious pericardial
effussion 1.5%). There were no procedure-related strokes or TIA.
After 101 patient years’ follow up, the actual stroke rate was
1.98%. The estimated annual stroke risk was 5.6%, according to
the average CHADS
2
score of 2.6.
19
Although randomised, controlled trials comparing the ACP
device versus either warfarin or no anticoagulant treatment are
still currently in progress, observational studies have shown that
the actual incidence of stroke is less than half of the predicted
risk using the CHADS
2
score when used in patients in whom
warfarin is contra-indicated.
17-19
In the 12 South African patients presented here, nine had
had at least one major bleed requiring blood transfusion
despite a sub-therapeutic/therapeutic INR level. No bleeds
were related to warfarin toxicity. The average CHADS
2
-Vasc
score was 3.75, which gives an estimated annual stroke risk
of nearly 4% in patients who are unable to take warfarin. The
implantation success rate was 100%. There were no safety events
– in particular no stroke or TIA, no device embolisation and no
pericardial effusion.
All patients are currently on low-dose aspirin alone and there
have been no strokes or other cardio-embolic events to date.
There have been no deaths of any cause. No patients have had
any further major bleeds after stopping warfarin therapy.
Conclusion
In patients with AF and a CHADS
2
-Vasc score
>
2 who are
unable to take oral anticoagulant therapy, percutaneous occlusion
of the LAA is a reasonable option to consider. As more data
regarding this procedure become available over time and the
results confirm the current positive results, this procedure could
potentially become a first-line consideration in patients with AF
facing a lifetime of anticoagulation.
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