May
27,
2010 -- 3:50pm EDT
Stent Helpers: IVUS, OCT and FFR -- Intravascular
Tools At EuroPCR
This
graphic shows three intravascular imaging/therapeutic modalities that
were making news this month, both in the U.S. and in Paris
at the EuroPCR meeting ending tomorrow. Clockwise
they are Optical Coherence Tomography
(OCT), Intravascular
Ultrasound
(IVUS)
and Fractional Flow Reserve (FFR). You can read more about these
in depth in Angioplasty.Org's Intravascular
Imaging Center.
Briefly, OCT and IVUS are ways of imaging the inside
of a coronary artery during a standard invasive catheterization or angioplasty.
Both of
these imaging technologies can help the
cardiologist see things not visible on standard X-ray angiography
(an angiogram is essentially a "shadow"
image). The placement, sizing and expansion of a stent can all be
measured more accurately via intravascular
imaging.
There is a difference between OCT and IVUS. OCT is a
far higher resolution image, but IVUS penetrates the arterial wall
deeper, revealing anatomical information hidden below the surface.
All of this is discussed in our interview with OCT expert Dr.
Giulio Guagliumi who discusses how both imaging modalities are useful
and that the "combination is the true projection for the future".
FFR measures intracoronary blood pressure and has been
shown in the
FAME study to be useful in decision-making about whether
or not a blockage needs to be stented. In FAME, FFR-guided stenting
used 1/3 less stents and improved outcomes by 28%.
Recent news for OCT was that earlier this month the
FDA approved LightLab's OCT device -- the first approval for this
technology in the United States. Two weeks later, having seen a
future for OCT, St. Jude Medical announced it was acquiring LightLab
for $90 million.
A competing
OCT system from Volcano currently has European
approval and is awaiting an okay from FDA; the company
anticipates commercial release in the U.S. sometime mid-2011.
Volcano has been a leader in IVUS imaging since its inception
and at EuroPCR announced a new digital IVUS catheter, the lower profile Eagle
Eye® Platinum,
which is more deliverable and can fit through a 5F guide, making it ideal
for transradial
procedures done via the wrist. The only other IVUS system is the iLab,
manufactured by Boston Scientific.
An interesting new cross-over product was also introduced
by Volcano, the VIBE™ RX
Vascular Imaging Balloon Catheter, which combines
IVUS with a dilatation balloon to provide image-guided therapy. This
is a concept being explored by Volcano -- and a future system of
Forward-Looking IVUS may make inroads into solving the problem
of chronic total occlusions (CTO). Andreas
Gruentzig,
the inventor of coronary angioplasty, once told me that unless angioplasty
could solve the problem of CTOs, it would never be able to completely
compete with bypass surgery.
Finally FFR was in the news as the two-year FAME data,
first presented at TCT last September, were published
online in JACC. The original findings were sustained, leading to the
conclusion that:
Routine measurement of FFR in patients
with multivessel CAD undergoing PCI with drug-eluting stents
significantly reduces mortality and myocardial infarction at
2 years when compared with standard angiography-guided PCI.
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This conclusion is one reason why 18 months ago St.
Jude Medical (them again?) acquired the
Swedish manufacturer of FFR catheters, Radi Medical Systems. The
competing FFR system is made by...Volcano (them again?) and it just
received FDA and CE Mark approval for its latest FFR product, the PrimeWire
PRESTIGE™ Pressure
Guide Wire.
So, to recap the acquisitions and new product introductions:
St. Jude Medical now offers FDA-approved OCT and FFR; Boston Scientific
offers IVUS; Volcano offers IVUS, FFR and anticipates FDA approval
of OCT -- the company is also poised to launch various new "image-guided
therapies". (BTW, a report yesterday on theheart.org states
that, with its recent acquisitions, "St Jude boasts the only intravascular
ultrasound platform with both OCT and fractional-flow-reserve technology."
To our knowledge, St. Jude does not offer an IVUS system, unless
they bought Boston Scientific when we weren't looking.)
One last point is that the advantage of utilizing products
from the same manufacturer is being able
to use the same console or the same integrated cath lab system with
all devices, especially if they are used in combination, in order
to minimize the extra time and effort required to add on these intravascular
"stent helpers" for the benefit of patients and procedural outcomes.
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