Will a Heart Stent from the Wrist RIVAL
One from the Leg? At Angioplasty.Org,
we are about to mark the fourth anniversary of our Transradial
Access Center, where we have been evangelizing an approach
used around the world for catheter-based diagnostic and interventional
procedures: using the radial artery in the wrist for catheterizations
and PCI (angioplasty and stents) instead of the femoral artery
in the leg.
It's an approach that is used 50% or more
of the time in other countries, but is still in the single digits
(pun intended) here in the United States. You can read why the
U.S. has been behind the curve in our
many articles on the subject of the transradial approach.
But all this soon may be changing, if the results
of an important study, being presented at this year's American College
of Cardiology meeting, support the investigators' hypothesis:
"...that radial access site PCI will
be associated with significantly less major bleeding and access
site complications compared with a femoral approach, without
increasing the risk of ischemic events. The overall benefit-risk
profile will favor a trans-radial approach.
The study is dubbed RIVAL (RadIal Vs.
FemorAL Access for
Coronary Intervention Study) and, as of last month, had enrolled
over 7,000 patients. It's actually a sub-study of the CURRENT-OASIS
7 trial, which tested double-dose clopidogrel after PCI.
But RIVAL will be looking at the incidence within
30 days of death, heart attack, stroke and non-CABG major bleeding
in Acute Coronary Syndrome (ACS) patients who are experiencing unstable
angina or heart attack (either NSTEMI or STEMI) and who are going
to be treated with angioplasty and/or stents. Included in the definition
of non-CABG major bleeding is access-site hemorrhage requiring intervention,
retroperitoneal bleeding, where significant blood loss into the retroperitoneal
space occurs, often undetected right away, large hematomas or any
significant reduction in hemoglobin where there is no overt source
of bleeding. And RIVAL will compare the 30-day results of those patients
where femoral access was used vs. those who were treated via the
transradial wrist approach.
As Sunil V. Rao, MD, FACC,
Assistant Professor of Medicine at Duke University Medical
Center and Director of the Cardiac Cath Lab at the Durham VA
Medical Center in North Carolina, told Angioplasty.Org in his exclusive
interview :
"...this will be the largest multicenter
randomized trial worldwide ever done in the radial approach
with hard clinical endpoints: death or MI. This will be a huge
addition to our knowledge base and what the role of radial
is in a high-risk patient population."
Previous smaller studies have shown a significant
reduction in bleeding complications with the transradial approach,
and some have posited that mortality and bleeding complications are
related.
Speaking of complications, if you take a look at
just two topics in our Patient Forum (Complications
from Femoral Caths and Complications
from Vascular Closure Devices) you'll find over 1,300 posts from
patients who have suffered from bleeding complications with the femoral
approach, not to mention trauma to the femoral nerve or complications
from various vascular closure devices (which are not used in radial
procedures).
It's not that the femoral approach is terrible.
Quite the contrary. Over 90% of patients do perfectly well with femoral
caths -- and the radial approach is not possible in all patients.
But when less than 7% of all procedures in the U.S. are done via
the wrist, and the vast number of U.S. interventional cardiologists
don't even know how to do radial procedures, something has to change.
And on Monday morning, April 4, 2011, when the
RIVAL results have been presented to the ACC/i2 Joint Session at
ACC.11 in New Orleans, that change may well be accelerated.
Transradial Cath in Bakersfield I'm
always keeping an eye on the growing number of news stories about
a "revolutionary new way to open the coronary arteries":
the transradial approach, that is, where the radial artery in the
wrist is used as the entry point for catheters, angioplasty balloons
and stents. This
latest TV report was broadcast Friday on KGET-TV, Channel 17
in Bakersfield, California.
It's a good report because it not only interviews
Dr. Tommy Lee, the interventional cardiologist who has started doing
radial caths (about 100 so far) because he feels it is safer, but
it has a couple patients talking about their experience. Dr. Lee
states in the broadcast that he believes radial is the future of
cardiac catheterization:
"We've done over a 100 procedures here
at [Bakersfield] Memorial now and we've had no bleeding complications
-- the patients just love the results."
Of course, a cardiologist in Europe might look
at this broadcast and smile, because transradial to a European cardiologist
(or a Chinese, Japanese or Indian cardiologist) is neither new nor
revolutionary -- in OUS (Outside the United States) the transradial
approach is used 40-50% of the time. Many cardiologists use it 90%.
It's just that it has taken a long time for this approach to be accepted
in the U.S. (You can read all about this in Angioplasty.Org's
Transradial Center.)
But this technique, first described in 1989 by Montreal
cardiologist Dr. Lucien Campeau, finally is catching on in
the U.S. -- the chief advantages are reduction in bleeding complications,
comfort for the patient and cost-savings for the healthcare system
(since the complications are lower and patients can be safely discharged
the same day).
BTW, a shout-out to Cindy Welch, whose blog "Designs
from the Heart" is where I first saw this interview.
Smoking After Sex: A Double Heart Attack
Risk? Okay.
Now that I have your attention.... Sure,
we all know that smoking significantly increases the risk of
having a heart attack...but sex? Well a study, published in
this week's Journal of the American Medical Association (JAMA)
looks at this topic, in an article titled, "Association
of Episodic Physical and Sexual Activity With Triggering of
Acute Cardiac Events". And it's a topic that a not
insignificant number of readers writing into Angioplasty.Org's
Patient Forum are concerned about.
It's not exactly a new thought. Back in 2004, we
linked to this
New York Times article which reported on a 1996 study; it basically
came to the same conclusions. But two Tufts researchers looked at
14 studies in the published medical literature and came up with statistical
values that put a relative risk number on these activities.
So (drum roll, please...) episodic physical activity
increased one's heart attack risk by 345% -- and episodic sexual
activity increased it by 270%. Sounds scary, except that the authors
emphasize that these risks are actually not high, because they are
transient (occurring during or close to the activity) and "because
exposure to physical and sexual activity is infrequent." (This
study looked at 55-64 year-olds, so I'm not even gonna go there!)
Because of these factors, the researchers also stated that the absolute
risk increase for heart attack associated with 1 hour of additional
physical or sexual activity per week was estimated as 2 to 3 per
10 000 person-years. Comforting.
The most important finding, however, was that these
risks were significantly reduced in people who normally had high
levels of habitual physical activity (we would assume that includes
sexual activity).
On a serious note, these questions are of real
concern to heart patients. Our Patient Forum gets queries like this
one last weekend in our topic on "Angioplasty
Recovery Period":
"Delicate subject....How soon after
having a stent is it safe for a man to have sex & if another
stent is needed in a few weeks, is it safer to wait till after
that?" -- Broken Hearted, Australia
For Broken-Hearted and other patients, we recommend
your cardiologist as the person to ask -- he or she has your records
and knows your clinical health status and can make recommendations
regarding both physical and sexual activity. As the research study
states, the better shape you're in, the less the risk.
For more information from the Tufts
researchers, Drs. Issa J. Dahabreh and Jessica K. Paulus, check out
the video below, courtesy of JAMA.
It's great to hear of everyone's victories
recovery-wise, both major and minor. I had 3 coronary stents
in Nov 2010 during 3 separate procedures and the cardio told
me exercise as I wish... So, 2 10km running races and a half-marathon
completed since the stents went in, and I'm now training for
triathlons! I quit smoking and have lost over 10kgs and workout
about an hour each day. I tell you all this because I'm so
impressed by the medical intervention and how it can turn around
our lives... The angina before I was diagnosed was agonising
and I couldn't even walk 100 metres! Anyway, for the future
I'm hoping to regain my professional pilot medical and be back
to flying in about 3 months. Best of luck to everyone undergoing
angio and stenting! -- David J.
I've written about this before --
that our Forum often winds up serving as a kind of "complaint
department" for people having problems after stents, angioplasty,
angiograms, etc. And these types of posts are important because they
allow patients to share stories and discover they are not alone with
these issues. (Indeed, Angioplasty.Org's Forum Topics currently get
over 30,000 views a month.)
So it is always great to read posts like David's
to remember that these medical procedures "can turn around
our lives...".
Tomorrow's case will be a 65-year-old man
and the plan is to perform PCI of his distal Left Main and LAD
obstructions using stents delivered via the radial approach. The
case operator will be Dr. Shamin Sharma of Mount Sinai and the
moderator Dr. Sameer Mehta of University of Miami Medical Center.
Dr. Mehta's recent LUMEN-AMI program featured the use of the transradial
approach in STEMI. You can read our
exclusive interview with Dr. Mehta on Angioplasty.Org.
And for patients who are trying to find an interventional
cardiologist experienced in using the radial approach, check out
Angioplasty.Org's Transradial
Hospital Locator.
Wanted: Marathoners with Stents, Pacemakers,
Heart Valves Medtronic
(NYSE: MDT) has made its yearly announcement that
it is looking for runners from around the world who have benefited
from medical technology to participate in the company's 6th
Annual Medtronic Global Heroes program. I "liked" this
event on their
Facebook page because the idea of people living their lives
to the fullest after having a catastrophic medical crisis, and
being rescued by modern medical technology, goes right to the (okay...pun
coming...) heart of the matter.
For example, former honorary captain for
this program is Alberto
Salazar, a world-renown marathon champion. Salazar is 52 and
in 2007 collapsed from sudden cardiac arrest. He was revived via
CPR and received an implantable cardioverter-defibrillator (ICD)
to treat arrhythmia. He continues to train runners and had three
participating in the Beijing Olympics. He is "committed to
spreading the word about running and living safely with a chronic
health condition."
As I've written before, I am always amazed by the
people who continue their athletic activities after having a device
implanted (most could outrun me with no difficulty -- but that's
another story...). Our Forum Topic, "Exercise,
Sport, Physical Activity After Stent", has the stories of
scores of stent and heart patients who continue to run, ride horses,
etc. We even recently connected with Kevin,
an IronMan AAA stent graft athlete, who is continuing to train
after receiving this life-saving device, although AAA Stent graft
patients are not eligible for the Medtronic Marathon, at least not
for now. Sorry, Kevin...but maybe next year!
Anyway, we applaud the invitation to heart patients.
So often, after people discover they have coronary artery disease,
a significant and understandable depression can set in: they feel
their lives are over. Studies confirm that depression itself is a
risk factor for heart disease. So it's not just a PR event. It is
clinically important -- efficacious, as we say in the medical field
-- to see events like the Global Heroes Marathon.
To apply or recommend someone to be a 2011 Medtronic
Global Hero, visit medtronic.com/globalheroes.
Good luck!