Preventing Nephron Loss at
Centro Cardiologico Monzino (CCM)
Based on an interview with Dr. Antonio Bartorelli of the Centro Cardiologico Monzino (Milan, Italy)
About Dr. Bartorelli and the CCM
Dr. Bartorelli is professor of cardiology at the University of Milan and has been a practicing
interventional cardiologist for over 30 years. During this time, he has published 240 papers
and 10 books chapters. In 2005, Dr. Bartorelli and his collaborator, Dr. Giancarlo Marenzi,
published the first book on this serious complication entitled Contrast Induced
Nephropathy.1
The interventional cardiology team at CCM is at the forefront of cardiac catheterization
practice. Each year they perform approximately 4,300 catheterizations, over 2,000
percutaneous coronary interventions (PCI) along with peripheral angioplasty procedures
and percutaneous cardiac valve interventions.
Contrast-Induced Nephropathy Basics
Prof. Bartorelli on CIN
Contrast-Induced Nephropathy (CIN) is a form of acute
renal failure that is caused by exposure to contrast media
during image-guided cardiology and radiology procedures.
Patients with pre-existing kidney dysfunction are
particularly at risk for developing CIN.
CIN can cause acute nephron loss. This loss of nephrons
can be detected by a transient increase in a patient’s
serum creatinine, often 24-48 hours after the
catheterization was performed. Even though a patients
serum creatinine may return to baseline, lost nephrons
cannot be replaced and long-term kidney damage has
occurred. A number of studies have demonstrated that a
patient who develops a transient rise in serum creatinine
(the definition of CIN) after contrast exposure will have
significantly reduced long term outcomes. Results from
two such studies are displayed below2,3:
Why have you made preventing CIN a focus of your
research?
In our cath lab, we are treating more and more elderly
patients with several comorbidities, including chronic kidney
disease, who are at high risk of developing acute renal failure
after the procedure. Dialysis is a disaster for these patients. If
your patient goes to dialysis, he is a “dead man walking” over
75 years of age.
What do you tell colleagues who think that CIN is a
temporary bump in creatinine that usually resolves on its
own?
It is now quite clear that any creatinine increase is not just a
sign of temporary renal dysfunction but indicates significant
nephron loss. If you talk about nephron loss, a physician can
understand what we are talking about. It is a function that is
lost forever. The kidney is very forgiving, until a certain point.
These patients, not rarely, need sequential interventions.
When you have sequential injury to the kidney, you see renal
function going down over months. Maybe two years later the
patient goes on dialysis.
It is a silent worsening of a very important function. So there is
no exterior sign of the damage. So the point is nephron loss.
The analogy is with the loss of myocardial cells,
myocardiocytes, in acute myocardial infarction, it’s a similar
concept.
1
Bartorelli, AL., Marenzi, G.; Contrast-Induced Nephropathy: In Interventional
Cardiovascular Medicine, 2005
2
Gruberg L et al. J. Am. Coll. Cardiol. 2000;36(5):1542-1548.
3
Goldenberg I et al. Am. J. Nephrol. 2009;29(2):136–144.
Interview with Dr. Antonio Bartorelli
On Using RenalGuard® at CCM
Who are the patients that you treat with RenalGuard in
your cath lab?
Patients with eGFRs below 30 and those with eGFRs
between 30 and 60 who have an additional risk factor are
treated with RenalGuard at our center.
How well integrated is RenalGuard into your cath lab?
The RenalGuard system at Monzino is in the flow of the
cath lab. Last Friday, I saw two patients on stretchers
going into the cath lab with two RenalGuard systems in a
row. I believe this is a sign that this preventative
treatment is now embedded in the flow.
The MYTHOS Trial1
Dr. Bartorelli and his team at CCM conducted the first
randomized control trial on RenalGuard, MYTHOS. Their trial
compared the rates of CIN in at-risk patients who received
RenalGuard Therapy to patients who received standard
overnight hydration. The results indicate that patients with
pre-existing renal dysfunction treated with RenalGuard
developed CIN at a rate 62% lower than those who were
treated with overnight hydration.
All of the nurses in the CCU, ICU, cath lab and the ward
know how to setup the system and how to connect the
system to the patient. It’s a routine treatment now.
What did it take to get RenalGuard integrated?
One of our fellows, Dr. Cristina Ferrari, who was involved
in the first randomized trial with the RenalGuard at
Monzino, trained all of the nurses in the lab. She was the
proctor. Now, the nurses train each other. The nurses love
it- it’s very simple to operate, much easier than bringing
the patients in for overnight hydration, and they love
seeing the impact that it has on reducing adverse events
for patients.
Some physicians are concerned about the use of Foley
catheters, has this been a problem at Monzino?
As a matter of fact, when my patients have a Foley
catheter in a complex case, I am less disturbed by the
patient asking to urinate. Think about a CTO [chronic total
occlusion] that can take 2 or 3 hours. Indeed, all of the
CTO’s at CCM have a Foley catheter just because of the
length of the case. A Foley catheter should not be seen as
a limiting factor. It stays too shortly. You start seeing
urinary infections (UTIs) if the catheter stays for days, and
during RenalGuard treatment, it’s only in for a few hours.
RenalGuard System is CE-marked for the intended use of temporary (up to
14 days) replacement of urine output by infusion of a matched volume of
sterile replacement solution to maintain a patient’s intravascular fluid
volume, and has demonstrated accurate matched replacement and an
appropriate safety profile with normal saline
PLC, RenalGuard and RenalGuard Therapy are trademarks of PLC Systems Inc.
Br00036 Rev. A
REMEDIAL II2
The results of MYTHOS were confirmed by a multi-center
trial, REMEDIAL II. That study evaluated RenalGuard Therapy
against hydration with sodium bicarbonate in a population of
patients at high risk of developing CIN. RenalGuard reduced
the incidence of CIN by 60% using the standard definition. In
addition, the data showed that RenalGuard reduced the need
for dialysis within the month after the catheterization from
4.8% to 0.7%, an 85% reduction.
1
2
Marenzi et al. JACC Cardiovasc Interv. 2012;5(1):90-7.
Briguori et al. Circulation, 2011;124:1260-1269.
459 Fortune Blvd.
Milford, MA 01757
Phone: 508-541-8800
www.plcmed.com