126. Unlocking Hypertension Control: The Role of Renal Denervation (CE)

Hypertension (HTN) is a leading cause of death and disability in nearly half of all Americans. Alarmingly, almost 50% of individuals with HTN are unaware of their condition, and only about 20% have it under proper medical control. Nurse practitioners (NPs) play a crucial role in managing HTN, particularly in patient communication, shared decision-making and clinical expertise. On today’s episode, Dr. Leslie Davis and Maria Bonanni explore how renal denervation (RDN) reduces hypertension, and discuss clinical trials, patient selection and recent regulatory approvals. They also highlight the NP’s role in screening and educating patients about RDN through shared decision-making.

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This activity is supported by an independent medical educational grant from Medtronic

Episode Transcript

(00:12):
From the American Association of NursePractitioners,
I'm your host, nurse practitioner and AANPeducation specialist Michele McKay.
And this is NP Pulse,
The voice of the nurse practitioner.
Welcome to NP Pulse, AANP’s official podcast,

(00:36):
bringing you unique nurse practitionervoices and expertise on issues
that matter to NPs and to our patients.
NP Pulse podcast listeners may claim
CE credit for this programthrough September 2025.
After you listen to the podcast,simply go to aanp.org/cecenter,

(00:56):
register for this activity,
enter the participation codeyou hear at the end of the podcast,
and then complete the post-testand evaluation.
Hypertensionis a leading cause of death and disability
each and every year,in nearly half of all Americans.
Perhaps more alarmingly,nearly half of all individuals
with hypertensionare unaware of their condition,

(01:17):
and a meager 20% have the conditionunder proper medical control.
Though often seen as a mildhealth issue of relatively minimal
consequence, the issue is far from benign.
Nearly 700,000 U.S.
deaths are attributable to hypertensionon an annualized basis,
making hypertension one of the leadingcauses of death and disability

(01:37):
in the U.S..
Nurse practitionersserve an essential and irreplaceable role
in executing the clinical functionsfor patients with hypertension,
especially in patient-centriccommunication and shared decision-making.
In addition to their clinical expertiseand acumen
in the diagnostic and treatment processes.
On today's episode, Doctor Leslie Davisand Maria Bonnani discuss the mechanism

(02:01):
by which renal denervationexerts its antihypertensive effects,
offering a deep dive into the clinicaltrials behind this innovative procedure.
They also review the processfor selecting patients
who will benefit from renal denervation,as a therapeutic approach,
as well as review recentregulatory approvals that mark
a significant milestone in the treatmentof uncontrolled hypertension.

(02:24):
Finally,they will review the role of the nurse
practitioner in screening forand educating the patient
on renal denervationusing shared clinical decisio-making.
Pleasejoin me in welcoming Leslie and Maria.
Hello, my name is Leslie Davis.
I am an associate professor at the University
of North Carolina at Chapel Hill.

(02:45):
I am also an AANP fellow.
I'm proud to say. I have apart-time nurse practitioner
practice at UNC Chapel Hillin the division of cardiology,
specifically in the hypertensive clinic.
We're an American HeartAssociation certified
hypertensive center.
Relevant to today's podcast,
I have no financialrelationships to disclose.

(03:08):
So, hi, I am Maria. I'ma nurse practitioner at the
hospital of the Universityof Pennsylvania.
My practice primarilyfocuses on managing patients
with resistant and difficult
to control hypertension within our renal
hypertension department.
We are also an AHA certifiedhypertension center.
Penn has been activelyinvolved in renal denervation
research studies for over adecade, primarily led by Dr.

(03:30):
Debbie Cohen, who I work closely with.
I personally served
as a sub investigator inmultiple renal denervation trials
for about the last five years.
I'm excited to participate inthis podcast with you, Leslie,
particularly as we delveinto renal denervation,
which is a technology thatis transforming the landscape
of hypertension management.
I do have one disclosure.
I am a speaker

(03:51):
and work on the advisoryboard from Medtronic,
though all financialrelationships have been mitigated.
So today's objectives includeexamining the mechanism
by which renal denervation exerts an
antihypertensive effect.
We're also gonna summarize theevidence in base of support
of renal denervation asa therapeutic approach
to hypertension management,
including recent regulatory approvals.

(04:13):
And lastly, we'll discussthe standard of care pathways
for the safe, effectiveimplementation of renal denervation
for hypertension managementwith a focus on the role
of the nurse practitioner onthe multidisciplinary team.
So I'll kick it off withcontent. Again, I'm Leslie.
I would like to thank theAANP for inviting Maria

(04:34):
and I to participate in this podcast.
I'd also like to thank on behalf of Maria
and I, our sponsor Medtronic.
So to kick it off for ourlisteners, I just sort
of wanna set the stage,Maria, we have sort of a call
to action with hypertension, the burden
and the urgency to act.

(04:55):
As many of us know aspracticing nurse practitioners
or maybe some NP studentsare our listeners
that hypertension is highlyprevalent, in the US about 50%
of adults in America have hypertension.
It's about a third worldwide,so large number of patients.
And the level of control is not very good.

(05:18):
Only about one fourth havecontrolled blood pressure.
And as defined by the 2018American Heart Association,
American College of Cardiologytreatment goals controlled
means less than about 130
and less than 80 millimeters of mercury.
So that means like threequarters are not controlled.

(05:38):
Now we all know the traditionalguideline directed medical
therapy for those diagnosedwith high blood pressure
or hypertension in addition
to lifestyle changes are ourstandard therapy with one
of three classes of meds.
Broadly, RASP blockerssuch as ACE inhibitors
or ARBs, second calcium channel blockers,

(06:00):
third diuretics, which would be thiazide
or thiazide-like diuretics.
Standard treatment isusually a fourth agent,
might be an aldosterone antagonist.
But we know that guidelinedirected therapy works well
in many but not all.
And so there are limitations
for traditional guidelinedirected medical therapy

(06:22):
for treating hypertension.
And over the years we are alwayslooking for new strategies
to help not only treat hypertension,
but control that blood pressure to goal.
Now there are many reasonsthat we need new therapies.
As our listeners well know,
our patients have a huge pill burden.
Even when I live inmy silo in my clinic, I try

(06:45):
and tell patients that onaverage you're gonna be on three
to four medications to try andcontrol this blood pressure.
Now that's in addition to all their meds
for other conditionslike diabetes, arthritis,
whatever their comorbid conditions are.
Also in the real world, peoplehave medication intolerances
where they either have side effects

(07:06):
or they just can't toleratefor whatever reason,
a particular class of medications.
We also know the studiesshow up to about 30
or 40% are non-adherent withmedications and treatment.
Some of that's intentional,some non-intentional.
And then we have patientsthat prefer another way
to either compliment their therapy

(07:26):
to reduce their pill burden
or it's just another way to treat.
And darn it, some patientsare just flat out resistant
to standard treatmentdespite these good medicines.
So I've used a term beforeI pitch it to you, Maria.
You know, I've used thisterm resistant hypertension.
We use it as clinicians,
but our patients don't necessarily know

(07:48):
always what that means.
And what I mean thereis like they're on three
different meds from threedifferent classes at at least
moderate doses andthey're still not to goal
or maybe they're on four ormore medicines to get to goal.
So that's considered,
and there's differentdefinitions around the world,

(08:09):
but that's our definition in general
of resistant hypertensionin the US guidelines.
And there's many reasonssomebody might be difficult
to control or truly resistantthat we can talk about later.
But I'm getting ready topitch it to you, Maria.
You know, I know when patientsask me what are the causes
of high blood pressure?
And I try and thinkabout, well some people

(08:30):
or many people have just this overactive
sympathetic nervous system.
I call it a revved upsympathetic nervous system
and it can be a keydriver in hypertension,
but this very much relatesto renal denervation.
So Maria, can you talk to us a little more
to our listeners aboutthe pathophysiology behind
how these catheter-basedinterventions like renal

(08:52):
denervation can offer anew pathway for treatment
to get patients to goal?
Sure thing, Leslie,happy to take over here
and appreciate the background, and,
and really kind of goinginto all of the issues
that are really prevalentin both of our clinics
that I know, we deal withthese issues every day.
The concept of renaldenervation dates back
to the earliest 20th century.

(09:12):
When researchers observed the relationship
between the renal nerves
and blood pressure regulation, we know
that increased adrenergicactivity contributes
to not only the development
but also the maintenance of hypertension.
And locally at the kidneylevel, efferent sympathetic outflow
to the kidney leads todecreased renal blood flow,
increased renin release

(09:33):
and subsequent sodium retention
while afferent sympathetic fiberssend signals to the brain
to stimulate centralsympathetic nerve activity
and contributes toneurogenic hypertension.
So with this knowledgein the mid 20th century,
surgical procedures such as sympathectomy,
which involved actuallyremoving the sympathetic nerves

(09:53):
surgically were attempted tomanage high blood pressure.
The procedures were invasive
and associated with significant mortality
and morbidity. Followingthose same principles,
catheter-based interventionalrenal denervation was invented
at the beginning of the 21st century.
And renal denervation ablates the afferent
and efferent sympathetic nervesin the renal arteries.

(10:16):
And the strategy of the procedure is
to maximize nerve disruptionby applying ablation treatments
to each renal artery.
And it reduces sympatheticactivity both locally in the
kidney by reducing renin activity
and increasing renal blood flow,
but also systemically
through lowering globalsympathetic activity.

(10:36):
Now, in an attempt to give theaudience a little look into
what renal denervationactually looks like, Leslie,
would you be able to kind of run us
through a basic overview ofwhat the treatment involves?
Sure. Maria, andthank you for reviewing,
brings back memories ofthe efferent, the afferent,
all this stuff from pathophysiology.
But it's really interesting to hear that.

(10:56):
So when we think about theprocedure, something to that,
if you're new to this
or you're explaining to patients,I think the key things are
to emphasize this isan outpatient procedure
that occurs in the cath lab.
It usually takes about anhour to an hour and a half.
Many will go home the sameday. This is a planned procedure.

(11:18):
Some may stay overnight.
for surveillance. I sort
of think about is elective cardiac CASS.
I see a lot of patients that have those.
So you, you come in early in the morning,
you'll have this procedureand most will go home,
but you leave the door openthat some may stay overnight
for surveillance. Like cath procedures,
the conscious sedation,
the patient will be awakebreathing on their own.

(11:40):
They like to hear that, IV sedation
and in most cases, anesthesiais not typically involved
with that procedure.
It's done by an interventionalcardiologist at this time the
groin is the site of insertion.
So a catheter is inserted into the groin.
There are some potential future
or development of potentiallya radial approach,

(12:02):
but currently the procedureis done through the groin,
it's threaded into the renal artery
and that can be guided byultrasound, x-ray, CT scan.
When people ask about level of discomfort,
well pain meds are usuallygiven as part of the sedation
and they might not remember any pain,
but if there's pain, it'sconsidered a minimal level

(12:24):
of discomfort during the procedure.
Mostly visceral pain when the energy
or sensory innervation isgiven to the renal arteries
for the denervation. Observation,I know maybe we'll get to
that later to talk more about what happens
after they're left thehospital or left the procedure.
But generally immediate postprocedure, there's observation

(12:46):
for a few hours, two to fourhours laying flat, not moving,
watching for bleeding at that access site.
Initially, you know,expectations of the procedure.
It's not like a magic wand,
but boom, it's, it's youknow, immediate reduction
and sustained right away.
But post procedure there is a reduction.

(13:06):
Some of that may be due to the sedation,
but when we talk about expectations,
most we'll see a reduction inthat first two to three months
and the effect will improve over time.
We can talk about that later,
but I think that's sort ofan overview of the procedure.
Maria, do you haveanything to add with that?
No, I think that was a,a really good overview.
I think that it'simportant for us to be able

(13:27):
to understand the procedureat least somewhat, to be able
to endorse this to our patientsso that they understand.
I think there's a lot of anxiety
and when you tell any patientsto undergo a procedure.
So if we can really givefull explanations as well as,
which we'll get intoany type of side effects
or risks, it's really importantfor the patient to have
that information before makingtheir informed decision.

(13:49):
So I think at this point I'd like to kind
of dive into the FDA indication
and describe the two currentsystems that were FDA approved
so we can get a better ideaof the specific technologies
and then we'll delve into some data.
So the two recently FDA approvedtechnologies in catheter
renal denervation are theradiofrequency ablation,

(14:10):
which is Medtronic'sSymplicity Spryal system.
And then there's also Recor’s Paradise Ultrasound system,
which is an ultrasound-based denervation.
Both techniques aim toachieve the same goal
of reducing the sympathetic nerve activity
that we discussed earlierin the renal arteries
and to lower blood pressure.
And I also wanted to talka little bit about the FDA

(14:31):
approval, which was givenin November of 2023.
And it's important to note thatthe approval is quite broad.
So the language specificallystates that RDN was approved,
quote, to reduce blood pressure
as an adjunctive treatment inpatients with hypertension,
in whom lifestyle modifications
and antihypertensivemedications do not adequately

(14:52):
control blood pressures.
I think it's interesting thatthey use such broad language
and as Leslie mentionedearlier, you know half
of the US population
and about a quarter
of the world's population has hypertension
and many are not at goal.
So this is a procedurethat can really be applied
to many patients.
So maybe at this pointwe'll delve into the

(15:14):
data a little bit.
So this is a lot to kind of go through.
So I'll try to go throughit and keep it interesting.
The earliest studies wereSymplicity HTN 1 and 2,
and these were reallyproof of concept studies
that used first generationradiofrequency devices, which at
that time was a flexible catheterwith a unipolar electrode.

(15:35):
They were both open labelrandomized control trials,
which determined that RDN was feasible
and safe. In HTN-1
we saw drops of about27 millimeters of mercury
in systolic bloodpressure. And Symplicity HTN 2
also showed significantreductions about 32 millimeter
drop in blood pressure in thepatients that were treated

(15:55):
with RDN versus the control group.
Then came Symplicity HTN 3.
This was a randomizedsham controlled trial
that was really aimed toaddress some of the limitations
of the previous studies.
But this study interestinglydid not meet its endpoint
and showed no significantdifference in blood pressure
reduction between the RDN group

(16:16):
and the sham group at six months,
which was their primary endpoint.
- So Maria, I have a question then.
So when sometimes we hear as clinicians
or we hear as researchers
that a study didn'treach its endpoint, Ooh,
that sounds mysterious.
And you, you specified theydidn't obtain a statistically

(16:37):
significant drop in blood pressure
with the renal denervation procedure.
I mean, I like how you walkedus through those early phases,
proof of concept
and then having thatrandomized controlled trial
with a sham.
Some of our listeners,I've helped with a study
before as a, as a researchassistant with sham, explain

(16:57):
what sham means
and maybe explain justbriefly how do you take
that into context Is,is that really bad news,
you don't reach a statistical significance
or how did the authors really talk about
that?
The sham procedure is very interesting.
So essentially for patients,whether they were treated
or not, they went
through the procedurenot knowing either way.

(17:18):
So they would go into the cath lab,
be prepped exactly the same.
There was actually a script
that the interventionalcardiologist, at least at Penn,
the interventional cardiologistswere the ones doing the
procedure that they would read through.
So every patient wouldhear the exact same thing,
even if the energy wasn'tbeing delivered, noises
that could indicate thatpossibly being done were made

(17:39):
and no one knew other than theinterventional cardiologist
knew whether the patientswere treated or not.
So all of the pre
and post up of thesepatients, whether it be
with the research coordinators
or myself as a sub investigator,
we had no idea whether thesepatients were treated or not.
So definitely interesting study.
They don't always have studies
where they actually doprocedures on patients

(17:59):
without any intervention.
But you know, this studyparticularly there was thought
that potentially the reasonwhy the primary endpoint wasn't
met was because placebo effect
or Hawthorne effect, whichis very common in research
studies, there is some variabilityin medication adherence
and in this studyactually drug metabolites
weren't tested for.
So it's always really hard toknow what patients are taking

(18:22):
and what they're not taking,
which is really importantwhen you wanna try
to understand the significance
of differences between groups.
This study also relied on officeblood pressure measurements
and not ambulatory bloodpressure measurements.
You'll see in when wetalk about future studies
where they include that as well.
And also there's some thought
because this study also usedthat first generation catheter

(18:43):
and subsequent studies will include
that multi-electrode catheterthere was better success.
So now I'm gonna go into those studies.
The next studies, as Imentioned, two things were new.
One, there was this newmulti-electrode catheter
that was used and alsothere was a new technique.
So in the previous trials theyablated really just the main

(19:05):
renal artery with theradiofrequency catheters.
In the subsequent studies,
they treated the main renal arteries
but they would also treatthe accessory arteries.
The first study I wannatalk about is the SPYRAL HTN-OFF MED
Pivotal Trial.
This was the first sham controlled,
randomized controlledtrial which did demonstrate
significant difference inblood pressure reduction

(19:25):
between both the treatmentand control groups.
It included over 300 patients
and they were one-to-one randomized
after they followed about afour week washout period on
antihypertensives.
The primary outcome was defined
as mean change in the 24 hoursystolic blood pressure from
baseline, three months
after either the sham or the treatment.

(19:48):
And the trial did demonstratea significant reduction
of about four millimeters
of mercury in the 24 hoursystolic blood pressure in the
renal denervation group.
There was also a significant decrease in
between the two groups in officeblood pressure at the three
month mark, which wastheir secondary endpoint.
And then I'm gonna talkabout SPYRAL HTN-ON MED.

(20:08):
So this is a single blindedrandomized sham controlled study
that actually randomized80 patients, again one
to one-to-one RDN versus sham.
And this study, sincethey were on medications,
the protocol did includemonitoring of blood
and urine samples for medication
metabolities, to help reduce some of the issues

(20:29):
in previous trials. Theprimary endpoint was defined
as the difference in 24 hour ambulatory
systolic blood pressure.
at six months. The results
of the SPYRAL HTN-ON MED demonstrated safety
and efficacy of RDN atthe three month mark
and comparison of thetwo groups did favor RDN
with a 10 millimeter reductionin ambulatory blood pressure.

(20:50):
Though despite this, the primaryendpoint was not met at the
six month mark,
though all secondary endpointswere consistently meaningful.
The authors argued thatthis may be explained
by the higher number of antihypertensives
that were taken at the sixmonth mark by the sham group
and thought this might beactually a resultant of Covid.
And this was during the Covid pandemic.
They assumed that, you know,most patients were pretty aware

(21:12):
of their health, they werechecking their blood pressures,
more people were checkingtheir pulse oxes all the time,
taking their temperatures.
I think everyone in Americabought both a pulse ox and
several thermometers toassess for any signs of Covid.
And so the thought was thatpotentially the sham group was
more treated, again,
reducing the statistic significanceof the treatment group.

(21:33):
- So Maria, some of the keytakeaways I've got from this,
so early on, the studies,
just like early clinicaltrials have to show
that it's a safe procedure
and it works to do whatit's intended to do,
but you really wanna see adifference between groups
and statistical significance too.
But things you're describingare real world context.

(21:55):
So I really like this about these trials
that these are real world context,
although it's a sham so thatno one feels disenfranchised,
that they didn't getthat fancy new procedure
after consenting.
Ultimately you wanted realworld practice to play out,
but scientifically you'recomparing these outcomes

(22:16):
and things happen, patient'sbehavior may change,
other clinicians' behaviors will change
and they'll look at theseblood pressure readings.
So having a clinical trial, I'moversimplifying it probably,
but having a clinical trial really try
and separate all those thingsthat could confound an outcome

(22:36):
or could relate and explain the meaning.
You've done a really goodjob of talking about that.
So that helped me.
And so you also emphasize
that systolic bloodpressure is a lot about
what we're gonna talk about
and that's consistent with myknowledge of clinical trials.
We really focus on systolicblood pressure lowering.

(22:57):
So can you share a little more about,
I know the RADIANCE studies followed this,
can you talk us a littlebit more through that one?
- Yeah, so I'd love to take a few minutes
and discuss some of the trials
through the RADIANCEClinical Trial Program.
And just to remindeveryone, this is the use
of the Paradise EndovascularUltrasound technology.

(23:18):
So this is different.
The Spyral studies is
that multi-electroderadio frequency catheter
where this is an ultrasoundthat again does the same thing
or the the end goal is thesame, but they are different.
There's three studies I wanna talk about.
The first is the RADIANCE-HTN SOLO.
This was a single blinded,randomized sham controlled trial
that was designed to evaluate the efficacy

(23:40):
of the ultrasound catheter without the use
of antihypertensives.
It included about 146 individuals,
one-to-one randomized intosham and renal denervation
after about a four week bloodpressure medication washout.
This study's primary endpointwas change in daytime
ambulatory systolic blood pressure at the

(24:02):
two month follow up.
So a shorter kind of interval of time.
And this study did show asignificant reduction in daytime
systolic blood pressure
and between the two groupswas about 6.3 millimeters
of mercury and also met allof its secondary endpoints.
The next study I wannatalk about is a
RADIANCE-HTN TRIO study.
Again, this is a singleblind sham controlled trial

(24:24):
where patients were switched
to a once a day fixed dosesingle pill combination
that included calciumchannel blocker, ARB
and the thiazide diuretic.
And after four weeks onthe standardized therapy,
then patients were randomly assigned
to either getting theultrasound denervation
versus sham procedure.
The primary endpoint of thistrial was change in daytime

(24:47):
ambulatory systolic bloodpressure at that two month mark
and in the renal denervationgroup there was a median
reduction of about four and ahalf millimeters of mercury.
Again, secondary endpoints,
which I'm not gonna go intospecifically were also met.
And then lastly, RADIANCE II.
And this was a study wherepatients were randomized two
to one getting the procedure versus sham.

(25:09):
And all of these patients wentthrough a four week period
before the randomization where all
of their antihypertensiveswere discontinued
and they were actually keptoff their medications at least
until the two month mark.
This was of course,
except if patients hadvery high blood pressure
or were symptomatic, theywould receive escape drugs.

(25:29):
The primary endpoints of this study was
to look at daytime ambulatorysystolic blood pressures
and it did demonstrateabout a 6.3 millimeter
of mercury difference betweenthe treated and sham groups.
So I know that's a lot ofinformation to regurgitate
and for you to absorb.
And so I think to summarize, we can show
that really all trials at thispoint really did show similar

(25:51):
clinical meaningfulblood pressure reduction.
And there's also solid evidence
that these procedures haveexcellent safety profile.
And I think if you wanted
to maybe average the responsein blood pressure in either
the two or six month mark,
because again, if youthink the RADIANCE studies,
their follow up periodswere a little bit shorter,
where the Symplicity trialswent out about six months,

(26:13):
we can see about a five to 10 millimeter
of mercury drop insystolic blood pressure.
Leslie, can you help put thisinto context for us?
Yes, f I think about, as I'm listening
and our listeners are hearing
what you're saying about this data, I try
and say, what are thesetake home messages?
And I'm thinking

(26:34):
that we know from past research
that even a five millimeter mercury
of blood pressure reductionsystolic can improve
cardiovascular outcomes by about 10%.
A 10 millimeter reduction canreduce all cause mortality
about 20%.
So when I talk to patients
and just over the years guidelinedirected medical therapy,

(26:57):
every time I add a classof meds or recommend it
and they take it on average, most low
or medium dose of meds,
you wanna get a doubledigits about 10 millimeters
mercury reduction.
And to hear you talk aboutthis initial response
of anywhere from five to10 millimeters of mercury
or some of them on average, maybe 15

(27:19):
or 20, you know, even 18.
That's good, that's really good.
So put it in context,
and I'm hearing what you're saying is all
of this is in real world context
and all these designs
of these catheter-basedprocedures over time got more
precise in the researchprocedure to see the effect

(27:39):
of this renal denervation.
So I really like that.
I'm also hearing it's not a cure for all
because you've gotta, in somepatients reduce more than 10
or 20 based on where theirunderlying blood pressure is.
So it might not mean thatyou necessarily reduce
or discontinue medications
because you've mentionedwhether they were in sham

(28:01):
or the intervention group thatgot the renal denervation,
that meds continued to be used
to basically get people to goal.
And so, you know, I,
I really think talking aboutthese benefits has helped.
So Maria, we've talked about the benefits.
Do you have any othercomments about the benefits

(28:23):
before we move on to the safety profile?
- Yeah, the one thing Idid wanna also touch on is
that there is a globalSymplicity registry,
which is a prospective openlabel single arm all-comer
registry that includes over3000 treated patients globally.
And so the goal of it is reallyto still evaluate safety
and efficacy of the treatment

(28:45):
with specifically theSymplicity and catheter.
with specifically theSymplicity RDN catheter.
There's been many studies
that have looked at thislarge group of patients
and did show that over time there seems
to be a continued reductionin blood pressure.
There's a study that looksabout three years out
and in that group the averagereduction in blood pressure
is about 18 millimeters of mercury.
So I think the pointthat you made is great.

(29:06):
Not all patients respond.
And again, these are averages, right?
So there's gonna be patientswho respond greater, less
and those that don't respond at all.
So when we also look at thesestudies, we think about 70%
of patients respond and wereally don't know which patients.
There's also been some, you know, studies
where they looked at manysubgroup analyses of the data
to say is it sex, is it race, is it age,

(29:29):
is it comorbidities?
How can we better identifythe 70% of patients
who will respond?
And we haven't gotten there yet.
So hopefully, you know,
when this procedure doescome commercially available,
you know, our plan as partof a AHA certified program,
we're working with othersacross the country to really try
to collect some real world data so

(29:49):
that we can then learn morefrom this in the future.
Thanks for bringing some of that stuff up.
I think it's great.And maybe we can jump a
little bit into safety.
So Maria, right before we go to safety,
just a quick question.
So is it fair to say in myclinic when I start meds,
the higher the blood pressureis, maybe the more response?
Can you say, you mentionedabout subgroups, is it fair

(30:11):
to say those with higher blood pressure
or more uncontrolled bloodpressure, however they got there,
but the higher the bloodpressure, is it fair
to say the more responsivethey are to this procedure?
Like, like we do with meds?
Yeah, Leslie, that's, thatis something that they've seen.
So again, yeah, so not specificgroups have they necessarily
ben able to identifywhich say 70% respond,

(30:33):
but they have looked
and they've shown that if you come in
with a higher starting bloodpressure, that you tend
to have a better response.
So again, some of thesestudies aren't large
and necessarily gonna beapplicable in the future
for all patients, butit is something we've
seen and that's a great point.
Okay, so we can move into safety.
I was just bringing up those points

(30:55):
that I've read in the literature
and just getting your take as an expert.
So as I think about safety,
and we we're gonna talk ina little while about shared
decision-making and,
and really we as nurse practitionersreally lean into shared
decision-making and shareddecision-making is a must
with any procedure.
And we may consider this aminor procedure, day procedure in

(31:17):
the cath lab, but allprocedures can be a big deal
to patients and families.
But in general, we've talked about,
or what I've heard in mytake home messages are
that this renal denervationprocedure is considered safe.
It's been through allthese clinical trials,
it's been FDA approvedfor safety and efficacy.

(31:37):
And in general, whenI read the literature,
I've read these studies andI'll get you to comment on this,
but very low rates of major complications.
And so I was just sort ofgonna run through a few minor
or major complications.
Again, very, very smallpercentages relatively.
As we think about acuteprocedure related complications,

(31:58):
you can divide them intovascular access site,
that femoral area,
and then we can also go torenovascular complications
or acute kidney injury.
So thinking about thevascular access site,
you can divide them inbetween minor and major.
Minor complications are a small hematoma

(32:19):
or bruising at the sitethat may occur to maybe four
or 5% of the patients.
And that's not uncommonwith any vascular access,
especially in the groin.
And major vascular accesssite issues are like a larger
hematoma, a retroperitoneal bleed,
which we know is rare even withthese procedures, AV fistula

(32:41):
or pseudoaneurysm formation,
collectively these are about less than 1%,
so less than one out
of every a hundred patients.If we think about the kidney
vascular complications
and these collectivelyabout less than 1%, again,
less than one out of a hundred patients,
that could includerenal artery dissection,
distal perforation, intracapsular,

(33:04):
renal hematoma, a newrenal artery stenosis
or aortic dissection.
Again, collectively very rare.
And then last, acute kidney injury,
less than 1% they aregetting contrast dye.
Just like many proceduresdone in the cath lab
or the interventional space.
When I read about later complications,

(33:28):
they're even less, less than 0.2%
that there may be a late development
of renal artery stenosis.
Or when you think aboutworsening kidney function,
if you take into considerationof what's expected as
as adults age, especiallyif they have hypertension
or they started with mild
to moderate reduced kidneyfunction on average,

(33:50):
my understanding is no significancedifference compared the
sham versus those thatactually got the procedure.
So I did a walkthrough.
When we talk about complications,does that sound about
what you were hearing, reading,
seeing from the clinical trials?
I think what you verbalizedhere is really spot on.
Those risks are outside of the, you know,

(34:11):
very minor access site complications.
Any real significant sideeffect is exceedingly rare
and in really the realm of afew patients in the, you know,
now thousands of patientsthat have been treated
with renal denervation.
And while it is important,obviously we need to share this
with our patients, it's, it'sreally almost a non-issue.
And I think the questionabout the kidney potential

(34:35):
influence on GFR is, I thinkis a, is important when I have,
I work in the nephrology department, all
of my patients ask me
after I bring up renal denervation is,
is this gonna harm my kidneys?
Which I should respond bysaying if I'm your nephrologist
or nephrology NP,
why would I recommend something
that's gonna hurt your kidneys?
But agreed, yes. So there is, you know,
a normal decline in GFR overtime in aging as we all know.

(34:58):
And so the studies have looked
and seen that there's beenno significant difference.
Interestingly, there wasactually a small study
that included about 30 patientsthat did actually indicate
that there may actually beimprovement in renal function
among those that were treated.
But this data is obviously small, but
nonetheless I thinkreassuring that we don't have
to about these complicationsin the patients.

(35:19):
So now I'd love to walk our listeners
through patient selection.
So when I think aboutwho's a typical patient
who has maybe seen in our clinic
or maybe seen as our listeners out there,
nurse practitioners andother clinicians, I try
and think of those withuncontrolled hypertension
and you, Maria, you'vealready talked about,

(35:41):
which was very helpful.
That really a broad FDAindication, that's those
that are uncontrolled,either they're controlled
with a high pill burden
or a high cardiovascular risk mortality,
but I'm thinking about it'snot the first time someone has
high blood pressure
or we're working 'em up forthat primary hypertension,

(36:03):
it's the patients withuncontrolled hypertension.
You also have to, if we thinkabout an algorithm of care,
rule out those that aredifficult to control,
which could be non-adherence
and secondary causes that wecan go through in a little bit.
But scenarios like Maria,
you've mentioned the FDAindication is broad, millions

(36:24):
of patients could theoretically qualify
and receive this therapy.
And if I had to put 'em really in three
or four buckets of who Ihave the top of the list
for patient selection,uncontrolled blood pressure,
despite guideline directedmedical therapy, those
with resistant hypertension
or two, this bucket of pillburden is just unacceptable.

(36:46):
Remember they have this condition
and potentially other comorbidities, those
with too many medication intolerances,
whether it's an allergy or an intolerance.
And then those who just don'twanna have so many pills
and seek an alternativeor an adjunctive therapy.
So Maria, is that sort of who you think
of this potential patient group?

(37:08):
I know you talked about inclusion criteria
for these studies, but
as this becomes morecommercially available,
what do you think about forpotential patient groups?
Yeah, no I agree. I thinkthat the groups
that you touched on are the ones
that immediately come to mind.
And I think the other one thatI do think about is patients
with high cardiovascular risk.
If patients aren't still to goal

(37:30):
but we know that they've hadhistories of heart attacks
or strokes, we may wannado even a better job
controlling their blood pressures.
And so I do think of patients
that have this highcardiovascular risk as,
as a potential other group to treat.
I agree with you that it's important
to rule out secondarycauses of hypertension.
And so when I approach patients

(37:50):
who I think might be a goodcandidate for renal denervation,
I do tend to bring it up even in the first
or second visit while we'reworking up these other secondary
causes trying to get theirblood pressures better managed.
As you know, I'm sure you getlots of referrals on patients
that aren't onguideline based therapy.
So we do try to adjusttheir medications, get them

(38:11):
to goal without needing anything else,
especially if they're not interested
initially in the procedure.
Once we kind of get through that, I like
to have had planted thisseed kind of early on
and so the patient knows
that there could be potential other
treatments going forward.
We see a lot of patients
and medications have theirown their own issues.
And I think it was a great pointearlier that, you know, I'm

(38:32):
so laser focused onhypertension, I know exactly
how many antihypertensivepatients are taking,
but they're also takingthree diabetic meds, meds
for hyperlipidemia, you know,all sorts of other things.
And so this is just really a small number
of the total number ofpills that they're taking.
So that's a good summary.
I like that view of givingthem the big picture early on

(38:54):
and I like that thought about you
and I see people, they come to us
because the bloodpressure is not controlled
or the traditional ways toget people to a controlled
or guideline directed thattarget blood pressure.
It's just not working.
So we're not seeing thegarden variety first
time they're diagnosed.
I like the idea, it makesme think back when I used

(39:15):
to work more with heart failure patients
that you get the big picture of
what the journey's gonna be like
and it may involve this or that.
So you plant the seed.
And so we've talked aboutapproaching a patient,
I really like that you do that.
Everything we've been talkingabout today has implied
or explicitly discussedshared decision-making.

(39:35):
Now we've talked aboutshared decision-making
and how important that is.
We haven't mentioned that italso needs to be evaluated
by those that do the procedure
to make sure the patient is suitable
and I'm not the one to look at
that anatomy or that sort of thing.
So this ensuring shareddecision-making in combination
with the physician assisted suitability

(39:57):
from the interventionist.
So I think we need to bring that up
but I, I get the impressionfrom what you've discussed
and from what's discussedin the literature,
that there's gonna be alot of people that qualify.
And if your patients are interested
and you think they'reappropriate, the workup
that I think about,
and we, we did a lot ofthis, our site did some
of these clinical trials too.

(40:17):
I was the clinician
and not necessarily theresearch coordinator
or the co-investigator,
but we first as standard practice,
what we do in our clinic isconfirm blood pressure outside
of that clinical setting.
Maria, you mentioned ambulatoryblood pressure monitoring,
but we also as standardpractice, you, you get something
beyond that clinic measurement

(40:38):
to rule out white coat hypertension
but also to rule out mask hypertension.
It may be higher outside
and also error so
that ambulatory blood pressure
monitoring is a good way to go.
Or even home blood pressure monitoring.
Just to confirm thatblood pressure reading.
We're gonna talk a little more later,
I think we have in our agenda

(40:58):
to talk about secondary causes,
but we do traditionally work up patients
for secondary causes.
What we've been talking aboutall along is also approaching
a patient setting the expectations of
how this is in the larger picture
that we now have differenttools in the toolkit
for our paradigm fortreating blood pressure.
This will involve a referralto an interventionist

(41:20):
or in the interim the clinical trials
that are doing these studies.
And traditionally I would think
that patient selection is performed
by at least two independent providers.
We have a cardiologist
and a nephrologist in our clinic,
so whether it's a nephrologist
or hypertensive specialist thatthey would talk about this.

(41:40):
And then the interventionistperforming the
renal denervation.
Now the hope is
that there might be otheron ramps in the future of
who could refer or whocould talk about it.
And that's why we're doing this podcast.
So we're all familiar with that
this could be part ofthe toolkit. In my mind,
I wanna think about what isthe nurse practitioner role,
how do we look atmultidisciplinary team care?

(42:03):
I've seen many expert consensus documents
or decision pathways from manysocieties around the world.
The European Society, those in Asia,
those in the United States
and all have inserted thisnew treatment paradigm
for treating hypertension.
They all make note ofconsistent safety and efficacy

(42:24):
and how I see the nurse practitioner role,
and I'm interested to hearwhat you say as well, Maria,
that we need to recognize thatrenal denervation is here,
it offers a new treatment paradigm
and in general, who are the patients
that we could do patientscreening when we think about it.
Given that this FDA indicationis broad, it's important

(42:46):
to make sure we'rechoosing the right patients
to even offer this treatment.
And I really like what yousaid about making it part
of the discussion early on.
We do know from researchstudies that sometimes providers
and clinicians think, oh,
only it's my worst uncontrolled patients
or those with the highest burden,
or those that I think might like it.

(43:08):
But if we really wannaoffer equitable care
and really have patient-centereddiscussions, we need
to think broadly about who could qualify.
And some recommendations talkabout considering all patients
that are going throughthese secondary workups
that are going through the reninaldosterone testing to look
for primary hyperaldosteronism,maybe those being evaluated

(43:32):
for renal artery stenosis.
If it's not there, couldthis be a treatment.
Or fibromuscular dysplasia, those
that are getting sleepstudies with hypertension,
uncontrolled hypertension.
So we're already lookingfor secondary causes
and we all know thatsecondary causes are about 5%
or less of those with hypertension.
So as you're thinkingabout secondary causes,

(43:54):
you also think broadly of
what else could a patientbe a candidate for?
We've mentioned that anurse practitioner role,
it's very important toconfirm these out of office
or out of clinic bloodpressure readings, either
through home blood pressure readings
or the 24 hour ambulatoryblood pressure monitoring.
We've talked at least severaltimes about the importance

(44:15):
of excluding thesesecondary hypertensions.
And we also, I think weare setting the stage today
that many nurse practitionersare in practice.
So it takes all of us asa multidisciplinary team
and referral patterns to just set up
that process in your own clinical site.
Patient education's veryimportant, facilitating

(44:37):
that patient and family
or caregiver discussionabout the procedural consent.
And I think setting theseexpectations, nurse practitioners
that very much a part of ourrole that it's not a cure
for hypertension.
You talked about the bell curve,
that 70% will have modestblood pressure reductions
and so far the evidenceshows that it continues

(44:59):
to improve over time,
but we cannot guarantee less medications.
Maria, I would like topitch it to you to say,
do you have any comments about the role
for nurse practitioners?
And maybe you also cantalk about the follow-up
after the procedure.
Can you talk about the NP role?
Yes, Leslie, I think
that nurse practitionersare uniquely skilled

(45:21):
and able to take thisrole during the RDN kind
of commercialization.
So you know, nurse practitionersare able to, you know,
make good connections with patients
and be able to kind ofexplain all of this kind
of background information, cometo a shared decision-making
with patients and thenalso really take over
in your facility to help kind

(45:43):
of run even hypertension programs
or renal denervation programs.
So I think to maybe to take a step back,
I think it's important that ifyou're gonna be adopting RDN
in your hospital facility, it'simportant to have some type
of program, right?
So either it can be a formal,
AHA certified program likeyou and I, you know, work.
But you know, there's also, you know,

(46:03):
you can also have informalhypertension centers
where you've identified a team
that has a specialinterest in hypertension.
This includes people from themedical assistants teaching
them how to check goodblood pressure readings
to the providers that aregonna be seeing them in clinic
to be able to rule outall the secondary causes,
to including theinterventional cardiologist.
And so, you know, again, I don't think it,

(46:24):
you need an AHA hypertensioncenter officially,
but there needs to be someformal kind of framework of
how these patients aregonna be seen and followed.
So again, whether a referral comes from
outside, I'm gonna see themin the nephrology department
and then refer to cardiology,
are they also gonna getfunneled to cardiology?
How is the follow-up gonna look like?
So I think that's also really important.

(46:45):
Are the patients gonnafollow with me in nephrology?
Are we gonna refer them backto their primary care doctors?
So I think, you know, everyone'ssituation can be different
and unique. At Penn particularly,
we've thought about this a lot
and we've kind of comeup with our own kind
of post procedure follow-up that's kind of mimicked
by the previous studies.
So our plan would be,

(47:05):
and at Penn in general,
most resistant hypertensionreferrals get routed to myself
or the providers
and physicians that seeresistant hypertension in the
nephrology department.
And then once we've completedthat secondary workup
and feel like this patientis a good candidate,
patient's agreeable, we actually refer them
for the procedure itself.
So they actually don'tmeet the procedure list

(47:26):
unless they prefer to.
We usually have them godirectly for the procedure
and then they do follow up with us
and we have an idea
that we're gonna followthem every few months, kind
of again, similar to whatthey were followed in
the clinical trial.
So maybe a month, 3, 6, 12 months
after the procedure to try to make sure
that we're getting really goodblood pressure measurements,

(47:46):
assessing medication reconciliation
and any symptoms post procedure.
The studies all looked at therenal arteries post procedure.
So we've also thought aboutincluding things like renal
dopplers or CTAs,
which obviously can be difficultfrom an insurance approval
perspective or cost perspective.
But thinking about includingthose post procedure,

(48:07):
we'll also collect data likeA BMP potentially thinking
about ambulatory bloodpressure cuff monitoring
and you know, staying incontact with patients.
So our, our plan would be to meet patients
and then come up with a regimen for them
to be checking their pressures at home
and then sending them back to us so
that we can follow them closely
and make med adjustments if necessary.

(48:28):
Again, I think reallyimportant to set expectations.
I like totell patients, you know,
you're not gonna talkto me two months after
and come off all of your medications,
but you know, over timepotentially we can reduce your,
your medications
or at least mostimportantly get you to goal
to reduce long-term cardiovascular risk.
Any other thoughts aboutfollow up from you, Leslie,

(48:48):
or any other things that youthink that would be important
for us to follow patients post procedure?
Well, the themes that I thinkabout when you were talking
about that, I see the NProle still as an advocate.
And if we're an advocate forour patients, we sometimes have
these one-on-onediscussions or, or with them

(49:08):
and their family or caregiver and,
and we really get toknow our patients and,
and even when we talkabout the limitations
or sort of the barriersthat get in the way
of blood pressure control.
So sometimes they're more open with us.
I don't have a randomizedcontrolled trial to say that,
but I, I know what partof our role is to advocate

(49:28):
that this would be a good candidate.
The other thing that I'm hearingis having a system in place
and it's not a one size fits all,
but it can be from low tech all the way up
to high tech if you were a site
that did the clinical trials.
I see this meeting with alot of DNP students lately
and coming up with practicechanges or implementation.

(49:49):
I see implementing a systematic way
for blood pressure just ingeneral for hypertension,
but also of how to the referralpattern and the follow up.
I love that, that you talked through that.
I love that hopefully some ofour listeners in primary care
or internal medicine, if they read
that their patient hasundergone this procedure

(50:10):
that we're hearing, it'sstill very important
to monitor the bloodpressure, to monitor the meds
and to see what's going on.
So I really like hearingthat we're all in it together
with the patient at the center.
So thank you very much. Maria.
You've mentioned a few times
and I've mentioned commercially available.
Can you talk about what is available now?

(50:32):
How does insurance
or other payors relate towhat's available now versus
what we hope to beavailable in the future?
Sure. I will start bysaying I'm no insurance expert
by any means, so I'll give you kind
of my general understandingof how things work
and, and where we are.
So currently at this point,
and again, this may be dateddepending on when this podcast

(50:53):
comes out, but there isno standard reimbursement
for renal denervation.
This is still being worked through.
So from my understanding, CMS
and you know, with insurancesare kind of working through
what are these CPT codes gonna be,
what's the reimbursement gonna be like?
And so it's not reallyavailable across the board.
That being said, there are institutions
that are attempting prior authorization

(51:15):
and getting these proceduresapproved kind of on a case
by case basis.
And again, from my understanding,
there's varying levels of success.
Some institutions are gettingapproval, I don't know
what the reimbursement is.
I know that some centersare essentially just paying
for the catheter, that'sthe, the cost, you know,
and then potentially billingfor say like a renal angiogram

(51:36):
and so not, you know,getting all of that kind
of reimbursement but getting some
reimbursement to do the procedure.
At Penn, what we're currentlydoing is when we get a
referral, again, I'm seeing them in clinic
or one of the hypertensiondocs I work with.
And then if they're interested,
we funnel them if possibleinto one of the studies
that we still have open,which is called AFFIRM.
It's a Medtronic study

(51:57):
and that's currently enrolling right now.
And so we do try to refer patients there.
It's a study that's not asham controlled study, it's,
you know, everyone gets treated.
It's really just to gather more data
and then if they're notinterested in being part
of the research protocol, wedo have a list that we're kind
of basically following patients
and so when we have moreinformation about the

(52:18):
reimbursement, you know, wecould reach back out to them
and kind of start treating themon a more commercial basis.
So yeah, just commercialmeaning not using the insurance
to get reimbursement for, Leslie,
I'm just curious, any otherquestions about the insurance
approvals or anything thatyou've heard from patients
that you'd like me to try to clarify?
Well, we did have one patient a year

(52:38):
or so ago that had this in another country
and so we were all curious.
This was a year or two ago,
so I was very interested in that.
And then some patients,
it reminds me again back inthe day when I was doing heart
failure halftime, that wouldbring in a newspaper article.
That's how long ago it was
where they would read about this new procedure
and how they can get it.
In this day and age, some

(52:59):
of our patients are reading about it
because of what's online or
however they get their news sources
and they talk to us about,and we too are keeping a list
and we get calls even Iknow our interventionists
and our hypertensivespecialists, cardiologists
and nephrologists we'reworking through the process of
how our system will be.

(53:21):
And so I think this is veryhelpful that at the timing
of this exact podcastrecording things are changing.
It's not quite a year since FDA approval,
but you get FDA approval first
and then you move intohow the payors, similar to
how we've done other patientsin the cardiology space
with defibrillatorsand that sort of thing.

(53:41):
So I think it's, it's very helpful.
What I would love to know topitch it back to you, Maria,
as we think about, as we'recoming to a close here,
you know, any futurethoughts or expectations.
So I think renal denervationreally presents an exciting
approach for hypertension management.
Most adults in Americahave high blood pressure,

(54:03):
almost half, most ofthem are uncontrolled.
And so renal denervationreally has the potential
to revolutionize one of theworld's most prevalent problems.
And I think it's proven to be safe,
efficacious, and durable.
And I think it's really promising
to see the data that we reviewed.
And I think despite all theexcitement, it is important

(54:24):
to recognize that the reductionin blood pressure may be
modest in some patients andsome patients may not respond.
But that it is imperativefor us as nurse practitioners
to have patients developrealistic expectations
and for us to engage in ashared decision-making model
with patients and, you know,
ongoing patient follow up isreally important in this group

(54:45):
and hopefully we'll beable to gather, you know,
some real world data on patients
that get treated in the future to be able
to learn even more.
What about you, Leslie, aswe're kind of wrapping up here,
any thoughts or, or otherkind of conclusions?
Well, one thing I know, and you know,
and I'm sure many of ourlisteners know that hypertension,

(55:07):
especially uncontrolledhigh blood pressure
or hypertension, is sortof the common denominator
for many other cardiovascular conditions.
Angina, myocardial infarction,heart failure, stroke, PAD
that we, you had talked about,
high risk cardiovascularoutcomes, poor outcomes.
So if we can crack that nut,maybe we can prevent some

(55:28):
of these other bad outcomes.
And I also, as we look to the future,
if we can be the voice,the nurse practitioners,
this commercially availabletreatment in the future,
I sure hope that there'sequity in the approach
that we not further havehealth disparities of those
that have and have not.

(55:49):
So let's consider not justthose with severe cases
or those who we think have resources
that would consider thisalternative quote unquote approach.
Let's think of this as adjunctiveto our current treatment
or as a different option.
Let's just think of who could qualify,
have the shared decision-making.

(56:09):
So in a health equitylens, I just certainly hope
that we can look towardsoffering this to any patient
that would qualify that's interested.
So that's, that's sortof my parting thought.
Just, you know, peace for the world
and offer it to everybody that qualifies.
I want to conclude also thatthis has been wonderful.
I've learned from you, I hopeour listeners have learned

(56:32):
from this podcast.
I once again wanna thank the AANP
for inviting both of us
to participate in this podcast.
I wanna thank our sponsor Medtronic.
Otherwise this podcast wouldnot be available through AANP
and I just hope everybody has a good day
and just walks out therewith this information
to improve clinicaloutcomes in our patients.

(56:55):
Thank you for an amazing podcast,Leslie and Maria.
It's been an absolute pleasure listeningto you and gaining your perspectives
and insights on this exciting updateon renal denervation.
Remember that you may claim CE creditfor this program through September 2025
by logging in to the CE centerat aanp.org/cecenter.

(57:16):
Register for this programand enter RENAL24 in the code prompt,
and then complete the post-test and evaluation.
Thank you for listening.
And as always,be kind, be safe, be effective,
and be the voiceof the nurse practitioner.