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Bridging the Gap: Equity and Access in Cardiac Transplantation

May 06, 2026
ID
14184

Transcript

  • 04:07Got, like, twenty people on
  • 04:09there.
  • 05:38Okay.
  • 05:40Good afternoon, everyone.
  • 05:44I'm here to introduce,
  • 05:46doctor Michael Furey, who will
  • 05:48be,
  • 05:49giving our Yale Cardiovascular Medicine
  • 05:52Grand Rounds.
  • 05:53He's one of our,
  • 05:55excellent
  • 05:56graduating fellows.
  • 05:58So Mike graduated from Georgetown
  • 06:00University School of Medicine,
  • 06:02and was fortunately recruited up
  • 06:04here in New Haven
  • 06:06to do his internal medicine
  • 06:07residency with the Yale internal
  • 06:09medicine residency program,
  • 06:11where he was recognized early
  • 06:13and often for
  • 06:14both his clinical excellence and
  • 06:16and research excellence.
  • 06:18He received the doctor Peggy
  • 06:19Bea Award for outstanding clinical
  • 06:21teacher.
  • 06:22And after completing his internal
  • 06:24medicine residency here, went on
  • 06:25to do a chief residency.
  • 06:27And we were fortunate enough
  • 06:29to recruit him here for
  • 06:30our cardiology fellowship,
  • 06:32where I've had the opportunity
  • 06:33to really work closely with
  • 06:34Mike. He's worked with a
  • 06:35number of our other colleagues
  • 06:36as well.
  • 06:38He has, an impressive publication
  • 06:40record that includes,
  • 06:42publications in journals such as
  • 06:43Jack Heart Failure and the
  • 06:45European Heart Journal.
  • 06:46And his focus, in terms
  • 06:48of research has been on
  • 06:50how to use the electronic
  • 06:52health record, as well as
  • 06:53implementation science to improve heart
  • 06:55failure care, risk prediction, and
  • 06:57policy for cardiac transplantation.
  • 07:00I personally had the pleasure
  • 07:02of watching Mike grow over
  • 07:03his time during fellowship
  • 07:05here,
  • 07:08and, he's really become and
  • 07:10blossomed into a truly excellent
  • 07:12clinician educator.
  • 07:14We've worked together both in
  • 07:15the CICU and,
  • 07:17at the bedside in the
  • 07:18clinic. And, I can say
  • 07:20that,
  • 07:21Mike really is a truly
  • 07:23compassionate
  • 07:23physician who provides really the
  • 07:25highest quality of care to
  • 07:26his patients.
  • 07:28So I'm looking forward to
  • 07:29your talk today, Mike, as
  • 07:30well as to, see where
  • 07:31your career in cardiology takes
  • 07:32you.
  • 07:41Thank you so much, doctor
  • 07:42Sikand, and for everyone in
  • 07:44the department for,
  • 07:46inviting me to,
  • 07:48present at this week's grand
  • 07:49rounds.
  • 07:50My talk is titled bridging
  • 07:52the gap,
  • 07:53equity and access in cardiac
  • 07:55transplantation.
  • 07:57I don't have any disclosures
  • 07:59to report.
  • 08:00So for this talk, I'd
  • 08:02like to achieve a few
  • 08:03different learning objectives.
  • 08:05First, I wanna help you
  • 08:07understand
  • 08:08our organ allocation system here
  • 08:10in the United States and
  • 08:11how it, has changed clinical
  • 08:13practice after they made a
  • 08:15revision to their policies back
  • 08:17in two thousand eighteen.
  • 08:20And second,
  • 08:21I wanna show you,
  • 08:23a variety of factors that
  • 08:24can contribute to a concept
  • 08:26known as center level variation
  • 08:28and how that can, impact
  • 08:30a patient's,
  • 08:32overall likelihood of getting a
  • 08:33transplant.
  • 08:36So to start, I'd like
  • 08:37to present a case. This
  • 08:38is a fifty two year
  • 08:39old who has a history
  • 08:40of nonischemic cardiomyopathy
  • 08:43with reduced, left ventricular ejection
  • 08:45fraction,
  • 08:46and he comes to the
  • 08:47hospital with progressive shortness of
  • 08:49breath and fatigue.
  • 08:51He's hypotensive,
  • 08:53tachycardic,
  • 08:54tachypneic,
  • 08:54and hypoxic re requiring
  • 08:57non rebreather,
  • 08:58support.
  • 09:00He overall appears unwell.
  • 09:02He's diaphoretic
  • 09:03with an elevated JVP,
  • 09:05cool extremities, and bilateral
  • 09:07crackles.
  • 09:10His labs are suggested of
  • 09:11decreased end organ perfusion,
  • 09:12and, ECHO once again shows,
  • 09:15severe global hypokinesis.
  • 09:17He's admitted to the cardiac
  • 09:19intensive care unit where he
  • 09:20started on inotropes,
  • 09:23and,
  • 09:24becomes
  • 09:25slightly more hypotensive
  • 09:27and has slight worsening of
  • 09:28his end organ perfusion.
  • 09:30He undergoes a right heart
  • 09:31cath that shows a reduced
  • 09:32cardiac index with elevated filling
  • 09:35pressures.
  • 09:36Given these findings,
  • 09:38the decision is made to
  • 09:39start him on mechanical circulatory
  • 09:42support, specifically with an Impella
  • 09:44device.
  • 09:45And the patient is listed
  • 09:46for, cardiac transplantation
  • 09:49at status two level.
  • 09:51He remains
  • 09:53on inotropes
  • 09:54and, Impella support,
  • 09:56for over two weeks where
  • 09:58his transplant team submits,
  • 10:00an exception for him to
  • 10:02remain at that status.
  • 10:04A few more weeks go
  • 10:05by,
  • 10:07and he ultimately receives a
  • 10:08donor organ offer coming from
  • 10:11around two hundred fifty miles
  • 10:13away
  • 10:14from New Haven, comes from
  • 10:16a hepatitis c positive donor
  • 10:18that was,
  • 10:20declined by several other transplant
  • 10:22centers in the region.
  • 10:24And he ultimately undergoes
  • 10:26successful heart transplant
  • 10:28and does well,
  • 10:29in the postoperative
  • 10:31course.
  • 10:32So I wanna use this
  • 10:33case to highlight a few,
  • 10:36important factors
  • 10:37about,
  • 10:38how variable the cardiac transplant
  • 10:40process can be.
  • 10:43And to do that, I
  • 10:44wanna first explore
  • 10:46a few of the different
  • 10:47components
  • 10:47of the process,
  • 10:49the different agencies are involved,
  • 10:51and how,
  • 10:52they have evolved over time.
  • 10:55So the United Network for
  • 10:56Organ Sharing also goes by
  • 10:58UNOS.
  • 10:59It's a nonprofit,
  • 11:01organization that helps to oversee,
  • 11:03solid organ transplant in the
  • 11:05United States.
  • 11:06And before it was created,
  • 11:08from the mid nineteen fifties
  • 11:10to the early nineteen seventies,
  • 11:13the individual transplant hospitals
  • 11:15and organ procurement organizations
  • 11:18would manage all aspects of
  • 11:19the organ recovery
  • 11:21and transplant.
  • 11:22So if an organ was
  • 11:24found, it could not be
  • 11:26used at a local hospital
  • 11:27to the donor. There wasn't
  • 11:29really a system,
  • 11:30that would
  • 11:31allow anyone to find a
  • 11:33matching candidate,
  • 11:35elsewhere.
  • 11:35So many of the organs
  • 11:36ultimately could not be used
  • 11:38because they couldn't find a
  • 11:40compatible
  • 11:41recipient in time.
  • 11:43And that changed in nineteen
  • 11:45seventy seven
  • 11:46when, the first computer based
  • 11:48organ sys matching system called
  • 11:50UNOS was developed,
  • 11:52and then congress,
  • 11:53in nineteen eighty four passed
  • 11:55the National Organ Transplant Act,
  • 11:57which established a framework for
  • 11:59a national organ recovery and
  • 12:01allocation system. And the goal
  • 12:03was to help ensure
  • 12:05that, the process was carried
  • 12:07out in a fair and
  • 12:08efficient way
  • 12:10and led to equitable distribution
  • 12:12of donated organs based on
  • 12:13medical criteria.
  • 12:16Later in nineteen eighty six,
  • 12:18UNOS became
  • 12:20under federal contract
  • 12:21to operate both, the organ
  • 12:23procurement and transplantation network, OPTN,
  • 12:26and the scientific registry of
  • 12:28transplant recipients.
  • 12:30And UNOS works by ranking
  • 12:32transplant candidates according to their
  • 12:35medical urgency.
  • 12:36It started as a two
  • 12:37tier system,
  • 12:39later developed into a three
  • 12:41tier system,
  • 12:42most recently was changed to
  • 12:44a six tier system in
  • 12:45two thousand eighteen.
  • 12:47And UNOS created,
  • 12:49different regions across the the
  • 12:51United States based on, patient
  • 12:54referral patterns and organ sharing
  • 12:56patterns.
  • 12:57The state of Connecticut, it's
  • 12:59located in region one,
  • 13:01with the other New England
  • 13:02states like Massachusetts,
  • 13:04Rhode Island, New Hampshire, Maine,
  • 13:06and part of, Vermont.
  • 13:09So how does the system
  • 13:11work? Well, once again,
  • 13:13UNOS ranks
  • 13:14transplant candidates by their medical
  • 13:16urgency
  • 13:17and aims to match them,
  • 13:20by other medical factors like
  • 13:21blood type, height, weight with,
  • 13:24donor organs that become available.
  • 13:27And then each donor organ
  • 13:28has a rank order match
  • 13:30list that's offered to
  • 13:32prospective transplant candidates at centers
  • 13:35across, the country.
  • 13:37Generally prioritizes
  • 13:38local candidates,
  • 13:40and once an offer is
  • 13:42made, each transplant center has,
  • 13:44the ability to accept or
  • 13:46reject that offer at their
  • 13:48own discretion.
  • 13:50In two thousand and eighteen,
  • 13:52UNOS implemented
  • 13:54this new six tier
  • 13:56allocation policy that replaced the
  • 13:58old three tier system.
  • 14:00And this was done to
  • 14:01better stratify,
  • 14:03transplant candidates,
  • 14:05by their
  • 14:06mortality on the wait list,
  • 14:08helped to shorten,
  • 14:09wait list times for the
  • 14:11sickest patients,
  • 14:12tried to add objective criteria
  • 14:14for a variety of, cardiac
  • 14:16conditions,
  • 14:18and then it further broadened,
  • 14:20sharing of, donor organs
  • 14:22to a geographic
  • 14:23radius of, five hundred miles.
  • 14:26Now status, one patients are
  • 14:29considered the highest medical priority,
  • 14:31while statuses two through six
  • 14:33are considered
  • 14:34lower medical priority,
  • 14:36in descending order. So if
  • 14:38a patient is, placed on
  • 14:40ECMO
  • 14:41or, has a mechanical circulatory
  • 14:44support device
  • 14:45and has a significant arrhythmia,
  • 14:47they are considered the highest
  • 14:49priority listing.
  • 14:51Without arrhythmia, m c MCS
  • 14:53devices
  • 14:54can achieve a status two
  • 14:56listing.
  • 14:57Notably,
  • 14:58patients with durable LVADs
  • 15:01were now status three,
  • 15:03under the new system and
  • 15:05previously had a higher designation
  • 15:07in the older system.
  • 15:09Similarly, patients on IV inotropes
  • 15:12were, previously considered,
  • 15:15high medical urgency under the
  • 15:17old system
  • 15:18have, gone down to,
  • 15:20status three or four in
  • 15:22the new system.
  • 15:24And it's important to note
  • 15:25that listing a patient,
  • 15:28requires that our great transplant
  • 15:30teams,
  • 15:31rejustify
  • 15:33the patient's listing every two
  • 15:34weeks.
  • 15:35So they need to redemonstrate,
  • 15:37every two weeks that the
  • 15:39patient requires
  • 15:40an MCS device, inotropes,
  • 15:43whatever their, level of support
  • 15:45is, and that they're not,
  • 15:46able to receive,
  • 15:48an LVAD. And that's because
  • 15:51the two long term treatment
  • 15:52options we have for,
  • 15:54end stage heart failure are
  • 15:56heart transplant
  • 15:57and, durable LVAD.
  • 16:01So,
  • 16:02this two thousand eighteen
  • 16:04policy change had a very
  • 16:06significant impact
  • 16:07on,
  • 16:08clinical practice patterns, which I'll
  • 16:12explore,
  • 16:13in detail through the rest
  • 16:14of the talk.
  • 16:16This was a study that
  • 16:17was led by doctor Clancy
  • 16:19Mullen here,
  • 16:20of cardiac surgery as well
  • 16:22as doctor Ahmad in in
  • 16:23his heart failure outcomes research
  • 16:25group.
  • 16:26And,
  • 16:27it showed that pretty early
  • 16:29on, even after this,
  • 16:31policy change, that the use
  • 16:33of durable LVADs,
  • 16:35declined pretty substantially.
  • 16:37And you might infer based
  • 16:38on what I I showed
  • 16:40you a few slides ago
  • 16:41that this might be because
  • 16:43of
  • 16:44a changing
  • 16:45MCS support strategy
  • 16:47that prioritizes
  • 16:49patients who have temporary,
  • 16:52MCS devices,
  • 16:54who get higher priority status
  • 16:55in the new system compared
  • 16:57with,
  • 16:58durable LVAD devices, which were,
  • 17:02a lower priority in the
  • 17:03the organ allocation system.
  • 17:06And this has been supported
  • 17:08by a few other studies
  • 17:09that found that balloon pump
  • 17:11use as well as ECMO
  • 17:13use have increased,
  • 17:15since,
  • 17:16the policy change, which, those
  • 17:18two, as I mentioned,
  • 17:20now have higher priority status
  • 17:22under the new system.
  • 17:25So with all these,
  • 17:27potential changes in clinical behavior,
  • 17:30it, you know, raised questions
  • 17:31in my mind how much,
  • 17:33subjectivity
  • 17:35there ultimately is in this,
  • 17:37cardiac transplant
  • 17:38process.
  • 17:39We have all of these
  • 17:41objective criteria that I showed
  • 17:43you in the the different
  • 17:44tiers,
  • 17:45but, you know, there seems
  • 17:46to be some sort of
  • 17:47inherent subjectivity,
  • 17:50that ultimately,
  • 17:51in my view, has a
  • 17:52tangible impact on, equitable
  • 17:55organ allocation.
  • 17:59And the primary drivers of
  • 18:01this subjectivity,
  • 18:03are factors that contribute to
  • 18:05something called center level variation.
  • 18:10There are four main, components
  • 18:12to this,
  • 18:13that I'll I'll go through
  • 18:14one by one.
  • 18:16Bridging strategy,
  • 18:17listing practices,
  • 18:19exception,
  • 18:21utilization,
  • 18:22and donor organ acceptance.
  • 18:26So starting with, bridging strategy,
  • 18:29I started talking about how
  • 18:30there has been, some changes
  • 18:32to how we use MCS
  • 18:34devices since two thousand eighteen.
  • 18:36And this has been, borne
  • 18:38out both in national trends
  • 18:40as well as,
  • 18:42differences between individual
  • 18:44transplant centers.
  • 18:45Balloon pumps ultimately remain the
  • 18:47most common bridging strategy
  • 18:49followed by Impella devices and
  • 18:52then ECMO.
  • 18:53ECMO,
  • 18:55gives patients the highest likelihood
  • 18:56of transplant,
  • 18:57but it also carries the
  • 18:59highest mortality,
  • 19:01rate on the wait list.
  • 19:02But there are also other,
  • 19:04device related complications
  • 19:06that, patients may incur while
  • 19:08awaiting transplant even if they're
  • 19:10relatively,
  • 19:11stable on the wait list.
  • 19:14Bottom line is that,
  • 19:16the choice of the bridging
  • 19:17strategy
  • 19:18is not just a choice
  • 19:20about how we're treating the
  • 19:21patient, but also impacts
  • 19:23how likely it is for
  • 19:24them to ultimately get a
  • 19:26transplant.
  • 19:28So this is some data
  • 19:29from a twenty twenty two
  • 19:31study. It showed that balloon
  • 19:33pump and ECMO utilization
  • 19:35have, increased significantly since two
  • 19:37thousand eighteen,
  • 19:39whereas the use of durable
  • 19:41LVADs has decreased.
  • 19:44And the same study took,
  • 19:46their findings a little bit
  • 19:47further.
  • 19:49They looked at variation
  • 19:51between centers and how they
  • 19:52use mechanical
  • 19:54circulatory support.
  • 19:57Each bar in this graph
  • 19:59reference represents an individual transplant
  • 20:01center,
  • 20:03and how it's been using,
  • 20:05MCS.
  • 20:06And you can see that,
  • 20:08while some centers have a
  • 20:09relatively
  • 20:10low,
  • 20:11proportion
  • 20:12towards the left side of
  • 20:13the graph,
  • 20:14others are nearly using,
  • 20:16mechanical circulatory support a hundred
  • 20:18percent of the time,
  • 20:20for their patients that get
  • 20:22transplanted.
  • 20:23The authors also found that,
  • 20:26the number,
  • 20:27the the,
  • 20:29the,
  • 20:30the use of MCS was
  • 20:32associated with,
  • 20:33overall number of transplants
  • 20:35performed,
  • 20:37at that center,
  • 20:38which,
  • 20:39suggested that,
  • 20:41you know, we're making changes
  • 20:43in our clinical
  • 20:44decision making,
  • 20:46as to the support that
  • 20:47we're using,
  • 20:48rather than changes in,
  • 20:50patient demographics or patient,
  • 20:53acuity.
  • 20:54And, ultimately, this can have,
  • 20:56an impact on equitable access
  • 20:58to transplant for some patients.
  • 21:02So now,
  • 21:03I'd like to talk about
  • 21:04listing behavior and how that
  • 21:05can also be,
  • 21:07a major,
  • 21:08determinant of a patient's access
  • 21:10to transplant.
  • 21:11So many different transplant centers
  • 21:13have,
  • 21:14varying thresholds
  • 21:16for,
  • 21:17you know, listing patients,
  • 21:19whether they're listing them very
  • 21:20early on while they're relatively
  • 21:22stable
  • 21:23or, when they've progressed to
  • 21:25a more acute status.
  • 21:29They also need to make
  • 21:30decisions
  • 21:31about, you know, using inotropes,
  • 21:33MCS, or ECMO.
  • 21:35And since two thousand eighteen,
  • 21:37it's been observed that higher
  • 21:39priority listings have increased
  • 21:41despite,
  • 21:42you know, the clinical status
  • 21:44of patients remaining relatively stable.
  • 21:49Another facet that's, important to
  • 21:51mention
  • 21:52is that each center has
  • 21:53its own policies
  • 21:55for even listing patients for
  • 21:57transplant.
  • 21:59They might only
  • 22:00opt to list candidates who
  • 22:02are younger than a certain
  • 22:03age cutoff
  • 22:04or have varying leniency,
  • 22:07in their,
  • 22:08practice to list the patient
  • 22:10of a certain BMI,
  • 22:12who have
  • 22:13a history of substance use,
  • 22:15some up suboptimal
  • 22:16social support
  • 22:18or,
  • 22:19others,
  • 22:20psychosocial
  • 22:21issues.
  • 22:23So this graph,
  • 22:25depicts individual
  • 22:27transplant centers each represented by,
  • 22:30a dot,
  • 22:32and their probability of listing
  • 22:33patients
  • 22:34as a high priority, either
  • 22:36status one or two,
  • 22:38in the new allocation system.
  • 22:40Those are, highlighted in, the
  • 22:42red,
  • 22:44dots with with bars, and
  • 22:46the pre,
  • 22:47two thousand eighteen data is
  • 22:49listed in the blue.
  • 22:52So overall, it shows that
  • 22:53the policy change
  • 22:55since, two thousand eighteen,
  • 22:57nearly ninety five percent of
  • 22:58centers list patients
  • 23:01list more patients at a
  • 23:02high priority status compared to
  • 23:04their practices before the policy
  • 23:07change.
  • 23:08It also shows that there's,
  • 23:10once again, significant variation between
  • 23:12the centers enlisting their patients
  • 23:15as high priority status even
  • 23:17when they controlled for their
  • 23:19individual medical factors.
  • 23:21So overall,
  • 23:23this highlights that some centers
  • 23:25are more likely to list
  • 23:26patients as a higher priority,
  • 23:28compared to others.
  • 23:31So, when I was a
  • 23:32resident, I did,
  • 23:34a research project
  • 23:36where we looked at, what
  • 23:37happens for patients since the
  • 23:39two thousand eighteen allocations is
  • 23:41some change who are considered
  • 23:43low urgency.
  • 23:44I thought the findings were,
  • 23:46interesting.
  • 23:48You know, I I we
  • 23:49looked at both pre and
  • 23:50post,
  • 23:52two thousand eighteen, but, you
  • 23:53know, since that change,
  • 23:55you know, obviously, the number
  • 23:57of patients transplanted at a
  • 23:58lower
  • 23:59urgency
  • 24:00is much lower than
  • 24:02those, transplanted at a higher
  • 24:04urgency.
  • 24:05But those who were considered
  • 24:07low urgency,
  • 24:09were usually older
  • 24:11and received,
  • 24:12donor,
  • 24:13organs from,
  • 24:15donors that were considered higher
  • 24:17risk either with, you know,
  • 24:18hepatitis c, diabetes,
  • 24:21or,
  • 24:22older age. And we'll discuss
  • 24:23some of those factors in
  • 24:25the coming slides. But I
  • 24:26also found,
  • 24:28you know, not surprisingly,
  • 24:30they had longer wait list
  • 24:32times than the higher urgency
  • 24:33candidates.
  • 24:36But, ultimately,
  • 24:38their outcomes remained,
  • 24:39pretty similar to,
  • 24:41those who were of the
  • 24:43higher, urgency.
  • 24:44So there's a bit of
  • 24:45a trade off.
  • 24:47You know, the high urgency
  • 24:48patients are sicker.
  • 24:50They receive hearts faster. They're
  • 24:52typically getting the the,
  • 24:55you know,
  • 24:56parts that are of optimal
  • 24:58quality
  • 24:59compared to the lower urgency
  • 25:01candidates who are a bit
  • 25:02more stable. However, the lower
  • 25:04urgency candidates,
  • 25:06ultimately have similar outcomes.
  • 25:08And, this may be informative,
  • 25:11to transplant centers as they,
  • 25:13you know, consider risk benefits
  • 25:15and,
  • 25:16preferences with their patients in,
  • 25:19making decisions about this.
  • 25:22Another,
  • 25:23contributor to center level variation
  • 25:26is,
  • 25:27the concept of exceptions.
  • 25:29So,
  • 25:29an exception's a request that
  • 25:32is submitted by the transplant
  • 25:34team,
  • 25:36that,
  • 25:37justifies
  • 25:38their current
  • 25:40listing in the allocation system.
  • 25:44It has to be done
  • 25:45every fourteen days as I
  • 25:46mentioned.
  • 25:47And it may be just
  • 25:48because,
  • 25:50the patient is not a
  • 25:51candidate for,
  • 25:53a therapy that would confer
  • 25:55them a higher status,
  • 25:57or it could be,
  • 25:59more of a administrative,
  • 26:02challenge and that their blood
  • 26:04pressure is not their systolic
  • 26:05blood pressure is not is
  • 26:07ninety two instead of, below
  • 26:09ninety,
  • 26:10which,
  • 26:11you know, may or may
  • 26:12not be clinically consequential
  • 26:14if they're on multiple forms
  • 26:16of,
  • 26:17cardiac support.
  • 26:19And I think exceptions were
  • 26:21interesting to bring up because
  • 26:23there's great variability in,
  • 26:25centers,
  • 26:27willingness
  • 26:28or practice patterns to submit
  • 26:30them, but also because there's
  • 26:33some data that
  • 26:34suggests,
  • 26:35patients,
  • 26:36who had a re
  • 26:38exception request submitted
  • 26:39were twenty five percent,
  • 26:41more likely to get a
  • 26:43transplant compared to those listed
  • 26:45according to
  • 26:47standard criteria.
  • 26:48So this can have,
  • 26:50a tangible impact on,
  • 26:52access to transplant for patients.
  • 26:56So this is just some
  • 26:57data about how exceptions have
  • 27:00been,
  • 27:00used
  • 27:01both before and after two
  • 27:03thousand eighteen.
  • 27:06And,
  • 27:07you know, focusing primarily on
  • 27:09the bottom set of graphs,
  • 27:10which is post post two
  • 27:12thousand eighteen,
  • 27:13it showed that
  • 27:14overall some there was increased
  • 27:16use of exceptions
  • 27:18and that,
  • 27:19they were primarily used for
  • 27:21patients,
  • 27:22in status one, two, and
  • 27:24four. Their,
  • 27:26their utilization increased substantially.
  • 27:30And this is from a
  • 27:31separate study that looked at
  • 27:32both geographic
  • 27:34patterns of exception use as
  • 27:36well as,
  • 27:37individual transplant center use of
  • 27:39exceptions.
  • 27:40So looking at the geography
  • 27:42first on the left,
  • 27:45exceptions were more commonly used
  • 27:46in regions three and four,
  • 27:48which represent the southwestern
  • 27:51US,
  • 27:51while,
  • 27:53you know, other regions like
  • 27:55five, six in the western
  • 27:56US and parts of, the
  • 27:57Midwest were less likely to
  • 28:00submit,
  • 28:01exception requests.
  • 28:02And the authors of this
  • 28:03study
  • 28:04mentioned that this could be
  • 28:05because,
  • 28:08there are longer wait list
  • 28:09times for,
  • 28:10patients in,
  • 28:12the reg regions where
  • 28:15exception utilization was high.
  • 28:18The figure on the right
  • 28:19is interesting because it looks
  • 28:20at individual transplant centers and
  • 28:23how they vary in exception
  • 28:24utilization.
  • 28:26So So you can see
  • 28:27that,
  • 28:28the the size of the
  • 28:29circles
  • 28:30represents,
  • 28:31you know, the number of
  • 28:33transplants, that are performed at
  • 28:34that center.
  • 28:36And, it's once again stratified
  • 28:38by
  • 28:39region.
  • 28:40So there are some high
  • 28:42volume centers,
  • 28:44that use transplant or,
  • 28:46exceptions quite frequently.
  • 28:48There are other high volume
  • 28:50centers
  • 28:51even in the same region
  • 28:52that,
  • 28:54you know, use,
  • 28:56exception requests much less frequently.
  • 28:58So it's sort of,
  • 29:00across the board, a great
  • 29:02deal of variation
  • 29:03in how they're being applied.
  • 29:06And finally, this is just
  • 29:08a quick graph showing,
  • 29:10you know, once again, as
  • 29:12I mentioned that, patients who
  • 29:14had exceptions submitted on their
  • 29:15behalf,
  • 29:16had a higher likelihood
  • 29:18of, getting a transplant even
  • 29:21after adjusting for,
  • 29:23variety of medical factors.
  • 29:28Moving on, I wanna talk
  • 29:29about how centers differ in
  • 29:32their,
  • 29:32donor organ acceptance.
  • 29:35There are some centers that
  • 29:36might be more likely to
  • 29:38accept donors,
  • 29:40accept organs from donors that
  • 29:43are older than forty years
  • 29:45of age or so or
  • 29:46that are hepatitis
  • 29:47c
  • 29:49positive
  • 29:49or that come from a
  • 29:51longer distance from the transplant
  • 29:53center, typically around five hundred
  • 29:56miles.
  • 29:57Or,
  • 29:58there are, different
  • 30:01practices as to,
  • 30:03accepting organs that have been
  • 30:04rejected by,
  • 30:06many other transplant centers, which
  • 30:08is a metric known as
  • 30:10the, donor sequence number.
  • 30:13Another metric is the acceptance
  • 30:16ratio,
  • 30:17which compares how likely a
  • 30:19transplant center is,
  • 30:21to accept an organ,
  • 30:24with a national average.
  • 30:26And, these metrics are actually
  • 30:28available online for both, patients
  • 30:31to
  • 30:32review if if they're so
  • 30:34inclined or even clinicians,
  • 30:36to be able to compare
  • 30:37their, program to others in
  • 30:39the region.
  • 30:41And, you know, this data
  • 30:42is pretty interesting because it
  • 30:44can show that some centers
  • 30:46are maybe even three or
  • 30:47four times more likely,
  • 30:50than, you know, an average
  • 30:52center to accept organs that
  • 30:54might be considered higher risk,
  • 30:57by a variety of metrics
  • 30:58compared to the national average.
  • 31:02The implication
  • 31:03of all of this is
  • 31:04that,
  • 31:06you know, one patient might
  • 31:07have
  • 31:08different access to different donor
  • 31:10pools,
  • 31:11depending on the transplant center
  • 31:14they go to or the
  • 31:15area that they live.
  • 31:18So this was a nice
  • 31:19figure that demonstrates,
  • 31:21their,
  • 31:23different centers with,
  • 31:25different acceptance rates of donor
  • 31:27organs,
  • 31:29based on their
  • 31:30geography
  • 31:31in, the UNOS region.
  • 31:34You can see,
  • 31:35you know, some of these
  • 31:37centers have very high acceptance
  • 31:39rates
  • 31:41and,
  • 31:42receive a lot of first
  • 31:43offer,
  • 31:45organs from the procurement networks.
  • 31:48Others have
  • 31:49high first offer rates, but,
  • 31:52low overall acceptance rates. And
  • 31:54the converse is also true
  • 31:56for
  • 31:56centers that,
  • 31:58you know, have a low
  • 31:59acceptance rate and don't receive,
  • 32:02many offers.
  • 32:04There's been additional,
  • 32:06supporting data
  • 32:08that,
  • 32:09you know, transplant centers that
  • 32:10have a higher acceptance rates
  • 32:12had lower rates of wait
  • 32:13list mortality overall and a
  • 32:16higher incidence
  • 32:17of, transplant at one year,
  • 32:19which I think makes intuitive
  • 32:21sense if they have a
  • 32:23larger donor pool that's,
  • 32:26available.
  • 32:27But, there's been a lot
  • 32:28of concern raised,
  • 32:30in the transplant
  • 32:32community
  • 32:33about, you know, how outcomes
  • 32:34might be,
  • 32:35impacted if these, quote, unquote,
  • 32:38lower quality,
  • 32:39organs
  • 32:40are used.
  • 32:41So I wanted to explore
  • 32:43that a little bit more.
  • 32:45I mentioned the donor sequence
  • 32:47number
  • 32:48is,
  • 32:49the number of times that
  • 32:51a a potential organ has
  • 32:52been
  • 32:53offered and then rejected by
  • 32:56a transplant center. And typically,
  • 32:58around fifty times is considered,
  • 33:02you know, a high donor
  • 33:03sequence number.
  • 33:05So this was a study
  • 33:06that looked at the outcomes
  • 33:08of patients who got a
  • 33:09transplant
  • 33:10with an organ that had
  • 33:11a high
  • 33:12donor sequence number compared to
  • 33:14low donor sequence number. And
  • 33:16it ultimately found that, you
  • 33:18know, the outcomes were pretty
  • 33:19similar,
  • 33:22three years after transplant.
  • 33:25It also looked at reasons
  • 33:27for why or factors associated
  • 33:29with,
  • 33:30why an organ might have
  • 33:31a high donor sequence number.
  • 33:33And they tended to be
  • 33:34from donors of older age
  • 33:36who had hypertension, diabetes,
  • 33:39a re a lower ejection
  • 33:40fraction,
  • 33:41or were hepatitis c positive.
  • 33:47On the,
  • 33:48the the point of hepatitis
  • 33:50c donors,
  • 33:52it's kind of striking that,
  • 33:53you know, since as of
  • 33:55the last, data I found
  • 33:56on this back in twenty
  • 33:58twenty two, only about half
  • 33:59of,
  • 34:00transplant centers were,
  • 34:03allowing,
  • 34:04you know, hep c positive
  • 34:06donor organs. I'd suspect if
  • 34:07that was
  • 34:08updated,
  • 34:10in more recent years, that
  • 34:11number is increasing, which I
  • 34:12think is good because overall,
  • 34:15you know, a few different
  • 34:17studies have noted that
  • 34:19outcomes are similar using these
  • 34:21types of organs, and the
  • 34:23wait list times are shorter,
  • 34:24which is,
  • 34:26good for our, patients and
  • 34:28expands their,
  • 34:29access to cardiac transplant.
  • 34:33Up for a little bit
  • 34:34more debate is,
  • 34:36the ischemic time and acceptance
  • 34:39of,
  • 34:39donor organs from older donors.
  • 34:43So there's the overall concern
  • 34:45is that if
  • 34:48a organ has a prolonged
  • 34:50ischemic time, typically less than
  • 34:52four hours is considered adequate,
  • 34:55that, you know,
  • 34:57it it it could be
  • 34:58an increased risk of rejection
  • 35:01in the short term, which
  • 35:02is, you know, one of
  • 35:03the dreaded fears of of
  • 35:05using, you know, organs that
  • 35:06might not be of of,
  • 35:08optimal quality.
  • 35:11But, you know, this has
  • 35:12been studied a little bit,
  • 35:13and I think the evidence
  • 35:15is a little bit mixed.
  • 35:17You know, a lot of
  • 35:18centers
  • 35:19have a a cutoff
  • 35:21of using,
  • 35:22organs from donors who are
  • 35:24forty years old or less.
  • 35:26Some have a little bit
  • 35:28more lenient,
  • 35:29you know, forty to forty
  • 35:31five. Some might even go
  • 35:32up to,
  • 35:33donors that are fifty years.
  • 35:35I would say that's probably
  • 35:36the limit because,
  • 35:38there's been some evidence showing
  • 35:40that,
  • 35:42those those organs are at
  • 35:43the highest risk of rejection.
  • 35:46But there have been also
  • 35:47some analyses that look at,
  • 35:49factors beyond the age. And
  • 35:51when those analyses,
  • 35:53adjust for,
  • 35:55different medical factors,
  • 35:56that
  • 35:58initial,
  • 36:01adverse,
  • 36:03impact of donor age,
  • 36:05was reduced.
  • 36:07So, I think that's something
  • 36:08that requires a little bit
  • 36:10more,
  • 36:12exploration
  • 36:13and consistency,
  • 36:15in our studies.
  • 36:16And on the point of
  • 36:17ischemic time,
  • 36:19there have been development of
  • 36:21more novel,
  • 36:22cooling and perfusion,
  • 36:24strategies in recent years, specifically,
  • 36:27the Sherpa pack, which
  • 36:29provides sort of uniform cooling
  • 36:31for the the organ while
  • 36:33it's being transplanted
  • 36:35and allows it, to travel
  • 36:36safely for up to four
  • 36:38hours.
  • 36:38And then, you know, the
  • 36:40TransMedics
  • 36:40device, which can,
  • 36:43sort of artificially
  • 36:44perfuse
  • 36:45the donor organ with oxygenated
  • 36:47blood.
  • 36:48Some have called it, you
  • 36:49know, the heart in a
  • 36:50box,
  • 36:51and, you know, how, that
  • 36:53can impact ischemic times, the
  • 36:56amount of distance that, can
  • 36:58be traveled.
  • 36:59All of this is also
  • 37:01important because these technologies might
  • 37:03not,
  • 37:04be available,
  • 37:05to all transplant centers and
  • 37:06only,
  • 37:07to those who have, you
  • 37:09know, the highest level of
  • 37:10resources.
  • 37:13And finally, I wanted to
  • 37:14talk a little bit about,
  • 37:16transplant
  • 37:17volume,
  • 37:19which can contribute to center
  • 37:20level variation.
  • 37:22And it also has a
  • 37:23very tangible impact on a
  • 37:24patient's likelihood
  • 37:26of getting a transplant.
  • 37:28So even, in the same
  • 37:30UNOS region where the,
  • 37:33donor organ supply is pretty,
  • 37:36similar,
  • 37:37there can be up to
  • 37:38a thirty percent difference in,
  • 37:41transplant rates.
  • 37:43And this might be due
  • 37:44to a variety of factors
  • 37:46such as,
  • 37:48greater temporary MCS capabilities
  • 37:51or, more resources for,
  • 37:53organ procurement at,
  • 37:55those high volume centers.
  • 37:59These are some data that
  • 38:00show,
  • 38:01how this, transplant center volume
  • 38:04relates to the likelihood of
  • 38:07transplant.
  • 38:08It found that,
  • 38:09among the different,
  • 38:11clinical factors associated with getting
  • 38:13a transplant
  • 38:15was use of,
  • 38:17the sorry. The highest,
  • 38:20the most important factor for,
  • 38:22getting a transplant was being
  • 38:23at a high volume transplant
  • 38:25center, followed then, by ECMO
  • 38:28and then,
  • 38:29balloon pump use.
  • 38:31And not surprisingly,
  • 38:33based on what I've,
  • 38:35showed you thus far,
  • 38:36the factor least associated
  • 38:38with getting a transplant was
  • 38:40LVAD use.
  • 38:42So, being at, a high
  • 38:44volume center,
  • 38:47improves significantly,
  • 38:48your likelihood of getting a
  • 38:50transplant.
  • 38:51Now,
  • 38:52imagine if your nearest transplant
  • 38:54center didn't
  • 38:56have a high transplant
  • 38:57volume.
  • 38:59Would you try to go
  • 39:01be listed at a high
  • 39:02volume center?
  • 39:03What if that wasn't feasible
  • 39:05for you economically,
  • 39:07geographically?
  • 39:10You know? Is that,
  • 39:12fair for,
  • 39:13patients who are unable to
  • 39:15to be at those centers?
  • 39:18This is some data that,
  • 39:21shows,
  • 39:22transplant rates between centers,
  • 39:25in the same geographic region.
  • 39:27Once again,
  • 39:28supporting the notion of,
  • 39:30center level
  • 39:31disparities.
  • 39:33Each line represents
  • 39:35the range of values
  • 39:36that
  • 39:37exist within a organ procurement
  • 39:39organization,
  • 39:40and the diamonds represent the
  • 39:42individual transplant centers. So despite
  • 39:45having
  • 39:46this shared,
  • 39:47organ supply
  • 39:48and a relatively small geographic
  • 39:50distance,
  • 39:51there were,
  • 39:53you know, major differences,
  • 39:55in their transplant rates.
  • 39:58So I was curious,
  • 39:59to look into what the
  • 40:01high volume centers are doing.
  • 40:03And I found a nice
  • 40:04study,
  • 40:05that found that looked at
  • 40:07the practice patterns of
  • 40:09at least the listing patterns
  • 40:10of,
  • 40:11the top ten,
  • 40:13performing,
  • 40:14heart transplant centers by volume.
  • 40:17Even, among this group, I
  • 40:19think there's
  • 40:20a great deal of variability
  • 40:22in how they're,
  • 40:24listing their patients.
  • 40:26But you can see that,
  • 40:28in a majority of cases,
  • 40:30they're listing their patients at
  • 40:32high priority,
  • 40:33status one or two,
  • 40:36which,
  • 40:37once again suggests that there
  • 40:39might be there is a
  • 40:40component of clinical behavior,
  • 40:43that's driving,
  • 40:45you know, variable experiences in
  • 40:47the transplant process.
  • 40:50I read a paper,
  • 40:52by the Oregon Procurement
  • 40:54and Transplant Network,
  • 40:56about the ethics that underline
  • 40:59organ,
  • 41:00allocation.
  • 41:01And it said that equitable
  • 41:04access to transplant
  • 41:05is dependent on,
  • 41:07consistent management
  • 41:08of advanced heart failure
  • 41:11and cardiogenic
  • 41:12shock across transplant centers.
  • 41:15So,
  • 41:16you know, based on what
  • 41:17I've shared with you and
  • 41:19what I've,
  • 41:20learned,
  • 41:21I'm not sure that we're
  • 41:23achieving,
  • 41:24equity with these substantial,
  • 41:27variations
  • 41:28in,
  • 41:30transplant center practices.
  • 41:33And I'm not the only
  • 41:34one that has,
  • 41:36raised concern about potential,
  • 41:39inequities in this process.
  • 41:42This was a New York
  • 41:43Times,
  • 41:44article from last year
  • 41:46with sort of a jarring
  • 41:48headline.
  • 41:49But,
  • 41:50the premise was that
  • 41:52there's so much, you know,
  • 41:53gamesmanship
  • 41:54and strategy
  • 41:56involved in this process,
  • 41:58that, you know, in some
  • 42:00instances,
  • 42:02the waiting lists are completely
  • 42:03bypassed,
  • 42:05to direct organs to,
  • 42:08certain transplant centers.
  • 42:11But,
  • 42:12you know, with all this
  • 42:13talk about,
  • 42:15policy,
  • 42:17I wanted to recenter the
  • 42:18discussion,
  • 42:20to what's most important, and
  • 42:22that is, the patient experience.
  • 42:25So some of you may
  • 42:26remember doctor,
  • 42:28Colby Salerno, who was here
  • 42:30as one of the advanced
  • 42:31heart failure fellows last year
  • 42:33and is now a transplant
  • 42:35cardiologist
  • 42:35at Baystate.
  • 42:37And he, has the unique
  • 42:39perspective
  • 42:40of not only being a
  • 42:42transplant cardiologist, but also
  • 42:44a heart transplant recipient.
  • 42:47And he wrote, an article,
  • 42:49last year,
  • 42:51in Jack heart failure, which
  • 42:53I thought reframed,
  • 42:54the discussion pretty nicely.
  • 42:56So, I'll read you some
  • 42:58some excerpts from that. He
  • 43:00said my journey began at
  • 43:01age twelve when I was
  • 43:02diagnosed with hypertrophic cardiomyopathy.
  • 43:06Years later, when I progressed
  • 43:07to end stage heart failure,
  • 43:08an LVAD was not an
  • 43:09option for me, and I
  • 43:10was listed for a transplant.
  • 43:12I spent a hundred and
  • 43:13eighty consecutive
  • 43:15days in the cardiac intensive
  • 43:17care unit
  • 43:18before receiving my life saving
  • 43:20lifesaving donor heart.
  • 43:23And this month will mark,
  • 43:24I think, fourteen years since,
  • 43:26his initial transplant.
  • 43:28I think just the,
  • 43:31that that one sentence about
  • 43:33the time he waited,
  • 43:35is is so,
  • 43:37important because, you know, patients,
  • 43:39you know, lose their freedom
  • 43:41being hospitalized,
  • 43:42all of the things that
  • 43:43they, you know, love doing
  • 43:45outside of the hospital, and
  • 43:46it can be such a
  • 43:47grueling process. So we have
  • 43:49to,
  • 43:50remember that.
  • 43:51And then, you know, at
  • 43:52the bottom here, he said,
  • 43:53my story is a testament
  • 43:55to the importance of patient
  • 43:56preference.
  • 43:57Patients are more than medical
  • 43:58conditions
  • 43:59or entries on a transplant
  • 44:01list. They have dreams, aspirations,
  • 44:04and unique definitions
  • 44:06of what constitutes
  • 44:07a life worth living.
  • 44:12So just circling back to
  • 44:14the the case I presented
  • 44:15at the beginning,
  • 44:17I think
  • 44:18through this talk, I've highlighted
  • 44:20a few different points where,
  • 44:23a patient's
  • 44:24likelihood of getting a transplant
  • 44:25could be,
  • 44:26significantly
  • 44:27impacted.
  • 44:28We didn't really get into
  • 44:29the individual patient
  • 44:31and his
  • 44:32specific risk factors,
  • 44:34but, you know, knowing whether
  • 44:36he could even be
  • 44:38a candidate that's listed as
  • 44:40a huge consideration in and
  • 44:41of itself.
  • 44:43The choice of MCS was
  • 44:44impactful,
  • 44:46choosing a status one or
  • 44:48two listing for that patient,
  • 44:51submitting exception requests,
  • 44:53and then,
  • 44:54acceptance of,
  • 44:56the donor organ that,
  • 44:58came from a hepatitis c,
  • 45:00donor.
  • 45:01And then,
  • 45:03also important but not necessarily
  • 45:06involved in the case,
  • 45:08the transplant center volume.
  • 45:12So to conclude,
  • 45:13the takeaway messages would be
  • 45:16that,
  • 45:17center level variation is
  • 45:19a real phenomenon,
  • 45:21and can lead to variable
  • 45:23pathways to getting a heart
  • 45:24transplant.
  • 45:25And,
  • 45:26the transplant center,
  • 45:28can be a significant
  • 45:30factor itself,
  • 45:32in that journey.
  • 45:34And,
  • 45:35sort of the analogy that
  • 45:37a lot of people who
  • 45:38work in the space share
  • 45:40is that,
  • 45:42since two thousand eighteen,
  • 45:43the rules
  • 45:44of
  • 45:46the allocation process game were
  • 45:48changed.
  • 45:49And then, subsequently,
  • 45:50as we've seen, the the
  • 45:52players in that game, the
  • 45:53transplant centers,
  • 45:54the patients,
  • 45:55they sort of adapted their
  • 45:57strategy,
  • 45:58to give themselves the best
  • 46:00chance to win the game.
  • 46:01So I think,
  • 46:03going forward,
  • 46:04we need to reevaluate some
  • 46:06of,
  • 46:08the rules of the game
  • 46:09to,
  • 46:10try to better achieve equity
  • 46:12in this process.
  • 46:15So I'd just like to
  • 46:16thank,
  • 46:17doctors Ahmad and Sikand
  • 46:19as well as,
  • 46:21doctors Sen and Clark in
  • 46:22our heart failure division who,
  • 46:25have not only been clinical
  • 46:27mentors, research mentors, but they
  • 46:29really helped me with,
  • 46:32coming up with this concept
  • 46:33and and and presenting this
  • 46:35talk today.
  • 46:37The fellowship program for supporting
  • 46:38me through the years.
  • 46:41That's it. Thank you very
  • 46:43much.
  • 46:55Alright. Good
  • 46:57job.
  • 47:02Mike, and that was just
  • 47:03that was a really great
  • 47:04talk. I learned a a
  • 47:05ton
  • 47:06to both, you know, increasing
  • 47:07my knowledge also is disturbing
  • 47:09to now understand that knowledge.
  • 47:11And so, you know, it's
  • 47:12kind of like under,
  • 47:14you know, looking at the
  • 47:15carried interest deduction and how
  • 47:17that's impacted, you know, the
  • 47:18choice of careers for our
  • 47:20youth and going into, you
  • 47:22know, the capital markets and
  • 47:23and how the rules of
  • 47:24the game, like you said,
  • 47:25impact our practice.
  • 47:27So giving you the benefit
  • 47:28of the doubt though, since
  • 47:29we're all ethical physicians here
  • 47:31in this space,
  • 47:32is there data to support
  • 47:35that
  • 47:36is there any data to
  • 47:37support the change that the
  • 47:38change in the rules
  • 47:40and the adaptation to the
  • 47:42increase or more frequent use
  • 47:43of MCS
  • 47:44has changed outcomes even for
  • 47:46subgroups of populations, those higher
  • 47:48risk populations.
  • 47:49Was that,
  • 47:50accentuation
  • 47:51and adaptation to the rules
  • 47:53associated with any change in
  • 47:54or improvement in in care?
  • 47:58What I can say that,
  • 48:01in terms of determining the
  • 48:03causality
  • 48:04between, you know, selecting an
  • 48:06m c MCS device or
  • 48:08not, I think just the
  • 48:09pattern that we see over
  • 48:10and over between all these
  • 48:11studies is pretty clear.
  • 48:14However, we can't really, you
  • 48:15know, link it a hundred
  • 48:16percent to that.
  • 48:18In terms of,
  • 48:20overall outcomes,
  • 48:21not really sure. I don't
  • 48:22know if you have any
  • 48:23I mean, that's a incredible
  • 48:25question, and it's, one of
  • 48:27the things that we addressed
  • 48:28in that JAC paper that
  • 48:29showed that the durable LVADs
  • 48:31went down.
  • 48:32So the before two thousand
  • 48:34and eighteen, the patients who
  • 48:35were critically ill would end
  • 48:37up getting an LVAD.
  • 48:39Those patients
  • 48:40are now getting heart transplants.
  • 48:43So if you were to
  • 48:44say that, you know, for
  • 48:45a young person getting an
  • 48:46LVAD
  • 48:47is better
  • 48:48heart transplant, I think most
  • 48:50people in our field would
  • 48:51say a transplant.
  • 48:52From a Kaplan Meier point
  • 48:54of view, they may be
  • 48:55equivalent. But what happened was
  • 48:56that the patients who are
  • 48:57getting LVADs are now getting
  • 48:59heart transplants.
  • 49:00So that's where, the move,
  • 49:03you know, you went from,
  • 49:04like, mechanical
  • 49:05durable support to temporary support
  • 49:07to get a heart transplant.
  • 49:08So that's the big and
  • 49:09then the number of heart
  • 49:10transplants, like, tripled during this
  • 49:12time as well.
  • 49:15Just to add on to
  • 49:16that, I think and to
  • 49:18tie into
  • 49:19Mike's talk, there's a lot
  • 49:20of center variability
  • 49:22based on that. So depending
  • 49:24on what center you're seen
  • 49:25at,
  • 49:26even after the two thousand
  • 49:28eighteen change, you may be
  • 49:30more likely to get a
  • 49:31heart transplant, but at a
  • 49:32different center,
  • 49:33the same patient may get
  • 49:35an LVAD.
  • 49:36And I think that's
  • 49:37something that is not really
  • 49:40known, and I think patients
  • 49:41themselves don't really know this.
  • 49:43So it really depends on
  • 49:44what hospital you you are
  • 49:46seen at
  • 49:47or what health system you're
  • 49:49seen at, because a lot
  • 49:50of transplant centers are obviously
  • 49:52part of bigger health systems.
  • 49:53And so most patients are
  • 49:55not being evaluated initially at
  • 49:56a heart transplant center, but
  • 49:58are seen in an affiliate
  • 49:59hospital and subsequently referred in.
  • 50:00So wherever your referral pattern
  • 50:02goes to would then depend
  • 50:04sort of what kind of
  • 50:05therapy you got.
  • 50:09Yeah. I'll ask a question
  • 50:11while I'm moving around here.
  • 50:12So you shared some,
  • 50:14observations that
  • 50:16the, transplant volume
  • 50:18influences the likelihood of an
  • 50:20organ
  • 50:21being allocated.
  • 50:23And I'm curious if you
  • 50:24can explore that a little
  • 50:25bit. And,
  • 50:28what does that mean with
  • 50:29regards
  • 50:31to the utilization of of
  • 50:32sub substandard organs, hep c,
  • 50:36you know,
  • 50:37organs that come that need
  • 50:38that need bypass
  • 50:40from older owners.
  • 50:42Can you explore whether
  • 50:44those centers are doing more
  • 50:46of that
  • 50:47to,
  • 50:48you know, to
  • 50:50to game the system to
  • 50:52be more,
  • 50:53you know, acceptable for
  • 50:56allocation requests.
  • 50:57Mhmm.
  • 50:58Yes. I think,
  • 51:00there is some data to
  • 51:01support that,
  • 51:03you
  • 51:04organs that are considered of
  • 51:06marginal quality are being used
  • 51:08up by those high volume
  • 51:10centers and that they're being,
  • 51:12you know, more aggressive in
  • 51:13working with the, organ procurement
  • 51:17networks,
  • 51:18to, you know, get access
  • 51:20to those,
  • 51:21you know, organs and transplant
  • 51:23their patients.
  • 51:25You know, something else I
  • 51:26I didn't address is that
  • 51:28there's also
  • 51:29sort of this,
  • 51:30you know, balance between,
  • 51:33you know, volume,
  • 51:35outcomes, which,
  • 51:37are significantly
  • 51:38important in reimbursement,
  • 51:41structures that,
  • 51:43are provided.
  • 51:44So, you know, obviously, you
  • 51:45wanna have very good outcomes,
  • 51:47which would help with,
  • 51:49your reimbursement
  • 51:50for procedures,
  • 51:51but you also want to
  • 51:53have,
  • 51:54you know, high volume of
  • 51:56transplants
  • 51:57to be able to
  • 52:01offer patients.
  • 52:02And,
  • 52:03I think some of the
  • 52:04data I presented,
  • 52:06suggests that, you know, we
  • 52:08can explore being a little
  • 52:10a little bit more,
  • 52:12lenient in terms of the,
  • 52:14you know, quality of the
  • 52:16organ. We're,
  • 52:18you know, allowing for patients,
  • 52:20with the caveat that we,
  • 52:23you know, have these discussions
  • 52:24with the patient, assess their
  • 52:26preference, assess the the risk
  • 52:28benefits for that individual
  • 52:30person.
  • 52:30Yeah. And that maybe is
  • 52:31a follow-up
  • 52:32comment I'd like to explore
  • 52:34as well, which is the
  • 52:35role of the patient in
  • 52:37deciding
  • 52:38the limits of the types
  • 52:39of organs that they might
  • 52:41be willing to accept. So
  • 52:42could you, help us understand,
  • 52:45the shared decision making around
  • 52:47hep c
  • 52:48and marginal donors and and
  • 52:50what discussions
  • 52:52happen with patients and what
  • 52:53are what's an expected
  • 52:54kind of pathway for that
  • 52:56that decision or are they
  • 52:57not involved at all? And
  • 52:59and, yeah. So I think
  • 53:00I know the answer, but
  • 53:01but if you get to
  • 53:03get, to get your perspective,
  • 53:04and, Nick, you might have
  • 53:05to Nick, you might have
  • 53:06to go up to the
  • 53:07podium there. Yeah. I mean,
  • 53:08I can I'll let these
  • 53:09guys speak to that because
  • 53:11they do it more often.
  • 53:12But I can tell you
  • 53:13even when I was, you
  • 53:15you know, training on
  • 53:16the advanced heart failure service,
  • 53:18I remember,
  • 53:19you know, seeing a patient
  • 53:20similar to the one I
  • 53:21presented. In this case, his
  • 53:23wait time had been
  • 53:25significantly
  • 53:26longer,
  • 53:27and,
  • 53:28I think he had had
  • 53:28some initial resistance to
  • 53:31this specific question of a
  • 53:33hepatitis c donor.
  • 53:35And it took, you know,
  • 53:37a number of conversations
  • 53:38where,
  • 53:41actually, it was doctor Salerno,
  • 53:43who, you know, was, you
  • 53:45know, just reeducating
  • 53:46and teaching and and trying
  • 53:48to, you know, help him
  • 53:50understand that,
  • 53:51you know, being accepting of
  • 53:53of that type of organ
  • 53:54might, you know, help him
  • 53:55get a a heart transplant,
  • 53:58sooner.
  • 53:59So
  • 54:00from what I've seen, the
  • 54:01patient is at the forefront
  • 54:03of that discussion,
  • 54:05in terms of, you know,
  • 54:06the the practices of the
  • 54:08department. Maybe you wanna talk
  • 54:10Yeah. I can just briefly
  • 54:12add on to that.
  • 54:14So sort of by regulatory
  • 54:17guidelines, our consent process does
  • 54:20look specifically at whether,
  • 54:22a patient will accept a
  • 54:23hepatitis c donor or not,
  • 54:26because you're giving that person
  • 54:28a known communicable
  • 54:29disease.
  • 54:31However,
  • 54:32the reality is that you
  • 54:33may be giving them other
  • 54:34diseases, other things that come
  • 54:36with
  • 54:37the the donor that they
  • 54:38don't know about. Hepatitis c
  • 54:39is just something that's prominent.
  • 54:41I think at this stage
  • 54:42when it was first being
  • 54:43rolled out, it was very
  • 54:44controversial.
  • 54:46I think it's much less
  • 54:47so now where we're basically
  • 54:49at the point where
  • 54:51I would say not a
  • 54:52hundred percent, but virtually that
  • 54:54of of our patients agree
  • 54:55to accept hepatitis c donors.
  • 54:58But we do have an
  • 55:00extensive consent process where there's
  • 55:02a lot of first shared
  • 55:03decision making. But I think
  • 55:05particularly in our region and
  • 55:06with our wait times, it
  • 55:07you know, I talk to
  • 55:08patients about that being something
  • 55:10that could be the reason
  • 55:12that they don't get heart.
  • 55:13And, you know, you just
  • 55:14have to know that. There's
  • 55:16also,
  • 55:17you know, a a lot
  • 55:18of talk now around donation
  • 55:19after circulatory death, which is,
  • 55:22a little bit different than
  • 55:23traditional brain death donors. And
  • 55:25we talk with our patients
  • 55:26about accepting DCD donors, which,
  • 55:30you know, data has shown
  • 55:31in Yale participated in in
  • 55:32this original,
  • 55:34clinical trial that those patient
  • 55:35outcomes are similar. But,
  • 55:37because the heart, actually has
  • 55:39to be arrested before being
  • 55:41resuscitated, there's some concern that
  • 55:42you could have graft dysfunction
  • 55:44and other issues. So our
  • 55:45patients are informed of that
  • 55:47we will be looking into
  • 55:48DCD donors. Currently, though, they
  • 55:50have the right to say
  • 55:51no to that.
  • 55:52But, again, most of our
  • 55:54patients accept that because it
  • 55:55really is part of the
  • 55:56reality of getting an organ.
  • 55:59But there's so many other
  • 56:00factors that go into selection
  • 56:02of a donor that patients
  • 56:03don't necessarily know about.
  • 56:06And I think as, you
  • 56:08know, Colby had alluded to
  • 56:09in his his editorial
  • 56:11as as of right now,
  • 56:13the current allocation system does
  • 56:14not
  • 56:15give, any weight to a
  • 56:17patient preference as to what
  • 56:19they would want,
  • 56:21for themselves. So and I
  • 56:23think Mike went into it,
  • 56:24but the current system works
  • 56:26is that we have to
  • 56:27readjustify
  • 56:27every two weeks somebody waits
  • 56:30why they cannot get durable
  • 56:31mechanical circulatory support, meaning an
  • 56:34LVAD. So if someone continues
  • 56:36to wait on the transplant
  • 56:37list after two weeks, we
  • 56:38have to justify and say,
  • 56:40well, no. This person is
  • 56:41not a candidate for an
  • 56:42LVAD, which is inherently unfair
  • 56:44because some people are gonna
  • 56:45get organs quicker. And, again,
  • 56:47some patients may have a
  • 56:49very strong preference for one
  • 56:50or the other. So the
  • 56:51current system doesn't take that
  • 56:52into account.
  • 56:55Can I ask a question
  • 56:57along that line from
  • 56:59the video? Variability
  • 57:01in practice because,
  • 57:02a lot of the centers
  • 57:04won't even consent patients for
  • 57:05DCD or hep c because
  • 57:07they will consider it standard
  • 57:08of care.
  • 57:09And you can make a
  • 57:10case for that because the
  • 57:11outcomes are identical.
  • 57:14We're one of those centers
  • 57:15that is more conservative in
  • 57:16that regard. I mean, you
  • 57:17know, Nick's old institution, the
  • 57:19head of the transplant center
  • 57:20at NYU,
  • 57:21got a heart transplant with
  • 57:22a hep c donor and
  • 57:23wrote about it in the
  • 57:24in the New York Times.
  • 57:26So it's the outcomes that
  • 57:27are identical, and there's so
  • 57:28many other factors that,
  • 57:30like, will lead to different
  • 57:32outcomes that you can't really
  • 57:33consent everyone for every little
  • 57:35thing. So there's a good
  • 57:36case to be made that
  • 57:37you just sign one consent,
  • 57:39and that should cover all
  • 57:40these things. The second thing
  • 57:42is that there is, like,
  • 57:43this perception of, like,
  • 57:45less than ideal donor in
  • 57:46the United States
  • 57:48that
  • 57:49works against us because there's
  • 57:50no data that, you
  • 57:52know, less desirable organs will
  • 57:54lead to worse outcomes.
  • 57:56In Europe, for example, there's
  • 57:58far less,
  • 57:59drug overdose and other things
  • 58:01that lead to younger organs,
  • 58:03and their outcomes are the
  • 58:04same.
  • 58:05And there's multiple,
  • 58:06studies that have shown that,
  • 58:08you know, these
  • 58:09less than ideal organs lead
  • 58:11to those identical
  • 58:12outcomes.
  • 58:13So I think there's this
  • 58:14perception that we're and we
  • 58:16turned down a lot more
  • 58:17organs
  • 58:18in the US than
  • 58:20European countries. So I think
  • 58:21that there is a you
  • 58:23know, the centers that are
  • 58:24more aggressive
  • 58:25are
  • 58:27very aggressive in terms of
  • 58:28donor select the donor selection
  • 58:30as well. So that's one
  • 58:32aspect that can be modified.
  • 58:34Yeah. I think that's very
  • 58:35informative
  • 58:36and
  • 58:37that
  • 58:38that there's no
  • 58:40units or OPTN
  • 58:42requirement
  • 58:43on the kinds of consent
  • 58:45that are mandated
  • 58:46for these things, which I
  • 58:47would have thought would have
  • 58:48been consistent across centers.
  • 58:51And, you know, if someone
  • 58:52hasn't evaluated
  • 58:54that consent process
  • 58:56as a variable and in
  • 58:57terms of organ allocation, and
  • 58:59and I think it would
  • 59:00be a wonderful study to
  • 59:02do.
  • 59:03Any other Bob, maybe the
  • 59:05last question, and then
  • 59:07Yeah. I think this whole
  • 59:08idea of the high risk,
  • 59:09donors was very interesting. One
  • 59:11is,
  • 59:12you know, just the fact
  • 59:13that thing that they get,
  • 59:14rejected by fifty different people
  • 59:16and then get put in
  • 59:17and do just as well.
  • 59:18It's just amazing.
  • 59:20But when you you were
  • 59:21able to link it to
  • 59:22the centers,
  • 59:23but is there any way
  • 59:24to link
  • 59:25when something gets rejected or,
  • 59:27you know, when a center
  • 59:28doesn't accept it to those
  • 59:30patients? Because there's gonna be
  • 59:31an inherent time lag bias
  • 59:33in that, that there are
  • 59:34certain patients that don't get.
  • 59:36Now maybe a patient that
  • 59:37didn't take that, you know,
  • 59:39gets
  • 59:40transplanted two days later, but
  • 59:41they also there's gonna be
  • 59:42a certain number of them.
  • 59:43They're gonna die in the
  • 59:44transplant list
  • 59:45waiting for a heart that
  • 59:46they've been rejected.
  • 59:48Right. Because if you turn
  • 59:50down a donor
  • 59:51and then that patient has
  • 59:53to wait an extra month
  • 59:54to get another heart,
  • 59:55that month
  • 59:57will lead to will translate
  • 59:59to
  • 60:00real changes
  • 01:00:01in their they may
  • 01:00:04survive,
  • 01:00:05but their quality of life
  • 01:00:06is gonna be much worse
  • 01:00:08than if they got that
  • 01:00:08heart sooner. And that is
  • 01:00:10not captured appropriately. So there
  • 01:00:12is a real downside. Is
  • 01:00:13there any way to link
  • 01:00:14that with the data? Or
  • 01:00:15when you reject this when
  • 01:00:17you reject a heart, is
  • 01:00:18that linked to who you
  • 01:00:19rejected or it's just linked
  • 01:00:20to your center?
  • 01:00:23That that goes into, like,
  • 01:00:24weightless mortality, but I don't
  • 01:00:26know if there's any, like,
  • 01:00:27individual
  • 01:00:28you know? But, you know,
  • 01:00:30every day that you're on
  • 01:00:31ECMO or INTELLA, like, you
  • 01:00:32get complications, you get more.
  • 01:00:34It's a culture that needs
  • 01:00:35to,
  • 01:00:37like over to viable overall.
  • 01:00:40Some of our if you
  • 01:00:41if a transplant goes well,
  • 01:00:42you can live, like, twenty,
  • 01:00:43thirty years. And
  • 01:00:45if it doesn't, you know,
  • 01:00:46if it doesn't
  • 01:00:47go as well, then you're
  • 01:00:49you know, great with these
  • 01:00:50and other things. So I
  • 01:00:51think they're real at a
  • 01:00:53patient level,
  • 01:00:55impact of of those delays.
  • 01:00:59Fantastic talk. I know you
  • 01:01:01learned a lot through this
  • 01:01:02process and and through your
  • 01:01:03entire
  • 01:01:04Yale journey, and, we're excited
  • 01:01:06to see how you do
  • 01:01:07into the future. So congratulations.
  • 01:01:09Thank you.