Henry Ford Health System Henry Ford Health System
Henry Ford Health System Scholarly Commons Henry Ford Health System Scholarly Commons
Cardiology Articles Cardiology/Cardiovascular Research
8-16-2021
Hot topics in interventional cardiology: Proceedings from the Hot topics in interventional cardiology: Proceedings from the
society for cardiovascular angiography and interventions (SCAI) society for cardiovascular angiography and interventions (SCAI)
2021 think tank 2021 think tank
Srihari S. Naidu
Suzanne J. Baron
Marvin H. Eng
Shyam K. Sathanandam
David A. Zidar
See next page for additional authors
Follow this and additional works at: https://scholarlycommons.henryford.com/cardiology_articles
Authors Authors Srihari S. Naidu, Suzanne J. Baron, Marvin H. Eng, Shyam K. Sathanandam, David A. Zidar, Dmitriy N. Feldman, Frank F. Ing, Faisal Latif, Michael J. Lim, Timothy D. Henry, Sunil V. Rao, George D. Dangas, James B. Hermiller, Ramesh Daggubati, Binita Shah, Lawrence Ang, Herbert D. Aronow, Subhash Banerjee, Lyndon C. Box, Ronald P. Caputo, Mauricio G. Cohen, Megan Coylewright, Peter L. Duffy, Andrew M. Goldsweig, Donald J. Hagler, Beau M. Hawkins, Ziyad M. Hijazi, Sasanka Jayasuriya, Henri Justino, Andrew J. Klein, Chad Kliger, Jun Li, Ehtisham Mahmud, John C. Messenger, Brian H. Morray, Sahil A. Parikh, John Reilly, Eric Secemsky, Mehdi H. Shishehbor, Molly Szerlip, Steven J. Yakubov, Cindy L. Grines, Jennifer Alvarez-Breckenridge, Colleen Baird, David Baker, Charles Berry, Manisha Bhattacharya, Seth Bilazarian, Rosanne Bowen, Kevin Brounstein, Cole Cameron, Rafael Cavalcante, Casey Culbertson, Pedro Diaz, Susan Emanuele, Erin Evans, Rob Fletcher, Tina Fortune, Priya Gaiha, Devi Govender, Dan Gutfinger, Kurt Haggstrom, Andrea Herzog, Denise Hite, Bethany Kalich, Ann Kirkland, Toni Kohler, Holly Laurisden, Kevin Livolsi, Lois Lombardi, Sarah Lowe, Kevin Marhenke, Joie Meikle, Neil Moat, Megan Mueller, Roberto Patarca, Jeff Popma, Novena Rangwala, Chuck Simonton, Jerry Stokes, Margaret Taber, Christopher Tieche, John Venditto, Nick E.J. West, and Laurie Zinn
S C A I T H I N K T AN K P RO C E E D I N G
Hot topics in interventional cardiology: Proceedings fromthe society for cardiovascular angiography and interventions(SCAI) 2021 think tank
Srihari S. Naidu MD, FAHA, FSCAI1 | Suzanne J. Baron MD, FSCAI2 |
Marvin H. Eng MD, FSCAI3 | Shyam K. Sathanandam MD, FSCAI4 |
David A. Zidar MD, PhD, FSCAI5 | Dmitriy N. Feldman MD, FSCAI6 |
Frank F. Ing MD, MSCAI7 | Faisal Latif MD, FSCAI8 | Michael J. Lim MD, FSCAI9 |
Timothy D. Henry MD, MSCAI10 | Sunil V. Rao MD, FSCAI11 |
George D. Dangas MD, PHD, MSCAI12 | James B. Hermiller MD, MSCAI13 |
Ramesh Daggubati MD, FSCAI14 | Binita Shah MD, FSCAI15 |
Lawrence Ang MD, FSCAI16 | Herbert D. Aronow MD, FSCAI17 |
Subhash Banerjee MD, FSCAI18 | Lyndon C. Box MD, FSCAI19 |
Ronald P. Caputo MD, FSCAI20 | Mauricio G. Cohen MD, FSCAI21 |
Megan Coylewright MD, FSCAI22 | Peter L. Duffy MD, MMM, FSCAI23 |
Andrew M. Goldsweig MD, FSCAI24 | Donald J. Hagler MD, MSCAI25 |
Beau M. Hawkins MD, FSCAI8 | Ziyad M. Hijazi MD, MPH, MSCAI26,27 |
Sasanka Jayasuriya MD, FSCAI28 | Henri Justino MD, FSCAI29 |
Andrew J. Klein MD, FSCAI30 | Chad Kliger MD, FSCAI31 | Jun Li MD, FSCAI32 |
Ehtisham Mahmud MD, FSCAI33 | John C. Messenger MD, FSCAI34 |
Brian H. Morray MD35 | Sahil A. Parikh MD, FSCAI36 | John Reilly MD, FSCAI37 |
Eric Secemsky MD, FSCAI38 | Mehdi H. Shishehbor MD, FSCAI39 |
Molly Szerlip MD, FSCAI40 | Steven J. Yakubov MD, MSCAI41 |
Cindy L. Grines MD, MSCAI42 | And the members of the SCAI 2020 Think Tank
Consortium: Lindsay Ackman43 | Jennifer Alvarez-Breckenridge44 | Colleen Baird45 |
David Baker46 | Charles Berry45 | Manisha Bhattacharya44 |
Seth Bilazarian MD47 | Rosanne Bowen48 | Kevin Brounstein49 |
Cole Cameron50 | Rafael Cavalcante48 | Casey Culbertson51 | Pedro Diaz44 |
Susan Emanuele46 | Erin Evans43 | Rob Fletcher49 | Tina Fortune45 |
Priya Gaiha MD52 | Devi Govender47 | Dan Gutfinger45 | Kurt Haggstrom44 |
Andrea Herzog44 | Denise Hite44 | Bethany Kalich53 | Ann Kirkland54 |
Toni Kohler50 | Holly Laurisden50 | Kevin Livolsi45 | Lois Lombardi51 |
Sarah Lowe54 | Kevin Marhenke53 | Joie Meikle55 | Neil Moat MD45 |
Megan Mueller54 | Roberto Patarca44 | Jeff Popma MD54 | Novena Rangwala51 |
Received: 28 July 2021 Accepted: 28 July 2021
DOI: 10.1002/ccd.29898
Catheter Cardiovasc Interv. 2021;1–10. wileyonlinelibrary.com/journal/ccd © 2021 Wiley Periodicals LLC. 1
Chuck Simonton MD47 | Jerry Stokes43 | Margaret Taber48 |
Christopher Tieche54 | John Venditto MD, MBA56 | Nick E. J. West MD45 |
Laurie Zinn44
1Department of Cardiology, Westchester Medical Center and New York Medical College, Valhalla, New York, USA
2Division of Cardiology, Department of Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA
3Center for Structural Heart Disease, Henry Ford Health System, Detroit, Michigan, USA
4Department of Cardiology, Le Bonheur Children's Hospital, Memphis, Tennessee, USA
5Department of Cardiology, UH Harrington Heart & Vascular Institute, Cleveland, Ohio, USA
6Department of Cardiology, Weill Cornell Medical Center, New York, USA
7Department of Cardiology, UC Davis Medical Center, Sacramento, California, USA
8Department of Cardiology, The University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, USA
9Department of Cardiology, St. Louis University School of Medicine, Saint Louis, Missouri, USA
10Department of Cardiology, The Christ Hospital Health Network, Cincinnati, Ohio, USA
11Department of Cardiology, Duke University Health System, Durham, North Carolina, USA
12The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York, USA
13Department of Cardiology, Ascension St. Vincent Cardiovascular Research Institute, Carmel, Indiana, USA
14Department of Cardiology, The West Virginia University School of Medicine, Morgantown, West Virginia, USA
15Department of Cardiology, NYU Grossman School of Medicine, New York, USA
16Division of Cardiovascular Medicine, The University of California, San Diego, California, USA
17Department of Cardiology, Lifespan Cardiovascular Institute/Brown Medical School, Providence, Rhode Island, USA
18Department of Cardiology, Dallas Veterans Affairs Medical Center, Dallas, Texas, USA
19Department of Cardiology, West Valley Medical Center, Caldwell, Idaho, USA
20Department of Cardiology, Levine Heart and Wellness, Naples, Florida, USA
21Cardiac Catheterization Laboratory, University of Miami Miller School of Medicine, Miami, Florida, USA
22Department of Cardiology, Erlanger Health System, Chattanooga, Tennessee, USA
23Department of Cardiology, West Florida Hospital, Pensacola, Florida, USA
24Division of Cardiovascular Medicine, The University of Nebraska Medical Center, Omaha, Nebraska, USA
25Division of Pediatric Cardiology and Department of Cardiovascular Diseases, Mayo Clinic Health System, Rochester, Minnesota, USA
26Cardiology, Weill Cornell Medical College, New York, USA
27Sidra Medicine, Doha, Qatar
28Cardiology, Ascension Columbia St. Mary's Hospital Milwaukee, Milwaukee, Wisconsin, USA
29Division of Cardiology, Department of Pediatrics, Texas Children's Hospital, Houston, Texas, USA
30Department of Cardiology, Piedmont Heart Institute, Atlanta, Georgia, USA
31Department of Medicine, Division of Cardiovascular Medicine, Northwell Health Lenox Hill Hospital, New York, USA
32Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
33Coronary Care Unit, University of California, San Diego, California, USA
34Department of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
35Department of Cardiology, Seattle Children's Hospital, Seattle, Washington, USA
36Division of Cardiology and Center for Interventional Vascular Therapy, Columbia University Irving Medical Center, New York, USA
37Division of Cardiovascular Medicine, Department of Medicine, Stony Brook University Hospital, Stony Brook, New York, USA
38Department of Internal Medicine, Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
39Harrington Heart & Vascular Institute, UH Harrington Heart & Vascular Institute, Cleveland, Ohio, USA
40Division of Cardiology, Baylor Scott & White The Heart Hospital – Plano, Plano, Texas, USA
41Department of Cardiology, OhioHealth Heart & Vascular Physicians, Columbus, Ohio, USA
42Department of Cardiology, Northside Hospital Cardiovascular Institute, Atlanta, Georgia, USA
43TandemLife, LivaNova, Pittsburgh, Pennsylvania, USA
44Cordis, Santa Clara, California, USA
2 NAIDU ET AL.
45Abbott, Santa Clara, California, USA
46Philips Healthcare, Cambridge, Massachusetts, USA
47ABIOMED, Danvers, Massachusetts, USA
48Boston Scientific, Marlborough, Massachusetts, USA
49Shockwave Medical, Santa Clara, California, USA
50W. L. Gore, Newark, Delaware, USA
51GE Healthcare, Chicago, Illinois, USA
52Siemens Medical Solutions USA, Malvern, Pennsylvania, USA
53Amgen, Thousand Oaks, California, USA
54Medtronic, Minneapolis, Minnesota, USA
55Getinge US, Wayne, New Jersey, USA
56AstraZeneca, Wilmington, Delaware, USA
Correspondence
Srihari S. Naidu, Westchester Medical Center,
100 Woods Road, Macy Pavilion Room 134,
Valhalla, NY, USA.
Email: [email protected]
Abstract
The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a
collaborative venture that brings together interventional cardiologists, administrative
partners, and select members of the cardiovascular industry community annually for
high-level field-wide discussions. The 2021 Think Tank was organized into four paral-
lel sessions reflective of the field of interventional cardiology: (a) coronary interven-
tion, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart
disease. Each session was moderated by a senior content expert and co-moderated
by a member of SCAI's Emerging Leader Mentorship program. This document pre-
sents the proceedings to the wider cardiovascular community in order to enhance
participation in this discussion, create additional dialog from a broader base, and
thereby aid SCAI, the industry community and external stakeholders in developing
specific action items to move these areas forward.
K E YWORD S
congenital heart disease, coronary artery disease, pediatrics, peripheral arterial disease,structural heart disease intervention
1 | INTRODUCTION
The annual Society for Cardiovascular Angiography and Interventions
(SCAI) Think Tank brings together content experts, SCAI leaders, and key
industry partners for a one-day session on timely topics within the four
pillars of interventional cardiology—coronary, peripheral, structural, and
congenital. The themes of this year centered on quality assurance of cor-
onary and peripheral procedures, either at ambulatory surgical centers or
in the hospital setting, the need to expand indications for minimally inva-
sive structural procedures to meet the needs of an aging cardiovascular
population, and the need to track implantable devices over time in our
pediatric patients with congenital heart disease (CHD) who have now
been able to achieve a longer life expectancy into young adulthood, mid-
dle age, and beyond. It is hoped that these discussions stimulate further
initiatives within SCAI, our members, and our industry colleagues to
meet these contemporary demands and help us achieve better outcomes
for our cardiovascular patients.
2 | CORONARY: PERCUTANEOUSCORONARY PROCEDURES IN THEAMBULATORY SURGERY CENTER—WHATDOES THIS MEAN TO THE PRACTICE,OVERSIGHT, VALUE, AND QUALITY OFPROCEDURAL AREAS?
Over the last 35 years, percutaneous coronary intervention (PCI) has
evolved considerably in terms of device technology, pharmacologic
options, and procedural techniques. In parallel with these scientific
advancements by our members and industry partners, the rates of
PCI-related complications have dropped precipitously despite the
increasing anatomic and clinical complexity seen more routinely now
in patients presenting with coronary artery disease.1,2 Accordingly,
same-day discharge after PCI has been increasingly adopted and PCI
has been expanded to centers without cardiothoracic surgical back
up.3,4 With these developments in care processes and improved
NAIDU ET AL. 3
outcomes, PCI is now in the early stages of being performed in non-
hospital outpatient facilities (e.g., ambulatory surgical centers [ASCs]).
While there are potential benefits to the performance of PCI in ASCs,
including cost-savings,5 wider access to care, a more gratifying patient
experience, and greater physician autonomy, there are no published
data on the safety of PCI performed in ASCs specifically. Hence, the
true risk of adverse clinical outcomes in this setting is unknown,
prompting concerns regarding quality and oversight.
As a national society comprising over 4000 members of the inter-
ventional cardiology community, SCAI is in a unique position to help
define the quality benchmarks for the evaluation of catheterization
laboratories and for the performance of PCI. In keeping with this role,
SCAI in 2020 proactively generated and published two complemen-
tary expert consensus statements detailing guidance for the optimal
performance of complex PCI as well as for the development of an
ASC-based PCI program.6,7 Notably, it was recommended that poten-
tially high-risk procedures, such as the treatment of unprotected left
main lesions, chronic total occlusions, and severely calcified lesions
be referred to a hospital-based setting.6 Nevertheless, with the
recent Centers for Medicare & Medicaid Services (CMS) decision all-
owing for the reimbursement of complex PCI procedures in ASCs, a
growing (albeit small) number of atherectomy procedures are now
being performed in these centers. As such, a group of key opinion
leaders from the interventional community, representing both physi-
cians and industry partners, convened at the 2021 SCAI Virtual
Think Tank to deliberate how PCI in ASCs should be performed,
especially when case selection falls outside of our initial recommen-
dations, and the role that SCAI should play in optimizing quality in
these settings.
During the discussion, the overarching theme was related to the
importance of ensuring optimal outcomes for patients undergoing PCI
at ASCs (Figure 1). In the spirit of patient transparency, there was a
strong sentiment that informed consent must include a clear acknowl-
edgement of the possible consequences of the absence of services
and equipment that are normally present in a hospital-based setting
(e.g., cardiac anesthesiology, mechanical circulatory support, and car-
diothoracic surgery) and that financial incentives (if any) for the physi-
cian to perform the procedure at the ASC should be made clear to the
patient. Additionally, while catastrophic complications are expected to
be rare if case selection is appropriate, transfer protocols in the event
of a major complication should be clearly communicated to the care
team and the potential need for emergency transfer made clear to the
patient prior to the procedure.
As was clearly defined in SCAI's statement on ASC-based PCI
programs,6 certain standards for the facility itself, the equipment
available at the ASC facility, and the qualifications of all personnel
(e.g., nursing, technologist, and physician) practicing at the ASC were
felt to be of paramount importance. In particular, there was consider-
able discussion regarding the use of intravascular imaging and physio-
logic testing. Multiple studies have demonstrated improved outcomes
with the use of these strategies when compared with angiographically
guided PCI alone.8–12 The availability of these technologies is neces-
sary to determine the need for revascularization and optimize PCI out-
comes. Nevertheless, given the lack of CMS reimbursement for
intravascular ultrasound and optical coherence tomography, there
was concern that monetary considerations could limit the use of these
evidence-based tools in an ASC setting. As such, it was felt that SCAI
needs to continue to actively advocate for additional CMS reimburse-
ment for these adjunctive procedures, and assure their availability and
use in ASC facilities, in order to promote best practices and decrease
the potential for inappropriate PCI not only in ASCs, but in any PCI
center.
In order to ensure that ASCs performing PCI adhere to best prac-
tices, there was further consensus that some form of data monitoring
would be necessary for ongoing quality assurance. In fact, since it is
expected that the majority of PCIs performed at ASCs will and should
be lower risk, it was proposed that a higher benchmark for safety out-
comes should be considered. While existing national cardiovascular
registries, such as the NCDR CathPCI registry, do provide a wealth of
information regarding volumes, outcomes, and procedural appropri-
ateness in the hospital setting, currently there is no existing registry
that evaluates metrics specific to an ASC site of service. Since the pri-
mary focus for monitoring ASCs would be to assess safety
(as opposed to a repository of data for research), it was agreed that
the development of a scaled-back registry, focused only on the essen-
tial measures of quality (including appropriate PCI, complication rates
and discharge protocols based on best practices), is needed and that
participation in such a registry should be tied to reimbursement in
order to guarantee ASC site involvement. The Outpatient Endo-
vascular and Interventional Society (OEIS) is currently developing a
cardiac module within their national registry, specifically focused on
cardiac interventions performed at ASCs and outpatient interventional
suites and may provide an opportunity in the near future to imple-
ment a quality assessment program for ASCs performing PCIs. It was
recognized that the major barrier to implementing this process would
be the cost involved and the need for a clinical director (e.g., cath lab
director) to provide physician and data oversight at the ASC, and it is
recommended that payers and ASC facilities take this into
F IGURE 1 Key recommendations for high-quality ASC-based PCIprogram. ASC, ambulatory surgical centers; PCI, percutaneouscoronary intervention
4 NAIDU ET AL.
consideration when negotiating contracts and determining reimburse-
ment policies for procedures performed in an ASC setting.
In summary, there was a general consensus that SCAI should con-
tinue to advocate that ASCs abide by the expert recommendations laid
out in the recent position statement, supplemented by the updated
2021 Cath Lab Best Practices Consensus Document,13 on the perfor-
mance of PCI at an ASC.6 In order to preserve patient safety and ensure
high-quality outcomes, proper incentives to promote best practices (such
as the use of intravascular imaging or physiology-guided PCI) and
requirements to engage in the reporting of quality metrics are needed.
By working together with state and federal governing bodies and agen-
cies, SCAI has the opportunity to play a large and important role in the
evolving landscape of ASCs performing PCI.
3 | PERIPHERAL: UNDERSTANDING THEVALUE ASSESSMENT OF PERIPHERALTECHNOLOGIES IN ACUTE AND CHRONICINFRAINGUINAL INTERVENTIONS
The focus of the endovascular session was to discuss emerging issues
related to device selection for endovascular treatment of peripheral
artery disease, including critical limb ischemia. Stakeholders from the
interventional cardiology community, industry, and SCAI leadership
were in attendance. SCAI has a long history of prioritizing quality ini-
tiatives regarding best practices and the appropriate use criteria in
peripheral vascular interventions (PVI).14 The society has provided
several consensus guidelines (class of recommendation and level of
evidence) for device selection in specific clinical or anatomic subsets,
based on comparative device safety and effectiveness data.15,16 How-
ever, recent studies continue to show marked heterogeneity of treat-
ment practices in real world settings, both when performed in hospital
or at an ASC.17 The SCAI think tank provided a forum to discuss sev-
eral interrelated issues pertaining to SCAI's role in guiding hospitals
and clinicians regarding utilization of peripheral endovascular technol-
ogies. It is hoped that standardization aligned with best practices will
serve the wider community by minimizing disparities of care demo-
graphically and geographically.
There was uniform support for SCAI's role in monitoring practice
patterns, device utilization, and outcomes in PVI. Given SCAI's man-
date to promote and enhance quality care and physician education,
these activities were deemed to be consistent with the mission of the
society. In addition, given SCAI's prior quality initiatives in publishing
expert consensus statements and appropriateness criteria, there is
precedent and expertise for these initiatives within the SCAI member-
ship. Past lessons from highly publicized examples of rarely appropri-
ate PCIs highlight the legal exposure to physicians and health care
systems as well as the negative impact such cases can have on the
reputation of the interventional cardiology community. For these rea-
sons, it was agreed that SCAI, physician membership, and industry
partners should be aligned in fostering transparency regarding prac-
tice patterns with an eye toward understanding and disseminating
best practice guidance to the peripheral interventional community.
The Think Tank group agreed that SCAI should be involved in the
study of practice variation and valuation of devices related to peripheral
endovascular procedures. There was less agreement about how best to
improve the quality of patient care and minimize costs. One barrier is the
identification of operators and institutions that are outliers, with respect
to quality and/or appropriateness of device utilization. It is not known
how much practice variation should be expected, however. There was
interest in joining resources with other physician groups and societies
(e.g. Society for Vascular Surgery) on policy statements to broaden global
impact of such initiatives. More generally, we should consider promoting
ethical business principles such as the value agenda, which in this con-
text might include evaluation of practices based on the following param-
eters: (1) improved organization and integration of care, (2) established
measures to evaluate outcomes and cost of care, (3) process for bundled
payments for patient care cycles, (4) integrated care delivery across sepa-
rate facilities within a health care system, (5) expand or build services
across a geographic region to improve access to care, (6) lifecycle man-
agement with emphasis on value-based care, and (7) appropriate
reimbursement.
One option to identify “at risk” operators or laboratories would
be to put quality assurance metrics in place, including peer review for
appropriateness of PVIs, review of device selection and utilization,
and review of adherence to guidelines and expert consensus docu-
ments. There was a debate about whether an outside review board
could assist with oversight and accountability for operators and insti-
tutions, and whether there should be reimbursement for such reviews.
There was moderate interest, but no consensus achieved, about how
this could be financed and whether a SCAI-led, industry-funded mech-
anism could be put in place.
Another option offered to address practice variation and under- or
overutilization of certain devices was organizing a peripheral laboratory
certification or accreditation process through SCAI, which could certify
or accredit laboratories after a comprehensive peer-based review. SCAI
would provide guidance and issue accreditation to programs meeting
specific requirements, such as a random peer case review program and
QA/QI process. Accreditation for ASCs should not be based purely on
adjusted complication rates, but also on short- and long-term outcomes,
as well as procedure and device appropriateness.
There was general agreement that there should be awareness
that proliferation of ASCs nationwide has occurred without proper
professional societal quality/utilization/appropriateness evaluations in
place. The office-based lab (OBL)/ASCs were not necessarily deemed
to be the problem, and in fact, many patients seem to prefer to
receive care in an OBL/ASC setting. However, the current financial
incentives of OBL/ASC physicians and lack of oversight regarding
appropriateness of procedures and device selection pose a potential
concern. One topic, which was debated, was whether OBL/ASCs per-
forming endovascular procedures should be required to be part of a
PVI registry. Physicians in attendance and stakeholders from industry
were keenly interested in a concept of a comprehensive registry that
would include data on costs, procedural complications/outcomes, and
patient reported short- and long-term outcomes. Mandatory participa-
tion would be necessary for full engagement, complete quality
NAIDU ET AL. 5
metrics, and accountability. However, the feasibility of such a registry
for ASCs might be limited since outpatient-based laboratories do not
generally have an infrastructure for data collection, as already dis-
cussed in the coronary section above. Whether self-reported patient
data would be accurate and impactful was also discussed.
Another central topic discussed was whether observational/regis-
try data would change physician practice patterns. There was moder-
ate pessimism that such data would impact practice patterns since, for
instance, even high-quality randomized controlled trials have not
resulted in large-scale utilization of drug-coated balloons. There was
consensus that given the strong influence of reimbursement on physi-
cian behavior, SCAI members and industry should strive to work with
payers to realign payment structure, with an emphasis on evidenced-
based outcomes-based metrics. There was a view that consensus doc-
uments may not help to change physician behavior unless they can be
enforced. Thus, linking registry participation to reimbursement by
payers was discussed.
In summary, there was general agreement that issues related to
PVI procedural appropriateness, heterogeneity in device selection,
variance in cost and practice patterns were all linked in complex ways
and are important priorities for SCAI to be engaged in (Table 1). The
expansion of OBL/ASCs was recognized as an opportunity to create
SCAI-led quality assurance metrics, such as peer review for appropri-
ateness of PVI and review of device selection/utilization. Several
options, such as development of a SCAI-led certification or accredita-
tion process for operators and laboratories and participation in PVI
registries were identified as discussed above. There was a consensus
that SCAI should advocate for realignment of financial incentives with
an emphasis on outcomes-based metrics.
4 | STRUCTURAL: ENHANCINGINNOVATION IN STRUCTURAL HEARTPROCEDURES—EMERGING INDICATIONSFOR VALVES, CLIPS, AND PLUGS
As more cardiovascular patients survive to an advanced age, with inher-
ent associated comorbidities including frailty, cardiac procedures will
need to continue to evolve to treat diseases via percutaneous (rather
than open surgical) methods. The current era of minimally invasive
devices for structural heart disease (SHD) interventions presents clini-
cians with a toolbox to develop creative solutions. As expected, these
solutions involve permutations of utilizing medical devices in methods
novel to their intended purpose, or in the United States device regula-
tory framework, outside of their approved “labeled” indication.For example, transcatheter valves are approved for transcatheter
aortic valve replacement (TAVR) in patients with severe aortic steno-
sis. However, there are complex patients for whom adjunctive proce-
dures have evolved to overcome challenges to successfully
performing TAVR that are not part of the food and drug administra-
tion (FDA) labeling for the procedure (e.g., BASILICA).18 Furthermore,
given that there are no similar valves approved for replacement of the
mitral valve, operators have utilized the available aortic valves to
perform transcatheter mitral valve replacement (TMVR). While such
“off-label” use of a product may gain traction within the interven-
tional cardiology community through podium presentations, case
reports, and social media,19 a presentation bias occurs as operators
are reluctant to share deaths or serious complications. Thus, quality
and safety remain a concern regarding appropriate case section, tech-
nical skillsets, complication management, and post-procedure care. In
addition, the medical device industry, charged with assuring proper
use of their products through operator training, support, and guid-
ance, are unable to assist to assure optimal procedural outcomes
when the devices are used off-label. While measurement and commu-
nication of quality within the interventional community and to the
public remains a challenge already for FDA-approved procedures, it is
exceedingly difficult for off-label device procedures.
TABLE 1 Practice variation in device selection in PVI procedures
Practice variation in peripheral vascular interventions (PVI)
Lessons learned and emergingchallenges
Potential societal initiatives andsolutions
•PVI and device selection can
be affected by financial
incentives
•Expanded local and national
peer review board/system
•Financial incentives can lead
to:
•SCAI-led industry funded
peripheral laboratory
certification and/or
accreditation for OBL/ASCs.
•Unnecessary procedures,
adverse outcomes, and
harm to patients
•Establish a comprehensive
outpatient PVI registry, with
participation being linked to
reimbursement
•Healthcare disparities •Realignment of financial
incentives to emphasize
evidence-based and outcomes-
based metrics
•Additional expense to
payers and health care
systems
•Engagement with other
physician groups and vascular
societies
•Patient and societal mistrust
•Identifying “at risk” operators/outliers is challenging
•OBL/ASCs expansion is
occurring without a
mechanism to evaluate
appropriateness, quality, and
safety
•Consensus/guidelinedocuments are not being
followed and do not lead to
higher quality care
•Physician behavior is strongly
linked to reimbursement
•Reimbursement is not
necessarily linked to best PVI
practices
Abbreviations: ASC, ambulatory surgical centers; OBL, office-based lab;
SCAI, society for cardiovascular angiography and interventions.
6 NAIDU ET AL.
The specialty of interventional cardiology has historically been
at the forefront of innovation and improved patient care by generat-
ing the data to support novel procedures (e.g., randomized con-
trolled trials, well-conducted observational studies). Furthermore,
carefully designed registries are used to examine off-label device
use and supplements the research on approved products beyond the
randomized data.20,21 To date, these innovations have principally
been in the areas of coronary and peripheral vascular procedures,
however. Notably, and in contrast, the field of SHD has developed
with unique challenges that necessitate a different pathway for
meeting deficiencies in patient/procedural care. These include
(1) The mandate of the “Heart Team” approach with the physical
presence of both cardiac surgeons and interventional cardiologists
to evaluate and treat patients cooperatively; and (2) National Cover-
age Decisions that closely associate FDA labeling of devices, clinical
trial data, and reimbursement for structural heart procedures. In
essence, enhancing treatment for patients with SHD now involves
the complexity of the medical device industry, federal government,
cardiac surgery, and interventional cardiology. The mission of SCAI
is to lead the global interventional cardiology community in educa-
tion, advocacy, research, and quality of patient care. Clearly, to
achieve all of these aims, SCAI must endeavor to enhance and
improve the treatment of patients with SHD moving forward.
4.1 | Alignment of operators, industry, andregulators
To allow iterative expansion of labeled indications for devices
and/or procedures, SCAI has the unique ability to unite operators,
the medical device industry, and the FDA to devise acceptable next
steps to achieve this result (Figure 2). SCAI think tank consensus
was to consider single-arm studies and more specific device/proce-
dure registry data that could be utilized for this goal and SCAI could
be the organizing “sponsor” to facilitate the process. In this way,
multicenter industry sponsored studies would still be undertaken to
expand indications and procedures (e.g., TAVR in patients with mod-
erate aortic stenosis) as has been the current and accepted stan-
dard. However, leaflet altering procedures such as BASILICA
preceding TAVR would not require such randomized trial data to
become “on-label” for appropriate patients. Furthermore, single arm
studies and appropriate registry data would be large enough to
develop standards for patient outcomes that should be acceptable
for such procedures. Lastly, reimbursement for these procedures
continues to be an issue for operators, and SCAI would be appropri-
ately empowered with this type of data to pursue opportunities to
appropriately affect reimbursement and payment decisions.
4.2 | Organization of education and training
Education and training are ongoing needs with continued proce-
dural innovations and SCAI is ideally suited to fulfill this need. Pre-
viously, SCAI has developed position statements, training
requirement statements and supported e-book learning for inter-
ventional procedures. All of these avenues should be considered
for training in the structural heart arena with a focus on adapting
the best available media and computing resources to support train-
ing programs. Likewise, there is a need for “expert consultative”services in which “experts” in the field could be consulted for pro-
cedural advice prior to an operator taking on an advanced proce-
dure. These could be facilitated by SCAI by organizing and
publicizing an available “expert panel” of individuals agreeable to
providing such a service as well as by providing the optimal
method of communication between parties. The concept of “virtualproctoring” was also brought forward given the rapid development
in hardware and software (e.g., augmented reality and virtual real-
ity) to allow such interactions currently and in the near future,
although there are multiple potential liability concerns that would
have to be considered prior to implementation.
4.3 | Partnership with congenital interventionalists
It was recognized that a great deal of symmetry exists between these
structural heart treatment issues proposed and those faced by our
colleagues in the CHD arena. Thus, moving forward, the proposed
efforts by SCAI should not occur specifically to the structural heart
arena or specific procedures, but rather be developed as more general
templates and pathways to allow for iterative expansion of
indications.
To summarize, clearly innovation and meeting the needs of an
aging population require that our tools and techniques expand signifi-
cantly in the structural heart space. Alignment of relevant stake-
holders and agreement on a process to facilitate appropriate FDA
approvals, potentially orchestrated by SCAI, together with organiza-
tion of novel educational and training initiatives, will all be pivotal to
expand treatment options in a safe and efficacious manner.
F IGURE 2 SCAI as the intermediary to align structural operators,the medical industry, and the food and drug administration. SCAI,society for cardiovascular angiography and interventions
NAIDU ET AL. 7
5 | CONGENITAL: HOW CAN THEPEDIATRIC INTERVENTIONAL COMMUNITYEFFECTIVELY TRACK IMPLANTABLEDEVICES FROM CHILDHOOD TOADULTHOOD?
At the CHD Think Tank discussion, members of the pediatric/
congenital interventional cardiology community met with corpo-
rate representatives of CHD device manufacturers and discussed
the current status of device-tracking from childhood into adult
life, identified gaps in this process, and offered possible strategies
and solutions to fill these gaps. The discussion revolved around
how SCAI can engage the various stakeholders including physi-
cians, industry, and patients together to establish an improved
system for device tracking.
Survival of children born with CHD into adulthood has steadily
improved over the past three decades.22 This has brought about sev-
eral new challenges in the management of adult survivors of CHD.
One of these involves tracking of devices implanted during infancy
and childhood into adult life. Tracking poses unique challenges, as
infants and children who are treated can now outlive the physicians
implanting the devices, device-tracking registries, the manufacturer,
and even currently available technology. Further, CHD patients often
require reoperations where devices may be explanted or modified.
Repeat interventions may also alter the original implanted device or
additional devices may be implanted superimposed onto previously
implanted devices. Clearly, then, details of the type, medical device
manufacturer, model, size, and number of devices implanted previ-
ously, along with the implant dates, procedure notes, and potential
procedural challenges encountered are vital for the proper transfer
and continued care of pediatric CHD patients transitioning to adult
care. However, this effort will require a standardized device tracking
mechanism, collaboration of all stakeholders, and addressing of con-
cerns over potential HIPAA violations to enable proper transfer of
information.
5.1 | Gaps in the current device-tracking practicesfor CHD patients
There are no standardized tracking systems currently available for
devices implanted to treat CHDs and the gaps are multifactorial
(Table 2). Industry tracks certain devices as mandated by the FDA,
which include devices that have the potential to result in a serious
adverse health consequence in the event of a device failure, are
implanted for more than one year, and whenever the device is
intended to be a life sustaining or life supporting device outside of a
hospital setting (e.g., implantable pacemakers).23,24 However, this pro-
cess is not universally applied to all permanently implantable medical
devices (e.g., vascular stents and plugs) and active surveillance in some
cases. In addition, when it does occur, the tracking process is typically
not beyond a few years post-implant. One of the pitfalls for industry
tracking devices is that the company can track only those devices that
are registered, and tracking is dependent on the operator to submit
the device registration information. Furthermore, industry has no
standardized methods of tracking of devices used off-label, which is a
common practice across the CHD interventional community. The FDA
also does not require all implantable devices to be registered. For
example, there is no requirement to register stents, which are often
used for treatment of vascular stenoses in CHD. Moreover, follow-up
for CHD patients is frequently not streamlined during the transition
to adult congenital cardiology care.
Most hospitals typically have an internal device-tracking system
for patients within the health care system. Currently, most electronic
medical records (EMR) are not built with any robust device-tracking
platform. In addition, the EMRs of distinct hospital systems most typi-
cally do not communicate with each other. Therefore, as pediatric
patients' age and move out of parental care and insurance, details of
their implanted devices are often lost. National registries such as the
NCDR (National Cardiovascular Data Registry), and the CCISC
(Congenital Cardiovascular Interventional Study Consortium) are nei-
ther built specifically for device-tracking, nor are they kept active or
updated regarding long-term device related issues such as late device
malfunction, device explantation, device reintervention, or change in
the patient's clinical situation.24–26
TABLE 2 Summary of tracking of implantable devices in CHD:gaps and strategies for improvement
Tracking of implantable devices from childhood to adulthood
GapsStrategies to streamline devicetracking
•No tracking system
currently available
•Prioritization of certain devices for
tracking throughout the lifetime of
CHD patients
•Industry tracks devices only
if FDA mandated
•Backfilling into currently available
registries and device-tracking
systems within industry
•Tracking can only occur if
device registration is
submitted
•Develop a system to track off-label
use of devices
•Lack of active surveillance •Establishment of a SCAI registry
specifically for device tracking for
CHD patients
•Off-label use of devices for
CHD prevents tracking
•Partnering with EMR systems to
develop electronic device
registration and tracking
algorithms
•Transition of care is not
streamlined into
adulthood
•Development of patient specific,
health passports
•Gaps in transfer of EMR
between hospital systems
•Regulatory agencies/insurance
carriers to mandate device
registration/tracking
•Complexities in allowing
patient access to medical
records
Abbreviations: CHD, congenital heart disease; EMR, electronic medical
records.
8 NAIDU ET AL.
There are two other gaps in the mechanisms for transfer of medi-
cal records—the patient having personal access to their medical
records in a passport-like file so that they can easily transmit it to a
new physician without requiring institution to institution transfer of
medical records, and a registry system to contain this passport. This is
much more complicated, obviously, and risks breaches in privacy.
5.2 | Strategies for SCAI to develop a streamlineddevice tracking process for CHD patients
There exists a great opportunity for SCAI to engage physicians, indus-
try partners, regulatory bodies, and insurance carriers to develop a
simple, easy to use, and streamlined device tracking system for
patients with CHD that can be updated periodically with follow-up
patient and device related data while ensuring that patient privacy is
protected. The following points were made during the group discus-
sion and summarized in (Table 2):
1. There is common agreement among the stakeholders of the impor-
tance of tracking devices used to treat CHD.
2. The CHD and industry representatives are enthusiastic to engage
and collaborate with SCAI in developing a process for device track-
ing throughout the lifetime of children born with CHDs.
3. Specific strategies for device tracking can include but are not lim-
ited to:
a. Prioritization of implantable devices for tracking throughout the
lifetime of the CHD patient, depending on long-term complica-
tions, impact on future surgeries or other medical care (i.e., MRI
compatibility of certain devices).
b. Backfilling of missing patient and device related information into
currently available registries and device-tracking systems within
the device industry.
c. Develop a system to track off-label use of devices.
d. Establishment of a national registry by SCAI specifically for CHD
device tracking which includes tracking of multiple device implants,
explants, and device reinterventions in a single patient.
e. Partnering with EMR systems to develop electronic device regis-
tration and tracking algorithms for implantable devices, which
allows sharing of HIPAA compliant device information among vari-
ous EMR platforms.
f. Development of a patient specific, health passport. With the wide-
spread use of smart phones throughout the United States and
around the world, these patient health passports can be created as
a cellphone/tablet application (Apps) that can be constantly
updated through the internet “cloud.” Voluntary patient participa-
tion and “opting-in” within these Health Passport Apps can obviate
health privacy concerns.
While there remain financial costs to developing such dependable
tracking systems, there are also potential financial benefits. For exam-
ple, tracking of off-label use of devices may provide important
retrospective data that can be used to gain eventual FDA approval for
the off-label indication to treat CHD as well as to develop proper CPT
codes and valuation for the procedure.
Compliance to register an implanted device can be a challenge.
However, strategies involving regulatory agencies and insurance car-
riers to mandate registration of implanted devices by the hospital or
implanter prior to reimbursement can improve compliance. Some of
these rules are already in practice for SHD. Alliance with insurance
carriers could also ensure reputation incentives for transparent, self-
reporting, and improved ratings for hospitals to participate in device
tracking registries.
In summary, the SCAI CHD Think Tank group of CHD physicians
and industry representatives had a very fruitful discussion regarding
tracking of devices throughout the lifetime of patients with CHD.
There was group consensus that there is a need for establishing a sim-
ple pathway for continuous tracking of these devices. There exists a
great opportunity for SCAI to engage physicians, industry partners,
regulatory bodies, and insurance carriers to develop a robust device-
tracking system not just for CHD, but for other types of interventional
cardiovascular procedures with permanent implants. SCAI has an
opportunity to play an important role and can have a significant
impact in the progress of interventional therapies by tracking of medi-
cal devices for patients with CHD.
6 | CONCLUSION
SCAI is committed to enhancing safety, quality, and efficacy of percuta-
neous procedures. The current topics highlight areas of growth within
our field, including the move to ambulatory surgical centers, providing
more uniformity and standardization of care across geographies and
demographics, following our pediatric congenital patients as they age
and move through life, and rapidly evolving technology and techniques
in the structural arena to meet the needs of a diverse, aging population.
Hopefully, this initial discussion fuels attempts at collaboration to meet
these challenges, and we welcome any further discussion from impor-
tant stakeholders and the wider cardiovascular community.
CONFLICTS OF INTEREST
No conflicts of interest.
ORCID
Suzanne J. Baron https://orcid.org/0000-0002-8319-5637
Marvin H. Eng https://orcid.org/0000-0002-0334-6504
Timothy D. Henry https://orcid.org/0000-0003-1123-0533
George D. Dangas https://orcid.org/0000-0001-7502-8049
Ramesh Daggubati https://orcid.org/0000-0002-2257-6997
Binita Shah https://orcid.org/0000-0001-8872-8001
Lawrence Ang https://orcid.org/0000-0002-3206-7432
Mauricio G. Cohen https://orcid.org/0000-0003-2038-6070
Andrew M. Goldsweig https://orcid.org/0000-0003-2952-7837
Donald J. Hagler https://orcid.org/0000-0002-0331-3294
Brian H. Morray https://orcid.org/0000-0001-7587-7518
NAIDU ET AL. 9
Sahil A. Parikh https://orcid.org/0000-0002-7740-1481
Mehdi H. Shishehbor https://orcid.org/0000-0002-4888-2431
Molly Szerlip https://orcid.org/0000-0002-4907-1825
Steven J. Yakubov https://orcid.org/0000-0002-0952-7509
Cindy L. Grines https://orcid.org/0000-0003-1653-6443
REFERENCES
1. Masoudi FA, Ponirakis A, de Lemos JA, et al. Trends in
U.S. cardiovascular care: 2016 report from 4 acc national cardiovascu-
lar data registries. J Am Coll Cardiol. 2017;69:1427-1450.
2. Waldo SW, Gokhale M, O'Donnell CI, et al. temporal trends in coro-
nary angiography and percutaneous coronary intervention: insights
from the va clinical assessment, reporting, and tracking program.
JACC Cardiovasc Interv. 2018;11:879-888.
3. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI
guideline for percutaneous coronary intervention. A report of the Ameri-
can College of Cardiology Foundation/American Heart Association Task
Force on practice guidelines and the society for cardiovascular angiogra-
phy and interventions. J Am Coll Cardiol. 2011;58:e44-e122.
4. Amin AP, Crimmins-Reda P, Miller S, et al. Novel patient-centered
approach to facilitate same-day discharge in patients undergoing elec-
tive percutaneous coronary intervention. J Am Heart Assoc. 2018;
7(4):e005733.
5. Centers for Medicare & Medicaid Services (CMS), HHS. Medicare
Program: Changes to Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs; Revisions of Organ Procurement Organizations Conditions
of Coverage; Prior Authorization Process and Requirements for
Certain Covered Outpatient Department Services; etc. 2019;84 FR
61142:61142-61492.
6. Box LC, Blankenship JC, Henry TD, et al. SCAI position statement
on the performance of percutaneous coronary intervention in
ambulatory surgical centers. Catheter Cardiovasc Interv. 2020;96:
862-870.
7. Riley RF, Henry TD, Mahmud E, et al. SCAI position statement on opti-
mal percutaneous coronary interventional therapy for complex coro-
nary artery disease. Catheter Cardiovasc Interv. 2020;96:346-362.
8. Mentias A, Sarrazin MV, Saad M, et al. Long-term outcomes of coro-
nary stenting with and without use of intravascular ultrasound. JACC
Cardiovasc Interv. 2020;13:1880-1890.
9. Raber L, Ueki Y. Outcomes of intravascular ultrasound-guided percu-
taneous coronary intervention in the United States. JACC Cardiovasc
Interv. 2020;13:1891-1893.
10. Xaplanteris P, Fournier S, Pijls NHJ, et al. Five-year outcomes with PCI
guided by fractional flow reserve. N Engl J Med. 2018;379:250-259.
11. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve ver-
sus angiography for guiding percutaneous coronary intervention.
N Engl J Med. 2009;360:213-224.
12. Parikh RV, Liu G, Plomondon ME, et al. Utilization and outcomes of
measuring fractional flow reserve in patients with stable ischemic
heart disease. J Am Coll Cardiol. 2020;75:409-419.
13. Naidu SS, Abbott JD, Bagai J, et al. SCAI expert consensus update on
best practices in the cardiac catheterization laboratory. Catheter
Cardiovasc Interv. 2021. https://doi.org/10.1002/ccd.29744. [Epub
ahead of print].
14. Klein AJ, Jaff MR, Gray BH, et al. SCAI appropriate use criteria for
peripheral arterial interventions: An update. Catheter Cardiovasc
Interv. 2017;90(4):E90-E110.
15. Feldman DN, Armstrong EJ, Aronow HD, et al. SCAI consensus guide-
lines for device selection in femoral-popliteal arterial interventions.
Catheter Cardiovasc Interv. 2018;92(1):124-140.
16. Feldman DN, Armstrong EJ, Aronow HD, et al. SCAI guidelines on
device selection in aorto-Iliac arterial interventions. Catheter Cardi-
ovasc Interv. 2020;96(4):915-929.
17. Hicks CW, Holscher CM, Wang P, et al. Use of atherectomy during
index peripheral vascular interventions. JACC Cardiovasc Interv.
2021;14(6):678-688.
18. Khan JM, Greenbaum AB, Babaliaros VC, et al. The BASILICA trial:
prospective multicenter investigation of intentional leaflet laceration
to prevent TAVR coronary obstruction. JACC Cardiovasc Interv.
2019;12:1240-1252.
19. Goldsweig AM, Galper BZ, Alraies C, et al. #SoMe for #IC: Optimal
use of social media in interventional cardiology. Catheter Cardiovasc
Interv. 2021;98(1):97-106.
20. Jenkins KJ, Beekman Iii RH, Bergersen LJ, et al. Databases for
assessing the outcomes of the treatment of patients with congenital
and paediatric cardiac disease – the perspective of cardiology. Cardiol
Young. 2008;18:116-123.
21. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence —what is it and what can it tell us? N Engl J Med. 2016;375:2293-2297.
22. Everitt IK, Gerardin JF, Rodriguez FH 3rd, Book WM. Improving the
quality of transition and transfer of care in young adults with congeni-
tal heart disease. Congenital Heart Dis. 2017;12(3):242-250.
23. Kinard M, McGiffert L. Medical device tracking—how it is and how it
should be. JAMA Intern Med. 2021;181(3):305-306.
24. U.S. Food & Drug Administration. September 27, 2018. https://www.
fda.gov/medical-devices/postmarket-requirements-devices/medical-
device-tracking
25. Food & Drug Administration. April 01, 2020. https://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=821
26. U.S. Food & Drug Administration. March 27, 2014. https://www.fda.
gov/media/71205/download
How to cite this article: Naidu SS, Baron SJ, Eng MH,
Sathanandam SK, Zidar DA, Feldman DN, et al. Hot topics in
interventional cardiology: Proceedings from the society for
cardiovascular angiography and interventions (SCAI) 2021
think tank. Catheter Cardiovasc Interv. 2021;1–10. https://
doi.org/10.1002/ccd.29898
10 NAIDU ET AL.