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Funding sources

This research did not receive any speciﬁc grant from funding

agencies in the public, commercial, or not-for-proﬁt sectors.

Ethics statement and patient consent

The REMEDIAL IV will be conducted according to the principles of

the Declaration of Helsinki

and Good Clinical Practice

and has been

approved by the local ethic committees. All participants or their legally

authorized representatives must provide written informed consent.

Supplementary material

To access the supplementary material accompanying this article,

visit the online version of the Journal of the Society for Cardiovascular

Angiography & Interventions at 10.1016/j.jscai.2023.100980.

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C. Briguori et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100980 5

Original Research

Development and Description of a National Cohort of Patients With

Chronic Limb-Threatening Ischemia

Alexander C. Fanaroff, MD, MHS

, Elias J. Dayoub, MD, MSHP

, Lin Yang, MS

Kaitlyn Shultz, MS

, Omar I. Ramadan, MD, MSc

, Elizabeth A. Genovese, MD

Grace J. Wang, MD, MSCE

, Scott M. Damrauer, MD

, Eric A. Secemsky, MD,

MSc

, Sahil A. Parikh, MD

, Ashwin S. Nathan, MD, MS

, Michael R. Jaff, DO

Peter W. Groeneveld, MD, MS

, Jay Giri, MD, MPH

Cardiovascular Medicine Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;

Penn Cardiovascular Outcomes,

Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania;

Leonard Davis Institute for Health Economics, Philadelphia,

Pennsylvania;

Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, Pennsylvania;

Division of Vascular

Surgery and Endovascular Therapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;

Department of Genetics, Perelman

School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;

Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia,

Pennsylvania;

Smith Center for Cardiovascular Outcomes Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Harvard University,

Boston, Massachusetts;

Center for Interventional Cardiovascular Care, Division of Cardiology, Vagelos College of Physicians and Surgeons, Columbia

University Irving Medical Center, New York, New York;

Boston Scientiﬁc Corporation, Marlborough, MA;

General Internal Medicine Division, Perelman

School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

ABSTRACT

Background: Chronic limb-threatening ischemia (CLTI) is a common condition with high rates of morbidity and mortality. Despite extensive literature

documenting poor outcomes in patients with CLTI, as well as racial, ethnic, socioeconomic, and geographic disparities in these outcomes, process measures

for high-quality CLTI care have not been developed. We developed the Chronic Limb threatening Ischemia Process PERformace (CLIPPER) cohort to develop

and test the validity of CLTI care quality measures.

Methods: Using inpatient and outpatient claims data from patients with fee-for-service Medicare from 2010 to 2019, we created a coding algorithm to

identify patients with CLTI. To qualify for a CLTI diagnosis, patients had to have either diagnostic codes for peripheral artery disease and for ulceration,

infection, or gangrene on the same inpatient or outpatient claim or a CLTI-speciﬁc diagnostic code. Patients were also required to have a procedural code

indicating arterial vascular testing within 6 months before or after the earliest qualifying CLTI diagnostic code(s). We describe baseline characteristics and

long-term outcomes of this cohort.

Results: The ﬁnal cohort compri sed 1,130, 065 patients d iagnos ed with CLTI be tween 2010 and 201 9. Mean (SD) age of the cohort was 75  5.8

years; 48.4% were women, and 14.6 % were Black. Within 30 days of CLTI diagnosis, 20.4% of patients underwen t either percutaneous or

surgical revascularization. Within 6 months, 3.3% of patients underwent major amputation; 16.7% of patients died within 1 year and 50.3% within 5

years.

Conclusions: We described the development of a cohort of fee-for-service Medicare patients with CLTI using inpatient and outpatient Medicare claims data.

CLIPPER will be a resource for developing a set of process measures that can be captured from administrative claims data, with plans to describe their

association with limb outcomes and corresponding racial, ethnic, socioeconomic, sex-based, and geographic variability.

Abbreviations: CLIPPER, Chronic Limb threatening Ischemia Process PERformance; CLTI, chronic limb-threatening ischemia; CPT, Current Procedural Terminology; HF, heart failure;

ICD, International Classiﬁcation of Diseases; MI, myocardial infarction; PAD, peripheral artery disease.

Keywords: access and evaluation; critical limb ischemia; health care quality; peripheral artery disease.

* Corresponding author: alexander.fanaroff@pennmedicine.upenn.edu (A.C. Fanaroff).

https://doi.org/10.1016/j.jscai.2023.100982

Received 21 March 2023; Received in revised form 3 April 2023; Accepted 10 April 2023

Available online 19 May 2023

the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100982

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Introduction

Peripheral artery disease (PAD), deﬁned as partial or complete oc-

clusion of at least 1 major lower extremity peripheral artery by athero-

sclerotic disease, affects 17% of patients aged 65 years or older.

1,2

Patients with PAD may be asymptomatic, experience symptoms with

ambulation, or develop chronic limb-threatening ischemia (CLTI), a con-

dition characterized by rest pain, nonhealing wounds, and gangrene.

3–5

Most studies describing the natural history of PAD indicate that 5% to

10% of patients with asymptomatic PAD progress to CLTI.

Tre a t m e n t f o r

CLTI involves endovascular or surgical revascularization to improve limb

perfusion, local wound care to control infection and improve wound

healing,and guideline-directedmedical therapy to reduce cardiovascular

disease risk.

Without prompt and aggressive treatment, >20% of pa-

tients with CLTI will undergo major lower extremity amputation within 12

months after diagnosis and >20% will die.

7,8

For multiple common and morbid cardiovascular diseases—such as

heart failure (HF), myocardial infarction (MI), and stroke—quality metrics

have been derived from administrative data to measure processes of

care (including time to appropriate revascularization), describe dispar-

ities in treatment and outcomes, create benchmarks by which individual

hospitals and health systems can be evaluated, and catalyze local and

national quality improvement efforts.

9–14

Like these conditions, CLTI is

common, is highly morbid, and requires prompt treatment, yet no

similar quality metrics have been developed to measure processes of

care related to CLTI. Although numerous studies have described

nationwide gaps in PAD diagnosis and management, as well as racial,

geographic, and socioeconomic disparities in PAD outcomes,

15–24

little

is understood about process measures underlying those gaps or hos-

pital/health system variability in care processes or outcomes. Devel-

opment and validation of a set of process measures related to CLTI

management that can be obtained from Medicare claims data could

facilitate large-scale quality improvement efforts to advance manage-

ment of this highly morbid condition.

We therefore used Medicare fee-for-service Part A and B data to

deﬁne the Chronic Limb threatening Ischemia Process PERformance

cohort (CLIPPER), a cohort of patients with CLTI and longitudinal follow-

up, including processes of care (outpatient visits, diagnostic imaging,

inpatient admissions, and revascularization) and short-term and long-

term outcomes. Within CLIPPER, we will study the association of pro-

cess measures with outcomes, seeking to deﬁne process measures that

can be used as quality indicators. In this manuscript, we describe how

the cohort was developed, baseline characteristics of included patients,

and short-term and long-term clinical outcomes.

Methods

Data sources

CLIPPER was created using Medicare fee-for-service claims data,

including inpatient Medicare Provider Analysis and Review (MEDPAR)

ﬁles derived from Part A claims, Part B carrier claims, enrollment infor-

mation, vital status data, and chronic conditions data for 100% of pa-

tients with diagnostic codes consistent with CLTI. The University of

Pennsylvania institutional review board designated this study as exempt

from review. Analyses were conducted using SAS 9.4 (SAS Institute).

Study cohort, inclusion criteria, and exclusion criteria

CLIPPER consists of patients aged between 66 years or older and 86

years or younger at the time of a CLTI diagnosis between July 1, 2010,

and December 31, 2019. The lower age limit was selected to ensure

that all patients had at least 6 months of data to identify comorbidities

before the initial CLTI diagnosis, as Medicare becomes universal at the

age of 65 years. The upper age limit was selected to exclude very old

patients in whom percutaneous or surgical revascularization—the key

therapeutic intervention in CLTI—might be contraindicated due to

frailty or otherwise limited life expectancy. Patients with CLTI were

identiﬁed using International Classiﬁcation of Diseases, Ninth Edition

(ICD-9) codes (for CLTI episodes on or before September 30, 2015) and

tenth Edition (ICD-10) codes (for CLTI episodes after September 30,

2015) according to the algorithm outlined in Table 1. This coding al-

gorithm was generated by manual review of ICD-9 and ICD-10 codes

along with literature review.

25,26

It was largely based on a similar, pre-

viously published algorithm using ICD-9 codes only, which had 75%

sensitivity compared with a gold standard of chart review, and a κ value

of 0.80.

We translated this coding schema to ICD-10 codes. Broadly,

included patients had to have (1) a diagnostic code indicating PAD and

a diagnostic code indicating ulceration or infection on the same

episode of care or (2) a diagnostic code speciﬁc for CLTI. Because CLTI

requires anatomic conﬁrmation of obstructive lower extremity arterial

disease and diagnostic codes are occasionally used by clinicians before

diagnostic conﬁrmation, we restricted the cohort to patients who had

actually undergone testing for PAD within 6 months before or 6 months

after they otherwise met criteria for CLTI by the diagnostic coding al-

gorithm. Testing for PAD was deﬁned using Current Procedural Ter-

minology (CPT) codes for ankle-brachial index measurement,

computed tomography angiography, magnetic resonance angiog-

raphy, arterial duplex ultrasonography, invasive angiography, or endo-

vascular revascularization (Table 2). Endovascular revascularization was

included as a test for PAD because some patients may have undergone

diagnostic angiography followed by ad hoc revascularization, and

administrative claims may not have captured the diagnostic angiog-

raphy procedure. When describing the proportion of patients under-

going each testing modality, patients who were included based only on

a code for endovascular revascularization were counted as having un-

dergone diagnostic angiography.

Rutherford classiﬁcations were assigned to each patient based on a

coding algorithm applied to the initial episode of care in which patients

entered the cohort. The presence of a code for gangrene indicated

Rutherford Class 6. The presence of a code for osteomyelitis or ulcer

indicated Rutherford Class 5. All other patients were assigned to

Rutherford Class 4.

Outcomes

Outcomes evaluated in CLIPPER include all-cause mortality, major

lower extremity amputation, minor lower extremity amputation,

percutaneous lower extremity revascularization, surgical lower extrem-

ity revascularization, and all-cause hospital admission. All-cause mor-

tality was ascertained from Medicare denominator ﬁles. All procedural

outcomes were ascertained from ICD-9, ICD-10, or CPT codes. Sup-

plemental Table S1 includes all codes used to identify these outcomes.

Statistical analysis

We describe baseline demographic and clinical characteristics of

the study sample with continuous variables presented as mean with SD

or median with IQR and categorical variables are presented as count

with proportion. We created Kaplan-Meier and cumulative incidence

curves, as appropriate, for all-cause mortality, lower extremity revas-

cularization (percutaneous or surgical), and major lower extremity

amputation over the 10-year follow-up. We also stratiﬁed by Rutherford

classes to evaluate whether clinical severity of CLTI as deﬁned by our

algorithm correlated with worse outcomes. In addition to curves

created for the overall cohort, we also created separate curves for pa-

tients with single CLTI-speciﬁc ICD-9 or ICD-10 codes (ICD-9: 440.22,

2 A.C. Fanaroff et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100982

440.23, or 440.24; ICD-10: I70.22x, I70.23x, I70.24x, I70.25x, I70.26x,

E08.52, E09.52, E10.52, E11.52, or E13.52) as a sensitivity analysis. We

also describe baseline characteristics and outcomes of patients

excluded from the sample due to a lack of lower extremity arterial

testing.

Results

Overall, 1,999,924 patients aged between 66 and 86 years met

criteria for CLTI by virtue of our coding algorithm (1 code for PAD plus

1 code for ulceration or infection in the same episode of care, or 1

CLTI-speciﬁc code) between 2010 and 2019. Of these patients,

869,859 did not undergo lower extremity arterial testing in the 6

months before or 6 months after they otherwise met criteria for CLTI

by administrative claims and were excluded (Figure 1), leaving a ﬁnal

analytic cohort of 1,130,065 patients. Baseline characteristics and

outcomes of patients who were excluded due to lack of lower ex-

tremity arterial testing are presented in Supplemental Table S2 and

Supplemental Figure S1. Compared with patents included in the

cohort, these patients w ere older, had fewer cardiovascular and

noncardiovascular comorbidities, and had a substantially lower inci-

dence of revascularization and major amputation over short-term and

long-term follow-ups.

The proportion of patients meeting each qualifying diagnostic code

is shown in Supplemental Table S3. Of 807,217 patients included into

the cohort during the ICD-9 era, 453,565 (56.2%) presented with 1 of

the 3 CLTI-speciﬁc codes; 282,426 (61.4%) of the 460,042 patients

included into the cohort during the ICD-10 era presented with 1 of the

10 CLTI-speciﬁc codes.

Patients in the cohort had a mean (SD) age of 75.3  5.8 years

and 48.4% (n ¼ 546,480) were women; 77.4% (n ¼ 874,798) were

white and 14.6% (n ¼ 165,431) were Black. Categorized by Ruth-

erford class at the time of the initial CLTI diagnosis, 49.9% (n ¼

564,155) were Rutherford 4, 40.7% (n ¼ 460,120) Rutherford 5, and

9.4% (n ¼ 105,790) Rutherford 6. The mean Elixhauser comorbidity

score was 5.5  3.1, and 81.5% (n ¼ 921,106) of patients had hy-

pertension, 50.0% (n ¼ 565,316) diabetes mellitus, and 26.0% (n ¼

293,744) HF (Table 3). With respect to diagnostic testing within the 6

months before or after e ntry into the cohort, 69.1% (n ¼ 780,750)

underwent ankle-brachial index testing, 53.8% (n ¼ 607,844) duplex

ultrasonography, and 32.7% (n ¼ 370,558) invasive angiography;

48.4% (n ¼ 546,819) of patients underwent more than one imaging

test. Within 30 days of CLTI diagnosis, 20.4% of patients underwent

either percutaneous or surgical revascularization, of which 28.0% was

within 6 months (Figure 2). Patients with Rutherford class 4 were least

likely to undergo revascularization, whereas those with Rutherford

classes 5 and 6 were more likely to.

Table 2. CPT codes indicating testing for peripheral artery disease.

Testing modality CPT codes

Ankle-brachial index 93922, 93923, 93924

Arterial duplex ultrasound 93925, 93926

Computed tomographic angiography 75635, 73706, 72191

Invasive angiography 36200, 36245, 36246, 36247, 36248, 75625, 75710, 75716, 75736

Magnetic resonance angiography 73725, 72198

Endovascular revascularization 37220, 37221, 37222, 37223, 37224, 37225, 37226, 37227, 37228, 37229, 37230, 37231, 37232, 37233, 37234, 37235

CPT, Current Procedural Terminology.

Table 1. Coding algorithm for identifying patients with CLTI.

Codes indicating peripheral artery disease Codes indicating ulcer or infection Codes speciﬁ c for CLTI

ICD-9 codes

(before

September 30,

2015)

250.7x, 249.70,

249.71

Diabetes with

peripheral circulatory

disorders

707.1x Lower extremity

ulcer, except

decubitus

440.22 Lower extremity

atherosclerosis with rest

pain

440.20, 440.21,

440.29

Lower extremity

atherosclerosis

730.0x, 730.1x, 730.2x Osteomyelitis 440.23 Lower extremity

atherosclerosis with

ulceration

–– 785.4 Gangrene 440.24 Lower extremity

atherosclerosis with

gangrene

–– 682.6, 682.7, 681.1 Lower extremity

cellulitis

––

ICD-10 codes (after

September 30,

2015)

I70.21x, I70.29x,

I70.20x

Lower extremity

atherosclerosis

M86.1x, M86.2x, M86.3x,

M86.4x, M86.6x, M86.7x,

M86.8x, M86.9

Osteomyelitis I70.22x Lower extremity

atherosclerosis with rest

pain

I73.9 Peripheral vascular

disease

I96 Gangrene I70.23x, I70.24x,

I70.25x

Lower extremity

atherosclerosis with

ulceration

–– L97.1x, L97.2x L97.3x,

L97.4x, L97.5x, L97.6x,

L97.8x, L97.9x,

Lower extremity

ulcer, except

decubitus

I70.26x Lower extremity

atherosclerosis with

gangrene

–– E08.621, E09.621, E10.621,

E11.621, E13.621, E09.622,

E10.622, E11.622, E13.622

Diabetes with ulcer E08.52, E09.52,

E10.52, E11.52,

E13.52

Diabetes with peripheral

angiopathy and

gangrene

–– L03.03x, L03.115, L03.116,

L03.119

Lower extremity

cellulitis

––

For a diagnosis of CLTI, patients had to have either 1 diagnosis indicating lower extremity peripheral artery disease and 1 indicating ulceration or infection in the same

claim (MEDPAR or Part B) or a speciﬁc CLTI code.

CLTI, chronic limb-threatening ischemia.

A.C. Fanaroff et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100982 3

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Over long-term follow-up, 16.7% of the patients died by 1-year

follow-up, 35.1% by 3-year follow-up, 50.3% by 5-year follow-up,

and 76.5% by 10-year follow-up (Figure 3). Risk of major amputation

was highest in the 6 months following CLTI diagnosis, with 3.3% of

patients undergoing major amputation in this time frame. Approxi-

mately 1% of surviving patients underwent major amputation between

6 and 12 months’ follow-up, and major amputations continued to

accumulate at a rate of approximately 0.5% to 1.0% per year over

long-term follow-up. The risk of all-cause death and major amputation

was highest for patients with Rutherford class 6, followed by

Rutherford class 5 and Rutherford class 4. Similarly, >50% of the pa-

tients were admitted to the hospital through the 1-year follow-up, with

higher rates in patients with Rutherford classes 5 and 6 than those with

Rutherford class 4. Event rates for patients with one of the CLTI-

speciﬁc diagnostic codes were similar to those in the entire cohort

(Supplemental Figure S2).

Discussion

In this article, we described the creation of CLIPPER, a cohort of 1.13

million patients aged between 66 and 86 years with fee-for-service

Medicare diagnosed with CLTI between 2010 and 2019 (Central Illus-

tration). Through an extensive manual review of ICD-9 and ICD-10

codes and review of existing literature, we developed a novel process

for comprehensively identifying patients with CLTI in both inpatient and

outpatient settings using inpatient and outpatient Medicare claims

data, supplemented with procedure codes for arterial testing required

to diagnose CLTI. Consistent with what is known about patients with

CLTI, CLIPPER consists of older individuals with multiple comorbidities,

and Black patients are overrepresented in comparison with the overall

population of fee-for-service Medicare beneﬁciaries (14.6% vs 9.2%).

Outcomes for patients in CLIPPER are poor, consistent with previously

described outcomes for patients with CLTI. Given longitudinal

follow-up and the opportunity for statistical adjustment using methods

appropriate for administrative claims data, this data set can be used to

describe associations between process measures related to CLTI care

and outcomes and to describe existing racial, ethnic, socioeconomic,

sex-based, and geographic disparities in delivery of quality CLTI care on

a national scale.

Process and outcome measures captured from administrative claims

data and registries have been used as a key indicator of quality care in

highly morbid cardiovascular conditions such as HF, MI, and stroke.

9–14

Hospital-level risk-adjusted mortality and readmission rates for these

conditions are publicly reported by the Centers for Medicare and

Medicaid Services (CMS), and process measures like door-to-balloon

and door-to-needle times and times from presentation to electrocar-

diogram and brain imaging are reported by CMS and others. Although

the modern quality assessment and improvement regime is not without

its ﬂaws and critics,

foundational efforts to measure processes and

outcomes have had wide-ranging impact on stroke, MI, and HF

care.

29–31

CLTI has a similar prognosis to these 3 cardiovascular con-

ditions. In our study, short-term and long-term mortality after CLTI

diagnosis was comparable with that after HF hospitalization, stroke, and

MI, with 15% to 20% of the patients dying within 1 year and 50% of the

patients dying within 5 years after diagnosis.

32–34

Although CLTI is not

as common as HF, MI, or stroke, there were ~100,000 patients diag-

nosed per year in CLIPPER, which focused on a population of elderly

individuals with traditional Medicare coverage. Despite the morbidity of

CLTI and its prevalence, there has been no similar, widespread effort to

capture process measures and outcomes to improve quality of care for

CLTI. Ongoing, laudable efforts to measure the quality of lower ex-

tremity vascular care, such as the Vascular Quality Initiative and the

National Cardiovascular Data Registry’s Peripheral Vascular Intervention

Registry, have included only patients undergoing lower extremity

revascularization,

35,36

which our study shows is a minority of the overall

CLTI population. Furthermore, procedure-focused registries exclude

patients who may be too frail or high-risk to undergo procedures,

introducing selection bias and limiting the ability of procedure-based

registries to accurately assess disease-speciﬁc quality and out-

comes.

In addition, CLIPPER allows decade-long longitudinal

assessment of both contact with the health care system in the form of

visits, admissions, diagnostic testing, or procedures. Such longitudinal,

disease-focused follow-up is more difﬁcult to obtain in

procedure-speciﬁc registries.

Table 3. Baseline characteristics and arterial testing of the overall cohort.

Variable Total (N ¼ 1,130,065)

Baseline characteristics

Age, y 75.3  5.8

Female sex 546,480 (48.4)

Race/ethnicity

White 874,798 (77.4)

Black 165,431 (14.6)

Asian 22,646 (2.0)

Hispanic 34,042 (3.0)

Native American 6,570 (0.6)

Other/unknown 26,578 (2.4)

Region

Midwest 232,658 (20.6)

Northeast 246,788 (21.8)

South 467,127 (41.3)

West 179,001 (15.8)

Rutherford class

4 564,155 (49.9)

5 460,120 (40.7)

6 105,790 (9.4)

Elixhauser comorbidities 5.5  3.1

Congestive heart failure 293,744 (26.0)

Valvular heart disease 203,107 (18.0)

Diabetes mellitus 565,316 (50.0)

Hypertension 921,106 (81.5)

Chronic kidney disease 297,198 (26.3)

Chronic lung disease 326,160 (28.9)

Cardiac arrhythmia 82,696 (7.3)

Obesity 164,643 (14.6)

Depression 151,314 (13.4)

Imaging tests within 6 mo before or after CLTI diagnosis

Ankle-brachial index 780,750 (69.1)

Computed tomography angiography 142,244 (12.6)

Invasive angiography 370,558 (32.7)

Magnetic resonance angiography 15,783 (1.4)

Duplex ultrasound 607,844 (53.8)

More than 1 test 546,819 (48.4)

Values are n (%) unless or mean  SD.

CLTI, chronic limb-threatening ischemia.

Figure 1.

Flow diagram of patient cohort included in the study. The CLIPPER cohort consisted

of patients aged between 66 and 86 years who had fee-for-service (FFS) Medicare,

inpatient or outpatient billing codes indicating CLTI, and at least 1 episode of arterial

testing within the 6 months before or after the episode meeting coding criteria for CLTI.

CLTI, chronic limb-threatening ischemia.

4 A.C. Fanaroff et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100982

Lack of data describing quality of care and outcomes for patients

with CLTI is partially attributable to the logistical challenges in capturing

patients with CLTI. Unlike HF hospitalization, MI, and stroke, CLTI is

often managed in the outpatient setting,

and capturing the full cohort

of patients with incident CLTI diagnoses necessarily requires the use of

outpatient billing codes. In CLIPPER, we used Medicare Part A and B

claims, enabling us to identify patients with CLTI whether they present

to an outpatient clinic, outpatient-based catheterization laboratories, or

ambulatory surgical centers or for inpatient admission. CLTI presents

heterogeneously from a symptom and anatomic standpoint, and billing

codes reﬂect this heterogeneity, challenging attempts to algorithmically

identify patients with CLTI from administrative claims.

Although we

did not validate our coding scheme by a chart review, it has face validity

for several reasons: (1) the required codes are logical extensions of the

diagnostic process for capturing CLTI (presence of PAD plus evidence of

rest pain, infection, ulceration, or gangrene); (2) the demographics and

comorbidities of the patient population match those of previously

described CLTI cohorts; (3) mortality is similar to that described in other

CLTI cohorts; (4) revascularization, death, and amputation were more

common in patients with more severe (higher Rutherford class) CLTI;

and 5) patients had claims submitted for diagnostic testing appropriate

for CLTI diagnosis conﬁrmation contemporaneous with their entry into

the cohort.

7,8

Notably, the incidence of major amputation and revas-

cularization are lower in CLIPPER compared with some other reports;

however, most of these reports included patients diagnosed only in the

inpatient setting or who underwent a revascularization procedure. The

incidences of revascularization and amputation in CLIPPER are com-

parable with other cohorts that included an all-comers CLTI population,

including those who did not undergo intervention and/or were not

diagnosed while hospitalized.

40,41

Using the nationwide data in CLIPPER, future studies will investigate

the association between process measures related to CLTI care and

outcomes—such as time from CLTI diagnosis to attempt at revascular-

ization, receipt of wound care and other specialty vascular care, and use

of diagnostic imaging or attempt at revascularization before amputa-

tion. We will also investigate racial, ethnic, sex-based, geographic, and

between-hospital variation in these process measures. Disparities in

PAD and CLTI outcomes have been widely reported,

19–21,23,42–45

but

the extent to which process measures contribute to, or can better

describe, these disparities have not. Better understanding of the as-

sociation between these process measures and outcomes would have

important implications for improving CLTI care and reducing disparities

by allowing health systems to focus quality improvement efforts on

these process measures. Because these process measures can be ob-

tained from publicly available data, they could also serve as a template

for national quality assessment and improvement programs.

Limitations

The coding scheme we use to identify patients with CLTI has not

been validated by chart review. However, our algorithms build on prior

PAD work with ICD-9 codes that have been validated by chart review.

Moreover, the demographics and outcomes of CLIPPER are reasonable

for this patient population. Second, CLTI is a heterogeneous disease

process, which is reﬂected in the different outcomes for patients with

Rutherford 4, 5, and 6 disease. When developing process measures for

the care of patients with CLTI, it may be important to consider this

heterogeneity. Third, patients with Medicare Advantage—who

comprise an increasing proportion of Medicare beneﬁciaries—were not

included in this cohort, but the majority of Medicare beneﬁciaries

during the study period had fee-for-service coverage and were eligible

for inclusion in CLIPPER.

Moreover, CLIPPER excludes patients

younger than 65 and older than 86 years. Although CLIPPER's age

range includes most patients with CLTI,

2,41

it does exclude important

subgroups of younger and older patients, and it will be important for

future studies conducted using this cohort to clearly acknowledge the

patients to which results do and do not apply. Lastly, administrative data

lack rich clinical detail regarding severity of illness, anatomic factors,

and detailed comorbidity assessments that may affect CLTI prognosis.

We also do not have data on use of guideline-directed medical therapy,

which is strongly associated with outcomes in this population.

Figure 2.

Incidence of lower extremity revascularization in the study cohort overall and by Rutherford class. The incidence of percutaneous or surgical lower extremity revascularization was

highest immediately after CLTI diagnosis, with 20.4% of patients undergoing revascularization within 30 days and 28.0% within 6 months. CLTI, chronic limb-threatening ischemia.

A.C. Fanaroff et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100982 5

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were able to classify patients by Rutherford class, an important prog-

nostic indicator. Although there are limitations related to the use of

administrative data to assign Rutherford classiﬁcation—for example, a

patient with distal toe gangrene would be Rutherford class 6 in our

coding schema but Rutherford class 5 using detailed clinical data—the

strong observed association between Rutherford classes and outcomes

indicates the broad effectiveness of our use of claims data to classify

patients. Detailed clinical and anatomic detail are only available within

the conﬁnes of chronic disease registries, which are necessarily limited

to those hospitals with the ﬁnancial and administrative capacity to

participate. In the context of CLTI, the use of registries for quality

improvement would exclude many vulnerable low-income patients

Figure 3.

Incidence of all-cause death, major

amputation, and all-cause hospital

admission in the study cohort overall

and by Rutherford class. The cumulative

incidence of (A) all-cause mortality; (B)

major amputation, and (C) all-cause hos-

pital admission. Over 1-year follow-up,

16.7% of the patients died; >50% died

through 5 years and >75% through 10

years. Within 6 months of CLTI diagnosis,

3.3% of the patients underwent major

lower extremity amputation; the rate

slowed down thereafter but 0.5% to 1.0%

of the surviving patients continued to un-

dergo major lower extremity amputation

each year over long-term follow-up. Over

1-year follow-up, >50% of the patients

were admitted to the hospital, and ~90%

were admitted at least once over the

course of long-term follow-up. CLTI,

chronic limb-threatening ischemia.

6 A.C. Fanaroff et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100982

without access to well-resourced hospitals with specialized vascular

care,

16,45,47

and would lead to considerable challenges obtaining lon-

gitudinal follow-up data. Therefore, use of administrative claims data-

—carefully analyzed and with limitations clearly delineated—is the best

current solution for examining process measures for CLTI care.

Conclusions

In this article, we describe the development of CLIPPER, a cohort of

fee-for-service Medicare patients with CLTI captured in inpatient and

outpatient Medicare claims data. Consistent with what is known about

CLTI, the cohort consists of older adults with signiﬁcant comorbidity

burden, with Black individuals overrepresented. CLIPPER will be a

resource for developing a set of process measures that can be obtained

from administrative claims data and for describing their association with

limb outcomes and racial, ethnic, sex-based, socioeconomic, and

geographic variability.

Peer review statement

Associate Editor Sahil A. Parikh had no involvement in the peer re-

view of this article and has no access to information regarding its peer

review. Full responsibility for the editorial process for this article was

delegated to Editor in Chief Alexandra J. Lansky.

Declaration of competing interest

Alexander C. Fanaroff reports research grants to the institution from

the American Heart Association, National Institutes of Health, and

Cardiovascular Systems, Inc. Grace J. Wang receives research funding

from Boston Scientiﬁc as site principal investigator for the ELEGANCE

Registry. Eric A. Secemsky receives research grants from AstraZeneca,

BD Bard, Boston Scientiﬁc, Cook Medical, CSI, Medtronic, Philips, and

UCSF; he consults for Cardiovascular Systems, Inc., Medtronic, and

Philips and is on the speaking bureau of BD Bard, Cook Medical, and

Medtronic. Sahil A. Parikh receives institutional research funding from

Abbott, Boston Scientiﬁc, Shockwave Medical, TriReme Medical, Sur-

modics, Veryan Medical, Concept Medical, and Acotec. He serves on

advisory boards for Abbott, Boston Scientiﬁc, Cordis, Medtronic, and

Philips. He has served as a consultant to Canon, Penumbra, Inari,

Abiomed, and Terumo. He has minor equity shares in Encompass

Vascular, eFemoral, and Advanced NanoTherapies. Ashwin S. Nathan

has received institutional research funding and speaker fees from

Abiomed and Biosense-Webster. Michael R. Jaff is an employee of

Boston Scientiﬁc Corporation. Jay Giri reports research funds to the

institution and serving on advisory boards for Boston Scientiﬁc, Inari

Medical, Recor Medical, Abiomed, Abbott Vascular, Biosense-Webster,

and Astra Zeneca. All other authors report no disclosures relevant to the

contents of this manuscript.

Funding

Cohort creation and this analysis were funded by an unrestricted

grant from Boston Scientiﬁc. Alexander C. Fanaroff is supported by a

career development grant from the American Heart Association

(17FTF33661087).

Ethics statement and patient consent

The protocol for this study was reviewed by the University of

Pennsylvania institutional review board and designated as exempt from

review, with waivers of the requirements for informed consent and

HIPAA authorization.

Supplementary material

To access the supplementary material accompanying this article,

visit the online version of the Journal of the Society for Cardiovascular

Angiography & Interventions at 10.1016/j.jscai.2023.100982.

Central Illustration.

Development of the CLIPPER cohort. CLIPPER includes 1.13 million patients with CLTI as deﬁned by ICD-9 and ICD-10 codes, plus a code for lower extremity arterial testing. Use of

inpatient and outpatient claims allows description of baseline characteristics, details of hospitalizations and outpatient visits, and outcomes including death, revascularization, and major

amputation. CLTI, chronic limb-threatening ischemia; ICD, International Classi ﬁ cation of Diseases.

A.C. Fanaroff et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100982 7

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Imaging and Case Report

Embolization of a Fully-Deployed Transcatheter Aortic Valve Implant

Caused by Chest Compression During Cardiopulmonary Resuscitation

Haitham Amin, MD

,HusamA.Noor,MD

, Nooraldaem Yousif, MD

, Angel Espinosa, MD

Khalid Almerri, MD

Mohammed Bin Khalifa Specialist Cardiac Centre, Kingdom of Bahrain;

Chest Disease Hospital, Kuwait

We report a case of a 74-year-old woman who developed an

embolized transcatheter aortic valve implant after cardiopulmonary

resuscitation (CPR), which is an unexpected sequel of CPR.

A second

transcatheter heart valve was implanted, capturing the distal frame of

the embolized valve (valve-in-valve strategy). Moreover, this case

highlights the feasibility, safety, and efﬁcacy of using this approach to

avoid the need for surgical bailout.

Case report

A 74-year-old woman presented with exertional shortness of breath

caused by a low gradient, normal ejection fraction, severe aortic stenosis.

She was functionally limited, which favored a transcatheter aortic valve

replacement (TAVR) consensus during the heart team discussion. Given

the area and perimeter of the annulus, a 26-mm Evolut Pro Plus valve

(Medtronic) was deemed appropriate. A 14F Sentrant sheath (Medtronic)

was placed in the right femoral artery, and a 6F right radial artery sheath

enabled placement of a 6F pigtail catheter in the noncoronary cusp for

aortic root aortograms. An Amplatz-1 catheter was used to cross the

native aortic valve (AV), with the placement of a regular SAFARI wire

(Boston Scientiﬁc). The Evolut valve was delivered to the AV through the

delivery catheter system with an inline sheath using commissural align-

ment, with pacing at 140 bpm during the later stages of valve deploy-

ment. A 3-mm depth deployment was planned. After successful valve

deployment, the delivery system catheter was removed, with reinsertion

of the 14F Medtronic sheath over the SAFARI wire in situ (Figure 1Aand

Supplemental Videos1 and 2). There was a drop in AV gradients between

pre-TAVR and post-TAVR from 34 to 0 mm Hg with negligible aortic

regurgitation (AR) (Figure 1B, C).

The procedure was deemed successful, and the plan had been to end

with an aortogram to document valve expansion and lack of paravalvular

leak. The left ventricular (LV) pigtail was removed over a 0.035-inch ex-

change J wire; unfortunately, it pulled out the 14F Medtronic sheath. To

reinsert the sheath, the dilator was reintroduced, and the unit was pushed

in without initial ﬂuoroscopic guidance. After resistance was noted, an

angiographic image revealed perforation of the common femoral artery

(CFA), with the sheath-dilator having transected the femoral artery and

residing outsideof thearterialstructures (Figure1D). The 0.035-inch J wire

did not provide the same stiffness as the SAFARI wire to keep the sheath-

dilator from being directed toward the wall, resulting in perforation.

The patient became hypotensive and went into hemorrhagic shock

and cardiac arrest. CPR was started with immediate intubation and

aggressive ﬂuid and inotrope resuscitation. The right external iliac ar-

tery was stented with two 6  37-mm stent grafts to seal the CFA

perforation. Final angiographic cine imaging showed good sealing of

the perforation with no residual leak (Figure 1E).

The patient regained return of spontaneous circulation (ROSC) but

continued to be hypotensive even with vasopressor support. A recheck

aortogram showed embolization of the Evolut valve, with occlusion of

the coronary arteries and concomitant AR (Figure 1F and Supplemental

Video 3). Then, an EN-Snare was inserted from the left femoral artery

(LFA) to snare the embolized valve to the ascending aorta and re-

establish coronary blood ﬂow. A second 26-mm Evolut Pro Plus valve

was crimped and prepared for delivery from the LFA. Another 14F

sheath was inserted from the LFA with an Amplatzer Superstiff wire, and

the LV was re-entered using an Amplatz-1 catheter. A 6F pigtail catheter

was used to place a SAFARI wire into the LV while making sure that both

the wire and catheter passed within the embolized valve in the

ascending aorta. Attempts at delivery of the second Evolut valve were

thwarted by its interaction with the ﬁrst deployed valve, pushing the

latter down back to the coronary sinuses. Therefore, the embolized

valve had to be held in place with the EN-Snare, whereas the second

valve was positioned within the LV annulus (Figure 1G, H and Supple-

mental Videos 4 and 5). Valve deployment and release was performed

using LV pacing at 140 bpm. This valve was postdilated with a 21-mm

Crystal balloon to obtain optimal expansion and decrease para-

valvular leak. Repeat hemodynamic assessment showed no AV

gradient, and an aortogram showed trivial AR and excellent coronary

blood

ﬂow

(Figure 1I, J and Supplemental Video 6).

Keywords: aortic stenosis; cardiopulmonary resuscitation; embolization; Evolut valve; transcatheter aortic valve replacement.

* Corresponding Author: hamin@mkcc.bh (H. Amin).

https://doi.org/10.1016/j.jscai.2023.100966

Received 25 February 2023; Received in revised form 11 March 2023; Accepted 20 March 2023

the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100966

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