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allow the polymer time to expand and hydrate fully. When using multiple

Esprit BTK scaffolds, the distal scaffold was deployed ﬁrst, followed by

the proximal scaffold(s), and an abutting, the nonoverlapping conﬁgu-

ration, was recommended.

Postdilatation of the scaffold was required for all treated lesions

using a noncompliant or semicompliant balloon sized 1:1 to the refer-

ence vessel diameter. The postdilatation balloon length was selected

such that the balloon stayed within the margins of the scaffold to avoid

edge dissection or trauma to the nontreated segment. In addition, the

scaffold was not expanded beyond the dilatation limit of 0.5 mm above

the nominal diameter to prevent scaffold damage. For the PTA arm, the

target lesions were treated per standard of care at the discretion of the

proceduralist without mandated inﬂation times or maximum/minimum

inﬂation pressure to ensure a valid comparison between the Esprit BTK

scaffold and contemporary PTA practice. If a PTA balloon used in either

study arm was unable to cross or inﬂate to its nominal diameter, that

subject was deregistered.

Successful target lesion treatment was assessed on magniﬁed

orthogonal angiographic views of the target lesion, and run-off vessels

were assessed to conﬁrm the absence of distal embolization. Acute

procedural success was deﬁned as residual diameter stenosis <30%,

ﬁnal number of run-off vessels equivalent to or greater than the number

at initial angiography, absence of residual dissection (Grade  type C),

and/or angiographic complications including distal embolization,

perforation or thrombosis.

Follow-up

Clinical, in-person follow-up was performed at 30 days, 3 months, 6

months, and 1 year and will be continued annually to complete 5 years

of follow-up. These visits assessed adverse events, changes in post-

procedure medications, Rutherford-Becker class, and ABI/toe brachial

index measurement. Patient-reported outcome measures (EQ-5D-5L,

WIQ, and PAQ) were collected for the ﬁrst year only. For subjects with

an index wound, assessments took place to assess healing and infection

at 2, 6, and 12 weeks. Quantitative measurements were taken from

wound images which were assessed by the wound core laboratory. If

the wound was not healed at 3 months, there was an additional

assessment at 6- and 12-month follow-ups. New wound occurrence, or

recurrence of a previously healed wound, was also assessed and eval-

uated at ongoing visits. DUS to assess both lesion patency and binary

restenosis was performed at 30 days, 6 months, 1, 2, and 3 years, then

analyzed by the DUS core laboratory. Table 2 provides a summary of

each follow-up visit with assessments performed.

Trial blinding procedures

All subjects were blinded to their assigned treatment, and study

site personnel were trained to avoid disclosing the treatment

assignment. Subject blinding was maintained until all subjects had

completed their 5-year follow-up visit. The treating physician was

not blinded to the assigned treatment. Monitoring source docu-

mentation to identify inappropriate unblinding was performed with

protocol deviations issued for t he patient or unauthorized personnel

unblinding.

End point analysis

Primary end points

There was a primary efﬁcacy end point and primary safety end point

for the RCT.

The primary efﬁcacy end point was a composite of limb salvage and

primary patency at 12 months. Speciﬁcally, it was deﬁned as freedom

from the above-ankle amputation of the index limb, 100% total occlusion

of the target vessel, binary restenosis of the target lesion, and clinically-

driven target lesion revascularization (CD-TLR). Binary restenosis was

deﬁned as the presence of signiﬁcant restenosis >50% by angiography

or peak systolic velocity ratio (PSVR) 2.

0 by DUS, based on the best

available evidence.

Each target lesion was interrogated for the pres-

ence of a raised PSVR. The core laboratory then used additional sec-

ondary criteria (correlating factors) to conﬁrm any target lesion stenosis.

These factors included visible stenosis on B-mode imaging, focalincrease

in the absolute peak velocity, poststenotic turbulence, change in wave-

form shape, and/orvelocity drop distalto the stenosis. If a PSVR couldnot

be calculated, then these secondary factors were used to determine

signiﬁcant stenosis, or if indeterminate (discordant), the subject was

considered nondiagnostic and excluded from the analysis. If a subject

underwent both angiogram and DUS at the same time point, the

angiogram was used as the primary determinant of binary restenosis.

The primary safety end point was freedom from major adverse limb

events and peri-operative death (MALE þ POD). MALE included above-

ankle amputation of the index limb and major reintervention deﬁned as

a new surgical bypass graft, interposition graft, thrombectomy, or

thrombolysis. POD was deﬁned as peri-operative mortality from any

cause within 30 days of the index procedure.

Both primary analyses must pass for the trial to be successful. PK

substudy subjects were not included in the primary analysis population

of the LIFE-BTK RCT and will not contribute to determining the primary

end points for the RCT.

Secondary end points

There were 2 statistically powered secondary end points adjudi-

cated at 12 months. These included (1) binary restenosis of the target

lesion and (2) a composite end point of freedom from above-ankle

amputation of the index limb, total occlusion of the target vessel, and

CD-TLR. Details of those power calculations are given in the statistical

analysis section.

Table 2. Summary of follow-up assessments.

Follow-up Assessments

14 d (3 d) Index wound assessment

30 d (7 d) Medications review, adverse events review, ABI/TBI measurement,

Rutherford-Becker class, index wound assessment, new wound

assessment, WIQ, PAQ, EQ-5D-5L

30 d (14 d) DUS

42 d (7 d) Index wound assessment

90 d (14 d) Medications review, adverse events review, ABI/TBI measurement,

Rutherford-Becker class, index wound assessment, new wound

assessment, WIQ, PAQ, EQ-5D-5L

180 d (28 d) DUS, medications review, adverse events review, ABI/TBI

measurement, Rutherford-Becker class, index wound assessment,

new wound assessment, WIQ, PAQ, EQ-5D-5L

1y(28 d) DUS, medications review, adverse events review, ABI/TBI

measurement, Rutherford-Becker class, index wound assessment,

new wound assessment, WIQ, PAQ, EQ-5D-5L

2y(28 d) DUS, medications review, adverse events review, ABI/TBI

measurement, Rutherford-Becker class, new wound assessment

3y(28 d) DUS, medications review, adverse events review, ABI/TBI

measurement, Rutherford-Becker class, new wound assessment

4y(28 d) Medications review, adverse events review, ABI/TBI measurement,

Rutherford-Becker class, new wound assessment

5y(28 d) Medications review, adverse events review, ABI/TBI measurement,

Rutherford-Becker class, new wound assessment

ABI, Ankle-brachial index; DUS, duplex ultrasound; EQ-5D-5L, EuroQol - 5 Di-

mensions, 5 Levels; PAQ, peripheral artery questionnaire; TBI, toe brachial index;

WIQ, Walking Impairment Questionnaire.

6 R.L. Varcoe et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100964

The complete list of secondary end points is given in Table 3.

Some of these are quantitative, such as procedural, technical, and

clinical success, amputation-free survival, Rutherford-Becker class,

freedom from above-ankle amputation of the index limb, and

clinically-driven target lesion/vessel revascularization. Those clinical

end points were evaluated at 1 month, 3 months, 6 months, 1 year,

and annually through 5 years. Other secondary end points were

descriptive, informational e nd points, which were patient-reported.

They include the EQ-5D-5L, WIQ, and PAQ, which are to be

analyzed and reported at baseline, 30 days, 3 months, 6 months, and 1

year. Finally, cost per quality-adjusted life-year and cost per clinical

event will also be evaluated. The cost analysis will be performed on

the prospective data collected as part of the LIFE-BTK study.

Statistical analysis plan

The primary efﬁcacy end point will be evaluated in a superiority

analysis comparing the Esprit BTK DRS arm against PTA at 1 year with a

1-sided

of 0.025 using Pearson’s

test or Fisher exact test. An

approximate 20% treatment effect favoring the Esprit BTK arm was

expected based on historical data.

14,17,27,28

Our assumption was that

the end point rates would be 75% and 55% for the Esprit BTK arm and

PTA arm, respectively. Based on those assumptions, an effective sample

size of 222 (148 for the Esprit BTK arm and 74 for the PTA arm) would

provide approximately 84% power using Pearson’s

test or Fisher

exact test. Therefore, a sample size of 261 subjects was calculated to

account for a 15% attrition rate at 1 year because of the withdrawal, loss

to follow-up, and uninterpretable imaging data.

The primary safety end point will be evaluated in a noninferiority

analysis using the difference in rates between Esprit BTK and PTA with a

1-sided

of 0.025 calculated with the Farrington-Manning method. It

was assumed that the end point rates would be 95% for the Esprit BTK

arm and PTA arm, respectively.

In addition, conventional and landmark Kaplan-Meier analyses will

be performed for the primary safety and efﬁcacy end points. The

landmark analysis will be from 0 to 30 days, 30 days to 6 months, and 30

days to 1 year. The conventional analysis will extend for the entire 5-year

follow-up period.

Both powered secondary end points will be evaluated in a superi-

ority analysis using the difference in rates to compare the 2 study arms

with a 1-sided

of 0.025. The rates for the ﬁrst powered secondary end

point (12-month binary restenosis) were assumed at 15% and 35% for

the Esprit BTK and PTA arms, respectively. For the second powered

secondary end point (12-month freedom from index limb major

amputation, target vessel occlusion, and CD-TLR), it was assumed that

the end point rates would be 83% and 65% for the Esprit BTK and PTA

arms, respectively. Those assumptions were based on contemporary

published literature.

14,16,17,29,30

PK substudy

The LIFE-BTK PK substudy was a prospective, single-arm, open-

label, nonrandomized substudy. It was designed to enroll approxi-

mately 7 subjects, all of whom have undergone treatment with the

Esprit BTK DRS in narrowed or occluded infrapopliteal arteries. Three of

those will have had paclitaxel drug-coated balloon treatment for inﬂow

artery lesions before DRS placement; the other 4 will not.

The objective of the substudy was to determine the PKs of ever-

olimus delivered by the Esprit BTK DRS in a separate, nonrandomized

cohort of subjects receiving the Esprit DRS. Eligibility criteria were

similar to the RCT, and exceptions included subtle differences in the

angiographic inclusion criteria, the number of target lesions, and the

total scaffolded segment length allowed. In the substudy, there was no

limit on the number of lesions that could be treated, and the total

scaffold length must have been between 170 to 256 mm, compared to

the maximum 170 mm allowed in the RCT. In addition, the longer-

treated segments were included to evaluate the PKs of everolimus at

a higher drug dose. The list of PK substudy inclusion and exclusion

criteria is also given in Table 1.

The scaffold implantation strategy for the PK substudy was the same

as for the RCT. Staged procedures, where an inﬂow lesion was treated in

a separate encounter, were allowed in the RCT but not in the PK

substudy.

Euroﬁns I ADME BIOANALYSES was the core laboratory used for

blood sample analysis. They provided materials for blood sampling

and handling. In brief, arterial or venous blood samples were

collected in ethylenediami net etr aacet ic acid-coated tubes, s tored,

processed, and shipped according to the Investigator Laboratory

Manual. Blood samples were taken before, during, and at speciﬁc

intervals after the procedure (Table 4) to deter mine the systemic

release kinetics of everolimus. The PK analysis of everolimus was then

carried out by the core laboratory, which included analysis of PK pa-

rameters t

max

, AUC

0-24h

, AUC

0-t

, AUC

0-∞

, λ

1/2term

,andCL

(Table 5). Whole blood concentration-time data was listed by nominal

sampling time. To explore the dose proportionality of everolimus, a

regression analysis on dose normalized to 1 μg for everolimus was

performed.

Conclusion

Fully resorbable, drug-eluting scaffolds have the potential to reduce

the intimal hyperplasia and restenosis which plague percutaneous an-

gioplasty. In addition, the scaffolds used in the LIFE-BTK trial provide

mechanical support to overcome the elastic recoil, residual plaque

Table 3. Secondary end points.

Procedural

Acute procedure success

Device success - for Esprit arm only

Technical success

Clinical success

Angiographic acute gain (in-segment)

Angiographic acute gain (in-device) - for Esprit arm only

Clinical end points evaluated at 1 mo, 3 mo, 6 mo, 1 y, and annually through 5 y

Composite of limb salvage and primary patency (primary efﬁcacy end point)

Freedom from MALEþPOD (primary safety end point)

Freedom from: above-ankle amputation in index limb, 100% total occlusion of the

target vessel, and clinically-driven target lesion revascularization (CD-TLR)

Freedom from major amputation and CD-TLR

Freedom from above-ankle amputation

Freedom from restenosis

Binary restenosis

Amputation-free survival

All-cause death

Arterial thrombosis

Major reintervention on index limb

Primary assisted patency

Secondary patency

CD-TLR

Clinically-driven target vessel revascularization (CD-TVR)

CD-TVR distal to the target lesion

CD-TVR proximal to the target lesion

Index wound assessment for healing (14 d, 30 d, 42 d, 90 d, 180 d, and 1 y)

Index wound assessment for infection (14 d, 30 d, 42 d, 90 d, 180 d, and 1 y)

Rutherford-Becker clinical category, and change from baseline for the treated limb

Occurrence of new wound

Acute limb ischemia

Peripheral embolization

MALE þ POD, major adverse limb events and peri-operative death.

Amputation-free survival is deﬁned as freedom from both above-ankle

amputation and death.

R.L. Varcoe et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100964 7

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burden, and ﬂow-limiting dissections that often occur during BTK in-

terventions but do so in a manner that avoids the use of a permanent

implant. Moreover, by leaving behind a temporary implant, the artery

remains unencumbered by a metal stent which may act as an impedi-

ment to future interventions and maintains the potential for blood

vessel wall remodeling and return of physiological contractility, the holy

grail of BTK intervention. However, those theoretical advantages must

be evaluated in large-scale clinical trials which compare the Esprit BTK

DRS to balloon angioplasty before it is approved for widespread use.

Primarily, the LIFE-BTK trial was designed to demonstrate both non-

inferiority of its safety end point (Freedom from MALE þ POD) and the

superiority of its efﬁcacy end point (freedom from above-ankle ampu-

tation, target vessel occlusion, target lesion binary restenosis and/or

CD-TLR) against PTA to support US regulatory approval of this novel

device. Second, it will assess a raft of clinically important secondary end

points and evaluate the cost-effectiveness of the device in due course.

Finally, the PK substudy will gather additional pharmacological safety

information, which will be particularly relevant should the study be

successful and the device goes on to be utilized in longer, real-world

tibial lesions in clinical practice. Enrollment in LIFE-BTK has now been

completed, and the release of the initial results is anticipated for the fall

of 2023.

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 Associate Editor Andrew M. Goldsweig.

Declaration of competing interest

Ramon Varcoe is a consultant to Abbott Vascular, Medtronic, Inter-

vene, Surmodics, Philips Medical, Boston Scientiﬁc, Nectero Medical,

W.L. Gore, Alucent Biomedical, and BD Bard, receiving modest hono-

raria, as well as a shareholder in EBR Systems, Provisio Medical Inc and

Vesteck Inc. Sahil Parikh, receives institutional research funding from

Abbott Vascular, Acotec, Boston Scientiﬁc, Concept Medical, Med-

tronic, Shockwave Medical, Surmodics, and TriReme Medical. In addi-

tion, he serves on advisory boards for Abbott Vascular, Boston Scientiﬁc,

Cordis, Janssen, Medtronic, and Philips and receives honoraria from

Canon, Inari, Penumbra and Terumo. Brian DeRubertis serves on

Abbott Vascular, Medtronic, and Boston Scientiﬁc advisory boards. He

receives honoraria and/or consulting fees from Abbott Vascular, Med-

tronic, Boston Scientiﬁc, BD Bard, and Penumbra. Jennifer Jones-

McMeans, Nutte Teraphongphom, and Jin Wang are employees of

Abbott Vascular. Ido Weinberg is a consultant for Penumbra and

Magneto Thrombectomy Solutions. Andrew Holden is a medical advi-

sory board member for Medtronic, Gore, Philips, and Boston Scientiﬁc

and a clinical investigator for Bard-BD, Boston Scientiﬁc, Cagent

Vascular, Cook Medical, Endologix, Endospan, Gore Medical, Intact

Vascular, Medtronic, Philips, Reﬂow Medical, Shockwave Medical,

TriReme Medical. Raghu Kolluri is a consultant to Abbott, Auxetics,

Boston Scientiﬁc, Daiichi Sankyo, Inari, Koya Medical, Medtronic,

Penumbra, Philips, and Surmodics. In addition, he serves on data safety

monitoring boards for Prairie Educational Research Cooperative and

Syntactyx. He is a board member of VIVA Foundation, a 501c3 Cor-

poration. Hector Garcia-Garcia receives research grants from Philips,

Abbott Vascular, Boston Scientiﬁc, Neovasc, MedAlliance, Medis, Bio-

tronik, and speaker’s bureau from ACIST, Medis, and Boston Scientiﬁc.

He is on the advisory board for Abbott Vascular. Steven Kum is a

medical advisory board member for Boston Scientiﬁc, LimFlow, Xeltis,

and Bypass Solutions and receives an honorarium and traveling grants

from Medtronic, Abbott Vascular, BD, OrbusNeich, and PEDRA. Marc

Bonaca is the Executive Director of CPC, a non-proﬁt academic

research organization afﬁliated with the University of Colorado that

receives research grant/consulting funding from Abbott, Agios, Alexion

Pharma, Alnylam, Amgen, Angionetics, ARCA Biopharma, Array,

AstraZeneca, Atentiv, Audentes, Bayer, Better Therapeutics, Brigham

and Women’

s Hospital, Bristol-Myers Squibb, Cardiol Therapeutics,

CellResear

ch, Cook Medical, Cook, CSL Behring, Eidos Therapeutics,

EP Trading Co, Esperion Therapeutics, EverlyWell, Faraday, Fortress

Biotech, HDL Therapeutics, Heartﬂow, Hummingbird Bioscience,

Insmed, Janssen, Kowa Research, Lexicon, Merck, Medtronic, Mod-

erna, Novate Medical, Novo Nordisk, Pﬁzer, PhaseBio, PPD Develop-

ment, Prairie Education and Research, Prothena Biosciences,

Regeneron, Regio Biosciences, Saniﬁt Therapeutics, Sanoﬁ, Smith and

Nephew, Stealth BioTherapeutics, University of Colorado, Worldwide

Clinical Trials, Wraser, Yale Cardiovascular Research Group. He also

reports stock in Medtronic and Pﬁzer and consulting fees from

Audentes. Danielle Bajakian is on the advisory board of Abbott Vascular

and Boston Scientiﬁc. Lawrence Garcia is a consultant who serves on

the advisory boards for Abbott Vascular, Boston Scientiﬁc, Medtronic,

Table 4. Pharmacokinetic substudy blood draw time points.

Time point Allowed time window

Preprocedure On the day of the index procedure prior to

implantation of the ﬁrst Esprit BTK

Index procedure blood

draw 1

Immediately after the ﬁrst scaffold has been

implanted, this can be arterial from the sheath

Index procedure blood

draw 2 and/or more

Every 15 min after the ﬁrst scaffold has been implanted

until the last scaffold has been implanted, this can be

arterial from the sheath

0 min When the last Esprit BTK is deployed, ie, the last Esprit

BTK delivery catheter is removed from the body

10 min 2 min

30 min 6 min

1h 12 min

2h 24 min

4h 48 min

6h 72 min

12 h 144 min

24 h (1 d) 4.8 h

48 h (2 d) 9.6 h

72 h (3 d) 14.4 h

96 h (4 d) 19.2 h

120 h (5 d) 24 h

168 h (7 d) 33.6 h

336 h (14 d) 67.2 h

720 h (30 d) 144 h

1440 h (60 d) 288 h

BTK, below-the-knee.

Table 5. Pharmacokinetic Substudy analysis parameters.

Parameter Deﬁnition

max

(ng/mL) Maximal observed blood everolimus concentration

max

(h) Time to reach the maximal observed blood everolimus

concentration

AUC

24 h

(ng*h/mL) Area under the blood everolimus concentration vs time

curve from time 0 up to 24 h postplacement of the last

Esprit BTK, calculated by the linear up/log down

trapezoidal method

AUC

last

(ng*h/mL) Area under the blood everolimus concentration vs time

curve from time 0 up to the last quantiﬁable concentration,

calculated by the linear up/log down trapezoidal method

AUC

0-∞

(ng*h/mL) Area under the blood everolimus concentration vs time

curve from time zero and extrapolated to inﬁnite time,

(1/h) Terminal rate constant, determined by linear regression of

terminal points of the in-linear analyte concentration-time

curve

1/2

(h) Terminal half-life, calculated as t

1/2

¼ 0.693/λ

CL (L/h) Clearance, calculated as dose/AUC

0-∞

8 R.L. Varcoe et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100964

and Philips and is the founder of Innovation Vascular Partners Consul-

ting. He holds equity interests in Orchestra Medical, Transit Medical,

Syntervention, Primacea, Cagent Vascular, and R3 Medical. Prakash

Krishnan is consultant to Abbott Vascular, BD, Medtronic. Ehrin Arm-

strong is a consultant to Abbott Vascular, BD Bard, Boston Scientiﬁc,

Gore, Medtronic, Shockwave Medical, and Philips. Mehdi Shishehbor is

a global advisory board member and consultant for Abbott Vascular,

Medtronic, Boston Scientiﬁc, Terumo, Philips, ANT, and Inquis Medical.

John Rundback is a consultant to Abbott Vascular, Angiodynamics, BD

Bard, Boston Scientiﬁc, Cardiovascular Systems, Cordis, Inari Medical,

Inquis Medical, Janssen Pharmaceutical, Medtronic, Philips, and

shareholder in Avail, Aveera, Kalmaro, and Protexa. D. Metzger is a

consultant for Abbott Vascular, Endologix, Boston Scientiﬁc, Penumbra,

Shockwave, and Medtronic and a VIVA board member.

Funding sources

This work was supported by the Abbott Vascular.

Ethics statement and patient consent

The research reported has adhered to the relevant ethical guidelines

and that patient consent has been obtained.

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R.L. Varcoe et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100964 9

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Imaging and Case Report

Extraplaque Laser to Assist in Crossing Occlusion (EL TACO): A Novel

Method for Uncrossable Lesions

Jarrod D. Frizzell, MD, MS

, Brett L. Wanamaker, MD

, James A. Kong, MD

Heart and Vascular Institute, The Christ Hospital, Cincinnati, Ohio;

Division of Cardiovascular Medicine, Frankel Cardiovascular Center, University of

Michigan, Ann Arbor, Michigan

Uncrossable coronary lesions are those that have been successfully

traversed with a guide wire into the distal lumen but are unable to be

crossed with a balloon or other equipment for successful percutaneous

coronary interventions (PCIs). These are commonly encountered in

chronic total occlusions (CTOs), representing up to 9% of such lesions.

Published algorithms have delineated systematic approaches for solv-

ing uncrossable lesions to improve PCI success.

2,3

Methods described

include increasing guide support, employing smaller balloons,

balloon-assisted microdissection, alternative microcatheters (stiffer or

smaller proﬁle), atherectomy (laser or rotational), or hydraulic fracturing

with microcatheter injections. A subset of approaches involves intro-

ducing a second wire into the subintimal space for balloon anchoring

or external plaque modiﬁcation via an “external cap crush.”

2,3

In this

latter technique, an inﬂated balloon within the subintimal space sur-

rounding the uncrossable lesion modiﬁes the resistant area such that

equipment may pass over the luminal wire. Although laser atherectomy

has been described in uncrossable algorithms, and its use has previ-

ously been safely demonstrated in the subintimal space as part of CTO

PCI,

here we describe the use of extraplaque laser to assist in crossing

occlusions, a novel technique for uncrossable lesions.

Case report

A 76-year-old man with a history of aortic stenosis with prior me-

chanical aortic valve replacement, hypertension, and hyperlipidemia

had new anginal symptoms that were initially managed with empiric

antianginals. He later had a separate syndrome that led to the diagnosis

of esophageal cancer. Cardiac catheterization for persistent angina

showed critical lesions in the right coronary and left circumﬂex arteries,

as well as a short CTO of the mid left anterior descending coronary

artery (LAD) (Figure 1A). A multidisciplinary heart team considered him

ineligible for coronary artery bypass grafting due to redo sternotomy,

age, and active cancer and recommended complete revascularization

by PCI. After successful PCI of his right coronary and left circumﬂex

arteries, there was a failed attempt at LAD CTO PCI. He began

chemotherapy and radiation treatment for his cancer. In the weeks

following, he was admitted on 3 occasions with unstable anginal

symptoms and found to have non–ST-elevation myocardial infarctions

each time. Although his antianginal regimen was increased to the point

where he was on maximally tolerated doses of 3 different agents

(metoprolol, isosorbide mononitrate, and ranolazine), he continued to

have symptoms. The addition of a calcium channel blocker was limited

by hypotension. Because of continued symptoms and prior failed PCI

attempt, he was transferred during the next admission to a high-volume

CTO PCI center.

After use of Fielder XT-A (Asahi Intecc), Gladius Mongo (Asahi

Intecc), Pilot 200 (Abbott), Gladius (Asahi Intecc), and Gaia Next 3

(Asahi Intecc) wires, the lesion was crossed with a Sion Black (Asahi

Intecc) supported by a Corsair Pro XS microcatheter (Asahi Intecc);

however, the microcatheter was unable to cross the lesion. The

following methods were attempted using published algorithms.

2,3

1.5-mm Takeru balloon (Terumo) would not advance, including far

enough for effective balloon-assisted microdissection. A 0.9-mm Exci-

mer laser (Philips) would not cross the lesion at the highest settings

(ﬂuency, 80 mJ/mm

; frequency, 80 Hz). Attempting to exchange the

Sion Black for a Rotadrive wire (Boston Scientiﬁc) in anticipation of

rotational atherectomy was unsuccessful. Last, a dual-lumen micro-

catheter (Sasuke, Asashi Intecc) was used to introduce a Gladius Mongo

wire, which was subsequently knuckled into the subintimal space

around the lesion. An external cap crush over the subintimal wire was

unsuccessful, as even a 1.5-mm balloon would not pass.

Next, the laser was taken over the Mongo wire, where it initially

stopped at the point of subintimal entry (Figure 1B). While engaging at

ﬂuency and frequency settings of 80/80, gentle pressure was applied

that led to advancement of the laser into the dissection plane sur-

rounding the CTO segment, and it was stopped in the subintimal plane

just distal to the occlusion. Flushing with saline or contrast was not

Keywords: atherectomy; chronic total occlusion; percutaneous coronary intervention; uncrossable lesion.

* Corresponding author: jarrod.frizzell@thechristhospital.com (J.D. Frizzell).

https://doi.org/10.1016/j.jscai.2023.100983

Received 14 February 2023; Received in revised form 3 April 2023; Accepted 10 April 2023

Available online 4 May 2023

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

Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100983

performed for 2 reasons. First, because the lesion was uncrossable, the

laser may act as a “plug” obstructing ﬂow, leading to increasing pres-

sure in the proximal vessel with risk of hydraulic dissection and proximal

extension, jeopardizing the large diagonal and other vessels. Second, if

the laser was as obstructive to ﬂow as presumed, then the focal pho-

toablative effect would predominate. Reduced ﬂow around the laser

may avoid the usual cavitation of the medium (saline or contrast) with

less photomechanical effect, thus decreasing the risk of perforation or

expansion of subintimal hematoma. Following use of the laser, the

microcatheter was advanced through the lesion and Sion Black

exchanged for a Rotadrive wire, over which rotational atherectomy was

performed with a 1.5-mm burr (ROTAPRO, Boston Scientiﬁc)

(Figure 1C). Intravascular ultrasound at the CTO segment showed focal

disruption of circumferential calcium adjacent to the dissection plane

(Figure 1D) corresponding to the extraplaque laser modiﬁcation of the

CTO segment. Overlapping 3.5 mm  38 mm and 2.5 mm  38 mm

drug-eluting stents were placed from the LAD ostium through the mid

vessel, postdilated proximally with a 4.5-mm noncompliant balloon and

in the midsection with a 3.5-mm noncompliant balloon. Intravascular

ultrasound showed full stent expansion and apposition (Figure 1E) with

no residual lesion by angiography (Figure 1F).

Discussion

Extraplaque laser to assist in crossing occlusions is a novel method

to assist in successful PCI for uncrossable lesions and may serve as a

useful adjunct to previously published algorithms.

Declaration of competing interest

Jarrod Frizzell has received consulting fees and honoraria from Asahi

Intecc. Brett Wanamaker and James Kong report no ﬁnancial interests.

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 patient consented to de-identiﬁed use of pertinent information

and images.

References

1. Karacsonyi J, Karmpaliotis D, Alaswad K, et al. Prevalence, indications and

management of balloon uncrossable chronic total occlusions: insights from a

contemporary multicenter US registry. Catheter Cardiovasc Interv. 2017;90(1):12–20.

2. Riley RF, Walsh SJ, Kirtane AJ, et al. Algorithmic solutions to common problems

encountered during chronic total occlusion angioplasty: the algorithms within the

algorithm. Catheter Cardiovasc Interv. 2019;93(2):286–297.

3. Elrayes MM, Xenogiannis I, Nikolakopoulos I, et al. An algorithmic approach to

balloon-uncrossable coronary lesions. Catheter Cardiovasc Interv. 2021;97(6):

E817–E825.

4. Ribeiro MH, Dallan LAP, Boukhris M, et al. Excimer laser atherectomy in an

uncrossable long chronic total occlusion through the subintimal space. Acta

Cardiol. 2021;76(8):914–915.

Figure 1.

Extraplaque laser to assist in crossing

occlusions stepwise approach. (A) Chronic

total occlusion (CTO) of mid left anterior

descending (arrow) with bridging collateral

providing distal ﬂow in conjunction with

retrograde collaterals (not shown). (B) A 0.9-

mm Excimer laser (Philips) shown at the

point of subintimal entry over the Gladius

Mongo wire (Asahi Intecc), with continued

ablation until just distal to the CTO segment

(arrowhead). (C) A 1.5-mm rotational athe-

rectomy burr (ROTAPRO, Boston Scientiﬁc)

taken through the lesion. (D) Intravascular

ultrasound following the extraplaque laser to

assist in crossing occlusion method with

subsequent rotational atherectomy showing

subintimal space used in extraplaque laser to

assist in crossing occlusion (asterisk) and

disruption of circumferential calciﬁcation

adjacent to the dissection plane (arrow). (E)

Post–percutaneous coronary intervention

intravascular ultrasound at the site of CTO

showing full stent expansion and apposition.

(F) Angiography after percutaneous coronary

intervention showing no residual lesion.

2 J.D. Frizzell et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100983

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Original Research

First Human Use of Shockwave L6 Intravascular Lithotripsy Catheter in

Severely Calciﬁed Large Vessel Stenoses

J.D. Corl, MD, Douglas Flynn, RTR, Timothy D. Henry, MD, Dean J. Kereiakes, MD

The Heart and Vascular Institute and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio

ABSTRACT

Background: Intravascular lithotripsy (IVL) modiﬁes superﬁcial and deep vascular calcium by delivering pulsatile sonic pressure energy that fractures calcium

in situ with the consequent enhancement of transmural vessel compliance, limitation of ﬁbroelastic recoil, and optimization of stent implantation. To date, the

use of IVL as an adjunct to facilitat e stent implantation has been limited by large target vessel size and eccentricity of calcium distribution.

Methods: The Shockwave L6 IVL balloon delivery system includes 6 sonic energy emitters mounted on the shaft of a 30.0-mm long balloon with diameters

ranging from 8.0 to 12.0 mm. The balloon nominal pressure is 4 atm. We describe ﬁrst human use of this novel IVL delivery system to facilitate covered stent

implantation in severely calciﬁed stenoses involving the distal abdominal aorta and bilateral iliac arteries.

Results: Full IVL balloon expansion was achieved at low pressures (3 atm), despite the severity of calciﬁcation, with subsequent safe and effective covered

stent implantation.

Conclusions: The Shockwave L6 balloon seems to expand the application of IVL to the treatment of severely calciﬁed large vessels, such as the abdominal

aorta and iliac arteries.

Introduction

Advanced age and an increasing frequency of diabetes, systemic

hypertension, and chronic kidney disease contribute to an increased

prevalence and severity of vascular calciﬁcation.

Calciﬁed plaque

negatively affects procedural, early, and late clinical outcomes after

percutaneous vascular intervention. Moderate to severe vascular cal-

cium leads to stent underexpansion, asymmetry, and malapposition,

2,3

which may be associated with adverse clinical events such as restenosis

and thrombosis.

Multiple technologies have been developed to

modify vascular calciﬁcation with the intent to optimize stent expansion

and improve subsequent clinical outcomes.

4,5

These technologies have

been limited by target vessel size and the depth and eccentricity of

calcium distribution. Intravascular lithotripsy (IVL) modiﬁes both super-

ﬁcial and deep vascular calcium by delivering pulsatile sonic pressure

energy that fractures calcium in situ, thus enhancing transmural vessel

compliance and limiting ﬁbroelastic recoil with a subsequent optimi-

zation of stent expansion.

The safety and the effectiveness of IVL to

facilitate optimal coronary stent implantation and to enhance long-term

primary vessel patency after femoropopliteal peripheral vascular inter-

vention has been demonstrated in large-scale clinical trials and pooled

analyses of trials.

7-9

We report the ﬁrst human use of a novel, IVL de-

livery system designed to treat severely calciﬁed aortic and large pe-

ripheral artery stenoses.

Device description

The Shockwave L6 IVL catheter is purpose-built to address severe

calciﬁcation in large peripheral vessels (Central Illustration A). The

balloon catheter is offered in 4 inﬂated diameters—8.0, 9.0, 10.0, and

12.0 mm—all of which are 30.0 mm in length and feature 6 sonic energy

emitters incorporated into the shaft of the balloon. With its compact

emitter design, L6 offers a consistent, high sonic energy output across

the entire length of the balloon (Central Illustration B), which differs

from the energy proﬁle of the M5/M5þ IVL balloon (Central Illustration

C). The L6 is a 0.018-inch guide wire compatible to provide support

needed in large vessel interventions. The L6 provides low-pressure

lesion preparation to minimize complications related to barotrauma,

and IVL therapy can be delivered at 2-4 atm with a nominal pressure of 4

atm and rated burst pressure of 6 atm. The L6 balloon provides a

maximum of 300 sonic pressure pulses.

Abbreviations: CIA, common iliac artery; IVL, intravascular lithotripsy.

Keywords: calcium modiﬁcation; peripheral vascular intervention; vascular calciﬁcation.

* Corresponding author: Dean.Kereiakes@thechristhospital.com (D.J. Kereiakes).

https://doi.org/10.1016/j.jscai.2023.100969

Received 30 January 2023; Received in revised form 14 March 2023; Accepted 20 March 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) 100969

Case descriptions

Aortic case

A 65-year-old woman with a medical history of coronary artery dis-

ease, hyperlipidemia, hypertension, and diabetes mellitus was referred

for evaluation and treatment of severe, bilateral, lifestyle limiting

claudication in August 2022. An aortoiliac duplex study showed a

marked velocity elevation (~400 cm/s) in the distal abdominal aorta

consistent with a severe stenosis. Monophasic ﬂow was noted in the

bilateral iliac systems.

Diagnostic angiography through the right radial artery showed a

severely calciﬁed, 90% stenosis of the distal abdominal aorta, 75%

stenosis in the distal left superﬁcial femoral artery, and occluded

Central Illustration.

Shockwave L6 peripheral IVL balloon catheter. (A) Three channels with 6 emitters along the shaft of the 30 mm balloon. (B) Shockwave L6 sonic energy proﬁle, which is more

uniformly intense along the length of the balloon than observed with (C) the Shockwave M5/M5þ peripheral IVL balloon sonic energy proﬁle. The L6 IVL balloon has a unique sonic

energy proﬁle. Panel C reproduced with permission from Kereiakes et al.

Figure 1.

Abdominal aorta procedural components and imaging. (A, B) Computed tomography angiography (CTA) of abdominal aorta and iliac arteries. (C) Diagnostic angiogram abdominal

aorta. (D) Intravascular lithotripsy (IVL) of abdominal aorta using a 12.0-  30.0-mm Shockwave L6 balloon. (E) Deployment of 11.0-  39.0-mm Viabahn VBX balloon expandable

covered stent. (F) Final angiogram of abdominal aorta after IVL and stent deployment.

2 J.D. Corl et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100969

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anterior tibial arteries bilaterally. Abdominal computed tomography

angiography showed a heavily calciﬁed, greater than 90% stenosis of

the infrarenal abdominal aorta with a reference vessel diameter of 12.0-

14.0 mm (Figure 1A, B). Revascularization options such as both endo-

vascular and surgical approaches were discussed, and the patient was

referred for surgical consultation owing to the severity of vascular

calciﬁcation. She elected to proceed with an endovascular approach

because of the risks associated with surgery.

The patient returned to the catheterization laboratory for the inter-

ventional procedure in November 2022. A 25-cm 8F Brite Tip sheath

(Cordis) was placed through the right common femoral artery and a 5F

sheath was placed through the right radial artery. A 150.0-cm, 0.035-

inch NaviCross support catheter (Terumo) was advanced to the

abdominal aorta through the right radial sheath for angiographic im-

ages during the intervention. An abdominal angiogram was performed

(Figure 1C), and a 0.018-inch guide wire was advanced across the

abdominal aortic stenosis through the femoral sheath. IVL was per-

formed (180 pulses) in the abdominal aorta using a 12.0-  30.0-mm

Shockwave L6 balloon inﬂated to 3 atm (Figure 1D). An 11.0-  39.0-

mm Viabahn VBX balloon expandable covered stent (W.L. Gore) was

deployed in the abdominal aorta (Figure 1E) and postdilation per-

formed with a 14.0-  20.0-mm balloon. The ﬁnal abdominal aortogram

showed an excellent angiographic result (Figure 1F).

Common iliac artery case

A 74-year-old man with a medical history of coronary artery disease,

hypertension, diabetes, tobacco use, hyperlipidemia, obstructive sleep

apnea, and peripheral artery disease presented with severe bilateral

claudication symptoms. Noninvasive vascular study revealed obstruc-

tive peripheral artery disease involving the bilateral common iliac ar-

teries (CIAs).

Peripheral angiography from the right radial approach revealed

severely calciﬁed stenoses involving bilateral CIAs (Figure 2A, B), and

the decision was made to proceed with percutaneous revascularization.

Bilateral common femoral 8F sheaths were placed using ultrasound

guidance.

Intravascular ultrasound (IVUS) of right CIA revealed severe calciﬁ-

cation with lumen narrowing (Figure 2C) and a reference vessel diam-

eter of 11.7 mm (Figure 2D). The IVUS images of the left CIA also

showed a severely calciﬁed stenosis (Figure 2E) and a reference vessel

diameter of 10.98 mm (Figure 2F). IVL was performed (150 pulses

bilaterally) using a 12.0-  30.0-mm Shockwave L6 balloon inﬂated to 3

atm. Viabahn VBX balloon expandable covered stents were deployed

bilaterally followed by postdilation with a 12.0-mm diameter balloon in

both covered stents. The postinterventional aortogram showed an

excellent angiographic result (Figure 3A, B).

Figure 2.

Diagnostic imaging of bilateral iliac arteries. (A) Diagnostic angiogram of the right common iliac artery (CIA). (B) Diagnostic angiogram of left CIA. (C) Intravascular ultrasound (IVUS)

of severe, heavily calciﬁed stenosis in the right CIA. (D) IVUS of the right CIA reference vessel. (E) IVUS of severe, heavily calciﬁed stenosis in the left CIA. (F) IVUS of the left CIA

reference vessel.

J.D. Corl et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100969 3

Discussion

Both a severely calciﬁed abdominal aorta stenosis and bilateral CIA

stenoses were safely and effectively treated with the novel Shockwave

L6 balloon and Viabahn covered stents. Alternative treatment options

would have included either surgical grafting/endarterectomy or stan-

dard balloon angioplasty, followed by endovascular covered stent

deployment. Owing to the density of the calciﬁed plaque in these

cases, high-pressure balloon angioplasty would likely have been

necessary to achieve effective adequate predilation before stent

deployment. Balloon angioplasty in large, heavily calciﬁed vessels

carries signiﬁcant risks including atheroembolization, arterial dissection,

and perforation or vessel rupture. These risks are further increased when

high pressures are required. Perforation or rupture, speciﬁcally

involving the abdominal aorta and iliac arteries, may be particularly

catastrophic because direct manual compression cannot be applied.

IVL can facilitate effective in situ calcium fracture and plaque modiﬁ-

cation in severely calciﬁed stenoses without the complications associ-

ated with barotrauma from high-pressure balloon inﬂation.

7-9

Indeed,

low-pressure (3 atm) L6 balloon inﬂations achieved full balloon expan-

sion in both cases, and higher balloon pressures were not performed

until after covered stent implantation to optimize stent expansion.

In this context, it is important to note that the sonic pressure wave

proﬁle of L6 differs from that of the currently available M5/M5þ,S4or

C2 IVL catheters.

In the other catheters, the peaks of the sonic pressure

waves geographically correlate with the location of the emitters on the

shaft of the balloon catheters. The M5/M5þ has the highest sonic

pressure wave peak, which corresponds to the middle emitter on the

balloon shaft that has its own individual energy source (Central Illus-

tration C).

All other emitters are coupled and share a single energy

source between them. Because of the position of the emitters on the

shaft of the L6 balloon catheter, the sonic pressure wave peak is higher

and more uniform across the surface of the balloon delivery system

(Central Illustration B). These initial cases suggest that large vessel

(abdominal aorta and iliac artery) calcium modiﬁcation by the Shock-

wave L6 IVL balloon is feasible to facilitate stent deployment during

percutaneous vascular intervention. Although more clinical experience

is required, the Shockwave L6 balloon seems to expand application of

IVL to facilitate endovascular intervention in large vessels such as the

abdominal aorta and CIAs.

Peer review statement

Deputy Editor Dean J. Kereiakes had no involvement in the peer

review 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 Associate Editor Sahil A. Parikh.

Declaration of competing interest

J.D. Corl is a clinical investigator, speaker, and consultant for

Shockwave Medical and has equity holdings for Shockwave Medical.

Douglas Flynn and Timothy Henry have no relevant disclosures. Dean

Kereiakes is a consultant for Shockwave Medical.

Funding sources

There was no ﬁnancial support required or provided for this

research.

Ethics statement and patient consent

Both patients signed the informed consent forms before the pro-

cedure for transcatheter intervention including Shockwave IVL. These

procedures were performed as part of a limited product release of an

Figure 3.

Preinterventional and postinterventional angiograms. (A) Preinterventional angiogram of the bilateral iliac arteries. (B) Final angiogram of the bilateral common iliac arteries (CIA)

after intravascular lithotripsy (IVL) using a 12.0-  30.0-mm Shockwave L6 balloon with deployment of an 11.0-  39.0-mm Viabahn VBX balloon expandable covered stent in each CIA

and stent after dilation using a 12.0-mm balloon.

4 J.D. Corl et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100969

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