CORONARY INTERVENTIONS

T R A N S L AT I O N A L R E S E A R C H

EuroIntervention 2023;19-online publish-ahead-of-print May 2023

Configuration of two-stent coronary bifurcation techniques in
explanted beating hearts: the MOBBEM study
Stefano Cangemi1, MD; Francesco Burzotta1,2*, MD, PhD; Francesco Bianchini1, MD; Amanda DeVos3, BS;
Thomas Valenzuela3, PhD; Carlo Trani1,2, MD; Cristina Aurigemma2, MD, PhD; Enrico Romagnoli2, MD, PhD;
Jens Flensted Lassen4, MD, PhD; Goran Stankovic5, MD, PhD; Paul Anthony Iaizzo3, PhD
1. Department of Cardiovascular and Pulmonary Sciences, Università Cattolica del Sacro Cuore, Rome, Italy; 2. Department of
Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; 3. Visible Heart Laboratories,
Department of Surgery, University of Minnesota, Minneapolis, MN, USA; 4. Department of Cardiology B, Odense University
Hospital & University of Southern Denmark, Odense C, Denmark; 5. Department of Cardiology, Clinical Center of Serbia,
Belgrade, Serbia and Faculty of Medicine, University of Belgrade, Belgrade, Serbia
S. Cangemi and F. Burzotta contributed equally and should be considered co-first authors.

This paper also includes supplementary data published online at: https://eurointervention.pcronline.com/doi/10.4244/EIJ-D-22-00063

KEYWORDS
Abstract
Background: In patients with complex coronary bifurcation lesions undergoing percutaneous coronary
intervention (PCI), various 2-stent techniques might be utilised. The Visible Heart Laboratories (VHL) offer
• bifurcation
an experimental environment where PCI results can be assessed by multimodality imaging.
• coronary artery
Aims: We aimed to assess the post-PCI stent configuration achieved by 2-stent techniques in the VHL and
disease
to evaluate the procedural factors associated with suboptimal results.
• coronary
Methods: Bifurcation PCI with 2-stent techniques, performed by expert operators in the VHL on explanted
bifurcation lesion
beating swine hearts, was studied. The adopted bifurcation PCI strategy and the specific procedural steps
• culotte
applied in each procedure were classified according to Main, Across, Distal, Side (MADS)-2 and to their
• DK-crush
adherence to the European Bifurcation Club (EBC) recommendations. Microcomputed tomography (micro-
• drug-eluting stent
CT) was used to assess the post-PCI stent configuration. The primary endpoint was “suboptimal stent
• kissing balloon
implantation”, defined as a composite of stent underexpansion (<90%), side branch ostial area stenosis
inflation
>50% and the gap between stents.
• POT
Results: A total of 82 PCI with bifurcation stenting were assessed, comprised of 29 crush, 25 culotte,
• TAP
28 T/T and small protrusion (TAP) techniques. Suboptimal stent implantation was observed in as many as
53.7% of the cases, regardless of baseline anatomy or the stenting strategy. However, less frequent use of
the proximal optimisation technique (POT; p=0.015) and kissing balloon inflations (KBI; p=0.027) and no
DOI: 10.4244/EIJ-D-22-00063

adherence to EBC recommendations (p=0.004, p multivariate=0.006) were significantly associated with the
primary endpoint.
Conclusions: Commonly practised bifurcation 2-stent techniques may result in imperfect stent configura-
tions. More frequent use of POT/KBI and adherence to expert recommendations might reduce the occur-
rence of post-PCI suboptimal stent configurations.

*Corresponding author: Università Cattolica del Sacro Cuore, Largo Francesco Vito, 1, 00168 Roma, Italy.
E-mail: [email protected]

© Europa Digital & Publishing 2023. All rights reserved. SUBMITTED ON 23/01/2023 - REVISION RECEIVED ON 1st 25/03/2023 / 2nd 31/03/2023 - ACCEPTED ON 03/04/2023

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Abbreviations connected to an ex vivo Visible Heart apparatus10,11. Subsequently,

CBL coronary bifurcation lesions each heart was warmed and perfused with a Krebs-Henseleit
DES drug-eluting stent buffer and then defibrillated with an ~30 J shock to induce a sinus
EBC European Bifurcation Club rhythm. Next, bifurcation PCI was performed on the reanimated
KBI kissing balloon inflation hearts under multimodality imaging guidance with standard fluoro-
Micro-CT microcomputed tomography scopy (OEC Elite Fluoroscopy). Intracoronary angioscopy was
MSE minimum stent expansion performed in parallel, using 2.4 and 4.0 mm fiberscopes (Olympus
MV main vessel Corporation) placed immediately proximal to the bifurcation to
PCI percutaneous coronary intervention allow direct intracoronary visualisation of each procedural step.
POT proximal optimisation technique After ex vivo stenting procedures were performed on a given study
SB side branch day, each heart was then fixed in an end-diastolic state using a for-
VHL Visible Heart Laboratories malin fixation chamber in order to keep the coronaries patent and
to allow for the subsequent micro-CT scanning. Experiments were
Introduction executed in accordance with the most recent recommendations of
The improvement of percutaneous coronary intervention (PCI) the “Guide for the Care and Use of Laboratory Animals”12, and
for coronary bifurcation lesions (CBL) is a hot topic in interven- the animal research protocol used in this laboratory was reviewed
tional cardiology1. The implantation of 1 drug-eluting stent (DES) and approved by the University of Minnesota Institutional Animal
in the main vessel (MV) represents the gold standard for unse- Care and Use Committee.
lected CBL, while 2-stent techniques − the implantation of DES
in both the MV and the side branch (SB) − are often needed to PCI IN CORONARY BIFURCATIONS
treat complex bifurcation lesions2,3. Of note, a variety of 2-stent Expert interventional cardiologists from all over the world
techniques have been described, and various sequences of the pro- were invited to the VHL and performed the procedures under
cedural steps can be adopted for their implantation4,5, potentially the guidance of standard fluoroscopy (OEC Elite Fluoroscopy).
affecting the final stent configuration achieved5. Thus, the assess- Commercially available guiding catheters, guidewires (Cougar/
ment of bifurcation stenting techniques in experimental settings Thunder/Zinger; Medtronic), balloons (Euphora and Euphora
might help to identify the most valuable technical sequences6. For NC; Medtronic) and DES (Resolute Onyx and Resolute Integrity;
such scenarios, the Visible Heart Laboratories (VHL) provides an Medtronic) were used.
experimental environment where bifurcation stenting techniques The exclusion criteria were 1) intended bifurcation stenting
can be practised in a setting similar to a clinical one and evalu- technique other than crush, culotte, or T/T and small protusion
ated using unique multimodal imaging modalities7-9. In the present (TAP); and 2) the absence of complete video recordings allowing
study, we assessed the post-PCI stent configuration achieved by a reconstruction of the sequence of interventions performed dur-
2-stent techniques practised in the VHL and evaluated the proce- ing the procedure.
dural factors associated with suboptimal results.
MULTIMODAL IMAGING
Methods During the procedure, intracoronary angioscopy, using 2.4 and
The aim of the MultimOdality two-stent Bifurcation techniques 4.0 mm fiberscopes (Olympus Corporation), was placed proximal
comparison in a BEating heart Model (MOBBEM) study was to to the bifurcation in order to allow direct intracoronary visuali-
assess, through microcomputed tomography (micro-CT), the proce- sation of each procedural step. In parallel, a multichannel digital
dural results obtained by expert operators practising different 2-stent recording system continuously registered heart function and oper-
bifurcation techniques in an explanted beating heart model and to ator technique. After the stenting procedures, the hearts were fixed
identify the procedural predictors of suboptimal stent implantation. using a formalin fixation chamber9, which preserved them in an
end-diastolic state, keeping the coronaries well dilated. After fixa-
VISIBLE HEART LABORATORIES METHODOLOGIES tion, the hearts were scanned with an X3000 micro-CT scanner
The study was conducted at the Visible Heart Laboratories (VHL; (North Star Imaging) that allowed for computational stent recon-
University of Minnesota, Minneapolis, MN, USA). VHL performs structions with approximately 20-micron resolution. From these
experimental research in which harvested porcine and human scans, the resulting stent(s) and anatomies were three-dimension-
hearts are reanimated and attached to supporting equipment that ally (3D) reconstructed, segmented, and rendered using medical
permits them to beat outside the body for 6-8 h, thus, providing imaging software (Mimics; Materialise).
enough time to perform bifurcation PCI7-9. In the present study,
adult healthy swine (70-95 kg) were anaesthetised and intubated, TWO-STENT TECHNIQUE ASSESSMENT
then, after exposition of the heart through a medial sternotomy, Two-stent techniques were practised according to the individual dis-
cardioplegia was delivered via aortic root cannulae. The heart cretion of different interventional cardiologists. For the present study,
was then explanted, and all major vessels were cannulated and all procedural images (angioscopy, video camera recordings) were

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EuroIntervention 2023;19-online publish-ahead-of-print May 2023

reviewed by a trained interventional cardiologist in order to establish were used to divide the procedures into those following EBC best
the intended bifurcation stenting technique and ensure that the spe- practice recommendations, or not3,5. In particular, procedures were
cific sequence of ballooning steps applied were classified according considered to adhere to EBC recommendations when the follow-
to the Main, Across, Distal, Side (MADS)-2 classification5. In par- ing steps for each of the 2-stent techniques were applied:
ticular, the following data were collected for each PCI performed: − T/TAP: MV stent-POT-KBI-SB stent-POT-KBI (T/TAP on top
− anatomical data, including type of vessels involved (left main of provisional with final POT only in the case of sufficient space
bifurcation, left anterior descending artery-first diagonal, cir- that does not reach the carina);
cumflex artery-left marginal artery, right coronary artery-acute − culotte: first stent-POT-KBI-second stent-POT-KBI-POT (i.e.,
marginal artery/posterior descending artery), angles of the bifur- culotte with triple POT and double KBI);
cations and diameters of the vessels; − crush: SB stent-POT-KBI-MV stent-POT-KBI-POT (i.e., double
− the number, dimensions and type of balloons and stents used; kissing [DK]-crush with the crushing balloon size similar to the
− the planned stenting technique that included the following families POT balloon size)
of commonly adopted 2-stent techniques: crush, culotte, T/TAP; Ballooning steps (including POT and KBI) were performed using
− the type and number of bifurcation-specific ballooning steps non-compliant or semicompliant balloons, according to the opera-
adopted during the procedure, including proximal optimisation tor’s preference.
technique (POT), kissing balloon inflation (KBI) or isolated side
branch dilation. PROCEDURAL RESULT ASSESSMENT AND PRIMARY STUDY
Double-stenting techniques performed in this study were as ENDPOINT
follows: For the present study, the postprocedural micro-CT examinations
− T/TAP: stenting of the “operative” main vessel and distal rewir- were assessed (blind to the procedural steps applied), focusing
ing of the jailed branch13, followed by ballooning and the on a bifurcation’s region of interest (ROI) that comprised the
implantation of the second stent in the SB aiming to cover its 5 mm of the MV proximal to the SB take-off, the first 5 mm
ostium (and in case of TAP, accepting the creation of a possible of the distal MV after the SB take-off and the first 5 mm of the
small neocarina, with a balloon ready for kissing in the other SB (Figure 1). The bifurcation angle was measured analysing
vessel); the 3D images obtained at postprocedural micro-CT (heart fixed
− culotte: overlapping stents in the proximal MV from either SB in an end-diastolic state). The quantitative analyses performed
and distal MV stents, regardless of the length of stent overlap in the ROI were focused to detect stent underexpansion, SB
and the order of first stent implantation (SB or distal MV); ostial area stenosis, and gaps between stents. Underexpansion
− crush: the first stent was deployed in the SB, protruding into the was defined as a minimal stent area (minimal luminal area in
MV, followed by its crush using an MV balloon. the stented segment) <90% of the reference minimal lumen in
While the stent implantation phases were used to classify the pro- the three examined segments (proximal MV, distal MV and SB)
cedures into the three groups, the sequence of ballooning steps (Figure 2A)14. The ostial area free of stent struts was measured

PCI with common 2-stent techniques Video recordings analysed (blind Micro-CT of the final stent
practised in the VHL by different to the final stent configuration configuration achieved performed
invited operators achieved) and procedures classified and quantitatively analysed (blind
according to MADS-2 to the procedure steps)

SB

Proximal MV

POT Side Kissing

Distal MV

Figure 1. Outline of the study design. MADS: Main, Across, Distal, Side classification; micro-CT: microcomputed tomography; MV: main
vessel; PCI: percutaneous coronary intervention; POT: proximal optimisation technique; SB: side branch; VHL: Visible Heart Laboratories

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from the 3D projection of the SB ostium and defined as the ratio Results
of the area of the largest opened stent cell to the referential SB CHARACTERISTICS OF TREATED BIFURCATIONS AND OF
lumen area15 (Figure 2B). Planimetric ostial area stenosis was BIFURCATION STENTING PROCEDURES
defined as the area outside of the largest opened stent cell (ref- Out of 102 consecutive procedures with 2-stent techniques per-
erential SB lumen area-the largest opened stent cell lumen area) formed in the VHL between 2017 and 2022, a total of 82 bifurcation
divided by the referential SB lumen area (Figure 2B). Significant PCI with planned 2-stent techniques were enrolled in the study (see
SB ostium stenosis was defined as planimetric ostial area steno- selection algorithm in Supplementary Figure 1). The characteristics
sis >50% of the reference. Since the intention of dual stenting of the treated bifurcations are reported in Table 1. The left anterior
techniques is to entirely cover the coronary bifurcation with stent descending artery (LAD)-diagonal was the most common bifurcation
struts, the bifurcation area not covered by stent struts was called treated followed by the left circumflex artery (LCx)-obtuse marginal
the “stent gap”. A significant stent gap was defined as a distance bifurcation. The treated bifurcations were large, with a mean vessel
between stent struts >1 mm with a partial (>180°) to circumfer- size of 4.0 mm in the proximal MV, 3.4 mm in the distal MV and
ential (360°) pattern in the ROI (Figure 2C). The primary end- 2.7 mm in the SB. The crush technique was used in 29 bifurcations
point of the study was “suboptimal stent implantation”, defined
as a composite endpoint of stent underexpansion (in the proxi-
Table 1. Baseline characteristics.
mal or distal MV or SB), SB ostium stenosis and stent gap. The
individual components of the primary endpoint constituted the Parameters
secondary endpoints of the study. Number of bifurcations treated 82 (100)
Left main bifurcation 4 (4.9)
STATISTICAL ANALYSIS LAD-diag 39 (47.6)
Continuous variables were reported as means±standard devia- LCx-OM1 21 (25.6)
tion if normally distributed or medians and quartiles otherwise; RCA-acute marg/PDA 19 (23.2)
discrete variables were reported as raw number and percent- Proximal bifurcation angle (between proximal MV and SB), ° 134.7±15.7
ages. The Student’s t-test, the Mann-Whitney U test, and χ2 tests Distal bifurcation angle (between distal MV and SB), ° 55.0±15.8
were used for bivariate analysis, as appropriate. Multivariable Distal bifurcation angle <70° 65 (79.3)
logistic regression was used to identify independent predictors Proximal MV reference diameter, mm 4.0±0.5
of the prespecified study endpoints. Any multivariable regres- Distal MV reference diameter, mm 3.4±0.4
sion model included all variables results nominally significant SB reference diameter, mm 2.7±0.5
at bivariate association with the endpoint itself. All data ana- Data are expressed as mean±standard deviation or n (%). diag: diagonal; LAD: left
lyses were conducted using statistical software SPSS-PASW 23 anterior descending artery; LCx: left circumflex artery; marg: marginal; MV: main vessel;
OM1: first obtuse marginal artery; PDA: posterior descending artery; RCA: right coronary
(IBM), and a two-tailed p-value <0.05 was considered statisti- artery; SB: side branch
cally significant for all tests.

A Stent underexpansion B SB ostial stenosis C Stent gap

MSA <90% of reference (reference SB ostium lumen area- (distance between stent
(MV or SB) lumen area largest opened stent cell lumen area / struts >1 mm >180°)
reference SB ostium lumen area >50%)

Reference area
MSA
5 mm

Largest opened stent cell lumen area

MSA Reference area

Reference SB lumen area

Figure 2. Suboptimal stent implantation features definitions. A) Stent underexpansion. B) SB ostial stenosis. C) Stent gap. MSA: minimum stent
area; MV: main vessel; SB: side branch

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(35.4%), the culotte in 25 (30.5%) and T/TAP in 28 (34.1%). The imperfections that are detailed in Table 3. Despite the experi-
procedural characteristics are reported in detail in Table 2. At least mental setting and the absence of atherosclerosis, stent under-
one POT and KBI was performed in each procedure. In the entire expansion was detected in 36.6% of cases, planimetric ostial
study, the average number of POT was 2.0 and the average number area stenosis in 15.9% and a stent gap in 13.4%. Therefore, the
of KBI was 1.5, thus reflecting the relevance of these ballooning primary study endpoint of suboptimal stent result was found in
techniques in common 2-stent technique practice. Overall, 56 pro- as many as 53.7% of the treated bifurcations. The occurrence
cedures (68.3%) were performed using the sequence of balloon- of suboptimal stent implantation was not significantly different
ing steps recommended by EBC best practices. Of note, adherence regardless of baseline bifurcation characteristics (Supplementary
to EBC recommendations differed across the different techniques: Table 2) or the intended bifurcation stenting technique (Table 3,
14/29 for crush, 18/25 for culotte, and 24/28 for T/TAP (p<0.001). Figure 3). However, suboptimal stent expansion was also assoc-
iated with other adverse stent configuration features, such as
SUBOPTIMAL STENT IMPLANTATION AND ITS PREDICTORS longer metallic neocarinas (p=0.001) and higher ellipticity indi-
Supplementary Table 1 reports the overall micro-CT postpro- ces at the distal MV (p=0.001). When assessing the procedural
cedural features observed. The stent configuration achieved predictors of suboptimal stent implantation, in univariate analy-
after PCI was characterised by the presence of a series of sis, less frequent use of POT (p=0.013) and KBI (p=0.019) and
the absence of adherence to EBC recommendations were the
Table 2. Procedural characteristics. only significant factors (Table 4). In the multivariate analysis,
Techniques Value a lack of adherence to EBC recommendations was the only sta-
Crush 29 (35.4) tistically significant predictor of suboptimal stent implantation
Culotte 25 (30.5) (odds ratio [OR] 0.225, 95% confidence interval [CI]: 0.078-
0.646; p=0.006). Figure 4 shows three examples of micro-CT
Inverted Culotte 12 (14.6)
achieved with the main techniques (crush, culotte and T/TAP),
T/TAP 28 (34.1)
practised according to EBC recommendations, demonstrating
Inverted T/TAP 1 (1.2)
successful stent implantation.
Stent implanted size, mm 3.5±0.6
in the MV
length, mm 21.4±5.9
PREDICTORS OF SECONDARY ENDPOINTS
Stent implanted size, mm 2.7±0.5
in the SB
A series of procedural characteristics were associated with stent
length, mm 16.9±4.1
underexpansion, including the use of culotte technique (protec-
POT Balloon-to-artery ratio 1.1±0.6 tive factor; p=0.010), the use of crush technique (risk factor;
characteristics^
Atmospheres 15.0±3.8 p=0.035), lower incidence of POT (p=0.001), lower incidence of
Kissing balloon MV balloon to distal MV artery ratio 1.0±0.1 KBI (p=0.030), and lack of adherence to EBC recommendations
inflation
characteristics^
SB balloon to SB artery ratio 1.0±0.1 (p=0.007). In the multivariable analysis, only less frequent use of
Atmospheres 13.2±2.3 POT independently predicted the occurrence of stent underexpan-
Number of isolated SB dilations 0.9±0.6 sion (OR 0.435, 95% CI: 0.220-0.861; p=0.017). Stent gap was
Number of POT(s) 2.0±0.9 significantly influenced by baseline characteristics (more common
Number of kissing(s) 1.5±0.6 in the procedures performed in the LCx-OM1 [first obtuse marginal
EBC recommendations followed 56 (68.3) artery] bifurcation; p=0.018; and less common in LAD bifurcations;
Data are expressed as mean±standard deviation or n (%). ^in the case of p=0.006). In the multivariable analysis, only stenting performed in
multiple POT or kissing balloon inflations, the reported values are those the LCx-OM1 bifurcation independently predicted the occurrence
used in the last inflation. EBC: European Bifurcation Club; MV: main
vessel; POT: proximal optimisation techniques; SB: side branch; T/ of a stent gap (OR 0.087, 95% CI: 0.011-0.715; p=0.023). Finally,
TAP: T/T and small protusion no significant predictor of ostial SB stenosis was recognised.

Table 3. Study endpoints.

Postprocedural adverse features Total T/TAP (n= 28) Culotte (n=25) Crush (n=29) p-value
Stent underexpansion (<90%) 30 (36.6) 11 (39.3) 4 (16.0) 15 (51.7) 0.023
– Proximal MV underexpansion 5 (6.1) 2 (7.1) 0 3 (10.3) 0.274
– Distal MV underexpansion 13 (15.9) 5 (17.8) 2 (8.0) 6 (20.7) 0.417
– Side branch underexpansion 21 (25.6) 9 (32.1) 3 (12.0) 9 (31.0) 0.173
SB ostial area stenosis (>50%) 13 (15.9) 3 (10.7) 4 (16.0) 6 (20.7) 0.588
Stent gap (>1 mm for >180°) 11 (13.4) 5 (17.8) 4 (16.0) 2 (6.9) 0.432
Suboptimal stent result (primary endpoint) 44 (53.7) 17 (60.7) 10 (40.0) 17 (58.6) 0.256
Data are expressed as n (%). MV: main vessel; SB: side branch; T/TAP: T/T and small protrusion

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A %
100
B
90

80 p=NS p multiv=0.006
70

60

50

40

30

20

10

0
Crush Culotte T/TAP EBC EBC
recommendations recommendations
not followed followed

Figure 3. Suboptimal stent implantation. Suboptimal stent implantation according to 2-stent technique (A) and adherence to EBC
recommendations during PCI (B). EBC: European Bifurcation Club; PCI: percutaneous coronary intervention; T/TAP: T/T and small
protrusion

Table 4. Predictors of suboptimal stent results.

patients receiving 2 stents are known to have an increased risk
Technical Suboptimal Optimal p-value p-value of late stent thrombosis16 and mortality17. Accordingly, the search
characteristics stent result stent result univariate multivariate
for improvements in PCI technique for these patients is ongoing.
Number of POT(s) 1.8±0.9 2.2±0.8 0.015 -
To this end, the present study conducted in a preclinical, unique,
Number of kissing experimental PCI simulation setting showed that:
1.4±0.6 1.7±0.5 0.027 -
balloon inflations
− the practice of 2-stent techniques are not warranted to achieve
EBC
recommendations 24 (42.9) 32 (57.1) 0.004 0.003 the intended stent conformation (considering that, a “suboptimal
followed stent result” is often detected by micro-CT at the procedure’s
Data are expressed as mean±standard deviation or n (%). EBC: European Bifurcation end);
Club; POT: proximal optimisation technique
− the application of (repeated) bifurcation PCI-specific ballooning
techniques (namely POT and KBI) is probably more important
Discussion for successful stent implanation than stenting technique selection;
Two-stent techniques are commonly adopted during PCI for coro- − a series of recommended sequences for POT and KBI, which
nary bifurcation lesions with high anatomical complexity. Yet, have been developed in recent years and are recommended by

(DK) CRUSH CULOTTE T/TAP

Figure 4. Examples of post-PCI micro-CT obtained with the three different 2-stent techniques conducted according to EBC recommendations.
DK: double kissing; EBC: European Bifurcation Club; micro-CT: microcomputed tomography; PCI: percutaneous coronary intervention;
T/TAP: T/T and small protrusion

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expert consensus, might enhance the efficacy of popular tech- to EBC recommendations. As a final remark, the overall clini-
niques like crush, culotte and T/TAP. cal impact of the suboptimal stent configurations found in the
Within the limits of results stemming from an animal exper- present study cannot established. Indeed, when high resolution
imental model, these findings provide original, useful insights imaging is applied in clinical practice, post-PCI imperfections
regarding 2-stent techniques. are often seen in successful bifurcation stenting procedures using
Bifurcation PCI is a hot topic in interventional cardiology and 1-stent techniques as well20.
preclinical evaluations of stenting techniques may safely gener-
ate important insights1. Among the different possible experimen- Limitations
tal settings, VHL is particularly interesting as it allows operators This preclinical ex vivo model derived from reanimated swine
to practise stenting techniques in an environment almost identi- hearts has intrinsic limitations, considering that bifurcation PCI
cal to a clinical one7. The interest generated by this model among were performed on healthy porcine coronary arteries, character-
bifurcation stenting experts prompted many committed interven- ised by increased elasticity and/or compliance of the vessel wall
tional cardiologists to visit the VHL and to practise bifurcation that might have increased the stress to the stents and emphasised
PCI, including 2-stent techniques. Among different imaging the effects of balloon-induced modifications. Furthermore, bal-
modalities available in the VHL9, micro-CT is the highest reso- loon and stent placement were monitored using angiography and
lution 3D modality, allowing a precise assessment of post-PCI angioscopy according to the operators’ discretion, but familiar-
stent conformation. Thus, we adopted this methodology to search ity with angioscopy cannot come from clinical practice so its
for stent imperfections like underexpansion, uncovered areas eventual use during procedural steps might have represented
and SB ostium obstruction that are undesired in 2-stent tech- a possible confounder. Finally. this is a retrospective study of
niques but are seldom recognised as causes of clinical failures prospectively recorded procedures performed without a dedi-
by intracoronary imaging. The major finding was that 2-stent cated research protocol, so the occurrence of unrecognised bias
techniques are associated with a disturbingly high rate of tech- cannot be ruled out.
nical imperfections (53.7%), even when performed in healthy
coronary artery bifurcations by expert operators. In this field, Conclusions
comparisons between different proposed stenting techniques are This study using the unique preclinical environment offered by
often undertaken with the aim of determining which technique VHL shows that, despite the absence of atherosclerosis, dif-
has a better clinical performance18. Yet, in the present experi- ferent 2-stent bifurcation techniques in a beating heart might
mental model where experts practised the techniques they sub- commonly result in imperfect stent configurations. A higher
sequently came to master, imperfect stent implantantion results number of POT/KBI and best practice recommendations
were not significantly different between the three major fami- might reduce the occurrence of suboptimal stent configura-
lies of techniques (crush, culotte and T/TAP), which are often tions. These findings might be useful in bifurcation PCI prac-
regarded as completely different from an operative point of view. tice and need to be further evaluated in clinical settings.
This finding fits with other experimental studies19 and supports
the concept of the inherent imperfection shared by 2-stent tech-
niques (all are affected by the need to completely change the
Impact on daily practice
PCI for complex coronary bifurcation lesions is a clinical chal-
DES geometry). Moving from technique selection to the spe-
lenge and 2-stent techniques requiring multiple steps are often
cific modality of its realisation, different operators practise the
needed. The MOBBEM study evaluated the stent configura-
same techniques using different ballooning steps. For instance,
tion achieved after PCI with 2-stent techniques in explanted
the ballooning steps are recognised to be pivotal for stent defor-
beating hearts via micro-CT. Despite a favourable experimen-
mations needed during bifurcation stenting3,5. Accordingly, we
tal environment for 2-stent techniques (no atherosclerosis,
found that multiple POT and KBI are useful during all 2-stent
no clinical environment), suboptimal stent implantation was
techniques to achieve the best technical result. In this regard,
observed in as many as 53.7% of cases and should call maxi-
the sequence of ballooning steps might have a pivotal role. Over
mum attention to the clinical practice of 2-stent techniques. In
years, the EBC reviewed available data on technical steps and
the study, neither baseline anatomy nor the stenting strategy
developed recommendations regarding best practices for popu-
influenced the occurrence of suboptimal stent implantation.
lar 2-stent techniques3,5. Such recommendations comprised the
However, less frequent usage of bifurcation PCI-specific bal-
use of multiple POT and KBI and also highlighted sequences for
looning techniques (POT and KBI) was more closely assoc-
their application that might facilitate the achievement of the opti-
iated with suboptimal stent implantation. Finally, a series of
mal result. The value of such recommendations is supported by
recommended sequences for POT and KBI, developed during
the present study in which the performance of PCI in accordance
the past years and recommended by expert consensus, might
with them was significantly associated with reduced occurrence
enhance the efficacy of popular techniques like crush, culotte
of imperfect stent implantation results. Figure 4 shows micro-
and T/TAP.
CT examples of successful bifurcation techniques that adhered

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EuroIntervention 2023;19-online publish-ahead-of-print May 2023

Funding 8. Iles TL, Burzotta F, Lassen JF, Iaizzo PA. Stepwise visualisation of a provisional
bifurcation stenting procedure - multimodal visualisation within a reanimated human
This research was supported in part via an educational grant from
heart utilising Visible Heart methodologies. EuroIntervention. 2020;16:e734-7.
the University of Minnesota’s Medical School as well as from the 9. Valenzuela TF, Burzotta F, Iles TL, Lassen JF, Iaizzo PA. Assessment of single and
Institute for Engineering in Medicine. The work was also sup- double coronary bifurcation stenting techniques using multimodal imaging and 3D
modeling in reanimated swine hearts using Visible Heart® methodologies. Int J
ported via a research contract with Medtronic PLC, who also Cardiovasc Imaging. 2021;37:2591-601.
donated all the stenting supplies. 10. Hill AJ, Laske TG, Coles JA Jr, Sigg DC, Skadsberg ND, Vincent SA, Soule CL,
Gallagher WJ, Iaizzo PA. In vitro studies of human hearts. Ann Thorac Surg.
2005;79:168-77.
Conflict of interest statement
11. Spencer JH, Sundaram CC, Iaizzo PA. The relative anatomy of the coronary arterial
F. Burzotta received speaker fees from Abbott Vascular, Abiomed, and venous systems: implications for coronary interventions. Clin Anat. 2014;27:
Medtronic, and Terumo. C. Trani received speaker fees from Abbott 1023-9.
Vascular, Abiomed, Medtronic, Chiesi, Boston Scientific, and Terumo. 12. National Research Council (US) Committee for the Update of the Guide for the
Care and Use of Laboratory Animals. Guide for the Care and Use of Laboratory
C. Aurigemma received speaker fees from Abbott Vascular, Abiomed, Animals. 8th ed. Washington (DC): National Academies Press (US); 2011.
Medtronic, Terumo, and Daiichi Sankyo. E. Romagnoli received speaker 13. Burzotta F, De Vita M, Sgueglia G, Todaro D, Trani C. How to solve difficult side
fees from Abbott Vascular and Terumo. T. Valenzuela has a contract branch access? EuroIntervention. 2010;6 Suppl J:J72-80.

with Medtronic. J.F. Lassen has received speaker fees from Medtronic, 14. Ali Z, Landmesser U, Karimi Galougahi K, Maehara A, Matsumura M,
Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG,
Boston Scientific, and Abbott. G. Stankovic has received speaker fees Wijns W, Mintz GS, Ben-Yehuda O, McGreevy RJ, Zhang Z, Rapoza RR, West NEJ,
from Medtronic, Abbott, Boston Scientific, and Terumo. P.A. Iaizzo Stone GW. Optical coherence tomography-guided coronary stent implantation com-
pared to angiography: a multicentre randomised trial in PCI - design and rationale of
has a research contract with, and serves as an educational consult- ILUMIEN IV: OPTIMAL PCI. EuroIntervention. 2021;16:1092-9.
ant for Medtronic. F. Bianchini receives a research grant from Abbott 15. Ormiston JA, Webster MW, Webber B, Stewart JT, Ruygrok PN, Hatrick RI. The
Vascular. The other authors have no conflicts of interest to declare. “crush” technique for coronary artery bifurcation stenting: insights from micro-com-
puted tomographic imaging of bench deployments. JACC Cardiovasc Interv. 2008;1:
351-7.
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6. Antoniadis AP, Mortier P, Kassab G, Dubini G, Foin N, Murasato Y,
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EuroIntervention. 2015;11:V40-3. doi/10.4244/EIJ-D-22-00063

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Supplementary data

Supplementary Table 1. Postprocedural conformation achieved by the 2 implanted stents as

assessed by micro-CT.

POST-PROCEDURAL STENT
Mean ± SD
CHARACTERISTICS

Stent to artery ratio in the proximal MV 1.08 ± 0.17

Stent to artery ratio in distal MV 1.04 ± 0.21

Stent to artery ratio in the SB 0.95 ± 0.17

Ellipticity index proximal MV 1.27 ± 0.12

Ellipticity index in the distal MV 1.22 ± 0.21

Ellipticity index in the SB 1.25 ± 0.22

Metallic carina length (mm) 1.7 ± 1.0

MV: main vessel; SB: side branch

Supplementary Table 2. Stent result according to baseline bifurcation characteristics.

PARAMETERS
Suboptimal stent Optimal stent
P
result result

Left Main 3 (6.8%) 1 (2.6%) 0.365

LAD-DIAG 19 (43.2%) 20 (52.6%) 0.264

LCX-OM 11 (25.0%) 10 (26.3%) 0.545

RCA- Acute Marg/PDA 12 (27.3%) 7 (18.4%) 0.248

Bifurcation Angle < 70° 35 (79.5%) 30 (78.6%) 0.5

Proximal MV Reference Diameter 3.895 ± 0.5 3.857 ± 0.514 0.301

Distal MV Reference Diameter 3.369 ± 0.398 3.422 ± 0.441 0.574

SB Reference Diameter 2.715 ± 0.506 2.767 ± 0.422 0.617

Data are expressed as n (%). LAD: Left Anterior Descending artery; DIAG: diagonal; LCX: Left

Circumflex artery; OM: Obtuse Marginal; RCA: Right coronary artery; PDA: Posterior Descending

artery; Marg: marginal; MV: main vessel; SB: side branch

Supplementary Figure 1. MOBBEM study algorithm.