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j.jacc.2017.09.090

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
B18
was 77.49.4 years, 92 (76%) were man, median NYHA class was 3.0
(IQR 3.0-3.0), mean LVEF was 50.613.9% and mean aortic gradient
was 40.814.8 mmHg. Trans-femoral access was used in 86 (71.1%)
patients, a trans-apical in 31 (25.6%), a subclavian in 3 (2.5%) and a
trans-aortic in 1 (0.8%). Mean mitro-aortic distance at CT was
8.34.1 mm. An aortic balloon-expandable valve was used in 74 (61%)
cases. Mean size of employed aortic prostheses was 26.33.2 mm, a
mean of 160.18.1 ml of iodine contrast was used, and procedures
took a mean of 97.058.2 min. Procedural success was achieved in 114
(94%) patients, with effective reduction of mean aortic gradients
(10.17.8 vs 40.814.8 mmHg; p<0.001). Balloon predilatation was
performed in 52 (43%) patients. No cases of post-procedural severe
aortic regurgitation or device embolization were observed. Balloon
post-dilatation was needed in 18 (15%) patients. One case of surgery
conversion was needed. 4 patients needed a second valve implanted.
No cases of mitral prosthesis malfunctioning due to TAVR were reported. We observed 7 (5%) cases of in-hospital death. Median hospital stay length was 9 (range 1-65) days. 7 (5%) patients needed a new
permanent pacemaker implantation. 3 (2.5%) periprocedural strokes,
10 (8%) major vascular complications, 10 (8%) major bleedings and 1
(0.8%) case of periprocedural myocardial infarction occurred. No
differences in outcomes were found between patients with mitral
mechanical or biological prostheses. At a median follow-up of
20.412.5 months, 21 (17.5%) deaths occurred. Of these, 11 (9.2%) were
cardiac-related (mostly due to advanced heart failure). However, 1
was related to mitral prosthesis dysfunction and 1 to mitral prosthesis
thrombosis. No cases of stroke or myocardial infarction and no cases
requiring repeat cardiac surgery were recorded. 17 (14.2%) patients
were subsequently hospitalized due to heart failure. Overall, at
follow-up, a significant NYHA class reduction to 2.0 (IQR 2-3) vs 3.0
(IQR 3.0-3.0); p<0.001 was noted and mean aortic gradients remained
significantly lower (8.94.6 vs 42.915.1 mmHg; p<0.001) than
baseline.
CONCLUSION To our knowledge this is the largest case-series
reporting on TAVR procedural and clinical outcomes in the setting of
PMP. Our preliminary analyses show how the procedure is feasible
and safe, with low rates of complications. Benefits of TAVR intervention were maintained at follow-up, even in this potentially higher
risk subgroup of patients.
CATEGORIES STRUCTURAL: Valvular Disease: Aortic
INTRAVASCULAR IMAGING AND PCI
Abstract nos: 41 - 44
TCT-41
Initial Pre-clinical Porcine and Ex-Vivo Human Coronary Images
with a Hybrid Intravascular Ultrasound and Optical Coherence
Tomography System
Brian Courtney,1 Brian Li,2 Natasha Alves-Kotzev,2 Mark Harduar,3
M. Saleem,3 Jill Weyers,2 Angela Kim,2 Amandeep Thind,4
Jagdish Butany5
1
Sunnybrook Research Institute and Conavi Medical Inc., Toronto,
Ontario, Canada; 2Sunnybrook Research Institute, Toronto, Ontario,
Canada; 3Conavi Medical Inc., Toronto, Ontario, Canada; 4Conavi
Medical Inc, Toronto, Ontario, Canada; 5University Health Network,
Toronto, Ontario, Canada
BACKGROUND Intravascular ultrasound (IVUS) and optical coherence
tomography (OCT) are widely used to image coronary arteries, plaque
and devices, but are currently only available on separate catheters and
systems. Hybrid IVUS OCT may facilitate a practical approach to collecting the high resolution and high-contrast images of OCT along
with the deeper penetration depth of IVUS.
METHODS A 2.8F imaging system was developed that collects inherently co-registered 40 MHz IVUS and OCT images at up to 100 frames
per second. Coronary arteries were harvested from formalin-fixed
hearts at autopsy under an REB approved protocol and imaged via
hybrid IVUS-OCT pullback. Histology was performed for comparison
using H&E and Masson’s Trichrome staining. The system was also
tested in vivo in porcine coronary arteries under an Animal Care
Committee approved protocol.
RESULTS Co-registered images of a range of pathologies were
generated using IVUS, OCT and histology, including normal sections,
deep and superficial calcifications, fibroatheromas with thin and thick
caps, early-staged lesions and stent thrombosis. Pullback was performed in a porcine animal model, including the demonstration of
stent malapposition. The left panel in the figure demonstrates an in
vivo IVUS image of a stented artery, while the right panel is the corresponding OCT image. Both images were acquired simultaneously at
the same cross-section.
CONCLUSION In vivo imaging of coronary anatomy using a hybrid
IVUS OCT catheter and system is feasible. Upcoming clinical investigations will assess the utility of this technology in assessing
coronary anatomy, plaque characteristics and procedural results.
CATEGORIES IMAGING: Imaging: Intravascular
TCT-42
Long-term Consequences Of Optical Coherence Tomography
Findings During Percutaneous Coronary Intervention:
The Centro Per La Lotta Contro l’Infarto - Optimization
Of Percutaneous Coronary Intervention (CLI-OPCI)
LATE Study
Enrico Romagnoli,1 Alessio La Manna,2 Francesco Burzotta,3
Laura Gatto,4 Valeria Marco,5 Chiara Russo,5 Alessandro Di Giorgio,6
Alberto Boi,7 Ugo Limbruno,8 Massimo Fineschi,9 Franco Fabbiocchi,10
Nevio Taglieri,11 Francesco Versaci,12 Carlo Trani,13
Corrado Tamburino,14 Fernando Alfonso,15 Gary Mintz,16
Francesco Prati4
1
San Giovanni Addolorata Hospital; C.L.I Foundation, Rome, Rome,
Italy; 2University of Catania, Catania, Catania, Italy; 3Institute of
Cardiology, Catholic University of the Sacred Heart, Policlinico A.
Gemelli, Rome, Rome, Italy; 4San Giovanni Addolorata Hospital; C.L.I.
Foundation, Rome, Rome, Italy; 5C.L.I. Foundation, Rome, Rome, Italy;
6
Policlinico G. Martino, Messina, Messina, Italy; 7Ospedale Brotzu,
Cagliari, Cagliari, Italy; 8ASL 9 Grosseto Hospital, Grosseto, Grosseto,
Italy; 9Azienda Ospedaliera Universitaria Senese Siena, Siena, Siena,
Italy; 10Centro Cardiologico Monzino, IRCCS, Milan, Milan, Italy;
11
Policlinico Sant’Orsola-Malpighi, Bologna, Bologna, Italy; 12Ospedale
Santa Maria Goretti, Latina, Latina, Italy; 13Institute of Cardiology,
Catholic University of the Sacred Heart, Policlinico A. Gemelli, Italy,
Rome, Rome, Italy; 14Ferrarotto Hospital, Cardiology Division,
University of Catania, Catania, Italy; 15Hospital Universitario de la
Princesa, Madrid, Spain; 16Cardiovascular Research Foundation,
New York, New York, United States
BACKGROUND Optical coherence tomography (OCT)-defined suboptimal stent deployment is an independent predictor of device failure
in the first year of follow-up; however, its impact on long-term
outcome remains undefined. The aim of this study is to evaluate
clinical consequences of OCT findings on long-term outcome of
percutaneous coronary interventions (PCI).
METHODS In the context of the multicenter Centro per la Lotta contro
l’Infarto-Optimisation of Percutaneous Coronary Intervention (CLIOPCI) project, we compared long-term clinical outcome of patients
undergoing PCI according to end-procedural OCT findings.
RESULTS To date the CLI-OPCI project enrolled 1422 lesions out of
1211 patients from 13 independent OCT-experienced centers. Endprocedural OCT assessment revealed suboptimal stent implantation in
30.9% of lesions, with increased incidence in patients experiencing
device-oriented cardiovascular events (DoCE) (52.8% vs. 28.0%,
p<0.001). At median follow-up of 833 (interquartile range 415-1447)
days, in-stent minimum lumen area (MLA) <4.5mm2 (HR 1.82,
p<0.001), distal stent edge dissection >200mm (HR 2.03, p¼0.004),
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
and significant plaque of reference vessel with lumen area <4.5mm2
at either distal (HR 5.22, p<0.001) or proximal (HR 5.67, p<0.001)
stent edges were independent predictors of device failure.
Conversely, other OCT parameters like in-stent MLA/mean reference
lumen area <70%, stent malapposition and intra-stent plaque/
thrombus protrusion were not associated with worse outcomes. Using
multivariable Cox hazard analysis, the presence of at least one of
these significant criteria for suboptimal OCT stent deployment was
confirmed as independent predictor of DoCE (HR¼1.92, p¼0.001).
B19
HCP lesions (154 vs. 184 mmHg, p¼0.02). In both BVS and EES,
oversized device selection was associated with good device expansion
even in HCP lesions (BVS p¼0.01, EES p¼0.01).
CONCLUSION In ABSORB Japan, significantly smaller device expansion in calcified lesions observed in the BVS arm may, in part, be
attributable to procedural differences between the 2 devices. Further
studies are warranted to clarify appropriate optimization strategy for
BVS in this lesion subset.
CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds
TCT-44
Frequency and Impact of Acute Stent Deformation After PCI of
Left Main Coronary Artery Disease: An EXCEL trial intravascular
ultrasound substudy
Song-Yi Kim,1 Akiko Maehara,2 Bela Merkely,3 Imre Ungi,4
Ad Van Boven,5 Erick Schampaert,6 Roxana Mehran,7 Ori Ben-Yehuda,8
Ovidiu Dressler,2 A. Pieter Kappetein,9 Joseph Sabik,10
Patrick Serruys,11 Gary Mintz,2 Gregg Stone12
1
Cardiovascular research foundation, New York, New York, United
States; 2Cardiovascular Research Foundation, New York, New York,
United States; 3Semmelweis University Heart and Vascular Center,
Budapest, Hungary; 4University of Szeged, Szeged, Hungary; 5Medisch
Centrum Leeuwarden, Haren, Netherlands; 6Hopital du Sacre-Coeur de
Montreal, Montreal, Quebec, Canada; 7Zena and Michael A. Wiener
Cardiovascular Institute, Mount Sinai Hospital, New York, New York,
United States; 8Cardiovascular Research Foundation, Columbia
University Medical Center, New York, New York, United States;
9
Department of Cardiothoracic Surgery, Erasmus University Medical
Center, Rotterdam, Netherlands; 10Department of Thoracic and
Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland,
Ohio, United States; 11Imperial College, London, United Kingdom;
12
Cardiovascular Research Foundation, Columbia University Medical
Center/NewYork-Presbyterian Hospital, New York, New York, United
States
CONCLUSION Suboptimal stent deployment, defined according to
specific quantitative OCT criteria, was confirmed as independent
outcome predictor at long-term follow-up.
CATEGORIES IMAGING: Imaging: Intravascular
TCT-43
Bioresorbable Scaffold for the Treatment of Calcified Coronary
Lesions: IVUS Insights from the ABSORB Japan Trial
Kozo Okada,1 Yasuhiro Honda,2 Hideki Kitahara,2
M. Brooke Hollak,3 Paul G. Yock,2 Hajime Kusano,4 Wai-Fung Cheong,5
Krishna Sudhir,4 Peter J. Fitzgerald,2 Takeshi Kimura6
1
Stanford University School of Medicine, Division of Cardiovascular
Medicine, Stanford Cardiovascular Institute, Stanford, California,
United States; 2Division of Cardiovascular Medicine, Stanford
University School of Medicine, Stanford, California, United States;
3
Stanford University School of Medicine, Division of Cardiovascular
Medicine, Stanford, California, United States; 4Abbott Vascular, Santa
Clara, California, United States; 5Abbott Vascular, Los Altos, California,
United States; 6Kyoto University Hospital, Kyoto, Japan
BACKGROUND This study aimed to evaluate influence of calcified
plaque (CP) on device expansion after bioresorbable vascular scaffold
(BVS) implantation, compared with everolimus-eluting stents (EES).
METHODS In the ABSORB Japan trial, volumetric IVUS was performed
at post-procedure in 146 lesions (98 Absorb BVS: 48 EES, 2:1
randomization). Device expansion was evaluated as a ratio of average
device area (%volume expansion) or minimum device area (%area
expansion) to mean reference lumen area. CP score was calculated by
grading the measured calcium angle as 0 to 4 (for 0 , <90 , 90-180 ,
180-270 and >270 , respectively) for the entire device segment
analyzed at 1-mm intervals. Device sizing was evaluated by [nominal
device diameter - mean reference diameter] classified as undersized
(-0.25 mm), properly sized (-0.25 to 0.25 mm) and oversized
(>0.25 mm).
RESULTS Overall, BVS had smaller device expansion than EES, which
was particularly prominent in high CP-score (HCP) lesions (CP score median). In the EES arm, HCP lesions were post-dilated more
frequently with a non-compliant balloon (87.5% vs. 45.5%, p<0.01) at
higher dilation pressure (184 vs. 154 mmHg, p<0.05) than non-HCP
lesions. In contrast, the BVS arm showed no procedural difference
between the HCP and non-HCP lesions; thus, the post-dilation pressure was significantly lower in BVS than in EES for the treatment of
BACKGROUND Acute stent deformation may have deleterious complications. The frequency and impact of acute stent deformation after
left main coronary artery (LMCA) PCI are unknown.
METHODS EXCEL (n¼1,905) was a multicenter, randomized trial
comparing PCI with everolimus-eluting stents (n¼948) to CABG
(n¼957) in pts with LMCA disease. Stent deformation by IVUS was
defined as multiple overlapping strut layers within a single stent
accompanied by stent shortening. As an exploratory endpoint, we
defined LMCA lesion failure as cardiac death, LM-related MI or
ischemia-driven LM revascularization (TLR).
RESULTS Among 500 pts with analyzable final IVUS, acute LM stent
deformation was observed in 33 pts (6.6%) and was most commonly
located at the LMCA ostium (27/33 [81.8%]), although struts protruding into the aorta was not a risk factor (Table). Stent edge dissection
was more frequent in pts with compared to those without acute LM
stent deformation, although MSA was not significantly lower (Table).
The 3-year event rate attributable to LMCA lesion failure was greater
in pts with than without stent deformation (HR [95%CI] ¼ 2.15 [1.05,
4.40], p¼0.04) in the multivariable Cox proportional hazard model
(Table).
Any protruding struts in the aorta
Minimum stent area (MSA) in
Deformation (D)
Deformation (-)
(n[33)
(n[467)
60%
8.8 (7.2, 11.7)
54.7%
9.9 (8.3, 11.5)
p-value
0.57
0.21
LMCA (mm2)
Any stent edge dissection
27.3%
12.0%
0.03
28.3%
13.9%
0.02
3-year event rates related to
LMCA lesion
Cardiac death/MI/ischemia-driven
TLR
- Cardiac death
9.4%
3.6%
0.08
- MI
18.9%
4.7%
0.0005
- Ischemia-driven TLR
19.9%
8.0%
0.02
3.1%
1.1%
0.29
Definite/probable stent
thrombosis
CONCLUSION In EXCEL, acute LM stent deformation was not infrequent (6.6%) and was related to adverse clinical outcomes.
CATEGORIES IMAGING: Imaging: Intravascular
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