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Outcomes of patients who undergo percutaneous coronary intervention with covered
stents for coronary perforation: A systematic review and pooled analysis of data
Short title: Outcomes of patients with PCI and covered stents
Vinayak Nagaraja,1* Konstantin Schwarz,2* Stuart Moss,3 Chun Shing Kwok,4,5 Mark
Gunning5
*Both authors contributed equally
Affiliations
1. Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland
Clinic, Cleveland, Ohio
2. Cardiology Department, Worcestershire Royal Hospital, Worcester, United Kingdom
3. Orange Base Hospital, New South Wales, Australia
4. School of Primary, Community and Social Care, Keele University, Stoke-on-Trent,
United Kingdom
5. Royal Stoke University Hospital, Stoke-on-Trent, United Kingdom
Corresponding Author:
Konstantin Schwarz
Cardiology Department,
Worcestershire Royal Hospital,
Worcester, United Kingdom
Tel: +44(0) 1905 763333
Email: [email protected]
Word count: 3,320
Keywords: covered stents; coronary perforation; percutaneous coronary intervention
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Abstract
Objectives: This review aims to evaluate the adverse outcomes for patients after treatment
with covered stents.
Background: Coronary perforation is a potentially fatal complication of percutaneous
coronary revascularization which may be treated using covered stents. Studies have evaluated
long term outcomes among patients who received these devices, but hitherto no literature
review has taken place.
Methods: We conducted a systematic review of adverse outcomes for patients after treatment
with covered stents. Data from studies were pooled and outcomes were compared according
to stent type.
Results: A total of 29 studies were analyzed with data from 725 patients who received
covered stents. The proportion of patients with chronic total occlusions, vein graft PCI,
intracoronary imaging and rotational atherectomy were 16.9%, 11.5%, 9.2% and 6.6%,
respectively. The stents used were primarily PTFE(70%) and Papyrus(20.6%). Mortality,
major adverse cardiovascular events, pericardiocentesis/tamponade and emergency surgery
were 17.2%, 35.3%, 27.1% and 5.3%, respectively. Stratified analysis by use of PTFE,
Papyrus and pericardial stents, suggested no difference in mortality(p=0.323), or target lesion
revascularization (p=0.484). Stent thrombosis, pericardiocentesis/tamponade and emergency
CABG occurred more frequently in patients with PTFE stent use(p=0.011, p=0.005, p=0.012
respectively). In-stent restenosis was more common with pericardial stent use(<0.001, pooled
analysis for 1st and 2nd generation pericardial stents).
Conclusions: Cases of coronary perforation which require implantation of a covered stent are
associated with a high rate of adverse outcomes. The use of PTFE covered stents appears to
be associated with more stent thrombosis, pericardiocentesis/tamponade and emergency
CABG when compared to Papyrus or pericardial stents.
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Introduction
Coronary perforation is a rare and potentially fatal complication of percutaneous
revascularization1. The incidence is around 0.5%2, and in-hospital and 5 year mortality are
8% and 47% respectively2. Some of the independent factors associated with 30 day mortality
are advanced age, diabetes mellitus, renal dysfunction, the use of rotational atherectomy, the
use of cutting balloons, higher lesion complexity, and glycoprotein IIb/IIIa inhibitor use2,3.
Covered stents are considered an effective bail out strategy for large vessel coronary
perforation especially with a Ellis type II-III coronary perforation4 that cannot be salvaged
using a prolonged balloon inflation1. The most widely used covering on devices in current
practice are polytetrafluoroethylene (PTFE) (Direct-Stent®, BeGraft coronary stent graft
system, GRAFTMASTER®), polyurethane (PK Papyrus stent) and pericardium (second
generation pericardial stents Aneugraft® Dx stent, “Over and Under OU” – first generation
pericardial stents)5. However, the superiority of one device over the other is difficult to
determine in observational data of a rare, and life-threatening complication of PCI. Covered
stents may lead to higher rates of stent thrombosis, perhaps as result of more metal compared
to conventional drug eluting stents6. This raises the question of the optimal duration of
antiplatelet therapy. SCAAR, a Swedish registry is the largest published series, and reported
selected outcomes from 265 patients. In order to better understand the body of evidence on
the use of covered stents, we performed a systematic review regarding their use in the context
of coronary perforation.
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Methods
The Preferred Reporting Items for Systematic reviews and Meta‐Analyses (PRISMA)
guidelines was utilized to conduct this systematic review7.
Selection criteria
Covered stents used in the context of large vessel coronary perforation during
percutaneous coronary intervention with no restriction based on language, study
design or the indication for PCI
Studies not reporting mortality or cardiovascular events were excluded
A systematic search was performed of MEDLINE, Current Contents Connect, Google
Scholar, Cochrane library, PubMed, EMBASE, Science Direct, and Web of Science till
August 2019. The following MeSH terms were used “coronary perforation” and “covered
stents” AND “Percutaneous coronary intervention” OR “PCI.” The references of the included
studies and appropriate review articles were assessed for further pertinent articles. Multiple
reviewers (V.N., S.M.M. and K.S.) autonomously checked all publications for studies
potentially meeting the inclusion criteria. The full reports of these studies were retrieved, and
data were independently extracted based on study design, clinical/procedural characteristics,
follow up duration, pharmacology.
The main outcomes analysed were mortality, cardiac death, MACE, stent thrombosis,
target lesion revascularisation (TLR), in-stent restenosis (ISR) and peri-procedural
complications including pericardiocentesis, tamponade and need for emergency open cardiac
surgery. An additional objective was to collect data on bleeding complications and the
antiplatelet strategies used. However, these were reported inconsistently, preventing reliable
data interpretation.
The data were pooled from available published studies and descriptive frequency
statistics were expressed as absolute numbers and percentages. Our secondary analysis
compared outcomes between the two most common stent types (PTFE coated versus
Polyurethane coated stents). Other stent types were used too rarely to allow such meaningful
secondary analysis. The comparison of outcomes was calculated using Fisher’s exact test and
statistical significance was assumed if p<0.05. Data were analysed using GraphPad Prism
version 5 software (San Diego, USA).
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Results
The process of study selection is shown in Figure 1. From a total of 319 studies in our
search, only 29 reports were included in the analysis6,8-35. The description of the included
studies is shown in Table 1. The final review incorporated 16 case reports and 13
observational studies. These originated from the United States, United Kingdom, France,
Spain, Italy, Greece, Sweden, Turkey, Iraq, Taiwan, Republic of China, Japan, South Korea
and Australia. The largest study6 had 265 individuals. The follow-up period across the studies
ranged from 0 day to 85 months (≥6 months follow up was achieved in 63% of all patients
[n=459]).
The collective summary of the demographics, lesion characteristics, stent platforms
along with extracted date are presented in Table 2. Among studies that reported data on
demographics, the proportion of patients who were male was 74.4% and the overall age
ranged from 40-93 years. With respect to the indication for PCI, the majority were for acute
coronary syndrome (62.2% STEMI or ACS) while the remainder were for stable angina
(37.8%). Chronic total occlusions accounted for 16.9% and vein grafts for 11.5% of PCI
cases which resulted in coronary perforation needing a covered stent. Intracoronary imaging
and rotational atherectomy accounted for 9.2% and 6.6%, respectively. The covered stents
used were primarily PTFE and Papyrus which accounted for 70.0% and 20.6% of cases,
respectively.
The main outcomes for the studies are described in Table 3, and these were derived
from the full extracted data in Supplementary Table 1 and 2. Where in-hospital mortality and
MACE had been reported, these outcomes were 9.8% and 24.0%, respectively while the
long-term mortality and MACE figures were 17.2% and 35.3%, respectively. Myocardial
infarction occurred in 10.9%. Suspected stent thrombosis was 6.2%, and this was confirmed
angiographically in 5.0%. Pericardiocentesis or tamponade occurred in 27.1% of patients and
emergency surgery in 5.3%.
Stratified analysis by type of stent revealed no difference in mortality (p=0.323) or
target lesion revascularization (p=0.484). However, in-stent restenosis appeared to occur
more frequently in patients with pericardial stents (p<0.001). Pericardial stents were
associated with less stent thrombosis, mainly driven by the difference when compared to
PTFE stents (p=0.011, the difference to Papyrus stent was not statistically significant).
Pericardiocentesis or tamponade and emergency CABG were observed less frequently with
Papyrus stent use (p=0.005 and 0.012 respectively), Table 3, Figure 2. Unfortunately, the
information on antiplatelet use was very inconsistent and could be established in only 127
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cases. In those cases all patients had aspirin and 99.2% had P2Y12 inhibitor. The intended
length of double antiplatelet treatment varied from 6 months to indefinitely.
Discussion
In this systematic review, we describe outcomes following the implantation of
covered stents for the purpose of bailing out coronary perforations. Perforation occurred and
covered stents were required where the complexity of the coronary artery disease being
treated was higher than usual (16% chronic total occlusions, 12% coronary grafts, 60%
concomitant multi-vessel disease or left main stem disease)2. The use of intracoronary
imaging in this complex anatomy (9%) was fairly low. This may partly reflect limited
availability of this technology at the time of some of the older reports. However, it might also
be postulated that a failure to employ intracoronary imaging in complex lesions, may have
contributed to the higher incidence of coronary perforation observed. Unrecognised heavy
calcification, or imperfect sizing of the initial balloon or stent, could be contributory factors.
This analysis shows a high overall complication rate in patients needing covered
stents when compared to routine PCI. The in-hospital mortality was 9.8% and the long-term
figure was 17.2%. This is similar to data reported by Harnek et al6 in the SCAAR registry.
Furthermore, the overall MACE rate of 35.3% is very high and is in keeping with a
previously reported 38% three year incidence of MACE by Kawamoto et al35. Peri-procedural
emergency complications were higher than expected in the setting of routine PCI2.
Tamponade requiring pericardiocentesis was recorded in 27.1% and emergency surgery was
undertaken in 5.3%.
We observed high rates of adverse outcomes in the population who received covered
stents but determining the reasons for this is challenging. First, the coronary perforation
confers poor prognosis and this complication may be associated with a high-risk elderly
comorbid population who may have fragile vessels. Secondly, the existence or progression of
coronary artery disease in patients who have received covered stents may contribute to future
events. Third, the treatment with a covered stent may alter the propensity to develop future
events. The process involving neo-endothelialisation and smooth muscle migration across
few square centimetres of PTFE or polyurethane membrane could be delayed when compared
to modern generation uncovered stents, where endothelium needs to grow just few
micrometers around the struts. This concern of only partial neointimal coverage of a PTFE
stent compared to complete coverage of an everolimus eluting stent in the same patient was
anecdotally shown in a case report by angioscopy and optical coherence tomography by
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Kongoji22. While the observational nature of our review cannot reliably determine the
mechanism for the poor outcomes, the reason for the high rates of adverse events is likely a
culmination of multiple factors.
PTFE coated, polyurethane coated (Papyrus) and pericardial stents were compared for
respective outcomes. There was no difference in mortality or target lesion revascularisation,
Table 3, Figure 2. However, there was less incidence of stent thrombosis in papyrus and
pericardial stents compared to PTFE stents. Pericardiocentesis was more common in PTFE
stent use. Emergency CABG was least likely in patients with papyrus stents; Table 3, Figure
2. These data suggest that whereas long term safety profile maybe equivalent for all three
stent types, the peri-procedural complication rate appears to be higher in the PTFE covered
stents and in-stent restenosis increased in pericardial stent group. The increase ISR
occurrence with pericardial rate includes a pooled analysis of first- and second-generation
pericardial stents. It is not possible to draw conclusion that the same finding would apply to
the second-generation pericardial stents only. Unfortunately, the numbers in this subgroup
would too low to allow a reliable conclusion. One explanation for the finding of less
incidence of tamponade and need for bailout emergency surgery could be the fact that the
modern polyurethane covered stents have smaller strut sizes comparable to modern
generation DES and are deliverable via smaller French size catheters compared to the bulkier
PTFE covered stents. Accordingly, in a modest size registry (n=61), Hernandez-Enriquez et
al described that procedures where polyurethane covered stents were used resulted in a
shorter delivery time, and cardiac arrest was reported less frequently when compared to PTFE
covered stents34. No difference in mortality was observed in that series.
It is unlikely that a randomised trial comparing covered stent technology in the
context of coronary perforation would ever be contemplated. Therefore, there is a reliance
upon collation of observational data in a report such as this one. In future, prospective PCI
registries with detailed standardised information recording procedural data, and long-term
follow up would certainly be informative in this high-risk cohort. This would guide device
selection, as well as determination of the optimal antiplatelet drug regimen in this setting.
This review has several limitations. Data available from individual reports and
registries vary in quality of available information and make this retrospective systematic
review challenging. Not all originally intended outcomes (such as bleeding complications or
correlations of stent thrombosis to double anti-platelet treatment) could be established. This
retrospective analysis of previously published cases cannot rule out a predisposition due to
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publication bias and it is possible that unpublished cases carried out different outcome
profile.
In conclusion, coronary perforation remains a rare, but potentially catastrophic
complication of percutaneous coronary intervention. Cases of coronary perforation which
require implantation of a covered stent have significant mortality and high MACE rate. The
use of polyurethane covered stents is associated with less tamponade/pericardiocentesis need
and emergency surgery when compared to PTFE covered stent use.
List of Supports/Grants Information: None
Acknowledgements: None
Conflicts of interest disclosures: The authors have no conflicts of interest to declare.
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List of Table and Figures
Table 1: Description of included studies and population
Table 2: Pooled summary of the demographics, lesions, type of stent used and outcomes
from the included studies
Table 3: Comparison of outcomes between the polytetrafluoroethylene versus Papyrus
stents
Figure 1: Flow diagram of study inclusion
Figure 2: Comparison of outcomes for polytetrafluoroethylene versus Papyrus stents
Supplementary Table 1: Coronary lesion, device use and stent type
Supplementary Table 2: Follow up and outcomes
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1. Xenogiannis I, Brilakis ES. Advances in the treatment of coronary perforations:
Catheter Cardiovasc Interv. 2019;93:921-922.
2. Kinnaird T, Kwok CS, Kontopantelis E, Ossei-Gerning N, Ludman P, deBelder M,
Anderson R, Mamas MA. Incidence, Determinants, and Outcomes of Coronary Perforation
During Percutaneous Coronary Intervention in the United Kingdom Between 2006 and 2013:
An Analysis of 527 121 Cases From the British Cardiovascular Intervention Society
Database. Circ Cardiovasc Interv. 2016;9. pii:e003449.
3. Shaukat A, Tajti P, Sandoval Y, Stanberry L, Garberich R, Nicholas Burke M, Gossl
M, Henry T, Mooney M, Sorajja P, Traverse J, Bradley SM, Brilakis ES. Incidence,
predictors, management and outcomes of coronary perforations. Catheter Cardiovasc Interv.
2019;93:48-56.
4. Ellis SG, Ajluni S, Arnold AZ, Popma JJ, Bittl JA, Eigler NL, Cowley MJ, Raymond
RE, Safian RD, Whitlow PL. Increased coronary perforation in the new device era. Incidence,
classification, management, and outcome. Circulation. 1994;90:2725-30.
5. Ismail Kilic K, Fabris E, Serdoz R, Caiazzo G, Foin N, Abou-Sherif S, di Mario C.
Coronary covered stents. EuroIntervention. 2016;12:1288-1295.
6. Harnek J, James SK, Lagerqvist B. Very long-term outcome of coronary covered
stents: a report from the SCAAR registry. EuroIntervention. 2019;14:1660-7.
7. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred Reporting Items for
Systematic Reviews and Meta-Analyses: The PRISMA Statement. J Clin Epidemiol.
2009;62:1006-12.
8. Ziakas A, Economou F, Feloukidis C, Kiratlidis K, Stiliadis I. Left anterior
descending artery perforation treated with graft stenting combining dual catheter and side
branch graft stenting techniques. Herz. 2012;37:913-6.
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List of Table and Figures
Table 1: Description of included studies and population
Table 2: Pooled summary of the demographics, lesions, type of stent used and outcomes
from the included studies
Table 3: Comparison of outcomes between the polytetrafluoroethylene versus Papyrus
stents
Figure 1: Flow diagram of study inclusion
Figure 2: Comparison of outcomes for polytetrafluoroethylene versus Papyrus stents
Supplementary Table 1: Coronary lesion, device use and stent type
Supplementary Table 2: Follow up and outcomes
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Table 1: Description of included studies and populationAuthor/Year Study design Country Patients Mean age % Male PresentationAlici 201329 Case report Turkey 1 60 years 100% Crescendo anginaBilge 200333 Case report Turkey 1 43 years 100% ACSBonello 200532 Case report France 1 55 years 100% ACSChae 199731 Case report South Korea 1 65 years 100% Crescendo anginaChen 201530 Retrospective observational study Israel 9 70 years 78% ACS 67%, stable angina 33%.Copeland 201228 Retrospective observational study USA 21 - - -Ekici 201427 Case report Turkey 1 74 years 100% Crescendo anginaFujimoto 201626 Case report Japan 1 77 years 100% Exertional anginaGuttmann 201725 Retrospective observational study United Kingdom 31 70 years (in perforation
group)69% (in perforation group)
ACS 45.6%, stable angina 54.4%.
Harnek 20196 Retrospective observational study Sweden 265 - - -Hernandez 201834 Retrospective observational study Spain and France 61 76 years 75% ACS 37.7%, stable angina 62.2%.Javaid 200624 Retrospective observational study USA 13 69 years (all perforation
cases)68% (in all perforation cases)
ACS 69% in all perforation cases.
Kaluski 200923 Case report USA 1 93 years 0% Unstable anginaKandzari 20199 Observational study USA 80 - - -Kawamoto 201535 Retrospective observational study Japan 57 74 years 67% ACS 9%.Kongoji 201722 Case report Japan 1 78 years 100% Staged PCILee 201621 Retrospective observational study Taiwan 48 68 years 77% ACS 55%, stable angina 45%.McCormick 201520 Case report Australia 1 56 years 0% NSTEMIMirza 201819 Retrospective observational study Iraq 15 60 years 63% -Moriyama 201718 Case report Japan 1 79 years 0% Stable anginaNameki 200317 Case report Japan 1 62 years 100% Exertional angina, failed LIMA (CABG 2
months earlier)Pavani 201816 Retrospective observational study Italy and Spain 96 70 years 76% (all patients) ACS 46%, stable angina 54% in all
patients.Pavlidis 201215 Case report United Kingdom 1 71 years 0% Exertional anginaSandoval 201714 Case report USA 1 86 years 100% NSTEMISecco 201613 Retrospective observational study United Kingdom 3 72 years (all patients) 78% (all patients) -Wang 201412 Retrospective observational study China 10 69 years 60% ACSYilmaz 200211 Case report Turkey 1 64 years 100% STEMI
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Yorgun 201210 Case report Turkey 1 53 years 100% Chest painZiakas 20128 Case report Greece 1 55 years 100% Exertional Angina
ACS=acute coronary syndrome, NSTEMI=non-ST elevation myocardial infarction, STEMI=ST elevation myocardial infarction
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Table 2: Pooled summary of the demographics, lesions, type of stent used and outcomes from the included studies
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ACS=acute coronary syndrome, STEMI=ST elevation myocardial infarction, CTO=chronic total occlusion, PTFE=polytetrafluoroethylene, AVG#=arteriovenous graft, MACE=major adverse cardiovascular events *Used or ‘mechanism of rupture’, #Autologous vein graft, LMS left main stem †Periprocedural or during follow up- not clear in some studies, TLR target lesion revascularization, ISR in-stent restenosis
24
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Table 3: Comparison of outcomes between the polytetrafluoroethylene versus Papyrus stents
TLR target lesion revasccularization, ISR in-stent restenosis, PTFE polytetrafluoroethylene
* p<0.05
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Figure 1: Flow diagram of study inclusion
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Figure 2: Comparison of outcomes for polytetrafluoroethylene versus Papyrus stents
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Supplementary Table 1: Coronary lesion, device use and stent typeAuthor/Year
High Risk Lesion CTO Vein graft
Arterial graft
LMS or MVD
Calcific lesion (B or C type lesion)
IVUS OCT IC imaging
Pressure wire
Device (rotablation/laser/shockwave)
Type of Stent
Alici 201329 - 0 0 0 1 1 0 0 0 0 0 PTFE
Bilge 200333 - 0 0 0 0 0 0 0 0 0 Perforation by thrombectomy catheter
PTFE
Bonello 200532
- 0 0 0 0 - 0 0 0 0 0 PTFE
Chae 199731 - 0 0 0 0 1 0 0 0 0 0 AVG Coated
Chen 201530 66% calcified lesions 0 0 1 - 6 - - - 1 Pericardial
Copeland 201228
- - - - - - - - - - PTFE
Ekici 201427 Intra-myocardial bridged segment
0 0 0 0 Myocardial bridge
0 0 0 0 0 PTFE
Fujimoto 201626
Subtotal calcified LAD occlusion with rotational atherectomy
1 0 0 1 1 1 0 1 0 1 PTFE
Guttmann 201725
- - - - - - - - - - Covered stent
Harnek 20196 - 17 66 4 162 312 23 2 25 10 - PTFE 199; Over and Under 36; Aneugraft 27; Papyrus 60
Hernandez 2018 34
39 Significantly calcified; 13 CTO
13 0 0 29 39 - - - 1x rotablation (mechanism of rupture). Mechanism of rupture 2.
Papyrus 22 and PTFE
Javaid 200624 - - - - - - - - - - PTFE
Kaluski 200923
Multivessel and significant calcification
0 0 0 1 1 0 0 0 0 0 PTFE
Kandzari 20199
- 3 0 Papyrus
Kawamoto 201535
- 25 0 0 - 54 9 (Total 9 IVUS or OCT)
9 0 5 PTFE
Kongoji 201722
Tortuous LAD 0 0 0 1 0 0 0 0 0 0 PTFE
Lee 201621 31% calcified lesions 14 0 0 0 15 8 (Total 8 IVUS or
8 0 2 PTFE
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OCT)McCormick 201520
CTO of mid LAD 1 0 0 0 - 0 0 0 0 0 PTFE
Mirza 201819 - - - - - - - - - - Covered Stent 15
Moriyama 201718
Tortuous and calcified LAD with rotational atherectomy
0 0 0 1 1 0 0 0 0 1 PTFE
Nameki 200317
Coronary aneurysm post coronary artery laceration
0 0 0 1 0 0 0 0 0 0 PTFE
Pavani 201816
- 22 4 0 80 - - - - Mechanism of rupture 4 PTFE 96; Pericardial 6
Pavlidis 201215
SVG lesion between two previous stents
0 1 0 0 1 0 0 0 0 Filterwire use, but probably oversizing the cause
PTFE
Sandoval 201714
Instent restenosis 0 0 0 0 0 0 0 0 0 0 PTFE
Secco 201613 - - - - - - - - - 1 Pericardial
Wang 201412 1 CTO; 4 significantly calcified; 8 multi-vessel
1 0 0 8 - - - - - Covered stent
Yilmaz 200211
LAD requiring laser angioplasty
0 0 0 0 1 0 0 0 0 1 (laser) PTFE
Yorgun 201210
- 0 0 0 0 0 0 0 0 0 0 PTFE
Ziakas 20128 CTO LAD 1 0 0 0 1 0 0 0 0 0 PTFE
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Supplementary Table 2: Follow up and outcomes
Author/Year
Follow up In hospital mortality
In hospital MACE
Mortality overall (IP and FU)
MACE overall
Cardiac death
Stroke MI Stent thrombosis
Major bleed or blood transfusion
Pericardiocentesis/ Tamponade
Emergency surgery (CABG)
TLR ISR Complications
Alici 201329 >1 week 0 - - - 0 0 - 0 1 1 0 0 0 No issues on re-look angiography 1 week later.
Bilge 200333 - 0 - - - - - - - - 1 0 - - 1 pericardiocentesis, no information on follow up after taken to CCU and stabilized.
Bonello 200532
6 months 0 0 0 0 0 0 0 0 0 0 0 0 0 Presented 6 months later with constrictive pericarditis,
Chae 199731 8 days 1 NA 0 0 NA 0 1 1 0 NA NA Died from septic shock 8 days post implantation.
Chen 201530 Up to 15 months
0 0 0 2 0 0 2 1 - 3 - - 3 2 representations with instentrestenoses; 1 stent thrombosis; 1 occluded artery on re-look.
Copeland 201228
29-85 months 1 1 1 5 1 0 3 2 - 2 1 3 3 2 emergent surgery and 1 elective surgery for restenosis; 2 tamponade requiring drainage; 1 death due to acute ST, one ST after 2 weeks, survived, 26 pat PTFE attempted, n=21 success,
Ekici 201427 4 months 0 0 0 0 0 0 0 0 0 0 0 0 0 No complications, seen at 2 months, but currently on 4 months on medical treatment and DAPT 12 months.
Fujimoto 201626
- 0 - - - - - - - - 1 0 - - No complications.
Guttmann 201725
- 5 7 7 - - 8 (6 angio confirmed, 2 probable)
- - 4 - - 26 discharged alive, 4 emergent surgery; 6 definite and 2 probable stent thromboses within 1 year,
Harnek 20196 1 year 13 44 - - 22 16 - 57 4 34 25 2 emergent surgery; 31 1-month mortality; 44 1-year mortality; 25 1-year restenosis; 16 1-year stent thrombosis.
Hernandez 201834
1 year 11 14 21 22 19 - 5 2 - 23 7 4 3 23 pericardiocentesis; 11 cardiac arrests; 4 IABP; 2 ECMO; 14 In hospital MACE; 7 emergent surgery; 2 1-year stent thrombosis; 3 1-year in-stent restenosis, overall 11 1-year MACE, 3 1year Surgery.
Javaid 200624 93% >1 year 3 - - - - - - - - 2 4 - - 4 CABGs; 2 tamponade.
Kaluski 200923
7 days 0 1 0 1 0 0 1 0 1 1 0 0 0 Pericardiocentesis; IABP.
Kandzari 20199
- 8 8 8 - - 1 - 7 0 - - 7 pericardiocentesis; survey from Papyrus company 16 countries, n=80, success delivery n=76, successful sealing n=73, total 100 stents used in 80 patients.
Kawamoto 201535
3 years 4 16 7 17 6 - 16 2 - 16 9 5 - 14 required multiple PTFE covered stents; 16 MACCE at 30 days; 9 surgical repairs at 30 days; 0 stent thromboses at 30 days; 2 late stent thromboses at 2 years.
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Kongoji 201722
3 years 0 0 0 0 0 0 0 0 0 0 0 0 0 No complications. Well seated stent on angiography at 9 months, uncovered struts on OCT and angioscopy.
Lee 201621 3 years 8 - 13 - 9 - 2 5 - 20 1 12 - 41% underwent a pericardiocentesis; IABP 33%; ECMO 29%.
McCormick 201520
1 week 0 0 0 0 0 0 - 0 0 0 0 0 0 Covered stent malapposition on 1 week staged angiography, post dilated and confirmed satisfactory placement with IVUS.
Mirza 201819 2 years 0 0 0 0 1 1 0 13 0 - - 13 Pericardiocentesis; 1 in-stent thrombosis.
Moriyama 201718
6 months 0 1 0 1 0 0 1 0 1 0 0 0 Cardiac arrest requiring pericardiocentesis and IABP, 3 month CT patent stents, angina free on 6 month clinic follow up, periprocedural MI
Nameki 200317
6 months 0 0 0 0 0 0 0 0 0 0 0 0 0 No complications. Follow up angiogram at 6 months unremarkable.
Pavani 201816
- 15 - 21 - - - - 5 - 28 7 9 -
Pavlidis 201215
2 days 0 - 0 - 0 0 - 0 0 0 0 0 0 Small pericardial effusion not requiring drainage.
Sandoval 201714
- 0 0 0 0 0 0 - 0 0 0 0 - - No complications.
Secco 201613 32 months 1 1 1 - 1 - - - - - - - - No early or late stent thrombosis.
Wang 201412 31 months 1 2 2 0 1 1 probable - 9 0 - 1 9 pericardiocentesis; 1 instent restenosis at 67 months. 1 SCD after 13 months.
Yilmaz 200211
12 days 0 0 0 0 0 0 1 1 1 0 0 Cardiac arrest requiring pericardiocentesis and salvage CABG
Yorgun 201210
3 years 0 0 0 0 0 0 0 0 0 0 0 0 0 Small pericardial effusion not requiring drainage, DAPT 6 months, repeat angiogram 3 years later showed patent stent.
Ziakas 20128 6 months 0 0 0 0 0 0 0 0 0 0 0 0 0 No complications. Normal stress testing 6 months after..
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