eprints.keele.ac.uk REF (5).docx · Web viewOutcomes of patients who undergo percutaneous...

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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mailto:[email protected]

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



Supplementary Table 1: Coronary lesion, device use and stent type


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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

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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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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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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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