scholarly journals Clinical Outcomes of Self-Made Polyurethane-Covered Stent Implantation for the Treatment of Coronary Artery Perforations

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiaoyue Song ◽  
Qing Qin ◽  
Shufu Chang ◽  
Rende Xu ◽  
Mingqiang Fu ◽  
...  

Objectives. The present study aimed to investigate the short- and long-term clinical outcomes of self-made polyurethane-covered stents (PU-CS) in patients for the management of coronary artery perforation (CAP) during percutaneous coronary intervention (PCI). Background. Coronary artery perforation is reckoned as a serious complication in PCI and associated with considerable morbidity and mortality. Covered stents have been used for treating the life-threatening CAP during PCI. But in some catheterization laboratories, no commercial CS is immediately available when there is an urgent need for CS to rescue the coronary rupture site. Methods. We retrospectively identified 24 patients who underwent 31 self-made PU-CS implantations due to CAP in Zhongshan Hospital, Fudan University, from June 2015 to January 2020. Results. The total procedural success rate of CS to seal the perforation was 79.2%. Nine patients (37.5%) developed cardiac tamponade, of which 8 patients (33.3%) underwent pericardiocentesis and 4 patients (16.7%) underwent cardiac surgeries. Except for 4 cardiac death cases (16.7%), none of myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis (ST) was reported during hospital stay. Data from 22 patients (91.7%) were available at 610.4 ± 420.9 days of follow-up. Major adverse cardiac events (MACE) occurred in 6 patients (27.3%), including 5 cases of cardiac death and one TLR case. Conclusions. Self-made PU-CS demonstrates high rates of successful delivery and sealing of severe CAP during PCI. Although the in-hospital mortality remains high after PU-CS implantation, the long-term follow-up shows favorable clinical outcomes, indicating the feasibility of PU-CS in treating CAP.

2021 ◽  
Vol 10 (22) ◽  
pp. 5441
Author(s):  
Jerzy Bartuś ◽  
Rafał Januszek ◽  
Damian Hudziak ◽  
Michalina Kołodziejczak ◽  
Łukasz Kuźma ◽  
...  

Data on the clinical outcomes comparing synthetic fluorocarbon polymer polytetrafluoroethylene- (PTFE, GraftMaster) and polyurethane- (Papyrus) covered stents (CSs) to seal coronary artery perforations (CAPs) are limited. We aimed to evaluate 30-day and 1-year clinical outcomes after PCI complicated by CAP and treated with CS. We assessed 106 consecutive patients with successful CAP sealing (122 CSs): GraftMaster (51 patients, 57 CSs) or Papyrus CS (55 patients, 65 CSs). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac death, target lesion revascularisation (TLR), and myocardial infarction (MI). The mean age of subjects was 69 ± 9.6 years (53.8% males). No significant differences were identified between the GraftMaster and Papyrus groups at the 30-day follow-up for MACE, cardiac death, MI and stent thrombosis (ST), while significantly lower rate of TLR and TVR (p = 0.02) were confirmed in the Papyrus group. At one year, differences remained similar between stents for MACE, a trend towards a lower rate of TLR (p = 0.07), MI (p = 0.08), and ST (p = 0.08), and higher for cardiac death (p = 0.07) was observed in the Papyrus group. This real-life registry of CAP illustrated that the use of Papyrus CS is associated with lower rates of TLR and TVR at 30-day follow-up in comparison to the GraftMaster CSs and no significant differences between both assessed CS at one year of follow-up.


PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0249698
Author(s):  
Wojciech Wańha ◽  
Rafał Januszek ◽  
Michalina Kołodziejczak ◽  
Łukasz Kuźma ◽  
Mateusz Tajstra ◽  
...  

Background Data regarding the clinical outcomes of covered stents (CSs) used to seal coronary artery perforations (CAPs) in the all-comer population are scarce. The aim of the CRACK Registry was to evaluate the procedural, 30-days and 1-year outcomes after CAP treated by CS implantation. Methods This multicenter all-comer registry included data of consecutive patients with CAP treated by CS implantation. The primary endpoint was the composite of major adverse cardiac events (MACEs), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI). Results The registry included 119 patients (mean age: 68.9 ± 9.7 years, 55.5% men). Acute coronary syndrome, including: unstable angina 21 (17.6%), NSTEMI 26 (21.8%), and STEMI 26 (21.8%), was the presenting diagnosis in 61.3%, and chronic coronary syndromes in 38.7% of patients. The most common lesion type, according to ACC/AHA classification, was type C lesion in 47 (39.5%) of cases. A total of 52 patients (43.7%) had type 3 Ellis classification, 28 patients (23.5%) had type 2 followed by 39 patients (32.8%) with type 1 perforation. Complex PCI was performed in 73 (61.3%) of patients. Periprocedural death occurred in eight patients (6.7%), of which two patients had emergency cardiac surgery. Those patients were excluded from the one-year analysis. Successful sealing of the perforation was achieved in 99 (83.2%) patients. During the follow-up, 26 (26.2%) patients experienced MACE [7 (7.1%) cardiac deaths, 13 (13.1%) TLR, 11 (11.0%) MIs]. Stent thrombosis (ST) occurred in 6 (6.1%) patients [4(4.0%) acute ST, 1(1.0%) subacute ST and 1(1.0%) late ST]. Conclusions The use of covered stents is an effective treatment of CAP. The procedural and 1-year outcomes of CAP treated by CS implantation showed that such patients should remain under follow-up due to relatively high risk of MACE.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
I Matsoukis ◽  
A Karanasos ◽  
C Patsa ◽  
N Anousakis-Vlachochristou ◽  
K Triantafyllou ◽  
...  

Abstract Background/Introduction Revascularization of the proximal segment of left anterior descending artery (pLAD) demonstrates an additional prognostic significance in survival for patients with multivessel disease. It is also indicated for symptomatic relief in patients with stable angina who are receiving optimal medical treatment in the presence of limiting angina or angina equivalent. Both coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are still commonly needed as therapeutic options for pLAD disease. Moreover, Everolimus-eluting stents (EES) have demonstrated superiority in safety and efficacy among other types of second or new generation drug-eluting stents. Purpose We aim to evaluate the long-term outcomes of PCI with EES compared to CABG surgery with left internal mammary artery, in patients with stable angina and an isolated single vessel pLAD disease. Methods The sample consisted of 824 patients with isolated pLAD and chronic stable angina; 445 participants were included in the EES-PCI group, and 379 were included in the CABG group. The study's primary endpoint was the occurrence of major adverse cardiac events (MACEs), namely, cardiac death, myocardial infarction (MI) not attributed to a non-target vessel and target lesion revascularization as a composite index. Secondary endpoints were Patient-Related Outcome (PRO; a composite index of all-cause mortality, any MI related to any coronary artery, any revascularization conducted to any coronary artery), individual components of MACEs, recurrence of stable or unstable angina or a nonfatal arrhythmia and disease progression of other lesions. For the comparisons between the two groups, chi-square tests and Fisher's exact tests, were used, as appropriate. Results During the 4.6 years of follow-up period, no statistically significant difference was observed between the two study groups in respect to the primary endpoint MACE (8.1% versus 7.4%, p=0.71). Concerning secondary endpoints, repeat revascularization (3.6% versus 2.9%, p=0.58), cardiac death (2.9% versus 3.2%, p=0.84), MI (1.6% versus 1.3%, p=0.76) and PRO (16.9% versus 17.7%, p=0.76) did not significantly differ between the two groups. Recurrence of angina was more frequent in the EES-PCI group (14.9% versus 8.4%, p=0.005) even though higher Class of angina was found less common in EES patients than in CABG patients (p<0.001). Patients treated with EES-PCI had lower rates of onset of arrhythmias compared to those treated with CABG (6.3% versus 11.9%, p=0.005). Finally, revascularization in other than target lesion was more frequent in the stent than in the surgery arm (6.3% versus 3.2%, p=0.04); as a consequence, higher rates of revascularization in any vessel was recorded in the PCI group than the CABG one (9.9% versus 5.8%, p=0.03). Conclusion PCI with EES seem to have similar long-term clinical outcomes compared with CABG in patients with isolated pLAD disease. Funding Acknowledgement Type of funding source: None


2019 ◽  
Author(s):  
Tilman Stephan ◽  
Nadine Goldberger ◽  
Mirjam Keßler ◽  
Dominik Felbel ◽  
Manuel Rattka ◽  
...  

Abstract Background: Percutaneous coronary intervention (PCI) of left main coronary artery disease (LMD) is associated with appropriate clinical and angiographic outcomes, resulting in a class I recommendation in patients with less complex coronary anatomy. Due to higher SYNTAX scores and worse clinical outcomes, PCI in distal LMD is accomplished with a lower strength of recommendations for revascularization compared to ostial LM lesions. We compare angiographic and clinical outcomes of ostial/midshaft lesions versus distal lesion in LMD after PCI. Methods: This retrospective study included 176 patients with LMD undergoing PCI with drug-eluting stents. The study population was divided into 34 patients with ostial/midshaft LMD and 142 patients with distal LMD. Patients were routinely scheduled for 9 months of angiographic and 12 months of clinical follow-up. Quantitative coronary analysis (QCA) was performed for all lesions, using an 11-segment model. Primary outcome was MACE (major adverse cardiac events) defined as a composite of cardiac death, myocardial infarction and target lesion revascularization (TLR). Results: The primary outcome measure was comparable in both cohorts after 12 months follow-up (20.6% in ostial/midshaft LMD vs. 17.6% in distal LMD, P=0.71). As expected, TLR rates were increased in distal LM lesions compared to ostial LM lesions, but without reaching statistical significance (14.1% vs. 5.9%, P=0.15). Late lumen loss (LLL) in ostial/midshaft LMD was 0.42±0.33mm. In distal LM lesions value for LLL in the main vessel was 0.42±0.97 mm, with the highest values observed in segments adjacent to the bifurcation (0.37±1.13mm and 0.37±0.73 mm). On cox proportional regression analysis LLL in a bifurcation segment (P=0.03, HR 1.68 [1.1-2.7]) and diabetes mellitus (P=0.046, HR 2.77 [1.0-7.5] were independent correlates for occurrence of MACE. Conclusion: PCI of distal LM lesions result in comparable angiographic and clinical outcomes compared to ostial LM lesions. Highest rates for binary restenosis were observed in segments nearest to the bifurcation.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Shoichi Kuramitsu ◽  
Hiroaki Matsuda ◽  
Hiroyuki Jinnouchi ◽  
Takashi Hiromasa ◽  
Takenori Domei ◽  
...  

Background: Late adverse events such as stent thrombosis (ST) or late target-lesion revascularization (TLR) after sirolimus-eluting stents (SES) implantation remain an important concern. However, there is little data regarding clinical outcome beyond 5 years after SES implantation. We sought to assess very long-term clinical outcome after SES implantation. Methods: Between April 2004 and December 2006, a total of 686 patients with 894 lesions underwent percutaneous coronary intervention only with SES. We assessed the major adverse cardiac events (MACE), defined as a composite of cardiac death, TLR, definite ST. Results: At 10 years, cumulative incidence of MACE and cardiac death were 50.8% and 8.2%, respectively. Cumulative incidence of TLR within 1 year was 12.6%. However, late TLR beyond 1 year continued to occur without attenuation up to 10 years (2.3%/year) (5 years, 22.8%; 10 years, 33.3%). Cumulative incidence of definite ST was low (30 days, 0.3%; 1 year, 0.9%; 5 years, 1.8%; and 10 years, 3.3%), whereas definite ST also continued to occur without attenuation (0.27%/year). The predictors of MACE were hemodialysis (hazard ratio [HR] 2.87, 95% confidence intervals [CI]:1.76-4.53, p <0.001) and age ≥75 years (HR 1.72, 95% CI: 1.31-2.26, p <0.001). Conclusions: Late catch-up phenomenon regarding ST and TLR continued up to 10 years without attenuation. Careful clinical follow-up is required in patients treated with SES beyond 5 years.


2020 ◽  
Author(s):  
Xuhe Gong ◽  
Li Zhou ◽  
Xiaosong Ding ◽  
Hui Chen ◽  
Hongwei Li

Abstract Background: Coronary chronic total occlusions (CTOs) are correlated with increased risk of adverse clinical outcomes. The optimal treatment strategy for CTO has not been well established. We sought to examine the impact of CTO percutaneous coronary intervention (PCI) on long-term clinical outcome in the real world.Methods: A total of 592 consecutive patients with CTO in Beijing Friendship Hospital from June 2017 to December 2019 were enrolled, 29 patients were excluded due to Coronary artery bypass grafting (CABG). After exclusion, 563 patients were divided into the no-revascularized group (CTO-NR group, n=263) and successful revascularized group (CTO-R group, n=300). The primary endpoint was cardiac death; Secondary endpoint was major adverse cardiac and cerebrovascular events (MACCE), a composite of all-cause death, cardiac death, recurrent myocardial infarction, target lesion revascularization, re-hospitalization, heart failure, and stroke.Results: Percent of Diabetes mellitus (53.2% vs 39.7), Chronic kidney disease (8.7% vs 3.7%), CABG history (7.6% vs 1%), three vessel disease(96.2% vs 90%) and left main coronary artery disease (25.1% vs 13.7%) was significantly higher in the CTO-NR group than in success PCI group (all P<0.05). Moreover, the CTO-NR group has lower EF (0.58±0.11 vs 0.61±0.1, p=0.001) and FS (0.31±0.07 vs 0.33±0.07, p=0.002). At a median follow-up of 12 months, CTO revascularization was superior to CTO no-revascularization in terms of cardiac death (adjusted hazard ratio [HR]: 0.27, 95% conference interval [CI] 0.11-0.64). The superiority of CTO revascularization was consistent for MACCE (HR: 0.55, 95% CI 0.35-0.79). At multivariable Cox hazards regression analysis, CTO revascularization remains one of the independent predictors of lower risk of cardiac death and MACCE.Conclusions: Successful revascularization by PCI may bring more clinical benefits. The presence of LVEF<0.5 and LM-disease was associated with an incidence of cardiac death; CTO revascularization was a protected predictor of cardiac death.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Lim ◽  
H M Yang ◽  
M H Yoon ◽  
K W Seo ◽  
B J Choi ◽  
...  

Abstract Aims The clinical meaning of a trans-stent pressure gradient after DES implantation has not been estimated adequately. We evaluated the usefulness of a fractional flow reserve (FFR) gradient across the stent (ΔFFRstent) for long-term clinical outcomes after percutaneous coronary intervention (PCI) with a drug-eluting stent (DES). Methods and results FFR pull-back and intravascular ultrasound (IVUS) were performed after successful PCI in 135 left anterior descending artery lesions. ΔFFRstent was defined as the FFR gradient across the stent. The ΔFFRstent/length was defined as the ΔFFRstent value divided by the total stent length multiplied by 10 [= (ΔFFRstent ÷ stent length) x 10]. Major adverse cardiac events (MACEs) were the composite of all-cause death, target vessel related myocardial infarction, and target lesion revascularisation. Despite successful PCI without significant complications on IVUS, ΔFFRstent >0 was observed in 98.5% of cases. ΔFFRstent ≥0.04 and ΔFFRstent/length ≥0.009 predicted suboptimal stenting defined as final minimal stent area <5.5 mm2. During 2183±898 days, the MACE-free survival rate was significantly lower in patients with ΔFFRstent ≥0.04 and ΔFFRstent/length ≥0.009 compared to those with lower values (69.6 vs. 93.4%, log-rank p=0.031; 72.1 vs. 97.7%, log-rank p=0.003, respectively). ΔFFRstent/length ≥0.009 (hazard ratio 10.1, p=0.032) was an independent predictor of MACE. Trans-stent FFR and MACE Conclusion A trans-stent FFR gradient was frequently observed in DES-treated patients despite successful PCI results. ΔFFRstent and ΔFFRstent/length are useful indicators for optimising a DES and are related to long-term outcomes.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xuhe Gong ◽  
Li Zhou ◽  
Xiaosong Ding ◽  
Hui Chen ◽  
Hongwei Li

Abstract Background Coronary chronic total occlusions (CTOs) are related to increased risk of adverse clinical outcomes. The optimal treatment strategy for CTO has not been well established. We sought to examine the impact of CTO percutaneous coronary intervention (PCI) on long-term clinical outcome in the real world. Methods A total of 592 patients with CTO were enrolled. 29 patients were excluded due to coronary artery bypass grafting (CABG). After exclusion, 563 patients were divided into the no-revascularized group (CTO-NR group, n = 263) and successful revascularized group (CTO-R group, n = 300). The primary endpoint was cardiac death; secondary endpoint was major adverse cardiac and cerebrovascular events (MACCE), a composite of all-cause death, cardiac death, recurrent myocardial infarction, target lesion revascularization, re-hospitalization, heart failure, and stroke. Results Percent of Diabetes mellitus (53.2% vs 39.7), Chronic kidney disease (8.7% vs 3.7%), CABG history (7.6% vs 1%), three vessel disease (96.2% vs 90%) and left main coronary artery disease (25.1% vs 13.7%) was significantly higher in the CTO-NR group than in success PCI group (all P < 0.05). Moreover, the CTO-NR group has the lower ejection fraction (EF) (0.58 ± 0.11 vs 0.61 ± 0.1, p = 0.001) and fraction shortening (FS) (0.31 ± 0.07 vs 0.33 ± 0.07, p = 0.002). At a median follow-up of 12 months, CTO revascularization was superior to CTO no-revascularization in terms of cardiac death (adjusted hazard ratio [HR]: 0.27, 95% conference interval [CI] 0.11–0.64). The superiority of CTO revascularization was consistent for MACCE (HR: 0.55, 95% CI 0.35–0.79). At multivariable Cox hazards regression analysis, CTO revascularization remains one of the independent predictors of lower risk of cardiac death and MACCE. Conclusions Successful revascularization by PCI may bring more clinical benefits. The presence of low left ventricular ejection fraction (LVEF) and LM-disease was associated with an incidence of cardiac death; CTO revascularization was a protected predictor of cardiac death. Graphical abstract Successful revascularization by PCI offered CTO patients more clinical benefits, manifested by lower incidence of cardiac death during follow-up. The presence of LVEF < 0.5 and left main coronary artery disease (LM disease) was associated with an incidence of cardiac death; CTO revascularised was a protected predictor of cardiac death.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
N Takahashi ◽  
T Dohi ◽  
T Funamizu ◽  
H Endo ◽  
H Wada ◽  
...  

Abstract Background Inflammatory status pre-percutaneous coronary intervention (PCI) and post-PCI has been reported not only associated with poor prognosis, but also to impair renal function. Statins reduce cardiovascular events by lowering lipids and have anti-inflammatory impacts, but residual inflammatory risk (RIR) exists. It remains unclear that the synergistic effect of RIR and chronic kidney disease (CKD) on long-term clinical outcome in stable coronary artery disease (CAD) patients undergoing PCI in statin era. Aim The aim of this study was to investigate the long-term combined impact of RIR evaluating hs-CRP at follow-up and CKD among stable CAD patients undergoing PCI in statin era. Methods This is a single-center, observational, retrospective cohort study assessing consecutive 2,984 stable CAD patients who underwent first PCI from 2000 to 2016. We analyzed 2,087 patients for whom hs-CRP at follow-up (6–9 months later) was available. High residual inflammatory risk was defined as hs-CRP &gt;0.6 mg/L according to the median value at follow up. Patients were assigned to four groups as Group1 (high RIR and CKD), Group2 (low RIR and CKD), Group3 (high RIR and non-CKD) or Group4 (low RIR and non-CKD). We evaluated all-cause death and major adverse cardiac events (MACE), defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Results Of patients (83% men; mean age 67 years), there were 299 (14.3%) patients in group 1, 201 (9.6%) patients in group 2, 754 (36.1%) patients in group 3, and 833 (39.9%) patients in group 4. The median follow-up period was 5.2 years (IQR, 1.9–9.9 years). In total, 189 (frequency, 16.1%) cases of all-cause death and 128 (11.2%) MACE were identified during follow-up, including 53 (4.6%) CV deaths, 27 (2.4%) MIs and 52 (4.8%) strokes. The rate of all-cause death and MACE in group 1 was significantly higher than other groups (p&lt;0.001, respectively). There was a stepwise increase in the incidence rates of all-cause death and MACE. After adjustment for important covariates, the presence of high RIR and/or CKD were independently associated with higher incidence of MACE and higher all-cause mortality. (shown on figure). Conclusion The presence of both high RIR and CKD conferred a synergistic adverse effect on the risk for long-term adverse cardiac events in patients undergoing PCI. Kaplan-Meier curve Funding Acknowledgement Type of funding source: None


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Kiro Barssoum ◽  
Ashish Kumar ◽  
Devesh Rai ◽  
Adnan Kharsa ◽  
Medhat Chowdhury ◽  
...  

Background: Long term outcomes of culprit multi-vessel and left main patients who presented with Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) and underwent either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) are not well defined. Randomized trials comparing the two modalities constituted mainly of patients with stable coronary artery disease (SCAD). We performed a meta-analysis of studies that compared the long term outcomes of CABG vs. PCI in NSTE-ACS. Methods: Medline, EmCare, CINAHL, Cochrane databases were queried for relevant articles. Studies that included patients with SCAD and ST-elevation myocardial infarction were excluded. Our primary outcome was major adverse cardiac events (MACE) at 3-5 years, defined as a composite of all-cause mortality, stroke, re-infarction and repeat revascularization. The secondary outcome was re-infarction at 3 to 5 years. We used the Paule-Mandel method with Hartung-Knapp-Sidik-Jonkman adjustment to estimate risk ratio (RR) with 95% confidence interval (CI). Heterogeneity was assessed using Higgin’s I 2 statistics. All statistical analysis was carried out using R version 3.6.2 Results: Four observational studies met our inclusion criteria with a total number of 6695 patients. At 3 to 5 years, the PCI group was associated with a higher risk of MACE as compared to CABG, (RR): 1.52, 95% CI: 1.28 to 1.81, I 2 =0% (PANEL A). The PCI group also had a higher risk of re-infarctions during the period of follow up, RR: 1.88, 95% CI 1.49 to 2.38, I 2 =0% (PANEL B). Conclusion: In this meta-analysis, CABG was associated with a lower risk of MACE and re-infarctions as compared to PCI during 3 to 5 years follow up period.


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