Coronary Artery Perforation Research Articles

Clinical Experience of the PK Papyrus Covered Stent in Patients With Coronary Artery Perforations: Results From a Multi-Center Humanitarian Device Exemption Survey

Background/purposeThe PK Papyrus covered coronary stent system (Biotronik AG, Bülach, Switzerland) is intended for treatment of coronary artery perforation (CAP) and is approved for use under a Humanitarian Device Exemption (HDE) in the United States (US). Methods/materialsThe retrospective data analysis includes cases reported from the US PK Papyrus HDE post-market surveillance clinical dataset with CAP cited as the reason for PK Papyrus stent use. ResultsFrom April 2019 to July 2021, PK Papyrus device registration forms citing CAP as the reason for use were received for 1094 cases from 335 US hospital programs. Ellis classification was assessed as: type III cavity spilling/IV, 11.0%; type III, 57.9%; type II, 23.8%; type I, 7.3%. Mechanisms of perforation included: balloon angioplasty (42.3%), stent placement (31.3%), atherectomy (13.9%), and guidewire (10.9%). The majority (72.6%) of cases involved single covered stent placement. Successful PK Papyrus delivery was reported in 97.7% of cases with successful perforation sealing in 92.1%. Emergency cardiac surgery and in-hospital death occurred in 6.3% and 12.4% of cases, respectively. Pericardiocentesis was performed in 30.2% of patients. Acute/subacute stent thrombosis occurred in 10 patients (1.1%). ConclusionAs the largest dataset of patients treated with a covered stent for CAP, these data provide significant insight into patient characteristics, procedural outcome, and in-hospital clinical events associated with this life-threatening complication. These results demonstrate that the PK Papyrus stent is a safe and effective method to seal CAP and with the potential to reduce high morbidity and mortality associated with this event.

Preclinical Assessment of a Rapid Anastomotic Device for HeartMate 3 Apical Cuff Implantation

<h3>Purpose</h3> The HeartMate3 (HM3) LVAD requires an apical cuff (AC) to left ventricle (LV) anastomosis. We developed an AC attachment device for the standard HM3 AC with 12 anchors and 4 compression plates. A Gen1 delivery tool requires a hand-held driver and sequential anchor delivery. A Gen2 delivery tool with a targeting system and improved anchors has a planetary gear mechanism that drives all anchors simultaneously. The study purpose was to assess functionality and hemostasis of HM3 AC anastomosis. <h3>Methods</h3> Standard HM3 ACs were implanted without cardiopulmonary bypass (CPB) in 8 calves (110 to 130 kg): left thoracotomy (n=2), median sternotomy (n=6). Implant time was from epicardial contact to complete anchor deployment. Blood pressure (BP) was measured by arterial line. After anchor deployment and AC attachment heparin was administered to ACT over 400 seconds. Fibrillation (n=2), rapid pacing (n=1) and vena cava inflow occlusion (n=5) were used for LV coring and custom AC plug insertion with resuscitation to baseline BP. Functionality and hemostasis were qualitatively assessed. Supraphysiologic testing (norepinephrine, 0.15 mcg/kg/min) was assessed in 4 cases (Gen1, n=3; Gen2, n=1). <h3>Results</h3> Implants were simple. Gen1 (n=6) implant time range was 63 to 94 seconds. Gen2 (n=2) times were 26 and 32 seconds. Prior to anticoagulation hemostasis was excellent. Five cases were assessed for post-plug hemostasis (2 fibrillated and 1 paced could not be resuscitated). After resuscitation there was minimal to no bleeding in 3 cases (2 Gen 1, 1 Gen 2). In 2 cases (1 Gen1, 1 Gen2) sutures were required at a single anchor site: 1 Gen1 had localized bleeding due to a single anchor failure (cap separation), 1 Gen2 had bleeding at a coronary artery perforation. Excellent hemostasis was maintained at supraphysiologic pressures (n=4, systolic BP range 211-248 mmHg). <h3>Conclusion</h3> Rapid HM3 apical cuff attachment is feasible. Hemostasis was excellent even at significant supraphysiologic blood pressure. Advantages are: 1) No HM3 AC manufacturing changes are required, 2) Implant time is greatly decreased, 3) Implant is easy without CPB, 4) Implant site targeting is precise, 5) The area of impacted myocardium is limited to the area under the AC sewing skirt, and 6) Low device profile permits use with mini-thoracotomy access. Suturing buttressing is feasible and may be necessary in case of coronary artery perforation.

TCTAP C-096 Coronary Artery Perforation or Normal Friday Night

TCTAP C-096 Coronary Artery Perforation or Normal Friday Night

Changing trends in the incidence, management and outcomes of coronary artery perforation over an 11-year period: single-centre experience

IntroductionCoronary artery perforation (CP) is a rare but life-threatening complication of percutaneous coronary intervention (PCI). This study aimed to assess the incidence, management and outcomes of CP over time.MethodsA single-centre...

Coronary artery perforation after bioresorbable scaffold implantation treated with a new generation covered stent\u2014OCT insights

BackgroundCoronary artery perforation is a rare but potentially lethal complication of percutaneous coronary intervention (PCI) with an associated mortality of 7–17%. We report the case of coronary artery perforation complicating Absorb bioresorbable vascular scaffold (BVS) implantation and the associated technical challenges with managing this life-threatening complication.Case reportA 46-year-old male was referred to our institution and underwent PCI with an Absorb bioabsorbable vascular scaffold (BVS) to a proximal LAD long segment bifurcation lesion. Following pre-dilation and deployment of the 3.5 × 28 mm Absorb BVS, high pressure post-dilation of the distal scaffold was complicated by a large, Ellis type III coronary perforation with no flow to the distal LAD beyond the rupture, and associated with a large pericardial effusion confirmed on bedside transthoracic echocardiogram (TTE). The insult was temporised with prolonged balloon inflation within the Absorb BVS immediately proximal to the site of perforation, permitting urgent insertion of a pericardial drain. After deflation of the balloon, a 3.0 × 21 mm BeGraft covered stent was deployed across the perforation, restoring normal LAD flow and abolishing the perforation. Cardio-pulmonary resuscitation was not required and the patient remained conscious throughout the procedure. TTE demonstrated normal left ventricular function and the patient was discharged 3 days later. Repeat angiography at 3 months showed patent stents with TIMI III flow, and optical coherence tomography (OCT) showed good expansion and apposition of the proximal Absorb BVS and BeGraft. The patient has remained well 4 years after PCI with no major cardiovascular events.ConclusionThe utility of bioresorbable scaffold technology remains controversial although meticulous implantation techniques are associated with improved clinical outcomes. Adoption of the Pre-dilatation, Sizing and Post-dilatation (‘PSP’) method of BVS implantation with routine aggressive vessel preparation and scaffold optimization however may contribute to a higher risk of vessel perforation. The case emphasises the importance of accurate sizing of the vessel with intracoronary imaging and demonstrates the value of newer generation covered stents with single-layer design and slimmer crossing profile producing improved deliverability and procedural success.

CRT-100.99 Clinical Experience of the PK Papyrus Covered Stent in Patients With Coronary Artery Perforations

CRT-100.99 Clinical Experience of the PK Papyrus Covered Stent in Patients With Coronary Artery Perforations

Successful management of distal coronary artery perforation with the modified cut balloon technique during percutaneous coronary intervention.

Successful management of distal coronary artery perforation with the modified cut balloon technique during percutaneous coronary intervention.

A Coronary Artery Perforation: Successful Complication Management after Intravascular Ultrasound Imaging Guided Covered Stent Implantation

A coronary artery perforation is a rare, but dangerous periprocedural complication. In this case the perforation stented with two covered stents, balloon inflations applied. Despite the treatment extravasation persisted. Intravascular ultrasound (IVUS) imaging identified the reasons of persisting extravasation. IVUS guided third covered stent implantation leaded to the successful treatment.

Effectiveness of Intra-Coronary Injection of Sodium Nitroprusside for the Treatment of Coronary No-Reflow through Punctured Coronary Balloon

Rapid restoration of thrombolysis in myocardial infarction III in case of no-reflow during percutaneous coronary intervention is imperative. Application of punctured coronary balloon intracoronary injection of sodium nitroprusside is a prompt, safe and effective method. To investigate the effectiveness of intracoronary injection of sodium nitroprusside via punctured coronary balloon in the treatment of no-reflow in coronary artery is the main objective of the study. We retrospectively analyzed 76 patients treated with intracoronary injection of sodium nitroprusside via punctured coronary balloon for coronary no-reflow. All 76 patients successfully completed intracoronary injection of sodium nitroprusside with the improvement of no-reflow in coronary artery for thrombolysis in myocardial infarction grade III in 74 patients. There were two complications which occurred in the early application of this technique. One was a punctured coronary balloon fracture left in the distal coronary artery and the other was a difficult pullback of the punctured coronary balloon catheter. After improving the application method, later no more complications occurred in 67 patients and no complications such as coronary guide wire pulling out of the coronary artery, coronary artery dissection, coronary artery perforation and coronary artery air embolism occurred. Coronary no-reflow treatment with intracoronary injection of sodium nitroprusside via punctured coronary balloon is safe and effective when properly applied.

Intracoronary Lithotripsy in Calcified Coronary Lesions: A Multicenter Observational Study.

The aim of this study was to evaluate the feasibility, effectiveness, and safety of coronary intravascular lithotripsy (IVL; Shockwave Medical) in the treatment of severe coronary artery calcification (CAC) in a real-world setting. Severe CAC can be an arduous obstacle in interventional cardiology, often leading to suboptimal results of percutaneous coronary interventions (PCI). Coronary IVL is a novel technique that modulates severe CAC, thereby facilitating stent implantation. In this multicenter observational study, data from 134 IVL procedures in 5 Belgian hospitals were prospectively obtained. Successful delivery of the IVL catheter was achieved in all cases but 1 (99.3%). The primary endpoint was final overall procedural success, which was obtained in 88.1% of cases, an aggregate of 92.6% in de novo lesions and 77.5% in stent underexpansion or in-stent restenosis (ISR). IVL therapy effect was considered successful by the operators in 94% of cases, with 68.7% achieving optimal and 25.3% achieving suboptimal results. The 1-month major adverse cardiovascular event rate was 3%, including 2 cardiovascular deaths (1 in-stent thrombosis and 1 coronary artery perforation). This real-world experience suggests that Shockwave IVL is a feasible, effective, and safe technique for the treatment of heavily calcified coronary lesions.

In-house custom-made sandwich stenting for coronary artery perforation

In-house custom-made sandwich stenting for coronary artery perforation

Clinical Outcomes following Large Vessel Coronary Artery Perforation Treated with Covered Stent Implantation: Comparison between Polytetrafluoroethylene- and Polyurethane-Covered Stents (CRACK-II Registry).

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.

C58. Management of Ellis Type V RV Branch Coronary Perforation Using Handmade Covered-stent: a case report

Abstract Coronary perforation is a rare but life-threatening complication of percutaneous coronary intervention (PCI) requiring urgent management including balloon inflation, thrombin, microcoils, fat embolization, autologous blood clots administration, heparin-reversing agent, covered-stent implantation, or surgery. We report a case of Ellis type V RV branch coronary artery perforation during PCI treated with a handmade covered-stent. A 69-year-old female presented with typical angina in three days. She was hemodynamically stable and no sign of congestion. Laboratory results showed leukocytosis, mild elevation of liver transaminase, elevated CK-MB level, mild hypoalbuminemia. ECG showed sinus rhythm with atrial bigeminy, late-onset inferoposterior and RV MI, and first-degree AV block. TTE revealed reduced LV systolic function (LVEF 45%), impaired LV relaxation, reduced RV function, marked LV hypokinetic in inferior, inferoseptal, apicoseptal, and inferolateral wall, and mild ischemic mitral regurgitation. DCA result showed 90 – 95% tubular stenosis in mid-LAD and total occlusion in proximal-RCA with grade V thrombus. She had an anomaly of RV branch angle that resembles the RCA so that the guidewire perforated the distal part of the RV branch artery. PCI was done using hydrophilic wire to distal RCA. Ellis type V perforation was found following multiple balloon inflation in RV branch. Perforation was managed with a handmade covered-stent using a Sirolimus-eluting stent with Tegaderm film. TIMI flow 3 was reached without thrombi or residual stenosis. In medical centers that have limited resources, handmade covered-stents can be used as an option after unsuccessful balloon inflation trial.

C58. Management of Ellis Type V RV Branch Coronary Perforation Using Handmade Covered-stent: a case report

Abstract Coronary perforation is a rare but life-threatening complication of percutaneous coronary intervention (PCI) requiring urgent management including balloon inflation, thrombin, microcoils, fat embolization, autologous blood clots administration, heparin-reversing agent, covered-stent implantation, or surgery. We report a case of Ellis type V RV branch coronary artery perforation during PCI treated with a handmade covered-stent. A 69-year-old female presented with typical angina in three days. She was hemodynamically stable and no sign of congestion. Laboratory results showed leukocytosis, mild elevation of liver transaminase, elevated CK-MB level, mild hypoalbuminemia. ECG showed sinus rhythm with atrial bigeminy, late-onset inferoposterior and RV MI, and first-degree AV block. TTE revealed reduced LV systolic function (LVEF 45%), impaired LV relaxation, reduced RV function, marked LV hypokinetic in inferior, inferoseptal, apicoseptal, and inferolateral wall, and mild ischemic mitral regurgitation. DCA result showed 90 – 95% tubular stenosis in mid-LAD and total occlusion in proximal-RCA with grade V thrombus. She had an anomaly of RV branch angle that resembles the RCA so that the guidewire perforated the distal part of the RV branch artery. PCI was done using hydrophilic wire to distal RCA. Ellis type V perforation was found following multiple balloon inflation in RV branch. Perforation was managed with a handmade covered-stent using a Sirolimus-eluting stent with Tegaderm film. TIMI flow 3 was reached without thrombi or residual stenosis. In medical centers that have limited resources, handmade covered-stents can be used as an option after unsuccessful balloon inflation trial.

Coil Embolization for Coronary Artery Perforation: A Retrospective Analysis of 110 Patients.

Objective Coil embolization (CE) for coronary artery perforation (CAP) has not been thoroughly evaluated. This study aimed to evaluate the extent of myocardial damage and impact on cardiac function after CE for CAP. Methods A total of 110 consecutive patients treated with CE for CAP were retrospectively identified. The degree of myocardial damage and impact on cardiac function were evaluated. Results Forty-nine (44.5%) cases involved chronic total occlusions. A guidewire was the cause of perforation in 97 (88.2%) patients. The success rate of CE was 98.2%. Almost all patients were prescribed either antiplatelet drugs or anticoagulant medication or both. Patients with perforation types III and IV were found to be prone to creatinine kinase (CK) elevation and epicardial main vessel perforation, thereby causing myocardial damage. No changes were noted in the ejection fraction (EF) in patients with type V distal perforation and collateral channel perforation, while patients with perforation of the epicardial main vessel may show impaired cardiac function afterward. Conclusions CE is safe and effective for treating CAP, especially when collateral channels and distal vessels are involved. Meanwhile, efforts should be taken to prevent CAP in epicardial main vessels since it may be difficult to treat with CS and cause myocardial damage when bailed out with CE leading to vessel sacrifice. We found that it was not necessary to change the anticoagulant regimen after CE owing to its ability to achieve robust hemostasis.

TCT-384 Incidence, Treatment, and Outcomes of Coronary Artery Perforation During Percutaneous Coronary Intervention: Insights From the PROGRESS-COMPLICATIONS Registry

TCT-384 Incidence, Treatment, and Outcomes of Coronary Artery Perforation During Percutaneous Coronary Intervention: Insights From the PROGRESS-COMPLICATIONS Registry

Treatment delay and clinical outcomes in patients with ST-elevation myocardial infarction during the COVID-19 pandemic

Abstract Background The COVID-19 pandemic negatively affected access to health-care system and timeline of treatment. The fear of contamination might potentially forbear from accessing the emergency system.mFurthermore, pandemic-specific protocols require additional time to prepare medical stuff and catheterization laboratory before procedure. Thus, patients with ST-segment elevation myocardial infarction (STEMI) might be exposed to a longer delay for revascularization and higher risk of mortality. Purpose The aim of this study was to evaluate treatment delay and clinical outcomes in COVID-19 positive and negative patients with STEMI treated with percutaneous coronary intervention (PCI) during on- and off hours. Methods All consecutive patients with STEMI treated with PCI and stent implantation between 1st March 2020 and 31st December 2020 were enrolled into analysis. To overcome potential bias related to the non-randomized design a propensity score match (PSM) was used to compare COVID-19 positive and negative patients for both working frames hours. The study group consisted of 877 matched pairs treated during regular hours (everyday 7:00AM-16:59PM) and 418 matched pairs with PCI performed during off-hours (everyday 17:00PM and 06:59AM) in 151 tertiary invasive cardiology centers in Poland (the ORPKI Polish National Registry). Results After PSM there were no differences between COVID-19 positive and negative patients in baseline characteristics during both on- and off-hours. However, patients diagnosed with COVID-19 were admitted with cardiac arrest more frequently as compared to COVID-19 negative patients during regular working hours (180 (20.5%) vs. 64 (7.30%); p=0.001). There were no differences in radiation doses and total amount of contrast between both groups. Similarly, no differences in rate of periprocedural complications were observed despite of time of intervention, including stroke, access-site-related bleeding, allergic reaction and coronary artery perforation. Furthermore, there were no differences in periprocedural mortality between both groups (on-hours: COVID-19 negative vs. COVID-19 positive: 17 (1.9%) vs. 11 (1.3%),p=0.3; off-hours: COVID-19 negative vs. COVID-19 positive: 4 (1.0%) vs. 7 (1.7%),p=0.5). However, COVID-19 positive patients were exposed to longer time from first medical contact to angiography during both on-hours (133.76 (±137.10) vs. 117.14 (±135.83) [min]; p=0.001) and off-hours (148.08 (±201.56) vs. 112.19 (±138.72) [min]; p=0.003). Time from pain to first medical contact remained similar during both working frame hours (On-hours and off-hours, respectively: p=0.7 and p=0.9). Conclusions Patients diagnosed with COVID-19 might experience a longer time from first medical contact to revascularization. There was no impact of COVID-19 diagnosis on rate of periprocedural mortality or periprocedural complication, irrespective of time of intervention. System-level changes might be crucial to improve health-care during COVID-19 pandemic. Funding Acknowledgement Type of funding sources: None.

A Case Series of Eight Coronary Artery Perforations and a Review of the Up-to-Date Literature

Percutaneous coronary intervention has become a fundamental diagnostic and treatment strategy in coronary artery disease. Much like any procedure, it is not without risk; in fact, a rare but life-threatening complication as a result of percutaneous coronary intervention is coronary artery perforations (CAP). The risk of CAPs correspondingly rises in relation to the difficulty of the procedure, location of lesion, and complexity of anatomy. It follows then that early recognition and instigation of an appropriate treatment strategy is key in reducing the mortality and morbidity associated with CAPs. The authors present eight case reports of varying difficulties, their analogous management, and a literature review of management approaches in treating CAPs in order to provide a review of management strategies and to highlight the importance of immediate recognition of a potentially fatal complication.

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

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.

Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: Multicentre CRACK registry.

BackgroundData 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.MethodsThis 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).ResultsThe 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].ConclusionsThe 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.