Pericardial Covered Stent for Coronary Perforations

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1 Catheterization and Cardiovascular Interventions 00:00 00 (2015) Original Studies Pericardial Covered Stent for Coronary Perforations Shmuel Chen, 1 MD, Chaim Lotan, 1 MD, Ronen Jaffe, 2 MD, Ronen Rubinshtein, 2 MD, Eyal Ben-Assa, 3 MD, Ariel Roguin, 4 MD, PhD, Boris Varshitzsky, 1 MD, and Haim D. Danenberg, 1 * MD Objectives: To evaluate initial and long term results of coronary perforation treatment with pericardial covered stent. Background: Iatrogenic coronary perforation is a rare life threatening complication of percutaneous coronary interventions (PCI) occurring in % of cases. Covered stents are the mainstay of therapy for coronary perforation. However, polytetrafluoroethylene covered stents are bulky with limited flexibility and thus may not be easy to deliver in difficult anatomy. Therefore, they are reserved to perforations in proximal or mid straight segments where their delivery is relatively easy. The pericardial covered stent is a highly deliverable fully covered stent that may be used to treat coronary perforations. Only a single case has been reported of the use of this stent in its previous version for the treatment of coronary perforation. Methods: The electronic databases of four tertiary medical centers were retrospectively reviewed for cases of coronary perforations in which PCS was used. During a five years period, between 2008 and 2013, 18,364 patients underwent PCI in these centers. Nine cases of perforations for which balloon dilatation was not sufficient and pericardial covered stent was used were recorded. Results: All nine cases were successfully treated with pericardial covered stent. Six of the patients underwent repeated angiography at 2 15 months, and in two of them instent restenosis that warranted repeated angioplasty was observed. One of them was catheterized for NSTEMI 3 months after the covered stent implantation, and stent thrombosis was demonstrated. Conclusions: Pericardial covered stents offer a safe and effective therapy for coronary perforation when balloon inflation and reversal of anticoagulation are insufficient. VC 2015 Wiley Periodicals, Inc. Key words: pericardial covered stent; coronary perforation; PCI complications INTRODUCTION Coronary artery perforation is a rare but potentially fatal complication of percutaneous coronary interventions (PCI), occurring when a dissection or intimal tear completely penetrates the arterial wall leading to either vessel puncture or in more severe cases to vessel rupture [1]. Most cases are caused by distal wire trauma, while balloons and stents responsible for the rest, typically more proximally [2]. Perforations can be classified into three types: Type I, extraluminal crater without extravasation; Type II, pericardial or myocardial blushing or Type III, perforation 1 mm diameter with contrast streaming and cavity spilling. Type I is a relatively benign condition, whereas Types II and III can cause a significant accumulation of blood in the pericardial space, which can lead to tamponade and 1 Department of Cardiology, Hadassah Hebrew University Medical Center, Jerusalem, Israel 2 Department of Cardiology, Lady Davis Carmel Hospital, Haifa, Israel 3 Department of Cardiology, Tel Aviv Medical Center, Tel Aviv, Israel 4 Department of Cardiology, Rambam Medical Center, Rappaport - Faculty of Medicine, Technion, Israel Institute of Technology, Israel Conflict of Interest: Drs. Lotan and Danenberg serve as consultants to ITGI. *Correspondence to: Haim D. Danenberg, MD Heart Institute, Hadassah Hebrew University Medical Center P.O.B 12000, Jerusalem, Israel IL haimd@ekmd.huji.ac.il Received 29 June 2014; Revision accepted 11 April 2015 DOI: /ccd Published online 00 Month 2015 in Wiley Online Library (wileyonlinelibrary.com) VC 2015 Wiley Periodicals, Inc.

2 2 Chen et al. rapid hemodynamic collapse. Mortality following coronary perforation is high, reported to range from 5.9 to 7.4% [2 4]. Therefore, an urgent intervention is required for these cases. The immediate recommended therapy for prevention of further extravasation is prolonged balloon inflation proximal to the perforation site concomitantly with reversal of anticoagulation. Following failure of this therapy and continuous bleeding, the options are immediate open-heart surgery with its associated risks or intraluminal sealing of the perforation with a covered stent that will and restore a nonbreached vessel wall. The last option is relevant for relatively proximal perforations caused, as mentioned above, by balloon or stent whereas distal perforations usually caused by wire trauma can readily treated by coil embolization. There are two major types of covered stents according to their overlay: polytetrafluoroethylene (PTFE) covered stents (Symbiot, Boston Scientific; Jostent, Abbott and Nuvasc, Cardiovasc) and pericardial covered stents. The PTFE covered stent consists of a distensible PTFE membrane sandwiched between two stainless steel slotted tube, balloonexpandable stents. The pericardial covered stent (PCS, ITGI Medical, Or Akiva, Israel) is a highly deliverable, balloon-expandable stent allows prompt deployment in case of need. It is a stainless steel stent ( lm strut thickness) 100% covered (under and over) with a heterologous tissue (105 5 lm layer of equine pericardium), designed to set a barrier between the coronary blood vessel wall and its lumen (Fig. 1). The stent is available in EU, UK, Scandinavia, Eastern Europe, South Africa, Honk Kong, Colombia and Mexico, in 2.5, 3.0, 3.5, and 4.0 mm diameters and 13, 18, 23, and 27 mm lengths. The catheter inner diameter suitable for the stent is The pericardial covered stent has a shelf life of 3 years. Only one case of coronary perforation treated with a pericardial covered stent has been reported [5]. Recently, two case reports described the use of a mesh covered stent (MGuard stent, Inspire MD) for sealing of coronary perforations [6,7]. Yet, this stent is not designed to fully cover the vessel wall but rather to allow flow through its 20 mm mesh cells. Here we present nine new cases of coronary perforations that were safely and effectively treated with pericardial covered stent. Fig. 1. Pericardial covered stent is a balloon-expandable stent 100% covered (over and under) with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.] METHODS The electronic databases of four tertiary medical centers were retrospectively reviewed for cases of coronary perforations in which PCS was used. During a five years period, between 2008 and 2013, 18,364 patients underwent PCI in these centers. Nine cases of perforations for which balloon dilatation was not sufficient were recorded. All cases were treated with PCS and pericardiocentesis was required in three patients. There were no cases in which surgery or the use of another endovascular technique (such as coil embolization) were required. Six of the nine cases underwent repeated angiography at 2 15 months. RESULTS Patients are presented in Table I. All patients but three (#6, 8, 9) were admitted with an acute coronary syndrome. Perforations were treated initially with proximal balloon inflation followed by PCS deployment. Three patients underwent emergent pericardiocentesis during index procedure. Six of the patients underwent repeated angiography at 2 15 months, and in two of them instent restenosis that warranted repeated angioplasty was observed. The restenosis was within the body of the covered stent in both cases. One patient (#5) was catheterized for NSTEMI three months later and stent thrombosis was demonstrated. Three out of these six patients (#2, 6, and 8) were asymptomatic and were catheterized for diagnostic purposes (during TAVI - #2 and 6 and follow up - #8). The covered stents were found to be patent in patients #2 and 6 while in patient #8 the artery (RCA) was occluded at the ostium, proximal to the stent. DISCUSSION Coronary perforations are an emergency situation that while rare in current PCI practice may be life threatening and warrants an immediate intervention. The present case series describes the use of the novel pericardial covered stent as a valid option to treat

3 Pericardial Covered Stent 3 TABLE I. Clinical and Angiographic Characteristics Angiographic F/U (months) Clinical F/U (month/ presentation) Angiographic result Covered-stent size D X L (mm) Clinical picture Perforation grade Patient Age/gender Diagnosis Location of perforation Good flow, no perforation 32/Asymptomatic II Chest pain, 1 53/M NSTE-ACS Anastomosis RIMA-LAD during PCI to RIMA 2 80/M NSTE-ACS PCI to Mid LAD (calcified artery) III Tamponade Occlusion of D1 11/Asymptomatic 4/Patent 3 69/F STEMI Distal LAD during primary PCI Good flow, no perforation 15/NSTEMI 15/Instent restenosis II Chest pain, to mid LAD (restenosis, calcified artery) 4 81/M NSTE-ACS CX (calcified artery) III Tamponade Good flow, no perforation 4/UA 4/Instent restenosis 5 51/M NSTEMI M1 II Asymptomatic Good flow, no perforation 3/NSTEMI 3/Stent thrombosis Good flow, no perforation 7/Asymptomatic 7/Patent III Tamponade, Asystole 6 84/F Stable angina Proximal LAD (calcified artery) I Asymptomatic Good flow, no perforation 12/Asymptomatic Good flow, no perforation 3/Asymptomatic 2/occluded RCA III Chest pain, 7 78/M NSTE-ACS Mid LAD (calcified artery) 8 67/M Stable angina Mid RCA (calcified artery) with Rotablation II Chest pain Good flow, no perforation 4/Asymptomatic 9 66/M Stable angina Tight lesion in the mid LAD, Abbreviations: PCI, percutaneous coronary intervention; RIMA, right internal mammary artery; LAD, left anterior descending; CX, circumflex; DES, drug eluting stent; BMS, bare metal stent; D1, first diagonal; M1, first marginal; NSTE-ACS, non ST elevation acute coronary syndrome. coronary perforation even in cases with complex coronary anatomy. The coronary anatomy in the cases described was complex in most cases due to vessel tortuosity and presence of calcifications (as detailed below). In case #1, the stent was deployed through a highly tortuous right internal mammary arterial graft and advanced via an existing stent (Fig. 2). Cases #3 4, and 6 8 warranted the crossing of highly calcified tortuous vessels, with (#3,6-8) or without (#4) an existing stent. In addition to the successful acute results, angiographic follow-up in two patients (#2 and 6) demonstrates good late vessel patency (Fig. 3). Thus, this report highlights this percutaneous therapeutic alternative to coronary perforations as safe and effective in challenging anatomies, reducing the need for emergency surgery. Efficacy of Covered Stents Contemporary, coronary perforation is an uncommon phenomenon, thus data regarding the treatment with covered stents is relatively rare and relies on small number of patients. Briguori et al. reported the use of PTFE-covered stents in 11 of 12 patients who had coronary ruptures that were unsuccessfully sealed with prolonged balloon inflation and reversal of anticoagulation. Success rates were up to 91% for Type II and III perforations with low incidence of cardiac tamponade or need for emergency surgery [8]. Alas, the PTFEcovered stent is relatively bulky and stiff and thus its use is reserved to large non-calcified epicardial vessels and not the tortuous calcified vessels, which are more prone to perforate upon balloon inflation. The avoidance of a sandwich configuration used in the PTFEcovered stent, markedly enhances flexibility of PCS in angulated or tortuous vessels, and delivery of a stent was easily accomplished in cases #3,6 8 using a 6 Fr guiding catheter, through a stented section of the vessel with marked angulation and calcification. Testing of the PCS in both phantom and porcine coronary models has shown superior deliverability over PTFE-stents by and mm, respectively, (P < 0.05 for both models) [5]. Stent Thrombosis and Restenosis The rate of stent thrombosis and restenosis in patients with perforation treated with pericardial covered stents, is not known. A randomized trial was conducted to compare PTFE-covered stent with a bare metal stent for prevention of restenosis and major adverse cardiac events in patients undergoing SVG treatment (the RECOVERS trial), found a higher incidence of 30-day nonfatal myocardial infarction compared to non-covered stents (10.3 vs. 3.4%,

4 4 Chen et al. Fig. 2. Angiography of patient #1. A: Perforation at the distal anastomosis of a right internal mammary artery (RIMA) graft to the left anterior descending (LAD) coronary artery after deployment of a drug eluting stent (24*3 mm). B: Following implantation of a pericardial covered stent. C: Tortuous and narrowed RIMA to LAD pathway through which the covered stent was transferred. Fig. 3. Serial angiogram demonstrating the pattern of instent restenosis in patient #3. A, B: before and after contrast injection, respectively. respectively) [9]. Nevertheless, restenosis rates at 6- month follow-up, were similar. Another study in which PTFE-covered stents were used in various clinical settings (coronary perforations, aneurysms, degenerated saphenous vein grafts, complex lesions, and in-stent restenosis), found that subacute stent thrombosis and restenosis occurred in 5.7 and 31.6% of the patients, respectively [10]. The relatively higher incidences compared with standard stents may be related to delayed endothelialization and increased susceptibility to thrombus formation in PTFE-covered stents [11]. In theory, the rate of this complications might be lower with pericardial covered stents due to better endothelialization of biomaterial, as was previously shown for pericardial patches which support cell infiltration after implantation into the arterial circulation [12]. Nevertheless, until more data becomes available, treatment with dual antiplatelet therapy for at least 3 months should be considered. CONCLUSIONS Coronary perforation is a life threatening complication of PCI. Pericardial covered stents offer a safe and effective therapy when balloon inflation and reversal of anticoagulation are insufficient. Our report in real life patients shows that PCSs are highly deliverable in challenging coronary anatomy and thus may be useful for emergency treatment of coronary perforation. REFERENCES 1. Rogers JH, Lasala JM. Coronary artery dissection and perforation complicating percutaneous coronary intervention. J Invasive Cardiol 2004;16:

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