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(Circulation. 2000;102:3028.)
© 2000 American Heart Association, Inc.

Brief Rapid Communication

Emergency Polytetrafluoroethylene-Covered Stent Implantation to Treat Coronary Ruptures

Carlo Briguori, MD, PhD; Takahiro Nishida, MD; Angelo Anzuini, MD; Carlo Di Mario, MD, PhD; Eberhard Grube, MD; Antonio Colombo, MD

From Centro Cuore Columbus, Milan, Italy, and the Department of Cardiology, Heart Center, Siegburg, Germany (E.G.).

Correspondence to Antonio Colombo, MD, Centro Cuore Columbus, Via M. Buonarroti, 48, I-20145, Milan, Italy. E-mail columbus{at}micronet.it

	Abstract

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Background—Coronary perforation is a life-threatening complication of percutaneous interventions. In the past few years, the implantation of covered stents has emerged as a strategy for treatment when the traditional conservative approach (ie, prolonged balloon inflation and reversal of anticoagulation) fails.

Methods and Results—Since May 1997 (when polytetrafluoroethylene [PTFE]-covered stents were available at our institutions), 11 of the 12 consecutive patients who had coronary ruptures that were unsuccessfully sealed with prolonged balloon inflation and reversal of anticoagulation were treated with 12 PTFE-covered stents (PTFE group). The efficacy of the PTFE-covered stent was compared with that of noncovered stents, which were used to treat 17 perforations (non-PTFE group). One patient sustained a very distal perforation that was not suitable for covered stent sealing and underwent emergency surgery. All vessel ruptures treated with PTFE-covered stent implantation were successfully sealed. The time necessary to deploy the stent was 10±3 minutes (range, 4 to 15 minutes). All patients but one were discharged from the hospital and had an optimal early clinical outcome. One patient underwent emergency bypass surgery and died in the intensive care unit. The occurrence of cardiac tamponade and the necessity for emergency surgery was significantly lower in the PTFE group than in the non-PTFE group. At 14±4 months, the 10 discharged patients had not experienced any major adverse cardiac events.

Conclusions—This preliminary study supports the utility of the PTFE-covered stent for the nonsurgical treatment of vessel ruptures.

Key Words: angioplasty • coronary disease • hemorrhage • stents

	Introduction

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Coronary artery perforation during percutaneous transluminal coronary angioplasty remains a rare but life-threatening complication.^{1 2 3 4} A surgical approach to treat the coronary perforations is necessary in 37% to 63% of cases.^{1 2 3 4 5} The implantation of covered stents has emerged as a strategy to treat perforation.^{6 7 8} Polytetrafluoroethylene (PTFE)-covered stents are easy and rapid to deploy, and they have emerged as a new tool for the nonsurgical treatment of this life-threatening complication.^{9 10 11}

	Methods

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Patient Population
Since March 1993, 49 coronary perforations have occurred at the authors’ institutions during 10 945 percutaneous interventions (0.45%). Using May 1997 (when PTFE-covered stents were available at our institutions) as the cutoff time, we separated patients into the non-PTFE group (25 perforations occurred during 6567 procedures [0.40%] before May 1997), and the PTFE group (24 coronary perforations occurred during 4378 percutaneous interventions [0.5%] after May 1997). According to the efficacy of conventional nonsurgical treatment, patients were classified as those who (1) achieved adequate sealing of the perforation with a conventional method (n=12 in PTFE group and n= 8 in non-PTFE group; P=0.16) and (2) did not achieve adequate sealing of the perforation (n=12 in PTFE group and n=17 in non-PTFE group; P=0.16) with a conventional method. This report deals with the patients in whom adequate sealing of the perforation was not achieved with conventional conservative management.

Coronary perforations were classified according to method of Ellis et al.¹ Two-dimensional echocardiography and pulsed-wave Doppler were performed to assess the presence and severity of pericardial effusion.

Management of Vessel Perforation
A conventional strategy to treat perforation includes prolonged perfusion balloon inflation and reverse-heparin anticoagulation with protamine to reach an activated clotting time <130 s; a platelet transfusion is also administered if abciximab was given. If cardiac tamponade occurs, pericardiocentesis is performed.

When the conventional strategy was not able to seal perforations, the eventual nonsurgical strategy was, in the non-PTFE group, noncovered stent implantation when the patient did not already have a stent at the perforation site and the procedure seemed feasible and, in the PTFE group, PTFE-covered stent implantation.

We used the JOSTENT stent (JOMED), a balloon-expandable, slotted-tube stent manufactured by sandwiching a layer of PTFE between 2 stents, as our PTFE-covered stent. The potential diameter of the stent is 2.5 to 5.0 mm. The stent is currently Prior to European Community approval (CE mark), but the protocol was approved by the local ethics committees. After stent implantation, angiographic optimization was performed with high-pressure balloon dilation to achieve <20% residual stenosis by visual estimate. In 6 patients (50%), the final stent apposition was evaluated by intravascular ultrasound (3.2-F monorail system with a 30-MHz transducer-tipped catheter; Ultracross Cardiovascular Imaging System, Boston Scientific Co.). Angiographic measurements were performed with an automated computer-based system (Cardiovascular Measurement System, MEDIS).

Monitoring After Successful Nonsurgical Management
Antiplatelet therapy consisted of 325 mg/d aspirin indefinitely and 250 mg of ticlopidine BID for 3 months. Serial echocardiography was performed to detect pericardial effusion. Major adverse cardiac events (MACEs), which included death, Q- and non–Q-wave myocardial infarction, and coronary bypass surgery, were assessed. Non–Q-wave myocardial infarction was defined as chest pain or ST-segment or T-wave abnormalities associated with an increase of total creatine kinase 2 times above normal values, with a positive creatine kinase-MB fraction without any new pathological Q waves. Clinical follow-up was obtained by an interview or a telephone conversation with the patient. Exercise tests were routinely performed at 1 to 2 months after the procedure. Repeated angiography was performed at 6 months after stent placement or earlier if clinically indicated. Restenosis was defined as a stenosis 50% at the angiographic follow-up.

Statistical Analysis
Differences between groups were assessed by ² analysis for categorical variables and Student’s t test for continuous variables. P<0.05 was significant.

	Results

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PTFE Group
Eleven of the 12 cases were deemed suitable for PTFE-covered stent implantation (Tables 1 and 2). In one case, in which a perforation occurred during guidewire distal migration, the rupture site was distal and not suitable for covered stent sealing. In this case, abciximab was used. This patient had a platelet transfusion (to resolve the effect of abciximab administered before the procedure) and underwent emergency surgery. All PTFE-covered stents were successfully deployed at the perforation site at a mean pressure of 15+4 atm (range, 12 to 18 atm). All 11 coronary ruptures were successfully sealed. In 10 cases, only one PTFE-covered stent was implanted, and in one case, an additional PTFE-covered stent was necessary to completely seal the rupture. The time necessary to deploy the stent was 10±3 minutes (range, 4 to 15 minutes). In no case did stent loss occur. Final TIMI flow was 3 in all but one case. An example of coronary perforation treated with the PTFE-covered stent is represented in the Figure.

View this table: [in this window] [in a new window]   Table 1. Clinical Characteristics of the 12 PTFE Ruptures and the 17 Non-PTFE Ruptures

View this table: [in this window] [in a new window]   Table 2. Angiographic Characteristics, Potential Mechanisms of Vessel Rupture, and In-Hospital Outcome of the PTFE and Non-PTFE Groups

View larger version (83K): [in this window] [in a new window]   Figure 1. Type III perforation of right coronary artery after rotational atherectomy and eventual balloon dilatation. A, Baseline angiography revealed a tight and calcified stenosis in proximal segment and a subtotal occlusion in mid segment. B, Rotablator burr (1.25 mm) in place. C, Balloon dilatation (3.0x30 mm) after rotational atherectomy. D, Evidence of class III (brisk extravasation) perforation in proximal segment. E, Final result after 2 PTFE-covered stents (19 mm and 12 mm) were implanted. There is no evident contrast extravasation, and original lesion has been successfully treated.

Non-PTFE Group
To seal the coronary rupture, a noncovered stent (Palmaz-Schatz) was implanted at the perforation site in 5 of the 17 cases (Tables 1 and 2). This strategy was successful in only 2 cases (40%). In the remaining 15 cases, urgent bypass surgery was necessary.

Clinical Outcome
The in-hospital outcomes of the patients in the PTFE and non-PTFE groups are summarized in Table 2. The in-hospital MACE rate was significantly lower in the PTFE group. In particular, PTFE-covered stent implantation reduced the occurrence of cardiac tamponade and the necessity of bypass surgery. Pericardial or mediastinal effusion without hemodynamic impairment was identified by echocardiography in 5 PTFE patients and 17 non-PTFE patients (P<0.001). At 14±4 months (range, 6 to 26 months) , the 10 PTFE patients discharged from the hospital had not experienced any MACEs. Exercise tests were performed by all 10 patients and were positive in 2 of them. Angiographic follow-up was performed in 7 of the 9 eligible patients (78%) at 6±2 months. Two patients had angiographic restenosis (29%); one of them underwent repeat percutaneous transluminal coronary angioplasty.

	Discussion

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Angiographic evidence of perforation has been reported in 0.1% to 3.0% of the lesions treated with various intervention techniques.^{1 2 3 4} Nonsurgical management of coronary perforation (that is, prolonged balloon inflation at the site of contrast extravasation and immediate reversal of anticoagulation) often fails, and emergency surgery is necessary.^{1 2}

Covered Stents
In the past few years, covered stents have become an alternative to surgery when conservative approaches fail. Some case reports have shown promising results with autologous venous-covered stents.^{6 8} However, this strategy is technically demanding and may be difficult to perform in emergency situations like coronary rupture. Of note, the time interval from vein harvest to covered stent deployment has been reported as between 20 and 45 minutes.^{6 8} In contrast, PTFE-covered stent implantation is easy, rapid, and does not require extensive training.

In our study, PTFE-covered stents successfully sealed 91% of coronary perforations after other conservative approaches failed. Compared with the non-PTFE group, PTFE-covered stent significantly reduced the necessity for emergency surgery. Time to deploy the PTFE-covered stent and, subsequently, to seal the perforation was relatively short, and this may explain why cardiac tamponade occurred in only one patient. Furthermore, none of the 10 patients effectively treated with the PTFE-covered stent implantation experienced any MACEs at follow-up, and angiographic restenosis was 29% (2 of 7 patients). The lack of late thrombo-occlusive events⁹ in the PTFE group could be due to (1) the frequent use (50%) of intravascular ultrasound to assess proper stent implantation, (2) the routine use of final high pressure balloon inflation, (3) the prolonged (3 months) ticlopidine administration after the procedure, and (4) the fact that this event has a very low frequency of occurrence and it was evaluated in a small group.

Study Limitations
Because of the small sample size and the nonrandomized nature of the study, no firm conclusions can be drawn about the incidence of restenosis and late stent thrombosis. The limited flexibility of this stent restricts its implantation to lesions accessible with no or moderate tortuosity. Furthermore, this device prevents any access to side branchs.

	Acknowledgments

 
Dr Briguori was supported in part by a Fellowship Grant from the Italian Society of Cardiology.

Received August 3, 2000; revision received October 17, 2000; accepted October 18, 2000.

	References

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Briguori, C. Articles by Colombo, A. Search for Related Content PubMed PubMed Citation Articles by Briguori, C. Articles by Colombo, A. Related Collections Catheter-based coronary interventions: stents