Author + information
- Received May 10, 1996
- Revision received August 6, 1996
- Accepted October 9, 1996
- Published online February 1, 1997.
- Ferdinand Kiemeneij, MD, PhDA,*,
- Gert Jan Laarman, MD, PhDA,
- Ton Slagboom, MDA and
- Ron van der Wieken, MDA
- ↵*Dr. Ferdinand Kiemeneij, Amsterdam Department of Interventional Cardiology (ADIC)-OLVG, 1e Oosterparkstraat 279, 1090 HM Amsterdam, The Netherlands.
Objectives. This study was performed to explore the feasibility of coronary Palmaz-Schatz stent implantation on an outpatient basis.
Background. To optimize the applicability of coronary stenting by limiting bleeding complications and length of hospital stay, the transradial approach has been demonstrated to be an effective technique. Immediate ambulation opens the way to outpatient treatment.
Methods. Patients selected for Palmaz-Schatz stent implantation received anticoagulation with Coumadin. At an international normalized ratio >2.5, stenting was performed through the radial approach. Starting in December 1994, patients were treated with Ticlopidin. Heparin was administered during the procedure. Suitability for same-day discharge was assessed on the basis of preprocedural, postprocedural and periprocedural criteria. Patients were mobilized after immediate sheath removal, followed by same-day discharge. Follow-up examinations were performed the next day, at 2 weeks and at 1 month after stenting.
Results. Of 188 patients who underwent Palmaz-Schatz coronary stent implantation through the radial artery between May 1994 and July 1995, 88 remained in the hospital for various reasons. In the 100 outpatients (Canadian Cardiovascular Society classes III and IV, n = 90 [90%]), 125 stents had been implanted to cover 110 lesions. No cardiac or bleeding events were encountered within 24 h (95% confidence interval 0 to 3.6) of stenting. At 2-week follow-up, one patient was readmitted (day 4) because of a bleeding abdominal aortic aneurysm requiring operation. Two patients were readmitted 2 weeks after discharge, one with subacute thrombosis and one with angina and anemia that was treated with blood transfusions. At 1-month follow-up, no complications were observed.
Conclusions. After an optimal transradial Palmaz-Schatz coronary stent result, patients can safely be discharged on the day of treatment.
(J Am Coll Cardiol 1997;29:323–7)
Elective implantation of Palmaz-Schatz coronary stents is very rarely associated with acute (<24 h) coronary incidents, if the stent is optimally expanded and there are no angiographic predictors of stent occlusion. This phenomenon may allow coronary stenting to be performed on an outpatient basis if the patient can be ambulatory immediately after the procedure and the risk of bleeding complications under anticoagulation is minimized. Transfemoral artery implantation of metallic coronary stents carries the hazard of bleeding complications during the postoperative course when the patient is receiving intense anticoagulation ([1–3]), even during prolonged bed rest.
Stent implantation through 6F guiding catheters by means of the radial artery has been demonstrated ([4–6]) to be an effective means of reducing the risk of major bleeding complications in patients who are not restricted to prolonged immobilization. During a feasibility study on transradial stenting conducted by our department, the hospital stay was limited to 1 day in 22 patients receiving therapeutic levels of anticoagulation. None of these patients developed major complications after the procedure and early after discharge. Thus, the transradial artery approach has the potential to allow performance of Palmaz-Schatz stent implantation on an outpatient basis, which reduces costs and increases patient comfort.
We therefore conducted an open, prospective, single-center study to explore the feasibility of transradial Palmaz-Schatz coronary stenting on an outpatient basis.
1.1 Study cohort.
From May 1994 to December 1994, patients referred for elective stent implantation received anticoagulation with Coumadin before admission. Most patients came directly from home, or in some instances from the referring hospital, to the catheterization laboratory of our department. At the start of the procedure, the international normalized ratio (INR) was assessed. At an INR >2.5, the patient was considered suitable to participate in the study. Starting in December 1994, patients were treated with Ticlopidin and aspirin, without Coumadin. Of 100 outpatients participating in this study, 44 patients received Coumadin, and 56 were treated with Ticlopidin.
Patients were studied after providing written informed consent. Transradial angioplasty procedures are performed as part of ongoing protocols approved by the institutional review board of our hospital.
1.2 Outpatient triage.
On the basis of selected variables, patients were discharged on the same day of stenting or remained in the hospital. Excluded were patients who underwent stenting through the femoral artery (e.g., negative Allen test results, failed or suboptimal transfemoral PTCA, failed cannulation of the coronary artery through the radial approach, participation in 8F stent study protocols). Preprocedural reasons for extended hospital stay were unstable angina pectoris, suboptimal adjustment during Coumadin therapy (INR <2.5) before Ticlopidin was available, poor clinical condition and social circumstances. Procedural reasons were transient closure, resucitation, prolonged chest pain, persistent electrocardiographic changes, suboptimal stent results, sidebranch occlusion, entry site complications and failed transradial attempt. All cardiac and vascular events during a postprocedural 6-h observation period formed additional reasons against same-day discharge.
1.3 Transradial stent implantation technique.
The technique of transradial angioplasty and stent implantation ([4, 5]) has been described in detail elsewhere. In brief, the right arm was abducted and the wrist hyperextended. After local anaesthesia, the radial artery was punctured with an Arrow 20-gauge radial artery catheterization set or with a Kimmal needle. After appearance of pulsatile flow from the needle, an 0.025-in., 260-cm long, J-shaped guide wire (Schneider) was introduced through this system, followed by insertion of a 6F arterial introducer. As a result of ongoing experience, we preferred to use 23-cm long instead of 10-cm long 6F introducer sheaths to prevent radial artery spasm and to facilitate guiding catheter manipulations. Meticulous care was directed toward optimal selection of the guiding catheter, with respect to backup support and coaxial alignment. We selected Scimed Express or Schneider Goldy balloon catheters for predilation and stent delivery because of low profile and ease of advancement over the guide wire and through the guiding catheter and because of proper fixation of the stent, once crimped on the balloon. One or more 7-, 10-, 14-, 15- or 18-mm Palmaz-Schatz coronary stents (Johnson & Johnson Interventional Systems) were used. After delivery, the stent diameter and geometry were optimized by successive dilations with higher inflation pressures or with larger balloon catheters of intermediate compliance. Procedures were performed by two operators (F.K., G.J.L.).
1.4 Coronary analysis.
Qualitative and quantitative coronary analysis of the target coronary segments was performed with the Philips Poly Diagnost (C2) Digital Cardiac Imaging System before angioplasty and after the final balloon inflation under standardized conditions by the operating cardiologist or a trained technician (F.U., G.J.L., T.S.).
1.5 Medical treatment.
Initially, elective patients were pretreated with Coumadin at least 1 week before the procedure. The INR was assessed just before the procedure. At an INR >2.5, the patient received 10,000 IU of heparin after sheath insertion and 500 mg of aspirin intravenously. No heparin was given after the procedure. From December 1994, 54 patients were treated with Ticlopidin (250 mg twice a day), which was continued for 30 days. Aspirin (100 mg) was continued after hospital discharge.
1.6 Introducer sheath removal and hemostasis.
The arterial sheath was removed immediately after withdrawal of the guiding catheter, and an occlusive tourniquet was applied at the radial puncture site for a minimum of 30 min. Pressure was gradually released until hemostasis was obtained. A pressure dressing over the punctured artery was applied for 6 h. Patients were encouraged to walk but were advised to restrict movement of the wrist joint.
1.7 Predischarge examinations.
The clinical status of the patient was evaluated by a physician, and the radial artery was examined for adequate hemostasis and the presence of pulsations. A new pressure dressing was applied, followed by application of a sling to support the forearm. Written instructions were given to the patient, followed by oral explanation. The patient was advised to remove the pressure bandage the next day. Before discharge, the patient was instructed how to achieve hemostasis by local pressure, in case of puncture site bleeding. In case of uncontrollable bleeding or other emergency situation, patients were instructed to contact their general practitioner, their cardiologist, the first-aid department of our hospital, the 24-h service of our cardiology department or one of the available emergency telephone numbers.
1.8 End points.
Successful outpatient treatmentwas defined as an uncomplicated course within the first 24 h after the stent procedure. Successful short-term outcomeafter coronary stenting was defined as an uncomplicated course in the first month after discharge. Follow-up was considered uncomplicatedif none of the following end points were met: death, acute myocardial infarction, need for coronary artery bypass graft surgery, need for PTCA of the stented coronary artery, angina caused by stent restenosis or occlusion and any bleeding requiring hospital admission. Occlusion of the radial artery was considered to be a major event only if the forearm or hand showed signs of ischemia (e.g., functional disability by claudication, necrosis or surgical recanalization).
The day after discharge and 2 weeks after stenting, the patient was interviewed by telephone and was questioned about the occurrence of any complications or discomfort. The patient’s questions were also addressed during these interviews. At 1 month follow-up, the patient was seen and screened for entry site-related and cardiac complications. Radial artery pulse was also examined by palpation.
1.10 Statistical analysis.
Results are expressed as mean value ± SD or are presented with 95% confidence intervals.
2.1 Study patients.
Of 188 patients who underwent Palmaz-Schatz coronary stent implantation through the radial artery between May 1994 and July 1995, 88 (46.8%) were considered unsuitable for treatment on an outpatient basis, according to one or more of the previously described triage criteria. The remaining 100 patients were considered suitable for outpatient treatment and underwent stenting for primary lesions in native coronary arteries (n = 60), native coronary artery restenosis after previous PTCA (n = 20) and venous coronary bypass graft stenosis (n = 19). One patient underwent stent implantation for a suboptimal PTCA result. The clinical and angiographic characteristics are shown in Table 1andTable 2, respectively.
2.2 Procedural results.
Stent implantation was successful in all 100 patients. For 110 lesions, 125 stents were implanted (range 1 to 4/patient). Reference and minimal lumen diameters increased from 3.5 ± 0.5 and 1.1 ± 0.4 mm to 3.7 ± 0.4 and 3.4 ± 0.4 mm, respectively. Mean diameter stenosis improved from 68 ± 9% to 8 ± 6%. In one patient, a type B dissection parallel to the stent was visible. No residual obstructions could be detected by digitized coronary angiography.
2.3 Clinical observation.
Effective hemostasis was obtained within 1 h in all patients, and all were discharged on the day of coronary stent implantation after an uneventful observation period. Of these 100 patients, 92 were actually discharged home the same day. Eight patients stayed one night in the referring hospital at the request of the referral center. Because these patients, according to our criteria for suitability for outpatient treatment, were not admitted to our clinic, they were included in the study.
2.4 Twenty-four hour follow-up.
None of the 100 patients had bleeding from the radial artery puncture site. No cardiac complications were encountered (95% confidence interval [CI] 0 to 3.6).
2.5 Fourteen-day follow-up.
Three patients were readmitted to our hospital. Four days after stent implantation, one patient with an aneurysm of the abdominal aorta requiring vascular surgery was admitted with signs of bleeding from this aneurysm and was successfully operated on the same day. This patient underwent stent implantation for severe anginal complaints caused by a stenosis in the left circumflex coronary artery (LCx). Because the right coronary artery (RCA) was occluded, and left ventricular function (and anterior wall motion) was severely compromised, the LCx was the last remaining functional vessel. Coronary angioplasty was required before any operation for the aortic aneurysm could be undertaken. The patient had taken Coumadin for 2 months because of poor left ventricular function. No additional anticoagulant agents other than except for dipyridamole were added to his medication. Therefore, this complication was not considered related to the stent implantation. The second patient readmitted had evidence of subacute stent thrombosis 2 weeks after discharge resulting in a Q wave myocardial infarction. This patient, who had Coumadin therapy, underwent elective stenting after PTCA for a third restenosis in a narrowed (2.5-mm diameter) RCA. A third patient was readmitted, also 2 weeks after discharge, with angina and anemia caused by both hematuria and a hematoma in the forearm. This patient recovered after undergoing blood transfusions. The remaining 97 patients were free of bleeding and cardiac complications (95% CI 0.62 to 8.5).
2.6 One-month follow-up.
At 1 month follow-up, no additional bleeding and cardiac complications were recorded. No patient had disability of the hand or signs of ischemia. In all patients the radial artery was patent at physical examination (95% CI 0 to 3.6).
3.1 Rationale for outpatient coronary angioplasty.
Coronary angioplasty is usually performed on a clinical basis. The major reason for keeping the patient under clinical observation is the risk of abrupt reocclusion of the treated vessel. The incidence of abrupt closure after balloon angioplasty was 7.5% in the early National Heart, Lung, and Blood Institute (NHLBI) PTCA registry (1977 to 1981) () and 6.8% in the second NHLBI PTCA registry (1985 to 1986) (). In a more recent survey by Myler et al. (), the incidence was 4.9%. This complication usually requires an immediate attempt to obtain restoration of flow by repeat PTCA, coronary stenting or emergency bypass surgery. The other major reason for the patient to remain in the hospital is immobilization to reduce the risk of access site-related bleeding complications.
Because the number of patients undergoing PTCA is still increasing, there is a need to reduce costs because resources are limited. In centers with high case loads, the restricted number of available hospital beds may pose a problem. Coronary angioplasty on an outpatient basis may offer a solution to this problem (). In addition, early mobilization after sheath removal and same-day discharge are usually appreciated by patients.
3.2 Prerequisites for outpatient strategies.
The ideal combination of requirements for outpatient PTCA should contain the following elements: high procedural success rates, low risk of abrupt coronary artery closure, low risk of access site-related bleeding complications and immediate ambulation of the patient. In our recent experience in 100 patients undergoing transradial stent implantation, the procedural success rate was 96%, and no stent occlusion was encountered in electively treated patients (). Because an optimal result after stenting may be considered a safeguard against abrupt vessel occlusion, the first and second prerequisites for outpatient angioplasty are met.
3.3 Low bleeding complication rates and immediate ambulation.
Access site-related bleeding is the main hazard of coronary stenting in patients receiving a complex anticoagulation regimen, even though the incidence of local bleeding complications has been reduced by the replacement of Coumadin by Ticlopidin ([11–14]) therapy.
The radial artery is a safe entry site on theoretic grounds. Compared with the brachial artery, the distal radial artery has a superficial course, lies isolated from major veins and nerves and is easy to compress, and an occlusion is a subclinical event, in the presence of a well developed palmar arch. The brachial and femoral arteries run deep under the skin, together with major nerves and veins, which makes bleeding more difficult to control, with substantial risk for damage to the surrounding structures. Brachial artery occlusion will require surgical intervention to restore patency.
In our feasibility study on transradial coronary stenting (), one patient developed subcutaneous bleeding from the radial artery requiring surgical decompression of the hematoma. With appropriate instructions, most patients are able to address minor radial artery bleeding themselves. If, after an observation period of 6 h, no access site-related bleeding occurs, we consider hemostasis to be safely established. Together with the immediate ambulation of the patient after the procedure, the third and fourth requirements for outpatient angioplasty are also met.
3.4 Limitations of transradial stenting.
The applicability of transradial angioplasty is mainly determined by local anatomic obstacles, such as negative Allen test results or narrow-diameter radial arteries. However, the success rate is high with practice. The main hazard of implanting bare stents through 6F guiding catheters is the risk for stent loss and embolization. Therefore, meticulous care must be directed toward optimal guiding catheter selection, predilation and crimping technique.
3.5 Limitations of outpatient strategies.
The exclusion criteria that we applied for outpatient stenting are not generally applicable for all stents. In the present study, Palmaz-Schatz stents were used with a high predictability of clinical and angiographic outcome for experienced users. Novel users of any stent type should keep patients under observation until enough experience has been accumulated with the device to foresee complications in the early postprocedural phase.
It is acknowledged that abrupt stent occlusion can occur at any time during the 6-h observation period from latent proximal or distal tears that may not have been obvious during angiography. If any doubt as to the final result exists, intravascular ultrasound can be performed through 6F guiding catheters (). Because stent thrombosis is a serious event, frequently leading to myocardial infarction, major concern for stent thrombosis is addressed beyond the first 24 h. One can argue that a proper observation period after suboptimal stent result should be at least 1 week. However, the low incidence of stent thrombosis in patients with an optimal angiographic stent result does not justify to keeping ambulant patients under prolonged clinical observation.
It is also acknowledged that minor bleeding in the hospital may become a major problem when the patient is at home. Therefore, we keep the pressure dressing in place for 24 h. No entry-site bleeding and no cardiac complications were encountered early after discharge. For same-day discharge, ample information was given to the patient to optimize the safety of this new approach.
3.6 Logistic consequences.
In our experience, ∼80% of all patients undergoing elective stenting can be treated through the radial artery, because in ∼20% of patients, this approach is contraindicated due to negative Allen test results, anatomic variations, patient preference and use of 6F-incompatible stents. This proportion is currently decreasing as more 6F-compatible stents become commercially available. In addition, larger stent systems can be used through the radial artery if 7F guiding catheters are used. Of the patients who undergo transradial stenting patients at our clinic (±80% of all patients with stenting), at present ∼70% are treated on an outpatient basis. That this percentage is higher than that reported in the present study (100 outpatients [53.2%] of 188 undergoing transradial stenting) is due to the fact that clinical anticoagulation with Coumadin is no longer required since its replacement by Ticlopidine. Technical refinements and improved success rates of transradial procedures also contribute to the currently increasing number of outpatient stent procedures.
Because ad hoc coronary stenting after a diagnostic procedure may additionally increase efficiency, this can be a further argument in favor of the radial artery as the entry site for diagnostic procedures, especially if ad hoc stenting is planned for suspected restenosis after previous PTCA. Stimulated by the favorable results of the present study, the feasibility of outpatient PTCA is currently being evaluated by our department.
- confidence interval
- international normalized ratio
- left circumflex coronary artery
- National Heart, Lung, and Blood Institute
- percutaneous transluminal coronary angioplasty
- right coronary artery
- Received May 10, 1996.
- Revision received August 6, 1996.
- Accepted October 9, 1996.
- The American College of Cardiology
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