Outpatient coronary stent implantation.

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.

A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study.

OBJECTIVES: This study sought to compare procedural and clinical outcomes of percutaneous transluminal coronary angioplasty (PTCA) performed with 6F guiding catheters introduced through the radial, brachial or femoral arteries. BACKGROUND: Transradial PTCA has been demonstrated to be an effective and safe alternative to transfemoral PTCA; however, no randomized data are currently available. METHODS: A randomized comparison between transradial, transbrachial and transfemoral PTCA with 6F guiding catheters was performed in 900 patients. Primary end points were entry site and angioplasty related. Secondary end points were quantitative coronary analysis after PTCA, procedural and fluoroscopy times, consumption of angioplasty equipment and length of hospital stay. RESULTS: Successful coronary cannulation was achieved in 279 (93.0%), 287 (95.7%) and 299 (99.7%) patients randomized to undergo PTCA by the radial, brachial and femoral approaches, respectively. PTCA success was achieved in 91.7%, 90.7% and 90.7% (p = NS) of patients, with 88.0%, 87.7% and 90.0% event free at 1-month follow-up, respectively (p = NS). Major entry site complications were encountered in seven patients (2.3%) in the transbrachial group, six (2.0%) in the transfemoral group and none in the transradial group (p = 0.035). Transradial PTCA led to asymptomatic loss of radial pulsations in nine patients (3%). Procedural and fluoroscopy times were similar, as were consumption of guiding and balloon catheters and length of hospital stay ([mean +/- SD] 1.5 +/- 2.5, 1.8 +/- 3.8 and 1.8 +/- 4.2 days, respectively). CONCLUSIONS: With experience, procedural and clinical outcomes of PTCA were similar for the three subgroups, but access failure is more common during transradial PTCA. Major access site complications were more frequently encountered after transbrachial and transfemoral PTCA.

First international new intravascular rigid-flex endovascular stent study (FINESS): clinical and angiographic results after elective and urgent stent implantation. The FINESS Trial Investigators.

OBJECTIVES: The purpose of this study was to determine the feasibility, safety and efficacy of elective and urgent deployment of the new intravascular rigid-flex (NIR) stent in patients with coronary artery disease. BACKGROUND: Stent implantation has been shown to be effective in the treatment of focal, new coronary stenoses and in restoring coronary flow after coronary dissection and abrupt vessel closure. However, currently available stents either lack flexibility, hindering navigation through tortuous arteries, or lack axial strength, resulting in suboptimal scaffolding of the vessel. The unique transforming multicellular design of the NIR stent appears to provide both longitudinal flexibility and radial strength. METHODS: NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter international registry from December 1995 through March 1996. Nine-, 16- and 32-mm long NIR stents were manually crimped onto coronary balloons and deployed in native coronary (94%) and saphenous vein graft (6%) lesions. Seventy-four percent of patients underwent elective stenting for primary or restenotic lesions, 21% for a suboptimal angioplasty result and 5% for threatened or abrupt vessel closure. Fifty-two percent of patients presented with unstable angina, 48% had a previous myocardial infarction, and 45% had multivessel disease. Coronary lesions were frequently complex, occurring in relatively small arteries (mean [+/-SD] reference diameter 2.8 +/- 0.6 mm). Patients were followed up for 6 months for the occurrence of major adverse cardiovascular events. RESULTS: Stent deployment was accomplished in 98% of lesions. Mean minimal lumen diameter increased by 1.51 +/- 0.51 mm (from 1.09 +/- 0.43 mm before to 2.60 +/- 0.50 mm after the procedure). Mean percent diameter stenosis decreased from 61 +/- 13% before to 17 +/- 7% after intervention. A successful interventional procedure with < 50% diameter stenosis of all treatment site lesions and no major adverse cardiac events within 30 days occurred in 95% of patients. Event-free survival at 6 months was 82%. Ninety-four percent of surviving patients were either asymptomatic or had mild stable angina at 6 month follow-up. CONCLUSIONS: Despite unfavorable clinical and angiographic characteristics of the majority of patients enrolled, the acute angiographic results and early clinical outcome after NIR stent deployment were very promising. A prospective, randomized trial comparing the NIR stent with other currently available stents appears warranted.

Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial.

OBJECTIVES: This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. BACKGROUND: The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation. METHODS: Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle. RESULTS: No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. CONCLUSIONS: The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.

Transradial Palmaz-Schatz coronary stenting on an outpatient basis: results of a prospective pilot study.

BACKGROUND: The applicability of Palmaz Schatz coronary stent implantation is limited by bleeding complications and prolonged hospitalization. Coronary stenting on an outpatient basis, may be the ultimate means to reduce costs of this treatment. Since bleeding and stent occlusion were infrequent complications in a group of 100 ambulatory patients who underwent stent implantation via the radial artery in our department, we performed a pilot study to determine the feasibility of using coronary stenting on an outpatient basis. METHODS: Patients selected for Palmaz Schatz stent implantation, were adequately adjusted on coumadin. At an INR > 2.5, stenting was performed via the radial approach. Based on pre-, post- and procedural criteria, considering clinical status, procedural course and outcome, absence of predictors for stent occlusion and of events during 4 to 6 hours observation, patients were considered candidates for same-day discharge. Heparin was administered only during the procedure. Immediately after the procedure, the arterial sheath was removed. Patients were mobilized and were discharged with a pressure dressing over the puncture site. Follow-up was performed on the next day, at 2 weeks and at one month. RESULTS: Between May and September 1994, 47 patients underwent Palmaz Schatz stent implantation via the radial artery. Of these, 27 remained hospitalized for reasons, considered to be incompatible with outpatient treatment. Twenty patients (CCS-class III and IV; n = 17 (85%)) received 29 stents for 23 lesions, distributed in 21 vessels and were discharged the day of treatment. No cardiac or bleeding events were encountered within 24 hours. At 2 weeks follow-up, one patient was readmitted (day 4) because of a bleeding abdominal aortic aneurysm, requiring surgery. At 1 month follow-up, no bleeding, entry-site and cardiac complications were noted. CONCLUSION: Since no complications were encountered (95% confidence interval; 0-17%) in the first 24 hours after optimal coronary stent implantation in patients with an adequate preprocedural level of anticoagulation, a larger feasibility study of outpatient coronary stenting will be undertaken.

[Streptokinase in impending heart infarct]. / Streptokinase bij het dreigende hartinfarct.

A patient is described with an impending myocardial infarction due to presence of an intracoronary thrombus in an otherwise normal left anterior descending artery. This case illustrates that intracoronary and intravenous administration of streptokinase can be of value in the treatment of impending myocardial infarction.

Safety, efficacy and costs associated with direct coronary stenting compared with stenting after predilatation: A randomised controlled trial.

OBJECTIVES: Comparison of the in-hospital success rates, procedural costs and short-term clinical outcomes of direct stenting versus stenting after balloon predilatation. METHODS: Altogether, 400 patients with angina pectoris and/or myocardial ischaemia due to coronary stenoses in a single native vessel were randomised to either direct stenting or stenting after predilatation. Baseline characteristics were evenly distributed between the two groups. RESULTS: Procedural success rates were similar (96.0% direct stenting group vs. 94.5% predilatation) as well as final successful stent implantation (98.3 vs. 97.8%), while the primary success rate of direct stenting alone was 88.3%, p=0.01. In multivariate analysis, angiographic lesion calcification was an independent predictor of unsuccessful direct stenting (odds ratio 7.1, 95% confidence interval 2.8-18.2, p<0.0001). Rates of troponin I rises >0.15 µg/l, used as a measure of distal embolisation, were similar in both groups (17.8 vs. 17.1%). Rates of major adverse cardiac events at 30 days were 4.5% in the direct stenting group versus 5.5% in the predilated group (ns). Direct stenting was associated with savings in fluoroscopy time, and angiographic contrast agent use, and a reduction in utilisation of angioplasty balloons (0.4 vs. 1.17 balloons per patient, p<0.001). Mean per patient procedural costs associated with direct stenting versus predilatation were €2545±914 versus €2763±842 (p=0.01), despite the implantation of more stents in the directly stented group. CONCLUSION: Compared with a strategy of stenting preceded by balloon predilatation, direct stenting was equally safe and effective, with similar in-hospital and 30-day clinical outcomes, and modest procedural cost-savings. A calcified lesion predicted unsuccessful direct stenting.

Balloon-Assisted Tracking to Overcome Radial Spasm during Transradial Coronary Angiography: A Case Report.

Spasm of the radial artery is the most important cause of failure to perform coronary angiography via the transradial approach. Spasmolytic cocktail may prevent radial artery spasm but is relatively contraindicated in patients with aortic stenosis or diminished left ventricular function. In this case report we describe a recently published technique to overcome severe radial spasm during transradial coronary angiography in a patient with moderate aortic valve stenosis.

Immediate versus deferred coronary angioplasty in non-ST-segment elevation acute coronary syndromes.

BACKGROUND: The field of acute coronary syndromes is characterised by an increasing tendency towards early invasive catheter-based diagnostics and therapeutics-a practice based on observational and retrospective data. OBJECTIVE: To compare immediate versus deferred angioplasty in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) METHODS: A randomised, prospective multicentre trial was performed in patients admitted with NSTE-ACS, eligible for percutaneous coronary intervention (PCI). Interim analysis was performed after enrolment of 251 patients; PCI was appropriate in 142 patients. These patients were randomised to immediate PCI (n = 73) or deferred PCI (24-48 h) (n = 69). Patients received protocol-driven glycoprotein IIb/IIIa blockers, aspirin and clopidogrel. The primary end point was a composite of death, non-fatal myocardial infarction (MI) or unplanned revascularisation, at 30 days. After hospital discharge outpatient follow-up was performed at 30 days and 6 months. RESULTS: The incidence at 30 days of the primary end point was 60% in the group receiving immediate PCI and 39% in the group receiving deferred PCI (relative risk (RR) = 1.5, 95% CI 1.09 to 2.15; p = 0.004). No deaths occurred in either group. MI was significantly more common in the group receiving immediate PCI (60% vs 38%, RR = 1.6, 95% CI 1.12 to 2.28, p = 0.005). Unplanned revascularisation was similar in both groups. The observed difference was preserved over 6-months' follow-up. CONCLUSIONS: Immediate PCI was associated with an increased rate of MI in comparison with a 24-48 h deferred strategy, despite aggressive antithrombotic treatment. The results suggest that PCI for high-risk patients with non-refractory NSTE-ACS should be delayed for at least 24 h after hospital admission. TRIAL REGISTRATION NUMBER: ISRCTN80874637.

Coronary air embolism treated with aspiration catheter.

Coronary air embolism remains a recognised complication of coronary catheterisation despite a strong emphasis on prevention. Current treatment consists of supportive measures with 100% oxygen and analgesia. Recent case reports describe the use of mechanical treatments aimed at dispersing or removing the air embolus with variable success. A case of coronary air embolism causing an acute coronary syndrome is described that was definitively treated with an aspiration system. The effectiveness of the aspiration system in the distal section of an obtuse marginal artery indicates that such dedicated aspiration systems may prove useful in the standard treatment of air embolism.

Bailout techniques for failed coronary angioplasty using 6 French guiding catheters.

Coronary angioplasty (PTCA) through 6 French (F) guiding catheters is feasible, although acute or threatened closure following coronary artery dissections may occur. This report describes our experience with the treatment of suboptimal results in 13 patients from a population of 144 patients who had PTCA through 6F guiding catheters. Patients were treated with a new low profile autoperfusion catheter (ACS, Flowtrack40) or with Palmaz Schatz stents, advanced through 6F guiding catheters. PTCA was performed via the radial artery in 11 pts (85%) or via the femoral artery in two patients (15%). In two patients, (15%) PTCA was complicated by an dissection associated with complete loss of flow (TIMI 0) and a dissection was considered to lead to abrupt closure in the remaining 11 patients (85%), despite the presence of normal flow. A Flow-track40 perfusion catheter was successfully applied in three of four patients. In one patient a persisting dissection after restoration of flow by a perfusion catheter was treated with three Palmaz Schatz stents. Implantation of Palmaz Schatz stents was attempted as primary technique in nine patients. In one patient the stent could not cross a dissection in the proximal LAD via the radial artery. With an 8F system via the femoral artery, two stents could successfully be deployed with the stent delivery system. In another patient the stent could not be advanced across a subtotal residual stenosis in a tortuous left anterior descending coronary artery. Despite normal antegrade flow and emergency bypass surgery, this patient developed a non-Q-myocardial infarction. In the remaining patients, the clinical course was uncomplicated.(ABSTRACT TRUNCATED AT 250 WORDS)

Percutaneous transradial artery approach for coronary Palmaz-Schatz stent implantation.

The purpose of this study was to evaluate feasibility, safety, and efficacy of implantation of unsheathed Palmaz-Schatz coronary stents via the radial artery. Anticoagulation after coronary stenting has the hazard of vascular complications if large-bore guiding catheters are introduced via the femoral artery. Such complications have serious local sequelae, are associated with suboptimal anticoagulation, and prolong hospitalization. By combining 6F guiding catheters and low-profile dilatation catheters with bare Palmaz-Schatz stents, smaller vessels such as the radial artery can be selected as the entry site. It is postulated that no major puncture site-related complications occur because hemostasis is easily achieved and no veins and nerves are near the radial artery. With double blood supply to the hand, radial artery occlusion is well tolerated. Twenty-five bare Palmaz-Schatz stents were implanted via the radial artery through 6F guiding catheters in 20 consecutive patients for venous bypass graft stenosis (n = 9; 45%), native coronary artery restenosis (n = 7; 35%) and suboptimal transradial artery PTCA (n = 4; 20%). Immediately after stent implantation and assessment of the result by means of computerized quantitative coronary analysis, the arterial sheath was withdrawn followed by intense anticoagulation and free ambulation of the patient. Radial artery function and anatomy were assessed by two-dimensional and Doppler ultrasound examination. Lesions (n = 24) were of type A (n = 13; 54%), B (n = 6; 25%) and C (n = 5; 21%). The reference diameter of the stented segments was 3.2 +/- 0.5 mm (2.2 to 4.2 mm).(ABSTRACT TRUNCATED AT 250 WORDS)

Transradial artery Palmaz-Schatz coronary stent implantation: results of a single-center feasibility study.

The purpose of this study was to evaluate the feasibility and safety of implantation of unsheathed Palmaz-Schatz coronary stents introduced via the radial artery. Anticoagulation after coronary stenting carries the risk of vascular complications if large-bore guiding catheters are introduced via the femoral artery. These complications have serious local sequelae and lead to suboptimal anticoagulation and prolonged hospitalization. By combining 6F guiding catheters and low-profile dilatation catheters mounted with Palmaz-Schatz stents, smaller vessels such as the radial artery can be selected as the entry site. It is hypothesized that with this technique major puncture site-related complications rarely occur because hemostasis is easily achieved and because no veins and nerves are near this artery. With the double blood supply to the hand, radial artery occlusion is well tolerated. In 100 consecutive patients, stent implantation was attempted for 122 lesions in 104 vessels. Immediately after stent implantation and final angiography, the introducer sheath was withdrawn and intense anticoagulation and mobilization initiated. The radial artery puncture site was studied by two-dimensional and Doppler ultrasound. Successful stent implantation via the radial artery was achieved in 96 patients. In 2 patients, arterial puncture failed but was followed by successful stenting via another entry site. In 1 patient, stent implantation was achieved with a stent delivery system via the femoral artery after a failed attempt to cross the lesion with a bare stent via the radial approach, complicated by groin bleeding requiring transfusions and vascular surgery.(ABSTRACT TRUNCATED AT 250 WORDS)

Percutaneous transradial artery approach for coronary stent implantation.

A new approach for implantation of Palmaz Schatz coronary stents is reported. We describe the technique and rationale of coronary stenting with miniaturized angioplasty equipment via the radial artery. This technique is illustrated in three patients. One patient underwent Palmaz Schatz stent implantation for a saphenous vene coronary bypass graft stenosis, the second patient for a restenosis in the anterior descending coronary artery after atherectomy, and the third patient for a second restenosis after balloon angioplasty in the circumflex coronary artery.

Improved anticoagulation management after Palmaz Schatz coronary stent implantation by sealing the arterial puncture site with a vascular hemostasis device.

Sealing the arterial puncture site with a vascular hemostasis device has the potential to maintain optimal anticoagulation after stent implantation. The level of heparinization during the first 3 days after successful stent implantation was retrospectively compared between 2 groups of medically treated patients with (group A; n = 18) and without (group B; n = 17) a Vasoseal after sheath removal. The number of APTTs sampled in group A and B was 233 and 168, respectively. Respective mean values of APTT (seconds) in group A and B were 180 +/- 79 and 172 +/- 91 at day 1 (p = NS), 132 +/- 43 and 125 +/- 61 at day 2 (p = NS) and 123 +/- 36 and 116 +/- 48 at day 3 (p = NS). More APTTs were suboptimal (< 80 secs) in group B (34/168; 20%) compared to group A (17/233; 7%) [p < 0.001]. More patients in group B compared to group A had 1 or more (14/17; 82% vs. 8/18; 44%; p = 0.04), 2 or more (10/17; 59% versus 3/18; 17%; p = 0.02) and 3 or more (8/17; 47% vs. 2/18; 11%; p = 0.03) suboptimal APTTs. Bleeding complications were seen in 4 patients without and in 3 patients with a Vasoseal. Thus application of a vascular hemostasis device results in a less variable anticoagulation after coronary stenting, but it does not abolish entry site-related bleeding complications.

Mode of deployment of coronary Palmaz-Schatz stents after implantation with the stent delivery system: an intravascular ultrasound study.

The stent delivery system (SDS) is a sheath-covered Palmaz-Schatz stent mounted on a 3.0, 3.5, or 4.0 mm compliant polyethylene balloon catheter; the balloon resists maximal inflation pressures of 5.7, 6.2, or 6.0 atm, respectively. It is postulated that these pressures are too low to obtain optimal stent deployment. Because optimal stent deployment is a prerequisite for optimal short- and long-term outcome, we performed an intravascular ultrasound study to the mode of stent deployment after delivery with the SDS and after high-pressure dilatations with low-compliant, oversized balloon catheters. In 23 patients an intravascular ultrasound study (30 MHz, 4.3F transducer) was performed to the geometry of 29 stents immediately after delivery with the SDS and after successive high-pressure inflations with low-compliant balloons. After delivery with the SDS (3.3 +/- 0.4 mm), stent diameter was 3.0 +/- 0.4 mm. After high-pressure dilatations (12.4 +/- 1.4 atm) with low-compliant balloons (3.9 +/- 0.5 mm), stent diameter increased to 3.4 +/- 0.4 mm (p < 0.001). Only 8 (28%) stents were completely and symmetrically expanded to the corresponding reference diameter with good apposition after delivery with the SDS. Diameter of incomplete deployed stents (n = 16) was 2.8 +/- 0.3 mm. After high-pressure dilatations with low-compliant balloons (3.9 +/- 0.5 mm), diameter increased to 3.4 +/- 0.4 mm (p < 0.001). Now 20 (69%) stents (p = 0.004) became completely and symmetrically expanded to a diameter corresponding to the reference diameter. In conclusion, most stents are suboptimally deployed after delivery with the stent delivery system.(ABSTRACT TRUNCATED AT 250 WORDS)

Transradial artery coronary angioplasty.

This study explored the feasibility and safety of percutaneous coronary balloon angioplasty (PTCA) with miniaturized PTCA equipment via the radial artery. Coronary angioplasty (PTCA) via the femoral or brachial arteries may be associated with rare vascular complications such as bleeding and damage to the artery and adjacent structures. It was postulated that PTCA via the radial artery with miniaturized angioplasty equipment is feasible and that no major puncture site-related complications occur because hemostasis is obtained easily and because no major structures are near the radial artery. With double blood supply to the hand, radial artery occlusion is well tolerated. In 100 patients with collateral blood supply to the right hand, PTCA was attempted with 6F guiding catheters and rapid-exchange balloon catheters for exertional angina (87 patients) or nonexertional angina (13 patients). Angioplasty was attempted in 122 lesions (type A n = 67 [55%], Type B n = 37 [30%], and type C n = 18 [15%]). Pre- and post-PTCA computerized quantitative coronary analysis was performed. Radial artery function and structure were assessed clinically and with Doppler and two-dimensional ultrasound on the day of discharge. Coronary catheterization via the radial artery was successful in 94 patients (94%). The 6 remaining patients had successful PTCA via the femoral artery (n = 5) or the brachial artery (n = 1). Procedural success (120 of 122 lesions) was achieved in 92 patients (98%) via the radial artery and in 98 patients of the total study population.(ABSTRACT TRUNCATED AT 250 WORDS)