Outpatient coronary angioplasty: feasible and safe.

This study tested the safety and feasibility of coronary angioplasty on an outpatient basis. The purpose of this approach includes cost-effectiveness and patient comfort. Six hundred forty-four patients were randomized to either transradial or transfemoral PTCA using 6 Fr equipment. Patients were triaged to outpatient management based on a predefined set of predictors of an adverse outcome in the first 24 hr after initially successful coronary angioplasty. Three hundred seventy-five patients (58%) were discharged 4-6 hr after PTCA; 42% stayed in hospital overnight. In the outpatient group, one adverse event occurred (subacute stent thrombosis 7 hr postdischarge, nonfatal myocardial infarction). There were no major vascular complications. In the hospital group, 19 patients (7%) sustained an adverse cardiac even in the first 24 hr; 1 patient died. Patients treated via the femoral route had more (minor) bleeding complications (19 patients; 6%); in 17 of these, this was the sole reason that discharge was delayed. PTCA on an outpatient basis, performed via the radial or the femoral artery with low-profile equipment, is safe and feasible in a considerable part of a routine PTCA population. A larger proportion of transradial patients can be discharged due to a reduction in (minor) bleeding complications.

Complete versus culprit vessel percutaneous coronary intervention in multivessel disease: a randomized comparison.

BACKGROUND: The purpose of this study was to compare the safety, efficacy, and costs of complete versus "culprit" vessel revascularization in multivessel coronary artery disease treated with percutaneous coronary interventions (PCI). METHODS: Patients with multivessel disease and an identified culprit vessel were randomly assigned to complete revascularization of vessels > or =50% stenoses (n = 108) versus revascularization limited to the culprit vessel (n = 111). The primary end point, major adverse cardiac events (MACE), were defined as cardiac or noncardiac death, myocardial infarction, need for coronary artery bypass graft surgery, and repeat PCI up to 1 year. RESULTS: Despite equal MACE at 24 hours (6.3% vs 7.4%), strategy success was higher in the culprit vessel than in the complete revascularization group (93.7% vs 81.5%, P =.007). MACE rates at 1 month (14.4% vs 9.3%), 1 year (32.4% vs 26.9%), and 4.6 +/- 1.2 years (40.4% vs 34.6%) were similar in both groups. Repeat PCI was performed more often in the culprit vessel group (31.2% vs 21.2%, P =.06). A lower consumption of medical material was associated with lower procedural costs in the culprit vessel group (5784 vs 7315 Euros; P <.001). However, between 1 year and the end of follow-up, costs had equalized in both groups. CONCLUSIONS: Complete versus culprit vessel revascularization in multivessel coronary disease treated with PCI was associated with a lower strategy success rate, similar MACE rates, and initially higher costs. However, over the long term, more repeat PCIs were conducted in patients treated by culprit revascularization only, mostly because of the need to treat lesions initially left untreated. As a consequence, incremental costs had equalized within 1 year. The decision of whether to perform culprit vessel or complete revascularization can be made on an individual basis.

Impact of operator volume on overall major adverse cardiac events following direct coronary stent implantation versus stenting after predilatation.

OBJECTIVES: To determine the impact of operator experience on procedural, clinical and angiographic outcome after (direct) coronary stent implantation. BACKGROUND: Although for other forms of percutaneous coronary interventions an inverse relationship between operator volume and patient outcomes has been shown, the impact of operator volume on outcome after direct stenting has never been investigated. METHODS: A retrospective analysis was performed on data from a prospective randomized trial comparing direct stenting with that after predilatation. The trial consisted of 400 patients with stable and unstable angina pectoris and/or myocardial ischemia due to a coronary stenosis of a single native vessel eligible in 1999-2001 for direct stenting. For a single-center high-volume clinic (>1500 cases/year), the authors compared the most experienced operators (case load: >4000) with well trained practitioners (case load: 175). One hundred and fifteen patients were identified who were treated by high-volume and 180 who were treated by medium-volume operators. RESULTS: Baseline patient characteristics were evenly distributed among groups. High-volume, compared with medium-volume operators, were faster (30.8 versus 42.2 minutes, p < 0.001), needed less frequent postdilatation (15% versus 24%, p = 0.06) and had lower fluoroscopy times (7.5 versus 11.2 minutes, p < 0.001), lower contrast usage (180 versus 228 ml, p < 0.001), lower procedural costs (euro1982 versus euro2164, p = 0.05) and reduced rates of major adverse cardiac and cerebral event (MACCE) at six months (12.2 versus 21.1%, p = 0.03). The medium-volume operator group experienced higher angiographic binary restenosis rates after direct stenting compared with stenting after predilatation (31.5 versus 14.9%, p = 0.005). CONCLUSIONS: Stenting performed by high-volume operators resulted in a 50% reduction in MACCE as compared with medium-volume physicians, which also had twice as much restenosis when using direct stenting. Hence, the more demanding technique of direct stenting should not be performed by unsupervised operators who have not yet completed their training. Furthermore, prolonged training periods and even more intensive supervision by experienced operators seems mandatory.

Safe and effective direct implantation of a new stent through 5 F. guiding catheters with delivery from the radial artery: initial results of a prospective registry.

OBJECTIVES: To evaluate the safety and efficacy of the direct implantation of a new stent via the radial artery through a 5 F. guiding catheter. Background advances in the design of stents and stent delivery systems have facilitated the performance of direct stenting and the use of thinner guiding catheters. METHODS: This registry enrolled prospectively 125 patients (147 lesions, 20.4% AHA/ACC class B2/C) who underwent elective percutaneous coronary revascularization procedures for stable or unstable angina between November 2000 and March 2001. RESULTS: Cannulation of the radial artery was attempted in 92.7% and was successful in 91.0% of cases. Direct stenting was successful in 88.7% of lesions and procedural success was 99.3%. In-hospital major adverse cardiac events occurred in 1.6% of cases (one death, one semi-urgent coronary artery bypass operation). The final rate of successful stent implantation through 5 F. guiding catheters was 96.7%. There were no access-site-related complications. Failure to cross the lesion occurred in 10% of attempts. At a mean follow-up of 7 +/- 2.8 months after discharge from hospital, 79% of patients had remained free of angina, and 89% had remained free of ischemic events. CONCLUSIONS: Direct stenting with a new stent design was safe, effective, and could be accomplished through 5 F. guiding catheters with favorable long-term clinical outcomes.

Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: a randomized double-blind comparison of coated and uncoated sheaths.

Radial artery spasm may cause severe discomfort during radial artery sheath removal. A hydrophilic-coated sheath may reduce the force required to remove a radial sheath. This force may be quantified using an automatic pullback device (APD). The objective of this study was to assess if a hydrophilic coating reduces the required force and discomfort associated with removal of a radial sheath following transradial coronary intervention. Ninety patients undergoing percutaneous coronary intervention via the radial artery were randomly assigned to two groups receiving either coated or uncoated introducer sheaths. Radifocus Introducer II (Terumo) 25 cm, 6 Fr radial sheaths and sheaths that were identical apart from the presence of the coating were used in all patients. The APD was used for sheath removal at the end of the procedure. Three patients (7%) in the coated group experienced discomfort during automatic sheath removal, compared to 12 patients (27%) in the uncoated group (P = 0.02). The maximum pullback force (MPF) was significantly lower in the coated compared to the uncoated group (0.24 +/- 0.31 vs. 0.44 +/- 0.33 kg; P = 0.003). Similarly, the mean pullback force was significantly lower in the coated group (0.14 +/- 0.23 vs. 0.32 +/- 0.24 kg; P < 0.001). Only one patient (2%) in each group had an MPF greater than 1.0 kg together with clinical evidence of radial artery spasm. Removal of the coated Terumo Radifocus sheath requires less force than an identical uncoated sheath. The coated sheath was also associated with less discomfort for the patient.

Evaluation of a spasmolytic cocktail to prevent radial artery spasm during coronary procedures.

Radial artery spasm is a frequent complication of the transradial approach for coronary angiography and angioplasty. Recently, we have been able to quantify spasm using the automatic pullback device. The objective of this study was to assess the efficacy of an intra-arterial vasodilating cocktail in reducing the incidence and severity of radial artery spasm. A hundred patients undergoing coronary procedures via the radial artery were divided into two groups of 50 each. Patients in group A received intra-arterial cocktail (5 mg of verapamil plus 200 micro g nitroglycerine in 10 ml of normal saline), while patients in group B did not receive any vasodilating drug. The pullback device was used for sheath removal at the end of the procedure. Seven (14%) patients in group A experienced pain (i.e., pain score of III-V) during automatic sheath removal, as compared to 17 (34%) in group B (P = 0.019). The mean pain score was significantly lower in group A than in group B (1.7 +/- 0.94 vs. 2.08 +/- 1.07; P = 0.03). The maximal pullback force (MPF) was also significantly lower for group A (0.53 +/- 0.52 kg; range, 0.10-3.03 kg) as compared to group B (0.76 +/- 0.45 kg; range, 0.24-1.99 kg; P = 0.013). Only 4 (8%) patients in group A had an MPF value greater than 1.0 kg, suggesting the presence of significant radial artery spasm, as opposed to 11 (22%) in group B (P = 0.029). Administration of an intra-arterial vasodilating cocktail prior to sheath insertion reduces the occurrence and severity of radial artery spasm.