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Aims: To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES)., Methods: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years., Results: Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup., Conclusion: Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Interventional cardiologists are exposed to radiation-induced diseases, partly due to patient's scatter radiation., Objectives: We sought to compare the radiation exposure (RE) of the cardiac catheterization room staff using SEPARPROCATH®, a novel radio-protective drape versus standard shielding equipment., Methods: This was a two-step prospective, randomized pilot trial: first, in experimental conditions using a phantom model, and second, during cardiac catheterization. Primary end-point was operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP). Secondary end-points were nurse RE, operator and nurse CD, DAP, and fluoroscopy time., Results: A total of 51 patients were included. SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm 2 without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm 2 , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively. Similar reductions were observed for operator and nurse CDs. No difference was found in DAP (19 [11-29] vs. 14 [10-32] Gy.cm 2 without SEPARPROCATH®, p value 0.81)., Conclusion: SEPARPROCATH® offers significant additional radioprotection to the operator and nurse during cardiac catheterization without affecting patient safety., (© 2019 Wiley Periodicals, Inc.)

Aortic pseudo-aneurysm following the Bentall procedure is a rare but potentially severe complication. Surgical reintervention represents a high risk. We report on two cases with different pseudo-aneurysm types which were successfully treated using two different percutaneous techniques. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Objectives: This multicentre study sought to report the safety and efficacy of the ATRIASEPT septal occluder to repair atrial septal defect (ASD)., Background: The ATRIASEPT is a low profile, flexible, double disk occluder with centering system specifically designed for closure of ostium secundum ASD., Method: Patients were enrolled from four participating European sites and followed up for 12 months post procedure. Outcomes were evaluated, including closure success and incidence of adverse events., Results: Seventy-six patients received the ATRIASEPT device. Mean size of the defect was 15 +/- 4 mm. Closure success was observed in 69 patients (89%) at the end of the procedure. Sixty-four patients had a six-month follow up with a complete closure by 58 patients (90%). Minor adverse events occurred in two patients. Significant functional improvement was reported by all symptomatic patients., Conclusion: Percutaneous closure of ASD ostium secundum type defects with the ATRIASEPT is safe and effective with high success rate and excellent mid-term outcome.

Objectives: This multi-centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept device., Background: PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo-embolism. Currently, different devices are used for PFO closure., Methods: Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo-embolism. Peri-procedural and mid-term complications were reported., Results: Four-hundred thirty patients (mean age 50.7 +/- 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow-up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri-procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid-term follow-up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04)., Conclusion: This multi-centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo-embolic events., (2008 Wiley-Liss, Inc.)

Goal: Analysis of the 3-year outcome of the original population of the TAXi trial which compared the efficacy of the paclitaxel (PES) and the sirolimus (SES) stents in a randomized "real world" investigation., History: The widespread use of drug-eluting stents strongly modified the world of interventional cardiology. The TAXi trial was a randomized comparison between PES and SES and showed similar efficacy between the two prostheses. Recently, emerging discussions raised questions about potential long-term risk with the use of DES. The present work attempts to describe the long-term outcome of the patients compared during the TAXi trial., Method: During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PES group (102 patients) and to the SES group (100 patients). The primary aim of the present investigation was the comparison of combined incidence of cardiac death, myocardial infarction, and target lesion revascularization within 36-months., Results: No difference in mortality of all causes was noted in the PES and the SES groups (3% vs. 7%, P=0.98) or in major adverse cardiac event free survival (89% vs. 83%, P=0.28). Four stent thromboses were observed, two in the PES group (205 and 788 days) and two in the SES group (210 and 772 days)., Conclusion: The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis., (Copyright (c) 2007 Wiley-Liss, Inc.)

We report the first experience obtained with the new Intrasept device. We attempted to treat 35 patients with a mean age of 43 +/- 21 years. The mean size of the defect was 17/15 mm. It was successfully closed in 31 patients. In the remaining four the device could not be stabilized because of excessive defect size. A small residual shunt was present immediately following implantation in three patients. No complications occurred during the procedure and at 6 months, 31 patients had an uneventful outcome. Only one patient had a small residual shunt. No thrombus, embolization, or device fracture was documented during a mean follow-up of 17 +/- 11 months. Percutaneous closure of ASD ostium secundum is feasible with the Intrasept device with a high success rate and very good medium-term outcome. Our initial experience and results were excellent with small to medium size defects, however, large defects (>20 mm) remain challenging., (2006 Wiley-Liss, Inc.)

Restenosis has long remained the major limitation of intracoronary stenting, but several randomized trials have recently shown that the use of drug-eluting stents appear to reduce markedly the risk of recurrence following treatment of de novo lesions. To evaluate whether the results of randomized trials can be generalized to routine clinical practice, all patients receiving at least one sirolimus-eluting stent (SES) in two Swiss hospitals were entered into a prospective registry. Only target vessels with a reference diameter > 3.5 mm were excluded. Clinical follow-up was obtained after 6 months. A total of 183 patients were included. The procedural success was 97.8% and the incidence of in-hospital MACE was 2.2%. At 7 +/- 2 months, 95.6% of the patients were event-free, and target lesion revascularization was required in only three patients (1.6%). The excellent medium-term results obtained with the SES in randomized trials can be replicated in routine clinical practice., (Copyright 2004 Wiley-Liss, Inc.)

More than 70% of percutaneous coronary interventions are followed by a stent implantation. In-stent restenosis still occurs in 20-30% of patients and remains a therapeutic challenge. At present only vascular brachytherapy has been shown to be an effective treatment option. We report here one case of recurrent in-stent restenosis after vascular brachytherapy that was successfully treated by a second beta radiation treatment., (Copyright 2002 Wiley-Liss, Inc.)

To determine the feasibility and safety of an intracoronary beta-radiation device in preventing the recurrence of in-stent restenosis (ISR) after successful angioplasty, we studied 37 patients treated with beta-radiation (30-mm strontium-90 source) after angioplasty. The mean reference diameter was 2.9 +/- 0.5 mm, and 62% of lesions were diffuse, including four total occlusions. Beta-radiation was successfully delivered in 36 of 37 (97%) cases. Over the course of 7.1 +/- 4.5 mo follow-up, there were no myocardial infarctions and three deaths: one from preexisting malignancy, one from progressive cardiac failure, and one from sudden cardiac death. Target vessel revascularization (TVR) was performed in seven of 36 (19%) patients. Thirty patients underwent angiography at 6 mo; three (10%) experienced restenosis (diameter stenosis > 50%) at the target site, four (13%) had edge stenoses, and two (7%) had late (> 1 mo) thrombotic occlusions. Beta-radiation for ISR is associated with encouragingly low rates of target lesion restenosis and TVR. Further improvements are needed to solve the limitations of the edge effect and late occlusion.

To evaluate the clinical efficacy of endoluminal stenting in the setting of percutaneous intervention for small coronary artery lesions, we reviewed our results on stenting with the 2.5-mm GFX stent (Arterial Vascular Engineering, Santa Rosa, CA) during an 18-month study period. A total of 120 patients with significant coronary artery disease in vessels

This randomised trial compared the Micro Stent I and the Palmaz-Schatz stent for the elective treatment of short (<8 mm long), new-onset coronary stenoses. The primary endpoints were restenosis rate and minimal luminal diameter at 6 mo angiographic follow-up. The secondary endpoints were angiographic and procedural success of stenting and a composite clinical endpoint at 6 mo (death, myocardial infarction, and target site revascularisation). A total of 93 patients were randomised. Clinical and angiographic characteristics of the two groups were comparable. Angiographic success of stenting was 96% in both groups, and there were no complications so that the procedural success was also 96% in both groups. The restenosis rate was 29% for Micro Stent I and 27% for the Palmaz-Schatz stent (P = NS). The minimal luminal diameter at 6 mo was 1.75 +/- 0.72 mm in the Micro Stent I group and 1.84 +/- 0.59 in the Palmaz-Schatz group (P = NS). At 6 mo, a clinical endpoint was reached by 21% of the patients in the Micro Stent I group and by 11% in the Palmaz-Schatz group (P = NS). In conclusion, the elective treatment of short coronary stenosis with the Micro Stent I or the Palmaz-Schatz stent resulted in similar early and late outcomes. In particular, the late angiographic results were very similar.

We have been investigating the safety and efficacy of multiple and different stent types placed in the unfavorable situation of a very long dissection (> 20 mm) after coronary angioplasty. We report our preliminary experience in 20 patients who were treated by the following combinations: Palmaz-Schatz and Micro stent (14 patients). Wallstent and Micro stent (4 patients); Wiktor and Micro stent (1 patient); and Palmaz-Schatz, Micro and Wallstent (1 patient). Normal distal flow was restored in all except one (no reflow phenomenon) patient and complete covering of the dissection was obtained in all but two patients. Event-free survival at 30 days was 90% (18 of 20 patients). During follow-up (mean period: 8 +/- 3 months), two patients died. Of the 18 other patients, 16 remained asymptomatic and free of complications. Symptomatic restenosis was treated by standard angioplasty in the two remaining patients. In conclusion, placement of different stent types seems a feasible, safe, and efficient treatment for very long dissections caused by standard angioplasty.

In order to compare the efficacy of two different stent types in case of bailout stenting, 65 patients, with abrupt or threatened vessel closure following coronary angioplasty, were randomly assigned to either Wiktor (Medtronic Inc., Minneapolis, MN, 33 patients) or Palmaz-Schatz (Johnson & Johnson Interventional, Warren, NJ, 32 patients) stent implantation. Stenting was technically feasible in all except one patient and immediately successful in reverting ischemia and vessel closure in 60 patients (92%). At hospital discharge, complication rates were comparable: early vessel closure, 18% (Wiktor) versus 13% (Palmaz-Schatz) (P = 0.53); any clinical event (such as death, myocardial infarction, and surgical revascularization): 18% (Wiktor) versus 22% (Palmaz-Schatz) (P = 0.71). At 6 months follow-up, these complication rates remained equal: restenosis, 38% (Wiktor) versus 27% (Palmaz-Schatz) (P = 0.42); any clinical and angiographic (vessel closure and restenosis) event: 45% (Wiktor) and 41% (Palmaz-Schatz) (P = 0.69). Baseline, direct postprocedural, and follow-up quantitative coronary analysis data were similar, with, however, an exception for the postprocedural residual stenosis [28% (24-32%) (Wiktor) and 21% (18-23%) (Palmaz-Schatz] (means and 95% confidence intervals). In conclusion, despite a discrete postprocedural angiographic benefit observed with the Palmaz-Schatz stent, the long-term clinical and angiographic outcome is similar in both treatment groups. The choice whether to implant a Wiktor or Palmaz-Schatz stent may probably be left to the discretion of the operator and his experience with one particular device.

From April 1986 through April 1993, 58 intracoronary stents (41 Wall and 17 Wiktor stents) were implanted for the treatment of saphenous vein graft stenosis in 40 symptomatic patients. The indication was a primary stenosis in 44 and restenosis in 14 procedures. In-hospital complications were subacute stent thrombosis (2%), myocardial infarction (2%), and emergency coronary artery bypass grafting (CABG) (2%). Complications during a mean follow-up period of 42+/-27 months were restenosis (35% by patient, 33% by lesion), myocardial infarction (12%), late bypass grafting (12%), and death (7%). On quantitative coronary angiographic analysis, the mean minimal luminal diameter (and its confidence interval) increased from 1.3 mm (1.1-1.5 mm, preprocedure) to 2.9 mm (2.7-3.1 mm, postprocedure) and 2.2 mm (2.0-2.5 mm, 6 months follow-up, 95% angiographic follow-up). Progression of the underlying coronary artery disease and restenosis were the main reasons for a continual decline of the proportion without cardiac event on a Kaplan-Meier estimate. Restenosis occurred in one-third of cases beyond the first 6 months of follow-up. A relative risk ratio analysis for restenosis, performed on 14 variables, disclosed an increased risk for the following variables: (1) stenting of the proximal, distal or anastomosis part of the vein graft (relative risk 2.41, confidence interval: 1.28-3.59), (2) the implantation of stents < 4.5 mm (2.59, 1.18-4.00), and (3) stenting of a redo-CABG vein graft (2.37, 1.17-3.58). Saphenous vein graft stenting seems to be characterized by excellent immediate clinical and angiographic results; in particular, stent thrombosis is rare.(ABSTRACT TRUNCATED AT 250 WORDS)

This report demonstrates two specific complications that occurred during implantation of a Wiktor (Medtronic, Inc., Minneapolis, MN) coronary stent: stent shortening and elongation were observed and attributed to the unique coil structure of the device. Major cardiac events occurred during follow-up as a consequence of this stent deformation. Therefore, semiurgent bypass surgery should be considered to treat this complication.

Stent migration and embolization are well-known complications of intracoronary stenting with balloon-mounted stents. During an elective stenting procedure of a proximal right coronary artery stenosis, a 3.5 mm Wiktor stent (Medtronic Inc., Minneapolis) was displaced from its delivery balloon. The guiding catheter and the delivery system were withdrawn, leaving the stent around a 3 m 0.014 inch High Torque floppy guidewire (ACS, Santa Clara, CA) in the abdominal aorta. An 40 cm 5F Alligator Forceps catheter (Cook OB/Gyn., Spencer, IN), introduced through a cut-off 8F coronary guiding catheter, allowed improved torque control of the retrieval catheter and a safe and successful withdrawal of the stent through the arterial introducer sheet.

This paper presents our initial experience with a new low-profile balloon "on-a-wire" catheter, the Bijou. The concept of this balloon is to provide an additional side lumen with the advantages of (1) the ability to measure pressure gradient, (2) the possibility of drug infusion, and (3) the ability to advance a steerable guidewire through this side lumen. The balloon has been tested in 15 patients; 14 underwent an elective procedure for stable angina pectoris (with 2 cases of restenosis) and one an emergency angioplasty in a case of acute myocardial infarction. The stenosis was located on the left anterior descending artery in 11 procedures, on the right in 3, on a marginal branch in 2, on the circumflex and a saphenous vein graft in 1. All stenoses could be dilated successfully (residual stenosis < 25%). The transstenotic pressure gradient felt from 49 +/- 13 mmHg to 7 +/- 4 mm Hg after angioplasty. Except for an uncomplicated dissection in 3 patients, no other complication was noted. With this new catheter, the double-lumen configuration adds the advantages of an "over-the-wire" to an "on-a-wire" system.