Edouard Benit

Vascular Responses at Proximal and Distal Edges of Paclitaxel-Eluting Stents Serial Intravascular Ultrasound Analysis From the TAXUS II Trial

Background—On the basis of brachytherapy experience, edge stenosis has been raised as a potential limitation for drug-eluting stents. We used serial intravascular ultrasound (IVUS) to prospectively analyze vessel responses in adjacent reference segments after implantation of polymer-controlled paclitaxel-eluting stents. Methods and Results—TAXUS II was a randomized, double-blind trial with 2 consecutive patient cohorts that compared slow-release (SR) and moderate-release (MR) paclitaxel-eluting stents with control bare metal stents (BMS). By protocol, all patients had postprocedure and 6-month follow-up IVUS. Quantitative IVUS analysis was performed by an independent core laboratory, blinded to treatment allocation, in 5-mm vessel segments immediately proximal and distal to the stent. Serial IVUS was available for 106 SR, 107 MR, and 214 BMS patients. For all 3 groups, a significant decrease in proximal-edge lumen area was observed at 6 months. The decrease was comparable (by ANOVA, P =0.194) for patients in the SR (−0.54±2.1 mm2) and MR (−0.88±1.9 mm2) groups compared with the BMS (−1.02±1.9 mm2) group. For the distal edge, a significant decrease in lumen area was only observed with BMS (−0.91±2.0 mm2, P <0.0001); this decrease was significantly attenuated with SR (0.08±2.0 mm2) and MR (−0.19±1.7 mm2) stents (P <0.0001 by ANOVA). Negative vessel remodeling was observed at the proximal (−0.48±2.2 mm2, P =0.011) but not the distal edges of BMS and at neither edge of SR or MR stents. Conclusions—The marked reduction in in-stent restenosis with SR or MR stents is not associated with increased edge stenosis at 6-month follow-up IVUS. In fact, compared with BMS, there is instead a significant reduction in late lumen loss at the distal edge with TAXUS stents.

Accelerated vascular repair following percutaneous coronary intervention by capture of endothelial progenitor cells promotes regression of neointimal growth at long term follow-up: final results of the Healing II trial using an endothelial progenitor cell capturing stent (Genous R stent).

AIMS The study sought to define the long-term angiographic and clinical outcome of a bio-engineered stent, able to sequester endothelial progenitor cells (EPC) to the stent to promote the post-stenting vascular repair response. METHODS AND RESULTS The HEALING-II was a multicentre, prospective registry, including 63 patients treated with the implantation of a Genous EPC capture stent. Serial quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) analysis was performed at 6 and 18 month. The 18 month composite MACE rate was 7.9%, whereas 6.3% clinically justified target lesion revascularisations were observed. Although patients received one month of clopidogrel, no (sub)acute or late angiographic stent thrombosis occurred. At 6 month follow-up, in-stent late luminal loss was 0.78+/-0.39 mm and percent in-stent volume obstruction was 22.9+/-13.7% (mean+/-sd). Serial angiographic and IVUS analyses were available in 30 event-free patients at post-procedure, 6 months and 18 months. From 6 months to 18 months follow-up, a significant late regression of neointimal hyperplasia was observed on QCA (late luminal loss 0.59+/-0.31, 24.4% reduction or 16.9% by matched serial analysis) and IVUS (percent in-stent volume obstruction 20.3+/-14.3%, 11.4% reduction or 9.6% by matched serial analysis). The relative increase in circulating EPC titers at long-term follow-up correlated with neointimal compaction in individual patients, suggestive of an EPC-mediated vascular repair response. CONCLUSIONS The HEALING II study suggests that the EPC capture stent, aimed to stimulate the coronary vascular repair response, significantly promotes late regression of neointimal hyperplasia up to 18 months after stent implantation.

Brachial, radial, or femoral approach for elective Palmaz-Schatz stent implantation: A randomized comparison

UNLABELLED From October 1994 to November 1995, 150 male eligible patients were randomly assigned to Palmaz-Schatz stent implantation through 6 French catheters using the femoral (puncture) (n = 56), radial (puncture) (n = 56), or brachial (cutdown) (n = 38) approach at 6 participating Belgian centers. Acenocoumarol was given for 1 month after stenting. END POINTS Primary-entry site complications (bleeding, haematoma, transfusion, occlusion, surgery) poststent implantation. Secondary-success rate, stent thrombosis, Q or non Q wave MI, repeat PTCA, CABG, CVA, haemorrage, death. There were no statistically significant differences between the three groups for base line and angiographic patient characteristics, procedural characteristics, in hospital outcome, average hospitalisation time after stenting, events during the month after stenting, or local complications at 1 month follow-up. The only statistically significant difference was the arterial time of the procedure: mean +/- SD (minutes) brachial 31.0 +/- 10.02 *P < 0.001, femoral 42.2 +/- 21.8, radial 55.8 +/- 31.3 **P < 0.0001 (*brachial vs. femoral, **brachial vs. radial). There was a clear trend toward more technical difficulties and more problems with the radial approach. In each group: vascular surgery at entry site: 0%, blood transfusion: 0%. In our study, local complications and length of hospital stay were similar with the three possible approaches, and brachial approach was associated with a shorter arterial time.

Frequency of a positive modified Allen's test in 1,000 consecutive patients undergoing cardiac catheterization

The modified Allens test (A.T.) is used to prove the adequacy of the blood supply through the ulnar artery to the hand. The test is considered normal if, after compression of both the ulnar and radial arteries followed by repeated clenching of the fingers to squeeze out the blood, the normal or a slightly more pronounced red color of the palm of the hands returns within < 10 sec after release of only the ulnar artery. It is important to perform the test whenever intravascular access to the radial artery is planned. The objective of this study was to determine the percentage of patients presenting a clearly positive (< 5 sec), a moderately positive (between 5-9 sec), or a negative A.T. (10 sec and more), We performed an A.T. on 1,000 consecutive and different patients undergoing cardiac catheterization, on the right wrist, two times, each time by a different examinator trained in this test. An A.T. was performed on 1,000 patients:640 men, 360 women, mean age 62.3 yr (range 28-90 yr). In our population of patients, the relative percentages of a clearly positive (< 5 sec), moderately positive (between 5-9 sec), or negative modified Allens test (10 sec and more) is 49%, 24%, and 27%, respectively.

Cardiac Rehabilitation Reduces the Rate of Major Adverse Cardiac Events after Percutaneous Coronary Intervention

Background: Despite multiple publications on effects of rehabilitation in cardiac patients, rehabilitation is not fully known to be of value in post-percutaneous coronary intervention (PCI) patients. Aims: To investigate the influence of cardiac rehabilitation on the incidence of major adverse cardiac events (MACEs) in post-PCI patients. Methods: Retrospectively and nonrandomized 140 post-PCI patients (107 males, mean age 62 (7) years) participated in a 3-month rehabilitation program, starting 2 weeks post-PCI, while 83 post-PCI patients (54 males, mean age 68 (8) years) did not and were all followed up for 15 months. Data on cardiac medication prescription and incidence of MACE (including angina pectoris with or without reintervention, restenosis, myocardial infarction, revascularisation with re-PCI or CABG, and death) were collected. The relationship with cardiovascular risk factors including sex, smoking behaviour, obesity, diabetes mellitus, hypertension, familiar predisposition, and hypercholesterolemia was analysed. Results: The incidence of total MACE in the rehabilitation group is significantly lower than in the control group (24% vs. 42%, respectively; P<0.005). The incidence of documented restenosis, angina pectoris with resulting reintervention, all revascularisations, and death is significantly lower in the rehabilitation group, compared with the control group. Conclusion: The incidence of MACE and restenosis is significantly lower when PCI patients are included in a cardiac rehabilitation program.

Final results of the HEALING IIB trial to evaluate a bio-engineered CD34 antibody coated stent (Genous™Stent) designed to promote vascular healing by capture of circulating endothelial progenitor cells in CAD patients

OBJECTIVE To assess the safety and efficacy of the Genous™ endothelial progenitor cell (EPC) capturing stent in conjunction with HmG-CoA-reductase inhibitors (statins) to stimulate EPC recruitment, in the treatment of patients with de novo coronary artery lesions. METHODS AND RESULTS The HEALING IIB study was a multi-center, prospective trial, including 100 patients. The primary efficacy endpoint was late luminal loss by QCA at 6-month follow-up (FU). Although statin therapy increased relative EPC levels by 5.6-fold, the angiographic outcome at 6 month FU was not improved in patients with an overall in-stent late luminal loss of 0.76±0.50 mm. The composite major adverse cardiac events (MACE) rate was 9.4%, whereas 6.3% clinically justified target lesion revascularizations (TLRs) were observed. 2 Patients died within the first 30 days after stent implantation due to angiographically verified in-stent thrombosis. At 12 month FU, MACE and TLR increased to 15.6% and 11.5% respectively and stabilized until 24 month FU. 18 Month angiographic FU showed a significant decrease in late luminal loss (0.67±0.54, 11.8% reduction or 10% by matched serial analysis, P=0.001). CONCLUSION The HEALING IIB study suggests that statin therapy in combination with the EPC capture stent does not contribute to a reduction of in-stent restenosis formation for the treatment of de novo coronary artery disease. Although concomitant statin therapy was able to stimulate EPC recruitment, it did not improve the angiographic outcome of the bio-engineered EPC capture stent. Remarkably, angiographic late loss was significantly reduced between 6 and 18 months.

Six months clinical, angiographic, and IVUS follow-up after PTFE graft stent implantation in native coronary arteries.

INTRODUCTION Restenosis remains a problem even after stent implantation. An important breakthrough could be the use of graft stents, functioning as a mechanical barrier between the blood flow and the vessel wall, and possibly inducing less restenosis by more limited hyperplasia and minimal transgraft tissue penetration. OBJECTIVE To assess the acute and 6 months clinical, angiographic and IVUS results of a new balloon expandable coronary polytetrafluoroethylene (PTFE) graft stent (Jomed). METHOD Ten patients with a short (< or = 15 mm length) de novo proximal stenosis in a large (> or = 3 mm diameter) coronary artery were treated by elective implantation of a graft stent (19 mm stent, 15 mm graft). Clinical assessment, quantitative coronary angiography (QCA) and intracoronary ultrasound (IVUS) were performed before, immediately after and 6 months after implantation. A stress test was also done at 6 months. RESULTS The coronary arteries treated were: RCA in 7 patients, LCX in 2 patients, LAD in 1 patient. Mean balloon size was 3.7 mm diameter, and mean inflation pressure was 18 atm (min. 12, max. 23). Additional stenting was needed in 3 patients. Two patients showed a minimal rise in CK (< 250 IU/l) and 1 patient needed a transfusion. No patient experienced a (sub)acute nor late thrombosis. As shown in the table, no restenosis was seen in the body of the graft stent. In 2 patients a restenosis was detected in the proximal and/or distal parts of the stent which are not covered by the graft. In 1 patient a restenosis was found outside the stent. All patients remained asymptomatic with a negative stress test at 6 months follow-up (FU). [table in text] CONCLUSIONS A graft stent could indeed reduce the restenosis rate after stenting, in the part of the stent covered by the graft, but the uncovered distal and proximal parts are the weak points in this type of stent. For this reason, technical ameliorations in the construction of this graft stent are needed, e.g. a complete coverage of the stent by the PTFE graft and less rigidity of the stent causing reduced vessel trauma at the edges of the stent during implantation.

Immediate sheath removal after PCI using a Femostop is feasible and safe. Results of a registry.

Background — Due to antithrombotic therapy before, during, and after percutaneous coronary intervention (PCI), and due sometimes to the need for an urgent reintervention, the arterial femoral sheath is generally not removed immediately after PCI, unless a vascular closing device is used.This strategy causes discomfort to the patient, increases the workload for the nursing staff, and bears a risk of local complications. Objective — The purpose of this registry is to demonstrate that immediate sheath removal after PCI is safe and feasible with the ultimate goal of enhancing patient care and hospital efficiency. Methods — In patients undergoing PCI, the femoral arterial sheath was removed immediately after PCI in the cath lab, using a Femostop®, without manual compression. The patient’s discomfort and the complication rate were measured.The overall time given to haemostasis was assessed. Results — A total of 339 patients were included. Patient discomfort during Femostop® placement was assessed as follows: 85% suffered none, 2% slight, 3% moderate, and 10% severe discomfort. Complication rates were: 36% ecchimosis, 10% haematoma <6 cm, 5% haematoma>or = 6 cm (literature data of manual compression – LDMC – 5.1% to 9%), 1% pseudoaneurysm (LDMC 1% to 1.8%), 0.6% need for transfusion (LDMC 2.5%), 0.3% need for vascular repair (LDMC 1.5% to 2.7%).The patient’s immobilisation time after PCI was reduced from at least 10 hours to 6 hours.The time given to haemostasis was also reduced. Conclusion — Immediate sheath removal using a Femostop® is feasible, safe, and improves the patient’s comfort. The complication rate is equal or even lower to that reported after classical manual compression. Early ambulation improves the patient’s comfort, and reduced time given to haemostasis causes organisational benefit. If a vascular closing device is not routinely used after PCI (for example, for economical reasons), immediate sheath removal after PCI could be the routine strategy.

Coronary aneurysm five months after intracoronary beta-irradiation.

Intracoronary beta-irradiation is believed to be useful in preventing restenosis after coronary angioplasty or as adjunct therapy of an in-stent restenosis. Intracoronary aneurysms after gamma-irradiation were reported by Condado et al. in 1995, especially after doses higher than 25 Gy and without a centering device. In repeated small trials using intracoronary beta-irradiation no aneurysms were reported at 6 months follow-up. We report the development of a coronary aneurysm at 5 months after intracoronary beta-irradiation and stenting. Intracoronary brachytherapy is a new promising technique although one should be cautious about its possible unknown long-term complications.

Transcatheter left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation: results from the Belgian registry.

AIMS This study aimed to assess the safety and efficacy at midterm follow-up of left atrial appendage occlusion (LAAO) using different devices, in real life in Belgium. METHODS AND RESULTS Between June 2009 and November 2016, 457 consecutive patients (63% male, 75±12 yrs, CHA2DS2-VASc 4±0.6, HAS-BLED 3.5±0.7) undergoing LAAO were included. Technical success was 97.1%. There were 19 periprocedural major adverse events (4.1%) including three deaths (0.6%), nine tamponades (1.9%), four major bleedings (0.8%) and two device embolisations (0.4%). Among patients successfully implanted having a complete follow-up (672 patient-years, median follow-up 370 days), the actual annual stroke rate was 1.2%, lower than the expected stroke risk of 4% (70% reduction). The observed bleeding rate was 2%, while the calculated risk was 3.7% (46% reduction). Kaplan-Meier analysis showed a similar overall survival (93±2% and 87±3% versus 91±3% and 87±4%; p=0.35) and event-free survival (92±2% and 84±3% versus 88±3% and 80±5%; p=0.17) at one and two years, for the ACP/Amulet versus the WATCHMAN groups of patients, respectively. CONCLUSIONS The data from the Belgian left atrial appendage occlusion registry suggest that the procedure is effective and relatively safe in a real-world setting, using either the WATCHMAN or the ACP/Amulet device.