Giovanni Amoroso

Mechanical Prevention of Distal Embolization During Primary Angioplasty: Safety, Feasibility, and Impact on Myocardial Reperfusion

Background—Effective myocardial reperfusion after primary percutaneous coronary intervention (PCI) may be limited by distal embolization. We tested the safety, feasibility, and efficacy of the FilterWire-Ex (FW), a distal embolic protection device, as an adjunct to primary PCI. Methods and Results—Fifty-three consecutive patients undergoing primary PCI with FW protection were compared with a matched control group treated by primary PCI alone. Successful FW positioning was obtained in 47 patients (89%) without complications. Histological analysis of the content of the last 13 filters showed multiple embolic debris in all cases. FW use was associated with lower postinterventional corrected TIMI frame count (22±14 versus 31±19; P =0.005) and higher occurrence of grade 3 myocardial blush (66% versus 36%; P =0.006) and early ST-segment elevation resolution (80% versus 54%; P= 0.006). At multivariate analysis, FW use was the only independent predictor of early ST-segment elevation resolution and of grade 3 myocardial blush. FW patients showed lower peak creatine kinase-MB release (236±172 versus 333±219 ng/mL; P =0.013) and greater improvement at 30 days in left ventricular wall motion score index (−0.30±0.19 versus −0.18±0.26; P= 0.008) and ejection fraction (+7±4% versus +4±7%; P =0.012). Conclusions—FW use during primary PCI is feasible and safe. Distal embolization prevention appears to exert a beneficial effect on markers of myocardial reperfusion and on left ventricular function improvement at 30 days.

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

Routine use of the transradial approach in primary percutaneous coronary intervention: procedural aspects and outcomes in 2209 patients treated in a single high-volume centre

Objective To examine the feasibility of a routine transradial approach (TRA) in primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI). Design A single-centre observational study with prospective data collection. Setting A high-volume interventional centre in Amsterdam, The Netherlands. Patients Procedural data were analysed for 2209 consecutive patients presenting with STEMI without cardiogenic shock, between January 2001 and December 2008. Interventions PPCI routinely performed by the TRA. Main Outcome Measures The primary outcomes of interest were the need for crossover to another vascular access site, the achievement of procedural success and their trends over time. Secondary outcome measures were trends in total procedural duration, fluoroscopy times and use of equipment. Results In a total of 2209 procedures the radial artery was the primary access site, comprising 96.1% of all procedures performed during the study period. In 84 cases (3.8%) access site crossover was needed. Crossover rates decreased from 5.9% in 2001–2 to 1.5% in 2007–8 (p=0.001). The procedural success rate was 94.1%, which remained stable over the years. Despite an increased complexity of PPCI (more non-left anterior descending infarct-related arteries, thrombus aspiration and multivessel PPCI), total procedural duration decreased from 38 min (IQR 28–50) in 2001–2 to 24 min (18–33) in 2007–8, p<0.001 for trend. Conclusions Systematic use of the TRA in PPCI yields low access site crossover, high procedural success rates and excellent procedural performances. It can therefore represent the primary access site in the vast majority of STEMI patients.

Use of the Stereotaxis Niobe® Magnetic Navigation System for Percutaneous Coronary Intervention: Results From 350 Consecutive Patients

Introduction: The Stereotaxis Niobe® magnetic navigation system (MNS; Stereotaxis, St. Louis, MO) facilitates precise vector based navigation of magnetically‐enabled guidewires for percutaneous coronary intervention (PCI) by using two permanent magnets located on opposite sides of the patient table to produce a controllable magnetic field. The objective of this study is to describe the results of a large patient series using this system, to compare the results with a historical control group, and to detail the MNS learning curve. Methods: We prospectively collected data on 439 lesions in 350 consecutive PCI patients using the MNS predominantly using the radial approach. All data were entered into a customized database to capture the key parameters and then compared with a previously collected stent registry from the same center. Results: In 410/439 lesions (93%) the wire crossed the lesion successfully using the MNS. Twenty‐five of the 35 failures were chronic total occlusions. No wire perforations or dissections occurred in this population. Lesion crossing time was 81 ± 168 sec (mean ± SD), and fluoroscopy time was 64 ± 123 sec. A clear learning curve was evident after the first 80 patients. Contrast use was reduced when compared with a historical control group. Procedural and fluoroscopy times were similar. Conclusions: Use of the MNS may enable the successful performance of more complex procedures in the cardiac catheterization laboratory with an improvement in time efficiency.

Overview of the transradial approach in percutaneous coronary intervention.

Thirteen years have passed since the first percutaneous coronary intervention was performed at Onze Lieve Vrouwe Gasthuis in Amsterdam using the transradial approach (TRA). Since then TRA has spread through the interventional community and many centres have now adopted TRA as the arterial access of choice. This review is focused on the hot issues and the latest developments in this field. The following subjects will be addressed and discussed: drawbacks and learning curve, procedural technique, indications (with particular attention to acute coronary patients), complications, contraindications, nurse workload, patient management, and economics.

Transradial access for primary percutaneous coronary intervention: the next standard of care?

Objective Primary percutaneous coronary intervention (PPCI) has been acknowledged by the most recent European guidelines to be the preferred treatment for ST elevation myocardial infarction (STEMI). Patients undergoing PPCI are expected to receive a broad spectrum of anticoagulants and antiplatelet agents, which increases the risk of bleedings, in most cases, at the site of vascular access. The burden of bleeding complications after PPCI is as negative as that of ischemic complications not only on in-hospital morbidity, but also on mid- and long–term survival. Owing to the unique features of the radial artery, transradial approach (TRA) seems able to overcome most of the problems related to vascular access particularly in case of STEMI. In this short review we discuss the results of the latest studies and we highlight not only the safety and feasibility of TRA-PPCI, but also the advantages in terms of morbidity and mortality. We finally report on our experience at OLVG Amsterdam, and how TRA can also change the logistics in case of a PPCI programme (short stay).

Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study

AIMS In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up. METHODS AND RESULTS This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%. CONCLUSIONS This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.

Clinical and Procedural Predictors of Nurse Workload During and After Invasive Coronary Procedures: The Potential Benefit of a Systematic Radial Access

Background: Invasive coronary procedures are increasing in number and complexity over time. This trend translates in an increased need for economical and human resources, among which is nurse staffing the most affected. Aims: To identify possible predictors of nurse workload, during and after diagnostic and interventional procedures. Methods: Two hundred and sixty consecutive patients were included: 52 and 208 patients underwent femoral and radial access, respectively. Nurse workload was calculated with a self-developed model. Results: Cathlab nurse workload was 103 [63–156] min. Independent predictors of increased Cathlab nurse workload were: femoral access, failed radial access and cross-over, interventional procedures, procedural time, urgent procedures. Cathlab nurse workload was 174 [134–218] and 86 [58–126] min, for femoral and radial access, respectively (p < 0.001). Among the overall population, 174/260 patients (44 females, mean age 66 ± 11 years) were hospitalised at our Center after the procedure. Fifty-six and 118 patients had femoral and radial access, respectively. Ward nurse workload was 457 [226–954] min. Independent predictors of increased Ward nurse workload were: access-site complication, length of in-hospital stay, admission to CCU, interventional procedures. Ward nurse workload was 386 [226–652] and 720 [314–1375] min, respectively for radial and femoral access (p < 0.001). Conclusions: A systematic radial access is an effective strategy for reducing nurse workload, both during, by simplifying nurse tasks in the CathLab, and after coronary invasive procedures, by preventing access-site complications, shortening in-hospital stays, and reducing admissions to CCU.

Percutaneous Ulnar Artery Approach for Primary Coronary Angioplasty: Safety and Feasibility

Transradial approach in primary and rescue angioplasty may be advantageous with respect to the femoral access due to the lower incidence of vascular complications. Ulnar cannulation has been proposed for elective procedures in patients not suitable for transradial approach. We here report on 13 patients undergoing primary angioplasty performed using the transulnar approach. Ulnar access was finally obtained in 10 patients, sheath insertion time ranged from 2 to 5 min, time from arterial puncture to vessel recanalization ranged from 21 to 36 min. Primary angioplasty was successful in all patients. At 30‐day echo color Doppler, all ulnar arteries were patent and with a physiologic pattern of flow. Subcutaneous hemorrhage of the forearm was observed in two patients, whereas hematoma, pseudoaneurysm, thrombus, and arterovenous fistula were not observed. In conclusion, transulnar access may represent an additional option in patients undergoing primary angioplasty when the radial artery access site is not available. Catheter Cardiovasc Interv 2004;61:56–59.

The impact of coronary artery disease on the coronary vasomotor response to nonionic contrast media.

BACKGROUND Coronary artery disease (CAD) alters the vasomotor response to a variety of pharmacological agents. We tested the hypothesis that CAD also has an impact on the coronary vasomotor response to radiologic contrast media. METHODS AND RESULTS We performed quantitative coronary angiography in 42 patients without angiographic evidence of CAD and 38 patients with CAD in the left coronary artery. Angiographically smooth coronary segments (n=235) were analyzed for changes on luminal diameters and coronary venous oxygen saturation in response to 3 media: the nonionic dimer iodixanol, the nonionic monomer iopromide, and the ionic agent ioxaglate. In subjects without CAD, we assessed the effects of intracoronary administration of the nitric oxide synthase inhibitor N(G)-monomethyl-L-arginine and of the cyclooxygenase inhibitor indomethacin on such changes. Iodixanol induced coronary vasodilation in subjects without CAD (8.8+/-8.6%, P<0.001). Patients with CAD exhibited no significant diameter changes in segments >/=20 mm apart from a stenosis (4.7+/-9.4%, P=NS) and significant constriction in segments <20 mm from a stenosis (-3.8+/-4.6%, P<0. 05). Similar results were obtained with iopromide, but no changes were found with ioxaglate. All contrast media induced transient (<35 seconds) increases in coronary venous oxygen saturation in all subjects. Indomethacin, but not N(G)-monomethyl-L-arginine, blunted the vasodilating effect of iodixanol and iopromide (by 80% and 76%, respectively; P<0.001). CONCLUSIONS Nonionic contrast media induce a vasodilatory response in normal vessels not by a mechanism involving increased flow or endothelial nitric oxide synthesis, but rather by depending on preserved vascular cyclooxygenase activity. CAD changes normal epicardial vasodilatory response into vasoconstriction.