Analysis of left main coronary artery bifurcation lesions treated with biolimus‐eluting DEVAX AXXESS plus nitinol self‐expanding stent: Intravascular ultrasound results of the AXXENT trial

Objective: To assess the efficacy of the AXXESS stent on the treatment of left main coronary artery (LMCA) bifurcation lesions using IVUS. Background: The treatment of LMCA bifurcation lesions remains challenging even with the use of drug‐eluting stents. The AXXESS system is a biolimus A9‐eluting self‐expanding stent, dedicated to the treatment of bifurcation lesions. Methods: Data were obtained from the AXXENT trial, a prospective, single‐arm, multicenter study designed to evaluate the efficacy of the AXXESS stent on the treatment of LMCA bifurcation lesions. IVUS was available in 26 cases at 6‐months follow‐up. Volumetric and cross‐sectional analyses within the AXXESS stent, and cross‐sectional analyses at the ostia of left anterior descending (LAD) and left circumflex coronary arteries (LCX) were performed. Results: Within the AXXESS stent, percent neointimal volume obstruction was (3.0 ± 4.1)% with a minimal lumen area of 10.3 ± 2.6 mm². AXXESS stent volume showed an 12.4% increase at follow‐up compared with postprocedure (P = 0.04). Lumen area was significantly smaller in the LCX ostium compared with the LAD ostium at follow‐up (3.6 ± 1.3 mm² vs. 5.5 ± 2.0 mm², P = 0.0112). There was greater neointimal formation in the LCX ostium compared with the LAD ostium (1.37 ± 1.20 mm² vs. 0.30 ± 0.36 mm², P = 0.0003). Conclusions: The AXXESS stent in the LMCA showed enlargement through 6‐months follow‐up and significant neointimal suppression. Greater neointimal formation and relatively inadequate stent expansion may contribute to luminal narrowing in the LCX ostium. © 2008 Wiley‐Liss, Inc.     

First nine‐month complete invasive assessment (angiography,IVUS, and OCT) of the novel NEVO™ sirolimus‐eluting stent with biodegradable polymer

At present, percutaneous coronary intervention with drug‐eluting stent (DES) implantation represents the default strategy to treat coronary artery disease in many institutions around the world. However, concerns regarding long‐term safety of first‐generation DES have prompted the development of novel DES systems such as the NEVO? (Cordis Corporation, Johnson & Johnson, Warren, NJ) sirolimus‐eluting stent with biodegradable polymer and reservoir technology. In the current report, we present, for the first time, a complete midterm invasive assessment of a patient treated with this novel device in the Res‐Elution I study. © 2010 Wiley‐Liss, Inc.     

Value of intravascular ultrasound in the management of coronary chronic total occlusions

Failure of guide wire crossing is the commonest reason for failed procedure in chronic total occlusion (CTO) of the coronary arteries. Intravascular ultrasound can be useful in some cases to achieve. Successful guide wire crossing into the distal true lumen of the coronary artery. We describe two cases demonstrating the role of intravascular ultrasound in successful recannalization of the CTO. © 2009 Wiley‐Liss, Inc.     

Four‐year clinical follow‐up of the XIENCE V everolimus‐eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: The SPIRIT II trial

This report describes the 4‐year clinical outcomes of the SPIRIT II study, which randomized 300 patients to treatment with the XIENCE V everolimus‐eluting stent (EES), or the TAXUS paclitaxel‐eluting stent. At 4‐year clinical follow‐up, which was available in 256 (85.3%) patients, treatment with EES lead to a trend for lower rates of ischemia‐driven major adverse cardiovascular events, a composite of cardiac death, myocardial infarction, and ischemia‐driven target lesion revascularization (EES 7.7% vs. paclitaxel‐eluting stent 16.4%, P = 0.056). Treatment with EES also resulted in a trend toward lower rates of cardiac death and numerically lower rates of myocardial infarction, ischemia‐driven target lesion revascularization, and stent thrombosis. Overall, this study reports numerically fewer clinical events in patients treated with EES at 4‐year follow‐up, which is consistent with results from earlier follow‐up. © 2010 Wiley‐Liss, Inc.     

Extramural vessel wall hematoma causing a reduced vessel diameter after coronary stenting: Diagnosis by intravascular ultrasound and treatment by stent implantation

An extramural vessel wall hematoma occured immediately after implanting a coronary stent in an in-stent-restenosis of the intermedius branch. Angiography showed a significant luminal reduction distal to the intervention site. Intravascular ultrasound revealed an extramural echolucent zone compressing the vessel lumen. Stent implantation compressed the hematoma and allowed adequate myocardial perfusion. This demonstrates the value of intravascular ultrasound (IVUS) in cases of unusual angiographic results which can help to manage complications after coronary intervention. Cathet. Cardiovasc. Diagn. 43:438–443, 1998. © 1998 Wiley-Liss, Inc.     

Wandering coronary stenoses: Adrenaline‐induced coronary artery spasm in a patient resuscitated from cardiac arrest

A 68‐year‐old ex‐smoker man with history of allergy, presented to the emergency department with progressive dyspnea one hour following self‐medication with aspirin for troublesome headache. Examination revealed diffuse sibilant rhonchi over both lungs. Electrocardiogram showed signs of ischemia. In the intensive care unit, he received bronchodilators, nitroglycerin, and aspirin. Bronchospasm increased, and then the patient was shocked, and developed cardiac arrest. After resuscitation, he was kept on mechanical ventilation and adrenaline infusion. He was sceduled for coronary angiography. The left system demonstrated stenosis of the mid‐segment of the left anterior descending artery (LAD), which was totally occluded distally, stenosis of the left circumflex (LCx) with a mild plaque in its marginal branch. The right system demonstrated stenosis of the mid‐segment of the right coronary artery (RCA), with diffusely diseased posterior descending artery (PDA) and posterolateral left ventricular branch (PLLV). Successful direct stenting was performed to the RCA. Angiography demonstrated worsening of the distal stenosis in the PLLV and complete occlusion of the PDA. Balloon dilatation of the PLLV was adequate, but dilatation of the PDA failed. Repeat angiography of the left system revealed an occluded LCx with critical stenosis of its marginal branch; nevertheless, the LAD was as before. Balloon dilatation of the distal LAD was attempted without improvement, yet, angiography therein, demonstrated “migration” of the stenoses in the LCx. The procedure was halted, adrenaline infusion discontinued, and an intra‐aortic balloon pump inserted. The patient was discharged one day later. Follow‐up angiography 6 months later demonstrated mild atherosclerotic coronary irregularities. © 2010 Wiley‐Liss, Inc.     

Novel guidewire‐based stent delivery system: Examination by intravascular ultrasound

This report describes the first‐in‐man experience with a novel 0.014‐in. guidewire‐based, self‐expanding stent delivery system designed for small or tortuous coronary arteries that may be difficult to access with conventional stent‐delivery systems. © 2008 Wiley‐Liss, Inc.     

Angiographically confirmed stent thrombosis in contemporary practice: Insights from intravascular ultrasound

Objective : We hypothesized that patients presenting with stent thrombosis (ST) have a high prevalence of stent underexpansion and malapposition when assessed by intravascular ultrasound (IVUS). Background : IVUS can provide mechanistic insight into mechanical factors, including stent underexpansion, malapposition, and fracture that may predispose to ST. Methods : All consecutive cases of angiographically confirmed ST from a multicenter registry (from 2005 to 2010) were reviewed. All IVUS images were reviewed off‐line for the presence of stent underexpansion, malapposition, and fracture. Kaplan–Meier analysis was used to determine whether use of IVUS at the time of ST was associated with long‐term mortality and major adverse cardiovascular events. Results : IVUS was performed in 32 of 173 subjects with ST (18%). Stent underexpansion was present in 82% of cases and in all cases of early ST, with a mean stent expansion of 0.7 ± 0.23 by MUSIC criteria. Stent malapposition was most frequently observed in very late ST (40%). In‐hospital mortality was similar between subjects who had IVUS performed at the time of ST when compared with the non‐IVUS group (3.2% vs. 4.3%, P = 0.8). Subjects who had IVUS performed at the time of ST had lower rates of mortality (HR 0.4, 95% CI 0.1‐1.6, P =0.2) and major adverse cardiovascular events (HR 0.5, 95% CI 0.2–1.4, P =0.2) at follow‐up, but these values were not statistically significant. Conclusions : There is a high prevalence of stent underexpansion in early ST, while the prevalence of malapposition is higher in very late ST. Use of IVUS during treatment for ST may identify mechanisms underlying the development of ST. © 2012 Wiley Periodicals, Inc.     

Novel stent system for bifurcation lesions: examination by intravascular ultrasound.

Bifurcation disease represents a mechanical and biological challenge for definitive interventional treatment. This case report discusses an experience with a novel stent system designed for the treatment of bifurcation lesions.     

The AST petal dedicated bifurcation stent: first-in-human experience.

The aim of this first-in-human study was to evaluate the feasibility and safety of the novel AST petal side-access bifurcation stent. Outcomes following percutaneous coronary intervention for bifurcations remain inferior to those of nonbifurcated lesions. Even with drug-eluting stents, restenosis occurs especially at the side-branch (SB) ostium. The petal stent uniquely deploys strut elements into the SB, supporting the ostium and carina. The primary endpoint of this 13-patient prospective registry was in-hospital major adverse cardiac events (MACE). Secondary end points included acute minimum lumen diameter (MLD) at the SB ostium, lesion success, device success, procedural success, 30-day MACE, and 4-month SB ostial MLD. The study lesion was successfully treated in 13 patients with the study stent being successfully implanted in 12. Target lesions were left anterior descending coronary artery in nine subjects, left circumflex in three, and right coronary artery in one. In-hospital MACE were limited to two non-Q-wave myocardial infarctions. In-stent main branch MLD increased from a mean of 0.63 +/- 0.45 mm to 2.61 +/- 0.47 mm at the index procedure and for this initial bare metal version of the stent, 4-month mean MLD measured 1.02 +/- 0.42 mm and there was target vessel revascularization on two patients. The feasibility of safely deploying this first-generation petal stent was demonstrated in selected patients with challenging coronary bifurcation lesions. It is a promising platform for drug delivery, with unique scaffolding of the side-branch ostium.     

“Over‐and‐under” pericardial covered stent with paclitaxel balloon in a saphenous vein graft

Treatment of vein graft disease remains a challenge in interventional cardiology because of the risk of embolization and no‐reflow phenomenon. Currently available distal protection devices have their limitations. The PTFE‐covered stents may be well suited for venous graft lesion treatment, but those available commercially to date have poor crossing profiles, and deliverability and high rates of restenosis. We report the first use of over‐and‐under pericardium‐covered stent in combination with drug‐eluting balloon to treat venous graft disease. © 2009 Wiley‐Liss, Inc.     

Evaluation of intermediate coronary stenosis with intravascular ultrasound and fractional flow reserve: Its use and abuse

Clinical decision making in patients with intermediate coronary stenosis is still debated. Intravascular ultrasound (IVUS) examination and/or functional assessment of coronary stenosis by fractional flow reserve (FFR) are currently used to define the severity of such lesions. There are very few studies with a small sample size that have a head‐to‐head comparison between IVUS and FFR in the evaluation of angiographically de novo intermediate lesions. There are no randomized, controlled trials to demonstrate the superiority of IVUS versus FFR in providing improved clinical outcomes in comparison with angiography alone. However, the issue of superiority might be irrelevant, because IVUS and FFR could be complementary techniques to be used in the catheterization laboratory to provide critical anatomic and functional data that permit more accurate decisions in the management of the patient. © 2009 Wiley‐Liss, Inc.     

Stent malapposition caused by improper rewiring during left main intervention: The role of intravascular ultrasound in avoidance and management—A case report

The optimal technique for bifurcation stenting of distal Left main (LM) lesions remains unestablished and controversial. Some techniques with superior stent apposition, such as culotte technique were supposed to be associated with lower rate of stent thrombosis. However, with culotte technique, the double‐stent layer at the carina and in the proximal part of the bifurcation, may lead to difficult or improper rewiring of the side branch before final kissing balloon postdilatation (KBP). We describe a case of distal LM disease associated with distal left circumflex (LCX) and posterior descending artery stenosis. During LM stenting using culotte technique, improper rewiring of LCX before final KBP caused malapposition of the inner sent layer at the mid part of LM. Despite the optimal angiographic result, intravascular ultrasound (IVUS) was able to detect stent malapposition and guided further management to achieve complete stent apposition. The present case indicates that IVUS is an essential tool for LM stenting particularly when applying double stent strategy requiring final rewiring before KBP. Moreover, we suggest that some tools, such as Crusade and Venture catheters, can be used to ensure proper rewiring and hence, prevent subsequent stent malapposition, which may lead to catastrophic complications such as early and late LM stent thrombosis. © 2011 Wiley‐Liss, Inc.     

Analysis of bifurcation lesions treated with novel drug-eluting dedicated bifurcation stent system: intravascular ultrasound results of the AXXESS PLUS trial.

OBJECTIVE: The aim of this intravascular ultrasound (IVUS) study was to assess the efficacy of the AXXESS Plus stent system for the treatment of bifurcation coronary lesions. BACKGROUND: The AXXESS Plus is a novel bifurcation drug-eluting stent, comprised of a self-expanding flare-shaped stent platform and bioabsorbable polymer coating that releases Biolimus A9. METHODS: Data were obtained from the AXXESS PLUS trial, a prospective, multicenter, nonrandomized, single-arm study to evaluate safety and efficacy. Six-month follow-up IVUS analysis was available in 49 cases. Volumetric analysis using Simpson's method within the AXXESS stent, and cross-sectional analysis at the ostium of main branch and/or side branch was performed. Impact of bifurcation angle on stent expansion at the carina was also evaluated. Results: Within the AXXESS stent, neointimal volume obstruction percentage was 2.3% +/- 2.2%, with a minimum lumen area of 7.9 +/- 2.6 mm(2). Lumen area was 5.2 +/- 1.7 mm(2) at main branch ostium, and 4.0 +/- 1.5 mm(2) at side branch ostium. In two cases, incomplete stent apposition was observed at the proximal edge of the AXXESS stent. In one case, a gap between the AXXESS stent and an additional stent was observed. Greater bifurcation angle inversely correlated with smaller stent area at side branch ostium (r = -0.54, P = 0.03) but not at main branch ostium (r = -0.2, P = 0.29). CONCLUSIONS: This novel self-expanding, drug-eluting bifurcation stent demonstrated effective lesion coverage along with significant neointimal suppression equivalent to current generation balloon-expandable drug-eluting stent technology.     

Magnetic navigation system used successfully to cross a crushed stent in a bifurcation that failed with conventional wires.

Bifurcation lesions can be technically demanding to manage, and even in the era of drug eluting stents, their procedural success is variable. The use of the crush technique followed by "kissing" balloon postdilatation has been shown to improve the overall outcome. However, crossing the crushed stent is essential to allow performance of a final dilatation with "kissing" balloons and is regarded as the main Achilles' heel of this technique. In this report, we describe the first reported, planned procedure to use a magnetic navigation system to steer a wire through the crushed stent to use "kissing" balloons that had previously failed with conventional wires.     

A novel three‐dimensional quantitative coronary angiography system: In‐vivo comparison with intravascular ultrasound for assessing arterial segment length

Background : Accurate on‐line assessments of vessel dimensions are of utmost importance for selecting the appropriate stent size in coronary interventions. Recently a new three‐dimensional quantitative coronary angiography (3D QCA) analytical software package was developed to accurately assess the vessel dimensions for the planning and guidance of such coronary interventions. This study aimed to validate the 3D QCA software package for assessing arterial segment length by comparing with intravascular ultrasound (IVUS). In addition, the difference in the two measurements from 3D QCA and IVUS for curved segments was studied. Methods : A retrospective study including 20 patients undergoing both coronary angiography and IVUS examinations of the left coronary artery was set up for the validation. The same vessel segments of interest between proximal and distal markers were identified and measured on both angiographic and IVUS images, by the 3D QCA software and by a quantitative IVUS software package, respectively. In addition, the curvature of each of the segments of interest was assessed and the correlation between the accumulated curvature of the segment and the difference in segment lengths measured from the two imaging modalities was analyzed. Results : 37 vessel segments of interest were identified from both angiographic and IVUS images. The 3D QCA segment length was slightly longer than the IVUS segment length (15.42 ± 6.02 mm vs. 15.12 ± 5.81 mm, P = 0.040). The linear correlation of the two measurements was: 3D QCA Length = ?0.09 + 1.03 × IVUS Length (r² = 0.98, P < 0.001). Bland‐Altman plot showed that the difference in the two measurements was not correlated with the average of the two measurements (P = 0.141), but with the accumulated curvature of the segment (P = 0.015). After refining the difference by the correlation, the average difference of the two measurements decreased from 0.30 ± 0.86 mm (P = 0.040) to 0.00 ± 0.78 mm (P = 0.977). Conclusions : The 3D QCA software package can accurately assess the actual arterial segment length. The difference in segment lengths measured from 3D QCA and IVUS was correlated with the accumulated curvature of the segment. © 2010 Wiley‐Liss, Inc.