Coronary Balloon Research Articles

Endoscopic retrograde cholangiopancreatography in patients with previous acute coronary syndrome.

Background/AimsEndoscopic retrograde cholangiopancreatography (ERCP) is considered a high-risk procedure in patients with previous acute coronary syndrome (ACS); however, clinical studies are rare in the literature. The aim of this study was to investigate the safety and efficacy of ERCP in patients with previous ACS.MethodsWe retrospectively reviewed the medical records of patients with previous ACS who underwent ERCP between January 2007 and August 2012. The clinical characteristics, ERCP diagnoses, treatment results, and complications were analyzed.ResultsFifty patients underwent ERCP an average of 41.6 months after ACS. The most common indication for ERCP was calculous cholangitis. After deep biliary cannulation, endoscopic sphincterotomy, biliary stone removal and endoscopic biliary drainage were successfully performed. Immediate postsphincterotomy bleeding occurred in seven patients, which was successfully controlled using endoscopic therapy. Elevation of cardiac troponin I levels were observed in three patients (6%) before ERCP, and all of these patients were diagnosed with pancreatobiliary disease combined with recurrent ACS, which was treated with coronary artery stent insertion (n=2) and balloon angioplasty (n=1).ConclusionsTherapeutic ERCP is effective and safe in patients with previous ACS. Cardiac troponin I elevation should be considered a warning sign for recurrent ACS in patients who undergo ERCP.

First report of stent thrombosis after a switch therapy resulting from ticagrelor-related dyspnea

Keyword: Acute coronary syndrome Stent thrombosis Ticagrelor Balloon angioplasty and subsequent stenting (a 2.4 mm × 18 mm sirolimus-eluting stent, EXCEL, JW, China) of the right coronary artery (RCA) lesion was performed with good angiographic results (Fig. 1B). He was discharged from the hospital on a regimen of aspirin (100 mg once daily) and ticagrelor (90 mg twice daily). Ten days later, the patients still complained of dyspnea and went to his local clinic. Ticagrelor was switched to clopidogrel 75 mg daily without loading dose. Clopidogrel therapy was commenced at about 12 h after the last dose of ticagrelor. Dyspnea was alleviated by the

Reliability of ST-Segment Shifts in the Synthesized V3R–V5R Leads After Coronary Balloon Inflations During Percutaneous Coronary Intervention

Obtaining a right-chest electrocardiogram is essential for diagnosing concomitant right ventricular infarction in patients with inferior wall acute myocardial infarctions. A software program to synthesize right-chest electrocardiographic waveforms from 12-lead electrocardiographic waveforms is available in Japan. However, its reliability has not been fully investigated. Accordingly, the aim of this study was to examine the reliability of ST-segment shifts in the synthesized V3R to V5R leads. ST-segment shifts in actual and synthesized V3R to V5R leads were compared during the last 10 seconds of 131 balloon inflations while performing elective percutaneous coronary intervention in 56 patients with coronary artery disease. ST-segment shifts in the actual and synthesized V3R, V4R, and V5R leads were correlated (r = 0.96, p <0.001, r = 0.94, p <0.001, and r = 0.91, p <0.001, respectively). A Bland-Altman analysis showed that the bias between ST-segment shifts in the actual and synthesized V3R to V5R leads was -3.1, -5.4, and -4.2 μV, respectively, while the limits of agreement between the ST-segment shifts in the actual and synthesized V3R to V5R leads were -59.2 to 52.9, -61.9 to 51.1, and -59.7 to 51.3 μV, respectively. The κ coefficients for ST-segment elevation of ≥50 and ≥100 μV in the actual and synthesized V3R, V4R, and V5R leads were 0.83 and 0.81, 0.66 and 0.83, and 0.57 and 0.80, respectively. In conclusion, these results indicate that ST-segment shifts in the synthesized V3R to V5R leads have acceptable reliability, suggesting that synthesized right-chest electrocardiography can be used to diagnose concomitant right ventricular infarction in patients with inferior wall acute myocardial infarctions.

Physical ischaemia induced by isometric exercise facilitated collateral development in the remote ischaemic myocardium of humans.

The aim of the present study was to investigate the effects of isometric-handgrip-induced PIT (physical ischaemia training) on remote coronary recruitment and growth. A total of 74 CAD (coronary artery disease) patients were randomly assigned to either the IHG (isometric handgrip group) or NEG (non-exercise group). Patients in the IHG performed isometric handgrip exercises during 1min of coronary balloon occlusion, whereas patients in the NEG remained sedentary. CFI (collateral flow index), HR (heart rate), SBP (systolic blood pressure) and DBP (diastolic blood pressure) were evaluated before and at the end of occlusion. In a second study, 21 CAD patients were randomly divided into the IHT (isometric handgrip training) group or the NTG (non-training group). Patients in the IHT group performed 3 months of IHT, whereas patients in the control group remained sedentary. SPECT (single-photon emission computed tomography) was used to evaluate myocardial perfusion, and VEGF (vascular endothelial growth factor) levels were determined using ELISA. In the IHG, CFI was significantly higher than in the control group (P<0.01). HR, SBP and DBP in the IHG were significantly higher than in the NEG (P<0.01) at the end of occlusion. In the second study, myocardial perfusion (P<0.05) and left ventricular ejection fraction (P<0.01) were significantly improved in the IHT group. VEGF levels in the IHT group were significantly increased (P<0.01). Levels of VEGF were negatively correlated with the summed rest score of SPECT (r=-0.60, P<0.01). In conclusion, isometric handgrip exercise-induced PIT may promote remote collateral recruitment and growth in CAD patients.

E-050 Navigation of a Distal Cerebral Embolic Protection Device through Significant Vascular Tortuosity with a Novel Rapid Exchange Catheter System during Carotid Artery Stenting

IntroductionCarotid stenosis is a prevalent cause of ischemic cerebrovascular disease. Carotid endarterectomy and carotid artery stenting (CAS) have both been shown to provide effective and durable reductions in the risk...

Myocardial infarction due to intracoronary embolization of percutaneous coronary intervention packaging

Intracoronary device loss is occasionally encountered and removal is commonly performed at the time of the procedure. We report a case of removal of a retained coronary balloon protective plastic tubing inadvertently left in the coronary artery for a month and associated with myocardial infarction. Optical coherence tomography was used to visualize the foreign body prior to removal with a snare. To our knowledge this is the first report of a removal of disposable packaging equipment after prolonged intracoronary dwell time.

The preemptive use of extracorporeal membrane oxygenation to facilitate high risk percutaneous cardiac interventions: left main percutaneous coronary interventions and percutaneous balloon aortic valvuloplasty.

As percutaneous cardiac interventions continue to evolve, high-risk procedures are being performed on patients deemed too ill for surgery. What were once considered lower-risk procedures compared with open cardiac interventions may no longer be so because of the complex nature of the interventions and the complex comorbidities of the patients on whom these are being performed. We present a case involving high-risk percutaneous cardiac interventions (left main coronary angioplasty and aortic balloon valvuloplasty), facilitated by the use of extracorporeal membrane oxygenation in a critically ill patient with severe aortic stenosis, left main coronary disease, and ischemic cardiomyopathy.

Abstract 200: Development and Proof of Concept Testing of an Ex Vivo Perfusion Chamber for Studying Platelet Adhesion to Coronary Stents Under Physiological Conditions

Background: Current-generation drug-eluting stents unblock atherosclerotic arteries, inhibit restenosis, but also render the artery prone to thrombosis by inhibiting endothelial cell function. Hence, there is strong clinical interest in developing stents that inhibit restenosis, yet are less thrombogenic. Goals of this study were to 1) develop an ex vivo method to measure platelet adhesion and aggregation on coronary stents under clinically-relevant conditions, and 2) test the hypothesis that treating metal stents with trimethylsilane (TMS) through a novel glow discharge process that coats stents with a nanoscale layer of hydrophobic plasma coating, with or without additional post-deposition glow discharge treatment with NH 3 and O 2 gas, generating elemental nitrogen and oxygen on the stent surface, inhibits platelet adhesion to stents. Methods: Bare-metal stents (BMS) made of 316L stainless steel was deployed in Masterflex tubing by inflating an over-the-wire coronary balloon within the stent. Tubing containing stents was filled with porcine indium-labeled platelets in anticoagulated whole blood and the ends were connected to create a closed circuit, which was connected to a peristaltic pump to generate unidirectional flow with shear stress of 67 s -1 , similar to that present in human coronary arteries. After 30 min of continuous flow at 37°C the tubing was disconnected and extensively rinsed to remove blood. Platelet adhesion to stents was measured with a gamma counter and by scanning electron microscopy (SEM). Results: Platelet adhesion to metal stents treated with TMS followed by NH 3 and O 2 (DC-TMS+NH 3 /O 2 ) was 56±8.2% reduced compared to BMS (n=12; P=0.003), whereas TMS treatment alone did not significantly inhibit platelet adhesion. SEM confirmed significantly decreased platelet deposition on DC-TMS+ NH 3 /O 2 stents vs. BMS. Conclusions: A novel glow discharge surface modification involving TMS, NH 3 , and O 2 gas generates stents with a bioactive surface that resists platelet adhesion under physiological conditions. Our ex vivo perfusion circuit facilitates rapid and precise comparison of stent thrombogenicity under physiological conditions, which should prove useful to other investigators developing coronary stents for clinical use.

Myocardial Infarction and Functional Outcome Assessment in Pigs

Introduction of newly discovered cardiovascular therapeutics into first-in-man trials depends on a strictly regulated ethical and legal roadmap. One important prerequisite is a good understanding of all safety and efficacy aspects obtained in a large animal model that validly reflect the human scenario of myocardial infarction (MI). Pigs are widely used in this regard since their cardiac size, hemodynamics, and coronary anatomy are close to that of humans. Here, we present an effective protocol for using the porcine MI model using a closed-chest coronary balloon occlusion of the left anterior descending artery (LAD), followed by reperfusion. This approach is based on 90 min of myocardial ischemia, inducing large left ventricle infarction of the anterior, septal and inferoseptal walls. Furthermore, we present protocols for various measures of outcome that provide a wide range of information on the heart, such as cardiac systolic and diastolic function, hemodynamics, coronary flow velocity, microvascular resistance, and infarct size. This protocol can be easily tailored to meet study specific requirements for the validation of novel cardioregenerative biologics at different stages (i.e. directly after the acute ischemic insult, in the subacute setting or even in the chronic MI once scar formation has been completed). This model therefore provides a useful translational tool to study MI, subsequent adverse remodeling, and the potential of novel cardioregenerative agents.

Myocardial infarction and functional outcome assessment in pigs.

Introduction of newly discovered cardiovascular therapeutics into first-in-man trials depends on a strictly regulated ethical and legal roadmap. One important prerequisite is a good understanding of all safety and efficacy aspects obtained in a large animal model that validly reflect the human scenario of myocardial infarction (MI). Pigs are widely used in this regard since their cardiac size, hemodynamics, and coronary anatomy are close to that of humans. Here, we present an effective protocol for using the porcine MI model using a closed-chest coronary balloon occlusion of the left anterior descending artery (LAD), followed by reperfusion. This approach is based on 90 min of myocardial ischemia, inducing large left ventricle infarction of the anterior, septal and inferoseptal walls. Furthermore, we present protocols for various measures of outcome that provide a wide range of information on the heart, such as cardiac systolic and diastolic function, hemodynamics, coronary flow velocity, microvascular resistance, and infarct size. This protocol can be easily tailored to meet study specific requirements for the validation of novel cardioregenerative biologics at different stages (i.e. directly after the acute ischemic insult, in the subacute setting or even in the chronic MI once scar formation has been completed). This model therefore provides a useful translational tool to study MI, subsequent adverse remodeling, and the potential of novel cardioregenerative agents.

Function of natural internal mammary-to-coronary artery bypasses and its effect on myocardial ischemia.

The function of naturally existing internal mammary (IMA)-to-coronary artery bypasses and their quantitative effect on myocardial ischemia are unknown. The primary end point of this study was collateral flow index (CFI) obtained during two 1-minute coronary artery balloon occlusions, the first with and the second without simultaneous distal IMA occlusion. The secondary study end point was the quantitatively determined intracoronary ECG ST-segment elevation. CFI is the ratio of simultaneously recorded mean coronary occlusive pressure divided by mean aortic pressure both subtracted by mean central venous pressure. A total of 180 pairs of CFI measurements were performed among 120 patients. With and without IMA occlusion, CFI was 0.110±0.074 and 0.096±0.072, respectively (P<0.0001). The difference of CFI obtained in the presence minus CFI obtained in the absence of IMA occlusion was highest and most consistently positive during left IMA with left anterior descending artery occlusion and during right IMA with right coronary artery occlusion (ipsilateral occlusions): 0.033±0.044 and 0.025±0.027, respectively. This CFI difference was absent during right IMA with left anterior descending artery occlusion and during left IMA with right coronary artery occlusion (contralateral occlusions): -0.007±0.034 and 0.001±0.023, respectively (P=0.0002 versus ipsilateral occlusions). The respective CFI differences during either IMA with left circumflex artery occlusion were inconsistently positive. Intracoronary ECG ST-segment elevations were significantly reduced during ipsilateral IMA occlusions but not during contralateral or left circumflex artery occlusions. There is a functional, ischemia-reducing extracardiac coronary artery supply via ipsilateral but not via contralateral natural IMA bypasses. http://www.clinicaltrials.gov. Unique identifier: NCTO1676207.

TCTAP C-025 The Effectiveness and Usefulness of Coronary Perfusion Balloon (Ryusei) in PCI Using Excimer Laser Coronary Angioplasty (ELCA)

### Patient initials or identifier number R.F. 72y.o. Male 0002491609 ### Relevant clinical history and physical exam Present illness: He had chest pain and oppression feeling. 72y.o male, Chief complain: chest pain, Present illness: (On October 4, 2012,) he had a severe chest pain, and

Bioabsorbable Stent Quo Vadis: A Case for Nano-Theranostics

Percutaneous coronary intervention (PCI) is one of the most commonly performed invasive medical procedures in medicine today. Since the first coronary balloon angioplasty in 1977, interventional cardiology has seen a wide array of developments in PCI. Bare metal stents (BMS) were soon superseded by the revolutionary drug-eluting stents (DES), which aimed to address the issue of restenosis found with BMS. However, evidence began to mount against DES, with late-stent thrombosis (ST) rates being higher than that of BMS. The bioabsorbable stent may be a promising alternative, providing vessel patency and support for the necessary time required and thereafter degrade into safe non-toxic compounds which are reabsorbed by the body. This temporary presence provides no triggers for ST, which is brought about by non-endothelialized stent struts and drug polymers remaining in vivo for extended periods of time. Likewise, nano-theranostics incorporated into a bioabsorbable stent of the future may provide an incredibly valuable single platform offering both therapeutic and diagnostic capabilities. Such a stent may allow delivery of therapeutic particles to specific sites thus keeping potential toxicity to a minimum, improved ease of tracking delivery in vivo by embedding imaging agents, controlled rate of therapy release and protection of the implanted therapy. Indeed, nanocarriers may allow an increased therapeutic index as well as offer novel post-stent implantation imaging and diagnostic methods for atherosclerosis, restenosis and thrombosis. It is envisioned that a nano-theranostic stent may well form the cornerstone of future stent designs in clinical practice.

A cockscomb-like aneurysm of the right coronary artery after bare metal stent implantation.

Coronary artery aneurysm (CAA) formation is an uncommon but potentially life-threatening event after coronary balloon angioplasty or stent implantation. In this report, we present a case of a patient who had a cockscomb-like aneurysm after bare metal stent implantation which was successfully treated with a coronary graft stent.

Role of biomaterials in prevention of in‐stent restenosis

Coronary balloon angioplasty and coronary stenting are the procedures used in healing coronary artery disease. However, injury of arteries during angioplasty and stenting causes cell stimulations in tissue. Cell movement and thrombosis lead to re-narrowing of widened vessel called restenosis. Several new types of carriers and technology have been developed to suppress and/or prevent restenosis. Authors review the polymeric materials featured in drug/gene carrier systems, nanovehicles, and stent coating materials against restenosis.

The effect of heart rate reduction by ivabradine on collateral function in patients with chronic stable coronary artery disease

ObjectiveTo evaluate the effect of heart rate reduction by ivabradine on coronary collateral function in patients with chronic stable coronary artery disease (CAD).MethodsThis was a prospective randomised placebo-controlled monocentre trial...

Percutaneous transluminal pulmonary valvuloplasty in a child with tricuspid atresia, ventricular septal defect, and severe pulmonary valve stenosis

Percutaneous transluminal pulmonary valvuloplasty may be indicated in not only isolated pulmonary valve stenosis, but also complex congenital heart diseases. Because palliative surgery for increasing pulmonary blood flow entails a risk of scar formation and immediate postoperative complications, catheter intervention is preferred, if possible. However, an acute-angled, twisted, or tortuous access route or a small valve orifice occasionally makes it difficult for the catheter to reach or cross the target. We succeeded in performing this intervention for such a complex stenosis effectively and safely in a patient with tricuspid atresia, ventricular septal defect (VSD), and severe pulmonary valve stenosis, thereby evading surgery. In previous reports, the catheter for this cardiac anomaly was accessed via the femoral vein. In the present case, the catheter was advanced through the femoral artery via the aorta, left ventricle, VSD, and right ventricle to the pulmonary valve, using a micro-catheter in a telescopic manner, in combination with a coronary balloon dilatation catheter. This maneuver, which has not been reported previously, made it much easier to perform the procedure as compared to the femoral vein approach, despite the acute turn and the pinhole orifice. Moreover, reported complications of the femoral vein approach, including bradycardia, hypotension, and valve regurgitation, were not observed in this case. We conclude that the femoral artery approach can be a safe and effective alternative in patients for whom a more conventional procedure has been unsuccessful.

Using Oxidized Low-Density Lipoprotein Autoantibodies to Predict Restenosis after Balloon Angioplasty in Patients with Acute Myocardial Infarction

ObjectivesOxidized low-density lipoproteins (oxLDL) and oxidized low-density lipoprotein autoantibodies (OLAB) have been detected in human plasma and atherosclerotic lesions. OLAB appear to play a role in the clearance of oxLDL from circulation. Higher levels of OLAB appear to be associated with a reduced risk of a wide range of cardiovascular diseases. We investigated the prognostic value of plasma oxLDL and OLAB in patients undergoing primary coronary balloon angioplasty for acute ST-elevation myocardial infarction (STEMI).MethodsPlasma oxLDL and OLAB concentrations were measured in 56 patients with acute STEMI before primary angioplasty, and then 3 days, 7 days and 1 month after the acute event. Follow-up angiography was repeated 6 months later to detect the presence of restensosis (defined as >50% luminal diameter stenosis). The thrombolysis in myocardial infarction (TIMI) risk score was calculated to determine the relationship between OLAB/oxLDL ratio and TIMI risk scores.ResultsOf the 56 patients, 18 (31%) had angiographic evidence of restenosis. Plasma OLAB concentrations were significantly lower in the restenosis group before angioplasty (181±114 vs. 335±257 U/L, p = 0.003), and at day 3 (155±92 vs. 277±185 U/L, p<0.001) and day 7 (177±110 vs. 352±279 U/L, p<0.001) after the acute event. There was no difference in oxLDL concentration between the two groups. The ratio of OLAB/oxLDL positively correlated with TIMI risk scores before angioplasty (p for trend analysis, p = 0.004), at day 3 (p = 0.008) and day 7 (p<0.001) after STEMI.SignificanceA relative deficit of OLAB, and hence likely impaired clearance of oxLDL, is associated with the risk of arterial restenosis after primary angioplasty for acute STEMI.

Quantitative magnetic resonance imaging can distinguish remodeling mechanisms after acute myocardial infarction based on the severity of ischemic insult

The type and extent of myocardial infarction encountered clinically is primarily determined by the severity of the initial ischemic insult. The purpose of the study was to differentiate longitudinal fluctuations in remodeling mechanisms in porcine myocardium following different ischemic insult durations. Animals (N = 8) were subjected to coronary balloon occlusion for either 90 or 45 min, followed by reperfusion. Imaging was performed on a 3 T MRI scanner between day‐2 and week‐6 postinfarction with edema quantified by T2, hemorrhage by T2*, vasodilatory function by blood‐oxygenation‐level‐dependent T2 alterations and infarction/microvascular obstruction by contrast‐enhanced imaging. The 90‐min model produced large transmural infarcts with hemorrhage and microvascular obstruction, while the 45 min produced small nontransmural and nonhemorrhagic infarction. In the 90‐min group, elevation of end‐diastolic‐volume, reduced cardiac function, persistence of edema, and prolonged vasodilatory dysfunction were all indicative of adverse remodeling; in contrast, the 45‐min group showed no signs of adverse remodeling. The 45‐ and 90‐min porcine models seem to be ideal for representing the low‐ and high‐risk patient groups, respectively, commonly encountered in the clinic. Such in vivo characterization will be a key in predicting functional recovery and may potentially allow evaluation of novel therapies targeted to alleviate ischemic injury and prevent microvascular obstruction/hemorrhage. Magn Reson Med, 70:1095–1105, 2013. © 2012 Wiley Periodicals, Inc.

Outcomes of concomitant percutaneous coronary intervention and balloon aortic valvuloplasty

Coronary artery disease often coexists with severe aortic stenosis. The feasibility and safety of combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) are unknown. To compare outcomes and complications of combined BAV and PCI with BAV alone. The study cohort consisted of 409 patients with severe aortic stenosis undergoing BAV from 1/2007 to 12/2010. Overall, 329 patients underwent BAV alone and 80 underwent concomitant PCI. Clinical and hemodynamic data, as well as acute and intermediate-term outcomes, were collected. At the operator's discretion PCI was done before BAV in 66 (82.5%) and after in 14 (17.5%). Patients who underwent concomitant procedures had a higher incidence of prior stroke and a lower incidence of atrial fibrillation. Procedure time and fluoroscopic time were significantly greater in the BAV/PCI group, (90.0 ± 36.6 vs. 72.8 ± 39.8, P = 0.002 and 20.5 ± 10.9 vs. 12.9 ± 7.0, P < 0.001). Significantly more radiographic contrast was used in the BAV/PCI group (95.1 ± 45.5 vs. 36.7 ± 38.4 cm(3) , P < 0.001. Serious adverse events occurred with equal frequency 13.7 and 17.3%, P = 0.44). Transfusion requirement was also similar (21.2% vs. 20.0%, P = 0.81). The frequency of a periprocedural increase in troponin or creatinine was also similar. In the BAV alone group the mortality rate was 48.6% (n = 160) during a mean follow-up of 191 days, and in the BAV/PCI group the mortality rate was 40% (n = 32) during mean follow-up of 175.5 day, P = 0.34. Combined BAV and PCI are safe and are associated with similar complications as BAV alone and may offer protection against myocardial ischemia during BAV.