Intracoronary Hemodynamic Effects of Pressure‐Controlled Intermittent Coronary Sinus Occlusion (PICSO): Results from the First‐In‐Man Prepare PICSO Study

Background: Myocardial reperfusion is frequently suboptimal after ST‐segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI). Using a balloon‐tipped catheter positioned in the coronary sinus (CS), pressure‐controlled intermittent coronary sinus occlusion (PICSO) results in an intermittent obstruction of coronary venous outflow of the left anterior descending artery (LAD), and may improve myocardial perfusion by augmenting redistribution of blood to the border zone of ischemic myocardium. We sought to document the intracoronary hemodynamic effects of PICSO during PCI. Methods: We included 15 patients with stable angina scheduled for PCI of the LAD. Balloon occlusion of the LAD was performed twice, once with and once without PICSO and lasting maximally 3 minutes each, to document the effect of PICSO on CS pressure and LAD wedge pressure. Results: Catheter delivery was successful in all patients. The study protocol could not be conducted in 5 patients due to initial calibration difficulties (n = 3), a pressure wire problem (n = 1), and a vagal response at the start of the procedure (n = 1). In the remaining 10 patients, CS occlusion caused a marked increase in mean CS pressure (4.1 ± 7.3 mmHg vs. 22.0 ± 12.6 mmHg; P < 0.001) and CS pulse pressure (4.3 ± 0.8 mmHg vs. 36.1 ± 6.3 mmHg; P < 0.001). Concomitantly, mean distal LAD wedge pressure and wedge pulse pressure increased (32.4 ± 12.2 mmHg vs. 35.5 ± 12.6 mmHg; P < 0.001 and 39.1 ± 27.2 mmHg vs. 45.9 ± 26.0 mmHg; P < 0.001, respectively). At 30 day follow‐up, no device‐related events occurred. Conclusions: PICSO safely augments CS pressure, thereby increasing LAD coronary wedge pressure. These findings support further evaluation of PICSO in the setting of STEMI. (J Interven Cardiol 2012;25:549–556)     

First‐in‐Man Experience With the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions

Objectives

To describe the first‐in‐man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI.

Background

Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal.

Methods

Prospective, single‐centre, non‐randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria—TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST‐resolution >70% at 90 minutes after vessel reperfusion—was also evaluated.

Results

Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre‐specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration.

Conclusions

This first‐in‐man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI. (J Interven Cardiol 2016;29:155–161)

     

First Clinical Experience With Celt ACD®: A Femoral Arterial Puncture Closure Device

Introduction

This prospective nonrandomized study compared the safety and efficacy of a novel arterial closure device (ACD) in common femoral artery procedures to that of the FDA submitted historical manual pressure control group, who underwent either a diagnostic angiogram (DA) or a percutaneous coronary intervention (PCI) procedure.

Methods and Results

A total of 55 patients were enrolled in this study of the novel ACD. Of the 55 patients, 39 were enrolled in the DA group and 16 were enrolled in the PCI group. Six patients were excluded. A device was deployed in 49 patients. Time to hemostasis (TTH), time to ambulation (TTA), device function, and device‐related vascular complications were measured. In the device group, the TTH for the combined DA and PCI patients was 32 seconds (0.54 ± 0.93 minutes), significantly lower when compared with 16.0 ± 12.2 minutes (P < 0.0001) for the control group. Overall major vascular complication rate did not differ significantly, device group (1/49) and the historical control group (1/217). TTA in the combined PCI and DA device group was 226.4 ± 231.9 at the German site (site ambulation policy). In the Irish site, the average TTA in the PCI group was 187 minutes (n = 8) and 85 minutes (n = 14) in the DA group.

Conclusion

The Celt ACD® device is safe, effective, and significantly decreases the TTH compared to manual pressure and has a low vascular complications rate. The device may be effective in early ambulation and discharge of patients postcoronary intervention procedures.

     

Transcatheter Closure of Patent Ductus Arteriosus: Experience with a New Device

Transcatheter closure is the preferred method of treatment of patent ductus arteriosus (PDA). Detachable coils are widely used to close small ducts, while the Amplatzer duct occluder (ADO) is generally employed for moderate or large ducts. Recently a new device, the Amplatzer duct occluder II (ADO II), a nitinol flexible mesh, with a symmetrical design to provide high conformability for treatment of all types of PDA, has received the European Community mark approval. We report on one of the first experience, four cases (1 male, 3 female, age ranging from six months to seven years old) with different type and size of PDA treated with the new device. The use of this new Amplatzer duct occluder in our experience has the advantage of ease and safety of placement, conformability, stability, low profile catheters, adaptability for long ducts as in type E. Copyright © 2009 Wiley Periodicals, Inc.     

LCZ696, a First‐in‐Class Angiotensin Receptor‐Neprilysin Inhibitor: The First Clinical Experience in Patients With Severe Hypertension

The safety of LCZ696, a novel angiotensin receptor‐neprilysin inhibitor, was evaluated for the first time in patients with severe hypertension in this 8‐week, multicenter, open‐label study. Thirty‐five Japanese patients with either office systolic blood pressure (SBP) ≥180 mm Hg or diastolic blood pressure (DBP) ≥110 mm Hg received LCZ696 200 mg. If blood pressure was uncontrolled, the LCZ696 dose was increased to 400 mg after 2 weeks (if there were no safety concerns; n=32), followed by an optional addition of another antihypertensive drug (except angiotensin receptor blocker and angiotensin‐converting enzyme inhibitor) after 4 weeks (n=21). Reductions in office SBP/DBP (baseline, 173.4 mm Hg/112.4 mm Hg) and pulse pressure (baseline, 61.0 mm Hg) at week 8 were 35.3/22.1 mm Hg and 13.2 mm Hg, respectively. The overall incidence of adverse events was 48.6% with no reports of dizziness, hypotension, or angioedema. The LCZ696‐based regimen was generally well‐tolerated and could present a treatment option for severe hypertension in Asian patients especially in reducing SBP and pulse pressure.     

Percutaneous Closure of a Large PDA in a 35‐Year‐Old Man with Elevated Pulmonary Vascular Resistance

The presence of a large patent ductus arteriosus (PDA) may result in significant pulmonary hypertension, which may not be reversible. We present the case of a 35‐year‐old man with pulmonary hypertension who had successful percutaneous closure of a large PDA with an Amplatzer muscular ventricular septal defect occluder and resolution of his pulmonary hypertension. The use of prior balloon test occlusion of the PDA suggested that the procedure would be successful, despite the lack of an immediate fall in the pulmonary artery pressure.     

Real-World Experience of the MANTA Closure Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

Background/purposeThe MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access-site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania).Methods/materialsPost-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports.ResultsOf the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1).ConclusionsOur analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD.     

First‐in‐Man Study of Dedicated Bifurcation Sirolimus‐eluting Stent: 12‐month Results of BiOSS LIM® Registry

Objectives

The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent ‐ sirolimus‐eluting BiOSS LIM® (Balton, Poland) in 12‐month Registry.

Background

The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions.

Methods

This was the international, 3‐center registry, which enrolled patients with non‐ST‐elevation acute coronary syndrome (NSTE‐ACS) and stable angina. Provisional T‐stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months.

Results

A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE‐ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug‐eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow‐up (11 ± 1 months) there was 1 non‐cardiac death (1.7%), 1 non‐ST‐elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in‐stent thrombosis. Overall TLR was 8.3% (clinically driven TLR – 1.7%, angiographically driven – 6.6%). Mean late lumen loss was as follows: In main vessel – 0.35 ± 0.33 mm, in main branch – 0.34 ± 0.27 mm and in side branch – 0.18 ± 0.38 mm.

Conclusion

Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long‐term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis. (J Interven Cardiol 2015;28:51–60)

     

Short‐Term Outcomes of Patent Ductus Arteriosus Closure With New Occlutech® Duct Occluder: A Multicenter Study

Aim

Over the past 2 decades, transcatheter occlusion of patent ductus arteriosus (PDA) with coils and the duct occluders evolved to be the procedure of choice. A new device, the Occlutech PDA® occluder (ODO) device has been designed. Herein, we aimed to evaluate the characteristics and short‐term results of patients who underwent transcatheter closure of PDA using the ODO.

Methods

We reviewed the clinical records of 60 patients from different centers in Turkey between December 2013 and January 2016. The medical records were reviewed for demographic characteristics and echocardiographic findings. Device size was selected on the narrowest diameter of PDA.

Results

The median patient age was 2.5 years (6 months–35 years), and median PDA diameter was 2.5 mm (1.2–11 mm). Fifty‐eight of 60 patients (96.6%) had successful ODO implantation. The occlusion rates were 37/58 (63.7%) at the end of the procedure, 51/58 (87.9%) at 24–48 hours post‐procedure, and 57/58 (98.2%) on echocardiography at a median follow‐up of 7.6 months.

Conclusion

Our results indicate that transcatheter closure of PDA using the ODO is effective. Larger studies and longer follow‐up are required to assess whether its shape and longer length make it superior to other duct occluders in large, tubular, or window‐type ducts. (J Interven Cardiol 2016;29:325–331)

     

Comprehensive First‐Line Magnetic Resonance Imaging in Hypertension: Experience From a Single‐Center Tertiary Referral Clinic

European guidelines recommend that patients with hypertension be assessed for asymptomatic organ damage and secondary causes. The authors propose that a single magnetic resonance imaging (MRI) scan can provide comprehensive first‐line imaging of patients assessed via a specialist hypertension clinic. A total of 200 patients (56% male, aged 51±15 years, office BP 168±30/96±16 mm Hg) underwent MRI of the heart, kidneys, renal arteries, adrenals and aorta. Comparisons were made with other imaging modalities where available. A total of 61% had left ventricular hypertrophy (LVH), 14% had reduced ejection fraction, and 15 patients had myocardial infarcts. Echocardiography overdiagnosed LVH in 15% of patients and missed LVH in 14%. Secondary causes were identified in 14.5% of patients: 12 adrenal masses, 10 renal artery stenoses, seven thyroid abnormalities, one aortic coarctation, one enlarged pituitary gland, one polycystic kidney disease, and one renal coloboma syndrome. This comprehensive MRI protocol is an effective method of screening for asymptomatic organ damage and secondary causes of hypertension.     

The PREHAMI (PREsillion™ in high‐risk acute myocardial infarction) registry

Objectives : To evaluate the efficacy of the new Cobalt–Chromium (Co‐Cr) Presillion? stent for the treatment of high‐risk acute myocardial infarction (MI) patients. Background : Percutaneous coronary intervention (PCI) with stent represents the gold standard treatment for acute MI. Methods and Results : We enrolled patients with high‐risk acute MI (either ST‐segment elevation MI or non‐ST‐segment elevation MI) treated with PCI using a new Co‐Cr bare metal stent with closed cells design and limited balloon compliance. We considered high‐risk features as one of the following: age ≥70 years, ejection fraction ≤35%, glomerular filtration rate ≤60 mL/min, diabetes mellitus, rescue PCI, or chronic atrial fibrillation or other conditions requiring long‐term oral anticoagulation therapy. Primary outcome of the study was rate of major adverse cardiac events (MACE) defined as all‐cause death, new MI, and target‐vessel revascularization. A total of 129 consecutive patients were enrolled (69 ± 11 years, 74% men): 71 (55%) patients with ST‐segment elevation MI and 58 (45%) patients with non‐ST‐segment elevation MI. A total of 153 vessels (169 lesions and 179 stents) were treated. The device success rate was high (98.8%). In‐hospital MACE rate was 5.4% mainly because of death associated with the acute MI. At 1‐year follow‐up, the MACE rate was 17.3%, with 11% all‐cause death (7.9% of cardiac origin), 0.6% of stent thrombosis, and 4.6% target‐vessel revascularization. Conclusions : The use of the Co‐Cr Presillion stent in patients with high‐risk acute MI treated invasively seems to be safe and efficacious with optimal deliverability and good long‐term outcomes and represents a good option in the treatment of these patients. © 2011 Wiley‐Liss, Inc.     

The paclitaxel‐eluting coroflex™ please stent study (PECOPS I): The 3‐year clinical follow‐up

Background : The evaluation of drug‐eluting devices in humans should include longterm follow‐up owing to risk of late target vessel thrombosis with the possible fatal sequel. Methods and Results : Therefore, the three‐year clinical outcome of the paclitaxeleluting Corofiex^® Please stent in patients with de‐novo coronary lesions was evaluated in the single‐arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 ± 0.12 years following stent deployment. In the intention‐to‐treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in‐segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 ± 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (?3.0 ± 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3‐year MACE rate was 22/123 (17.9%). Conclusion : The present study describes the paclitaxel‐eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low. © 2009 Wiley‐Liss, Inc.