Aspiration thrombectomy using a novel 088 catheter and specialized delivery catheter

BackgroundWe describe the first-in-human experience using the Route 92 Medical Aspiration System to perform thrombectomy in the initial 45 consecutive stroke patients enrolled in the SUMMIT NZ trial. This aspiration system includes a specifically designed delivery catheter which enables delivery of 0.070 inch and 0.088 inch aspiration catheters.MethodsThe SUMMIT NZ trial is a prospective, multicenter, single-arm study with core lab imaging adjudication. Patients presenting with acute ischemic stroke from large vessel occlusion are eligible to enrol. The study has had three phases which transitioned from use of the 0.070 inch to the 0.088 inch catheter.ResultsVessel occlusions were located in the internal carotid artery (27%), M1 (60%) and M2 (13%). Median baseline National Institutes of Health Stroke Scale (NIHSS) was 16 (IQR 10). Across the three phases, the first-pass reperfusion rate of modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b was 62% using the Route 92 Medical system; this rate was 29% in phase 1, 56% in phase 2, and 80% in phase 3. The first-pass reperfusion rate of mTICI ≥2c was 42% overall, 29% in phase 1, 33% in phase 2%, and 55% in phase 3. A final reperfusion rate of mTICI ≥2b was achieved in 96% of cases, with 36% of cases using adjunctive devices. Patients had an average improvement of 6.7 points in NIHSS from baseline at 24 hours, and at 90 days 48% were functionally independent (modified Rankin Scale 0–2).ConclusionsIn this early experience, the Route 92 Medical Aspiration System has been effective and safe. The system has design features that improve catheter deliverability and have the potential to increase first-pass reperfusion rates in aspiration thrombectomy.

Insufficient procedural anticoagulation during leadless pacing led to catheter-related thrombosis in a hemodialysis patient

Background Leadless pacemaker was a promising innovation than traditional transvenous pacemaker, the procedural complications were prone to be bleeding-related. However, very few reports also concerned about the thrombus formation during the procedure. Case presentation A hemodialysis patient with diabetic gangrene of right foot suffered from catheter-related thrombosis during leadless pacing, resulting in failure of recapture the pacemaker. A low activated clotting time (ACT) level of 104 s confirmed the insufficiency of anticoagulation. Finally, the whole delivery catheter had to be removed from the delivery sheath, another new pacemaker system was applied and successfully implanted after adjusting the ACT level to 248 s. Conclusion Catheter-related thrombosis could be a large obstacle for leadless pacemaker implantation. In addition to routine anticoagulation, ACT monitoring might be necessary during the procedure.

Pericardial effusion caused by accidently placing a Micra transcatheter pacing system into the coronary sinus

Background Leadless pacemaker has been acknowledged as a promising pacing strategy to prevent pocket and lead-related complications. Although rare, cardiac perforation remains a major safety concern for implantation of Micra transcatheter pacing system (TPS). Case presentation A 83-year-old female with low body mass index (18.9 kg m−2) on dual anti-platelet therapy, was indicated for Micra TPS implantation due to sinus arrest and paroxysmal atrial flutter. The patient developed mild pericardial effusion during the procedure since the delivery catheter was accidentally placed into the coronary sinus for several times. Cardiac perforation with moderate pericardial effusion and pericardial tamponade was detected 2 h post-procedure. The patient was treated with immediately pericardiocentesis and recovered without further invasive therapy. Conclusion Pericardial effusion caused by accidently placing a delivery catheter into the coronary sinus is rare but should be carefully considered in Micra TPS implantation, especially for those with periprocedural anti-platelet therapy.

Comparison of delivery catheter-based and stylet-based right ventricular lead placement at the right ventricular septum under fluoroscopic guidance judged by cardiac CT (Mt. FUJI): a study protocol for the Mt. FUJI randomised controlled trial

IntroductionPacing-induced cardiomyopathy occasionally occurs in patients undergoing pacemaker implantation. Although compared with right ventricular (RV) apical pacing, RV septal pacing can attenuate left ventricular dyssynchrony; the success rate of lead placement on the RV septum using the stylet system is low. Additionally, no randomised controlled trial has addressed the issue regarding the accuracy of RV lead placement on the RV septum using the stylet and delivery catheter systems. This study hypothesises that a newly available delivery catheter system can improve the accuracy of RV lead placement on the RV septum.Methods and analysisIn a multicentre, prospective, randomised, single-blind, controlled trial, 70 patients with pacemaker indication owing to atrioventricular block will be randomised to either the delivery catheter or stylet group before the pacemaker implantation procedure. The position of the RV lead tip will be assessed using ECG-gated cardiac CT in all patients within 4 weeks after pacemaker implantation. Lead tip positions are classified into three groups: (1) RV septum, (2) anterior/posterior edge of the RV septal wall and (3) RV free wall. The primary endpoint will be the success rate of RV lead tip placement on the RV septum, which will be evaluated using cardiac CT.Ethics and disseminationThis study will be conducted according to the stipulations of the Helsinki Declaration and the institutional review board of Hamamatsu University School of Medicine. The results of the study will be disseminated at several research conferences and will be published in peer-reviewed journals.Trial registration numberjRCTs042200014; Pre-results.

Rendezvous endovascular common carotid artery stenting (RECCAS) technique for symptomatic steno-occlusive disease

This report describes a patient who presented with acute but transient right arm weakness and altered sensation secondary to severe stenosis of the left common carotid artery (CCA) origin. Endovascular stenting of the stenosed origin was achieved utilising a novel rendezvous technique through combined retrograde common carotid artery and anterograde transfemoral approaches. This technique has numerous potential advantages over traditional transfemoral endovascular and open retrograde common carotid artery approaches. It allows increased procedural control and success in traversing the stenosis and provides a smooth transition for the stent delivery catheter. An open cutdown procedure or open surgical technique is not required. Our patient recovered well from the procedure with no complications within the three-month follow up period.

Use of Mullins sheath to prevent prolapse of Gore Cardioform ASD Occluder in a child with severe scoliosis

Transcatheter device closure of an atrial septal defect (ASD) may require an additional supportive technique in challenging cases. We report a 15-year-old male with moderate-sized ASD and severe scoliosis. In spite of adequate positioning of the Gore Cardioform ASD occluder, the device was pulled into the right atrium by a retrieval cord due to the acute release of strong tension between the delivery catheter and its device upon locking. This phenomenon was prevented by the use of Mullins sheath, resulting in a successful release of the device. The use of a Mullins sheath may be considered to deliver a Gore Cardioform ASD device in selected cases.