Endovascular treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery using the sinus-SuperFlex-635 stent: twelve-month results from the HERO Registry.

BACKGROUND: The aim of this study was to evaluate the safety and performance of the sinus-SuperFlex-635 self-expandable nitinol stent (Optimed GmbH) for the treatment of steno-occlusive lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). METHODS: The prospective, multicenter, observational HERO study recruited 117 eligible patients (83 men; mean age 69.4±9.7y) from 7 centers in Belgium. RESULTS: A total of 129 stents were successfully deployed in 121 lesions in 117 patients (100%). The patients presented with symptomatic ≥50% stenosis or chronic total occlusion (CTO) (30.6%). Mean lesion length was 71.4±56.3 mm. Moderate to severe calcification was present in 82.6% of the lesions. Acute lesion success (<30% residual stenosis) was achieved in 96.0%. There were no in-hospital serious adverse events. Duplex ultrasound-driven primary patency at 12 months was recorded in 84 of 107 (78.5%) lesions. The overall target lesion revascularization (TLR) rate was 8.4% at 12 months; the target extremity revascularization (TER) rate was 4.7%. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford class, without the need for TLR (i.e. primary sustained clinical improvement) in 83.9% of patients and with the need for TLR in 90.6% of patients (i.e. secondary sustained clinical improvement). CONCLUSIONS: Based on the high primary patency, low stent fracture rate and significant clinical improvement, combined with refined stent design and long stent availability, the sinus-SuperFlex-635 self-expandable nitinol stent proves its value in the treatment of complex femoropopliteal lesions.

Endovascular repair of an extracranial carotid artery aneurysm complicated by late stent thrombosis.

Extracranial carotid artery aneurysms (ECAA) are extremely rare, accounting for less than 1% of all peripheral artery aneurysms. The most common presentation is central neurologic dysfunction, typically due to embolization of thrombus from the aneurysm. Historically open surgical intervention is the treatment of choice for symptomatic ECAA. Recent data suggest that endovascular repair is a valuable alternative, with a high procedural success rate and relatively low complication rate. We present a case of an ECAA with symptoms of vision loss, successfully treated by endovascular covered stenting but complicated by late in stent thrombosis and cerebral infarction. The patient was subsequently treated with IV thrombolysis and life-long warfarin. The patient had discrete residual symptoms at follow-up 3 months later.

Initial experience with a novel hybrid vascular graft for peripheral artery disease.

This report describes the successful use of a new hybrid vascular graft as a conduit for above knee femoro-popliteal bypass surgery. The graft consists of a proximal (heparin coated) expanded polytetrafluoroethylene section but ends distally as a nitinol reinforced self-expandable stent that is covered and constrained, allowing a sutureless distal anastamosis. With this graft the creation of above knee bypasses in situations where lesions extend to the popliteal artery behind the knee, or in cases where the above knee popliteal artery is severely calcified is still possible. This avoids the necessity of an infragenicular bypass with potentially inferior long-term patency rates, especially when no autologous venous bypass material is available.

The use of video motion analysis to determine the impact of anatomic complexity on endovascular performance in carotid artery stenting.

OBJECTIVE: Video motion analysis (VMA) uses fluoroscopic sequences to derive information on catheter and guidewire movement and is able to calculate two-dimensional catheter tip path length (PL) on the basis of frame-by-frame pixel coordinates. The objective of this study was to evaluate the effect of anatomic complexity on the efficiency of completion of defined stages of simulated carotid artery stenting as measured by VMA. METHODS: Twenty interventionists each performed a standardized easy, medium, and difficult carotid artery stenting case in random order on an ANGIO Mentor (Simbionix, Airport City, Israel) simulator. Videos of all procedures were analyzed using VMA software, and performance was expressed in terms of two-dimensional guidewire tip trajectory distance (PL). Comparisons of PL were used to identify differences in cannulation performance of the participants between the three cases of varying difficulty. The procedure was subdivided into four procedural phases: arch navigation, common carotid artery (CCA) cannulation, external carotid manipulation, and carotid lesion crossing. Comparisons of PL were used to identify differences in performance between the three cases of varying difficulty for each of the procedural phases. RESULTS: There were significant differences in PL in relation to anatomic complexity, with a stepwise increase in PL from easy to difficult cases: easy, median of 5000 pixels (interquartile range, 4075-5403 pixels); intermediate, 9059 (5974-14,553) pixels; difficult, 17,373 (11,495-26,594) pixels (P < .001). Similarly, during CCA cannulation, there was a stepwise increase in PL from easy to difficult cases: easy, 749 (603-1403) pixels; intermediate, 3274 (1544-8142) pixels; difficult, 8845 (5954-15,768) pixels (P < .001). There were no observed differences across the groups of anatomic difficulty for the phases of arch navigation, external carotid manipulation, and carotid lesion crossing. CONCLUSIONS: Increasing anatomic complexity leads to significant increases in PL of endovascular tools, in particular during CCA cannulation. This increase in tool movement may have a bearing on clinical outcome.

Carotid Artery Stenting - Strategies to Improve Procedural Performance and Reduce the Learning Curve.

Carotid artery stenting (CAS) remains an appealing intervention to reduce the stroke risk because of its minimal invasive nature. Nevertheless, landmark randomised controlled trials have not been able to resolve the controversies surrounding this complex procedure as the peri-operative stroke risk in a non-selected patient population still seems to be higher after CAS in comparison to carotid endarterectomy. What is more, these trials have highlighted that patient outcome after CAS is influenced by patient- and operator-dependant factors. The CAS procedure exhibits a definitive learning curve resulting in higher complication rates if the procedure is performed by inexperienced interventionists or in low-volume centres. This article will outline strategies to improve the performance of physicians carrying out the CAS procedure by means of proficiency-based training, credentialing, virtual reality rehearsal and optimal patient selection.

Improving results for carotid artery stenting by validation of the anatomic scoring system for carotid artery stenting with patient-specific simulated rehearsal.

OBJECTIVE: Carotid artery stenting (CAS) is a technically demanding procedure with a risk of periprocedural stroke. A scoring system based on anatomic criteria has been developed to facilitate patient selection for CAS. Advancements in simulation science also enable case evaluation through patient-specific virtual reality (VR) rehearsal on an endovascular simulator. This study aimed to validate the anatomic scoring system for CAS using the patient-specific VR technology. METHODS: Three patients were selected and graded according to the CAS scoring system (maximum score, 9): one easy (score, <4.9), one intermediate (score, 5.0-5.9), and one difficult (score, >7.0). The three cases were performed on the simulator in random order by 20 novice interventionalists pretrained in CAS. Technical performances were assessed using simulator-based metrics and expert-based ratings. RESULTS: The interventionalists took significantly longer to perform the difficult CAS case (median, 31.6 vs 19.7 vs 14.6 minutes; P<.0001) compared with the intermediate and easy cases; similarly, more fluoroscopy time (20.7 vs 12.1 vs 8.2 minutes; P<.0001), contrast volume (56.5 vs 51.5 vs 50.0 mL; P=.0060), and roadmaps (10 vs 9 vs 9; P=.0040) were used. The quality of performance declined significantly as the cases became more challenging (score, 24 vs 22 vs 19; P<.0001). CONCLUSIONS: The anatomic scoring system for CAS can predict the difficulty of a CAS procedure as measured by patient-specific VR. This scoring system, with or without the additional use of patient-specific VR, can guide novice interventionalists in selecting appropriate patients for CAS. This may reduce the perioperative stroke risk and enhance patient safety.

Simulated procedure rehearsal is more effective than a preoperative generic warm-up for endovascular procedures.

INTRODUCTION: Patient-specific simulated rehearsal (PsR) of a carotid artery stenting procedure (CAS) enables the interventionalist to rehearse the case before performing the procedure on the actual patient by incorporating patient-specific computed tomographic data into the simulation software. This study aimed to evaluate whether PsR of a CAS procedure can enhance the operative performance versus a virtual reality (VR) generic CAS warm-up procedure or no preparation at all. METHODS: During a 10-session cognitive/technical VR course, medical residents were trained in CAS. Thereafter, in a randomized crossover study, each participant performed a patient-specific CAS case 3 times on the simulator, preceded by 3 different tasks: a PsR, a generic case, or no preparation. Technical performances were assessed using simulator-based metrics and expert-based ratings. RESULTS: Twenty medical residents (surgery, cardiology, radiology) were recruited. Training plateaus were observed after 10 sessions for all participants. Performances were significantly better after PsR than after a generic warm-up or no warm-up for total procedure time (16.3 ± 0.6 vs 19.7 ± 1.0 vs 20.9 ± 1.1 minutes, P = 0.001) and fluoroscopy time (9.3 ± 0.1 vs 11.2 ± 0.6 vs 11.2 ± 0.5 minutes, P = 0.022) but did not influence contrast volume or number of roadmaps used during the "real" case. PsR significantly improved the quality of performance as measured by the expert-based ratings (scores 28 vs 25 vs 25, P = 0.020). CONCLUSIONS: Patient-specific simulated rehearsal of a CAS procedure significantly improves operative performance, compared to a generic VR warm-up or no warm-up. This technology requires further investigation with respect to improved outcomes on patients in the clinical setting.

Recent advancements in medical simulation: patient-specific virtual reality simulation.

BACKGROUND: Patient-specific virtual reality simulation (PSVR) is a new technological advancement that allows practice of upcoming real operations and complements the established role of VR simulation as a generic training tool. This review describes current developments in PSVR and draws parallels with other high-stake industries, such as aviation, military, and sports. METHODS: A review of the literature was performed using PubMed and Internet search engines to retrieve data relevant to PSVR in medicine. All reports pertaining to PSVR were included. Reports on simulators that did not incorporate a haptic interface device were excluded from the review. RESULTS: Fifteen reports described 12 simulators that enabled PSVR. Medical procedures in the field of laparoscopy, vascular surgery, orthopedics, neurosurgery, and plastic surgery were included. In all cases, source data was two-dimensional CT or MRI data. Face validity was most commonly reported. Only one (vascular) simulator had undergone face, content, and construct validity. Of the 12 simulators, 1 is commercialized and 11 are prototypes. Five simulators have been used in conjunction with real patient procedures. CONCLUSIONS: PSVR is a promising technological advance within medicine. The majority of simulators are still in the prototype phase. As further developments unfold, the validity of PSVR will have to be examined much like generic VR simulation for training purposes. Nonetheless, similar to the aviation, military, and sport industries, operative performance and patient safety may be enhanced by the application of this novel technology.

Patient-specific simulation in carotid artery stenting.

AIMS: Patient-specific virtual reality (VR) simulation is a technologic advancement that allows planning and practice of the carotid artery stenting (CAS) procedure before it is performed on the patient. The initial findings are reported, using this novel VR technique as a tool to optimize technical and nontechnical aspects of this complex endovascular procedure. METHODS: In the angiography suite, the same interventional team performed the VR rehearsal and the actual CAS on the patient. All proceedings were recorded to allow for video analysis of team, technical, and nontechnical skills. RESULTS: Analysis of both procedures showed identical use of endovascular tools, similar access strategy, and a high degree of similarity between the angiography images. The total procedure time (24.04 vs 60.44 minutes), fluoroscopy time (11.19 vs 21.04 minutes), and cannulation of the common carotid artery (1.35 vs 9.34) took considerably longer in reality. An extensive questionnaire revealed that all team members found that the rehearsal increased the subjective sense of teamwork (4/5), communication (4/5), and patient safety (4/5). CONCLUSION: A VR procedure rehearsal is a practical and feasible preparatory tool for CAS and shows a high correlation with the real procedure. It has the potential to enhance the technical, nontechnical, and team performance. Further research is needed to evaluate if this technology can lead to improved outcomes for patients.

Symptomatic atraumatic dissection of a left internal mammary artery graft five years after coronary artery bypass graft surgery.

The case of a spontaneous dissection of a left internal mammary artery grafted on to the diagonal branch and the left anterior descending artery is reported. The clinical and diagnostic features of this condition are discussed. Despite an extensive literature search, no such case was found. The present case is the first to be reported. It was speculated that extensive kinking of the left internal mammary artery contributed to the pathogenesis of this syndrome.

Thrombosis of a patent foramen ovale closure device: thrombolytic management.

Transcatheter closure of a patent foramen ovale (PFO) offers a valuable alternative to surgery in selected patients with presumed paradoxical embolism. Like for all other devices, several complications have been described. Although the majority of these complications are caused by technical problems of the device itself, thrombosis is a relatively infrequent but feared finding, as it may result in recurrent embolic events and persistent neurological deficits. The majority of the complications after implantation are dealt with by surgical removal of the device and subsequent surgical closure of the PFO. The present case report describes biatrial thrombosis of a PFO device that was successfully treated with thrombolytics and GP IIb/IIIa receptor blockers. In stable patients, this pharmaco-therapeutic approach should be attempted to save the thrombosed PFO device and could therefore offer a valuable alternative to surgical removal of the device.

Intoxication with taxus baccata: cardiac arrhythmias following yew leaves ingestion.

The use of yew leaves (Taxus Baccata) as a means of deliberate self-harm is infrequent. The potent effect of the toxin is primarily cardiac and results in rhythm alterations and ultimately ventricular fibrillation. As there is no known antidote, and classic antiarrhythmic therapy proves to be ineffective, a prompt diagnosis is of great importance as immediate supportive action is the only valuable alternative. This case describes a 43-year-old women who attempted suicide by ingesting the leaves of Taxus Baccata. We discuss the effects and the difficulty of treatment associated with yew leaf poisoning.