Comparative ergonomic workflow and user experience analysis of MRI versus fluoroscopy-guided vascular interventions:an iliac angioplasty exemplar case study

Purpose A methodological framework is introduced to assess and compare a conventional fluoroscopy protocol for peripheral angioplasty with a new magnetic resonant imaging (MRI)-guided protocol. Different scenarios were considered during interventions on a perfused arterial phantom with regard to time-based and cognitive task analysis, user experience and ergonomics. Methods Three clinicians with different expertise performed a total of 43 simulated common iliac angioplasties (9 fluoroscopic, 34 MRI-guided) in two blocks of sessions. Six different configurations for MRI guidance were tested in the first block. Four of them were evaluated in the second block and compared to the fluoroscopy protocol. Relevant stages’ durations were collected, and interventions were audio-visually recorded from different perspectives. A cued retrospective protocol analysis (CRPA) was undertaken, including personal interviews. In addition, ergonomic constraints in the MRI suite were evaluated. Results Significant differences were found when comparing the performance between MRI configurations versus fluoroscopy. Two configurations [with times of 8.56 (0.64) and 9.48 (1.13) min] led to reduce procedure time for MRI guidance, comparable to fluoroscopy [8.49 (0.75) min]. The CRPA pointed out the main influential factors for clinical procedure performance. The ergonomic analysis quantified musculoskeletal risks for interventional radiologists when utilising MRI. Several alternatives were suggested to prevent potential low-back injuries. Conclusions This work presents a step towards the implementation of efficient operational protocols for MRI-guided procedures based on an integral and multidisciplinary framework, applicable to the assessment of current vascular protocols. The use of first-user perspective raises the possibility of establishing new forms of clinical training and education

Randomized trial of Legflow® paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): Study protocol for a randomized controlled trial

Background: Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow® paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.Methods/Design: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera® stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.Discussion: The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.Trial registration: ISRCTN47846578

Angioplasty, Various Techniques and Challenges in Treatment of Congenital and Acquired Vascular Stenoses

The field of performing transcatheter interventions to treat vascular lesions has exploded over the past 20 years. Not only has the technology changed, especially in the arena of balloon/stent devices, but the techniques of approaching complex lesions has evolved over the past decade. Lesions that no one would have imagined treating back in the 1990's are now being done routinely in the catheterization suite. This book provides an update on the current techniques and devices used to treat a wide variety of lesions. Though, at first, the outward appearance of the topics appears to be varied, they are all related by the common thread of treating vascular lesions. We hope, by publishing this book, to accomplish two things: First, to offer insight from experts in their field to treat, both medically and procedurally, complex vascular lesions that we frequently encounter. Secondly, we hope to promote increased communication between areas of medicine that frequently don't communicate, between adult interventional cardiologists, pediatric interventional cardiologists, interventional radiologists, and neurosurgeons. Much can be learned from our respective colleagues in these areas which can further our own world of interventions

S-Nitrosoglutathione reduces asymptomatic embolization after carotid angioplasty

Background: The major complication of carotid angioplasty is embolic stroke, which may occur after balloon inflation and deflation or in the early postintervention period. Platelet adhesion and aggregation to the angioplasty site with subsequent embolization seems to plays a major role in early postangioplasty embolization and stroke. During this period, asymptomatic embolic signals can be detected in patients by transcranial Doppler ultrasound despite aspirin and heparin treatment. S-Nitrosoglutathione (GSNO) is a nitric oxide donor that appears to have relative platelet specificity. We evaluated its effectiveness in reducing embolization after carotid angioplasty. Methods and results: Sixteen patients undergoing carotid angioplasty and stenting for symptomatic 70% internal carotid artery stenosis were randomized in a double-blind manner to GSNO or placebo given after surgery for 90 minutes. All patients were pretreated with aspirin and given heparin for 24 hours after the procedure. Transcranial Doppler recordings were made from the ipsilateral middle cerebral artery for 1 hour before treatment and at 0 to 3, 6, and 24 hours after treatment. GSNO resulted in a rapid reduction in the frequency of embolic signals of 95% at 0 to 3 hours and 100% at 6 hours (P=0.007 and P=0.01 versus placebo, respectively). In the placebo group, 2 patients experienced ipsilateral stroke after the angioplasty. No cerebrovascular events occurred in the GSNO group. Conclusions: S-Nitrosoglutathione was highly effective in rapidly reducing the frequency of embolic signals after endovascular treatment for symptomatic high-grade carotid stenosis

Carotid Artery Stenting: A Single Center “Real World” Experience

BACKGROUND:Percutaneous carotid artery stenting (CAS) became a widely used procedure in patients with symptomatic and asymptomatic carotid artery stenosis. However its role compared to carotid endarterectomy (CAD) remains questioned. We analysed the safety of carotid artery stenting program of a prospective CAS register program of a tertiary teaching hospital. METHOD:Between July 2003 and December 2010, 208 patients underwent CAS procedure. Baseline, procedural and follow-up data were prospectively collected. Primary peri-interventional outcome was defined as 30-day major adverse events (MAE), including death, stroke or myocardial infarction, and mid- to long-term follow-up outcome included ipsilateral stroke, myocardial infarction or death. Secondary outcome was restenosis rate ≥ 50% per lesion. RESULTS:Unilateral carotid artery interventions were performed in 186 patients. In 22 patients CAS was performed bilaterally as stages procedures. The 30-day MAE rate was 1.9% consisting of two contralateral strokes and two ipsilateral stroke. Mean clinically follow-up was 22 months. Mid- to long-term MAE was 8.1% with 6.3% (n = 13) deaths, 1.9% (n = 4) myocardial infarctions and 0.9% (n = 2) ipsilateral stroke. The restenosis rate ≥ 50% per lesion was 4.3% at a mean follow-up of 22 months. Target lesion revascularization was performed in one patient, because of restenosis at 9 months follow-up after first CAS. CONCLUSION:Implementation of a carotid artery stenting program at a tertiary, teaching hospital is a safe method for treatment of carotid artery stenosis. The adverse event rate during mid-to-long-term follow-up suggests an appropriate patient selection

Assessment of Coronary Flow Reserve During Angioplasty Using A Doppler Tip Balloon Catheter. Comparison With Digital Subtraction Cineangiography

Intracoronary blood flow velocity measurements with a Doppler probe and the radiographic assessment of myocardial perfusion with contrast media previously have been used to investigate regional coronary flow reserve. In the present study we applied both techniques in the same patients to measure the immediate improvement in coronary flow reserve as a result of angioplasty. In addition we compared papaverine induced hyperemia with reactive hyperemia following transient transluminal occlusion of a major coronary artery. In 13 consecutive patients with a single proximal stenosis, coronary flow reserve was measured pre‐ and postangioplasty by digital subtraction cineangiography, while pre‐ and postangioplasty Doppler measurements before and after papaverine were obtained in the proximal part of the stenotic vessel. After the last transluminal occlusion, reactive hyperemia recorded with the Doppler probe was also compared to the coronary flow reserve measurement obtained during papaverine induced hyperemia. As a result of the angioplasty, coronary flow reserve measured with the radiographic technique (mean ± SD) increased from 1.1 ± 0.4 to 2.2 ± 0.4 (P < 0.001), while coronary flow reserve measured with the Doppler probe (mean ± SD) increased from 1.2 ± 0.3 to 2.4 ± 0.4 (P < 0.001). Pharmacologically induced hyperemia measured with the radiographic technique and the Doppler probe were linearly related (r = 0.91 with a SEE 0.3) and confirmed the reliability of the intracoronary measurements. Using these two independent techniques, coronary flow reserve immediately after angioplasty was found to be substantially improved but still abnormal. In addition, the magnitude of hyperemia induced by papaverine was comparable to the reactive hyperemia following transluminal occlusion, although the latter measurement was recorded with the angioplasty catheter still across the dilated lesion. (J Interven Cardiol, 1988:1:1) Copyrigh

Drug Coated Balloon (DCB) angioplasty; DCB Norwich Registry (2009-2015) and a Propensity Score Matched Comparison between DCB and Second Generation Drug Eluting Stents.

Background Drug coated balloons are semi compliant balloons coated with a chemotherapeutic drug to reduce neo intimal hyperplasia thus reducing the risk of re-stenosis. The lack of any permanent metal/polymer in the coronary artery may reduce future risk of adverse clinical events. Objectives The main objective of the DCB NORWICH observational registry was to assess the efficacy and safety of drug coated balloon angioplasty in a real world setting. The propensity matched analysis compared clinical outcomes between DCB-only angioplasty and second generation drug eluting stents (DES). Methods All patients who received DCB angioplasty in the Norfolk and Norwich University Hospitals NHS Foundation Trust from 01/01/2009 to 31/12/2015 were included retrospectively in the DCB NORWICH registry study. In the propensity score matched study, DCB-only PCI in de novo vessels were compared to second generation DES. Clinical outcomes were obtained from the National Institute for Cardiovascular Outcomes Research and NHS Digital. Results A total of 1394 lesions in 1122 patients were treated with DCBs. There were 1026 lesions in 812 patients in the de novo group. The mean age was 65.8. 60.1% presented with MI or acute coronary syndrome. 12 month all cause death was 3.6%, MI 3.1% and target lesion revascularisation (TLR) 2.1%. MACE (death, MI, TLR) was 8.1%. No definite treated segment thrombosis was noted up to 12 months. The propensity score matched study had 904 DCB and 1424 DES treated de novo lesions. Results showed no difference in clinical outcomes between PCI with DCB-only strategy vs. 2nd generation DES. The MACE rate for the DCB arm met the pre specified non-inferiority margin of 4.5%. Conclusions DCB-only PCI is safe and feasible in a wide range of patients and showed no difference in clinical outcomes compared to second generation DES up to 12 month

Coronary stenting : a quantitative angiographic and clinical evaluation

Following implantation of the first coronary stent in 1986 by Jacques Puel in Toulouse, coronary stenting has, from a sequence of pioneering registries in the late 1980's to an era of randomized trials in the 1990's, come to adopt a prominent role in today's practice of interventional cardiology. In its conventional naked metallic form, coronary stenting represents a mechanical approach to a biological problem. When appropriately deployed, the coronary stent can tack back dissections and restore normal flow in vessels with threatened or acute closure and provides a means to optimize elective angioplasty of primary and recurrent stenoses in both native coronary arteries and aorto