World Federation for Interventional Stroke Treatment (WIST) multispecialty training guidelines for endovascular stroke intervention.

Introduction: Today, endovascular treatment (EVT) is the therapy of choice for strokes due to acute large vessel occlusion, irrespective of prior thrombolysis. This necessitates fast, coordinated multi-specialty collaboration. Currently, in most countries, the number of physicians and centres with expertise in EVT is limited. Thus, only a small proportion of eligible patients receive this potentially life-saving therapy, often after significant delays. Hence, there is an unmet need to train a sufficient number of physicians and centres in acute stroke intervention in order to allow widespread and timely access to EVT. Aim: To provide multi-specialty training guidelines for competency, accreditation and certification of centres and physicians in EVT for acute large vessel occlusion strokes. Material and methods: The World Federation for Interventional Stroke Treatment (WIST) consists of experts in the field of endovascular stroke treatment. This interdisciplinary working group developed competency - rather than time-based - guidelines for operator training, taking into consideration trainees' previous skillsets and experience. Existing training concepts from mostly single specialty organizations were analysed and incorporated. Results: The WIST establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in EVT. WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. Conclusions: WIST multispecialty guidelines outline competency and quality standards for physicians and centres to perform safe and effective EVT. The role of quality control and quality assurance is highlighted.

World Federation for Interventional Stroke Treatment (WIST) Multispecialty Training Guidelines for Endovascular Stroke Intervention.

INTRODUCTION: Today, endovascular treatment (EVT) is the therapy of choice for strokes due to acute large vessel occlusion, irrespective of prior thrombolysis. This necessitates fast, coordinated multi-specialty collaboration. Currently, in most countries, the number of physicians and centres with expertise in EVT is limited. Thus, only a small proportion of eligible patients receive this potentially life-saving therapy, often after significant delays. Hence, there is an unmet need to train a sufficient number of physicians and centres in acute stroke intervention in order to allow widespread and timely access to EVT. AIM: To provide multi-specialty training guidelines for competency, accreditation and certification of centres and physicians in EVT for acute large vessel occlusion strokes. MATERIAL AND METHODS: The World Federation for Interventional Stroke Treatment (WIST) consists of experts in the field of endovascular stroke treatment. This interdisciplinary working group developed competency - rather than time-based - guidelines for operator training, taking into consideration trainees' previous skillsets and experience. Existing training concepts from mostly single specialty organizations were analysed and incorporated. RESULTS: The WIST establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in EVT. WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. CONCLUSIONS: WIST multispecialty guidelines outline competency and quality standards for physicians and centres to perform safe and effective EVT. The role of quality control and quality assurance is highlighted. SUMMARY: The World Federation for Interventional Stroke Treatment (WIST) establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in endovascular treatment (EVT). WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. WIST multispecialty guidelines outline competency and quality standards for physicians and centers to perform safe and effective EVT. The role of quality control and quality assurance is highlighted. SIMULTANEOUS PUBLICATION: The WIST 2023 Guidelines are published simultaneously in Europe (Adv Interv Cardiol 2023).

Myocardial mechanics of percutaneous intramyocardial septal radiofrequency ablation.

OBJECTIVE: Echocardiography-guided Percutaneous IntraMyocardial Septal Radiofrequency Ablation (PIMSRA, Liwen procedure) is a novel treatment option for hypertrophic obstructive cardiomyopathy (HOCM). The impact of PIMSRA on myocardial mechanics is unknown. METHODS: Between October 2016 and June 2019, PIMSRA and 3-dimentional speckle tracking echocardiography were performed in 82 patients. Echocardiographic imaging, qualitative and quantitative clinical assessment were completed at baseline, immediately postprocedure and 1-year follow-up. RESULTS: There was a significant reduction in the peak left ventricular outflow tract (LVOT) gradients immediately following PIMSRA and at 1-year follow-up (resting gradients: from 83.50 (61.25) to 23.00 (41.75) mm Hg, p<0.001 and 13.50 (21.75) mm Hg, p<0.001, respectively; stress-induced gradients: from 118.25 (96.02) to 47.00 (74.50) mm Hg (1 year), p<0.001). There was an improvement in exercise time on stress echocardiography (p<0.001) and distance by 6 min walk test (p=0.034). Immediately after PIMSRA, there was a significant reduction in radial and circumferential strain in the ablated segments (p<0.001), with no change of longitudinal strain. At 1-year follow-up, the radial and circumferential strain recovered in the ablated segments. Meanwhile, left ventricular regional and global longitudinal strain had improved significantly (p<0.05). CONCLUSIONS: PIMSRA is an effective treatment for symptomatic HOCM that resulted in a sustained improvement in exercise capacity, a persistent decrease in LVOT gradient, and a measurable increase in myocardial contractile function. TRIAL REGISTRATION NUMBER: NCT04777188.

First-in-man application of Liwen RF™ ablation system in the treatment of drug-resistant hypertrophic obstructive cardiomyopathy.

Objectives: This study sought to evaluate the clinical applicability of the Liwen Liu RF™ ablation system for percutaneous intramyocardial septal radiofrequency ablation (PIMSRA). Background: Data on new cardiac radiofrequency ablation devices for the treatment of hypertrophic obstructive cardiomyopathy (HOCM) are limited. Materials and methods: From July 2019 to July 2020, a total of 68 patients with drug-resistant HOCM, who underwent PIMSRA with the Liwen RF™ ablation system, which has an ablation electrode of stepless adjustable length, were prospectively enrolled. Safety endpoints included, amongst others, the occurrence of pericardial effusion and/or hemorrhage, cardiac arrhythmias, device failure and procedural death. The reduction in left ventricular outflow tract (LVOT) gradients at 12 months follow-up were used as a surrogate marker for device efficacy. Results: All procedures were technically successful. The total energy output time of the system was 75.8 (IQR: 30.0) min, and the average power was 43.61 ± 13.34 watts. No ablation system error occurred. The incidence of pericardial effusion or hemorrhage, transient arrhythmia and resuscitation was 8.8, 39.7, and 1.5% during procedure, respectively. None of the patients died. During 30-day follow-up, there were no complications with the exception of a pericardial effusion in one patient (1.5%). No further complications were reported after 30 days. The patients' resting [baseline: 75 (IQR: 48) vs. 12-months: 12 (IQR: 19) mmHg, p < 0.001] and provoked [baseline: 122 (IQR: 53) vs. 12-months: 41 (IQR: 59) mmHg, p < 0.001] LVOT gradients decreased significantly during follow-up. Conclusion: In this study, we demonstrate the safety and feasibility of the Liwen RF™ ablation system to treat HOCM. The system allows for significant and sustainable LVOT gradient reduction during 12-months of follow-up. Hence, the Liwen RF™ ablation system is a promising new device that has the potential to become an alternative to existing septal reduction concepts in HOCM patients.

Transcatheter Closure of Large Atrial Septal Defects in Adults.

OBJECTIVE: To examine the outcomes of percutaneous closure of large atrial septal defects (ASDs) (≥25 mm). BACKGROUND: Data on long-term results after closure of large ASDs are limited. METHODS: We reviewed the records of 275 consecutive patients who underwent transcatheter closure of large (≥25 mm) ASDs from January 1999 until December 2016 in our center. The most common indication for closure was a large left-to-right shunt. Follow-up (FU) was performed at regular intervals thereafter. Results after closure of ASDs with diameters of 25-30 mm, >30-35 mm and >35 mm were compared. RESULTS: Percutaneous closure was technically successful in 99.6%. Mean FU time was 4.8 years (0-15.5 years). Peri-operative (30-day) adverse events occurred in 20.4% and included death in 0.7% (one unrelated to the procedure and one of unknown cause), device erosion in 0.7%, device embolization in 2.9%, pericardial effusion in 5.5%, air embolism in 0.4%, new onset atrial fibrillation in 10.5%, transient supraventricular tachycardia in 0.4% and fever in 0.7%. Late (>30 days after the procedure) atrial fibrillation occurred in 5.8%. There was one device erosion >15 years after the implantation treated successfully surgically. Complete defect closure was achieved in 95.6%. CONCLUSION: Device closure of large ASDs is feasible, safe and effective with high technical success and low risk of serious periprocedural complications. Nevertheless, in very large defects (>40 mm), both options, surgery and percutaneous closure should be considered. Device or procedural long-term adverse events are rare.

Blood pressure lowering with alcohol-mediated renal denervation using the Peregrine infusion Catheter is independent of injection site location.

OBJECTIVES: The current analysis utilized core laboratory angiographic data from a prospective, single-arm, open-label, multi-center feasibility study to ascertain whether the location of alcohol infusion within main renal arteries during renal denervation (RDN) had an impact on the BP-lowering effect at 6 months. BACKGROUND: The influence of the location of alcohol infusion during RDN, within the main renal artery (proximal, middle, or distal), on the magnitude of the blood pressure (BP) lowering is unstudied. METHODS: The Peregrine Catheter was used to perform alcohol-mediated RDN with an infusion of 0.6 mL of alcohol per artery as the neurolytic agent in 90 main arteries and four accessory arteries of 45 patients with hypertension. RESULTS: No relationship between the site of alcohol infusion and change from baseline in both office systolic and 24-hour systolic ambulatory BP (ABP) at 6 months was observed. When analyzed at the artery level, the least squares (LS) mean changes ± SEM from baseline to 6 months post-procedure in 24-hour systolic ABP when analyzed by renal arterial location were -11.9 ± 2.4 mmHg (distal), -10 ± 1.6 mmHg (middle), and -10.6 ± 1.3 mmHg (proximal) (all p < 0.0001 for change from baseline within groups). The results were similar for office systolic BP. There was no difference between treated locations (proximal is reference). CONCLUSION: In this post-hoc analysis, the location of alcohol infusion within the main renal artery using the Peregrine system, with alcohol as the neurolytic agent for chemical RDN, did not affect the magnitude of BP changes at 6 months.

Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension.

[Figure: see text].

Acute stroke intervention for acute embolic procedural strokes performed by cardiologists.

Acute ischemic stroke is a feared complication during cardiovascular procedures associated with high morbidity and mortality if not immediately recognized and treated. We conducted a review of cases at our center where patients experienced an acute, procedure-related ischemic stroke and underwent immediate endovascular stroke treatment by the interventional cardiologists trained in acute endovascular stroke intervention. Baseline demographics, procedural and follow-up data were collected. Three patients were identified in whom the percutaneous procedure (peripheral arterial intervention, transapical NeoChord [NeoChord Inc, Minnesota, USA] implantation and transcatheter aortic valve implantation, respectively) was complicated by an acute embolic ischemic stroke. In all cases, cerebral vessel re-canalization was technically successful with thrombolysis in cerebral infarction (TICI) IIB/III flow. Follow-up computed tomography scans showed no infarct demarcation, oedema or intracranial hemorrhage. One patient survived with no neurological symptoms at 6-month follow-up whereas the two other patients died of unrelated intensive care complications and decompensated heart failure. We conclude that endovascular stroke treatment during cardiovascular interventions can be performed by interventional cardiologists with appropriate training. It offers the unique opportunity to treat cerebral embolization in a time-efficient manner, potentially improving morbidity and mortality of affected patients.

[Left Atrial Appendage Closure - step by step]. / Vorhofohrverschluss ­ Schritt für Schritt.

Thrombus formation due to atrial fibrillation is the most common cause of embolic stroke. Anticoagulation offers an effective prophylaxis. However, anticoagulation in turn has an inherent increased risk of bleeding. Patients with non-valvular atrial fibrillation who have contraindications for anticoagulation may profit from a closure of the left atrial appendage. The most commonly and best studied devices for this are the WATCHMAN™ and the AMPLATZER Amulet™ Occluders.In this How-To article, the aim is to offer a general overview of the indications, contraindications and complications as well as the implantation and postoperative management of patients receiving LAA closure by example of the WATCHMAN FLX™ Occluder.

Post-Market Clinical Follow-Up With the Patent Foramen Ovale Closure Device IrisFIT (Lifetech) in Patients With Stroke, Transient Ischemic Attack, or Other Thromboembolic Events.

BACKGROUND: A patent foramen ovale (PFO) has been associated with embolic strokes and transient ischemic attacks (TIAs). Catheter closure of PFO is effective in preventing recurrent events. Residual shunts and procedure or device related complications can occur, including atrial fibrillation and thrombus formation. This study examines the initial experience with a new PFO closure device, the IrisFIT PFO-Occluder (Lifetech Scientific, Shenzhen, China). METHODS: 95 patients with indications for PFO closure underwent percutaneous closure with the IrisFIT PFO-Occluder. The primary endpoint was the rate of accurate device placement with no/small residual shunt at 3 or 6 months follow-up. All patients underwent transoesophageal echocardiography (TEE) after 1 to 6 months. In case of a residual shunt, an additional TEE was performed after 12 months. Clinical follow-up was performed up to a mean of 33.1 ± 3.6 months. RESULTS: The device was successfully implanted in 95 (100%) patients with no relevant procedural complications. At final TEE follow-up (7.6 ± 3.9 months) the effective closure rate was 96.8% with 1 moderate and 2 large residual shunts. There were 8 cases of new onset atrial fibrillation and 2 TIAs. There were no cases of device embolization or erosion. CONCLUSION: The IrisFIT occluder is a new PFO closure device with several advantages compared to other devices. In this small study cohort, technical success rate, closure rate and adverse event rate were comparable to other devices. The rate of new onset atrial fibrillation was higher in comparison to other studies and warrants further investigation.

Alcohol-Mediated Renal Sympathetic Neurolysis for the Treatment of Hypertension: The Peregrine™ Infusion Catheter.

Renal sympathetic denervation using conventional non-irrigated radiofrequency catheters has potential technical shortcomings, including limited penetration depth and incomplete circumferential nerve damage, potentially impacting therapeutic efficacy. Against this background, second generation multi-electrode, radiofrequency and ultrasound renal denervation systems have been developed to provide more consistent circumferential nerve ablation. Irrigated catheters may allow deeper penetration while minimizing arterial injury. In this context, catheter-based chemical denervation, with selective infusion of alcohol, a potent neurolytic agent, into the perivascular space, may minimize endothelial, intimal and medial injury while providing circumferential neurolysis. Animal studies demonstrate pronounced renal norepinephrine level reductions and consistent renal nerve injury after perivascular alcohol infusion using the Peregrine Catheter. Early clinical studies demonstrated significant blood pressure reductions and a reasonable safety profile. Randomized sham-controlled trials (NCT03503773, NCT02910414) are underway to examine whether the aforementioned theoretical advantages of alcohol-medicated denervation with the Peregrine System™ Kit translate into clinical benefits.

CT-Overlay Hybrid Imaging to Facilitate Sentinel Cerebral Protection System Deployment in the Presence of an Anomalous Vertebral Artery Originating From the Aortic Arch During Transcatheter Aortic Valve Implantation.

Stroke remains an important risk during transcatheter aortic valve implantation (TAVI). Though the use of the double-filter Sentinel cerebral protection system (Boston Scientific, Marlborough, MA, USA) may lower the stroke risk, the deployment of this device requires manipulation within the aortic arch and cranial arch vessels potentially causing dislodgment of atherosclerotic debris in the process thereby possibly offsetting its benefit with regards to reducing cerebral embolization. Apart from patient selection, minimizing maneuvering during deployment may improve the safety of device deployment. In this context, we illustrate a case using three-dimensional computed tomography (CT) - overlay to facilitate Sentinel cerebral protection system deployment during TAVI. Emphasis in this case rests on demonstration of how aforementioned periprocedural imaging may facilitate negotiation of anatomical variants and avoid inadvertent cannulation of an anomalous left vertebral artery originating from the aortic arch. Imaging guidance with this concept may minimize device manipulation and reduce the risk of cerebral embolization. Further systematic evaluation is needed to demonstrate whether this approach improves clinical outcomes.