A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.

Introduction: Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism. Aim: To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm2) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine. Material and methods: Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers. Results: The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001). Conclusions: This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658).

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).

Left Atrial Appendage Occlusion Strengths and Weaknesses of the Lobe-Only Occluder Concept in Theory and in Practice.

Left atrial appendage closure aims to eliminate the stasis component of Virchow triad by eliminating a cul-de-sac that favors thrombosis, particularly when atrial contractility becomes inefficient, such as in atrial fibrillation. Left atrial appendage closure devices have a common objective of sealing the appendage completely, with device stability and avoidance of device thrombosis. Two main device designs have been used to perform left atrial appendage closure: those that use a pacifier design (lobe + disk) and those that use a plug (single lobe) design. This review highlights the potential features and benefits of the single-lobe devices.

Transvenous Right Greater Splanchnic Nerve Ablation in Heart Failure and Preserved Ejection Fraction: First-in-Human Study.

BACKGROUND: Ablation of the right-sided greater splanchnic nerve (GSN) can reduce excessive splanchnic vasoconstriction, potentially improving the handling of volume shifts in patients with heart failure with preserved ejection fraction (HFpEF). OBJECTIVES: The purpose of this study was to assess a novel catheter procedure of right-sided GSN ablation to treat HFpEF: splanchnic ablation for volume management. METHODS: This trial included 11 HFpEF patients (8 women, age 70 ± 8 years) with New York Heart Association functional class II or III symptoms, ejection fraction ≥50%, and elevated pulmonary capillary wedge pressure at rest or with exercise. After splanchnic ablation for volume management, follow-up at 1, 3, 6, and 12 months included 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and echocardiography. RESULTS: There were no device-related adverse cardiac events or clinical sequelae following right GSN ablation through 12 months. Patients experienced clinical improvements by 1 month that were sustained through 12 months. KCCQ score improved from baseline median 48 (IQR: 35-52) to 65 (IQR: 58-77) at 1 month and 80 (IQR: 77-88) at 12 months (P < 0.05). The 6-minute walk test distance increased from baseline 292 ± 82 m to 341 ± 88 m at 1 month and 359 ± 75 m at 12 months (P < 0.05). The NT-proBNP decreased from a baseline mean of 1,292 ± 1,186 pg/mL to 1,202 ± 797 pg/mL (P = 0.585) at 1 month, to 472 ± 226 pg/mL (P = 0.028) at 6 months, and to 379 ± 165 pg/mL (P = 0.039) at 12 months. CONCLUSIONS: In this open-label, single-arm feasibility study, right-sided GSN ablation was safe and improved mostly subjective clinical metrics in patients with HFpEF over 12 months. (Endovascular GSN Ablation in Subjects With HFpEF; NCT04287946).

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.

Left Atrial Appendage Occlusion Strengths and Weaknesses of the Lobe-Only Occluder Concept in Theory and in Practice.

Left atrial appendage closure aims to eliminate the stasis component of Virchow triad by eliminating a cul-de-sac that favors thrombosis, particularly when atrial contractility becomes inefficient, such as in atrial fibrillation. Left atrial appendage closure devices have a common objective of sealing the appendage completely, with device stability and avoidance of device thrombosis. Two main device designs have been used to perform left atrial appendage closure: those that use a pacifier design (lobe + disk) and those that use a plug (single lobe) design. This review highlights the potential features and benefits of the single-lobe devices.

Endovascular Baroreflex Amplification With the MobiusHD Device in Patients With Heart Failure and Reduced Ejection Fraction: Interim Analysis of the First-in-Human Results.

Background: Endovascular baroreflex amplification with the MobiusHD, a self-expanding stent-like device that is implanted in the internal carotid artery, was designed to reduce the sympathetic overactivity that contributes to progressive heart failure with reduced ejection fraction. Methods: Symptomatic patients (New York Heart Association class III) with heart failure with reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤40%) despite guideline directed medical therapy and n-terminal pro-B type natriuretic peptide (NT-proBNP) levels ≥400 pg/mL in whom carotid ultrasound and computed tomographic angiography demonstrated absence of carotid plaque were enrolled. Baseline and follow-up measures included 6-minute walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ OSS), and repeat biomarkers and transthoracic echocardiography. Results: Twenty-nine patients underwent device implantation. The mean age was 60.6 ± 11.4 years, and all had New York Heart Association class III symptoms. Mean KCCQ OSS was 41.4 ± 12.7, mean 6MWD was 216.0 ± 43.7 m, median NT-proBNP was 1005.9 pg/mL (894, 1294), and mean LVEF was 34.7 ± 2.9%. All device implantations were successful. Two patients died (161 days and 195 days) and one stroke occurred (170 days) during follow-up. For the 17 patients with 12-month follow-up, mean KCCQ OSS improved by 17.4 ± 9.1 points, mean 6MWD increased by 97.6 ± 51.1 meters, a mean 28.4% reduction from the baseline NT-proBNP concentration was found, and mean LVEF improved by 5.6% ± 2.9 (paired data). Conclusion: Endovascular baroreflex amplification with the MobiusHD device was safe and effected positive changes in quality of life, exercise capacity, and LVEF, consistent with observed reductions in NT-proBNP levels.

Safety and feasibility of peri-device leakage closure after LAAO: an international, multicentre collaborative study.

BACKGROUND: Residual peri-device leakage (PDL) is frequent after left atrial appendage occlusion (LAAO). Little is known about management strategies, procedural aspects and outcomes of interventional PDL closure. AIMS: The aim of this study was to assess the safety and feasibility of PDL closure after LAAO. METHODS: Fifteen centres contributed data on baseline characteristics, in-hospital and follow-up outcomes of patients who underwent PDL closure after LAAO. Outcomes of interest included acute success and complication rates and long-term efficacy of the procedure. RESULTS: A total of 95 patients were included and a cumulative number of 104 leaks were closed. The majority of PDLs were detected within 90 days (range 41-231). Detachable coils were the most frequent approach (42.3%), followed by the use of the AMPLATZER Vascular Plug II (29.8%) and the AMPLATZER Duct Occluder II (17.3%). Technical success was 100% with 94.2% of devices placed successfully within the first attempt. There were no major complications requiring surgical or transcatheter interventions. During follow-up (96 days [range 49-526]), persistent leaks were found in 18 patients (18.9%), yielding a functional success rate of 82.7%, although PDLs were significantly reduced in size (pre-leak sizemax: 6.1±3.6 mm vs post-leak sizemax: 2.5±1.3 mm, p<0.001). None of the patients had a leak >5 mm. Major adverse events during follow-up occurred in 5 patients (2 ischaemic strokes, 2 intracranial haemorrhages, and 1 major gastrointestinal bleeding). CONCLUSIONS: Several interventional techniques have become available to achieve PDL closure. They are associated with high technical and functional success and low complication rates.

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.

Transcatheter Treatment of Residual Significant Mitral Regurgitation Following TAVR: A Multicenter Registry.

OBJECTIVES: The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit. BACKGROUND: The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging. METHODS: This was an international registry of 23 TAVR centers. RESULTS: In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05). CONCLUSIONS: For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274).