ABSTRACT
Acute limb ischemia (ALI) due to arterial thromboembolic occlusion is a critical emergency in vascular medicine, requiring attention for rapid diagnosis and intervention, to prevent limb loss and major amputation, which is associated with patient disability in the long term. Traditionally, surgical embolectomy has been used for the treatment of ALI. Endovascular treatment of ALI traditionally involved catheter-directed thrombolysis. This option, however, poses some limitations, including an increased risk for access site and systemic bleeding complications, especially in patients with high bleeding risk. Therefore, in the last decades, several devices have been developed and tested for the mechanical endovascular treatment of ALI. Such devices involve either rotational thrombectomy or continuous thrombus aspiration. While rotational thrombectomy is limited in rather large arteries due to the risk of dissection and perforation in arteries <3 mm, continuous thrombus aspiration can be applied in smaller vessels and tortuous anatomies. In our case series we present a minimal-invasive endovascular approach for the treatment of two patients with ALI due to thrombotic occlusion of tortious and small diameter arteries. Minimal-invasive mechanical thrombectomy using the Penumbra Aspiration System emerged as a successful alternative to surgical embolectomy, enabling prompt treatment and with a short hospital stay for both patients. Our article therefore highlights the use of continuous thrombus aspiration in small diameter vessels and tortuous anatomies, which may represent a contraindication for the use of rotational thrombectomy. In addition, this technique may be applied even in patients with higher bleeding risk since additional lysis is not necessary in patients, where complete thrombus removal can be achieved by this device.
Subject(s)
Endovascular Procedures , Thrombectomy , Humans , Thrombectomy/instrumentation , Thrombectomy/adverse effects , Treatment Outcome , Male , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Aged , Female , Ischemia/diagnosis , Ischemia/surgery , Ischemia/therapy , Middle Aged , Thromboembolism/etiology , Thromboembolism/diagnosis , Acute DiseaseABSTRACT
OBJECTIVES: The objective of this study was to enhance the efficiency of aortic arch replacement through the development of a novel frozen elephant trunk (FET) prosthesis with an endovascular side branch for left subclavian artery (LSA) connection. After successful pre-clinical testing, the feasibility and safety of implementing this innovative prosthesis in human subjects were investigated. METHODS: Between September 2020 and September 2021, 4 patients (mean age 67) with conditions such as penetrating ulcer, non A-non B aortic dissection and chronic arch aneurysm underwent surgery utilizing the customized device. Surgeries were performed under high moderate hypothermia (27°C), employing bilateral selective antegrade cerebral perfusion (SACP) and distal aortic perfusion. Anastomosis of the FET prosthesis with the aortic arch occurred in zone 1, followed by separate reimplantation of the left common carotid artery and the brachiocephalic artery. RESULTS: All patients were discharged in good clinical condition. The mean aortic cross-clamp, antegrade selective cerebral perfusion and distal aortic perfusion times were 111, 71 and 31 min, respectively. Endovascular extension of the side branch for the LSA was required in all cases to prevent endoleak formation. One patient received a stent graft extension at the end of the operation, while 2 others underwent the procedure during their hospital stay. One patient was diagnosed with an endoleak at the first follow-up after 3 months, and endoleak sealing was achieved via the brachial artery with an extension stent graft. CONCLUSIONS: Preliminary clinical outcomes suggest that the newly designed FET prosthesis shows promise in simplifying total arch replacement. These initial findings provide a foundation for planned clinical studies to further assess the effectiveness of this modified surgical hybrid graft, with particular attention to the length and diameter of the LSA sidearm.
Subject(s)
Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Endovascular Procedures , Subclavian Artery , Humans , Subclavian Artery/surgery , Aged , Male , Blood Vessel Prosthesis Implantation/methods , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/adverse effects , Middle Aged , Endovascular Procedures/methods , Endovascular Procedures/instrumentation , Aortic Dissection/surgery , Prosthesis Design , Aortic Aneurysm, Thoracic/surgery , Female , Aorta, Thoracic/surgeryABSTRACT
INTRODUCTION: Retrograde Endovascular Balloon Occlusion of the Aorta (REBOA) is an effective management for the transient responder, but the ischemic consequences of complete aortic occlusion currently limit its use. Multiple DoD-funded preclinical studies have clearly demonstrated that partial REBOA reduces distal ischemia to potentially extend safe occlusion times, while still providing effective temporization of noncompressible torso hemorrhage. Early versions of REBOA devices were designed to completely occlude the aorta and had little ability to provide partial occlusion. Recently, a new REBOA device (pREBOA-PRO) was designed specifically to allow for partial occlusion, with the hypothesis that this may reduce the complications of aortic occlusion and extend safe occlusion times while maintaining the benefits on cardiac and cerebrovascular circulation as well as reductions in resuscitation requirements. MATERIALS AND METHODS: To ascertain the impact of a new purpose-built partial REBOA device on the extension of safe occlusion time, the Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) trial compared available data from the pREBOA-PRO with existing data from 200 clinical uses of pREBOA-PRO and available data in the AAST AORTA Registry were reviewed to design primary endpoints and clinical evidence for a prospective multi-center trial, the PROMPT Study. Together with the endpoints identified in preclinical studies of partial REBOA, primary endpoints for the PROMPT study were identified and power analyses were conducted to determine the target patient enrollment goals. RESULTS: Results from the clinical implementation of partial REBOA at a single trauma center were used to conduct the initial power analysis for the primary endpoint of Acute Kidney Injury (AKI) after prolonged occlusion. The rate of AKI after complete REBOA was 55% (12/20) compared to 33% (4/12) after partial REBOA (Madurska et al., 2021). With an alpha of 0.05 and power (ß) of 0.8, the projected sample size for comparison on a dichotomous outcome is 85 patients for the assessment of AKI. Initial power and endpoint analyses have been confirmed and extended with the ongoing analysis of partial and complete REBOA reported in the AORTA database. These analyses confirm preclinical findings which show that compared to complete REBOA, partial REBOA is associated with extended occlusion time in zone 1 (complete: 31 min vs. partial: 45 min, P = 0.003), lower rates of AKI after zone 1 occlusion (complete: 33% vs. partial: 19%, P = 0.05) and reduced resuscitation requirements (e.g., 25% reduction in pRBC administration: complete: 18 units vs. partial: 13 units, P = 0.02). CONCLUSIONS: The DoD-funded PROMPT study of partial REBOA will provide prospective observational clinical data on patients being treated with pREBOA-PRO. Outcomes will be stratified based on partial or complete occlusion to address whether partial REBOA has additional clinical benefits over complete REBOA, such as decreased distal ischemia, extension of safe occlusion time, improved hemodynamics during transition to and from occlusion, and reduced interoperative bleeding and blood product use. The results from this study are expected to confirm previous data demonstrating reduction of ischemic sequalae, improved transition to reperfusion, and reduced resuscitative requirements compared to complete REBOA.
Subject(s)
Aorta , Balloon Occlusion , Humans , Balloon Occlusion/methods , Balloon Occlusion/standards , Balloon Occlusion/instrumentation , Balloon Occlusion/statistics & numerical data , Prospective Studies , Male , Female , Adult , Endovascular Procedures/methods , Endovascular Procedures/instrumentation , Middle Aged , Resuscitation/methods , Resuscitation/instrumentation , Resuscitation/standards , Resuscitation/statistics & numerical data , Hemorrhage/therapy , Hemorrhage/prevention & control , Treatment OutcomeABSTRACT
Fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms is increasingly replacing open repair as the primary modality of treatment. Mid- and long-term results are encouraging and support its use in the correct settings. Nevertheless, appropriateness of indication for treatment, patient selection, and surgeon and hospital performance has not been clearly evaluated and reviewed. The objective of this review article was to identify areas in which appropriateness of care is relevant and can be optimized when considering treatment of patients with fenestrated and branched endovascular repair for complex abdominal and thoracoabdominal aortic aneurysms.
Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Endovascular Procedures , Patient Selection , Prosthesis Design , Humans , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Treatment Outcome , Risk Factors , Clinical Decision-Making , Stents , Risk Assessment , Postoperative Complications/etiologyABSTRACT
Infective native arterial aneurysms and inflammatory aortic aneurysms are rare but morbid pathologies seen by vascular surgeons in the emergency setting. Presentation is not always clear, and a full workup must be obtained before adopting a management strategy. Treatment is multidisciplinary and is tailored to every case based on workup findings. Imaging with computed tomography, magnetic resonance, or with fluorodeoxyglucose-positron emission tomography aids in diagnosis and in monitoring response to treatment. Open surgery is traditionally performed for definitive management. Endovascular surgery may offer an alternative treatment in select cases with acceptable outcomes. Neither technique has been proven to be superior to the other. Physicians should consider patient's anatomy, comorbidities, life expectancy, and goals of care before selecting an approach. Long-term pharmacological treatment, with antibiotics in case of infective aneurysms and immunosuppressants in case of inflammatory aneurysms, is usually required and should be managed in collaboration with infectious disease specialists and rheumatologists.
Subject(s)
Aneurysm, Infected , Anti-Bacterial Agents , Aortic Aneurysm, Abdominal , Aortitis , Endovascular Procedures , Humans , Aneurysm, Infected/microbiology , Aneurysm, Infected/diagnostic imaging , Aneurysm, Infected/surgery , Aneurysm, Infected/therapy , Aneurysm, Infected/diagnosis , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Treatment Outcome , Anti-Bacterial Agents/therapeutic use , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Aortitis/therapy , Aortitis/diagnostic imaging , Aortitis/diagnosis , Risk Factors , Predictive Value of Tests , Emergencies , Aortography , Immunosuppressive Agents/therapeutic use , Vascular Surgical Procedures , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/adverse effects , Emergency Service, HospitalABSTRACT
BACKGROUND: Currently, the treatment outcomes for complex congenital arteriovenous malformations (AVMs) remain unsatisfactory. This article reports on the utilization of an abdominal aortic stent graft, in conjunction with embolization techniques, for managing acute heart failure triggered by complex congenital arteriovenous malformations in the lower limb. CASE PRESENTATION: We present a case involving a patient with congenital AVMs in the lower limb, who had suffered from prolonged swelling in the left lower limb and recently developed symptoms of heart failure. At the age of 67, the patient was definitively diagnosed with a complex congenital AVMs in the lower limb. This article delves into the practical experiences and limitations encountered in employing an abdominal aortic stent graft, coupled with embolization, to address acute heart failure caused by complex congenital AVMs in the lower limb. CONCLUSIONS: Our article presents the initial report on the challenges and limitations encountered in treating acute heart failure triggered by complex congenital AVMs in the lower limb, utilizing a combination of abdominal aortic stent graft placement and embolization techniques.
Subject(s)
Arteriovenous Malformations , Embolization, Therapeutic , Endovascular Procedures , Heart Failure , Lower Extremity , Stents , Humans , Embolization, Therapeutic/instrumentation , Treatment Outcome , Arteriovenous Malformations/therapy , Arteriovenous Malformations/diagnostic imaging , Lower Extremity/blood supply , Endovascular Procedures/instrumentation , Heart Failure/therapy , Heart Failure/diagnosis , Heart Failure/physiopathology , Heart Failure/etiology , Aged , Blood Vessel Prosthesis Implantation/instrumentation , Male , Blood Vessel Prosthesis , FemaleABSTRACT
BACKGROUND: The introduction of radial-specific equipment has made transradial (TR) aortoiliac (AI) endovascular therapy (EVT) more convenient. OBJECTIVES: The authors aimed to investigate the perioperative outcomes of the TR approach in patients undergoing AI EVT for symptomatic peripheral artery disease. METHODS: The COMFORT (Contemporary Strategy for Aortoiliac Intervention) registry was a prospective, multicenter, observational study enrolling patients with symptomatic peripheral artery disease undergoing AI EVT between January 2021 and June 2023. The primary outcome was perioperative complications, whereas the secondary outcomes included core laboratory-evaluated residual stenosis >30%, time to hemostasis, time to ambulation, 30-day patency, and 30-day limb symptoms. These outcomes were compared between TR and non-TR AI EVT after propensity score matching. RESULTS: The TR approach was selected for 231 of the 947 patients (24.3%). The TR approach was chosen more in patients with a higher ankle-brachial index, chronic total occlusion, aortic lesion, bare nitinol stent implantation, and plain angioplasty, whereas it was chosen less in patients with dialysis, a history of AI EVT, chronic limb-threatening ischemia, bilateral calcification, and simultaneous infrainguinal EVT (all P < 0.05). After propensity score matching, the incidence of perioperative complications did not differ significantly between the groups (TR group: 6.0% vs non-TR group: 5.1%; P = 0.69). The proportions of residual stenosis, 30-day patency, and 30-day limb symptoms were not significantly different (all P > 0.05); however, the time to hemostasis and the time to ambulation were shorter in the TR group (both P < 0.05). CONCLUSIONS: Non-TR AI EVT and TR AI EVT using radial-specific equipment were associated with a similar risk of perioperative complications. The TR approach helps shorten the time required for hemostasis and ambulation.
Subject(s)
Endovascular Procedures , Iliac Artery , Peripheral Arterial Disease , Radial Artery , Registries , Vascular Patency , Humans , Female , Male , Aged , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Prospective Studies , Radial Artery/physiopathology , Treatment Outcome , Time Factors , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Iliac Artery/surgery , Middle Aged , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/diagnostic imaging , Risk Factors , Risk Assessment , Aged, 80 and over , Catheterization, Peripheral/adverse effects , Stents , PuncturesSubject(s)
Catheterization, Peripheral , Endovascular Procedures , Iliac Artery , Radial Artery , Humans , Radial Artery/diagnostic imaging , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Catheterization, Peripheral/adverse effects , Endovascular Procedures/instrumentation , Treatment Outcome , Punctures , Risk Factors , Aortic Diseases/diagnostic imaging , Aortic Diseases/therapy , Aortic Diseases/physiopathologyABSTRACT
Management of wide-necked aneurysms in cavernous ICA has significantly evolved in the endovascular era, with flow diverters and stent-assisted coiling being an effective modality. It is vital to select the type of stent according to the arterial anatomy, hemodynamics, and device characteristics. We report a catastrophic complication of laser-cut stent used for SAC of cavernous ICA aneurysm performed at another center 5 years back, presenting with regrowth and massive life-threatening epistaxis managed successfully. In tortuous angulated anatomy, laser-cut stents are difficult to place, poorly visible, and the device opening is uncertain. Unlike braided stents, laser-cut stents do not provide flow diversion effect, stent migration, and buckling phenomena are more likely to occur with laser-cut stents. We intend to discuss the technical fallacies behind using laser-cut stents in such case scenarios and the optimal treatment approach for such cases with an attitude to learn from such complications.
Subject(s)
Intracranial Aneurysm , Stents , Humans , Intracranial Aneurysm/surgery , Intracranial Aneurysm/therapy , Embolization, Therapeutic/methods , Endovascular Procedures/methods , Endovascular Procedures/instrumentation , Carotid Artery, Internal/surgery , Male , Middle Aged , FemaleABSTRACT
Venous compressive disorders are a heterogenous group of vascular syndromes characterized by extrinsic venous compression that can lead to complications of venous hypertension or venous thrombosis. Endovascular damage secondary to deep venous thrombosis (DVT) can result in post-thrombotic syndrome (PTS), a potentially debilitating condition that can be associated with significant morbidity in the pediatric population. Here we discuss 4 venous compressive disorders: iliac vein compression (May-Thurner syndrome [MTS]); subclavian vein compression at the venous thoracic inlet (Paget-Schroetter syndrome); left renal vein compression (nutcracker syndrome); and popliteal vein compression (popliteal entrapment syndrome) with a focus on clinical evaluation and diagnostic methods. Where endovascular therapy is appropriate, specific procedural considerations including procedure indications, equipment, procedural steps, technical challenges, complications, clinical follow-up and expected outcomes are discussed.
Subject(s)
Endovascular Procedures , May-Thurner Syndrome , Humans , May-Thurner Syndrome/therapy , May-Thurner Syndrome/diagnostic imaging , May-Thurner Syndrome/physiopathology , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Treatment Outcome , Phlebography , Renal Nutcracker Syndrome/diagnostic imaging , Renal Nutcracker Syndrome/physiopathology , Renal Nutcracker Syndrome/therapy , Predictive Value of Tests , Popliteal Vein/diagnostic imaging , Popliteal Vein/physiopathology , Risk Factors , Subclavian Vein/diagnostic imaging , Subclavian Vein/physiopathology , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathologyABSTRACT
Pediatric venous occlusions are a growing cause of morbidity and mortality, especially in hospitalized patients. Catheter-directed recanalization is a safe and effective treatment option in appropriately selected patients. Benefits of catheter directed therapies (CDTs) include the prevention of pulmonary embolism and end organ failure acutely as well as superior vena cava syndrome and post-thrombotic syndrome chronically. Timely diagnosis, recognition of underlying factors for thrombosis, and familiarity with the spectrum of tools and techniques for CDT are essential to optimizing outcomes in the acute setting. Recanalization of chronic venous occlusions can similarly provide symptomatic relief and achieve long term vessel patency. This review will detail the scope, techniques, and outcomes for CDT in the treatment of acquired systemic deep vein occlusions.
Subject(s)
Radiography, Interventional , Venous Thrombosis , Humans , Child , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy , Venous Thrombosis/physiopathology , Treatment Outcome , Child, Preschool , Adolescent , Infant , Phlebography , Vascular Patency , Age Factors , Risk Factors , Infant, Newborn , Male , Female , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Catheterization, Peripheral/adverse effects , Predictive Value of TestsABSTRACT
Objective. Follow-up computed tomography angiography (CTA) is necessary for ensuring occlusion effect of endovascular coiling. However, the implanted metal coil will introduce artifacts that have a negative spillover into radiologic assessment.Method. A framework named ReMAR is proposed in this paper for metal artifacts reduction (MARs) from follow-up CTA of patients with coiled aneurysms. It employs preoperative CTA to provide the prior knowledge of the aneurysm and the expected position of the coil as a guidance thus balances the metal artifacts removal performance and clinical feasibility. The ReMAR is composed of three modules: segmentation, registration and MAR module. The segmentation and registration modules obtain the metal coil knowledge via implementing aneurysms delineation on preoperative CTA and alignment of follow-up CTA. The MAR module consisting of hybrid convolutional neural network- and transformer- architectures is utilized to restore sinogram and remove the artifact from reconstructed image. Both image quality and vessel rendering effect after metal artifacts removal are assessed in order to responding clinical concerns.Main results. A total of 137 patients undergone endovascular coiling have been enrolled in the study: 13 of them have complete diagnosis/follow-up records for end-to-end validation, while the rest lacked of follow-up records are used for model training. Quantitative metrics show ReMAR significantly reduced the metal-artifact burden in follow-up CTA. Qualitative ranks show ReMAR could preserve the morphology of blood vessels during artifact removal as desired by doctors.Significance. The ReMAR could significantly remove the artifacts caused by implanted metal coil in the follow-up CTA. It can be used to enhance the overall image quality and convince CTA an alternative to invasive follow-up in treated intracranial aneurysm.
Subject(s)
Artifacts , Computed Tomography Angiography , Endovascular Procedures , Metals , Humans , Endovascular Procedures/instrumentation , Image Processing, Computer-Assisted/methods , Follow-Up Studies , FemaleABSTRACT
INTRODUCTION: Treatment of anterior cerebral artery (ACA) aneurysms is still not well established. The Leo stent with blood flow direction is a retrievable stent for intracranial aneurysms, whereas it needs to be studied clearly in patients with ACA aneurysms. METHODS: Consecutive patients with ACA aneurysms were retrospectively enrolled in three neurosurgical centers between January 2016 and October 2021. The data on demographics, aneurysm characteristics, symptom resolution, and postoperative course were collected and analyzed. The aneurysm occlusion status was appraised by Raymond-Ray Occlusion Class (RROC). RESULTS: A total of 57 patients with ACA aneurysms were included in our study. Immediate postprocedural angiograms showed that 20 aneurysms (35.1%) were in complete occlusion (RROC 1), 26 aneurysms (45.6%) were in near-complete occlusion (RROC 2), 11 aneurysms (19.3%) were in incomplete occlusion (RROC 3). The angiographic follow-up found that the rate of complete occlusion increased to 57.9%, and near-completion and incomplete occlusion dropped to 29.8% and 12.3%, respectively. The angiographic result of the last follow-up improved significantly (Z=- 2.805, P=0.005). Univariate analysis indicated that distal location of aneurysms (Z=4.538, P=0.033) and ruptured aneurysms (χ2=.6120, P=0.032) were potential risk factors for intra-parent artery narrowing. Furthermore, multivariate logistic regression analysis found that A3 aneurysms (95% CI 1.427~32.744, P=0.016) are the key risk factor for intra-parent artery narrowing. CONCLUSIONS: The Leo stent is safe and effective for aneurysms located in ACA circulations. The overall occlusion degree improved during follow-up. A distal, small artery was the risk factor for intra-parent artery narrowing.
Subject(s)
Intracranial Aneurysm , Stents , Humans , Male , Intracranial Aneurysm/surgery , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Female , Middle Aged , Stents/adverse effects , Retrospective Studies , Aged , Treatment Outcome , Adult , Endovascular Procedures/methods , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Anterior Cerebral Artery/surgery , Anterior Cerebral Artery/diagnostic imaging , Embolization, Therapeutic/methods , Embolization, Therapeutic/instrumentation , Cerebral AngiographyABSTRACT
BACKGROUND: Innominate artery aneurysms (IAAs) are rare and may result in rupture, distal arterial embolization, or local compression without timely treatment. Rupture is the most dangerous of these complications. This article reports a case of innominate artery bifurcation pseudoaneurysm. CASE PRESENTATION: The patient was a 45-year-old man who was admitted to the emergency department due to chest discomfort. The computed tomographic angiography (CTA) imaging indicated the presence of a 3.6*2.4 cm saccular aneurysm in the bifurcation of the innominate artery, involving both the right proximal subclavian and common carotid arteries. The patient's vital signs were normal, there was equal blood pressure in the upper arms and no neurological dysfunction was observed. Gadolinium-enhanced magnetic resonance angiography indicated that the circle of Willis was intact. The treatment involved open surgery combined with endovascular therapy. The external carotid artery was first transposed to the right subclavian artery (RSA) and an 8-mm woven Dacron graft was inserted in the middle. The covered stent graft was then placed in the proximal part of the innominate artery to close the entrance of the aneurysm. Lastly, an occluder was implanted at the origin of the RSA. There were no perioperative or postoperative complications. At 1-year follow-up, no aneurysm was observed on CTA and the right vertebral artery was patent. CONCLUSIONS: This study indicated that the combined use of endovascular therapy and open repair surgery is an effective strategy to treat innominate artery bifurcation pseudoaneurysm.
Subject(s)
Aneurysm, False , Blood Vessel Prosthesis Implantation , Brachiocephalic Trunk , Endovascular Procedures , Stents , Humans , Male , Middle Aged , Aneurysm, False/diagnostic imaging , Aneurysm, False/surgery , Aneurysm, False/etiology , Aneurysm, False/therapy , Brachiocephalic Trunk/diagnostic imaging , Brachiocephalic Trunk/surgery , Endovascular Procedures/instrumentation , Treatment Outcome , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Computed Tomography Angiography , Magnetic Resonance AngiographyABSTRACT
BACKGROUND: Stent-assisted carotid artery revascularization employing surgical cutdown for transcervical access and dynamic flow reversal (TCAR) is gaining popularity. TCAR, despite maximized intra-procedural cerebral protection, shows a marked excess of 30-day neurologic complications in symptomatic vs. asymptomatic stenoses. The TCAR conventional single-layer stent (free-cell area 5.89mm2) inability to seal embologenic lesions may be particularly relevant after the flow reversal neuroprotection is terminated. METHODS: We evaluated peri-procedural and 30-day major adverse cerebral and cardiac events (MACCE) of TCAR (ENROUTE, SilkRoad Medical) paired with MicroNET-covered neuroprotective stent (CGuard, InspireMD) in consecutive patients at elevated risk of complications with transfemoral/transradial filter-protected stenting (increased lesion-related and/or access-related risk). CGuard (MicroNET free cell area ≈0.02-0.03 mm2) has level-1 evidence for reducing intra- and abolishing post-procedural lesion-related cerebral embolism. RESULTS: One hundred and six increased-risk patients (age 72 [61-76] years, median [Q1-Q3]; 60.4% symptomatic, 49.1% diabetic, 36.8% women, 61.3% left-sided index lesion) were enrolled in three vascular surgery centers. Angiographic stenosis severity was 81 (75-91)%, lesion length 21 (15-26)mm, increased-risk lesional characteristics 87.7%. Study stent use was 100% (no other stent types). 74.5% lesions were predilated; post-dilatation rate was 90.6%. Flow reversal duration was 8 (5-11)min. One stroke (0.9%) occurred in an asymptomatic patient prior to establishing neuroprotection (index lesion disruption with the sheath insertion wire); there were no other peri-procedural MACCE. No further adverse events occurred by 30-days. 30-day stent patency was 100% with normal velocities and absence of any in-stent material by Duplex Doppler. CONCLUSIONS: Despite a high proportion of increased-risk lesions and clinically symptomatic patients in this study, TCAR employing the MicroNET-covered anti-embolic stent showed 30-day MACCE rate <1%. This suggests a clinical role for combining maximized intra-procedural prevention of cerebral embolism by dynamic flow reversal with anti-embolic stent prevention of peri- and post-procedural cerebral embolism (TOPGUARD NCT04547387).
Subject(s)
Carotid Stenosis , Embolic Protection Devices , Intracranial Embolism , Prosthesis Design , Stents , Humans , Aged , Female , Male , Carotid Stenosis/surgery , Carotid Stenosis/physiopathology , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/complications , Middle Aged , Treatment Outcome , Intracranial Embolism/prevention & control , Intracranial Embolism/etiology , Time Factors , Risk Factors , Cerebrovascular Circulation , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Prospective Studies , Stroke/prevention & control , Stroke/etiologyABSTRACT
BACKGROUND: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature. METHODS: Using the data collected in the ROADSAVER observational, European multicenter CAS study, a prespecified comparative analysis evaluating the impact of the operator's specialization was performed. We used major adverse event (MAE) rate at 30-day follow-up, defined as the cumulative incidence of any death or stroke, and its components as outcome measures. RESULTS: A total of 1965 procedures were analyzed; almost half 878 (44.7%) were performed by radiologists (interventional/neuro), 717 (36.5%) by cardiologists or angiologists, and 370 (18.8%) by surgeons (vascular/neuro). Patients treated by surgeons were the oldest (72.9±8.5), while radiologists treated most symptomatic patients (58.1%) and more often used radial access (37.2%). The 30-day MAE incidence achieved by cardiologists/angiologists was 2.0%, radiologists 2.5%, and surgeons 1.9%; the observed differences in rates were statistically not-significant (P=0.7027), even when adjusted for baseline patient/lesion and procedural disparities across groups. The corresponding incidence rates for death from any cause were 1.0%, 0.8%, and 0.3%, P=0.4880, and for any stroke: 1.4%, 2.3%, and 1.9%, P=0.4477, respectively. CONCLUSIONS: Despite the disparities in patient selection and procedural preferences, the outcomes achieved by different specialties in real-world, contemporary CAS practice remain similar when using modern devices and techniques.
Subject(s)
Endovascular Procedures , Radiologists , Stents , Stroke , Humans , Aged , Male , Female , Treatment Outcome , Europe , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Stroke/etiology , Stroke/epidemiology , Time Factors , Risk Factors , Carotid Stenosis/therapy , Carotid Stenosis/mortality , Carotid Stenosis/surgery , Surgeons , Practice Patterns, Physicians' , Cardiologists , Aged, 80 and over , Healthcare Disparities , Specialization , Clinical Competence , Middle Aged , Risk AssessmentABSTRACT
BACKGROUND: The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS. METHODS: This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021. The primary outcome was the 30-day rate of major adverse events (MAE; i.e. any death or stroke) after CAS. Procedural details and outcomes were compared between patients with complex anatomical features and those without. RESULTS: One or more complex anatomical characteristics were identified in 1639 (83.4%) patents. Patients with complex anatomies were older and had a higher prevalence of arterial hypertension, cardiovascular disease, and prior stroke. Between patients with or without complex anatomical features, no significant differences were found either in procedural techniques, or in 30-day MAE (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.76 (0.35, 1.66); p=0.4905) and any stroke (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.89 (0.37, 2.17); p=0.8032) incidence. Furthermore, neither the presence of specific types of anatomic complexity nor their number (per patient) markedly influenced the 30-day MAE and any stroke incidence. CONCLUSIONS: In this real-world cohort of patients undergoing CAS with the Roadsaver DLMS, no significant difference in the occurrence of 30-day MAE and any stroke was observed between patients with or without high-risk anatomical features.
Subject(s)
Carotid Stenosis , Endovascular Procedures , Prosthesis Design , Stents , Stroke , Humans , Aged , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/therapy , Carotid Stenosis/surgery , Carotid Stenosis/mortality , Male , Female , Prospective Studies , Treatment Outcome , Risk Factors , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Time Factors , Middle Aged , Risk Assessment , Stroke/etiology , Stroke/prevention & control , Aged, 80 and overABSTRACT
The physician office offering imaging guided endovascular and minimally invasive interventional procedures is often referred to as an OBL (office based lab), OIS (office interventional suite), or OES (office endovascular suite). Initially, OBL's depended upon the national societies of interventional radiology (SIR), vascular surgery (SVS) and interventional cardiology (SCAI) to advocate for them. However, the OBL space needed a voice dedicated to advocating for the appropriate reimbursement of procedures in the OBL to allow the OBL to survive as a viable site of service and become integral to healthcare delivery in the US healthcare system. This need led to the formation of the Outpatient Endovascular & Interventional Society (OEIS). The society is multispecialty and ensures safety in outpatient care in all sites of service while maintaining a focus on the OBL. The mission of the OEIS is to advocate for patients to have the ability to choose their provider and be able to receive safe and effective healthcare in a more friendly and far less costly site of service for them.
Subject(s)
Ambulatory Care , Endovascular Procedures , Radiography, Interventional , Societies, Medical , Humans , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , History, 20th Century , History, 21st Century , Organizational Objectives , Patient Advocacy/history , Radiography, Interventional/history , Societies, Medical/history , United StatesABSTRACT
Office based interventional procedures continue to increase in number and scope. An overview of the Outpatient Endovascular and Interventional Society (OEIS) National Registry (OEISNR) is described in this article. Currently there is one production module enrolling peripheral artery interventional procedures, and a new cardiac module encompassing both diagnostic catheterization/percutaneous coronary interventions and electrophysiology procedures is undergoing beta testing. A new embolization module with uterine fibroid embolization (UFE) as the initial modality is nearly initial development completion and expected to enter beta in 2024. The OEISNR has over 338 participating physicians and has enrolled over 42,000 cases since inception in 2017 with an extremely high rate of technical success (97%) and very low complication rates (2.15% overall, 1.65% minor complications, 0.53% major complications). More detailed data breakdowns including patient demographics and comorbidities, indications, lesion characteristics, treatment modalities and device utilization, complication details, and data integrity data are contained in this report. Sample analytics, sample dashboards, and structural details are illustrated and included.