Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

Purpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain.

Patients And Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period.

Mobility Rates After Lower-Limb Amputation for Patients Treated with Physician-Led Collaborative Care Model.

Background: Clinical outcomes after major lower-limb amputation have been historically poor. The current care provided to most amputees is often disorganized and without physician supervision. The primary purpose of this study is to examine rates of postamputation mobility achieved with a prosthesis by patients with chronic limb-threatening ischemia and/or diabetes who required major lower-limb amputation and were treated under an established physician-led collaborative care pathway.

Impact of Patient and Procedural Factors on Outcomes Following Mesenteric Bypass.

Background: Mesenteric bypass (MB) for patients with acute (AMI) and chronic mesenteric ischemia (CMI) is associated with cardiovascular (CV) and pulmonary morbidity.

Methods: Patients with AMI and CMI from 2008 to 2019 were identified to determine independent predictors of CV (cardiac arrest, MI, DVT, and stroke) and pulmonary (pneumonia and ventilator time>48 h) morbidities in patients undergoing MB.

Results: 377 patients were identified.

Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry.

Objective: Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System was designed to improve seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) using EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks through one year.

Risk Factors for Acute Renal Failure After Endovascular Aneurysm Repair.

Background: Acute kidney injury (AKI) after endovascular aortic aneurysm repair (EVAR) is uncommon though carries significant morbidity. Procedural risk factors are not well established for acute renal failure (ARF) that requires initiation of dialysis. The goal of this study was to examine the impact of ARF on patients undergoing EVAR and identify risk factors for ARF using a large, national dataset.

One-Year Results of the Portico Transcatheter Aortic Heart Valve Using the Next-Generation FlexNav Delivery System.

Background: The FlexNav delivery system (DS) features a hydrophilic coating, stability layer, and integrated sheath to facilitate valve deployment in vessel diameters ≥5.0 mm.

Methods: Data were pooled from 2 concurrent prospective, multicenter, premarket studies (PORTICO IDE [n = 147] and FlexNav EU CE Mark [n = 46]) to evaluate the safety and efficacy of the FlexNav DS to deliver the Portico valve in the Global FlexNav study.

Prophylactic Left Atrial Appendage Exclusion in Cardiac Surgery Patients With Elevated CHADS-VASc Score: Results of the Randomized ATLAS Trial.

Objective: Patients with elevated CHADS-VASc scores are at high risk for atrial fibrillation (AF) and thromboembolic events (TE) after cardiac surgery. Left atrial appendage exclusion (LAAE) is a permanent, continuous approach to stroke prevention in AF, overcoming limitations of oral anticoagulation (OAC). We report ATLAS trial results focused on LAAE technical success and perioperative safety and TE rates with and without LAAE in cardiac surgery patients who developed postoperative AF (POAF).

Evaluating the optimal training paradigm for transcarotid artery revascularization based on worldwide experience.

Background: Transcarotid artery revascularization (TCAR) is a new hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to that of traditional in-person training on live cases.

Contemporary Outcomes After Partial Resection of Infected Aortic Grafts.

Introduction: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection.

Methods: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded.

Intraoperative repair of mitral paravalvular leak with Amplatzer plug.

Background And Aim Of The Study: Significant paravalvular leaks may complicate mitral valve replacement (MVR), especially in the setting of mitral annular calcification. Correction has been accomplished postoperatively by endovascular delivery of Amplatzer plugs (Abbott Medical) with good results. Intraoperative delivery of Amplatzer plugs at the index operation may reduce postoperative paravalvular leaks.

Extracellular Matrix Patches for Endarterectomy Repair.

Patch repair is the preferred method for arteriotomy closure following femoral or carotid endarterectomy. Choosing among available patch options remains a clinical challenge, as current evidence suggests roughly comparable outcomes between autologous grafts and synthetic and biologic materials. Biologic patches have potential advantages over other materials, including reduced risk for infection, mitigation of an excessive foreign body response, and the potential to remodel into healthy, vascularized tissue.

Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.

Objectives: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS).

Background: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm.

Methods: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.

In situ bypass and extra-anatomic bypass procedures result in similar survival in patients with secondary aortoenteric fistulas.

Objective: The optimal revascularization modality in secondary aortoenteric fistula (SAEF) remains unclear in the literature. The purpose of this investigation was to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients with SAEF.

Methods: A retrospective, multi-institutional study of SAEF from 2002 to 2014 was performed using a standardized database.

Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm.

Objective: Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA.

Methods: In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements.

Diagnosis and relining techniques for delayed type IIIB endoleaks with the second-generation AFX endograft.

Type IIIB endoleaks resulting from endograft fabric tear are an uncommon but serious late complication of endovascular aortic aneurysm repair. The Strata fabric used in the earlier generation AFX endograft (updated to Duraply in October 2014) has been associated with an increased frequency of these events. Herein we report on two patients exhibiting delayed type IIIB endoleaks after AFX device insertion to treat an abdominal aortic aneurysm and discuss optimal relining techniques.

Migrated embolization coil causes intestinal obstruction.

Visceral artery pseudoaneurysm is a rare, potentially fatal entity, but proper identification and management with coil embolization can lead to good outcomes. Embolization coils can migrate to various destinations, causing delayed complications in several case reports. A case of small bowel obstruction due to migrated embolization coils from a gastroduodenal pseudoaneurysm 6 years after initial treatment is presented.

Delayed Metallic Embolization of a Cor-Knot Fastener.

 The Cor-Knot device is a titanium fastener which is widely used in cardiac valve procedures. Adverse events associated with use of the device have been rare.  A patient underwent robotic mitral valve repair using the Cor-Knot fastener.

Coil Embolization of Spontaneous Splenic Arteriovenous Fistula for Treatment of Portal Hypertension.

BACKGROUND Splenic arteriovenous fistula (AVF) is a rare cause of portal hypertension which may manifest with abdominal pain, diarrhea, ascites, and/or hematemesis. Fistula formation may be traumatic or spontaneous. Eighty-six percent of spontaneous splenic AVFs occur in women, and 55% are associated with a preexisting splenic artery aneurysm.

TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve.

Background: The TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) trial (NCT01700439) evaluated the performance of the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis.

Methods: TRANSFORM was a prospective, nonrandomized, multicenter (n = 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon-expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve.

Plasmacytic Aortitis with Occlusion of the Right Coronary Artery.

BACKGROUND Inflammation of the aortic wall, known as aortitis, is a rare clinical entity which is frequently asymptomatic, or identified when the patient presents with an aortic aneurysm or dissection. It is most often caused by infection or autoimmune vasculitides such as giant cell or Takayasu's arteritis. CASE REPORT The case presented is that of a 55-year-old man with symptomatic occlusion of the right coronary artery caused by a plasmacytic aortitis suggestive of IgG4 disease, which was successfully treated with coronary artery bypass grafting and an ascending aortic graft.

Options for treatment of spontaneous mesenteric artery dissection.

Objective: Mesenteric artery dissection was once thought to be rare but has been identified more frequently with increasing use of computerized tomographic angiographic imaging. Multiple reports advocate a wide range of treatment including medical therapy, endovascular, and surgical intervention, with no clear guidelines for the application of each treatment.

Methods: A systematic review of the literature was analyzed and used to create a treatment algorithm that was applied to nine patients in our institution.