Device regulation and surveillance in vascular care: Challenges and opportunities.

Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.

Evaluating the impact of an interdisciplinary integrated limb preservation service operating concurrently with a single-specialty service.

BACKGROUND: This study examined the efficacy of an interdisciplinary limb preservation service (LPS) in improving surgical outcomes for diabetic foot ulcer (DFU) patients compared to traditional care. METHODS: Data from January 1, 2017 to September 30, 2020 were retrospectively reviewed. An interdisciplinary LPS clinic began on August 1, 2018, coexisting with a preexisting single specialty service. Primary outcomes were major/minor amputation rates and ratios and hospital length of stay. Surgical endpoints pre- and post-LPS launch were compared. RESULTS: Among 976 procedures for 731 unique DFU patients, most were male (80.4%) and Hispanic (89.3%). Patient demographics were consistent before and after LPS initiation. Major amputation rates decreased by 45.5% (15.4%-8.4%, p = 0.001), with outpatient procedures increasing over 5-fold (3.3% pre-LPS to 18.7% post-LPS, p < 0.001). Hospital stay reduced from 10.1 to 8.5 days post-LPS (p < 0.001). The major to minor amputation ratio declined from 22.4% to 12.7%. CONCLUSIONS: The interdisciplinary LPS improved patient outcomes, marked by fewer major amputations and reduced hospital stays, suggesting the model's potential for broader application.

Prospective assessment of dynamic changes in frailty and its impact on early clinical outcomes following physician-modified fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

INTRODUCTION: Frailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up. METHODS: Consecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test. RESULTS: Seventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: -96 mm2, P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm2, P = .6). CONCLUSIONS: Preoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline.

Use of Iliac Branch Endoprosthesis to Rescue Inadvertent False Lumen Deployment of the Innominate Branch Stent During Physician-Modified Fenestrated-Branched Aortic Arch Repair.

A 70-year-old male with a history of 3 prior median sternotomies and on anticoagulation presented with acute chest and back pain associated with a pseudoaneurysm of the ascending and aortic arch in the setting of residual dissection involving the innominate, proximal right carotid, and subclavian arteries. A physician-modified triple vessel fenestrated-branched arch endograft was deployed. The innominate branch stent was deployed from the right carotid cut down, while the left carotid and left subclavian branch stents were placed from a femoral approach. Postoperatively, the innominate branch was found to be deployed in the false lumen of the dissected native innominate artery, leading to continued pressurization of the pseudoaneurysm. This was rescued by placing a Gore Iliac Branch Endoprosthesis (IBE) into the innominate branch through a temporary conduit sewn to the right carotid artery with a right subclavian branch placed via a brachial artery cut down into the internal iliac gate. The use of IBE allowed branch stent extension past the dissected native vessels. The patient had an uneventful recovery without neurologic complications. At 3-month follow-up, the patient remains well with an excluded pseudoaneurysm, and patent bifurcated innominate, bilateral carotid, and subclavian artery branches. A Gore IBE can be utilized in a dissected innominate artery to create an innominate branch device during fenestrated-branched endovascular arch repair.

Dual-Lumen Stenting of Dissected Superior Mesenteric Artery During Fenestrated Branched Endovascular Repair of a Post-dissection Thoracoabdominal Aortic Aneurysm.

PURPOSE: Long-segment aortic branch dissections have been considered a relative contraindication for fenestrated-branched endovascular aneurysm repair (FB-EVAR). This case report describes a technique of dual-lumen stenting of a fully-dissected superior mesenteric artery (SMA) to preserve patency of the true and false lumens during FB-EVAR. CASE REPORT: A 67-year-old man presented with a 6.0 cm extent III chronic post-dissection thoracoabdominal aortic aneurysm. The patient had highly-complex anatomy including dissection of the entire SMA. The true and false lumens of the dissected SMA were noted to be supplying different branches, requiring preservation of both lumens. The patient underwent a staged physician-modified FB-EVAR. A modified endograft containing 5 fenestrations and 1 branch cuff was introduced and the celiac, true-lumen SMA, and 3 renal arteries were sequentially catheterized using staggered deployment of the modified endograft. The false lumen SMA stent was catheterized via the branch cuff. Molded parallel grafting ("eye-of-the-tiger") technique was used to achieve double D configuration between the true and false lumens of the SMA. CONCLUSION: This case demonstrates feasibility of dual-lumen stenting to incorporate dissected target vessels during FB-EVAR while preserving flow to both the true and false lumens and the second-order branches they supply. CLINICAL IMPACT: We report a novel technique that allows incorporation of branch vessels affected by long segment dissection during fenestrated branched endovascular aortic repairs. This has potential advantage of preserving flow to all secondary branches of the dissected target vessels, while reducing the risk of type Ic endoleak.

Comparative outcomes of physician-modified fenestrated-branched endovascular repair of post-dissection and degenerative complex abdominal or thoracoabdominal aortic aneurysms.

OBJECTIVE: Fenestrated-branched endovascular repair has become a favorable treatment strategy for patients with complex abdominal aortic aneurysms (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs) who are high risk for open repair. Compared with degenerative aneurysms, post-dissection aneurysms can pose additional challenges for endovascular repair. Literature on physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for post-dissection aortic aneurysms is sparse. Therefore, the aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs. METHODS: A single-center institutional database was retrospectively reviewed for patients that underwent PM-FBEVAR between 2015 and 2021. Infected aneurysms and pseudoaneurysms were excluded. Patient characteristics, intraoperative details, and clinical outcomes were compared between degenerative and post-dissection cAAAs or TAAAs. The primary outcome was 30-day mortality. The secondary outcomes included technical success, major complications, endoleak, target vessel instability, and reintervention. RESULTS: Of the 183 patients who underwent PM-FBEVAR in the study, 32 had aortic dissections, and 151 had degenerative aneurysms. There was one 30-day death (3.1%) in the post-dissection group and eight 30-day deaths (5.3%) in the degenerative aneurysm group (P = .99). Technical success, fluoroscopy time, and contrast usage were similar between the post-dissection and degenerative groups. Reintervention during follow-up (28% vs 35%; P = .54) and major complications were not statistically significantly different between the two groups. Endoleak was the most common reason for reintervention, with the post-dissection group having a higher rate of type IC, II, and IIIA endoleaks (31% vs 3%; P < .0001; 59% vs 26%; P = .0002; and 16% vs 4%; P = .03). During the mean follow-up of 14 months, all-cause mortality was similar between the groups (12.5% vs 21.9%; P = .23). CONCLUSIONS: PM-FBEVAR is a safe treatment for post-dissection cAAAs and TAAAs with high technical success. However, endoleaks requiring reintervention were more frequent in post-dissection patients. The impact of these reinterventions on long-term durability will be assessed with continued follow-up.

Use of retrograde left subclavian branch portal of Gore TAG thoracic branch endoprosthesis for physician-modified fenestrated branched endovascular repair of thoracoabdominal aortic aneurysm.

A 75-year-old man who had undergone zone 2 thoracic endovascular repair of a symptomatic penetrating aortic ulcer using a Gore TAG thoracic branch endoprosthesis (TBE) device (W.L. Gore & Associates) 5 years before had presented with an enlarging extent I thoracoabdominal aortic aneurysm. A physician-modified five-vessel fenestrated-branched endograft repair was performed using preloaded wires. The visceral renal vessels were sequentially catheterized from the left brachial access via the TBE portal, and the endograft was deployed in staggered fashion. At 1 year of follow-up, imaging studies demonstrated a stable aneurysm sac, patent visceral renal branches, and no endoleak. The retrograde portal of Gore TAG TBE can facilitate fenestrated-branched endovascular repair of thoracoabdominal aortic aneurysms.

Contemporary indications, techniques, and outcomes of physician-modified endografts for the treatment of complex abdominal and thoracoabdominal aortic aneurysms.

The article describes contemporary indications, techniques, and outcomes of physician-modified endografts (PMEGs) for the treatment of complex aortic aneurysms. Physician-modified endografting has been performed with high technical success rates and lower complication rates compared with traditional open surgery for complex aortic aneurysms. Various techniques have been reported for the design, modification, and implantation of PMEGs, using different off-the-shelf devices. Although PMEGs are used more commonly for urgent and emergent repair of symptomatic or ruptured complex abdominal and thoracoabdominal aortic aneurysms in patients who do not have access to manufactured devices, some centers have reported utilization of PMEGs in elective cases under the aegis of the US Food and Drug Administration-approved Investigational Device Exemption protocols. Although the initial outcomes of PMEGs are promising, continued surveillance remains a crucial component to determine long-term durability. All treatment options for complex abdominal and thoracoabdominal aortic aneurysms should be considered carefully, with PMEGs reserved for those cases unsuitable for other repair alternatives, and at centers with the volume and expertise to execute the procedure with high technical success and low morbidity and mortality rates. With the continued evolution of endovascular technology, the role and indications for PMEGs are expected to change.

Comparative early results of in situ fenestrated endovascular aortic repair and other emergent complex endovascular aortic repair techniques for ruptured suprarenal and thoracoabdominal aortic aneurysms at a regional aortic center.

INTRODUCTION: Emergent endovascular repair of suprarenal (SRAAAs) and thoracoabdominal aortic aneurysms (TAAAs) poses a significant challenge due to the need for branch vessel incorporation, time constraints, and lack of dedicated devices. Techniques to incorporate branch vessels have included parallel grafting, physician-modified endografts, double-barrel/reversed iliac branch device, and in situ fenestration (ISF). This study describes a single-center experience and the associated outcomes when using these techniques for ruptured SRAAAs and TAAAs. METHODS: A retrospective review of patients who underwent endovascular repair of ruptured SRAAAs and TAAAs from July 2014 to March 2021 with branch vessel incorporation was performed. Clinical presentation, intraoperative details, and postoperative outcomes of those who underwent ISF were compared with those who underwent repair using non-ISF techniques. The primary outcome of interest was in-hospital mortality. Secondary outcomes were major adverse events including myocardial infarction, respiratory failure, renal dysfunction, new onset dialysis, bowel ischemia, stroke, and spinal cord ischemia. RESULTS: Forty-two patients underwent endovascular repair for ruptured SRAAAs and TAAAs, 18 of whom underwent ISF repair. Seventy-two percent of ISF patients were hypotensive before surgery, compared with 46% of the patients who underwent repair using non-ISF techniques (physician-modified endografts, parallel grafting, or double-barrel/reversed iliac branch device). The total procedural and fluoroscopy times were similar between the two groups despite a greater mean number of branch vessels incorporated with the ISF technique (3.1 vs 2.2 per patient, P = .015). In-hospital mortality was 19% for all ruptures and 25% for ruptures with hypotension. Compared with the non-ISF group, in-hospital mortality trended lower in the ISF group (11% vs 25%, P = .233), reaching statistical significance when comparing patients who presented with hypotension (8% vs 45%, P = .048). The rate of major adverse events was 57% across all techniques and did not significantly differ between the ISF and non-ISF groups, with postoperative renal dysfunction being the most frequent complication (48%). Overall, ISF became the most commonly used technique later in the study period. CONCLUSIONS: Although emergent endovascular repair of ruptured SRAAAs/TAAAs remains a challenge, a number of techniques are available for expeditious treatment. In this series, ISF was associated improve survival, including a fivefold reduction in mortality in patients presenting with hypotension, and has now become the dominant technique at our center. Despite these advantages, postoperative complications and reinterventions are common. Further experience and longer-term follow-up are needed to validate these initial results and assess durability.

Physician-Modified Fenestrated Endovascular Repair for Iatrogenic Innominate Vein Injury.

Iatrogenic innominate vein injuries are rare complications associated with internal jugular venous catheters. These complications are accompanied by high morbidity and mortality rates in patients with severe underlying medical conditions. Without proper treatment, emergency surgery may be needed due to acute cardiac tamponade or hemothorax. Endovascular repair can be advantageous for patients with significant medical comorbidities. Herein, we report the case of a 62-year-old female with an iatrogenic injury to the innominate vein at the subclavian vein and internal jugular confluence due to a malpositioned left internal jugular catheter. A customized fenestrated endograft was positioned with fenestration oriented to the internal jugular vein and a new tunneled catheter was inserted across the fenestration into the superior vena cava upon removal of the malpositioned catheter. In addition, a brachio-basilic arteriovenous fistula was created. At one month follow-up, the patient had a palpable thrill over the arteriovenous fistula and a functioning tunneled catheter.

Use of Inner Branches During Physician-Modified Endografting for Complex Abdominal and Thoracoabdominal Aortic Aneurysms.

OBJECTIVES: Endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms have been performed widely in an increasing number of centers, utilizing custom-manufactured or physician-modified stent grafts containing fenestrations and side-arm branches for visceral and renal artery incorporation. Alternatively, inner branch configurations may be useful in complex anatomy, where application of fenestrations or side-arm branches can be challenging. Our study aims to evaluate the incidence of target vessel instability when incorporated with inner branch configurations, and report clinical outcomes of patients who underwent fenestrated/branched endovascular aortic repairs (F-BEVAR) containing one or more inner branches. METHODS: We reviewed patients who underwent F-BEVAR with at least one inner branch configuration for complex abdominal or thoracoabdominal aortic aneurysms at Keck Hospital of University of Southern California from 2014 to 2020. Endpoints were mortality, major adverse events (MAE), technical success, and target vessel instability. Target vessel instability was assessed using follow-up computed tomography (CT) and duplex imaging. RESULTS: Out of the 175 patients who underwent F-BEVAR for complex abdominal and TAAA during the study period, 17 patients had at least one inner branch configuration. All were deemed high-risk for open repair with multiple cardiovascular and/or pulmonary comorbidities. Eight (47%) patients had extent I, II, III thoracoabdominal aortic aneurysms, and 10 (59%) had prior aortic repairs. A total of 68 target vessels were incorporated (mean = 4 vessels/patient, range=1~6), of which 40% were inner branch configurations, most commonly for renal arteries. Technical success was 94.1%. There was one perioperative mortality due to massive myocardial infarction, as well as one patient who needed temporary hemodialysis. No device-related mortalities were observed. At 30 days, primary inner branch patency was 100% with no target vessel instability or reintervention. At mean follow-up of 5.8 months, the overall survival was 94% with one patient who expired from unknown cause. Overall primary inner branch patency was 96.3%, due to occlusion of a long lumbar artery branch with no clinical sequelae. CONCLUSION: Inner branch configurations can provide a safe alternative technique of branch incorporation during complex endovascular aortic repair.