Factors associated with lack of clinical improvement after vein ablation in the vascular quality initiative.

BACKGROUND: Insurance companies have adopted variable and inconsistent approval criteria for chronic venous disease (CVD) treatment. Although vein ablation (VA) is accepted as the standard of care for venous ulcers, the treatment criteria for patients with milder forms of CVD remain controversial. This study aims to identify factors associated with a lack of clinical improvement (LCI) in patients with less severe CVD without ulceration undergoing VA to improve patient selection for treatment. METHODS: We performed a retrospective analysis of patients undergoing VA for CEAP C2 to C4 disease in the Vascular Quality Initiative varicose veins database from 2014 to 2023. Patients who required intervention in multiple veins, had undergone prior interventions, or presented with CEAP C5 to C6 disease were excluded. The difference (Δ) in venous clinical severity score (VCSS; VCSS before minus after the procedure) was used to categorize the patients. Patients with a ΔVCSS of ≤0 were defined as having LCI after VA, and patients with ≥1 point decrease in the VCSS after VA (ΔVCSS ≥1) as having some benefit from the procedure and, therefore, "clinical improvement." The characteristics of both groups were compared, and multivariable regression analysis was performed to identify factors independently associated with LCI. A second analysis was performed based on the VVSymQ instrument, which measures patient-reported outcomes using five specific symptoms (ie, heaviness, achiness, swelling, throbbing pain, and itching). Patients with LCI showed no improvement in any of the five symptoms, and those with clinical improvement had a decrease in severity of at least one symptom. RESULTS: A total of 3544 patients underwent initial treatment of CVD with a single VA. Of the 3544 patients, 2607 had VCSSs available before and after VA, and 420 (16.1%) had LCI based on the ΔVCSS. Patients with LCI were more likely to be significantly older and African American and have CEAP C2 disease compared with patients with clinical improvement. Patients with clinical improvement were more likely to have reported using compression stockings before treatment. The vein diameters were not different between the two groups. The incidence of complications was overall low, with minor differences between the two groups. However, the patients with LCI were significantly more likely to have symptoms after intervention than those with improvement. Patients with LCI were more likely to have technical failure, defined as vein recanalization. On multivariable regression, age (odds ratio [OR], 1.01; 95% confidence interval [CI], 1.00-1.02) and obesity (OR, 1.47; 95% CI, 1.09-2.00) were independently associated with LCI, as was treatment of less severe disease (CEAP C2; OR, 1.82; 95% CI, 1.30-2.56) compared with more advanced disease (C4). The lack of compression therapy before intervention was also associated with LCI (OR, 6.05; 95% CI, 4.30-8.56). The analysis based on the VVSymQ showed similar results. CONCLUSIONS: LCI after VA is associated with treating patients with a lower CEAP class (C2 vs C4) and a lack of compression therapy before intervention. Importantly, no significant association between vein size and clinical improvement was observed.

Variations and inconsistencies in venous ablation coverage policies between single-state and multistate carriers in the United States.

BACKGROUND: Vein ablation is a common and effective treatment for patients with chronic venous insufficiency. The overuse of vein ablation despite the existence of evidence-based guidelines has resulted in insurance companies developing restrictive policies for coverage that create barriers to appropriate care. This study compares the insurance coverage by single-state carriers (SSCs) and multistate carriers (MSCs), highlighting the variations and inconsistencies in the various policies. METHODS: The American Venous Forum Venous Policy Navigator was reviewed for the various policies available in the United States. The policies were divided into SSCs and MSCs. The characteristics of the policies, including the anatomic and hemodynamic criteria for specific veins, duration of conservative treatment, disease severity, symptoms, and types of procedures covered, were compared between the two groups. SAS, version 9.4 (SAS Institute Inc) was used for statistical analysis. RESULTS: A total of 122 policies were analyzed and divided between SSCs (n = 85; 69.7%) and MSCs (n = 37; 30.3%). A significant variation was found in the size requirement for great saphenous vein ablation. Although 48% of the policies did not specify a size criterion, the remaining policies indicated a minimal size, ranging from 3 to 5.5 mm. However, no significant differences were found between SSCs and MSCs. Similar findings were encountered for the small and anterior accessory saphenous veins. MSCs were more likely to define a saphenous reflux time >500 ms compared with SSCs (81.1% vs 58.8%; P = .04). A significant difference was found between the SSCs and MSCs in the criteria for perforator ablation in terms of size and reflux time. MSCs were significantly more likely to provide coverage for mechanochemical ablation than were SSCs (24.3% vs 8.2%; P = .03). SSCs were more likely to require ≥12 weeks of compression stocking therapy than were MSCs (76.5% vs 48.7%; P = .01). No significant differences were found in the clinical indications between the two groups; however, MSCs were more likely to mention major hemorrhage than were SSCs. CONCLUSIONS: The results of this study highlight the variations in policies for venous ablation, in particular, the striking inconsistencies in size criteria. MSCs were more likely to cover mechanochemical ablation and require a shorter duration of conservative therapy before intervention compared with SSCs. Evidence-based guidance is needed to develop more coherent policies for venous ablation coverage.

Comparison Study of Iliac Branch Endoprosthesis when Used on and off Label.

BACKGROUND: The aim of this study is to compare how instructions for use (IFU) affected perioperative and intermediate term outcomes for common iliac artery aneurysms (CIAA) treated with the Gore Excluder iliac branch endoprosthesis (IBE). METHODS: A retrospective analysis was performed of all patients treated at two affiliated academic centers from September 2016 to May 2020. Outcomes were compared between IFU and nonIFU IBE cases. Criteria for nonIFU included: (1) use with a nonGore aortic endoprosthesis (n = 10), (2) isolated IBE (n = 3), and (3) requiring nondedicated covered stents for additional extension into a more suitable landing zone in the ipsilateral internal iliac artery or one of its branches (n = 11). Perioperative and intermediate term data were collected for both groups. The primary end points were free from the major adverse event (MAE) at 30 days and primary effectiveness at 1 year. RESULTS: A total of 51 CIAA (39 patients) were treated with an IBE. Overall, 15 patients were treated under IFU and 24 under nonIFU. The IFU group mean age was older (72 vs. 67 years, P = 0.03), and males (97%) were primarily treated. Comorbidities were similar except nonIFU had more patients with previous endovascular abdominal aortic aneurysm repair on presentation (0 vs. 4 cases, P = 0.04). Procedure (178 vs. 264 min, P = 0.02) and fluoroscopy (52 vs. 74 min, P = 0.04) times were longer in the nonIFU group. Technical success was 100% for both groups, and there was no difference in device related reintervention at 30 days (0 vs. 1, P = 0.44). There was no MAE in either group at 30 days. Intervention for any endoleak was similar between the groups (2 vs. 3, P = 0.94). Percent CIAA sac regression was similar between the groups (19% vs. 18%, P = 0.21). There was no difference for primary effectiveness at 1 year (93% vs. 92%, P = 0.85). There was one death per group at one year not related to an aortic or iliac cause. CONCLUSIONS: In properly selected patients with complex anatomy, IBE can be used with nondedicated aortic and internal iliac components with good early term outcomes.

Sharp Recanalization with the Upstream GoBack Catheter for Chronic Occlusive Ilio-Caval Thrombosis.

Recanalization of chronic iliofemoral deep vein thrombosis is indicated to reduce symptoms and improve quality of life. However, recanalization is dependent on the ability to cross chronic obstructions. We present a case of chronically thrombosed inferior vena cava and common iliac veins that failed conventional crossing techniques but were successfully recanalized using the recently approved Upstream GoBack Crossing Catheter.

A comparison of stenting versus hemodialysis reliable outflow graft for hemodialysis patients with recurrent central venous obstructions.

BACKGROUND: Central venous occlusive disease is a common cause of upper extremity arteriovenous access dysfunction in hemodialysis patients. When refractory to balloon angioplasty, the treatment options include central venous stenting and hemodialysis reliable outflow (HeRO; Merit Medical, South Jordan, Utah) graft. The purpose of the present study was to evaluate the outcomes of these options. METHODS: A retrospective review was performed of patients who had undergone central venous stenting or HeRO placement for central venous obstruction from December 2008 to March 2018. The primary outcomes were the reintervention rates, patency, and mortality. RESULTS: A total of 75 hemodialysis patients were identified after failed balloon angioplasty for central venous obstruction. Of the 75 patients, 44 underwent central venous stenting comprising coverage of the subclavian vein (n = 27), innominate vein (n = 18), and/or superior vena cava (n = 5). Six stent patients later underwent HeRO placement. The stents used were stent grafts in 65% (Viabahn, n = 9; Fluency/Flair, n = 19; iCast, n = 2; and other, n = 1) and bare metal stents in 35% (Wall-stent, n = 6; Protégé, n = 1; Cobalt, n = 1; and other, n = 9). The remaining 31 patients underwent HeRO graft placement. The venous outflow component insertion sites were the internal jugular (n = 20), external jugular (n = 1), subclavian (n = 6), axillary (n = 2), and other (n = 2). The stent and HeRO groups were similar in the previous central venous intervention rates (median, 0.6 [interquartile range (IQR), 0-3.0]; vs median, 3.5 [IQR, 0-10.1] annually; P = .679). After the index procedure, no difference was found between the two groups in the frequency of dialysis circuit interventions annually (median, 2.0 [IQR, 0-6.0]; vs median, 2.0 [IQR, 0-7.0]; P = .291) nor central venous interventions (ie, angioplasty of the central veins or within the portion of the HeRO inside the central veins) annually (median, 2.0 [IQR, 0-4.1]; vs median, 0 [IQR, 0-2.4]; P = .419). The 1-year access circuit primary patency was 8.1% for stenting and 22.2% for HeRO (P = .109). The 2-year access circuit secondary patency was 40.0% for stenting and 52.4% for HeRO (P = .401). The all-cause mortality was similar at 1 year (3.7% vs 4.8%; P = .856) and 2 years (11.8% vs 23.5%; P = .368). CONCLUSIONS: Central venous stenting and HeRO were shown to have similar rates of reintervention and patency. The results from the present study suggest that the multiple treatment options available for this problematic disease process can yield similar results when careful patient selection is applied.

Optimal In Situ Fenestration Technique With Laser Perforation and Balloon Dilation for Aortic Stent-Grafts.

PURPOSE: To evaluate the response of various stent-grafts after laser fenestration and dilation with noncompliant balloons to determine the optimal therapeutic combination for this treatment technique. MATERIALS AND METHODS: Five aortic stent-grafts were evaluated ex vivo: the Bolton RelayPlus, Jotec E-vita Thoracic 3G, Medtronic Valiant, Cook Zenith Alpha, and Vascutek Anaconda. Small holes were created using an excimer laser with the grafts submerged in saline. Five rows of 5 fenestrations were created, 4 holes in each row were dilated once with a 6-, 8-, 10-, or 12-mm-diameter noncompliant balloon to the specified nominal pressure (one hole served as the control). The saline solution from each stent-graft was collected and qualitatively analyzed for debris. The fenestrations were evaluated under light and scanning electron microscopes. The maximum diameter and area for each fenestration were measured. The direction and length of tears were assessed. RESULTS: The fenestration was feasible and reproducible in all the stent-grafts. The mean area of fenestration ranged from 7.63±1.63 to 14.75±0.73 mm2 when using balloons of 6- and 8-mm diameter, respectively. The 10- and 12-mm-diameter balloons caused a significant increase in area, variability, and tearing. The Anaconda graft tended to tear in the weft direction, while the other devices tore in the warp direction when using the 10- and 12-mm-diameter balloons. Dilation of the RelayPlus and Anaconda grafts with 6- and 8-mm-diameter balloons provided minimal tearing and precise fenestrations. Melted fiber remnants were observed after filtration of the saline solution for all devices. CONCLUSION: Laser fenestration and dilation with noncompliant balloons is a relatively simple and reproducible option for revascularization in urgent, complex aortic endovascular repairs. In our model, large balloons (ie, >10 mm) increased the destruction and tearing of the fabric. The maximum dilation recommended is 6 to 8 mm to avoid significant tears. Development of stent-grafts or novel fabrics designed explicitly for fenestration is needed to reduce potential complications.

The impact of a rapid imaging protocol in acute cholecystitis-prospective cohort study.

INTRODUCTION: In this study we assess the impact of a "rapid imaging protocol" (RIP) on outcomes in patients with suspected acute cholecystitis (AC). METHODS: From January 2017 to January 2018, a prospective cohort study was implemented using a RIP with hepatoscintigraphy (HIDA) or CT scan (first available, goal within 4 h) in patients (n = 52) presenting with highly suspected AC and a clinical feature score of ≥1. For the latter, the following presenting features were scored as follows: 1 point for WBC count ≥10,000 (109/L), 1.5 points for glucose ≥140 (mg/dl), and/or 1 point for age ≥50 yrs. The historical control was all patients admitted with suspected AC in a 1.5-year period (n = 117) under our previous "delayed imaging protocol" (DIP), which used US ± HIDA (post-admission) in select patients. Primary end points included: compare outcome and quality measures between the groups, evaluate diagnostic imaging performance for AC, and evaluate our proposed clinical feature score in the setting of AC. RESULTS: Histopathologic features consistent with AC was more frequent in patients in the RIP (64% vs 39%, p = 0.008). The pooled positive predictive value of HIDA and CT scan for AC were 85% vs 94%, respectively. The RIP was associated with a significant reduction in time to surgery, length of stay, and conversions to open (p < 0.001, respectively). A clinical feature score of 3.5 predicted the likelihood of AC in 95% of the cases (x2 for linear trend = 42, p < 0.001). CONCLUSION: A protocol centered around rapid identification, defined clinical criteria (i.e. clinical feature score), and confirmation with non-user dependent imaging modalities has resulted in favorable outcomes. CT may be the study of choice when the likelihood of AC is high because it is superior at identifying severity.

Identification and management of cough-induced laryngotracheitis.

Chronic cough is associated with repetitive injury to the upper airway and trachea, which can lead to an underdiagnosed pathology known as "cough-induced" laryngotracheitis (CILT). In this report, we describe a case of CILT that responded well to dual therapy.

Symptomatic, unilateral, isolated, complete persistent sciatic vein.

Persistent sciatic vein is a rare anomaly of mesodermal development. When found, it is often associated with varicosities in abnormal distributions, pain, limb congestion, and hypertrophy. In this report, we describe a case of an isolated, complete persistent sciatic vein with an atypical anatomy and onset.

Hybrid operative thrombectomy is noninferior to percutaneous techniques for the treatment of acute iliofemoral deep venous thrombosis.

OBJECTIVE: Hybrid operative thrombectomy (HOT) is a novel technique for the treatment of acute iliofemoral deep venous thrombosis (IFDVT) and is an alternative to percutaneous techniques (PTs) that use thrombolytics. In this study, we compare perioperative and intermediate outcomes of HOT vs PT as interventions for early thrombus removal. METHODS: From July 2008 to May 2015, there were 71 consecutive patients who were treated with either PT (n = 31) or HOT (n = 40) for acute or subacute single-limb IFDVT. HOT consisted of surgical thrombectomy with balloon angioplasty with or without stenting by a single incision and fluoroscopically guided retrograde valve manipulation to extract the thrombus. PT included catheter-directed thrombolysis with or without pharmacomechanical thrombectomy using the Trellis-8 system (Bacchus Vascular, Santa Clara, Calif). Patients who presented with bilateral DVT (n = 4), inferior vena cava involvement (n = 8), or venous gangrene (n = 1) were excluded. Perioperative outcomes, quality measures, and thrombus resolution were compared between the two treatment groups. Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification, Villalta score, and venous duplex ultrasound at intermediate follow-up were also analyzed. RESULTS: The left limb was the most common site of the IFDVT overall. Technical success (≥50% resolution) was 100% for both groups, and >80% resolution was achieved in all patients treated with HOT. There were eight major bleeding events in the PT group compared with three in the HOT group (P = .04). PT patients had a significantly longer length of stay (13 vs 10 days; P = .028) compared with HOT. At 2-year duplex ultrasound examination, there was no difference between HOT and PT in mean reflux times at the femoral-popliteal segment. At 2 years, 85% and 87% of the patients (HOT vs PT, respectively) had not developed post-thrombotic syndrome, and there was no difference between the groups for mean Villalta score (2.1 ± 1.9 vs 2.3 ± 2; P = .79). CONCLUSIONS: PT and HOT have demonstrated good outcomes in the perioperative and intermediate periods. HOT is noninferior to PT as a technique for early thrombus removal and has the advantages that thrombus resolution is established in one operation and length of stay is significantly decreased. HOT avoids thrombolytic therapy, which may reduce major bleeding events.

Clinical implications of hepatobiliary scintigraphy and ultrasound in the diagnosis of acute cholecystitis.

BACKGROUND: We assess the performance of ultrasound (US) and hepatobiliary scintigraphy (HIDA) as confirmatory studies in acute cholecystitis (AC) and demonstrate our current imaging protocol's impact on outcomes. STUDY DESIGN: Between January 2013 to July 2014, 117 patients were admitted through the emergency room with a preliminary diagnosis of AC. Overall, 106/117 (91%) of the patients received US preadmission and 34/117 (29%) received a HIDA post admission. Primary end points included: 1) diagnostic test reliability for AC, and 2) outcome and quality measures (time to surgery, LOS, costs, etc.). RESULTS: Laparoscopic cholecystectomy was performed in 96/117 (82%) and open cholecystectomy in 21/117 (18%) of the patients. Overall, histopathologic features consistent with AC was present in 46/117 (39%). AC alone was present in 23/117 (20%), and AC superimposed on chronic cholecystitis was present in 23/117 (20%). For AC, US had a sensitivity and specificity of 26% and 80%, respectively. HIDA scan had a sensitivity and specificity of 87% and 79%, respectively. Time to surgery (TTS) was 4 vs 2.3 days in patients who received HIDA vs US alone (p = 0.001), and length of stay (LOS) was 6.7 vs 4.3 days, respectively (p = 0.001). Age >50 years, glucose >140 (mg/dl), and WBC count >10 (×109 /L) were statistically significant independent variables associated with AC. CONCLUSION: HIDA scan is superior to US as a diagnostic study in the setting of AC. Our current protocol of delayed HIDA (post-admission) was associated with increased TTS, LOS, and overall costs. Early confirmation with HIDA in high risk patients may hasten treatment allocation and improve outcomes in the setting of AC.

Symptomatic iliofemoral deep venous thrombosis treated with hybrid operative thrombectomy.

During the past 15 years, strategies that promote immediate and complete thrombus removal have gained popularity for the treatment of acute-onset iliofemoral deep venous thrombosis. In this case report, we describe a novel operative approach to venous thrombus removal known as hybrid operative thrombectomy. The technique employs a direct inguinal approach with concomitant retrograde advancement of a balloon catheter by femoral venotomy. Moreover, it provides effective thrombus removal through a single incision, with or without stent placement, and has the advantage of a completion venogram.

Large cardiac tumor managed with resection and two ventricular assist devices.

Symptomatic cardiac tumors can lead to a rapid clinical deterioration and death. Prompt surgical resection is ideal in this situation as it is the only proven treatment to date. We report the radical resection of a large malignant cardiac tumor that obstructed the right ventricular outflow tract. Extensive resection precluded reconstruction and limited the ability to implant a total artificial heart; thus, 2 paracorporeal devices were implanted instead.

General surgery considerations in the era of mechanical circulatory assist devices.

Much of the success of left ventricular assist devices (LVAD) can be attributed to the second-generation HeartMate II (Thoratec, Pleasanton, CA, USA), which is the most commonly used device to date. The latest generation of LVADs is currently undergoing clinical trials worldwide. Developers have focused on improving the limitations of the second generation with emphasis on enhancing efficiency further, decreasing complications, and increasing ease of implantability. Clinical management of a patient with an LVAD is also an excellent example of the multidisciplinary approach of care that is undoubtedly the future of medicine.

Ventricular assist devices (VAD) therapy: new technology, new hope?

Ventricular assist devices are commonly utilized in the treatment of end-stage heart failure. Advances in continuous flow technology have improved efficiency, size, implantability, extended support, and overall patient outcomes. This has led to an expanded role of left ventricular assist device (LVAD) clinical use and applications. This review describes the advances and current state of LVAD devices and provides a future outlook for this technology.