Safety and efficacy of stenting nonthrombotic iliac vein lesions in octogenarians and nonagenarians in an office setting

Vascular ◽  
2017 ◽  
Vol 26 (1) ◽  
pp. 70-74 ◽  
Author(s):  
Pavel Kibrik ◽  
Justin Eisenberg ◽  
Ahmad Alsheekh ◽  
Syed Ali Rizvi ◽  
Afsha Aurshina ◽  
...  

Objectives Treatment options for venous insufficiency are rapidly evolving in the office setting and include venography, intravascular ultrasound, and venous stenting. Non-thrombotic iliac vein lesions assessment and treatment in an office setting is currently an area of interest. The purpose of this study is to demonstrate the safety and efficacy of evaluating non-thrombotic iliac vein lesion with this office-based procedure in octogenarians and nonagenarians. Methods From January 2012 through December 2013, 300 non-thrombotic iliac vein lesion limbs in 192 patients with venous insufficiency ≥80 years old were evaluated for non-thrombotic iliac vein lesion. Patients were evaluated and treated with venography, intravascular ultrasound, and stent placement for significant lesions demonstrated by greater than 50% diameter or cross-sectional area reduction. Group 1: 168 of these patients were octogenarians; female/male ratio was 1.75:1, bilateral in 89/168 patients (53%), left sided in 131/259 limbs (51%), right sided in 128 limbs (49%), average age 83.5 ± 2.6 years (range 80–89) compared to Group 2: 24 nonagenarians; female/male was 3:1, bilateral in 17/24 patients (70%), left sided in 20/41 limbs (49%), right sided in 21/41 limbs (51%), average age 92.9 ± 2.2 years (range 90–99). Stent related outcomes were evaluated with communication to the patient within 24 h to assess post-procedure pain followed by serial iliocaval ultrasonography. Results Out of the 300 limbs evaluated, in Group 1, 86% of limbs had stents placed compared to 90% in Group 2 and 11% of both groups had two stents placed. Overall improvement in pain, edema, and ulcers was reported in 147 (59%) of octogenarians and 24 (65%) of nonagenarians. There were no surgical site infections, pseudo-aneurysms, arteriovenous fistulas, or femoral artery injuries. No patients required transfusion within three days post-operatively and there were no 30-day mortalities in both sets of patients. Conclusions Our results demonstrate that there is no statistical difference in the outcome of performing venography, intravascular ultrasound, and stent placement in an office-based setting in octogenarians and nonagenarians. Both groups maintained a similar safety profile with low morbidity and mortality. In conclusion, we believe that the treatment of non-thrombotic iliac vein lesion in an office-based setting is safe and efficacious in both groups.

Vascular ◽  
2019 ◽  
Vol 27 (6) ◽  
pp. 617-622 ◽  
Author(s):  
Jesse Chait ◽  
Nikolay Davis ◽  
Yuriy Ostrozhynskyy ◽  
Sareh Rajaee ◽  
Natalie Marks ◽  
...  

Objective Fluoroscopic-guided interventions have become a major part of the modern vascular surgeon’s practice. Imaging is typically required to safely and effectively perform both simple and complex endovascular interventions. With an ever-increasing volume of fluoroscopic-guided interventions being performed each year, the minimization of harmful radiation exposure has become of paramount concern for both patients and providers. The purpose of this study was to identify the extent of radiation exposure associated with venography and iliac vein stenting, an intervention utilized in the management of chronic venous insufficiency. Methods This was a single-center, retrospective analysis of 40 venograms performed on 29 unique patients over a three-month period. Patients with signs and symptoms of chronic venous insufficiency who failed conservative therapy underwent evaluation of the vena cava and iliofemoral veins with venography and intravascular ultrasound. Stent placement was performed if a >50% cross-sectional area or diameter reduction was identified via intravascular ultrasound. All patients were found to have non-thrombotic iliac vein lesions. All patients wore two individual film badge dosimeters – one on their chest and the other on the abdomen. The same mobile C-arm system was used for all interventions. Results There were 15 males and 14 females, with an average age of 70.6 years old (SD ± 9.5; range 53–89) and a mean body mass index of 33.9 kg/m2. Sixteen limbs had C6 disease, 10 had C4 disease, and 14 had C3 disease. Thirty-eight of the 40 procedures resulted in stent placement, with an average of 1.13 stents placed per intervention. The average fluoroscopy time was 76.5 s (SD ± 36.9; range 7.8–209.5), and the mean cumulative air kerma was 1.08 mGy (SD ± 0.55; range 0.362–2.24). Average cumulative air kerma was higher in procedures resulting >1 stent placement compared to those with placement of ≤1 stent (1.44 vs. 1.02 mGy; p = 0.04). Fluoroscopy time was also higher in procedures with >1 stent placed (120.1 vs. 68.8 s; p = 0.0004). The mean deep dose equivalent per procedure from the patient-worn abdominal badge was 0.221 mSv. Conclusion With the adjunctive use of intravascular ultrasound, iliac vein stenting can be safely and effectively performed with very low utilization of fluoroscopy, and therefore radiation exposure can be minimized for both patients and surgeons. Placement of >1 iliac vein stent resulted in higher cumulative air kerma and fluoroscopy time.


2020 ◽  
pp. 64-75
Author(s):  
E. Burleva ◽  
O. Smirnov ◽  
S. Tyurin

The purpose of the study was to conduct a comparative assessment of the course of the postoperative period after phlebectomy and thermal ablation in patients with varicose veins of the lower extremities in the system of the great saphenous vein (GSV) with class C2 of chronic venous insufficiency (CVI) — CEAP class C2. Materials and methods: 455 patients (455 limbs) with CEAP class C2. Group 1 (n = 154) received stripping + minimally invasive phlebectomy; Group 2 — endovenous laser ablation (EVLA) of GSV trunk + sclerotherapy of varicose veins; 3 group (n = 150) — radiofrequency ablation (RFA) of the GSV + sclerotherapy. All patients were united by a single tactical solution — the elimination of pathological vertical reflux in GSV. In each group, patients were with similar hemodynamic profile were selected (Group 1 = 63; Group 2 = 61; Group 3 = 61). The course of the postoperative period (from 2 days to 2 months) was compared for pain (visual analog scale — VAS), clinical symptoms of chronic venous insufficiency, degree of satisfaction (Darvall questionnaire), and duration of disability. Statistical processing was carried out using Excel programs for Windows XP, MedCalc® (version 11.4.2.0., Mariakerke, Belgium). Results: Postoperative pain is more pronounced (during day 1 for Group 1–4.0, Group 2–3.0, Group 3–2.0) and more prolonged (up to 4 days) after open surgeries (p < 0.05). The dynamics of the clinical symptoms of CVI (including varicose syndrome and use of compression therapy) could not be fully evaluated in connection with the ongoing sclerotherapy procedures for patients of Groups 2 and 3. Satisfaction of patients with aesthetic aspects was higher than expected in all groups. Reliable statistical differences proved decrease in days of disability (Group 1–14; Group 2–4; Group 3–3) and earlier return to physical activities and work in patients after thermal ablation in comparison with phlebectomy. Conclusion: The study shows that all three methods for eliminating vertical reflux in the GSV can be proposed for a large category of patients with CEAP of class C3 and C2. Medical and social rehabilitation of patients using endovascular thermal ablation technologies proceeds faster, which is beneficial both for the patients and for society.


1998 ◽  
Vol 15 (2) ◽  
pp. 143-149 ◽  
Author(s):  
Timothy D. Parish

Introduction: The aesthetic presentation and subsequent management of varicosis are well accepted. However, the association of pain and its impact on varicosis is less well understood. The purpose of this study is to define the interrelationship of pain with the anatomic and physiological presentation of patients with primary varicosis. Materials and Methods: This is an ongoing prospective demographic study of sequential patients presenting randomly at the Varicosis and Laser Center of Alabama for the evaluation of varicosis. All patients were given standard questionnaires to evaluate their reasons for presentation. Later in the study, those who selected pain were asked to identify the perceived intensity of their pain by the use of “smiley faces.” Patients were clinically divided into three groups: group 1, those with spider and reticular vein disease; group 2, those with mixed large- and small-vein disease; and group 3, those with large-vein disease (>4 mm). Results: Seventy-seven percent of patients presenting with varicosis had pain. The correlation of pain with varicosis may indicate a more prevalent association with chronic venous insufficiency. This association was of greater significance in those patients with large-vein disease (>4 mm). The use of smiley faces to monitor perceived intensity of pain revealed a significant result in all clinical groups. The character of the pain was described in multiple terms. Discussion: Pain is a prevalent condition in those patients presenting with primary varicosis. Pain is associated with a greater likelihood of chronic venous insufficiency, in large-vein disease. The association of varicosis with pain and chronic venous insufficiency allows categorization into four functional classes.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2893-2893 ◽  
Author(s):  
Andrew D. Zelenetz ◽  
Jacob D. Soumerai ◽  
Deepa Jagadeesh ◽  
Nishitha Reddy ◽  
Anastasios Stathis ◽  
...  

Abstract Background: ME-401, a potent and selective oral PI3kδ inhibitor, achieved a high rate of early and durable responses in patients with follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) when administered once daily in 28-day cycles on a continuous schedule (CS) in a dose escalation Phase 1b study (Soumerai et al, ASCO 2018:#7519). The most common adverse events (AEs) were the delayed onset (beyond Cycle 2) of grade 3 diarrhea and rash, which were reversible with drug interruption and/or corticosteroids. These delayed AEs were thought to be due to pathway inhibition in regulatory T cells (Treg) leading to a disruption in immune homeostasis. We hypothesized that an intermittent schedule (IS) beyond Cycle 2 might mitigate or reduce the incidence of significant delayed AEs. The IS tested was selected based on the kinetics of Treg repopulation, and consists of ME-401 administered on days 1-7 of a 28-day cycle. We report preliminary results of this strategy. Methods: Group 1 included 31 patients with relapsed FL (n = 22) or CLL/SLL (n = 9) who received ME-401 on a CS at doses ≥60 mg per day. 11/29 patients (38%) who received >2 cycles of therapy had developed delayed grade 3 AEs on CS and could be re-challenged with either the CS or IS (from December 2017 onward) following recovery from toxicity. The other 18/29 patients (62%) had not developed a grade 3 AEs of interest on CS and, beginning in December 2017, were switched to IS after a median of 26 weeks (range, 8-49) of daily dosing. Group 2 included 15 patients with relapsed FL (n = 9), diffuse large B-cell lymphoma (n = 4), marginal zone lymphoma (MZL, n = 1), and CLL (n = 1) who received rituximab 375 mg/m2 x 8 doses over 6 months and ME-401 at 60 mg daily x 2 cycles then switched to the IS. Group 3 includes 30 patients with relapsed FL/CLL/SLL enrolling in an expansion cohort of ME-401 alone at 60 mg daily x 2 cycles then switching to IS. Results: Group 1: Of the 11 patients who developed a delayed grade 3 AE on CS, 6 were never re-challenged, 2 were re-challenged with CS with recurrence of their AE, and 3 were re-challenged with IS without recurrence of their AE. Of the 18 patients switched to the IS, and with a median follow-up of 5.2 months (range, 2.3-6.6) on IS, 3 developed grade 3 diarrhea on IS, 2 in the first cycle and 1 in the second cycle after the switch to IS, of whom 2 have been re-treated with IS for 1+ and 5+ months without recurrence of the AE. One patient was not evaluable for response due to discontinuation on Day 28 for personal reasons and 27/30 (90%) evaluable patients achieved an objective response. With a median follow-up of 9.4 months (range, 2.2-17.5) from enrollment, only 2/27 (7%) responders had disease progression (PD) on CS and were discontinued. Of the 18 patients who were switched to IS, only 1 SLL patient with a partial response (PR) achieved on CS developed PD on IS and was successfully rescued with switch back to CS. Another CLL patient in PR on CS had 10% increase in SPD from nadir in Cycle 5 on the IS and was switched back to CS. Group 2: 10/15 patients have completed 2 cycles of daily dosing at the time of analysis and were systematically switched to IS. With a median follow-up of 3.4 months (range, 1.5-5.7) on IS, only 1/10 patients developed delayed grade 3 diarrhea in the first cycle after switch to IS. 7/10 patients (70%) with FL/MZL achieved an objective response and no PD was reported with a median follow-up of 5.2 months (range, 3.1-7.5) from enrollment. Conclusions: Preliminary data suggest that switching to an intermittent schedule consisting of ME-401 administered on days 1-7 of a 28-day cycle following 2 cycles of continuous daily dosing was associated with a low rate of delayed grade 3 AEs and was associated with preservation of response in the vast majority of patients. All delayed grade 3 AEs of interest on IS occurred within 1-2 cycles of switching from CS to IS, suggesting that these might have represented a delayed effect of daily dosing. IS may also be a suitable re-treatment strategy in patients with delayed AEs on CS. Safety and efficacy data for the expansion cohort of 30 patients treated with ME-401 at 60 mg for 2 cycles then switched to IS will be presented at the meeting. A randomized study comparing CS and IS in FL is planned. Disclosures Zelenetz: Abbvie: Research Funding; Celgene: Consultancy; AstraZeneca: Consultancy; Novartis/Sandoz: Consultancy; Amgen: Consultancy; Gilead: Consultancy, Research Funding; Genentech/Roche: Consultancy, Research Funding. Reddy:MEI Pharma: Research Funding. Stathis:Oncology Therapeutic Development: Research Funding. Ghalie:MEI Pharma: Employment, Equity Ownership; Viracta Therapeutics: Membership on an entity's Board of Directors or advisory committees. Pagel:Pharmacyclics, an AbbVie Company: Consultancy; Gilead: Consultancy.


2005 ◽  
Vol 119 (4) ◽  
pp. 272-276 ◽  
Author(s):  
Kenny P Pang

A collapsible airway is often the common denominator in sleep-disordered breathing (SDB). The upper respiratory tract includes the nasal passage, nasopharynx, oral cavity, oropharynx, base-of-tongue region and the hypopharynx. It is believed that the highest amount of resistance in the upper respiratory tract is in the nasal cavities, and particularly the nasal valve. Most authors believe that when considering surgical options for patients with obstructive sleep apnoea (OSA) it is imperative to correct nasal pathology together with the other sites of airway obstruction. In this retrospective study, I sought to investigate the safety and efficacy of one-stage nasal and multi-level pharyngeal surgery. I compared two groups of patients: group 1, receiving one-stage nasal and multi-level pharyngeal surgery; and group 2, receiving only multi-level pharyngeal surgery. In group 1, nine out of 12 patients (75 per cent) met the criteria for surgical success, with a mean pre-operative apnoea-hypopnoea index (AHI) decreasing from 36.3 to 8.9 post-operatively (p<0.0002), while in group 2, 25 out of 40 patients met the surgical success criteria (62.5 per cent), with their mean AHI decreasing from 52.6 to 10.2 (p<0.0000). When comparing the surgical success rates between the two groups, it was not statistically significant, at p>0.106. There were no postoperative respiratory-related complications despite having bilateral nasal Merocel (tampon) packing in place (in group 1), and none of the patients in either group had any desaturation, hypoxaemia, apnoea or OSA-related complications. This series suggests that, with adequate post-operative monitoring, it is both safe and efficacious to perform both nasal and multi-level pharyngeal surgery in the one surgical session.


2020 ◽  
Vol 35 (10) ◽  
pp. 771-776
Author(s):  
Atıf Yolgösteren ◽  
Leyla Köse Leba ◽  
Aylin Bican Demir

Background We aimed to investigate of chronic venous insufficiency on patients with sleep disorder due to restless legs syndrome. Method Five hundred forty-one cases on whom polysomnography was performed due to sleep disorder were evaluated retrospectively. Forty patients with restless legs syndrome were determined. They were examined by history, physical examination, and duplex ultrasonography in terms of chronic venous insufficiency. The sleep stage rates of both groups were compared (that the rate of total sleep time in polysomnography to sleep stages is expressed as minute and percentage has been defined as sleep stage rate). Result Chronic venous insufficiency was identified in 20 out of 40 patients (group 1; female, 90%). In group 2, there were patients with only restless legs syndrome but with no chronic venous insufficiency (female, 80%). The mean ages of both groups were 56.4 ± 11.8 and 54.3 ± 14.7 years. Stage 1 sleep rate in group 1 was 5% ± 2.7 and in group 2 was 8% ± 3.8 (p = 0.006). Periodic limb movement index (polysomnography finding evaluating involuntary leg movements during sleep) was 11.4 ± 17.5 in group 1, and it was 29.4 ± 37.9 in group 2 (p = 0.006). Conclusion We recommend that chronic venous insufficiency should be investigated in patients with primary restless legs syndrome diagnosis.


Vascular ◽  
2017 ◽  
Vol 25 (3) ◽  
pp. 249-252 ◽  
Author(s):  
Ahmad Alsheekh ◽  
Anil Hingorani ◽  
Natalie Marks ◽  
Yuriy Ostrozhynskyy ◽  
Enrico Ascher

Background The development and use of minimally invasive procedures provide improved options for the management of symptoms of chronic venous insufficiency. While many patients with iliac venous occlusive disease and superficial venous insufficiency improve with combined iliac venous stenting and correction of superficial venous reflux, some patients have symptoms which persist. The goal of this study was to identify clinical factors related to persistent symptoms in patients with leg swelling after treatment of both iliac vein stenting and thermal ablation. Methods This observational study analyzed data for patients who underwent both iliac vein stent placement as well as endovenous ablation (either RFA or EVLT) as a management for chronic venous insufficiency between February 2012 and February 2014. Follow-up was performed after completion of both procedures and inquiring for improvement of swelling. Statistical analysis performed using Chi-square and student's t-test. Results Of the total 173 patients who underwent both endovenous closure and iliac vein stent placements, 55 (31.8%) patients were men; 29 (16%) patients stated they had no improvement after these procedures. The average age of patients who did not improve was 68.8 (±16.7 SD) years and 66.2 (±13.3 SD) years for patients who improved. Over all, the classification of the presenting symptoms by CEAP classification demonstrated 25.4%, 53.2%, 5.8%, and 15.6%, for C3–C6, respectively. There was no correlation with failure to improve the swelling with: age ( P = .44), gender ( P = .33), presenting symptom ( P = .67), use of calcium channel blockers ( P = .85), nitroglycerin ( P = .86), Plavix ( P = .07), aspirin ( P = .55), Synthyroid ( P = .55), Coumadin ( P = .14), angiotensin receptor blocker ( P = .81), β Blockers ( P = .61), angiotensin converting enzyme inhibitors ( P = .88), furosemide 40 mg ( P = .74), hydrochlorothiazide 12.5 mg ( P = .07), hydrochlorothiazide 25 mg ( P = .48), and EVLT vs. RFA ( P = .91). The use of furosemide (20 mg) was associated with continued swelling ( P = .01). The use of dual diuretics (furosemide and hydrochlorothiazide) was associated with persistent swelling even after these combined endovenous procedures P = .03). Conclusion These preliminary data suggest that the treatment with diuretics may be associated with failure to relieve lower extremity swelling despite combined endovascular therapy for chronic venous insufficiency.


2011 ◽  
Vol 45 (11) ◽  
pp. 1371-1377
Author(s):  
Alexandra Oschman ◽  
Amanda Gansen ◽  
Howard Kilbride ◽  
Tracy Sandritter

Background:: A consensus has not been established for the standard treatment of hyperkalemia in the neonatal population. Most treatment regimens include a dextrose/insulin infusion. Additional agents used include calcium, sodium bicarbonate, polystyrene sulfonate, and albuterol. This study assessed the safety and efficacy of a potassium cocktail (k-cocktail) containing dextrose, insulin, calcium gluconate, and sodium lactate for treatment of neonatal hyperkalemia. Objective: To determine whether modifications to a potassium cocktail formulation, based on a prior quality improvement project, resulted in a decrease in the incidence of hyperglycemia and acidosis associated with its use, and to evaluate the effectiveness of the k-cocktail in lowering serum potassium levels and the incidence of adverse effects. Methods: We conducted a retrospective cohort study of neonates with hyperkalemia who received 2 k-cocktail formulations (group 1 [n = 13], original formulation, dextrose:insulin 5:1; group 2 [n = 26], modified formulation, dextrose: insulin 3.3:1). Group 2 subjects were matched 2:1 by gestational age and birth weight with those in group 1. Variables related to safety and effectiveness of therapy were assessed by medical record review. The following tests were used to assess group differences: χ2, Fisher exact, 2-tailed t-tests, and mixed linear models. Results: The incidence of hyperglycemia during the modified k-cocktail infusion in group 2 decreased from 76.9% to 217% (p = 0.001). Serum blood glucose concentrations increased during the infusion, on average, for group 1 infants and were unchanged during the infusion for those in group 2. The incidence of acidosis during the infusion was similar between groups (group 1 [76.9%] vs group 2 [68.2%]; p = 0.58). No significant adverse events were observed. Serum potassium concentrations decreased similarly in both groups. Conclusions: An intravenous infusion including a dextrose:insulin ratio of 3.3:1. compared with a higher ratio, results in less hyperglycemia and appears to be as effective in decreasing potassium concentrations in newborns.


2021 ◽  
Vol 8 ◽  
Author(s):  
Zi-liang Song ◽  
Shao-hui Wu ◽  
Dao-liang Zhang ◽  
Wei-feng Jiang ◽  
Mu Qin ◽  
...  

Objectives: To evaluate the clinical safety and efficacy of radiofrequency catheter ablation for atrial fibrillation patients with a history of stroke.Methods and Results: A total of 116 symptomatic, drug-refractory AF patients with a history of stroke, and 1:2 matched patients without a history of stroke were enrolled. Of these, 28 cases occurred stroke within 3 months (Group 1), 88 cases with stroke history longer than 3 months (Group 2), and 232 cases without stroke (Group 3). PVI was performed in all patients, extended to ablation of linear lesions ablation. The periprocedural stroke rates and other procedure-related in-hospital complications did not differ significantly among the three groups. The maintenance rate of SR after the procedure showed no significant difference (p = 0.333), 52.7, 66.4, and 70.7% in Group 1, 2, and 3, respectively. Furthermore, the comparison between a history of stroke and those without it were also shown no significant difference (p = 0.351).Conclusions: Radiofrequency ablation for AF patients occurred stroke, even within 3 months is safe and effective, without higher periprocedural complication rate and recurrence rate.


2021 ◽  
Vol 14 (3) ◽  
pp. 1543-1549
Author(s):  
S. Brigida ◽  
Arul Amutha Elizabeth ◽  
G. Soujania ◽  
R. Poornima Poornima

Introduction: Superficial dermatophytosis is a common public health problem in India, due to its tropical climate with heat and humidity. Today, the triazoles, mainly Itraconazole and the allylamines, chiefly Terbinafine, are the main ammunitions against dermatophytes. This study is undertaken to compare the safety and efficacy of both the drugs. Materials and Methods: This study was conducted to find the efficacy of Oral Terbinafine and Oral Itraconazole in Tinea Corporis/Tinea Cruris infection. The primary efficacy parameter was change in composite score (pruritus, erythema, pigmentations) from baseline to end of the treatment period. And to compare the safety of Oral Terbinafine and Oral Itraconazole by comparing the following parameters, Liver enzymes - SGOT/SGPT before and after treatment with the study drugs. Drug Dosage: Group 1: Drug –Tab. Terbinafine: Dose 500 mg per day once daily at bedtime for 2 weeks. Group 2: Drug –Tab. Itraconazole: Dose 200 mg per day, once daily at bedtime for 2 weeks. Results: The study participants show significant reduction in itching at the second follow up (after 2 weeks of drug completion) in both groups. Pruritis was reduced in 92% subjects in group 1 and 97.5% subjects in group 2. There was 87% reduction in erythema in group 1 and 93% reduction in group 2. Pigmentations were seen in 2% subjects in both groups indicating relapse of infection. Conclusion: The significant outcome of the study was that oral Itraconazole 200mg/day for 14 days(2 weeks) can be the better antifungal.


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