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Predictors of Recanalization for Incompetent Great Saphenous Veins Treated With Cyanoacrylate Glue
Journal of Vascular Surgery: Venous and Lymphatic Disorders
Abstracts
609
Volume 5, Number 4 the rate of VTE was 9.1% overall (104 of 1137) and similar between groups (blunt trauma, 9% [n ¼ 73]; deep venous thrombosis [DVT], 6.6%; pulmonary embolus [PE] 2.7% vs penetrating trauma, 9.6% [n ¼ 31]; DVT, 7.7%; PE, 2.5%; P ¼ .76). The mean time in days to first prophylaxis was the same in both groups (2 days). The Greenfield Risk Assessment Profile (RAP) can be used to stratify the VTE risk of trauma patients. In both blunt and penetrating trauma, patients with VTE had higher mean Greenfield Risk Assessment Profile (RAP) scores than those not experiencing a VTE (blunt: 13 [6] vs 8 [4]; P < .001; penetrating: 12 [4] vs 7 [4]; P < .001). In the blunt trauma group and considering all individual RAP variables, more patients with VTE than without VTE had abnormal coagulation results (49.3% vs 35.7%; P ¼ .02), femoral catheters (9.6% vs 3.9%; P ¼ .03), repair and/or ligation of vascular injury (15.1% vs 5.4%; P ¼ .001), complex leg fractures (34.2% vs 18.5%; P ¼ .001), Glasgow Coma Scale score less than 8 (31.5% vs 10.7%; P < .001), 4 or more transfusions (51.4% vs 17.6%; P < .001), operation time longer than 2 hours (35.6% vs 16.4%; P < .001), and pelvic fractures (43.8% vs 21.4%; P < .001). However utilizing multivariable analysis, only receiving 4 or more transfusions (odds ratio [OR], 3.47; 95% confidence interval [CI], 2.04-5.91), Glasgow Coma Scale score less than 8 (OR, 2.75; 95% CI, 1.53-4.94), and pelvic fracture (OR, 2.09; 95% CI, 1.23-3.55) predicted VTE with an area under the receiver operator curve of 0.730. In the penetrating trauma group and considering all RAP variables, more patients with VTE than without VTE had abnormal coagulation results (64.5% vs 44.4%; P ¼ .03), femoral catheters (16.1% vs 5.5%; P ¼ .02), repair and/or ligation of vascular injury (54.8% vs 25.3%; P < .001), 4 or more transfusions (74.2% vs 39.6%; P < .001), operation time longer than 2 hours (74.2% vs 50.5%; P ¼ .01), Abbreviated Injury Score for the abdomen greater than 2 (64.5% vs 42.3%; P ¼ .02), and were aged 40 to 59 years (41.9% vs 23.2%; P ¼ .02). Utilizing multivariable analysis, only repair and/or ligation of vascular injury (OR, 3.32; 95% CI, 1.37-8.03), Abbreviated Injury Score for the abdomen greater than 2 (OR, 2.77; 95% CI, 1.196.45), and age 40 to 59 years (OR, 2.69; 95% CI, 1.19-6.08) predicted VTE with an area under the receiver operator curve of 0.760. Comments: This study confirms that the Greenfield RAP is a valid tool to assess the overall risk of VTE in trauma patients either blunt or penetrating. However, the mechanism of injury may be one factor which is underestimated in current scoring systems used to assess VTE risk and stratification by this distinction might improve the scoring system. In blunt trauma, those patients specifically at risk are those requiring significant transfusions (indicative of more injury), have poor neurologic status and are afflicted with a pelvic fracture. In the penetrating trauma patient, vascular injury (patients specific to our practices), severe abdominal injury, and of a younger age place the patient at increased risk.
Predictors of Recanalization for Incompetent Great Saphenous Veins Treated With Cyanoacrylate Glue Chan YC, Law Y, Cheung GC, Cheng SW. J Vasc Interv Radiol 2017;28:665-71. Conclusions: The use of endovenous cyanoacrylate to treat varicose veins caused by incompetent GSV is safe. Great saphenous veins (GSVs) < 6.6 mm in diameter had a closure rate of 90.0% at 12 months. Despite 97.2% closure rates at 1 week, recanalization was observed in GSVs with larger diameters and the closure rate at 12 months was only 58.6%. Summary: This study is a retrospective review of a prospectively collected database. From September 2014 to June 2016, 108 legs in 55 consecutive patients (34 female) with duplex ultrasound proven saphenofemoral junction (SFJ) and/or great saphenous vein (GSV) incompetence were included in the study. Bilateral varicose veins were present in 53 patients. The majority of patients had C3 (60%) or C4a (27.3%) disease. The median age was 65 years (range, 39-86 years) and the median GSV diameter was 6.6 mm (range, 2.3-11.4 mm) and underwent a median treatment length was 28 cm (range, 15-41 cm). The Venous Clinical Severity Score (VCSS) and the Aberdeen Varicose Veins Severity Score (AVVQ) were consistent mild to moderate disease. The procedure was performed under local anesthesia via a 5-F long sheath supplied in the VenaSeal set and the cyanoacrylate (VenaSeal) was prepared and attached to the delivery system. In patient head-down position, the tip of the sheath/cyanoacrylate catheter was advanced to within 4 cm of the SFJ. With occlusion compression at the SJV with the ultrasound probe, glue was injected with two injections of 0.09 mL given 1 centimeter apart followed by 3 minutes of local compression. This sequence of
injections with 30 second ultrasound compression was repeated every 3 centimeters until the entire length of the GSV was treated. Ultrasonography confirmed GSV ablation and lack of deep venous thrombosis. Stab phlebectomy removed varicosities in all patients. All patients were discharged the same day and instructed to use full-length compression stockings for at least one month. All patients underwent serial clinical and duplex ultrasound examinations at 1 week, 1 month, 6 months, 12 months, and 24 months after the procedure. The primary endpoint was procedural success rate with obliteration of the GSV, lack of deep vein thrombosis, and lack of clinical recurrence of varicose veins. Complete closure of the saphenous vein was defined as noncompressibility and/or absence of flow signal along the entire treated saphenous vein segment on Doppler ultrasound with no discrete segments of patency exceeding 5 cm from the SFJ. Additional documentation included postoperative pain score (0-10 scale), ecchymosis score (minimal, mild, moderate, severe) at site of puncture and avulsions, side effects and serious adverse events possibly related to treatment at discharge time and follow-up and time to return to work. The VCSS, AVVQ, and 36-item short form health survey (SF-36) were sequentially assessed preoperatively and at 1 month, 6 months, 1 year, and 2 years postoperatively. Continuous variables were mean and standard deviation (SD) or median and interquartile range. Categorical variable were summarized as count and percentage. Closure rates over time were estimated using the KaplanMeier method. Preoperative venous characteristics, including the diameter of the GSV (measured in the supine position), treatment length of the GSV, presence of incompetent thigh perforators, CEAP clinical classification and grade of operator (trainers or trainees) were analyzed as predictors of recanalization. Assumption of proportionality was verified using log minus log plots. Proportional hazards were assumed if parallel lines were observed. Return to work/normal activity was 1 day (median range, 1-16 days). Procedural complications were two cases of minimal extension of thrombus into the common femoral vein treated with subcutaneous heparin for 1 week, four cases of thrombophlebitis in the GSV treated with anti-inflammatory drugs and one minor wound infection at a stab site treated with oral antibiotics. Pain ratings were low at a median of 0 and ecchymosis was mild in 31 legs and moderate in three and generally located at stab phlebectomy sites. Kaplan-Meier analysis showed GSV closure rates were 97.2%, 92.3%, 89.2%, and 75.7% at 1 week, 1 month, 6 months, and 12 months after the procedure. Except for three cases (2 midthigh to lower leg, 1 midthigh at a perforator, and all found at 1-year follow-up), all recanalizations were continuous with the SFJ. With a median follow-up period of 5 months (range, 0-18 months), four legs had clinical recurrence of varicose veins. Mean GSV diameter > 6.6 mm was the only significant predictor for recanalization (hazard ratio, 12.1; 95% confidence interval, 1.6-92.7; P ¼ .016). VCSS decreased from a mean of 6.18 at baseline to 2.39, 2.24, 1.57, and 1.41 at 1, 3, 6, and 12 months of follow-up; patients with recanalization had rebound in their scores at 12 months. AVVQ scores decreased from a mean of 25.38 at baseline to 7.87, 6.29, 4.29, and 2.83 at the same time periods and patients with recanalization had rebound in scores at 6 months and 12 months. The results of VCSS and AVVQ correlated well with recanalization found on duplex ultrasound. The physical and mental mean scores of the SF-36 did not significantly change over the course of this study. Comments: Many methods of ablating the great saphenous vein have surfaced with decreasing demands for anesthesia and less discomfort for the patient. The use of cyanoacrylate glue to seal the vein lumen is one such method with early reports demonstrating results that revival the more standard heat methods of ablation. This study questions whether large diameter (>6.6 cm) great saphenous veins can be effectively treated with this glue without at least increasing the amount injected to compensate for larger vein diameters. There is some variation in the techniques used by these authors not used in the US which might impact how the study is interpreted but they are minor in my opinion.
Hospitalization With Infection and Incident Venous Thromboembolism: The ARIC Study Cowan LT, Lutsey PL, Pankow JS, Cushman M, Folsom AR. Thrombosis Research 2017;151:74-8. Conclusions: The results of this study support the hypothesis that infection in hospitalized patients is a trigger for VTE in excess of that due just for the need of hospitalization. VTE preventive measures may prevent VTE events if used in the peri-infection period but clinical trials are needed.
Abstracts
609
Volume 5, Number 4 the rate of VTE was 9.1% overall (104 of 1137) and similar between groups (blunt trauma, 9% [n ¼ 73]; deep venous thrombosis [DVT], 6.6%; pulmonary embolus [PE] 2.7% vs penetrating trauma, 9.6% [n ¼ 31]; DVT, 7.7%; PE, 2.5%; P ¼ .76). The mean time in days to first prophylaxis was the same in both groups (2 days). The Greenfield Risk Assessment Profile (RAP) can be used to stratify the VTE risk of trauma patients. In both blunt and penetrating trauma, patients with VTE had higher mean Greenfield Risk Assessment Profile (RAP) scores than those not experiencing a VTE (blunt: 13 [6] vs 8 [4]; P < .001; penetrating: 12 [4] vs 7 [4]; P < .001). In the blunt trauma group and considering all individual RAP variables, more patients with VTE than without VTE had abnormal coagulation results (49.3% vs 35.7%; P ¼ .02), femoral catheters (9.6% vs 3.9%; P ¼ .03), repair and/or ligation of vascular injury (15.1% vs 5.4%; P ¼ .001), complex leg fractures (34.2% vs 18.5%; P ¼ .001), Glasgow Coma Scale score less than 8 (31.5% vs 10.7%; P < .001), 4 or more transfusions (51.4% vs 17.6%; P < .001), operation time longer than 2 hours (35.6% vs 16.4%; P < .001), and pelvic fractures (43.8% vs 21.4%; P < .001). However utilizing multivariable analysis, only receiving 4 or more transfusions (odds ratio [OR], 3.47; 95% confidence interval [CI], 2.04-5.91), Glasgow Coma Scale score less than 8 (OR, 2.75; 95% CI, 1.53-4.94), and pelvic fracture (OR, 2.09; 95% CI, 1.23-3.55) predicted VTE with an area under the receiver operator curve of 0.730. In the penetrating trauma group and considering all RAP variables, more patients with VTE than without VTE had abnormal coagulation results (64.5% vs 44.4%; P ¼ .03), femoral catheters (16.1% vs 5.5%; P ¼ .02), repair and/or ligation of vascular injury (54.8% vs 25.3%; P < .001), 4 or more transfusions (74.2% vs 39.6%; P < .001), operation time longer than 2 hours (74.2% vs 50.5%; P ¼ .01), Abbreviated Injury Score for the abdomen greater than 2 (64.5% vs 42.3%; P ¼ .02), and were aged 40 to 59 years (41.9% vs 23.2%; P ¼ .02). Utilizing multivariable analysis, only repair and/or ligation of vascular injury (OR, 3.32; 95% CI, 1.37-8.03), Abbreviated Injury Score for the abdomen greater than 2 (OR, 2.77; 95% CI, 1.196.45), and age 40 to 59 years (OR, 2.69; 95% CI, 1.19-6.08) predicted VTE with an area under the receiver operator curve of 0.760. Comments: This study confirms that the Greenfield RAP is a valid tool to assess the overall risk of VTE in trauma patients either blunt or penetrating. However, the mechanism of injury may be one factor which is underestimated in current scoring systems used to assess VTE risk and stratification by this distinction might improve the scoring system. In blunt trauma, those patients specifically at risk are those requiring significant transfusions (indicative of more injury), have poor neurologic status and are afflicted with a pelvic fracture. In the penetrating trauma patient, vascular injury (patients specific to our practices), severe abdominal injury, and of a younger age place the patient at increased risk.
Predictors of Recanalization for Incompetent Great Saphenous Veins Treated With Cyanoacrylate Glue Chan YC, Law Y, Cheung GC, Cheng SW. J Vasc Interv Radiol 2017;28:665-71. Conclusions: The use of endovenous cyanoacrylate to treat varicose veins caused by incompetent GSV is safe. Great saphenous veins (GSVs) < 6.6 mm in diameter had a closure rate of 90.0% at 12 months. Despite 97.2% closure rates at 1 week, recanalization was observed in GSVs with larger diameters and the closure rate at 12 months was only 58.6%. Summary: This study is a retrospective review of a prospectively collected database. From September 2014 to June 2016, 108 legs in 55 consecutive patients (34 female) with duplex ultrasound proven saphenofemoral junction (SFJ) and/or great saphenous vein (GSV) incompetence were included in the study. Bilateral varicose veins were present in 53 patients. The majority of patients had C3 (60%) or C4a (27.3%) disease. The median age was 65 years (range, 39-86 years) and the median GSV diameter was 6.6 mm (range, 2.3-11.4 mm) and underwent a median treatment length was 28 cm (range, 15-41 cm). The Venous Clinical Severity Score (VCSS) and the Aberdeen Varicose Veins Severity Score (AVVQ) were consistent mild to moderate disease. The procedure was performed under local anesthesia via a 5-F long sheath supplied in the VenaSeal set and the cyanoacrylate (VenaSeal) was prepared and attached to the delivery system. In patient head-down position, the tip of the sheath/cyanoacrylate catheter was advanced to within 4 cm of the SFJ. With occlusion compression at the SJV with the ultrasound probe, glue was injected with two injections of 0.09 mL given 1 centimeter apart followed by 3 minutes of local compression. This sequence of
injections with 30 second ultrasound compression was repeated every 3 centimeters until the entire length of the GSV was treated. Ultrasonography confirmed GSV ablation and lack of deep venous thrombosis. Stab phlebectomy removed varicosities in all patients. All patients were discharged the same day and instructed to use full-length compression stockings for at least one month. All patients underwent serial clinical and duplex ultrasound examinations at 1 week, 1 month, 6 months, 12 months, and 24 months after the procedure. The primary endpoint was procedural success rate with obliteration of the GSV, lack of deep vein thrombosis, and lack of clinical recurrence of varicose veins. Complete closure of the saphenous vein was defined as noncompressibility and/or absence of flow signal along the entire treated saphenous vein segment on Doppler ultrasound with no discrete segments of patency exceeding 5 cm from the SFJ. Additional documentation included postoperative pain score (0-10 scale), ecchymosis score (minimal, mild, moderate, severe) at site of puncture and avulsions, side effects and serious adverse events possibly related to treatment at discharge time and follow-up and time to return to work. The VCSS, AVVQ, and 36-item short form health survey (SF-36) were sequentially assessed preoperatively and at 1 month, 6 months, 1 year, and 2 years postoperatively. Continuous variables were mean and standard deviation (SD) or median and interquartile range. Categorical variable were summarized as count and percentage. Closure rates over time were estimated using the KaplanMeier method. Preoperative venous characteristics, including the diameter of the GSV (measured in the supine position), treatment length of the GSV, presence of incompetent thigh perforators, CEAP clinical classification and grade of operator (trainers or trainees) were analyzed as predictors of recanalization. Assumption of proportionality was verified using log minus log plots. Proportional hazards were assumed if parallel lines were observed. Return to work/normal activity was 1 day (median range, 1-16 days). Procedural complications were two cases of minimal extension of thrombus into the common femoral vein treated with subcutaneous heparin for 1 week, four cases of thrombophlebitis in the GSV treated with anti-inflammatory drugs and one minor wound infection at a stab site treated with oral antibiotics. Pain ratings were low at a median of 0 and ecchymosis was mild in 31 legs and moderate in three and generally located at stab phlebectomy sites. Kaplan-Meier analysis showed GSV closure rates were 97.2%, 92.3%, 89.2%, and 75.7% at 1 week, 1 month, 6 months, and 12 months after the procedure. Except for three cases (2 midthigh to lower leg, 1 midthigh at a perforator, and all found at 1-year follow-up), all recanalizations were continuous with the SFJ. With a median follow-up period of 5 months (range, 0-18 months), four legs had clinical recurrence of varicose veins. Mean GSV diameter > 6.6 mm was the only significant predictor for recanalization (hazard ratio, 12.1; 95% confidence interval, 1.6-92.7; P ¼ .016). VCSS decreased from a mean of 6.18 at baseline to 2.39, 2.24, 1.57, and 1.41 at 1, 3, 6, and 12 months of follow-up; patients with recanalization had rebound in their scores at 12 months. AVVQ scores decreased from a mean of 25.38 at baseline to 7.87, 6.29, 4.29, and 2.83 at the same time periods and patients with recanalization had rebound in scores at 6 months and 12 months. The results of VCSS and AVVQ correlated well with recanalization found on duplex ultrasound. The physical and mental mean scores of the SF-36 did not significantly change over the course of this study. Comments: Many methods of ablating the great saphenous vein have surfaced with decreasing demands for anesthesia and less discomfort for the patient. The use of cyanoacrylate glue to seal the vein lumen is one such method with early reports demonstrating results that revival the more standard heat methods of ablation. This study questions whether large diameter (>6.6 cm) great saphenous veins can be effectively treated with this glue without at least increasing the amount injected to compensate for larger vein diameters. There is some variation in the techniques used by these authors not used in the US which might impact how the study is interpreted but they are minor in my opinion.
Hospitalization With Infection and Incident Venous Thromboembolism: The ARIC Study Cowan LT, Lutsey PL, Pankow JS, Cushman M, Folsom AR. Thrombosis Research 2017;151:74-8. Conclusions: The results of this study support the hypothesis that infection in hospitalized patients is a trigger for VTE in excess of that due just for the need of hospitalization. VTE preventive measures may prevent VTE events if used in the peri-infection period but clinical trials are needed.