Evaluation of five different aneurysm scoring systems to predict mortality in ruptured abdominal aortic aneurysm patients.

BACKGROUND: Ruptured abdominal aortic aneurysms (RAAAs) are associated with a high overall mortality (up to 25% to 35%) ≤30 days when offered surgical treatment. Risk prediction models can provide valuable information on surgical risks, guide clinical decision making, and help identify patients who should not be operated on to prevent futile surgery. Finally, they can be used to evaluate clinical outcome. Different aneurysm scores are available. New ones (with only four parameters) are being developed, such as the Dutch Aneurysm Score (DAS). This study analyzed and compared these scoring models. METHODS: The study selected consecutive patients who presented with RAAA in two large vascular centers (Medisch Centrum Alkmaar and St. Antonius Nieuwegein) between 2005 and 2015. Variables necessary to retrospectively evaluate the scoring systems were registered in the patients' medical files. The discriminatory power and calibration were assessed using the receiver operating characteristic curve and the Hosmer-Lemeshow χ2 test. RESULTS: The study included 347 consecutive patients with RAAA. There were 298 men (85.9%), and the mean ± standard deviation age was 72.6 ± 8.1 years. The receiver operating characteristic curves were developed for the DAS, Glasgow Aneurysm Score (GAS), Edinburgh Ruptured Aneurysm Score, Vancouver Scoring System (VSS), and Hardman Index. The area under the curve was better for the VSS (0.716; 95% confidence interval [CI], 0.647-0.786) than for the other scoring systems. Areas under the curve for the DAS (0.664; 95% CI, 0.592-0.736), Hardman Index (0.664; 95% CI, 0.592-0.736), Edinburgh Ruptured Aneurysm Score (0.621; 95% CI, 0.543-0.700), and GAS (0.591; 95% CI, 0.517-0.665) were slightly smaller, although only the difference between the VSS and GAS was statistically significant. Calibration showed a good fit for all models. CONCLUSIONS: The performance of the tested models for the prediction of mortality in RAAA patients was comparable, with only a statistically significant difference between the VSS and the GAS in favor of the VSS. However, an almost perfect prediction is needed to withhold intervention, and no existing scoring system is capable of that.

Results of endovascular repair of infrarenal aortic aneurysms using the Endurant stent graft.

OBJECTIVE: Recent reports showed that the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, Calif) is safe and effective for endovascular repair of abdominal aortic aneurysms (AAAs). However, due to its relatively recent introduction, only short-term follow-up data are available. This study presents the 4-year results using this device. METHODS: All clinical data, including detailed anatomic information of the first 100 consecutive patients treated with the Endurant stent graft for an infrarenal AAA in three Dutch high-volume hospitals, were prospectively collected. Computed tomography angiography was routinely performed before the procedure, ≤ 1 month, and at 1 year post-endovascular aneurysm repair. Thereafter, the imaging modality during yearly follow-up was individualized (duplex ultrasound imaging or computed tomography angiography). Patients were classified as within or outside the instructions for use (IFU) for analysis. Study end points were primary clinical success, overall and AAA-related mortality, and sac morphology changes and endoleak during follow-up. Estimates were obtained using Kaplan-Meier plots. RESULTS: The study included 100 consecutive patients (88 men) with a median age of 74 years (interquartile range [IQR], 67-79 years) and median AAA diameter of 58 mm (IQR, 55-65 mm), between December 2007 and March 2009. Twenty patients (20%) were treated outside the IFU (18, outside proximal neck IFU, one outside iliac IFU, and one outside both IFUs). Median follow-up was 48 months (IQR, 36-53 months), and no patients were lost. One contained rupture was observed after 1.5 months due to graft infection. No patients had graft migration. Two type Ia endoleaks, 5 type Ib endoleaks, and 15 type II endoleaks were found. Primary clinical success was 97%, 90%, 84% and 77% at 1, 2, 3, and 4 years, respectively. Primary clinical success was comparable for patients treated within or outside IFU (P = .20), although both patients outside iliac IFU needed a secondary iliac intervention. Over time, maximum aneurysm diameter decreased ≥ 5 mm, remained stable, and increased ≥ 5 mm in 58%, 32%, and 10% of the patients, respectively. All-cause mortality was 20% at 4 years, with a 3% AAA-related mortality. CONCLUSIONS: The 4-year follow-up data of the Endurant stent graft for AAA treatment shows its use results in a low AAA-related mortality with adequate prevention of rupture or aneurysm growth. Although patients with very challenging anatomy were treated in our series, primary clinical success rates were comparable for patients treated within and outside the IFU. However, both patients outside the iliac IFU needed a secondary iliac intervention. The knowledge of the present results may aid in improving outcomes in the future.

Incidence and treatment results of Endurant endograft occlusion.

OBJECTIVE: The Endurant endograft (Medtronic Inc, Minneapolis, Minn) is a new-generation device specifically developed to perform well in complex abdominal aortic aneurysm anatomy. Previous reports on the 1- and 2-year results of endovascular aneurysm repair (EVAR) with the Endurant endograft showed excellent outcome, including prevention of migration and type I endoleaks, but occurrence and outcome of post-EVAR occlusion have not been determined in a large multicenter patient cohort with midterm follow-up, which is the objective of this study. METHODS: Data of consecutive patients treated with the Endurant from December 2007 to April 2012 in three Dutch tertiary vascular referral hospitals were prospectively gathered and retrospectively analyzed. Follow-up consisted of regular office visits, computed tomography angiography at 1 and 12 months after EVAR, and subsequently, duplex ultrasound imaging or computed tomography angiography at regular intervals. Patients with ruptured aneurysms or with earlier abdominal aortic surgery were excluded. The incidence and clinical outcome of endograft occlusions were analyzed. An expert review board assessed all cases in the search for possible causes of occlusion. RESULTS: Included were 496 patients (87.7% male), who were a median age of 74 years (range, 68-78 years). Median follow-up was 1.7 years (range, 0-4.6 years). Twenty graft occlusions (4.0%) occurred during follow-up. Median time between primary EVAR and detection of the occlusion was 1 month, with 55% occurring ≤ 60 postoperative days and 90% ≤ 1 year. No association was found between occlusion and sex (P = .28), age (P = .96), or use of an aortouniiliac device (P = .66). Technical error was the considered cause of the occlusion in 12 patients (60%). The estimated freedom from occlusion was 98.4% at 30 days, 95.7% at 1 year, and 95.3% at 3 years. Presenting symptoms of occlusion were acute limb ischemia in 50%. Treatment was surgical (75%) or percutaneous (25%). Successful revascularization was achieved in 17 of 20 patients, but reocclusions occurred in five, resulting in a transfemoral amputation in one patient. Occlusion-related mortality was 0.6% (3 of 496). CONCLUSIONS: At a median follow-up of 1.7 years, Endurant endograft occlusion occurred in 4.0% of 496 patients. Most occlusions occurred ≤ 2 months after EVAR, and rarely after 1 year. A technical justification for occlusion could be found for 60% of patients. A more liberal intraoperative and early postoperative (re)intervention strategy may reduce the occlusion rates and improve outcome.

Mid-term proximal sealing zone evaluation after fenestrated endovascular aortic aneurysm repair.

BACKGROUND: Fenestrated endovascular aortic aneurysm repair (FEVAR) is used in pararenal abdominal aortic aneurysms to achieve a durable proximal seal. This study investigated the mid-term course of the proximal fenestrated stent graft (FSG) sealing zone on the first and latest available post-FEVAR computed tomographic angiography (CTA) scan in a single-center series. METHODS: In 61 elective FEVAR patients, the shortest length of circumferential apposition between the FSG and the aortic wall (shortest apposition length [SAL]) was retrospectively assessed on the first and last available postoperative CTA scans. Patient records were reviewed for FEVAR-related procedural details, complications, and reinterventions. RESULTS: The median (interquartile range) time between the FEVAR procedure and the first and last CTA scan was 35 (30-48) days and 2.6 (1.2-4.3) years, respectively. The median (interquartile range) SAL was 38 (29-48) mm, and 44 (34-59) mm on the first and last CTA scans, respectively. During follow-up, the SAL increased >5 mm in 32 patients (52%), and decreased >5 mm in six patients (10%). Reintervention was performed for a type 1a endoleak in one patient. Twelve other patients needed 17 reinterventions for other FEVAR-related complications. CONCLUSIONS: Good mid-term apposition of the FSG in the pararenal aorta was achieved post-FEVAR, and the occurrence of type 1a endoleaks was low. The number of reinterventions was substantial, however, but for reasons other than loss of proximal seal.

Drug coated balloon supported Supera stent versus Supera stent in intermediate and long-segment lesions of the superficial femoral artery: 2-year results of the RAPID Trial.

BACKGROUND: Endovascular treatment of occlusive disease of the superficial femoral artery (SFA) has evolved from plain old balloon angioplasty (POBA) through primary stenting strategy to drug eluting technology-based approach. The RAPID Trial investigates the added value of drug coated balloons (DCB, Legflow) in a primary stenting strategy (Supera stent) for intermediate (5-15 cm) and long segment (>15 cm) SFA lesions. METHODS: In this multicenter, patient-blinded trial, 160 patients with intermittent claudication, ischemic rest pain, or tissue loss due to intermediate or long SFA lesions were randomized (1:1) between Supera + DCB and Supera. Primary endpoint was primary patency at 2 years, defined as freedom from restenosis on duplex ultrasound (peak systolic velocity ratio <2.4). RESULTS: At 2 years, primary patency was 55.1% (95% CI: 43.1-67.1%) in the Supera + DCB group versus 48.3% (95% CI: 35.6-61.0%) in the Supera group (P=0.957). Per protocol analysis showed a primary patency rate of 60.9% (95% CI: 48.6-73.2%) in the Supera + DCB group versus 49.8% (95% CI: 36.9-62.7%) in the Supera group (P=0.469). The overall mortality rate was 5% in both groups (P=0.975). Sustained functional improvement was similar in both groups. CONCLUSIONS: The 2-year results in the current trial of a primary Supera stenting strategy are consistent with other trials reporting on treatment of intermediate and long SFA lesions. A DCB supported Supera stent strategy did not improve patency rate compared to a Supera stent only strategy.

Mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency.

OBJECTIVE: This study evaluated the feasibility, safety, and 1-year results of mechanochemical endovenous ablation (MOCA) of great saphenous vein (GSV) insufficiency. METHODS: A consecutive 106 patients were treated for primary GSV insufficiency with MOCA by the ClariVein device and polidocanol. The primary outcome measures were technical success, clinical success, and anatomic success after 1 year of follow-up. Secondary outcome measures were postprocedural pain, complications, general- and disease-specific quality of life, and time to return to work. Patients were evaluated with clinical examination and duplex ultrasonography at 6 weeks, 6 months, and 1 year after treatment. RESULTS: The technical success was 99%. The mean postprocedural pain during the first 14 days after treatment was 7.5 mm (interquartile range [IQR], 0.0-10.0 mm) per day on a 0- to 100-mm visual analog scale. The time to return to normal activities and work was 1.0 day (IQR, 0-1.0 day) and 1.0 day (IQR, 1.0-4.0 days), respectively. No major complications were recorded. At 1-year follow-up, the clinical success was 93%. The Venous Clinical Severity Score decreased significantly from 4.0 (IQR, 3.0-5.0) before treatment to 1.0 (IQR, 0-1.0) (P < .001) 1 year after MOCA. At 1 year, 88.2% of the treated GSVs remained occluded as measured by duplex ultrasonography. Twelve patients had a recanalization, of which eight were partial. Disease-specific quality of life and the RAND 36-Item Health Survey scores improved significantly at 1-year follow-up. CONCLUSIONS: MOCA is a safe and effective technique in the treatment of GSV insufficiency with good clinical and anatomic success at 1-year follow-up. The technique is related to low postprocedural pain scores, low complication rate, improved quality of life, and rapid resumption of normal activities and work.

Mechanochemical endovenous ablation versus radiofrequency ablation in the treatment of primary small saphenous vein insufficiency (MESSI trial): study protocol for a randomized controlled trial.

BACKGROUND: Minimally invasive endothermal techniques, for example, radiofrequency ablation (RFA), have revolutionized the treatment of insufficient truncal veins and are associated with an excellent outcome. The use of thermal energy requires the instillation of tumescent anesthesia around the vein. Mechanochemical endovenous ablation (MOCA™) combines mechanical endothelial damage, using a rotating wire, with simultaneous infusion of a liquid sclerosans. Tumescent anesthesia is not required as no heat is used. Prospective studies using MOCA™ in both great and small saphenous veins showed good anatomical and clinical results with fast postoperative recovery. METHODS/DESIGN: The MESSI trial (Mechanochemical Endovenous ablation versus radiofrequency ablation in the treatment of primary Small Saphenous vein Insufficiency) is a multicenter randomized controlled trial in which a total of 160 patients will be randomized (1:1) to MOCA™ or RFA. Consecutive patients with primary small saphenous vein incompetence, who meet the eligibility criteria, will be invited to participate in this trial. The primary endpoint is anatomic success, defined as occlusion of the treated veins objectified with duplex ultrasonography at 1 year follow-up. Secondary endpoints are post-procedural pain, initial technical success, clinical success, complications and the duration of the procedure. Initial technical success is defined as the ability to position the device adequately, treat the veins as planned and occlude the treated vein directly after the procedure has been proven by duplex ultrasonography. Clinical success is defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS). Power analyses are conducted for anatomical success and post-procedural pain.Both groups will be evaluated on an intention-to-treat principle. DISCUSSION: The hypothesis of the MESSI trial is that the anatomic success rate of MOCA™ is not inferior to RFA. The second hypothesis is that post-procedural pain is significantly less after MOCA compared to RFA. TRIAL REGISTRATION: NTR4613 Date of trial registration: 28 May 2014.

[Ingrown toenail]. / Ingegroeide teennagel. Pas opereren als perifere vaatziekte is uitgesloten.

Three patients, men aged 58, 79 and 78 years, with onychocryptosis in their right, left and right hallux respectively, were treated by partial nail extraction and phenolisation of the nail bed. The wound did not heal and the symptoms worsened. The ankle-brachial index was < 0.9, which is an indication of peripheral arterial disease. This was confirmed by ultrasonography, CT and magnetic resonance angiography (MRA). In the first patient, endovascular arterial dilatation did not result in enough circulation and hallux amputation was needed. The second patient recovered after a femorofibular bypass, and the third one after a femoropopliteal bypass. Treatment of ingrown toenails might result in major complications, if a patient suffers from known or unknown peripheral arterial disease. If an ingrown toenail needs surgical treatment, efforts should be made to determine whether the patient suffers from peripheral arterial disease. This can be done by interviewing the patient, physical examination and measuring the ankle-brachial index. For diabetic patients the ankle-brachial index is not reliable; therefore toe pressure waves should be measured before surgical treatment. If signs of peripheral arterial disease are detected, the patient should be referred to the vascular surgeon before surgical treatment of the ingrown toenail.