MR imaging after patellar MACI and MPFL reconstruction: a comparison of isolated versus combined procedures.

OBJECTIVE: To qualitatively and quantitatively evaluate the 2.5-year MRI outcome after Matrix-associated autologous chondrocyte implantation (MACI) at the patella, reconstruction of the medial patellofemoral ligament (MPFL), and combined procedures. METHODS: In 66 consecutive patients (age 22.8 ± 6.4years) with MACI at the patella (n = 16), MPFL reconstruction (MPFL; n = 31), or combined procedures (n = 19) 3T MRI was performed 2.5 years after surgery. For morphological MRI evaluation WORMS and MOCART scores were obtained. In addition quantitative cartilage T2 and T1rho relaxation times were acquired. Several clinical scores were obtained. Statistical analyses included descriptive statistics, Mann-Whitney-U-tests and Pearson correlations. RESULTS: WORMS scores at follow-up (FU) were significantly worse after combined procedures (8.7 ± 4.9) than after isolated MACI (4.3 ± 3.6, P = 0.005) and after isolated MPFL reconstruction (5.3 ± 5.7, P = 0.004). Bone marrow edema at the patella in the combined group was the only (non-significantly) worsening WORMS parameter from pre- to postoperatively. MOCART scores were significantly worse in the combined group than in the isolated MACI group (57 ± 3 vs 88 ± 9, P < 0.001). Perfect defect filling was achieved in 26% and 69% of cases in the combined and MACI group, respectively (P = 0.031). Global and patellar T2 values were higher in the combined group (Global T2: 34.0 ± 2.8ms) and MACI group (35.5 ± 3.1ms) as compared to the MPFL group (31.1 ± 3.2ms, P < 0.05). T2 values correlated significantly with clinical scores (P < 0.005). Clinical Cincinnati scores were significantly worse in the combined group (P < 0.05). CONCLUSION: After combined surgery with patellar MACI and MPFL reconstruction inferior MRI outcomes were observed than after isolated procedures. Therefore, patients with need for combined surgery may be at particular risk for osteoarthritis.

Patellar instability MRI measurements are associated with knee joint degeneration after reconstruction of the medial patellofemoral ligament.

OBJECTIVE: To qualitatively and quantitatively evaluate the 2-year magnetic resonance imaging (MRI) outcome after MPFL reconstruction at the knee and to assess MRI-based risk factors that predispose for inferior clinical and imaging outcomes. MATERIALS AND METHODS: A total of 31 patients with MPFL reconstruction were included (22 ± 6 years, 10 female). MRI was performed preoperatively in 21/31 patients. Two-year follow-up MRI included quantitative cartilage T2 and T1rho relaxation time measurements at the ipsilateral and contralateral knee. T2relative was calculated as T2patellofemoral/T2femorotibial. Morphological evaluation was conducted via WORMS scores. Patellar instability parameters and clinical scores were obtained. Statistical analyses included descriptive statistics, t-tests, multivariate regression models, and correlation analyses. RESULTS: Two years after MPFL reconstruction, all patellae were clinically stable. Mean total WORMS scores improved significantly from baseline to follow-up (mean difference ± SEM, - 4.0 ± 1.3; P = 0.005). As compared to patients with no worsening of WORMS subscores over time (n = 5), patients with worsening of any WORMS subscore (n = 16) had lower trochlear depth, lower facetal ratio, higher tibial-tuberosity to trochlear groove (TTTG) distance, and higher postoperative lateral patellar tilt (P < 0.05). T2relative was higher at the ipsilateral knee (P = 0.010). T2relative was associated with preoperatively higher patellar tilt (P = 0.021) and higher TTTG distance (P = 0.034). TTTG distance, global T2 values, and WORMS progression correlated with clinical outcomes (P < 0.05). CONCLUSION: MPFL reconstruction is an optimal treatment strategy to restore patellar stability. Still, progressive knee joint degeneration and patellofemoral cartilage matrix degeneration may be observed, with patellar instability MRI parameters representing particular risk factors.

Duplex Ultrasound Investigation for the Detection of Obstructed Iliocaval Venous Stents.

OBJECTIVE: Duplex ultrasound (DUS) is used for routine surveillance of stents in iliocaval veins, but direct visualisation is often challenging. Duplex ultrasound criteria for detecting venous stent obstruction (VSO) have not been defined to date. METHODS: A nested case control study of 120 patients (42 ± 17 years, 53% women, mean 2.7 ± 1.8 stents) was performed, and the performance of various duplex parameters for detecting VSO (defined as > 50% lumen diameter reduction or occlusion) was tested, confirmed by biplane venography or intravascular ultrasound (IVUS). Forty patients with VSO (25 with stent occlusion, 15 with >50% in stent stenosis) were matched to 80 control patients by age, gender and index diagnosis who fulfilled the following criteria: (1) ongoing symptom control (Villalta score < 5), (2) good image quality of entire stent segment, (3) spontaneous colour Doppler signal > 50% of lumen in entire stent segment, (4) at least two DUS where the baseline DUS was obtained within 24 h after successful venous intervention. RESULTS: The best test was the combination of peak flow velocity and flow pattern analysis at the stent inlet. A peak flow velocity >10 cm/s and a flow pattern spontaneously modulated by respiration ruled out VSO with a specificity of 93.7% (95% CI 86.0%-97.3%). A peak flow velocity ≤10 cm/s or any Doppler flow pattern other than spontaneously modulated by respiration was 92.1% (95% CI 79.2%-97.3%) sensitive to detect VSO. CONCLUSION: The combination of peak flow velocity and analysis of Doppler flow pattern at the stent inlet is accurate to diagnose or rule out stent occlusion. Indirect criteria should always be combined with direct visualisation of iliocaval stents since those may be less sensitive for detecting stent stenosis.

Increased augmentation index in patients with Ehlers-Danlos syndrome.

BACKGROUND: Ehlers-Danlos Syndrome (EDS) comprises a heterogeneous group of diseases characterized by joint hypermobility, connective tissue friability, and vascular fragility. Reliable prognostic factors predicting vascular disease progression (e.g. arterial aneurysms, dissections, and ruptures) in EDS patients are still missing. Recently, applanation tonometry derived augmentation index (AIx), an indirect marker of arterial stiffness, has shown to be positively associated with progression of aortic disease in Marfan syndrome. In this study, we assessed aortic AIx in patients with EDS and matched healthy controls. METHODS: We performed noninvasive applanation tonometry in 61 adults with EDS (43 women and 18 men aged 39.3 ± 14.6 years) and 61 age-, gender-, height-, and weight-matched healthy controls. Radial artery pulse waveforms were recorded and analyzed using the SphygmoCor System (AtCor Medical, Sydney, NSW, Australia). Calculated AIx was adjusted to a heart rate of 75/min. Groups were compared and association between AIx and EDS was determined by univariate and multivariate regression analysis. RESULTS: EDS patients were categorized in classical type EDS (34%), hypermobile type EDS (43%), vascular type EDS (5%), or remained unassignable (18%) due to overlapping features. EDS patients showed a significantly increased aortic AIx compared to healthy controls (22.8% ± 10.1 vs 14.8% ± 14.0, p < 0.001). EDS showed a positive association with AIx; independent of age, sex, height, blood pressure, medication, and pack years of smoking. CONCLUSIONS: Patients with EDS showed elevated AIx, indicating increased arterial stiffness when compared to healthy controls. Further investigations are needed in order to assess the prognostic value of increased AIx for cardiovascular outcomes in patients with EDS.

Reliable semiquantitative whole-joint MRI score for the shoulder joint: The shoulder osteoarthritis severity (SOAS) score.

BACKGROUND: Shoulder osteoarthritis causes severe pain and functional disability. Preventive surgical procedures aiming to halt the progression of degenerative changes are increasingly applied. However, no MRI-based score exists that may be applied for scoring of osteoarthritic changes and their progression. PURPOSE: To establish a semiquantitative MRI-based shoulder osteoarthritis severity (SOAS) evaluation system and to test its reliability. STUDY TYPE: Retrospective. SUBJECTS: A total of N = 60 patients (73.2 ± 7.3 years; 30/60 female) was included; n = 15 subjects for each of the four radiographic grades of osteoarthritis (Samilson score 0 to 3). ASSESSMENT: Based on the MRIs of the shoulder, the SOAS scoring system was created. All MRIs were assessed by six readers. The severity of degeneration was evaluated for: rotator cuff, labral-bicipital-complex, cartilage, osseous findings, joint capsule, and acromion. The total SOAS score ranged between 0 (absence of osteoarthritis) and 100 (most severe osteoarthritis). SOAS scores were correlated with radiographic Samilson, Hamada and Kellgren-Lawrence (KL) gradings. STATISTICS: Pearson correlations, t-tests, receiver operating characteristics (ROC) and interclass correlation coefficients (ICC). RESULTS: Intra- (ICC = 0.99) and interreader agreement (ICC 0.96-0.98) for the total SOAS score was excellent. The range of SOAS scores was from 1 to 88. SOAS correlated significantly with radiographic Samilson and KL scores (R = 0.82, P < 0.001), but not with Hamada scores (R = -0.07, P = 0.60). The highest correlations with Samilson scores were found for cartilage (R = 0.82, P < 0.001) and osseous findings (R = 0.86, P < 0.001). SOAS scores were significantly different between different Samilson grades (Samilson 0, 13.4 ± 7.6; Samilson 1, 26.0 ± 9.1; Samilson 2, 38.2 ± 19.2; Samilson 3, 65.5 ± 13.0; P < 0.05). The ability of the SOAS score to predict incident radiographic shoulder OA (KL grade ≥2) was excellent (AUC = 0.91; P < 0.001). DATA CONCLUSION: The newly developed semiquantitative MRI-based SOAS score represents the severity of global shoulder OA and structure-specific shoulder degeneration with excellent reliability in a standardized manner and may therefore be helpful in MRI research studies of the shoulder. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2018.

Cartilage repair surgery prevents progression of knee degeneration.

PURPOSE: To investigate, whether cartilage repair surgery for focal osteochondral defects at the knee results in less degenerative changes over 6 years in a MR imaging follow-up than morphologically initially identical defects in non-operated control subjects from the osteoarthritis initiative (OAI). METHODS: A total of 32 individuals received baseline and follow-up MRI. In n = 16 patients with cartilage repair [osteochondral autograft transfer system (OATS), n = 12; spongiosa-augmented matrix-associated autologous chondrocyte implantation (MACI), n = 4] MRI was performed preoperatively and after 5.7 ± 2.3 year follow-up. Baseline MRIs of non-operated subjects from the OAI were screened for initially identical cartilage defects (n = 16). Morphological knee abnormalities were assessed using WORMS, AMADEUS and MOCART scores. A sagittal 2D MSME sequence was implemented for quantitative cartilage T2 relaxation time measurements in all (0, 2, 4, 6 and 8-years) follow-ups from the OAI and in the postoperative MRI protocol. RESULTS: For both groups, focal osteochondral defects were located at the femoral condyle in 8/16 cases (5 medial, 3 lateral) and at the patella in 8/16 cases. At baseline, the mean cartilage defect size ± SD was 1.4 ± 1.3 cm2 for the control group and 1.3 ± 1.2 cm2 for the cartilage repair group (n.s.). WORMS scores were not significantly different between the cartilage repair group and the control group at baseline [mean difference ± SEM (95%CI); 0.5 ± 2.5 (- 4.7, 5.7), n.s.]. During identical follow-up times, the progression of total WORMS scores [19.9 ± 2.3 (15.0, 24.9), P < 0.001] and of cartilage defects scores in the affected (P < 0.001) and in the opposing (P = 0.029) compartment was significantly more severe in non-operated individuals (P < 0.05). In non-operated subjects, T2 values increased continuously from baseline to the 8-year follow-up (P = 0.001). CONCLUSIONS: Patients with cartilage repair showed less progression of degenerative MRI changes at 6-year follow-up than a control cohort from the OAI with initially identical osteochondral defects. Patients with focal cartilage defects may profit from cartilage repair surgery since it may prevent progression of early osteoarthritis at the knee joint. LEVEL OF EVIDENCE: Prognostic study, Level II.

Cessation of anticoagulation therapy following endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis.

Background: The optimal duration of anticoagulation therapy (AT) following catheter-based therapy of acute iliofemoral deep vein thrombosis (IFDVT) with stent placement is unknown. Theoretically, resolving the underlying obstructive iliac vein lesion by a stent may eliminate the main trigger for recurrence, the post-thrombotic syndrome (PTS), and the need for extended-duration AT. Patients and methods: From 113 patients with acute IFDVT who underwent endovascular thrombus removal and stent placement, we compared patency rates and clinical outcomes between 58 patients on limited-duration AT (3-12 month) and 55 patients on extended-duration AT (> 12 months). Results: Mean follow-up duration was 26 ± 18 (range 3-77) months; it was 24 ± 18 (range 3-69) months after cessation of AT in the limited-duration AT group. In comparison to patients with extended-duration AT, patients with limited-duration AT were younger (38 versus 54 years; p < 0.001), more often female (74 % versus 49 %; p = 0.01), and had less often prior venous thromboembolism (VTE) (9 % versus 35 %; p = 0.001). May-Thurner syndrome was more frequent in the limited-duration AT group (66 % versus 38 %; p = 0.004). Overall, primary and secondary patency rates at 24 months were 80 % (95 % CI, 70-87 %) and 95 % (95 % CI, 88-98 %), respectively, with no difference between the groups. Overall, 17 (15 %) patients developed recurrent VTE, of which 14 (82 %) events were thrombotic stent occlusions, and 13 (76 %) events occurred during AT. In the limited-duration AT group, 98 % patients were free from the PTS at two years with a VTE recurrence rate of 3.5 per 100 patient years after cessation of AT. Conclusions: In selected patients with acute IFDVT and patent venous stent, particularly in younger and otherwise healthy patients with May-Thurner syndrome, it appears to be safe to discontinue AT 3-12 months after endovascular treatment. Clinical Trial Registration: The study is registered on the National Institutes of Health website (ClinicalTrials.gov; identifier NCT02433054).

Early Recoil After Balloon Angioplasty of Erection-Related Arteries in Patients With Arteriogenic Erectile Dysfunction.

PURPOSE: To evaluate the incidence of elastic recoil in patients presenting with erectile dysfunction (ED) undergoing endovascular revascularization of the pudendal or penile arteries. METHODS: A consecutive series of 21 ED patients (mean age 58.3±9.3 years) undergoing minimally invasive revascularization of 31 arteries was analyzed. ED lesions included the pudendal arteries (n=27) and the penile artery (n=4). Mean lesion length was 20.6±13.9 mm. Minimal lumen diameter (MLD) measurements were assessed at baseline, immediately after balloon angioplasty, and 10 minutes thereafter. Early recoil was defined as an MLD reduction >10%. Elastic recoil with >10% lumen compromise was treated with drug-coated balloons, while severe elastic recoil (>30%) required drug-eluting stents (DES). The International Index of Erectile Function (IIEF-15) score was obtained prior to and 3 months after the procedure to obtain information on functional outcomes subsequent to angioplasty. RESULTS: Mean MLD at baseline was 0.9±0.6 mm, which improved to 2.0±0.9 mm immediately after balloon dilation. At 10 minutes after dilation, the MLD was 1.7±1.0 mm. Elastic recoil was observed in all 31 lesions and resulted in a mean lumen compromise of 21.2%. Severe (>30%) recoil was observed in 14 arteries, which underwent DES therapy. The IIEF-15 score improved from 31.3±11.2 at baseline to 49.8±16.8 (p<0.001) at the 3-month follow-up. CONCLUSION: Endovascular revascularization constitutes a safe and feasible treatment modality to restore erectile function in patients with arteriogenic ED and ineffective conservative management. Early elastic recoil is very frequent subsequent to balloon dilation of small-caliber erection-related arteries. Thus, mechanical scaffolding with DES is required in a high subset of ED patients to provide favorable early angiographic and clinical results.

Sensitivities of in vivo markers of arterial organ damage in patients with peripheral atherosclerosis.

BACKGROUND: Biomarkers of vascular diseases such as ankle-brachial index (ABI), peripheral pulse pressure (pPP), central pulse pressure (cPP), and pulse wave velocity (PWV) allow assessment of arterial organ damage (AOD). However, the utility of markers other than ABI in patients with peripheral arterial disease (PAD), which are also associated with a significant increase of cardiovascular events, remains unclear. PATIENTS AND METHODS: Asymptomatic (n = 21) and symptomatic patients (n = 46) with a positive sonography for PAD or history of lower limb revascularization were included. ABI, pPP, cPP, and PWV were assessed. PWV were performed using a brachial cuff-based method (aortic PWV (aPWV)) and oscillography (carotid-femoral pulse wave velocity (cfPWV)), respectively. The two methods for PWV were compared using Bland Altman analysis. Sensitivities of ABI, pPP, cPP, cfPWV, and aPWV for AOD were calculated. RESULTS: Sixty-seven patients (35.8 % female, mean age 69, range 39-91 years) had a significantly higher aPWV than cfPWV (median 10.5 m/s (IQR: 8.8-12.65 m/s) vs. median 9.0 m/s (IQR: 7.57-10.55 m/s), p = 0.0013). There was no correlation between cfPWV and age (r = 0.311, p = 0.116). Bland Altman analysis revealed a mean difference of -1.04 (-2SD; -6.38 to + 2SD; 4.31). The sensitivities for AOD were 68.7 % for ABI, 61.2 % for aPWV, 40.3 % for cfPWV, 31.3 % for peripheral PP, and 10.4 % for central aortic PP (p < 0.001). CONCLUSIONS: Brachial-derived aPWV differs from the gold standard assessment (cfPWV), which may be underestimated in PAD due to atherosclerotic obstructions along the aorto-iliac segment. The sensitivities of noninvasive in vivo markers of AOD vary widely and tend to underestimate the actual presence of AOD.

Use of a stent graft in tumor erosion of the common femoral artery with life-threatening bleeding.

We report a case of a 56-year-old male patient with a life-threatening left common femoral artery bleeding due to tumor erosion. The patient had a history of advanced high-grade pleomorphic leiomyosarcoma of the left groin with pulmonary metastasis. Clinical examination revealed a massive tumor bulking at the left groin with necrosis and phleb- and lymphedema. Given the circumstances, open surgery was not possible. Thus, it was decided to treat the patient with an endovascular procedure. The postprocedural course was uneventful, the patient received blood product and was hemodynamically stable. He was discharged at day six with ambulatory follow-up. Endovascular therapy using stent grafts to exclude a life-threatening bleeding is a valuable alternative treatment option in oncologic patients with limited life expectancy, which are unsuitable for surgery.

Erectile dysfunction - overview from a cardiovascular perspective.

Erectile dysfunction (ED) is an evolving health problem with growing incidence in the ageing male population with potentially predictive value for cardiovascular and other chronic diseases. ED shares the common cardiovascular risk factors. The aetiology of ED is numerous including neurogenic, psychogenic, arteriogenic, and venogenic reasons. The origin of arteriogenic ED is frequently atherosclerosis. Patients not adequately responding to conservative measures including oral medication are often referred to further vascular diagnostics and therapy. At present, the refinements in endovascular therapy allow for minimal-invasive revascularization of erection-related arteries. The role of endovascular therapy in the complex framework of the multifactorial causes of ED requires further scientific scrutiny.

Percutaneous sclerotherapy for spongiform venous malformations - analysis of patient-evaluated outcome and satisfaction.

BACKGROUND: Congenital venous malformations are frequently treated with sclerotherapy. Primary treatment goal is to control the often size-related symptoms. Functional impairment and aesthetical aspects as well as satisfaction have rarely been evaluated. PATIENTS AND METHODS: Medical records of patients who underwent sclerotherapy of spongiform venous malformations were reviewed and included in this retrospective study. The outcome of sclerotherapy as self-reported by patients was assessed in a 21 item questionnaire. RESULTS: Questionnaires were sent to 166 patients with a total of 327 procedures. Seventy-seven patients (48 %) with a total of 159 procedures (50 %) responded to the survey. Fifty-seven percent of patients were male. The age ranged from 1 to 38.1 years with a median age of 16.4 years. The lower extremities were the most common treated area. Limitations caused by the venous malformation improved in the majority of patients (e.g. pain improvement 87 %, improvement of swelling 83 %) but also worsening of symptoms occurred in a minority of cases. Seventy-seven per cent would undergo sclerotherapy again. CONCLUSIONS: Sclerotherapy for treatment of venous malformations results in significant reduction of symptoms. Multiple treatments are often needed, but patients are willing to undergo them.

Credentialing in interventional therapy in Europe - comparison of curricula including endovascular therapy of arterial diseases.

The prevalence of peripheral artery disease (PAD) is continuously increasing. In addition, the treatment of PAD has changed substantially over the last decades. Novel treatment modalities and diagnostic tools were developed and endovascular therapy was established as a first-line therapy. In consequence, vascular medicine has become an interdisciplinary field, involving different specialties such as internal medicine/cardiology, internal medicine/angiology, vascular surgery, and (interventional) radiology. Attributed to the expanding field and to ensure high quality and standardized training, various curricula were developed. Not only within the different medical disciplines but across countries. We compared the training programmes in Germany, Switzerland, and Europe and found a great variety in these curricula and programmes. Nevertheless, we identified first attempts to harmonize training requirements within the various societies: the interdisciplinary guidelines of the German Society for Cardiology (DGK) and the German Society of Angiology, the adoption of European standards on a national level, and the Swiss initiative of the Union of Vascular Societies of Switzerland (UVSS). The standard and level of training is high in all curricula and societies. However, further harmonization is needed to optimize patient care and ensure a uniform quality level across different vascular societies.

Bleeding Risk Profile in Patients With Symptomatic Peripheral Artery Disease.

PURPOSE: To assess the bleeding risk profile using the HAS-BLED score in patients with symptomatic peripheral artery disease (PAD). METHODS: A post hoc analysis was performed using data from a series of 115 consecutive patients (mean age 72.4±11.4 years; 68 men) with symptomatic PAD undergoing endovascular revascularization. The endpoint of the study was to assess bleeding risk using the 9-point HAS-BLED score, which was previously validated in cohorts of patients with and without atrial fibrillation. For the purpose of this study, the low (0-1), intermediate (2), and high-risk (≥3) scores were stratified as low/intermediate risk (HAS-BLED <3) vs high risk (HAS-BLED ≥3). RESULTS: The mean HAS-BLED score was 2.76±1.16; 64 (56%) patients had a HAS-BLED score ≥3.0. Patients with PAD Rutherford category 5/6 ischemia had an even higher mean HAS-BLED score (3.20±1.12). Logistic regression analysis revealed aortoiliac or femoropopliteal segment involvement, chronic kidney disease, as well as Rutherford category 5/6, to be independent risk factors associated with a HAS-BLED score ≥3. CONCLUSION: Patients with PAD, especially those presenting with Rutherford category 5/6 ischemic symptoms, have high HAS-BLED scores, suggesting increased risk for major bleeding. Prospective clinical validation of the HAS-BLED score in patients with PAD may help with the risk-benefit assessment when prescribing antithrombotic therapy.

Technical Results of Vacuum-Assisted Thrombectomy for Arterial Clot Removal in Patients with Acute Limb Ischemia.

PURPOSE: To assess the efficacy and safety of a vacuum-assisted thrombectomy (VAT) catheter system for treating patients with acute limb ischemia (ALI). MATERIALS AND METHODS: A retrospective study evaluated VAT systems (Penumbra, Alameda, California) in a consecutive series of 30 patients with ALI. ALI was defined as clinical symptoms within 2 weeks of presentation. The primary endpoint was improvement in blood flow across a lesion by improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures. Target lesions were grouped anatomically into above-the-knee (ATK) or below-the-knee (BTK) lesions. RESULTS: In 30 patients, 33 lesions (ATK, n = 13; BTK, n = 20) were treated. No complications were attributed to the VAT systems. The primary endpoint was obtained in 24/33 (72.7%) lesions (BTK, 17/20 [85.0%]; ATK, 7/13 [53.9%]; P = .050 by χ(2) test). TIMI scores were similar at baseline but differed after VAT between the ATK and BTK groups (P < .025 by t test). ATK lesions required more concomitant angioplasty or stent placement, or both (P < .015 by χ(2) test). CONCLUSIONS: VAT is a safe, technically successful short-term therapeutic option for thrombus removal in patients with ALI.

Fixed low-dose ultrasound-assisted catheter-directed thrombolysis for intermediate and high-risk pulmonary embolism.

AIMS: No standardized local thrombolysis regimen exists for the treatment of pulmonary embolism (PE). We retrospectively investigated efficacy and safety of fixed low-dose ultrasound-assisted catheter-directed thrombolysis (USAT) for intermediate- and high-risk PE. METHODS AND RESULTS: Fifty-two patients (65 ± 14 years) of whom 14 had high-risk PE (troponin positive in all) and 38 intermediate-risk PE (troponin positive in 91%) were treated with intravenous unfractionated heparin and USAT using 10 mg of recombinant tissue plasminogen activator per device over the course of 15 h. Bilateral USAT was performed in 83% of patients. During 3-month follow-up, two [3.8%; 95% confidence interval (CI) 0.5-13%] patients died (one from cardiogenic shock and one from recurrent PE). Major non-fatal bleeding occurred in two (3.8%; 95% CI, 0.5-13%) patients: one intrathoracic bleeding after cardiopulmonary resuscitation requiring transfusion, one intrapulmonary bleeding requiring lobectomy. Mean pulmonary artery pressure decreased from 37 ± 9 mmHg at baseline to 25 ± 8 mmHg at 15 h (P < 0.001) and cardiac index increased from 2.0 ± 0.7 to 2.7 ± 0.9 L/min/m(2) (P < 0.001). Echocardiographic right-to-left ventricular end-diastolic dimension ratio decreased from 1.42 ± 0.21 at baseline to 1.06 ± 0.23 at 24 h (n = 21; P < 0.001). The greatest haemodynamic benefit from USAT was found in patients with high-risk PE and in those with symptom duration < 14 days. CONCLUSION: A standardized catheter intervention approach using fixed low-dose USAT for the treatment of intermediate- and high-risk PE was associated with rapid improvement in haemodynamic parameters and low rates of bleeding complications and mortality.

Real Time Intraprocedural Ultrasound Measurements of the Radial and Ulnar Arteries in 565 Consecutive Patients Undergoing Cardiac Catheterization and/or Percutaneous Coronary Intervention via the Wrist: Understanding Anatomy and Anomalies May Improve Access Success.

OBJECTIVES: Ultrasound evaluation of both the radial artery (RA) and ulnar artery (UA) in patients undergoing cardiac catheterization/percutaneous coronary intervention. BACKGROUND: Arterial access from the wrist is almost exclusively obtained from the RA. Crossover to secondary femoral arterial access was observed in up to 7.6% in randomized multicenter trials utilizing palpation guided RA access. METHODS: Intraprocedural ultrasound evaluation of the RA and UA was performed in a consecutive series of patients. A difference of ≥20% in diameter was defined as significant. In the case of a dual artery, measurements of the dual arteries and the proximal confluens were obtained. RESULTS: A total of 566 RA/UA measurements were analysed (patients: n = 565, female: n = 201 [35.5%], mean age: 66.5 years). Overall, the RA measured 3.03 ± 0.57 mm and the UA 2.70 ± 0.57 mm (P < 0.01). The RA was larger in 210 (37.1%) and the UA in 37 (6.5%) measurements. A dual RA was present in 25 (4.4%) measurements. The mean diameters of the smaller and larger of the dual RAs were 1.82 ± 0.37 and 2.59 ± 0.36 mm (P < 0.01). The corresponding proximal confluens measured 3.10 ± 0.40 mm. No dual UA was observed. CONCLUSION: In 10.9 % of patients, a larger UA or a dual RA with a more accessible confluens was observed. This information can only be obtained using ultrasound and may improve arterial access from the wrist if the larger UA or RA confluens is accessed instead of blind palpation guided RA access.

Evolving Techniques to Improve Radial/Ulnar Artery Access: Crossover Rate of 0.3% in 1,000 Consecutive Patients Undergoing Cardiac Catheterization and/or Percutaneous Coronary Intervention via the Wrist.

OBJECTIVES: To evaluate several techniques to reduce crossover rates in wrist artery access in patients undergoing cardiac catheterization (CC)/percutaneous coronary intervention (PCI). BACKGROUND: Palpation-guided radial artery (RA) access for CC/PCI is associated with a crossover rate to femoral artery (FA) access in up to 7.6%. METHODS: A retrospective analysis of a single-center consecutive series of patients undergoing CC/PCI was performed. After one 0.4 mg sublingual NTG tablet, the RA and UA were assessed by intraprocedural ultrasound imaging to select the more suitable artery for ultrasound-guided access. A tight "knuckle wire" technique using a 0.014 inch Prowater® coronary wire was used to negotiate RA, UA, and brachial loops when a standard wire would not easily cross. Crossover was defined as any reason requiring secondary arterial access from the contralateral arm or FA. RESULTS: A total of 1,162 consecutive patients treated from January 2012 to April 2014 were evaluated. Primary arterial access from the wrist (RA/UA) was performed in 1,000 (86.1%, RA: 977, UA 23) and planned FA access in 162 patients (13.9%). The overall crossover rate from the wrist was 0.3% as a result of 3/1,000 patients requiring crossover to the contralateral arm (radial loop: n = 1, brachial loop: n = 1, vessel injury: n = 1). No crossover to the FA was necessary. All primary FA access sites were successful. CONCLUSIONS: Crossover rates of primary wrist artery access to alternative arterial access for CC/PCI can be reduced to less than 1% applying the aforementioned techniques.

Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study).

PURPOSE: To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). METHODS: In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. RESULTS: Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. CONCLUSION: Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.

Single-Center Experience Comparing the Application of Small-Caliber versus Large-Caliber Arterial Access Closure in a Consecutive Series of Patients.

PURPOSE: To compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP device (St. Jude Medical, Inc, St. Paul, Minnesota). MATERIALS AND METHODS: In this investigator-initiated, retrospective analysis, a consecutive series of 137 patients (n = 92 male patients [67.2%]; overall mean age, 71.0 y ± 9.8) was evaluated. Common femoral artery access was performed in all patients, and either unfractionated heparin or bivalirudin was used for anticoagulation. Access site complications were defined as follows: type 0, no bleeding; type 1, no actionable bleeding; type 2, actionable bleeding. RESULTS: The 8-F Angio-Seal VIP device was used for closure of ≤ 8-F femoral access in 76 patients (55.5%) and for 9-F to 12-F femoral access in 61 patients (44.5%). Access site complications were observed after 8-F Angio-Seal deployment in 11 patients (8.0%) (≤ 8 F, n = 5 [6.6%]; 9-12 F, n = 6 [9.8%]; P = .54). Comparing ≤ 8-F with 9-F to 12-F femoral access, type 1 complications were observed in 3 and 6 patients (P = .19) and type 2 complications were observed in 2 and 0 patients (P = .50), respectively. All type 1 complications were managed by applying external compression. Type 2 complications (n = 2 pseudoaneurysms) were treated with thrombin injection in 1 patient and secondary percutaneous intervention in 1 patient. CONCLUSIONS: Use of the 8-F Angio-Seal for the closure of > 8-F femoral access is safe and effective. Complication rates when using the 8-F Angio-Seal for closure of ≤ 8-F and 9-F to 12-F femoral access are comparable.