The p48 flow diverter: First clinical results in 25 aneurysms in three centers.

BACKGROUND: The novel low-profile p48 flow diverter has been designed to treat aneurysms on small vessels of 1.75-3mm. We report our first clinical experiences. METHODS: Between March 2018-January 2020, 22 patients with 25 aneurysms were treated with the p48 in 3 centers. One patient had 3 aneurysms covered by one p48 and one patient had 2 aneurysms. There were 5 men, 17 women, with a mean age of 55 years (median 59, range 29-73 years). RESULTS: In 25 aneurysms, 24 p48 flow diverters were placed. In 1 patient additional coils were placed in the aneurysm. Procedural vessel rupture by the micro guidewire occurred in 2 patients and vessel rupture during p48 balloon dilatation occurred in 1 patient. Overall, the permanent morbidity rate was 13.6% (3 of 22, 95%CI 3.9-34.2%) and mortality was 4.5% (1 of 22, 95%CI <0.01-23.5%). Most complications were procedure-related and not device-specific. Of 22 patients with 25 aneurysms treated with p48, 18 patients with 20 aneurysms had angiographic follow-up after 5-18 months. Of 19 aneurysms, 10 were occluded and 7 showed a remnant. Two aneurysms were open after 6 months. Three aneurysms were still not occluded after 12, 14, and 18 months and these 3 were retreated. Retreatment rate was 16% (3 of 19) and the adequate occlusion rate was 90% (17 of 19). CONCLUSIONS: Treatment of aneurysms in small-caliber vessels with the p48 is feasible and effective but is not without complications. More data is needed to establish indications, safety, and efficacy more accurately.

Trauma of the spine and spinal cord: imaging strategies.

Traumatic injuries of the spine and spinal cord are common and potentially devastating lesions. We present a comprehensive overview of the classification of vertebral fractures, based on morphology (e.g., wedge, (bi)concave, or crush fractures) or on the mechanism of injury (flexion-compression, axial compression, flexion-distraction, or rotational fracture-dislocation lesions). The merits and limitations of different imaging techniques are discussed, including plain X-ray films, multi-detector computed tomography (MDCT), and magnetic resonance imaging (MRI) for the detection. There is growing evidence that state-of-the-art imaging techniques provide answers to some of the key questions in the management of patients with spine and spinal cord trauma: is the fracture stable or unstable? Is the fracture recent or old? Is the fracture benign or malignant? In summary, we show that high-quality radiological investigations are essential in the diagnosis and management of patients with spinal trauma.

Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study.

PURPOSE: To prospectively assess the short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures (VCF) treated with percutaneous vertebroplasty (PV) compared with optimal pain medication (OPM). METHODS: Randomization of patients in 2 groups: treatment by PV or OPM. After 2 weeks, patients from the OPM arm could change therapy to PV. Patients were evaluated 1 day and 2 weeks after treatment. Visual analog score (VAS) for pain and analgesic use were assessed before, and 1 day and 2 weeks after start of treatment. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Roland-Morris Disability (RMD) questionnaire scores were assessed before and 2 weeks after start of treatment. Follow-up scores in patients requesting PV treatment after 2 weeks OPM treatment were compared with scores during their OPM period. RESULTS: Eighteen patients treated with PV compared with 16 patients treated with OPM had significantly better VAS and used less analgesics 1 day after treatment. Two weeks after treatment, the mean VAS was less but not significantly different in patients treated with OPM, whereas these patients used significantly less analgesics and had better QUALEFFO and RMD scores. Scores in the PV arm were influenced by occurrence of new VCF in 2 patients. After 2 weeks OPM, 14 patients requested PV treatment. All scores, 1 day and 2 weeks after PV, were significantly better compared with scores during conservative treatment. CONCLUSION: Pain relief and improvement of mobility, function, and stature after PV is immediate and significantly better in the short term compared with OPM treatment.

Pain response in the first trimester after percutaneous vertebroplasty in patients with osteoporotic vertebral compression fractures with or without bone marrow edema.

BACKGROUND AND PURPOSE: Presence of bone marrow edema (BME) in osteoporotic vertebral compression fractures (VCF) detected by MR imaging as selection criterion for percutaneous vertebroplasty (PV) is speculative. To clarify significance of BME in VCF, we assessed pain response after PV in patients with VCF with full BME versus patients with VCF with absent BME. METHODS: From a cohort of patients with painful VCF selected for PV, pain response in 14 patients with absent BME in VCF was prospectively compared with pain response in 31 patients with full BME in VCF. Pain was evaluated before PV and at 1 and 3 months after PV with visual analog scores and analgesics used. Back pain in general and at treated vertebral levels was assessed. RESULTS: Pain decrease after PV at treated levels was observed in 10 (71%) patients with absent BME in VCF at both follow-up periods and in 29 (94%) patients with full BME 1 month after PV and 30 (97%) at 3 months after PV. Differences between the groups were significant (P = .04 at 1 month; P = .01 at 3 months). Pain response was not affected by other patient or imaging characteristics. General back pain after PV was comparable in both groups after PV (P = .08 at 1 month; P = .4 at 3 months). CONCLUSION: Pain decrease after PV in patients with VCF is more frequently observed when full BME is present. Because 71% of patients with VCF with absent BME responded favorably on pain, PV should not be withheld based on absence of BME alone.

Bone marrow edema in osteoporotic vertebral compression fractures after percutaneous vertebroplasty and relation with clinical outcome.

BACKGROUND AND PURPOSE: Little is known about the evolution of bone marrow edema (BME) in osteoporotic vertebral compression fractures (VCF) after percutaneous vertebroplasty (PV) or about its relation with relief of pain. In this study, we prospectively assessed changes in BME with MR imaging at 3, 6, and 12 months after PV and related changes in BME with pain evolution and analgesic use over time. METHODS: BME percentage was assessed in 64 patients after PV of 89 VCF with serial MR imaging follow-up at 3, 6, and 12 months. Pain was assessed before PV and at every follow-up interval by visual analog scale for pain and type of analgesic used. Relation between changes in BME and pain evolution was assessed in a subgroup of 31 patients with a single treated VCF and neither new VCF at follow-up nor pain at another untreated level. RESULTS: BME gradually decreased over time. At 1 year after PV, 29% of treated VCF still demonstrated BME. Once BME disappeared, it did not return. Pain relief was most striking the first 3 months after PV and remained constant thereafter. There was no relation between relief of pain and extent, presence, or absence of BME after PV. CONCLUSION: A gradual decrease of BME in osteoporotic VCF treated with PV is apparent during 12 months of MR imaging follow-up. Decrease of BME is unrelated to relief of pain.

[Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: first short term results]. / Percutane vertebroplastiek bij osteoporotische wervelinzakkingsfracturen: eerste kortetermijnresultaten.

OBJECTIVE: To describe the technique of percutaneous vertebroplasty and the short-term results in patients with symptomatic, osteoporotic vertebral compression fractures. DESIGN: Prospective follow-up study. METHOD: In a pilot-study to evaluate the short-term safety and effectiveness of percutaneous vertebroplasty, 18 consecutive patients with a total of 33 osteoporotic thoracic or lumbar vertebral compression fractures were treated from October 2001 to June 2002 with a follow-up of 3-6 months. The indication for treatment was a symptomatic, therapy-resistant osteoporotic vertebral compression fracture. Percutaneous vertebroplasty was performed under radiographic control, after previous intraossal venography, using bone cement mixed with barium sulphate. Post-procedural follow-up consisted of radiological evaluation with conventional thoracolumbar X-rays and MRI scans, and interviews of the patients. RESULTS: Percutaneous vertebroplasty was technically successful in 31 of 33 vertebral fractures (94%), and in 16 of 18 patients (89%). One patient with extreme venous contrast leakage could not be treated. Sixteen patients had less or no pain after treatment. One patient retained thoracolumbar back pain after inadequate cementations and refused further treatment. None of the patients reported aggravation of symptoms following the procedure. Contrast leakage was absent in 18 vertebrae. In 8 vertebrae there was contrast leakage to paravertebral veins. In three of these cases the leakage was so severe that embolisation was performed, with success in one case. In 13 vertebrae, cement leakage to intervertebral and paravertebral spaces and pedicular cement spurs were seen, without clinical consequences. Immediately after the procedure and during follow-up there were no clinically relevant complications. CONCLUSION: Percutaneous vertebroplasty was a technically feasible treatment in these patients with symptomatic, therapy-resistant, osteoporotic vertebral fractures. The first short-term results were comparable with results in the literature. A prospective randomised intervention study will be needed to compare percutaneous vertebroplasty with optimal conservative treatment.

[Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: review of the literature]. / Percutane vertebroplastiek bij de behandeling van osteoporotische wervelinzakkingsfracturen; literatuuronderzoek.

OBJECTIVE: To determine the effectiveness and safety of percutaneous vertebroplasty for the treatment of osteoporotic vertebral compression fractures as published in the scientific literature. DESIGN: Literature review. METHOD: Medline and the Cochrane library were searched with the terms 'percutaneous vertebroplasty', 'vertebral compression fractures', 'osteoporotic' and 'osteoporosis'. Criteria for inclusion were: (a) the studies had to have been published in the period January 1985-August 2002, (b) the study population had to include at least 10 patients, (c) the patients had to have been treated with percutaneous vertebroplasty, and (d) the diagnosis had to have been 'osteoporotic vertebral compression fracture'. RESULTS: Twelve studies met the inclusion criteria. Pain relief was seen in 60%-100% of the patients within the first 24 hours and this result improved to 78-100% in the long term (maximum 4 years). The complications immediately after the procedure were related to cement leakages and were mostly of no clinical consequence. Serious complications such as pulmonary embolism were rare. In the long term, percutaneous vertebroplasty was associated with an increased risk of fractures in the adjacent vertebrae. CONCLUSION: Percutaneous vertebroplasty seems to be effective and safe in the treatment of osteoporotic vertebral compression fractures. A prospective randomised intervention study has, however, not yet been performed. For the time being, percutaneous vertebroplasty should be reserved for carefully selected patients in whom conservative therapy has not produced results.

Quality of palliation and possible benefit of extra-anatomic reconstruction in recurrent dysphagia after resection of carcinoma of the esophagus.

BACKGROUND: After "curative" resection of carcinoma of the esophagus, late secondary dysphagia almost invariably indicates locoregional tumor recurrence. The retrosternal reconstruction route is advocated to prevent ingrowth of tumor recurrence in the neoesophagus. STUDY DESIGN: To evaluate the quality of palliation after "curative" resection of carcinoma of the esophagus and the possible benefit of the retrosternal reconstruction route, we retrospectively analyzed the records of patients who had resection of a malignant tumor of the esophagus, or the gastroesophageal junction, and a prevertebral reconstruction. The extra-anatomic route would have been only beneficial for patients with intrathoracic tumor recurrence distant from the anastomosis and causing gastrointestinal symptoms. RESULTS: Between 1983 and 1989, 209 patients (mean age of 61.3 years at the time of operation) had "curative" resection and prevertebral reconstruction in the institution of this study. Seventy-three patients (35 percent) had locoregional tumor recurrence. Univariate and multivariate analysis of various risk factors for locoregional recurrence showed that the presence of positive lymph nodes (pN1), especially if located at the celiac trunk (pM1), and a macroscopically non-radical R2 resection were the most important risk factors. Forty-six patients (22 percent) had secondary dysphagia as a result of locoregional tumor recurrence, mostly (18 percent) within two years postoperatively. Dysphagia lasted on average 5.3 months (range of 0.3 to 21.5 months) before the patients died. In 27 patients (13 percent), dysphagia would probably have been prevented by using a retrosternal reconstruction route. CONCLUSIONS: These data are an argument in favor of the extra-anatomic, retrosternal reconstruction route after limited transthoracic or transhiatal resection in the presence of positive lymph nodes. This method seems especially indicated if the nodes are located at the celiac trunk and in case of a macroscopically nonradical R2 resection.

Recurrence pattern of oesophageal carcinoma after limited resection does not support wide local excision with extensive lymph node dissection.

The recurrence pattern after 'limited' resection for oesophageal carcinoma was analysed to determine whether more extensive local excision of tumour in combination with radical lymphadenectomy improves locoregional disease control and long-term survival. A total of 143 patients who underwent limited surgery with curative intent between 1983 and 1989 were studied: 90 with squamous cell carcinoma (group 1) and 53 with adenocarcinoma (group 2) of the thoracic oesophagus. One patient was lost to follow-up. Tumour recurrence occurred in 40 patients (44 per cent) in group 1 and 35 (66 per cent) in group 2. Locoregional recurrence in isolation occurred in 11 per cent of patients in group 1 and 8 per cent of those in group 2; locoregional recurrence was detected in combination with tumour elsewhere in 19 and 28 per cent respectively. In conclusion, one-third of patients at the most might potentially have benefited from more radical local tumour resection. Theoretical advantages such as a prolonged disease-free interval and definite cure should be weighed against the higher risk of serious complications. More extensive procedures should therefore be performed only in controlled clinical studies.

[Intra-abdominal adhesions and foreign-body granulomas following earlier laparotomy]. / Intra-abdominale adhesies en vreemd-lichaamgranulomen na eerdere laparotomie.

OBJECTIVE: To determine the prevalence of foreign body granulomas in intra-abdominal adhesions in patients subjected to relaparotomy. DESIGN: Cross-sectional. SETTING: University Hospital Rotterdam-Dijkzigt, the Netherlands. METHOD: From July 1991 to September 1992, 119 patients were subjected to relaparotomy. Presence, distribution and quality of adhesions were scored during the relaparotomy and adhesion samples were taken for histological examination. RESULTS: Adhesions were present in 94% of the patients; they were most frequently attached to small bowel (83%) and omentum (78%). The number of adhesions was significantly smaller in patients with a history of only one minor operation than in those with one major or multiple laparotomies. Foreign body granulomas were found in 22% of the patients with adhesions. These were caused by suture material (19%) or starch glove powder (6%); a combination of both occurred in 3% of the patients. When granulomas were present, the median interval between present and most recent laparotomy was significantly shorter than when no granulomas were found. In patients with adhesions who had had the previous operation less than 6 months previously, granulomas were present in 71%. In contrast, 13% of the patients operated upon longer than 6 months previously had granulomas. CONCLUSIONS: In young adhesions foreign body granulomas occur in large percentages of the cases. This suggests that the intra-abdominal presence of foreign material is an important cause of adhesion formation. Therefore, intra-abdominal contamination with suture material and glove powder should be avoided.