Multiple pipeline embolization devices improves aneurysm occlusion without increasing morbidity: A single center experience of 140 cases.

INTRODUCTION: Rates of aneurysm occlusion with the pipeline embolization device (PED) has varied widely in the literature from 55.7% to 93.3% at 6 months, which may reflect a difference in technique including sizing and number of devices used. METHODS: 140 cases at our institution were retrospectively reviewed, and aneurysms treated with a single PED vs. multiple were compared. RESULTS: Complete aneurysm occlusion was achieved in 86.9% at 6 months, 91.8% at 1 year, and 97.6% at longest follow-up. Retreatment with an additional device was required in 7 (5.1%). Major and minor complication rate within 30 days was 1.4% and 5.0%, and at greater than 30 days was 0.8% and 3.1%. Patients treated with multiple PEDs had significantly higher rates of aneurysm occlusion at 6 months (92.9% vs. 75.6%, p = 0.017) and 12 months (98.4% vs. 81.1%, p = 0.014), with no difference in complications. The two groups were similar aside from a higher number of ophthalmic and paraophthalmic aneurysms treated with multiple PEDs (23.4% vs. 6.5%, p = 0.004; and 35.1% vs. 17.4%, p = 0.020), and more posterior communicating artery and recurrent aneurysms treated with a single PED (28.3% vs. 3.2%, p = 0.001; 23.9% vs. 8.5%, p = 0.031). The use of multiple PEDs was found to be an independent predictor of aneurysm occlusion in a multivariate analysis (p = 0.015). CONCLUSIONS: The use of multiple PEDs for intracranial aneurysms leads to significantly higher occlusion rates without added morbidity. This benefit is particularly appropriate for ophthalmic segment aneurysms, while more distal segments with eloquent perforating branches should be managed with caution.

Predicting the need for retreatment in venous sinus stenting for idiopathic intracranial hypertension.

BACKGROUND: Idiopathic intracranial hypertension is a disease of raised intra-cranial pressure of unknown etiology. Lateral cerebral venous sinus stenosis (VSS) has been increasingly reported in these patients, and stenting has emerged as an alternative treatment for medically refractory symptoms. Treatment efficacy on meta-analysis appears promising, but identifying which patients are likely to benefit most, and which are likely to require repeat procedures, is currently unclear. METHODS: We retrospectively reviewed a prospectively collected database of 79 patients treated with venous sinus stenting at a single academic center with minimum follow-up of 18 months. We extracted baseline clinical data, as well as manometry at lumbar puncture and during angiography, and used logistic regression to identify parameters that could predict stent failure. RESULTS: Retreatment rate after successful VSS was 13.9%. Lumbar puncture opening pressure (OP) was shown to significantly predict treatment failure (ß=0.06; OR=1.064 (1.003-1.135); P=0.039). This effect remained significant when age, sex and body mass index were added to the model (ß=0.06; OR=1.066 (1.002-1.140); P=0.043). OP was correlated with venous sinus manometry readings in the superior sagittal and transverse sinus pre-stent placement, as well trans-stenotic gradient (P<0.001). CONCLUSIONS: Higher lumbar puncture OP was associated with an increased risk of stent failure in transverse sinus stenting for idiopathic intracranial hypertension, although the performance of this model as a linear discriminator was poor. Further studies are required to better assess which patients are at greatest risk of treatment failure.

Outcome predictors after retransplantation in relapsed acute lymphoblastic leukemia: a multicenter, retrospective study.

Retransplantation is the only curative treatment option for patients with acute lymphoblastic leukemia (ALL) that has relapsed after allogeneic hematopoietic cell transplantation (allo-HCT); however, data in this setting remain scant. Hence, this multicenter, retrospective study aims to determine outcome predictors after retransplantation in relapsed ALL. We examined 55 recipients who underwent multiple allo-HCTs during 2006-2018. The 2-year overall survival (OS), progression-free survival (PFS), and non-relapse mortality rates were 35.9%, 29.1%, and 23.6%, respectively. We observed a trend of better outcome in Ph + ALL (n = 22) patients compared with non-Ph ALL (n = 33) patients; the 2-year PFS was 40.9% versus 21.2%, indicating a beneficial effect of more potent second- or third-generation tyrosine kinase inhibitors. Univariate analysis revealed that late relapse after the previous transplant was the only significant predictor of better transplant outcome among Ph + ALL patients, whereas factors related to prolonged OS/PFS in non-Ph ALL patients were late relapse after the previous transplant, longer duration from disease relapse/progression to second or more allo-HCT, disease status at the transplantation, and good performance status. Nevertheless, further investigations are warranted to determine whether novel molecular-targeted agents with higher efficacy and fewer toxicities could exceed conventional chemotherapies as a bridging strategy to next allo-HCT and improve the outcomes of non-Ph ALL patients.

Impact of Gradual Adoption of EVAR in Elective Repair of Abdominal Aortic Aneurysm: A Retrospective Cohort Study from 2009 to 2015.

INTRODUCTION: The recommendations about the preferred type of elective repair of abdominal aortic aneurysm (AAA) still divides guidelines committees, even nowadays. The aim is to assess outcomes after AAA repair focusing on differences between endovascular aneurysm repair (EVAR) and open surgical repair (OSR). METHODS: The observational retrospective cohort study of consecutive patients submitted to elective AAA repair at a tertiary center, 2009-2015. Exclusion criteria were as follows: nonelective cases or complex aortic aneurysms. Primary outcomes were postoperative complications, length of hospital stay, survival, freedom from aortic-related mortality, and vascular reintervention. Time trends were assessed along the period under analysis. RESULTS: From a total of 211 included patients, those submitted to EVAR were older (74 ± 7 vs. 67 ± 9 years; P < 0.001), presented a higher prevalence of hypertension (83.5% vs. 68.5%, P = 0.004), obesity (28.7% vs. 14.3%, P = 0.029), previous cardiac revascularization (30.5% vs. 14.7%, P = 0.005), heart failure (17.2% vs. 5.2%, P = 0.013), and chronic obstructive pulmonary disease (32.8% vs. 13.3%, P = 0.002). Patients were followed during a median of 49 months. EVAR resulted in a significantly shorter length of hospital stay (median 4 and interquartile range 3 vs. 8 (9); P < 0.001), lower 30-day complications (10.6% vs. 22.8%, P = 0.017), lower aortic-related mortality, and similar reintervention after adjustment with a propensity score. Along the time under analysis, EVAR became the predominate type of repair (P = 0.024), the proportion of complications decreased (P = 0.014), and the 30-day mortality (P = 0.035). CONCLUSIONS: Although EVAR was offered to patients with more comorbidities, better and durable outcomes were achieved after EVAR, favoring its adoption for elective AAA repair.

Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study.

BACKGROUND: The first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs. METHODS: The SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death. RESULTS: Of 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death. CONCLUSIONS: The findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02719522.

Comparing Retreatments and Expenditures in Flow Diversion Versus Coiling for Unruptured Intracranial Aneurysm Treatment: A Retrospective Cohort Study Using a Real-World National Database.

BACKGROUND: Flow diverters (FDs) have marked the beginning of innovations in the endovascular treatment of large unruptured intracranial aneurysms, but no multi-institutional studies have been conducted on these devices from both the clinical and economic perspectives. OBJECTIVE: To compare retreatment rates and healthcare expenditures between FDs and conventional coiling-based treatments in all eligible cases in Japan. METHODS: We identified patients who had undergone endovascular treatments during the study period (October 2015-March 2018) from a national-level claims database. The outcome measures were retreatment rates and 1-yr total healthcare expenditures, which were compared among patients who had undergone FD, coiling, and stent-assisted coiling (SAC) treatments. The coiling and SAC groups were further categorized according to the number of coils used. Retreatment rates were analyzed using Cox proportional hazards models, and total expenditures were analyzed using multilevel mixed-effects generalized linear models. RESULTS: The study sample comprised 512 FD patients, 1499 coiling patients, and 711 SAC patients. The coiling groups with ≥10 coils and ≥9 coils had significantly higher retreatment rates than the FD group with hazard ratios of 2.75 (1.30-5.82) and 2.52 (1.24-5.09), respectively. In addition, the coiling group with ≥10 coils and SAC group with ≥10 coils had significantly higher 1-year expenditures than the FD group with cost ratios (95% CI) of 1.30 (1.13-1.49) and 1.31 (1.15-1.50), respectively. CONCLUSION: In this national-level study, FDs demonstrated significantly lower retreatment rates and total expenditures than conventional coiling with ≥ 9 coils.

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.

BACKGROUND: Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. OBJECTIVE: To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. METHODS: PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. RESULTS: A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). CONCLUSIONS: Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. TRIAL REGISTRATION: NCT02186561.

Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort.

BACKGROUND AND OBJECTIVE: Stent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial. METHOD: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints. RESULTS: 30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths. CONCLUSION: The Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort. CLINICAL TRIALGOV REGISTRATION NUMBER: NCT0234058;Results.

Outcomes of Retreatment for Intracranial Aneurysms - A Meta-Analysis.

BACKGROUND: Long-term results from the International Subarachnoid Hemorrhage Trial (ISAT) and Barrow Ruptured Aneurysm Trial (BRAT) indicate considerably higher retreatment rates for aneurysms treated with coiling compared to clipping, but do not report the outcome of retreatment. OBJECTIVE: To evaluate retreatment related outcomes. METHODS: A meta-analysis in accordance with PRISMA guidelines was conducted using Medline search engines PubMed and EMBASE to identify articles describing outcomes after retreatment for intracranial aneurysms. Pooled prevalence rates for complete occlusion rate and mortality were calculated. Outcomes of different treatment and retreatment combinations were not compared because of indication bias. RESULTS: Twenty-five articles that met the inclusion criteria were included in the meta-analysis. Surgery after coiling had a pooled complete occlusion rate of 91.2% (95% confidence interval [CI]: 87.0-94.1) and a pooled mortality rate of 5.6% (95% CI: 3.7-8.3). Coiling after coiling had a pooled complete occlusion rate of 51.3% (95% CI: 22.1-78.0) and a pooled mortality rate of 0.8% (95% CI: 0.15-3.7). Surgery after surgery did not provide a pooled estimate for complete occlusion as only one study was identified but had a pooled mortality rate of 5.9% (95% CI: 3.1-11.2). Coiling after surgery had a pooled complete occlusion rate of 56.1% (95% CI: 11.4-92.7) and a pooled mortality rate of 9.3% (95% CI: 4.1-19.9). All pooled incidence rates were produced using random-effect models. CONCLUSION: Surgical retreatment was associated with a high complete occlusion rate but considerable mortality. Conversely, endovascular retreatment was associated with low mortality but also a low complete occlusion rate.

Treatment strategies for recurrent and residual aneurysms after Woven Endobridge implantation.

BACKGROUND: Woven Endobridge (WEB) embolization is a safe and efficient technique for endovascular treatment of intracranial aneurysms. However, the management of aneurysm recurrence after WEB placement has not been well described to date. We present our multicenter experience of endovascular retreatment of aneurysm recurrence after WEB implantation. METHODS: This is a multicenter study of patients who underwent endovascular retreatment after WEB implantation in three German tertiary care centers. Treatment strategies, complications, and angiographic outcome were retrospectively assessed. RESULTS: Among 122 aneurysms treated with the WEB device, 15 were retreated. Of these, six were initially treated with the WEB only, two were pretreated by coiling, and seven large aneurysms were treated in a multimodality approach. Ten were true aneurysm remnants and five were neck remnants. The reasons for retreatment were WEB migration (n=6), initial incomplete occlusion (n=5), and WEB compression (n=4). Retreatment strategies included coiling (n=4), stent-assisted coiling (n=7), flow diversion (n=3), and placement of an additional WEB (n=1). All procedures were technically successful and there were no procedure-related complications. Among 11 patients available for follow-up after retreatment, three were retreated again. At last angiographic follow-up, available in 11/15 cases at a median of 23 months, complete occlusion was obtained in eight cases and neck remnants in three. CONCLUSIONS: This pilot study shows that endovascular retreatment of recurrent or residual aneurysms after WEB implantation can be done safely and can achieve adequate occlusion rates.

Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up.

PURPOSE: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year. RESULTS: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment. CONCLUSIONS: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. TRIAL REGISTRATION NUMBER: NCT02390037.

Long-term retreatment rates of cerebral aneurysms in a population-level cohort.

BACKGROUND: The likelihood of retreatment in patients undergoing procedures for cerebral aneurysms (CAs) has an important role in deciding the optimal treatment type. Existing determinations of retreatment rates, particularly for unruptured CAs, may not represent current clinical practice. OBJECTIVE: To use population-level data to examine a large cohort of patients with treated CAs over a 10-year period to estimate retreatment rates for both ruptured and unruptured CAs and explore the effect of changing treatment practices. METHODS: We used administrative data from all non-federal hospitalizations in California (2005-2011) and Florida (2005-2014) and identified patients with treated CAs. Surgical clipping (SC) and endovascular treatments (ETs) were defined by corresponding procedure codes and an accompanying code for ruptured or unruptured CA. Retreatment was defined as subsequent SC or ET. RESULTS: Among 19 482 patients with treated CAs, ET was performed in 12 007 (62%) patients and SC in 7475 (38%). 9279 (48%) patients underwent treatment for unruptured CAs and 10203 (52%) for ruptured. Retreatment after 90 days occurred in 1624 (8.3%) patients (11.2% vs 3.7%, ET vs SC). Retreatment rates for SC were greater in unruptured than in ruptured aneurysms (4.6% vs 3.1%), but the opposite was true for ET (10.6% vs 11.8%). 85% of retreatments were within 2 years of the index treatment. Retreatment was associated with age (OR=0.99, 95% CI 0.98 to 0.99), female sex (OR=1.5, 95% CI 1.3 to 1.7), Hispanic versus white race (OR=0.86, 95% CI 0.75 to 0.98), and ET versus SC (OR=3.25, 95% CI 2.85 to 3.71). The adjusted 2-year retreatment rate decreased from 2005 to 2012 for patients with unruptured CAs treated with ET (11% to 8%). CONCLUSIONS: Retreatment rates for CAs treated with ET were greater than those for SC. However, for patients with unruptured CAs treated with ET, we identify a continuous decline in retreatment rate over the past decade.

Selective compromise of hypoplastic posterior communicating artery variants with aneurysms treatable by coil embolization: clinical and radiologic outcomes.

BACKGROUND: Posterior communicating artery (PcoA) compromise may serve as adjunctive treatment in patients with hypoplastic variants of PcoA who undergo coil embolization of PcoA aneurysms. However, procedural safety and the propensity for later recanalization are still unclear. OBJECTIVE: To evaluate clinical and radiologic outcomes of coil embolization in this setting, focusing on compromise of PcoA. METHODS: As a retrospective review, we examined 250 patients harboring 291 aneurysms of hypoplastic PcoAs, all consecutively treated by coil embolization between January 2004 and June 2016. PcoA compromise was undertaken in conjunction with 81 of the treated aneurysms (27.8%; incomplete 53; complete 28). Medical records and radiologic data were assessed during extended monitoring. RESULTS: During the mean follow-up of 33.9±24.6 months (median 36 months), a total of 107 (36.8%) coiled aneurysms showed recanalization (minor 50; major 57). Recanalization rates were as follows: PcoA preservation 40.5% (85/210); incomplete PcoA occlusion 34.0% (18/53); complete PcoA occlusion 14.3% (4/28). Aneurysms >7 mm (HR 3.40; P<0.01), retreatment for recanalization (HR 3.23; P<0.01), and compromise of PcoA (P<0.01) emerged from multivariate analysis as significant risk factors for recanalization. Compared with PcoA preservation, complete PcoA compromise conferred more favorable outcomes (HR 0.160), whereas incomplete compromise of PcoA fell short of statistical significance. Thromboembolic infarction related to PcoA compromise did not occur in any patient. CONCLUSION: PcoA compromise in conjunction with coil embolization of PcoA aneurysms appears safe in hypoplastic variants of PcoA, helping to prevent recanalization if complete occlusion is achieved.

Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms.

OBJECTIVE: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs). METHODS: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency. RESULTS: There were 145 patients (46%) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54%) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83%) treated in the first half of experience to CMDs in 144 patients (91%) treated in the second half of experience (P < .001). Patients treated by PMEGs had significantly (P < .05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98% vs 99.5%; P = .02). Thirty-day mortality was 5.5% for PMEGs (PRAs, 1.2%; extent IV 3.8% and extent I-III, 17.1%) and 0% for CMDs (P = .0018). Patients treated by PMEGs had significantly more (P < .001) MAEs (48% vs 23%) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P = .001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P < .001). At 3 years, patient survival (68% ± 4% vs 67% ± 8%; P = .11), freedom from reintervention (68% ± 4% vs 68% ± 8%; P = .17), primary (94% ± 2% vs 92% ± 2%; P = .64) and secondary target vessel patency (98% ± 1% vs 98% ± 1%; P = .89), and freedom from renal function deterioration (75% ± 4% vs 65% ± 6%; P = .24) were similar for patients treated by PMEGs or CMDs, respectively. CONCLUSIONS: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs.

Relationship Between Operator Volume and Long-Term Outcomes After Percutaneous Coronary Intervention.

BACKGROUND: Although many studies show an inverse association between operator procedural volume and short-term adverse outcomes after percutaneous coronary intervention (PCI), the association between procedural volume and longer-term outcomes is unknown. METHODS: Using the National Cardiovascular Data Registry CathPCI registry data linked with Medicare claims data, we examined the association between operator PCI volume and long-term outcomes among patients ≥65 years of age. Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low- (<50 PCIs), intermediate- (50-100), and high- (>100) volume operators. One-year unadjusted rates of death and major adverse coronary events (MACEs; defined as death, readmission for myocardial infarction, or unplanned coronary revascularization) were calculated with Kaplan-Meier methods. The proportional hazards assumption was not met, and risk-adjusted associations between operator volume and outcomes were calculated separately from the time of PCI to hospital discharge and from hospital discharge to 1-year follow-up. RESULTS: Between July 1, 2009, and December 31, 2014, 723 644 PCI procedures were performed by 8936 operators: 2553 high-, 2878 intermediate-, and 3505 low-volume operators. Compared with high- and intermediate-volume operators, low-volume operators more often performed emergency PCI, and their patients had fewer cardiovascular comorbidities. Over 1-year follow-up, 15.9% of patients treated by low-volume operators had a MACE compared with 16.9% of patients treated by high-volume operators ( P=0.004). After multivariable adjustment, intermediate- and high-volume operators had a significantly lower rate of in-hospital death than low-volume operators (odds ratio, 0.91; 95% CI, 0.86-0.96 for intermediate versus low; odds ratio, 0.79; 95% CI, 0.75-0.83 for high versus low). There were no significant differences in rates of MACEs, death, myocardial infarction, or unplanned revascularization between operator cohorts from hospital discharge to 1-year follow-up (adjusted hazard ratio for MACEs, 0.99; 95% CI, 0.96-1.01 for intermediate versus low; hazard ratio, 1.01; 95% CI, 0.99-1.04 for high versus low). CONCLUSIONS: Unadjusted 1-year outcomes after PCI were worse for older adults treated by operators with higher annual volume; however, patients treated by these operators had more cardiovascular comorbidities. After risk adjustment, higher operator volume was associated with lower in-hospital mortality and no difference in postdischarge MACEs.

Ten-year trends in traumatic brain injury: a retrospective cohort study of California emergency department and hospital revisits and readmissions.

OBJECTIVE: To describe visits and visit rates of adults presenting to emergency departments (EDs) with a diagnosis of traumatic brain injury (TBI). TBI is a major cause of death and disability in the USA; yet, current literature is limited because few studies examine longer-term ED revisits and hospital readmission patterns of TBI patients across a broad spectrum of injury severity, which can help inform potential unmet healthcare needs. DESIGN: We performed a retrospective cohort study. SETTING: We analysed non-public patient-level data from California's Office of Statewide Health Planning and Development for years 2005 to 2014. PARTICIPANTS: We identified 1.2 million adult patients aged ≥18 years presenting to California EDs and hospitals with an index diagnosis of TBI. PRIMARY AND SECONDARY OUTCOME MEASURES: Our main outcomes included revisits, readmissions and mortality over time. We also examined demographics, mechanism and severity of injury and disposition at discharge. RESULTS: We found a 57.7% increase in the number of TBI ED visits, representing a 40.5% increase in TBI visit rates over the 10-year period (346-487 per 100 000 residents). During this time, there was also a 33.8% decrease in the proportion of patients admitted to the hospital. Older, publicly insured and black populations had the highest visit rates, and falls were the most common mechanism of injury (45.5% of visits). Of all patients with an index TBI visit, 40.5% of them had a revisit during the first year, with 46.7% of them seeking care at a different hospital from their initial hospital or ED visit. Additionally, of revisits within the first year, 13.4% of them resulted in hospital readmission. CONCLUSIONS: The large proportion of patients with TBI who are discharged directly from the ED, along with the high rates of revisits and readmissions, suggest a role for an established system for follow-up, treatment and care of TBI.

Artritis reumatoide y miastenia gravis ocular: efectividad del rituximab en el manejo de ambas enfermedades / Rheumatoid arthritis and ocular myasthenia gravis: Effectiveness of rituximab in the management of these two diseases

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ÖGRO survey on radiotherapy capacity in Austria : Status quo and estimation of future demands.

BACKGROUND: A comprehensive evaluation of the current national and regional radiotherapy capacity in Austria with an estimation of demands for 2020 and 2030 was performed by the Austrian Society for Radiation Oncology, Radiobiology and Medical Radiophysics (ÖGRO). MATERIALS AND METHODS: All Austrian centers provided data on the number of megavoltage (MV) units, treatment series, fractions, percentage of retreatments and complex treatment techniques as well as the daily operating hours for the year 2014. In addition, waiting times until the beginning of radiotherapy were prospectively recorded over the first quarter of 2015. National and international epidemiological prediction data were used to estimate future demands. RESULTS: For a population of 8.51 million, 43 MV units were at disposal. In 14 radiooncological centers, a total of 19,940 series with a mean number of 464 patients per MV unit/year and a mean fraction number of 20 (range 16-24) per case were recorded. The average re-irradiation ratio was 14%. The survey on waiting times until start of treatment showed provision shortages in 40% of centers with a mean waiting time of 13.6 days (range 0.5-29.3 days) and a mean maximum waiting time of 98.2 days. Of all centers, 21% had no or only a limited ability to deliver complex treatment techniques. Predictions for 2020 and 2030 indicate an increased need in the overall number of MV units to a total of 63 and 71, respectively. CONCLUSION: This ÖGRO survey revealed major regional differences in radiooncological capacity. Considering epidemiological developments, an aggravation of the situation can be expected shortly. This analysis serves as a basis for improved public regional health care planning.

Endovascular treatment for cerebral vasospasm following aneurysmal subarachnoid hemorrhage: predictors of outcome and retreatment.

OBJECTIVE: Although endovascular therapy has been widely adopted for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage (aSAH), its effect on clinical outcomes remains incompletely understood. The aims of this retrospective cohort study are to evaluate the outcomes of endovascular intervention for post-aSAH vasospasm and identify predictors of functional independence at discharge and repeat endovascular vasospasm treatment. METHODS: We assessed the baseline and outcomes data for patients with aSAH who underwent endovascular vasospasm treatment at our institution, including intra-arterial (IA) vasodilator infusion and angioplasty. Statistical analyses were performed to determine factors associated with good outcome at discharge (modified Rankin Scale 0-2) and repeat endovascular vasospasm treatment. RESULTS: The study cohort comprised 159 patients with a mean age of 52 years. Good outcome was achieved in 17% of patients at discharge (26/150 patients), with an in-hospital mortality rate of 22% (33/150 patients). In the multivariate analysis, age (OR 0.895; p=0.009) and positive smoking status (OR 0.206; p=0.040) were negative independent predictors of good outcome. Endovascular retreatment was performed in 34% (53/156 patients). In the multivariate analysis, older age (OR 0.950; p=0.004), symptomatic vasospasm (OR 0.441; p=0.046), initial treatment with angioplasty alone (OR 0.096; p=0.039), and initial treatment with combined IA vasodilator infusion and angioplasty (OR 0.342; p=0.026) were negative independent predictors of retreatment. CONCLUSION: We found a modest rate of functional independence at discharge in patients with aSAH who underwent endovascular vasospasm treatment. Older patients and smokers had worse functional outcomes at discharge. Initial use of angioplasty appears to decrease the need for subsequent retreatment.

Population-Based Study on Patterns of Cardiac Stress Testing After Percutaneous Coronary Intervention.

BACKGROUND: The appropriate use criteria considers cardiac stress testing within 2 years after percutaneous coronary intervention (PCI) to be rarely appropriate, unless prompted by symptoms or change in clinical status. Little is known about the patterns of cardiac stress testing after PCI in the single-payer Canadian healthcare system, where mechanisms for reimbursement are different from the United States. METHODS AND RESULTS: Frequency and timing of cardiac stress testing within 2 years of PCI performed between April 2004 and March 2013 in Ontario, Canada, was determined from linked provincial databases. Subsequent rates of coronary angiography and revascularization after stress testing were ascertained. Of the 112 691 patients with PCI, 67 442 (59.8%) underwent at least 1 stress test, with 38 267 (34.0%) undergoing repeat stress testing (ie, >1 stress test) within 2 years. Patients who underwent stress testing were younger, had less medical comorbidities, were more likely to reside in urban areas, and had higher incomes. Spikes in incidence of repeat stress testing were observed at 3 to 4 months, 6 to 7 months, and 12 to 13 months after the prior stress test. Of those tested, only 5.9% underwent subsequent coronary angiography, and only 3.1% underwent repeat revascularization within 60 days of stress testing. CONCLUSIONS: More than half of all patients undergo cardiac stress testing within 2 years of PCI, with one third undergoing repeat stress tests. Only 1 of 30 tested patients underwent repeat revascularization. These findings reinforce the appropriate use criteria recommendations against routine stress testing after PCI. Further work is needed to aid with the selection of patients most likely to benefit from stress testing after PCI.