Estimation of hypertension (HTN) occurrence, severity changes, and patterns of antihypertensive (AH) use in patients (pts) receiving VEGF inhibitors for the treatment of cancer.

e16541 Background: Reports have examined the occurrence and management of HTN in pts receiving VGEF inhibitors, but typically have small samples and represent single institutions. This study used a large claims database to describe how the use of VGEF inhibitors impacted the occurrence, severity and management of HTN. Methods: Claims data (2004-2009) from Medstat’s MarketScan database identified pts with bevacizumab (BEV), sorafeninb (SO) and sunitinib (SU) claims and an approved cancer indication. First prescription claim for a VGEF inhibitor was the index date; treatment period began on this date and ended 30-60 days after the last VEGF inhibitor claim. Pts were followed for 12 months pre and post index date. HTN was defined as at least one ICD-9 (401.xx) or AH prescription claim. Cohort A (A) included pts with no HTN prior to index date; Cohort B (B) included pts with HTN prior to index date. A was divided into cohort A1 (A1): no HTN pre or post index date; and cohort A2 (A2): HTN post index date. HTN severity was defined in accordance with CTCAE v4.0 as: pre-HTN and no AH claims (grade [gr] 1); 1 or 2+ AH claims within 90 days (gr 2, 3); or life threatening complications (gr 4). Cardiac complication ICD-9 codes were collected. Results: 2177 pts received BEV (89.3%), SO (4.9%) and SU (5.8%). A had 1041 pts; 32% (A2) had HTN. B had 1136 pts. Gr 1 HTN incidence increased during the treatment period in A1 (0.1 to 0.7%) and A2 (0.9 to 12.3%), but decreased in B (12 to 7.5%). Gr 2 HTN increased from 1.2 to 48% (A2) and 26.4 to 32.4% (B). Gr 3 HTN increased from 0 to 18.6% (A2) and 33.5 to 41% (B). Gr 4 HTN occurred in 3.4% (A1), 8.4% (A2) and 6.3% (B) of pts within one year post index date. B had higher complication rates (16.7%) than A1 (2.3%) and A2 (9.6%). 286 (85.9%) pts in A2 received AH; median time to AH initiation was 96 days. Pts in A2 required 0.9 AH during the treatment period compared to 1.3 in B. Initial AH class did not affect complication rates in A2. Conclusions: We observed clinically relevant HTN in a significant proportion of pts receiving VEGF inhibitors with real world data. HTN incidence increased in all cohorts, regardless of baseline HTN. Pts should be monitored carefully for HTN.

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Ponatinib Treatment in CML and Ph+ ALL Patients: Real-Life Data from the Czech Registries

Blood ◽

10.1182/blood-2019-126395 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5905-5905

Author(s):

Eva Koriťáková ◽

Michael Doubek ◽

Edgar Faber ◽

Daniela Žáčková ◽

Jan M. Horáček ◽

...

Keyword(s):

Lymphoblastic Leukemia ◽

Philadelphia Chromosome ◽

Significant Proportion ◽

Real Life ◽

Chronic Phase ◽

Clinical Activity ◽

Real World Data ◽

Abl Kinase ◽

Number Of Patients ◽

One Year

Patients with newly diagnosed chronic myeloid leukemia (CML) frequently receive imatinib. Although initial response rates are high, imatinib fails in up to 40% of patients because of disease resistance, frequently because of BCR-ABL kinase domain mutations, or side effects. Patients who discontinue imatinib may have a response to second-generation tyrosine kinase inhibitors (TKIs). Ponatinib (PON) is a potent oral TKI active against unmutated and mutated BCR-ABL kinase. PON is indicated also in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients. Clinical activity of PON was confirmed in the phase II PACE trial, however lack of real world data is evident. The aim of this non-interventional study was to analyze data on PON treatment and its efficacy in the Czech patients with CML / Ph+ ALL. The study was designed as a one-off retrospective data collection from 3 national registry databases INFINITY, CAMELIA and DATOOL ALL in the period 2014-2018. In total, the study comprised 27 patients treated with PON at 7 centers; 16 (59.3%) patients were treated for chronic phase (CP) CML, 4 (14.8%) patients for accelerated- or blast-phase (AP/BP) CML and 7 (25.9%) patients for Ph+ ALL. The 16 CP CML patients (68.8% males) had median age at the start of PON treatment 59.7 years (range 28.6-81.4), were heavily pretreated (75% with ≥ 3 TKIs) with median time from diagnosis to start of PON treatment 4.8 (0.2-16.8) years; 37.5% of them had mutations (18.8% with T315l), 75.0% had comorbidities. The 11 AP/BP CML / Ph+ ALL patients (54.5% males) were younger with median age 56.6 (31.2-74.7) years, were less pretreated (36.4% with ≥ 3 TKIs) with a shorter time from diagnosis to start of PON treatment 2.0 (0.4-22.0) years; almost twice as many (72.7%) of them had mutations (54.5% with T315l), 63.6% had comorbidities. The most common reason for switching to ponatinib was hematologic resistance (37.5% of CP CML and 54.5% of AP/BP CML / Ph+ ALL patients). The other most frequent indications were cytogenetic resistance, non-hematologic and hematologic intolerance (18.8%, 12.5% and 12.5% of CP CML patients and 9.1%, 9.1% and 0% of AP/BP CML / Ph+ ALL patients, respectively). Interestingly, starting dose of PON was 45 mg/day as recommended in the product SmPC only in of about half of the patients (43.8% of CP CML and 54.5% of AP/BP CML / Ph+ ALL patients). Median treatment duration was 16.1 (0.8-49.9) months in CP CML patients and only 2.9 (0.2-36.1) months in AP/BP CML / Ph+ ALL patients. Early (in the first 3 months) and late termination of the treatment occurred in 12.5% and 31.3% of CP CML and 54.5% and 27.3% of AP/BP CML / Ph+ ALL patients, respectively. Disease progression was the major reason for treatment termination (50%). In terms of safety, only 1 patient discontinued therapy due to congestive heart failure, and 1 due to vascular adverse event although more than half of the patients had cardiovascular comorbidities and history of cardiovascular disease. PON efficacy was evaluated in 14 CP CML patients and 5 AP/BP CML / Ph+ ALL who were treated beyond 3 months (Figure 1). More than half of CP CML patients achieved MMR (57.1%) and 40% of AP/BP CML / Ph+ ALL achieved undetectable disease. Estimated percentage of CHR, CCyR and MMR in CP CML patients after one year of treatment was 85.7%, 50% and 50%, respectively. Nevertheless, 5 (35.7%), 2 (14.3%) and 1 (7.1%) patients had CHR, CCyR and MMR at start of PON treatment, respectively. In AP/BP CML / Ph+ ALL patients, estimated percentage of CR and CMR after one year was 100% and 40%, respectively. However, 2 patients (20%) had CR at the start of PON treatment. Despite limited number of patients, our analysis confirmed PON efficacy in real-life setting with a significant proportion of heavily pre-treated patients achieving durable molecular responses in both CP and AP/BP CML / Ph+ ALL groups. Our data are comparable to the PACE trial results. This study partially fills the gap in RWE data and significantly contributes to the evaluation of real-life clinical practice in rare disease area. Figure 1. Cumulative incidence of responses on ponatinib treatment in A) CP CML (N=14) and B) AP/BP CML / Ph+ ALL (N=5) patients that continued ponatinib treatment beyond 3 months. Figure 1 Disclosures Žáčková: Bristol Myers Squibb: Consultancy; Novartis: Consultancy; Angelini: Consultancy; Incyte: Consultancy. Kellnerová:Angelini Pharma: Employment.

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The Probability of A1C Goal Attainment in Patients with Uncontrolled Type-2 Diabetes in a Large Integrated Delivery System: A Prediction Model

10.2337/figshare.12200135 ◽

2020 ◽

Author(s):

Kevin M Pantalone ◽

Anita D Misra-Hebert ◽

Todd M Hobbs ◽

Sheldon X Kong ◽

Xinge Ji ◽

...

Keyword(s):

Type 2 Diabetes ◽

Goal Attainment ◽

Index Date ◽

Cleveland Clinic ◽

Patient Characteristics ◽

Psychiatric Disease ◽

Lower Probability ◽

Factors Associated ◽

One Year

Objective: To assess patient characteristics and treatment factors associated with uncontrolled type 2 diabetes (T2D) and the probability of A1C goal attainment. Research Design and Methods: Retrospective cohort study using the electronic health record at Cleveland Clinic. Patients with uncontrolled T2D (A1C>9%) were identified on the index date of 12/31/2016 (n=6,973), grouped by attainment (n=1,653 [24.7%) or non-attainment (n=5,320 [76.3%]) of A1C<8% by 12/31/2017, and subgroups compared on a number of demographic and clinical variables. Based on these variables, a nomogram was created for predicting probability of A1C goal attainment. Results: For the entire population, median age at index date was 57.7 years (53.3% male), and the majority were white (67.2%). Median A1C was 10.2%. Obesity (50.6%), cardiovascular disease (46.9%) and psychiatric disease (61.1%) were the most common comorbidities. Metformin (62.7%) and sulfonylureas (38.7%) were the most common anti-diabetes medications. Only 1,653 (24%) patients achieved an A1C <8%. Predictors of increased probability of A1C goal attainment were older age, white/non-Hispanic race/ethnicity, Medicare health insurance, lower baseline A1C, higher frequency of endocrinology/primary care visits, DPP-4i use, thiazolidinedione use, metformin use, GLP-1RA use, and fewer classes of anti-diabetes drugs. Factors associated with lower probability included insulin use and longer time in the T2D database (both presumed as likely surrogates for duration of T2D). Conclusions: A minority of patients with an A1C>9% achieved an A1C<8% at one year. While most identified predictive factors are non-modifiable by the clinician, pursuit of frequent patient engagement and tailored drug regimens may help improve A1C goal attainment.

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Pros and cons of navigated versus conventional total knee arthroplasty—a retrospective analysis of over 2400 patients

Archives of Orthopaedic and Trauma Surgery ◽

10.1007/s00402-021-03834-y ◽

2021 ◽

Author(s):

Matthias Meyer ◽

Tobias Renkawitz ◽

Florian Völlner ◽

Achim Benditz ◽

Joachim Grifka ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Retrospective Analysis ◽

Outcome Measures ◽

Knee Arthroplasty ◽

Mechanical Axis ◽

Complication Rates ◽

Total Knee ◽

One Year ◽

Navigated Tka ◽

Surgery Duration

Abstract Introduction Because of the ongoing discussion of imageless navigation in total knee arthroplasty (TKA), its advantages and disadvantages were evaluated in a large patient cohort. Methods This retrospective analysis included 2464 patients who had undergone TKA at a high-volume university arthroplasty center between 2012 and 2017. Navigated and conventional TKA were compared regarding postoperative mechanical axis, surgery duration, complication rates, one-year postoperative patient-reported outcome measures (PROMs) (WOMAC and EQ-5D indices), and responder rates as defined by the criteria of the Outcome Measures in Rheumatology and Osteoarthritis Research Society International consensus (OMERACT-OARSI). Results Both navigated (1.8 ± 1.6°) and conventional TKA (2.1 ± 1.6°, p = 0.002) enabled the exact reconstruction of mechanical axis. Surgery duration was six minutes longer for navigated TKA than for conventional TKA (p < 0.001). Complication rates were low in both groups with comparable frequencies: neurological deficits (p = 0.39), joint infection (p = 0.42 and thromboembolic events (p = 0.03). Periprosthetic fractures occurred more frequently during conventional TKA (p = 0.001). One-year PROMs showed excellent improvement in both groups. The WOMAC index was statistically higher for navigated TKA than for conventional TKA (74.7 ± 19.0 vs. 71.7 ± 20.7, p = 0.014), but the increase was not clinically relevant. Both groups had a similarly high EQ-5D index (0.23 ± 0.24 vs. 0.26 ± 0.25, p = 0.11) and responder rate (86.5% [256/296] vs. 85.9% [981/1142], p = 0.92). Conclusion Both methods enable accurate postoperative leg alignment with low complication rates and equally successful PROMs and responder rates one year postoperatively. Level of evidence III. Retrospective cohort study.

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POS0681 VOCLOSPORIN FOR LUPUS NEPHRITIS: INTERIM ANALYSIS OF THE AURORA 2 EXTENSION STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.372 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 585.2-586

Author(s):

A. Saxena ◽

P. Mina-Osorio ◽

C. Mela ◽

V. Berardi

Keyword(s):

Lupus Nephritis ◽

Treatment Period ◽

Interim Analysis ◽

Low Dose ◽

Extension Study ◽

Creatinine Ratio ◽

Urine Protein ◽

Pre Treatment ◽

One Year ◽

Change In Mean

Background:Voclosporin, a novel calcineurin inhibitor (CNI), has been tested successfully in two pivotal trials in adult patients with lupus nephritis.Previously reported results from the Phase 3 AURORA 1 study and the Phase 2 AURA-LV study showed that compared with mycophenolate mofetil (MMF) and low-dose steroids alone, the addition of voclosporin significantly increased the renal response rate and reduced proteinuria, as measured by urine protein creatinine ratio (UPCR), in patients with lupus nephritis (LN) at approximately one year of treatment (48 weeks in AURA-LV and 52 weeks in AURORA 1).Objectives:Patients that completed one year of treatment in the AURORA 1 study were eligible to enroll into the two-year, blinded, controlled extension study, AURORA 2. Here we report the first interim analysis of the ongoing AURORA 2 study.Methods:Patients completing AURORA 1 were eligible to continue the same randomized treatment of voclosporin (23.7 mg BID) or placebo, in combination with MMF (1 g BID) and low-dose oral steroids in the AURORA 2 extension. This interim analysis evaluated UPCR and estimated glomerular filtration rate (eGFR) in patients with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.Results:116 patients in the voclosporin arm and 100 patients in the control arm enrolled in the extension study, of which 73 patients in the voclosporin arm and 51 patients in the control arm had received two years of treatment at the time of this interim analysis. Mean UPCR at pre-treatment (AURORA 1) baseline was 3.94 mg/mg in the voclosporin arm (n=116) and 3.87 mg/mg in the control arm (n=100). The LS mean change in UPCR from pre-treatment baseline to year two was -3.1 mg/mg for the voclosporin arm (n=73) and -2.1 mg/mg for control arm (n=51; Table 1). Mean eGFR at pre-treatment (AURORA 1) baseline was 79.6 mL/min for the voclosporin arm (n=116) and 78.9 mL/min for the control arm (n=100) and at year two, was 79.0 mL/min for the voclosporin arm (n=73) and 82.9 mL/min for the control arm (n=51). There was a small early decrease in mean eGFR in the first four weeks of treatment (in AURORA 1) after which eGFR remained stable throughout year one and year two. Additionally, there were no unexpected new AEs observed in patients who continued with voclosporin treatment compared to control-treated patients for more than one year.Table 1.UPCRControl (n=100)Voclosporin (n=116)Treatment Comparison of Voclosporin to ControlnUPCR (mg/mg)nUPCR (mg/mg)UPCR (mg/mg)p-valuePre-treatment baseline, mean1003.871163.94NCNCChange from pre-treatment baseline, LS mean Year 1100-2.4116-3.0-0.60.0080 Year 251-2.173-3.1-1.00.0004LS, least squares; NC, not calculated; UPCR, urine protein creatinine ratio.Mixed effects model for repeated measures (MMRM) analysis of LS mean change from pre-treatment baseline for UPCR included terms for baseline covariate, treatment, visit and treatment by visit interaction. Integrated results include data from pre-treatment baseline of AURORA 1, the one-year treatment period in AURORA 1 and up to a one-year treatment period in AURORA 2.Conclusion:Patients in the voclosporin treatment arm maintained meaningful reductions in proteinuria with no change in mean eGFR at two years of treatment. Additional AURORA 2 efficacy and safety data will be provided at the conclusion of the study.Disclosure of Interests:Amit Saxena: None declared, Paola Mina-Osorio Shareholder of: Aurinia Pharmaceuticals Inc., Employee of: Aurinia Pharmaceuticals Inc., Christopher Mela Shareholder of: Aurinia Pharmaceuticals Inc., Employee of: Aurinia Pharmaceuticals Inc., Vanessa Berardi Shareholder of: Aurinia Pharmaceuticals Inc., Employee of: Aurinia Pharmaceuticals Inc.

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The Probability of A1C Goal Attainment in Patients with Uncontrolled Type-2 Diabetes in a Large Integrated Delivery System: A Prediction Model

10.2337/figshare.12200135.v2 ◽

2020 ◽

Author(s):

Kevin M Pantalone ◽

Anita D Misra-Hebert ◽

Todd M Hobbs ◽

Sheldon X Kong ◽

Xinge Ji ◽

...

Keyword(s):

Type 2 Diabetes ◽

Goal Attainment ◽

Index Date ◽

Cleveland Clinic ◽

Patient Characteristics ◽

Psychiatric Disease ◽

Lower Probability ◽

Factors Associated ◽

One Year

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MO273A NOVEL APPROACH TO ASSESS THE DEMOGRAPHIC AND CLINICAL CHARACTERISTICS OF IMMUNOGLOBULIN A NEPHROPATHY (IGAN) PATIENTS IN A US REAL-WORLD SETTING

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfab104.0031 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

Raymond Przybysz ◽

Rina Mehta ◽

Gisela Rovira Tomas ◽

Carolina Aldworth ◽

Jim Doherty ◽

...

Keyword(s):

Kidney Function ◽

Clinical Characteristics ◽

Index Date ◽

Immunoglobulin A ◽

Significant Proportion ◽

Immunoglobulin A Nephropathy ◽

Targeted Interventions ◽

The Us ◽

The Mean ◽

Severe Deterioration

Abstract Background and Aims Immunoglobulin A nephropathy (IgAN) is a chronic glomerular disease that affects approximately 100,000-200,000 people in the US. Approximately 15-40% of IgAN patients will eventually progress to end stage kidney disease (ESKD) within 10-20 years of diagnosis, and there is currently no targeted therapy for this disease. Decreased kidney function, persistent proteinuria and hypertension are some of the clinical manifestations of IgAN, and with demographic aspects (e.g. ethnicity) are considered as predictors of disease progression. The aim of this study is to better understand the demographic and clinical characteristics of IgAN patients in the US identified via physician notes. Method This is a descriptive, retrospective study of adult (≥ 18 years) IgAN patients in Optum® Electronic Health Records (EHRs), between January 2007 and December 2019. Optum® EHRs contain de-identified clinical and medical administrative data from 96 million people in 50 states that come from more than 140,000 providers at 740 hospitals and over 7,000 clinics. Identification of IgAN patients is challenging because there are no specific ICD codes for this disease so we used natural language processing of physician notes and chose patients with at least two IgAN records with the first one considered to be the index date, and no negative mention, as well as a biopsy procedure. Here, we present the baseline demographic and clinical characteristics of the identified patients up to 12 months before and at the index date. Results A total of 1803 patients with a biopsy record (22% of all patients with at least two IgAN records in their EHRs in our study) were included in this analysis; results are presented in Table 1. The mean age was 48 years, and the majority of patients were male (60.9%) and white (75.7%). Proteinuria levels of ≥1 g/day were found in 34% of patients. The mean eGFR was 45 ml/min/1.73m2 and 21.6% of patients had severe deterioration of kidney function (eGFR <15). The mean creatinine level was 3 mg/dL. Pain, edema and fatigue/tiredness were reported in 39.6%, 18.1% and 13.4% of patients, respectively. Hypertension was reported in 73% of patients. Based on the ICD 9 (585.6) and ICD-10 (N18.6) codes for diagnosis, 17.5% of patients had ESKD in our study. Conclusion In our cohort, a significant proportion of patients were found to have high proteinuria levels and severe deterioration of kidney function or ESKD. Moreover, edema and fatigue were recorded for a noticeable proportion of patients. In addition to the commonly reported symptoms, our study also found that pain was reported in a high proportion of patients. These findings highlight the clinical and symptom burden to patients with IgAN, suggesting that future targeted interventions are needed to reduce the burden and delay the progression of this disease.

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Clinical and Contrast-Enhanced Ultrasound Echography Outcomes in Psoriatic Arthritis Patients after One Year of Continuous Therapy with Anti-TNF Drugs

ISRN Dermatology ◽

10.1155/2014/932721 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 3

Author(s):

Claudio Bonifati ◽

Fulvia Elia ◽

Dario Graceffa ◽

Fabrizio Ceralli ◽

Elisa Maiani ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Significant Proportion ◽

Joint Inflammation ◽

Joint Involvement ◽

Contrast Enhanced Ultrasound ◽

Continuous Therapy ◽

Clinical Variables ◽

Contrast Enhanced ◽

Before And After ◽

One Year

Background. We wanted to verify retrospectively the proportion of patients with psoriatic arthritis who were in remission after 1 year of continuous therapy with either etanercept or adalimumab. Remission was defined as the absence of both clinical and contrast-enhanced ultrasound (CEUS) findings suggestive of joint inflammation. Patients and Methods. The data of twenty-five patients with psoriatic arthritis were available for the clinical and CEUS evaluations before and after 1 year of continuous therapy with etanercept or adalimumab. The count of swollen (ACR66), tender (ACR68), and active inflamed joints (AJC) was used to measure the severity of joint involvement. PASI was used to score the severity of psoriasis. HAQ, DLQI, VAS pain, and VAS itching were administered to each patient before starting therapy and every 3 months, up to 1 year. Results. Eight (32%) out of twenty-five patients were in remission after 1 year of therapy with etanercept or adalimumab. A significant reduction of all clinical variables analysed was seen during the course of therapy. Conclusion. Although a significant proportion of patients achieved remission of arthritis after 1 year of effective anti-TNF therapy, the majority of them continued to have either clinical or CEUS findings suggestive of persistence of joint inflammation.

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Patterns in neurosurgical adverse events: open cerebrovascular neurosurgery

Neurosurgical FOCUS ◽

10.3171/2012.7.focus12181 ◽

2012 ◽

Vol 33 (5) ◽

pp. E15 ◽

Cited By ~ 33

Author(s):

Judith M. Wong ◽

John E. Ziewacz ◽

Allen L. Ho ◽

Jaykar R. Panchmatia ◽

Albert H. Kim ◽

...

Keyword(s):

Subarachnoid Hemorrhage ◽

Adverse Events ◽

Significant Proportion ◽

Current Evidence ◽

Neurophysiological Monitoring ◽

Complication Rates ◽

Vessel Occlusion ◽

Surgeon Experience ◽

Major Vessel ◽

Monitoring Technologies

Object As part of a project to devise evidence-based safety interventions for specialty surgery, we sought to review current evidence concerning the frequency of adverse events in open cerebrovascular neurosurgery and the state of knowledge regarding methods for their reduction. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. Methods The authors performed a PubMed search using search terms “cerebral aneurysm”, “cerebral arteriovenous malformation”, “intracerebral hemorrhage”, “intracranial hemorrhage”, “subarachnoid hemorrhage”, and “complications” or “adverse events.” Only papers that specifically discussed the relevant complication rates were included. Papers were chosen to be included to maximize the range of rates of occurrence for the reported adverse events. Results The review revealed hemorrhage-related hyperglycemia (incidence rates ranging from 27% to 71%) and cerebral salt-wasting syndromes (34%–57%) to be the most common perioperative adverse events related to subarachnoid hemorrhage (SAH). Next in terms of frequency was new cerebral infarction associated with SAH, with a rate estimated at 40%. Many techniques are advocated for use during surgery to minimize risk of this development, including intraoperative neurophysiological monitoring, but are not universally used due to surgeon preference and variable availability of appropriate staffing and equipment. The comparative effectiveness of using or omitting monitoring technologies has not been evaluated. The incidence of perioperative seizure related to vascular neurosurgery is unknown, but reported seizure rates from observational studies range from 4% to 42%. There are no standard guidelines for the use of seizure prophylaxis in these patients, and there remains a need for prospective studies to support such guidelines. Intraoperative rupture occurs at a rate of 7% to 35% and depends on aneurysm location and morphology, history of rupture, surgical technique, and surgeon experience. Preventive strategies include temporary vascular clipping. Technical adverse events directly involving application of the aneurysm clip include incomplete aneurysm obliteration and parent vessel occlusion. The rates of these events range from 5% to 18% for incomplete obliteration and 3% to 12% for major vessel occlusion. Intraoperative angiography is widely used to confirm clip placement; adjuncts include indocyanine green video angiography and microvascular Doppler ultrasonography. Use of these technologies varies by institution. Discussion A significant proportion of these complications may be avoidable through development and testing of standardized protocols to incorporate monitoring technologies and specific technical practices, teamwork and communication, and concentrated volume and specialization. Collaborative monitoring and evaluation of such protocols are likely necessary for the advancement of open cerebrovascular neurosurgical quality.

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Abstract 14833: National Trends in Complications and 30-day Re-hospitalization After Lead Removal/extraction: Analysis From a Cohort Of 42,878 Patients

Circulation ◽

10.1161/circ.132.suppl_3.14833 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Siva K Mulpuru ◽

Peter A Noseworthy ◽

Lindsey R Sangaralingham ◽

Raphael Mawangi ◽

Abhishek J Deshmukh ◽

...

Keyword(s):

Cardiac Surgery ◽

Lead Removal ◽

Complication Rates ◽

Respiratory Complications ◽

Cardiac Device ◽

Cerebrovascular Complications ◽

Heart Failure Exacerbation ◽

Using Data ◽

One Year ◽

National Trends

Introduction: As the US population ages and indications for cardiac device implantation expand, there is a concomitant increase in patients undergoing lead removal/extraction (LR/E).. We sought to examine trends in outcomes and complications associated with LR/E. Methods: We conducted a retrospective analysis using data from a large U.S. commercial insurance database (privately insured and Medicare Advantage patients) identifying all patients undergoing LR/E between 2004 and 2013 with at least one year continuous medical plan enrollment prior to LR/E (to identify baseline comorbidities). Using ICD9 codes and CPT codes, major complications (hemorrhage requiring transfusion, vascular injury, pericardial complications, respiratory complications, cerebrovascular complications, and requirement for cardiac surgery) associated with LR/E and 30-day readmission rates were evaluated. Results: Among 42,878 patients who underwent LR/E (median age of 62 ( 54, 72) years, 70% male); approximately 1 in 40 experienced a major adverse event (2.4%) during the study period. Respiratory complications were the most common complication and 311 patients required cardiac surgery. 30-day readmission occurred in 11.1% of the total population. The most common reasons for readmission were heart failure exacerbation (18.7%) and device related complications (13.2%). Conclusion: The observed complication rates after LE/R in clinical practice are similar to those seen in recent clinical trials and have been relatively stable over the past 10 years.

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Minimally invasive calcaneal osteotomy

Foot & Ankle Orthopaedics ◽

10.1177/2473011418s00484 ◽

2018 ◽

Vol 3 (3) ◽

pp. 2473011418S0048

Author(s):

Kar Teoh ◽

Kartik Hariharan

Keyword(s):

Length Of Stay ◽

Minimally Invasive ◽

Average Length ◽

Achilles Tendinopathy ◽

Complication Rates ◽

Union Rate ◽

Average Length Of Stay ◽

Calcaneal Osteotomy ◽

Cavus Foot ◽

One Year

Category: Hindfoot Introduction/Purpose: A calcaneal osteotomy can be used to treat a variety of pathologic entities in which the hindfoot needs realignment. Minimally invasive calcaneal osteotomy (MICO) is becoming increasingly popular due to being soft tissue friendly, its ability to place other incisions nearby and high union rate. Previous studies have look specifically at medialising MICO or comparing open calcaneal osteotomy versus MICO. The purpose of our study was to compare 3 different types of commonly used MICO in our centre. Methods: Sixty-two MICO which fit the criteria were included in this study. They were performed in our unit from 2010 and 2016 and all patients had at least one year follow up data. The type of osteotomies was as follows: Medialising, n = 34, Lateralising, n =15 and Zadek (Dorsal closing wedge), n =13. Clinical and radiographic data were recorded. The diagnosis for 31/34 of the medialising MICO was Stage 2 PTTD, the diagnosis for 12/15 of the lateralising MICO was cavus foot, while the diagnosis for all Zadek MICO was for insertional Achilles tendinopathy. Apart from the Zadek MICO, the other MICO were all associated with other procedures. The average age (years) were as follows: Medialising, 58 (30 – 74); Lateralising, 33 (14 – 67) and Zadek, 47 (42-62). Results: The average calcaneal displacement was 10.2 (range: 8 – 12) mm for medialising MICO, and 6.6 (4 – 8) mm for lateralising MICO(p=0.021). Average time to union was 7.8 (5.4 – 11.6) weeks for medialising MICO, 6.2 (4.6 to 7.9) weeks for lateralising MICO, and 6.1 (4.1 – 7.6) weeks for Zadek MICO. All the MICO healed radiologically and clinically. Five (8%) patients (Medialising, n = 2; Lateralising n =2; Zadek, n =1) reported transient sural nerve paraesthesia following surgery. Wound problems developed in 5 patients (Lateralising, n =3; Zadek, n =2). The number of total complications were as follow: Medialising, n = 5, Lateralising, n = 7 and Zadek, n =5. Average length of stay was as follows: Medialising, 2(0-8) days; Lateralising, 1(0-3) day and Zadek, 1(0-3) day. Conclusion: Minimally invasive calcaneal osteotomy was safe with a high union rate and low complication rates and length of stay across all 3 common osteotomies. The average calcaneal displacement was significantly less for lateralising than medialising which is similar to reported figures for open osteotomy. Wound problems were more likely for lateralising and Zadek MICO compared to medialising and this could be because of how the osteotomies are shifted.

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