Von Willebrand Factor/Factor VIII Concentrate (Humate-P®) for Surgical Prophylaxis of Excessive Bleeding in Patients with Von Willebrand Disease (VWD).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1791-1791
Author(s):  
Joan Cox Gill ◽  
J. DiPaola ◽  
J. Bernstein ◽  
C. A. Leissinger ◽  
L. Valentino ◽  
...  
Keyword(s):  
Adverse Events ◽  
Surgical Procedures ◽  
Oral Surgery ◽  
Coagulation Factor ◽  
Major Surgery ◽  
Serious Adverse Events ◽  
Excessive Bleeding ◽  
Safety And Efficacy ◽  
Estimated Blood Loss ◽  
Von Willebrand

Abstract Optimal dosing to prevent excessive surgical bleeding in VWD is being investigated in an ongoing prospective, uncontrolled, open-labeled study to establish the safety and efficacy of replacement therapy with a VWF/FVIII concentrate (Humate-P®). This protocol-defined interim analysis describes the results in the first eighteen (18) patients (6 males, 12 females) of a total of 30 planned. Seven patients had Type 1 VWD, 6 had Type 2 (2 with 2A, 3 with 2B, 1 with 2M), and 5 had Type 3. All patients had pre-operative pharmacokinetic assessments to individualize the loading and maintenance doses of VWF/FVIII concentrate utilized for surgery. Fourteen patients had major surgical procedures including neurosurgery, joint replacement, tonsillectomy and complete oral restoration; three had minor procedures; and one had oral surgery. Hemostatic efficacy was assessed by investigators on a four-point scale (excellent, good, moderate/poor, none) immediately after surgery, 24 hours after the last VWF/FVIII concentrate infusion, and 14 days post-op. Good and excellent efficacy were combined into one endpoint of effective hemostasis. Expected estimated blood loss (EBL) was defined prior to the procedure, and actual EBL was recorded post-op. Adverse events were collected throughout the trial until follow-up 4 weeks post-op. Hemostasis was effective in 17/18 patients (94.4%) immediately after surgery; in 17/17 patients (100%) 24 hours after the last VWF/FVIII conc infusion; and in 18/18 (100%) patients 14 days after surgery. Median actual EBL did not exceed expected EBL in any surgery category. Four patients received transfusions (one for pre-existing anemia, three for serious adverse events). Loading doses of VWF/FVIII concentrate ranged from 36 to 135 IU/kg. Maintenance doses were determined by daily monitoring of plasma coagulation factor levels. Median durations of treatment were 2 days for oral surgery, and 4 days for both minor and major surgery. Post-op nausea (n=5) and fever (n=3) were the most commonly reported adverse events. Nausea, headache, and dizziness were considered possibly related to VWF/FVIII concentrate in one patient each; these events were mild in severity and resolved without sequelae. Bleeding-related serious adverse events were reported in three patients: one with GI bleeding post-laparoscopic gastro-jejunal bypass; one with post-craniotomy subdural and intracranial bleeding; and one with post-hysteroscopy/dilatation & curettage hemorrhage followed by hysterectomy. Hemostasis was considered effective in these 3 by the investigators, and in 2 patients by an independent DSMB review; hemostasis was considered ineffective by the DSMB only in the patient with post-hysteroscopy bleeding. No thromboembolic complications or changes in viral titers were observed. This analysis supports VWF/FVIII concentrate safety and efficacy to prevent excessive bleeding during and after a range of surgical procedures in patients with VWD. Enrollment in the trial continues.

Biologic Response and Adverse Events To Stimate In Patients With Von Willebrand Disease

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2365-2365
Author(s):  
Xiangqian Song ◽  
Leonard A. Valentino ◽  
Mindy L. Simpson ◽  
Lisa Boggio
Keyword(s):  
Adverse Events ◽  
Factor Viii ◽  
Biological Response ◽  
Coagulation Factor ◽  
Von Willebrand Disease ◽  
Excessive Bleeding ◽  
Initial Adhesion ◽  
Von Willebrand

Abstract von Willebrand factor (VWF) is a large multimeric glycoprotein secreted from platelet α-granules and Weibel-Palade bodies of endothelial cells. VWF mediates the initial adhesion of platelets at sites of vascular injury and binds to and stabilizes blood coagulation factor VIII in the circulation to protect it from inactivation and clearance. von Willebrand disease (VWD) is the most common hereditary bleeding disorder and results from the deficiency or dysfunction of VWF leading to mucocutaneous bleeding, including epistaxis, menorrhagia, and excessive bleeding after trauma or surgery. Bleeding in patients with VWD is treated with infusion of plasma-derived VWF containing FVIII concentrates or 1-desamino-8-D-arginine vasopressin (DDAVP, desmopression). DDAVP is an analog of vasopressin antidiuretic hormone which can stimulate the exocytosis of VWF from storage sites and increase VWF and FVIII levels. DDAVP can be administrated by intravenous and intranasal routes. There are several reports of the safety and efficacy of intravenous DDAVP, but few with concentrated intranasal DDAVP (Stimate®). Here we report on the efficacy and safety of Stimate® in patients with VWD Methods Hospital records for 72 patients with VWD who received Stimate® from 1998 to 2012 were reviewed. The primary endpoint was the patients’ biological response to Stimate®, defined as at least a 3 fold increase compared to baseline of both ristocetin cofactor activity (VWF:RCo), factor VIII procoagulant activity (FVIII:C), or both VWF:RCo and FVIII:C are over 100% after Stimate®. Individuals not meeting the response criteria were deemed to be nonresponse. The adverse events were analyzed between different VWD types, response, age, gender, and race. Result Of those 72 VWD patients, 45 have type 1 (62%), 7 have type 2 (10%), and in 20 cases the subtype was unclear (28%). Responsive to Stimate® was observed in 43 (95.6%) of type 1, 4 (57.1%) of type 2, and 19 (95%) in which the diagnosis was unclear. In total, 16 patients (22.2%) had adverse events: 1 – allegoric response, 8 - mild headache, 4 - mild hyponatremia, and 4 - blood pressure (BP) reduced more than 20 mmHg. Conclusion Patients with VWD 1 have higher response rates to Stimate® than patients with VWD 2 in our test. The Stimate® is effective and safe for treatment of VWD. Disclosures: Valentino: Baxter, Bayer, Biogen Idec, GTC Biotherapeutics, Inspiration Biopharmaceuticals, Novo Nordisk: Consultancy, Membership on an entity’s Board of Directors or advisory committees.

Abstract 15821: Safety and Efficacy of Non-invasive Ventilation During Exercise Training in Patients With Acute Heart Failure. A Randomized Prospective Controlled Study

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Mayron F Oliveira ◽  
Rita L Santos ◽  
Vanessa M Mendez ◽  
Priscila A Sperandio ◽  
Iracema I Umeda ◽  
...  
Keyword(s):  
Heart Failure ◽  
Exercise Training ◽  
Adverse Events ◽  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Invasive Ventilation ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Non Invasive ◽  
Non Invasive Ventilation

Background: Exercise training (ET) is well established to improve functional capacity and quality of life in patients (pts) with chronic heart failure. However, the ET benefits in acute heart failure (AHF) are unknown. Purpose: We aimed to study the safety and efficacy of ET alone or combined with non-invasive ventilation (NIV) compared to standard medical treatment in hospitalized pts with AHF. Methods: Twenty-nine pts with AHF (68% ischemic), 56±7 years, left ventricle ejection fraction of 25±5%, NTproBNP of 2456±730, 6-minute walk test distance (6MWD = 225±39meters) were randomized into 3 groups: ET + NIV with sub therapeutic positive airway pressure (PAP) (ET,n=9), ET + NIV set to 14 of inspiratory and 8 cmH2O of expiratory PAP, respectively (EV,n=11) and standard treatment (CO,n=9). The ET and EV groups performed a daily session of unloaded exercise on cycle ergometer for 20 min or tolerance limit, for 8 consecutives days. In EV and ET, oxygen pulse saturation (SpO2), heart rate (HR), respiratory rate (RR), blood pressure (BP), blood lactate were measured at baseline (D1), during exercise, and at day 10 (D10). Serious adverse events (death or worsening heart failure) were also assessed on D10. Results: Length of hospital stay was shorter in EV group (17±10 days) compared to ET (23±8 days) and CO (39±15 days) (p<0,05). There were more serious adverse events in CO (66,6%) compared to both EV and ET (15%). Dobutamine use at D10 was less frequent in EV (18,2%) and ET (22,2%) groups than in CO (33,3%) (p<0.05). There was a marked improvement in Δ6MWD between D1 and D10 in EV (Δ127±72 meters), though increase in Δ6MWD was also seen in ET (Δ72±26 meters) and CO (Δ41±19meters), p<0,05. The EV group also showed higher endurance and lower peak HR at end-exercise than ET at D10 (128±10 vs. 92±8 min and 73±12 vs. 104±25 bpm, respectively; p<0,05). There was a similar reduction in NTproBNP levels but no differences were found in BP, SpO2, RR and blood lactate. Conclusion: Aerobic exercise in AHF was safe, reduced length of hospital stay and need for inotropics at D10. NIV + ET increased exercise endurance with lower cardiovascular stress.

Safety and Efficacy of Fremanezumab for the Prevention of Migraine: a Meta-analysis from Random Clinical Trails

2020 ◽  
Author(s):  
Bixi Gao ◽  
Nan Sun ◽  
Yanbo Yang ◽  
Yue Sun ◽  
Mingjia Chen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Neurological Diseases ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Therapeutic Drugs ◽  
Primary Endpoints ◽  
Calcitonin Gene ◽  
Clinical Trails

Abstract Background Fremanezumab (TEV-48125) is a fully humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several clinical trails have been conducted to investigate the safety and efficacy of fremanezumab, but there is no systematic review of existing literature has been performed. Hence, we performed a meta-analysis to investigate the efficacy and safety of fremanezumab for prevention of migraine. Method Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3379 patients were finally included in our study. Result We pooled 3379 patients from 5 RCTs, the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. In addition, after using fremanezumab, the risk of at least one adverse event (P=0.001) or related to the trail regimen (P=0.0005) significantly increase compared with placebo. Conclusions Fremanezumab has good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but not serious adverse events.

von Willebrand Factor/Factor VIII Concentrate (Humate-P®) Is Safe and Effective in the Prevention of Perioperative Bleeding in Patients with Very Low von Willebrand Factor: Ristocetin Cofactor (VWF:RCo).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4071-4071
Author(s):  
Joan Cox Gill ◽  
Cindy A. Leissinger ◽  
Jorge DiPaola ◽  
Jonathan Bernstein ◽  
Margaret V. Ragni ◽  
...  
Keyword(s):  
Adverse Events ◽  
Factor Viii ◽  
Von Willebrand Factor ◽  
Treatment Duration ◽  
Major Surgery ◽  
Minor Surgery ◽  
Hemostatic Efficacy ◽  
Von Willebrand ◽  
Tooth Extractions ◽  
Willebrand Factor

Abstract Optimal dosing to prevent excessive surgical bleeding in von Willebrand Disease (VWD) was investigated in an open-label study of replacement therapy with a von Willebrand factor/factor VIII concentrate (VWF/FVIII, Humate-P®). This analysis focused on the subset of patients with very low VWF, defined as those with baseline VWF:RCo levels of &lt;12 IU/dL. Of a total of 35 patients, 17 had very low levels of VWF:RCo; of these 17 “severe” VWD patients, 12 had type 3 VWD, one each had types 1, 2A or 2B, and 2 had type 2M VWD. Previous pharmacokinetic data in each patient was utilized to calculate pre-operative and immediate postoperative doses to raise plasma VWF:RCo and FVIII to 80–100 IU/dL for major surgery and 50–60 IU/dL for minor and oral surgery; subsequent doses were adjusted based on VWF:RCo levels. Eleven patients underwent major surgery including orthopedic, gynecologic and plastic surgery, and multiple tooth extractions; 4 had minor surgery and 2 had single tooth extractions. Hemostatic efficacy was assessed by investigators as excellent, good, moderate/poor, or none immediately after the surgery, 24 hours after the last VWF/FVIII infusion and 14 days post-op. Expected and actual estimated blood loss (EBL) was compared, transfusions recorded and adverse events (AEs) documented. The median loading dose was higher among subjects with severe VWD types (71 IU/kg, range 39 to 135) compared with non-severe VWD (44 IU/kg, range 17 to 121). Subjects with severe VWD types also used higher total doses (median: 280 IU/kg, range 63 to 859) and had longer treatment duration (6 days, range 1–26) than subjects with non-severe VWD types (median total dose: 208 IU/kg, range 79 to 1699; and treatment duration: 4.5 days, range 2–19). Hemostasis was rated as effective (good or excellent efficacy) in 15/17 (88.2%) patients immediately postoperatively, in 17/17 (100%) patients 24 hours after the last infusion (primary endpoint), and in 17/17 (100%) patients 14 days postoperatively. A bleeding related serious AE occurred in one patient; she had hemorrhage post-hysteroscopic resection of uterine fibroids followed by hysterectomy; actual EBL exceeded expected EBL and hemostatic efficacy was considered moderate/poor immediately post-op but good/excellent at the other time points. Three other surgery-related hemorrhagic events were mild in the severe VWD types; in the non-severe VWD patients, 1 severe, 1 moderate and 2 mild hemorrhagic adverse events were reported; none of these were considered to be related to poor efficacy of the drug. No thromboembolic complications or changes in viral titers were observed in the study. We conclude that patients with very low baseline VWF levels can safely undergo both major and minor surgery with VWF/FVIII concentrate when dosing is calculated to achieve and maintain hemostatic VWF levels based on VWF:RCo monitoring. It is important to base therapeutic decisions on the severity of disease as assessed by baseline plasma VWF and FVIII levels as well as VWD type.

Safety and Effectiveness of Desmopressin for the Management of Delivery and Major Surgery in Patients with Mild-Moderate Von Willebrand Disease: Final Analysis of the Prodeswil Study

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 759-759
Author(s):  
Augusto Bramante Federici ◽  
Giancarlo Castaman ◽  
Alfonso Iorio ◽  
Emily Oliovecchio ◽  
Prodeswil Investigators
Keyword(s):  
Side Effects ◽  
Clinical Efficacy ◽  
Oral Surgery ◽  
Biological Response ◽  
Von Willebrand Disease ◽  
Major Surgery ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Bleeding Episodes ◽  
Von Willebrand

Abstract Introduction. Despite the fact that desmopressin (DDAVP) is considered the treatment of choice in the majority of patients with inherited von Willebrand disease (VWD), there are still open questions about the efficacy and safety of the use of DDAVP to manage recurrent bleeding episodes, delivery and major surgery. In fact, to avoid tachyphylaxis and possible side effects with repeated DDAVP injections, VWF concentrates are usually preferred to manage delivery and major surgery also in VWD patients proven to be DDAVP-responsive. No prospective data have been reported so far to correlate biological response with DDAVP clinical efficacy in VWD and guide clinical practice. Design, aims and methods. ProDesWilis an investigator-driven Pro spective study on D esmopressin e fficacy and s afety of patients with inherited von Wil lebrand disease assessed at enrolment for DDAVP biological response during a test-infusion. Inclusion criteria: VWD diagnosis without any age restriction according to bleeding score >4, VWF activity levels <45U/dL, and at least another affected member in the family. DDAVP Biological Response: VWD were classified as complete, partial or no-responders as previously reported (Blood 2008;111:3531). Treatment regimens: DDAVP given intravenously or subcutaneously (0.3 ug/Kg) or by nasal spray (4 ug/Kg) according to preparations available in different countries with or without standard doses of anti-fibrinolytic agents (Epsilon-amino-caproic acid, EACA or tranexamic acid, TA). In case of major surgery, DDAVP was used together with TA using a 3dayOn-4dayOff-3dayOn schedule. DDAVP efficacy-safety evaluated with criteria currently used for VWF concentrates, with poor efficacy defined when VWF concentrates were needed. Patients were prospectively followed up for 24 months by ProDesWil Investigators who reported detailed information about DDAVP therapy used for bleeds, deliveries, oral and minor/major surgeries Results. 268 patients were enrolled in this 24-month prospective study. DDAVP-biological response: 225/268 (85%) patients met inclusion criteria as VWD1(n=184), VWD1C (n=14), VWD2A(n=15), VWD2M(n=12). The 14 VWD1C with accelerated clearance carried C1130F and R1205H mutations. DDAVP biological response was complete, partial and absent in 89%, 10% and 1% of all VWD. DDAVP clinical efficacy and safety: during the 24-month follow-up 84/225 (37.3%) received DDAVP for bleeding episodes (n=104), oral surgeries (n=33), deliveries (n=12), other minor/major surgeries (n=25). Total DDAVP injections were 652 with median, range/episode during bleeds (2,1-12), oral surgeries (1,1-10), deliveries (3,1-13), minor/major surgeries (3.6,1-16). Clinical efficacy was excellent/good in bleeds (93.3%), oral surgery (100%), deliveries (91.7%), minor/major surgeries (92.3%). All VWD treated for oral surgery with (75%) and without (25%) EACA/TA had excelled/good outcomes. Efficacy was rated excellent/good in 96/104 bleeds, with 8 episodes rated poor during menorrhagia (n=4) in 2 VWD1 and 2 VWD2A, during nose (n=2) and gastrointestinal (n=2) bleeds in 3 VWD2A and 1 VWD1C. 11/12 deliveries had excellent/good outcome with poor response in only one VWD1C who required VWF concentrates after caesarean section. All the 11/25 cases with minor surgeries had excellent outcomes. Among the 14/25 major surgeries [abdominal (n=5), hysterectomy (n=3), tonsillectomy (n=3), orthopaedic and others (n=3)] 2 episodes (partial resection of kidney in VWD2A and tonsillectomy in VWD1) were rated poor. Side effects (16 cases) were mainly minor (flushing, headache, tachycardia) with water retention reported only in 2 patients who received >12 doses of DDAVP for delivery or major surgery. Conclusions: DDAVP is an effective, safe and cheap treatment for managing patients with mild-moderate VWD who showed complete biological response to this drug. Therefore, DDAVP must be always recommended as first line therapy in responsive VWD not only in bleeds and oral surgery but also in deliveries and major surgeries. On the other hands, DDAVP should be used with caution in VWD2A and VWD1 with partial response. The additional use of EACA/TA should be considered especially when DDAVP is required for more than 4 days. Disclosures No relevant conflicts of interest to declare.

scholarly journals Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study

2015 ◽  
Vol 42 (5) ◽  
pp. 799-809 ◽  
Author(s):  
Atsushi Ogata ◽  
Koichi Amano ◽  
Hiroaki Dobashi ◽  
Masayuki Inoo ◽  
Tomonori Ishii ◽  
...  
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Additional Treatment ◽  
Joint Disease ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Safety And Efficacy ◽  
American College Of Rheumatology ◽  
Open Label Extension

Objective.To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA).Methods.Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks.Results.The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy.Conclusion.TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

scholarly journals Management of Perioperative Anticoagulation in Patients with VWD

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1100-1100
Author(s):  
Mario Von Depka ◽  
Carsten Detering ◽  
Stefanie Döpke ◽  
Mahnaz Ekhlasi-Hundrieser
Keyword(s):  
Risk Factors ◽  
Body Weight ◽  
Surgical Procedures ◽  
Thrombotic Event ◽  
Coagulation Factor ◽  
Post Surgery ◽  
Thrombosis Risk ◽  
Perioperative Anticoagulation ◽  
Factor Concentrate ◽  
Von Willebrand

Abstract Objectives: von Willebrand disease (VWD) is the most common hereditary bleeding disorder. This study reviews the management of perioperative anticoagulation in patients with VWD undergoing surgical procedures. Risk factors for VTE with von Willebrand factor (VWF) concentrate use are older age, previous VTE, obesity, surgery, hormone replacement therapy use, antifibrinolytic therapy use and high post infusion FVIII levels. Currently, there are few data from randomized clinical trials assessing efficacy and possible complications of perioperative VTE prophylaxis in VWD patients. Methods: A total number of 116 surgeries were performed (minor: n=64 and major: n=52) in this retrospective, single-centre study. They were divided into groups of perioperative non-anticoagulation (n=54) and perioperative anticoagulation (n=62), who all received coagulation factor concentrate (CFC). Sub-analyses were done according to the type of concentrate used. Anticoagulation was performed using different low molecular weight heparins (LMWH) according to standard protocols or body-weight adapted doses in patients with either elevated body-mass-index or additional thrombosis risk factors. Blood samples had been collected pre- and post-surgery (up to 21 days) to analyse PT, aPTT, PFA, and trough levels of FVIII coagulant activity (FVIII:C), VWF activity (VWF:GPIbM) and antigen (VWF:Ag), respectively. Furthermore, the median doses of CFC/kg and the median total number of infusions were calculated. The rates of clinically overt thrombosis as well as bleeding were assessed during the post-operative phase. Results: The majority of patients suffered from VWD type 1 (104), 9 patients with type 2A, 2 with type 2M and 1 with type 3 VWD. Humate-P (H) was used in 55 patients and 61 patients received Wilate (W). Using W, we found parallel curves for FVIII:C, VWF-antigen and VWF:GPIbM, respectively. Using H, less concordance between VWF:Ag and VWF:GPIbM was visible and FVIII:C tends to increase between D3 to D10 in spite of decreasing VWF:Ag and VWF:GPIbM. This observation was visible in minor as well as major surgical procedures. LMWH (Enoxaparin, Nadroparin and Certaparin) were used in doses between 30 and 100 mg/injection (mean 46.0 ± 18.5 mg/injection) and a mean of 32.2 ± 24.6 injections in total (range: 8-112). In one patient a significant haematoma occurred (1/116; 0.9%), also one thrombotic event was documented in a different patient (1/116; 0.9%). Conclusion: Using standard dose LMWH in patients with no overt increased thrombosis risk as well as body-weight-adapted LMWH in high risk patients seem to be safe and effective in VWD patients receiving coagulation factor concentrate perioperatively. However, prospective randomized comparative studies are required to determine the optimal indication as well as type of anticoagulation according to the CFC treatment regimen in this setting. Disclosures No relevant conflicts of interest to declare.

Tissue Welding Forceps Usage in Superficial Parotidectomy: A Clinical Assessment

2008 ◽  
Vol 74 (1) ◽  
pp. 51-55
Author(s):  
Randall G. Michel ◽  
Kang Tsau ◽  
Bernard I. Weinstock
Keyword(s):  
Blood Loss ◽  
Blood Vessel ◽  
Surgical Procedures ◽  
Clinical Assessment ◽  
Facial Weakness ◽  
Facial Paresis ◽  
Superficial Parotidectomy ◽  
Safety And Efficacy ◽  
Tissue Welding ◽  
Estimated Blood Loss

Tissue welding forceps (TWF) have been used effectively in a number of surgical procedures including blood vessel harvesting and tonsillectomy. Our objective was to assess the safety and efficacy of TWF usage in superficial parotidectomy. We performed a retrospective review of 25 patients between November 2002 and July 2006 who underwent superficial parotidectomy using TWF. The inpatient and outpatient records were reviewed for diagnosis, operative times, estimated blood loss, and postoperative facial paresis. Only one of the 25 patients (4%) who underwent superficial parotidectomy using TWF had transient postoperative facial weakness and no procedure had blood loss of greater than 150 cc. This initial evaluation suggests that use of TWF is safe in superficial parotidectomy and may help reduce the development of postoperative facial paresis.

Periprocedural safety and efficacy after left atrial appendage closure in a large UK tertiary centre: 10-year experience

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Briosa E Gala ◽  
MTB Pope ◽  
C Monteiro ◽  
M Leo ◽  
TR Betts
Keyword(s):  
Adverse Event ◽  
High Risk ◽  
Adverse Events ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Tertiary Centre ◽  
Procedural Success

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left atrial appendage (LAA) thrombus is responsible for up 90% of atrial fibrillation (AF) related ischaemic strokes. Mechanical closure of the LAA is an alternative stroke prevention strategy in patients with non-valvular AF who are at a high risk of bleeding. LAA morphology is highly variable which may affect acute procedural success rates. Purpose This study sought to examine the periprocedural safety and efficacy, and short-term outcomes in patients undergoing left atrial appendage occlusion (LAAO) device implantation in a large UK tertiary centre. Methods This retrospective study included all patients listed for a LAAO device in our institution from January 2010 to December 2020. Medical notes, procedural and imaging reports were reviewed and adverse event rates were calculated at discharge, 30 and 90 days. A Cox regression model was used for multivariable analysis with pre-specified covariates to assess outcomes at 90 days. Results Of 237 patients listed for a LAAO device, 8 (3.4%) had a LAA thrombus and the procedure was abandoned (4 had a successful implant at a later date). In 225 (94.9%) patients a LAAO device was implanted and 4 (1.7%) had unsuitable anatomy precluding device deployment. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 major or life-threatening bleeding episodes).  The mean procedural and fluoroscopy time were 52.5 ± 30.5 and 8.0 ± 5.9 minutes, respectively. Three different LAAO devices were used (136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac Plug) with no significant difference in acute procedural success (97.8%, 98.2% and 94.4%, p = 0.41, respectively). Complete seal was achieved in 202 (92%) patients with only 1 (0.4%) moderate leak. Procedure-related mortality was 1.3% and non-fatal serious adverse events occurred in 5 (2.1%) patients. At 90 days, 28 patients experienced an adverse event (KM 12.5%; 95% CI, 8%-16.1%) and 16 patients suffered a serious adverse event (KM 7.1%; 95% CI, 3.7%-10.4%). In a covariate-adjusted Cox model, CHA2DS2-VASc score less than 4 had hazard ratio of 0.21 (95% CI, 0.06 -0.71, p = 0.01) for serious events at 90 days. Conclusion The acute procedural success rate was high (97%) with a low number of periprocedural complications. Serious adverse events at both 30 and 90-days were low in keeping with other published registries. Abstract Figure.

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