Executive Summary : Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines

The purpose of this scientific statement is to provide an up-to-date overview of the postthrombotic syndrome (PTS), a frequent, chronic complication of deep venous thrombosis (DVT), and to provide practical recommendations for its optimal prevention, diagnosis, and management The intended audience for this scientific statement includes clinicians and other healthcare professionals caring for patients with DVT

Members of the writing panel were invited by the American Heart Association Scientific Council leadership because of their multidisciplinary expertise in PTS Writing Group members have disclosed all relationships with industry and other entities relevant to the subject The Writing Group was subdivided into smaller groups that were assigned areas of statement focus according to their particular expertise After systematic review of relevant literature on PTS (in most cases, published in the past 10 years) until December 2012, the Writing Group incorporated this information into this scientific statement, which provides evidence-based recommendations The American Heart Association Class of Recommendation and Levels of Evidence grading algorithm (Table 1) was used to rate the evidence and was subsequently applied to the draft recommendations provided by the writing group After the draft statement was approved by the panel, it underwent external peer review and final approval by the American Heart Association Science Advisory and Coordinating Committee External reviewers were invited by the American Heart Association The final document reflects the consensus opinion of the entire committee Disclosure of relationships to industry is included with this document (Writing Group Disclosure Table)

View this table:

Table 1 
Classification of Recommendations and Levels of Evidence



### Background

DVT refers to the formation of blood clots in ≥1 deep veins, usually of the lower or upper extremities PTS, the most common long-term complication of DVT, occurs in a limb previously affected by DVT PTS, sometimes referred to as postphlebitic syndrome or secondary venous stasis syndrome, is considered a …

The Postthrombotic Syndrome: Evidence-Based Prevention, Diagnosis, and Treatment Strategies A Scientific Statement From the American Heart Association

Background Experimental data indicate that reducing factor XI levels attenuates thrombosis without causing bleeding, but the role of factor XI in the prevention of postoperative venous thrombosis in humans is unknown. FXI-ASO (ISIS 416858) is a secondgeneration antisense oligonucleotide that specifically reduces factor XI levels. We compared the efficacy and safety of FXI-ASO with those of enoxaparin in patients undergoing total knee arthroplasty. Methods In this open-label, parallel-group study, we randomly assigned 300 patients who were undergoing elective primary unilateral total knee arthroplasty to receive one of two doses of FXI-ASO (200 mg or 300 mg) or 40 mg of enoxaparin once daily. The primary efficacy outcome was the incidence of venous thromboembolism (assessed by mandatory bilateral venography or report of symptomatic events). The principal safety outcome was major or clinically relevant nonmajor bleeding. Results Around the time of surgery, the mean (±SE) factor XI levels were 0.38±0.01 units per milliliter in the 200-mg FXI-ASO group, 0.20±0.01 units per milliliter in the 300-mg FXI-ASO group, and 0.93±0.02 units per milliliter in the enoxaparin group. The primary efficacy outcome occurred in 36 of 134 patients (27%) who received the 200-mg dose of FXI-ASO and in 3 of 71 patients (4%) who received the 300-mg dose of FXI-ASO, as compared with 21 of 69 patients (30%) who received enoxaparin. The 200-mg regimen was noninferior, and the 300-mg regimen was superior, to enoxaparin (P<0.001). Bleeding occurred in 3%, 3%, and 8% of the patients in the three study groups, respectively. Conclusions This study showed that factor XI contributes to postoperative venous thromboembolism; reducing factor XI levels in patients undergoing elective primary unilateral total knee arthroplasty was an effective method for its prevention and appeared to be safe with respect to the risk of bleeding. (Funded by Isis Pharmaceuticals; FXI-ASO TKA ClinicalTrials.gov number, NCT01713361.)

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Factor XI Antisense Oligonucleotide for Prevention of Venous Thrombosis

The prevalence of obesity in the population is unlikely to decline, and is likely to contribute to the increasing demand for hip or knee arthroplasty. Conflicting data exist on the risk and benefits of total joint arthroplasty in obese patients. The purpose of this manuscript is to define and identify areas of concern for obese patients undergoing total joint arthroplasty. A workgroup of total joint arthroplasty surgeons from the American Association of Hip and Knee Surgeons (AAHKS) was tasked with identifying key questions regarding obesity and total joint arthroplasty. The workgroup evaluated the available literature and sought to create a review regarding obesity and total joint arthroplasty to complement and guide the surgeon-patient discussion in addition to identifying areas of future research.

Obesity and total joint arthroplasty. A literature based review

Enhanced recovery after surgery (ERAS) protocols produce significant clinical and economic benefits in a range of surgical subspecialties. There is a long tradition of applying clinical pathways to the perioperative care of joint arthroplasty patients. Enhanced recovery after surgery represents the next step in the evolution of standardized care. To date, reports of full ERAS pathways for hip or knee arthroplasty are lacking. In this narrative review, we present the evidence base that can be usefully applied to constructing ERAS pathways for hip or knee arthroplasty. The history and rationale for applying ERAS to joint arthroplasty are explained. Evidence demonstrates improved outcomes after joint arthroplasty when a standardized approach to care is implemented. The efficacy of individual ERAS components in hip or knee replacement is considered, including preoperative education, intraoperative anaesthetic techniques, postoperative analgesia, and early mobilization after joint arthroplasty. Interventions lacking high-quality evidence are identified, together with recommendations for future research. Based on currently available evidence, we present a model ERAS pathway that can be applied to perioperative care of patients undergoing hip or knee arthroplasty.

Enhanced recovery after surgery for primary hip and knee arthroplasty: a review of the evidence.

Venous thromboembolism (VTE) is defined as the obstruction, partial or complete, of one or more veins of deep circulation. It is a condition that can lead to a deterioration in his state of health until death, manifesting as deep vein thrombosis (DVT) or pulmonary embolism (PE). The major orthopedic surgery and the surgical oncology are frequently associated with thromboembolic complications, because of conditions that are often critical in these patients. It is estimated that in Italy DVT has an incidence that varies between 50 and 150 new cases per 100,000 population, while the prevalence would be between 2.5 and 5%. In the absence of thromboprophylaxis, the orthopedic surgery lead to a high increased risk of VTE. In elective hip replacement, in the absence of prophylaxis, the incidence of DVT and of fatal PE is about 50% and 2% respectively. In elective knee arthroplasty the risk of venous thromboembolic complications is even higher. It is estimated that 56.2% of the costs of prophylaxis with Low Molecular Weight Heparin (LMWH) in patients undergoing major orthopedic surgery are attributable to the cost of drugs (about € 200), followed (with 44.8%) by the cost of administration (approximately € 159). The average total cost/day was estimated at € 8 per patient. In Italy, it has been estimated an annual cost for new cases between 215 and 260 million €. The clinical advantages of the New Oral Anticoagulants (NOA) appear to be substantially clear, the major concern with regard to their reimbursement is therefore linked to the financial impact, due to the higher cost per day of the NOA compared with LMWH. To this end, it was built a model of budget impact, in the perspective of the Italian NHS, from the data related to cases of major surgical orthopedic procedures and a meta-analysis on the pivotal RCT, which aims to measure the differential effects in terms of prevention of VTE. The results show that the financial impact of the NOA in the prophylaxis of major orthopedic surgery is not particularly relevant. In fact, the major pharmaceutical costs that, at national level, amount to € 10.8 mil. (€ 15.2 mil. in the case of prolonged prophylaxis in knee operations) would be more than offset by savings in terms of fewer treatments of VTE, which is based on the assumption of more than 4,000 cases, up to about 6,600 in hypothesis best efficacy.

/pdf/prevention-of-vte-in-orthopedic-surgery-patients-bofd0hdftp.pdf

Prevention of VTE in orthopedic surgery patients

Venous thromboembolism (VTE) is defined as the obstruction, partial or complete, of one or more veins of deep circulation. It is a condition that can lead to a deterioration in his state of health until death, manifesting as deep vein thrombosis (DVT) or pulmonary embolism (PE). The major orthopedic surgery and the surgical oncology are frequently associated with thromboembolic complications, because of conditions that are often critical in this patients. It is estimated that in Italy DVT has an incidence that varies between 50 and 150 new cases per 100,000 population, while the prevalence would be between 2.5 and 5%. In the absence of thromboprophylaxis, the orthopedic surgery lead to a high increased risk of VTE. In elective hip replacement, in the absence of prophylaxis, the incidence of DVT and of fatal PE is about 50% and 2% respectively. In elective knee arthroplasty the risk of venous thromboembolic complications is even higher. It is estimated that 56.2% of the costs of prophylaxis with Low Molecular Weight Heparin (LMWH) in patients undergoing major orthopedic surgery are attributable to the cost of drugs (about € 200), followed (with 44.8%) to the cost administration (approximately € 159). The average total cost /day was estimated at € 8 per patient (€ 2.7). In Italy, it has been estimated an annual cost for new cases between 215 and 260 million €. The clinical advantages of the new oral anticoagulants (NOA) appear to be substantially clear, the major concern with regard to their reimbursement is therefore linked to the financial impact, due to the higher cost per day of the NOA compared with LMWH. To this end, it was built a model of budget impact, from the perspective of the Italian NHS, from the data related to cases of major surgical orthopedic procedures and a meta-analysis on the pivotal RCT, which aims to measure the differential effects in terms of prevention of VTE. The results show that the financial impact of the NOA in the prophylaxis of major orthopedic surgery is not particularly relevant. In fact, the major pharmaceutical costs that, at national level, amount to € 10.8 mil. (€ 15.2 in the case of prolonged prophylaxis in knee operations) would be more than offset by savings in terms of fewer treatments of VTE, which is based on the assumption of more than 4,000 cases, up to about 6,600 in hypothesis best efficacy.

Emilio Mazza

Papers

Prevention of VTE in orthopedic surgery patients

La prevenzione del tromboembolismo venoso nella chirurgia ortopedica maggiore Prevention of VTE in orthopedic surgery patients