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A Novel Blood-saving Plan for Less-invasive Primary Total Hip Replacement

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Abstract

We conducted a quality improvement program to examine the effect of a blood-saving plan during primary total hip replacement (THR) performed using a non-vascular less invasive approach (LI-THR) and compared the results with historical control subjects. Erythropoietin and tranexamic acid (TA) were administrated for selected patients. Analysis of 221 (study group) and 186 (historic group) LI-THRs showed reductions in total blood loss (1177 mL and 1605 mL, respectively), the rate of blood transfusion (0% and 8%), and the rate of postoperative anemia (10% vs. 22%). TA decreased the blood loss by 20% in a group of 133 patients compared to a control group of 82 patients who did not receive TA. This novel blood plan for LI-THR changed practice, improved quality of care, and allowed all patients to remain blood transfusion free.

Blood loss and transfusion rates remain high during THR, despite the availability of multiple strategies to prevent or reduce the likelihood of these outcomes.¹ Less-invasive THRs have been shown to reduce the amount of intraoperative blood loss, but surgeons have expressed concern that these techniques have been promoted in the absence of sound clinical data supporting their efficacy and safety.

In early 2003, the senior investigator (H.H.) began performing LI-THR by reducing the skin incision during a preferred approach. No learning curve was observed in the early application of this less-invasive technique, and the procedure was considered similar to and as safe as the standard procedure.² More difficult cases were included as the senior investigator’s skills in performing this technique progressed, to the point where — after the first 100 LI-THRs —these surgeries accounted for 90% of the primary THRs performed by the same surgeon. Preliminary results provided no evidence supporting the usefulness of a perioperative cell-saver system during these surgeries.²

Our prospective study was designed to document the actual blood loss and blood transfusion requirements after primary unilateral LI-THR performed without the use of autotransfusion systems. Therefore, in 2005, we stopped the use of these devices and discontinued the use of autologous blood transfusions. We also stopped utilizing preoperative blood donation.

Materials and Methods

Study Design

This quality-assurance for a novel blood-management program was nested in a prospective observational study on unilateral THR using a less-invasive approach. Less-invasive THR was defined as a THR performed using specially designed instrumentation through a skin incision =10 cm in length (with measurements made at the time of closure).² Patients with previous ipsilateral hip surgery and severe dysplasia were excluded from undergoing LI-THR. No patients were excluded for medical reasons such as hematologic disease or anticoagulant medication given before surgery. In addition, no patients with complications or major bleeding episodes were excluded.

The study group consisted of 210 patients (221 consecutive LI-THRs) operated between October 2005 and May 2007. Eleven patients (9 men) underwent bilateral LI-THR procedures, which were performed separately during different hospital stays. The interval between the operations was on average 9.7 months (range, 4-14 months). Therefore, each hip was considered a separate case

The most frequent morbidities were hypertension (51%), diabetes (12%), and history of coronary disease (9%). (Table 1)

The results of the study were compared with those of a historical control group comprising 186 hips (181 patients) operated between January 2004 and September 2005 using the same surgical and anesthetic procedure. The two groups were similar with the exception of the blood plan used. In the study group, no autotransfusion systems were implemented, whereas in the historical group, blood salvage reinfusion systems were used (Cell Saver; Fresenius, Bad Homburg, Germany or Constavac; Stryker, Kalamazoo, Mich. Preoperative donation of autologous blood units was not implemented in either group. The historical group was matched using the same inclusion criteria as that used for the study group. Baseline data are provided in Table 1. No statistically significant differences were observed between the two study arms with respect to age, sex, body mass index, preoperative functional Postel and Merle d’Aubigné score (PMA score), preoperative hematocrit (Ht) level, American Society of Anesthesiologist (ASA) score, length of incision, or operating time. The proportion of patients operated for primary osteoarthritis was significantly higher in the study group.

Surgical Technique

All surgeries were performed in the same horizontal laminar airflow operating room with the patient in the lateral position. The same surgeon (H.H.), who had performed 300 LI-THR procedures prior to the study, operated on all patients. All patients received antibiotic prophylaxis with cefazolin at the time of operation. Cefazolin-allergic patients received vancomycin.

Cementless implants, the SL-Plus stem and the EP-FIT cup (Smith & Nephew Orthopaedics AG, Rotkreuz, Switzerland), were exclusively implanted. Each operative procedure was preceded by preoperative planning using x-rays to determine the maximum size of the stem, the femoral offset, and limb lengthening. An anterolateral surgical approach was used with a one-third anterior split of the gluteus medius. The tendon of the one-third gluteus medius was kept in continuity with the anterior part of the vastus lateralis by sawing a trochanteric medallion to achieve a digastric flap. In the next step, the gluteus minimus and capsule were incised as a single layer along the neck of femur and detached from the femur at the distal part. The capsule was not excised. At the time of closure, the capsule was sutured jointly with the gluteus minimus and reattached to the femur via transosseous nonabsorbable stitches.

During surgery, the femoral canal was prepared with double-tapered broaches of incremental sizes powered by a pneumatic hammer (Woodpecker, Integral Medizinaltechnik, Lucerne, Switzerland). Resistance to the progressive distal advance of the motorized broaches into the femur allowed for the identification of the maximum implant size. On the acetabular side, specially designed curved instrumentation was used for reaming the acetabulum and inserting the cup.

All surgeries were performed under general anesthesia. Anesthesia was induced with propofol, sufentanyl, and atracurium. Patients were intubated, and ventilation was controlled with a nitrous oxide/oxygen mixture. Maintenance of anesthesia was ensured by reinjections of sufentanyl and sevoflurane inhalation or by propofol and sufentanyl target-controlled infusion. Air warming set at 37·C via a blanket applied on the upper body was used through- out the procedure. The mean value for body temperature recorded at the entry to recovery room was 35.8·C (range, 34.4-37.4). Systemic controlled hypotension was not used; the anesthesiologist‘s plan was limited to maintaining mean arterial pressure values in the 20% to 25% range less than the usual awake values.

In all groups, the same rehabilitation protocol was prescribed. Immediate full weight bearing was allowed. All patients were free to ambulate the second day after surgery. The use of one crutch was prescribed for 1 month.

Blood Management

In the study group, baseline hemoglobin (Hb) levels were optimized using epoetin alpha (EPREX, Janssen, Titusville, NJ) in patients with a baseline Hb level of <11.5 g/dL or less. Beginning 3 weeks before surgery, 4 doses of 40.000 UI were injected, 1 a week, in combination with an oral supplementation of ferrous sulfate, given 200 mg twice daily for a minimum of 21 days before the operation.

In the absence of contraindications (arterial disease, history of myocardial infarction, coronary disease, history of deep venous thrombosis, or pulmonary emboli), 140 patients (144 hips) received tranexamic acid (TA) (EXACYL, Sanofi-Aventis, Bridgewater, NJ) via an intravenous perfusion of 30 mg/kg initiated at the moment of the incision.

The care program for patients taking antithrombotic medication before the operation consisted of continuous administration of aspirin, clopidogrel replacement by aspirin, and vitamin K agonist substitution through prophylactic injections of low-molecular-weight heparin (LMWH).

Drains were used steadily in the historical group, although they were not used systematically in the study group.

In all patients, postoperative care included a pain control program and thromboembolic prophylaxis using either fondaparinux 2.5 mg (Arixtra, GlaxoSmithKline, Philadelphia, Pa.) or tinzaparin 4500 IU (Innohep, Leo Pharma, Buckinghamshire, United Kingdon) during the first week. Thrombosis prophylaxis was extended to 6 weeks using tinzaparine 4500 in all cases except those in which vitamin K agonists were re-established.

All patients underwent a Doppler ultrasound of both inferior limbs between postoperative day 5 and 7, or earlier in cases of early discharge or if there was any clinical suspicion of deep vein thrombosis.

Nonsteroidal anti-inflammatory drug prophylaxis was not used to prevent heterotopic ossification.

The guideline threshold for blood transfusion was an Hb level of <8 g/dL in patients with no cardiac disease and an Hb level of <10 g/dL in patients with impaired cardiac function.

Assessment of Blood Loss, Complications, and Treatment Costs

Sex and weight were recorded for each patient to calculate the estimated patient blood volume from Gilcher rules. A set of laboratory records, including hematocrit and Hb measured through a venous blood sample, was collected during the preoperative and postoperative period.

Baseline Hb and hematocrit levels were measured at the time of the assessment office visit when the surgery was planned 30±7 days before admission to the clinic for the surgery. Preoperative Hb (day -1) was measured 1 day before surgery in patients treated preoperatively by EPO to evaluate the effect of this treatment regarding increases in Hb levels.

During the postoperative period, hematocrit and Hb levels were recorded on the morning of day 1 (specifically, between 12 and 21 hours after the operation) and at day 7±1 to calculate the total blood loss.

The length of stay and the number and type of postoperative complications were recorded for each patient. Major complications were defined as death within 90 days after the procedure, perioperative myocardial infarction, cerebrovascular accident, and symptomatic pulmonary embolism.

Our clinic financed the use of TA, the collection of autologous concentrates, the postoperative blood salvage systems, and the transfusion of allogeneic red blood cell units. EPO treatment was covered by national health insurance in France. Our analysis of cost was conducted using the same costs recently reported by Martinez.³

Statistical Analysis

Unpaired parametric (t test) and nonparametric (Mann-Whitney, chi-square) tests were used to compare data between study and control groups. We used Stata 9.0 (Stata Corp, College Station, Tex.) for all analyses.

Results

Blood Loss

In comparison with historical control subjects, study patients experienced reductions in total blood loss (1605 mL vs 1177 mL, respectively), the rate of blood transfusion (8% vs 0%, respectively), and postoperative anemia (22% vs 10%, respectively) (Table 2).

The study patients who received TA (140 patients) had less blood loss than those who had not received TA (1064 mL vs 1340 mL, respectively; P = .001). Thereby, only 6% of study patients receiving TA were found with an Hb level <10 g/dL during the postoperative period vs. 16% for the remaining patients who did not receive TA (P = .006).

None of the study patients with an Hb level <10 g/dL during the postoperative period were given blood transfusions because none of them had impaired cardiac function or symptomatic anemia (Figure 1).

In the study group, following EPO injections, Hb levels increased preoperatively 2 g/dL on average. In these patients, discharge Hb levels were close to those observed at baseline (Table 3).

There was no significant difference from the overall study group in average total blood loss in those patients (37/210) taking antithrombotic medication before the operation (1145 mL; range, 7%-48% of the estimated blood volume).

Complications

A list of major postoperative complications is shown in Table 2. The incidence of major bleeding episodes was nil in both groups. No patient needed to return to the operating room for evacuation and debridement of visible hematoma.

Cost Savings

An important reduction in clinic costs was observed in the study group because of the lack of blood transfusions and the nonutilization of a perioperative cell-saver system in these patients (Table 4). Reductions in clinic costs were linked to the use of TA, the administration of which is economically practical.

Discussion

This study demonstrates that recent improvements in surgical and anesthetic procedures allow for performing routine primary LI-THRs using a nonvascular approach. This is the first such study to observe a zero rate of blood transfusion during THR (and LI-THR) for a large cohort of patients despite a number of patients having several preoperative medical comorbidities. Although none of the study patients underwent blood transfusions, only a minor percentage of patients developed postoperative anemia (10% of the cohort). This finding is important because Hb status at discharge has been proven to influence quality of life, recovery times, and mortality.⁴

A few series of THRs still have been performed without blood transfu-sion, but the cohorts of participants were comparably small, severe postoperative anemia was noted, and EPO treatment was administered frequently due to special patient requests made on religious grounds.⁵

In this series, no patients were preoperatively opposed to receiving eventual homologous blood transfusions if needed. EPO was prescribed infrequently (4%), only in patients with baseline Hb levels <11.5 g/dL. Remarkably, none of the patients who received EPO had to undergo blood transfusions or developed postoperative anemia.

We compared the efficacy of a pharmacologic transfusion-sparing strategy with a preceding blood plan using blood cell salvage for LI-THR. Autotransfusion from preoperative donation, acute normovolemic hemodilution or controlled hypotension were not used in either of the groups.

We did not use blood salvage for our novel blood-saving plan because the collected blood was too little during our commencing practice of LI-THR.⁶

A reduction in blood loss has been also reported in several,^7,8 but not all,⁹ studies of primary THR performed using small incisions.

In this series, the decrease in Hb concentrations from preoperative levels noted during the first postoperative morning on day 1 was 11.8% on average (10.8% in those given TA). This drop indicates that using a small-incision anterolateral modified approach may indeed be the surgical approach to the hip associated with the low- est amount of bleeding. A search of relevant literature was unable to uncover a low- er drop in Hb levels. In a series of THRs performed through a posterior approach, this drop was regularly greater than 20%, regardless of the size of the incision¹⁰ or whether postoperative blood salvage was used.¹¹ Astore et al¹² obtained a drop of 15% using a minimally invasive approach combined with the use of an innovative bipolar sealing technology capable of delivering superior hemostasis.

Figure 2: Vascular circle of the hip.

We considered it unlikely that electrocoagulation would be as efficient in our small-incision surgical procedure because this approach was not vascular. Indeed, in soft-tissue surgical procedures, there are several differences between operations performed through a small or a standard incision with the modified anterolateral approach. First, the dissection required with a small incision is minimal. The soft-tissue connections and attachments between the layers are preserved. As a result, the extravasations of blood into the surrounding tissues are potentially reduced. Second, the vastus lateralis tendon is incised only 1 cm with the mini-incision, compared with 5 to 7 cm with the standard-incision procedure. Minimizing the incision of this tendon avoids the need for hemostasis to the transversal branch of the circumflex artery (Figure 2). Finally, retaining the capsule allows for reducing the space available for residual blood in the joint.

In using a mini-incision anterolateral approach with capsule excision, Higuchi observed that the average intraoperative blood loss was statistically correlated with the length of the incision, whereas postoperative blood loss was not.¹³

The effect of TA to reduce the immediate postoperative bleeding was demonstrated in conventional THR through several randomized double-blinded controlled studies.^14-16

This study is the first and only study to have investigated the effect of TA during LI-THR.

We observed a 20% decrease in total blood loss in patients having received this antifibrinolytic agent. This reduction is not as great as that noted in conventional THRs using TA administration at the same moment of operation^14-16; therefore, it was sufficient in this series to minimize the incidence on postoperative anemia. Importantly, the safety regarding the use of TA in this series was found concordant with the literature. Specifically, we did not observe any increased incidence of deep venous thrombosis or pulmonary embolism.

In all cases, we implanted an uncemented tapered titanium stem of the Zweymüller design after intraoperatively using a vibration-assisted broaching system, which allows for a reduction in the risk of femur fracture¹⁷ and ensures consistent implant stability, with no significant negative impact on surgical time and bleeding observed.

Although the experience of the surgeon has been shown to influence bleeding in THR performed using a transtrochanteric approach, the duration of surgery has not.¹⁸

Oganda et al⁹ have also emphasized the importance of physician experience for ensuring the safety of LI-THR.

The potential savings in clinical costs observed in our series of patients are quite significant. Study patients avoided all the cumulative risks associated with blood transfusion. In addition, the cost of blood management was drastically reduced with the administration of TA, which is a relatively low-cost treatment. When we noted increases in cost in our study patients, they were primarily due to the use of EPO, although the small number of patients who received EPO (only 4% of the cohort of participants) offset the financial impact of this treatment (Table 4).

Our study has several potential limitations. First, although our study data were made uniform by eliminating variables in the surgical and anesthetic procedure, TA efficacy was not analyzed through a randomized clinical study. Second, our results were obtained by a high hip volume surgeon with extensive experience, and the replication of these results may be unlikely for surgeons not experienced with this relative technically demanding surgical approach.

Conclusion

Recent improvements in surgical and anesthetic practices allowed us to perform routine LI-THRs using a nonvascular approach to the hip with an uncemented procedure under general anesthesia, with all patients remaining transfusion free. Despite this lack of blood transfusion, the rate of postoperative anemia was low.

The potential savings associated with keeping all patients transfusion free during THR is considerable with regard to current medicolegal climate and contemporary shortfalls in blood availability.¹

References

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Authors

Drs Hourlier and Liné are from the Polyclinique de la Thiérache, Service d’Orthopédie, Wignehies, France. Peter Fennema, MSc, is from Smith & Nephew Orthopaedics AG, Rotkreuz, Switzerland.

Drs Hourlier and Liné have no relevant financial relationships to disclose. Peter Fennema, MSc, is an employee of Smith & Nephew Orthopaedics AG, Rotkreuz, Switzerland.

Correspondence should be addressed to Hervé Hourlier, MD, Polyclinique de la Thiérache, Service d‘Orthopédie, Route de Féron, 59212 Wignehies, France.