Three sets of guidelines offer options to surgeons

No matter which guidelines are followed or espoused, all experts recommended documenting one’s decision.

LAS VEGAS - Three sets of guidelines give orthopedic surgeons options for venous thromboembolism prophylaxis in total joint replacement procedures.

The seemingly conflicting guidelines can be confusing, so experts here at the American Academy of Orthopaedic Surgeons (AAOS) 76th Annual Meeting espoused their particular views and urged their colleagues to consider these options carefully.

“A clinical guideline is a document that is supposed to improve overall patient care. It should address key questions; it should have a defined evidence base [and] strength of recommendation. It is always a consensus process, and it is not the ‘be all, end all.’ It should help guide future research,” Paul F. Lachiewicz, MD, said.

“What a clinical guideline is not,” he said, “is a predefined protocol, a dogmatic statement incapable of changing, and it is not a substitute for your sound clinical judgment.”

Therefore, no matter which guidelines a surgeon or hospital chooses, the reason for each choice in each patient must be documented.

The three guidelines under discussion are from the American College of Chest Physicians (ACCP), the AAOS and the Surgical Care Improvement Project (SCIP).

American College of Chest Physicians

The ACCP is a multispecialty group that makes best practice recommendations for prevention of all forms of thromboembolic disease, Fred D. Cushner, MD, said.

“A clinical guideline is a document that is supposed to improve overall patient care .”

— Paul F . Lachiewicz, MD

The ACCP guidelines for prevention of deep venous thrombosis (DVT) were based on prospective randomized controlled studies. This level of data warrants the ACCP guidelines grade of 1A, which is their highest recommendation.

“These guidelines have been around for a long time. … They have been refined,” Lachiewicz said. “And, believe it or not, the ACCP is starting to change. They are starting to see more of a surgeon’s viewpoint.”

The first requirement of the ACCP guidelines is that each hospital must have a documented formal, active strategy.

These guidelines automatically consider all total joint replacement (TJR) patients to be at high risk of a thromboembolic event regardless of age, activity level or comorbidities. The guidelines also recommend additional caution with neuraxial anesthesia or analgesia when using anticoagulants, Lachiewicz said.

He outlined the latest ACCP pulmonary embolism (PE) prophylaxis guidelines, which recommend using low-molecular-weight heparin (LMWH), fondaparinux or warfarin for primary total hip arthroplasty (THA).

The ACCP has recommended against aspirin alone, dextran, unfractionated heparin or foot pumps as the sole method of prophylaxis. However, in 2008, for the first time, the optimal use of mechanical prophylaxis with intermittent pneumatic compression was deemed a grade 1A recommendation for patients at high risk of bleeding.

In knee replacement, the grade 1A recommendations are LMWH, fondaparinux and warfarin. Intermittent compression as an alternative option is a grade 1B recommendation, which is still a high recommendation. The ACCP recommends against aspirin alone, unfractionated heparin or venous foot pump.

“However, if you deem that the patient has a high risk of bleeding based on your surgical judgment or other comorbidities or patient history, the ACCP recommend the optimal use of mechanical prophylaxis with intermittent pneumatic compression,” Lachiewicz said.

The ACCP grade 1A recommended postoperative duration of medication is 10 days for all TJR patients. The grade 1A recommendation for THA patients is to extend LMWH to 35 days; for knee replacement patients, the same recommendation (LMWH only) is slightly less highly recommended.

Even though these guidelines are thorough and include the highest level of research, Lachiewicz said orthopedic surgeons are not entirely satisfied with them.

“Their review omits from consideration all cohort studies of one method or multimodal prophylaxis, and many of us feel that prospective randomized studies of a pharmaceutical agent efficacy include carefully selected patients, usually with fewer comorbidities than [we] are seeing in practice and [with] a low risk for bleeding,” he said.

“The ACCP guidelines are a good resource for everybody.”

— Fred D. Cushner, MD

“Many of us feel that, in these studies, drainage and bleeding relevant to the surgeon may be underreported. And, finally, there is no importance given to patient outcome,” Lachiewicz said.

Cushner said these guidelines may not be specific to orthopedics, but argued that may be an advantage.

“The ACCP guidelines are a good resource for everybody,” Cushner said. “It is multispecialty. Orthopedics is involved, but sometimes having other specialties involved is actually an advantage.”

AAOS

In an effort to focus more specifically on the concerns of the orthopedic surgeons, an AAOS committee conducted a literature review using a broader spectrum of studies and focusing on fatal and symptomatic PEs, as well as bleeding and drainage.

“The outcome was to look at symptomatic PE. We were going to look at a variety of interventions, including stacked modalities,” Lachiewicz, a committee member, said.

The AAOS hired the Center for Clinical Evidence Synthesis, a group that provides assistance, literature review and synthesis for a wide variety of specialists, to research their guidelines. The guidelines were based on prospective studies looking at total venous thromboembolism (VTE) after TJR conducted since 1996, because it was deemed that the procedures had changed drastically over time.

They included any cohort study with at least 100 patients and any randomized trial with more than 10 patients per treatment. There were no studies looking at the natural history of thromboembolic disease after total joint replacement without VTE prophylaxis. Only 42 articles met the criteria, weakening the recommendation level slightly.

“If you are going to follow the AAOS guidelines, you have to follow the whole package. The whole package is a consensus process. Just because a guideline is a consensus process does not devalue it,” Lachiewicz said.

The group found the following: the rate of PE over the past 10 years with any type of prophylaxis is about 1 in 300; the PE death rate with any type of treatment is 1 in 1,700; the bleeding death rate was about 1 in 3,000; and major bleeding was more common when a systemic rather than mechanical or aspirin prophylaxis was used.

Based on these findings, the group devised their own guidelines for PE prophylaxis treatment.

“The first thing is that the surgeon should assess the patient preoperatively for pulmonary embolism risk and bleeding risk,” Lachiewicz said. “In the [AAOS] guidelines, if you feel this patient is in danger of bleeding, you can state that and say, ‘It is my judgment that this patient should have no prophylaxis’ either for a certain length of time or whatever your clinical judgment deems.”

This assessment can change intraoperatively and, if so, the surgeon must use his or her judgment to change the presumed protocol, document that change, and proceed.

Once the level of risk is determined, the following protocols can be followed.

If the patient is at standard risk for both PE and bleeding, he or she may receive aspirin, LMWH, pentasaccharide or warfarin with an international normalized ratio (INR) goal of less than 2. With an elevated risk of PE and standard risk of bleeding, the patient may receive LMWH, pentasaccharide or warfarin with the same INR goal. With a standard risk of PE and elevated risk of bleeding, the patient may receive aspirin, warfarin with the same INR or no pharmaceutical treatment. With elevated risk in both categories, the AAOS suggests aspirin, warfarin with a goal INR of less than 2 or no pharmaceutical treatment.

“We feel that every patient should have mechanical prophylaxis. Either starting intraoperatively or immediately postoperatively, [he or she should have] some type of compression of their leg veins to prevent clots,” Lachiewicz said.

He also mentioned that general anesthesia, as was shown by the ACCP, should be avoided.

“It is becoming apparent that these operations should be done under regional anesthesia as the literature seems to support a lower chance of having serious blood clots with that,” he said.

In addition, patients should be mobilized quickly following surgery and scanning is no longer necessary for all patients.

Cushner voiced his concern with the AAOS guideline instructions to identify patients at high risk of bleeding.

“A lot of factors that correlate with bleeding do not necessarily translate to bleeding complications,” he said.

Also, he said it is equally challenging to identify patients at a low risk for PE.

“In my practice, everybody seems to be at high risk,” he said. “It is very hard to identify the low-risk patient [who] would benefit from a less aggressive protocol.”

Lastly, he questioned the application of the AAOS guidelines in practice because of their involved nature.

“How many people are actually taking the guidelines of the AAOS and individualizing them, applying them to different standards, actually looking at the bleeding rate, or just making it a generic rule that everybody gets aspirin and compression devices?” Cushner asked.

Lachiewicz explained that if one is to implement these guidelines, he or she must use the entire protocol in conjunction with his or her judgment.

“We feel that patients should be evaluated for the risk of PE and bleeding postop. Consider the risk-benefit ratio in your decision and document your decision,” he said.

“You should give a copy of the Academy’s guidelines to your hospital’s patient safety officer or chief of staff,” Lachiewicz said. “But if you are going to follow the guidelines, you are going to follow the entire package — all the recommendations — and document that you do so.”

SCIP

The SCIP guidelines are from a national quality forum of voluntary consensus standards. These are used by the Joint Commission and are becoming more widespread in hospitals throughout the United States.

Lachiewicz said the SCIP guidelines often mirror those of the ACCP, but allow for a physician to choose intermittent pneumatic compression or foot pumps if the patient has a contraindication for the suggested medications.

“If you are going to follow the guidelines, you are going to follow the entire package — all the recommendations.”

— Paul F . Lachiewicz, MD

“You have to document initiation of prophylaxis 24 hours preop to 24 hours postop and this was recommended by the technical expert panel,” Lachiewicz said. “However, for example, if the patient has an epidural, you are going to pass the performance measure if you order mechanical prophylaxis” as long as you document it.

Cushner said the SCIP guidelines give instruction about treatment for total knee, total hip and hip fractures, but there are procedures left uncovered, such as knee arthroscopy and trauma procedures.

Lachiewicz said he is concerned with age of the data in that there are no SCIP references later than 2004. He also raised questions about the Joint Commission’s use of these guidelines.

“They are now going to be used by the Joint Commission and [Centers for Medicare & Medicaid Services] to measure inpatient hospital quality,” he said. “I can tell you [that] many of us feel it is not possible to eliminate all symptomatic VTE, even if you order the correct prophylaxis.”

Conclusions

Each of these guidelines offers something different to orthopedic surgeons, no matter which they choose to follow.

“It is just finding the balance. You want to have a low DVT rate but not an expansive increase in bleeding. I think we can all agree on that,” Cushner said. “The bottom line is [that] we do not know what the real DVT rate is. Life is not a phase 3 study.”

In clinical practice, surgeons use multiple modalities such as mechanical compression combined with aspirin or warfarin on unrestricted patients, all of which vary greatly from the studies upon which these guidelines are based, he said.

“The bottom line of a guideline is [that] it does not substitute for the individual surgeon’s experience, nor does it omit the particular individual patient and [the patient’s] needs,” Lachiewicz said. “The main thing for these joint commissions for hospitals is [that] the surgeon now has to document within 24 hours that he has thought about this issue and he is going to be proactive about it.”

For more information:

• Paul F. Lachiewicz, MD, can be reached at UNC Department of Orthopedics, 242 Burnett-Womack CB #7055, Chapel Hill, NC 27599; 919-966-9073; e-mail: Paul_Lachiewicz@med.unc.edu. He has no direct financial interest in any products or companies mentioned in this article.
• Fred D. Cushner, MD, can be reached at 210 East 64 St., 4th Floor, New York, NY 10021; 212-870-9740; e-mail: fcush@att.net. He is a consultant for Clearant, Conmed and Zimmer, Inc.

References:

1. Lachiewicz PF. Guidelines for VTE prophylaxis. Presented at the American Academy of Orthopaedic Surgeons 76th Annual Meeting. February 25-28, 2009. Las Vegas.
2. Cushner FD. Unmet needs in DVT prophylaxis goals. Presented at the American Academy of Orthopaedic Surgeons 76th Annual Meeting. February 25-28, 2009. Las Vegas.