Clinical Review

The authors report no financial relationships relevant to this article.

Barbed suture is a relatively new technology that has the potential to greatly facilitate laparoscopic suturing. Two barbed sutures, each a different type, are available, or soon will be:

• the Quill bidirectional barbed suture (Angiotech Pharmaceuticals) was approved by the US Food and Drug Administration (FDA) in 2004 for soft-tissue approximation and has been sold in the United States since 2007 ( FIGURE 1A )¹
• the V-Loc 180 unidirectional barbed suture (Covidien) won FDA approval in March for soft-tissue approximation. It should be available in October ( FIGURE 1B ).

(Note: We have performed laparoscopic surgery using the Quill suture, but not the V-Loc 180, both as part of clinical research and in practice.)

In the bidirectional suture, barbs are cut into suture in a direction opposite to the needle; the barbs change direction at the midpoint of the suture, and needles are swaged onto both ends ( FIGURE 1A ).²

The anchoring of bidirectional barbed suture resists migration and can be conceptualized as a “continuous interrupted” suture without knots; it has been shown to have tissue-holding performance that is at least equal to knot-anchored suture.^3,4

A suture with bidirectional barbs offers several advantages:

• Because it self-anchors and is balanced by the countervailing barbs, no knots are required
• It self-anchors every 1 mm of tissue, yielding more consistent wound opposition; this may result in a more “watertight” seal
• Because it is knotless, it can securely reapproximate tissues in less time, at less cost, and with less aggravation.^5,6

Note: Whether these characteristics apply to unidirectional barbed suture remains to be determined.

FIGURE 1 Two types of barbed suture

Bidirectional suture, in which barbs are cut into suture and change direction at the midpoint.

Unidirectional suture has a loop at the distal end to facilitate initial suture fastening.

Specifications

Because the effective diameter of suture is decreased when barbs are cut into it, barbed suture is rated one suture size smaller than smooth suture. A 0 barbed suture, for example, equals a 2-0 smooth suture.

In the current version of the Quill suture, there is a segment of approximately 7 cm of smooth suture proximal to each needle. A second-generation Quill will be released this year, with barbs extending all the way to the needles. Bidirectional barbed suture materials currently include polydioxanone (PDO), poliglecaprone 25 (Monoderm), nylon, and polypropylene.

The V-Loc 180 is a unidirectional barbed polyglyconate (Maxon) suture with a loop at the distal end to facilitate initial fastening.

Case experience

We have performed more than 200 laparoscopic surgeries using Quill suture since March 2008; most involved total laparoscopic hysterectomy and laparoscopic myomectomy. We have also used Quill suture for laparoscopic sacrocolpopexy and uterosacral ligament suspension.

We have had outstanding clinical results: no cuff evisceration and only minor cases of vaginal bleeding or spotting in the immediate postoperative period.⁷ In one case, reoperation was necessary after laparoscopic myomectomy, but the repeat surgery was performed to treat small-bowel obstruction that was not directly related to the hysterotomy repair.

Technique

For vaginal-cuff closure, we use 0 PDO suture on a 36-mm half-circle taper-point needle. We initially used half of a 14×14-cm suture with a LapraTy clip on the distal end. We began the repair at the distal end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite, and continuing proximally until the other uterosacral ligament was incorporated into the repair.

More recently, we have been using the 7×7-cm 0 PDO because it is now available with the 36-mm half-circle taper-point needle. Regardless of suture material, it is important to obtain a full-thickness bite, with a 1-cm margin on the vaginal mucosa on each bite.

With the shorter suture, we begin closure in the middle of the cuff and take each needle to the opposite end of the cuff ( FIGURE 2 ). We incorporate the uterosacral ligament into the final bite on each side, and we cut the suture without a knot or a LapraTy clip.

FIGURE 2 Closing the vaginal cuff with bidirectional barbed suture For myomectomy closure, we use 14×14-cm 0 PDO suture on a 36-mm half-circle taper-point needle. If the hysterotomy is longer than 8 cm, we prefer to use 24×24-cm suture. We tack the first needle to the opposite anterior abdominal wall to avoid having the suture become entangled. We close the deepest layer using the first needle; we use the second needle to close the more superficial layer and the serosa, if possible ( FIGURE 3 ). If the suture is used beyond the barbed portion, we cut the needles and apply a LapraTy clip. Sometimes, three or four layers are needed to close a deep myometrial defect. 2/0 Monoderm can also be used for the serosa, continuously or as a baseball stitch.

FIGURE 3 Myomectomy closure with bidirectional barbed suture

The authors report no financial relationships relevant to this article.

Barbed suture is a relatively new technology that has the potential to greatly facilitate laparoscopic suturing. Two barbed sutures, each a different type, are available, or soon will be:

• the Quill bidirectional barbed suture (Angiotech Pharmaceuticals) was approved by the US Food and Drug Administration (FDA) in 2004 for soft-tissue approximation and has been sold in the United States since 2007 ( FIGURE 1A )¹
• the V-Loc 180 unidirectional barbed suture (Covidien) won FDA approval in March for soft-tissue approximation. It should be available in October ( FIGURE 1B ).

(Note: We have performed laparoscopic surgery using the Quill suture, but not the V-Loc 180, both as part of clinical research and in practice.)

In the bidirectional suture, barbs are cut into suture in a direction opposite to the needle; the barbs change direction at the midpoint of the suture, and needles are swaged onto both ends ( FIGURE 1A ).²

The anchoring of bidirectional barbed suture resists migration and can be conceptualized as a “continuous interrupted” suture without knots; it has been shown to have tissue-holding performance that is at least equal to knot-anchored suture.^3,4

A suture with bidirectional barbs offers several advantages:

• Because it self-anchors and is balanced by the countervailing barbs, no knots are required
• It self-anchors every 1 mm of tissue, yielding more consistent wound opposition; this may result in a more “watertight” seal
• Because it is knotless, it can securely reapproximate tissues in less time, at less cost, and with less aggravation.^5,6

Note: Whether these characteristics apply to unidirectional barbed suture remains to be determined.

FIGURE 1 Two types of barbed suture

Bidirectional suture, in which barbs are cut into suture and change direction at the midpoint.

Unidirectional suture has a loop at the distal end to facilitate initial suture fastening.

Specifications

Because the effective diameter of suture is decreased when barbs are cut into it, barbed suture is rated one suture size smaller than smooth suture. A 0 barbed suture, for example, equals a 2-0 smooth suture.

In the current version of the Quill suture, there is a segment of approximately 7 cm of smooth suture proximal to each needle. A second-generation Quill will be released this year, with barbs extending all the way to the needles. Bidirectional barbed suture materials currently include polydioxanone (PDO), poliglecaprone 25 (Monoderm), nylon, and polypropylene.

The V-Loc 180 is a unidirectional barbed polyglyconate (Maxon) suture with a loop at the distal end to facilitate initial fastening.

Case experience

We have performed more than 200 laparoscopic surgeries using Quill suture since March 2008; most involved total laparoscopic hysterectomy and laparoscopic myomectomy. We have also used Quill suture for laparoscopic sacrocolpopexy and uterosacral ligament suspension.

We have had outstanding clinical results: no cuff evisceration and only minor cases of vaginal bleeding or spotting in the immediate postoperative period.⁷ In one case, reoperation was necessary after laparoscopic myomectomy, but the repeat surgery was performed to treat small-bowel obstruction that was not directly related to the hysterotomy repair.

Technique

For vaginal-cuff closure, we use 0 PDO suture on a 36-mm half-circle taper-point needle. We initially used half of a 14×14-cm suture with a LapraTy clip on the distal end. We began the repair at the distal end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite, and continuing proximally until the other uterosacral ligament was incorporated into the repair.

More recently, we have been using the 7×7-cm 0 PDO because it is now available with the 36-mm half-circle taper-point needle. Regardless of suture material, it is important to obtain a full-thickness bite, with a 1-cm margin on the vaginal mucosa on each bite.

With the shorter suture, we begin closure in the middle of the cuff and take each needle to the opposite end of the cuff ( FIGURE 2 ). We incorporate the uterosacral ligament into the final bite on each side, and we cut the suture without a knot or a LapraTy clip.

FIGURE 2 Closing the vaginal cuff with bidirectional barbed suture For myomectomy closure, we use 14×14-cm 0 PDO suture on a 36-mm half-circle taper-point needle. If the hysterotomy is longer than 8 cm, we prefer to use 24×24-cm suture. We tack the first needle to the opposite anterior abdominal wall to avoid having the suture become entangled. We close the deepest layer using the first needle; we use the second needle to close the more superficial layer and the serosa, if possible ( FIGURE 3 ). If the suture is used beyond the barbed portion, we cut the needles and apply a LapraTy clip. Sometimes, three or four layers are needed to close a deep myometrial defect. 2/0 Monoderm can also be used for the serosa, continuously or as a baseball stitch.

FIGURE 3 Myomectomy closure with bidirectional barbed suture

The authors report no financial relationships relevant to this article.

Barbed suture is a relatively new technology that has the potential to greatly facilitate laparoscopic suturing. Two barbed sutures, each a different type, are available, or soon will be:

• the Quill bidirectional barbed suture (Angiotech Pharmaceuticals) was approved by the US Food and Drug Administration (FDA) in 2004 for soft-tissue approximation and has been sold in the United States since 2007 ( FIGURE 1A )¹
• the V-Loc 180 unidirectional barbed suture (Covidien) won FDA approval in March for soft-tissue approximation. It should be available in October ( FIGURE 1B ).

(Note: We have performed laparoscopic surgery using the Quill suture, but not the V-Loc 180, both as part of clinical research and in practice.)

In the bidirectional suture, barbs are cut into suture in a direction opposite to the needle; the barbs change direction at the midpoint of the suture, and needles are swaged onto both ends ( FIGURE 1A ).²

The anchoring of bidirectional barbed suture resists migration and can be conceptualized as a “continuous interrupted” suture without knots; it has been shown to have tissue-holding performance that is at least equal to knot-anchored suture.^3,4

A suture with bidirectional barbs offers several advantages:

• Because it self-anchors and is balanced by the countervailing barbs, no knots are required
• It self-anchors every 1 mm of tissue, yielding more consistent wound opposition; this may result in a more “watertight” seal
• Because it is knotless, it can securely reapproximate tissues in less time, at less cost, and with less aggravation.^5,6

Note: Whether these characteristics apply to unidirectional barbed suture remains to be determined.

FIGURE 1 Two types of barbed suture

Bidirectional suture, in which barbs are cut into suture and change direction at the midpoint.

Unidirectional suture has a loop at the distal end to facilitate initial suture fastening.

Specifications

Because the effective diameter of suture is decreased when barbs are cut into it, barbed suture is rated one suture size smaller than smooth suture. A 0 barbed suture, for example, equals a 2-0 smooth suture.

In the current version of the Quill suture, there is a segment of approximately 7 cm of smooth suture proximal to each needle. A second-generation Quill will be released this year, with barbs extending all the way to the needles. Bidirectional barbed suture materials currently include polydioxanone (PDO), poliglecaprone 25 (Monoderm), nylon, and polypropylene.

The V-Loc 180 is a unidirectional barbed polyglyconate (Maxon) suture with a loop at the distal end to facilitate initial fastening.

Case experience

We have performed more than 200 laparoscopic surgeries using Quill suture since March 2008; most involved total laparoscopic hysterectomy and laparoscopic myomectomy. We have also used Quill suture for laparoscopic sacrocolpopexy and uterosacral ligament suspension.

We have had outstanding clinical results: no cuff evisceration and only minor cases of vaginal bleeding or spotting in the immediate postoperative period.⁷ In one case, reoperation was necessary after laparoscopic myomectomy, but the repeat surgery was performed to treat small-bowel obstruction that was not directly related to the hysterotomy repair.

Technique

For vaginal-cuff closure, we use 0 PDO suture on a 36-mm half-circle taper-point needle. We initially used half of a 14×14-cm suture with a LapraTy clip on the distal end. We began the repair at the distal end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite, and continuing proximally until the other uterosacral ligament was incorporated into the repair.

More recently, we have been using the 7×7-cm 0 PDO because it is now available with the 36-mm half-circle taper-point needle. Regardless of suture material, it is important to obtain a full-thickness bite, with a 1-cm margin on the vaginal mucosa on each bite.

With the shorter suture, we begin closure in the middle of the cuff and take each needle to the opposite end of the cuff ( FIGURE 2 ). We incorporate the uterosacral ligament into the final bite on each side, and we cut the suture without a knot or a LapraTy clip.

FIGURE 2 Closing the vaginal cuff with bidirectional barbed suture For myomectomy closure, we use 14×14-cm 0 PDO suture on a 36-mm half-circle taper-point needle. If the hysterotomy is longer than 8 cm, we prefer to use 24×24-cm suture. We tack the first needle to the opposite anterior abdominal wall to avoid having the suture become entangled. We close the deepest layer using the first needle; we use the second needle to close the more superficial layer and the serosa, if possible ( FIGURE 3 ). If the suture is used beyond the barbed portion, we cut the needles and apply a LapraTy clip. Sometimes, three or four layers are needed to close a deep myometrial defect. 2/0 Monoderm can also be used for the serosa, continuously or as a baseball stitch.

FIGURE 3 Myomectomy closure with bidirectional barbed suture

The authors report no financial relationships relevant to this article.

This article is adapted from the December 2008 installment of The Journal of Family Practice’s “Guideline Update” series. The Journal of Family Practice is an NLM-indexed publication of Quadrant HealthCom Inc., publisher of OBG Management.

• What are the critical steps in the assessment of a patient who suffers chronic pain?
• What are the four biologic mechanisms of pain?
• When is referral to a pain specialist recommended?

Answers to these questions are summarized below, and in the 2008 edition of Assessment and Management of Chronic Pain, a practice guideline developed and first published in 2005 by the Institute for Clinical Systems Improvement (ICSI), which also funded the work. ICSI is a collaboration of 57 medical groups sponsored by six Minnesota health plans. A third edition of the guideline, released in August 2008, summarizes current evidence about the assessment and treatment of chronic pain in mature adolescents (16 to 18 years old) and adults.

A distinct challenge to clinicians

Chronic pain—a persistent, life-altering condition—is one of the most challenging disorders for primary care physicians to treat. Unlike the case with acute pain, for which we seek to cure the underlying biologic condition, the goal of chronic pain management is to improve function in the face of pain that may never completely resolve.

Achieving that goal, according to the new guideline, requires a patient-centered, multifaceted approach—often involving a health-care team that includes specialists in behavioral health and physical rehabilitation—that is coordinated by a primary care physician. An effective treatment plan must address biopsychosocial factors as well as spiritual and cultural issues. Patients must be taught self-management skills focused on fitness, stress reduction, and maintaining a healthy lifestyle.

Medications may be part of the treatment plan but should not be the sole focus, according to the guideline. Opioids are an option when other therapies fail.

The updated ICSI guideline also addresses the effects of various therapies, the role of psychosocial factors, and the identification of barriers to treatment. The comprehensive guideline, which has 172 references and nine appendices, also features two easy-to-use algorithms. One addresses the assessment of chronic pain ( FIGURE 1 ) and the other deals with chronic pain management ( FIGURE 2 ).

Both algorithms identify Level-I and Level-II strategies that can be readily adapted to primary care practice. They are extremely helpful to physicians who are evaluating and developing a care plan for a patient who has chronic pain.

FIGURE 1 Chronic pain assessment

HIV, human immunodeficiency virus; ICSI, Institute for Clinical Systems Improvement; MS, multiple sclerosis.
*Pain types and contributing factors are not mutually exclusive. Patients frequently have more than one type of pain, as well as overlapping contributing factors.
Source: Institute for Clinical Systems Improvement. Reprinted with permission.

4 objectives

This latest guideline was developed to:

• improve the treatment of adult chronic-pain patients by encouraging physicians to complete an appropriate biopsychosocial assessment (and reassessment)
• improve patients’ function by recommending development and use of a comprehensive treatment plan that includes a multispecialty team
• improve the use of Level-I and Level-II treatment approaches to chronic pain
• provide guidance on the most effective use of nonopioid and opioid medications in the treatment of chronic pain.

With these objectives in mind, the ICSI work group conducted a comprehensive literature review, giving priority to randomized controlled trials (RCTs), meta-analyses, and systematic reviews. The work group used a seven-tier grading system to rate the evidence and a three-category system for the worksheets in the guideline appendices.

For this article, we converted evidence ratings in the guideline into so-called strength-of-recommendation taxonomy, or SORT.¹

What aspects of practice have changed?

In addition to reflecting the latest research, the new guideline contains a number of clarifications. For example: The update states that medications are not the “sole” focus of treatment and should be used, when necessary, as part of an overall approach to pain management. (The previous version noted that medications were not the “primary” focus.)

The management algorithm ( FIGURE 2 ) now leads with “core principles”—a term suggesting greater importance than the former term, “general management,” implied. Clinical highlights, a synthesis of key recommendations, have been revised to better align with the guideline’s main components—assessment, functional goals, patient-centered/biopsychosocial care planning, Level-I versus Level-II approaches, and medication and patient selection.

Other changes in the guideline may contribute to clinicians’ understanding of chronic pain and its complex presentation. The guideline now includes a statement about allodynia and hyperalgesia to indicate that both may play an important role in any pain syndrome—not just in complex regional pain syndrome. Information about fibromyalgia symptoms and myofascial pain has been added. The definitions page now has an entry for “biopsychosocial model,” as well as language designed to stress the differences between untreated acute pain and ongoing chronic pain.

FIGURE 2 Chronic pain management
* DIRE, diagnosis, intractability, risk, efficacy.
Source: Institute for Clinical System Improvement. Reprinted with permission.

A limitation, an improvement

A limitation of the guideline is the lack of studies addressing the effectiveness of a comprehensive, multidisciplinary treatment approach to chronic pain management; most studies consider single-therapy management. An improvement, on the other hand, is that the evidence levels for each strategy are now listed within the section describing it—a notable change that makes it easier to identify the quality of individual recommendations.

As has been the case in the past, this latest edition of the guideline offers a number of tools for physicians. The assessment and management algorithms walk clinicians through decision-making. In addition, the following nine appendices provide practical guidance to physicians in various aspects of patient evaluation and care:

• Brief Pain Inventory (Short Form)
• Patient Health Questionnaire (PHQ-9)
• Functional Ability Questionnaire
• Personal Care Plan for Chronic Pain
• DIRE (diagnosis, intractability, risk, efficacy) Score: Patient Selection for Chronic Opioid Analgesia
• Opioid Agreement Form
• Opioid Analgesics
• Pharmaceutical Interventions for Neuropathic Pain
• Neuropathic Pain Treatment Diagram.

Source

As noted, the source document for this guideline is: Assessment and Management of Chronic Pain. 3rd ed. Bloomington (Minn): Institute for Clinical Systems Improvement (ICSI); 2008 July.

The complete guideline is available at: pain__chronic__assessment_and_management_of__guideline_.html " target="_blank"> http://www.icsi.org/pain__chronic__assessment_and_management_of_14399/
pain__chronic__assessment_and_management_of__guideline_.html . (Accessed August 18, 2009.)

The authors report no financial relationships relevant to this article.

This article is adapted from the December 2008 installment of The Journal of Family Practice’s “Guideline Update” series. The Journal of Family Practice is an NLM-indexed publication of Quadrant HealthCom Inc., publisher of OBG Management.

• What are the critical steps in the assessment of a patient who suffers chronic pain?
• What are the four biologic mechanisms of pain?
• When is referral to a pain specialist recommended?

Answers to these questions are summarized below, and in the 2008 edition of Assessment and Management of Chronic Pain, a practice guideline developed and first published in 2005 by the Institute for Clinical Systems Improvement (ICSI), which also funded the work. ICSI is a collaboration of 57 medical groups sponsored by six Minnesota health plans. A third edition of the guideline, released in August 2008, summarizes current evidence about the assessment and treatment of chronic pain in mature adolescents (16 to 18 years old) and adults.

A distinct challenge to clinicians

Chronic pain—a persistent, life-altering condition—is one of the most challenging disorders for primary care physicians to treat. Unlike the case with acute pain, for which we seek to cure the underlying biologic condition, the goal of chronic pain management is to improve function in the face of pain that may never completely resolve.

Achieving that goal, according to the new guideline, requires a patient-centered, multifaceted approach—often involving a health-care team that includes specialists in behavioral health and physical rehabilitation—that is coordinated by a primary care physician. An effective treatment plan must address biopsychosocial factors as well as spiritual and cultural issues. Patients must be taught self-management skills focused on fitness, stress reduction, and maintaining a healthy lifestyle.

Medications may be part of the treatment plan but should not be the sole focus, according to the guideline. Opioids are an option when other therapies fail.

The updated ICSI guideline also addresses the effects of various therapies, the role of psychosocial factors, and the identification of barriers to treatment. The comprehensive guideline, which has 172 references and nine appendices, also features two easy-to-use algorithms. One addresses the assessment of chronic pain ( FIGURE 1 ) and the other deals with chronic pain management ( FIGURE 2 ).

Both algorithms identify Level-I and Level-II strategies that can be readily adapted to primary care practice. They are extremely helpful to physicians who are evaluating and developing a care plan for a patient who has chronic pain.

FIGURE 1 Chronic pain assessment

HIV, human immunodeficiency virus; ICSI, Institute for Clinical Systems Improvement; MS, multiple sclerosis.
*Pain types and contributing factors are not mutually exclusive. Patients frequently have more than one type of pain, as well as overlapping contributing factors.
Source: Institute for Clinical Systems Improvement. Reprinted with permission.

4 objectives

This latest guideline was developed to:

• improve the treatment of adult chronic-pain patients by encouraging physicians to complete an appropriate biopsychosocial assessment (and reassessment)
• improve patients’ function by recommending development and use of a comprehensive treatment plan that includes a multispecialty team
• improve the use of Level-I and Level-II treatment approaches to chronic pain
• provide guidance on the most effective use of nonopioid and opioid medications in the treatment of chronic pain.

With these objectives in mind, the ICSI work group conducted a comprehensive literature review, giving priority to randomized controlled trials (RCTs), meta-analyses, and systematic reviews. The work group used a seven-tier grading system to rate the evidence and a three-category system for the worksheets in the guideline appendices.

For this article, we converted evidence ratings in the guideline into so-called strength-of-recommendation taxonomy, or SORT.¹

What aspects of practice have changed?

In addition to reflecting the latest research, the new guideline contains a number of clarifications. For example: The update states that medications are not the “sole” focus of treatment and should be used, when necessary, as part of an overall approach to pain management. (The previous version noted that medications were not the “primary” focus.)

The management algorithm ( FIGURE 2 ) now leads with “core principles”—a term suggesting greater importance than the former term, “general management,” implied. Clinical highlights, a synthesis of key recommendations, have been revised to better align with the guideline’s main components—assessment, functional goals, patient-centered/biopsychosocial care planning, Level-I versus Level-II approaches, and medication and patient selection.

Other changes in the guideline may contribute to clinicians’ understanding of chronic pain and its complex presentation. The guideline now includes a statement about allodynia and hyperalgesia to indicate that both may play an important role in any pain syndrome—not just in complex regional pain syndrome. Information about fibromyalgia symptoms and myofascial pain has been added. The definitions page now has an entry for “biopsychosocial model,” as well as language designed to stress the differences between untreated acute pain and ongoing chronic pain.

FIGURE 2 Chronic pain management
* DIRE, diagnosis, intractability, risk, efficacy.
Source: Institute for Clinical System Improvement. Reprinted with permission.

A limitation, an improvement

A limitation of the guideline is the lack of studies addressing the effectiveness of a comprehensive, multidisciplinary treatment approach to chronic pain management; most studies consider single-therapy management. An improvement, on the other hand, is that the evidence levels for each strategy are now listed within the section describing it—a notable change that makes it easier to identify the quality of individual recommendations.

As has been the case in the past, this latest edition of the guideline offers a number of tools for physicians. The assessment and management algorithms walk clinicians through decision-making. In addition, the following nine appendices provide practical guidance to physicians in various aspects of patient evaluation and care:

• Brief Pain Inventory (Short Form)
• Patient Health Questionnaire (PHQ-9)
• Functional Ability Questionnaire
• Personal Care Plan for Chronic Pain
• DIRE (diagnosis, intractability, risk, efficacy) Score: Patient Selection for Chronic Opioid Analgesia
• Opioid Agreement Form
• Opioid Analgesics
• Pharmaceutical Interventions for Neuropathic Pain
• Neuropathic Pain Treatment Diagram.

Source

As noted, the source document for this guideline is: Assessment and Management of Chronic Pain. 3rd ed. Bloomington (Minn): Institute for Clinical Systems Improvement (ICSI); 2008 July.

The complete guideline is available at: pain__chronic__assessment_and_management_of__guideline_.html " target="_blank"> http://www.icsi.org/pain__chronic__assessment_and_management_of_14399/
pain__chronic__assessment_and_management_of__guideline_.html . (Accessed August 18, 2009.)

The authors report no financial relationships relevant to this article.

This article is adapted from the December 2008 installment of The Journal of Family Practice’s “Guideline Update” series. The Journal of Family Practice is an NLM-indexed publication of Quadrant HealthCom Inc., publisher of OBG Management.

• What are the critical steps in the assessment of a patient who suffers chronic pain?
• What are the four biologic mechanisms of pain?
• When is referral to a pain specialist recommended?

Answers to these questions are summarized below, and in the 2008 edition of Assessment and Management of Chronic Pain, a practice guideline developed and first published in 2005 by the Institute for Clinical Systems Improvement (ICSI), which also funded the work. ICSI is a collaboration of 57 medical groups sponsored by six Minnesota health plans. A third edition of the guideline, released in August 2008, summarizes current evidence about the assessment and treatment of chronic pain in mature adolescents (16 to 18 years old) and adults.

A distinct challenge to clinicians

Chronic pain—a persistent, life-altering condition—is one of the most challenging disorders for primary care physicians to treat. Unlike the case with acute pain, for which we seek to cure the underlying biologic condition, the goal of chronic pain management is to improve function in the face of pain that may never completely resolve.

Achieving that goal, according to the new guideline, requires a patient-centered, multifaceted approach—often involving a health-care team that includes specialists in behavioral health and physical rehabilitation—that is coordinated by a primary care physician. An effective treatment plan must address biopsychosocial factors as well as spiritual and cultural issues. Patients must be taught self-management skills focused on fitness, stress reduction, and maintaining a healthy lifestyle.

Medications may be part of the treatment plan but should not be the sole focus, according to the guideline. Opioids are an option when other therapies fail.

The updated ICSI guideline also addresses the effects of various therapies, the role of psychosocial factors, and the identification of barriers to treatment. The comprehensive guideline, which has 172 references and nine appendices, also features two easy-to-use algorithms. One addresses the assessment of chronic pain ( FIGURE 1 ) and the other deals with chronic pain management ( FIGURE 2 ).

Both algorithms identify Level-I and Level-II strategies that can be readily adapted to primary care practice. They are extremely helpful to physicians who are evaluating and developing a care plan for a patient who has chronic pain.

FIGURE 1 Chronic pain assessment

HIV, human immunodeficiency virus; ICSI, Institute for Clinical Systems Improvement; MS, multiple sclerosis.
*Pain types and contributing factors are not mutually exclusive. Patients frequently have more than one type of pain, as well as overlapping contributing factors.
Source: Institute for Clinical Systems Improvement. Reprinted with permission.

4 objectives

This latest guideline was developed to:

• improve the treatment of adult chronic-pain patients by encouraging physicians to complete an appropriate biopsychosocial assessment (and reassessment)
• improve patients’ function by recommending development and use of a comprehensive treatment plan that includes a multispecialty team
• improve the use of Level-I and Level-II treatment approaches to chronic pain
• provide guidance on the most effective use of nonopioid and opioid medications in the treatment of chronic pain.

With these objectives in mind, the ICSI work group conducted a comprehensive literature review, giving priority to randomized controlled trials (RCTs), meta-analyses, and systematic reviews. The work group used a seven-tier grading system to rate the evidence and a three-category system for the worksheets in the guideline appendices.

For this article, we converted evidence ratings in the guideline into so-called strength-of-recommendation taxonomy, or SORT.¹

What aspects of practice have changed?

In addition to reflecting the latest research, the new guideline contains a number of clarifications. For example: The update states that medications are not the “sole” focus of treatment and should be used, when necessary, as part of an overall approach to pain management. (The previous version noted that medications were not the “primary” focus.)

The management algorithm ( FIGURE 2 ) now leads with “core principles”—a term suggesting greater importance than the former term, “general management,” implied. Clinical highlights, a synthesis of key recommendations, have been revised to better align with the guideline’s main components—assessment, functional goals, patient-centered/biopsychosocial care planning, Level-I versus Level-II approaches, and medication and patient selection.

Other changes in the guideline may contribute to clinicians’ understanding of chronic pain and its complex presentation. The guideline now includes a statement about allodynia and hyperalgesia to indicate that both may play an important role in any pain syndrome—not just in complex regional pain syndrome. Information about fibromyalgia symptoms and myofascial pain has been added. The definitions page now has an entry for “biopsychosocial model,” as well as language designed to stress the differences between untreated acute pain and ongoing chronic pain.

FIGURE 2 Chronic pain management
* DIRE, diagnosis, intractability, risk, efficacy.
Source: Institute for Clinical System Improvement. Reprinted with permission.

A limitation, an improvement

A limitation of the guideline is the lack of studies addressing the effectiveness of a comprehensive, multidisciplinary treatment approach to chronic pain management; most studies consider single-therapy management. An improvement, on the other hand, is that the evidence levels for each strategy are now listed within the section describing it—a notable change that makes it easier to identify the quality of individual recommendations.

As has been the case in the past, this latest edition of the guideline offers a number of tools for physicians. The assessment and management algorithms walk clinicians through decision-making. In addition, the following nine appendices provide practical guidance to physicians in various aspects of patient evaluation and care:

• Brief Pain Inventory (Short Form)
• Patient Health Questionnaire (PHQ-9)
• Functional Ability Questionnaire
• Personal Care Plan for Chronic Pain
• DIRE (diagnosis, intractability, risk, efficacy) Score: Patient Selection for Chronic Opioid Analgesia
• Opioid Agreement Form
• Opioid Analgesics
• Pharmaceutical Interventions for Neuropathic Pain
• Neuropathic Pain Treatment Diagram.

Source

As noted, the source document for this guideline is: Assessment and Management of Chronic Pain. 3rd ed. Bloomington (Minn): Institute for Clinical Systems Improvement (ICSI); 2008 July.

The complete guideline is available at: pain__chronic__assessment_and_management_of__guideline_.html " target="_blank"> http://www.icsi.org/pain__chronic__assessment_and_management_of_14399/
pain__chronic__assessment_and_management_of__guideline_.html . (Accessed August 18, 2009.)

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the AAN.

The guidelines also suggest that, if possible, women who have epilepsy avoid taking more than one epilepsy drug during pregnancy because the use of multiple antiseizure medications increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy. When a fetus is exposed to one of these drugs, cognitive development may be impaired.

Safe pregnancy is likely—if no seizures occur

Aside from the risks known to be associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have well-controlled epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

However, a just-published study suggests that the presence of seizures during pregnancy confers some degree of risk, according to data from Yi-Hua Chen, PhD, and colleagues, of Taipei Medical University and General Cathay Hospital in Taiwan.⁴

Chen and associates performed a retrospective cross-sectional study that linked two nationwide population-based data sets from Taiwan. The study focused on 1,016 women who had epilepsy and who delivered singleton infants from 2001 to 2003; these women had been diagnosed with epilepsy within 2 years prior to their index delivery. Women who had epilepsy were further stratified into two groups: those who did and those who did not have seizures during pregnancy. They were compared with 8,128 women who had no chronic disease.

Women who experienced seizures during pregnancy were more likely to give birth to preterm, small, or low-birth-weight babies than were women who did not have epilepsy. In addition, women who experienced seizures during pregnancy were more likely to give birth to a small-for-gestational-age infant than were women who had epilepsy but who did not have seizures.

Some previous studies had reported a link between adverse pregnancy outcomes and a mother’s epilepsy, but others found no association, Chen and colleagues observed.

“Our study further illuminates these conflicting data to suggest that it is the seizures themselves that seem to contribute greatly to the increased risk of infants being delivered preterm, of low birthweight, and small for gestational age. For women who remained seizure-free throughout pregnancy, null or mild risk was identified, compared with unaffected women,” they wrote.

As a safeguard, measure blood levels
of antiseizure drugs

The guidelines from the AAN and AES recommend that pregnant women who have epilepsy consider having their blood tested regularly.

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free,” said Harden.

Antiepileptic drugs should be administered at the lowest dosage and lowest plasma level that protects against tonic-clonic seizures and other complex partial seizures.⁵

Do not withdraw antiepileptic drugs during pregnancy

Some physicians attempt to discontinue an antiepileptic drug when a woman has gone 2 years without experiencing a seizure.⁵ In this scenario, the likelihood that seizures will recur within 6 and 12 months is 12% and 32%, respectively.⁶ Because of the risk that seizures will recur, and the increased likelihood of adverse outcomes associated with seizures during pregnancy, antiepileptic medication should not be discontinued during gestation.

Nor should a woman attempt to transition from one antiepileptic drug to another during pregnancy solely for the purpose of reducing teratogenicity.⁵ Doing so could precipitate seizures and exposes the fetus to the potentially hazardous effects of an additional antiseizure medication during a critical period. Moreover, there may be no advantage associated with switching drugs once a pregnancy has been established.⁷

Screen for malformations rigorously

Comprehensive screening for fetal anomalies early in the pregnancy is recommended for two main reasons:

• If a malformation is identified, the mother has the option of terminating the pregnancy
  
• Even if the patient decides not to terminate a gestation in which fetal anomaly has been identified, the information may help the practitioner determine the best mode and place of delivery.
  

Cesarean delivery may be warranted if the mother
has had recent seizures

Although most women who have epilepsy can expect to have a normal vaginal delivery, elective cesarean should be considered if the mother has experienced frequent seizures during the third trimester, or if she has a history of stress-related status epilepticus.⁵

Tonic-clonic seizures occur during labor in 1% to 2% of women who have epilepsy, and in an additional 1% to 2% of women in the 24 hours immediately following delivery.

Plasma levels of antiepileptic medication should be monitored during the third trimester and delivery to ensure that the medication is given in adequate strength to prevent seizures. In addition, the patient should be counseled about the importance of taking her medication consistently during this period.⁵

If the patient experiences a seizure during labor and delivery, treat her promptly with an intravenous benzodiazepine, preferably lorazepam.⁸ However, be aware that phenobarbital, primidone, and benzodiazepines remain in neonatal plasma for several days after delivery and may cause sedation or neonatal withdrawal syndrome.⁹

Do not give magnesium sulfate for epileptic seizures unless the seizures first appear during the third trimester or immediate postpartum period and could be associated with eclampsia. In such cases, treat the eclampsia and evaluate the patient for other potential causes of the seizures.⁵

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the AAN.

The guidelines also suggest that, if possible, women who have epilepsy avoid taking more than one epilepsy drug during pregnancy because the use of multiple antiseizure medications increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy. When a fetus is exposed to one of these drugs, cognitive development may be impaired.

Safe pregnancy is likely—if no seizures occur

Aside from the risks known to be associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have well-controlled epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

However, a just-published study suggests that the presence of seizures during pregnancy confers some degree of risk, according to data from Yi-Hua Chen, PhD, and colleagues, of Taipei Medical University and General Cathay Hospital in Taiwan.⁴

Chen and associates performed a retrospective cross-sectional study that linked two nationwide population-based data sets from Taiwan. The study focused on 1,016 women who had epilepsy and who delivered singleton infants from 2001 to 2003; these women had been diagnosed with epilepsy within 2 years prior to their index delivery. Women who had epilepsy were further stratified into two groups: those who did and those who did not have seizures during pregnancy. They were compared with 8,128 women who had no chronic disease.

Women who experienced seizures during pregnancy were more likely to give birth to preterm, small, or low-birth-weight babies than were women who did not have epilepsy. In addition, women who experienced seizures during pregnancy were more likely to give birth to a small-for-gestational-age infant than were women who had epilepsy but who did not have seizures.

Some previous studies had reported a link between adverse pregnancy outcomes and a mother’s epilepsy, but others found no association, Chen and colleagues observed.

“Our study further illuminates these conflicting data to suggest that it is the seizures themselves that seem to contribute greatly to the increased risk of infants being delivered preterm, of low birthweight, and small for gestational age. For women who remained seizure-free throughout pregnancy, null or mild risk was identified, compared with unaffected women,” they wrote.

As a safeguard, measure blood levels
of antiseizure drugs

The guidelines from the AAN and AES recommend that pregnant women who have epilepsy consider having their blood tested regularly.

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free,” said Harden.

Antiepileptic drugs should be administered at the lowest dosage and lowest plasma level that protects against tonic-clonic seizures and other complex partial seizures.⁵

Do not withdraw antiepileptic drugs during pregnancy

Some physicians attempt to discontinue an antiepileptic drug when a woman has gone 2 years without experiencing a seizure.⁵ In this scenario, the likelihood that seizures will recur within 6 and 12 months is 12% and 32%, respectively.⁶ Because of the risk that seizures will recur, and the increased likelihood of adverse outcomes associated with seizures during pregnancy, antiepileptic medication should not be discontinued during gestation.

Nor should a woman attempt to transition from one antiepileptic drug to another during pregnancy solely for the purpose of reducing teratogenicity.⁵ Doing so could precipitate seizures and exposes the fetus to the potentially hazardous effects of an additional antiseizure medication during a critical period. Moreover, there may be no advantage associated with switching drugs once a pregnancy has been established.⁷

Screen for malformations rigorously

Comprehensive screening for fetal anomalies early in the pregnancy is recommended for two main reasons:

• If a malformation is identified, the mother has the option of terminating the pregnancy
  
• Even if the patient decides not to terminate a gestation in which fetal anomaly has been identified, the information may help the practitioner determine the best mode and place of delivery.
  

Cesarean delivery may be warranted if the mother
has had recent seizures

Although most women who have epilepsy can expect to have a normal vaginal delivery, elective cesarean should be considered if the mother has experienced frequent seizures during the third trimester, or if she has a history of stress-related status epilepticus.⁵

Tonic-clonic seizures occur during labor in 1% to 2% of women who have epilepsy, and in an additional 1% to 2% of women in the 24 hours immediately following delivery.

Plasma levels of antiepileptic medication should be monitored during the third trimester and delivery to ensure that the medication is given in adequate strength to prevent seizures. In addition, the patient should be counseled about the importance of taking her medication consistently during this period.⁵

If the patient experiences a seizure during labor and delivery, treat her promptly with an intravenous benzodiazepine, preferably lorazepam.⁸ However, be aware that phenobarbital, primidone, and benzodiazepines remain in neonatal plasma for several days after delivery and may cause sedation or neonatal withdrawal syndrome.⁹

Do not give magnesium sulfate for epileptic seizures unless the seizures first appear during the third trimester or immediate postpartum period and could be associated with eclampsia. In such cases, treat the eclampsia and evaluate the patient for other potential causes of the seizures.⁵

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the AAN.

The guidelines also suggest that, if possible, women who have epilepsy avoid taking more than one epilepsy drug during pregnancy because the use of multiple antiseizure medications increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy. When a fetus is exposed to one of these drugs, cognitive development may be impaired.

Safe pregnancy is likely—if no seizures occur

Aside from the risks known to be associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have well-controlled epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

However, a just-published study suggests that the presence of seizures during pregnancy confers some degree of risk, according to data from Yi-Hua Chen, PhD, and colleagues, of Taipei Medical University and General Cathay Hospital in Taiwan.⁴

Chen and associates performed a retrospective cross-sectional study that linked two nationwide population-based data sets from Taiwan. The study focused on 1,016 women who had epilepsy and who delivered singleton infants from 2001 to 2003; these women had been diagnosed with epilepsy within 2 years prior to their index delivery. Women who had epilepsy were further stratified into two groups: those who did and those who did not have seizures during pregnancy. They were compared with 8,128 women who had no chronic disease.

Women who experienced seizures during pregnancy were more likely to give birth to preterm, small, or low-birth-weight babies than were women who did not have epilepsy. In addition, women who experienced seizures during pregnancy were more likely to give birth to a small-for-gestational-age infant than were women who had epilepsy but who did not have seizures.

Some previous studies had reported a link between adverse pregnancy outcomes and a mother’s epilepsy, but others found no association, Chen and colleagues observed.

“Our study further illuminates these conflicting data to suggest that it is the seizures themselves that seem to contribute greatly to the increased risk of infants being delivered preterm, of low birthweight, and small for gestational age. For women who remained seizure-free throughout pregnancy, null or mild risk was identified, compared with unaffected women,” they wrote.

As a safeguard, measure blood levels
of antiseizure drugs

The guidelines from the AAN and AES recommend that pregnant women who have epilepsy consider having their blood tested regularly.

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free,” said Harden.

Antiepileptic drugs should be administered at the lowest dosage and lowest plasma level that protects against tonic-clonic seizures and other complex partial seizures.⁵

Do not withdraw antiepileptic drugs during pregnancy

Some physicians attempt to discontinue an antiepileptic drug when a woman has gone 2 years without experiencing a seizure.⁵ In this scenario, the likelihood that seizures will recur within 6 and 12 months is 12% and 32%, respectively.⁶ Because of the risk that seizures will recur, and the increased likelihood of adverse outcomes associated with seizures during pregnancy, antiepileptic medication should not be discontinued during gestation.

Nor should a woman attempt to transition from one antiepileptic drug to another during pregnancy solely for the purpose of reducing teratogenicity.⁵ Doing so could precipitate seizures and exposes the fetus to the potentially hazardous effects of an additional antiseizure medication during a critical period. Moreover, there may be no advantage associated with switching drugs once a pregnancy has been established.⁷

Screen for malformations rigorously

Comprehensive screening for fetal anomalies early in the pregnancy is recommended for two main reasons:

• If a malformation is identified, the mother has the option of terminating the pregnancy
  
• Even if the patient decides not to terminate a gestation in which fetal anomaly has been identified, the information may help the practitioner determine the best mode and place of delivery.
  

Cesarean delivery may be warranted if the mother
has had recent seizures

Although most women who have epilepsy can expect to have a normal vaginal delivery, elective cesarean should be considered if the mother has experienced frequent seizures during the third trimester, or if she has a history of stress-related status epilepticus.⁵

Tonic-clonic seizures occur during labor in 1% to 2% of women who have epilepsy, and in an additional 1% to 2% of women in the 24 hours immediately following delivery.

Plasma levels of antiepileptic medication should be monitored during the third trimester and delivery to ensure that the medication is given in adequate strength to prevent seizures. In addition, the patient should be counseled about the importance of taking her medication consistently during this period.⁵

If the patient experiences a seizure during labor and delivery, treat her promptly with an intravenous benzodiazepine, preferably lorazepam.⁸ However, be aware that phenobarbital, primidone, and benzodiazepines remain in neonatal plasma for several days after delivery and may cause sedation or neonatal withdrawal syndrome.⁹

Do not give magnesium sulfate for epileptic seizures unless the seizures first appear during the third trimester or immediate postpartum period and could be associated with eclampsia. In such cases, treat the eclampsia and evaluate the patient for other potential causes of the seizures.⁵

When Harry Reich performed the first laparoscopically assisted vaginal hysterectomy in 1989, he advocated the use of sutures for control of the uterine vessels. Monopolar, bipolar, and laser instruments available at that time were inherently risky to use along the pelvic sidewall because of their potential for 1) considerable thermal energy spread beyond the area of treatment (bipolar, NG:YAG laser, monopolar) and 2) unreliable hemostasis (CO₂ laser).

Minimally invasive surgical practice has driven meaningful advances in instrumentation and technique over the past 20 years. The constraints inherent in laparoscopic surgery, although somewhat mitigated by robotics, have generated a proliferation of technologies to obtain reliable hemostasis. Every device now on the market claims to “seal” vessels. In this article, I review the mechanism of action of these instruments and compare their strengths and weaknesses, based on high-quality scientific evidence.

Two studies highlight vessel ligation

Newcomb WL, Hope WW, Schmeizer TM, et al. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009;23:90–96.

Lamberton GR, Hsi RS, Jin DH, et al. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol. 2008;22:2307–2312.

Many energy-delivery systems are available for the gynecologic surgeon; any of them can be used effectively and safely under most circumstances. Before we can make an informed choice about which system is best for our own practice, however, we need to be aware of the strengths and limitations of the systems overall ( TABLE ).

These two studies focus on the following devices:

• Gyrus PK Tissue Management System, PKS Cutting Forceps, and Plasma Trissector (all from Gyrus Medical). These are bipolar electrosurgical devices designed to deliver high current and very low voltage to tissue. Tissue impedance is continuously monitored between the jaws of the instrument, and energy delivery is adjusted accordingly. These systems deliver electrosurgical energy through a series of rapid pulses, thereby allowing the tissue to cool briefly and limiting the heating of adjacent tissue. Protein in the vessel walls is denatured and forms a coagulum, which occludes the lumen.
• Harmonic Scalpel (Ethicon EndoSurgery). This device uses a high-frequency ultrasonic transducer (55,000 cycles/second) to create mechanical vibration of one of the two jaws. The device can be used to vaporize tissue (cut) or achieve hemostasis by coagulation. As with the other devices, protein is denatured and vessels are occluded by formation of a coagulum.
• Ligamax 5 Endoscopic Multiple Clip Applier (Ethicon). This device is a sterile, single-patient-use, 5-mm, endoscopic, multiple-clip applicator that delivers 15 medium or large titanium clips that close to 8.8 mm, the same clip size as the 10-mm applicator. Ligamax 5 has long, thin angled jaws (8.4 mm) that extend beyond vessels and ducts to improve visibility. It includes a long, 33-cm shaft for additional reach, and an anti-clip drop-ratchet mechanism for control over clip closure.
• EnSeal Tissue Sealing and Hemostasis System and EnSeal PTC (SurgRx). EnSeal utilizes nanotechnology to control the energy at the electrode–tissue interface. The jaws contain a temperature-sensitive matrix with embedded conductive carbon spherules designed to “sense” tissue characteristics. It uses extremely high jaw compression to create uniform tissue effects. It does not require a dedicated electrosurgical unit for use; an adapter can be purchased that permits use with most generators.
• LigaSure V (Valleylab). LigaSure is a bipolar electrosurgical device designed to deliver high current and very low voltage to tissue. It monitors tissue impedance between the jaws of the instrument and continuously adjusts the delivery of energy.

TABLE

Rating vessel-sealing devices: 5 measures of success

FIGURE How energy-based vessel-sealing works

(A) When the carotid artery of an animal model was sealed using a standard bipolar forceps, the lumen remained open and a proximal thrombus developed. (B) When LigaSure was used, the artery was fused and the lumen obliterated with one 5-second application. (C and D) When a renal artery was sealed with LigaSure, the lumen of the vessel walls fused completely.

What the studies found

Newcomb and associates compared blood-vessel-sealing ability of the following devices:

• Gyrus 5-mm PKS Cutting Forceps
• Gyrus Plasma Trissector
• Harmonic Scalpel
• EnSeal Tissue Sealing and Hemostasis System
• LigaSure V, using the LigaSure Generator (Valleylab)
• LigaSure V, using the Force Triad Generator (Valleylab)
• Ligamax 5 Endoscopic Multiple Clip Applier.

The authors assessed mean seal times and burst pressures. Used on medium and large vessels, the Harmonic Scalpel and Gyrus products had significant failure rates: 8% to 22% for the Harmonic Scalpel and 41% to 92% for the pulsed, bipolar Gyrus systems.

The shortest sealing times for medium to large vessels were achieved with the LigaSure V using the Force Triad Generator. The Gyrus systems were the fastest devices when vessels were 2 to 3 mm in diameter.

There were no seal failures with the Ligamax, EnSeal, or LigaSure products.

Second study involved repeated applications

Lamberton and colleagues tested 5-mm laparoscopic devices under controlled temperature and humidity using a laparoscopic simulator, focusing on the following systems:

• LigaSure V
• Gyrus PK
• Harmonic Scalpel
• EnSeal Tissue Sealing and Hemostasis System.

The authors used 5-mm bovine arteries to assess sealing time, burst pressure, lateral thermal spread, and smoke production, as well as both subjective and objective effects on visibility.

Each device was used 10 times to determine burst pressure, lateral thermal spread, visibility, and smoke production. The devices were applied 20 times to measure time to seal, based on the devices’ preprogrammed endpoints.

The Harmonic Scalpel produced the lowest thermal spread and least smoke, but also had the lowest mean burst pressure.

The Gyrus PK generated the most smoke and had variable burst pressure. Although it had the fastest sealing times, in three of 10 trials there was a completely open arterial lumen following transection. In addition, 50% of applications involved burst pressures below 50 mm Hg.

Maximum temperatures 2 mm from the device were 49.9°C for the Harmonic Scalpel, 55.5°C for LigaSure, 58.9°C for EnSeal, and 64.5°C for Gyrus PK.

LigaSure was the highest-rated device overall, with the highest burst pressure and fastest sealing time.

EnSeal was the slowest and had variable burst pressures.

Clinical implications of the trials

These studies—neither of which was industry-sponsored—suggest that larger vessels cannot be controlled consistently and effectively using the Harmonic Scalpel or Gyrus systems. The Harmonic Scalpel is most user-dependent.

So what’s the bottom line? In the end, according to Andrew Brill, MD, past president of AAGL, “it’s not the wand, it’s the magician.”

When Harry Reich performed the first laparoscopically assisted vaginal hysterectomy in 1989, he advocated the use of sutures for control of the uterine vessels. Monopolar, bipolar, and laser instruments available at that time were inherently risky to use along the pelvic sidewall because of their potential for 1) considerable thermal energy spread beyond the area of treatment (bipolar, NG:YAG laser, monopolar) and 2) unreliable hemostasis (CO₂ laser).

Minimally invasive surgical practice has driven meaningful advances in instrumentation and technique over the past 20 years. The constraints inherent in laparoscopic surgery, although somewhat mitigated by robotics, have generated a proliferation of technologies to obtain reliable hemostasis. Every device now on the market claims to “seal” vessels. In this article, I review the mechanism of action of these instruments and compare their strengths and weaknesses, based on high-quality scientific evidence.

Two studies highlight vessel ligation

Newcomb WL, Hope WW, Schmeizer TM, et al. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009;23:90–96.

Lamberton GR, Hsi RS, Jin DH, et al. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol. 2008;22:2307–2312.

Many energy-delivery systems are available for the gynecologic surgeon; any of them can be used effectively and safely under most circumstances. Before we can make an informed choice about which system is best for our own practice, however, we need to be aware of the strengths and limitations of the systems overall ( TABLE ).

These two studies focus on the following devices:

• Gyrus PK Tissue Management System, PKS Cutting Forceps, and Plasma Trissector (all from Gyrus Medical). These are bipolar electrosurgical devices designed to deliver high current and very low voltage to tissue. Tissue impedance is continuously monitored between the jaws of the instrument, and energy delivery is adjusted accordingly. These systems deliver electrosurgical energy through a series of rapid pulses, thereby allowing the tissue to cool briefly and limiting the heating of adjacent tissue. Protein in the vessel walls is denatured and forms a coagulum, which occludes the lumen.
• Harmonic Scalpel (Ethicon EndoSurgery). This device uses a high-frequency ultrasonic transducer (55,000 cycles/second) to create mechanical vibration of one of the two jaws. The device can be used to vaporize tissue (cut) or achieve hemostasis by coagulation. As with the other devices, protein is denatured and vessels are occluded by formation of a coagulum.
• Ligamax 5 Endoscopic Multiple Clip Applier (Ethicon). This device is a sterile, single-patient-use, 5-mm, endoscopic, multiple-clip applicator that delivers 15 medium or large titanium clips that close to 8.8 mm, the same clip size as the 10-mm applicator. Ligamax 5 has long, thin angled jaws (8.4 mm) that extend beyond vessels and ducts to improve visibility. It includes a long, 33-cm shaft for additional reach, and an anti-clip drop-ratchet mechanism for control over clip closure.
• EnSeal Tissue Sealing and Hemostasis System and EnSeal PTC (SurgRx). EnSeal utilizes nanotechnology to control the energy at the electrode–tissue interface. The jaws contain a temperature-sensitive matrix with embedded conductive carbon spherules designed to “sense” tissue characteristics. It uses extremely high jaw compression to create uniform tissue effects. It does not require a dedicated electrosurgical unit for use; an adapter can be purchased that permits use with most generators.
• LigaSure V (Valleylab). LigaSure is a bipolar electrosurgical device designed to deliver high current and very low voltage to tissue. It monitors tissue impedance between the jaws of the instrument and continuously adjusts the delivery of energy.

TABLE

Rating vessel-sealing devices: 5 measures of success

FIGURE How energy-based vessel-sealing works

(A) When the carotid artery of an animal model was sealed using a standard bipolar forceps, the lumen remained open and a proximal thrombus developed. (B) When LigaSure was used, the artery was fused and the lumen obliterated with one 5-second application. (C and D) When a renal artery was sealed with LigaSure, the lumen of the vessel walls fused completely.

What the studies found

Newcomb and associates compared blood-vessel-sealing ability of the following devices:

• Gyrus 5-mm PKS Cutting Forceps
• Gyrus Plasma Trissector
• Harmonic Scalpel
• EnSeal Tissue Sealing and Hemostasis System
• LigaSure V, using the LigaSure Generator (Valleylab)
• LigaSure V, using the Force Triad Generator (Valleylab)
• Ligamax 5 Endoscopic Multiple Clip Applier.

The authors assessed mean seal times and burst pressures. Used on medium and large vessels, the Harmonic Scalpel and Gyrus products had significant failure rates: 8% to 22% for the Harmonic Scalpel and 41% to 92% for the pulsed, bipolar Gyrus systems.

The shortest sealing times for medium to large vessels were achieved with the LigaSure V using the Force Triad Generator. The Gyrus systems were the fastest devices when vessels were 2 to 3 mm in diameter.

There were no seal failures with the Ligamax, EnSeal, or LigaSure products.

Second study involved repeated applications

Lamberton and colleagues tested 5-mm laparoscopic devices under controlled temperature and humidity using a laparoscopic simulator, focusing on the following systems:

• LigaSure V
• Gyrus PK
• Harmonic Scalpel
• EnSeal Tissue Sealing and Hemostasis System.

The authors used 5-mm bovine arteries to assess sealing time, burst pressure, lateral thermal spread, and smoke production, as well as both subjective and objective effects on visibility.

Each device was used 10 times to determine burst pressure, lateral thermal spread, visibility, and smoke production. The devices were applied 20 times to measure time to seal, based on the devices’ preprogrammed endpoints.

The Harmonic Scalpel produced the lowest thermal spread and least smoke, but also had the lowest mean burst pressure.

The Gyrus PK generated the most smoke and had variable burst pressure. Although it had the fastest sealing times, in three of 10 trials there was a completely open arterial lumen following transection. In addition, 50% of applications involved burst pressures below 50 mm Hg.

Maximum temperatures 2 mm from the device were 49.9°C for the Harmonic Scalpel, 55.5°C for LigaSure, 58.9°C for EnSeal, and 64.5°C for Gyrus PK.

LigaSure was the highest-rated device overall, with the highest burst pressure and fastest sealing time.

EnSeal was the slowest and had variable burst pressures.

Clinical implications of the trials

These studies—neither of which was industry-sponsored—suggest that larger vessels cannot be controlled consistently and effectively using the Harmonic Scalpel or Gyrus systems. The Harmonic Scalpel is most user-dependent.

So what’s the bottom line? In the end, according to Andrew Brill, MD, past president of AAGL, “it’s not the wand, it’s the magician.”

When Harry Reich performed the first laparoscopically assisted vaginal hysterectomy in 1989, he advocated the use of sutures for control of the uterine vessels. Monopolar, bipolar, and laser instruments available at that time were inherently risky to use along the pelvic sidewall because of their potential for 1) considerable thermal energy spread beyond the area of treatment (bipolar, NG:YAG laser, monopolar) and 2) unreliable hemostasis (CO₂ laser).

Minimally invasive surgical practice has driven meaningful advances in instrumentation and technique over the past 20 years. The constraints inherent in laparoscopic surgery, although somewhat mitigated by robotics, have generated a proliferation of technologies to obtain reliable hemostasis. Every device now on the market claims to “seal” vessels. In this article, I review the mechanism of action of these instruments and compare their strengths and weaknesses, based on high-quality scientific evidence.

Two studies highlight vessel ligation

Newcomb WL, Hope WW, Schmeizer TM, et al. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009;23:90–96.

Lamberton GR, Hsi RS, Jin DH, et al. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol. 2008;22:2307–2312.

Many energy-delivery systems are available for the gynecologic surgeon; any of them can be used effectively and safely under most circumstances. Before we can make an informed choice about which system is best for our own practice, however, we need to be aware of the strengths and limitations of the systems overall ( TABLE ).

These two studies focus on the following devices:

• Gyrus PK Tissue Management System, PKS Cutting Forceps, and Plasma Trissector (all from Gyrus Medical). These are bipolar electrosurgical devices designed to deliver high current and very low voltage to tissue. Tissue impedance is continuously monitored between the jaws of the instrument, and energy delivery is adjusted accordingly. These systems deliver electrosurgical energy through a series of rapid pulses, thereby allowing the tissue to cool briefly and limiting the heating of adjacent tissue. Protein in the vessel walls is denatured and forms a coagulum, which occludes the lumen.
• Harmonic Scalpel (Ethicon EndoSurgery). This device uses a high-frequency ultrasonic transducer (55,000 cycles/second) to create mechanical vibration of one of the two jaws. The device can be used to vaporize tissue (cut) or achieve hemostasis by coagulation. As with the other devices, protein is denatured and vessels are occluded by formation of a coagulum.
• Ligamax 5 Endoscopic Multiple Clip Applier (Ethicon). This device is a sterile, single-patient-use, 5-mm, endoscopic, multiple-clip applicator that delivers 15 medium or large titanium clips that close to 8.8 mm, the same clip size as the 10-mm applicator. Ligamax 5 has long, thin angled jaws (8.4 mm) that extend beyond vessels and ducts to improve visibility. It includes a long, 33-cm shaft for additional reach, and an anti-clip drop-ratchet mechanism for control over clip closure.
• EnSeal Tissue Sealing and Hemostasis System and EnSeal PTC (SurgRx). EnSeal utilizes nanotechnology to control the energy at the electrode–tissue interface. The jaws contain a temperature-sensitive matrix with embedded conductive carbon spherules designed to “sense” tissue characteristics. It uses extremely high jaw compression to create uniform tissue effects. It does not require a dedicated electrosurgical unit for use; an adapter can be purchased that permits use with most generators.
• LigaSure V (Valleylab). LigaSure is a bipolar electrosurgical device designed to deliver high current and very low voltage to tissue. It monitors tissue impedance between the jaws of the instrument and continuously adjusts the delivery of energy.

TABLE

Rating vessel-sealing devices: 5 measures of success

FIGURE How energy-based vessel-sealing works

(A) When the carotid artery of an animal model was sealed using a standard bipolar forceps, the lumen remained open and a proximal thrombus developed. (B) When LigaSure was used, the artery was fused and the lumen obliterated with one 5-second application. (C and D) When a renal artery was sealed with LigaSure, the lumen of the vessel walls fused completely.

What the studies found

Newcomb and associates compared blood-vessel-sealing ability of the following devices:

• Gyrus 5-mm PKS Cutting Forceps
• Gyrus Plasma Trissector
• Harmonic Scalpel
• EnSeal Tissue Sealing and Hemostasis System
• LigaSure V, using the LigaSure Generator (Valleylab)
• LigaSure V, using the Force Triad Generator (Valleylab)
• Ligamax 5 Endoscopic Multiple Clip Applier.

The authors assessed mean seal times and burst pressures. Used on medium and large vessels, the Harmonic Scalpel and Gyrus products had significant failure rates: 8% to 22% for the Harmonic Scalpel and 41% to 92% for the pulsed, bipolar Gyrus systems.

The shortest sealing times for medium to large vessels were achieved with the LigaSure V using the Force Triad Generator. The Gyrus systems were the fastest devices when vessels were 2 to 3 mm in diameter.

There were no seal failures with the Ligamax, EnSeal, or LigaSure products.

Second study involved repeated applications

Lamberton and colleagues tested 5-mm laparoscopic devices under controlled temperature and humidity using a laparoscopic simulator, focusing on the following systems:

• LigaSure V
• Gyrus PK
• Harmonic Scalpel
• EnSeal Tissue Sealing and Hemostasis System.

The authors used 5-mm bovine arteries to assess sealing time, burst pressure, lateral thermal spread, and smoke production, as well as both subjective and objective effects on visibility.

Each device was used 10 times to determine burst pressure, lateral thermal spread, visibility, and smoke production. The devices were applied 20 times to measure time to seal, based on the devices’ preprogrammed endpoints.

The Harmonic Scalpel produced the lowest thermal spread and least smoke, but also had the lowest mean burst pressure.

The Gyrus PK generated the most smoke and had variable burst pressure. Although it had the fastest sealing times, in three of 10 trials there was a completely open arterial lumen following transection. In addition, 50% of applications involved burst pressures below 50 mm Hg.

Maximum temperatures 2 mm from the device were 49.9°C for the Harmonic Scalpel, 55.5°C for LigaSure, 58.9°C for EnSeal, and 64.5°C for Gyrus PK.

LigaSure was the highest-rated device overall, with the highest burst pressure and fastest sealing time.

EnSeal was the slowest and had variable burst pressures.

Clinical implications of the trials

These studies—neither of which was industry-sponsored—suggest that larger vessels cannot be controlled consistently and effectively using the Harmonic Scalpel or Gyrus systems. The Harmonic Scalpel is most user-dependent.

So what’s the bottom line? In the end, according to Andrew Brill, MD, past president of AAGL, “it’s not the wand, it’s the magician.”