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Ablative fractional lasers treat scars like ‘a magic wand’
SAN DIEGO – .
“I tell patients it’s like boiling water in a tea kettle and watching the vapor form,” Dr. Waibel, a dermatologist with the Miami Dermatology and Laser Institute, said at the annual Masters of Aesthetics Symposium. “You literally ‘steam off’ their bad scar and the human body will heal that wound to almost normal skin. It’s the closest thing we have to a magic wand.”
In the not-too-distant past, dermatologists “were treating scars just to make them look better,” she said. However, thanks to groundbreaking work by clinicians at Naval Medical Center San Diego, the use of ablative fractional lasers to treat scars was found to improve range of motion in patients, as well as their pain and pruritus. “It represents a major innovation that heals in ways not previously possible,” said Dr. Waibel, who is also chief of dermatology at Baptist Hospital in Miami. “We’re not just healing the scar; we’re healing the skin back to its physiological normal place. A lot of these patients suffer quite a bit.”
Dr. Waibel likened her scar treatment approach to a three-course meal. Lesion color drives her choice of what device to use as an “appetizer” treatment. Most scars are either red (erythematous), brown (hyperpigmented), or white (hypopigmented). Though every scar is unique and individually evaluated for treatment, typically she uses pulsed dye laser, intense pulsed light, or broadband light therapy to treat erythematous/early scars; nonablative fractional lasers to treat atrophic scars, and the thulium or 1,470-nm laser to treat hyperpigmented scars. The “main course” device in her practice is an ablative fractional erbium or CO2 laser.
“Once I treat the scar three to five times, I might switch to a nonablative laser, but I’m really an ablative fractional user,” Dr. Waibel said. “Dessert” can be whatever adjunctive therapies you need, she continued. This may include triamcinolone acetonide, 5-fluorouracil, poly-l-lactic acid, hyaluronidase, Z-plasty, punch biopsies, shave biopsies, compression, chemical reconstruction of skin scars (CROSS), and subcision.
For erythematous surgical and trauma scars, she uses a combination of pulsed dye laser and ablative fractional laser. “Same day, same treatment; one after each other,” she said. She favors using intense pulsed light for donor sites because it has filters that address both melanin and hemosiderin, superiority for scar erythema, and deeper penetration with greater speed to treat large surface areas.
One recent advance in the vascular arena is the new 595-nm pulsed dye laser by Candela, known as the VBeam Prima. It features increased energy, a 15-nm spot size, a zoom hand piece, once-a-day calibration, and contact cooling, which may be better for pigmented and possibly microvascular structures. The device is cleared for treating conditions like rosacea, acne, spider veins, port-wine stains, wrinkles, warts and stretch marks, as well as photoaging and benign pigmented lesions.
Dr. Waibel’s go-to device for treating a hypertrophic, hyperpigmented surgical scar is a 1927-nm or 1470-nm nonablative fractional laser, followed by a fractional ablative laser and injection of 1-2 ccs of 5-fluorouracil only to elevated areas. Hypopigmented scars are “by far the toughest to treat,” she said. However, she has a formula for these, too, and recently conducted a trial comparing the efficacy of nonablative fractional laser, ablative fractional laser, and ablative fractional laser followed by laser-assisted delivery of bimatoprost (Latisse) to treat hypopigmentation.
Surgical scars get better on their own in many cases, but sometimes early intervention is warranted. “Most surgeons will tell patients, ‘Wait a year. What you have [in terms of scar formation] is what you have,’” Dr. Waibel said. “If a surgical scar becomes hypertrophic, it does so within a month of surgery. I don’t prophylactically treat surgical scars unless the patient has had multiple surgeries in the same location with trouble healing. But if it’s been 6 months to a year, or if the patient is developing hypertrophic scars, then I will treat.”
Acne scars are challenging, because patients want to look good right away. “With deep scars, it takes several treatments to see good improvements,” she said. “I tell all my acne scar patients it takes a year [to get good results].”
Most burn patients require three to six treatment sessions, “but sometimes you get remarkable improvement sooner,” she said. “That’s due to the patient’s healing.” She and her associates recently completed an unpublished study that examined early intervention of fractional ablative laser versus control in 20 subjects with acute burn injuries who ranged in age from 18 to 80 years. The subjects underwent treatment with an ablative fractional CO2 laser within 3 months of sustaining the burn injury, leaving an untreated control area for comparison. According to Dr. Waibel, 100% of the blinded physician evaluators graded the laser-treated area correctly, compared with the control area. In addition, a significant improvement in all points of the Manchester Scar Scale was observed in the laser-treated area. “The earlier you treat burn and trauma patients, the easier it is to get them back to normal,” she said.
Dr. Waibel disclosed that she has conducted clinical research for Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.
SAN DIEGO – .
“I tell patients it’s like boiling water in a tea kettle and watching the vapor form,” Dr. Waibel, a dermatologist with the Miami Dermatology and Laser Institute, said at the annual Masters of Aesthetics Symposium. “You literally ‘steam off’ their bad scar and the human body will heal that wound to almost normal skin. It’s the closest thing we have to a magic wand.”
In the not-too-distant past, dermatologists “were treating scars just to make them look better,” she said. However, thanks to groundbreaking work by clinicians at Naval Medical Center San Diego, the use of ablative fractional lasers to treat scars was found to improve range of motion in patients, as well as their pain and pruritus. “It represents a major innovation that heals in ways not previously possible,” said Dr. Waibel, who is also chief of dermatology at Baptist Hospital in Miami. “We’re not just healing the scar; we’re healing the skin back to its physiological normal place. A lot of these patients suffer quite a bit.”
Dr. Waibel likened her scar treatment approach to a three-course meal. Lesion color drives her choice of what device to use as an “appetizer” treatment. Most scars are either red (erythematous), brown (hyperpigmented), or white (hypopigmented). Though every scar is unique and individually evaluated for treatment, typically she uses pulsed dye laser, intense pulsed light, or broadband light therapy to treat erythematous/early scars; nonablative fractional lasers to treat atrophic scars, and the thulium or 1,470-nm laser to treat hyperpigmented scars. The “main course” device in her practice is an ablative fractional erbium or CO2 laser.
“Once I treat the scar three to five times, I might switch to a nonablative laser, but I’m really an ablative fractional user,” Dr. Waibel said. “Dessert” can be whatever adjunctive therapies you need, she continued. This may include triamcinolone acetonide, 5-fluorouracil, poly-l-lactic acid, hyaluronidase, Z-plasty, punch biopsies, shave biopsies, compression, chemical reconstruction of skin scars (CROSS), and subcision.
For erythematous surgical and trauma scars, she uses a combination of pulsed dye laser and ablative fractional laser. “Same day, same treatment; one after each other,” she said. She favors using intense pulsed light for donor sites because it has filters that address both melanin and hemosiderin, superiority for scar erythema, and deeper penetration with greater speed to treat large surface areas.
One recent advance in the vascular arena is the new 595-nm pulsed dye laser by Candela, known as the VBeam Prima. It features increased energy, a 15-nm spot size, a zoom hand piece, once-a-day calibration, and contact cooling, which may be better for pigmented and possibly microvascular structures. The device is cleared for treating conditions like rosacea, acne, spider veins, port-wine stains, wrinkles, warts and stretch marks, as well as photoaging and benign pigmented lesions.
Dr. Waibel’s go-to device for treating a hypertrophic, hyperpigmented surgical scar is a 1927-nm or 1470-nm nonablative fractional laser, followed by a fractional ablative laser and injection of 1-2 ccs of 5-fluorouracil only to elevated areas. Hypopigmented scars are “by far the toughest to treat,” she said. However, she has a formula for these, too, and recently conducted a trial comparing the efficacy of nonablative fractional laser, ablative fractional laser, and ablative fractional laser followed by laser-assisted delivery of bimatoprost (Latisse) to treat hypopigmentation.
Surgical scars get better on their own in many cases, but sometimes early intervention is warranted. “Most surgeons will tell patients, ‘Wait a year. What you have [in terms of scar formation] is what you have,’” Dr. Waibel said. “If a surgical scar becomes hypertrophic, it does so within a month of surgery. I don’t prophylactically treat surgical scars unless the patient has had multiple surgeries in the same location with trouble healing. But if it’s been 6 months to a year, or if the patient is developing hypertrophic scars, then I will treat.”
Acne scars are challenging, because patients want to look good right away. “With deep scars, it takes several treatments to see good improvements,” she said. “I tell all my acne scar patients it takes a year [to get good results].”
Most burn patients require three to six treatment sessions, “but sometimes you get remarkable improvement sooner,” she said. “That’s due to the patient’s healing.” She and her associates recently completed an unpublished study that examined early intervention of fractional ablative laser versus control in 20 subjects with acute burn injuries who ranged in age from 18 to 80 years. The subjects underwent treatment with an ablative fractional CO2 laser within 3 months of sustaining the burn injury, leaving an untreated control area for comparison. According to Dr. Waibel, 100% of the blinded physician evaluators graded the laser-treated area correctly, compared with the control area. In addition, a significant improvement in all points of the Manchester Scar Scale was observed in the laser-treated area. “The earlier you treat burn and trauma patients, the easier it is to get them back to normal,” she said.
Dr. Waibel disclosed that she has conducted clinical research for Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.
SAN DIEGO – .
“I tell patients it’s like boiling water in a tea kettle and watching the vapor form,” Dr. Waibel, a dermatologist with the Miami Dermatology and Laser Institute, said at the annual Masters of Aesthetics Symposium. “You literally ‘steam off’ their bad scar and the human body will heal that wound to almost normal skin. It’s the closest thing we have to a magic wand.”
In the not-too-distant past, dermatologists “were treating scars just to make them look better,” she said. However, thanks to groundbreaking work by clinicians at Naval Medical Center San Diego, the use of ablative fractional lasers to treat scars was found to improve range of motion in patients, as well as their pain and pruritus. “It represents a major innovation that heals in ways not previously possible,” said Dr. Waibel, who is also chief of dermatology at Baptist Hospital in Miami. “We’re not just healing the scar; we’re healing the skin back to its physiological normal place. A lot of these patients suffer quite a bit.”
Dr. Waibel likened her scar treatment approach to a three-course meal. Lesion color drives her choice of what device to use as an “appetizer” treatment. Most scars are either red (erythematous), brown (hyperpigmented), or white (hypopigmented). Though every scar is unique and individually evaluated for treatment, typically she uses pulsed dye laser, intense pulsed light, or broadband light therapy to treat erythematous/early scars; nonablative fractional lasers to treat atrophic scars, and the thulium or 1,470-nm laser to treat hyperpigmented scars. The “main course” device in her practice is an ablative fractional erbium or CO2 laser.
“Once I treat the scar three to five times, I might switch to a nonablative laser, but I’m really an ablative fractional user,” Dr. Waibel said. “Dessert” can be whatever adjunctive therapies you need, she continued. This may include triamcinolone acetonide, 5-fluorouracil, poly-l-lactic acid, hyaluronidase, Z-plasty, punch biopsies, shave biopsies, compression, chemical reconstruction of skin scars (CROSS), and subcision.
For erythematous surgical and trauma scars, she uses a combination of pulsed dye laser and ablative fractional laser. “Same day, same treatment; one after each other,” she said. She favors using intense pulsed light for donor sites because it has filters that address both melanin and hemosiderin, superiority for scar erythema, and deeper penetration with greater speed to treat large surface areas.
One recent advance in the vascular arena is the new 595-nm pulsed dye laser by Candela, known as the VBeam Prima. It features increased energy, a 15-nm spot size, a zoom hand piece, once-a-day calibration, and contact cooling, which may be better for pigmented and possibly microvascular structures. The device is cleared for treating conditions like rosacea, acne, spider veins, port-wine stains, wrinkles, warts and stretch marks, as well as photoaging and benign pigmented lesions.
Dr. Waibel’s go-to device for treating a hypertrophic, hyperpigmented surgical scar is a 1927-nm or 1470-nm nonablative fractional laser, followed by a fractional ablative laser and injection of 1-2 ccs of 5-fluorouracil only to elevated areas. Hypopigmented scars are “by far the toughest to treat,” she said. However, she has a formula for these, too, and recently conducted a trial comparing the efficacy of nonablative fractional laser, ablative fractional laser, and ablative fractional laser followed by laser-assisted delivery of bimatoprost (Latisse) to treat hypopigmentation.
Surgical scars get better on their own in many cases, but sometimes early intervention is warranted. “Most surgeons will tell patients, ‘Wait a year. What you have [in terms of scar formation] is what you have,’” Dr. Waibel said. “If a surgical scar becomes hypertrophic, it does so within a month of surgery. I don’t prophylactically treat surgical scars unless the patient has had multiple surgeries in the same location with trouble healing. But if it’s been 6 months to a year, or if the patient is developing hypertrophic scars, then I will treat.”
Acne scars are challenging, because patients want to look good right away. “With deep scars, it takes several treatments to see good improvements,” she said. “I tell all my acne scar patients it takes a year [to get good results].”
Most burn patients require three to six treatment sessions, “but sometimes you get remarkable improvement sooner,” she said. “That’s due to the patient’s healing.” She and her associates recently completed an unpublished study that examined early intervention of fractional ablative laser versus control in 20 subjects with acute burn injuries who ranged in age from 18 to 80 years. The subjects underwent treatment with an ablative fractional CO2 laser within 3 months of sustaining the burn injury, leaving an untreated control area for comparison. According to Dr. Waibel, 100% of the blinded physician evaluators graded the laser-treated area correctly, compared with the control area. In addition, a significant improvement in all points of the Manchester Scar Scale was observed in the laser-treated area. “The earlier you treat burn and trauma patients, the easier it is to get them back to normal,” she said.
Dr. Waibel disclosed that she has conducted clinical research for Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.
REPORTING FROM MOAS 2018
Troponin I: Powerful all-cause mortality risk marker in COPD
PARIS – High relative even after researchers adjusted for all major cardiovascular and COPD prognostic indicators, according to a late-breaker presentation at the annual congress of the European Respiratory Society.
Troponin I is detectable in the plasma of most patients with COPD, but relative increases in troponin I correlate with greater relative increases in most cardiovascular and COPD risk factors, according to Benjamin Waschki, MD, Pulmonary Research Institute, LungenClinic, Grosshansdorf, Germany.
The relationship between increased troponin I and increased all-cause mortality was observed in an on-going prospective multicenter cohort of COPD patients followed at 31 centers in Germany. The cohort is called COSYCONET and it began in 2010. The current analysis evaluated 2,020 COPD patients without regard to stage of disease.
There were 136 deaths over the course of follow-up. Without adjustment, the hazard ratio (HR) for death was more than twofold higher in the highest quartile of troponin I (equal to or greater than 6.6 ng/mL), when compared with the lowest (under 2.5 ng/mL) (HR, 2.42; P less than .001). Graphically, the mortality curves for each of the quartiles began to separate at about 12 months, widening in a stepwise manner for greater likelihood of death from the lowest to highest quartiles.
The risk of death from any cause remained elevated for the highest relative to lowest troponin I quartiles after adjusting for cardiovascular risk factors and after adjusting for COPD severity. Again, there was a distinct stepwise separation of the mortality curves for each higher troponin quartile,
Of particular importance, troponin I remained predictive beyond the BODE index, which is a currently employed prognostic mortality predictor in COPD, according to Dr. Waschki. When defining elevated troponin as greater than 6 ng/ML and a high BODE score as greater than 4, mortality was higher for those with a high BODE and low troponin than a high troponin and low BODE, (P less than .001), but a high troponin I was associated with a higher risk of mortality when BODE was low (P less than .001). Moreover, when both troponin I and BODE were elevated, all-cause mortality was more than doubled, relative to those without either risk factor (HR, 2.56; P = .003), Dr. Waschki reported.
After researchers adjusted for major cardiovascular risk factors, such as history of MI and renal impairment, and for major COPD risk factors, such as 6-minute walk test and BODE index, those in the highest quartile had a more than 50% greater risk of death relative to those in the lower quartile over the 3 years of follow-up (HR, 1.69; P = .007), according to Dr. Waschki.
Although troponin I is best known for its diagnostic role in MI, it is now being evaluated as a risk stratifier for many chronic diseases, such as heart failure and chronic kidney disease, explained Dr. Waschki in providing background for this study. He reported that many groups are looking at this as a marker of risk in a variety of chronic diseases.
In fact, a group working independently published a study in COPD just weeks before the ERS Congress that was complementary to those presented by Dr. Waschki. In this study, the goal was to evaluate troponin I as a predictor of cardiovascular events and cardiovascular death (Adamson PD et al. J Am Coll Cardiol 2018;72:1126-37). Performed as a subgroup analysis of 1,599 COPD patients participating in a large treatment trial, there was an almost fourfold increase in the risk of cardiovascular events (HR, 3.7; P = .012) when those in the highest quintile of troponin I (greater than 7.7 ng/ML) were compared with those in the lowest quintile (less than 2.3 ng/mL).
When compared for cardiovascular death, the highest quintile, relative to the lowest quintile, had a more than 20-fold increased risk of cardiovascular death (HR 20.1; P = .005). In the Adamson et al. study, which evaluated inhaled therapies for COPD, treatment response had no impact on troponin I levels or on the risk of cardiovascular events or death.
Based on this study and his own data, Dr. Waschki believes troponin I, which is readily ordered laboratory value, appears to be a useful tool for identifying COPD patients at high risk of death.
“The major message is that after adjusting for all known COPD and cardiovascular risk factors, troponin I remains a significant independent predictor of mortality,” he said.
Dr. Waschki reports no relevant conflicts of interest.
PARIS – High relative even after researchers adjusted for all major cardiovascular and COPD prognostic indicators, according to a late-breaker presentation at the annual congress of the European Respiratory Society.
Troponin I is detectable in the plasma of most patients with COPD, but relative increases in troponin I correlate with greater relative increases in most cardiovascular and COPD risk factors, according to Benjamin Waschki, MD, Pulmonary Research Institute, LungenClinic, Grosshansdorf, Germany.
The relationship between increased troponin I and increased all-cause mortality was observed in an on-going prospective multicenter cohort of COPD patients followed at 31 centers in Germany. The cohort is called COSYCONET and it began in 2010. The current analysis evaluated 2,020 COPD patients without regard to stage of disease.
There were 136 deaths over the course of follow-up. Without adjustment, the hazard ratio (HR) for death was more than twofold higher in the highest quartile of troponin I (equal to or greater than 6.6 ng/mL), when compared with the lowest (under 2.5 ng/mL) (HR, 2.42; P less than .001). Graphically, the mortality curves for each of the quartiles began to separate at about 12 months, widening in a stepwise manner for greater likelihood of death from the lowest to highest quartiles.
The risk of death from any cause remained elevated for the highest relative to lowest troponin I quartiles after adjusting for cardiovascular risk factors and after adjusting for COPD severity. Again, there was a distinct stepwise separation of the mortality curves for each higher troponin quartile,
Of particular importance, troponin I remained predictive beyond the BODE index, which is a currently employed prognostic mortality predictor in COPD, according to Dr. Waschki. When defining elevated troponin as greater than 6 ng/ML and a high BODE score as greater than 4, mortality was higher for those with a high BODE and low troponin than a high troponin and low BODE, (P less than .001), but a high troponin I was associated with a higher risk of mortality when BODE was low (P less than .001). Moreover, when both troponin I and BODE were elevated, all-cause mortality was more than doubled, relative to those without either risk factor (HR, 2.56; P = .003), Dr. Waschki reported.
After researchers adjusted for major cardiovascular risk factors, such as history of MI and renal impairment, and for major COPD risk factors, such as 6-minute walk test and BODE index, those in the highest quartile had a more than 50% greater risk of death relative to those in the lower quartile over the 3 years of follow-up (HR, 1.69; P = .007), according to Dr. Waschki.
Although troponin I is best known for its diagnostic role in MI, it is now being evaluated as a risk stratifier for many chronic diseases, such as heart failure and chronic kidney disease, explained Dr. Waschki in providing background for this study. He reported that many groups are looking at this as a marker of risk in a variety of chronic diseases.
In fact, a group working independently published a study in COPD just weeks before the ERS Congress that was complementary to those presented by Dr. Waschki. In this study, the goal was to evaluate troponin I as a predictor of cardiovascular events and cardiovascular death (Adamson PD et al. J Am Coll Cardiol 2018;72:1126-37). Performed as a subgroup analysis of 1,599 COPD patients participating in a large treatment trial, there was an almost fourfold increase in the risk of cardiovascular events (HR, 3.7; P = .012) when those in the highest quintile of troponin I (greater than 7.7 ng/ML) were compared with those in the lowest quintile (less than 2.3 ng/mL).
When compared for cardiovascular death, the highest quintile, relative to the lowest quintile, had a more than 20-fold increased risk of cardiovascular death (HR 20.1; P = .005). In the Adamson et al. study, which evaluated inhaled therapies for COPD, treatment response had no impact on troponin I levels or on the risk of cardiovascular events or death.
Based on this study and his own data, Dr. Waschki believes troponin I, which is readily ordered laboratory value, appears to be a useful tool for identifying COPD patients at high risk of death.
“The major message is that after adjusting for all known COPD and cardiovascular risk factors, troponin I remains a significant independent predictor of mortality,” he said.
Dr. Waschki reports no relevant conflicts of interest.
PARIS – High relative even after researchers adjusted for all major cardiovascular and COPD prognostic indicators, according to a late-breaker presentation at the annual congress of the European Respiratory Society.
Troponin I is detectable in the plasma of most patients with COPD, but relative increases in troponin I correlate with greater relative increases in most cardiovascular and COPD risk factors, according to Benjamin Waschki, MD, Pulmonary Research Institute, LungenClinic, Grosshansdorf, Germany.
The relationship between increased troponin I and increased all-cause mortality was observed in an on-going prospective multicenter cohort of COPD patients followed at 31 centers in Germany. The cohort is called COSYCONET and it began in 2010. The current analysis evaluated 2,020 COPD patients without regard to stage of disease.
There were 136 deaths over the course of follow-up. Without adjustment, the hazard ratio (HR) for death was more than twofold higher in the highest quartile of troponin I (equal to or greater than 6.6 ng/mL), when compared with the lowest (under 2.5 ng/mL) (HR, 2.42; P less than .001). Graphically, the mortality curves for each of the quartiles began to separate at about 12 months, widening in a stepwise manner for greater likelihood of death from the lowest to highest quartiles.
The risk of death from any cause remained elevated for the highest relative to lowest troponin I quartiles after adjusting for cardiovascular risk factors and after adjusting for COPD severity. Again, there was a distinct stepwise separation of the mortality curves for each higher troponin quartile,
Of particular importance, troponin I remained predictive beyond the BODE index, which is a currently employed prognostic mortality predictor in COPD, according to Dr. Waschki. When defining elevated troponin as greater than 6 ng/ML and a high BODE score as greater than 4, mortality was higher for those with a high BODE and low troponin than a high troponin and low BODE, (P less than .001), but a high troponin I was associated with a higher risk of mortality when BODE was low (P less than .001). Moreover, when both troponin I and BODE were elevated, all-cause mortality was more than doubled, relative to those without either risk factor (HR, 2.56; P = .003), Dr. Waschki reported.
After researchers adjusted for major cardiovascular risk factors, such as history of MI and renal impairment, and for major COPD risk factors, such as 6-minute walk test and BODE index, those in the highest quartile had a more than 50% greater risk of death relative to those in the lower quartile over the 3 years of follow-up (HR, 1.69; P = .007), according to Dr. Waschki.
Although troponin I is best known for its diagnostic role in MI, it is now being evaluated as a risk stratifier for many chronic diseases, such as heart failure and chronic kidney disease, explained Dr. Waschki in providing background for this study. He reported that many groups are looking at this as a marker of risk in a variety of chronic diseases.
In fact, a group working independently published a study in COPD just weeks before the ERS Congress that was complementary to those presented by Dr. Waschki. In this study, the goal was to evaluate troponin I as a predictor of cardiovascular events and cardiovascular death (Adamson PD et al. J Am Coll Cardiol 2018;72:1126-37). Performed as a subgroup analysis of 1,599 COPD patients participating in a large treatment trial, there was an almost fourfold increase in the risk of cardiovascular events (HR, 3.7; P = .012) when those in the highest quintile of troponin I (greater than 7.7 ng/ML) were compared with those in the lowest quintile (less than 2.3 ng/mL).
When compared for cardiovascular death, the highest quintile, relative to the lowest quintile, had a more than 20-fold increased risk of cardiovascular death (HR 20.1; P = .005). In the Adamson et al. study, which evaluated inhaled therapies for COPD, treatment response had no impact on troponin I levels or on the risk of cardiovascular events or death.
Based on this study and his own data, Dr. Waschki believes troponin I, which is readily ordered laboratory value, appears to be a useful tool for identifying COPD patients at high risk of death.
“The major message is that after adjusting for all known COPD and cardiovascular risk factors, troponin I remains a significant independent predictor of mortality,” he said.
Dr. Waschki reports no relevant conflicts of interest.
REPORTING FROM ERS CONGRESS 2018
Key clinical point: Elevated troponin I identifies COPD patients with increased mortality risk independent of all other clinical risk markers.
Major finding: With high troponin I levels, all-cause mortality was increased 69% after researchers adjusted for other risk markers.
Study details: Analysis drawn from on-going multicenter cohort study
Disclosures: Dr. Waschki reports no relevant conflicts of interest.
Pregnancy registries are a valuable resource
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
GBS in T2DM patients: Study highlights pros and cons, need for better patient selection
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
REPORTING FROM ADA 2018
Key clinical point: Bariatric surgery lowers mortality, CVD, and renal and other risks in obese T2DM patients but also has high complication rates.
Major finding: All-cause mortality, CVD, and renal disease risks were 49%, 34%, and 42% lower, respectively, in cases vs. controls.
Study details: A matched observational cohort study of 5,321 cases and 5,321 controls.
Disclosures: Dr. Liakopoulos reported having no disclosures.
Source: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
Arthritis prevalent in older adults with any degree of depression
Arthritis is highly prevalent in older adults with any degree of depression, results of a recent study suggest.
Doctor-diagnosed arthritis was reported by more than 50% of older adults with mild depression, according to results of the study, which was based on data from the National Health and Nutrition Examination Survey (NHANES).
The prevalence of arthritis exceeded 60% in participants with moderate depression, and approached 70% for those with severe depression, according to the study, published in the International Journal of Geriatric Psychiatry.
Based on those findings, arthritis and depression need to be viewed as frequently co-occurring physical and psychosocial issues, reported Jessica M. Brooks, PhD, of the department of psychiatry at Dartmouth College, Lebanon, N.H., and her coauthors.
“It may be critical for mental health care providers to provide regular arthritis-related pain assessments and evidence‐based treatments for co‐occurring arthritis in older adults with or at risk for depression,” Dr. Brooks and her colleagues said in their report.
Their analysis was based on 2,483 women and 2,309 men aged 50 years and older (mean age, 64.5 years) who had participated in the NHANES survey between 2011 and 2014. Out of that sample, 2,094 participants (43.7%) said they had been told by a doctor that they had arthritis, the researchers said.
The rate of arthritis was 38.2% for participants with no depressive symptoms as indicated by a 0-4 score on the 9-item Patient Health Questionnaire (PHQ-9). By comparison, rates of arthritis were 55.0%, 62.9%, and 67.8% for those with mild, moderate, or severe depression by PHQ-9.
Individuals with arthritis had a significantly higher mean PHQ-9 score, at 4.6, compared with 2.6 for those without arthritis (P less than .001), the investigators said.
that controlled for age, gender, comorbid conditions, and other factors such as smoking history.
Establishing prevalence rates of arthritis in older adults with depression is an “important step” toward informing mental health professionals on the need to identify and treat arthritis-related pain, Dr. Brooks and her coauthors said.
“Addressing arthritis in mental health treatment and behavioral medicine may also help to reduce the overlapping cognitive, behavioral, and somatic symptoms in older adults with depressive symptoms and arthritis, which may be difficult for providers to disentangle through brief screening procedures and treat through conventional depression care,” they wrote.
The investigators cited several limitations. For example, the cross-sectional nature of the study makes it difficult to draw conclusions about causality. In addition, Dr. Brooks and her colleagues did not distinguish between different types of arthritis.
The researchers declared no conflicts of interest. The study was supported by several U.S. institutes, including the National Institute of Mental Health, and by numerous entities related to Dartmouth, including the Dartmouth Health Promotion and Disease Prevention Research Center. The Howard and Phyllis Schwartz Philanthropic Fund also provided funding.
SOURCE: Brooks JM et al. Int J Geriatr Psychiatry. 2018 Sep 19. doi: 10.1022/gps.4971.
Arthritis is highly prevalent in older adults with any degree of depression, results of a recent study suggest.
Doctor-diagnosed arthritis was reported by more than 50% of older adults with mild depression, according to results of the study, which was based on data from the National Health and Nutrition Examination Survey (NHANES).
The prevalence of arthritis exceeded 60% in participants with moderate depression, and approached 70% for those with severe depression, according to the study, published in the International Journal of Geriatric Psychiatry.
Based on those findings, arthritis and depression need to be viewed as frequently co-occurring physical and psychosocial issues, reported Jessica M. Brooks, PhD, of the department of psychiatry at Dartmouth College, Lebanon, N.H., and her coauthors.
“It may be critical for mental health care providers to provide regular arthritis-related pain assessments and evidence‐based treatments for co‐occurring arthritis in older adults with or at risk for depression,” Dr. Brooks and her colleagues said in their report.
Their analysis was based on 2,483 women and 2,309 men aged 50 years and older (mean age, 64.5 years) who had participated in the NHANES survey between 2011 and 2014. Out of that sample, 2,094 participants (43.7%) said they had been told by a doctor that they had arthritis, the researchers said.
The rate of arthritis was 38.2% for participants with no depressive symptoms as indicated by a 0-4 score on the 9-item Patient Health Questionnaire (PHQ-9). By comparison, rates of arthritis were 55.0%, 62.9%, and 67.8% for those with mild, moderate, or severe depression by PHQ-9.
Individuals with arthritis had a significantly higher mean PHQ-9 score, at 4.6, compared with 2.6 for those without arthritis (P less than .001), the investigators said.
that controlled for age, gender, comorbid conditions, and other factors such as smoking history.
Establishing prevalence rates of arthritis in older adults with depression is an “important step” toward informing mental health professionals on the need to identify and treat arthritis-related pain, Dr. Brooks and her coauthors said.
“Addressing arthritis in mental health treatment and behavioral medicine may also help to reduce the overlapping cognitive, behavioral, and somatic symptoms in older adults with depressive symptoms and arthritis, which may be difficult for providers to disentangle through brief screening procedures and treat through conventional depression care,” they wrote.
The investigators cited several limitations. For example, the cross-sectional nature of the study makes it difficult to draw conclusions about causality. In addition, Dr. Brooks and her colleagues did not distinguish between different types of arthritis.
The researchers declared no conflicts of interest. The study was supported by several U.S. institutes, including the National Institute of Mental Health, and by numerous entities related to Dartmouth, including the Dartmouth Health Promotion and Disease Prevention Research Center. The Howard and Phyllis Schwartz Philanthropic Fund also provided funding.
SOURCE: Brooks JM et al. Int J Geriatr Psychiatry. 2018 Sep 19. doi: 10.1022/gps.4971.
Arthritis is highly prevalent in older adults with any degree of depression, results of a recent study suggest.
Doctor-diagnosed arthritis was reported by more than 50% of older adults with mild depression, according to results of the study, which was based on data from the National Health and Nutrition Examination Survey (NHANES).
The prevalence of arthritis exceeded 60% in participants with moderate depression, and approached 70% for those with severe depression, according to the study, published in the International Journal of Geriatric Psychiatry.
Based on those findings, arthritis and depression need to be viewed as frequently co-occurring physical and psychosocial issues, reported Jessica M. Brooks, PhD, of the department of psychiatry at Dartmouth College, Lebanon, N.H., and her coauthors.
“It may be critical for mental health care providers to provide regular arthritis-related pain assessments and evidence‐based treatments for co‐occurring arthritis in older adults with or at risk for depression,” Dr. Brooks and her colleagues said in their report.
Their analysis was based on 2,483 women and 2,309 men aged 50 years and older (mean age, 64.5 years) who had participated in the NHANES survey between 2011 and 2014. Out of that sample, 2,094 participants (43.7%) said they had been told by a doctor that they had arthritis, the researchers said.
The rate of arthritis was 38.2% for participants with no depressive symptoms as indicated by a 0-4 score on the 9-item Patient Health Questionnaire (PHQ-9). By comparison, rates of arthritis were 55.0%, 62.9%, and 67.8% for those with mild, moderate, or severe depression by PHQ-9.
Individuals with arthritis had a significantly higher mean PHQ-9 score, at 4.6, compared with 2.6 for those without arthritis (P less than .001), the investigators said.
that controlled for age, gender, comorbid conditions, and other factors such as smoking history.
Establishing prevalence rates of arthritis in older adults with depression is an “important step” toward informing mental health professionals on the need to identify and treat arthritis-related pain, Dr. Brooks and her coauthors said.
“Addressing arthritis in mental health treatment and behavioral medicine may also help to reduce the overlapping cognitive, behavioral, and somatic symptoms in older adults with depressive symptoms and arthritis, which may be difficult for providers to disentangle through brief screening procedures and treat through conventional depression care,” they wrote.
The investigators cited several limitations. For example, the cross-sectional nature of the study makes it difficult to draw conclusions about causality. In addition, Dr. Brooks and her colleagues did not distinguish between different types of arthritis.
The researchers declared no conflicts of interest. The study was supported by several U.S. institutes, including the National Institute of Mental Health, and by numerous entities related to Dartmouth, including the Dartmouth Health Promotion and Disease Prevention Research Center. The Howard and Phyllis Schwartz Philanthropic Fund also provided funding.
SOURCE: Brooks JM et al. Int J Geriatr Psychiatry. 2018 Sep 19. doi: 10.1022/gps.4971.
FROM THE INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY
Key clinical point: “It may be critical for mental health care providers to provide regular arthritis-related pain assessments” for older adults with or at risk for depression.
Major finding: Rates of arthritis were 55.0%, 62.9%, and 67.8% for those with mild, moderate, or severe depression, respectively, according to the 9-item Patient Health Questionnaire-9 scores.
Study details: Findings on 2,483 women and 2,309 men aged 50 years and older who participated in the National Health and Nutrition Examination Survey.
Disclosures: Dr. Brooks and her coauthors declared no conflicts of interest. The study was supported by several U.S. institutes, including the National Institute of Mental Health, and by numerous entities related to Dartmouth, including the Dartmouth Health Promotion and Disease Prevention Research Center. The Howard and Phyllis Schwartz Philanthropic Fund also provided funding.
Source: Brooks JM et al. Int J Geriatr Psychiatry. 2018 Sep 19. doi: 10.1002/gps.4971.
Cannabinoids may raise pain tolerance, not relieve pain itself
The belief that cannabinoids address chronic pain by relieving it has been challenged by a meta-analysis that finds cannabinoids have effects on pain thresholds that may, instead, make pain more tolerable.
The systematic review and meta-analysis comprised 18 placebo-controlled studies looking at the effect of plant-based or synthetic cannabinoids on experimental pain in 442 healthy participants. The conclusions were published Sept. 19 in JAMA Psychiatry.
“Cannabinoid drugs may prevent the onset of pain by producing small increases in pain thresholds,” wrote Martin J. De Vita and his colleagues, “but may not reduce the intensity of experimental pain already being experienced; instead, cannabinoids may make experimental pain feel less unpleasant and more tolerable, suggesting an influence on affective processes.”
Ten of the studies analyzed measured changes in pain thresholds and showed a small but significant association between cannabinoids and higher pain thresholds (95% confidence interval, 0.054-0.318; P = .006). Five studies examined pain unpleasantness, and showed that cannabinoids were associated with reduced unpleasantness ratings, compared with placebo (95% CI, 0.104-0.472; P = .002).
Among the eight studies that measured pain tolerance, a significant association was found between cannabinoid administration and higher pain tolerance (95% CI, 0.015-0.436; P = .04).
However, the 13 studies looking at pain intensity found no association between cannabinoid use and changes in the intensity of pain (CI, –0.120-0.154), nor were reductions in pain sensitivity to mechanical stimulation found in the three studies that measured mechanical hyperalgesia (95% CI, –0.059-0.244; P = .23).
The analysis did see significant effects according to the type of cannabinoid; plant-based cannabis had significantly stronger associations with reductions in pain unpleasantness compared to dronabinol and other synthetic THC preparations. However, both plant-based cannabis and dronabinol were associated with increases in pain tolerance, whereas other synthetic THC preparations were associated with significant reductions in pain tolerance.
Mr. De Vita, of the department of psychology at Syracuse (N.Y.) University, and his colleagues stressed that the systematic review and meta-analysis focused solely on studies of experimental pain, which “merely approximates features of clinical pain,” and specifically excluded individuals with chronic pain.
The absence of neuropathic pain data is “especially limiting, given that neuropathic pain is the primary condition for which modest empirical evidence exists that supports cannabinoid analgesia,” they wrote.
In particular, they drew attention to the finding that cannabinoids did not appear to have any effect on mechanical hyperalgesia, which they said suggests that cannabinoids might not address central sensitization in people with neuropathic pain.
The authors also raised the question of whether cannabinoids simply relieve pain by making people feel good or “high,” much like other intoxicating substances such as alcohol. They argued that the answer depends on what outcome is desired from treatment.
“If treatment aims to relieve pain without producing intoxication, psychoactive cannabinoids may not suffice,” they wrote. Ultimately, they said, the relief from pain experienced by some patients might be driven largely by an “affective rather than a sensory component.”
Among the limitations cited by the researchers is the focus on studies of experimental pain. “To produce evidence that supports the generalizability of the current findings, pain reactivity research must be conduced in clinical samples,” Mr. De Vita and his colleagues wrote.
The study was partly supported by the Syracuse University STEM Fellowship, and the National Institute on Alcohol Abuse and Alcoholism. No conflicts of interest were declared.
SOURCE: De Vita MJ et al. JAMA Psychiatry. 2018 Sep 19. doi: 10.1001/jamapsychiatry.2018.2503.
The belief that cannabinoids address chronic pain by relieving it has been challenged by a meta-analysis that finds cannabinoids have effects on pain thresholds that may, instead, make pain more tolerable.
The systematic review and meta-analysis comprised 18 placebo-controlled studies looking at the effect of plant-based or synthetic cannabinoids on experimental pain in 442 healthy participants. The conclusions were published Sept. 19 in JAMA Psychiatry.
“Cannabinoid drugs may prevent the onset of pain by producing small increases in pain thresholds,” wrote Martin J. De Vita and his colleagues, “but may not reduce the intensity of experimental pain already being experienced; instead, cannabinoids may make experimental pain feel less unpleasant and more tolerable, suggesting an influence on affective processes.”
Ten of the studies analyzed measured changes in pain thresholds and showed a small but significant association between cannabinoids and higher pain thresholds (95% confidence interval, 0.054-0.318; P = .006). Five studies examined pain unpleasantness, and showed that cannabinoids were associated with reduced unpleasantness ratings, compared with placebo (95% CI, 0.104-0.472; P = .002).
Among the eight studies that measured pain tolerance, a significant association was found between cannabinoid administration and higher pain tolerance (95% CI, 0.015-0.436; P = .04).
However, the 13 studies looking at pain intensity found no association between cannabinoid use and changes in the intensity of pain (CI, –0.120-0.154), nor were reductions in pain sensitivity to mechanical stimulation found in the three studies that measured mechanical hyperalgesia (95% CI, –0.059-0.244; P = .23).
The analysis did see significant effects according to the type of cannabinoid; plant-based cannabis had significantly stronger associations with reductions in pain unpleasantness compared to dronabinol and other synthetic THC preparations. However, both plant-based cannabis and dronabinol were associated with increases in pain tolerance, whereas other synthetic THC preparations were associated with significant reductions in pain tolerance.
Mr. De Vita, of the department of psychology at Syracuse (N.Y.) University, and his colleagues stressed that the systematic review and meta-analysis focused solely on studies of experimental pain, which “merely approximates features of clinical pain,” and specifically excluded individuals with chronic pain.
The absence of neuropathic pain data is “especially limiting, given that neuropathic pain is the primary condition for which modest empirical evidence exists that supports cannabinoid analgesia,” they wrote.
In particular, they drew attention to the finding that cannabinoids did not appear to have any effect on mechanical hyperalgesia, which they said suggests that cannabinoids might not address central sensitization in people with neuropathic pain.
The authors also raised the question of whether cannabinoids simply relieve pain by making people feel good or “high,” much like other intoxicating substances such as alcohol. They argued that the answer depends on what outcome is desired from treatment.
“If treatment aims to relieve pain without producing intoxication, psychoactive cannabinoids may not suffice,” they wrote. Ultimately, they said, the relief from pain experienced by some patients might be driven largely by an “affective rather than a sensory component.”
Among the limitations cited by the researchers is the focus on studies of experimental pain. “To produce evidence that supports the generalizability of the current findings, pain reactivity research must be conduced in clinical samples,” Mr. De Vita and his colleagues wrote.
The study was partly supported by the Syracuse University STEM Fellowship, and the National Institute on Alcohol Abuse and Alcoholism. No conflicts of interest were declared.
SOURCE: De Vita MJ et al. JAMA Psychiatry. 2018 Sep 19. doi: 10.1001/jamapsychiatry.2018.2503.
The belief that cannabinoids address chronic pain by relieving it has been challenged by a meta-analysis that finds cannabinoids have effects on pain thresholds that may, instead, make pain more tolerable.
The systematic review and meta-analysis comprised 18 placebo-controlled studies looking at the effect of plant-based or synthetic cannabinoids on experimental pain in 442 healthy participants. The conclusions were published Sept. 19 in JAMA Psychiatry.
“Cannabinoid drugs may prevent the onset of pain by producing small increases in pain thresholds,” wrote Martin J. De Vita and his colleagues, “but may not reduce the intensity of experimental pain already being experienced; instead, cannabinoids may make experimental pain feel less unpleasant and more tolerable, suggesting an influence on affective processes.”
Ten of the studies analyzed measured changes in pain thresholds and showed a small but significant association between cannabinoids and higher pain thresholds (95% confidence interval, 0.054-0.318; P = .006). Five studies examined pain unpleasantness, and showed that cannabinoids were associated with reduced unpleasantness ratings, compared with placebo (95% CI, 0.104-0.472; P = .002).
Among the eight studies that measured pain tolerance, a significant association was found between cannabinoid administration and higher pain tolerance (95% CI, 0.015-0.436; P = .04).
However, the 13 studies looking at pain intensity found no association between cannabinoid use and changes in the intensity of pain (CI, –0.120-0.154), nor were reductions in pain sensitivity to mechanical stimulation found in the three studies that measured mechanical hyperalgesia (95% CI, –0.059-0.244; P = .23).
The analysis did see significant effects according to the type of cannabinoid; plant-based cannabis had significantly stronger associations with reductions in pain unpleasantness compared to dronabinol and other synthetic THC preparations. However, both plant-based cannabis and dronabinol were associated with increases in pain tolerance, whereas other synthetic THC preparations were associated with significant reductions in pain tolerance.
Mr. De Vita, of the department of psychology at Syracuse (N.Y.) University, and his colleagues stressed that the systematic review and meta-analysis focused solely on studies of experimental pain, which “merely approximates features of clinical pain,” and specifically excluded individuals with chronic pain.
The absence of neuropathic pain data is “especially limiting, given that neuropathic pain is the primary condition for which modest empirical evidence exists that supports cannabinoid analgesia,” they wrote.
In particular, they drew attention to the finding that cannabinoids did not appear to have any effect on mechanical hyperalgesia, which they said suggests that cannabinoids might not address central sensitization in people with neuropathic pain.
The authors also raised the question of whether cannabinoids simply relieve pain by making people feel good or “high,” much like other intoxicating substances such as alcohol. They argued that the answer depends on what outcome is desired from treatment.
“If treatment aims to relieve pain without producing intoxication, psychoactive cannabinoids may not suffice,” they wrote. Ultimately, they said, the relief from pain experienced by some patients might be driven largely by an “affective rather than a sensory component.”
Among the limitations cited by the researchers is the focus on studies of experimental pain. “To produce evidence that supports the generalizability of the current findings, pain reactivity research must be conduced in clinical samples,” Mr. De Vita and his colleagues wrote.
The study was partly supported by the Syracuse University STEM Fellowship, and the National Institute on Alcohol Abuse and Alcoholism. No conflicts of interest were declared.
SOURCE: De Vita MJ et al. JAMA Psychiatry. 2018 Sep 19. doi: 10.1001/jamapsychiatry.2018.2503.
FROM JAMA PSYCHIATRY
Key clinical point: Cannabinoids might relieve experimental pain by making people feel good or “high,” much like other intoxicating substances such as alcohol.
Major finding: Cannabinoids improve pain thresholds (95% confidence interval, 0.054-0.3,18; P = .006) and pain unpleasantness (95% CI, 0.104-0.472; P = .002).
Study details: Systematic review and meta-analysis of 18 placebo-controlled studies of experimental pain.
Disclosures: The study was partly supported by the Syracuse University STEM Fellowship, and the National Institute on Alcohol Abuse and Alcoholism. No conflicts of interest were declared.
Source: De Vita MJ et al. JAMA Psychiatry. 2018 Sep 19. doi: 10.1001/jamapsychiatry.2018.2503.
Connecting at TCT 2018
The 30th anniversary of the Transcatheter Cardiovascular Therapeutics meeting in San Diego, sponsored by the Cardiovascular Research Foundation, will be the temporary home of more than 10,000 attendees. That’s up from about 9,400 last year.
Even so, that leaves a lot of folks who can’t be in sunny California. Keep in touch with friends near and far by using social media. Twitter hashtags for the meeting are #TCT2018 and #TCTConference.
The organizers encourage attendees to share their experiences and the educational content from the meeting, keeping in mind embargoes and some limitations, by posting photos, slides, or short video clips. Also, presentation slides will be online immediately after the sessions.
Attendees also can connect with each other using the the CRF Events app, available for free download here. But we recommend that meet outside if you can, considering the weather report.
The 30th anniversary of the Transcatheter Cardiovascular Therapeutics meeting in San Diego, sponsored by the Cardiovascular Research Foundation, will be the temporary home of more than 10,000 attendees. That’s up from about 9,400 last year.
Even so, that leaves a lot of folks who can’t be in sunny California. Keep in touch with friends near and far by using social media. Twitter hashtags for the meeting are #TCT2018 and #TCTConference.
The organizers encourage attendees to share their experiences and the educational content from the meeting, keeping in mind embargoes and some limitations, by posting photos, slides, or short video clips. Also, presentation slides will be online immediately after the sessions.
Attendees also can connect with each other using the the CRF Events app, available for free download here. But we recommend that meet outside if you can, considering the weather report.
The 30th anniversary of the Transcatheter Cardiovascular Therapeutics meeting in San Diego, sponsored by the Cardiovascular Research Foundation, will be the temporary home of more than 10,000 attendees. That’s up from about 9,400 last year.
Even so, that leaves a lot of folks who can’t be in sunny California. Keep in touch with friends near and far by using social media. Twitter hashtags for the meeting are #TCT2018 and #TCTConference.
The organizers encourage attendees to share their experiences and the educational content from the meeting, keeping in mind embargoes and some limitations, by posting photos, slides, or short video clips. Also, presentation slides will be online immediately after the sessions.
Attendees also can connect with each other using the the CRF Events app, available for free download here. But we recommend that meet outside if you can, considering the weather report.
Minilaparoscopy is the next step in minimally invasive surgery
Minimally invasive surgeons have been intrigued for more than 2 decades by the clinical aspects and benefits of minilaparoscopy. Miniature instruments (2-3.5 mm) were introduced starting in the late 1980s, and through the 1990s minilaparoscopic procedures were performed across multiple specialties. However, the instrumentation available at the time had limited durability and functionality (for example, a lack of electrosurgical capability), and clinical experience and resulting data were sparse. The minilaparoscopic approach failed to gain momentum and was never widely adopted.
In the past 5-10 years, with new innovations in technology and improved instrumentation, minilaparoscopy is undergoing a renaissance in surgical circles. Medical device companies have developed numerous electrosurgical and other advanced energy options as well as a variety of needle holders, graspers, and other instruments – all with diameters of 3.5 mm or less and with significantly more durability than the earlier generation of mini-instruments. While surgeons oftentimes still use larger telescopes for better visualization, 2- to 3.5-mm telescopes are available in various lengths and angles, and optic quality is continually improving.
The minilaparoscopic approach is more similar to conventional laparoscopy than laparoendoscopic single-site surgery, which has not met early expectations. It is a more logical next step in the evolution of minimally invasive surgery and its goals of further reducing surgical trauma and improving cosmesis. I am performing hysterectomies in which I place two 5-mm nonbladed trocars through incisions inside the umbilicus and a minilaparoscopic percutaneous cannula below the bikini line; it is a “hybrid” procedure, in essence, that incorporates the use of mini-instrumentation.
In addition to diagnostic laparoscopy, I also use minilaparoscopy for some of my patients who need ovarian cystectomy, oophorectomy, appendectomy, treatment of early-stage endometriosis or adhesiolysis. Throughout the world and across multiple specialties, it is being adopted for a wide range of adult and pediatric procedures, from abdominopelvic adhesions and inguinal hernia repair to cholecystectomy, and even to enhance diagnosis in the ED or ICU.1
The importance of surgical scars
The resurgence of interest in minilaparoscopy has been driven largely by its clinical advantages. From a clinical standpoint, less intrusion through the abdominal wall with the use of smaller instruments and fewer insertion points generally means less surgical trauma, and less analgesic medication and postoperative pain, for instance, as well as fewer vascular injuries and a more minimal risk of adhesions. Scar cosmesis also has been viewed as an advantage, just as it was when the abdominal hysterectomy was being replaced by laparoscopic hysterectomy starting in 1989. Still, for me, the clinical aspects have long been at the forefront.
My interest in providing my patients the very best cosmetic results changed after we surveyed patients who were scheduled for a hysterectomy in my practice over the span of 1 year. All patients seen during that time (from November 2012 to November 2013) were asked to complete a questionnaire on their knowledge of hysterectomy incisional scars, their perceptions, and their desires. Almost all of the 200 women who completed the survey – 93% – indicated that cosmetic issues such as scars are important to them (“slightly,” “moderately,” “quite,” or “extremely” important), and of these, 24% chose “extremely important.”
Asked how they feel about the appearance of their scars from prior abdominal surgery, 58% indicated the appearance bothered them to some extent, and 11% said they were “extremely” bothered. Almost all of the 200 patients – 92% – said they would be interested in a surgery that would leave no scars, and 45% said they were “extremely” interested.2
The findings juxtaposed the clinical benefits of more minimally invasive surgery – what had been foremost on my mind – with patients’ attention to and concern about scars. The study demonstrated that patient preferences are just as compelling, if not more, than what the surgeon wants. It showed, moreover, how important it is to discuss hysterectomy incision options – and patient preferences regarding incision location, size, and number – prior to surgery.
When asked about their familiarity with the locations of skin incisions in different hysterectomy procedures (abdominal, vaginal, laparoscopic, robotic, and mini), between 25% and 56% indicated they were not at all familiar with them. Familiarity was greatest with incisions in traditional laparoscopic hysterectomy. Yet patients want to have that knowledge: Almost all of the survey participants – 93% – indicated it is important to discuss the location, number, and size of incisions prior to surgery, and 59% said it is “extremely” important.
Patients also were asked to rank a short list of incision locations (above or below the belly button, and above or below the bikini line) from the least desirable to most desirable, and the results suggest just how different personal preferences can be. The most-desirable incision location was below the bikini line for 68% of patients, followed by above the belly button for 16%. The least-desirable location was above the belly button for 69%, followed by below the bikini line for 15%. Asked whether it is cosmetically superior for one’s incisions to be low (below the bikini line), 86% said they agreed.
Other research has similarly shown that cosmesis is important for women undergoing gynecologic surgery. For instance, women in another single-practice study were more likely to prefer single-site and traditional laparoscopic incisions over robotic ones when they were shown photos of an abdomen marked up with the incision lengths and locations typical for each of these three approaches.3 And notably, there has been research looking at the psychological impact of incisional scars specifically in patients who are morbidly obese.
While we may not be accustomed to discussing incisions and scars, it behooves us as surgeons to consider initiating a conversation about incisions with all our patients – regardless of their body mass index and prior surgical history – during the preoperative evaluation.
My hysterectomy approach
I have utilized one of the most recent developments in minilaparoscopy instrumentation – the MiniLap percutaneous surgical system (Teleflex) – to develop a mini technique for hysterectomy I’ve trademarked as the Cosmetic Hysterectomy. The percutaneous system has an outer diameter of 2.3 mm, integrated needle tips that facilitate insertion without a trocar, and a selection of integrated graspers (e.g., a miniature clutch or alligator) that open up to 12.5 mm and can be advanced and retracted through the cannula. The graspers can be locked onto the tissue, and the system itself can be stabilized extracorporeally so that it can be hands free.
For the hysterectomy, I make two 5-mm vertical incisions within the umbilicus – one for a nonbladed 5-mm trocar at 12 o’clock and the other for a second nonbladed 5-mm trocar at 6 o’clock, penetrating the fascia. The trocars house a 30-degree extra-long laparoscope with camera attached, and an advanced bipolar electrosurgery device.
The minilaparoscopic cannula is inserted in the lower-abdominal area through a single 1-mm stab incision, and one or two instruments can be placed as needed. Tissues can be removed vaginally once dissection is completed, and the vaginal cuff can be closed laparoscopically or vaginally. The edges of the minilaparoscopic cannula are approximated together and held with surgical glue or a sterile skin-closure strip. There is no need to close the fascia.4
The percutaneous system opens new windows for minimally invasive surgery. It can be moved and used in several locations throughout a surgical procedure such that we can achieve more patient-specific “incisional mapping,” as I’m now calling it, rather than uniformly utilizing standard trocar placement sites.
Even without use of this particular innovation, the use of smaller instruments is proving both feasible and advantageous. A study that randomized 75 women scheduled for a hysterectomy to traditional laparoscopy (with a 5- to 10-mm port size) or minilaparoscopy (with a 3-mm port size) found no statistically significant differences in blood loss, hemoglobin drop, pain scores, or analgesic use. The authors concluded that the smaller port sizes did not affect the ability to perform the procedure. Moreover, they noted, the minilaparoscopy group had consistently smaller scars and better cosmesis.5
Another retrospective study of perioperative outcomes with standard laparoscopic, minilaparoscopic, and laparoendoscopic single-site hysterectomy found that postoperative pain control and the need for analgesic medication was significantly less with minilaparoscopy and laparoendoscopic single-site (LESS) hysterectomy, compared with traditional laparoscopy. Pain and medication in patients undergoing minilaparoscopy was reduced by more than 50%, compared with the traditional laparoscopy group, which suggests less operative trauma.6
In my practice, postoperative analgesia is simply intranasal ketorolac tromethamine (Sprix) and/or long-acting tramadol (Conzip); opioids have been eliminated in all minilaparoscopic procedures. We have had no complications, including no trocar-site bleeding, nerve entrapments, trocar-site herniations, or infections. Not every patient is a candidate for consideration of a minilaparoscopic hysterectomy, of course. The patient who has extensive adhesions from multiple previous surgeries or a large uterus with fibroids, for instance, should be treated with traditional laparoscopy regardless of her concerns regarding cosmesis.
No two surgeons are alike; each has his/her own ideas, skill sets, and approaches. Minilaparoscopy may not be for everyone, but given the number of durable miniature instruments now available, it’s an approach to consider integrating into a variety of gynecologic procedures.
For a right salpingo-oophorectomy, for instance, a 3-mm trocar placed at 12 o’clock through the umbilicus can accommodate a 3-mm scope with a high-definition camera, and an 11-mm trocar placed at 6 o’clock can house an energy device. In the right and left lower quadrants, two additional 3-mm trocars can be placed – one to accommodate a grasping instrument and the other to house the scope after the fallopian tube has been transected. A specimen bag can be passed through the 11-mm trocar in the umbilicus for removal of the ovary and tube. With the umbilicus hiding the largest of scars, the procedure is less invasive with better cosmetic results.
Dr. McCarus disclosed that he is a consultant for Ethicon.
References
1. Surg Technol Int. 2015 Nov;27:19-30.
2. Surg Technol Int. 2014 Nov;25:150-6.
3. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):640-3.
4. Surg Technol Int 2013 Sep;23:129-32.
5. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.
6. Surg Endosc. 2012 Dec;26(12):3592-6.
Minimally invasive surgeons have been intrigued for more than 2 decades by the clinical aspects and benefits of minilaparoscopy. Miniature instruments (2-3.5 mm) were introduced starting in the late 1980s, and through the 1990s minilaparoscopic procedures were performed across multiple specialties. However, the instrumentation available at the time had limited durability and functionality (for example, a lack of electrosurgical capability), and clinical experience and resulting data were sparse. The minilaparoscopic approach failed to gain momentum and was never widely adopted.
In the past 5-10 years, with new innovations in technology and improved instrumentation, minilaparoscopy is undergoing a renaissance in surgical circles. Medical device companies have developed numerous electrosurgical and other advanced energy options as well as a variety of needle holders, graspers, and other instruments – all with diameters of 3.5 mm or less and with significantly more durability than the earlier generation of mini-instruments. While surgeons oftentimes still use larger telescopes for better visualization, 2- to 3.5-mm telescopes are available in various lengths and angles, and optic quality is continually improving.
The minilaparoscopic approach is more similar to conventional laparoscopy than laparoendoscopic single-site surgery, which has not met early expectations. It is a more logical next step in the evolution of minimally invasive surgery and its goals of further reducing surgical trauma and improving cosmesis. I am performing hysterectomies in which I place two 5-mm nonbladed trocars through incisions inside the umbilicus and a minilaparoscopic percutaneous cannula below the bikini line; it is a “hybrid” procedure, in essence, that incorporates the use of mini-instrumentation.
In addition to diagnostic laparoscopy, I also use minilaparoscopy for some of my patients who need ovarian cystectomy, oophorectomy, appendectomy, treatment of early-stage endometriosis or adhesiolysis. Throughout the world and across multiple specialties, it is being adopted for a wide range of adult and pediatric procedures, from abdominopelvic adhesions and inguinal hernia repair to cholecystectomy, and even to enhance diagnosis in the ED or ICU.1
The importance of surgical scars
The resurgence of interest in minilaparoscopy has been driven largely by its clinical advantages. From a clinical standpoint, less intrusion through the abdominal wall with the use of smaller instruments and fewer insertion points generally means less surgical trauma, and less analgesic medication and postoperative pain, for instance, as well as fewer vascular injuries and a more minimal risk of adhesions. Scar cosmesis also has been viewed as an advantage, just as it was when the abdominal hysterectomy was being replaced by laparoscopic hysterectomy starting in 1989. Still, for me, the clinical aspects have long been at the forefront.
My interest in providing my patients the very best cosmetic results changed after we surveyed patients who were scheduled for a hysterectomy in my practice over the span of 1 year. All patients seen during that time (from November 2012 to November 2013) were asked to complete a questionnaire on their knowledge of hysterectomy incisional scars, their perceptions, and their desires. Almost all of the 200 women who completed the survey – 93% – indicated that cosmetic issues such as scars are important to them (“slightly,” “moderately,” “quite,” or “extremely” important), and of these, 24% chose “extremely important.”
Asked how they feel about the appearance of their scars from prior abdominal surgery, 58% indicated the appearance bothered them to some extent, and 11% said they were “extremely” bothered. Almost all of the 200 patients – 92% – said they would be interested in a surgery that would leave no scars, and 45% said they were “extremely” interested.2
The findings juxtaposed the clinical benefits of more minimally invasive surgery – what had been foremost on my mind – with patients’ attention to and concern about scars. The study demonstrated that patient preferences are just as compelling, if not more, than what the surgeon wants. It showed, moreover, how important it is to discuss hysterectomy incision options – and patient preferences regarding incision location, size, and number – prior to surgery.
When asked about their familiarity with the locations of skin incisions in different hysterectomy procedures (abdominal, vaginal, laparoscopic, robotic, and mini), between 25% and 56% indicated they were not at all familiar with them. Familiarity was greatest with incisions in traditional laparoscopic hysterectomy. Yet patients want to have that knowledge: Almost all of the survey participants – 93% – indicated it is important to discuss the location, number, and size of incisions prior to surgery, and 59% said it is “extremely” important.
Patients also were asked to rank a short list of incision locations (above or below the belly button, and above or below the bikini line) from the least desirable to most desirable, and the results suggest just how different personal preferences can be. The most-desirable incision location was below the bikini line for 68% of patients, followed by above the belly button for 16%. The least-desirable location was above the belly button for 69%, followed by below the bikini line for 15%. Asked whether it is cosmetically superior for one’s incisions to be low (below the bikini line), 86% said they agreed.
Other research has similarly shown that cosmesis is important for women undergoing gynecologic surgery. For instance, women in another single-practice study were more likely to prefer single-site and traditional laparoscopic incisions over robotic ones when they were shown photos of an abdomen marked up with the incision lengths and locations typical for each of these three approaches.3 And notably, there has been research looking at the psychological impact of incisional scars specifically in patients who are morbidly obese.
While we may not be accustomed to discussing incisions and scars, it behooves us as surgeons to consider initiating a conversation about incisions with all our patients – regardless of their body mass index and prior surgical history – during the preoperative evaluation.
My hysterectomy approach
I have utilized one of the most recent developments in minilaparoscopy instrumentation – the MiniLap percutaneous surgical system (Teleflex) – to develop a mini technique for hysterectomy I’ve trademarked as the Cosmetic Hysterectomy. The percutaneous system has an outer diameter of 2.3 mm, integrated needle tips that facilitate insertion without a trocar, and a selection of integrated graspers (e.g., a miniature clutch or alligator) that open up to 12.5 mm and can be advanced and retracted through the cannula. The graspers can be locked onto the tissue, and the system itself can be stabilized extracorporeally so that it can be hands free.
For the hysterectomy, I make two 5-mm vertical incisions within the umbilicus – one for a nonbladed 5-mm trocar at 12 o’clock and the other for a second nonbladed 5-mm trocar at 6 o’clock, penetrating the fascia. The trocars house a 30-degree extra-long laparoscope with camera attached, and an advanced bipolar electrosurgery device.
The minilaparoscopic cannula is inserted in the lower-abdominal area through a single 1-mm stab incision, and one or two instruments can be placed as needed. Tissues can be removed vaginally once dissection is completed, and the vaginal cuff can be closed laparoscopically or vaginally. The edges of the minilaparoscopic cannula are approximated together and held with surgical glue or a sterile skin-closure strip. There is no need to close the fascia.4
The percutaneous system opens new windows for minimally invasive surgery. It can be moved and used in several locations throughout a surgical procedure such that we can achieve more patient-specific “incisional mapping,” as I’m now calling it, rather than uniformly utilizing standard trocar placement sites.
Even without use of this particular innovation, the use of smaller instruments is proving both feasible and advantageous. A study that randomized 75 women scheduled for a hysterectomy to traditional laparoscopy (with a 5- to 10-mm port size) or minilaparoscopy (with a 3-mm port size) found no statistically significant differences in blood loss, hemoglobin drop, pain scores, or analgesic use. The authors concluded that the smaller port sizes did not affect the ability to perform the procedure. Moreover, they noted, the minilaparoscopy group had consistently smaller scars and better cosmesis.5
Another retrospective study of perioperative outcomes with standard laparoscopic, minilaparoscopic, and laparoendoscopic single-site hysterectomy found that postoperative pain control and the need for analgesic medication was significantly less with minilaparoscopy and laparoendoscopic single-site (LESS) hysterectomy, compared with traditional laparoscopy. Pain and medication in patients undergoing minilaparoscopy was reduced by more than 50%, compared with the traditional laparoscopy group, which suggests less operative trauma.6
In my practice, postoperative analgesia is simply intranasal ketorolac tromethamine (Sprix) and/or long-acting tramadol (Conzip); opioids have been eliminated in all minilaparoscopic procedures. We have had no complications, including no trocar-site bleeding, nerve entrapments, trocar-site herniations, or infections. Not every patient is a candidate for consideration of a minilaparoscopic hysterectomy, of course. The patient who has extensive adhesions from multiple previous surgeries or a large uterus with fibroids, for instance, should be treated with traditional laparoscopy regardless of her concerns regarding cosmesis.
No two surgeons are alike; each has his/her own ideas, skill sets, and approaches. Minilaparoscopy may not be for everyone, but given the number of durable miniature instruments now available, it’s an approach to consider integrating into a variety of gynecologic procedures.
For a right salpingo-oophorectomy, for instance, a 3-mm trocar placed at 12 o’clock through the umbilicus can accommodate a 3-mm scope with a high-definition camera, and an 11-mm trocar placed at 6 o’clock can house an energy device. In the right and left lower quadrants, two additional 3-mm trocars can be placed – one to accommodate a grasping instrument and the other to house the scope after the fallopian tube has been transected. A specimen bag can be passed through the 11-mm trocar in the umbilicus for removal of the ovary and tube. With the umbilicus hiding the largest of scars, the procedure is less invasive with better cosmetic results.
Dr. McCarus disclosed that he is a consultant for Ethicon.
References
1. Surg Technol Int. 2015 Nov;27:19-30.
2. Surg Technol Int. 2014 Nov;25:150-6.
3. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):640-3.
4. Surg Technol Int 2013 Sep;23:129-32.
5. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.
6. Surg Endosc. 2012 Dec;26(12):3592-6.
Minimally invasive surgeons have been intrigued for more than 2 decades by the clinical aspects and benefits of minilaparoscopy. Miniature instruments (2-3.5 mm) were introduced starting in the late 1980s, and through the 1990s minilaparoscopic procedures were performed across multiple specialties. However, the instrumentation available at the time had limited durability and functionality (for example, a lack of electrosurgical capability), and clinical experience and resulting data were sparse. The minilaparoscopic approach failed to gain momentum and was never widely adopted.
In the past 5-10 years, with new innovations in technology and improved instrumentation, minilaparoscopy is undergoing a renaissance in surgical circles. Medical device companies have developed numerous electrosurgical and other advanced energy options as well as a variety of needle holders, graspers, and other instruments – all with diameters of 3.5 mm or less and with significantly more durability than the earlier generation of mini-instruments. While surgeons oftentimes still use larger telescopes for better visualization, 2- to 3.5-mm telescopes are available in various lengths and angles, and optic quality is continually improving.
The minilaparoscopic approach is more similar to conventional laparoscopy than laparoendoscopic single-site surgery, which has not met early expectations. It is a more logical next step in the evolution of minimally invasive surgery and its goals of further reducing surgical trauma and improving cosmesis. I am performing hysterectomies in which I place two 5-mm nonbladed trocars through incisions inside the umbilicus and a minilaparoscopic percutaneous cannula below the bikini line; it is a “hybrid” procedure, in essence, that incorporates the use of mini-instrumentation.
In addition to diagnostic laparoscopy, I also use minilaparoscopy for some of my patients who need ovarian cystectomy, oophorectomy, appendectomy, treatment of early-stage endometriosis or adhesiolysis. Throughout the world and across multiple specialties, it is being adopted for a wide range of adult and pediatric procedures, from abdominopelvic adhesions and inguinal hernia repair to cholecystectomy, and even to enhance diagnosis in the ED or ICU.1
The importance of surgical scars
The resurgence of interest in minilaparoscopy has been driven largely by its clinical advantages. From a clinical standpoint, less intrusion through the abdominal wall with the use of smaller instruments and fewer insertion points generally means less surgical trauma, and less analgesic medication and postoperative pain, for instance, as well as fewer vascular injuries and a more minimal risk of adhesions. Scar cosmesis also has been viewed as an advantage, just as it was when the abdominal hysterectomy was being replaced by laparoscopic hysterectomy starting in 1989. Still, for me, the clinical aspects have long been at the forefront.
My interest in providing my patients the very best cosmetic results changed after we surveyed patients who were scheduled for a hysterectomy in my practice over the span of 1 year. All patients seen during that time (from November 2012 to November 2013) were asked to complete a questionnaire on their knowledge of hysterectomy incisional scars, their perceptions, and their desires. Almost all of the 200 women who completed the survey – 93% – indicated that cosmetic issues such as scars are important to them (“slightly,” “moderately,” “quite,” or “extremely” important), and of these, 24% chose “extremely important.”
Asked how they feel about the appearance of their scars from prior abdominal surgery, 58% indicated the appearance bothered them to some extent, and 11% said they were “extremely” bothered. Almost all of the 200 patients – 92% – said they would be interested in a surgery that would leave no scars, and 45% said they were “extremely” interested.2
The findings juxtaposed the clinical benefits of more minimally invasive surgery – what had been foremost on my mind – with patients’ attention to and concern about scars. The study demonstrated that patient preferences are just as compelling, if not more, than what the surgeon wants. It showed, moreover, how important it is to discuss hysterectomy incision options – and patient preferences regarding incision location, size, and number – prior to surgery.
When asked about their familiarity with the locations of skin incisions in different hysterectomy procedures (abdominal, vaginal, laparoscopic, robotic, and mini), between 25% and 56% indicated they were not at all familiar with them. Familiarity was greatest with incisions in traditional laparoscopic hysterectomy. Yet patients want to have that knowledge: Almost all of the survey participants – 93% – indicated it is important to discuss the location, number, and size of incisions prior to surgery, and 59% said it is “extremely” important.
Patients also were asked to rank a short list of incision locations (above or below the belly button, and above or below the bikini line) from the least desirable to most desirable, and the results suggest just how different personal preferences can be. The most-desirable incision location was below the bikini line for 68% of patients, followed by above the belly button for 16%. The least-desirable location was above the belly button for 69%, followed by below the bikini line for 15%. Asked whether it is cosmetically superior for one’s incisions to be low (below the bikini line), 86% said they agreed.
Other research has similarly shown that cosmesis is important for women undergoing gynecologic surgery. For instance, women in another single-practice study were more likely to prefer single-site and traditional laparoscopic incisions over robotic ones when they were shown photos of an abdomen marked up with the incision lengths and locations typical for each of these three approaches.3 And notably, there has been research looking at the psychological impact of incisional scars specifically in patients who are morbidly obese.
While we may not be accustomed to discussing incisions and scars, it behooves us as surgeons to consider initiating a conversation about incisions with all our patients – regardless of their body mass index and prior surgical history – during the preoperative evaluation.
My hysterectomy approach
I have utilized one of the most recent developments in minilaparoscopy instrumentation – the MiniLap percutaneous surgical system (Teleflex) – to develop a mini technique for hysterectomy I’ve trademarked as the Cosmetic Hysterectomy. The percutaneous system has an outer diameter of 2.3 mm, integrated needle tips that facilitate insertion without a trocar, and a selection of integrated graspers (e.g., a miniature clutch or alligator) that open up to 12.5 mm and can be advanced and retracted through the cannula. The graspers can be locked onto the tissue, and the system itself can be stabilized extracorporeally so that it can be hands free.
For the hysterectomy, I make two 5-mm vertical incisions within the umbilicus – one for a nonbladed 5-mm trocar at 12 o’clock and the other for a second nonbladed 5-mm trocar at 6 o’clock, penetrating the fascia. The trocars house a 30-degree extra-long laparoscope with camera attached, and an advanced bipolar electrosurgery device.
The minilaparoscopic cannula is inserted in the lower-abdominal area through a single 1-mm stab incision, and one or two instruments can be placed as needed. Tissues can be removed vaginally once dissection is completed, and the vaginal cuff can be closed laparoscopically or vaginally. The edges of the minilaparoscopic cannula are approximated together and held with surgical glue or a sterile skin-closure strip. There is no need to close the fascia.4
The percutaneous system opens new windows for minimally invasive surgery. It can be moved and used in several locations throughout a surgical procedure such that we can achieve more patient-specific “incisional mapping,” as I’m now calling it, rather than uniformly utilizing standard trocar placement sites.
Even without use of this particular innovation, the use of smaller instruments is proving both feasible and advantageous. A study that randomized 75 women scheduled for a hysterectomy to traditional laparoscopy (with a 5- to 10-mm port size) or minilaparoscopy (with a 3-mm port size) found no statistically significant differences in blood loss, hemoglobin drop, pain scores, or analgesic use. The authors concluded that the smaller port sizes did not affect the ability to perform the procedure. Moreover, they noted, the minilaparoscopy group had consistently smaller scars and better cosmesis.5
Another retrospective study of perioperative outcomes with standard laparoscopic, minilaparoscopic, and laparoendoscopic single-site hysterectomy found that postoperative pain control and the need for analgesic medication was significantly less with minilaparoscopy and laparoendoscopic single-site (LESS) hysterectomy, compared with traditional laparoscopy. Pain and medication in patients undergoing minilaparoscopy was reduced by more than 50%, compared with the traditional laparoscopy group, which suggests less operative trauma.6
In my practice, postoperative analgesia is simply intranasal ketorolac tromethamine (Sprix) and/or long-acting tramadol (Conzip); opioids have been eliminated in all minilaparoscopic procedures. We have had no complications, including no trocar-site bleeding, nerve entrapments, trocar-site herniations, or infections. Not every patient is a candidate for consideration of a minilaparoscopic hysterectomy, of course. The patient who has extensive adhesions from multiple previous surgeries or a large uterus with fibroids, for instance, should be treated with traditional laparoscopy regardless of her concerns regarding cosmesis.
No two surgeons are alike; each has his/her own ideas, skill sets, and approaches. Minilaparoscopy may not be for everyone, but given the number of durable miniature instruments now available, it’s an approach to consider integrating into a variety of gynecologic procedures.
For a right salpingo-oophorectomy, for instance, a 3-mm trocar placed at 12 o’clock through the umbilicus can accommodate a 3-mm scope with a high-definition camera, and an 11-mm trocar placed at 6 o’clock can house an energy device. In the right and left lower quadrants, two additional 3-mm trocars can be placed – one to accommodate a grasping instrument and the other to house the scope after the fallopian tube has been transected. A specimen bag can be passed through the 11-mm trocar in the umbilicus for removal of the ovary and tube. With the umbilicus hiding the largest of scars, the procedure is less invasive with better cosmetic results.
Dr. McCarus disclosed that he is a consultant for Ethicon.
References
1. Surg Technol Int. 2015 Nov;27:19-30.
2. Surg Technol Int. 2014 Nov;25:150-6.
3. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):640-3.
4. Surg Technol Int 2013 Sep;23:129-32.
5. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.
6. Surg Endosc. 2012 Dec;26(12):3592-6.
Minilaparoscopy is a relevant surgical technique
With the wax and wane in the popularity of single-port surgery and with the advent of improved instrumentation, minilaparoscopy would appear to be the next long-lasting surgical technique to enhance postsurgical cosmetic appearance. For this reason, it is surprising that the use of minilaparoscopy has not been acknowledged and evaluated as a viable option more often in general surgery and urology. This, despite the fact that the use of this technique in hysterectomy was described nearly 20 years ago.1
Our minimally invasive gynecologic surgery (MIGS) team has utilized minilaparoscopy for diagnostic laparoscopy, lysis of adhesions, treatment of stage I, II, and occasionally stage III endometriosis, ovarian cystectomy, ureterolysis, presacral neurectomy, and total laparoscopic hysterectomy – as has our guest author Steven McCarus, MD. When performing hysterectomy via minilaparoscopy, our team closes the vaginal cuff laparoscopically, placing the suture transvaginally.
By removing the fibroid via a colpotomy incision, the Italian MIGS surgeon Fabio Ghezzi, MD, is able to perform myomectomy and hysterectomy routinely via minilaparoscopy.2 Articles have been published regarding the feasibility of performing minilaparoscopic surgery for both the treatment of benign adnexal mases3 and endometriosis.4
Dr. McCarus presents compelling evidence regarding the cosmetic advantage of minilaparoscopy, but the reported impact on pain has been variable: As Alyssa Small Layne et al. states, “Some studies associate minilaparoscopy with decreased pain, whereas others did not find a difference.”5 In part, this is attributable to the fact that no matter what technique is performed, the pathology must be excised. However, it is my belief that with improvements in instrumentation – as noted by Dr. McCarus and our collected added experience – the postoperative pain profile for the patient undergoing minilaparoscopy will change dramatically.
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Dr. McCarus, who is the chief of gynecological surgery at Florida Hospital Celebration Health, Celebration. With over 25 years of experience, Dr. McCarus is nationally known as a leader in the practice of minimally invasive gynecologic surgery.
It is a pleasure to welcome Dr. McCarus to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class.
References
1. J Am Assoc Gynecol Laparosc. 1999 Feb;6(1):97-100.
2. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.
3. J Clin Med Res. 2017 Jul;9(7):613-7.
4. Gynecol Minim Invasive Ther. 2013 Aug;2(3):85-8.
5. Curr Opin Obstet Gynecol. 2016 Aug;28(4):255-60.
With the wax and wane in the popularity of single-port surgery and with the advent of improved instrumentation, minilaparoscopy would appear to be the next long-lasting surgical technique to enhance postsurgical cosmetic appearance. For this reason, it is surprising that the use of minilaparoscopy has not been acknowledged and evaluated as a viable option more often in general surgery and urology. This, despite the fact that the use of this technique in hysterectomy was described nearly 20 years ago.1
Our minimally invasive gynecologic surgery (MIGS) team has utilized minilaparoscopy for diagnostic laparoscopy, lysis of adhesions, treatment of stage I, II, and occasionally stage III endometriosis, ovarian cystectomy, ureterolysis, presacral neurectomy, and total laparoscopic hysterectomy – as has our guest author Steven McCarus, MD. When performing hysterectomy via minilaparoscopy, our team closes the vaginal cuff laparoscopically, placing the suture transvaginally.
By removing the fibroid via a colpotomy incision, the Italian MIGS surgeon Fabio Ghezzi, MD, is able to perform myomectomy and hysterectomy routinely via minilaparoscopy.2 Articles have been published regarding the feasibility of performing minilaparoscopic surgery for both the treatment of benign adnexal mases3 and endometriosis.4
Dr. McCarus presents compelling evidence regarding the cosmetic advantage of minilaparoscopy, but the reported impact on pain has been variable: As Alyssa Small Layne et al. states, “Some studies associate minilaparoscopy with decreased pain, whereas others did not find a difference.”5 In part, this is attributable to the fact that no matter what technique is performed, the pathology must be excised. However, it is my belief that with improvements in instrumentation – as noted by Dr. McCarus and our collected added experience – the postoperative pain profile for the patient undergoing minilaparoscopy will change dramatically.
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Dr. McCarus, who is the chief of gynecological surgery at Florida Hospital Celebration Health, Celebration. With over 25 years of experience, Dr. McCarus is nationally known as a leader in the practice of minimally invasive gynecologic surgery.
It is a pleasure to welcome Dr. McCarus to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class.
References
1. J Am Assoc Gynecol Laparosc. 1999 Feb;6(1):97-100.
2. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.
3. J Clin Med Res. 2017 Jul;9(7):613-7.
4. Gynecol Minim Invasive Ther. 2013 Aug;2(3):85-8.
5. Curr Opin Obstet Gynecol. 2016 Aug;28(4):255-60.
With the wax and wane in the popularity of single-port surgery and with the advent of improved instrumentation, minilaparoscopy would appear to be the next long-lasting surgical technique to enhance postsurgical cosmetic appearance. For this reason, it is surprising that the use of minilaparoscopy has not been acknowledged and evaluated as a viable option more often in general surgery and urology. This, despite the fact that the use of this technique in hysterectomy was described nearly 20 years ago.1
Our minimally invasive gynecologic surgery (MIGS) team has utilized minilaparoscopy for diagnostic laparoscopy, lysis of adhesions, treatment of stage I, II, and occasionally stage III endometriosis, ovarian cystectomy, ureterolysis, presacral neurectomy, and total laparoscopic hysterectomy – as has our guest author Steven McCarus, MD. When performing hysterectomy via minilaparoscopy, our team closes the vaginal cuff laparoscopically, placing the suture transvaginally.
By removing the fibroid via a colpotomy incision, the Italian MIGS surgeon Fabio Ghezzi, MD, is able to perform myomectomy and hysterectomy routinely via minilaparoscopy.2 Articles have been published regarding the feasibility of performing minilaparoscopic surgery for both the treatment of benign adnexal mases3 and endometriosis.4
Dr. McCarus presents compelling evidence regarding the cosmetic advantage of minilaparoscopy, but the reported impact on pain has been variable: As Alyssa Small Layne et al. states, “Some studies associate minilaparoscopy with decreased pain, whereas others did not find a difference.”5 In part, this is attributable to the fact that no matter what technique is performed, the pathology must be excised. However, it is my belief that with improvements in instrumentation – as noted by Dr. McCarus and our collected added experience – the postoperative pain profile for the patient undergoing minilaparoscopy will change dramatically.
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Dr. McCarus, who is the chief of gynecological surgery at Florida Hospital Celebration Health, Celebration. With over 25 years of experience, Dr. McCarus is nationally known as a leader in the practice of minimally invasive gynecologic surgery.
It is a pleasure to welcome Dr. McCarus to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class.
References
1. J Am Assoc Gynecol Laparosc. 1999 Feb;6(1):97-100.
2. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.
3. J Clin Med Res. 2017 Jul;9(7):613-7.
4. Gynecol Minim Invasive Ther. 2013 Aug;2(3):85-8.
5. Curr Opin Obstet Gynecol. 2016 Aug;28(4):255-60.
TCT presents new, ‘massive’ integrated, hands-on learning center
pavilions devoted to specific fields.
This major innovation brings TCT back to basics, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
Dr. Granada was closely involved with the program and said it’s been in the works for a couple of years. The emphasis of these workshops is to teach physicians an understanding of anatomy. TCT is devoting a massive amount of space to this effort, about 60% of the exhibit hall. The eight pavilions are dedicated to training tracks, and every single tool available to interventional cardiologists will be there, he said.
If you preregistered before all 4,000 spots filled up some days ago, consider yourself lucky. But be assured that the TCT organizers are tracking the registrations, even those submitted after the limit was reached, to help them plan for next year’s meeting in San Francisco.
The workshops will run over 3 days, from Saturday through Monday, Sept. 22-24.
pavilions devoted to specific fields.
This major innovation brings TCT back to basics, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
Dr. Granada was closely involved with the program and said it’s been in the works for a couple of years. The emphasis of these workshops is to teach physicians an understanding of anatomy. TCT is devoting a massive amount of space to this effort, about 60% of the exhibit hall. The eight pavilions are dedicated to training tracks, and every single tool available to interventional cardiologists will be there, he said.
If you preregistered before all 4,000 spots filled up some days ago, consider yourself lucky. But be assured that the TCT organizers are tracking the registrations, even those submitted after the limit was reached, to help them plan for next year’s meeting in San Francisco.
The workshops will run over 3 days, from Saturday through Monday, Sept. 22-24.
pavilions devoted to specific fields.
This major innovation brings TCT back to basics, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
Dr. Granada was closely involved with the program and said it’s been in the works for a couple of years. The emphasis of these workshops is to teach physicians an understanding of anatomy. TCT is devoting a massive amount of space to this effort, about 60% of the exhibit hall. The eight pavilions are dedicated to training tracks, and every single tool available to interventional cardiologists will be there, he said.
If you preregistered before all 4,000 spots filled up some days ago, consider yourself lucky. But be assured that the TCT organizers are tracking the registrations, even those submitted after the limit was reached, to help them plan for next year’s meeting in San Francisco.
The workshops will run over 3 days, from Saturday through Monday, Sept. 22-24.