MRI scanner

Scientists say they have devised a way to track the movements, destination, and persistence of a broad range of cellular therapies, without resorting to invasive procedures.

In Magnetic Resonance in Medicine, the researchers described the first human tests using a perfluorocarbon (PFC) tracer in combination with non-invasive magnetic resonance imaging (MRI) to track therapeutic immune cells injected into patients with colorectal cancer.

“Initially, we see this technique used for clinical trials that involve tests of new cell therapies,” said study author Eric T. Ahrens, PhD, of the University of California, San Diego.

“Clinical development of cell therapies can be accelerated by providing feedback regarding cell motility, optimal delivery routes, individual therapeutic doses, and engraftment success.”

Currently, there is no accepted way to image cells in the human body that covers a broad range of cell types and diseases. Earlier techniques have used metal ion-based vascular MRI contrast agents and radioisotopes.

The former have proven difficult to differentiate in vivo. The latter raise concerns about radiation toxicity and do not provide the anatomical detail available with MRIs.

“This is the first human PFC cell tracking agent, which is a new way to do MRI cell tracking,” Dr Ahrens said. “It’s the first example of a clinical MRI agent designed specifically for cell tracking.”

He and his colleagues used a PFC tracer agent and an MRI technique that directly detects fluorine atoms in labeled cells. Fluorine atoms naturally occur in extremely low concentrations in the body, making it easier to observe cells labeled with fluorine using MRI.

In this case, the modified and labeled dendritic cells were first prepared from white blood cells extracted from the patient. The cells were then injected into patients with stage 4 metastatic colorectal cancer to stimulate an anticancer T-cell immune response.

The researchers did not assess the efficacy of the cell therapy, only their ability to detect the labeled cells and monitor what happened to them. Dr Ahrens said the technique worked as expected, with the surprising finding that only half of the delivered cell vaccine remained at the inoculation site after 24 hours.

“The imaging agent technology has been shown to be able to tag any cell type that is of interest,” Dr Ahrens said. “It is a platform imaging technology for a wide range of diseases and applications.”

“Non-invasive cell tracking may help lower regulatory barriers,” he added. “For example, new stem cell therapies can be slow to obtain regulatory approvals, in part, because it is difficult, if not impossible, with current approaches to verify survival and location of transplanted cells.”

“And cell therapy trials generally have a high cost per patient. Tools that allow the investigator to gain a ‘richer’ data set from individual patients mean it may be possible to reduce patient numbers enrolled in a trial, thus reducing total trial cost.”

MRI scanner

Scientists say they have devised a way to track the movements, destination, and persistence of a broad range of cellular therapies, without resorting to invasive procedures.

In Magnetic Resonance in Medicine, the researchers described the first human tests using a perfluorocarbon (PFC) tracer in combination with non-invasive magnetic resonance imaging (MRI) to track therapeutic immune cells injected into patients with colorectal cancer.

“Initially, we see this technique used for clinical trials that involve tests of new cell therapies,” said study author Eric T. Ahrens, PhD, of the University of California, San Diego.

“Clinical development of cell therapies can be accelerated by providing feedback regarding cell motility, optimal delivery routes, individual therapeutic doses, and engraftment success.”

Currently, there is no accepted way to image cells in the human body that covers a broad range of cell types and diseases. Earlier techniques have used metal ion-based vascular MRI contrast agents and radioisotopes.

The former have proven difficult to differentiate in vivo. The latter raise concerns about radiation toxicity and do not provide the anatomical detail available with MRIs.

“This is the first human PFC cell tracking agent, which is a new way to do MRI cell tracking,” Dr Ahrens said. “It’s the first example of a clinical MRI agent designed specifically for cell tracking.”

He and his colleagues used a PFC tracer agent and an MRI technique that directly detects fluorine atoms in labeled cells. Fluorine atoms naturally occur in extremely low concentrations in the body, making it easier to observe cells labeled with fluorine using MRI.

In this case, the modified and labeled dendritic cells were first prepared from white blood cells extracted from the patient. The cells were then injected into patients with stage 4 metastatic colorectal cancer to stimulate an anticancer T-cell immune response.

The researchers did not assess the efficacy of the cell therapy, only their ability to detect the labeled cells and monitor what happened to them. Dr Ahrens said the technique worked as expected, with the surprising finding that only half of the delivered cell vaccine remained at the inoculation site after 24 hours.

“The imaging agent technology has been shown to be able to tag any cell type that is of interest,” Dr Ahrens said. “It is a platform imaging technology for a wide range of diseases and applications.”

“Non-invasive cell tracking may help lower regulatory barriers,” he added. “For example, new stem cell therapies can be slow to obtain regulatory approvals, in part, because it is difficult, if not impossible, with current approaches to verify survival and location of transplanted cells.”

“And cell therapy trials generally have a high cost per patient. Tools that allow the investigator to gain a ‘richer’ data set from individual patients mean it may be possible to reduce patient numbers enrolled in a trial, thus reducing total trial cost.”

MRI scanner

Scientists say they have devised a way to track the movements, destination, and persistence of a broad range of cellular therapies, without resorting to invasive procedures.

In Magnetic Resonance in Medicine, the researchers described the first human tests using a perfluorocarbon (PFC) tracer in combination with non-invasive magnetic resonance imaging (MRI) to track therapeutic immune cells injected into patients with colorectal cancer.

“Initially, we see this technique used for clinical trials that involve tests of new cell therapies,” said study author Eric T. Ahrens, PhD, of the University of California, San Diego.

“Clinical development of cell therapies can be accelerated by providing feedback regarding cell motility, optimal delivery routes, individual therapeutic doses, and engraftment success.”

Currently, there is no accepted way to image cells in the human body that covers a broad range of cell types and diseases. Earlier techniques have used metal ion-based vascular MRI contrast agents and radioisotopes.

The former have proven difficult to differentiate in vivo. The latter raise concerns about radiation toxicity and do not provide the anatomical detail available with MRIs.

“This is the first human PFC cell tracking agent, which is a new way to do MRI cell tracking,” Dr Ahrens said. “It’s the first example of a clinical MRI agent designed specifically for cell tracking.”

He and his colleagues used a PFC tracer agent and an MRI technique that directly detects fluorine atoms in labeled cells. Fluorine atoms naturally occur in extremely low concentrations in the body, making it easier to observe cells labeled with fluorine using MRI.

In this case, the modified and labeled dendritic cells were first prepared from white blood cells extracted from the patient. The cells were then injected into patients with stage 4 metastatic colorectal cancer to stimulate an anticancer T-cell immune response.

The researchers did not assess the efficacy of the cell therapy, only their ability to detect the labeled cells and monitor what happened to them. Dr Ahrens said the technique worked as expected, with the surprising finding that only half of the delivered cell vaccine remained at the inoculation site after 24 hours.

“The imaging agent technology has been shown to be able to tag any cell type that is of interest,” Dr Ahrens said. “It is a platform imaging technology for a wide range of diseases and applications.”

“Non-invasive cell tracking may help lower regulatory barriers,” he added. “For example, new stem cell therapies can be slow to obtain regulatory approvals, in part, because it is difficult, if not impossible, with current approaches to verify survival and location of transplanted cells.”

“And cell therapy trials generally have a high cost per patient. Tools that allow the investigator to gain a ‘richer’ data set from individual patients mean it may be possible to reduce patient numbers enrolled in a trial, thus reducing total trial cost.”

Mantle cell lymphoma

PHILADELPHIA—The Bcl-2 inhibitor ABT-199 and the Bruton tyrosine kinase inhibitor ibrutinib can have a synergistic effect against mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL), preclinical data suggest.

In one set of experiments with MCL and CLL samples, the drugs induced apoptosis at a much higher rate when used together than when used alone.

However, in other experiments with CLL samples, ABT-199 and ibrutinib did not consistently display synergistic cytoxicity.

The researchers said this indicates substantial patient heterogeneity in response to the combination that may be due to variations in the genetic landscape.

Michael J. Weber, PhD, of the University of Virginia School of Medicine in Charlottesville, and his colleagues presented this research at the AACR conference Hematologic Malignancies: Translating Discoveries to Novel Therapies.

“We took an empirical but systematic approach to identify combinations of drugs that might improve the ability of ibrutinib to kill cancer cells,” Dr Weber said. “The combination of ibrutinib and ABT-199 was, by far, the most effective in our assays, and we are in the very earliest stages of planning a clinical trial to test this combination in the clinic.”

In previous studies, Dr Weber and his colleagues found that ibrutinib synergized with both ABT-199 and the proteasome inhibitor carfilzomib to kill MCL cell lines. In this study, the team assessed the effects of exposure to these 2 combinations on samples from patients with MCL or CLL.

The researchers found that apoptosis occurred in 23% of cells exposed to ABT-199 and ibrutinib in combination, compared to 3.8% of cells exposed to ibrutinib and 3% exposed to ABT-199.

The combination of ibrutinib and carfilzomib also increased apoptosis in MCL and CLL cells compared to either agent alone, though to a lesser degree than the ABT-199 combination. Apoptosis occurred in 5.5% of cells exposed to ibrutinib and carfilzomib, 3.8% exposed to ibrutinib, and 1.7% exposed to carfilzomib.

The researchers observed minimal apoptosis in normal T cells, both with the single agents and the combinations.

Further analysis showed that ibrutinib and ABT-199 worked synergistically to cause apoptosis in leukemic cells from 5 of 9 patients with CLL.

According to Dr Weber, the variable response to this combination points to the importance of understanding how these combinations work, so we can match the treatments with the most appropriate patients.

“Ibrutinib and ABT-199 target different pathways involved in promoting cancer cell survival and growth,” Dr Weber said.

“This is very intriguing because, in most instances where cancer cells are resistant to a particular molecularly targeted drug, we find that cancer cells adapt and find new ways to reactivate the pathway being targeted by the drug and that combinations of drugs targeting this pathway in different ways can improve outcomes. Here, we found that targeting a pathway outside the primary pathway was effective.”

This study was funded by the University of Virginia Cancer Center. Dr Weber declared no conflicts of interest.

Mantle cell lymphoma

PHILADELPHIA—The Bcl-2 inhibitor ABT-199 and the Bruton tyrosine kinase inhibitor ibrutinib can have a synergistic effect against mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL), preclinical data suggest.

In one set of experiments with MCL and CLL samples, the drugs induced apoptosis at a much higher rate when used together than when used alone.

However, in other experiments with CLL samples, ABT-199 and ibrutinib did not consistently display synergistic cytoxicity.

The researchers said this indicates substantial patient heterogeneity in response to the combination that may be due to variations in the genetic landscape.

Michael J. Weber, PhD, of the University of Virginia School of Medicine in Charlottesville, and his colleagues presented this research at the AACR conference Hematologic Malignancies: Translating Discoveries to Novel Therapies.

“We took an empirical but systematic approach to identify combinations of drugs that might improve the ability of ibrutinib to kill cancer cells,” Dr Weber said. “The combination of ibrutinib and ABT-199 was, by far, the most effective in our assays, and we are in the very earliest stages of planning a clinical trial to test this combination in the clinic.”

In previous studies, Dr Weber and his colleagues found that ibrutinib synergized with both ABT-199 and the proteasome inhibitor carfilzomib to kill MCL cell lines. In this study, the team assessed the effects of exposure to these 2 combinations on samples from patients with MCL or CLL.

The researchers found that apoptosis occurred in 23% of cells exposed to ABT-199 and ibrutinib in combination, compared to 3.8% of cells exposed to ibrutinib and 3% exposed to ABT-199.

The combination of ibrutinib and carfilzomib also increased apoptosis in MCL and CLL cells compared to either agent alone, though to a lesser degree than the ABT-199 combination. Apoptosis occurred in 5.5% of cells exposed to ibrutinib and carfilzomib, 3.8% exposed to ibrutinib, and 1.7% exposed to carfilzomib.

The researchers observed minimal apoptosis in normal T cells, both with the single agents and the combinations.

Further analysis showed that ibrutinib and ABT-199 worked synergistically to cause apoptosis in leukemic cells from 5 of 9 patients with CLL.

According to Dr Weber, the variable response to this combination points to the importance of understanding how these combinations work, so we can match the treatments with the most appropriate patients.

“Ibrutinib and ABT-199 target different pathways involved in promoting cancer cell survival and growth,” Dr Weber said.

“This is very intriguing because, in most instances where cancer cells are resistant to a particular molecularly targeted drug, we find that cancer cells adapt and find new ways to reactivate the pathway being targeted by the drug and that combinations of drugs targeting this pathway in different ways can improve outcomes. Here, we found that targeting a pathway outside the primary pathway was effective.”

This study was funded by the University of Virginia Cancer Center. Dr Weber declared no conflicts of interest.

Mantle cell lymphoma

PHILADELPHIA—The Bcl-2 inhibitor ABT-199 and the Bruton tyrosine kinase inhibitor ibrutinib can have a synergistic effect against mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL), preclinical data suggest.

In one set of experiments with MCL and CLL samples, the drugs induced apoptosis at a much higher rate when used together than when used alone.

However, in other experiments with CLL samples, ABT-199 and ibrutinib did not consistently display synergistic cytoxicity.

The researchers said this indicates substantial patient heterogeneity in response to the combination that may be due to variations in the genetic landscape.

Michael J. Weber, PhD, of the University of Virginia School of Medicine in Charlottesville, and his colleagues presented this research at the AACR conference Hematologic Malignancies: Translating Discoveries to Novel Therapies.

“We took an empirical but systematic approach to identify combinations of drugs that might improve the ability of ibrutinib to kill cancer cells,” Dr Weber said. “The combination of ibrutinib and ABT-199 was, by far, the most effective in our assays, and we are in the very earliest stages of planning a clinical trial to test this combination in the clinic.”

In previous studies, Dr Weber and his colleagues found that ibrutinib synergized with both ABT-199 and the proteasome inhibitor carfilzomib to kill MCL cell lines. In this study, the team assessed the effects of exposure to these 2 combinations on samples from patients with MCL or CLL.

The researchers found that apoptosis occurred in 23% of cells exposed to ABT-199 and ibrutinib in combination, compared to 3.8% of cells exposed to ibrutinib and 3% exposed to ABT-199.

The combination of ibrutinib and carfilzomib also increased apoptosis in MCL and CLL cells compared to either agent alone, though to a lesser degree than the ABT-199 combination. Apoptosis occurred in 5.5% of cells exposed to ibrutinib and carfilzomib, 3.8% exposed to ibrutinib, and 1.7% exposed to carfilzomib.

The researchers observed minimal apoptosis in normal T cells, both with the single agents and the combinations.

Further analysis showed that ibrutinib and ABT-199 worked synergistically to cause apoptosis in leukemic cells from 5 of 9 patients with CLL.

According to Dr Weber, the variable response to this combination points to the importance of understanding how these combinations work, so we can match the treatments with the most appropriate patients.

“Ibrutinib and ABT-199 target different pathways involved in promoting cancer cell survival and growth,” Dr Weber said.

“This is very intriguing because, in most instances where cancer cells are resistant to a particular molecularly targeted drug, we find that cancer cells adapt and find new ways to reactivate the pathway being targeted by the drug and that combinations of drugs targeting this pathway in different ways can improve outcomes. Here, we found that targeting a pathway outside the primary pathway was effective.”

This study was funded by the University of Virginia Cancer Center. Dr Weber declared no conflicts of interest.

EDINBURGH – Barbed absorbable sutures are a useful new tool to facilitate dermal closure of facial and nonfacial defects following tumor resection.

“These are not the bad old sutures that you might of heard about before, that were nonabsorbable sutures and attempted for use in cosmetic procedures,” Dr. John Strasswimmer said at the 15th World Congress on Cancers of the Skin.

Last year, Dr. Strasswimmer, medical director of melanoma and cutaneous oncology at the Lynn Cancer Institute in Boca Raton, Fla., reported his initial experience using a procedure he calls “Corseta” to close a large Mohs defect on the trunk of an 83-year-old man (JAMA Dermatol. 2013;149:853-4).

The procedure employs a barbed, bioabsorbable suture (Ethicon’s Stratafix and Covidien’s V-Loc) that is run in a continuous vertical looping manner in the subcutaneous layer, with minimal to no undermining of the wound. Undermining is typically used in cutaneous surgery to relieve tension or provide structure around anatomical landmarks, but it can increase the risk of bleeding, swelling, and patient discomfort, he said.

Instead, the first suture pass is placed in the deepest portion of the subcutaneous tissue and brought out within the more superficial subcutaneous layer. Each bite of the barbed suture extends peripherally at least 2.0 cm from the edge of the wound, so the point of tension is lateral to the wound margins. At every two passes, tension is placed evenly across the sutures to close the deepest layer of tissue and to engage the barbs, much like closing of a Victorian corset, Dr. Strasswimmer said.

The second arm of the suture is passed in a similar manner in the subcutaneous plane, superficial to the first pass.

“This is a lacing, not a suturing technique,” he said. “You get tissue approximation, but more importantly, because we’re bringing in all that deep tissue, you automatically get beautiful wound-edge eversion and very nice cosmetic results.”

Because the sutures have barbs cut into them, however, a 0-0 weight polydioxane or other absorbable material suture can have a breaking strength of a #2-0 suture. “You have to look very carefully at the manufacturer’s sizing and strength requirements,” Dr. Strasswimmer cautioned.

Since their initial case report, Dr. Strasswimmer and his colleagues have expanded use of the Corseta technique to more than 600 facial and nonfacial reconstructions. The Corseta procedure is not as helpful for curved topography such as the central face or scalp, he said in an interview. Still, of the 600 or so cases, none required conversion to another closure technique.

“The traditional closure technique would not have worked in those challenging cases,” Dr. Strasswimmer said. “In the most difficult situations, such as older patients with severely atrophic skin, even the best suturing won’t work. In that case, the Corseta at least produces a partial closure, thereby reducing the wound and accelerating healing.”
The Corseta procedure is often coupled with tumescent anesthesia to decrease the risk of bleeding, particularly in patients on anticoagulation, he noted.

The conference was sponsored by the Skin Cancer Foundation.

[email protected]

EDINBURGH – Barbed absorbable sutures are a useful new tool to facilitate dermal closure of facial and nonfacial defects following tumor resection.

“These are not the bad old sutures that you might of heard about before, that were nonabsorbable sutures and attempted for use in cosmetic procedures,” Dr. John Strasswimmer said at the 15th World Congress on Cancers of the Skin.

Last year, Dr. Strasswimmer, medical director of melanoma and cutaneous oncology at the Lynn Cancer Institute in Boca Raton, Fla., reported his initial experience using a procedure he calls “Corseta” to close a large Mohs defect on the trunk of an 83-year-old man (JAMA Dermatol. 2013;149:853-4).

The procedure employs a barbed, bioabsorbable suture (Ethicon’s Stratafix and Covidien’s V-Loc) that is run in a continuous vertical looping manner in the subcutaneous layer, with minimal to no undermining of the wound. Undermining is typically used in cutaneous surgery to relieve tension or provide structure around anatomical landmarks, but it can increase the risk of bleeding, swelling, and patient discomfort, he said.

Instead, the first suture pass is placed in the deepest portion of the subcutaneous tissue and brought out within the more superficial subcutaneous layer. Each bite of the barbed suture extends peripherally at least 2.0 cm from the edge of the wound, so the point of tension is lateral to the wound margins. At every two passes, tension is placed evenly across the sutures to close the deepest layer of tissue and to engage the barbs, much like closing of a Victorian corset, Dr. Strasswimmer said.

The second arm of the suture is passed in a similar manner in the subcutaneous plane, superficial to the first pass.

“This is a lacing, not a suturing technique,” he said. “You get tissue approximation, but more importantly, because we’re bringing in all that deep tissue, you automatically get beautiful wound-edge eversion and very nice cosmetic results.”

Because the sutures have barbs cut into them, however, a 0-0 weight polydioxane or other absorbable material suture can have a breaking strength of a #2-0 suture. “You have to look very carefully at the manufacturer’s sizing and strength requirements,” Dr. Strasswimmer cautioned.

Since their initial case report, Dr. Strasswimmer and his colleagues have expanded use of the Corseta technique to more than 600 facial and nonfacial reconstructions. The Corseta procedure is not as helpful for curved topography such as the central face or scalp, he said in an interview. Still, of the 600 or so cases, none required conversion to another closure technique.

“The traditional closure technique would not have worked in those challenging cases,” Dr. Strasswimmer said. “In the most difficult situations, such as older patients with severely atrophic skin, even the best suturing won’t work. In that case, the Corseta at least produces a partial closure, thereby reducing the wound and accelerating healing.”
The Corseta procedure is often coupled with tumescent anesthesia to decrease the risk of bleeding, particularly in patients on anticoagulation, he noted.

The conference was sponsored by the Skin Cancer Foundation.

[email protected]

EDINBURGH – Barbed absorbable sutures are a useful new tool to facilitate dermal closure of facial and nonfacial defects following tumor resection.

“These are not the bad old sutures that you might of heard about before, that were nonabsorbable sutures and attempted for use in cosmetic procedures,” Dr. John Strasswimmer said at the 15th World Congress on Cancers of the Skin.

Last year, Dr. Strasswimmer, medical director of melanoma and cutaneous oncology at the Lynn Cancer Institute in Boca Raton, Fla., reported his initial experience using a procedure he calls “Corseta” to close a large Mohs defect on the trunk of an 83-year-old man (JAMA Dermatol. 2013;149:853-4).

The procedure employs a barbed, bioabsorbable suture (Ethicon’s Stratafix and Covidien’s V-Loc) that is run in a continuous vertical looping manner in the subcutaneous layer, with minimal to no undermining of the wound. Undermining is typically used in cutaneous surgery to relieve tension or provide structure around anatomical landmarks, but it can increase the risk of bleeding, swelling, and patient discomfort, he said.

Instead, the first suture pass is placed in the deepest portion of the subcutaneous tissue and brought out within the more superficial subcutaneous layer. Each bite of the barbed suture extends peripherally at least 2.0 cm from the edge of the wound, so the point of tension is lateral to the wound margins. At every two passes, tension is placed evenly across the sutures to close the deepest layer of tissue and to engage the barbs, much like closing of a Victorian corset, Dr. Strasswimmer said.

The second arm of the suture is passed in a similar manner in the subcutaneous plane, superficial to the first pass.

“This is a lacing, not a suturing technique,” he said. “You get tissue approximation, but more importantly, because we’re bringing in all that deep tissue, you automatically get beautiful wound-edge eversion and very nice cosmetic results.”

Because the sutures have barbs cut into them, however, a 0-0 weight polydioxane or other absorbable material suture can have a breaking strength of a #2-0 suture. “You have to look very carefully at the manufacturer’s sizing and strength requirements,” Dr. Strasswimmer cautioned.

Since their initial case report, Dr. Strasswimmer and his colleagues have expanded use of the Corseta technique to more than 600 facial and nonfacial reconstructions. The Corseta procedure is not as helpful for curved topography such as the central face or scalp, he said in an interview. Still, of the 600 or so cases, none required conversion to another closure technique.

“The traditional closure technique would not have worked in those challenging cases,” Dr. Strasswimmer said. “In the most difficult situations, such as older patients with severely atrophic skin, even the best suturing won’t work. In that case, the Corseta at least produces a partial closure, thereby reducing the wound and accelerating healing.”
The Corseta procedure is often coupled with tumescent anesthesia to decrease the risk of bleeding, particularly in patients on anticoagulation, he noted.

The conference was sponsored by the Skin Cancer Foundation.

[email protected]

High rate of durable responses to pembrolizumab in metastatic melanoma

High rate of durable responses to pembrolizumab in metastatic melanoma

High rate of durable responses to pembrolizumab in metastatic melanoma

It gives me great pleasure to introduce this month’s surgical video. The following feature presentation was produced by my third-year fellow, Mireille Truong, MD, and my third-year resident, Sarah Horvath, MD. The focus of this surgical video is to compare and contrast total laparoscopic hysterectomy (TLH) with laparoscopic supracervical hysterectomy (LSH). The indication for the TLH case was refractory dysmenorrhea and for the LSH case was as part of a concomitant sacrocervicopexy. The particular methods for specimen removal demonstrated include through the colpotomy for TLH and cold knife manual morcellation within a bag using an Alexis retractor for LSH. 

The objectives of this surgical video are to:

• Highlight the clinical advantages and disadvantages between cervical removal or retention at the time of a minimally invasive laparoscopic hysterectomy
• Demonstrate the surgical nuances between TLH and LSH
• Provide a potential resource for patient counseling as well as medical student and resident education.

I encourage you to share this video as an educational resource with your colleagues, residents, students, and patients alike.

Vidyard Video

 

 

I hope to see you at the AAGL Global Congress on Minimally Invasive Gynecology in Vancouver, November 17–21, 2014. Visit www.aagl.org/globalcongress for more information.
  — Dr. Arnold Advincula, AAGL 2014 Scientific Program Chair
 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It gives me great pleasure to introduce this month’s surgical video. The following feature presentation was produced by my third-year fellow, Mireille Truong, MD, and my third-year resident, Sarah Horvath, MD. The focus of this surgical video is to compare and contrast total laparoscopic hysterectomy (TLH) with laparoscopic supracervical hysterectomy (LSH). The indication for the TLH case was refractory dysmenorrhea and for the LSH case was as part of a concomitant sacrocervicopexy. The particular methods for specimen removal demonstrated include through the colpotomy for TLH and cold knife manual morcellation within a bag using an Alexis retractor for LSH. 

The objectives of this surgical video are to:

• Highlight the clinical advantages and disadvantages between cervical removal or retention at the time of a minimally invasive laparoscopic hysterectomy
• Demonstrate the surgical nuances between TLH and LSH
• Provide a potential resource for patient counseling as well as medical student and resident education.

I encourage you to share this video as an educational resource with your colleagues, residents, students, and patients alike.

Vidyard Video

 

 

I hope to see you at the AAGL Global Congress on Minimally Invasive Gynecology in Vancouver, November 17–21, 2014. Visit www.aagl.org/globalcongress for more information.
  — Dr. Arnold Advincula, AAGL 2014 Scientific Program Chair
 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It gives me great pleasure to introduce this month’s surgical video. The following feature presentation was produced by my third-year fellow, Mireille Truong, MD, and my third-year resident, Sarah Horvath, MD. The focus of this surgical video is to compare and contrast total laparoscopic hysterectomy (TLH) with laparoscopic supracervical hysterectomy (LSH). The indication for the TLH case was refractory dysmenorrhea and for the LSH case was as part of a concomitant sacrocervicopexy. The particular methods for specimen removal demonstrated include through the colpotomy for TLH and cold knife manual morcellation within a bag using an Alexis retractor for LSH. 

The objectives of this surgical video are to:

• Highlight the clinical advantages and disadvantages between cervical removal or retention at the time of a minimally invasive laparoscopic hysterectomy
• Demonstrate the surgical nuances between TLH and LSH
• Provide a potential resource for patient counseling as well as medical student and resident education.

I encourage you to share this video as an educational resource with your colleagues, residents, students, and patients alike.

Vidyard Video

 

 

I hope to see you at the AAGL Global Congress on Minimally Invasive Gynecology in Vancouver, November 17–21, 2014. Visit www.aagl.org/globalcongress for more information.
  — Dr. Arnold Advincula, AAGL 2014 Scientific Program Chair
 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In a report released March 2014 by the American Society of Aesthetic Plastic Surgery, the top five surgical procedures for men were liposuction, eyelid surgery, rhinoplasty, male breast reduction, and ear surgery. However, the rate of noninvasive cosmetic procedures and sales of men’s grooming products is one of the leading segments of the beauty industry.

Although most scientific research and media are focused on the female aesthetic, understanding the specific needs of your male patients is key to patient satisfaction. Most men are generally less aware than are women of the treatment options and risks and benefits of procedures. Men also prefer treatments with less downtime and natural-looking results. This column continues our miniseries on aesthetic dermatology for the male patient.

In a general dermatology practice, there are several skin concerns often identified by male patients, and acne and rosacea are among them.

Acne: Men generally have thicker, more sebaceous skin than that of women. Although acne is a very common problem in teens and young men, there is a growing trend of cases of cystic acne in adult men who consume popular protein meal replacement or muscle enhancing shakes that contain whey protein. Whey is a protein derived from cow’s milk. Milk and dairy products act by increasing insulin-like growth factor 1, which has been linked to acne. Although few case reports have shown a link between dietary whey supplementation and acne, in my practice, men with cystic acne who report using whey supplementation products have had almost complete resolution of their acne without medical intervention after discontinuing these products.

Rosacea: Men have a higher density of facial blood vessels than women do, and often seek treatment for telangiectasias and overall facial erythema. For papulopustular rosacea, common treatments include oral antibiotics, topical antibiotics, topical azaleic acid, and topical anti-inflammatory medications. For erythematotelangiectatic rosacea, Mirvaso (brimonidine), a topical vasoconstrictor, can be applied to the skin for 8-12 hours of marked reduction in facial erythema. Although theoretically a great option for patients suffering from erythema, the effects of topical brimonidine are transient, and the gel requires daily application with no long-term benefit. Vascular laser treatments are effective for telangiectasias for both men and women. However, men with more granulomatous or phymatous rosacea often need a combination of treatments including antibiotics, oral isotretinoin and fractional ablative lasers.

Resources:

American Society for Plastic Surgery 2012 statistics.

“Whey protein precipitating moderate to severe acne flares in 5 teenaged athletes,” Cutis 2012;90:70-2.

Dr. Talakoub and Dr. Wesley are cocontributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

In a report released March 2014 by the American Society of Aesthetic Plastic Surgery, the top five surgical procedures for men were liposuction, eyelid surgery, rhinoplasty, male breast reduction, and ear surgery. However, the rate of noninvasive cosmetic procedures and sales of men’s grooming products is one of the leading segments of the beauty industry.

Although most scientific research and media are focused on the female aesthetic, understanding the specific needs of your male patients is key to patient satisfaction. Most men are generally less aware than are women of the treatment options and risks and benefits of procedures. Men also prefer treatments with less downtime and natural-looking results. This column continues our miniseries on aesthetic dermatology for the male patient.

In a general dermatology practice, there are several skin concerns often identified by male patients, and acne and rosacea are among them.

Acne: Men generally have thicker, more sebaceous skin than that of women. Although acne is a very common problem in teens and young men, there is a growing trend of cases of cystic acne in adult men who consume popular protein meal replacement or muscle enhancing shakes that contain whey protein. Whey is a protein derived from cow’s milk. Milk and dairy products act by increasing insulin-like growth factor 1, which has been linked to acne. Although few case reports have shown a link between dietary whey supplementation and acne, in my practice, men with cystic acne who report using whey supplementation products have had almost complete resolution of their acne without medical intervention after discontinuing these products.

Rosacea: Men have a higher density of facial blood vessels than women do, and often seek treatment for telangiectasias and overall facial erythema. For papulopustular rosacea, common treatments include oral antibiotics, topical antibiotics, topical azaleic acid, and topical anti-inflammatory medications. For erythematotelangiectatic rosacea, Mirvaso (brimonidine), a topical vasoconstrictor, can be applied to the skin for 8-12 hours of marked reduction in facial erythema. Although theoretically a great option for patients suffering from erythema, the effects of topical brimonidine are transient, and the gel requires daily application with no long-term benefit. Vascular laser treatments are effective for telangiectasias for both men and women. However, men with more granulomatous or phymatous rosacea often need a combination of treatments including antibiotics, oral isotretinoin and fractional ablative lasers.

Resources:

American Society for Plastic Surgery 2012 statistics.

“Whey protein precipitating moderate to severe acne flares in 5 teenaged athletes,” Cutis 2012;90:70-2.

Dr. Talakoub and Dr. Wesley are cocontributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

In a report released March 2014 by the American Society of Aesthetic Plastic Surgery, the top five surgical procedures for men were liposuction, eyelid surgery, rhinoplasty, male breast reduction, and ear surgery. However, the rate of noninvasive cosmetic procedures and sales of men’s grooming products is one of the leading segments of the beauty industry.

Although most scientific research and media are focused on the female aesthetic, understanding the specific needs of your male patients is key to patient satisfaction. Most men are generally less aware than are women of the treatment options and risks and benefits of procedures. Men also prefer treatments with less downtime and natural-looking results. This column continues our miniseries on aesthetic dermatology for the male patient.

In a general dermatology practice, there are several skin concerns often identified by male patients, and acne and rosacea are among them.

Acne: Men generally have thicker, more sebaceous skin than that of women. Although acne is a very common problem in teens and young men, there is a growing trend of cases of cystic acne in adult men who consume popular protein meal replacement or muscle enhancing shakes that contain whey protein. Whey is a protein derived from cow’s milk. Milk and dairy products act by increasing insulin-like growth factor 1, which has been linked to acne. Although few case reports have shown a link between dietary whey supplementation and acne, in my practice, men with cystic acne who report using whey supplementation products have had almost complete resolution of their acne without medical intervention after discontinuing these products.

Rosacea: Men have a higher density of facial blood vessels than women do, and often seek treatment for telangiectasias and overall facial erythema. For papulopustular rosacea, common treatments include oral antibiotics, topical antibiotics, topical azaleic acid, and topical anti-inflammatory medications. For erythematotelangiectatic rosacea, Mirvaso (brimonidine), a topical vasoconstrictor, can be applied to the skin for 8-12 hours of marked reduction in facial erythema. Although theoretically a great option for patients suffering from erythema, the effects of topical brimonidine are transient, and the gel requires daily application with no long-term benefit. Vascular laser treatments are effective for telangiectasias for both men and women. However, men with more granulomatous or phymatous rosacea often need a combination of treatments including antibiotics, oral isotretinoin and fractional ablative lasers.

Resources:

American Society for Plastic Surgery 2012 statistics.

“Whey protein precipitating moderate to severe acne flares in 5 teenaged athletes,” Cutis 2012;90:70-2.

Dr. Talakoub and Dr. Wesley are cocontributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

Sleeping infant

Credit: Vera Kratochvil

New research confirms that transfusing leukoreduced, cytomegalovirus (CMV)-seronegative blood products prevents CMV transmission in very-low-birth-weight (VLBW) infants.

The study showed that, with this approach, maternal breast milk becomes the primary source of postnatal CMV infection.

“Previously, the risk of CMV infection from blood transfusion of seronegative or leukoreduced transfusions was estimated to be 1% to 3%,” said Cassandra Josephson, MD, of Emory University School of Medicine in Atlanta, Georgia.

“We showed that, using blood components that are both CMV-seronegative and leukoreduced, we can effectively prevent the transfusion-transmission of CMV. Therefore, we believe that this is the safest approach to reduce the risk of CMV infection when giving transfusions to VLBW infants.”

Dr Josephson and her colleagues described this research in JAMA Pediatrics.

The researchers evaluated 462 mothers and 539 VLBW infants who were admitted to 3 neonatal intensive care units between January 2010 and June 2013.

A majority of mothers had a history of CMV infection prior to delivery (CMV sero-prevalence of 76.2%). The infants were enrolled in the study within 5 days of birth and had not received a blood transfusion at that time.

The infants were tested for congenital infection at birth and again at 5 additional intervals between birth and 90 days, discharge, or death.

Twenty-nine of the infants had CMV infection (cumulative incidence of 6.9% at 12 weeks). Five infants with CMV infection developed severe disease or died.

Although 2061 transfusions were administered to 310 of the infants (57.5%), the blood products were CMV-seronegative and leukoreduced, and none of the CMV infections was linked to transfusion.

Twenty-seven of 28 infections acquired after birth occurred among infants fed CMV-positive breast milk.

Dr Josephson and her colleagues estimate that between 1 in 5 and 1 in 10 VLBW infants who are fed CMV-positive breast milk from mothers with a history of CMV infection will develop postnatal CMV infection.

The American Academy of Pediatrics currently states that the value of routinely feeding breast milk from CMV-seropositive mothers to preterm infants outweighs the risks of clinical disease from CMV.

But the researchers noted that new strategies to prevent breast milk transmission of CMV are needed because freezing and thawing breast milk did not completely prevent transmission in this study.

The team said alternative approaches to prevent breast milk transmission of CMV could include routine CMV-serologic testing of pregnant mothers to enable counseling regarding the risk of infection, closer surveillance of infants with CMV-positive mothers, and pasteurization of breast milk until a corrected gestational age of 34 weeks (as recommended by the Austrian Society of Pediatrics).

In addition, routine screening for postnatal CMV infection may help identify infants who are likely to develop symptomatic disease.

The researchers also said the frequency of CMV infection in this study raises significant concern about the potential consequences of CMV infection among VLBW infants and points to the need for large, long-term follow-up studies of neurological outcomes in infants with postnatal CMV infection.

Sleeping infant

Credit: Vera Kratochvil

New research confirms that transfusing leukoreduced, cytomegalovirus (CMV)-seronegative blood products prevents CMV transmission in very-low-birth-weight (VLBW) infants.

The study showed that, with this approach, maternal breast milk becomes the primary source of postnatal CMV infection.

“Previously, the risk of CMV infection from blood transfusion of seronegative or leukoreduced transfusions was estimated to be 1% to 3%,” said Cassandra Josephson, MD, of Emory University School of Medicine in Atlanta, Georgia.

“We showed that, using blood components that are both CMV-seronegative and leukoreduced, we can effectively prevent the transfusion-transmission of CMV. Therefore, we believe that this is the safest approach to reduce the risk of CMV infection when giving transfusions to VLBW infants.”

Dr Josephson and her colleagues described this research in JAMA Pediatrics.

The researchers evaluated 462 mothers and 539 VLBW infants who were admitted to 3 neonatal intensive care units between January 2010 and June 2013.

A majority of mothers had a history of CMV infection prior to delivery (CMV sero-prevalence of 76.2%). The infants were enrolled in the study within 5 days of birth and had not received a blood transfusion at that time.

The infants were tested for congenital infection at birth and again at 5 additional intervals between birth and 90 days, discharge, or death.

Twenty-nine of the infants had CMV infection (cumulative incidence of 6.9% at 12 weeks). Five infants with CMV infection developed severe disease or died.

Although 2061 transfusions were administered to 310 of the infants (57.5%), the blood products were CMV-seronegative and leukoreduced, and none of the CMV infections was linked to transfusion.

Twenty-seven of 28 infections acquired after birth occurred among infants fed CMV-positive breast milk.

Dr Josephson and her colleagues estimate that between 1 in 5 and 1 in 10 VLBW infants who are fed CMV-positive breast milk from mothers with a history of CMV infection will develop postnatal CMV infection.

The American Academy of Pediatrics currently states that the value of routinely feeding breast milk from CMV-seropositive mothers to preterm infants outweighs the risks of clinical disease from CMV.

But the researchers noted that new strategies to prevent breast milk transmission of CMV are needed because freezing and thawing breast milk did not completely prevent transmission in this study.

The team said alternative approaches to prevent breast milk transmission of CMV could include routine CMV-serologic testing of pregnant mothers to enable counseling regarding the risk of infection, closer surveillance of infants with CMV-positive mothers, and pasteurization of breast milk until a corrected gestational age of 34 weeks (as recommended by the Austrian Society of Pediatrics).

In addition, routine screening for postnatal CMV infection may help identify infants who are likely to develop symptomatic disease.

The researchers also said the frequency of CMV infection in this study raises significant concern about the potential consequences of CMV infection among VLBW infants and points to the need for large, long-term follow-up studies of neurological outcomes in infants with postnatal CMV infection.

Sleeping infant

Credit: Vera Kratochvil

New research confirms that transfusing leukoreduced, cytomegalovirus (CMV)-seronegative blood products prevents CMV transmission in very-low-birth-weight (VLBW) infants.

The study showed that, with this approach, maternal breast milk becomes the primary source of postnatal CMV infection.

“Previously, the risk of CMV infection from blood transfusion of seronegative or leukoreduced transfusions was estimated to be 1% to 3%,” said Cassandra Josephson, MD, of Emory University School of Medicine in Atlanta, Georgia.

“We showed that, using blood components that are both CMV-seronegative and leukoreduced, we can effectively prevent the transfusion-transmission of CMV. Therefore, we believe that this is the safest approach to reduce the risk of CMV infection when giving transfusions to VLBW infants.”

Dr Josephson and her colleagues described this research in JAMA Pediatrics.

The researchers evaluated 462 mothers and 539 VLBW infants who were admitted to 3 neonatal intensive care units between January 2010 and June 2013.

A majority of mothers had a history of CMV infection prior to delivery (CMV sero-prevalence of 76.2%). The infants were enrolled in the study within 5 days of birth and had not received a blood transfusion at that time.

The infants were tested for congenital infection at birth and again at 5 additional intervals between birth and 90 days, discharge, or death.

Twenty-nine of the infants had CMV infection (cumulative incidence of 6.9% at 12 weeks). Five infants with CMV infection developed severe disease or died.

Although 2061 transfusions were administered to 310 of the infants (57.5%), the blood products were CMV-seronegative and leukoreduced, and none of the CMV infections was linked to transfusion.

Twenty-seven of 28 infections acquired after birth occurred among infants fed CMV-positive breast milk.

Dr Josephson and her colleagues estimate that between 1 in 5 and 1 in 10 VLBW infants who are fed CMV-positive breast milk from mothers with a history of CMV infection will develop postnatal CMV infection.

The American Academy of Pediatrics currently states that the value of routinely feeding breast milk from CMV-seropositive mothers to preterm infants outweighs the risks of clinical disease from CMV.

But the researchers noted that new strategies to prevent breast milk transmission of CMV are needed because freezing and thawing breast milk did not completely prevent transmission in this study.

The team said alternative approaches to prevent breast milk transmission of CMV could include routine CMV-serologic testing of pregnant mothers to enable counseling regarding the risk of infection, closer surveillance of infants with CMV-positive mothers, and pasteurization of breast milk until a corrected gestational age of 34 weeks (as recommended by the Austrian Society of Pediatrics).

In addition, routine screening for postnatal CMV infection may help identify infants who are likely to develop symptomatic disease.

The researchers also said the frequency of CMV infection in this study raises significant concern about the potential consequences of CMV infection among VLBW infants and points to the need for large, long-term follow-up studies of neurological outcomes in infants with postnatal CMV infection.

Blood sample collection

Credit: Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted marketing authorization for the T2Candida® Panel and the T2Dx® Instrument, a system that provides direct detection of 5 yeast pathogens in whole blood samples.

The system can detect Candida albicans, Candida tropicalis, Candida parapsilosis, Candida glabrata, and Candida krusei in patients with symptoms of, or medical conditions predisposing them to, invasive fungal infections.

It can take up to 6 days to detect yeast pathogens using blood culture, and even more time to identify the specific type of yeast present.

The T2Candida system can identify specific Candida pathogens from a single blood sample within 3 to 5 hours.

However, false positive results are possible with this system, so physicians should perform blood cultures to confirm T2Candida results, according to the FDA. Still, a negative test result may provide timely data that allows physicians to avoid or suspend unnecessary antifungal treatment.

“By testing 1 blood sample for 5 yeast pathogens—and getting results within a few hours—physicians can initiate appropriate antifungal treatment earlier and potentially reduce patient illness and decrease the risk of dying from these infections,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

How the system works

The T2Candida panel and T2Dx instrument are powered by T2MR, a miniaturized, magnetic-resonance-based diagnostic approach that measures how water molecules react in the presence of magnetic fields.

The system uses blood-compatible polymerase chain reaction to amplify Candida DNA, which then binds to superparamagnetic nanoparticles coated with a complementary DNA strand. The binding event causes the nanoparticles to cluster, which changes the sample’s T2 magnetic resonance signal.

If the system detects yeast DNA, it can then determine the species category to which the DNA belongs, which helps point healthcare providers to the appropriate treatment.

T2Dx is a fully automated, bench-top instrument. To perform a test, the patient sample is snapped onto a disposable test cartridge, which is preloaded with the necessary reagents. The cartridge is then inserted into T2Dx, which processes the sample and delivers a diagnostic test result.

Studies and FDA review

The FDA reviewed the T2Candida panel and the T2Dx instrument through the agency’s de novo classification process, a regulatory pathway for certain novel, low- to moderate-risk medical devices.

The FDA based its review on a clinical study of 1500 patients, in which the T2Candida system correctly categorized nearly 100% of the negative specimens as negative for the presence of yeast.

In a separate study of 300 blood samples with specific concentrations of yeast, the system correctly identified the organism in 84% to 96% of the positive specimens.

The T2Candida panel and T2Dx instrument are manufactured by T2 Biosystems, Inc.

Blood sample collection

Credit: Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted marketing authorization for the T2Candida® Panel and the T2Dx® Instrument, a system that provides direct detection of 5 yeast pathogens in whole blood samples.

The system can detect Candida albicans, Candida tropicalis, Candida parapsilosis, Candida glabrata, and Candida krusei in patients with symptoms of, or medical conditions predisposing them to, invasive fungal infections.

It can take up to 6 days to detect yeast pathogens using blood culture, and even more time to identify the specific type of yeast present.

The T2Candida system can identify specific Candida pathogens from a single blood sample within 3 to 5 hours.

However, false positive results are possible with this system, so physicians should perform blood cultures to confirm T2Candida results, according to the FDA. Still, a negative test result may provide timely data that allows physicians to avoid or suspend unnecessary antifungal treatment.

“By testing 1 blood sample for 5 yeast pathogens—and getting results within a few hours—physicians can initiate appropriate antifungal treatment earlier and potentially reduce patient illness and decrease the risk of dying from these infections,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

How the system works

The T2Candida panel and T2Dx instrument are powered by T2MR, a miniaturized, magnetic-resonance-based diagnostic approach that measures how water molecules react in the presence of magnetic fields.

The system uses blood-compatible polymerase chain reaction to amplify Candida DNA, which then binds to superparamagnetic nanoparticles coated with a complementary DNA strand. The binding event causes the nanoparticles to cluster, which changes the sample’s T2 magnetic resonance signal.

If the system detects yeast DNA, it can then determine the species category to which the DNA belongs, which helps point healthcare providers to the appropriate treatment.

T2Dx is a fully automated, bench-top instrument. To perform a test, the patient sample is snapped onto a disposable test cartridge, which is preloaded with the necessary reagents. The cartridge is then inserted into T2Dx, which processes the sample and delivers a diagnostic test result.

Studies and FDA review

The FDA reviewed the T2Candida panel and the T2Dx instrument through the agency’s de novo classification process, a regulatory pathway for certain novel, low- to moderate-risk medical devices.

The FDA based its review on a clinical study of 1500 patients, in which the T2Candida system correctly categorized nearly 100% of the negative specimens as negative for the presence of yeast.

In a separate study of 300 blood samples with specific concentrations of yeast, the system correctly identified the organism in 84% to 96% of the positive specimens.

The T2Candida panel and T2Dx instrument are manufactured by T2 Biosystems, Inc.

Blood sample collection

Credit: Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted marketing authorization for the T2Candida® Panel and the T2Dx® Instrument, a system that provides direct detection of 5 yeast pathogens in whole blood samples.

The system can detect Candida albicans, Candida tropicalis, Candida parapsilosis, Candida glabrata, and Candida krusei in patients with symptoms of, or medical conditions predisposing them to, invasive fungal infections.

It can take up to 6 days to detect yeast pathogens using blood culture, and even more time to identify the specific type of yeast present.

The T2Candida system can identify specific Candida pathogens from a single blood sample within 3 to 5 hours.

However, false positive results are possible with this system, so physicians should perform blood cultures to confirm T2Candida results, according to the FDA. Still, a negative test result may provide timely data that allows physicians to avoid or suspend unnecessary antifungal treatment.

“By testing 1 blood sample for 5 yeast pathogens—and getting results within a few hours—physicians can initiate appropriate antifungal treatment earlier and potentially reduce patient illness and decrease the risk of dying from these infections,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

How the system works

The T2Candida panel and T2Dx instrument are powered by T2MR, a miniaturized, magnetic-resonance-based diagnostic approach that measures how water molecules react in the presence of magnetic fields.

The system uses blood-compatible polymerase chain reaction to amplify Candida DNA, which then binds to superparamagnetic nanoparticles coated with a complementary DNA strand. The binding event causes the nanoparticles to cluster, which changes the sample’s T2 magnetic resonance signal.

If the system detects yeast DNA, it can then determine the species category to which the DNA belongs, which helps point healthcare providers to the appropriate treatment.

T2Dx is a fully automated, bench-top instrument. To perform a test, the patient sample is snapped onto a disposable test cartridge, which is preloaded with the necessary reagents. The cartridge is then inserted into T2Dx, which processes the sample and delivers a diagnostic test result.

Studies and FDA review

The FDA reviewed the T2Candida panel and the T2Dx instrument through the agency’s de novo classification process, a regulatory pathway for certain novel, low- to moderate-risk medical devices.

The FDA based its review on a clinical study of 1500 patients, in which the T2Candida system correctly categorized nearly 100% of the negative specimens as negative for the presence of yeast.

In a separate study of 300 blood samples with specific concentrations of yeast, the system correctly identified the organism in 84% to 96% of the positive specimens.

The T2Candida panel and T2Dx instrument are manufactured by T2 Biosystems, Inc.

Lab mice

Credit: Aaron Logan

Exercising during doxorubicin treatment can amplify the drug’s cancer-fighting ability, according to preclinical research.

Previous studies showed that adopting an exercise regimen before receiving doxorubicin could protect against the cardiac side effects associated with the drug.

Now, researchers have reported that exercising during doxorubicin treatment does not protect the heart, but it does help shrink tumors in mice.

Joseph Libonati, PhD, of the University of Pennsylvania in Philadelphia, and his colleagues reported these findings in the American Journal of Physiology—Regulatory, Integrative and Comparative Physiology.

The researchers conducted experiments with 4 groups of mice, all of which received an injection of melanoma cells.

During the next 2 weeks, 2 of the groups received doxorubicin in 2 doses, while the other 2 groups received placebo injections.

A treated group and a placebo group were put on exercise regimens, walking for 45 minutes 5 days a week on mouse-sized treadmills, while the rest of the mice remained sedentary.

After the 2-week trial, the researchers examined the animals’ hearts using echocardiogram and tissue analysis.

As expected, doxorubicin reduced the heart’s function and size and increased fibrosis. Mice that exercised were not protected from this damage.

“We looked, and the exercise didn’t do anything to the heart; it didn’t worsen it, it didn’t help it,” Dr Libonati said. “But the tumor data—I find them actually amazing.”

The mice that received doxorubicin and exercised had significantly smaller tumors after 2 weeks than mice that only received doxorubicin (P<0.05).

Further studies will investigate exactly how exercise enhances the effect of doxorubicin, but the researchers believe it could be, in part, because exercise increases blood flow to the tumor, bringing with it more of the drug in the bloodstream.

“If exercise helps in this way, you could potentially use a smaller dose of the drug and get fewer side effects,” Dr Libonati said.

Gaining a clearer understanding of the many ways that exercise affects various systems of the body could also pave the way for developing drugs that mimic the effects of exercise.

“People don’t take a drug and then sit down all day,” Dr Libonati said. “Something as simple as moving affects how drugs are metabolized. We’re only just beginning to understand the complexities.”

Lab mice

Credit: Aaron Logan

Exercising during doxorubicin treatment can amplify the drug’s cancer-fighting ability, according to preclinical research.

Previous studies showed that adopting an exercise regimen before receiving doxorubicin could protect against the cardiac side effects associated with the drug.

Now, researchers have reported that exercising during doxorubicin treatment does not protect the heart, but it does help shrink tumors in mice.

Joseph Libonati, PhD, of the University of Pennsylvania in Philadelphia, and his colleagues reported these findings in the American Journal of Physiology—Regulatory, Integrative and Comparative Physiology.

The researchers conducted experiments with 4 groups of mice, all of which received an injection of melanoma cells.

During the next 2 weeks, 2 of the groups received doxorubicin in 2 doses, while the other 2 groups received placebo injections.

A treated group and a placebo group were put on exercise regimens, walking for 45 minutes 5 days a week on mouse-sized treadmills, while the rest of the mice remained sedentary.

After the 2-week trial, the researchers examined the animals’ hearts using echocardiogram and tissue analysis.

As expected, doxorubicin reduced the heart’s function and size and increased fibrosis. Mice that exercised were not protected from this damage.

“We looked, and the exercise didn’t do anything to the heart; it didn’t worsen it, it didn’t help it,” Dr Libonati said. “But the tumor data—I find them actually amazing.”

The mice that received doxorubicin and exercised had significantly smaller tumors after 2 weeks than mice that only received doxorubicin (P<0.05).

Further studies will investigate exactly how exercise enhances the effect of doxorubicin, but the researchers believe it could be, in part, because exercise increases blood flow to the tumor, bringing with it more of the drug in the bloodstream.

“If exercise helps in this way, you could potentially use a smaller dose of the drug and get fewer side effects,” Dr Libonati said.

Gaining a clearer understanding of the many ways that exercise affects various systems of the body could also pave the way for developing drugs that mimic the effects of exercise.

“People don’t take a drug and then sit down all day,” Dr Libonati said. “Something as simple as moving affects how drugs are metabolized. We’re only just beginning to understand the complexities.”

Lab mice

Credit: Aaron Logan

Exercising during doxorubicin treatment can amplify the drug’s cancer-fighting ability, according to preclinical research.

Previous studies showed that adopting an exercise regimen before receiving doxorubicin could protect against the cardiac side effects associated with the drug.

Now, researchers have reported that exercising during doxorubicin treatment does not protect the heart, but it does help shrink tumors in mice.

Joseph Libonati, PhD, of the University of Pennsylvania in Philadelphia, and his colleagues reported these findings in the American Journal of Physiology—Regulatory, Integrative and Comparative Physiology.

The researchers conducted experiments with 4 groups of mice, all of which received an injection of melanoma cells.

During the next 2 weeks, 2 of the groups received doxorubicin in 2 doses, while the other 2 groups received placebo injections.

A treated group and a placebo group were put on exercise regimens, walking for 45 minutes 5 days a week on mouse-sized treadmills, while the rest of the mice remained sedentary.

After the 2-week trial, the researchers examined the animals’ hearts using echocardiogram and tissue analysis.

As expected, doxorubicin reduced the heart’s function and size and increased fibrosis. Mice that exercised were not protected from this damage.

“We looked, and the exercise didn’t do anything to the heart; it didn’t worsen it, it didn’t help it,” Dr Libonati said. “But the tumor data—I find them actually amazing.”

The mice that received doxorubicin and exercised had significantly smaller tumors after 2 weeks than mice that only received doxorubicin (P<0.05).

Further studies will investigate exactly how exercise enhances the effect of doxorubicin, but the researchers believe it could be, in part, because exercise increases blood flow to the tumor, bringing with it more of the drug in the bloodstream.

“If exercise helps in this way, you could potentially use a smaller dose of the drug and get fewer side effects,” Dr Libonati said.

Gaining a clearer understanding of the many ways that exercise affects various systems of the body could also pave the way for developing drugs that mimic the effects of exercise.

“People don’t take a drug and then sit down all day,” Dr Libonati said. “Something as simple as moving affects how drugs are metabolized. We’re only just beginning to understand the complexities.”

Thrombus

Credit: NHS

The US Food and Drug Administration (FDA) has approved the Xarelto Starter Pack™ for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

The pack provides a 30-day supply of Xarelto (rivaroxaban), which gives patients time to follow up with their primary care physician after leaving the hospital, without missing treatment.

Patients have the greatest risk of recurrence in the first 30 days after a DVT or PE.

“The starter pack will make a difference for patients impacted by blood clots by offering a 30-day supply of the drug in a new, convenient package, which may help support patients as they transition from the hospital to outpatient care,” said Paul Burton, MD, PhD, Vice President of Medical Affairs at Janssen, the company developing Xarelto.

The Xarelto Starter Pack™ will be available at pharmacies in October.

Xarelto is a factor Xa inhibitor that is FDA-approved to treat and prevent the recurrence of DVT/PE, as thromboprophylaxis in patients who have undergone knee or hip replacement surgery, and to reduce the risk of stroke in patients with non-valvular atrial fibrillation.

For DVT/PE patients, Xarelto is given twice daily at 15 mg with food for the first 21 days. On day 22, patients transition to a once-daily dose of 20 mg with food for the remainder of treatment.

Xarelto has a boxed warning stating that premature discontinuation of the drug increases the risk of thrombotic events, and epidural or spinal hematomas have occurred in Xarelto-treated patients who are receiving neuraxial anesthesia or undergoing spinal puncture.

For more details on Xarelto, see the full prescribing information.

Thrombus

Credit: NHS

The US Food and Drug Administration (FDA) has approved the Xarelto Starter Pack™ for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

The pack provides a 30-day supply of Xarelto (rivaroxaban), which gives patients time to follow up with their primary care physician after leaving the hospital, without missing treatment.

Patients have the greatest risk of recurrence in the first 30 days after a DVT or PE.

“The starter pack will make a difference for patients impacted by blood clots by offering a 30-day supply of the drug in a new, convenient package, which may help support patients as they transition from the hospital to outpatient care,” said Paul Burton, MD, PhD, Vice President of Medical Affairs at Janssen, the company developing Xarelto.

The Xarelto Starter Pack™ will be available at pharmacies in October.

Xarelto is a factor Xa inhibitor that is FDA-approved to treat and prevent the recurrence of DVT/PE, as thromboprophylaxis in patients who have undergone knee or hip replacement surgery, and to reduce the risk of stroke in patients with non-valvular atrial fibrillation.

For DVT/PE patients, Xarelto is given twice daily at 15 mg with food for the first 21 days. On day 22, patients transition to a once-daily dose of 20 mg with food for the remainder of treatment.

Xarelto has a boxed warning stating that premature discontinuation of the drug increases the risk of thrombotic events, and epidural or spinal hematomas have occurred in Xarelto-treated patients who are receiving neuraxial anesthesia or undergoing spinal puncture.

For more details on Xarelto, see the full prescribing information.

Thrombus

Credit: NHS

The US Food and Drug Administration (FDA) has approved the Xarelto Starter Pack™ for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

The pack provides a 30-day supply of Xarelto (rivaroxaban), which gives patients time to follow up with their primary care physician after leaving the hospital, without missing treatment.

Patients have the greatest risk of recurrence in the first 30 days after a DVT or PE.

“The starter pack will make a difference for patients impacted by blood clots by offering a 30-day supply of the drug in a new, convenient package, which may help support patients as they transition from the hospital to outpatient care,” said Paul Burton, MD, PhD, Vice President of Medical Affairs at Janssen, the company developing Xarelto.

The Xarelto Starter Pack™ will be available at pharmacies in October.

Xarelto is a factor Xa inhibitor that is FDA-approved to treat and prevent the recurrence of DVT/PE, as thromboprophylaxis in patients who have undergone knee or hip replacement surgery, and to reduce the risk of stroke in patients with non-valvular atrial fibrillation.

For DVT/PE patients, Xarelto is given twice daily at 15 mg with food for the first 21 days. On day 22, patients transition to a once-daily dose of 20 mg with food for the remainder of treatment.

Xarelto has a boxed warning stating that premature discontinuation of the drug increases the risk of thrombotic events, and epidural or spinal hematomas have occurred in Xarelto-treated patients who are receiving neuraxial anesthesia or undergoing spinal puncture.

For more details on Xarelto, see the full prescribing information.