Polycythemia vera

Credit: AFIP

The US Food and Drug Administration (FDA) has expanded the approved use of ruxolitinib (Jakafi) to include treatment of patients with polycythemia vera (PV).

This is the first drug approved by the FDA for this condition.

Ruxolitinib can now be used to treat PV patients who have an inadequate response to hydroxyurea or cannot tolerate the drug.

The FDA said the approval of ruxolitinib for PV patients will help decrease splenomegaly and the need for phlebotomy.

“The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease.”

Results from that study, the phase 3 RESPONSE trial, were presented at the 2014 ASCO Annual Meeting.  RESPONSE was funded by Incyte Corporation, the company developing ruxolitinib.

The trial included 222 patients who had PV for at least 24 weeks. All patients had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy procedure, and exhibited an enlarged spleen.

They were randomized to receive ruxolitinib at a starting dose of 10 mg twice daily or best available therapy (BAT) as determined by the investigator on a participant-by-participant basis. The ruxolitinib dose was adjusted as needed throughout the study.

The study was designed to measure the reduced need for phlebotomy beginning at week 8 and continuing through week 32, in addition to at least a 35% reduction in spleen volume at week 32.

Twenty-one percent of ruxolitinib-treated patients met this endpoint, compared to 1% of patients who received BAT. At week 32, 77% of patients on ruxolitinib and 20% on BAT achieved hematocrit control or spleen reduction.

Ruxolitinib was generally well-tolerated, but 3.6% of patients discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.

The most common events associated with ruxolitinib were anemia and thrombocytopenia. The most common non-hematologic events were headache, diarrhea, fatigue, dizziness, constipation, and shingles.

The FDA reviewed ruxolitinib’s use for PV under the agency’s priority review program because, at the time the application was submitted, the drug demonstrated the potential to be a significant improvement over available therapy. Ruxolitinib also received orphan product designation.

Ruxolitinib is currently approved in more than 60 countries for patients with myelofibrosis (MF). In 2011, the FDA approved the drug to treat patients with intermediate or high-risk MF, including primary MF, post-PV MF, and post-essential thrombocythemia MF.

Polycythemia vera

Credit: AFIP

The US Food and Drug Administration (FDA) has expanded the approved use of ruxolitinib (Jakafi) to include treatment of patients with polycythemia vera (PV).

This is the first drug approved by the FDA for this condition.

Ruxolitinib can now be used to treat PV patients who have an inadequate response to hydroxyurea or cannot tolerate the drug.

The FDA said the approval of ruxolitinib for PV patients will help decrease splenomegaly and the need for phlebotomy.

“The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease.”

Results from that study, the phase 3 RESPONSE trial, were presented at the 2014 ASCO Annual Meeting.  RESPONSE was funded by Incyte Corporation, the company developing ruxolitinib.

The trial included 222 patients who had PV for at least 24 weeks. All patients had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy procedure, and exhibited an enlarged spleen.

They were randomized to receive ruxolitinib at a starting dose of 10 mg twice daily or best available therapy (BAT) as determined by the investigator on a participant-by-participant basis. The ruxolitinib dose was adjusted as needed throughout the study.

The study was designed to measure the reduced need for phlebotomy beginning at week 8 and continuing through week 32, in addition to at least a 35% reduction in spleen volume at week 32.

Twenty-one percent of ruxolitinib-treated patients met this endpoint, compared to 1% of patients who received BAT. At week 32, 77% of patients on ruxolitinib and 20% on BAT achieved hematocrit control or spleen reduction.

Ruxolitinib was generally well-tolerated, but 3.6% of patients discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.

The most common events associated with ruxolitinib were anemia and thrombocytopenia. The most common non-hematologic events were headache, diarrhea, fatigue, dizziness, constipation, and shingles.

The FDA reviewed ruxolitinib’s use for PV under the agency’s priority review program because, at the time the application was submitted, the drug demonstrated the potential to be a significant improvement over available therapy. Ruxolitinib also received orphan product designation.

Ruxolitinib is currently approved in more than 60 countries for patients with myelofibrosis (MF). In 2011, the FDA approved the drug to treat patients with intermediate or high-risk MF, including primary MF, post-PV MF, and post-essential thrombocythemia MF.

Polycythemia vera

Credit: AFIP

The US Food and Drug Administration (FDA) has expanded the approved use of ruxolitinib (Jakafi) to include treatment of patients with polycythemia vera (PV).

This is the first drug approved by the FDA for this condition.

Ruxolitinib can now be used to treat PV patients who have an inadequate response to hydroxyurea or cannot tolerate the drug.

The FDA said the approval of ruxolitinib for PV patients will help decrease splenomegaly and the need for phlebotomy.

“The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease.”

Results from that study, the phase 3 RESPONSE trial, were presented at the 2014 ASCO Annual Meeting.  RESPONSE was funded by Incyte Corporation, the company developing ruxolitinib.

The trial included 222 patients who had PV for at least 24 weeks. All patients had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy procedure, and exhibited an enlarged spleen.

They were randomized to receive ruxolitinib at a starting dose of 10 mg twice daily or best available therapy (BAT) as determined by the investigator on a participant-by-participant basis. The ruxolitinib dose was adjusted as needed throughout the study.

The study was designed to measure the reduced need for phlebotomy beginning at week 8 and continuing through week 32, in addition to at least a 35% reduction in spleen volume at week 32.

Twenty-one percent of ruxolitinib-treated patients met this endpoint, compared to 1% of patients who received BAT. At week 32, 77% of patients on ruxolitinib and 20% on BAT achieved hematocrit control or spleen reduction.

Ruxolitinib was generally well-tolerated, but 3.6% of patients discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.

The most common events associated with ruxolitinib were anemia and thrombocytopenia. The most common non-hematologic events were headache, diarrhea, fatigue, dizziness, constipation, and shingles.

The FDA reviewed ruxolitinib’s use for PV under the agency’s priority review program because, at the time the application was submitted, the drug demonstrated the potential to be a significant improvement over available therapy. Ruxolitinib also received orphan product designation.

Ruxolitinib is currently approved in more than 60 countries for patients with myelofibrosis (MF). In 2011, the FDA approved the drug to treat patients with intermediate or high-risk MF, including primary MF, post-PV MF, and post-essential thrombocythemia MF.

CASE: Patient opts for myomectomy
A 41-year-old woman, G0, with symptomatic myomas wishes to preserve her reproductive organs rather than undergo hysterectomy. She chooses laparoscopic myomectomy.

Preoperative imaging with transvaginal ultrasound reveals a 4-cm posterior pedunculated myoma and a 5-cm fundal intramural myoma. Preoperative videohysteroscopy reveals external compression of the anterior intramural myoma without intracavitary extension. Both tubal ostia appear normal.

During a multipuncture technique with a 5-mm laparoscope and 5-mm accessory ports,¹ the abdomen and pelvis are evaluated. The 4-cm pedunculated myoma is visualized posteriorly and to the left of midline. The 5-cm intramural myoma enlarges the contour of the uterine fundus.

How would you proceed?

With intracorporeal electromechanical “power” morcellation under scrutiny due to the potential dissemination of benign and malignant tissue, many surgeons are seeking alternatives that will allow them to continue offering minimally invasive surgical options.^2–4

Intracorporeal power morcellation is used during minimally invasive gynecologic procedures, including total hysterectomy, supracervical hysterectomy, and myomectomy. Two current alternatives—­laparoscopic-assisted minilaparotomy and tissue extraction through a posterior colpotomy—show promise in minimizing the risks of tissue dissemination.^5–7 Regardless of the route selected for tissue extraction, the use of endoscopic specimen bags and surgical retractors may ease tissue removal and limit dissemination.

In this article, we describe contained transvaginal tissue extraction through a posterior colpotomy in the setting of laparoscopic myomectomy, describing an actual case. A video of our technique is available at obgmanagement.com.

Technique, tips, and tricks
Posterior colpotomy allows the removal of fibroids during laparoscopic myomectomy without the need to enlarge the abdominal incisions and without the use of intracorporeal power morcellation. Instead, tissue is extracted transvaginally. The incision is hidden in a natural orifice, the vagina.

Equipment consists of a:

• 5-mm laparoscope and 5-mm accessory ports

Figure 1: Equipment The AirSeal Access Port (Top) and LapSac specimen-retrieval bag (Bottom).

• LapSac specimen-retrieval bag (Cook Medical; various sizes available)
• AirSeal Access Port (SurgiQuest), 12 mm in diameter and 150 mm in length (FIGURE 1).

Preparatory steps Place a manipulator in the uterus and elevate it anteriorly. Position the AirSeal Access Port transvaginally, with the sharp tip below the cervix in the posterior fornix. Take care not to injure the rectum.

Confirm proper placement of the Access Port and visualize the posterior cul-de-sac laparoscopically.

Insert the 12-mm Access Port for pneumoperitoneum and the introduction and removal of suture, curved needles, and the specimen-retrieval bag.

The Access Port also provides excellent smoke evacuation and optimal visualization during the myomectomy. It is a new-concept laparoscopic port without any mechanical seal. The technology assists in maintaining pneumoperitoneum at a constant pressure despite the size of the opening.

Amputating the myomas
Choose a specimen-retrieval bag just slightly larger than the largest myoma. In this case, the larger of the two myomas is approximately 5 cm. Therefore, a 5 × 8 cm LapSac is appropriate. We roll up the LapSac and place it through the Access Port using smooth forceps, situating the bag in the abdomen prior to the start of the myomectomy, with the opening toward the uterus, so that the myomas can be collected as they are removed (FIGURE 2).

We then inject dilute vasopressin (one 20-unit ampule in 60 cc normal saline) near the base of the pedunculated myoma stalk and use monopolar electrosurgery to amputate the myoma. We place the myoma in the specimen-retrieval bag (FIGURE 3).

Next, we inject dilute vasopressin into the serosa overlying the intramural myoma and use electrosurgery to incise the serosa and myometrium. We enucleate the second myoma and place it in the bag. We then close the uterine incision using a combination of interrupted Vicryl and running V-Loc sutures on a curved CT-2 needle introduced through the Access Port (FIGURE 4).

Figure 2: Introduce the bag Introduce the LapSac through the Access Port. Figure 3: Contain the specimen Once it is amputated, place the myoma into the LapSac.

Figure 4: Close the uterine incision In preparation for closure, insert a curved CT-2 needle and suture material through the Access Port. Figure 5: Cinch the sac Cinch the LapSac prior to transvaginal removal.

Tissue extraction
We place a blunt-tipped grasper transvaginally through the 12-mm Access Port to retrieve the blue polypropylene drawstring of the specimen bag (FIGURE 5). We then deactivate the Access Port and AirSeal system.

The bag containing the myomas is too large to fit through the port and the posterior colpotomy, so it is necessary to remove the Access Port from the vagina without losing the drawstrings of the specimen bag (FIGURE 6).

We vaginally exteriorize the opening of the bag (FIGURE 7), reorient the pedunculated myoma, which is oblong in shape, using forceps, and remove it without morcellation.

Manual morcellation will be necessary for the second, larger myoma. We perform that morcellation sharply using a scalpel within the specimen retrieval bag, taking care not to puncture the bag (FIGURE 8). When the myoma pieces are small enough, we remove them, along with the bag, through the posterior colpotomy. We then close the colpotomy laparoscopically using two interrupted 0 Vicryl sutures, and we copiously irrigate the pelvis (FIGURE 9).

Figure 6: Remove the Access Port Prior to tissue extraction, remove the Access Port from the vagina. Figure 7: Exteriorize the bag Exteriorize the specimen-retrieval bag vaginally for tissue extraction.

Figure 8: Contain the morcellation Manually morcellate the specimen within the bag and remove it transvaginally. Figure 9: Close the colpotomy Close the colpotomy once both myomas and the specimen bag have been removed.

Benefits of this approach
The greatest benefit of this technique is the safe removal of specimens when performing fertility-sparing surgery. The 5-mm incisions are cosmetically inconspicuous. Moreover, the risk of port-site hernia is lower with 5-mm incisions, as opposed to extended incisions to remove specimens transabdominally.

The posterior colpotomy is associated with reduced pain and does not increase the rate of dyspareunia or infection; it also helps prevent pelvic adhesions.^8–11

In 1993, we reported the results of ­second-look laparoscopy in 22 women who had undergone laparoscopic posterior colpotomy for tissue extraction. None had obliterative adhesions in the posterior cul-de-sac.¹¹ This advantage is especially important in fertility-sparing surgery.

We have used this approach for specimen removal after several different procedures, including laparoscopic cystectomy and appendectomy.^12,13 For laparoscopic cystectomy, once the cyst is drained, we enucleate it and place the cyst capsule into a specimen bag that has been inserted transvaginally through a posterior colpotomy.¹² Laparoscopic appendectomy can be ­performed using a 12-mm stapler introduced via the colpotomy. We simply remove the specimen in its entirety through the posterior colpotomy.¹³

The bottom line: Gynecologic surgeons need to continue performing minimally invasive surgery for the benefit of patients. Moving forward and innovating to develop alternatives to intracorporeal power morcellation, when possible, should be our aim rather than falling back on surgeries through large abdominal incisions.

CASE: Resolved
At her 1-week postoperative visit, the patient’s 5-mm incisions are healing well and she has minimal pain.

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

CASE: Patient opts for myomectomy
A 41-year-old woman, G0, with symptomatic myomas wishes to preserve her reproductive organs rather than undergo hysterectomy. She chooses laparoscopic myomectomy.

Preoperative imaging with transvaginal ultrasound reveals a 4-cm posterior pedunculated myoma and a 5-cm fundal intramural myoma. Preoperative videohysteroscopy reveals external compression of the anterior intramural myoma without intracavitary extension. Both tubal ostia appear normal.

During a multipuncture technique with a 5-mm laparoscope and 5-mm accessory ports,¹ the abdomen and pelvis are evaluated. The 4-cm pedunculated myoma is visualized posteriorly and to the left of midline. The 5-cm intramural myoma enlarges the contour of the uterine fundus.

How would you proceed?

With intracorporeal electromechanical “power” morcellation under scrutiny due to the potential dissemination of benign and malignant tissue, many surgeons are seeking alternatives that will allow them to continue offering minimally invasive surgical options.^2–4

Intracorporeal power morcellation is used during minimally invasive gynecologic procedures, including total hysterectomy, supracervical hysterectomy, and myomectomy. Two current alternatives—­laparoscopic-assisted minilaparotomy and tissue extraction through a posterior colpotomy—show promise in minimizing the risks of tissue dissemination.^5–7 Regardless of the route selected for tissue extraction, the use of endoscopic specimen bags and surgical retractors may ease tissue removal and limit dissemination.

In this article, we describe contained transvaginal tissue extraction through a posterior colpotomy in the setting of laparoscopic myomectomy, describing an actual case. A video of our technique is available at obgmanagement.com.

Technique, tips, and tricks
Posterior colpotomy allows the removal of fibroids during laparoscopic myomectomy without the need to enlarge the abdominal incisions and without the use of intracorporeal power morcellation. Instead, tissue is extracted transvaginally. The incision is hidden in a natural orifice, the vagina.

Equipment consists of a:

• 5-mm laparoscope and 5-mm accessory ports

Figure 1: Equipment The AirSeal Access Port (Top) and LapSac specimen-retrieval bag (Bottom).

• LapSac specimen-retrieval bag (Cook Medical; various sizes available)
• AirSeal Access Port (SurgiQuest), 12 mm in diameter and 150 mm in length (FIGURE 1).

Preparatory steps Place a manipulator in the uterus and elevate it anteriorly. Position the AirSeal Access Port transvaginally, with the sharp tip below the cervix in the posterior fornix. Take care not to injure the rectum.

Confirm proper placement of the Access Port and visualize the posterior cul-de-sac laparoscopically.

Insert the 12-mm Access Port for pneumoperitoneum and the introduction and removal of suture, curved needles, and the specimen-retrieval bag.

The Access Port also provides excellent smoke evacuation and optimal visualization during the myomectomy. It is a new-concept laparoscopic port without any mechanical seal. The technology assists in maintaining pneumoperitoneum at a constant pressure despite the size of the opening.

Amputating the myomas
Choose a specimen-retrieval bag just slightly larger than the largest myoma. In this case, the larger of the two myomas is approximately 5 cm. Therefore, a 5 × 8 cm LapSac is appropriate. We roll up the LapSac and place it through the Access Port using smooth forceps, situating the bag in the abdomen prior to the start of the myomectomy, with the opening toward the uterus, so that the myomas can be collected as they are removed (FIGURE 2).

We then inject dilute vasopressin (one 20-unit ampule in 60 cc normal saline) near the base of the pedunculated myoma stalk and use monopolar electrosurgery to amputate the myoma. We place the myoma in the specimen-retrieval bag (FIGURE 3).

Next, we inject dilute vasopressin into the serosa overlying the intramural myoma and use electrosurgery to incise the serosa and myometrium. We enucleate the second myoma and place it in the bag. We then close the uterine incision using a combination of interrupted Vicryl and running V-Loc sutures on a curved CT-2 needle introduced through the Access Port (FIGURE 4).

Figure 2: Introduce the bag Introduce the LapSac through the Access Port. Figure 3: Contain the specimen Once it is amputated, place the myoma into the LapSac.

Figure 4: Close the uterine incision In preparation for closure, insert a curved CT-2 needle and suture material through the Access Port. Figure 5: Cinch the sac Cinch the LapSac prior to transvaginal removal.

Tissue extraction
We place a blunt-tipped grasper transvaginally through the 12-mm Access Port to retrieve the blue polypropylene drawstring of the specimen bag (FIGURE 5). We then deactivate the Access Port and AirSeal system.

The bag containing the myomas is too large to fit through the port and the posterior colpotomy, so it is necessary to remove the Access Port from the vagina without losing the drawstrings of the specimen bag (FIGURE 6).

We vaginally exteriorize the opening of the bag (FIGURE 7), reorient the pedunculated myoma, which is oblong in shape, using forceps, and remove it without morcellation.

Manual morcellation will be necessary for the second, larger myoma. We perform that morcellation sharply using a scalpel within the specimen retrieval bag, taking care not to puncture the bag (FIGURE 8). When the myoma pieces are small enough, we remove them, along with the bag, through the posterior colpotomy. We then close the colpotomy laparoscopically using two interrupted 0 Vicryl sutures, and we copiously irrigate the pelvis (FIGURE 9).

Figure 6: Remove the Access Port Prior to tissue extraction, remove the Access Port from the vagina. Figure 7: Exteriorize the bag Exteriorize the specimen-retrieval bag vaginally for tissue extraction.

Figure 8: Contain the morcellation Manually morcellate the specimen within the bag and remove it transvaginally. Figure 9: Close the colpotomy Close the colpotomy once both myomas and the specimen bag have been removed.

Benefits of this approach
The greatest benefit of this technique is the safe removal of specimens when performing fertility-sparing surgery. The 5-mm incisions are cosmetically inconspicuous. Moreover, the risk of port-site hernia is lower with 5-mm incisions, as opposed to extended incisions to remove specimens transabdominally.

The posterior colpotomy is associated with reduced pain and does not increase the rate of dyspareunia or infection; it also helps prevent pelvic adhesions.^8–11

In 1993, we reported the results of ­second-look laparoscopy in 22 women who had undergone laparoscopic posterior colpotomy for tissue extraction. None had obliterative adhesions in the posterior cul-de-sac.¹¹ This advantage is especially important in fertility-sparing surgery.

We have used this approach for specimen removal after several different procedures, including laparoscopic cystectomy and appendectomy.^12,13 For laparoscopic cystectomy, once the cyst is drained, we enucleate it and place the cyst capsule into a specimen bag that has been inserted transvaginally through a posterior colpotomy.¹² Laparoscopic appendectomy can be ­performed using a 12-mm stapler introduced via the colpotomy. We simply remove the specimen in its entirety through the posterior colpotomy.¹³

The bottom line: Gynecologic surgeons need to continue performing minimally invasive surgery for the benefit of patients. Moving forward and innovating to develop alternatives to intracorporeal power morcellation, when possible, should be our aim rather than falling back on surgeries through large abdominal incisions.

CASE: Resolved
At her 1-week postoperative visit, the patient’s 5-mm incisions are healing well and she has minimal pain.

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

CASE: Patient opts for myomectomy
A 41-year-old woman, G0, with symptomatic myomas wishes to preserve her reproductive organs rather than undergo hysterectomy. She chooses laparoscopic myomectomy.

Preoperative imaging with transvaginal ultrasound reveals a 4-cm posterior pedunculated myoma and a 5-cm fundal intramural myoma. Preoperative videohysteroscopy reveals external compression of the anterior intramural myoma without intracavitary extension. Both tubal ostia appear normal.

During a multipuncture technique with a 5-mm laparoscope and 5-mm accessory ports,¹ the abdomen and pelvis are evaluated. The 4-cm pedunculated myoma is visualized posteriorly and to the left of midline. The 5-cm intramural myoma enlarges the contour of the uterine fundus.

How would you proceed?

With intracorporeal electromechanical “power” morcellation under scrutiny due to the potential dissemination of benign and malignant tissue, many surgeons are seeking alternatives that will allow them to continue offering minimally invasive surgical options.^2–4

Intracorporeal power morcellation is used during minimally invasive gynecologic procedures, including total hysterectomy, supracervical hysterectomy, and myomectomy. Two current alternatives—­laparoscopic-assisted minilaparotomy and tissue extraction through a posterior colpotomy—show promise in minimizing the risks of tissue dissemination.^5–7 Regardless of the route selected for tissue extraction, the use of endoscopic specimen bags and surgical retractors may ease tissue removal and limit dissemination.

In this article, we describe contained transvaginal tissue extraction through a posterior colpotomy in the setting of laparoscopic myomectomy, describing an actual case. A video of our technique is available at obgmanagement.com.

Technique, tips, and tricks
Posterior colpotomy allows the removal of fibroids during laparoscopic myomectomy without the need to enlarge the abdominal incisions and without the use of intracorporeal power morcellation. Instead, tissue is extracted transvaginally. The incision is hidden in a natural orifice, the vagina.

Equipment consists of a:

• 5-mm laparoscope and 5-mm accessory ports

Figure 1: Equipment The AirSeal Access Port (Top) and LapSac specimen-retrieval bag (Bottom).

• LapSac specimen-retrieval bag (Cook Medical; various sizes available)
• AirSeal Access Port (SurgiQuest), 12 mm in diameter and 150 mm in length (FIGURE 1).

Preparatory steps Place a manipulator in the uterus and elevate it anteriorly. Position the AirSeal Access Port transvaginally, with the sharp tip below the cervix in the posterior fornix. Take care not to injure the rectum.

Confirm proper placement of the Access Port and visualize the posterior cul-de-sac laparoscopically.

Insert the 12-mm Access Port for pneumoperitoneum and the introduction and removal of suture, curved needles, and the specimen-retrieval bag.

The Access Port also provides excellent smoke evacuation and optimal visualization during the myomectomy. It is a new-concept laparoscopic port without any mechanical seal. The technology assists in maintaining pneumoperitoneum at a constant pressure despite the size of the opening.

Amputating the myomas
Choose a specimen-retrieval bag just slightly larger than the largest myoma. In this case, the larger of the two myomas is approximately 5 cm. Therefore, a 5 × 8 cm LapSac is appropriate. We roll up the LapSac and place it through the Access Port using smooth forceps, situating the bag in the abdomen prior to the start of the myomectomy, with the opening toward the uterus, so that the myomas can be collected as they are removed (FIGURE 2).

We then inject dilute vasopressin (one 20-unit ampule in 60 cc normal saline) near the base of the pedunculated myoma stalk and use monopolar electrosurgery to amputate the myoma. We place the myoma in the specimen-retrieval bag (FIGURE 3).

Next, we inject dilute vasopressin into the serosa overlying the intramural myoma and use electrosurgery to incise the serosa and myometrium. We enucleate the second myoma and place it in the bag. We then close the uterine incision using a combination of interrupted Vicryl and running V-Loc sutures on a curved CT-2 needle introduced through the Access Port (FIGURE 4).

Figure 2: Introduce the bag Introduce the LapSac through the Access Port. Figure 3: Contain the specimen Once it is amputated, place the myoma into the LapSac.

Figure 4: Close the uterine incision In preparation for closure, insert a curved CT-2 needle and suture material through the Access Port. Figure 5: Cinch the sac Cinch the LapSac prior to transvaginal removal.

Tissue extraction
We place a blunt-tipped grasper transvaginally through the 12-mm Access Port to retrieve the blue polypropylene drawstring of the specimen bag (FIGURE 5). We then deactivate the Access Port and AirSeal system.

The bag containing the myomas is too large to fit through the port and the posterior colpotomy, so it is necessary to remove the Access Port from the vagina without losing the drawstrings of the specimen bag (FIGURE 6).

We vaginally exteriorize the opening of the bag (FIGURE 7), reorient the pedunculated myoma, which is oblong in shape, using forceps, and remove it without morcellation.

Manual morcellation will be necessary for the second, larger myoma. We perform that morcellation sharply using a scalpel within the specimen retrieval bag, taking care not to puncture the bag (FIGURE 8). When the myoma pieces are small enough, we remove them, along with the bag, through the posterior colpotomy. We then close the colpotomy laparoscopically using two interrupted 0 Vicryl sutures, and we copiously irrigate the pelvis (FIGURE 9).

Figure 6: Remove the Access Port Prior to tissue extraction, remove the Access Port from the vagina. Figure 7: Exteriorize the bag Exteriorize the specimen-retrieval bag vaginally for tissue extraction.

Figure 8: Contain the morcellation Manually morcellate the specimen within the bag and remove it transvaginally. Figure 9: Close the colpotomy Close the colpotomy once both myomas and the specimen bag have been removed.

Benefits of this approach
The greatest benefit of this technique is the safe removal of specimens when performing fertility-sparing surgery. The 5-mm incisions are cosmetically inconspicuous. Moreover, the risk of port-site hernia is lower with 5-mm incisions, as opposed to extended incisions to remove specimens transabdominally.

The posterior colpotomy is associated with reduced pain and does not increase the rate of dyspareunia or infection; it also helps prevent pelvic adhesions.^8–11

In 1993, we reported the results of ­second-look laparoscopy in 22 women who had undergone laparoscopic posterior colpotomy for tissue extraction. None had obliterative adhesions in the posterior cul-de-sac.¹¹ This advantage is especially important in fertility-sparing surgery.

We have used this approach for specimen removal after several different procedures, including laparoscopic cystectomy and appendectomy.^12,13 For laparoscopic cystectomy, once the cyst is drained, we enucleate it and place the cyst capsule into a specimen bag that has been inserted transvaginally through a posterior colpotomy.¹² Laparoscopic appendectomy can be ­performed using a 12-mm stapler introduced via the colpotomy. We simply remove the specimen in its entirety through the posterior colpotomy.¹³

The bottom line: Gynecologic surgeons need to continue performing minimally invasive surgery for the benefit of patients. Moving forward and innovating to develop alternatives to intracorporeal power morcellation, when possible, should be our aim rather than falling back on surgeries through large abdominal incisions.

CASE: Resolved
At her 1-week postoperative visit, the patient’s 5-mm incisions are healing well and she has minimal pain.

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

“It takes 20 years to build a reputation and 5 minutes to ruin it. If you think about that, you’ll do things differently.”          
—Warren Buffet

CASE: Decline in new patients
A well-respected physician—one of the best in his field—notices that the number of new patients in his practice has fallen off drastically over the past year. Baffled, he hires a consultant, who discovers that the doctor’s online reputation has plummeted, thanks to four negative reviews and no positive ones.

What can the physician do to remedy the situation and restore his reputation?

The problem can be fixed, but it takes time—like major surgery. Rather than wait until negative reviews are posted, we recommend that you become proactive and take steps as soon as possible to secure your online reputation. That way, you won’t get caught by surprise when one or two unhappy patients try to smear your good name. In this article, we step you through a number of remedies and proactive strategies for boosting positive online reviews and combating negative ones.

The Internet: A one-stop source of information
The Internet has become everyone’s go-to source for pretty much any kind of data, including details on products, services, and people. Anyone can access all kinds of information simply by asking.

Today, people research medical conditions on the Web, often using Google. If you have done your search engine optimization, your Web site will come up in the first page of search results, making it possible for prospective patients to click through to your homepage. (For the scoop on search engine optimization, see Part 3 of this series, “Maximizing your online reach through SEO and pay-per-click,” which appeared in the September 2014 issue of OBG Management.)

If visitors like what they see at your site, they may make an appointment. But they are more likely to visit three or four other sites before making a decision. And in all likelihood, they will research each physician to find out what patients have to say about her or him. It’s no different than looking at the reviews of hotels or products you are considering.

You are an open book on the Internet. Only a few short years ago, your peers and patients knew your reputation primarily through word of mouth, which traveled at the speed of molasses. For the most part, that information was favorable. Today your exposure is much greater, and negative comments about you can be viewed by thousands of potential patients. The speed of information has increased, as well. What is posted on the Internet can become readily available to hundreds, thousands, and even millions of Web users in a nanosecond.

The Internet provides a forum for people to say whatever they want about their experiences, both positive and negative. Regrettably, the positive experiences do not find their way online nearly as often as the negative ones!

The bottom line? In today’s Internet-­savvy world, you need to pay regular attention to your online reputation. You need to take steps to ensure that your name and practice look their best and to negate any complaints that may appear.

What patients share about their experience with you
Many online review sites provide an opportunity for your patients to describe their experience with you and your practice. To name a few: RateMDs.com, Vitals.com, ­ZocDoc.com, healthgrades.com, ­UcompareHealth.com, Citysearch.com, yelp.com, and, of course, Google Plus reviews.

And when patients post comments on the Internet, you likely will be rated on:

• the patient’s wait time
• how your staff treated the patient
• the diagnosis
• your attitude
• the level of trust in your decisions
• treatment and outcome.

The online surfer searching for a reputable physician is likely to believe whatever he or she finds on the leading review sites.

The good news: Most physicians have a very favorable rating, averaging 9.3 out of 10 on a scale of 1 to 10. In fact, 70% of doctors have perfect scores!¹

The bad news: Someone who is unhappy with her treatment or outcome will go out of her way to find every online review site possible and proclaim your faults to the cyber-world, using the Internet as a forum, whether her facts are straight or not. Patients who are pleased and satisfied rarely bother to place a positive review.

How you can control your online reputation
It is incumbent upon you to keep an eye on your online reputation at all times. Here are some tips for taking charge:

• If someone posts a negative review, respond to them directly in the review site. Doing so does not violate privacy laws as long as you do not mention the patient’s name or give other identifying details. Explain your side of the story without confirming or denying that the reviewer is or was a patient. Do not mention the specifics of any patient’s condition.
• If you feel that a negative review is completely unjustified, file a dispute with the review site. Many review sites will remove the unfavorable content if you can convince them that the patient is merely ranting.
• To protect your reputation over the long term, use your name or practice name to set up an alert with Google Alerts by visiting the site Google.com/alerts.
• Do a Google search of your name and the name of your practice at least once a month and check out all the review sites that come up. Read the comments!

Develop a proactive system
You have a lot of control when it comes to protecting your online reputation, provided you are willing to take the time to set up a system to regularly request feedback or testimonials from your patients.

Regrettably, this is where most medical practices fall short, by failing to establish a system to solicit positive reviews.

The process need not be complicated. Such a system can be set in motion by scheduling a quick meeting with your staff to announce your plans to solicit testimonials from patients. Often there will be a flurry of activity for a couple of weeks before the task is forgotten. To keep your system from falling through the cracks, make a checklist and decide who on your staff is responsible for each step in the process. Go over the results in your staff meetings on a regular basis—ie, at least monthly.

You want to solicit positive reviews for use in two places:

• your Web site
• the review sites we mentioned earlier.

Posting testimonials on your Web site

Your site is the place prospective patients visit when they are looking for information about you and your services. Here are a few tips on gathering and posting testimonials:

• The best time to solicit feedback from the patient is after the follow-up appointment, when her needs have been met and she has had at least two experiences with your practice. If she is happy with her outcome, she is likely to be receptive to the idea of providing a testimonial while the details are fresh in her mind.
• Post testimonials on your homepage and every other page at your site. They should be visible when each page loads without the need to scroll down. A testimonial is worthless if it can’t be easily seen.
• Post testimonials in italics, with quotation marks around the comments to distinguish them from other elements on the page.
• Give each testimonial a headline in bold italics. Use key words likely to resonate with the reader. For example, if the patient reports: “I had a surgical procedure and it was a game changer. You turned my life around! Thank you!” the headline might be: “You turned my life around.”
• Create a Web page just for testimonials and order the comments and headlines so that they will appeal to a diversity of prospective patients. The visitor may not read every testimonial, but she will at least read and scroll through the headlines.

Gathering feedback: Your options

• One option for automating the gathering of feedback is to include a patient feedback survey on your Web site. It’s a convenient way to ask for comments. When the patient is in the office, you or your staff can simply ask her to visit the survey page on your site and answer the questions. The problem with this approach is that many patients will agree to complete the survey but few will actually follow through.
• A far more effective way to get patients to complete a survey while they are still in your office is to have the receptionist hand the patient an iPad after her appointment and ask her to take a couple of minutes to complete the survey. You can then transcribe her comments and post them on your site.
• Asking patients to post positive comments on review sites such as healthgrades.com is another option—but, again, patients are unlikely to follow through unless you make it as easy and fast as possible. The best way to do this is to provide your patient with a blueprint for how to proceed. We offer a “patient feedback” form that contains four or five questions (FIGURE). The answers to these questions will provide a great testimonial for the doctor and the practice. Providing your patients with the right questions to elicit an emotional response will help them describe their experiences more fully. If you let the patient create a testimonial on her own, you’ll probably just receive comments such as, “I’m very happy with my results” or “She is a great doctor.”
• Also provide patients with a step-by-step process for entering their feedback on the desired review sites. This can be a daunting task for your patient, so your instructions should be clear and simple. Better yet, have someone on your staff sit with the patient at a computer or iPad to help her through the process.
• Another way to control your online reputation is to capture positive comments at the point of service. In our practice, we have a testimonial poster in every exam room as well as the reception area. It contains a quick response (QR) code that can be scanned to allow the patient to submit a testimonial about her experience with the practice. With this system, we are able to collect three to five positive reviews every day.
  
  

FIGURE: Patient follow-up satisfaction survey

CASE: Resolved
The physician institutes a process in his practice to gather testimonials and positive feedback, and his staff takes time to help willing patients post their reviews online. He also disputes the negative comments that have already been posted online, offering an objective response to the complaints and asking the Web sites to take down the reviews that are merely ranting. In addition, he posts selected testimonials on the homepage of his Web site and adds a page that is just for testimonials.

Within a few weeks, the number of new patients scheduling appointments with him begins to increase until he once again enjoys a bustling practice.

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

“It takes 20 years to build a reputation and 5 minutes to ruin it. If you think about that, you’ll do things differently.”          
—Warren Buffet

CASE: Decline in new patients
A well-respected physician—one of the best in his field—notices that the number of new patients in his practice has fallen off drastically over the past year. Baffled, he hires a consultant, who discovers that the doctor’s online reputation has plummeted, thanks to four negative reviews and no positive ones.

What can the physician do to remedy the situation and restore his reputation?

The problem can be fixed, but it takes time—like major surgery. Rather than wait until negative reviews are posted, we recommend that you become proactive and take steps as soon as possible to secure your online reputation. That way, you won’t get caught by surprise when one or two unhappy patients try to smear your good name. In this article, we step you through a number of remedies and proactive strategies for boosting positive online reviews and combating negative ones.

The Internet: A one-stop source of information
The Internet has become everyone’s go-to source for pretty much any kind of data, including details on products, services, and people. Anyone can access all kinds of information simply by asking.

Today, people research medical conditions on the Web, often using Google. If you have done your search engine optimization, your Web site will come up in the first page of search results, making it possible for prospective patients to click through to your homepage. (For the scoop on search engine optimization, see Part 3 of this series, “Maximizing your online reach through SEO and pay-per-click,” which appeared in the September 2014 issue of OBG Management.)

If visitors like what they see at your site, they may make an appointment. But they are more likely to visit three or four other sites before making a decision. And in all likelihood, they will research each physician to find out what patients have to say about her or him. It’s no different than looking at the reviews of hotels or products you are considering.

You are an open book on the Internet. Only a few short years ago, your peers and patients knew your reputation primarily through word of mouth, which traveled at the speed of molasses. For the most part, that information was favorable. Today your exposure is much greater, and negative comments about you can be viewed by thousands of potential patients. The speed of information has increased, as well. What is posted on the Internet can become readily available to hundreds, thousands, and even millions of Web users in a nanosecond.

The Internet provides a forum for people to say whatever they want about their experiences, both positive and negative. Regrettably, the positive experiences do not find their way online nearly as often as the negative ones!

The bottom line? In today’s Internet-­savvy world, you need to pay regular attention to your online reputation. You need to take steps to ensure that your name and practice look their best and to negate any complaints that may appear.

What patients share about their experience with you
Many online review sites provide an opportunity for your patients to describe their experience with you and your practice. To name a few: RateMDs.com, Vitals.com, ­ZocDoc.com, healthgrades.com, ­UcompareHealth.com, Citysearch.com, yelp.com, and, of course, Google Plus reviews.

And when patients post comments on the Internet, you likely will be rated on:

• the patient’s wait time
• how your staff treated the patient
• the diagnosis
• your attitude
• the level of trust in your decisions
• treatment and outcome.

The online surfer searching for a reputable physician is likely to believe whatever he or she finds on the leading review sites.

The good news: Most physicians have a very favorable rating, averaging 9.3 out of 10 on a scale of 1 to 10. In fact, 70% of doctors have perfect scores!¹

The bad news: Someone who is unhappy with her treatment or outcome will go out of her way to find every online review site possible and proclaim your faults to the cyber-world, using the Internet as a forum, whether her facts are straight or not. Patients who are pleased and satisfied rarely bother to place a positive review.

How you can control your online reputation
It is incumbent upon you to keep an eye on your online reputation at all times. Here are some tips for taking charge:

• If someone posts a negative review, respond to them directly in the review site. Doing so does not violate privacy laws as long as you do not mention the patient’s name or give other identifying details. Explain your side of the story without confirming or denying that the reviewer is or was a patient. Do not mention the specifics of any patient’s condition.
• If you feel that a negative review is completely unjustified, file a dispute with the review site. Many review sites will remove the unfavorable content if you can convince them that the patient is merely ranting.
• To protect your reputation over the long term, use your name or practice name to set up an alert with Google Alerts by visiting the site Google.com/alerts.
• Do a Google search of your name and the name of your practice at least once a month and check out all the review sites that come up. Read the comments!

Develop a proactive system
You have a lot of control when it comes to protecting your online reputation, provided you are willing to take the time to set up a system to regularly request feedback or testimonials from your patients.

Regrettably, this is where most medical practices fall short, by failing to establish a system to solicit positive reviews.

The process need not be complicated. Such a system can be set in motion by scheduling a quick meeting with your staff to announce your plans to solicit testimonials from patients. Often there will be a flurry of activity for a couple of weeks before the task is forgotten. To keep your system from falling through the cracks, make a checklist and decide who on your staff is responsible for each step in the process. Go over the results in your staff meetings on a regular basis—ie, at least monthly.

You want to solicit positive reviews for use in two places:

• your Web site
• the review sites we mentioned earlier.

Posting testimonials on your Web site

Your site is the place prospective patients visit when they are looking for information about you and your services. Here are a few tips on gathering and posting testimonials:

• The best time to solicit feedback from the patient is after the follow-up appointment, when her needs have been met and she has had at least two experiences with your practice. If she is happy with her outcome, she is likely to be receptive to the idea of providing a testimonial while the details are fresh in her mind.
• Post testimonials on your homepage and every other page at your site. They should be visible when each page loads without the need to scroll down. A testimonial is worthless if it can’t be easily seen.
• Post testimonials in italics, with quotation marks around the comments to distinguish them from other elements on the page.
• Give each testimonial a headline in bold italics. Use key words likely to resonate with the reader. For example, if the patient reports: “I had a surgical procedure and it was a game changer. You turned my life around! Thank you!” the headline might be: “You turned my life around.”
• Create a Web page just for testimonials and order the comments and headlines so that they will appeal to a diversity of prospective patients. The visitor may not read every testimonial, but she will at least read and scroll through the headlines.

Gathering feedback: Your options

• One option for automating the gathering of feedback is to include a patient feedback survey on your Web site. It’s a convenient way to ask for comments. When the patient is in the office, you or your staff can simply ask her to visit the survey page on your site and answer the questions. The problem with this approach is that many patients will agree to complete the survey but few will actually follow through.
• A far more effective way to get patients to complete a survey while they are still in your office is to have the receptionist hand the patient an iPad after her appointment and ask her to take a couple of minutes to complete the survey. You can then transcribe her comments and post them on your site.
• Asking patients to post positive comments on review sites such as healthgrades.com is another option—but, again, patients are unlikely to follow through unless you make it as easy and fast as possible. The best way to do this is to provide your patient with a blueprint for how to proceed. We offer a “patient feedback” form that contains four or five questions (FIGURE). The answers to these questions will provide a great testimonial for the doctor and the practice. Providing your patients with the right questions to elicit an emotional response will help them describe their experiences more fully. If you let the patient create a testimonial on her own, you’ll probably just receive comments such as, “I’m very happy with my results” or “She is a great doctor.”
• Also provide patients with a step-by-step process for entering their feedback on the desired review sites. This can be a daunting task for your patient, so your instructions should be clear and simple. Better yet, have someone on your staff sit with the patient at a computer or iPad to help her through the process.
• Another way to control your online reputation is to capture positive comments at the point of service. In our practice, we have a testimonial poster in every exam room as well as the reception area. It contains a quick response (QR) code that can be scanned to allow the patient to submit a testimonial about her experience with the practice. With this system, we are able to collect three to five positive reviews every day.
  
  

FIGURE: Patient follow-up satisfaction survey

CASE: Resolved
The physician institutes a process in his practice to gather testimonials and positive feedback, and his staff takes time to help willing patients post their reviews online. He also disputes the negative comments that have already been posted online, offering an objective response to the complaints and asking the Web sites to take down the reviews that are merely ranting. In addition, he posts selected testimonials on the homepage of his Web site and adds a page that is just for testimonials.

Within a few weeks, the number of new patients scheduling appointments with him begins to increase until he once again enjoys a bustling practice.

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

“It takes 20 years to build a reputation and 5 minutes to ruin it. If you think about that, you’ll do things differently.”          
—Warren Buffet

CASE: Decline in new patients
A well-respected physician—one of the best in his field—notices that the number of new patients in his practice has fallen off drastically over the past year. Baffled, he hires a consultant, who discovers that the doctor’s online reputation has plummeted, thanks to four negative reviews and no positive ones.

What can the physician do to remedy the situation and restore his reputation?

The problem can be fixed, but it takes time—like major surgery. Rather than wait until negative reviews are posted, we recommend that you become proactive and take steps as soon as possible to secure your online reputation. That way, you won’t get caught by surprise when one or two unhappy patients try to smear your good name. In this article, we step you through a number of remedies and proactive strategies for boosting positive online reviews and combating negative ones.

The Internet: A one-stop source of information
The Internet has become everyone’s go-to source for pretty much any kind of data, including details on products, services, and people. Anyone can access all kinds of information simply by asking.

Today, people research medical conditions on the Web, often using Google. If you have done your search engine optimization, your Web site will come up in the first page of search results, making it possible for prospective patients to click through to your homepage. (For the scoop on search engine optimization, see Part 3 of this series, “Maximizing your online reach through SEO and pay-per-click,” which appeared in the September 2014 issue of OBG Management.)

If visitors like what they see at your site, they may make an appointment. But they are more likely to visit three or four other sites before making a decision. And in all likelihood, they will research each physician to find out what patients have to say about her or him. It’s no different than looking at the reviews of hotels or products you are considering.

You are an open book on the Internet. Only a few short years ago, your peers and patients knew your reputation primarily through word of mouth, which traveled at the speed of molasses. For the most part, that information was favorable. Today your exposure is much greater, and negative comments about you can be viewed by thousands of potential patients. The speed of information has increased, as well. What is posted on the Internet can become readily available to hundreds, thousands, and even millions of Web users in a nanosecond.

The Internet provides a forum for people to say whatever they want about their experiences, both positive and negative. Regrettably, the positive experiences do not find their way online nearly as often as the negative ones!

The bottom line? In today’s Internet-­savvy world, you need to pay regular attention to your online reputation. You need to take steps to ensure that your name and practice look their best and to negate any complaints that may appear.

What patients share about their experience with you
Many online review sites provide an opportunity for your patients to describe their experience with you and your practice. To name a few: RateMDs.com, Vitals.com, ­ZocDoc.com, healthgrades.com, ­UcompareHealth.com, Citysearch.com, yelp.com, and, of course, Google Plus reviews.

And when patients post comments on the Internet, you likely will be rated on:

• the patient’s wait time
• how your staff treated the patient
• the diagnosis
• your attitude
• the level of trust in your decisions
• treatment and outcome.

The online surfer searching for a reputable physician is likely to believe whatever he or she finds on the leading review sites.

The good news: Most physicians have a very favorable rating, averaging 9.3 out of 10 on a scale of 1 to 10. In fact, 70% of doctors have perfect scores!¹

The bad news: Someone who is unhappy with her treatment or outcome will go out of her way to find every online review site possible and proclaim your faults to the cyber-world, using the Internet as a forum, whether her facts are straight or not. Patients who are pleased and satisfied rarely bother to place a positive review.

How you can control your online reputation
It is incumbent upon you to keep an eye on your online reputation at all times. Here are some tips for taking charge:

• If someone posts a negative review, respond to them directly in the review site. Doing so does not violate privacy laws as long as you do not mention the patient’s name or give other identifying details. Explain your side of the story without confirming or denying that the reviewer is or was a patient. Do not mention the specifics of any patient’s condition.
• If you feel that a negative review is completely unjustified, file a dispute with the review site. Many review sites will remove the unfavorable content if you can convince them that the patient is merely ranting.
• To protect your reputation over the long term, use your name or practice name to set up an alert with Google Alerts by visiting the site Google.com/alerts.
• Do a Google search of your name and the name of your practice at least once a month and check out all the review sites that come up. Read the comments!

Develop a proactive system
You have a lot of control when it comes to protecting your online reputation, provided you are willing to take the time to set up a system to regularly request feedback or testimonials from your patients.

Regrettably, this is where most medical practices fall short, by failing to establish a system to solicit positive reviews.

The process need not be complicated. Such a system can be set in motion by scheduling a quick meeting with your staff to announce your plans to solicit testimonials from patients. Often there will be a flurry of activity for a couple of weeks before the task is forgotten. To keep your system from falling through the cracks, make a checklist and decide who on your staff is responsible for each step in the process. Go over the results in your staff meetings on a regular basis—ie, at least monthly.

You want to solicit positive reviews for use in two places:

• your Web site
• the review sites we mentioned earlier.

Posting testimonials on your Web site

Your site is the place prospective patients visit when they are looking for information about you and your services. Here are a few tips on gathering and posting testimonials:

• The best time to solicit feedback from the patient is after the follow-up appointment, when her needs have been met and she has had at least two experiences with your practice. If she is happy with her outcome, she is likely to be receptive to the idea of providing a testimonial while the details are fresh in her mind.
• Post testimonials on your homepage and every other page at your site. They should be visible when each page loads without the need to scroll down. A testimonial is worthless if it can’t be easily seen.
• Post testimonials in italics, with quotation marks around the comments to distinguish them from other elements on the page.
• Give each testimonial a headline in bold italics. Use key words likely to resonate with the reader. For example, if the patient reports: “I had a surgical procedure and it was a game changer. You turned my life around! Thank you!” the headline might be: “You turned my life around.”
• Create a Web page just for testimonials and order the comments and headlines so that they will appeal to a diversity of prospective patients. The visitor may not read every testimonial, but she will at least read and scroll through the headlines.

Gathering feedback: Your options

• One option for automating the gathering of feedback is to include a patient feedback survey on your Web site. It’s a convenient way to ask for comments. When the patient is in the office, you or your staff can simply ask her to visit the survey page on your site and answer the questions. The problem with this approach is that many patients will agree to complete the survey but few will actually follow through.
• A far more effective way to get patients to complete a survey while they are still in your office is to have the receptionist hand the patient an iPad after her appointment and ask her to take a couple of minutes to complete the survey. You can then transcribe her comments and post them on your site.
• Asking patients to post positive comments on review sites such as healthgrades.com is another option—but, again, patients are unlikely to follow through unless you make it as easy and fast as possible. The best way to do this is to provide your patient with a blueprint for how to proceed. We offer a “patient feedback” form that contains four or five questions (FIGURE). The answers to these questions will provide a great testimonial for the doctor and the practice. Providing your patients with the right questions to elicit an emotional response will help them describe their experiences more fully. If you let the patient create a testimonial on her own, you’ll probably just receive comments such as, “I’m very happy with my results” or “She is a great doctor.”
• Also provide patients with a step-by-step process for entering their feedback on the desired review sites. This can be a daunting task for your patient, so your instructions should be clear and simple. Better yet, have someone on your staff sit with the patient at a computer or iPad to help her through the process.
• Another way to control your online reputation is to capture positive comments at the point of service. In our practice, we have a testimonial poster in every exam room as well as the reception area. It contains a quick response (QR) code that can be scanned to allow the patient to submit a testimonial about her experience with the practice. With this system, we are able to collect three to five positive reviews every day.
  
  

FIGURE: Patient follow-up satisfaction survey

CASE: Resolved
The physician institutes a process in his practice to gather testimonials and positive feedback, and his staff takes time to help willing patients post their reviews online. He also disputes the negative comments that have already been posted online, offering an objective response to the complaints and asking the Web sites to take down the reviews that are merely ranting. In addition, he posts selected testimonials on the homepage of his Web site and adds a page that is just for testimonials.

Within a few weeks, the number of new patients scheduling appointments with him begins to increase until he once again enjoys a bustling practice.

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

An essential but often overlooked component of a successful minimally invasive gynecologic procedure is uterine manipulation. Regardless of whether conservative or extirpative surgery is being performed, the ability to optimally position the uterus within the pelvis is critical to safe and efficient surgical dissection. The addition of a colpotomizer cup to any uterine manipulator further enhances the ability to perform a conventional or robot-assisted laparoscopic hysterectomy.

The following video, produced by my third-year resident, Katherine Palmerola, MD, and my second-year fellow, Mireille Truong, MD, aims to provide a quick reference for gynecologists to use to help teach their surgical assistants the fundamentals of assembly and use of a uterine manipulator. This video also can be used as a resource for educating residents and medical students on the essentials of uterine manipulation.

The objectives of this video are to:

• outline the required instruments and steps for assembling a uterine manipulator and colpotomizer cup
• demonstrate the technical nuances of proper uterine manipulation intraoperatively
• highlight important clinical applications of uterine manipulation during pelvic surgery.

I hope this video proves to be a valuable resource for your practice.

– Dr. Arnold Advincula

Vidyard Video

 

 

 

Watch for these video topics coming soon:
• Tips and tricks to understanding retroperitoneal anatomy
• Simple versus radical hysterectomy: Anatomical nuances.

 

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.

An essential but often overlooked component of a successful minimally invasive gynecologic procedure is uterine manipulation. Regardless of whether conservative or extirpative surgery is being performed, the ability to optimally position the uterus within the pelvis is critical to safe and efficient surgical dissection. The addition of a colpotomizer cup to any uterine manipulator further enhances the ability to perform a conventional or robot-assisted laparoscopic hysterectomy.

The following video, produced by my third-year resident, Katherine Palmerola, MD, and my second-year fellow, Mireille Truong, MD, aims to provide a quick reference for gynecologists to use to help teach their surgical assistants the fundamentals of assembly and use of a uterine manipulator. This video also can be used as a resource for educating residents and medical students on the essentials of uterine manipulation.

The objectives of this video are to:

• outline the required instruments and steps for assembling a uterine manipulator and colpotomizer cup
• demonstrate the technical nuances of proper uterine manipulation intraoperatively
• highlight important clinical applications of uterine manipulation during pelvic surgery.

I hope this video proves to be a valuable resource for your practice.

– Dr. Arnold Advincula

Vidyard Video

 

 

 

Watch for these video topics coming soon:
• Tips and tricks to understanding retroperitoneal anatomy
• Simple versus radical hysterectomy: Anatomical nuances.

 

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.

An essential but often overlooked component of a successful minimally invasive gynecologic procedure is uterine manipulation. Regardless of whether conservative or extirpative surgery is being performed, the ability to optimally position the uterus within the pelvis is critical to safe and efficient surgical dissection. The addition of a colpotomizer cup to any uterine manipulator further enhances the ability to perform a conventional or robot-assisted laparoscopic hysterectomy.

The following video, produced by my third-year resident, Katherine Palmerola, MD, and my second-year fellow, Mireille Truong, MD, aims to provide a quick reference for gynecologists to use to help teach their surgical assistants the fundamentals of assembly and use of a uterine manipulator. This video also can be used as a resource for educating residents and medical students on the essentials of uterine manipulation.

The objectives of this video are to:

• outline the required instruments and steps for assembling a uterine manipulator and colpotomizer cup
• demonstrate the technical nuances of proper uterine manipulation intraoperatively
• highlight important clinical applications of uterine manipulation during pelvic surgery.

I hope this video proves to be a valuable resource for your practice.

– Dr. Arnold Advincula

Vidyard Video

 

 

 

Watch for these video topics coming soon:
• Tips and tricks to understanding retroperitoneal anatomy
• Simple versus radical hysterectomy: Anatomical nuances.

 

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.

EASIER COLORECTAL CANCER SCREENING
Cologuard^® from Exact Sciences is a new, FDA-approved, noninvasive stool DNA screening test for colorectal cancer. Cologuard has been proven to find 92% of colorectal cancers in average risk patients with 87% specificity. Available by prescription for people aged 50 years and older who are at average risk for colorectal cancer, Cologuard does not require medication, dietary restrictions, or prior bowel preparation.
FOR MORE INFORMATION, VISIT www.exactsciences.com

FRONT-CLOSURE SURGICAL BRA
Elizabeth Pink Surgical Bra™ from BFFL Co allows for mild compression and stretch, with a Velcro front closure and adjustable, padded shoulder straps. The pink bra has patent-pending side-drain openings to accommodate JP drain exit placement. JP drain bulbs can be attached to a loop and ring, eliminating the need for wearing a pouch or fanny pack during recovery.
FOR MORE INFORMATION, VISIT http://bfflco.com/

16-POCKET LAB COATS FOR MEN AND WOMEN
SCOTTeVEST has a new line of SeV lab coats styled for men and women with 16 pockets to carry medical devices and personal electronics. Some pockets are hidden for added security. The exterior white fabric is stain- and water-resistant and can be laundered and sanitized.
FOR MORE INFORMATION, VISIT www.scottevest.com

LAPAROSCOPIC SMOKE EVACUATION SYSTEM
The Plume-Away^® Smoke Evacuation System is now available to clinical users, reports CooperSurgical. The passive, disposable, multi-stage system traps smoke, particulates, and aerosolized pathogens while an activated charcoal membrane absorbs odors and chemical toxins. CooperSurgical claims the system removes 99.999% of 0.01 μm particles from surgical procedure sites, while the air-flow rate remains steady.
FOR MORE INFORMATION, VISIT www.CooperSurgical.com

NEW BABY BOTTLE DESIGN PREVENTS COLIC
Difrax claims the design of its S-Bottles allows the baby to swallow less air and therefore have less trouble with burping, vomiting, colic, and earache. When the bottle is being used, the teat is constantly filled with liquid and a valve in the bottle’s base prevents vacuum suction. A bottle warmer is available.
FOR MORE INFORMATION, VISIT www.difraxusa.com

HOME-USE CONCEPTION ASSISTANCE DEVICE
Rinovum Women’s Health announced that The Stork^® OTC, a conception-assistance device, is now available without a prescription in stores and online. Rinovum claims that The Stork OTC is a safe, easy way to perform cervical cap insemination at home, without drugs or invasive procedures.
FOR MORE INFORMATION, VISIT www.storkotc.com

MEASURE LIPIDS & GLUCOSE IN 2 MINUTES
The LipidPlus^® Lipid Profile and Glucose Measuring System from JANT Pharmacal Corporation uses a single test strip to measure total cholesterol, high-density lipoprotein (HDL), triglycerides, and to calculate low-density lipoprotein (LDL) with results in 2 minutes. Lipid and glucose test strips do not require refrigeration, and require a small blood sample. The system includes an analyzer that can store up to 200 results.
FOR MORE INFORMATION, VISIT www.lipidplus.com

ENCOURAGING BREAST SELF-EXAM
Circuelle™ Breast Ritual Crème is intended for use during twice-monthly breast self-examinations in the shower or bath. Circuelle claims that the lotion’s texture enables a woman’s fingertips to glide across her breast and underarm areas so she will notice something different, such as thickened skin, a lump, or change in the nipple. The moisturizing cream is paraben-, phthalate-, and petroleum-free, with organically derived ingredients including evening primrose oil, green tea extract, vitamins D and E, and essential oils. Circuelle also offers a Guide to Breast Self-Examination and tips to reduce the risk of breast cancer on its Web site.
FOR MORE INFORMATION, VISIT www.circuelle.com

RF DETECTION SYSTEM FOR L&D UNITS
RF Surgical Systems says it designed the RF Assure Delivery System for the labor and delivery (L&D) environment to locate and prevent the loss of sponges, towels, and gauze during vaginal delivery. After birth, a clinician uses the Verisphere sensor to scan the mother’s pelvic area and L&D room to obtain an accurate count of radio-frequency (RF) tag-embedded items.
FOR MORE INFORMATION, VISIT www.rfsurg.com

NEW WEB SITE FOR FERTILITY RESOURCES
Advanced Reproductive Care Inc. offers a full suite of products, services, and resources for infertility through its new Web site. There, patients can access a nationwide network of fertility services, from fertility treatment package options and payment plans to articles, newsletters, and informational videos addressing common questions and treatment options.
FOR MORE INFORMATION, VISIT www.arcfertility.com

EXCHANGE DATA USING PATIENTGRAPH
CareConnectors™ says that its PatientGraph™ software enables patients and health-care providers and enterprises to exchange traditional and nontraditional health-care data in a secure, HIPAA-compliant system. The 3-component platform allows trusted parties (including patients) to share information with authorized providers, devices, and services; provides programming interfaces to aid workflow; and offers software development kits to allow customization.
FOR MORE INFORMATION, VISIT www.careconnectors.com

EASIER COLORECTAL CANCER SCREENING
Cologuard^® from Exact Sciences is a new, FDA-approved, noninvasive stool DNA screening test for colorectal cancer. Cologuard has been proven to find 92% of colorectal cancers in average risk patients with 87% specificity. Available by prescription for people aged 50 years and older who are at average risk for colorectal cancer, Cologuard does not require medication, dietary restrictions, or prior bowel preparation.
FOR MORE INFORMATION, VISIT www.exactsciences.com

FRONT-CLOSURE SURGICAL BRA
Elizabeth Pink Surgical Bra™ from BFFL Co allows for mild compression and stretch, with a Velcro front closure and adjustable, padded shoulder straps. The pink bra has patent-pending side-drain openings to accommodate JP drain exit placement. JP drain bulbs can be attached to a loop and ring, eliminating the need for wearing a pouch or fanny pack during recovery.
FOR MORE INFORMATION, VISIT http://bfflco.com/

16-POCKET LAB COATS FOR MEN AND WOMEN
SCOTTeVEST has a new line of SeV lab coats styled for men and women with 16 pockets to carry medical devices and personal electronics. Some pockets are hidden for added security. The exterior white fabric is stain- and water-resistant and can be laundered and sanitized.
FOR MORE INFORMATION, VISIT www.scottevest.com

LAPAROSCOPIC SMOKE EVACUATION SYSTEM
The Plume-Away^® Smoke Evacuation System is now available to clinical users, reports CooperSurgical. The passive, disposable, multi-stage system traps smoke, particulates, and aerosolized pathogens while an activated charcoal membrane absorbs odors and chemical toxins. CooperSurgical claims the system removes 99.999% of 0.01 μm particles from surgical procedure sites, while the air-flow rate remains steady.
FOR MORE INFORMATION, VISIT www.CooperSurgical.com

NEW BABY BOTTLE DESIGN PREVENTS COLIC
Difrax claims the design of its S-Bottles allows the baby to swallow less air and therefore have less trouble with burping, vomiting, colic, and earache. When the bottle is being used, the teat is constantly filled with liquid and a valve in the bottle’s base prevents vacuum suction. A bottle warmer is available.
FOR MORE INFORMATION, VISIT www.difraxusa.com

HOME-USE CONCEPTION ASSISTANCE DEVICE
Rinovum Women’s Health announced that The Stork^® OTC, a conception-assistance device, is now available without a prescription in stores and online. Rinovum claims that The Stork OTC is a safe, easy way to perform cervical cap insemination at home, without drugs or invasive procedures.
FOR MORE INFORMATION, VISIT www.storkotc.com

MEASURE LIPIDS & GLUCOSE IN 2 MINUTES
The LipidPlus^® Lipid Profile and Glucose Measuring System from JANT Pharmacal Corporation uses a single test strip to measure total cholesterol, high-density lipoprotein (HDL), triglycerides, and to calculate low-density lipoprotein (LDL) with results in 2 minutes. Lipid and glucose test strips do not require refrigeration, and require a small blood sample. The system includes an analyzer that can store up to 200 results.
FOR MORE INFORMATION, VISIT www.lipidplus.com

ENCOURAGING BREAST SELF-EXAM
Circuelle™ Breast Ritual Crème is intended for use during twice-monthly breast self-examinations in the shower or bath. Circuelle claims that the lotion’s texture enables a woman’s fingertips to glide across her breast and underarm areas so she will notice something different, such as thickened skin, a lump, or change in the nipple. The moisturizing cream is paraben-, phthalate-, and petroleum-free, with organically derived ingredients including evening primrose oil, green tea extract, vitamins D and E, and essential oils. Circuelle also offers a Guide to Breast Self-Examination and tips to reduce the risk of breast cancer on its Web site.
FOR MORE INFORMATION, VISIT www.circuelle.com

RF DETECTION SYSTEM FOR L&D UNITS
RF Surgical Systems says it designed the RF Assure Delivery System for the labor and delivery (L&D) environment to locate and prevent the loss of sponges, towels, and gauze during vaginal delivery. After birth, a clinician uses the Verisphere sensor to scan the mother’s pelvic area and L&D room to obtain an accurate count of radio-frequency (RF) tag-embedded items.
FOR MORE INFORMATION, VISIT www.rfsurg.com

NEW WEB SITE FOR FERTILITY RESOURCES
Advanced Reproductive Care Inc. offers a full suite of products, services, and resources for infertility through its new Web site. There, patients can access a nationwide network of fertility services, from fertility treatment package options and payment plans to articles, newsletters, and informational videos addressing common questions and treatment options.
FOR MORE INFORMATION, VISIT www.arcfertility.com

EXCHANGE DATA USING PATIENTGRAPH
CareConnectors™ says that its PatientGraph™ software enables patients and health-care providers and enterprises to exchange traditional and nontraditional health-care data in a secure, HIPAA-compliant system. The 3-component platform allows trusted parties (including patients) to share information with authorized providers, devices, and services; provides programming interfaces to aid workflow; and offers software development kits to allow customization.
FOR MORE INFORMATION, VISIT www.careconnectors.com

EASIER COLORECTAL CANCER SCREENING
Cologuard^® from Exact Sciences is a new, FDA-approved, noninvasive stool DNA screening test for colorectal cancer. Cologuard has been proven to find 92% of colorectal cancers in average risk patients with 87% specificity. Available by prescription for people aged 50 years and older who are at average risk for colorectal cancer, Cologuard does not require medication, dietary restrictions, or prior bowel preparation.
FOR MORE INFORMATION, VISIT www.exactsciences.com

FRONT-CLOSURE SURGICAL BRA
Elizabeth Pink Surgical Bra™ from BFFL Co allows for mild compression and stretch, with a Velcro front closure and adjustable, padded shoulder straps. The pink bra has patent-pending side-drain openings to accommodate JP drain exit placement. JP drain bulbs can be attached to a loop and ring, eliminating the need for wearing a pouch or fanny pack during recovery.
FOR MORE INFORMATION, VISIT http://bfflco.com/

16-POCKET LAB COATS FOR MEN AND WOMEN
SCOTTeVEST has a new line of SeV lab coats styled for men and women with 16 pockets to carry medical devices and personal electronics. Some pockets are hidden for added security. The exterior white fabric is stain- and water-resistant and can be laundered and sanitized.
FOR MORE INFORMATION, VISIT www.scottevest.com

LAPAROSCOPIC SMOKE EVACUATION SYSTEM
The Plume-Away^® Smoke Evacuation System is now available to clinical users, reports CooperSurgical. The passive, disposable, multi-stage system traps smoke, particulates, and aerosolized pathogens while an activated charcoal membrane absorbs odors and chemical toxins. CooperSurgical claims the system removes 99.999% of 0.01 μm particles from surgical procedure sites, while the air-flow rate remains steady.
FOR MORE INFORMATION, VISIT www.CooperSurgical.com

NEW BABY BOTTLE DESIGN PREVENTS COLIC
Difrax claims the design of its S-Bottles allows the baby to swallow less air and therefore have less trouble with burping, vomiting, colic, and earache. When the bottle is being used, the teat is constantly filled with liquid and a valve in the bottle’s base prevents vacuum suction. A bottle warmer is available.
FOR MORE INFORMATION, VISIT www.difraxusa.com

HOME-USE CONCEPTION ASSISTANCE DEVICE
Rinovum Women’s Health announced that The Stork^® OTC, a conception-assistance device, is now available without a prescription in stores and online. Rinovum claims that The Stork OTC is a safe, easy way to perform cervical cap insemination at home, without drugs or invasive procedures.
FOR MORE INFORMATION, VISIT www.storkotc.com

MEASURE LIPIDS & GLUCOSE IN 2 MINUTES
The LipidPlus^® Lipid Profile and Glucose Measuring System from JANT Pharmacal Corporation uses a single test strip to measure total cholesterol, high-density lipoprotein (HDL), triglycerides, and to calculate low-density lipoprotein (LDL) with results in 2 minutes. Lipid and glucose test strips do not require refrigeration, and require a small blood sample. The system includes an analyzer that can store up to 200 results.
FOR MORE INFORMATION, VISIT www.lipidplus.com

ENCOURAGING BREAST SELF-EXAM
Circuelle™ Breast Ritual Crème is intended for use during twice-monthly breast self-examinations in the shower or bath. Circuelle claims that the lotion’s texture enables a woman’s fingertips to glide across her breast and underarm areas so she will notice something different, such as thickened skin, a lump, or change in the nipple. The moisturizing cream is paraben-, phthalate-, and petroleum-free, with organically derived ingredients including evening primrose oil, green tea extract, vitamins D and E, and essential oils. Circuelle also offers a Guide to Breast Self-Examination and tips to reduce the risk of breast cancer on its Web site.
FOR MORE INFORMATION, VISIT www.circuelle.com

RF DETECTION SYSTEM FOR L&D UNITS
RF Surgical Systems says it designed the RF Assure Delivery System for the labor and delivery (L&D) environment to locate and prevent the loss of sponges, towels, and gauze during vaginal delivery. After birth, a clinician uses the Verisphere sensor to scan the mother’s pelvic area and L&D room to obtain an accurate count of radio-frequency (RF) tag-embedded items.
FOR MORE INFORMATION, VISIT www.rfsurg.com

NEW WEB SITE FOR FERTILITY RESOURCES
Advanced Reproductive Care Inc. offers a full suite of products, services, and resources for infertility through its new Web site. There, patients can access a nationwide network of fertility services, from fertility treatment package options and payment plans to articles, newsletters, and informational videos addressing common questions and treatment options.
FOR MORE INFORMATION, VISIT www.arcfertility.com

EXCHANGE DATA USING PATIENTGRAPH
CareConnectors™ says that its PatientGraph™ software enables patients and health-care providers and enterprises to exchange traditional and nontraditional health-care data in a secure, HIPAA-compliant system. The 3-component platform allows trusted parties (including patients) to share information with authorized providers, devices, and services; provides programming interfaces to aid workflow; and offers software development kits to allow customization.
FOR MORE INFORMATION, VISIT www.careconnectors.com

Patients who are to undergo immunosuppressive therapy but are at high risk for reactivation of hepatitis B infection should receive antiviral prophylaxis, rather than being monitored for reactivation and treated only if it develops, according to a new guideline published online in Gastroenterology.

The American Gastroenterological Association conducted a rigorous review of the available evidence and compiled seven recommendations to guide clinicians and researchers in preventing HBV reactivation before patients initiate immunosuppressive therapy and in treating reactivated HBV if it arises during immunosuppressive therapy. “Despite the large number of published studies, in most cases our recommendations are weak because either (1) the quality of the available data and/or the baseline risk of HBV reactivation is low or uncertain, and/or (2) the balance of risks and benefits for a particular strategy does not overwhelmingly support its use,” said Dr. K. Rajender Reddy, lead writer of the guideline and professor of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and his associates.

CDC/Dr. Erskine Palmer

In contrast, the data supporting the recommendation to provide prophylaxis for high-risk patients are moderately robust, so that recommendation is strong, they noted.

Patients’ level of risk is based on their HBV serologic status and the type of immunosuppression they require. For example, patients are considered at high risk for HBV reactivation if they are hepatitis B surface antigen (HBsAg) positive/anti–hepatitis B core (HBc) positive or are HBsAg negative/anti-HBc positive and are to be treated with B-cell–depleting agents such as rituximab or ofatumumab. Also at high risk are HBsAg-positive/anti-HBc–positive patients to be treated with anthracycline derivatives such as doxorubicin or epirubicin, and HBsAg-positive/anti-HBc–positive patients to be treated with moderate- or high-dose corticosteroids for 4 weeks or longer.

In these high-risk patients, antiviral prophylaxis is definitely warranted, and it should extend for at least 6 months after the immunosuppressive therapy is completed, according to the guideline. In contrast, antiviral prophylaxis is “suggested” for moderate-risk patients, but those who place a higher value on avoiding antivirals and a lower value on avoiding HBV reactivation “may reasonably select no prophylaxis over antiviral prophylaxis,” Dr. Reddy and his associates said.

In contrast, routine antiviral prophylaxis is not recommended for patients undergoing immunosuppressive therapy who are at low risk for HBV reactivation.

Other recommendations in the new guideline concern which antiviral agents are preferred in different situations. The AGA strongly recommends antivirals that have a high barrier to resistance, in preference to lamivudine, in most patients. But it acknowledges that the evidence comparing various antivirals is weak, and that the drugs vary considerably in price. “Patients who put a higher value on cost and a lower value on avoiding the potentially small risk of resistance development may reasonably select the least expensive antiviral hepatitis B medication over more expensive antiviral drugs with a higher barrier to resistance,” Dr. Reddy and his associates said (Gastroenterol. 2014 [doi:10.1053/j.gastro.2014.10.039]).

The evidence regarding patient monitoring for HBV reactivation instead of prophylaxis is so sparse that the AGA makes no recommendation for or against this strategy at present. Most studies of the issue are of poor quality, use different definitions of HBV reactivation, have inconsistent reporting of patient outcomes, and disagree about the best methods and frequency of HBV DNA monitoring. Moreover, frequent monitoring requires “considerable” personnel resources, and the methods used in clinical studies may not even be adaptable to real world practice, the investigators said.

Patients who are to undergo immunosuppressive therapy but are at high risk for reactivation of hepatitis B infection should receive antiviral prophylaxis, rather than being monitored for reactivation and treated only if it develops, according to a new guideline published online in Gastroenterology.

The American Gastroenterological Association conducted a rigorous review of the available evidence and compiled seven recommendations to guide clinicians and researchers in preventing HBV reactivation before patients initiate immunosuppressive therapy and in treating reactivated HBV if it arises during immunosuppressive therapy. “Despite the large number of published studies, in most cases our recommendations are weak because either (1) the quality of the available data and/or the baseline risk of HBV reactivation is low or uncertain, and/or (2) the balance of risks and benefits for a particular strategy does not overwhelmingly support its use,” said Dr. K. Rajender Reddy, lead writer of the guideline and professor of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and his associates.

CDC/Dr. Erskine Palmer

In contrast, the data supporting the recommendation to provide prophylaxis for high-risk patients are moderately robust, so that recommendation is strong, they noted.

Patients’ level of risk is based on their HBV serologic status and the type of immunosuppression they require. For example, patients are considered at high risk for HBV reactivation if they are hepatitis B surface antigen (HBsAg) positive/anti–hepatitis B core (HBc) positive or are HBsAg negative/anti-HBc positive and are to be treated with B-cell–depleting agents such as rituximab or ofatumumab. Also at high risk are HBsAg-positive/anti-HBc–positive patients to be treated with anthracycline derivatives such as doxorubicin or epirubicin, and HBsAg-positive/anti-HBc–positive patients to be treated with moderate- or high-dose corticosteroids for 4 weeks or longer.

In these high-risk patients, antiviral prophylaxis is definitely warranted, and it should extend for at least 6 months after the immunosuppressive therapy is completed, according to the guideline. In contrast, antiviral prophylaxis is “suggested” for moderate-risk patients, but those who place a higher value on avoiding antivirals and a lower value on avoiding HBV reactivation “may reasonably select no prophylaxis over antiviral prophylaxis,” Dr. Reddy and his associates said.

In contrast, routine antiviral prophylaxis is not recommended for patients undergoing immunosuppressive therapy who are at low risk for HBV reactivation.

Other recommendations in the new guideline concern which antiviral agents are preferred in different situations. The AGA strongly recommends antivirals that have a high barrier to resistance, in preference to lamivudine, in most patients. But it acknowledges that the evidence comparing various antivirals is weak, and that the drugs vary considerably in price. “Patients who put a higher value on cost and a lower value on avoiding the potentially small risk of resistance development may reasonably select the least expensive antiviral hepatitis B medication over more expensive antiviral drugs with a higher barrier to resistance,” Dr. Reddy and his associates said (Gastroenterol. 2014 [doi:10.1053/j.gastro.2014.10.039]).

The evidence regarding patient monitoring for HBV reactivation instead of prophylaxis is so sparse that the AGA makes no recommendation for or against this strategy at present. Most studies of the issue are of poor quality, use different definitions of HBV reactivation, have inconsistent reporting of patient outcomes, and disagree about the best methods and frequency of HBV DNA monitoring. Moreover, frequent monitoring requires “considerable” personnel resources, and the methods used in clinical studies may not even be adaptable to real world practice, the investigators said.

Patients who are to undergo immunosuppressive therapy but are at high risk for reactivation of hepatitis B infection should receive antiviral prophylaxis, rather than being monitored for reactivation and treated only if it develops, according to a new guideline published online in Gastroenterology.

The American Gastroenterological Association conducted a rigorous review of the available evidence and compiled seven recommendations to guide clinicians and researchers in preventing HBV reactivation before patients initiate immunosuppressive therapy and in treating reactivated HBV if it arises during immunosuppressive therapy. “Despite the large number of published studies, in most cases our recommendations are weak because either (1) the quality of the available data and/or the baseline risk of HBV reactivation is low or uncertain, and/or (2) the balance of risks and benefits for a particular strategy does not overwhelmingly support its use,” said Dr. K. Rajender Reddy, lead writer of the guideline and professor of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and his associates.

CDC/Dr. Erskine Palmer

In contrast, the data supporting the recommendation to provide prophylaxis for high-risk patients are moderately robust, so that recommendation is strong, they noted.

Patients’ level of risk is based on their HBV serologic status and the type of immunosuppression they require. For example, patients are considered at high risk for HBV reactivation if they are hepatitis B surface antigen (HBsAg) positive/anti–hepatitis B core (HBc) positive or are HBsAg negative/anti-HBc positive and are to be treated with B-cell–depleting agents such as rituximab or ofatumumab. Also at high risk are HBsAg-positive/anti-HBc–positive patients to be treated with anthracycline derivatives such as doxorubicin or epirubicin, and HBsAg-positive/anti-HBc–positive patients to be treated with moderate- or high-dose corticosteroids for 4 weeks or longer.

In these high-risk patients, antiviral prophylaxis is definitely warranted, and it should extend for at least 6 months after the immunosuppressive therapy is completed, according to the guideline. In contrast, antiviral prophylaxis is “suggested” for moderate-risk patients, but those who place a higher value on avoiding antivirals and a lower value on avoiding HBV reactivation “may reasonably select no prophylaxis over antiviral prophylaxis,” Dr. Reddy and his associates said.

In contrast, routine antiviral prophylaxis is not recommended for patients undergoing immunosuppressive therapy who are at low risk for HBV reactivation.

Other recommendations in the new guideline concern which antiviral agents are preferred in different situations. The AGA strongly recommends antivirals that have a high barrier to resistance, in preference to lamivudine, in most patients. But it acknowledges that the evidence comparing various antivirals is weak, and that the drugs vary considerably in price. “Patients who put a higher value on cost and a lower value on avoiding the potentially small risk of resistance development may reasonably select the least expensive antiviral hepatitis B medication over more expensive antiviral drugs with a higher barrier to resistance,” Dr. Reddy and his associates said (Gastroenterol. 2014 [doi:10.1053/j.gastro.2014.10.039]).

The evidence regarding patient monitoring for HBV reactivation instead of prophylaxis is so sparse that the AGA makes no recommendation for or against this strategy at present. Most studies of the issue are of poor quality, use different definitions of HBV reactivation, have inconsistent reporting of patient outcomes, and disagree about the best methods and frequency of HBV DNA monitoring. Moreover, frequent monitoring requires “considerable” personnel resources, and the methods used in clinical studies may not even be adaptable to real world practice, the investigators said.

To the Editor:
A 42-year-old man with hypertension, hypothyroidism, and alcohol-related cirrhosis was admitted for evaluation of rapidly deteriorating mental status. He was referred from a rehabilitation facility where he had been admitted 4 days earlier after a hospitalization for hepatorenal syndrome and pneumonia. He was alert and ambulating until the day of the current admission. On arrival he was hypotensive(54/42 mm Hg); hypothermic (35°C, rectally); and unresponsive, except to painful stimuli. Jaundice, hepatosplenomegaly, ascites, and bilateral lower extremity edema were noted. There were multiple tense and flaccid bullous lesions containing serosanguineous fluid over both tibias and calves, without crepitus (Figure 1).

Figure 1. Left tibia with multiple hemorrhagic bullae and surrounding erythema and edema. The characteristic serosanguineous drainage was seen at the lower edge of the distal bulla.

Figure 2. Computed tomography of the legs with extensive subcutaneous edema and fluid collections around the knees.

Figure 3. Computed tomography of the legs with edematous changes of the anterior compart-ment muscles.

Laboratory test results revealed leukocytosis (total leukocytes, 10,900/mm³ [reference range, 4500–10,800/mm³), hypoglycemia (glucose, <20 mg/dL [reference range, 74–106 mg/dL]), renal insufficiency (serum creatinine, 2.5 mg/dL [reference range, 0.66–1.25 mg/dL]), metabolic acidosis (pH, 7.1 [reference range, 7.35–7.45]; bicarbonate, 13 mmol/L [reference range, 22–30 mmol/L]; lactic acid, 11.9 mmol/L [reference range, 0.7–2.1 mmol/L]), liver dysfunction (aspartate aminotransferase, 576 IU/L [reference range, 15–46 IU/L]), and coagulopathy with evidence of diffuse intravascular coagulation (total platelets, 75,000/mm³ [reference range, 150,000–450,000/mm³];  international normalized ratio, 9.5 [reference range, 0.8–1.2]; partial thromboplastin time, 108 seconds [reference range 23.0–35.0 seconds]; fibrinogen, 145 mg/dL [reference range, 228–501 mg/dL]; D-dimer, >20 µg/mL [reference range, 0.01–0.58 μg/mL]). Computed tomography of the pelvis and legs showed ascites, extensive subcutaneous edema, and cutaneous blisterlike lesions superior to the level of the ankles bilaterally. No gas, foreign bodies, collections, asymmetric facial thickening, or evidence of infection across tissue planes was present (Figures 2 and 3).

Specimens of blood and aspirates from the bullae at multiple lower leg sites were sent for microbiologic evaluation. The blood specimens were inoculated at bedside into aerobic and anaerobic blood culture bottles and incubated in an automated blood culture system. The aspirate samples were inoculated to trypticase soy agar with 5% sheep blood, Columbia-nalidixic acid agar, chocolate agar, MacConkey agar, and thioglycollate broth, which were incubated at 37ºC in air supplemented with 5% CO₂, and to CDC anaerobic blood agar, which was incubated under anaerobic conditions. Gram-stained smears of the aspirates from the bullae demonstrated few granulocytes and numerous large gram-positive bacilli (Figure 4). By the next day, growth of large gram-positive bacilli was detected in both aerobic and anaerobic blood culture bottles and in pure culture from all the bullae samples. The bacterial colonies on sheep blood agar were opaque and white-gray in color, with a rough surface, undulate margins, and surrounding β hemolysis. The isolate was a motile, catalase-positive, arginine-positive, salicin-positive, lecithinase-positive, and penicillin-resistant organism that was identified as Bacillus cereus.

Antimicrobial susceptibility testing for B cereus has not been standardized, but evaluation by broth microdilution suggested decreased susceptibility to penicillin (minimum inhibitory concentration [MIC], 2 µg/mL) and clindamycin (MIC, 2 µg/mL), but retained susceptibility to ciprofloxacin (MIC, ≤0.25 µg/mL), tetracycline (MIC, ≤1 µg/mL), rifampin (MIC, ≤1 µg/mL), and vancomycin (MIC, ≤2 µg/mL).

The patient was admitted to the intensive care unit and was treated initially with fluid resuscitation; transfusions; ventilatory support; and intravenous vancomycin, clindamycin, and imipenem. This regimen was changed to vancomycin and ciprofloxacin when culture and susceptibility results became available to complete a 14-day course. Signs of sepsis resolved and the mental status and skin lesions improved. Ultimately, the patient died due to complications of hepatic failure.

Bacillus cereus is a rod-shaped, gram-positive, facultative, aerobic organism that is widely distributed in the environment.¹ Spore formation makes B cereus resistant to most physical and chemical disinfection methods; as a consequence, it is a frequent contaminant in materials (eg, plants, dust, soil, sediment), foodstuffs, and clinical specimens.¹

Traditionally considered in the context of foodborne illness, B cereus is recognized increasingly as a cause of systemic and local infections in both immunosuppressed and immunocompetent patients. Nongastrointestinal infections reported include fulminant bacteremia, pneumonia, meningitis, brain abscesses, endophthalmitis, necrotizing fasciitis, and central line catheter–related and cutaneous infections.^1,2

Figure 4. Gram-stained smears of bulla aspirate revealed large gram-positive bacilli and debris in material aspirated from a left lower leg bulla (original magnification ×100 [oil immersion]).

Cutaneous lesions may have a variety of forms and appearance at initial presentation, including small papules or vesicles that progress into a rapidly spreading cellulitis^1,2 with a characteristic serosanguineous draining fluid,² single necrotic bullae,³ and gas-gangrenelike infections with extensive soft tissue involvement resembling clostridial myonecrosis.^1,4 Single or multiple papulovesicular lesions can even mimic cutaneous anthrax.^1-4 Necrotic or hemorrhagic bullous lesions,³ such as those observed in our patient, are rare.

Exposed areas such as extremities and digits are most often affected, presumably due to entrance of spores from soil, water, decaying organic material, or fomites through skin microabrasions or trauma-induced wounds.¹ Once in the tissue, the crystalline surface protein layer (S-layer) of the bacilli promotes adhesion to human epithelial cells and neutrophils,⁵ followed by release of virulence factors including proteases, collagenases, lecithinaselike enzymes, necrotizing exotoxinlike hemolysins, phospholipases, and most importantly a dermonecrotic vascular permeability factor.^1,5 Toxins produced by B cereus are similar to those closely related to Bacillus anthracis, the agent of anthrax.^1,2

When large gram-positive bacilli are observed in tissue or wound specimens, initial therapy should address both aerobic (Bacillus species) and anaerobic (Clostridium species) organisms.^1,4,6 Once B cereus is recovered, treatment should rely on susceptibility testing of the isolate. Bacillus cereus produces ß-lactamase, thus penicillin and cephalosporin should be avoided.¹ Vancomycin, clindamycin, aminoglycosides, and fluoroquinolones are the drugs of choice.^1,3,4,6 Daptomycin and linezolid also are active in vitro,¹ but clinical experience with these agents is limited. Necrotic infection or deep tissue involvement requires surgical intervention.

Numerous other organisms can cause cellulitis and soft tissue infections with hemorrhagic bullae.^1,3,6 Streptococci, particularly Streptococcus pyogenes, and occasionally staphylococci are the primary consideration in normal hosts without trauma.^3,6 In immunocompromised patients, including those with cirrhosis, diabetes mellitus, and malignancy, Clostridium perfringens and gram-negative organisms such as Escherichia coli, other enteric bacteria including Pseudomonas aeruginosa, Aeromonas, and halophilic Vibrio species are more frequent.^3,6

We describe a patient with underlying cirrhosis who developed bilateral lower extremity hemorrhagic bullous lesions and sepsis due to infection with B cereus, an emerging cause of serious infections in patients with underlying immunocompromising conditions such as cirrhosis, diabetes mellitus, and malignancy. Hemorrhagic bullae in immunocompromised patients are associated with sepsis and rapidly progressive illness, and rapid treatment is essential. Bacillus cereus should be included as a consideration in the differential diagnosis and management of patients presenting with bullous cellulitis and sepsis.

To the Editor:
A 42-year-old man with hypertension, hypothyroidism, and alcohol-related cirrhosis was admitted for evaluation of rapidly deteriorating mental status. He was referred from a rehabilitation facility where he had been admitted 4 days earlier after a hospitalization for hepatorenal syndrome and pneumonia. He was alert and ambulating until the day of the current admission. On arrival he was hypotensive(54/42 mm Hg); hypothermic (35°C, rectally); and unresponsive, except to painful stimuli. Jaundice, hepatosplenomegaly, ascites, and bilateral lower extremity edema were noted. There were multiple tense and flaccid bullous lesions containing serosanguineous fluid over both tibias and calves, without crepitus (Figure 1).

Figure 1. Left tibia with multiple hemorrhagic bullae and surrounding erythema and edema. The characteristic serosanguineous drainage was seen at the lower edge of the distal bulla.

Figure 2. Computed tomography of the legs with extensive subcutaneous edema and fluid collections around the knees.

Figure 3. Computed tomography of the legs with edematous changes of the anterior compart-ment muscles.

Laboratory test results revealed leukocytosis (total leukocytes, 10,900/mm³ [reference range, 4500–10,800/mm³), hypoglycemia (glucose, <20 mg/dL [reference range, 74–106 mg/dL]), renal insufficiency (serum creatinine, 2.5 mg/dL [reference range, 0.66–1.25 mg/dL]), metabolic acidosis (pH, 7.1 [reference range, 7.35–7.45]; bicarbonate, 13 mmol/L [reference range, 22–30 mmol/L]; lactic acid, 11.9 mmol/L [reference range, 0.7–2.1 mmol/L]), liver dysfunction (aspartate aminotransferase, 576 IU/L [reference range, 15–46 IU/L]), and coagulopathy with evidence of diffuse intravascular coagulation (total platelets, 75,000/mm³ [reference range, 150,000–450,000/mm³];  international normalized ratio, 9.5 [reference range, 0.8–1.2]; partial thromboplastin time, 108 seconds [reference range 23.0–35.0 seconds]; fibrinogen, 145 mg/dL [reference range, 228–501 mg/dL]; D-dimer, >20 µg/mL [reference range, 0.01–0.58 μg/mL]). Computed tomography of the pelvis and legs showed ascites, extensive subcutaneous edema, and cutaneous blisterlike lesions superior to the level of the ankles bilaterally. No gas, foreign bodies, collections, asymmetric facial thickening, or evidence of infection across tissue planes was present (Figures 2 and 3).

Specimens of blood and aspirates from the bullae at multiple lower leg sites were sent for microbiologic evaluation. The blood specimens were inoculated at bedside into aerobic and anaerobic blood culture bottles and incubated in an automated blood culture system. The aspirate samples were inoculated to trypticase soy agar with 5% sheep blood, Columbia-nalidixic acid agar, chocolate agar, MacConkey agar, and thioglycollate broth, which were incubated at 37ºC in air supplemented with 5% CO₂, and to CDC anaerobic blood agar, which was incubated under anaerobic conditions. Gram-stained smears of the aspirates from the bullae demonstrated few granulocytes and numerous large gram-positive bacilli (Figure 4). By the next day, growth of large gram-positive bacilli was detected in both aerobic and anaerobic blood culture bottles and in pure culture from all the bullae samples. The bacterial colonies on sheep blood agar were opaque and white-gray in color, with a rough surface, undulate margins, and surrounding β hemolysis. The isolate was a motile, catalase-positive, arginine-positive, salicin-positive, lecithinase-positive, and penicillin-resistant organism that was identified as Bacillus cereus.

Antimicrobial susceptibility testing for B cereus has not been standardized, but evaluation by broth microdilution suggested decreased susceptibility to penicillin (minimum inhibitory concentration [MIC], 2 µg/mL) and clindamycin (MIC, 2 µg/mL), but retained susceptibility to ciprofloxacin (MIC, ≤0.25 µg/mL), tetracycline (MIC, ≤1 µg/mL), rifampin (MIC, ≤1 µg/mL), and vancomycin (MIC, ≤2 µg/mL).

The patient was admitted to the intensive care unit and was treated initially with fluid resuscitation; transfusions; ventilatory support; and intravenous vancomycin, clindamycin, and imipenem. This regimen was changed to vancomycin and ciprofloxacin when culture and susceptibility results became available to complete a 14-day course. Signs of sepsis resolved and the mental status and skin lesions improved. Ultimately, the patient died due to complications of hepatic failure.

Bacillus cereus is a rod-shaped, gram-positive, facultative, aerobic organism that is widely distributed in the environment.¹ Spore formation makes B cereus resistant to most physical and chemical disinfection methods; as a consequence, it is a frequent contaminant in materials (eg, plants, dust, soil, sediment), foodstuffs, and clinical specimens.¹

Traditionally considered in the context of foodborne illness, B cereus is recognized increasingly as a cause of systemic and local infections in both immunosuppressed and immunocompetent patients. Nongastrointestinal infections reported include fulminant bacteremia, pneumonia, meningitis, brain abscesses, endophthalmitis, necrotizing fasciitis, and central line catheter–related and cutaneous infections.^1,2

Figure 4. Gram-stained smears of bulla aspirate revealed large gram-positive bacilli and debris in material aspirated from a left lower leg bulla (original magnification ×100 [oil immersion]).

Cutaneous lesions may have a variety of forms and appearance at initial presentation, including small papules or vesicles that progress into a rapidly spreading cellulitis^1,2 with a characteristic serosanguineous draining fluid,² single necrotic bullae,³ and gas-gangrenelike infections with extensive soft tissue involvement resembling clostridial myonecrosis.^1,4 Single or multiple papulovesicular lesions can even mimic cutaneous anthrax.^1-4 Necrotic or hemorrhagic bullous lesions,³ such as those observed in our patient, are rare.

Exposed areas such as extremities and digits are most often affected, presumably due to entrance of spores from soil, water, decaying organic material, or fomites through skin microabrasions or trauma-induced wounds.¹ Once in the tissue, the crystalline surface protein layer (S-layer) of the bacilli promotes adhesion to human epithelial cells and neutrophils,⁵ followed by release of virulence factors including proteases, collagenases, lecithinaselike enzymes, necrotizing exotoxinlike hemolysins, phospholipases, and most importantly a dermonecrotic vascular permeability factor.^1,5 Toxins produced by B cereus are similar to those closely related to Bacillus anthracis, the agent of anthrax.^1,2

When large gram-positive bacilli are observed in tissue or wound specimens, initial therapy should address both aerobic (Bacillus species) and anaerobic (Clostridium species) organisms.^1,4,6 Once B cereus is recovered, treatment should rely on susceptibility testing of the isolate. Bacillus cereus produces ß-lactamase, thus penicillin and cephalosporin should be avoided.¹ Vancomycin, clindamycin, aminoglycosides, and fluoroquinolones are the drugs of choice.^1,3,4,6 Daptomycin and linezolid also are active in vitro,¹ but clinical experience with these agents is limited. Necrotic infection or deep tissue involvement requires surgical intervention.

Numerous other organisms can cause cellulitis and soft tissue infections with hemorrhagic bullae.^1,3,6 Streptococci, particularly Streptococcus pyogenes, and occasionally staphylococci are the primary consideration in normal hosts without trauma.^3,6 In immunocompromised patients, including those with cirrhosis, diabetes mellitus, and malignancy, Clostridium perfringens and gram-negative organisms such as Escherichia coli, other enteric bacteria including Pseudomonas aeruginosa, Aeromonas, and halophilic Vibrio species are more frequent.^3,6

We describe a patient with underlying cirrhosis who developed bilateral lower extremity hemorrhagic bullous lesions and sepsis due to infection with B cereus, an emerging cause of serious infections in patients with underlying immunocompromising conditions such as cirrhosis, diabetes mellitus, and malignancy. Hemorrhagic bullae in immunocompromised patients are associated with sepsis and rapidly progressive illness, and rapid treatment is essential. Bacillus cereus should be included as a consideration in the differential diagnosis and management of patients presenting with bullous cellulitis and sepsis.

To the Editor:
A 42-year-old man with hypertension, hypothyroidism, and alcohol-related cirrhosis was admitted for evaluation of rapidly deteriorating mental status. He was referred from a rehabilitation facility where he had been admitted 4 days earlier after a hospitalization for hepatorenal syndrome and pneumonia. He was alert and ambulating until the day of the current admission. On arrival he was hypotensive(54/42 mm Hg); hypothermic (35°C, rectally); and unresponsive, except to painful stimuli. Jaundice, hepatosplenomegaly, ascites, and bilateral lower extremity edema were noted. There were multiple tense and flaccid bullous lesions containing serosanguineous fluid over both tibias and calves, without crepitus (Figure 1).

Figure 1. Left tibia with multiple hemorrhagic bullae and surrounding erythema and edema. The characteristic serosanguineous drainage was seen at the lower edge of the distal bulla.

Figure 2. Computed tomography of the legs with extensive subcutaneous edema and fluid collections around the knees.

Figure 3. Computed tomography of the legs with edematous changes of the anterior compart-ment muscles.

Laboratory test results revealed leukocytosis (total leukocytes, 10,900/mm³ [reference range, 4500–10,800/mm³), hypoglycemia (glucose, <20 mg/dL [reference range, 74–106 mg/dL]), renal insufficiency (serum creatinine, 2.5 mg/dL [reference range, 0.66–1.25 mg/dL]), metabolic acidosis (pH, 7.1 [reference range, 7.35–7.45]; bicarbonate, 13 mmol/L [reference range, 22–30 mmol/L]; lactic acid, 11.9 mmol/L [reference range, 0.7–2.1 mmol/L]), liver dysfunction (aspartate aminotransferase, 576 IU/L [reference range, 15–46 IU/L]), and coagulopathy with evidence of diffuse intravascular coagulation (total platelets, 75,000/mm³ [reference range, 150,000–450,000/mm³];  international normalized ratio, 9.5 [reference range, 0.8–1.2]; partial thromboplastin time, 108 seconds [reference range 23.0–35.0 seconds]; fibrinogen, 145 mg/dL [reference range, 228–501 mg/dL]; D-dimer, >20 µg/mL [reference range, 0.01–0.58 μg/mL]). Computed tomography of the pelvis and legs showed ascites, extensive subcutaneous edema, and cutaneous blisterlike lesions superior to the level of the ankles bilaterally. No gas, foreign bodies, collections, asymmetric facial thickening, or evidence of infection across tissue planes was present (Figures 2 and 3).

Specimens of blood and aspirates from the bullae at multiple lower leg sites were sent for microbiologic evaluation. The blood specimens were inoculated at bedside into aerobic and anaerobic blood culture bottles and incubated in an automated blood culture system. The aspirate samples were inoculated to trypticase soy agar with 5% sheep blood, Columbia-nalidixic acid agar, chocolate agar, MacConkey agar, and thioglycollate broth, which were incubated at 37ºC in air supplemented with 5% CO₂, and to CDC anaerobic blood agar, which was incubated under anaerobic conditions. Gram-stained smears of the aspirates from the bullae demonstrated few granulocytes and numerous large gram-positive bacilli (Figure 4). By the next day, growth of large gram-positive bacilli was detected in both aerobic and anaerobic blood culture bottles and in pure culture from all the bullae samples. The bacterial colonies on sheep blood agar were opaque and white-gray in color, with a rough surface, undulate margins, and surrounding β hemolysis. The isolate was a motile, catalase-positive, arginine-positive, salicin-positive, lecithinase-positive, and penicillin-resistant organism that was identified as Bacillus cereus.

Antimicrobial susceptibility testing for B cereus has not been standardized, but evaluation by broth microdilution suggested decreased susceptibility to penicillin (minimum inhibitory concentration [MIC], 2 µg/mL) and clindamycin (MIC, 2 µg/mL), but retained susceptibility to ciprofloxacin (MIC, ≤0.25 µg/mL), tetracycline (MIC, ≤1 µg/mL), rifampin (MIC, ≤1 µg/mL), and vancomycin (MIC, ≤2 µg/mL).

The patient was admitted to the intensive care unit and was treated initially with fluid resuscitation; transfusions; ventilatory support; and intravenous vancomycin, clindamycin, and imipenem. This regimen was changed to vancomycin and ciprofloxacin when culture and susceptibility results became available to complete a 14-day course. Signs of sepsis resolved and the mental status and skin lesions improved. Ultimately, the patient died due to complications of hepatic failure.

Bacillus cereus is a rod-shaped, gram-positive, facultative, aerobic organism that is widely distributed in the environment.¹ Spore formation makes B cereus resistant to most physical and chemical disinfection methods; as a consequence, it is a frequent contaminant in materials (eg, plants, dust, soil, sediment), foodstuffs, and clinical specimens.¹

Traditionally considered in the context of foodborne illness, B cereus is recognized increasingly as a cause of systemic and local infections in both immunosuppressed and immunocompetent patients. Nongastrointestinal infections reported include fulminant bacteremia, pneumonia, meningitis, brain abscesses, endophthalmitis, necrotizing fasciitis, and central line catheter–related and cutaneous infections.^1,2

Figure 4. Gram-stained smears of bulla aspirate revealed large gram-positive bacilli and debris in material aspirated from a left lower leg bulla (original magnification ×100 [oil immersion]).

Cutaneous lesions may have a variety of forms and appearance at initial presentation, including small papules or vesicles that progress into a rapidly spreading cellulitis^1,2 with a characteristic serosanguineous draining fluid,² single necrotic bullae,³ and gas-gangrenelike infections with extensive soft tissue involvement resembling clostridial myonecrosis.^1,4 Single or multiple papulovesicular lesions can even mimic cutaneous anthrax.^1-4 Necrotic or hemorrhagic bullous lesions,³ such as those observed in our patient, are rare.

Exposed areas such as extremities and digits are most often affected, presumably due to entrance of spores from soil, water, decaying organic material, or fomites through skin microabrasions or trauma-induced wounds.¹ Once in the tissue, the crystalline surface protein layer (S-layer) of the bacilli promotes adhesion to human epithelial cells and neutrophils,⁵ followed by release of virulence factors including proteases, collagenases, lecithinaselike enzymes, necrotizing exotoxinlike hemolysins, phospholipases, and most importantly a dermonecrotic vascular permeability factor.^1,5 Toxins produced by B cereus are similar to those closely related to Bacillus anthracis, the agent of anthrax.^1,2

When large gram-positive bacilli are observed in tissue or wound specimens, initial therapy should address both aerobic (Bacillus species) and anaerobic (Clostridium species) organisms.^1,4,6 Once B cereus is recovered, treatment should rely on susceptibility testing of the isolate. Bacillus cereus produces ß-lactamase, thus penicillin and cephalosporin should be avoided.¹ Vancomycin, clindamycin, aminoglycosides, and fluoroquinolones are the drugs of choice.^1,3,4,6 Daptomycin and linezolid also are active in vitro,¹ but clinical experience with these agents is limited. Necrotic infection or deep tissue involvement requires surgical intervention.

Numerous other organisms can cause cellulitis and soft tissue infections with hemorrhagic bullae.^1,3,6 Streptococci, particularly Streptococcus pyogenes, and occasionally staphylococci are the primary consideration in normal hosts without trauma.^3,6 In immunocompromised patients, including those with cirrhosis, diabetes mellitus, and malignancy, Clostridium perfringens and gram-negative organisms such as Escherichia coli, other enteric bacteria including Pseudomonas aeruginosa, Aeromonas, and halophilic Vibrio species are more frequent.^3,6

We describe a patient with underlying cirrhosis who developed bilateral lower extremity hemorrhagic bullous lesions and sepsis due to infection with B cereus, an emerging cause of serious infections in patients with underlying immunocompromising conditions such as cirrhosis, diabetes mellitus, and malignancy. Hemorrhagic bullae in immunocompromised patients are associated with sepsis and rapidly progressive illness, and rapid treatment is essential. Bacillus cereus should be included as a consideration in the differential diagnosis and management of patients presenting with bullous cellulitis and sepsis.

CHICAGO – Atrial fibrillation patients treated with an anticoagulant plus four or more other medications had significantly more bleeding complications than did those on fewer medications in a retrospective study.

“This is the first study examining polypharmacy in patients with nonvalvular atrial fibrillation,” Dr. Jonathan P. Piccini said at the American Heart Association Scientific Sessions. The main consequence is, “We should do everything we can to reduce the number of medications a patient receives,” he said.

His exploratory, retrospective analysis of data from more than 14,000 patients enrolled in an anticoagulant treatment trial showed that atrial fibrillation patients on an oral anticoagulant and taking a total of 10 or more medications concurrently had a 46% increased rate of a major bleed or clinically relevant nonmajor bleed. Patients taking five to nine medications had a 17% increased rate for this primary bleeding endpoint. Both increases were statistically significant, reported Dr. Piccini, a cardiologist at Duke University in Durham, N.C. Major bleeds alone were 90% higher in patients on at least 10 drugs and 47% higher in patients on 5-9 total drugs, compared with those on 4 or fewer, also statistically significant differences.

“Increasing medication use was associated with an increased risk of bleeding but not stroke,” he said. In addition, because the data came from a large trial that had compared the new oral anticoagulant rivaroxaban (Xarelto) with warfarin, the analysis was able to show that this polypharmacy effect was similar regardless of which anticoagulant patients took.

Polypharmacy was common among the 14,264 patients (average age, 73 years) enrolled in the trial, as 51% were on 5-9 drugs and 13% were on 10 or more drugs, with a minority of 36% forming the comparator group taking 4 or fewer medications.

The analysis used data collected from 14,264 patients enrolled in the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial, which was designed as a pivotal trial comparing the safety and efficacy of the new oral anticoagulant rivaroxaban with warfarin for stroke prevention in patients with nonvalvular atrial fibrillation (N. Engl. J. Med. 2011;365:883-91). Dr. Piccini and his associates assessed various measures of bleeding as well as strokes, vascular deaths, and all-cause deaths in the patients by their number of concomitant medications based on data collected at baseline when patients entered the trial. The relative hazard rates the investigators calculated were adjusted for all “clinically important covariates,” but Dr. Piccini acknowledged that residual confounding accounted for by the adjustments likely remained.

All-cause death was also significantly increased in patients taking at least 10 (a 43% increase) or 5-9 drugs (a 25% increase), compared with patients on 4 or fewer drugs. But the rate of stroke or nonstroke embolism was not significantly increased among patients on five or more drugs. The combined rate of stroke, nonstroke embolism, and vascular death was a statistically significant 25% higher in patients on at least 10 drugs, compared with those on 4 or fewer drugs, but there was no significant increase in patients on 5-9 drugs.

The link between higher numbers of concomitant medications and an increased bleeding rate likely has two explanations, Dr. Piccini said. It could happen because the drugs themselves promote bleeding, and because the need to prescribe multiple drugs is a marker for patients who are sicker and have more comorbidities and a higher underlying risk of bleeding.

ROCKET AF was sponsored by Janssen and Bayer. Dr. Piccini has been a consultant to and has received research funding from Janssen, Bayer, and several other companies.

[email protected]

On Twitter @mitchelzoler

CHICAGO – Atrial fibrillation patients treated with an anticoagulant plus four or more other medications had significantly more bleeding complications than did those on fewer medications in a retrospective study.

“This is the first study examining polypharmacy in patients with nonvalvular atrial fibrillation,” Dr. Jonathan P. Piccini said at the American Heart Association Scientific Sessions. The main consequence is, “We should do everything we can to reduce the number of medications a patient receives,” he said.

His exploratory, retrospective analysis of data from more than 14,000 patients enrolled in an anticoagulant treatment trial showed that atrial fibrillation patients on an oral anticoagulant and taking a total of 10 or more medications concurrently had a 46% increased rate of a major bleed or clinically relevant nonmajor bleed. Patients taking five to nine medications had a 17% increased rate for this primary bleeding endpoint. Both increases were statistically significant, reported Dr. Piccini, a cardiologist at Duke University in Durham, N.C. Major bleeds alone were 90% higher in patients on at least 10 drugs and 47% higher in patients on 5-9 total drugs, compared with those on 4 or fewer, also statistically significant differences.

“Increasing medication use was associated with an increased risk of bleeding but not stroke,” he said. In addition, because the data came from a large trial that had compared the new oral anticoagulant rivaroxaban (Xarelto) with warfarin, the analysis was able to show that this polypharmacy effect was similar regardless of which anticoagulant patients took.

Polypharmacy was common among the 14,264 patients (average age, 73 years) enrolled in the trial, as 51% were on 5-9 drugs and 13% were on 10 or more drugs, with a minority of 36% forming the comparator group taking 4 or fewer medications.

The analysis used data collected from 14,264 patients enrolled in the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial, which was designed as a pivotal trial comparing the safety and efficacy of the new oral anticoagulant rivaroxaban with warfarin for stroke prevention in patients with nonvalvular atrial fibrillation (N. Engl. J. Med. 2011;365:883-91). Dr. Piccini and his associates assessed various measures of bleeding as well as strokes, vascular deaths, and all-cause deaths in the patients by their number of concomitant medications based on data collected at baseline when patients entered the trial. The relative hazard rates the investigators calculated were adjusted for all “clinically important covariates,” but Dr. Piccini acknowledged that residual confounding accounted for by the adjustments likely remained.

All-cause death was also significantly increased in patients taking at least 10 (a 43% increase) or 5-9 drugs (a 25% increase), compared with patients on 4 or fewer drugs. But the rate of stroke or nonstroke embolism was not significantly increased among patients on five or more drugs. The combined rate of stroke, nonstroke embolism, and vascular death was a statistically significant 25% higher in patients on at least 10 drugs, compared with those on 4 or fewer drugs, but there was no significant increase in patients on 5-9 drugs.

The link between higher numbers of concomitant medications and an increased bleeding rate likely has two explanations, Dr. Piccini said. It could happen because the drugs themselves promote bleeding, and because the need to prescribe multiple drugs is a marker for patients who are sicker and have more comorbidities and a higher underlying risk of bleeding.

ROCKET AF was sponsored by Janssen and Bayer. Dr. Piccini has been a consultant to and has received research funding from Janssen, Bayer, and several other companies.

[email protected]

On Twitter @mitchelzoler

CHICAGO – Atrial fibrillation patients treated with an anticoagulant plus four or more other medications had significantly more bleeding complications than did those on fewer medications in a retrospective study.

“This is the first study examining polypharmacy in patients with nonvalvular atrial fibrillation,” Dr. Jonathan P. Piccini said at the American Heart Association Scientific Sessions. The main consequence is, “We should do everything we can to reduce the number of medications a patient receives,” he said.

His exploratory, retrospective analysis of data from more than 14,000 patients enrolled in an anticoagulant treatment trial showed that atrial fibrillation patients on an oral anticoagulant and taking a total of 10 or more medications concurrently had a 46% increased rate of a major bleed or clinically relevant nonmajor bleed. Patients taking five to nine medications had a 17% increased rate for this primary bleeding endpoint. Both increases were statistically significant, reported Dr. Piccini, a cardiologist at Duke University in Durham, N.C. Major bleeds alone were 90% higher in patients on at least 10 drugs and 47% higher in patients on 5-9 total drugs, compared with those on 4 or fewer, also statistically significant differences.

“Increasing medication use was associated with an increased risk of bleeding but not stroke,” he said. In addition, because the data came from a large trial that had compared the new oral anticoagulant rivaroxaban (Xarelto) with warfarin, the analysis was able to show that this polypharmacy effect was similar regardless of which anticoagulant patients took.

Polypharmacy was common among the 14,264 patients (average age, 73 years) enrolled in the trial, as 51% were on 5-9 drugs and 13% were on 10 or more drugs, with a minority of 36% forming the comparator group taking 4 or fewer medications.

The analysis used data collected from 14,264 patients enrolled in the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial, which was designed as a pivotal trial comparing the safety and efficacy of the new oral anticoagulant rivaroxaban with warfarin for stroke prevention in patients with nonvalvular atrial fibrillation (N. Engl. J. Med. 2011;365:883-91). Dr. Piccini and his associates assessed various measures of bleeding as well as strokes, vascular deaths, and all-cause deaths in the patients by their number of concomitant medications based on data collected at baseline when patients entered the trial. The relative hazard rates the investigators calculated were adjusted for all “clinically important covariates,” but Dr. Piccini acknowledged that residual confounding accounted for by the adjustments likely remained.

All-cause death was also significantly increased in patients taking at least 10 (a 43% increase) or 5-9 drugs (a 25% increase), compared with patients on 4 or fewer drugs. But the rate of stroke or nonstroke embolism was not significantly increased among patients on five or more drugs. The combined rate of stroke, nonstroke embolism, and vascular death was a statistically significant 25% higher in patients on at least 10 drugs, compared with those on 4 or fewer drugs, but there was no significant increase in patients on 5-9 drugs.

The link between higher numbers of concomitant medications and an increased bleeding rate likely has two explanations, Dr. Piccini said. It could happen because the drugs themselves promote bleeding, and because the need to prescribe multiple drugs is a marker for patients who are sicker and have more comorbidities and a higher underlying risk of bleeding.

ROCKET AF was sponsored by Janssen and Bayer. Dr. Piccini has been a consultant to and has received research funding from Janssen, Bayer, and several other companies.

[email protected]

On Twitter @mitchelzoler

SCOTTSDALE, ARIZ. – Exercise is a cornerstone of treating postural orthostatic tachycardia syndrome, according to Dr. Deborah Tepper.

“Exercise training is really the hot new way to treat this disorder. It’s been found to be very effective,” she said at a symposium sponsored by the American Headache Society.

Postural orthostatic tachycardia syndrome (POTS) is an autonomic disorder that causes symptoms resembling panic attacks, said Dr. Tepper, who is an internist at the Cleveland Clinic Neurological Center for Pain. Patients may report syncope, dizziness, palpitations, rapid or irregular breathing, fatigue, and chest pain, she said. But to be diagnosed with POTS, they must have an increase of at least 30 beats per minute within 10 minutes of standing or with the 60-degree tilt table test. Patients aged 12-19 years must have an increase in heart rate of at least 40 beats per minute. Blood pressure may drop or stay the same, but will not fall to the extent seen in orthostatic hypotension (that is, a systolic drop of 20 mm Hg or a diastolic fall of at least 10 mm Hg), Dr. Tepper noted.

Courtesy Wikimedia Commons/Adrian Pingstone/Creative Commons License

Deconditioning, chronic fatigue, anxiety, dehydration, and various medications increase the frequency and severity of POTS-related symptoms, Dr. Tepper said. Patients sometimes severely restrict exercise in an effort to control symptoms, but lying on the couch or going to bed “is the worst thing you can do with POTS,” she said. Instead, patients should start a graded exercise program by swimming or exercising in recumbent or seated positions. Exercise training increases the aldosterone-to-renin ratio, can reduce migraine, improves overall health and stamina, supports independent functioning, and can help restore the sleep-wake cycle.

Increasing salt and fluid intake and wearing compression socks also can improve symptoms – often to the extent that patients will not need new medications. But this conservative approach is inadequate in patients with risky occupations and is less effective when patients have frequent episodes of syncope, Dr. Tepper said.

“Beta-blockers remain an option if salts, fluids, and patient education are not enough,” she added.

Beta-blockers inhibit epinephrine release and therefore can improve the migraine and anxiety symptoms that can occur in patients with POTS, although they should not be used in patients with asthma, Dr. Tepper emphasized.

Medications such as fludrocortisone and midodrine should be reserved for patients with recurrent or resistant symptoms, according to Dr. Tepper. “Midodrine can be helpful in some people, although the evidence overall rates it as low to moderate,” she said. Midodrine is a direct vasoconstrictor and alpha-adrenergic agonist that increases vasomotor tone, but also can exacerbate headaches and may cause supine hypertension, urinary retention, and insomnia, she noted. Fludrocortisone increases plasma volume, but worsens migraine, increases fluid retention, and cannot be used in diabetic patients, she said.

Clinicians should refer patients for a cardiology evaluation if they do not improve or have risk factors such as a history of cardiac disease or a family history of sudden cardiac death, chest pain, a QRS interval of more than 120 ms, a corrected QT interval of more than 450 ms or less than 300 ms, or syncope with no warning or while lying down, Dr. Tepper said. She declared no conflicts of interest.

SCOTTSDALE, ARIZ. – Exercise is a cornerstone of treating postural orthostatic tachycardia syndrome, according to Dr. Deborah Tepper.

“Exercise training is really the hot new way to treat this disorder. It’s been found to be very effective,” she said at a symposium sponsored by the American Headache Society.

Postural orthostatic tachycardia syndrome (POTS) is an autonomic disorder that causes symptoms resembling panic attacks, said Dr. Tepper, who is an internist at the Cleveland Clinic Neurological Center for Pain. Patients may report syncope, dizziness, palpitations, rapid or irregular breathing, fatigue, and chest pain, she said. But to be diagnosed with POTS, they must have an increase of at least 30 beats per minute within 10 minutes of standing or with the 60-degree tilt table test. Patients aged 12-19 years must have an increase in heart rate of at least 40 beats per minute. Blood pressure may drop or stay the same, but will not fall to the extent seen in orthostatic hypotension (that is, a systolic drop of 20 mm Hg or a diastolic fall of at least 10 mm Hg), Dr. Tepper noted.

Courtesy Wikimedia Commons/Adrian Pingstone/Creative Commons License

Deconditioning, chronic fatigue, anxiety, dehydration, and various medications increase the frequency and severity of POTS-related symptoms, Dr. Tepper said. Patients sometimes severely restrict exercise in an effort to control symptoms, but lying on the couch or going to bed “is the worst thing you can do with POTS,” she said. Instead, patients should start a graded exercise program by swimming or exercising in recumbent or seated positions. Exercise training increases the aldosterone-to-renin ratio, can reduce migraine, improves overall health and stamina, supports independent functioning, and can help restore the sleep-wake cycle.

Increasing salt and fluid intake and wearing compression socks also can improve symptoms – often to the extent that patients will not need new medications. But this conservative approach is inadequate in patients with risky occupations and is less effective when patients have frequent episodes of syncope, Dr. Tepper said.

“Beta-blockers remain an option if salts, fluids, and patient education are not enough,” she added.

Beta-blockers inhibit epinephrine release and therefore can improve the migraine and anxiety symptoms that can occur in patients with POTS, although they should not be used in patients with asthma, Dr. Tepper emphasized.

Medications such as fludrocortisone and midodrine should be reserved for patients with recurrent or resistant symptoms, according to Dr. Tepper. “Midodrine can be helpful in some people, although the evidence overall rates it as low to moderate,” she said. Midodrine is a direct vasoconstrictor and alpha-adrenergic agonist that increases vasomotor tone, but also can exacerbate headaches and may cause supine hypertension, urinary retention, and insomnia, she noted. Fludrocortisone increases plasma volume, but worsens migraine, increases fluid retention, and cannot be used in diabetic patients, she said.

Clinicians should refer patients for a cardiology evaluation if they do not improve or have risk factors such as a history of cardiac disease or a family history of sudden cardiac death, chest pain, a QRS interval of more than 120 ms, a corrected QT interval of more than 450 ms or less than 300 ms, or syncope with no warning or while lying down, Dr. Tepper said. She declared no conflicts of interest.

SCOTTSDALE, ARIZ. – Exercise is a cornerstone of treating postural orthostatic tachycardia syndrome, according to Dr. Deborah Tepper.

“Exercise training is really the hot new way to treat this disorder. It’s been found to be very effective,” she said at a symposium sponsored by the American Headache Society.

Postural orthostatic tachycardia syndrome (POTS) is an autonomic disorder that causes symptoms resembling panic attacks, said Dr. Tepper, who is an internist at the Cleveland Clinic Neurological Center for Pain. Patients may report syncope, dizziness, palpitations, rapid or irregular breathing, fatigue, and chest pain, she said. But to be diagnosed with POTS, they must have an increase of at least 30 beats per minute within 10 minutes of standing or with the 60-degree tilt table test. Patients aged 12-19 years must have an increase in heart rate of at least 40 beats per minute. Blood pressure may drop or stay the same, but will not fall to the extent seen in orthostatic hypotension (that is, a systolic drop of 20 mm Hg or a diastolic fall of at least 10 mm Hg), Dr. Tepper noted.

Courtesy Wikimedia Commons/Adrian Pingstone/Creative Commons License

Deconditioning, chronic fatigue, anxiety, dehydration, and various medications increase the frequency and severity of POTS-related symptoms, Dr. Tepper said. Patients sometimes severely restrict exercise in an effort to control symptoms, but lying on the couch or going to bed “is the worst thing you can do with POTS,” she said. Instead, patients should start a graded exercise program by swimming or exercising in recumbent or seated positions. Exercise training increases the aldosterone-to-renin ratio, can reduce migraine, improves overall health and stamina, supports independent functioning, and can help restore the sleep-wake cycle.

Increasing salt and fluid intake and wearing compression socks also can improve symptoms – often to the extent that patients will not need new medications. But this conservative approach is inadequate in patients with risky occupations and is less effective when patients have frequent episodes of syncope, Dr. Tepper said.

“Beta-blockers remain an option if salts, fluids, and patient education are not enough,” she added.

Beta-blockers inhibit epinephrine release and therefore can improve the migraine and anxiety symptoms that can occur in patients with POTS, although they should not be used in patients with asthma, Dr. Tepper emphasized.

Medications such as fludrocortisone and midodrine should be reserved for patients with recurrent or resistant symptoms, according to Dr. Tepper. “Midodrine can be helpful in some people, although the evidence overall rates it as low to moderate,” she said. Midodrine is a direct vasoconstrictor and alpha-adrenergic agonist that increases vasomotor tone, but also can exacerbate headaches and may cause supine hypertension, urinary retention, and insomnia, she noted. Fludrocortisone increases plasma volume, but worsens migraine, increases fluid retention, and cannot be used in diabetic patients, she said.

Clinicians should refer patients for a cardiology evaluation if they do not improve or have risk factors such as a history of cardiac disease or a family history of sudden cardiac death, chest pain, a QRS interval of more than 120 ms, a corrected QT interval of more than 450 ms or less than 300 ms, or syncope with no warning or while lying down, Dr. Tepper said. She declared no conflicts of interest.