CME Course: Ethical Dilemmas in the Practice of Obstetrics, Gynecology & Reproductive Medicine
April 23, 2014
7:30 a.m. – 4 p.m.
Cleveland Clinic Ob/Gyn & Women’s Health Institute
Cleveland Clinic Main Campus, Cleveland, Ohio
This course will discuss the leading ethical issues and challenges in obstetrics and gynecology, maternal-fetal medicine, and reproductive endocrinology. Topics will address a number of different areas including maternal fetal interventions, conscientious objection, periviability, advances in prenatal testing, uterine transplantation, oocyte cryopreservation, gestational surrogacy, and the clinical translation of innovative and experimental procedures into patient care.
Ruth M. Farrell, MD, MA
Tommaso Falcone, MD
Amanda Kalan, MD
This activity has been approved for AMA PRA Category 1 Credit™.
Registration opens January 2014 and can be accessed at clevelandclinic.org/obgyn. For additional information contact Danielle Berry at firstname.lastname@example.org or 216.445.2358.
Embryoscope Adds Precision to In Vitro Fertilization
The health risks for both patient and fetus associated with high-order multiple pregnancy has spearheaded a movement to limit the overall number of embryos transferred during in vitro fertilization (IVF) to just two for young patients.
During IVF, patients undergo a surgical procedure to extract oocytes. The oocytes are subsequently inseminated or directly injected with sperm to create embryos. The average young patient generates eight to 15 embryos per IVF cycle.
Embryo selection for transfer is based on critical assessment of morphologic parameters during embryonic development. Currently, these morphological assessments are limited to once a day at set times, since repeated removal of embryos from the incubator environment for observation may result in undesired temperature and pH shifts in the embryo culture dish.
Embryo development is a dynamic event. Static observations on embryonic growth can therefore be limiting in their ability to discern differences between embryos at a similar cell stage. Numerous data suggest that the timing of specific events such as pronuclear formation, syngamy, early cleavage, compaction and cavitation are indicators of an embryo’s developmental potential.
The ability to continuously monitor an embryo’s progression toward these benchmarks may therefore aid in selecting the best embryos for uterine transfer.
The New Tool: EmbryoScope – An Incubator with Eyes
The EmbryoScope (Unisense ® Fertilitech, Rockland, Va.) is a new FDA –cleared incubator with a built-in camera that allows continual observation of embryos using time-lapse imaging. This special incubator and the software to simultaneously analyze and contrast developmental benchmarks for up to 72 embryos at a time (six patients with 12 embryos per dish) is a powerful new tool for the IVF laboratory. This instrument will also contribute to our understanding of early events in preimplantation embryo development and identification of new grading criteria that may be more predictive of implantation potential. The EmbryoScope also provides a safe, controlled environment for human embryo cultivation without disturbance.
Promising Early Results
We initiated a study in April 2012 to measure the effectiveness of the EmbryoScope in the clinical IVF laboratory. The study had three primary objectives: (1) to collect data on embryo development using continuous embryo monitoring, (2) to determine if kinetic data in conjunction with conventional grading criteria could be used to identify high-quality embryos, and (3) to determine if there are specific events or cleavage patterns that are more often associated with embryos leading to pregnancy or in vitro blastocyst formation.
Patients under 39 years of age with 10 or more mature oocytes and/or at least eight embryos were offered the opportunity to participate in this study. A total of 81 patients were enrolled. Embryo selection for transfer was based on conventional criteria.
Culture in the EmbryoScope yielded a wealth of information on normal growth patterns and cleavage anomalies, as well as high pregnancy outcomes. The results showed that the clinical pregnancy rate for patients having a Day 5 transfer was 72 percent (41/57) vs. 65 percent (13/20) for those having a Day 3 transfer.
Morphokinetic data indicated significant differences in timing of specific cellular events in embryos leading to formation of high-quality blastocysts and ultimately pregnancy. The laboratory is now using some of these morphokinetic criteria to aid in embryo selection for transfer with the hope of further increasing pregnancy rates and ultimately reducing the number of embryos being transferred.
For more information, contact Dr. Desai at 216.839.2907 or email@example.com.
Patient Receives Special Delivery from Cleveland Clinic
Pregnancy can be both a wonderful and challenging time for an expectant mother. But for some patients, the normal physiologic changes can become life-threatening, and underlying the excitement is constant fear.
That is exactly the way one Cleveland Clinic patient would explain her experience. Twenty-eight-year-old Tabitha McClendon was born with congenital bicuspid aortic valve stenosis. Although she was aware of her condition from an early age, she says she never experienced any symptoms, and it never really occurred to her that her “heart murmur” would become a problem during pregnancy.
After an echocardiogram indicated she had aortic stenosis, McClendon was referred to Cleveland Clinic’s Richard Krasuski, MD, Director of Adult Congenital Heart Disease Services, and Amy Merlino, MD, who specializes in high-risk maternal-fetal medicine. Along with the potential risks, the patient and her medical team discussed whether McClendon wanted to terminate the pregnancy, repair her heart and try again for a family from a healthier place.
“I was pretty scared. I was of course concerned for myself, but I was more concerned for my baby at that point,” she says. “I was already 16 weeks pregnant; I had already fallen in love.
”Hoping for the best but preparing for the worst, McClendon began to meet regularly with the specialists who would become her caregivers, confidants and supporters over the next six months.
A New Class of Patients
About 1 in 125 babies born in the United States comes into the world with congenital heart disease, says Dr. Krasuski. It’s the most common congenital defect.
“As recently as 30 years ago, most children with congenital heart disease did not survive into adulthood. If they did, they certainly weren’t healthy enough to bear children. However, as medical technology and strategies for managing these patients have advanced, we’re seeing more women with this disease who want to become pregnant, and the complexity of what we’re seeing is increasing,” he says.
“Probably at least a third of our patients in the Special Delivery Unit are there because the mom has congenital heart disease and they need the combined services we offer,” says Dr. Merlino. She says that is one of the primary reasons the Special Delivery Unit was created. It’s a collaboration that brings together a multidisciplinary team of maternal-fetal medicine specialists, neonatologists, geneticists and pediatric surgery specialists, as well as other specialists as required by the mother’s or baby’s condition.
And the collaboration between obstetrics and the cardiologists who have brought these patients to childbearing age, and who understand how their hearts react to the physiologic and physical changes in pregnancy, is fundamental to their care.
McClendon was monitored closely by her medical team. Unfortunately, her heart disease did progress over the course of her pregnancy. By her third trimester, she says normal daily activities became more challenging. She became easily winded and experienced some chest pain and tightening and light-headedness. An echocardiogram showed that her valve narrowing progressed during the course of her pregnancy, and her heart muscle was beginning to show the effects. McClendon would require a valve replacement, but with careful observation, the team was confident that the procedure could wait until after the birth of the baby.
McClendon was scheduled to deliver via a cesarean section because of the impact natural labor has on blood flow and the heart. She was able to carry to term, and under carefully planned and monitored general anesthesia, McClendon and her husband welcomed a healthy girl into the world on May 2, 2012.
Baby Olivia was monitored in the Special Delivery Unit while McClendon was monitored in the Cardiac Intensive Care Unit.
“The hardest part of the whole thing was not being able to hear my baby’s first cries,” McClendon says.
Five months after having her baby, McClendon was back at Cleveland Clinic receiving a tissue valve replacement via open heart surgery, with the hope that she may eventually be able to have another child. She’s now on the road to recovery.
“I’m feeling stronger every day,” she says. “I can finally change a diaper.”
The Road Ahead
According to Drs. Krasuski and Merlino, the departments are working to formalize their collaborative approach by instituting a cardio-obstetrics clinic specifically for patients like McClendon. The goal would be to arrange for the doctors to be available jointly once a month to streamline appointments for their patients.
“In the past I think people were scared away from this,” Dr. Krasuski says. “A lot of doctors told the female patient with heart disease who wanted to have a child that it was just too high risk, but the reality is that there’s a growing body of literature demonstrating that this can be done safely under the right circumstances.”
For more information about the Special Delivery Unit, contact Dr. Merlino at 440.366.9444.
Cleveland Clinic Performs One of the First Cases of Robotic Total Pelvic Exenteration
Robotic surgery represents a milestone in the management of gynecologic cancers. Cleveland Clinic has taken this milestone one step further with the successful performance of a robotic total intracorporeal pelvic exenteration in a patient with recurrent uterine cancer. It is one of the first documented cases of robotic-assisted total pelvic exenteration in the world. The surgery was conducted by Mehdi Kebria, MD, an associate staff member in the Department of Obstetrics and Gynecology.
Pelvic exenteration is a major operation during which the entire pelvic contents — the bladder, uterus, vagina and rectum — are removed and a conduit is reconstructed using a portion of small or large bowel to replace the bladder. This procedure is employed with the goal of curing women with central pelvic cancer recurrence or a gynecologic malignancy that remains after failure of initial definitive therapy.
Case: Recurrent Endometrial Cancer
An 80-year-old woman presented with a central recurrence of an endometrial cancer that had been surgically resected and then treated with radiation. The patient underwent robotic total intracorporeal pelvic exenteration with the creation of an ileal conduit and end colostomy. The pelvic exenteration was performed using the da Vinci® Surgical System.
An advantage of the robotic platform is that it allows the surgeon to precisely dissect the tissues down to the pelvic floor, often with minimal blood loss. Because the location of the cancer recurrence involved the bladder, and since the field was previously heavily radiated, the entire bladder had to be removed. The patient’s bladder, rectum and vagina were removed completely as one en bloc specimen through the vaginal orifice.
A portion of the distal ileum was used to create an ileal conduit, and the ureters were reimplanted to the ileal conduit. The final step in the procedure was formation of an end colostomy.
The surgery lasted about seven hours. “A pelvic exenteration using an open procedure in an 80-year-old patient would have been very risky considering her age and the potential complications of surgery,” says Dr. Kebria. “The published rate of major complications is as high as 25 percent, and there is a 5 percent risk of mortality from this surgery. With a laparotomy, the incision is large, the risk of complications is higher and the recovery would be protracted because of her age.”
Pelvic Exenteration Offers Advantages
Patients with recurrent gynecologic malignancies after primary treatment with surgery and radiation or radiation alone have a poor response to chemotherapy. Limited resection is difficult when high doses of radiation have been used for treatment of the original malignancy.
Evolving operative techniques and better patient selection have resulted in improved clinical outcomes with total pelvic exenteration, but morbidity, mortality and recovery time are still significant. Using a minimally invasive approach with robotically controlled instrumentation holds the potential for minimizing blood loss, reducing morbidity and hastening recovery.
The robotic platform offers superior visualization of the surgical site and improved precision with the use of much smaller articulating instruments, and it enhances dissection of previously radiated tissue, which is often fibrotic.
In addition, the procedure can resolve other related pelvic issues. For example, in the case presented above, the patient also had significant radiation proctitis with daily rectal bleeding, both of which were cured through this procedure.
Speedy Recovery, Minimal Blood Loss
The minimally invasive approach to total pelvic exenteration speeds up the recovery phase and reduces the risk of infection, says Dr. Kebria. “The woman was ambulatory in two days, and she was started on a regular diet and was able to tolerate her diet by postoperative day two. I saw her at her postoperative visit at four weeks after surgery, and she was doing quite well,” he says.
Blood loss was also much less than with an open procedure. In this patient, blood loss was less than 100 mL, compared with the liters of blood loss that is typical with open procedures.
“I would certainly use the robotic approach for my next exenteration; there are clearly many benefits to the patients without any compromises,” he says. “Robotic surgery allows me to perform very complex operations in a minimally invasive fashion. The instruments are tiny and can fit and function in any small cavity, which is an important advantage in any pelvic surgery.”
Cleveland Clinic also recently became the first center to perform robotic singlesite hysterectomy through a 2.5-cm incision at the umbilicus. So far, more than 25 such procedures have been performed at Cleveland Clinic.
Dr. Kebria can be reached at 216.445.7069 or firstname.lastname@example.org.
Total Laparoscopic Hysterectomy: Comparing Conventional with Robotically Assisted Procedures
According to new research led by Marie Fidela Paraiso, MD, robotically assisted total laparoscopic hysterectomies may not be the clear choice for minimally invasive benign gynecological indications.
In concert with other findings in this area, Cleveland Clinic's study found that although laparoscopic and robot-assisted hysterectomies are both safe approaches to a procedure that 1 in 9 women in the United States undergo, robotic-assisted hysterectomy requires longer operative time.
The Cleveland Clinic researchers — Beri Ridgeway, MD; Amy Park, MD; J. Eric Jelovsek, MD, MMEd; Matthew D. Barber, MD, MS; and Tommaso Falcone, MD, — along with Brigham and Women's Hospital's Jon Einarsson, MD, conducted a blinded, prospective, randomized trial at the two institutions. Sixty-two patients with similar demographics agreed to participate in the study, and were randomly assigned to a laparoscopic or a robotic group.
Fifty-three of the patients underwent their assigned procedure: 27 women were in the laparoscopic group and 26 had the robotic procedure. One patient in the laparoscopic group had incomplete data and was excluded from the final analysis. Ninety-two percent of the cases were completed per the randomization assignment.
The study was conducted between June 2007 and March 2011.
Five enrolling surgeons who had each performed between 75 and 400 total laparoscopic procedures participated in the study. All five surgeons had also completed robotic training that was provided by Intuitive Surgical Inc., the manufacturer of the da Vinci® system, and had performed at least 20 cases with that system before enrolling patients in this study.
Patients were carefully tracked throughout the procedure and for more than six months afterward. Operating room personnel recorded total operating room time and total case time and noted any intraoperative complications. Patients completed journals, and pain medications were tracked, both in the hospital and after discharge. Research nurses contacted patients by phone at six months post-procedure for additional follow-up.
Shorter Surgical Time for Traditional Laparoscopy
The major finding of the study was that the total operating time was significantly shorter in the laparoscopic group than in the robotic surgery cohort. There were no differences between the groups in estimated blood loss, hematocrit change or uterine weight.
“There are very few randomized trials in benign gynecology that have compared clinical outcomes between these two types of surgeries,” says Dr. Paraiso.
Other studies have suggested that although the robotic procedure times were longer, quality of life immediately after surgery was better than for those who underwent the laparoscopic procedure, but that advantage did not continue over time (Sarlos et al.). This research indicates that in experienced laparoscopic centers, laparoscopic hysterectomy should be the access of choice for benign disease.
As Wright et al. recently published in the New England Journal of Medicine, the frequency of robotic hysterectomy has increased exponentially since the introduction of the da Vinci system in 2007. Laparoscopic hysterectomy for benign reasons offers almost identical benefits at a lower cost per procedure.
Dr. Paraiso agrees with that assertion. Few randomized trials in benign gynecology have been conducted that examine the true costs and benefits of each approach weighed against the other.
Additional arguments hold that robotic-assisted surgery shortens the learning curve for those who practice it, although this effect does not remain for experienced practitioners. Unless there are specific situations where robotic-assisted surgery is most appropriate, as in morbid obesity or if the patient expresses a specific preference, the newest technology may not always be the right answer.
An Eye on the Future
Dr. Paraiso says that further studies are needed that take into account a complete calculation of costs involved in the two procedures inclusive of time lost to society while patients recover. Additional investigations should also consider surgeon ergonomics, overall surgeon tenure, and ways to further improve robotic efficiency and safety and diminish costs. “Increased hospital costs,” she says, “should be balanced by a shorter hospital stay or by an earlier return to work or to productive society.”
Dr. Paraiso can be reached at 216.444.3428 or email@example.com. The study is available online and in the May 2013 issue of American Journal of Obstetrics & Gynecology.