UPDATE ON TECHNOLOGY

The development of new medical technology continues at a brisk pace—and ObGyns and our patients often are the beneficiaries. Notable technological breakthroughs of the past include hormonal contraception, in vitro fertilization, the application of minimally invasive surgical devices and techniques to gynecologic procedures, and many other innovations.

The leaders in our specialty are innovators themselves, ever vigilant for developments that can help improve health and quality of life for our patients. Regrettably, however, many technologies spread widely before they are fully validated by published studies—or continue to be used long after a superior or less invasive intervention has come along. And many claims about new technology are based on marketing information rather than reliable data.

Another common occurrence in regard to published data: Findings in one well-defined sector of the population are extrapolated to all patients. Even clinicians who are careful about adopting new technology can overlook the fact that it was tested, and proven, in a subset of patients that may not be comparable to all their patients.

In this article, I offer two case studies that illustrate some of the challenges we face when it comes to applying scientific findings to our practice and assessing medical technologies. In both settings, the health of the patient should be our primary focus.

When it comes to technology, patient selection is key

CASE 1: Anovulatory patient requests endometrial ablation

A 34-year-old woman (G2P2) who is moderately obese (body mass index of 32 kg/m²) visits your office to request endometrial ablation to manage her irregular and heavy menses. She reached menarche at age 10, and her periods have been somewhat irregular ever since. She required ovarian stimulation with clomiphene citrate to achieve each of her pregnancies, and both children were delivered by cesarean section. She currently uses condoms for contraception but does not have a steady partner, and she desires no additional pregnancies.

The patient reports that her menses occur every 2 to 6 weeks, with flow lasting from 2 to 8 days. She is housebound for 2 days each cycle because of heavy flow and cramping. She takes no medications and has no other medical conditions.

On exam, she is centrally obese with a tender uterus that is 10- to 12-weeks’ size; no adnexal masses are palpable. All other findings are normal. A recent test for diabetes was negative, but her serum cholesterol and triglyceride levels are borderline elevated.

What intervention would you recommend to address the heavy bleeding?

With the advent of second-generation endometrial ablation devices in the late 1990s, women with refractory menorrhagia had a safe, reliable, minimally invasive alternative to hysterectomy that made it possible to treat the endometrial cavity without the technical challenges of resectoscopic surgery. More than 10 million women report menorrhagia each year in the United States—so it is no small problem.^1,2 Global endometrial ablation devices make management possible in an office setting, and recovery is significantly shorter than with hysterectomy. The three most prominent nonhysteroscopic ablation devices are (FIGURE):

• NovaSure (Hologic) uses bipolar radiofrequency energy to ablate tissue. Its probe contains stretchable gold-plated fabric that conforms to the endometrial surface.

• Gynecare Thermachoice (Ethicon) consists of an intrauterine balloon that is filled with hot liquid (temperatures of roughly 87°C) to ablate the endometrium

• Her Option (CooperSurgical) is a cryoablation system that consists of an intrauterine probe that forms an ice ball (temperatures of roughly –90°C) that destroys the uterine lining. Several applications are required to treat the majority of the cavity.

Use of these devices is widespread, although a nonsurgical alternative—the levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena)—was approved by the US Food and Drug Administration (FDA) in 2009 for the treatment of heavy menstrual bleeding.

Not only is the efficacy of the LNG-IUS for controlling menorrhagia equal to endometrial ablation, but it provides the additional benefits of reliable contraception and management of dysmenorrhea.

6 questions to ask before applying a technology

1. In which population was it studied?

One of the most important issues to consider when you are evaluating technology is the population in which it was studied. In other words, to whom do the findings apply?

Most endometrial ablation technologies were tested in women who had a uterus of normal size (mean, 8 cm) with no structural abnormalities (ie, no polyps or fibroids) and regular but very heavy periods. The findings from these studies now have been extrapolated in many cases to women who have hormonally induced abnormal bleeding, whose periods are irregular. That extrapolation may not be appropriate.

2. What is the diagnosis?