Regulatory warnings and use of surgical mesh in pelvic organ prolapse

Journal JAMA Internal Medicine
Authors Sedrakyan A, Chughtai B, & Mao J.
Year Published 2015
Link to article

In 2008, the FDA released a warning about the use of transvaginal mesh in pelvic organ prolapse repair procedures, advising all surgeons to seek special training in mesh implantation before using it in their own practice. A second warning was released in 2011 describing complications following mesh implantation as “not rare” and suggesting non-mesh pelvic organ prolapse repairs. This study used the New York State SPARCS database to look at trends in transvaginal mesh use since the second FDA warning in 2011. Use of mesh in pelvic organ prolapse repair decreased from a 30% rate of use in 2011 to a 23% rate of use in 2013, reflecting a change in practice in response to the second FDA warning, and a total of 22 physicians ceased mesh use altogether.

Population-Based Estimates of the Prevalence of Uterine Sarcoma Among Patients With Leiomyomata Undergoing Surgical Treatment

Journal JAMA Surgery
Authors Mao, Jialin ; Pfeifer,Samantha; Zheng, Xi Emily; Schlegel, Peter; Sedrakyan, Art
Year Published 2015
Link to publication

Abstract

Uterine leiomyomata are one of the most common gynecologic problems among women in the United States, with an annual diagnosis range from 2.0 to 12.8 per 1000 reproductive-age women.1 Intervention is a standard management for symptomatic patients, and various procedures include open and laparoscopic hysterectomy, myolysis, uterine artery embolization, and magnetic resonance–guided focused ultrasonographic surgery.

The practice of electric morcellation has been used by gynecologic surgeons during laparoscopic and robotic-assisted hysterectomies and myomectomies as a less invasive alternative to open surgery. In April 2014, the US Food and Drug Administration (FDA) stated that they discouraged the use of this technique over concern that morcellation may spread unsuspected sarcoma tissue. Based on the literature, the FDA reported that 1 in 352 women have unsuspected uterine sarcoma while undergoing surgery for presumed benign leiomyoma. A recent study using an all-payer database found that 1 in 368 women who underwent morcellation had uterine cancer. However, the estimates in this study were limited by the selective participation of hospitals and by the lack of pathologic confirmation. The literature estimates used by the FDA are prone to referral and reporting bias. We sought to determine the population-based estimates of the prevalence of uterine sarcoma, as well as the risks of major complications following open surgery.

Comparative Effectiveness of Robotic-Assisted vs Thoracoscopic Lobectomy.

Journal Journal of Endourology
Authors
Subroto Paul, MD, FCCP; Jessica Jalbert, PhD, MD; Abby J. Isaacs, MS; Nasser K. Altorki, MD, FCCP; O. Wayne Isom, MD; Art Sedrakyan, MD, PhD
Year Published 2014
Link to Publication

BACKGROUND:  Robotic-assisted lobectomy is being offered increasingly to patients. However, little is known about its safety, complication profile, or effectiveness.

METHODS:  Patients undergoing lobectomy in in the United States from 2008 to 2011 were identified in the Nationwide Inpatient Sample. In-hospital mortality, complications, length of stay, and cost for patients undergoing robotic-assisted lobectomy were compared with those for patients undergoing thoracoscopic lobectomy.

RESULTS:  We identified 2,498 robotic-assisted and 37,595 thoracoscopic lobectomies performed from 2008 to 2011. The unadjusted rate for any complication was higher for those undergoing robotic-assisted lobectomy than for those undergoing thoracoscopic lobectomy (50.1% vs 45.2%, P < .05). Specific complications that were higher included cardiovascular complications (23.3% vs 20.0%, P < .05) and iatrogenic bleeding complications (5.0% vs 2.0%, P < .05). The higher risk of iatrogenic bleeding complications persisted in multivariable analyses (adjusted OR, 2.64; 95% CI, 1.58-4.43). Robotic-assisted lobectomy costs significantly more than thoracoscopic lobectomy ($22,582 vs $17,874, P < .05).

CONCLUSIONS:  In this early experience with robotic surgery, robotic-assisted lobectomy was associated with a higher rate of intraoperative injury and bleeding than was thoracoscopic lobectomy, at a significantly higher cost.

Long term survival with thoracoscopic versus open lobectomy: propensity matched comparative analysis using SEER-Medicare database

Journal BMJ
Authors
Subroto Paul,  Abby J Isaacs,  Tom Treasure, Nasser K Altorki, Art Sedrakyan
Year Published 2014
Link to Publication

Abstract

OBJECTIVE:

To compare long term survival after minimally invasive lobectomy and thoracotomy lobectomy.

DESIGN:

Propensity matched analysis.

SETTING:

Surveillance, Epidemiology and End Results (SEER)-Medicare database.

PARTICIPANTS:

All patients with lung cancer from 2007 to 2009 undergoing lobectomy.

MAIN OUTCOME MEASURE:

Influence of less invasive thoracoscopic surgery on overall survival, disease-free survival, and cancer specific survival.

RESULTS:

From 2007 to 2009, 6008 patients undergoing lobectomy were identified (n=4715 (78%) thoracotomy). The median age of the entire cohort was 74 (interquartile range 70-78) years. The median length of follow-up for entire group was 40 months. In a matched analysis of 1195 patients in each treatment category, no statistical differences in three year overall survival, disease-free survival, or cancer specific survival were found between the groups (overall survival: 70.6% v 68.1%, P=0.55; disease-free survival: 86.2% v 85.4%, P=0.46; cancer specific survival: 92% v 89.5%, P=0.05).

CONCLUSION:

This propensity matched analysis showed that patients undergoing thoracoscopic lobectomy had similar overall, cancer specific, and disease-free survival compared with patients undergoing thoracotomy lobectomy. Thoracoscopic techniques do not seem to compromise these measures of outcome after lobectomy.

Precarious innovation of anti-infective coated devices

Journal The Lancet
Authors Sedrakyan, Art
Year Published 2014
Link to Publication

Surgeons focus on technical performance, teamwork, and communication to achieve the highest degree of safety. They will use new measures or devices that can potentially improve the safety and outcome of surgery, and often rely on sparse data from manufacturers to argue their case for the use of a new device in a hospital where costs might be of increasing concern. Heated debates are expected since recent studies have shown that most new devices do not have clinical or long-term safety data.1–3 One can no longer assume that new devices and equipment are superior products that have been carefully studied and selected. An increasing number of surgeons are becoming aware that incremental device innovations are based on scarce or no data and should not be adopted rapidly just because they are new