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.

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.

Comparative safety of endovascular and open surgical repair of abdominal aortic aneurysms in low-risk male patients.

Journal Journal of Vascular Surgery
Authors Siracuse, Jeffrey J., Heather L. Gill, Ashley R. Graham, Darren B. Schneider, Peter H. Connolly, Art Sedrakyan, and Andrew J. Meltzer
Year Published 2014
Link to Publication

Objective

The prevalence of significant comorbidities among patients with abdominal aortic aneurysms (AAAs) has contributed to widespread enthusiasm for endovascular AAA repair (EVAR). However, the advantages of EVAR in patients at low risk for open surgical repair (OSR) remain unclear. The objective of this study was to assess perioperative outcomes of EVAR and OSR in low-risk patients.

Methods

Patients undergoing EVAR and OSR for infrarenal AAAs were identified in the 2007 to 2010 National Surgical Quality Improvement Program data sets. AAA-specific risk stratification, by the Medicare aneurysm scoring system, was used to create matched low-risk (score <3) cohorts. Perioperative morbidity and mortality were assessed by crude comparisons of matched groups and regression models.

Results

Of 11,753 elective patients undergoing EVAR, 4339 (37%) were deemed low risk (score <3). A matched cohort of 1576 low-risk patients was developed from a total of 3804 (41%) undergoing OSR. The low-risk cohorts included only male patients and those <75 years of age, without significant cardiac, pulmonary, or vascular comorbidities. Mean age in both low-risk groups was 67 ± 6 years (P = NS). EVAR patients had higher rates of obesity (40% vs 33%; P < .001), diabetes (16% vs 13%; P = .005), history of cardiac intervention (24% vs 19%; P < .001), cardiac surgery (23% vs 20%; P = .02), steroid use (4% vs 2%; P = .002), and bleeding disorders/anticoagulation (9% vs 6%; P = .001) compared with OSR patients. There were no other differences between the matched cohorts. EVAR was associated with reduced 30-day mortality (0.5% vs 1.5%; P < .01) and reduced rates of major complications, including the following: sepsis (0.7% vs 3.2%; P < .01), unplanned intubation (1.0 vs 5.4%; P < .001), pneumonia (0.8% vs 6.1%; P < .001), acute renal failure (0.4% vs 2.7%; P < .001), and early reoperation (3.7% vs 6.0%; P < .001). Furthermore, EVAR was associated with reduced perioperative morbidity across organ systems, including venous thromboembolism (0.1% vs 0.3%; P = .001), transfusion requirement of more than 4 units (2.0% vs 13.0%; P < .001), cardiac arrest (0.2 vs 0.8; P = .001), neurologic deficits (0.2% vs 0.5%; P = .032), and urinary tract infections (1.2% vs 2%; P = .02).

Conclusions

Our results demonstrate that even among those male patients at low risk for OSR on the basis of comorbidities, EVAR is associated with reduced perioperative mortality and major complications. Whereas clinical decisions must account for safety and long-term effectiveness, the short-term benefit of EVAR is evident even among male patients at the lowest risk for OSR.

Multiple Outcomes and Multiple Sources of Evidence

Journal  Circulation: Cardiovascular Quality Outcomes
Authors Normand, Sharon-Lise T.
Year Published 2011
Link to Publication

 

Background

This issue contains 2 articles in our planned Statistical Primer on Methods or Interpretation Series. The goals of our series are to (1) familiarize cardiovascular outcomes researchers with design and analytic problems encountered in outcomes research, (2) point to potential solutions, and (3) introduce modern analytic approaches. The series’ inaugural article discussed approaches for handling missing data—approaches that have existed for several decades but have not been fully embraced by outcomes researchers. The second article focused on the “landmark analysis, an analytic approach in which patients having treatment-censoring events before a “landmark” time are excluded from analysis. In this issue, Teixeira-Pinto and Mauri address the problem of multiple outcomes, and Kwok and Lewis discuss the use of Bayesian hierarchical models.