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.

Prevalence and outcomes of anatomic lung resection for hemoptysis: an analysis of the nationwide inpatient sample database.

Journal The Annals of Thoracic Surgery
Authors Paul, Subroto; Andrews, Weston; Nasar, Abu; Port, Jeffrey L.; Lee, Paul C.; Stiles, Brendon M.; Sedrakyan, Art; Altorki, Nasser K.
Year Published 2014
Link to Publication

Abstract

BACKGROUND:

Pulmonary resection for hemoptysis carries an increased risk of death. However, the extent and predictors of risk are poorly characterized and based on institutional case series. We analyzed the Nationwide Inpatient Sample (NIS) database to determine the outcome of patients undergoing anatomic pulmonary resection who were admitted with a diagnosis of hemoptysis.

METHODS:

We queried the NIS for hospitalized patients who were admitted emergently or urgently with hemoptysis as the principal diagnosis or as a secondary or tertiary diagnosis. We examined the outcomes of those patients who underwent lobectomy or pneumonectomy. Logistic regression analysis was used to determine clinical characteristics that were independent risk factors for death.

RESULTS:

During a 10-year period, 457,523 admissions for the diagnosis of hemoptysis were identified, and 2,671 patients (0.58%) underwent resection, comprising lobectomy in 2,205 and pneumonectomy in 466. The median age was 58 years, and 1,682 (63%) were men. Compared with those patients resected without a diagnosis of hemoptysis, those admitted with a hemoptysis diagnosis had a higher mortality rate after pneumonectomy (15.2% vs 9.7 %, p = 0.320) and lobectomy (6.6% vs 3.0%, p = 0.006). Advanced age, associated bacterial infections, the presence of a lung abscess/necrosis, extent of resection, and associated diagnoses of sarcoidosis and renal failure were multivariable independent risk factors for death.

CONCLUSIONS:

Analysis of this national database with its inherent limitations demonstrates that major lung resection can be performed in the setting of hemoptysis with reasonable mortality rate. Advanced age, extent of resection, systemic illnesses such as renal failure, sarcoidosis, and the presence of a lung abscess are independent predictors of death.

Sex and risk of hip implant failure: assessing total hip arthroplasty outcomes in the United States.

Journal JAMA Internal Medicine
Authors Inacio, Maria CS; Ake, Christopher F.; Paxton, Elizabeth W.; Khatod, Monti; Wang, Cunlin; Gross, Thomas P.; Kaczmarek, Ronald G.; Marinac-Dabic, Danica; Sedrakyan, Art
Year Published 2014
Link to Publication

IMPORTANCE:

The role of sex in relationship to implant failure after total hip arthroplasty (THA) is important for patient management and device innovation.

OBJECTIVE:

To evaluate the association of sex with short-term risk of THA revision after adjusting for patient, implant, surgery, surgeon, and hospital confounders.

DESIGN AND SETTING:

A prospective cohort of patients enrolled in a total joint replacement registry from April 1, 2001, through December 31, 2010.

PARTICIPANTS:

Patients undergoing primary, elective, unilateral THA.

MAIN OUTCOME MEASURES:

Failure of THA, defined as revision procedure for (1) any reason, (2) septic reason, or (3) aseptic reason after the index procedure.

RESULTS:

A total of 35,140 THAs with 3.0 years of median follow-up were identified. Women constituted 57.5% of the study sample, and the mean (SD) patient age was 65.7 (11.6) years. A higher proportion of women received 28-mm femoral heads (28.2% vs 13.1%) and had metal on highly cross-linked polyethylene-bearing surfaces (60.6% vs 53.7%) than men. Men had a higher proportion of 36-mm or larger heads (55.4% vs 32.8%) and metal on metal-bearing surfaces (19.4% vs 9.6%). At 5-year follow-up, implant survival was 97.4% (95% CI, 97.2%-97.6%). Device survival for men (97.7%; 95% CI, 97.4%-98.0%) vs women (97.1%; 95% CI, 96.8%-97.4%) was significantly different (P = .01). After adjustments, the hazards ratios for women were 1.29 (95% CI, 1.11-1.51) for all-cause revision, 1.32 (95% CI, 1.10-1.58) for aseptic revision, and 1.17 (95% CI, 0.81-1.68) for septic revision.

CONCLUSIONS:

After considering patient-, surgery-, surgeon-, volume-, and implant-specific risk factors, women had a 29% higher risk of implant failure than men after THA in this community-based sample.

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Automated surveillance to detect post-procedure safety signals of approved cardiovascular devices

Journal JAMA (Journal of the American Medical Association)
Authors Resnic FS; Gross TP; Marinac-Dabic D; Loyo-Berríos N; Donnelly S; Normand SL; Matheny ME
Year Published 2010
Link to Publication – (PDF)

Context

Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.

Objective

To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices.

PATIENTS:

Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts.

MAIN OUTCOME MEASURE:

Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered.

RESULTS:

We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of postprocedural myocardial infarction (2.87% vs 2.25%; absolute risk increase, 0.62% [95% CI, 0.25%-0.99%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24% vs 3.50%; absolute increase, 0.74% [95% CI, 0.29%-1.19%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09% vs 0.72%; absolute increased risk, 0.37% [95% CI, 0.03%-0.71%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device.

CONCLUSION:

Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices.