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.

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.

Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing

Journal  BMC Medical Informatics and Decision Making
Authors Matheny ME; Normand SL; Gross TP; Marinac-Dabic D; Loyo-Berríos N,; Vidi VD; Donnelly S; Resnic FS.
Year Published 2011
Link to Publication

 

Background

Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery.

Methods

A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year.

Results

We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100% (5/5) and specificity of 98.8% (79/80).

Conclusions

The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions.

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.