From the Eastern Vascular Society
Fenestrated endovascular repair of abdominal aortic aneurysms is associated with increased morbidity but comparable mortality with infrarenal endovascular aneurysm repair Natalia O. Glebova, MD, PhD,a,b Shalini Selvarajah, MD, MPH,c Kristine C. Orion, MD,a James H. Black III, MD,a Mahmoud B. Malas, MD, MHS,c,d Bruce A. Perler, MD, MBA,a and Christopher J. Abularrage, MD,a,c Baltimore, Md; and Aurora, Colo Objective: A recent prospective study found that fenestrated endovascular abdominal aortic aneurysm (AAA) repair (FEVAR) was safe and effective in appropriately selected patients at experienced centers. As this new technology is disseminated to the community, it will be important to understand how this technology compares with standard endovascular AAA repair (EVAR). The goal of this study was to compare the outcomes of FEVAR vs EVAR of AAAs. Methods: The American College of Surgeons-National Surgical Quality Improvement Program database from 2005 to 2012 was queried for AAAs (International Classification of Diseases, Ninth Revision code 441.4). Patients were stratified according to procedure (FEVAR vs EVAR). A bivariate analysis was done to assess preoperative and intraoperative risk factors for postoperative outcomes. Thirty-day postoperative mortality and complication rates were described for each procedure type. Multivariable logistic regression was performed to assess the association between the type of procedure and the risk of postoperative complications. Results: A total of 458 patients underwent FEVAR and 19,060 patients underwent EVAR for AAA. Patients undergoing FEVAR were older (P [ .02) and less likely to have a bleeding disorder (P [ .046). Otherwise, the incidence of comorbidities in both groups was similar. FEVAR was associated with increased median operative time (156 vs 137 minutes; P < .001), and average postoperative length of stay (3.3 vs 2.8 days; P [ .03). There was a statistically significant increase in overall complications (23.6% vs 14.3%; P < .001) and postoperative transfusions (15.3% vs 6.1%, P < .001) and trends toward increased cardiac complications (2.2% vs 1.3%; P [ .09) and the need for dialysis (1.5% vs 0.8%; P [ .08) in the FEVAR group. Mortality (2.4% vs 1.5%; P [ .12) was not statistically different. On multivariable analysis, FEVAR remained independently associated with the need for postoperative transfusions when operative time was 75th percentile for respective procedures (adjusted odds ratio, 5.33; 95% confidence interval, 3.55-8.00; P < .001). Conclusions: Patients undergoing FEVAR are more likely than patients undergoing EVAR to receive blood transfusions postoperatively and are more likely to sustain postoperative complications. Although mortality was similar, trends toward increased cardiac and renal complications may suggest the need for judicious dissemination of this new technology. Future research with larger number of FEVAR cases will be necessary to determine if these associations remain. (J Vasc Surg 2015;61:604-10.)
From the Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins Hospital, Baltimorea; the Section of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Colorado Denver, Aurorab; the Center for Surgical Trials and Outcomes Research, Department of Surgery, The Johns Hopkins Hospital, Baltimorec; and the Division of Vascular Surgery, Department of Surgery, Johns Hopkins Bayview Medical Center, Baltimore.d Author conflict of interest: J.H.B. is a consultant for Cook Medical. Presented at the Twenty-eighth Annual Meeting of the Eastern Vascular Society, Boston, Mass, September 11-14, 2014. Reprint requests: Christopher J. Abularrage, MD, Division of Vascular Surgery and Endovascular Therapy, The Johns Hopkins Hospital, Halsted 671, 600 N Wolfe St, Baltimore, MD 21287 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2015 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2014.10.025
604
Open repair of juxtarenal abdominal aortic aneurysms (JAAAs) is known to be associated with increased risks compared with open repair of infrarenal AAA (IAAA). Many studies comparing open JAAA vs IAAA repair have shown that JAAA repair is associated with higher perioperative mortality.1-3 Furthermore, the rates of postoperative complications, including cardiac events, pulmonary morbidity, and renal insufficiency, are also higher in JAAA patients.1-4 Notably, renal insufficiency has been found to be transient in some studies2 and long-term in others.3 A smaller number of other studies have shown similar perioperative mortality4-8 and morbidity between JAAA and IAAA repair patients.5,6 Although endovascular AAA repair (EVAR) has become the predominant approach to the treatment of IAAA, there were initial concerns regarding the safety and outcomes of EVAR.9 As it became clear that EVAR was safe and effective
JOURNAL OF VASCULAR SURGERY Volume 61, Number 3
in clinical trials, the same could not be assumed once this technology was distributed to the general population. However, multiple randomized studies outside of the clinical trial setting found an early advantage to EVAR over open IAAA repair, with similar outcomes by 2 years.10 As EVAR with fenestrated endografts (FEVAR) has emerged as a new treatment paradigm for the repair of JAAA, investigations into the relative risks and benefits of FEVAR vs open JAAA repair have revealed comparable perioperative mortality (with some studies reporting higher mortality with open repair) and greater rates of postoperative complications, such as renal impairment, new onset of hemodialysis, and cardiac complications with open JAAA repair.11-13 The inherent early benefit of FEVAR over open JAAA repair is not surprising and is similar to the early benefit seen in EVAR over open IAAA repair. Thus, there is great enthusiasm that FEVAR will be just as beneficial as EVAR for IAAA when distributed to the community. However, FEVAR is a complex and more technically demanding operation than EVAR, and thus, whether inferior outcomes can be expected with FEVAR compared with EVAR upon dispersion outside of clinical trial centers is unclear. The aim of this study was to investigate the differences in perioperative outcomes between FEVAR and EVAR to determine whether the more complex FEVAR procedure is associated with increased risks of inferior perioperative outcomes. METHODS The Johns Hopkins Institutional Review Board approved this study. Data source and case selection criteria. The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database from 2005 to 2012 was used. Cases before 2011, when the Cook Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) was introduced, were included to include other devices used as part of an investigational device exemption (IDE) as well as to be able to evaluate for complications and outcomes related to learning curves. The NSQIP database contains demographic characteristics and preoperative, intraoperative, and postoperative clinical information abstracted by trained surgical case reviewers from clinical notes of systematically sampled major surgical cases from hospitals participating voluntarily. The NSQIP background, sampling methodology, and variable directory are published elsewhere.14,15 Because data in the NSQIP database are deidentified, informed consent was not obtained. For this study, we queried the NSQIP database for all patients aged $18 years who had undergone FEVAR or EVAR by using International Classification of Diseases (ICD), Ninth Revision code 441.4 (AAA without rupture) and then stratifying the results according to Current Procedural Terminology (CPT; American Medical Association, Chicago, Ill) codes 0078T for FEVAR and 34800, 34802, 34803, 34804, 34805 for EVAR. We excluded all cases with CPT codes reflecting open conversion
Glebova et al 605
(34830-34832) and retained only cases with a diagnosis of nonruptured AAA for subsequent analysis. These criteria were used to exclude zero patients in the FEVAR group and 21 patients in the EVAR group. Variables analyzed. Demographic factors, such as age, sex, and race, were collected. Age in years was analyzed as a continuous variable, with maximum age set to 90 years by NSQIP. Race and ethnicity was categorized as white, black, Hispanic, other race, and unknown or not reported. Patient weight and height were collected to calculate body mass index (BMI). Smoking status was evaluated using the NSQIP definition of active smokers that included individuals who had smoked cigarettes any time #1 year leading up to surgery. More than moderate alcohol consumption was defined as consumption of more than two drinks a day in the 2 weeks before surgery. Comorbidities assessed included hypertension, diabetes, myocardial infarction in the past 6 months, congestive heart failure, chronic obstructive pulmonary disease, stroke, with or without neurological deficit, dialysis dependence, history of bleeding disorder, need for packed red blood cell (PRBC) transfusion #72 hours of operation, and systemic inflammatory response syndrome. Also evaluated were preoperative functional status, history of a major surgical procedure #30 days before surgery, and preoperative thrombocytopenia (defined as platelet count of #150,000/mm3). Intraoperative details collected included patient’s American Society of Anesthesiologists (ASA) Physical Status Classification and surgical resident participation during surgery; performance of a brachial exposure, iliac conduit, iliac exposure, femoral exposure, or emergency operation; and total operative time in minutes. Outcome measures. NSQIP-defined postoperative outcomes that were analyzed included mortality; wound, cardiac, and pulmonary complications; the need to return to the operating room #30 days after the procedure, and length of stay (LOS) in days. NSQIP defines early postoperative blood transfusion of $4 units as “any transfusion (including autologous) of PRBC or whole blood of four or more units given from the time the patient leaves the operating room up to and including 72 hours post-operatively. This includes cell saver, and any hanging blood from the operating room that is finished outside the OR.” Statistical analysis. Bivariate analysis was performed to evaluate the distribution of demographic characteristics and preoperative risk factors. Operative details of patients undergoing EVAR were compared with those who underwent FEVAR. Counts and proportions are presented for categoric variables and were analyzed using c2 or Fisher exact (for cell counts
Fenestrated endovascular repair of abdominal aortic aneurysms is associated with increased morbidity but comparable mortality with infrarenal endovascular aneurysm repair Natalia O. Glebova, MD, PhD,a,b Shalini Selvarajah, MD, MPH,c Kristine C. Orion, MD,a James H. Black III, MD,a Mahmoud B. Malas, MD, MHS,c,d Bruce A. Perler, MD, MBA,a and Christopher J. Abularrage, MD,a,c Baltimore, Md; and Aurora, Colo Objective: A recent prospective study found that fenestrated endovascular abdominal aortic aneurysm (AAA) repair (FEVAR) was safe and effective in appropriately selected patients at experienced centers. As this new technology is disseminated to the community, it will be important to understand how this technology compares with standard endovascular AAA repair (EVAR). The goal of this study was to compare the outcomes of FEVAR vs EVAR of AAAs. Methods: The American College of Surgeons-National Surgical Quality Improvement Program database from 2005 to 2012 was queried for AAAs (International Classification of Diseases, Ninth Revision code 441.4). Patients were stratified according to procedure (FEVAR vs EVAR). A bivariate analysis was done to assess preoperative and intraoperative risk factors for postoperative outcomes. Thirty-day postoperative mortality and complication rates were described for each procedure type. Multivariable logistic regression was performed to assess the association between the type of procedure and the risk of postoperative complications. Results: A total of 458 patients underwent FEVAR and 19,060 patients underwent EVAR for AAA. Patients undergoing FEVAR were older (P [ .02) and less likely to have a bleeding disorder (P [ .046). Otherwise, the incidence of comorbidities in both groups was similar. FEVAR was associated with increased median operative time (156 vs 137 minutes; P < .001), and average postoperative length of stay (3.3 vs 2.8 days; P [ .03). There was a statistically significant increase in overall complications (23.6% vs 14.3%; P < .001) and postoperative transfusions (15.3% vs 6.1%, P < .001) and trends toward increased cardiac complications (2.2% vs 1.3%; P [ .09) and the need for dialysis (1.5% vs 0.8%; P [ .08) in the FEVAR group. Mortality (2.4% vs 1.5%; P [ .12) was not statistically different. On multivariable analysis, FEVAR remained independently associated with the need for postoperative transfusions when operative time was 75th percentile for respective procedures (adjusted odds ratio, 5.33; 95% confidence interval, 3.55-8.00; P < .001). Conclusions: Patients undergoing FEVAR are more likely than patients undergoing EVAR to receive blood transfusions postoperatively and are more likely to sustain postoperative complications. Although mortality was similar, trends toward increased cardiac and renal complications may suggest the need for judicious dissemination of this new technology. Future research with larger number of FEVAR cases will be necessary to determine if these associations remain. (J Vasc Surg 2015;61:604-10.)
From the Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins Hospital, Baltimorea; the Section of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Colorado Denver, Aurorab; the Center for Surgical Trials and Outcomes Research, Department of Surgery, The Johns Hopkins Hospital, Baltimorec; and the Division of Vascular Surgery, Department of Surgery, Johns Hopkins Bayview Medical Center, Baltimore.d Author conflict of interest: J.H.B. is a consultant for Cook Medical. Presented at the Twenty-eighth Annual Meeting of the Eastern Vascular Society, Boston, Mass, September 11-14, 2014. Reprint requests: Christopher J. Abularrage, MD, Division of Vascular Surgery and Endovascular Therapy, The Johns Hopkins Hospital, Halsted 671, 600 N Wolfe St, Baltimore, MD 21287 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2015 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2014.10.025
604
Open repair of juxtarenal abdominal aortic aneurysms (JAAAs) is known to be associated with increased risks compared with open repair of infrarenal AAA (IAAA). Many studies comparing open JAAA vs IAAA repair have shown that JAAA repair is associated with higher perioperative mortality.1-3 Furthermore, the rates of postoperative complications, including cardiac events, pulmonary morbidity, and renal insufficiency, are also higher in JAAA patients.1-4 Notably, renal insufficiency has been found to be transient in some studies2 and long-term in others.3 A smaller number of other studies have shown similar perioperative mortality4-8 and morbidity between JAAA and IAAA repair patients.5,6 Although endovascular AAA repair (EVAR) has become the predominant approach to the treatment of IAAA, there were initial concerns regarding the safety and outcomes of EVAR.9 As it became clear that EVAR was safe and effective
JOURNAL OF VASCULAR SURGERY Volume 61, Number 3
in clinical trials, the same could not be assumed once this technology was distributed to the general population. However, multiple randomized studies outside of the clinical trial setting found an early advantage to EVAR over open IAAA repair, with similar outcomes by 2 years.10 As EVAR with fenestrated endografts (FEVAR) has emerged as a new treatment paradigm for the repair of JAAA, investigations into the relative risks and benefits of FEVAR vs open JAAA repair have revealed comparable perioperative mortality (with some studies reporting higher mortality with open repair) and greater rates of postoperative complications, such as renal impairment, new onset of hemodialysis, and cardiac complications with open JAAA repair.11-13 The inherent early benefit of FEVAR over open JAAA repair is not surprising and is similar to the early benefit seen in EVAR over open IAAA repair. Thus, there is great enthusiasm that FEVAR will be just as beneficial as EVAR for IAAA when distributed to the community. However, FEVAR is a complex and more technically demanding operation than EVAR, and thus, whether inferior outcomes can be expected with FEVAR compared with EVAR upon dispersion outside of clinical trial centers is unclear. The aim of this study was to investigate the differences in perioperative outcomes between FEVAR and EVAR to determine whether the more complex FEVAR procedure is associated with increased risks of inferior perioperative outcomes. METHODS The Johns Hopkins Institutional Review Board approved this study. Data source and case selection criteria. The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database from 2005 to 2012 was used. Cases before 2011, when the Cook Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) was introduced, were included to include other devices used as part of an investigational device exemption (IDE) as well as to be able to evaluate for complications and outcomes related to learning curves. The NSQIP database contains demographic characteristics and preoperative, intraoperative, and postoperative clinical information abstracted by trained surgical case reviewers from clinical notes of systematically sampled major surgical cases from hospitals participating voluntarily. The NSQIP background, sampling methodology, and variable directory are published elsewhere.14,15 Because data in the NSQIP database are deidentified, informed consent was not obtained. For this study, we queried the NSQIP database for all patients aged $18 years who had undergone FEVAR or EVAR by using International Classification of Diseases (ICD), Ninth Revision code 441.4 (AAA without rupture) and then stratifying the results according to Current Procedural Terminology (CPT; American Medical Association, Chicago, Ill) codes 0078T for FEVAR and 34800, 34802, 34803, 34804, 34805 for EVAR. We excluded all cases with CPT codes reflecting open conversion
Glebova et al 605
(34830-34832) and retained only cases with a diagnosis of nonruptured AAA for subsequent analysis. These criteria were used to exclude zero patients in the FEVAR group and 21 patients in the EVAR group. Variables analyzed. Demographic factors, such as age, sex, and race, were collected. Age in years was analyzed as a continuous variable, with maximum age set to 90 years by NSQIP. Race and ethnicity was categorized as white, black, Hispanic, other race, and unknown or not reported. Patient weight and height were collected to calculate body mass index (BMI). Smoking status was evaluated using the NSQIP definition of active smokers that included individuals who had smoked cigarettes any time #1 year leading up to surgery. More than moderate alcohol consumption was defined as consumption of more than two drinks a day in the 2 weeks before surgery. Comorbidities assessed included hypertension, diabetes, myocardial infarction in the past 6 months, congestive heart failure, chronic obstructive pulmonary disease, stroke, with or without neurological deficit, dialysis dependence, history of bleeding disorder, need for packed red blood cell (PRBC) transfusion #72 hours of operation, and systemic inflammatory response syndrome. Also evaluated were preoperative functional status, history of a major surgical procedure #30 days before surgery, and preoperative thrombocytopenia (defined as platelet count of #150,000/mm3). Intraoperative details collected included patient’s American Society of Anesthesiologists (ASA) Physical Status Classification and surgical resident participation during surgery; performance of a brachial exposure, iliac conduit, iliac exposure, femoral exposure, or emergency operation; and total operative time in minutes. Outcome measures. NSQIP-defined postoperative outcomes that were analyzed included mortality; wound, cardiac, and pulmonary complications; the need to return to the operating room #30 days after the procedure, and length of stay (LOS) in days. NSQIP defines early postoperative blood transfusion of $4 units as “any transfusion (including autologous) of PRBC or whole blood of four or more units given from the time the patient leaves the operating room up to and including 72 hours post-operatively. This includes cell saver, and any hanging blood from the operating room that is finished outside the OR.” Statistical analysis. Bivariate analysis was performed to evaluate the distribution of demographic characteristics and preoperative risk factors. Operative details of patients undergoing EVAR were compared with those who underwent FEVAR. Counts and proportions are presented for categoric variables and were analyzed using c2 or Fisher exact (for cell counts
