Accepted Manuscript Aortic Root Surgery in the United States: A Report from the Society of Thoracic Surgeons Database Sotiris C. Stamou , MD, Ph.D Mathew L. Williams , MD Tyler M. Gunn , MD Robert C. Hagberg , MD Kevin W. Lobdell , MD Nicholas T. Kouchoukos , MD PII:

S0022-5223(14)00586-8

DOI:

10.1016/j.jtcvs.2014.05.042

Reference:

YMTC 8629

To appear in:

The Journal of Thoracic and Cardiovascular Surgery

Received Date: 30 April 2014 Accepted Date: 16 May 2014

Please cite this article as: Stamou SC, Williams ML, Gunn TM, Hagberg RC, Lobdell KW, Kouchoukos NT, Aortic Root Surgery in the United States: A Report from the Society of Thoracic Surgeons Database, The Journal of Thoracic and Cardiovascular Surgery (2014), doi: 10.1016/j.jtcvs.2014.05.042. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Aortic Root Surgery in the United States: A Report from the Society of Thoracic Surgeons Database

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Sotiris C. Stamou, MD, Ph.D,1 Mathew L. Williams, MD,2 Tyler M. Gunn, MD,1 Robert C. Hagberg, MD,3 Kevin W. Lobdell, MD4 Nicholas T. Kouchoukos, MD,5 1

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Department of Cardiothoracic Surgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa 2 Division of Thoracic and Cardiovascular Surgery, University of Louisville, Louisville, Kentucky 3 Hartford Hospital, Hartford, Connecticut, 4 Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina 5 Department of Cardiothoracic Surgery, Missouri Baptist Medical Center, St. Louis, Missouri

Presented at the 2012 AATS Aortic Symposium, New York, NY Word Count: 2394

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The authors of this manuscript do not have any conflicts of interest.

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No external sources of funding were used in creating this manuscript.

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Address Reprint Requests: Sotiris C. Stamou, M.D., Ph.D. SE 516 General Hospital University of Iowa Hospitals and Clinics Iowa City, IA 52242 E-mail: [email protected]

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Abstract Objective: The purpose of this study was to evaluate early clinical outcomes of aortic

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root surgery in the United States. Methods: The Society of Thoracic Surgeons database was queried to identify all patients who underwent aortic root replacement between 2004 and early 2010 (n=13,743).

Median age was 58 years (18 to 96 years), 3,961 were females (29%) and 12,059 were

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Caucasian (88%). Different procedures included placement of mechanical valve conduit

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(n=4,718, 34%), stented pericardial (n=879, 6.4%) or porcine bioprosthesis (n=478, 3.5%), stentless root (n=4,309, 31%), homograft (n=498, 3.6%) and valve sparing root replacement (n=1918, 14%).

Results: The median number of aortic root surgeries per site was two and only 5% of sites performed more than 16 aortic root surgeries per year. There was an increased trend

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to use biostented (porcine or pericardial valves) over the years (7% in 2004 vs. 14`% in 2009). Operative (raw) mortality was higher among patients with aortic stenosis (6.2%) who receive aortic root replacement independent of age. Mortality was higher in patients

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who had concomitant valve or CABG/valve surgery (21%). The lowest operative

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mortality was observed in patients who had aortic valve sparing procedures (1.9%). Conclusions: The majority of cardiac centers perform aortic root surgery in small volumes. The unadjusted operative mortality is higher in patients over 80 years old and among patients with aortic stenosis regardless of age, while valve sparing root surgery is associated with the lowest mortality. There was a trend towards increased use of stented tissue valves between 2004 and 2009. Abstract word count: 250

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Ultramini Abstract The Society of Thoracic Surgeons database was queried to identify all patients who underwent aortic root replacement between 2004 and 2010. Only five percent of sites

increased use of stented tissue valves between 2004 and 2009.

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Ultramini Abstract Word Count: 50

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performed more than 16 aortic root surgeries per year. There was a trend towards

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Introduction Aortic root replacement has historically associated with considerable morbidity and mortality.[1,2] Recent technical advances in thoracic aortic surgery and improvements in

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cerebral and myocardial protection has improved outcomes,[3] however, significant

morbidity and mortality remains in.[4] Contemporary outcomes of aortic root surgery in the United States are uncertain. The purpose of this study was to better evaluate the early

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clinical outcomes and institutional characteristics of aortic root surgery in the United

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States.

Methods Patients

The patient population analyzed in this study was obtained from the Society of Thoracic

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Surgeons (STS) Adult Cardiac Surgery Database (ACSD).[5] The study included all patients aged 18 years or more who underwent aortic root replacement between January 1, 2004, and early 2010 (n=13,743). Data was collected using versions v2.52 (years

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2004-2007) and v2.61 (years 2008-2010) of the STS database (http://www.sts.org/quality-research-patient-safety/national-database/database-

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managers/adult-cardiac-surgery-database/d ).

Exclusion criteria included patients with a) either active or treated endocarditis, b) type A aortic dissections, or c) had an aortic aneurysm with locations other than ascending aorta only or ascending aorta and aortic arch. When comparing valve types within aortic root reconstruction, only mechanical, stented (porcine or pericardial), stentless, and homograft

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valves were included; patients with autograft, ring or band annuloplasty, or had missing or mismatched valve types were excluded. Patients with unreported ages were excluded when comparing operative outcomes by age. Prior reoperation was defined as any

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previous open heart procedure, such as previous CABG, valve, or other cardiac, great vessel, or congenital surgery. Univariate analysis was utilized to compare surgical

outcomes in presence of preoperative conditions and concomitant procedures. When

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comparing outcomes in the presence of aortic stenosis, increased age, concomitant

CABG, concomitant valve, concomitant CABG and valve procedure, and concomitant

Results Patient and operative characteristics

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aortic aneurysm repair, missing data in the area of interest was imputed as negative.

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This study contained 13,746 patients who underwent aortic root surgery between 2004 and 2010 (Table 1). Ages in the study population ranged from 18 to 96 years, with a median age of 58 years, 3,961 were females (29%) and 12,059 were Caucasian (87%).

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1,918 patients had a valve sparing root procedure (15%) and 11,825 patients underwent root reconstruction with a valve conduit. The prevalence of various procedures were as

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follows: mechanical valve conduit (37%); stented pericardial (7%) or porcine bioprosthesis (4%); stentless root (33%); and homograft (4%). 2,724 patients had previously undergone cardiac surgery (21%). Concomitant procedures included coronary artery bypass grafting (n=3,811, 30%) and mitral and/or tricuspid valve surgery (n=1,201, 9%).

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Morbidity and Mortality The overall operative raw mortality of all patients undergoing aortic root surgery was 4.2%. The outcomes of patients with aortic stenosis, increased age, prior medial

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sternotomy, those undergoing select concomitant procedures, and various aortic root

procedures are presented in Table 2. Operative mortality increased with patient age from 2.4% in patients younger than 60 years of age to 15% in patients older than 80 years

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(Table 2). Aortic valve sparing root repair had the lowest incidence operative mortality and in-hospital stroke. Concomitant procedures were associated with higher operative

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mortality, longer length of stay, and increases in surgical complications such as stroke, reoperation for bleeding, acute renal failure, and acute renal failure requiring dialysis (appendix Tables 2-4). Operative mortality was higher among patients with aortic stenosis (6.2%) than those without (3.5%) who undergo aortic root replacement (Table

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4). The incidence of acute renal failure, renal failure requiring dialysis, and length of stay were increased in patient with aortic stenosis.

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Operative mortality, length of stay (LOS)>14 days, and total intensive care unit stay worsened significantly with increased patient age (Table 5). The operative mortality of

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patients ≥80 years was 15% and the rate of LOS>14 days was 23% compared to 2.3% and 6.1%, respectively, in patients younger than 60 years. The proportion of female patients increased from 23% to 51% in patients younger than 60 years of age and those older than 80 years, respectively. In-hospital reoperations for any reason were more frequent in patients of increasing age.

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Redo sternotomy and concomitant procedures Operative mortality and LOS >14 days was higher in patients with prior sternotomy (8.9 and 15%) compared to those without (3.5 and 8.6%) (Appendix Table 1). Concomitant

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procedures raised the operative mortality, rates of reoperation for bleeding, acute renal failure, and LOS>14 days (Appendix Tables 2 and 3). The operative mortality of

concomitant CABG, valve (mitral or tricuspid), and CABG and valve was 9.5%, 13%,

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and 21%, respectively (Table 4). Rates of acute renal failure and LOS>14 days were

9.5% and 16% for concomitant CABG, 13% and 22% for concomitant valve, and 17%

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and 30% for concomitant CABG and valve procedure.

Prosthesis preference

Aortic valve sparing aortic root procedures had an operative mortality of 1.9%, (Table 1)

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which was less than mechanical valve conduit (3.8%), stented tissue valve conduit (5.6%), stentless root (5.8%), and homograft (7.6%) (Table 3). The incidence of stroke was highest in homograft (4.0%) compared to mechanical valve conduit (2.0%) stented

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tissue valve (3.1%) stentless root (2.2%) and aortic valve sparing procedures (2.3%). Rates of acute renal failure, reoperation for bleeding, hemodialysis, and LOS>14 days

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were similar between aortic root procedures. Mechanical (44%) and bio-stentless (40%) valves were the most frequently used, while bio-stented pericardial (8.1%), bio-stented porcine (4.4%), and homograft (4.4%) valves were less common.

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Trends in aortic root surgery The percentage of patients undergoing aortic root surgery with either mechanical, biostented, stentless, and homograft valves, or valve sparing procedures were compared

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between 2004 and 2009 (appendix Table 5) . Mechanical and biostented valves have been the most frequently used prosthesis from 2004 to 2009, with stentless and homograft

valves becoming less common after 2006. The usage of biostented valves has nearly

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doubled in five years. The proportion of valve sparing aortic root procedures has

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remained approximately 15%.

Discussion

This study is a large contemporary cohort evaluating aortic root replacement surgery trends in the United States reported to date with 13,746 patients included from 2004 to

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2010. A recently published study by Williams and colleagues[4] analyzed patients reported in the STS ACSD from 2004 to 2009 that underwent proximal aortic replacement including combinations of aortic root ascending aorta with or without

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involvement of the aortic arch. Our study focuses specifically on aortic root replacement and omits repair of the ascending aorta and aortic arch. Multiple important findings were

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evident from this study and are discussed below.

Principal Findings Aortic root repair remains an uncommon procedure for the majority of surgical centers with only a few sites reporting large annual case volumes. In this study, the median number of aortic root surgeries per site was two and only 5% of institutions participating in the STS ACSD performed more than 16 aortic root surgeries in 2009 (Figure 1) .

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Another finding of this study was an increasing trend during aortic root reconstruction to use biostented (porcine or pericardial) rather than mechanical, homograph, or biostentless

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valves (Figure 2). In 2009, 14% of patients received a biostented valve, whereas only 7.6% received a biostented valve in 2004. The decision whether to implant a

bioprosthesis or a mechanical valve is largely dependent on the age of the patient and

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their preference towards one of two sets of complications: the requirement of chronic

anticoagulation therapy and its complications in mechanical valves, or structural valve

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deterioration (SVD) with a bioprosthesis.[6]

Two large randomized clinical trials, the Edinburgh Heart Valve Trial [7] and the Department of Veterans Affairs Trial (VA) [8] found that there were no statistically

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significant differences between mechanical and bioprosthesis for systemic embolism, valve thrombosis, and prosthetic endocarditis, as well as survival. However, increased rates of bleeding were found in patients with mechanical valves, and bioprosthetic aortic

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valve replacement SVD was higher in patient’s

Aortic root surgery in the United States: a report from the Society of Thoracic Surgeons database.

The purpose of the present study was to evaluate the early clinical outcomes of aortic root surgery in the United States...
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