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Quality of Life After Aortic Root Surgery: Reimplantation Technique Versus Composite Replacement
Ulrich F. W. Franke, MD, Anne Isecke, MD, Ragi Nagib, MD, Martin Breuer, MD, Jens Wippermann, MD, Katharina Tigges-Limmer, PhD, and Thorsten Wahlers, MD Department of Cardiac and Vascular Surgery, Robert Bosch Hospital, Stuttgart, Department of Cardiothoracic Surgery, Friedrich Schiller University of Jena, and Department of Cardiothoracic Surgery, University of Cologne, Cologne, Germany
Background. Recent studies indicate the safety of the aortic valve reimplantation technique (David operation) in the long-term follow-up. The aim of this study was to compare the results of the David operation with those of the aortic composite replacement procedure, with the focus on quality of life (QoL). Methods. Within a 6-year period, 143 patients received either an aortic composite replacement (composite group, n ⴝ 67) or the David-I operation (David group, n ⴝ 76). The QoL of 108 patients (87% of the living patients) was evaluated postoperatively by the 36-Item Short Form Health Survey. A subgroup analysis of QoL excluded patients with aortic stenosis and type A acute aortic dissection. Results. Hospital survival rates (89.6% versus 97.4%, p ⴝ 0.102), as well as actuarial 1-year survival rate (86.6% versus 91.9%) and 3-year survival rate (81.1% versus 91.9%) proved more successful among the David group.
Incidences of serious adverse events during the follow-up period (10.8% versus 28.3%, p ⴝ 0.008) were higher for patients of the composite group. The QoL was found to be compromised for patients of the composite group, in relation to all criteria outlined in the 36-Item Short Form Health Survey. Subgroup analysis without patients with dissection and aortic stenosis demonstrated a significantly better postoperative QoL for patients of the David group. Patients belonging to the composite group were more frequently compromised by prosthetic valve noise (p < 0.001). Conclusions. This study demonstrates the superiority of the aortic valve reimplantation compared with the aortic composite replacement, regarding both clinical outcome and postoperative QoL.
V
graft is considered the only alternative for the majority of patients undergoing one of the valve-sparing procedures. For this reason, we compared the results of the David-I operation, as our standard procedure, with those of patients who had undergone conduit replacement surgery.
alve-sparing aortic root operations have generated increasing interest during recent years. The aortic valve reimplantation technique, first described by Tirone David [1], as well as the remodeling technique of Magdi Yacoub [2], represents safe surgical procedures with reproducible long-term success [3, 4]. In contrast to the increasing number of publications supporting the safety and durability of reconstructive aortic root procedures, studies comparing the results of valve-sparing operations with those of the established aortic valve replacement have yet to be conducted. For a comparative outcome assessment, it is necessary to evaluate both the early and late follow-up stages. Whereas the early postoperative outcome is influenced predominantly by hospital survival and neurologic complications, the main potential benefits of valve-sparing procedures are a noted reduction in valve-related complications, such as stroke or bleeding, as well as an improved quality of life (QoL). Conduit replacement of the aortic valve and ascending aorta with a composite Accepted for publication July 21, 2010. Address correspondence to Dr Franke, Department of Cardiac and Vascular Surgery, Robert Bosch Hospital, Auerbachstr 110, Stuttgart, D-70376, Germany; e-mail: [email protected].
© 2010 by The Society of Thoracic Surgeons Published by Elsevier Inc
(Ann Thorac Surg 2010;90:1869 –75) © 2010 by The Society of Thoracic Surgeons
Patients and Methods This study was approved by the Ethics Committee of the Friedrich-Schiller University. All patients were asked to participate at this study at time of the QoL survey. From September 1999 to December 2005, a total of 143 consecutive patients underwent the aortic root operation. Two types of aortic root operations were performed. In the composite group, 67 patients received a total replacement of the aortic root using mechanical conduit prosthesis (CarboSeal; Sorin, Munchen, Germany). In the David group, 76 patients were operated on using the aortic valve reimplantation technique. The only 2 patients receiving a biological aortic root replacement within the study interval were excluded from the study. Table 1 displays the clinical profiles of both groups. Age, sex, and preoperative mortality risk did not differ 0003-4975/$36.00 doi:10.1016/j.athoracsur.2010.07.067
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Table 1. Clinical Profile of Patients Undergoing Aortic Root Surgery
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Number of patients Mean age, years, ⫾ SD Male sex EuroSCORE ⫾ SD Indication Isolated aneurysm Isolated AR Combined aneurysm and AR Combined aneurysm and AS Acute type A aortic dissection Chronic aortic dissection Bicuspid aortic valve Aortic arch aneurysm Marfan’s syndrome
David Group
Composite Group
76 58 ⫾ 14 56 (74) 8⫾3
67 56 ⫾ 12 53 (79) 7⫾4
14 (18) 3 (4) 40 (53)
3 (5) 6 (9) 20 (30)
0
21 (31)
16 (21)
15 (22)
3 (4) 15 (20) 24 (32) 3 (4)
2 (3) 33 (49) 38 (57) 3 (5)
p Value 0.238 0.449 0.180 ⬍0.001
⬍0.001 0.003 0.715
Percentages are shown in parentheses. AR ⫽ aortic regurgitation; AS ⫽ aortic stenosis; EuroSCORE ⫽ European System for Cardiac Operative Risk Evaluation.
between the groups. Patients of the composite group had a higher incidence of bicuspid aortic valves and concomitant aortic arch aneurysm. Furthermore, one third of the patients belonging to this group had aortic stenosis as the leading indication for operation. For the remaining two thirds of patients, the valve-sparing aortic root operation was considered an appropriate alternative. Sixteen patients from the David group (21%) and 15 patients from the composite group (22%) received emergency surgery owing to acute type A aortic dissection. The aortic valve reimplantation was performed by excising the aortic sinuses and preparation of the extraaortic annulus. Interrupted, horizontal mattress sutures with Teflon felts (Seracor, Serag-Wiessner, Germany), were placed through the left ventricular outflow tract along a single horizontal plane, and inserted through the basis of the selected Dacron graft (Hemashield Platinum Dacron DV vascular graft; Boston Scientific, Natick, MA). After being placed inside the tubular graft, the aortic commissures were fixed, followed by a scalloped, continuous suture line for the fixation of the free aortic margin. Slight anomalies between the cusps, resulting in incongruent central adaptation, were corrected by elevating sutures near the commissures (n ⫽ 27, 35%). In cases with valve prolapse, aortic cusps were shortened by plication of the free margin along the nodulus Arantii (n ⫽ 13, 17%). In 5 patients, cusps were partially decalcified before the decision concerning reimplantation was made. Composite grafts were implanted after resection of the aortic cusps, in an epianular or intraanular fashion, using interrupted mattress sutures with Teflon felts. The reimplantation of the coronary arteries was performed in the
same manner for both groups, employing the button technique. Operative variables are shown in Table 2. Patients were followed up by the referring cardiologists, who performed a Doppler echocardiographic examination, and were contacted annually by our team. The mean follow-up was 2.0 ⫾ 1.7 years for the David group and 2.5 ⫾ 1.5 years for the composite group. The range was 7 months to 7 years for both groups. The follow-up was closed on September 1, 2006.
Measuring Quality of Life We used the Medical Outcomes Trust, 36-Item Short Form Health Survey (SF-36), a survey with established overall reliability and validity, to evaluate patient’s QoL [5–7]. The SF-36 consists of 36 questions, grouped into 8 multiple-item domains, evaluating different aspects of daily life: (1) physical functioning represents limitations in lifting, climbing, bending, kneeling, walking, or running; (2) role physical represents a degree of physical health for which a person performs activities typical for their specific age and social responsibility, such as a job, community activities, and volunteer work; (3) bodily pain represents the intensity and duration of bodily pain and limitations in activities due to pain; (4) general health represents the beliefs and evaluations of a person’s overall health; (5) vitality is a measure of feelings of energy, pep, fatigue, and tiredness; (6) social functioning represents the ability to develop, maintain, and nurture mature social relationships (including family, friends, and spouse); (7) role emotional represents personal feelings about job performance or work, or other activities; and (8) mental health represents a person’s emotional, cognitive, and intellectual status [8]. Table 2. Operative Data
Number of patients Operation timea Cardiopulmonary bypass timea Aortic clamping timea Time of circulatory arresta Hypothermia, °C Selective antegrade brain perfusion Concomitant operative procedures Aortic arch replacement Coronary artery bypass Mitral valve reconstruction Vascular graft diameter, mm Side of arterial cannulation Ascending aorta Aortic arch Right axillary artery Femoral artery a
David Group
Composite Group
76 285 ⫾ 61 180 ⫾ 47
67 311 ⫾ 101 187 ⫾ 68
0.042 0.038
120 ⫾ 30 22 ⫾ 12 28.6 ⫾ 4.6 21 (28)
101 ⫾ 28 16 ⫾ 9 24.0 ⫾ 5.7 10 (15)
0.571 0.061 ⬍0.001 0.067
p Value
0.018 24 (32) 11 (14) 0 28 ⫾ 2
38 (57) 11 (16) 3 (5) 28 ⫾ 4
10 (13) 45 (59) 20 (26) 1 (2)
0 (0) 47 (70) 14 (21) 6 (9)
Mean time in minutes. Percentages are shown in parentheses.
0.101 0.040
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The survey was conducted in November 2005 and in July 2006, at least 6 months after the operation was performed. All long-term survivors were included into the survey; however, 3 patients from each group were unwilling to participate. Incorrect or incomplete survey forms were found for an additional 5 patients from each group, and had to be excluded, according to the SF-36 rules of handling. Additionally, all patients were questioned regarding typical heart-valve–related conditions. These questions were prepared by a psychologist (K.T.L.) specializing in QoL questionnaires. Consecutively, 61 of 76 patients from the David group (80%) and 47 of 67 patients belonging to the composite group (70%) were analyzed. For an additional QoL analysis, all patients with preoperative aortic stenosis or type A acute aortic dissection were excluded from the study. Patients with aortic dissection might be more seriously compromised by complications relating to the disease, than from the aortic operation itself. For patients with aortic stenosis, the valve-sparing operation is not considered an appropriate alternative. Consecutively, 49 recipients of the David group and 25 patients of the composite group were evaluated in relation to their postoperative QoL, after surgery for aortic valve insufficiency or ascending aortic aneurysm, or both. Demographic as well as operative data are shown in Table 3. Actuarial survival rates relating to this subgroup were comparable to that of the entire group (hospital, and 1-, 3-, and 5-year survival: David group 96.7%, 91.4%, 91.4%, and 84.9%, respectively; composite group 90.3%, 90.3%, 90.3%, 87.1%, respectively; p ⫽ 0.601).
Table 3. Clinical Profile and Operative Data of Groups After Exclusion of Patients With Aortic Valve Stenosis and Type A Acute Aortic Dissection
Number of patients Mean age, years, ⫾ SD Male sex EuroSCORE ⫾ SD Indication Isolated aneurysm Isolated AR Combined aneurysm and AR Chronic aortic dissection Bicuspid aortic valve Operation timea Cardiopulmonary bypass timea Aortic clamping timea a
David Group
Composite Group
60 59 ⫾ 14 46 (77) 7.5 ⫾ 2.5
31 54 ⫾ 14 24 (77) 6.8 ⫾ 3.1
14 (23) 3 (5) 40 (67)
3 (10) 6 (19) 20 (65)
3 (5) 14 (23) 285 ⫾ 61 180 ⫾ 47
2 (6) 19 (61) 311 ⫾ 101 187 ⫾ 68
120 ⫾ 30
101 ⫾ 28
p Value 0.067 0.936 0.123 0.854
⬍0.001 0.255 0.700 0.021
Mean time in minutes. Percentages shown in parentheses.
AR ⫽ aortic regurgitation; EuroSCORE ⫽ European System for Cardiac Operative Risk Evaluation.
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Statistical Analysis All data analyses were performed using SPSS software version 13.0 for Windows (SPSS Inc, Chicago, IL). Categorical variables are reported as frequencies, and all continuous variables are reported as mean ⫾ SD. Statistical comparisons between the study groups were analyzed using the unifactorial analysis of variance test for continuous variables, and the Mann-Whitney U test for categorical variables. Results generated by the SF-36 were analyzed using SF-36 software, to create the appropriate mean levels for the eight multiple-item domains. The results between groups were compared both exclusively and with the age and sex appropriate population norm of East Germany, as reported in the SF-36 manual. For the SF-36 comparison, we used the unifactorial analysis of variance test for continuous variables, and for the comparison of the additional valve-related questionnaire, the Mann-Whitney test. The Kaplan-Meier method was used to calculate estimates for actuarial long-term survival. All variables with univariate p value of less than 0.25, or those with known biological significance that failed to meet this critical ␣ level, were submitted to the multivariable model for Cox regression analysis, to determine the independent multivariable predictors of early and late outcomes. Variable retention criteria in the model were set at a p value of 0.05.
Results Clinical Outcome Nine patients died during the hospital follow-up (6.3%), 6 after elective operation and 3 after acute aortic dissection repair. Consecutively, the hospital survival rates were recorded at 97.4% (74 of 76 patients) for the David group and 89.6% (60 of 67 patients) for the composite group (p ⫽ 0.102). Causes of death include bowel ischemia (2), systemic inflammatory response syndrome with consecutive multiple organ failure (2), severe stroke (2), and rupture of the descending aorta, cardiac low output syndrome, and peptic ulcer bleeding (1 each). The univariate Cox regression analysis detected operation time (p ⬍ 0.001) and cardiopulmonary bypass time (p ⫽ 0.04) as significant risk factors affecting hospital mortality. Using the multivariate Cox regression analysis, only age was an independent risk factor affecting hospital mortality (p ⫽ 0.007). During the follow-up period, 10 more patients died. Actuarial 1-year, 3-year, and 5-year survival rates were 91.9%, 91.9%, and 85.3%, respectively, for patients belonging to the David group; and 86.6%, 83.2% and 81.1%, respectively, for those of the composite group (p ⫽ 0.146; Fig 1). Causes of death were found to be aortic disease related in 2 cases (rupture of descending or abdominal aneurysm), multiple organ failure in 4 cases (no detailed information available), and in 1 case, myocardial infarction, bronchial carcinoma, and pneumonia. A possible valve-related stroke was the cause of death of 1 patient who had undergone composite replacement surgery. Univariate risk factors for the overall mortality rates were
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stroke at any time after aortic root surgery were only the applied operative technique (p ⫽ 0.007) and the acute aortic dissection as underlying disease (p ⫽ 0.026; Table 5). Additionally, peripheral vascular embolic events occurred (p ⫽ 0.044) in 1 patient from the David group (1.4%) and 5 patients from the composite group (8.3%). Serious adverse events during the follow-up, defined as death, stroke, embolic events, or valve-related reoperation, were observed in 8 of 74 patients belonging to the David group (10.8%) and 17 of 60 composite group patients (28.3%; p ⫽ 0.007). Cox regression analysis revealed only age as well as acute aortic dissection as multivariate risk factors for SAE, but not the operation procedure (Table 6).
Quality of Life Fig 1. Actuarial survival after aortic root surgery. Numbers at the bottom of the graph represent the patients at risk yearly. Composite group (triangles, lower row) and David group (diamonds, upper row) were compared by Kaplan-Meier survival analysis.
age (p ⫽ 0.001), overall operation time (p ⬍ 0.001), cardiopulmonary bypass time (p ⬍ 0.001), aortic clamping time (p ⫽ 0.043), and the indication of acute aortic dissection (p ⫽ 0.030), but not the operation technique used. The multivariate analysis revealed only age (p ⬍ 0.001) and acute aortic dissection (p ⫽ 0.007) as variables for a poor long-term prognosis (Table 4). Early postoperative complications occurred in 16 patients belonging to the David group (21.1%) and 28 patients from the composite group (41.8%; p ⫽ 0.008). Evidence of a stroke was also found in 7 patients belonging to the composite group (10.4%) compared with no patients from the David group (p ⫽ 0.004). In addition, the need for permanent pacemaker assistance was found only in patients from the composite group (n ⫽ 7, 10.4%; p ⫽ 0.004). During the postoperative follow-up, 2 of 74 patients at risk within the David group (2.7%) and 9 of 60 patients at risk within the composite group (15.0%) had a stroke (p ⫽ 0.009). Multifactorial risk factors for the appearance of a
Quality of life was found to be impaired in all of the domains of the SF-36 questionnaire for patients belonging to the composite group: physical functioning 67.0 ⫾ 25.8 versus 75.4 ⫾ 24.0 (p ⫽ 0.043); role physical 59.2 ⫾ 44.2 versus 69.5 ⫾ 30.4 (p ⫽ 0.493); bodily pain 72.7 ⫾ 28.1 versus 80.9 ⫾ 22.5 (p ⫽ 0.145); general health 54.5 ⫾ 23.3 versus 67.0 ⫾ 19.1 (p ⫽ 0.003); vitality 53.0 ⫾ 24.2 versus 59.8 ⫾ 17.5 (p ⫽ 0.048); social function 79.1 ⫾ 22.8 versus 81.8 ⫾ 23.2 (p ⫽ 0.341); role emotional 69.0 ⫾ 19.3 versus 76.3 ⫾ 16.5 (p ⫽ 0.001); and mental health 68.8 ⫾ 19.1 versus 76.4 ⫾ 15.1 (p ⫽ 0.024). Figure 2 demonstrates the comparison between the two groups, as well as findings gathered from the East German population. By evaluating different age groups, it was discovered that patients less than 50 years of age, with a composite graft, are significantly more compromised in regard to both their general health (p ⫽ 0.007) and mental health (p ⫽ 0.034), when compared with patients of identical age who underwent the David operation. However, the results obtained from patients between the ages of 51 and 60 years demonstrated no discernible difference in the QoL of either group. The results generated from the subsequent category of 61- to 70-year-olds yielded far more conclusive disparities, signifying that patients belonging to the composite group
Table 4. Risk Factors Affecting Overall Mortality Survivors Number of patients Age, years Female sex Indication of AADA Operation technique David operation Composite graft Application of circulatory arrest Operation timeb Cardiopulmonary bypass timeb Aortic clamping timeb a
Cox regression analysis.
b
Deceased
124 56 ⫾ 13 30 (24) 25 (20)
19 67 ⫾ 10 4 (21) 8 (42)
69 55 50 (40) 285 ⫾ 66 175 ⫾ 49 123 ⫾ 31
7 12 12 (63) 374 ⫾ 133 233 ⫾ 83 109 ⫾ 30
Univariate p Valuea
Mean time in minutes. Percentages are shown in parentheses.
AADA ⫽ acute type A aortic dissection.
Multivariate p Valuea
0.001 0.615 0.030 0.156
⬍0.001 0.216 0.007 0.102
0.083 ⬍0.001 ⬍0.001 0.043
0.816 0.983 0.201 0.980
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Number of patients Age, years Female sex Indication of AADA Operation technique David operation Composite graft Application of circulatory arrest a
Nonstrokes
Stroke
126 57 ⫾ 13 30 (24) 26 (21)
17 57 ⫾ 14 4 (24) 7 (41)
74 52 51 (40)
2 15 11 (65)
Univariate p Valuea
Multivariate p Valuea
0.915 0.503 0.016 0.009
0.156 0.462 0.026 0.007
0.267
0.331
Cox regression analysis. Percentages are shown in parentheses.
AADA ⫽ acute type A aortic dissection.
were more impaired in relation to physical functioning (p ⫽ 0.045), general health (p ⫽ 0.015), role emotional (p ⬍ 0.001), and mental health (p ⫽ 0.032). The group of patients above the age of 80 proved too small for statistical comparison. Forty patients from the composite group (59.7%) and 6 from the David group were able to hear heart valve noises (p ⬍ 0.001). Nineteen patients from the composite group (40.5%) and 3 from the David group (4.9%) reported feeling moderately or severely disturbed by this noise (p ⬍ 0.001). Despite preoperative patient information stating that mechanical heart valves have an extreme low risk of failure, and aortic valve reconstruction has an unpredictable individual risk for longevity, one half of the patients with composite grafts (n ⫽ 23, 50.0%), compared with only one fourth of patients after the David reconstructive procedure (n ⫽ 17, 22.4%), were afraid the reconstructed heart valve would fail (p ⫽ 0.020). Patients from the David group estimated their overall condition at 7.6 ⫾ 1.7, on a scale from 0 to 10, compared with 5.8 ⫾ 2.8 for patients belonging to the composite group (p ⫽ 0.001).
The comparison between the subgroup of patients with aortic aneurysm or aortic valve insufficiency, as an underlying disease only, also revealed a better QoL for recipients of the David operation, within all domains. Significantly better results were recorded in relation to physical functioning 78.0 ⫾ 22.3 versus 63.0 ⫾ 30.0 (p ⫽ 0.041); general health 68.5 ⫾ 18.4 versus 52.8 ⫾ 24.1 (p ⫽ 0.004); role emotional 86.4 ⫾ 29.6 versus 58.7 ⫾ 44.4 (p ⫽ 0.005); and mental health 78.0 ⫾ 14.5 versus 67.2 ⫾ 19.7 (p ⫽ 0.021; Fig 3). Within this subgroup, 1 of 48 patients (2.1%) who had undergone the David operation and 9 of 25 recipients (36%) of composite replacement surgery felt disturbed moderately or severely by heart valve noises (p ⬍ 0.001). Self-evaluation of their overall condition also confirmed significantly better results for patients recovering from the David operation within this subgroup (on a scale from 0 to 10, David group 7.7 ⫾ 1.7, composite group 5.7 ⫾ 2.9; p ⫽ 0.004).
Comment Aortic valve-sparing operations have been developing rapidly over recent years. Reported hospital mortality
Table 6. Risk Factors Affecting Serious Adverse Events During Follow-Upa
Number of patients Age, years Female sex Indication of AADA Operation technique David operation Composite graft Application of circulatory arrest
Non-SAE
SAE
109
25
56 ⫾ 13 27 (25) 21 (19)
61 ⫾ 13 7 (28) 9 (36)
66 43 39 (36)
8 17 17 (68)
Univariate Multivariate p Valueb p Valueb
0.068 0.761 0.017
0.005 0.201 0.012
0.093
0.108
0.085
0.798
a Serious adverse events (SAE) were defined as death, stroke embolic b events, or valve-related reoperation. Cox regression analysis. Percentages are shown in parentheses.
AADA ⫽ acute type A aortic dissection.
Fig 2. Quality of life data compared with the average findings for the East German population. Both the David and composite groups were compared using the unifactorial analysis of variance. Standard deviation is stated in the text. (BP ⫽ bodily pain; GH ⫽ general health; MH ⫽ mental health; PF ⫽ physical functioning; RE ⫽ role emotional; RP ⫽ role physical; SF ⫽ social function; VT ⫽ vitality.)
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Table 5. Risk Factors Affecting Occurrence of Stroke at Any Time After Aortic Root Operation
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ADULT CARDIAC Fig 3. Quality of life data relating to the subgroup of patients with aortic valve regurgitation or aortic aneurysm, or both, as underlying pathology only, compared with the East German population norms. The David and composite groups were compared using the unifactorial analysis of variance. Standard deviation is stated in the text. (BP ⫽ bodily pain; GH ⫽ general health; MH ⫽ mental health; PF ⫽ physical functioning; RE ⫽ role emotional; RP ⫽ role physical; SF ⫽ social function; VT ⫽ vitality.)
ranges from 0% to approximately 10%, depending on incidence of acute type A aortic dissection, emergency, mean age, and Marfan’s syndrome [3, 9 –12]. Correspondingly, 1-year survival rates of more than 90%, and 10-year survival rates of approximately 80%, can be achieved [3, 9, 12]. The longevity of reconstruction results are reported as extremely stable, offering a freedom from valve-related reoperation recorded at between 90% and 100% after 5 years, depending on the underlying valve pathology and the chosen surgical technique [3, 9, 12]. In 1999, we opted for the David technique as our standard aortic valve-sparing procedure owing to the possibility of usage in all valve pathologies. The comparative results of David and colleagues [3], who found that the remodeling technique generated a higher rate of reoperation due to anular dilation, justified this decision. However, a review conducted by Albes and coworkers [13] in 2005 concluded no valid differences between the two valvesparing operations. Despite the increasingly widespread use of aortic valve-sparing operations, the number of studies comparing the resultant data with that of the established composite replacement surgery, is very limited [14]. Correspondingly, combined replacement of aortic valve and root is assumed to be the gold standard in terms of safety, efficacy, and longevity [13]. Our study was initiated to extend our experience and knowledge of the David reconstruction in comparison with the gold standard. The valve-sparing David operation allowed for a better survival rate and a lower incidence of postoperative complications. The relatively high incidence of severe adverse events during the follow-up period (11% David group versus 28% composite group), may have been influenced by the high proportion of acute type A aortic dissection, as a significant multivariate factor for poor long-term prognosis.
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The second aim of this study was to analyze the postoperative QoL after aortic root surgery, depending on the technique utilized. One of the most important arguments supporting the practice of valve-sparing aortic operation is the improved QoL, without the necessity for anticoagulation therapy and higher exercise capacity. However, no publications evaluating QoL of patients after valve-sparing aortic root operations currently exist. For this study, we developed a questionnaire modifying the standard SF-36-form to include specific questions regarding QoL after valve replacement surgery. Patients who underwent the David operation demonstrated a better postoperative QoL, in 5 of 8 items as detailed in the SF-36 questionnaire. These patients were compromised only slightly when compared with the East German average for that age category. As reported by Sjogren and colleagues [5], in relation to elderly cardiac patients, David group participants experienced an even better outcome regarding bodily pain and mental health, when compared with the general population. Patients belonging to the composite group were recorded as being significantly more compromised in relation to all items of the SF-36. The higher incidence of postoperative complications, especially the higher stroke rate, might be influenced by this observation. Because of the potential influence of underlying disease on the postoperative QoL, we excluded all patients with aortic valve stenosis and type A acute aortic dissection for a subsequent subgroup analysis. The findings of this analysis did not differ from those of the entire group. In addition, patients with aortic aneurysm or aortic valve regurgitation only demonstrated a better QoL after the David procedure, compared with patients who had received composite replacement surgery. Additionally, David patients were less disturbed by valve noise and estimated their overall QoL higher on a scale of 1 to 10. These findings demonstrate significant anomalies, which are in sharp contrast to other studies concerned with postoperative QoL after valve surgery. Most studies found little or no distinction between the different collectives after heart valve surgery [8, 15]. Limitations of this study are predominantly caused by the single-center approach, which does not allow for prospective randomization. A registry for valve-sparing aortic operations could produce more valid results. In conclusion, this comparative study demonstrates beneficial outcomes for patients undergoing the valvesparing David operation, compared with the alternative composite replacement of the aortic root. The David operation proved superior both in relation to survival rates and incidence of complications in the early and midterm follow-up, as well as in postoperative QoL.
References 1. David TE, Feindel CM. An aortic valve-sparing operation for patients with aortic incompetence and aneurysm of the ascending aorta. J Thorac Cardiovasc Surg 1992;103:617–21. 2. Sarsam MA, Yacoub M. Remodeling of the aortic valve anulus. J Thorac Cardiovasc Surg 1993;105:435– 8.
3. David TE, Feindel CM, Webb GD, Colman JM, Armstrong S, Maganti M. Long-term results of aortic valve-sparing operations for aortic root aneurysm. J Thorac Cardiovasc Surg 2006;132:347–54. 4. Pacini D, Marco LD, Suarez SM, et al. Aortic valve-sparing operations: early and midterm results. Heart Surg Forum 2006;9:E650 – 6. 5. Sjogren J, Thulin LI. Quality of life in the very elderly after cardiac surgery: a comparison of SF-36 between long-term survivors and an age-matched population. Gerontology 2004;50:407–10. 6. Accola KD, Scott ML, Spector SD, et al. Is the St. Jude Medical mechanical valve an appropriate choice for elderly patients? A long-term retrospective study measuring quality of life. J Heart Valve Dis 2006;15:57– 66. 7. Sedrakyan A, Vaccarino V, Paltiel AD, et al. Age does not limit quality of life improvement in cardiac valve surgery. J Am Coll Cardiol 2003;42:1208 –14. 8. Sedrakyan A, Hebert P, Vaccarino V, et al. Quality of life after aortic valve replacement with tissue and mechanical implants. J Thorac Cardiovasc Surg 2004;128:266 –72. 9. Yacoub MH, Gehle P, Chandrasekaran V, Birks EJ, Child A, Radley-Smith R. Late results of a valve-preserving operation
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10. 11.
12.
13. 14.
15.
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in patients with aneurysms of the ascending aorta and root. J Thorac Cardiovasc Surg 1998;115:1080 –90. Kallenbach K, Hagl C, Walles T, et al. Results of valvesparing aortic root reconstruction in 158 consecutive patients. Ann Thorac Surg 2002;74:2026 –33. Karck M, Kallenbach K, Hagl C, Rhein C, Leyh R, Haverich A. Aortic root surgery in Marfan syndrome: comparison of aortic valve-sparing reimplantation versus composite grafting. J Thorac Cardiovasc Surg 2004;127:391– 8. Aicher D, Langer F, Kissinger A, Lausberg H, Fries R, Schäfers HJ. Valve-sparing aortic root replacement in bicuspid aortic valves: a reasonable option? J Thorac Cardiovasc Surg 2004;128:662– 8. Albes JM, Stock UA, Hartrumpf M. Restitution of the aortic valve: what is new, what is proven, and what is obsolete? Ann Thorac Surg 2005;80:1540 –9. Kallenbach K, Pethig K, Schwarz M, Milz A, Haverich A, Harringer W. Valve sparing aortic root reconstruction versus composite replacement: perioperative course and early complications. Eur J Cardiothorac Surg 2001;20:77– 81. Detter C, Deuse T, Boehm DH, Reichenspurner H, Reichart B. Midterm results and quality of life after minimally invasive versus conventional aortic valve replacement. Thorac Cardiovasc Surg 2002;50:337– 41.
Notice From the American Board of Thoracic Surgery Regarding Trainees and Candidates for Certification Who Are Called to Military Service Related to the War on Terrorism The Board appreciates the concern of those who have received emergency calls to military service. They may be assured that the Board will exercise the same sympathetic consideration as was given to candidates in recognition of their special contributions to their country during the Vietnam conflict and the Persian Gulf conflict with regard to applications, examinations, and interruption of training.
© 2010 by The Society of Thoracic Surgeons Published by Elsevier Inc
If you have any questions about how this might affect you, please call the Board office at (312) 202-5900. Valerie W. Rusch, MD Chair The American Board of Thoracic Surgery
Ann Thorac Surg 2010;90:1875
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0003-4975/$36.00
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Background. Recent studies indicate the safety of the aortic valve reimplantation technique (David operation) in the long-term follow-up. The aim of this study was to compare the results of the David operation with those of the aortic composite replacement procedure, with the focus on quality of life (QoL). Methods. Within a 6-year period, 143 patients received either an aortic composite replacement (composite group, n ⴝ 67) or the David-I operation (David group, n ⴝ 76). The QoL of 108 patients (87% of the living patients) was evaluated postoperatively by the 36-Item Short Form Health Survey. A subgroup analysis of QoL excluded patients with aortic stenosis and type A acute aortic dissection. Results. Hospital survival rates (89.6% versus 97.4%, p ⴝ 0.102), as well as actuarial 1-year survival rate (86.6% versus 91.9%) and 3-year survival rate (81.1% versus 91.9%) proved more successful among the David group.
Incidences of serious adverse events during the follow-up period (10.8% versus 28.3%, p ⴝ 0.008) were higher for patients of the composite group. The QoL was found to be compromised for patients of the composite group, in relation to all criteria outlined in the 36-Item Short Form Health Survey. Subgroup analysis without patients with dissection and aortic stenosis demonstrated a significantly better postoperative QoL for patients of the David group. Patients belonging to the composite group were more frequently compromised by prosthetic valve noise (p < 0.001). Conclusions. This study demonstrates the superiority of the aortic valve reimplantation compared with the aortic composite replacement, regarding both clinical outcome and postoperative QoL.
V
graft is considered the only alternative for the majority of patients undergoing one of the valve-sparing procedures. For this reason, we compared the results of the David-I operation, as our standard procedure, with those of patients who had undergone conduit replacement surgery.
alve-sparing aortic root operations have generated increasing interest during recent years. The aortic valve reimplantation technique, first described by Tirone David [1], as well as the remodeling technique of Magdi Yacoub [2], represents safe surgical procedures with reproducible long-term success [3, 4]. In contrast to the increasing number of publications supporting the safety and durability of reconstructive aortic root procedures, studies comparing the results of valve-sparing operations with those of the established aortic valve replacement have yet to be conducted. For a comparative outcome assessment, it is necessary to evaluate both the early and late follow-up stages. Whereas the early postoperative outcome is influenced predominantly by hospital survival and neurologic complications, the main potential benefits of valve-sparing procedures are a noted reduction in valve-related complications, such as stroke or bleeding, as well as an improved quality of life (QoL). Conduit replacement of the aortic valve and ascending aorta with a composite Accepted for publication July 21, 2010. Address correspondence to Dr Franke, Department of Cardiac and Vascular Surgery, Robert Bosch Hospital, Auerbachstr 110, Stuttgart, D-70376, Germany; e-mail: [email protected].
© 2010 by The Society of Thoracic Surgeons Published by Elsevier Inc
(Ann Thorac Surg 2010;90:1869 –75) © 2010 by The Society of Thoracic Surgeons
Patients and Methods This study was approved by the Ethics Committee of the Friedrich-Schiller University. All patients were asked to participate at this study at time of the QoL survey. From September 1999 to December 2005, a total of 143 consecutive patients underwent the aortic root operation. Two types of aortic root operations were performed. In the composite group, 67 patients received a total replacement of the aortic root using mechanical conduit prosthesis (CarboSeal; Sorin, Munchen, Germany). In the David group, 76 patients were operated on using the aortic valve reimplantation technique. The only 2 patients receiving a biological aortic root replacement within the study interval were excluded from the study. Table 1 displays the clinical profiles of both groups. Age, sex, and preoperative mortality risk did not differ 0003-4975/$36.00 doi:10.1016/j.athoracsur.2010.07.067
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Table 1. Clinical Profile of Patients Undergoing Aortic Root Surgery
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Number of patients Mean age, years, ⫾ SD Male sex EuroSCORE ⫾ SD Indication Isolated aneurysm Isolated AR Combined aneurysm and AR Combined aneurysm and AS Acute type A aortic dissection Chronic aortic dissection Bicuspid aortic valve Aortic arch aneurysm Marfan’s syndrome
David Group
Composite Group
76 58 ⫾ 14 56 (74) 8⫾3
67 56 ⫾ 12 53 (79) 7⫾4
14 (18) 3 (4) 40 (53)
3 (5) 6 (9) 20 (30)
0
21 (31)
16 (21)
15 (22)
3 (4) 15 (20) 24 (32) 3 (4)
2 (3) 33 (49) 38 (57) 3 (5)
p Value 0.238 0.449 0.180 ⬍0.001
⬍0.001 0.003 0.715
Percentages are shown in parentheses. AR ⫽ aortic regurgitation; AS ⫽ aortic stenosis; EuroSCORE ⫽ European System for Cardiac Operative Risk Evaluation.
between the groups. Patients of the composite group had a higher incidence of bicuspid aortic valves and concomitant aortic arch aneurysm. Furthermore, one third of the patients belonging to this group had aortic stenosis as the leading indication for operation. For the remaining two thirds of patients, the valve-sparing aortic root operation was considered an appropriate alternative. Sixteen patients from the David group (21%) and 15 patients from the composite group (22%) received emergency surgery owing to acute type A aortic dissection. The aortic valve reimplantation was performed by excising the aortic sinuses and preparation of the extraaortic annulus. Interrupted, horizontal mattress sutures with Teflon felts (Seracor, Serag-Wiessner, Germany), were placed through the left ventricular outflow tract along a single horizontal plane, and inserted through the basis of the selected Dacron graft (Hemashield Platinum Dacron DV vascular graft; Boston Scientific, Natick, MA). After being placed inside the tubular graft, the aortic commissures were fixed, followed by a scalloped, continuous suture line for the fixation of the free aortic margin. Slight anomalies between the cusps, resulting in incongruent central adaptation, were corrected by elevating sutures near the commissures (n ⫽ 27, 35%). In cases with valve prolapse, aortic cusps were shortened by plication of the free margin along the nodulus Arantii (n ⫽ 13, 17%). In 5 patients, cusps were partially decalcified before the decision concerning reimplantation was made. Composite grafts were implanted after resection of the aortic cusps, in an epianular or intraanular fashion, using interrupted mattress sutures with Teflon felts. The reimplantation of the coronary arteries was performed in the
same manner for both groups, employing the button technique. Operative variables are shown in Table 2. Patients were followed up by the referring cardiologists, who performed a Doppler echocardiographic examination, and were contacted annually by our team. The mean follow-up was 2.0 ⫾ 1.7 years for the David group and 2.5 ⫾ 1.5 years for the composite group. The range was 7 months to 7 years for both groups. The follow-up was closed on September 1, 2006.
Measuring Quality of Life We used the Medical Outcomes Trust, 36-Item Short Form Health Survey (SF-36), a survey with established overall reliability and validity, to evaluate patient’s QoL [5–7]. The SF-36 consists of 36 questions, grouped into 8 multiple-item domains, evaluating different aspects of daily life: (1) physical functioning represents limitations in lifting, climbing, bending, kneeling, walking, or running; (2) role physical represents a degree of physical health for which a person performs activities typical for their specific age and social responsibility, such as a job, community activities, and volunteer work; (3) bodily pain represents the intensity and duration of bodily pain and limitations in activities due to pain; (4) general health represents the beliefs and evaluations of a person’s overall health; (5) vitality is a measure of feelings of energy, pep, fatigue, and tiredness; (6) social functioning represents the ability to develop, maintain, and nurture mature social relationships (including family, friends, and spouse); (7) role emotional represents personal feelings about job performance or work, or other activities; and (8) mental health represents a person’s emotional, cognitive, and intellectual status [8]. Table 2. Operative Data
Number of patients Operation timea Cardiopulmonary bypass timea Aortic clamping timea Time of circulatory arresta Hypothermia, °C Selective antegrade brain perfusion Concomitant operative procedures Aortic arch replacement Coronary artery bypass Mitral valve reconstruction Vascular graft diameter, mm Side of arterial cannulation Ascending aorta Aortic arch Right axillary artery Femoral artery a
David Group
Composite Group
76 285 ⫾ 61 180 ⫾ 47
67 311 ⫾ 101 187 ⫾ 68
0.042 0.038
120 ⫾ 30 22 ⫾ 12 28.6 ⫾ 4.6 21 (28)
101 ⫾ 28 16 ⫾ 9 24.0 ⫾ 5.7 10 (15)
0.571 0.061 ⬍0.001 0.067
p Value
0.018 24 (32) 11 (14) 0 28 ⫾ 2
38 (57) 11 (16) 3 (5) 28 ⫾ 4
10 (13) 45 (59) 20 (26) 1 (2)
0 (0) 47 (70) 14 (21) 6 (9)
Mean time in minutes. Percentages are shown in parentheses.
0.101 0.040
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The survey was conducted in November 2005 and in July 2006, at least 6 months after the operation was performed. All long-term survivors were included into the survey; however, 3 patients from each group were unwilling to participate. Incorrect or incomplete survey forms were found for an additional 5 patients from each group, and had to be excluded, according to the SF-36 rules of handling. Additionally, all patients were questioned regarding typical heart-valve–related conditions. These questions were prepared by a psychologist (K.T.L.) specializing in QoL questionnaires. Consecutively, 61 of 76 patients from the David group (80%) and 47 of 67 patients belonging to the composite group (70%) were analyzed. For an additional QoL analysis, all patients with preoperative aortic stenosis or type A acute aortic dissection were excluded from the study. Patients with aortic dissection might be more seriously compromised by complications relating to the disease, than from the aortic operation itself. For patients with aortic stenosis, the valve-sparing operation is not considered an appropriate alternative. Consecutively, 49 recipients of the David group and 25 patients of the composite group were evaluated in relation to their postoperative QoL, after surgery for aortic valve insufficiency or ascending aortic aneurysm, or both. Demographic as well as operative data are shown in Table 3. Actuarial survival rates relating to this subgroup were comparable to that of the entire group (hospital, and 1-, 3-, and 5-year survival: David group 96.7%, 91.4%, 91.4%, and 84.9%, respectively; composite group 90.3%, 90.3%, 90.3%, 87.1%, respectively; p ⫽ 0.601).
Table 3. Clinical Profile and Operative Data of Groups After Exclusion of Patients With Aortic Valve Stenosis and Type A Acute Aortic Dissection
Number of patients Mean age, years, ⫾ SD Male sex EuroSCORE ⫾ SD Indication Isolated aneurysm Isolated AR Combined aneurysm and AR Chronic aortic dissection Bicuspid aortic valve Operation timea Cardiopulmonary bypass timea Aortic clamping timea a
David Group
Composite Group
60 59 ⫾ 14 46 (77) 7.5 ⫾ 2.5
31 54 ⫾ 14 24 (77) 6.8 ⫾ 3.1
14 (23) 3 (5) 40 (67)
3 (10) 6 (19) 20 (65)
3 (5) 14 (23) 285 ⫾ 61 180 ⫾ 47
2 (6) 19 (61) 311 ⫾ 101 187 ⫾ 68
120 ⫾ 30
101 ⫾ 28
p Value 0.067 0.936 0.123 0.854
⬍0.001 0.255 0.700 0.021
Mean time in minutes. Percentages shown in parentheses.
AR ⫽ aortic regurgitation; EuroSCORE ⫽ European System for Cardiac Operative Risk Evaluation.
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Statistical Analysis All data analyses were performed using SPSS software version 13.0 for Windows (SPSS Inc, Chicago, IL). Categorical variables are reported as frequencies, and all continuous variables are reported as mean ⫾ SD. Statistical comparisons between the study groups were analyzed using the unifactorial analysis of variance test for continuous variables, and the Mann-Whitney U test for categorical variables. Results generated by the SF-36 were analyzed using SF-36 software, to create the appropriate mean levels for the eight multiple-item domains. The results between groups were compared both exclusively and with the age and sex appropriate population norm of East Germany, as reported in the SF-36 manual. For the SF-36 comparison, we used the unifactorial analysis of variance test for continuous variables, and for the comparison of the additional valve-related questionnaire, the Mann-Whitney test. The Kaplan-Meier method was used to calculate estimates for actuarial long-term survival. All variables with univariate p value of less than 0.25, or those with known biological significance that failed to meet this critical ␣ level, were submitted to the multivariable model for Cox regression analysis, to determine the independent multivariable predictors of early and late outcomes. Variable retention criteria in the model were set at a p value of 0.05.
Results Clinical Outcome Nine patients died during the hospital follow-up (6.3%), 6 after elective operation and 3 after acute aortic dissection repair. Consecutively, the hospital survival rates were recorded at 97.4% (74 of 76 patients) for the David group and 89.6% (60 of 67 patients) for the composite group (p ⫽ 0.102). Causes of death include bowel ischemia (2), systemic inflammatory response syndrome with consecutive multiple organ failure (2), severe stroke (2), and rupture of the descending aorta, cardiac low output syndrome, and peptic ulcer bleeding (1 each). The univariate Cox regression analysis detected operation time (p ⬍ 0.001) and cardiopulmonary bypass time (p ⫽ 0.04) as significant risk factors affecting hospital mortality. Using the multivariate Cox regression analysis, only age was an independent risk factor affecting hospital mortality (p ⫽ 0.007). During the follow-up period, 10 more patients died. Actuarial 1-year, 3-year, and 5-year survival rates were 91.9%, 91.9%, and 85.3%, respectively, for patients belonging to the David group; and 86.6%, 83.2% and 81.1%, respectively, for those of the composite group (p ⫽ 0.146; Fig 1). Causes of death were found to be aortic disease related in 2 cases (rupture of descending or abdominal aneurysm), multiple organ failure in 4 cases (no detailed information available), and in 1 case, myocardial infarction, bronchial carcinoma, and pneumonia. A possible valve-related stroke was the cause of death of 1 patient who had undergone composite replacement surgery. Univariate risk factors for the overall mortality rates were
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stroke at any time after aortic root surgery were only the applied operative technique (p ⫽ 0.007) and the acute aortic dissection as underlying disease (p ⫽ 0.026; Table 5). Additionally, peripheral vascular embolic events occurred (p ⫽ 0.044) in 1 patient from the David group (1.4%) and 5 patients from the composite group (8.3%). Serious adverse events during the follow-up, defined as death, stroke, embolic events, or valve-related reoperation, were observed in 8 of 74 patients belonging to the David group (10.8%) and 17 of 60 composite group patients (28.3%; p ⫽ 0.007). Cox regression analysis revealed only age as well as acute aortic dissection as multivariate risk factors for SAE, but not the operation procedure (Table 6).
Quality of Life Fig 1. Actuarial survival after aortic root surgery. Numbers at the bottom of the graph represent the patients at risk yearly. Composite group (triangles, lower row) and David group (diamonds, upper row) were compared by Kaplan-Meier survival analysis.
age (p ⫽ 0.001), overall operation time (p ⬍ 0.001), cardiopulmonary bypass time (p ⬍ 0.001), aortic clamping time (p ⫽ 0.043), and the indication of acute aortic dissection (p ⫽ 0.030), but not the operation technique used. The multivariate analysis revealed only age (p ⬍ 0.001) and acute aortic dissection (p ⫽ 0.007) as variables for a poor long-term prognosis (Table 4). Early postoperative complications occurred in 16 patients belonging to the David group (21.1%) and 28 patients from the composite group (41.8%; p ⫽ 0.008). Evidence of a stroke was also found in 7 patients belonging to the composite group (10.4%) compared with no patients from the David group (p ⫽ 0.004). In addition, the need for permanent pacemaker assistance was found only in patients from the composite group (n ⫽ 7, 10.4%; p ⫽ 0.004). During the postoperative follow-up, 2 of 74 patients at risk within the David group (2.7%) and 9 of 60 patients at risk within the composite group (15.0%) had a stroke (p ⫽ 0.009). Multifactorial risk factors for the appearance of a
Quality of life was found to be impaired in all of the domains of the SF-36 questionnaire for patients belonging to the composite group: physical functioning 67.0 ⫾ 25.8 versus 75.4 ⫾ 24.0 (p ⫽ 0.043); role physical 59.2 ⫾ 44.2 versus 69.5 ⫾ 30.4 (p ⫽ 0.493); bodily pain 72.7 ⫾ 28.1 versus 80.9 ⫾ 22.5 (p ⫽ 0.145); general health 54.5 ⫾ 23.3 versus 67.0 ⫾ 19.1 (p ⫽ 0.003); vitality 53.0 ⫾ 24.2 versus 59.8 ⫾ 17.5 (p ⫽ 0.048); social function 79.1 ⫾ 22.8 versus 81.8 ⫾ 23.2 (p ⫽ 0.341); role emotional 69.0 ⫾ 19.3 versus 76.3 ⫾ 16.5 (p ⫽ 0.001); and mental health 68.8 ⫾ 19.1 versus 76.4 ⫾ 15.1 (p ⫽ 0.024). Figure 2 demonstrates the comparison between the two groups, as well as findings gathered from the East German population. By evaluating different age groups, it was discovered that patients less than 50 years of age, with a composite graft, are significantly more compromised in regard to both their general health (p ⫽ 0.007) and mental health (p ⫽ 0.034), when compared with patients of identical age who underwent the David operation. However, the results obtained from patients between the ages of 51 and 60 years demonstrated no discernible difference in the QoL of either group. The results generated from the subsequent category of 61- to 70-year-olds yielded far more conclusive disparities, signifying that patients belonging to the composite group
Table 4. Risk Factors Affecting Overall Mortality Survivors Number of patients Age, years Female sex Indication of AADA Operation technique David operation Composite graft Application of circulatory arrest Operation timeb Cardiopulmonary bypass timeb Aortic clamping timeb a
Cox regression analysis.
b
Deceased
124 56 ⫾ 13 30 (24) 25 (20)
19 67 ⫾ 10 4 (21) 8 (42)
69 55 50 (40) 285 ⫾ 66 175 ⫾ 49 123 ⫾ 31
7 12 12 (63) 374 ⫾ 133 233 ⫾ 83 109 ⫾ 30
Univariate p Valuea
Mean time in minutes. Percentages are shown in parentheses.
AADA ⫽ acute type A aortic dissection.
Multivariate p Valuea
0.001 0.615 0.030 0.156
⬍0.001 0.216 0.007 0.102
0.083 ⬍0.001 ⬍0.001 0.043
0.816 0.983 0.201 0.980
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Number of patients Age, years Female sex Indication of AADA Operation technique David operation Composite graft Application of circulatory arrest a
Nonstrokes
Stroke
126 57 ⫾ 13 30 (24) 26 (21)
17 57 ⫾ 14 4 (24) 7 (41)
74 52 51 (40)
2 15 11 (65)
Univariate p Valuea
Multivariate p Valuea
0.915 0.503 0.016 0.009
0.156 0.462 0.026 0.007
0.267
0.331
Cox regression analysis. Percentages are shown in parentheses.
AADA ⫽ acute type A aortic dissection.
were more impaired in relation to physical functioning (p ⫽ 0.045), general health (p ⫽ 0.015), role emotional (p ⬍ 0.001), and mental health (p ⫽ 0.032). The group of patients above the age of 80 proved too small for statistical comparison. Forty patients from the composite group (59.7%) and 6 from the David group were able to hear heart valve noises (p ⬍ 0.001). Nineteen patients from the composite group (40.5%) and 3 from the David group (4.9%) reported feeling moderately or severely disturbed by this noise (p ⬍ 0.001). Despite preoperative patient information stating that mechanical heart valves have an extreme low risk of failure, and aortic valve reconstruction has an unpredictable individual risk for longevity, one half of the patients with composite grafts (n ⫽ 23, 50.0%), compared with only one fourth of patients after the David reconstructive procedure (n ⫽ 17, 22.4%), were afraid the reconstructed heart valve would fail (p ⫽ 0.020). Patients from the David group estimated their overall condition at 7.6 ⫾ 1.7, on a scale from 0 to 10, compared with 5.8 ⫾ 2.8 for patients belonging to the composite group (p ⫽ 0.001).
The comparison between the subgroup of patients with aortic aneurysm or aortic valve insufficiency, as an underlying disease only, also revealed a better QoL for recipients of the David operation, within all domains. Significantly better results were recorded in relation to physical functioning 78.0 ⫾ 22.3 versus 63.0 ⫾ 30.0 (p ⫽ 0.041); general health 68.5 ⫾ 18.4 versus 52.8 ⫾ 24.1 (p ⫽ 0.004); role emotional 86.4 ⫾ 29.6 versus 58.7 ⫾ 44.4 (p ⫽ 0.005); and mental health 78.0 ⫾ 14.5 versus 67.2 ⫾ 19.7 (p ⫽ 0.021; Fig 3). Within this subgroup, 1 of 48 patients (2.1%) who had undergone the David operation and 9 of 25 recipients (36%) of composite replacement surgery felt disturbed moderately or severely by heart valve noises (p ⬍ 0.001). Self-evaluation of their overall condition also confirmed significantly better results for patients recovering from the David operation within this subgroup (on a scale from 0 to 10, David group 7.7 ⫾ 1.7, composite group 5.7 ⫾ 2.9; p ⫽ 0.004).
Comment Aortic valve-sparing operations have been developing rapidly over recent years. Reported hospital mortality
Table 6. Risk Factors Affecting Serious Adverse Events During Follow-Upa
Number of patients Age, years Female sex Indication of AADA Operation technique David operation Composite graft Application of circulatory arrest
Non-SAE
SAE
109
25
56 ⫾ 13 27 (25) 21 (19)
61 ⫾ 13 7 (28) 9 (36)
66 43 39 (36)
8 17 17 (68)
Univariate Multivariate p Valueb p Valueb
0.068 0.761 0.017
0.005 0.201 0.012
0.093
0.108
0.085
0.798
a Serious adverse events (SAE) were defined as death, stroke embolic b events, or valve-related reoperation. Cox regression analysis. Percentages are shown in parentheses.
AADA ⫽ acute type A aortic dissection.
Fig 2. Quality of life data compared with the average findings for the East German population. Both the David and composite groups were compared using the unifactorial analysis of variance. Standard deviation is stated in the text. (BP ⫽ bodily pain; GH ⫽ general health; MH ⫽ mental health; PF ⫽ physical functioning; RE ⫽ role emotional; RP ⫽ role physical; SF ⫽ social function; VT ⫽ vitality.)
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Table 5. Risk Factors Affecting Occurrence of Stroke at Any Time After Aortic Root Operation
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ADULT CARDIAC Fig 3. Quality of life data relating to the subgroup of patients with aortic valve regurgitation or aortic aneurysm, or both, as underlying pathology only, compared with the East German population norms. The David and composite groups were compared using the unifactorial analysis of variance. Standard deviation is stated in the text. (BP ⫽ bodily pain; GH ⫽ general health; MH ⫽ mental health; PF ⫽ physical functioning; RE ⫽ role emotional; RP ⫽ role physical; SF ⫽ social function; VT ⫽ vitality.)
ranges from 0% to approximately 10%, depending on incidence of acute type A aortic dissection, emergency, mean age, and Marfan’s syndrome [3, 9 –12]. Correspondingly, 1-year survival rates of more than 90%, and 10-year survival rates of approximately 80%, can be achieved [3, 9, 12]. The longevity of reconstruction results are reported as extremely stable, offering a freedom from valve-related reoperation recorded at between 90% and 100% after 5 years, depending on the underlying valve pathology and the chosen surgical technique [3, 9, 12]. In 1999, we opted for the David technique as our standard aortic valve-sparing procedure owing to the possibility of usage in all valve pathologies. The comparative results of David and colleagues [3], who found that the remodeling technique generated a higher rate of reoperation due to anular dilation, justified this decision. However, a review conducted by Albes and coworkers [13] in 2005 concluded no valid differences between the two valvesparing operations. Despite the increasingly widespread use of aortic valve-sparing operations, the number of studies comparing the resultant data with that of the established composite replacement surgery, is very limited [14]. Correspondingly, combined replacement of aortic valve and root is assumed to be the gold standard in terms of safety, efficacy, and longevity [13]. Our study was initiated to extend our experience and knowledge of the David reconstruction in comparison with the gold standard. The valve-sparing David operation allowed for a better survival rate and a lower incidence of postoperative complications. The relatively high incidence of severe adverse events during the follow-up period (11% David group versus 28% composite group), may have been influenced by the high proportion of acute type A aortic dissection, as a significant multivariate factor for poor long-term prognosis.
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The second aim of this study was to analyze the postoperative QoL after aortic root surgery, depending on the technique utilized. One of the most important arguments supporting the practice of valve-sparing aortic operation is the improved QoL, without the necessity for anticoagulation therapy and higher exercise capacity. However, no publications evaluating QoL of patients after valve-sparing aortic root operations currently exist. For this study, we developed a questionnaire modifying the standard SF-36-form to include specific questions regarding QoL after valve replacement surgery. Patients who underwent the David operation demonstrated a better postoperative QoL, in 5 of 8 items as detailed in the SF-36 questionnaire. These patients were compromised only slightly when compared with the East German average for that age category. As reported by Sjogren and colleagues [5], in relation to elderly cardiac patients, David group participants experienced an even better outcome regarding bodily pain and mental health, when compared with the general population. Patients belonging to the composite group were recorded as being significantly more compromised in relation to all items of the SF-36. The higher incidence of postoperative complications, especially the higher stroke rate, might be influenced by this observation. Because of the potential influence of underlying disease on the postoperative QoL, we excluded all patients with aortic valve stenosis and type A acute aortic dissection for a subsequent subgroup analysis. The findings of this analysis did not differ from those of the entire group. In addition, patients with aortic aneurysm or aortic valve regurgitation only demonstrated a better QoL after the David procedure, compared with patients who had received composite replacement surgery. Additionally, David patients were less disturbed by valve noise and estimated their overall QoL higher on a scale of 1 to 10. These findings demonstrate significant anomalies, which are in sharp contrast to other studies concerned with postoperative QoL after valve surgery. Most studies found little or no distinction between the different collectives after heart valve surgery [8, 15]. Limitations of this study are predominantly caused by the single-center approach, which does not allow for prospective randomization. A registry for valve-sparing aortic operations could produce more valid results. In conclusion, this comparative study demonstrates beneficial outcomes for patients undergoing the valvesparing David operation, compared with the alternative composite replacement of the aortic root. The David operation proved superior both in relation to survival rates and incidence of complications in the early and midterm follow-up, as well as in postoperative QoL.
References 1. David TE, Feindel CM. An aortic valve-sparing operation for patients with aortic incompetence and aneurysm of the ascending aorta. J Thorac Cardiovasc Surg 1992;103:617–21. 2. Sarsam MA, Yacoub M. Remodeling of the aortic valve anulus. J Thorac Cardiovasc Surg 1993;105:435– 8.
3. David TE, Feindel CM, Webb GD, Colman JM, Armstrong S, Maganti M. Long-term results of aortic valve-sparing operations for aortic root aneurysm. J Thorac Cardiovasc Surg 2006;132:347–54. 4. Pacini D, Marco LD, Suarez SM, et al. Aortic valve-sparing operations: early and midterm results. Heart Surg Forum 2006;9:E650 – 6. 5. Sjogren J, Thulin LI. Quality of life in the very elderly after cardiac surgery: a comparison of SF-36 between long-term survivors and an age-matched population. Gerontology 2004;50:407–10. 6. Accola KD, Scott ML, Spector SD, et al. Is the St. Jude Medical mechanical valve an appropriate choice for elderly patients? A long-term retrospective study measuring quality of life. J Heart Valve Dis 2006;15:57– 66. 7. Sedrakyan A, Vaccarino V, Paltiel AD, et al. Age does not limit quality of life improvement in cardiac valve surgery. J Am Coll Cardiol 2003;42:1208 –14. 8. Sedrakyan A, Hebert P, Vaccarino V, et al. Quality of life after aortic valve replacement with tissue and mechanical implants. J Thorac Cardiovasc Surg 2004;128:266 –72. 9. Yacoub MH, Gehle P, Chandrasekaran V, Birks EJ, Child A, Radley-Smith R. Late results of a valve-preserving operation
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10. 11.
12.
13. 14.
15.
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in patients with aneurysms of the ascending aorta and root. J Thorac Cardiovasc Surg 1998;115:1080 –90. Kallenbach K, Hagl C, Walles T, et al. Results of valvesparing aortic root reconstruction in 158 consecutive patients. Ann Thorac Surg 2002;74:2026 –33. Karck M, Kallenbach K, Hagl C, Rhein C, Leyh R, Haverich A. Aortic root surgery in Marfan syndrome: comparison of aortic valve-sparing reimplantation versus composite grafting. J Thorac Cardiovasc Surg 2004;127:391– 8. Aicher D, Langer F, Kissinger A, Lausberg H, Fries R, Schäfers HJ. Valve-sparing aortic root replacement in bicuspid aortic valves: a reasonable option? J Thorac Cardiovasc Surg 2004;128:662– 8. Albes JM, Stock UA, Hartrumpf M. Restitution of the aortic valve: what is new, what is proven, and what is obsolete? Ann Thorac Surg 2005;80:1540 –9. Kallenbach K, Pethig K, Schwarz M, Milz A, Haverich A, Harringer W. Valve sparing aortic root reconstruction versus composite replacement: perioperative course and early complications. Eur J Cardiothorac Surg 2001;20:77– 81. Detter C, Deuse T, Boehm DH, Reichenspurner H, Reichart B. Midterm results and quality of life after minimally invasive versus conventional aortic valve replacement. Thorac Cardiovasc Surg 2002;50:337– 41.
Notice From the American Board of Thoracic Surgery Regarding Trainees and Candidates for Certification Who Are Called to Military Service Related to the War on Terrorism The Board appreciates the concern of those who have received emergency calls to military service. They may be assured that the Board will exercise the same sympathetic consideration as was given to candidates in recognition of their special contributions to their country during the Vietnam conflict and the Persian Gulf conflict with regard to applications, examinations, and interruption of training.
© 2010 by The Society of Thoracic Surgeons Published by Elsevier Inc
If you have any questions about how this might affect you, please call the Board office at (312) 202-5900. Valerie W. Rusch, MD Chair The American Board of Thoracic Surgery
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