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The David Procedure in Different Valve Pathologies: A Single-Center Experience in 236 Patients
Markus Liebrich, MD,* Marcin K. Kruszynski, MD,* Detlev Roser, MD, Christoph Meisner, PhD, Kai-Nicolas Doll, MD, Wolfgang B. Hemmer, MD, and Timo Weimar, MD Department of Cardiac Surgery, Sana Cardiac Surgery Stuttgart, Stuttgart, and Department of Medical Biometry, University of Tübingen, School of Medicine, Tübingen, Germany
Backround. Reports of the long-term outcome after the David procedure in different valve pathologies are limited. We compared our results in patients with tricuspid and bicuspid aortic valves, including those who required additional cusp repair. Methods. Between 1997 and 2011, 236 patients (76% males; mean age, 56 ⴞ 15; range, 12 to 79 years) underwent valve-sparing aortic root replacement (David procedure) for aortic regurgitation and were prospectively followed up clinically and echocardiographically. Results. The follow-up was 94% complete. Cumulative follow-up time was 896 patient-years (mean follow-up time, 4.5 ⴞ 2.7; range, 0.6 to 13.7 years). The 30-day mortality was 1.7% (4 of 236), and late mortality was 4% (10 of 232), with one cardiac-related death due to aortic valve regurgitation. Overall freedom from valve replacement was 94% and 87% at 5 and 10 years, respectively. In 201 patients with tricuspid aortic valves, freedom from
reoperation was 94% and 90% at 5 and 10 years, respectively. This was comparable to the 53 patients with bicuspid aortic valves, with a freedom from reoperation of 97% at 5 years (p ⴝ 0.632). Forty-two patients (18%) required additional cusp repair and had a 100% freedom from reoperation at 5 years. Overall, 10 patients (4%) required reoperation, with a mean interval of 11.5 ⴞ 10.7 months. Reasons for reoperation were recurrent aortic valve regurgitation grade II (n ⴝ 6), aortic stenosis (n ⴝ 2), endocarditis (n ⴝ 1), and a ruptured central plication (n ⴝ 1). Conclusions. The David procedure revealed excellent long-term outcomes independently from the valve morphology. Rates of reoperations and valve-related morbidity were acceptably low. Additional cusp repair was no predictor for failure of this procedure. (Ann Thorac Surg 2013;95:71– 6) © 2013 by The Society of Thoracic Surgeons
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permanent anticoagulation therapy and a superior hemodynamic performance are proposed benefits of this surgical technique; however, an increased risk of AV reoperation due to limited stability of the reconstructed AV might be a potential limitation, especially in certain patient subgroups presenting with a non-tricuspid AV [12]. The purpose of this study was to evaluate the longterm results of the David procedure in patients with tricuspid AV morphology compared with patients with a bicuspid AV and to assess if additional cusp repair is predictive of failure of the procedure.
n the past decade, valve-sparing aortic root replacement has been used increasingly as an alternative to prosthetic valve replacement for the treatment of concomitant pathology of the ascending aorta and the aortic valve (AV) [1]. AV-preserving techniques have been applied by remodeling of the aortic root or by reimplantation of the AV in a Dacron (DuPont, Wilmington, DE) graft to avoid the shortcomings of prosthetic heart valve replacement [2– 4]. Owing to the encouraging midterm valvular durability, indications for the David procedure have been expanded to bicuspid AVs, Marfan syndrome, Stanford type A acute aortic dissection, and autograft dilatation after the Ross operation [5–9]. However, data are conflicting about whether AV-sparing root procedures are superior to valve replacement and whether similar advantages to those of mitral valve reconstruction can be expected [1, 10, 11]. Freedom from the need for
Accepted for publication August 1, 2012. *Markus Liebrich and Marcin K. Kruszynski contributed equally to this work. Address correspondence to Dr Liebrich, Sana, Cardiac Surgery Stuttgart GmbH, Herdweg 2, 70174 Stuttgart, Germany; e-mail: m.liebrich@ sana.de.
© 2013 by The Society of Thoracic Surgeons Published by Elsevier Inc
Material and Methods This study was approved by the institutions Ethics Committee.
Patient Characteristics From August 1997 and January 2011, 2,36 patients (179 males; mean age, 56 ⫾ 15; range, 12 to 79 years) with various Dr Hemmer discloses a financial relationship with JOTEC Inc.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2012.08.010
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Table 1. Patient Characteristics Variablesa Isolated aneurysm of ascending aorta Stanford type A aortic dissection Acute Chronic Marfan syndrome Coronary artery disease Mitral valves disease Aortic arch aneurysm Ascending aorta max diameter, mm Annulus, mm Left ventricular ejection fraction
Tricuspid (n ⫽ 201)
Bicuspid (n ⫽ 35)
p Value
189 (94)
35 (100)
0.394
14 (7) 4 (2) 24 (12) 43 (21) 21 (10) 29 (14) 55.3 ⫾ 14.1
0 0 2 (6) 3 (9) 1 (3) 7 (20) 56.1 ⫾ 9.8
0.193 0.387 0.594 0.344 0.419 0.565 0.412
27.8 ⫾ 3.4 0.58 ⫾ 0.13
29.2 ⫾ 4.4 0.62 ⫾ 0.08
0.152 0.251
a Categoric data are shown as number (%) and continuous data as mean ⫾ standard deviation.
valve pathologies underwent aortic root replacement for aortic regurgitation using the David technique at Sana Cardiac Surgery Stuttgart. Patient demographics are summarized in Table 1.
Preoperative Assessment Transthoracic echocardiography, coronary angiogram, and computed tomography (CT) or magnetic resonance imaging scans were performed in selected patients. If transesophageal echocardiography (TEE) or CT scans revealed a Stanford type A acute aortic dissection, surgical therapy was initiated without further diagnostic procedures. A diagnosis of Marfan syndrome according to the Ghent nosology was known preoperatively or was confirmed through histopathologic examinations of the aortic wall [13]. Preoperative data are reported in Table 2. Indication for performing a David procedure was pathologically altered ascending aorta with dilated AV annulus. Absolute contraindications to the procedure were aortic cusps with large fenestrations, severe calcifications in bicuspid AV morphology, and an echocardiographically documented stenotic component of the AV [14].
3 to 5 mm. The aortic root was mobilized to a level just below the aortic annulus. In patients with tricuspid AV, a 28- or 30-mm Dacron graft was implanted to replace the ascending aorta. In patients with bicuspid AV, a larger graft prosthesis of 30 or 32 mm was used to comply with the typically slightly larger annulus and to avoid procedurerelated stenosis of the reconstructed AV. The proximal anastomosis was performed by horizontal U-stitch placed circumferentially through the left ventricular outflow tract using Teflon (DuPont) felts. The valve was then reimplanted into the prosthesis using a continuous suture line following the scalloped shape of the free margin of the native valve, allowing for correct cusp geometry and sufficient height of commissural resuspension within the prosthesis. The coronary ostia were implanted into the graft with a running suture. When additional replacement of the aortic arch was required, moderate hypothermic circulatory arrest (⬍ 28°C) with selective antegrade brain perfusion was initiated. In 6 patients (2.5%), a frozen elephant trunk was used (JOTEC Inc, Hechingen, Germany). Concomitant cardiac procedures were performed as needed and are reported in Table 3. Intraoperative TEE was used to assess valve function under physiologic hemodynamic conditions. Residual aortic regurgitation worse than grade I was considered not acceptable and a second reconstruction was attempted. No patient intended to treat required a prosthetic valve replacement at the time of the initial repair.
Operative Techniques for Cusp Repair In 42 patients, relevant prolapse of the free margin of 1 or 2 cusps was reconstructed by one of four options: a central plication along the nodule of Arantius (n ⫽ 31), a free margin reinforcement by weaving a double layer suture along the free margin (n ⫽ 7), a resuspension of the commissures (n ⫽ 3), or by narrowing of the commissures (n ⫽ 1) [16]. A reinforcement of the free margin of the aortic cusp with sutures was also used in the presence of stress fenestrations (n ⫽ 17, Fig 1A). In 34 patients, only 1 cusp had to be reconstructed; in TRICUSPID AV.
Table 2. Preoperative Clinical and Echocardiographic Data
Surgical Technique
Variables
In selected patients, a median sternotomy was performed and extracorporal circulation was established by cannulation of the ascending aorta and the right atrium. In patients with Stanford type A acute aortic dissection, the right subclavian artery was used for arterial cannulation before sternotomy. The procedure was routinely performed with moderate hypothermia, and myocardial protection was conducted with antegrade and retrograde intermittent cold blood cardioplegia. In all patients, the modified AV-sparing reimplantation technique, termed the David procedure, was performed as described previously [15]. After excision of the coronary ostia, the aortic sinuses were resected, leaving a remnant of
NYHA classification Grade I Grade II Grade III Grade IV Aortic valve insufficiency None or trace Grade I Grade II Grade III Grade IV
Tricuspid (n ⫽ 201) No. (%)
Bicuspid (n ⫽ 35) No. (%)
p Value
108 (54) 61 (30) 20 (10) 12 (6) 15 (7)
19 (54) 11 (32) 5 (14) 0 1 (2)
0.543 0.597 0.257 0.385 0.582
39 (19) 79 (39) 62 (30) 6 (3)
9 (26) 15 (43) 10 (29) 0
0.131 0.49 0.467 0.535
NYHA ⫽ New York Heart Association.
Table 3. Intraoperative Data Variablesa Size of vascular prosthesis, mm Additional procedures Coronary artery bypass grafting Mitral valve reconstruction Hemiarch replacement Full arch replacement Atrial septal defect closure Ventricular septal defect closure Tricuspid valve reconstruction Perfusion details Operation time, min Bypass time, min Cross-clamping time, min Circulatory arrest Duration of circulatory arrest, min
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Table 4. Cusp Pathology and Operative Techniques Tricuspid (n ⫽ 201)
Bicuspid (n ⫽ 35)
p Value
28.2 ⫾ 1.9
30.5 ⫾ 1.8
0.005
32 (16)
2 (6)
0.296
8 (4) 41 (20) 6 (3) 5 (2) 0
1 (3) 1 (3) 0 1 (3) 1 (3)
0.622 0.045 0.587 0.474 0.100
1 (0.5)
0
0.900
260 ⫾ 54 166 ⫾ 36 133 ⫾ 29 48 (24) 18 ⫾ 11
252 ⫾ 103 163 ⫾ 83 126 ⫾ 29 2 (6) 19 ⫾ 2
0.378 0.458 0.185 0.074 0.349
Continuous data are shown as mean ⫾ standard deviation and categoric data as number (%).
Variables Cusp pathology Prolapse Fenestration Calcification Operative techniques Central plication Free margin reinforcement Narrowing of commissures Resuspension of commissures Pericardial patch Diverse Number of reconstructed cusps One Two
Tricuspid (n ⫽ 201) No. (%)
Bicuspid (n ⫽ 35) No. (%)
p Value
42 (21) 17 (8) 11 (5)
24 (68) 0 5 (14)
⬍0.001 0.368 0.623
31 (15) 7 (3)
23 (66) 1 (3)
⬍0.001 0.223
1 (0.3)
0
...
3 (1)
0
...
4 (2) 3 (1)
0 0
... ...
34 (17) 8 (4)
10 (5) 14 (7)
0.344 ⬍0.001
a
8 patients, 2 cusps required intervention. The reference point for reconstruction was the cusp that had the highest free margin (Fig 1B). BICUSPID AV. Different anatomic variations of cusp fusion occur in patients with bicuspid AVs. Fusion of the right and left cusps was the most frequent form in our series (n ⫽ 32), in keeping with other published reports [17]. The aortic root geometry was typically asymmetric, with 2 rudimentary sinuses and a large noncoronary sinus. Dense fibrotic tissue or calcifications of the raphe between the left and right coronary sinus was repaired by triangular resection, readaption, and complete bicuspidalization with continuous sutures in a double-layer fashion (n ⫽ 11, Fig 1C). Prolapse of the free margin of the noncoronary cusp was seen in 23 patients and corrected
with commissural (n ⫽ 1) or central plication sutures (n ⫽ 22). In 10 patients, only 1 cusp had to be reconstructed; in 14 patients, both cusps. The details of cusp pathology and repair techniques are listed in Table 4. Obvious cusp prolapse was corrected before the AV-sparing reimplantation technique was performed. After the vascular graft was positioned, the AV geometry was reevaluated for cusp prolapse and any residual prolapse corrected. Gore-Tex sutures (W.L. Gore and Associates, Flagstaff, AZ) were used in all patients when cusp repair was indicated to avoid tear and damage of the cusp [18].
Follow-Up Clinical and echocardiographic data were collected prospectively at discharge, at 6 and 12 months, and annually thereafter. Follow-up consisted of in-house clinical examination and transthoracic echocardiography for determination of aortic regurgitation and peak and mean systolic
Fig 1. (A) Pericardial patching after resection of a calcified raphe between the left and right coronary leaflet. (B) Reimplanted tricuspid aortic valve. (C) Complete bicuspidalization in a bicuspid aortic valve Sievers type 1.
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Table 5. CHA2DS2-VASC Score
C H A2 D S2 V A Sc
Condition
Points
Congestive heart failure Hypertension ⬎140/90 mmHg Age ⱖ 75 years Diabetes Mellitus Prior Stroke Vascular disease Age 65–74 years Sex category (female sex)
1 1 2 1 2 1 1 1
gradients. Between the scheduled follow-up visits, contact was made with the referring physician to add clinically relevant information. Aortic regurgitation was defined as follows: I, mild; II, medium; III, moderate; and IV, severe [19]. Infectious, thromboembolic, and bleeding complications were recorded as recommended by published guidelines [20]. Patients were discharged with no anticoagulation if not indicated for other reasons.
Statistical Methods Subgroup comparisons were performed using the unpaired t tests for continuous variables, the Mann-Whitney U test for ordinal variables, and the 2 or Fisher exact test for categoric variables. Kaplan-Meier analysis was used for the evaluation of freedom from reoperation and freedom from aortic regurgitation. Subgroup comparisons were calculated by means of the log-rank test. Variables entered in the analysis of predictors for reoperation included age, sex, preoperative grade of AV regurgitation, AV morphology (tricuspid or bicuspid), Marfan syndrome, cusp calcification in bicuspid AVs, Stanford type A aortic dissection, or additional cusp repair. Continuous data are expressed as mean ⫾ standard deviation, unless otherwise specified. Data were analyzed by the department of medical biometry of the University of Tuebingen using JMP 8.0.1 software (SAS Institute Inc, Cary, NC).
Results Perioperative Outcome The AV was successfully reconstructed in all 236 patients. Overall 30-day mortality was 1.7% (4 of 236; elective operations: 3 of 222 [1.3%]; emergency operations: 1 of 14 [7%]). The causes of death in 1 patient each were global ventricular failure, right heart failure due to pulmonary embolism, multiple organ failure, and acute hemorrhagic pancreatitis. One valve-related death (0.4%) occurred in a patient who presented with an acute recurrence of AV regurgitation requiring reoperation with implantation of a biologic prosthesis 3 days after the initial procedure. Cause of death was the development of a massive systemic inflammatory response syndrome and consecutive multiorgan failure. No deaths occurred in the patient subgroup with bicuspid AV. Six patients (3.5%) required reexploration for bleeding. Myocardial revascularization was indicated in 2 patients
(0.9%) with severe ventricular arrhythmia intraoperatively with resulting ischemia. Neurologic complications were observed in 1 patient (0.4%) with additional replacement of the aortic arch who sustained a cerebral infarction with left-sided hemiplegia. Four patients (1.7%) had a transitory ischemic attack (TIA). Five patients (2.9%) required pacemaker implantation due to the development of grade III atrioventricular block. Mean intensive care unit length of stay was 1.9 ⫾ 2.1 days. Mean hospital stay was 12.3 ⫾ 4.1 days. At discharge, a properly functioning reconstructed valve with aortic regurgitation grade I or less was documented echocardiographically in all patients. The degree of regurgitation remained constant in most patients during follow-up. However, 10 patients (4.2%) had worsening aortic regurgitation requiring reoperation. Eight of these had tricuspid AVs. Patients with bicuspid AVs were younger (p ⬍ 0.001) and required additional reconstruction of pathologically altered cusps more often (p ⬍ 0.001). The length of time of aortic cross-clamp, circulatory arrest, and extracorporal circulation was significantly shorter in this patient group because they underwent fewer concomitant procedures (p ⬍ 0.001). At discharge, the degree of aortic regurgitation was reduced from preexisting 2.2 ⫾ 1.1 to 0.4 ⫾ 0.7 in patients with a tricuspid AV and from 1.9 ⫾ 1.0 to 0.4 ⫾ 0.6 in patients with a bicuspid AV. There was no significant difference at discharge in grade of regurgitation between patients with repaired tricuspid or bicuspid AVs (p ⫽ 0.354).
Long-Term Follow-Up Follow-up was 94% and totaled 896 patient-years, with a mean follow-up time of 4.5 ⫾ 2.9 years (range, 0.6 to 13.7 years). Ten patients (4%) died during follow-up. Causes of death were cancer in 3 patients and pneumonia, amyotrophic lateral sclerosis, multisystem organ failure, and a perforated aneurysm of the descending aorta in 1 patient each. One patient died after an operation on the descending aorta 7 years after the David procedure. The cause of death in 1 patient was unknown. Six patients (2.5%) had late complications. In 3 patients, cerebral hemorrhage occurred, all of whom were receiving warfarin therapy
Table 6. Anticoagulation Therapy Score
Anticoagulation
0 1
No antithrombotic therapy Oral anticoagulant
⬎2
Oral anticoagulant
Considerations No antithrombotic therapy Oral anticoagulant, either new oral anticoagulant drug or well-controlled warfarin at INR 2.0–3.0 (or aspirin 75– 325 mg daily) Oral anticoagulant, using either a new oral anticoagulant drug or wellcontrolled warfarin at INR 2.0–3.0
INR ⫽ international normalized ratio.
LIEBRICH ET AL THE DAVID PROCEDURE IN 236 PATIENTS
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Fig 2. Kaplan-Meier analysis of combined freedom from (A) aortic valve reoperation and (B) aortic regurgitation grade II or higher for patients with tricuspid valve (solid line) and bicuspid valve (broken line).
for CHA2DS2 (Tables 5 and 6) of 2 or higher [21]. Two patients had a TIA. One patient (0.4%) presented with late endocarditis of the reconstructed AV and required replacement of the AV with a stentless bioprosthesis 5 months after the initial operation. Overall freedom from valve replacement was 94% and 87% at 5 and 10 years, respectively (Fig 2A). In patients with tricuspid AV, freedom from aortic regurgitation grade II or higher was 94% and 91% and freedom from reoperations was 94% and 90% at 5 and 10 years, respectively (Fig 2B). This is comparable with a freedom from regurgitation grade II or higher of 97% and a freedom from reoperation of 94% at 5 years, respectively, in patients with bicuspid valve morphology (p ⫽ 0.629 and p ⫽ 0.632, respectively). Freedom from reoperation in patients without additional cusp repair was 92% and 87% at 5 and 10 years, respectively, which was not significantly different for patients who required additional cusp repair (freedom from reoperation 100% at 5 years, p ⫽ 0.211). In patients with Marfan syndrome, freedom from valve replacement and freedom from aortic regurgitation grade II and higher was 100% at 5 years. The preoperative degree of AV regurgitation was the only predictor for recurrent aortic regurgitation after the David procedure (grade 2.7 ⫾ 0.4 vs grade 2.1 ⫾ 1.0, p ⫽ 0.002). Reasons for reoperation were AV regurgitation due to degeneration of the AV and impossibility of repeat reconstruction in 6 patients, aortic valve stenosis in 2, late endocarditis in 1, and a ruptured central plication in 1. AV replacement in these patients was performed at a mean interval of 11.5 ⫾ 10.7 months after the initial operation, with no perioperative deaths.
Comment Indications for AV-sparing operations have steadily expanded to include patients with aneurysm of the ascending aorta, bicuspid AV, Marfan syndrome, Stanford type A dissection, and additional cusp pathologies [22]. This report confirms that a David procedure can be applied successfully in all of these pathologies without compromising the most important end points: freedom from reoperation and freedom from recurrent AV regurgitation. This was also true for patients with bicuspid AVs, who have not always been considered good candidates for valve-sparing procedures in the past [23].
Patients presenting with bicuspid AV were significantly younger (p ⫽ 0.001) than patients with tricuspid AV, a reflection of congenital AV disease [17]. This makes a reliable valve-sparing procedure the preferred option for this patient group because bioprostheses tend to show a faster degeneration rate in younger patients, whereas mechanical valves have a higher cumulative risk of thromboembolic and bleeding complications [10]. Our study had fewer patients with bicuspid than tricuspid valves. This can be explained by a lower prevalence of this morphology and by the fact that we initially performed AV reconstructive operations on undamaged tricuspid AVs and extended the indication to bicuspid AVs and additional cusp repair as we gained experience with this valve-sparing technique. The development of aortic aneurysm is strongly associated with bicuspid AV morphology [24]. This is independent of individual hemodynamic properties of the valve and also occurs after valve replacement [25]. We therefore lowered our threshold for replacement of the ascending aorta in these patients, which is in accordance with the observations of others [26]. In patients with bicuspid AV, a decrease in thickness of the aortic wall and the aortic annulus has been demonstrated, and dilatation of the ventricular-aortic junction with concomitant aortic regurgitation is common in these patients. The David procedure is felt to be an appropriate treatment for this indication [5]. However, because of the thin tissue, the sutures performed to avoid suture ruptures might have caused the more frequent requirement for pacemaker implantation in this patient subgroup (p ⫽ 0.007). Bicuspid AVs are also known to be associated with a higher risk for the development of valve stenosis after the David procedure. It is our policy, rather, to choose oversized Dacron grafts for these patients to avoid elevated transvalvular pressure gradients. Postoperative gradients in this series were low and, more important, remained constant throughout follow-up. Our results confirm previous reports that cusp pathology, such as fenestrations, prolapse, or fused cusps, should not be seen as a contraindication for an AVsparing operation [8]. Aicher and coworkers [27], who compared three different cusp repair techniques, revealed that different valve pathologies can be repaired successfully independently from the technique used. All patients with Stanford type A acute aortic dissection and significant aortic regurgitation showed none or trace regurgitation after the David procedure, and no
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patients required reoperation during follow-up. Our midterm and long-term results were comparable to those of a combined replacement of the AV and the ascending aorta [28]. Despite the complexity of the operation, it could also be performed with low morbidity and mortality in emergency cases. Earlier concerns that AV reconstruction was not suitable in Marfan patients due to the fibrillin defect have been rejected [29]. It is assumed that the reimplantation technique of the AV stabilizes the annulus and prevents further root dilatation in these patients [30]. For this reason, we also performed a reimplantation of the AV in patients with Marfan syndrome and concomitant aortic root aneurysm even if AV regurgitation was not present. Long-term results showed a stable valve performance and confirmed our policy for Marfan patients. Many studies have identified that neurologic disorders contribute significantly to morbidity and mortality after operations on the aorta. Operations of the ascending aorta and aortic arch have been identified as a risk factor for stroke. Postoperative stroke occurred in only 1 patient in our series, whereas 4 patients with TIA recovered by the time of discharge. Nötzold and colleagues [31] were able to demonstrate that the AV-sparing technique is more beneficial for cerebral blood flow because mechanical valves, even with anticoagulation, cause a significantly higher rate of microemboli than reconstructed valves. Cerebral hemorrhagic episodes occurred in 3 patients during the long-term follow-up who were anticoagulated for a CHA2DS2-VASC exceeding 2 or atrial fibrillation. In conclusion, the David procedure shows excellent long-term results irrespectively of the underlying valve pathology. Moreover, this technique can be performed with a low risk of valve-related morbidity and death. A high rate of freedom from reoperation is attained in both elective and emergency operations. The procedure should be also considered in patients with bicuspid AVs and patients requiring concomitant procedures.
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8. De Kerchove L, Boodhwani M, Glineur D, et al. Cusp prolapse repair in trileaflet aortic valves: free margin plication and free margin resuspension techniques. Ann Thorac Surg 2009;88:455– 61. 9. Petterson GB, Subramanian S, Flynn M, et al. Reoperations after the Ross procedure in adults: towards autograftsparing/Ross reversal. J Heart Valve Dis 2011;20:425–32. 10. Etz CD, Homann TM, Silovitz D, et al. Long-term survival after the Bentall procedure in 206 patients with bicuspid aortic valve. Ann Thorac Surg 2007;84:1186 –93. 11. Adams DH, Rosenhek R, Falk V. Degenerative mitral valve repair: best practice revolution. Eur Heart J 2010;31:1958 – 66. 12. Hanke T, Charitos E, Stierle U, et al. Factors associated with the development of aortic valve regurgitation over time after two different techniques of valve-sparing aortic root surgery. J Thorac Cardiovasc Surg 2009;137:314 –9. 13. Loeys BL, Dietz HC, Braverman AC, et al. The revised Ghent nosology for the Marfan syndrome. J Med Genet 2010;47: 476 – 85. 14. Hiratzka LF, Bakris GL, Beckman JA, et al. Guidelines for the diagnosis and management of patients with thoracic aortic disease. J Am Coll Cardiol 2010;55:e27– e129. 15. Shrestha M, Baraki H, Maeding I, et al. Long-term results after aortic valve-sparing operation (David I). Eur J Cardiothorac Surg 2012;41:56 – 61. 16. Pettersson GB, Crucean AC, Savage R, et al. Towards predictable repair of regurgitant aortic valves. J Am Coll Cardiol 2008;52:40 –9. 17. Sievers HH, Schmidtke C. A classification system for the bicuspid aortic valve from 304 surgical specimens. J Thorac Cardiovasc Surg 2007;133:1226 –33. 18. David TE, Armstrong S. Aortic cusp repair with Gore-Tex sutures during aortic valve-sparing operations. J Thorac Cardiovasc Surg 2010;139:1340 –2. 19. Wilkenshoff UM, Kruck I, Gast D, et al. Validity of continuos wave Doppler and colour Doppler in the assessment of aortic regurgitation. Eur Heart J 1994;15:1227–34. 20. Akins CW, Miller DC, Turina MI, et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions. Ann Thorac Surg 2008;85:1490 –5. 21. Lip GY, Nieuwlaat R, Pisters R, et al. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach. Chest 2010;137:263–72. 22. Albes JM. Aortic valve reconstruction: why, when, and how? Thorac Cardiovasc Surg 2010;58:61– 8. 23. Davierwala PM, David TE, Armstrong S, et al. Aortic valve repair versus replacement in bicuspid aortic valve disease. J Heart Valve Dis 2003;12:679 – 86. 24. Svensson LG, Rodriguez ER. Aortic organ disease epidemic, and why do balloons pop? Circulation 2005;112:1082– 4. 25. Yasuda H, Nakatani S, Stugaard M, et al. Failure to prevent progressive dilation of ascending aorta by aortic valve replacement in patients with bicuspid aortic valve: comparison with tricuspid aortic valve. Circulation 2003;108:II291– 4. 26. Svensson LG, Kim KH, Blackstone EH, et al. Bicuspid aortic valve surgery with proactive ascending aorta repair. J Thorac Cardiovasc Surg 2011;142:622–9. 27. Aicher D, Langer F, Adam O, et al. Cusp repair in aortic valve reconstruction: does the technique affect stability? J Thorac Cardiovasc Surg 2007;134:1533–9. 28. Mingke D, Dresler C, Stone CD, et al. Composite graft replacement of the aortic root in 335 patients with aneurysm or dissection. Thorac Cardiovasc Surg 1998;46:12–9. 29. Benedetto U, Melina G, Takkenberg JJ, et al. Surgical management of aortic root disease in Marfan syndrome: a systematic review and meta-analysis. Heart 2011;97:955– 8. 30. Bernhardt AM, Treede H, Rybcznski M, et al. Comparison of aortic root replacement in patients with Marfan syndrome. Eur J Cardiothorac Surg 2011;40:1052–7. 31. Nötzold A, Gerriets T, Eggers J, et al. Circulating microemboli after composite replacement or valve-sparing aortic root surgery. Thorac Cardiovasc Surg 2002;50:141– 4.
Backround. Reports of the long-term outcome after the David procedure in different valve pathologies are limited. We compared our results in patients with tricuspid and bicuspid aortic valves, including those who required additional cusp repair. Methods. Between 1997 and 2011, 236 patients (76% males; mean age, 56 ⴞ 15; range, 12 to 79 years) underwent valve-sparing aortic root replacement (David procedure) for aortic regurgitation and were prospectively followed up clinically and echocardiographically. Results. The follow-up was 94% complete. Cumulative follow-up time was 896 patient-years (mean follow-up time, 4.5 ⴞ 2.7; range, 0.6 to 13.7 years). The 30-day mortality was 1.7% (4 of 236), and late mortality was 4% (10 of 232), with one cardiac-related death due to aortic valve regurgitation. Overall freedom from valve replacement was 94% and 87% at 5 and 10 years, respectively. In 201 patients with tricuspid aortic valves, freedom from
reoperation was 94% and 90% at 5 and 10 years, respectively. This was comparable to the 53 patients with bicuspid aortic valves, with a freedom from reoperation of 97% at 5 years (p ⴝ 0.632). Forty-two patients (18%) required additional cusp repair and had a 100% freedom from reoperation at 5 years. Overall, 10 patients (4%) required reoperation, with a mean interval of 11.5 ⴞ 10.7 months. Reasons for reoperation were recurrent aortic valve regurgitation grade II (n ⴝ 6), aortic stenosis (n ⴝ 2), endocarditis (n ⴝ 1), and a ruptured central plication (n ⴝ 1). Conclusions. The David procedure revealed excellent long-term outcomes independently from the valve morphology. Rates of reoperations and valve-related morbidity were acceptably low. Additional cusp repair was no predictor for failure of this procedure. (Ann Thorac Surg 2013;95:71– 6) © 2013 by The Society of Thoracic Surgeons
I
permanent anticoagulation therapy and a superior hemodynamic performance are proposed benefits of this surgical technique; however, an increased risk of AV reoperation due to limited stability of the reconstructed AV might be a potential limitation, especially in certain patient subgroups presenting with a non-tricuspid AV [12]. The purpose of this study was to evaluate the longterm results of the David procedure in patients with tricuspid AV morphology compared with patients with a bicuspid AV and to assess if additional cusp repair is predictive of failure of the procedure.
n the past decade, valve-sparing aortic root replacement has been used increasingly as an alternative to prosthetic valve replacement for the treatment of concomitant pathology of the ascending aorta and the aortic valve (AV) [1]. AV-preserving techniques have been applied by remodeling of the aortic root or by reimplantation of the AV in a Dacron (DuPont, Wilmington, DE) graft to avoid the shortcomings of prosthetic heart valve replacement [2– 4]. Owing to the encouraging midterm valvular durability, indications for the David procedure have been expanded to bicuspid AVs, Marfan syndrome, Stanford type A acute aortic dissection, and autograft dilatation after the Ross operation [5–9]. However, data are conflicting about whether AV-sparing root procedures are superior to valve replacement and whether similar advantages to those of mitral valve reconstruction can be expected [1, 10, 11]. Freedom from the need for
Accepted for publication August 1, 2012. *Markus Liebrich and Marcin K. Kruszynski contributed equally to this work. Address correspondence to Dr Liebrich, Sana, Cardiac Surgery Stuttgart GmbH, Herdweg 2, 70174 Stuttgart, Germany; e-mail: m.liebrich@ sana.de.
© 2013 by The Society of Thoracic Surgeons Published by Elsevier Inc
Material and Methods This study was approved by the institutions Ethics Committee.
Patient Characteristics From August 1997 and January 2011, 2,36 patients (179 males; mean age, 56 ⫾ 15; range, 12 to 79 years) with various Dr Hemmer discloses a financial relationship with JOTEC Inc.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2012.08.010
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Table 1. Patient Characteristics Variablesa Isolated aneurysm of ascending aorta Stanford type A aortic dissection Acute Chronic Marfan syndrome Coronary artery disease Mitral valves disease Aortic arch aneurysm Ascending aorta max diameter, mm Annulus, mm Left ventricular ejection fraction
Tricuspid (n ⫽ 201)
Bicuspid (n ⫽ 35)
p Value
189 (94)
35 (100)
0.394
14 (7) 4 (2) 24 (12) 43 (21) 21 (10) 29 (14) 55.3 ⫾ 14.1
0 0 2 (6) 3 (9) 1 (3) 7 (20) 56.1 ⫾ 9.8
0.193 0.387 0.594 0.344 0.419 0.565 0.412
27.8 ⫾ 3.4 0.58 ⫾ 0.13
29.2 ⫾ 4.4 0.62 ⫾ 0.08
0.152 0.251
a Categoric data are shown as number (%) and continuous data as mean ⫾ standard deviation.
valve pathologies underwent aortic root replacement for aortic regurgitation using the David technique at Sana Cardiac Surgery Stuttgart. Patient demographics are summarized in Table 1.
Preoperative Assessment Transthoracic echocardiography, coronary angiogram, and computed tomography (CT) or magnetic resonance imaging scans were performed in selected patients. If transesophageal echocardiography (TEE) or CT scans revealed a Stanford type A acute aortic dissection, surgical therapy was initiated without further diagnostic procedures. A diagnosis of Marfan syndrome according to the Ghent nosology was known preoperatively or was confirmed through histopathologic examinations of the aortic wall [13]. Preoperative data are reported in Table 2. Indication for performing a David procedure was pathologically altered ascending aorta with dilated AV annulus. Absolute contraindications to the procedure were aortic cusps with large fenestrations, severe calcifications in bicuspid AV morphology, and an echocardiographically documented stenotic component of the AV [14].
3 to 5 mm. The aortic root was mobilized to a level just below the aortic annulus. In patients with tricuspid AV, a 28- or 30-mm Dacron graft was implanted to replace the ascending aorta. In patients with bicuspid AV, a larger graft prosthesis of 30 or 32 mm was used to comply with the typically slightly larger annulus and to avoid procedurerelated stenosis of the reconstructed AV. The proximal anastomosis was performed by horizontal U-stitch placed circumferentially through the left ventricular outflow tract using Teflon (DuPont) felts. The valve was then reimplanted into the prosthesis using a continuous suture line following the scalloped shape of the free margin of the native valve, allowing for correct cusp geometry and sufficient height of commissural resuspension within the prosthesis. The coronary ostia were implanted into the graft with a running suture. When additional replacement of the aortic arch was required, moderate hypothermic circulatory arrest (⬍ 28°C) with selective antegrade brain perfusion was initiated. In 6 patients (2.5%), a frozen elephant trunk was used (JOTEC Inc, Hechingen, Germany). Concomitant cardiac procedures were performed as needed and are reported in Table 3. Intraoperative TEE was used to assess valve function under physiologic hemodynamic conditions. Residual aortic regurgitation worse than grade I was considered not acceptable and a second reconstruction was attempted. No patient intended to treat required a prosthetic valve replacement at the time of the initial repair.
Operative Techniques for Cusp Repair In 42 patients, relevant prolapse of the free margin of 1 or 2 cusps was reconstructed by one of four options: a central plication along the nodule of Arantius (n ⫽ 31), a free margin reinforcement by weaving a double layer suture along the free margin (n ⫽ 7), a resuspension of the commissures (n ⫽ 3), or by narrowing of the commissures (n ⫽ 1) [16]. A reinforcement of the free margin of the aortic cusp with sutures was also used in the presence of stress fenestrations (n ⫽ 17, Fig 1A). In 34 patients, only 1 cusp had to be reconstructed; in TRICUSPID AV.
Table 2. Preoperative Clinical and Echocardiographic Data
Surgical Technique
Variables
In selected patients, a median sternotomy was performed and extracorporal circulation was established by cannulation of the ascending aorta and the right atrium. In patients with Stanford type A acute aortic dissection, the right subclavian artery was used for arterial cannulation before sternotomy. The procedure was routinely performed with moderate hypothermia, and myocardial protection was conducted with antegrade and retrograde intermittent cold blood cardioplegia. In all patients, the modified AV-sparing reimplantation technique, termed the David procedure, was performed as described previously [15]. After excision of the coronary ostia, the aortic sinuses were resected, leaving a remnant of
NYHA classification Grade I Grade II Grade III Grade IV Aortic valve insufficiency None or trace Grade I Grade II Grade III Grade IV
Tricuspid (n ⫽ 201) No. (%)
Bicuspid (n ⫽ 35) No. (%)
p Value
108 (54) 61 (30) 20 (10) 12 (6) 15 (7)
19 (54) 11 (32) 5 (14) 0 1 (2)
0.543 0.597 0.257 0.385 0.582
39 (19) 79 (39) 62 (30) 6 (3)
9 (26) 15 (43) 10 (29) 0
0.131 0.49 0.467 0.535
NYHA ⫽ New York Heart Association.
Table 3. Intraoperative Data Variablesa Size of vascular prosthesis, mm Additional procedures Coronary artery bypass grafting Mitral valve reconstruction Hemiarch replacement Full arch replacement Atrial septal defect closure Ventricular septal defect closure Tricuspid valve reconstruction Perfusion details Operation time, min Bypass time, min Cross-clamping time, min Circulatory arrest Duration of circulatory arrest, min
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Table 4. Cusp Pathology and Operative Techniques Tricuspid (n ⫽ 201)
Bicuspid (n ⫽ 35)
p Value
28.2 ⫾ 1.9
30.5 ⫾ 1.8
0.005
32 (16)
2 (6)
0.296
8 (4) 41 (20) 6 (3) 5 (2) 0
1 (3) 1 (3) 0 1 (3) 1 (3)
0.622 0.045 0.587 0.474 0.100
1 (0.5)
0
0.900
260 ⫾ 54 166 ⫾ 36 133 ⫾ 29 48 (24) 18 ⫾ 11
252 ⫾ 103 163 ⫾ 83 126 ⫾ 29 2 (6) 19 ⫾ 2
0.378 0.458 0.185 0.074 0.349
Continuous data are shown as mean ⫾ standard deviation and categoric data as number (%).
Variables Cusp pathology Prolapse Fenestration Calcification Operative techniques Central plication Free margin reinforcement Narrowing of commissures Resuspension of commissures Pericardial patch Diverse Number of reconstructed cusps One Two
Tricuspid (n ⫽ 201) No. (%)
Bicuspid (n ⫽ 35) No. (%)
p Value
42 (21) 17 (8) 11 (5)
24 (68) 0 5 (14)
⬍0.001 0.368 0.623
31 (15) 7 (3)
23 (66) 1 (3)
⬍0.001 0.223
1 (0.3)
0
...
3 (1)
0
...
4 (2) 3 (1)
0 0
... ...
34 (17) 8 (4)
10 (5) 14 (7)
0.344 ⬍0.001
a
8 patients, 2 cusps required intervention. The reference point for reconstruction was the cusp that had the highest free margin (Fig 1B). BICUSPID AV. Different anatomic variations of cusp fusion occur in patients with bicuspid AVs. Fusion of the right and left cusps was the most frequent form in our series (n ⫽ 32), in keeping with other published reports [17]. The aortic root geometry was typically asymmetric, with 2 rudimentary sinuses and a large noncoronary sinus. Dense fibrotic tissue or calcifications of the raphe between the left and right coronary sinus was repaired by triangular resection, readaption, and complete bicuspidalization with continuous sutures in a double-layer fashion (n ⫽ 11, Fig 1C). Prolapse of the free margin of the noncoronary cusp was seen in 23 patients and corrected
with commissural (n ⫽ 1) or central plication sutures (n ⫽ 22). In 10 patients, only 1 cusp had to be reconstructed; in 14 patients, both cusps. The details of cusp pathology and repair techniques are listed in Table 4. Obvious cusp prolapse was corrected before the AV-sparing reimplantation technique was performed. After the vascular graft was positioned, the AV geometry was reevaluated for cusp prolapse and any residual prolapse corrected. Gore-Tex sutures (W.L. Gore and Associates, Flagstaff, AZ) were used in all patients when cusp repair was indicated to avoid tear and damage of the cusp [18].
Follow-Up Clinical and echocardiographic data were collected prospectively at discharge, at 6 and 12 months, and annually thereafter. Follow-up consisted of in-house clinical examination and transthoracic echocardiography for determination of aortic regurgitation and peak and mean systolic
Fig 1. (A) Pericardial patching after resection of a calcified raphe between the left and right coronary leaflet. (B) Reimplanted tricuspid aortic valve. (C) Complete bicuspidalization in a bicuspid aortic valve Sievers type 1.
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Table 5. CHA2DS2-VASC Score
C H A2 D S2 V A Sc
Condition
Points
Congestive heart failure Hypertension ⬎140/90 mmHg Age ⱖ 75 years Diabetes Mellitus Prior Stroke Vascular disease Age 65–74 years Sex category (female sex)
1 1 2 1 2 1 1 1
gradients. Between the scheduled follow-up visits, contact was made with the referring physician to add clinically relevant information. Aortic regurgitation was defined as follows: I, mild; II, medium; III, moderate; and IV, severe [19]. Infectious, thromboembolic, and bleeding complications were recorded as recommended by published guidelines [20]. Patients were discharged with no anticoagulation if not indicated for other reasons.
Statistical Methods Subgroup comparisons were performed using the unpaired t tests for continuous variables, the Mann-Whitney U test for ordinal variables, and the 2 or Fisher exact test for categoric variables. Kaplan-Meier analysis was used for the evaluation of freedom from reoperation and freedom from aortic regurgitation. Subgroup comparisons were calculated by means of the log-rank test. Variables entered in the analysis of predictors for reoperation included age, sex, preoperative grade of AV regurgitation, AV morphology (tricuspid or bicuspid), Marfan syndrome, cusp calcification in bicuspid AVs, Stanford type A aortic dissection, or additional cusp repair. Continuous data are expressed as mean ⫾ standard deviation, unless otherwise specified. Data were analyzed by the department of medical biometry of the University of Tuebingen using JMP 8.0.1 software (SAS Institute Inc, Cary, NC).
Results Perioperative Outcome The AV was successfully reconstructed in all 236 patients. Overall 30-day mortality was 1.7% (4 of 236; elective operations: 3 of 222 [1.3%]; emergency operations: 1 of 14 [7%]). The causes of death in 1 patient each were global ventricular failure, right heart failure due to pulmonary embolism, multiple organ failure, and acute hemorrhagic pancreatitis. One valve-related death (0.4%) occurred in a patient who presented with an acute recurrence of AV regurgitation requiring reoperation with implantation of a biologic prosthesis 3 days after the initial procedure. Cause of death was the development of a massive systemic inflammatory response syndrome and consecutive multiorgan failure. No deaths occurred in the patient subgroup with bicuspid AV. Six patients (3.5%) required reexploration for bleeding. Myocardial revascularization was indicated in 2 patients
(0.9%) with severe ventricular arrhythmia intraoperatively with resulting ischemia. Neurologic complications were observed in 1 patient (0.4%) with additional replacement of the aortic arch who sustained a cerebral infarction with left-sided hemiplegia. Four patients (1.7%) had a transitory ischemic attack (TIA). Five patients (2.9%) required pacemaker implantation due to the development of grade III atrioventricular block. Mean intensive care unit length of stay was 1.9 ⫾ 2.1 days. Mean hospital stay was 12.3 ⫾ 4.1 days. At discharge, a properly functioning reconstructed valve with aortic regurgitation grade I or less was documented echocardiographically in all patients. The degree of regurgitation remained constant in most patients during follow-up. However, 10 patients (4.2%) had worsening aortic regurgitation requiring reoperation. Eight of these had tricuspid AVs. Patients with bicuspid AVs were younger (p ⬍ 0.001) and required additional reconstruction of pathologically altered cusps more often (p ⬍ 0.001). The length of time of aortic cross-clamp, circulatory arrest, and extracorporal circulation was significantly shorter in this patient group because they underwent fewer concomitant procedures (p ⬍ 0.001). At discharge, the degree of aortic regurgitation was reduced from preexisting 2.2 ⫾ 1.1 to 0.4 ⫾ 0.7 in patients with a tricuspid AV and from 1.9 ⫾ 1.0 to 0.4 ⫾ 0.6 in patients with a bicuspid AV. There was no significant difference at discharge in grade of regurgitation between patients with repaired tricuspid or bicuspid AVs (p ⫽ 0.354).
Long-Term Follow-Up Follow-up was 94% and totaled 896 patient-years, with a mean follow-up time of 4.5 ⫾ 2.9 years (range, 0.6 to 13.7 years). Ten patients (4%) died during follow-up. Causes of death were cancer in 3 patients and pneumonia, amyotrophic lateral sclerosis, multisystem organ failure, and a perforated aneurysm of the descending aorta in 1 patient each. One patient died after an operation on the descending aorta 7 years after the David procedure. The cause of death in 1 patient was unknown. Six patients (2.5%) had late complications. In 3 patients, cerebral hemorrhage occurred, all of whom were receiving warfarin therapy
Table 6. Anticoagulation Therapy Score
Anticoagulation
0 1
No antithrombotic therapy Oral anticoagulant
⬎2
Oral anticoagulant
Considerations No antithrombotic therapy Oral anticoagulant, either new oral anticoagulant drug or well-controlled warfarin at INR 2.0–3.0 (or aspirin 75– 325 mg daily) Oral anticoagulant, using either a new oral anticoagulant drug or wellcontrolled warfarin at INR 2.0–3.0
INR ⫽ international normalized ratio.
LIEBRICH ET AL THE DAVID PROCEDURE IN 236 PATIENTS
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Fig 2. Kaplan-Meier analysis of combined freedom from (A) aortic valve reoperation and (B) aortic regurgitation grade II or higher for patients with tricuspid valve (solid line) and bicuspid valve (broken line).
for CHA2DS2 (Tables 5 and 6) of 2 or higher [21]. Two patients had a TIA. One patient (0.4%) presented with late endocarditis of the reconstructed AV and required replacement of the AV with a stentless bioprosthesis 5 months after the initial operation. Overall freedom from valve replacement was 94% and 87% at 5 and 10 years, respectively (Fig 2A). In patients with tricuspid AV, freedom from aortic regurgitation grade II or higher was 94% and 91% and freedom from reoperations was 94% and 90% at 5 and 10 years, respectively (Fig 2B). This is comparable with a freedom from regurgitation grade II or higher of 97% and a freedom from reoperation of 94% at 5 years, respectively, in patients with bicuspid valve morphology (p ⫽ 0.629 and p ⫽ 0.632, respectively). Freedom from reoperation in patients without additional cusp repair was 92% and 87% at 5 and 10 years, respectively, which was not significantly different for patients who required additional cusp repair (freedom from reoperation 100% at 5 years, p ⫽ 0.211). In patients with Marfan syndrome, freedom from valve replacement and freedom from aortic regurgitation grade II and higher was 100% at 5 years. The preoperative degree of AV regurgitation was the only predictor for recurrent aortic regurgitation after the David procedure (grade 2.7 ⫾ 0.4 vs grade 2.1 ⫾ 1.0, p ⫽ 0.002). Reasons for reoperation were AV regurgitation due to degeneration of the AV and impossibility of repeat reconstruction in 6 patients, aortic valve stenosis in 2, late endocarditis in 1, and a ruptured central plication in 1. AV replacement in these patients was performed at a mean interval of 11.5 ⫾ 10.7 months after the initial operation, with no perioperative deaths.
Comment Indications for AV-sparing operations have steadily expanded to include patients with aneurysm of the ascending aorta, bicuspid AV, Marfan syndrome, Stanford type A dissection, and additional cusp pathologies [22]. This report confirms that a David procedure can be applied successfully in all of these pathologies without compromising the most important end points: freedom from reoperation and freedom from recurrent AV regurgitation. This was also true for patients with bicuspid AVs, who have not always been considered good candidates for valve-sparing procedures in the past [23].
Patients presenting with bicuspid AV were significantly younger (p ⫽ 0.001) than patients with tricuspid AV, a reflection of congenital AV disease [17]. This makes a reliable valve-sparing procedure the preferred option for this patient group because bioprostheses tend to show a faster degeneration rate in younger patients, whereas mechanical valves have a higher cumulative risk of thromboembolic and bleeding complications [10]. Our study had fewer patients with bicuspid than tricuspid valves. This can be explained by a lower prevalence of this morphology and by the fact that we initially performed AV reconstructive operations on undamaged tricuspid AVs and extended the indication to bicuspid AVs and additional cusp repair as we gained experience with this valve-sparing technique. The development of aortic aneurysm is strongly associated with bicuspid AV morphology [24]. This is independent of individual hemodynamic properties of the valve and also occurs after valve replacement [25]. We therefore lowered our threshold for replacement of the ascending aorta in these patients, which is in accordance with the observations of others [26]. In patients with bicuspid AV, a decrease in thickness of the aortic wall and the aortic annulus has been demonstrated, and dilatation of the ventricular-aortic junction with concomitant aortic regurgitation is common in these patients. The David procedure is felt to be an appropriate treatment for this indication [5]. However, because of the thin tissue, the sutures performed to avoid suture ruptures might have caused the more frequent requirement for pacemaker implantation in this patient subgroup (p ⫽ 0.007). Bicuspid AVs are also known to be associated with a higher risk for the development of valve stenosis after the David procedure. It is our policy, rather, to choose oversized Dacron grafts for these patients to avoid elevated transvalvular pressure gradients. Postoperative gradients in this series were low and, more important, remained constant throughout follow-up. Our results confirm previous reports that cusp pathology, such as fenestrations, prolapse, or fused cusps, should not be seen as a contraindication for an AVsparing operation [8]. Aicher and coworkers [27], who compared three different cusp repair techniques, revealed that different valve pathologies can be repaired successfully independently from the technique used. All patients with Stanford type A acute aortic dissection and significant aortic regurgitation showed none or trace regurgitation after the David procedure, and no
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patients required reoperation during follow-up. Our midterm and long-term results were comparable to those of a combined replacement of the AV and the ascending aorta [28]. Despite the complexity of the operation, it could also be performed with low morbidity and mortality in emergency cases. Earlier concerns that AV reconstruction was not suitable in Marfan patients due to the fibrillin defect have been rejected [29]. It is assumed that the reimplantation technique of the AV stabilizes the annulus and prevents further root dilatation in these patients [30]. For this reason, we also performed a reimplantation of the AV in patients with Marfan syndrome and concomitant aortic root aneurysm even if AV regurgitation was not present. Long-term results showed a stable valve performance and confirmed our policy for Marfan patients. Many studies have identified that neurologic disorders contribute significantly to morbidity and mortality after operations on the aorta. Operations of the ascending aorta and aortic arch have been identified as a risk factor for stroke. Postoperative stroke occurred in only 1 patient in our series, whereas 4 patients with TIA recovered by the time of discharge. Nötzold and colleagues [31] were able to demonstrate that the AV-sparing technique is more beneficial for cerebral blood flow because mechanical valves, even with anticoagulation, cause a significantly higher rate of microemboli than reconstructed valves. Cerebral hemorrhagic episodes occurred in 3 patients during the long-term follow-up who were anticoagulated for a CHA2DS2-VASC exceeding 2 or atrial fibrillation. In conclusion, the David procedure shows excellent long-term results irrespectively of the underlying valve pathology. Moreover, this technique can be performed with a low risk of valve-related morbidity and death. A high rate of freedom from reoperation is attained in both elective and emergency operations. The procedure should be also considered in patients with bicuspid AVs and patients requiring concomitant procedures.
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