Interact CardioVasc Thorac Surg 2009;9:113-116. doi:10.1510/icvts.2009.202622
© 2009 European Association of Cardio-Thoracic Surgery
ESCVS article - Aortic and aneurysmal |
Reimplantation valve-sparing aortic root replacement with the Valsalva graft: what have we learnt after 100 cases?
Fabrizio Settepani*,
Marcello Bergonzini,
Alessandro Barbone,
Enrico Citterio,
Alessio Basciu,
Diego Ornaghi,
Roberto Gallotti and
Giuseppe Tarelli
Department of Cardiac Surgery, Istituto Clinico Humanitas, Via Manzoni 56, cap: 20089, Rozzano (MI), Italy
Received 13 January 2009;
received in revised form 3 April 2009;
accepted 6 April 2009
 Presented at the 57th International Congress of the European Society for Cardiovascular Surgery, Barcelona, Spain, April 24–27, 2008.
*Corresponding author. Tel.: +39-02-82244602; fax: +39-02-82244691.
E-mail address: fabrizio.settepani{at}humanitas.it (F. Settepani).
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Abstract
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Objectives: Reimplantation valve-sparing aortic root replacement has been increasingly performed with improving perioperative and mid-term results. The success of this operation primarily depends on preserving the highly sophisticated dynamic function of the aortic valve by recreating an anatomical three-dimensional configuration similar to the normal aortic root, thus minimizing the mechanical stress and strain on the cusps. Over the years several techniques have been proposed to reproduce the sinuses of Valsalva. We reviewed our experience with aortic valve reimplantation by means of a modified Dacron graft that incorporates sinuses of Valsalva, in a series of 100 consecutive patients. Methods: During a 60-month period, 100 patients with aortic root aneurysm underwent aortic valve reimplantation using the Gelweave ValsalvaTM prosthesis. There were 74 males and the mean age was 60±12 years (range 28–83 years). Five patients had the Marfan's syndrome, 15 had a bicuspid aortic valve. Cusp repair was performed in five patients. The mean follow-up time was 28.6 months (range 1–60). Transesophageal echocardiogram was performed at the end of each procedure to assess the aortic valve in terms of competence, dynamic motion and level of coaptation within the graft. Results: There was one hospital death and two late deaths. Overall survival at 60 months was 91.7±5.1%. Five patients developed severe aortic incompetence (AI) during follow-up requiring aortic valve replacement (AVR). The 60 months freedom from re-operation due to AI was 90.9±4.4%. One patient had moderate AI at latest echocardiographic study. The 60 months freedom from AI>2+ was 91.6±7.9%. Cox regression identified cusp's repair as independent risk factor (P=0.001) for late reimplantation failure (AVR or AI>2+). There were no episodes of endocarditis and the majority of the patients (88%) were in New York Heart Association functional class I. Conclusions: The aortic valve reimplantation with the Gelweave ValsalvaTM prosthesis provided satisfactory mid-term results. An accurate assessment of the level of coaptation of the aortic cusps in respect to the lower rim of the Dacron graft by means of intraoperative transesophageal echocardiogram at the end of each procedure is mandatory in order to avoid early reimplantation failure. Cusp's repair may play an important role in the development of late AI. However, long-term results are needed in order to define the durability of this technique.
Key Words: Aortic valve; Valve-sparing; Aortic surgery
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1. Introduction
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Aortic valve reimplantation procedure introduced by David in 1995 [1], is now considered a safe operation with satisfactory mid- and long-term results. To overcome the main limit of this technique, the lack of the sinuses of Valsalva, in 2000 De Paulis introduced the Valsalva graft [2], a modified Dacron conduit that on implantation recreates the sinuses of Valsalva of normal shape and dimension [3]. Since then, an increasing number of surgeons have been using this prosthesis.
The aim of this retrospective single institution study is to review our experience with aortic valve reimplantation using the Valsalva graft, in a series of 100 consecutive patients during a 5-year period.
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2. Materials and methods
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From October 2002 to November 2007, 100 consecutive patients underwent aortic root reimplantation using the Valsalva graft. Patients' demographic profile is reported in Table 1. Our technique has been previously described in detail [4]. The Maselli technique to reposition the ‘Valsalva graft sinotubular junction’ [5] was used in three cases. The graft sizes used were 28 mm in two patients, 30 mm in 28 patients and 32 mm in 70 patients.
The mean cardiopulmonary bypass (CPB) time was 125±22 min (range 90–201) with a mean aortic cross-clamp time of 107±17 min (range 67–170). Hemiarch reconstruction using moderate hypothermic circulatory arrest (24 °C nasopharyngeal) and antegrade selective cerebral perfusion (ASPC) was performed in the only patient operated on for acute type A aortic dissection, with ASCP time of 27 min and HCA time of 29 min.
Cusp's repair was performed in five patients and all of them had a bicuspid aortic valve. Repair consisted of free margin shortening in two cases and triangular resection in three.
Concomitant procedures included mitral valve repair in nine patients (9%), scheduled coronary artery bypass in 12 patients (12%), non-scheduled coronary artery bypass in two patients (2%), atrial septal defect repair in one patient (1%), and radio frequency ablation for atrial fibrillation in two patients (2%).
Transesophageal echocardiogram was performed at the end of each procedure to assess the reimplanted valve's dynamic motion and incompetence grade. In all patients, the reconstruction of the ‘pseudo-sinuses’ assured a sufficient gap to avoid any contact between the open leaflet and the Dacron wall. None of the patients left the operating room with an AI greater than mild. From 2004 onwards, the level of coaptation of the aortic cusps within the Dacron graft was also evaluated. Since then, a level of coaptation >2 mm below the lower border of the Dacron graft was not considered acceptable. All the patients underwent a further transthoracic echocardiogram before discharge.
2.1. Follow-up
Follow-up was conducted by one investigator in December 2007 and was 100% complete. Transthoracic echocardiogram was used for AI evaluation. AI was scored as none, trivial, mild, moderate, or severe (0–4+). The mean follow-up time was 28.6 months, ranging from 1 to 60 months.
2.2. Statistical analysis
Continuous variables were expressed as the mean±S.D. and were analyzed by using the unpaired two-tailed t-test. Categorical variables were presented as percentage and were analyzed with the  2-test or Fisher exact test when appropriate. All preoperative, intraoperative and postoperative variables were first analyzed by using univariate analysis to determine whether any single factor influenced AI during follow-up. Variables that achieved a P-value of <0.2 in the univariate analysis were examined by using multivariate analysis with forward stepwise logistic regression to evaluate independent risk factors for the AI during follow-up. Estimates for long-term survival and freedom from morbid events were made by the Kaplan–Meier method. Differences between survival curves were evaluated with the log-rank statistic.
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3. Results
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There was one hospital death and two late deaths. The cause of the hospital death was sepsis at four months after reimplantation in a patient that had a cardiac arrest on postoperative day 4. Although resuscitation was successful, the patient had a devastating neurological injury due to anoxia. Coronary angiography demonstrated no evidence of coronary button occlusion, and the cause of the cardiac arrest remains unclear. The causes of late death were cardiac (sudden death) in one patient at 37 months and non-cardiac (hepatocellular carcinoma) in the other patient at 48 months. At the time of surgery, there was no evidence of hepatic neoplasm. Liver function test, hepatitis B and C markers were negative. Both patients had trivial AI at latest follow-up. Overall survival at 60 months was 91.7±5.1% (Fig. 1).
Eight patients required early re-exploration (<24 h) for bleeding and tamponade. Three patients developed postoperative myocardial infarction (creatinine phosphokinase >300 IU/myocardial band >5%) without hemodynamic deterioration and with no significant ejection fraction reduction. Intubation time longer than 48 h occurred in four cases. Postoperative renal failure requiring dialysis occurred in one patient. Two patients developed bacterial mediastinitis and were treated successfully with the vacuum-assisted closure device (VAC). Two patients underwent pacemaker implantation because of permanent atrio-ventricular block.
3.1. Re-operations and aortic valve function
During follow-up five patients developed significant AI requiring aortic valve replacement (AVR), respectively 1, 7, 8, 33, 42 months after the first procedure. Re-operated patients' details are shown in Table 2. The 60 months freedom from re-operation due to AI was 90.9±4.4% (Fig. 2).
At the closure of the study, the grade of AI among the 92 survived, non-re-operated patients was as follows: none or trivial (0–1+) 47 patients, mild (2+) 44 patients, moderate (3+) 1 patient, severe (4+) none.
The 60 months freedom from AI greater than mild was 91.6±7.9%. Cusp's repair turned out to be a significant risk factor for reimplantation failure (AVR or AI>2+) both to univariate analysis (P=0.002) and Cox regression (P=0.001).
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4. Discussion
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Since its introduction in 1995, the original aortic valve reimplantation technique underwent several modifications, mostly devised to reproduce the sinuses of Valsalva [6–8]. When we began our experience with this procedure in October 2002, we chose the Valsalva graft for two main reasons. Firstly, we thought it was based on a very simple and effective idea to reproduce an anatomical configuration very similar to the normal aortic root. Furthermore, over the years this graft has proven to be reliable and has shown encouraging mid-term results [9]. Although the radial compliance of this graft at the skirt (the prosthetic aortic root) has not been shown to be maintained over the years, its curvature is supposed to reduce the stress and strain of the aortic cusps during systole and diastole, perhaps providing a long durability of the native valve [10]. The second reason that led us to adopt the Valsalva graft is the simplicity of the implantation technique, as it is the same as the original one described by David [11] except for the need to measure the heights of the interleaflet triangles, tailoring the graft according to it. Indeed, the precise placement of the top of the commissures at the junction between the skirt and the tubular part of the graft (the prosthetic sinotubular junction) is crucial to obtain good cusps' coaptation. Because the heights of the three commissures are often unequal (the height of the interleaflet triangle between the non-coronary and the left coronary cusps is usually shorter than the other two), heights of all three interleaflet triangles are carefully measured. According to it, the Maselli modification [12] may be useful when an imperfect alignment between the prosthetic STJ and the top of the commissures is noted. We actually used this tip in three patients with good results in terms of cusps' coaptation.
The importance of intraoperative TEE at the end of each procedure in order to assess the competence and the dynamic motion of the valve is nowadays well known. Specifically, as previously suggested by the Hannover group [13], from 2004 onwards we pay particular attention to the level of coaptation of the cusps in respect to the lower rim of the graft. It has been shown that a level of coaptation within the tube graft is essential to achieve valve competence. Looking at it retrospectively, the intraoperative TEE of the patient re-operated on for severe AI one month after the first procedure (November 2002), showed a level of coaptation frankly below the lower rim of the Dacron graft. A second interesting element detected by TEE is the lack of contact between the open aortic leaflet and the Dacron wall that, as previously noted [3], could be an important characteristic for valve's durability in the long-term.
In our series, two out of five patients who underwent cusp's repair were re-operated on for severe AI with a strong statistical significance. It must be stressed that both had a bicuspid aortic valve with asymmetric cusps. The other three patients who underwent cusp's repair also had a bicuspid aortic valve but the asymmetry was less evident and required a less extensive cusp's repair. Therefore, according to our experience, we have recently adopted the policy to spare bicuspid aortic valves only in case of symmetric cusps with no need for extensive additional repair. However, other authors have described excellent results with bicuspid valve-sparing operations regardless of the valve's morphology. In particular, Aicher et al. in a clinical study comparing the results of valve-sparing root replacement in bicuspid and tricuspid aortic valve, failed to show any significant difference between the two groups in terms of valve durability [12]. Similarly, El Khoury et al. described encouraging results after cusp's prolapse correction during valve-sparing operation [13].
The results of our study, in terms of freedom from aortic valve re-operation, are consistent with the outcomes of others. Pacini et al. [14], in a similar mid-term study on aortic valve-sparing reimplantation, including 57 patients treated with the Valsalva graft, reported a three-year freedom from AVR of 92%. Kallenbach et al. reported, in a large series of aortic valve-sparing operations using a tubular graft, an actuarial freedom from re-operation of 95%, 91% and 87%, respectively, at 3, 5 and 10 years [15].
During follow-up none of the patients developed endocarditis. This must be regarded as a considerable advantage of valve-sparing procedure over the Bentall operation that has invariably a certain incidence of valve related complications including endocarditis either with mechanical or tissue valve [16–18].
The main limitations of this study are to be retrospective and the length of follow-up (maximum 60 months), but to our knowledge is one of the largest single-center experience with a valve-sparing operation using the Valsalva graft.
In conclusion, the aortic valve reimplantation with the Gelweave ValsalvaTM prosthesis provided satisfactory mid-term results. An accurate assessment of the valve's dynamic motion and of the level of cusps' coaptation within the graft by means of TEE at the end of each procedure is mandatory in order to avoid early reimplantation failure. Cusp's repair may play an important role in the development of late AI and should be performed with caution in cases of asymmetric bicuspid aortic valve. The radial extension of the skirt portion of the Valsalva graft over the years has not yet been demonstrated and should be investigated. Long-term results are needed in order to define the durability of this technique.
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Abstract
1. Introduction
