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Right arrow Valve disease

Ann Thorac Surg 2006;81:1599-1604
© 2006 The Society of Thoracic Surgeons

Original article: Cardiovascular

Minimally Invasive Versus Standard Approach Aortic Valve Replacement: A Study in 506 Patients

Ihsan Bakir, MD a , b , Filip P. Casselman, MD, PhD a , b , * , Francis Wellens, MD a , b , Hugues Jeanmart, MD a , b , Raphael De Geest, MD a , b , Ivan Degrieck, MD a , b , Frank Van Praet, MD a , b , Yvette Vermeulen, MS a , b , Hugo Vanermen, MD a , b

a Department of Cardiovascular Surgery, Siyami Ersek Thoracic and Cardiovascular Surgery Center, Istanbul, Turkey
b Cardiovascular and Thoracic Surgery Department, OLV Clinic, Aalst, Belgium

Accepted for publication December 2, 2005.

* Address correspondence to Dr Casselman, Cardiovascular and Thoracic Surgery Department, OLV Clinic, Moorselbaan 164, Aalst 9300, Belgium (Email: filip.casselman{at}olvz-aalst.be).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
BACKGROUND: Minimally invasive aortic valve replacement through partial upper sternotomy has been shown to reduce surgical trauma, and, supposedly, decrease postoperative pain, blood loss, and hospital stay.

METHODS: From October 1997 until November 2004, 506 patients received isolated aortic valve replacement, of which 232 underwent the minimal access J-sternotomy approach (group 1). The control group (group 2) consisted of 274 patients who underwent aortic valve replacements by median sternotomy. We retrospectively reviewed outcomes of the patients in the early follow-up period.

RESULTS: In group 1 and group 2, respectively, early mortality was 2.6% (6 patients) and 4.4% (12 patients). The minimal access group had reduced aortic cross-clamp and cardiopulmonary bypass times compared with conventional group: 61.8 ± 16.6 versus 69.5 ± 16.6 minutes (p < 0.05) and 88.8 ± 23.2 versus 100.2 ± 22.6 minutes (p < 0.05), respectively. Mean blood loss was lower in group 1 compared with group 2 (p < 0.05). Intensive care unit and hospital stays were shorter in the minimal access group: 2.1 ± 2.5 versus 2.5 ± 5.3 days (p = nonsignificant) and 10.8 ± 7.1 versus 12.8 ± 10.6 days (p < 0.05), respectively.

CONCLUSIONS: Aortic valve replacement can be performed safely through a partial upper sternotomy on a routine basis for isolated aortic valve disease.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
There is an increasing interest in minimally invasive cardiac surgery. For about 10 years, there has been a trend to perform aortic valve procedure using minimally invasive techniques to reduce surgical trauma [1, 2]. In 1996, Cosgrove and Sabik [3] introduced a longitudinal parasternal thoracotomy for aortic and mitral valve operation. Recently, different minimal approaches to aortic valve operation have been reported [4–7], such as right parasternal minithoracotomy, partial upper or lower sternotomy, and transverse sternotomy. Many of these reports provide practical technical information, and several have suggested that smaller incisions lessen surgical morbidity [8–10]. Prospective randomized studies [2, 11, 12] have shown that the proposed advantages of all these incisions include reduced pain and surgical trauma, less bleeding, earlier functional recovery, shorter hospital stay, and reduced cost.

We started minimally invasive aortic valve replacement (AVR) in October 1997 through a partial upper sternotomy. This study reports a single center's experience with minimally invasive AVR compared with a traditional full sternotomy approach over a 7-year period.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
This is a retrospective, nonrandomized review of a single-center series of AVR using either a partial or complete sternotomy approach. The Institutional Review Board approved this study. Individual consent was waived as data collection was obtained from patient records and the departmental database. A total of 506 patients underwent an aortic valve replacement as their first cardiac operation between October 1997 and November 2004. Of these, 232 were operated through a partial upper J ministernotomy (group 1) and 274 through conventional full sternotomy (group 2) approach. To make the two study groups comparable, we excluded patients undergoing reoperations and concomittant surgical procedures, root and ascending aorta replacements. The decision whether patients received a minimal access or conventional procedure was entirely based on general patient status, anatomical considerations, and above all, discretion of the attending surgeon.

Relevant preoperative clinical data comparing the two groups are depicted in Table 1. Preoperative aortic valve indications for surgery and pathology of the aortic valve are detailed in Table 2. There were no statistical differences between groups in terms of demographic data, cardiac status, and associated pathologies except the ages of the patients. The conventional group was older than the minimal access group. All patients had 6 weeks of follow-up after hospital discharge.


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  		Table 1. Preoperative Patient Characteristics of the Two Groups
 

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  		Table 2. Preoperative Aortic Valve Characteristics
 
Operative Technique
The surgical technique has been extensively described elsewhere [2, 8, 10, 11, 13–15]. In brief, conventional AVR was performed through a full sternotomy. In the minimally invasive group, a 6- to 8-cm midline skin incision was made beginning 2 cm above the angle of Louis until 4 to 6 cm below the angle. The sternum was incised with the oscillating saw down to one of the intercostal spaces, between second and fourth depending on the topographic relationships of the anatomic structures. Cannulation sites of group 1 for extracorporeal circulation (ECC) are shown in Table 3. Single femoral artery or femoral artery and femoral vein cannulation together are performed through a 3- to 4-cm oblique incision in the groin. Myocardial protection of both groups consists of mild systemic hypothermia (32°C), and antegrade or retrograde cold crystalloid cardioplegia. Transesophageal echocardiography (TEE) was used in all cases to evaluate paravalvular leak and to monitor intracardiac air when coming off bypass.


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  		Table 3. Cannulation Sites for Extracorporeal Circulation in Ministernotomy Group
 
Postoperatively, chest tubes remained 48 hours (or longer if necessary), regardless of whether bleeding stopped earlier and chest tube output became serous fluid. Postoperative analgesia consisted of 10 mg piritramide (Dipidolor; Janssen-Cilag, Beerse Belgium) intravenously and 10 mg piritramide intramuscularly at the time sedation was stopped in the intensive care unit (ICU). Once the patients were extubated, analgesics were only given at the patient's convenience [16].

Statistical Analysis
All statistical analysis were performed with Statistica package, release 5.1 (StatSoft, Tulsa, Oklahoma). Data are displayed as percentages for categorical variables and as means ± SD for continuous variables unless otherwise stated. Univariate analysis using Mann-Whitney U test and {chi}2 test was performed for statistical analysis. Statistical significance was considered at the level of p less than 0.05.


   Results
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 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
The types of valves implanted were similar for the two groups of patients (Table 4). Intraoperative characteristics of the two groups of patients are detailed in Table 4. Aortic cross-clamp and ECC times were shorter in minimal access AVR patients, and statistically significant differences were noted for these variables. Except for 1 patient in the conventional group, patients in both groups were successfully weaned from ECC without the need for mechanical circulatory support. None of the patients in either group required a second aortic valve replacement either for paravalvular leakage or endocarditis during the early follow-up. One patient with prosthetic valve endocarditis in the conventional group was cured with antibiotic treatment.


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  		Table 4. Time Requirements, Type of Implanted Valves, and Urgency of Intervention
 
Conversion to full sternotomy was necessary in 8 patients (2.9%) in the minimal access AVR group. These patients were considered in the minimal access group for all analysis according to the "intention-to-treat" principle.

The minimal access group had a 2.6% mortality rate (6 patients), and the conventional group had a 4.4% mortality rate (12 patients). This difference was not statistically significant. Table 5 displays other outcome variables. There were no significant differences in atrial fibrillation, stroke, pulmonary infection or insufficiency, pleural effusion rates, and other variables. Omentomyoplasty for mediastinitis was required for 1 patient in each group.


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  		Table 5. Complications
 
Although the extubation times and ICU stay for minimal access group were shorter than for conventional group (1.2 ± 1 versus 1.6 ± 4.1 days and 2.1 ± 2.5 versus 2.5 ± 5.3 days), statistically significant differences were not observed for these outcomes in surviving patients. Statistically significant differences were noted for postoperative chest tube output and hospital stay between the two groups in surviving patients (Table 6).


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  		Table 6. Outcome
 

   Comment
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 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
Over the last decade, several studies have demonstrated excellent postoperative outcomes among patients undergoing different minimally invasive approaches for cardiac surgical procedures [2]. After various studies on the feasibility and possible advantages of minimally invasive AVR, we have adopted the reversed J sternotomy approach for minimal access aortic valve surgery in the second half of 1997. It is well known that most of the incision-related complications of new techniques occur in the early period after the procedure. This study was performed to determine whether minimal access AVR offers benefits over the standard approach AVR in the early postoperative period in a center that is experienced in using minimally invasive techniques for about 10 years.

Outcome analysis of the patients affirmed that the upper J ministernotomy approach did not endanger the quality of the procedure, and that this technique is safe and effective for AVR. Although Cooley [17] claimed that the minimally invasive valvular operations required significantly more time than conventional valve operations, and even experienced surgeons reported longer ECC and cross-clamp times [18, 19], other prospective randomized [2, 20] and retrospective studies [8, 13, 14] demonstrated that the cross-clamp and ECC times were almost the same for both approaches and not significantly longer for the minimally invasive operations. We believe that, after gaining some experience and self-confidence, there is no reason not to do the same quality of surgery within acceptable time limits. Our 7 years of experience with the minimal access J sternotomy approach for AVR operations have demonstrated that the ECC and cross-clamp times are not dependant on the length of the incision. A possible explanation for the difference in results could be the level of experience of the centers involved.

The main drawback of ministernotomy is the difficulty of air removal from the heart at the end of the procedure [12, 13, 17], although it seemed that CO2 insufflation into the operation field, aortic needle aspiration, and TEE confirmation of the absence of air bubbles were sufficient to achieve good air removal from the left ventricle. In this series, no statistical difference in neurologic outcome has been reported between the groups. Two patients in group 1 with atrial fibrillation suffered a stroke on postoperative day 7. It is well known that the risk of perioperative stroke has been shown to be nearly threefold higher for patients with postoperative atrial fibrillation [21–23]. Three patients had a stroke on postopative days 2, 3, and 7, respectively, in the ministernotomy group, indicating that neurologic problems were not linked to peroperative insufficient air removal.

Postoperative atrial fibrillation (AF) still appears to occur even when minimally invasive AVR is performed [20]. Doll and colleagues [11] reported in their series of 434 patients that AF occurred in 60 patients (34%) of the ministernotomy group and 110 (43%) of the standard approach AVR group. In our study, AF developed in 72 patients (31.0%) in the minimal access AVR group and in 75 patients (27.3%) in the conventional group (p = not significant). Femoral vein cannulation was used in almost 90% of the patients in group 1, and the right atrial appendage was only manipulated in 10% of the ministernotomy group. Both groups had myocardial protection with cold crystalloid cardioplegia and adjuvant topical ice and intravenous lidoflazine. The type of cardioplegia does not seem to alter the risk of postoperative AF between the two groups [21, 24]. Approximately 50% of our patients were older than 70 years (Fig 1), and age was the primary factor in the development of AF in our series.


Figure 1
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  		Fig 1. Age distribution of patients between group 1, ministernotomy (white bars), and group 2, standard approach (black bars).

 
The increased stability of the thoracic cage and increased integrity of pleural cavities allow patients to mobilize early and cough more efficiently [7]. The significant reduction of postoperative lung function is influenced not only by the use of ECC but also by the length of the sternal incision [2, 25, 26]. Outcomes of our patients showed shorter extubation times and ICU stay in the ministernotomy group, but these variables did not reach statistical significance. Retrospective analysis of our results showed a significant reduction in hospital stay in the ministernotomy AVR group. Several other studies have also demonstrated reduced hospital stay and cost for minimal access AVR when compared with conventional AVR [10, 11, 13, 27]. Although hospital stay in both groups seems to be relatively long, we do not prefer early discharge during the process of adjusting anticoagulation regimen, especially in our series of older patients. Indeed, we also anticoagulate bioprostheses for 3 months postoperatively.

Our results show a nonsignificant difference between the groups for surgical bleeding complications. Revision for bleeding was necessary in 18 patients (7.8%) in group 1 and for 17 patients (6.2%) in group 2. Vanoverbeke and associates [13] have also found almost the same incidence (7.5%) for surgical revision in their series of ministernotomy AVR patients. As the incidence of bleeding problem was evenly spread in both studies, it does not seem to be a part of a learning curve or "incision-related" problem of the technique, and therefore meticulous attention to hemostasis during the procedure must be advocated for all approaches.

Cohn and colleagues [10] reported that one of the disadvantage of this technique was the use of the femoral area for cannulation and perfusion in many patients. In our series of 232 patients, there were only 2 groin explorations (0.009%) necessary for subcutaneous hematoma of 229 patients (98.7%) with femoral artery or vein cannulation. Femoral vein cannulation was used approximately in 90% of the ministernotomy group to improve exposure and comfort the surgeon during placing the annular sutures and tying the knots. Excellent exposure of the aortic valve through a partial sternotomy may be attained, if an adequate approach can be selected by the position of aortic valve and by the femoral vein cannulation (Table 3). Although the use of femoral artery or vein cannulation slightly increases the cost, it is balanced with a certain amount of cost reduction realized from the reduced duration of ECC and length of ICU and hospital stay (Fig 2), which are the major determinants of costs after cardiac surgery [11, 15, 28]. We also observed a faster mobilization in patients after the minimal access approach because of decreased pain from the incision. They also have less requirement for posthospital rehabilitation, an observation that agrees with other studies [10, 11, 14, 27]. Although the charges are being reimbursed by Social Security in the structure of the health care system in our country, if operations can be performed as effectively as the conventional approaches and significantly diminish the need for posthospital care, we believe that this is one of the major bonuses for the cost reduction of this technique.


Figure 2
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  		Fig 2. Resource use of group 1, ministernotomy patients (white bars), versus group 2, conventional aortic valve replacement patients (black bars). Values demonstrated are mean ± SE. *p < 0.05. (ICU = intensive care unit.)

 
The reported incidence of paravalvular leaks ranges from 0% to 4.4% [15, 29]. It is encouraging that intraoperative and control echocardiograms performed during the study follow-up did not show a prosthetic valve dysfunction, and none of the patients in either group required early aortic valve replacement for paravalvular leakage or endocarditis. Patients undergoing ministernotomy or conventional approaches showed no statistically significant differences for postoperative complications in this series.

We are well aware of the limitations of the study as it is single center and retrospective; however, there were no statistical differences between the groups in terms of preoperative patient characteristics and associated pathologies, although both groups were nonrandomly assigned to treatment. The proven advantages of ministernotomy were the reduced surgical trauma, less pain, decreased blood loss, shortened ICU and hospital stays, and good cosmesis [2, 14]. We know that new surgical techniques require experience and repetition before optimal results are achieved; however, if the same quality of operation can be performed safely through a less traumatic and cosmetically better incision resulting in shorter hospital stay and a lower overall cost, then our proposal is that the minimal access approach can be used on a routine basis for isolated primary aortic valve replacement.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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