Interact CardioVasc Thorac Surg 2009;9:510-518. doi:10.1510/icvts.2009.207597
© 2009 European Association of Cardio-Thoracic Surgery
Best evidence topic - Valves |
Is patient-prosthesis mismatch an independent risk factor for early and mid-term overall mortality in adult patients undergoing aortic valve replacement?
Stefano Ursoa,*,
Rafael Sadabab and
Gonzalo Aldamiz-Echevarriaa
a Department of Cardiac Surgery, Clinica Capio, Albacete, Spain
b Department of Cardiac Surgery, Policlinica Gipuzkoa, San Sebastian, Spain
Received 16 March 2009;
received in revised form 9 May 2009;
accepted 16 May 2009
*Corresponding author. Tel.: +34 9672427100; fax: +34 967245183.
E-mail address: stefano_urso{at}inwind.it (S. Urso).
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Abstract
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A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: is patient-prosthesis mismatch an independent risk factor for 30-day and mid-term overall mortality in adult patients undergoing aortic valve replacement (AVR)? Altogether, almost 400 papers were found using the reported search, of which 22 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The majority of the selected articles have focused their analysis on moderate mismatch defined mostly by the presence of an indexed effective orifice area (IEOA) 0.85 cm2/m2. In fact, because of the low incidence of patients with severe mismatch, these were often grouped for the statistical analysis with patients with moderate mismatch. Only six studies have analyzed the specific condition of severe mismatch (IEOA<0.65 cm2/m2). Three studies used the IEOA or indexed geometric orifice area (IGOA) as a continuous variable. We conclude that there is no strong evidence that moderate patient-prosthesis mismatch (PPM) (indexed IEOA0.85 and >0.65 cm2/m2) is an independent risk factor for 30-day or mid-term overall mortality for adult patients undergoing AVR. An exception could be represented by patients with poor ejection fraction, a condition that can make moderate mismatch a predictor of overall mortality after AVR. On the other hand, severe mismatch is a predictor of overall 30-day or mid-term mortality for patients undergoing AVR independently from the presence of poor ejection fraction. In conclusion, our review suggests that the condition of severe PPM should be always avoided, while the presence of moderate mismatch could be tolerated in patients with normal ejection fraction without any impact on overall survival.
Key Words: Aortic valve; Heart valve prosthesis; Mortality
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1. Introduction
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A best evidence topic was constructed according to a structured protocol. This is fully described in the ICVTS [1]
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2. Three-part question
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In [adult patients undergoing aortic valve replacement] is [patient-prosthesis mismatch] an independent risk factor [for 30-day and mid-term overall mortality]?
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3. Clinical scenario
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You are carrying out an aortic valve replacement (AVR) on a 75-year-old woman because of severe aortic stenosis. Her body surface area (BSA) is 1.60 m2. The aortic annulus diameter is 19 mm. Analyzing the hemodynamic characteristics of the most popular bioprosthesis, the one with the largest effective orifice area (EOA) is the Medtronic Mosaic (EOA=1.20 cm2) [2]. Thus, the indexed effective orifice area (IEOA) of this patient after the surgical procedure would be: 1.20/1.60=0.75 cm2/m2. So, according to the definition published by Pibarot and Dumesnil [2] this patient would suffer from moderate mismatch because of the presence of an IEOA<0.85 cm2/m2 and >0.65 cm2/m2. Should you carry out an annular enlargement in this patient accepting its operative risk to avoid moderate mismatch?
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4. Search strategy
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We searched Medline, Embase and Cochrane Library for publications containing the words aorta/OR aortic/OR AVR/OR aortic valve replacement, AND mismatch/OR mismatched/OR mismatching/OR patient-prosthesis mismatch/OR PPM, AND mortality updated to August 2008. Inclusion criteria were: studies analyzing the impact on mortality of patient-prosthesis mismatch (PPM) in adult patients (>18 years) undergoing AVR. The denomination of mismatch had to be based on IEOA, IGOA or Z value. We included data from only the last publication of centers that had produced sequential reports.
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5. Search outcome
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A total of 389 papers were identified using the reported search of which 22 represented the best evidence to answer the question. These studies are presented in Table 1.
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6. Results
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Bridges et al. [3] analyzed 42,310 patients, to our knowledge the largest sample population. Prosthesis with small GOA or EOA were reported to be associated with increased early operative mortality, but among patients receiving the same model and size prosthesis, elevations in BSA were associated with a decrease rather than an increase in operative mortality.
The authors concluded that in AVR, priority should be given to prosthesis durability, surgeon experience, technical ease and speed of implantation. Once these factors have been considered, it may be reasonable to give preference to higher projected in vivo EOA or GOA prosthesis.
Blackstone et al. [4] reported that an indexed GOA< 1.2 cm2/m2 increased 30-day mortality by 1–2%. However, the study was unable to identify mismatch as a risk factor for late survival. It was speculated that the multifactorial nature of the reduced survival after AVR may mask mismatch impact on long-term mortality. Blais et al. [5] who unlike the previous author used IEOA instead of IGOA values, showed that both severe and moderate mismatch were independent predictors of short-term mortality. Also, the impact of PPM on survival was maximum when it was severe and in patients with left ventricle dysfunction. Ruel et al. [6] confirmed the importance of left ventricle dysfunction in patients with moderate mismatch, showing clearly that this subgroup of patients had a higher late mortality than patients with PPM and normal ejection fraction.
Kohsaka et al. [7] and Tasca et al. [8] analyzed patients with pure aortic valve stenosis reporting a higher late-term mortality of patients with moderate mismatch.
Equally, Walther et al. [9] were able to show that moderate mismatch was a predictor of adverse outcome after AVR. Florath et al. [10] and Mohty et al. [11] were able to show independently that severe PPM, but not moderate PPM, was an independent risk factor for late survival. Yap et al. [12] confirmed that severe PPM was independently associated with higher early mortality.
On the other hand, Mascherbauer et al. [13], Fuster et al. [14], Nozohoor et al. [15], Moon et al. [16], Flameng et al. [17], Frapier et al. [18], Bovè et al. [19] and Rao et al. [20], mostly because of the low incidence of severe mismatch, grouped together, for the statistical analysis, patients with severe and moderate PPM. None of these studies was able to show that moderate PPM was an independent predictor of either early or late survival after AVR. Monin et al. [21] came to the same conclusions analyzing a sample population with low-gradient aortic stenosis. Milano et al. [22] analyzed a sample population receiving 19- or 21-mm mechanical prosthesis. According to this study, IEOA was not an independent predictor of early or late mortality, but it was a predictor of cardiac events. The lack of impact of PPM on late survival was also reported by Medallion et al. [23], who used a multivariable hazard function to study risk factors for overall mortality after AVR.
According to the study of Howell et al. [24], and in contrast to the above mentioned study which focused on severe PPM, an IEOA<0.60 cm2/m2 did not affect either in-hospital mortality or late mortality. This finding could be explained by the fact that, as opposed to all other articles based on IEOA, this study used the in vitro EOA values and not the in vivo EOA values. In vitro EOA values have been shown to have a very low sensitivity to detect PPM [25].
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7. Clinical bottom line
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Severe mismatch (IEOA<0.65 cm2/m2) could be a predictor of overall 30-day or mid-term overall mortality for patients undergoing AVR. Moderate PPM (IEOA0.85 cm2/m2) could be an independent risk factor of early or mid-term overall mortality in the subgroup of patients undergoing AVR with poor ejection fraction.
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8. Limitations
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Several confounding variables, including the sample populations, the use of EOA or GOA parameters and different lengths of follow-up could have jeopardized the results of the included studies and weakened our synthesis work. We think that an international registry may be the best method to obtain the correct statistical power in order to investigate if moderate PPM is a risk factor in patients with good ejection fraction, an issue that may require a very large sample population.
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Abstract
1. Introduction