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Ann Thorac Surg 2008;85:102-107. doi:10.1016/j.athoracsur.2007.05.010
© 2008 The Society of Thoracic Surgeons
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Eugene A. Grossi
Charles F. Schwartz
Gregory A. Crooke
Juan B. Grau
Greg H. Ribakove
F. Gregory Baumann
Alfred T. Culliford
Stephen B. Colvin
Aubrey C. Galloway
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Right arrow Valve disease

Original Articles: Cardiovascular

High-Risk Aortic Valve Replacement: Are the Outcomes as Bad as Predicted?

Eugene A. Grossi, MDa,*, Charles F. Schwartz, MDa, Pey-Jen Yu, MDa, Ulrich P. Jorde, MDb, Gregory A. Crooke, MDa, Juan B. Grau, MDa, Greg H. Ribakove, MDa, F. Gregory Baumann, PhDa, Patricia Ursumanno, PhDa, Alfred T. Culliford, MDa, Stephen B. Colvin, MDa, Aubrey C. Galloway, MDa

a Department of Cardiothoracic Surgery, Division of Cardiology, New York University School of Medicine, New York, New York
b Department of Medicine, Division of Cardiology, New York University School of Medicine, New York, New York

Accepted for publication May 1, 2007.

* Address correspondence to Dr Grossi, New York University Medical Center, 530 First Ave, Ste 9V, New York, NY 10016 (Email: grossi{at}cv.med.nyu.edu).

Presented at the Forty-third Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 29–31, 2007.


The authors disclose a financial relationship with Medtronic Inc. and Estech Corp.

 

   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 
Background: Percutaneous aortic valve replacement (PAVR) trials are ongoing in patients with an elevated European System for Cardiac Operative Risk Evaluation (EuroSCOREs), patients believed to have high mortality rates and poor long-term prognoses with valve replacement surgery. It is, however, uncertain that the EuroSCORE model is well calibrated for such high-risk AVR patients. We evaluated EuroSCORE prediction vs a single institution’s surgical results in this target population.

Methods: From January 1996 through March 2006, 731 patients with EuroSCOREs of 7 or higher underwent isolated AVR. In this cohort, 313 (42.8%) were septuagenarians, 322 (44.0%) were octogenarians or nonagenarians, 233 (31.9%) had had previous cardiac procedures, 237 (32.4%) had atheromatous aortas, and 127 (17.4%) had cerebrovascular disease. A minimally invasive approach was used in 469 (64.2%). Data collection was prospective. Long-term survival was computed from the Social Security Death Benefit Index.

Results: The mean EuroSCORE was 9.7 (median, 10), and the mean logistic EuroSCORE was 17.2%. Actual hospital mortality was 7.8% (57 of 731). Multivariate analysis showed ejection fraction of less than 0.30 (p = 0.002; odds ratio [OR], 3.13), chronic obstructive pulmonary disease (p = 0.019; OR, 2.14), and peripheral vascular disease (p = 0.048; OR, 2.13) were significant predictors of hospital mortality. Complication(s) occurred in 73 patients (9.9%). Freedom from all-cause death (including hospital mortality) was 72.4% at 5 years (n = 152). Age (p < 0.001), previous cardiac operations (p < 0.014; OR, 1.51), renal failure (p < 0.002; OR, 2.37), and chronic obstructive pulmonary disease (p < 0.007; OR, 1.30) were predictors of worse survival.

Conclusions: Logistic EuroSCORE greatly overpredicts mortality in these patients. Five-year survival is good, unlike suggestions from earlier EuroSCORE analyses. This raises concern about unknown long-term percutaneous prosthesis function. Clinical trials for these patients must include randomized surgical controls and have long-term end points.

It has been speculated that nearly one-third of patients with severe, symptomatic, single-valve heart disease who could benefit from valve replacement do not undergo surgical repair [1]. Most of these patients are deemed too high risk for an operation secondary to comorbidities such as advanced age and the presence of chronic obstructive pulmonary disease (COPD) or renal failure, or both [1]. With increasing life expectancy in the Western world [2], the size of this untreated cohort of high-risk patients is expected to increase.

This has fueled interest in the development of percutaneous approaches to aortic valve replacement (AVR) as an alternative treatment option for patients with perceived high operative risks. Percutaneous aortic valve replacement (PAVR) trials are currently ongoing in patients whose surgical risk is deemed excessive due to comorbidities. The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is currently used as a surrogate for operative mortality in the evaluation of the relative mortality benefits of patients treated with PAVR compared with surgical repair in these trials [3–5].

The EuroSCORE model is a risk-stratification system developed from a database of adult cardiac patients from several European countries to predict in-hospital mortality after cardiac surgical procedures [6]. Since its introduction in 1999, the EuroSCORE model has been validated by databases in Europe [7, 8], North America [9], and Japan [10]. It has also been shown to be a predictor of length of intensive care unit stay [11], cost [11], mid-term outcome [12], and long-term outcome [13] of open heart surgery. In patients undergoing heart valve procedures, the EuroSCORE model has been shown to be predictive of early mortality [14], postoperative complications [15], prolonged length of stay [15], and long-term mortality [16].

The use of EuroSCORE in predicting operative mortality for high-risk patients undergoing isolated AVRs has yet to be validated. Although the logistic EuroSCORE model has been shown to be a better predictor of mortality compared with the additive EuroSCORE in high-risk populations [17, 18], several studies have found that the logistic EuroSCORE model may overestimate the mortality of such patients undergoing valve procedures [19, 20]. This study, therefore, has two aims: (1) to evaluate perioperative and long-term outcomes of isolated AVR in patients designated as "high risk" by EuroSCORE evaluation, and (2) to determine the predictive value of standard and logistic EuroSCORE in such patients.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Discussion
 References
 
Patient Selection
This study was conducted with the approval of the New York University (NYU) School of Medicine Institutional Review Board with specific waiver of the need for individual patient consent. Between January 1996 and March 2006, 1507 consecutive patients underwent isolated AVR at the NYU Medical Center. Of these, 731 patients (48.5%) had an additive EuroSCORE of 7 or greater and were identified as high-risk patients. Operative techniques included direct aortic clamping, moderate systemic hypothermia, and multidose, cold blood cardioplegia. A full sternotomy approach was used in 262 patients (35.8%). Alternatively, among the 469 patients (64.2%) in whom a minimally invasive approach was chosen, a small right anterior thoracotomy was used in 436 (92.9%) and an upper ministernotomy approach was used in 33 (7.1%), as determined by surgeon preference. Arterial cannulation was placed in the ascending aorta in 89.6% of the patients.

Data Collection
Patient data were collected prospectively. The definitions used for preoperative risk factors and perioperative complications were those used by the New York State Cardiac Surgery Reporting System (NYS CSRS).

Hospital mortality was defined as death at any time before discharge from the hospital. Long-term survival was computed from the United States Social Security Death Benefit Index. Statistical analysis was performed using SPSS 15 software (SPSS Inc, Chicago, IL). Categoric variables were analyzed by the {chi}2 test, and odds ratios (OR) were calculated. Predictors of time-related mortality were analyzed by Cox regression analysis, and hazard ratios (HR) for significant covariants were calculated. A value of p < 0.05 was considered to be significant. Life-table analysis was used to calculate late survival curves.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Discussion
 References
 
Of the 1507 patients who underwent isolated AVR between January 1996 and March 2006, 731 had a EuroSCORE of 7 or higher and were identified as high risk; 332 had a EuroSCORE of 10 or higher. The demographics and preoperative characteristics of this cohort are listed in Table 1. Notably, 313 (42.8%) were septuagenarians, 322 (44.0%) were octogenarians or nonagenarians, 233 (31.9%) had previous cardiac surgery, 127 (17.4%) had cerebrovascular disease, 69 (9.4%) had a low ejection fraction (EF), and 34 (4.7%) had renal disease. A histogram of age distribution of the 731 patients is shown in Figure 1.


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  		Table 1 Clinical Characteristics of Study Population
 

Figure 1
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  		Fig 1. Histogram shows age distribution of patients undergoing isolated aortic valve replacement.

 
Early Results
The mean additive EuroSCORE was 9.7 (median, 10). The predicted hospital mortality was 17.2% according to the mean logistic EuroSCORE. Actual hospital mortality was 7.8% (57 of 731), giving an observed-over-expected mortality ratio of 0.45. Univariate analysis revealed that peripheral vascular disease (p = 0.003), emergency operation (p = 0.025), renal disease (p = 0.028), EF less than 0.30 (p < 0.001), COPD (p = 0.032), and the use of a full sternotomy approach (p = 0.014) correlated with increased hospital mortality (Table 2). On multivariate analysis, an EF of less than 0.30 (p = 0.002; OR, 3.13), COPD (p = 0.019; OR, 2.14), and peripheral vascular disease (p = 0.048; OR, 2.13) remained significant predictors of hospital mortality. The use of a minimally invasive approach was associated with a reduced risk of hospital mortality (p = 0.036; OR = 0.55; Table 3). Table 4 lists patient complications.


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  		Table 2 Preoperative Predictors of Hospital Mortality on Univariate Analysis
 

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  		Table 3 Preoperative Predictors of Hospital Mortality on Multivariate Analysis
 

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  		Table 4 Frequency of Postoperative Complications a
 
Late Survival
Long-term analysis revealed freedom from all cause death, including hospital mortality, was 72.4% at 5 years (Fig 2). Age (p < 0.001), previous cardiac surgery (p < 0.014; HR, 1.51), renal disease (p < 0.002; HR, 2.37), and COPD (p < 0.007; HR, 1.30) were significant independent predictors of all cause long-term mortality.


Figure 2
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  		Fig 2. Graph shows cumulative survival curve of patients considered high risk by the European System for Cardiac Operative Risk Evaluation (EuroSCORE) after isolated aortic valve replacement.

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Discussion
 References
 
The reported major adverse prognostic indicators for patients undergoing AVR include advanced age [21–23], impaired left ventricular systolic function [24–26], and the presence of renal disease [23, 27], all of which are factored into the calculation of the EuroSCORE. In fact, the EuroSCORE system has been shown to be one of the most accurate risk-stratification models for cardiac surgery. Geissler and colleagues [28] reported that the EuroSCORE had the highest predictive value among the six most commonly used risk scores for open heart surgery. Nilsson and colleagues [29] further compared 19 preoperative risk stratification models and found the discriminatory powers for death at 30 days and 1 year were highest with the EuroSCORE algorithm.

However, studies looking at octogenarians undergoing valvular surgery have demonstrated that the additive and logistic EuroSCORE models overestimate the mortality in such patients [19, 20], suggesting that the EuroSCORE may not be well calibrated for high-risk patients undergoing valvular procedures. This current report tests the calibration of EuroSCORE in a cohort of high-risk patients undergoing isolated AVR. We found that the EuroSCORE is a flawed metric that greatly overestimates the hospital mortality in this patient population and that the overall outcome and long-term survival of these patients were good.

The operative mortality of 7.8% reported in this series is comparable with that in other series of high-risk patients undergoing valve procedures [20, 30–35]. The overall mortality rate for patients undergoing cardiac operations has been decreasing during the past decade, particularly for higher-risk patients [10]. This may be due to improvements in surgical technology and perioperative critical care. Our study also showed that the long-term survival for high-risk patients undergoing isolated AVR is good, with 72.4% of the patients surviving 5 years after the operation. Thus, isolated AVR can be performed with relatively low operative risk and good long-term outcome in high-risk patients.

The development of PAVRs may offer promising treatment options for patients with severe aortic stenosis who are deemed inoperable owing to comorbid conditions. Cumulative data obtained from recent trials show that current PAVR technology has a successful implantation rate of only 80% and a mortality rate of 19% in patients after successful implantation [3, 4, 36]. Most important, PAVR must therefore be compared with conventional open-heart AVR. The data presented indicate that the EuroSCORE grossly overestimates the surgical mortality of high-risk patients undergoing isolated AVR. It is therefore not an accurate standard to select for "high-risk patients" or to determine the survival benefit of PAVR compared with conventional surgery.

Limitations
Although the data were collected prospectively, this was done using the standardized methods of the NYS CSRS database. The EuroSCORE calculations and definitions vs those used by the NYS CSRS are shown in the Appendix. Definitions of most risk factors were similar between the EuroSCORE and the NYS CSRS database; however, there were some exceptions. For example, pulmonary hypertension is a variable in the EuroSCORE model, but it is not reported in the NYS CSRS database. Such differences may result in an underscoring or underestimation of the EuroSCORE as used in this article. This would only further support our finding that the EuroSCORE model grossly overestimates surgical mortality of high-risk patients undergoing isolated AVR.


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  		Appendix Variables for EuroSCORE and New York State Cardiac Surgery Reporting System
 
Summary
The EuroSCORE model greatly overpredicts mortality in high-risk patients undergoing isolated AVR. Furthermore, unlike suggestions from earlier EuroSCORE analyses, the 5-year survival for these patients is good. Therefore, in the absence of an accurate predictive model for surgical mortality in high-risk patients undergoing isolated AVR, future PAVR trials should have randomized surgical controls and long-term end points in order to fully assess the mortality benefit of PAVR compared with surgery.


   Discussion
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
References
 
DR REDDY DANDOLU (Philadelphia, PA): Dr Grossi you mentioned a "nonsternotomy approach" for high-risk aortic valve replacement. Can you elaborate what exactly is your nonsternotomy approach?

DR GROSSI: The nonsternotomy approach, in approximately 90% of the patients, was a second or third right anterior thoracotomy approach with traditional cardiopulmonary bypass, and retrograde coronary sinus cardioplegia. Ten percent of the patients had an upper ministernotomy typically teeing off into the right-hand side.

DR MICHAEL A. BORGER (Leipzig, Germany): I must mention a point about your introduction. You quoted a 20% mortality rate for percutaneous aortic valves. However, we just published this month the biggest experience to date with transapical aortic valves, with a 30-day mortality rate of only 7%. My colleague, Tommy Walter, performed five of these procedures last week, with only one patient requiring an ICU [intensive care unit] bed. The other 4 went directly to the step-down unit. So it is a very impressive procedure, once you get the kinks worked out of the system.

My question is regarding different risk scoring systems. I believe Todd Dewey from Dallas has a paper on this subject at the upcoming AATS [American Association for Thoracic Surgery]: STS [Society of Thoracic Surgeons] Risk Scoring versus EuroSCORE Risk Scoring. Several people have observed that the EuroSCORE overestimates mortality risk in high-risk patients, similar to your observations. Should we be using STS risk scoring system or some other model?

DR GROSSI: No, I think we should have randomized surgical controls with long-term end points. That is the message.

DR BORGER: But you need to somehow identify your patients prior to enrollment in such a trial, correct? So what risk-scoring system should we use for inclusion and exclusion criteria? Or do you think that we should enroll both high- and low-risk patients?

DR GROSSI: No, I would think, to be fair, you are going to want to include high-risk patients. The point is you can cull the patients to be randomized, but you have to have a randomized, controlled experiment with long-term end points to really understand what we are getting with this new technology. If three-quarters of these patients are going to be alive at 5 years, we are going to have to be very sure about what we are putting into them.

DR MICHAEL E. JESSEN (Dallas, TX): Dr Grossi, do you have any idea why the EuroSCORE seems to make the prediction too high?

DR GROSSI: We were very conservative in our approach because New York State does not include some of the risk factors. We have gone through it in detail in the manuscript.

I think it is validated on all cardiac procedures, but it is not validated in particular patient cohorts, such as very elderly with serious comorbidity.

DR OCTAVIO E. PAJARO (Jacksonville, FL): You used an expected-to-observed ratio to decide that the EuroSCORE overpredicted the mortality. Did you try going back to the original study and actually doing another statistic, comparing the probability ratios at all?

DR GROSSI: No. We just looked at the absolute prediction and what reality was. We felt that was good enough to show the model. And it has to raise questions about, as we are testing this, what our plans are going to be.

DR PAJARO: I only bring that up because your group still had an 8% mortality, which most people would still consider pretty high. So would there be some number that you would feel more comfortable that this is too high?

DR GROSSI: You’re saying 8% in patients who 50% of them are 80 or 90 years old and a third of them had previous cardiac surgery?

DR PAJARO: Exactly. Somewhere, somebody chose: We’ll operate. And not included in the group is the one we turned down, or the group turned down. So was that the criteria you would use then, high risk and no surgeon would operate?

DR GROSSI: No, I don’t think that’s a fair trial of the technology either. I am not against the technology. I am just saying for us as surgeons to understand what the technology can do for our patients, we have to do it in a way that makes sense. And the only way to make sense is to have controlled trials.

We are going to have to look at long-term outcomes. Perhaps, it is not scary for us. If we just think about the three papers we just heard, I don’t think we can shortchange this patient population and say we are not going to be concerned about their long-term outcomes.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 

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M. J. Antunes
Percutaneous aortic valve implantation. The demise of classical aortic valve replacement?
Eur. Heart J., June 1, 2008; 29(11): 1339 - 1341.
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Eugene A. Grossi
Charles F. Schwartz
Gregory A. Crooke
Juan B. Grau
Greg H. Ribakove
F. Gregory Baumann
Alfred T. Culliford
Stephen B. Colvin
Aubrey C. Galloway
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