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Ann Thorac Surg 2008;86:1791-1797. doi:10.1016/j.athoracsur.2008.09.005
© 2008 The Society of Thoracic Surgeons
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Mariano Vicchio
Alessandro Della Corte
Luca Salvatore De Santo
Marisa De Feo
Giuseppe Caianiello
Michelangelo Scardone
Maurizio Cotrufo
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Original Articles: Adult Cardiac

Prosthesis-Patient Mismatch in the Elderly: Survival, Ventricular Mass Regression, and Quality of Life

Mariano Vicchio, MD, PhDa,b,*, Alessandro Della Corte, MD, PhDa,b, Luca Salvatore De Santo, MDa,b, Marisa De Feo, MD, PhDa,b, Giuseppe Caianiello, MDa,b, Michelangelo Scardone, MDa,b, Maurizio Cotrufo, MDa,b

a Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy
b Department of Cardiovascular Surgery and Transplants, V. Monaldi Hospital, Naples, Italy

Accepted for publication September 4, 2008.

* Address correspondence to Dr Vicchio, Via Cassano 150, Naples, 80144, Italy (Email: marianovicchio{at}libero.it).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: Evaluation of the impact of prosthesis-patient mismatch (PPM) on long-term outcome and quality of life (QOL) in elderly patients who underwent implantation of small size bileaflet prostheses for aortic stenosis.

Methods: Between September 1988 and September 2006, 377 patients aged greater than 70 years underwent aortic valve replacement with a small size bileaflet prosthesis (17, 19, and 21 mm) in one Institution. The study population's survivors (345 patients) were divided into three groups according to the indexed effective orifice area (EOAI): Group A included patients with EOAI less than 0.60 cm2/m2; group B included patients with EOAI ranging between 0.61 and 0.84 cm2/m2; and group C included patients with EOAI 0.85 cm2/m2 or greater. Cumulative and comparative analyses of long-term outcomes and of left ventricular mass regression were performed. The QOL was evaluated with the 36-Item Short Form Health Survey (SF-36) questionnaire.

Results: Overall hospital mortality was 8.5% (32 patients). Group A included 33 patients (9.6%), group B 175 (50.7%), and group C 137 (39.7%). Actuarial survival was 88.8% ± 0.016 at 1 year, 82.1% ± 0.022 at 5 years, and 76.7% ± 0.032 at 10 years. No difference emerged among the three groups. A significant reduction in left ventricular mass was observed in all groups and in all patient subsets of prosthetic size. The scores obtained in the SF-36 test were similar in the three groups and significantly higher than those of the general population (p < 0.001 in all domains).

Conclusions: Incidence of severe PPM is low after aortic valve replacement. Presence of severe or moderate PPM, did not influence long-term outcome, left ventricular mass regression and QOL in a population of septuagenarians.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
The risk of prosthesis-patient mismatch (PPM) is most commonly encountered in patients undergoing aortic valve replacement (AVR) for severe calcified aortic valve stenosis, a typical disease of ageing. Effects of PPM, nearly thirty years after the pioneering study by Rahimtoola [1], are still controversial. Some authors [2–5] sustained that increased transvalvular gradients after aortic valve replacement may hamper the regression of the left ventricular mass. Poor regression of the left ventricular hypertrophy and symptomatology with an indexed effective orifice area less than 0.85 cm2/m2 [6, 7], the cutoff most commonly considered for PPM definition [8], have been reported. Different series [7, 9] have focused on the influence of PPM on the early mortality, yielding controversial results. Similarly, while Mothy-Echahidi and colleagues [10] have reported a reduction in the late survival when a severe PPM was present, other authoritative investigators [11–13] have shown good long-term outcomes in a group of patients with PPM, both in terms of regression of left ventricular hypertrophy and in terms of late survival. Alternative strategies such as the implant of stentless bioprostheses [14–16] or aortic root enlargement associated with AVR with a larger prosthesis [17–19], have been proposed to minimize the risk of PPM occurrence. The choice of valve type in older patients is another controversial issue due to the trade off between extended life expectancy and the risks of oral anticoagulation. The aim of this study was to investigate the impact of PPM on long-term survival and quality of life in elderly patients undergoing aortic valve replacement with a mechanical prosthesis for aortic stenosis.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Study Population
Between September 1988 and September 2006, 377 consecutive patients older than 70 years underwent AVR for aortic valve stenosis, either isolated or associated to coronary artery by-pass grafting in one institution, receiving a small size (17, 19 or 21 mm) bileaflet mechanical prosthesis. All patients presented a small aortic annulus despite intraoperative complete valve and annular debridment of calcified tissue. Hospital survivors were enrolled in the study and divided into three groups according to the following indexed effective orifice area (EOAI; as measured at the routine one-year postoperative echocardiographic evaluation): group A, including patients with EOAI less than 0.60 cm2/m2, defined as having severe PPM; group B, including patients with EOAI ranging between 0.61 and 0.84 cm2/m2, defined moderate PPM; and group C, including patients with EOAI 0.85 cm2/m2 or greater, defined as having no PPM. The Ethics Committee of our Institution approved this study and waived the need to obtain patient consent.

Echocardiography
All patients underwent preoperative, postoperative (at discharge), 1-month, and 1-year follow-up echocardiographic evaluation, then further controls according to clinical requirements. Hospital survivors were invited to perform a new echocardiographic examination during October and November 2007, except those examined within the last 2 months at our institution (21 patients). The effective orifice area (EOA) was derived from the continuity equation: (LVOT2 x 0.785 x TVI1)/TVI2, where LVOT is the diameter of the left ventricular outflow tract and TVI1 and TVI2 are the time-velocity integrals at the left ventricular outflow tract and across the aortic valve, respectively. The mean gradient was measured by use of continuous-wave Doppler echocardiography and the simplified Bernoulli equation. All Doppler measurements were obtained as the average of at least 3 cycles in patients with sinus rhythm or more than 5 cycles in those with atrial fibrillation. The left ventricular mass index (LVMI) was calculated from Reichek's formula, and body surface area was calculated using the Dubois formula. The PPM was defined according to standard definitions as published by Dumesnil and colleagues [8].

Follow-Up and Quality of Life Assessment
Follow-up was conducted on all hospital survivors, by taking advantage of our institutional ambulatory activities. Since 1988 our Institutions have included an outpatient clinic structure completely dedicated to anticoagulation therapy monitoring activity as reported in a previous study [20]. We classified the complications following the Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations as proposed by the Society of Thoracic Surgeons [21]. In October and November 2007, at the anticoagulation outpatient clinic, the Medical Outcomes Trust Short Form 36-Item Health Survey (SF-36, Italian version) tool [22] was administered to our study population to assess perceived quality of life (QOL).

Statistical Analysis
Data were analyzed with SPSS statistical software (SPSS version 13.0; SPSS Inc, Chicago, IL). Distributions of continuous variables were expressed as mean ± standard deviation, while categoric variables were expressed as counts and percentage of the total. The preoperative and postoperative echocardiographic parameters were statistically compared using the paired student t test. The cumulative probability of freedom from an event and the actuarial survival was calculated utilizing the Kaplan-Maier method and expressed as percentage ± standard error. The scores obtained at the SF-36 test were compared, through the paired Student t test, with the sex- and age-matched Italian population.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
Study Population Features
Group A included 33 patients (9.6% of the hospital survivors), group B 175 patients (50.7% of the hospital survivors), and group C 137 patients (39.7% of the hospital survivors). Preoperative characteristics of the study population are reported in Table 1.


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  		Table 1 Preoperative Characteristics of the Study Population
 
Eighty-one (21.5%) patients underwent associated coronary artery bypass grafting. Sixty-nine survived the operation and at the follow-up 6 patients were classified in group A (18.2%), 36 in group B (20.6%), and 27 in group C (19.7%) (p = 0.12). As regards severity of associated coronary disease, 3 patients in group A, 19 in group B, and 15 in group C had one-vessel disease, 2 patients in group A, 7 in group B, and 5 in group C had two-vessel disease, and 1 patient in group A, 10 patients in group B, and 7 in group C had three-vessel disease. Therefore, no differences were observed in distribution of coronary disease severity in the three study groups.

Hospital Mortality and Long-Term Survival
Global hospital mortality was 8.5% (32 patients). The causes of early death were perioperative acute myocardial infarction in 6 patients (18.75%), low output syndrome in 5 patients (15.6%), stroke in 2 (6.25%), pulmonary infection in 10 (31.25%), multiorgan failure in 7 (21.9%), and malignant arrhythmia in 2 (6.25%). Three groups of patients were considered for analysis of possible impact of small prostheses on hospital mortality: the geometric orifice area was employed to obtain projected mismatch degree because some patients died in hospital before having performed an echocardiographic evaluation of the indexed EOA. Three patients died in the greater than 0.85 cm2/m2 subgroup, 17 in the 0.60 to 0.85 cm2/m2 subgroup, and 12 in the less than 0.60 cm2/m2 subgroup (p = 0.61).

Mean follow-up was 4.2 ± 3.1 years (median, 3.8 years) and ranged from 6 months to 16.5 years (1,570.57 patient years). During the follow-up time 34 late deaths occurred (9.6% of hospital survivors). Causes of death in the follow-up were sudden death in 4 patients, myocardial infarction in 1, intracranial hemorrhage in 1, ischemic stroke in 1, neoplasm in 8, respiratory failure in 7, cirrhosis in 3, dementia in 2, postoperative death (after reoperation for prosthetic endocarditis) in 1, and oldness and progressive general decay in 6. Overall actuarial survival (including hospital mortality) was 88.8% ± 0.016 at 1 year, 82.1% ± 0.022 at 5 years, and 76.7% ± 0.032 at 10 years. Ten-year survival (not including hospital mortality) was 81.2% ± 0.091 in group A, 83.6% ± 0.039 in group B, and 83% ± 0.062 in group C (p = 0.15) (Fig 1). A multivariate analysis for long-term mortality disclosed that PPM was not a predictor. Dialysis-dependent renal failure was found as predictor of long-term mortality (OR = 22; 95% CI 4.4 to 110).


Figure 1
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  		Fig 1. Actuarial survival (Kaplan-Meyer method) in survivors divided according to severity of prosthesis-patient mismatch (PPM): severe PPM, moderate PPM, no PPM.

 
Anticoagulation-Related and Valve-Related Complications
During the follow-up period, the mean international normalized ratio in this series was 2.15 ± 0.16. Four major hemorrhagic events occurred in 4 patients in the follow-up, including 2 cases of gastric bleeding (requiring surgery in 1 case), 1 intracranial bleeding, and 1 hematuria requiring hospitalization. Freedom from bleeding was 99.7% ± 0.003 at 1 year, 98.4% ± 0.008 at 5 years, and 96.9% ± 0.013 at 10 years. Thromboembolic complications were observed in 3 patients: 1 ischemic stroke, 1 transient ischemic attack, and1 pulmonary embolism. Freedom from thromboembolism was 99.7% ± 0.003 at 1 year, and 99% ± 0.006 at 5 years and 10 years, respectively.

Freedom from valve-related complications was 99.1% ± 0.005 at 1 year, 95.5% ± 0.013 at 5 years, and 94.7% ± 0.015 at 10 years. Ten-year freedom from valve-related complication in the three subgroups did not show significant difference (88.5% ± 0.063 in group A, 91.9% ± 0.034 in group B, and 91.4% ± 0.058 in group C, p = 0.26) (Fig 2).


Figure 2
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  		Fig 2. Actuarial freedom from valve-related complications (Kaplan-Meyer method) in the follow-up in the three groups (A, B, and C).

 
Hypertension
In our study population 248 patients were affected by hypertension.

Among the three groups no difference was observed in terms of incidence of preoperative hypertension (Table 1). Similarly the three study groups proved homogeneous for the prevalence of antihypertensive therapy in the postoperative period. At the follow-up, 23 patients (72.7%) in group A were on antihypertensive treatment, 122 in group B (69.7%), and 98 patients in group C (71.5%; p = not significant).

Echocardiographic Follow-up
Preoperative and postoperative echocardiographic data in group A, in group B, and in group C were reported in Table 2. A significant postoperative increase in the mean IEOA was disclosed in the three groups. A significant reduction in peak and mean trans-prosthetic gradient as well in left ventricular mass was observed in all groups of patients.


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  		Table 2 Preoperative Versus Postoperative Echocardiographic Data (Paired t Test) in Group A, in Group B, and in Group C
 
Quality of Life Results
All survivors answered the SF-36 questionnaire, and there was no statistical difference in the scores obtained in the three group of the study population in all of the eight domains of the test. When compared with the mean scores of the general Italian population matched for age and sex, significantly higher scores were reached by the three groups of the study population, with a p value of less than 0.001 in all domains. The scores obtained in the various domains for group A, group B, group C, and the general Italian population of the elderly were reported in Figure 3.


Figure 3
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  		Fig 3. The 36-Item Short Form Health Survey scores obtained in the eight domains of the questionnaire in group A, in group B, in group C, and in the Italian age and sex-matched population.

 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
Severe calcific aortic valve stenosis with small annulus is prevalent in the older age and this poses septuagenarians at higher risk of patient-prosthesis mismatch. Some investigators maintained the hypothesis that PPM is an independent predictor of long-term mortality [3, 6–8]. In contradiction, others found that survival after AVR appeared not to be adversely affected by PPM [11–13]. The problem of PPM assumes peculiar forms and specific aspects in the elderly, due to several reasons. First, in papers attempting more in-depth analysis of the possible prognostic value of PPM occurrence, it was found to affect survival only in younger patients [23]. Second, older age is diffusely considered an indication to bioprostheses and in the case of small annulus, small tissue valves (at least, stented models) may perform worse, in terms of hemodynamics, than small mechanical valves [24]. Third, scarce attention has been given so far to the potential for LVM regression in the older age, when remodeling processes are supposed to be somewhat delayed. Last, limited physical activity in the older age may allow for a choice of a small prosthesis without concerns of the impairment of quality of life (QOL) due to reduced exertion response, expectedly entailed by PPM. Few previous studies have focused on PPM in a large elderly patient series, and to our knowledge no investigation of the echocardiographic parameters, as those presented in the present report, has been issued so far.

PPM Effect on Survival
Rao and colleagues [3] reported that severe PPM after AVR was associated with decreased long-term survival and claimed that this result was due to the persistence of left ventricular hypertrophy in patients with small aortic prostheses. However, in that study patients with PPM had an increase in valve-related mortality, while the overall survival was similar, thereby valve-related mortality may have included deaths from embolic stroke, endocarditis, valve failure, and reoperation, unrelated to PPM. In the present series, consistent with the evidence forwarded by Moon and colleagues [23], no differences in mortality were observed between patients with and without severe and (or) moderate PPM, and, importantly, no differences in valve-related complications either. Medallion and associates reported in a large series of patients that the clinical outcomes after valve replacement might be related more to patient risk factors than to the presence of PPM [12]. Moreover, based on a study by Ross and Braunwald [25], American College of Cardiology/American Heart Association guidelines [26] suggest that patients with moderate gradients and no symptoms (unless scheduled for other types of cardiac operations) should not be considered for surgical indication, inasmuch as long-term survival is not impaired in these patients. Accordingly, an asymptomatic patient with mild to moderate gradients after AVR is not expected to have an increased risk of death owing to PPM. In the present study long-term survival was similar in the three groups of patients; moreover, the survival curve in the study population's survivors divided according the severity of PPM showed no statistical difference in terms of long-term outcome.

Mechanical Valve Implantation in the Elderly
Older age (>70 years in our experience) is commonly accepted as the main indication as to the choice of a tissue type of valve substitute, based on concerns with anticoagulation in a supposedly higher risk population. Due to a greater attention to the durability issue than to anticoagulation-related problems, also relying on the closeness of anticoagulation follow-up provided by a dedicated outpatient management protocol [27], it has been the policy of the present authors' Institution to implant biologic valves only in selected elderly patients with important comorbidities, contraindicating life-long anticoagulation, and (or) reasonably shorter life expectancy than the average healthy elderly population. The implantation of stentless valves has been proposed as an alternative strategy for patients presenting with a small aortic annulus in order to avoid PPM [14–16]. However, stentless valve implantation can be technically more demanding and there is no evidence in favor of an improved early and long-term survival in the elderly, nor of its effectiveness in reducing the risk of PPM [28–30].

Left Ventricular Mass Regression
The theory that PPM induces a poor LVM regression is not clearly demonstrated. In fact, a study by Hanayama and colleagues [31] found that patients with postoperative echocardiographic evidence of severe PPM (EOAI < 0.6 cm2/m2) showed no difference in terms of postoperative LVMI compared with those without severe PPM. The present authors have already reported a significant regression of the LVMI in 35 patients undergoing implantation of a 17-mm St. Jude Medical Hemodynamic Plus or a St. Jude Medical Regent prosthesis (St Jude Medical, Inc, St Paul, MN) for isolated aortic stenosis during the follow-up compared with the immediate preoperative period, despite a mean IEOA of 0.67 ± 0.14 cm2/m2 [32]. Moreover, recently our group has published a study [33] conducted on 147 elderly patients who underwent implanting of 19-mm mechanical prostheses, reporting similar left ventricular mass regression in patients with or without PPM. The present study has confirmed the previous experience, demonstrating a significant reduction in left ventricular mass in all patient subsets of prosthetic size and further showing a significant left ventricular mass regression both for the group of patients with PPM and for those without PPM. Previous studies have shown that the preoperative degree of ventricular hypertrophy [34] and postoperative hypertension can influence negatively the reduction of LVMI, evidencing that the left ventricular mass regression after AVR depends not only on prosthesis size and type implanted [35]. Probably the substantial homogeneity of the present patient population in terms of preoperative LVMI and of hypertension prevalence and treatment, could explain the lack of significant differences in the entity of LVMI regression between patients with and without PPM.

Quality of Life
Because improvement in QOL is considered to be one of the principal goals of valve surgery, methods of QOL assessment are increasingly adopted in the clinical research in this field. Moreover, important information about the change in QOL that patients scheduled for valve surgery can expect after the operation may be conveyed to them by reports on postoperative QOL. Indeed, whether advanced age modifies the expected QOL benefit has not been ascertained yet. The improvement in QOL for elderly patients undergoing cardiac surgical procedures [36], also compared with the preoperative patients' values or with a general population norm, has been already acknowledged in the past [37]. Koch and colleagues in a recent study [38] have shown that AVR patients report improvements in functional QOL and these are not influenced by PPM. Our results about the QOL were in accordance with those reported by Koch and colleagues, and showed that PPM does not affect the patient's perception of his own QOL. Patients in the present study obtained a mean score significantly higher, in all domains of the test, than that of the general Italian population matched for age and sex. When interpreting this result, it should be considered that 70% of the patients in our study population were in New York Heart Association III or IV functional class before the operation, so a high percentage of our patients experienced, for a various period of time, a moderate to severe limitation to their daily activity. The relief of symptoms and the return to predisease lifestyle can probably increase the perception of a patient's own health status. Similarly, an explanation for the low Italian general population scores could be that the healthy elderly are prone to compare their current physical and psychologic performances with those of their youth, with a resultant relative inability caused by the effects of the aging process itself. Consistent differences between the operated elderly and the age-matched control population were claimed by other authors [37] in a series of valve replacement, in particular for what concerned the "social functioning" and "emotional" domains.

Several studies compared the postoperative test score in heart-surgery patients with the test score obtained before the operation, and the result was a higher score in the test at 3 months after the operation, when the patients had a complete surgical resolution and a lifestyle similar to what they had before the onset of the disease [39]. In the present study no comparison could be made with preoperative SF-36 scores, but the excellent results in terms of perceived QOL confirm that patients should undergo similar tests when a relevant time period has passed after the operation. These results confirm our previous experience in which a study population of 147 elderly patients who underwent 19-mm mechanical prostheses implanting were divided into two group according to the presence or absence of PPM. The QOL in the patients with PPM was comparable with the QOL in the patients without PPM [33].

Limitations of the Study
This study presents some limitations that deserve acknowledgement. The first limitation is represented by the relatively short follow-up. However, our follow-up time compares favorably with those in other published series [5, 11, 23, 35]. The impact of PPM on hospital mortality has been evaluated by the use of the geometric orifice area index instead of the EOAI. This represented an inhomogeneity when compared with our analysis of the long-term impact of PPM, where EOAI was used for definition of subgroups. However for some patients who died in-hospital an echocardiographic evaluation of the EOAi postoperatively was not available. However, experts in the field of PPM recommend that the impact of it on survival be assessed at least 12 months after operation [40]. Finally, the impact of PPM on stress echocardiography results was not addressed; in elderly populations this has been considered a negligible issue [41]. Indeed, the good QOL performances of patients in the PPM groups testified to the lack of an impact on everyday life activity.

Conclusions
In our experience, incidence of severe PPM in the follow-up is very low. Presence of severe or moderate patient-prosthesis mismatch, although occurring in a large proportion of patients receiving small size bileaflet aortic valve prostheses, did not influence long-term outcome, left ventricular mass regression, and quality of life in a population of septuagenarians.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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