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Review
Patient-prosthesis mismatch following aortic valve replacement
  1. Rajdeep Bilkhu1,
  2. Marjan Jahangiri1,
  3. Catherine M Otto2
  1. 1 Department of Cardiothoracic Surgery, St Georges Hospital, London, UK
  2. 2 Division of Cardiology, Department of Medicine, University of Washington, Seattle, Washington, USA
  1. Correspondence to Dr Rajdeep Bilkhu, Department of Cardiothoracic Surgery, St Georges Hospital, London SW17 OQT, UK; rbilkhu{at}nhs.net

Abstract

Patient-prosthesis mismatch (PPM) occurs when an implanted prosthetic valve is too small for the patient; severe PPM is defined as an indexed effective orifice area (iEOA) <0.65 cm2/m2 following aortic valve replacement (AVR). This review examines articles from the past 10 years addressing the prevalence, outcomes and options for prevention and treatment of PPM after AVR. Prevalence of PPM ranges from 8% to almost 80% in individual studies. PPM is thought to have an impact on mortality, mainly in patients with severe PPM, although severe PPM accounts for only 10–15% of cases. Outcomes of patients with moderate PPM are not significantly different to those without PPM. PPM is associated with higher rates of perioperative stroke and renal failure and lack of left ventricular mass regression. Predictors include female sex, older age, hypertension, diabetes, renal failure and higher surgical risk score. PPM may be a marker of comorbidity rather than a risk factor for adverse outcomes. PPM should be suspected in patients with persistent cardiac symptoms after AVR when there is high prosthetic valve velocity or gradient and a small calculated effective orifice area. After exclusion of other causes of increased transvalvular gradient, re-intervention may be considered if symptoms persist and are unresponsive to medical therapy. However, this decision needs to consider the available options to relieve PPM and whether expected benefits justify the risk of intervention. The only effective intervention is redo surgery with implantation of a larger valve and/or annular enlargement. Therefore, focus needs to be on prevention.

  • valve disease surgery
  • transcatheter valve interventions
  • aortic stenosis

https://doi.org/10.1136/heartjnl-2018-313515

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    Aortic stenosis (AS) is the most common valvular heart disease in the developed world, with a prevalence in Europe of 1–3%.1 With an ageing population, the prevalence of AS is likely to increase. Aortic valve replacement (AVR) remains the only effective treatment for symptomatic patients with severe AS.2 Approximately 5800 aortic valve replacements are performed annually in the UK and approximately 29 500 in the USA.3 4 The benefit of a prosthetic aortic valve, whether implanted surgically or by a transcatheter approach, depends on effective relief of left ventricular (LV) outflow obstruction. Unfortunately, all prosthetic valves have suboptimal haemodynamics compared with a normal native valve, with the prosthetic valve orifice area and transvalvular gradient dependent on factors both intrinsic to the prosthesis (such as design and size) and specific to each patient (such as body size and transvalvular volume flow rate).

    The concept of patient-prosthetic mismatch (PPM) refers to the clinical situation in which the normally functioning prosthetic valve does not allow an adequate cardiac output without an excessive gradient across the valve. In simplistic terms, the prosthetic valve is too small for the patient’s body size. The presence and severity of PPM have been reported to affect early and late outcomes after AVR but the literature to date is conflicting, with some groups suggesting that PPM is common and associated with adverse outcomes and other groups suggesting PPM occurs infrequently and only rarely negatively impacts clinical outcomes.

    We set out to review the literature on PPM after AVR, focusing on the last 10 years. Our aims were to review prevalence and diagnosis, summarise the impact of PPM on early post-AVR morbidity and complications, LV mass regression, quality of life, need for re-intervention and long-term mortality. We also looked at factors which predict PPM following AVR and suggest approaches to prevent PPM.

    Definition and prevalence

    Based on observational clinical studies, the most common definition of severe PPM is an indexed effective orifice area (iEOA) <0.65 cm2/m2 with moderate PPM defined as an EOA between 0.65 and 0.85 cm2/m2.5 The incidence of PPM after AVR is unclear with prevalence ranging from about 8% to almost 80% in individual studies (table 1), with an estimated overall prevalence of 44% based on a meta-analysis of 34 observational studies that included a total of 27 186 patients.6 In the studies that graded severity of PPM, the prevalence of severe PPM ranged from only 0.5% to as high as 62% with moderate PPM from 11% to 90%. The reasons behind the wide variation in the prevalence of PPM are obscure but might include baseline patient differences, selection bias and ascertainment bias (variability in diagnosis). Although prospective population-based studies on the incidence of PPM after surgical AVR (SAVR) are lacking, our own clinical experience suggests that the incidence of clinically significant PPM is at the lower end of the values reported in the literature. Additionally, the incidence of PPM appears to be reducing with time, as indicated in a recent study by Fallon and colleagues.7

    View this table:
    Table 1

    Prevalence of PPM in selected studies

    Diagnosis

    Echocardiography is recommended early after AVR to provide baseline valve haemodynamics at a time when valve deterioration has not yet occurred. In patients with persistent symptoms after AVR, the diagnosis of PPM should be considered if there is a high gradient and small iEOA on this early post-AVR study, (figure 1); however, over-diagnosis should be avoided. A high transaortic velocity (and gradient) may be present without PPM in patients with a high cardiac output—for example, with fever or anaemia. High velocities also may be seen with bileaflet mechanical valves due to local acceleration in the narrow central slit-like orifice.8

    Figure 1
    Figure 1

    Suggested approach to evaluation of the patient with a high transaortic velocity on echocardiography after aortic valve replacement (AVR). Ao, aortic; EOA, effective orifice area; LVOT, left ventricular outflow tract; PPM, patient-prosthesis mismatch; TEE, transoesophageal echocardiography. Modified from: Mahjoub, Dahou, Dumesnil and Pibarot. Prosthetic valve dysfunction. In: Otto CM, ed. The Practice of Clinical Echocardiography, 5th edn. Elsevier, 2017. Figure 24.12 on page 472.

    Diagnosis of PPM is more challenging in patients presenting with symptoms months or years after AVR because a high gradient and small orifice area may be due to valve thrombosis, fibrosis or calcification, rather than to PPM. The first step in evaluation is comparison of the current echo study to the early post-AVR study to determine if valve function has deteriorated over time. A diligent search for other causes of symptoms is also appropriate, including coronary artery imaging, because symptoms of PPM are non-specific and most patients have multiple comorbidities. Transoesophageal echocardiography or cine computed tomographic imaging9 10 may be helpful to visualise leaflet anatomy and motion and to detect pannus or thrombus formation. With a mechanical valve prosthesis, cine CT allows assessment of disk motion and may demonstrate paravalvular pannus or thrombus. Often, the diagnosis of PPM is based on excluding prosthetic valve stenosis or non-cardiac conditions as the cause of symptoms in a patient with a high transvalvular gradient and small effective orifice area.

    Clinical outcomes

    Early post-AVR morbidity and complications

    It remains controversial whether PPM is associated with a higher rate of adverse outcomes early after AVR (table 2),11–21 with recent studies showing no significant difference in complications between those with and without PPM.11–13 17 19 However, some groups report a higher incidence of perioperative stroke in those with any degree of PPM,14 20 22 with one study showing an incidence of perioperative stroke in those with versus without PPM (3.9% vs 2.4%, P=0.02).16 A higher incidence of renal failure in patients with PPM has been reported in at least three studies.16 21 23 One study18 also reported a longer ventilation time and intensive care unit stay in patients with PPM. Inotrope requirement was noted to be higher in those with PPM in one study,21 while a different study reported higher use of an intra-aortic balloon pump postoperatively.20 Patients with AS undergoing AVR tend to be older and have multiple comorbidities, and those likely to have PPM often have a smaller body size. Thus, it remains unclear whether the possible higher rate of postoperative complications is due to PPM itself or is simply a surrogate marker of comorbidity and a more complex patient.

    View this table:
    Table 2

    Early complications and mortality in patients with PPM

    LV mass regression

    Physiologically, there is concern that the degree of residual LV outflow obstruction after AVR in patients with PPM will result in persistent LV hypertrophy, which might result in clinical symptoms due to diastolic or systolic dysfunction over time. In fact, several studies have shown less regression of LV mass in those with PPM, see table 4 .14 19 21 24–29 The effect of PPM on LV mass regression seems to show a dose-response relationship—greater degrees of PPM are associated with greater persistence of LV hypertrophy. Interestingly, LV mass regression appears to be lower in older adults (over 70–75 years) and in those with LV systolic dysfunction.26 Although LV mass regression is predictive of improved long-term survival, particularly when mass regression is >150 g,30 further studies are needed to determine if LV mass regression independently predicts prognosis or if it is a marker of more severe comorbidities.

    Quality of life

    The impact of PPM on quality of life (QOL) is challenging to study in elderly patients who have undergone AVR and have multiple causes of symptoms. However, studies to date have shown no statistically significant difference in QOL between those with and without PPM, using various methods to measure QOL.22 25 31 32

    It may be that placement of an appropriately sized prosthesis for the patient’s body surface area and reduction in the gradient may be all that is required for the patient to have a good QOL outcome following surgery, but there are few objective data to support this hypothesis at this time.

    Re-intervention for PPM

    Re-intervention for PPM is a problematic outcome measure for several reasons: the diagnosis of PPM may be missed, patients may be too high risk for or refuse a second aortic valve procedure and the reasons for re-intervention may be quite variable between centres.15 22 One group reported no significant difference in re-intervention rates in those with or without PPM (4.3% vs 3.9%, P=0.82). Another group reported on their series of 2404 consecutive patients undergoing SAVR that, during a follow-up period of up to 12 years, 89 patients (3.7%) required repeat SAVR.15 This was not found to be related to PPM; however, the overall incidence of PPM was reported at 90.1% so nearly all the patients were considered to have PPM. In this series, the reason for re-intervention was bioprosthetic valve degeneration in 80% of those undergoing the procedure, with no patients undergoing re-intervention for PPM per se.

    Long-term mortality

    Early mortality after AVR does not appear to be related to the presence of PPM but there may be some effect on long-term mortality (table 3). In our view, the data on PPM and late mortality is only convincing for patients younger than 70 years, with a smaller body size (<30 kg/m2) or with a lower ejection fraction (<50%).

    View this table:
    Table 3

    Long-term mortality

    A study by Mannacio and colleagues found that there was no significant difference in early mortality in those with and those without severe PPM; however, at follow-up at 5 and 10 years, mortality was greater in those with severe PPM.15 Swinkels and colleagues reported similar findings in a series of 673 patients who underwent SAVR.22

    In a recent meta-analysis by Dayan and colleagues of 58 reports, they identified that up to a moderate degree of PPM was associated with one and a half times increased risk of early mortality, and in patients with severe PPM, mortality was increased two and a half times.14 The trend towards lower survival was noted to continue during follow-up, with late mortality being higher in those with severe PPM. Another group demonstrated a statistically significant lower survival in those with PPM at 10 years; however, they concluded that PPM may be a surrogate marker of a higher risk, older population.16

    Price and colleagues identified that the impact of PPM on mortality varied depending on age at operation, with those under the age of 70 years having higher mortality.26 This was particularly true in those with underlying LV dysfunction. Of note, this group reported that in those above the age of 70, PPM did not have an impact on survival. This was similar to the conclusion by Moon and colleagues that PPM did not have a negative impact on late survival in those older than 70.33

    Similarly, in a large follow-up study of 2576 patients by Mohty and colleagues, they demonstrated that in patients with severe PPM, although there was an increase in late mortality, this only appeared to be the case in patients under the age of 70, in those with a body mass index <30 kg/m2 and in those with LV ejection fraction <50%.34

    Prevention of PPM

    Predictors of PPM

    Female sex is a strong clinical predictor of PPM after AVR, likely reflecting the smaller annulus area in women, making implantation of an adequately sized valve challenging. In addition, older age, hypertension, diabetes, renal failure and a higher surgical risk score predict the likelihood of PPM, again suggesting that PPM may be a surrogate marker for adverse outcomes, rather than their cause.14 22 34 The association of PPM with adverse clinical outcomes is most evident in younger patients and in those with LV systolic dysfunction.17

    Choice of surgical valve type and size

    The effective orifice size of a prosthetic valve is smaller than the sewing ring size due to the valve design and normal tapering of the flow stream as it passes through a prosthetic valve orifice.8 The effective orifice area for a given valve type and size can be calculated, and then indexed for patient body surface area, using data provided by the valve manufacturer. Calculation of the expected orifice area before implantation accurately identifies patients at risk of PPM and offers an opportunity to consider alternate approaches to prevent PPM.35

    A smartphone application (Cardio Valve, Digimednet) is available which allows the user to calculate the predicted indexed effective orifice area of individual prosthetic valves and identify the minimum size of prosthesis required to avoid PPM. Given the availability of data from valve manufacturers, and the ease with which PPM can be predicted, the routine prediction of iEOA would seem appropriate, particularly in those patients who are identified to be at risk of PPM and especially severe PPM.

    Modern pericardial bioprosthetic valves have been modified in their design to allow for placement of a larger bioprosthesis and avoid a high gradient across the valve.36 Some bioprosthetic valves are now designed with a lower profile to sit in a supra-annular position, which allows a larger valve size to be implanted. These valves have demonstrated good outcomes with low incidence of PPM during follow-up with no patients with severe PPM.37

    In addition to lower profile supra-annular valves, stentless valves have also been proposed as a means of reducing the incidence of PPM, particularly in those with small aortic roots.38 Given that one of the post hoc findings of the Placement of Aortic Transcatheter Valves (PARTNER) trial was the lower incidence of PPM after transcatheter AVR (TAVR) compared with SAVR,39 this is now an area of increasing interest.

    More recently, the use of sutureless valves has gained popularity, mainly for the advantages of marginal reductions in operative time, and for use in patients with small aortic roots. Some advocate sutureless valves in patients with a small aortic root to allow the placement of a larger bioprosthesis and therefore avoid PPM.40 However, there is concern that sutureless valves may be associated with more conduction disorders and paravalvular leaks.40

    Other surgical considerations

    The simplest method of preventing PPM is to choose the right valve and place as large a prosthesis as possible, in relation to the aortic annulus. However, in a recent in vitro model study, placing an oversized bioprosthetic valve resulted in reduced haemodynamic valve performance,41 possibly related to abnormal stresses around the hinge point of each leaflet, causing the hinge point to be shifted inwards and reducing the EOA of the valve. Although oversizing the valve has a deleterious effect on valve haemodynamics in vitro, clinical consequences of valve oversizing currently are unknown. On the other hand, there is also evidence to suggest that structural valve deterioration may be accelerated in the context of PPM.42

    Another approach to prevention of PPM is enlargement of the aortic root to allow the placement of a larger prosthesis, of which there are a number of different surgical techniques. Unfortunately, annular enlarging procedures add extra operative time and in particular longer cardiopulmonary bypass and aortic cross clamp times, which may negatively impact outcomes following surgery.43 They also add to the complexity of the procedure, although some groups have reported that aortic root enlargement can be performed with low operative risk.44 The same group, however, noted that enlargement of the aortic root does not appear to translate into improved long-term clinical outcomes.

    A pulmonic valve autograft (eg, the Ross Procedure) may be considered, particularly in younger patients at risk of PPM, because the native pulmonic valve has excellent haemodynamics when placed in the aortic position. A recent meta-analysis by Um and colleagues supports superior haemodynamics of the pulmonic autograft procedure over conventional AVR.45 However, the advantages of excellent haemodynamics and avoidance of anticoagulation may be outweighed by the complexity of the operation with two valve replacements and the long-term risk of deterioration of the pulmonic valve homograft, in addition to the pulmonic autograft in the aortic position.46 In addition, the neo-aortic sinuses are at risk of progressive dilation, requiring re-intervention in a subset of patients.

    Transcatheter aortic valve implantation

    Transcatheter aortic valve implantation (TAVI) may be considered to avoid PPM, particularly in older adults. In the randomised trial of a self-expanding TAVI valve, severe PPM occurred in 25% of those undergoing SAVR versus 6% of those undergoing TAVI.47 Across all studies, rates of PPM appear to be lower in patients undergoing TAVI compared with surgical AVR,39 48 with a meta-analysis, which included 4000 patients, concluding that the incidence of severe PPM following TAVI is only about 8%.48 Although this review did not show an impact of PPM on long-term survival, this may be due to the patients undergoing TAVI being generally older and frailer. Of course, disadvantages of TAVI, such as paravalvular regurgitation, might offset any beneficial effect of less PPM on LV mass regression and survival.39 In addition, we have robust data on TAVI durability only out to 5 years,49 so it is premature to advocate the use of TAVI to prevent PPM, particularly in younger patients given the durability of modern surgical bioprosthetic valves,50 and the low surgical mortality and morbidity rates at experienced valve centres.

    When to intervene in PPM

    In patients with persistent cardiac symptoms after AVR, when careful clinical and imaging evaluation have confirmed PPM and other causes of symptoms have been evaluated and treated, the following factors need to be considered: (1) Are there interventions available to relieve PPM in this patient? (2) Do the expected benefits justify the predicted risk of intervention? (figure 2). Unfortunately, once PPM is present, there may be few options available; implanting a larger valve or a valve with better haemodynamics would require a second operation and, possibily, an annular enlarging procedure. The risk of a second operation often is high and patients may be reluctant to undergo another intervention. Thus, as rates of intervention for PPM are very low, our focus needs to be on prevention (figure 1).

    Figure 2
    Figure 2

    Suggested approach to management of patients with aortic valve PPM. AVR, aortic valve replacement; EOA, effective orifice area; PPM, patient-prosthesis mismatch; pt, patient; TAVI, transcatheter aortic valve implantation.

    View this table:
    Table 4

    Left ventricular mass regression in patients with PPM

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    Footnotes

    • Contributors All authors have contributed equally to this work.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent Not required.

    • Provenance and peer review Commissioned; externally peer reviewed.