How to Avoid Prosthesis-Patient Mismatch

How to Avoid Prosthesis-Patient Mismatch
Philippe Pibarot, DVM, PhD, FACC, FAHA, FASE, FESC Canada Research Chair in Valvular Heart Diseases It’s a great pleasure and honnor for me to be here tonight to present you an update on this fascinating and very hot topic at the present time. First, I would like to thank xx, from St. Jude Medical for giving me the opportunity to present these data on prosthesis-patient-mismatch. INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUÉBEC Université LAVAL

BSA EOA PATIENT’S CARDIAC OUTPUT REQUIREMENTS PROSTHETIC VALVE EOA PPM occurs when the EOA of the prosthesis is too small in relation to patient’s body size / cardiac output requirements

Definition of PPM Based on Indexed EOA of Prosthesis
Mean Gradient (mmHg) Rest Exercise Mismatch Mismatch r=0.81 r=0.89 Stented Stentless Autograft Homograft This is a compendium of the results that we recorded over the years with different types of valve substitutes. And as you can see there is a very nice relationship between the indexed EOA and the postoperative gradients both at rest and during exercise. And to these days, and I will insist on this, the indexed EOA is the only parameter that has been shown to accurately predict the postoperative gradients and it is therefore the parameter that is used (and must be used) to define PPM. Important thing to underline here is that the relationship is curvilinear and once you get below 0.85, the pressure gradient and thus the LV workload will go up exponentially, and even more during exercise. Also interesting on these graphs is to see that the indexed EOAs are lower in stented prostheses and higher in stentless bioprostheses and even more in homografts and autografts. And this is consistent with the concept that of course stented prostheses have a larger supporting apparatus and are thus more obstructive than the other type of prosthesis, and hence this is not suprising that you would get lower EOAs and higher gradients. [This is actually a compendium of the data we recorded over the years showing this very nice curvilinear relationship between the indexed EOAand the mean gradients both at rest and during exercise. And to these days, and I will insist on this, this is the only parameter that has been shown to correlate and to be able to predict the postoperative gradients. There is none other. And we will discuss this point later on. Also interesting on these graphs is to see that the indexed EOA are lower in stented prostheses and higher in stentless bioprostheses and even more in homografts and autografts consistent with the concept that of course stented prostheses have a larger supporting apparatus are more obstructive than the other type of prosthesis, and hence this not suprising that you would get lower EOAs and higher gradients]. [And actually, we looked at this over the years. This slide shows a compendium of the results that we obtained over the years with different types of valve substitutes. And you can see that there is a very nice relationship between the indexed EOA and the postoperative gradients both at rest and during exercise. And actually, the indexed EOA is the only parameter that can accurately predict postop gradients and it is therefore the parameter that is used to define PPM. Important thing to underline here is that the relationship is curvilinear and once you get below 0.85, the pressure gradient and thus the LV workload will go up exponentially. In these graphs, it should also be noted that the majority of patients with a stented bioprosthesis have an indexed EOA  0.85 cm2/m2 and are therefore on this steep portion of the curve where gradients are relatively high at rest and increase markedly during exercise. In contrast, most patients with a stentless bioprosthesis and almost all patients with an aortic homograft or a pulmonary autograft have a larger indexed EOA and are therefore on the flat portion of the curve where gradients are low regardless of the level of flow]. Indexed EOA (cm2/m2) Pibarot & Dumesnil, JACC, 36: , 2000.

Severity and Prevalence of PPM in the Aortic Position
SEVERE MODERATE MILD/NONE (non significant) Indexed EOA (cm2/m2) According to these results, these are the criteria that we proposed to define the severity of PPM in the mitral position. Mismatch can be considered as being mild or non significant when the indexed EOA is larger than 1.2, as being moderate when the indexed EOA is between 1.2 and 0.9, and severe when it is below 0.9. 0.65 ( ) 0.85 ( ) Prevalence % %

Impact of PPM on Clinical Outcomes
Less regression of LVH Less recovery of coronary flow reserve Less regression of mitral regurgitation Less improvement in functional class / exercise capacity Increased incidence of late cardiac events Increased incidence of bioprosthesis SVD Negative impact on short- and long-term survival particularly if LV dysfunction Now, what’s the impact of mismatch on clinical outcomes. Well you have listed here different outcomes. And we will discuss briefly each (some) of them. So you have less improvement in functional class, increased incidence of late (adverse) cardiac events, lesser regression of LV hypertrophy, possibly increased bleeding complications, moderate impact on late mortality that is more than 8 years after operation, and major impact on perioperative mortality particularly if LV dysfunction is present. Now, what’s the impact of mismatch on clinical outcomes. Well you have listed here different outcomes.. So you have less improvement in functional class, increased incidence of late (adverse) cardiac events, lesser regression of LV hypertrophy, possibly increased bleeding complications, moderate impact on late mortality that is more than 8 years after operation, and major impact on perioperative mortality particularly if LV dysfunction is present. I won’t have the time to go through this in details. We will thus focus on this important point. Pibarot & Dumesnil, 92:1022-9, Pibarot & Dumesnil, JACC 2000; 36:

Head et al Eur Heart J. 33:1518-29;2012

Impact of PPM on All-Cause Mortality
Head et al Eur Heart J. 33: ;2012

Impact of PPM on Cardiac Mortality

Impact of PPM on Late Survival
2576 Patients with AVR ± CABG 100 80 61±2% Survival (%) P=0.008 60 57±3% 40 40±10% No signifcant PPM 20 Moderate PPM Mohty et al. JACC 2009; 53:39-47 Severe PPM Years 2 4 6 8 10

Late Survival vs. PPM and Preop. LVEF
100 100 80 80 52±2% 60 41±4% 60 Survival(%) P=0.007 P = NS 40 40 52±3% 29±5% No PPM No PPM 20 20 PPM PPM 2 4 6 8 10 12 14 2 4 6 8 10 12 14 Years Years Mohty et al. JACC 2009; 53:39-47

Late Survival vs. PPM Severity and Age
Age <70 yrs Age ≥70 yrs Adj RR=1.77 ( ) 100 100 80 80 76±3% 60 P = 0.02 60 P = 0.6 46±4% Survival(%) 74±3% 41±3% 40 40 No PPM No PPM 47±16% 20 Moderate PPM 20 Moderate PPM 34±13% The results of this study reveals that severe PPM has a significant negative effect on late survival in patients < 70 y.o. but not in the elderly population. These results are consistent with those of 2 other recent studies suggesting that the impact of PPM on postoperative outcomes is more pronounced in young patients than in older ones.5,15 This finding might be related to the fact that younger patients have higher cardiac output requirements. They indeed have higher basal metabolic rate and are generally more physically active. Also, because they have a longer life expectancy, younger patients are exposed to the risk of PPM for a longer period of time. Severe PPM Severe PPM 2 4 6 8 10 12 14 2 4 6 8 10 12 14 Years Years Mohty et al. JACC 2009; 53:39-47

Late Survival vs. PPM Severity and BMI
BMI <30 kg/m² BMI ≥30 kg/m² Adj RR=1.59 ( ) 100 100 63±6% 80 80 64±5% 60 60±2% 60 P = 0.9 Survival(%) P<0.0001 58±15% 40 40 54±3% No PPM No PPM 20 Moderate PPM 20 Moderate PPM An important finding of this study is that the PPM has an important negative impact on survival in patients with a BMI<30kg/m2 but no significant impact in obese patients. This finding is most likely related to the fact that the utilization of the body surface area for the normalization of EOA may overestimate the prevalence and severity of PPM in obese patients. Future studies will be necessary to determine if the indexation of EOA cannot be improved or refined in the case of obese patients. 25±12% Severe PPM Severe PPM 2 4 6 8 10 12 14 2 4 6 8 10 12 14 Years Years Mohty et al. JACC 2009; 53:39-47

Prevention of PPM Now the good news of course, as I told you is that PPM can be prevented. It can be almost completely avoided and I hope that soon it will be eradicated and will be considered as part of the history of valve surgery.

Recommendations for the Prevention of PPM
Avoid severe PPM (EOAI<0.65) in every patient undergoing AVR Avoid moderate PPM (EOAI<0.85) in: Patients with LV dysfunction a/o severe LVH Patients with concomitant MR Young (< yr) patients Athlete patients In light of the data published in the literature (that showed you), we should attempt to avoid severe PPM in every patient undergoing AVR and to avoid moderate PPM especially in high risk patients with poor LV function because these are the patients who are the most vulnerable to PPM. We should also attempt to avoid moderate PPM in young patients because these patients are generally more physically active and therefore have higher cardiac output requirements and moreover they are exposed to the risk of VP-PM for a longer period of time. And finally, it is of course important to optimize the postoperative indexed EOA in athlete patients to accommodate the larger cardiac output requirements under exercise conditions

Calculate the Projected Indexed EOA to Predict Risk of PPM
Hypothetical Prosthesis Model This is the type of chart that you can use to project the postoperative indexed EOA and predict the risk of PPM at the time of operation. So at the top of the table, you have the different sizes for a given model of prosthesis with the reference values of EOA for each size. And then on the left hand side, you have the BSA of the patient. If you are in the green area, this indicates that the pospoperative indexed EOAis higher than , so there is no risk of PPM. If, it’s yellow, it’s borderline values and if it’s red, it is definetely values consistent with mismatch and you can estimate the severity of the anticipated PPM. [And now the manufacturers are making things much easier for us]. The manufactures are coming out with these kind of charts and, interestingly, they are all using the same format, so it’s very convenient. This is the chart provided by Medtronic where you can see on the left hand side, the BSA of the patients and then the different sizes of a given type of prosthesis. If it’s in green, you are above If it’s yellow, it’s borderline values, and if it’s in red it’s definitely values consistent with mismatch. Now what do you do if you have a patient in the OR and you fall on the red zone ! Pibarot & Dumesnil, 92:1022-9, 2006

Options to Prevent PPM 1- Use better performing prosthesis
Newer generation supra-annular bioprosthesis Newer generation mechanical prosthesis Stentless bioprosthesis Sutureless bioprosthesis 2- Aortic root enlargement 3- Transcatheter aortic valve implantation So what are the surgical options if you anticipate that the patient is at risk of mismatch. You could go to another type of prosthesis with a better hemodynamic performance such as a, for example, a stentless bioprosthesis (with oversizing) a bileaflet mechanical valve of new generation. Or alternatively, you could perform a root enlargement to accommodate a larger prosthesis of the same type. However, I think that this more complex and invasive procedure should be considered only in extreme cases. The hemodynamic performance of the newer generations of prosthetic valves has been markedly improved so that you are generally able to achieve adequate matching in the majority of the patients without having to enlarge the aortic root. And I should have listed probably another choice that is that you accept the mismatch given the operative circumstances because this is not the only variable you have to contend with. If for instance, the projected indexed EOA is 0.8 or 0.75 and this a relatively old and less active patient with a good ventricular function, you could always accept that. But the choice is yours, but at least you are doing an informed decision on what prosthesis you implant and on how it will perform therefafter in this patient. [You could thus avoid PPM by using this strategy and I will show you that, in essence, this can be done]. On the other hand, the prevention of PPM becomes a more important (mandatory) consideration in the case of severe mismatch especially in high risk patients with poor LV function or in the young athlete patients. [I have listed them here and I usually say: here my contribution stops in the sense that I am not a cardiac surgeon, I don’t do the operation and this is your decision but at least you can take an enlightened decision given the additional information that is now available. The choice might be the use of a better performing prosthesis, such as a stentless bioprostheses, neweer generation mechanical prosthesis, homografts the Ross operation. Or it might be an aortic root enlargement. And I should have listed probably another choice is that you accept the mismatch given the circumstances because this is not the only variable you have to contend with. People would say, well I have this elderly patient, good ventricular function but other risk factors. If I prolong the operative time, the risk will increase. So you have to weigh in these factors against the other factors and then take an informed decision but at least you make an informed decision you are not going blindly and find out all of a sudden after the operation that the gradients is high and call the cardiologist in the operative room and ask him why is the gradient high ? [And I will show you in a moment how this usually happens and is resolved]].

Option #1: Use of prosthesis with better hemodynamic performance and thus better “EOAbility”
So what are the surgical options if you anticipate that the patient is at risk of mismatch. You could go to another type of prosthesis with a better hemodynamic performance such as a, for example, a stentless bioprosthesis (with oversizing) a bileaflet mechanical valve of new generation. Or alternatively, you could perform a root enlargement to accommodate a larger prosthesis of the same type. However, I think that this more complex and invasive procedure should be considered only in extreme cases. The hemodynamic performance of the newer generations of prosthetic valves has been markedly improved so that you are generally able to achieve adequate matching in the majority of the patients without having to enlarge the aortic root. And I should have listed probably another choice that is that you accept the mismatch given the operative circumstances because this is not the only variable you have to contend with. If for instance, the projected indexed EOA is 0.8 or 0.75 and this a relatively old and less active patient with a good ventricular function, you could always accept that. But the choice is yours, but at least you are doing an informed decision on what prosthesis you implant and on how it will perform therefafter in this patient. [You could thus avoid PPM by using this strategy and I will show you that, in essence, this can be done]. On the other hand, the prevention of PPM becomes a more important (mandatory) consideration in the case of severe mismatch especially in high risk patients with poor LV function or in the young athlete patients. [I have listed them here and I usually say: here my contribution stops in the sense that I am not a cardiac surgeon, I don’t do the operation and this is your decision but at least you can take an enlightened decision given the additional information that is now available. The choice might be the use of a better performing prosthesis, such as a stentless bioprostheses, neweer generation mechanical prosthesis, homografts the Ross operation. Or it might be an aortic root enlargement. And I should have listed probably another choice is that you accept the mismatch given the circumstances because this is not the only variable you have to contend with. People would say, well I have this elderly patient, good ventricular function but other risk factors. If I prolong the operative time, the risk will increase. So you have to weigh in these factors against the other factors and then take an informed decision but at least you make an informed decision you are not going blindly and find out all of a sudden after the operation that the gradients is high and call the cardiologist in the operative room and ask him why is the gradient high ? [And I will show you in a moment how this usually happens and is resolved]].

PPM Preventive Strategy Based on Selection of a Prosthesis with Better Hemodynamic Performance
44% Prevalence of PPM (%) Preventive Strategy 30% Even more impressive, if you look at the prevalence of PA hypertension before and after operation, depending on whether you have or you don’t have mismatch, you can see that in the patients with no mismatch the prevalence went from 69 down to 19%, whereas in the patients with mismatch there was no regression or decrease in the prevalence of PA hypertension. [And of course, we have to further document this and do the same exercise as we did for the aortic valve and determine if the physiological effect that we see here will translate into higher morbidity and mortality. Nonetheless, we all know that persisting pulmonary hypertension is not good news and that it is generally associated with increased morbidity and mortality. The prevention of mismatch is even a greater challenge in the mitral than in the aortic position because you can not do an enlargement of the annulus and the implantation of stentless bioprosthesis is very difficult. Fortunately, these days, we are getting more mitral valve repair and the best way to avoid mismatch is certainly to repair the valve rather than replace it. But still, some valve valves can not be repaired and need to be replaced. And if such is the case, this phenomenon needs to be paid attention]. [This needs to be more documented but we think this is a real phenomenon. The challenge there of course is that you can not do an enlargement of the annulus. So, it’s even a greater challenge than in the aortic position. (But again, we have to contend with these challenges). Fortunately, these days, we are getting more mitral valve repair and the best way to avoid mismatch is to repair the valve rather than replace it. But still, some valve valves can not be repaired and need to be replaced. And if such is the case, this phenomenon needs to be paid attention. And I think we have to further document this and do the same exercise as we did for the aortic valve and determine if the physiological effect that we see here translate into higher morbidity and mortality] [In this series, the prevalence of pulmonary hypertension defined as a systolic PA pressure higher than 40 mmHg went from 69% before operation down to 19 % after operation in patients with no PPM whereas it remained unchanged in patients with PPM. Moreover, in multivariate analysis, mismatch was, by far, the strongest independent predictor of the presence of pulmonary hypertension. So this study shows that persistent pulmonary hypertension is frequent after mitral valve replacement and that it is strongly and independently associated with the presence of mismatch. And again, the clinical implications of these findings are important given that PPM is frequent after MVR and it could eventually be avoided using a preventive strategy at the time of operation]. 9% 1% Bleiziffer et al., Heart, 93:615-20, 2007

Comparison of the Incidence of PPM: CEP Standard vs. CEP Magna
More recent studies using an independent sizer measuring the actual diameter of the annulus also show that most stented bioprosthesis will result in high incidences of PPM in patients with an annulus < 22 mm. And the patients with an actual annulus diameter represented 45% of the series. And in this recent paper, Botzenhardt et al. reported that in the patient with an aortic annulus less than 22 mm, the prevalence of mismatch is 63% with the CEP standard and 33% with the CEP Magna. In this study, the aortic annulus diameter was measured with the use of an independent sizer. So this is not the labeled valve size, this is the true annulus size. And these patients with a small annulus and where the prevalence of mismatch is extremely high represent an important proportion of the patient population: 44.5% in this series. These results indicate that even with present days bioprostheses, mismatch is still a frequent occurrence. Botzenhardt et al. J Thorac cardiovasc Surg, 53: , 2005

Prospective Randomized Study: Mosaic vs. CEP Magna
86 patients: intra-operative randomization to Mosaic or Magna Incidence of PPM (%) Even more impressive, if you look at the prevalence of PA hypertension before and after operation, depending on whether you have or you don’t have mismatch, you can see that in the patients with no mismatch the prevalence went from 69 down to 19%, whereas in the patients with mismatch there was no regression or decrease in the prevalence of PA hypertension. [And of course, we have to further document this and do the same exercise as we did for the aortic valve and determine if the physiological effect that we see here will translate into higher morbidity and mortality. Nonetheless, we all know that persisting pulmonary hypertension is not good news and that it is generally associated with increased morbidity and mortality. The prevention of mismatch is even a greater challenge in the mitral than in the aortic position because you can not do an enlargement of the annulus and the implantation of stentless bioprosthesis is very difficult. Fortunately, these days, we are getting more mitral valve repair and the best way to avoid mismatch is certainly to repair the valve rather than replace it. But still, some valve valves can not be repaired and need to be replaced. And if such is the case, this phenomenon needs to be paid attention]. [This needs to be more documented but we think this is a real phenomenon. The challenge there of course is that you can not do an enlargement of the annulus. So, it’s even a greater challenge than in the aortic position. (But again, we have to contend with these challenges). Fortunately, these days, we are getting more mitral valve repair and the best way to avoid mismatch is to repair the valve rather than replace it. But still, some valve valves can not be repaired and need to be replaced. And if such is the case, this phenomenon needs to be paid attention. And I think we have to further document this and do the same exercise as we did for the aortic valve and determine if the physiological effect that we see here translate into higher morbidity and mortality] [In this series, the prevalence of pulmonary hypertension defined as a systolic PA pressure higher than 40 mmHg went from 69% before operation down to 19 % after operation in patients with no PPM whereas it remained unchanged in patients with PPM. Moreover, in multivariate analysis, mismatch was, by far, the strongest independent predictor of the presence of pulmonary hypertension. So this study shows that persistent pulmonary hypertension is frequent after mitral valve replacement and that it is strongly and independently associated with the presence of mismatch. And again, the clinical implications of these findings are important given that PPM is frequent after MVR and it could eventually be avoided using a preventive strategy at the time of operation]. Dalmau et al. Inter. CardioVasc. and Thor. Surg –349, 2007

Prospective Randomized Study: Mosaic vs. CEP standard
100 patients: intra-operative randomization to Mosaic or CEP standard Indexed EOA (cm2/m2) * * Walther et al. Circulation; 110: II-74-78, 2004

PPM in New Generations of Bioprosthetic Valves
Results of the St Jude Medical Trifecta Multicenter Clinical trial Mild to Moderate PPM: 22% Severe PPM: 2% Bavaria et al. JTCS 147:590-7; 2014

RCT of Minimally Invasive Rapid Deployment Versus Conventional Full Sternotomy AVR
XCL Bypass Time: min min p<0.001 Severe PPM at 3 months: % % p=0.04 Borger et al. Ann Thorac Surg 99:17–25, 2015

Option #2: Aortic root enlargement

Propensity-Score Matched Cohorts
Whole Cohorts Propensity-Score Matched Cohorts Conclusion: Aortic annular enlargement in the modern era is a safe adjunct to AVR, and should be considered in selected patients to avoid PPM Peterson et al. Ann Thorac Surg 2007;83:2044-9

Prospective Strategy to Avoid PPM
657 consecutive patients age: 7312 years, 61 % women, BSA: 1.80 0.23 m2 Projected indexed EOA  0.85 cm2/m2 > 0.85 cm2/m2 Enlargement of aortic root + AVR: 114 pts (17%) Standard AVR: 543 pts (83%) Does this prospective strategy to prevent mismatch work. Is it feasible and efficient in the true life. Well, one group has applied such a strategy with success. This is the results of Castro and colleagues where they systematically calculated the projected indexed EOA using patient’s BSA and the reference EOA value of the prosthesis they wanted to implant. When this projected indexed EOA was over 0.85, they went on and did their standard aortic valve replacement and when it came out below 0.85, they enlarged the aortic root to implant a prosthesis that would avoid PPM. The results are quite compelling. As you can see, the overall prevalence of mismatch was 2.5 %. This is markedly lower compared to the 20 % prevalence they would have had if they had not used this preventive strategy. [And, interestingly, this was done at no expense to operative mortality. It was actually lower with this 0.9% than in the group who underwent standard AVR at 4.1 %. The difference is not statistically significant, it is just to say that in the hands of this group, the operative mortality was not higher as a result of aortic root enlargement and that mismatch was successfully avoided using this preventive strategy. In other institutions, given the experience, technical efficiency, and preference of the surgeon the choice might be different. It might be a stentless bioprosthesis, it might be a mechanical valve. It might be an homograft, whatever, as I said the choice is yours but at least you can project what you are going to have after operation and with this information you can avoid mismatch in a prospective manner. It works if you do the exercise.] [Nonetheless, it is important to underline that root enlargement is not the only alternative to avoid PPM. This procedure should be considered only in extreme cases. There is now a variety of excellent prosthetic valves available on the market. So you are generally able to achieve adequate patient-prosthesis matching in almost all patients. So ultimately PPM will become obsolete]. [So does this prospective strategy to avoid mismatch work ? This is a series from Castro and colleagues where they used exactly the prospective strategy that we suggested and they operated on 657 patients, calculated before operation the projected indexed EOA as we defined it and when it was below 0.85 they did an enlargement of the aortic root. Doing this exercise they had projected mismatch in 17% of the patients. And as a result of the enlargement of the aortic root, the incidence of mismatch went down from 17 to 2.6% at no expense to operative mortality. It was actually lower with this 0.9% than in the group who underwent standard AVR at 4.1 %. The difference is not statistically significant, it is just to say that in the hands of this group, the operative mortality was not higher as a result of aortic root enlargement and that mismatch was successfully avoided. In other instances, given the experience and technical efficiency of the surgeon the choice might be different. It might be a stentless valve, it might be a mechanical valve. It might be homografts, whatever, as I said my contribution stops there but you can project what’s you are going to have, do it and avoid it. It works if you do the exercise.] [Now, can this be done, does this work. Well, one group has applied such a strategy with success. This is the results of Castro and colleagues where they calculated the projected indexed EOA using patient’s BSA and the reference EOA value of the prosthesis they wanted to implant. When this projected indexed EOA was over 0.85, they went on and did their standard aortic valve replacement and when it came out below 0.85, they enlarged the aortic root to implant a prosthesis that would avoid PPM. The results are quite compelling. As you can see, the overall incidence of mismatch was 2.5 %. This is markedly lower compared to the 20 % prevalence they would have had if they had not used a preventive strategy. [And using such a strategy the incidence of PPM overall was 2.5 % instead of being the 17 % they would have had had they gone on to do their standard procedure in their 114 patients.] Nonetheless, it is important to underline that root enlargement is not the only alternative to avoid PPM. This procedure should be considered only in extreme cases. There is now a variety of excellent prosthetic valves available on the market. So you are generally able to achieve adequate patient-prosthesis matching in almost all patients. So ultimately PPM will become obsolete]. Prevalence of mismatch: 2.6 % 2.4 % Operative mortality: 0.9 % 4.1 % Castro et al., Ann Thorac Surg, 74, 2002.

Option #3: Transcatheter Aortic Valve Replacement

Severe Prosthesis-Patient Mismatch in Transcatheter vs. Surgical Valves
Clavel et al., JACC, 53; , 2009

Prosthesis-Patient Mismatch in PARTNER-IA: TAVR vs. SAVR
Subsets with Small Aortic Annulus (<20 mm) Whole Cohorts Pibarot et al. J Am Coll Cardiol 2014;64:1323–34

TAVR has less PPM but more PVL than SAVR
Pibarot et al. JACC 64:1323–34, 2014

Survival According to Annulus Size and Treatment: TAVR vs. SAVR
All-cause mortality (PARTNER-I Cohort A - RCT) Small Annulus Tertile Medium Annulus Tertile Large Annulus Tertile 1) VP-PM can be accurately identified and predicted with appropriate uses of both the measured and projected indexed valve effective orifice areas (EOAs). It is however essential that the latter be derived from reliable sources of normal reference EOAs. 2) Severe VP-PM has a significant impact on early and late mortality, whereas moderate VP-PM may have a significant effect on mortality in vulnerable subsets of patients, and particularly in those with depressed LV systolic function. 3) The preventive strategy to avoid VP-PM can be implemented successfully and should be individualized according to the anticipated severity of VP-PM and of the patient’s baseline risk profile Rodés-Cabau et al. Circ Intervention 2014

PPM and PVR According to Annulus Size and Treatment: TAVR vs. SAVR
Paravalvular regurgitation Prosthesis-Patient Mismatch Rodés-Cabau et al. Circ Intervention 2014

SAVR PPM PVR Small Medium Large Annulus TAVR PPM PVR

Months Post-Procedure
All-Cause Mortality 18.9% 14.1% Δ = 4.8 Δ = 6.5 22.2% 28.6% Log-rank P=0.04 The Surgical was 19.1% and TAVR was 14.2% in the paper This difference is due to the addl patients Superiority p-value was planned at 1 year – The fact that the difference is maintained is the most important. No. at Risk Transcatheter 391 378 354 334 219 Surgical 359 343 304 282 191 Months Post-Procedure 35

Major Stroke 36

Paravalvular Regurgitation (Paired)
37

Echocardiographic Findings
TAVR had significantly better valve performance over SAVR at all follow-up visits (P<0.001) 38

The lower incidence of PPM may explain the better survival in TAVR versus SAVR in the CoreValve High Risk Trial ? 1) VP-PM can be accurately identified and predicted with appropriate uses of both the measured and projected indexed valve effective orifice areas (EOAs). It is however essential that the latter be derived from reliable sources of normal reference EOAs. 2) Severe VP-PM has a significant impact on early and late mortality, whereas moderate VP-PM may have a significant effect on mortality in vulnerable subsets of patients, and particularly in those with depressed LV systolic function. 3) The preventive strategy to avoid VP-PM can be implemented successfully and should be individualized according to the anticipated severity of VP-PM and of the patient’s baseline risk profile

Prevention of PPM: Conclusions
Severe PPM has a significant impact on mortality & morbidity, whereas moderate PPM may have a significant effect in vulnerable subsets of patients There are now several options to prevent PPM: newer generations of prostheses including sutureless valves, aortic root enlargement, TAVR Preventive strategy should be individualized according to the anticipated severity of PPM and the patient’s baseline risk profile 1) VP-PM can be accurately identified and predicted with appropriate uses of both the measured and projected indexed valve effective orifice areas (EOAs). It is however essential that the latter be derived from reliable sources of normal reference EOAs. 2) Severe VP-PM has a significant impact on early and late mortality, whereas moderate VP-PM may have a significant effect on mortality in vulnerable subsets of patients, and particularly in those with depressed LV systolic function. 3) The preventive strategy to avoid VP-PM can be implemented successfully and should be individualized according to the anticipated severity of VP-PM and of the patient’s baseline risk profile

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How to Avoid Prosthesis-Patient Mismatch

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