Moderate Prosthesis-patient Mismatch Research Articles

Abstract 16029: Patient Prosthesis Mismatch Post Transcatheter Aortic Valve Replacement is Associated With Lack of Improved Left Ventricular Diastolic Function

Background: Patient prosthesis mismatch (PPM) is a frequent problem after transcatheter aortic valve replacement (TAVR) that results in adverse cardiac remodeling. This study sought to evaluate the association between PPM and changes in diastolic function post-TAVR. Methods: 339 patients (79.3+8.8 y, 44.4% female) who underwent TAVR for severe aortic stenosis between 2015-2018 with an echocardiogram (echo) at baseline and at 1-year were studied. Echo measurements were performed according to ASE guidelines. Moderate PPM is defined by an indexed effective orifice area (iEOA) of <0.85 to >0.65 cm 2 /m 2 , and severe PPM by an iEOA <0.65 cm 2 /m 2 . The aortic valve acceleration to ejection time ratio (AT/ET) was measured to further stratify patients with PPM and considered abnormal if >0.35. Student’s t-tests were used to compare diastolic function at baseline and 1-year. Results: We found that 26.2% of subjects had moderate PPM, 11.8% had severe PPM, and 8.3% had an AT/ET >0.35 (Table 1). Tissue velocity at both the medial and lateral mitral annulus was reduced at baseline and did not improve. Left atrial pressure (LAP) as assessed by E/e` improved in those without PPM (19.5+9.5 to 18.8+9.6, p=0.04) and those with moderate PPM (21+12.2 to 18.2+6.9, p=0.03), but not in those with severe PPM or with AT/ET>0.35. Right ventricular systolic pressure (RVSP) decreased significantly in patients with no or moderate PPM (39.6+13.6 mmHg to 35.5+10.8 mmHg, p=0.02 and 41.2+13.9 mmHg to 36+10.8 mmHg, p=0.006; respectively), while there was no significant decrease for patients with severe PPM or with AT/ET>0.35. Conclusion: We found that in patients undergoing TAVR, diastolic function was impaired as evidenced by low mitral tissue velocities, elevated LAP, and elevated RVSP. PPM resulted in less improvement of diastolic parameters including no improvement in LAP and RVSP. These findings suggest that severe PPM has an adverse effect on cardiac remodeling.

Perceval or Trifecta to Prevent Patient-Prosthesis Mismatch.

The Trifecta aortic valve has excellent hemodynamics characteristics. Moreover, the Perceval prosthesis may achieve better hemodynamics than the conventional valves; therefore, it has been proposed to reduce the incidence of patient–prosthesis mismatch. Our aim was to compare the prevalence of this complication between both prostheses. All patients who underwent valve replacement with a Perceval or a Trifecta from 2016 to 2020 at our institution were included. We calculated the prevalence of patient–prosthesis mismatch for each prosthesis and size and performed a multinomial logistic regression model to investigate the impact of choosing one prosthesis over the other. A total of 516 patients were analyzed. Moderate mismatch was present in 33 (8.6%) in the Trifecta group and 28 (21.4%) in the Perceval group, p < 0.001. Severe mismatch was present in 8 (2.1%) patients with Trifecta and 5 (3.8%) patients with Perceval, p = 0.33. Compared with the Perceval, the Trifecta prosthesis was shown to reduce moderate patient–prosthesis mismatch: OR = 0.5 (95% CI 0.3–0.9, p = 0.02). Both prostheses led to a similar risk of severe patient–prosthesis mismatch: OR = 0.9 (95% CI 0.3–2.8, p = 0.79). Both prostheses provide a very low risk of severe patient–prosthesis mismatch. Compared with the Perceval prothesis, the Trifecta prosthesis is able to reduce by 50% the risk of moderate mismatch.

Early evaluation of the aortic root after Nicks' procedure

Objective(s)To determine the influence of surgical techniques adopted to avoid suture line disruption, periprosthetic leakage, patch dislodgement, pericardial patch aneurysm formation, and the long-term stability of aortic root enlargement (ARE) during aortic valve replacement (AVR).MethodsOne hundred fifteen patients undergoing AVR or combined aortic and mitral valve replacements with Nicks' posterior ARE between 1997 and 2019 underwent long-term echocardiographic and angio-computed tomographic evaluation. Age was 11-72 years (AVR: median, 30; interquartile range, 21-47 years; AVR and mitral valve replacement: median, 27.5; interquartile range, 20-37.5 years). The aortotomy was closed using autologous pericardial patch and Teflon-buttressed sutures.ResultsHospital mortality was 1.7% (n = 2), with 4 (3.5%) late deaths. At a mean follow-up of 123.11 ± 77.67 months, the survival probability from Kaplan–Meier was 93.25 ± 0.03%. No cases of severe prosthesis–patient mismatch (PPM) were observed, and only 2 patients had moderate PPM. Median aortic root diameters at the level of sinus of Valsalva and sinotubular junction were 32 (29-35) mm and 33 (30-36) mm, respectively, at discharge, and were 33 (30-36) mm, and 33 (31-37) mm, respectively, at latest follow-up, with no cases of late pericardial patch aneurysm.ConclusionsARE is a safe adjunct to AVR in patients with a small aortic annulus to prevent PPM. Retention of a pericardial collar and Teflon-buttressed sutures is an expedient, safe, and effective technique in reducing bleeding at the enlarged ventriculo-aortic junction. Autologous pericardial patch aortoplasty is not associated with late aneurysm/pseudoaneurysm formation.

Long-term outcome of prosthesis-patient mismatch after transcatheter aortic valve replacement

BackgroundIncidence and long-term clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) are still unclear. MethodsWe enrolled 710 consecutive patients who underwent TAVR. PPM was defined as absent if the index orifice area (iEOA) was >0.85 cm2/m2, moderate if the iEOA was between 0.65 and 0.85 cm2/m2 or severe if the iEOA was <0.65 cm2/m2. ResultsAmong the 566 patients fulfilling the study criteria, the distribution of PPM was as follows: 50.5% none (n = 286), 43% moderate PPM (n = 243) and 6.5% severe PPM (n = 37). At 5-year follow-up, patients with severe PPM had a significantly higher incidence of the combined endpoint of cardiovascular death, acute myocardial infarction and stroke (p = .025) compared with the other patients. After adjusting the results for possible confounders, severe PPM remained an independent predictor of long-term adverse outcome (HR: 2.46; 95% Confidence Interval: 1.10–5.53). The independent predictors of severe PPM were valve-in-valve procedure and body mass index. Balloon-expandable valves were not associated with higher rates of severe PPM in comparison with self-expandable valves (8% vs. 5%, respectively, p = .245). ConclusionsIn our study severe PPM emerged as a risk factor for long-term major adverse cardiac and cerebrovascular events.

A077 Incidence, Predictors and Prognostic Impact of Patient-Prosthesis Mismatch Following Transcatheter Aortic Valve Implantation

Patient-prosthesis mismatch (PPM) describes a state where the effective orifice area (EOA) of a valve prosthesis is too small relative to the patient's body surface area (BSA). We reviewed the incidence and prognostic impact of PPM following transcatheter aortic valve implantation (TAVI). A retrospective review of patients undergoing TAVI in the Auckland Region between October 2011 and December 2018 was performed. PPM was classified as severe (<0.65 cm2/m2), moderate (0.65-0.85 cm2/m2), or none (>0.85 cm2/m2) on post-TAVI echocardiography. Multivariable logistic regression analysis was used to determine independent predictors of PPM. One-year clinical outcomes were analysed. A total of 294 patients were included in this study (median age 81 years, interquartile range [IQR] 76 to 85 years], BSA 1.87m2, IQR 1.69 to 2.05m2). SAPIEN XT or S3 valves were used in 239 patients (81.3%) and 24 (8.2%) had valve-in-valve TAVI. Moderate and severe PPM were observed following TAVI in 42 (14.3%) and 26 (8.8%) patients respectively. In our multivariate analysis, larger BSA, smaller left ventricular outflow tract (LVOT) diameter and valve-in-valve procedures were identified as independent predictors of severe PPM. There was no significant difference in 30 day or 1-year mortality between PPM groups. Larger BSA, smaller LVOT diameter and valve-in-valve TAVI were predictors of moderate or severe PPM. PPM did not have a significant prognostic impact on mortality following TAVI, consistent with larger international registries.

Determinants of Aortic Prosthesis Mismatch in a Brazilian Public Health System Hospital: Big Patients or Small Prosthesis?

BackgroundProsthesis-patient mismatch (PPM) is associated with worse outcomes.ObjectiveDetermine the frequency and evaluate preoperatory variables independently associated with severe PPM in a tertiary hospital focused on Public Health Care.MethodsA total of 316 patients submitted to aortic valve replacement, who had echocardiography performed within the first 30 days after surgery, were retrospectively analyzed. The indexed effective orifice area (iEOA) of the prosthesis was used to classify the patients into three groups, according to PPM, considering body mass index (BMI): severe PPM (iEOA) < 0.65 cm2/m2), mild to moderate PPM (iEOA, 0.65 cm2/m2 - 0.85 cm2/m2) and without PPM (iEOA > 0.85 cm2/m2) for a BMI < 30 kg/m2 and severe PPM (iEOA) < 0.55 cm2/m2), mild to moderate (iEOA, 0.55 cm2/m2- 0.70 cm2/m2) and without PPM (iEOA > 0.7 cm2/m2) for a BMI > 30 kg/m2. Statistical significance was considered when p < 0.05.ResultsiEOA was obtained in 176 patients. The frequency of severe and moderate PPM was 33.4% and 36.2%, respectively. Severe PPM patients were younger and had larger BMI, but smaller left ventricular outflow tract diameter (LVOTD). The independent variables used to predict severe PPM were male gender, BMI > 25 kg/m2, age < 60 years, LVOTD < 21 mm, and rheumatic etiology with an area under the ROC curve of 0.82.ConclusionThe frequency of severe PPM is high in a Brazilian population representative of the Public Health System, and it is possible to predict PPM from preoperative variables such as rheumatic valvular disease, gender, BMI, age and LVOTD.

Prevalence, Predictors and Survival Outcome of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement: A Single-Center Experience

INTRODUCTION: Prosthesis-patient mismatch (PPM) after surgical or transcatheter aortic valve replacement (SAVR or TAVR, respectively), remains a significant concern in large registries and has potentially affected clinical outcomes including mortality. This study aimed to determine the prevalence, predictors and survival outcome of patients with and without PPM post-TAVR at St. Luke’s Medical Center–Global City (SLMC-GC), Philippines. METHODS: This was a retrospective cohort analysis among patients who underwent TAVR at SLMC-GC between 2012 and 2018. We reviewed the procedural and follow-up records of patients from the TAVR clinic at SLMC-GC and identified those with PPM. The prevalence of PPM was computed and the characteristics and survival of those with and without PPM were compared. RESULTS: There were 133 patients included in the study. Severe and moderate PPM were observed in 4.5% and 11.3% of patients, respectively. No clinical, procedural or echocardiographic characteristic was identified as a significant independent predictor of PPM post-TAVR. The estimated mean survival of patients using the Kaplan–Meier method was 64.9 months (95% CI 52.7, 77.2 months) in the PPM group vs 62.1 months (95% CI 55.9, 68.4 months; log-rank p=0.72), which were not significantly different between groups. CONCLUSION: The incidence of moderate to severe PPM post-TAVR in our institution was 15.8%. The clinical, procedural and echocardiographic characteristics of patients with and without PPM post-TAVR did not significantly differ between groups. PPM has no significant impact on mortality among post-TAVR patients in Filipinos. KEYWORDS: Prosthesis-patient mismatch, Transcatheter aortic valve replacement, effective orifice area, Philippines

The effect of patient-prosthesis mismatch on survival after aortic and mitral valve replacement: a 10\u2009year, single institution experience

BackgroundThe evidence on the impact of patient-prosthesis Mismatch (PPM) on survival thus far has been conflicting. The aim of this study was to 1) study the effect of PPM on survival after isolated aortic and mitral valve replacement and 2) Assess the interaction between left ventricular function and PPM on survival.MethodsThe study cohort was patients who underwent isolated Aortic valve replacement (AVR) and Mitral valve replacement (MVR) over a 10-year period from 2008 to 2018. PPM was defined using the projected indexed effective orifice area (EOAi). The cohort was divided into different groups based on the degree of PPM. The severity of PPM was classified using threshold values of EOAi used in the literature. The Kaplan- Meier method was used to compare survival by degree of PPM. Multivariate Cox proportional hazards models were used to generate adjusted hazard ratios (HR) with 95% confidence intervals. An interactive term for ejection fraction (EF) was added to test whether EF modifies the effect of the PPM grade on survival. In addition, sub-group analysis based on left ventricular function was performed.ResultsIn the AVR cohort, there were a total of 1953 patients. The distribution of patients in the different PPM categories was as follows: no PPM 59.7%; moderate PPM 36.8%; severe PPM 3.5%. There was no significant difference in survival between the different groups. At 10 years, the adjusted HR between patients with severe PPM versus no PPM was 1.1(CI 0.5–2.4, p > 0.05) and the HR between those with moderate PPM versus no PPM was 0.97 (CI 0.74–1.23, p > 0.05). In the MVR cohort, there were a total of 298 patients. The distribution of PPM is as follows: no PPM 59.4%; and with PPM 40.6%. Again, there was no significant difference in survival between the groups. At 5 years, the adjusted HR between patients with PPM versus no PPM was 1.45 (CI 0.67–3.14, p > 0.05). In both groups, there was no significant interaction between left ventricular function (LVF) and degree of PPM on survival.ConclusionsIn our study cohort, the degree of PPM was not an independent predictor of survival after AVR or MVR. There was also no significant interaction between LV function and degree of PPM on survival.

Durability and clinical experience using a bovine pericardial prosthetic aortic valve

ObjectivesTo report the implant experience and long-term outcomes from a large tertiary care referral center on surgical aortic valve replacement (SAVR) with a contemporary stented pericardial bioprosthesis with anticalcification treatment. MethodsPatients underwent SAVR using the Trifecta valve at a single institution. Endpoints included procedural outcomes, adverse events, prosthesis–patient mismatch (PPM), long-term survival, and valve durability. Follow-up included 30-day, 6-month, and annual assessments. Treatment for structural valve deterioration (SVD) included surgical explant and valve-in-valve (V-in-V) transcatheter aortic valve implantation (TAVI). ResultsSAVR was performed in 1241 patients (median age, 73.5 ± 6.4 years; 54% male; median logistic EuroSCORE, 7.8) with concomitant procedures in 713 cases (57.5%). Intraprocedural mortality was 1.4%, and 30-day mortality was 6.0%. At hospital discharge, 68 patients (5.5%) had moderate PPM, and no patients had severe PPM. Adverse events included cardiac arrhythmias (44.7%, mostly atrial fibrillation), respiratory failure (22.9%), acute renal failure requiring temporary renal replacement therapy (12.9%), and low cardiac output syndrome (3.3%). Follow-up data were available over a total of 5469 patient-years (median duration of follow-up, 4.7 years). Freedom at 8 years from all-cause mortality, valve-related mortality, reoperation for SVD (redo SAVR or V-in-V TAVI), and endocarditis were 78.4%, 98.0%, 93.3%, and 96.5%, respectively. Of the 30 patients with SVD, 17 were treated by V-in-V TAVI and 13 underwent surgical explant. ConclusionsOutcomes from this large single-center cohort at increased surgical risk demonstrate excellent long-term durability of the Trifecta valve for SAVR and feasibility of treating SVD by V-in-V TAVI.

Impact of Suture Techniques for Aortic Valve Replacement on Prosthesis-Patient Mismatch

Many variables may affect the hemodynamic performance of the aortic valve prosthesis, and suture technique remains an important factor for determining maximum valve performance. The objective of this study was to determine the suture technique that produces better hemodynamic performance for aortic valve replacement (AVR). Patients who underwent AVR between January 2015 and September 2018 in our institution were analyzed. We compared the preoperative clinical information and 1-year postoperative hemodynamic data of interrupted pledget mattress sutures (pledgeted group), interrupted nonpledget mattress sutures (nonpledgeted group), and figure-of-8 nonpledget sutures (figure-of-eight group). We compared the incidence of prosthesis-patient mismatch (PPM) and cardiac adverse events among the groups and subanalyzed the PPM rate in a small aortic annulus (18 to 21 mm). A total of 439 patients underwent AVR (pledgeted, n= 212; nonpledgeted, n= 122; figure-of-eight, n= 105). The groups were similar in age (P= .359), sex (P= .055), underlying disease, and valve pathology. There was no difference in inhospital mortality or cardiac adverse events in each suture group (P= .282). The nonpledgeted suture had significantly lower moderate (P < .01) and severe PPM rates (P= .01) in patients with a small aortic annulus (18 to 21 mm). The interrupted nonpledget mattress suture offers complete supraannular implantation, which reduces the incidence of PPM and results inbetter hemodynamic improvement after small-sizeAVR.

Clinical outcome and hemodynamic performance of St. Jude Trifecta aortic prosthesis: short-term follow-up and risk factors analysis.

We retrospectively analysed the short-term outcome of the third-generation St. Jude Trifecta aortic prosthesis. Between December 2014 and December 2017, 177 patients (mean age 75.1±6.8 years, 95 males, 82 females) underwent aortic valve replacement with a St. Jude Trifecta aortic prosthesis and were followed up to 27±9 months. Preoperatively 92 patients (52.0%) were in NYHA class III-IV, EuroSCORE II was 3.2%±2.1%. Trifecta sizes implanted were 19 mm (n=46) (26%), 21 mm (n=69) (39%), 23 mm (n=46) (26%), 25 mm (n=16) (9%). Concomitant coronary artery bypass grafting was performed in 60 patients (34.0%). Operative mortality was 3.4% (1.7% for isolated aortic valve replacement versus 6.7% for combined aortic valve replacement and coronary artery bypass grafting) (P=0.084). The only independent predictor of mortality was the need for the mechanical ventilation greater than 24 hours (P=0.037); recently occurring myocardial infarction was risk factor for mortality at the univariate analysis only (P=0.013). Three-year survival was 84%±6%, freedom from cardiac death 98%±1%, freedom from prosthetic endocarditis 97%±1%. No thromboembolisms or structural valve degeneration were observed. Patient-prosthesis mismatch (PPM) was absent in 126 patients (71.2%), mild-to-moderate in 32 (18.1%), moderate in 19 (10.7%), severe in no any patient. Follow-up echocardiography showed an average mean and peak trans-aortic valve gradients reduction more than 70% in comparison with preoperative value (P<0.0001), and a significant regression of left ventricular hypertrophy (P<0.0001). Moderate PPM did not negatively affect survival. Concomitant severe coronary artery disease was found as an independent predictor of reduced survival (72%±12% versus 86%±6%) (P=0.015). Trifecta aortic prosthesis seems to provide very favourable clinical outcome and hemodynamic performance. At three years, survival was negatively affected by severe coronary artery disease detected at the time of operation. During short-term follow-up, no early structural valve degeneration was been observed. Due to low incidence of PPM and low peak and mean trans-prosthetic aortic valve gradients, third generation Trifecta aortic prosthesis should be considered as one of the best options in the setting of the aortic valve replacement surgery. However, a long-term follow-up is mandatory to confirm the early promising data.

Prosthesis-patient mismatch after transcatheter aortic valve implantation: prevalence and prognostic impact with respect to baseline left ventricular function

We aimed to assess the prevalence and features of prosthesis-patient mismatch (PPM) following transcatheter aortic valve implantation (TAVI) and its prognostic impact considering baseline left ventricular ejection fraction (LVEF). Data from 1,309 patients undergoing TAVI for severe aortic stenosis were derived from a single-centre dedicated TAVI registry. PPM was assessed according to echocardiography at discharge and was defined in accordance with VARC-2. Median follow-up time was 2.03 years. Moderate and severe PPM was detected in 22.9% and 12.9%, respectively. Patients with severe PPM had smaller annuli and more often received transcatheter heart valve (THV) sizes ≤23 mm. Supra-annular THV design showed the lowest rate of PPM. In patients with LVEF <40%, but not in those with LVEF ≥40%, severe PPM was associated with an increased three-year mortality rate (no vs. severe PPM for LVEF ≥40%: 34.6% vs. 29.5%, p=0.96; LVEF <40%: 45.1% vs. 68.0%, p=0.041) and was independently predictive of all-cause mortality according to multivariate analysis in these patients (HR 2.97; 95% CI: 1.58-5.59, p<0.001). The presence of severe PPM depends on annular dimensions and THV size and design and is an independent predictor of mortality in patients with reduced LVEF. Hence, the risk of PPM should be considered within the process of THV selection.

DOES VALVE CHOICE MATTER? A THEORETICAL MODEL COMPARING PROSTHESIS-PATIENT MISMATCH BETWEEN SAPIEN 3 AND EVOLUT R IN TRANSCATHETER AORTIC VALVE REPLACEMENT

Impact of transcatheter heart valve(THV) selection on prosthesis-patient mismatch(PPM) remains unknown. We aimed to compare incidence of moderate and severe PPM between Sapien3(S3) and EvolutR/Pro(ERP) in a theoretical model. From 10/2015 to 9/2018, standardized effective orifice area(EOA) of 1401

Surgical aortic valve replacement and patient-prosthesis mismatch: a meta-analysis of 108 182 patients.

This study sought to evaluate the impact of patient-prosthesis mismatch (PPM) on the risk of perioperative, early-, mid- and long-term mortality rates after surgical aortic valve replacement. Databases were searched for studies published until March 2018. The main outcomes of interest were perioperative mortality, 1-year mortality, 5-year mortality and 10-year mortality. The search yielded 3761 studies for inclusion. Of these, 70 articles were analysed, and their data were extracted. The total number of patients included was 108182 who underwent surgical aortic valve replacement. The incidence of PPM after surgical aortic valve replacement was 53.7% (58116 with PPM and 50066 without PPM). Perioperative mortality [odds ratio (OR) 1.491, 95% confidence interval (CI) 1.302-1.707; P < 0.001], 1-year mortality (OR 1.465, 95% CI 1.277-1.681; P < 0.001), 5-year mortality (OR 1.358, 95% CI 1.218-1.515; P < 0.001) and 10-year mortality (OR 1.534, 95% CI 1.290-1.825; P < 0.001) were increased in patients with PPM. Both severe PPM and moderate PPM were associated with increased risk of perioperative mortality, 1-year mortality, 5-year mortality and 10-year mortality when analysed together and separately, although we observed a higher risk in the group with severe PPM. Moderate/severe PPM increases perioperative, early-, mid- and long-term mortality rates proportionally to its severity. The findings of this study support the implementation of surgical strategies to prevent PPM in order to decrease mortality rates.

Impact of Prosthesis Size and Prosthesis–Patient Mismatch on Outcomes in Younger Female Patients Undergoing Aortic Valve Replacement

The effects of patient-prosthesis mismatch (PPM) after surgical aortic valve replacement (SAVR) suggest worse outcomes with smaller valves. We assessed clinical outcomes of younger females undergoing SAVR, using small and large prostheses, and the incremental risk of PPM. Between January 2002 and June 2015, 451 younger (age ≤65 years) female patients underwent SAVR. Patients were stratified into small prostheses (SP) ≤21 mm (n = 256) and large prostheses (LP) ≥23 mm (n = 195) groups. PPM was classified as moderate if indexed effective orifice area (iEOA) 0.65-0.85 cm2/m2, or severe if iEOA <0.65 cm2/m2. Operative mortality was not statistically different between SP and LP groups (2.4% vs 0.5%; P = 0.146). Unadjusted 10-year survival was 82% (95% confidence interval 77-87%), and was similar in both groups (P = 0.210). When grouped by standard PPM thresholds, only severe PPM was associated with significantly decreased survival (P = 0.007). A significant survival decrease was detected in LP group with iEOA ≤0.75 cm2/m2 (P < 0.001). Among SP patients, iEOA ≤0.65 cm2/m2 was associated with increased mortality (P = 0.075). After adjusting for potential confounders, Cox proportional hazard model identified iEOAs of ≤0.65 cm2/m2 (hazard ratio 1.85; P = 0.066) and ≤0.75 cm2/m2 (hazard ratio 2.3; P ≤ 0.003) as predictors of decreased long-term survival, in SP and LP groups, respectively. Among younger females who underwent SAVR, postoperative complications and in-hospital outcomes were substantially similar between the SP and LP groups. However, patients who received LP were adversely affected at lesser degrees of PPM than those who received SP. While SP patients may tolerate until iEOA ≤0.65 cm2/m2, our results suggest that moderate PPM of iEOA ≤0.75 for LP patients should be avoided.

Impact of Prosthesis-Patient Mismatch on 1-Year Outcomes after Transcatheter Aortic Valve Implantation: Meta-analysis of 71,106 Patients.

ObjectivesThis study sought to evaluate the impact of prosthesis-patient mismatch (PPM) on the risk of early-term mortality after transcatheter aortic valve implantation (TAVI).MethodsDatabases (Medical Literature Analysis and Retrieval System Online [MEDLINE], Excerpta Medica dataBASE [EMBASE], Cochrane Controlled Trials Register [CENTRAL/CCTR], ClinicalTrials.gov, Scientific Electronic Library Online [SciELO], Latin American and Caribbean Literature on Health Sciences [LILACS], and Google Scholar) were searched for studies published until February 2019. PPM after TAVI was defined as moderate if the indexed effective orifice area (iEOA) was between 0.85 cm2/m2 and 0.65 cm2/m2 and as severe if iEOA ≤ 0.65 cm2/m2.ResultsThe search yielded 1,092 studies for inclusion. Of these, 18 articles were analyzed, and their data extracted. The total number of patients included who underwent TAVI was 71,106. The incidence of PPM after TAVI was 36.3% (25,846 with PPM and 45,260 without PPM). One-year mortality was not increased in patients with any PPM (odds ratio [OR] 1.021, 95% confidence interval [CI] 0.979-1.065, P=0.338) neither in those with moderate PPM (OR 0.980, 95% CI 0.933-1.029, P=0.423). Severe PPM was separately associated with high risk (OR 1.109, 95% CI 1.041-1.181, P=0.001).ConclusionThe presence of severe PPM after TAVI increased early-term mortality. Although moderate PPM seemed harmless, the findings of this study cannot not rule out the possibility of it being detrimental, since there are other registries that did not address this issue yet.

Prosthesis patient mismatch is an independent predictor of congestive heart failure after transcatheter aortic valve replacement

Little is known about the impact of prosthesis-patient mismatch (PPM) on outcomes after trans-catheter aortic valve replacement (TAVR). We reported previously an increased risk of PPM with Sapien 3 transcatheter Heart valve (S3-THV). We aimed to investigate the one-year outcomes of patients operated on for severe aortic stenosis (AS) with S3-THV based on the occurrence of PPM. Indexed effective orifice area (iEOA) was estimated by post-procedural echocardiography(TTE). PPM was defined as moderate when 0.65 cm 2 ≤ Ieoa ≤ 0.85 cm 2 , or severe if iEOA < 0.65 cm 2 /m 2 . Inclusion criteria: severe symptomatic AS implanted with S3-THV. Primary endpoint: one-year overall mortality secondary endpoint: hospitalization for congestive heart failure (CHF). A total of 227 consecutives patients were included between January 2015 and December 2016. Of the 208 patients with complete follow-up, mean age was 81.9 ± 6, mean Euroscore2 was 4.35 ± 3.4, mean baseline LVEF was 58 ± 13%. At post-procedural TTE, moderate and severe PPM were observed in 69 (33%) and 10 (4.8%) patients respectively. Patients with PPM were younger (80.4 ± 7 vs. 82.9 ± 5, P = 0.007), had a larger body surface area (1.84 ± 0.19 vs. 1.77 ± 0.19, P = 0.01), a lower iEAO (0.73 ± 0.1 vs. 1.1 ± 0.2, P < 0.001) and a higher mean gradient (12 ± 4 vs. 14 ± 5 mmHg, P < 0.001). At 1 year, the estimated overall mortality was similar between the PPM and non PPM groups (5.1% vs. 5.4%, P = 0.97); the PPM group had a significantly higher incidence of CHF at one year follow-up (16.5% vs. 7%, P = 0.04). By multivariate analysis, PPM (HR = 2.4 [1.02–6], P = 0.04) independently predicted CHF whereas LVEF, Paravalvular leakage ≥1, age and male gender did not. By subgroup analysis, patients with MR ≥2 were more vulnerable to PPM as they experienced a prohibitive risk of CHF (HR = 51.4 [2.61–99], P = 0.006). PPM after TAVR with S3-THV is not a risk factor for midterm mortality but is an independent predictor of CHF, especially in the subset of patients with MR ≥2.

Body weight status and post-operative predictive significance of effective prosthetic orifice area after aortic valve replacement

The definition of prosthesis-patient mismatch (PPM) remains to be refined to enhance its prognosis insight after SAVR, especially in obese patients. To test the prognostic impact of effective and predicted prosthetic orifice area (OA) according to body weight status after surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS). Between 2009 and 2016, we prospectively explored all consecutive patients referred to our Heart Valve Clinic for a first SAVR for severe AS. Indexed OA predicted from reference normal value (iPOA) and calculated by transthoracic echocardiography (iEOA) were assessed at discharge. Patients were followed for major events (ME), i.e. cardiovascular death, cardiac hospitalization for acute heart failure and stroke. 762 patients were included with a mean follow-up of 4 ± 2.5 years. Severe PPM was more frequently observed with iEOA than iPOA (20.5% vs. 7%, P < 0.0001), with a significant but weak correlation between these 2 parameters ( P < 0.0001, r 2 = 0.21). After multivariable adjustment, low iEOA was the only related prosthetic parameters independently associated with long-term outcome ( P = 0.03), without any difference between moderate and severe PPM. The unique cut-off of 0.85 cm 2 /m 2 of iEOA showed the best accuracy to predict ME in lean and overweight but not in obese patients. This was observed irrespective of the type of prosthesis (mechanical vs biological). No EOA normalization allowed to link EOA to outcome, i.e. ME after SAVR were not driven by prosthetic orifice area in obese patients, suggesting an “obesity paradox”. iEOA with the unique cut-off of 0.85 cm 2 /m 2 showed the best accuracy to predict ME after SAVR in lean and overweight but not in obese patients. Further studies are needed to explore the lack of prognostic insight of PPM in obese patients.

Impact of prosthesis‐iteration evolution and sizing practice on the incidence of prosthesis–patient mismatch after transcatheter aortic valve replacement

To investigate the impact of the introduction of the next generation self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. PPM was assessed at 30 days post-TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95-0.99], P = 0.002), history of myocardial infarction (2.09 [1.00-4.34], P = 0.049), annulus maximum diameter (0.84 [0.77-0.92], P < 0.001), and THV oversizing (0.90 [0.87-0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23-8.53], P = 0.017 and 5.79[2.33-14.36], P < 0.001). The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.

Incidence and impact of prosthesis-patient mismatch following transcatheter aortic valve implantation.

The implications of prosthesis-patient mismatch (PPM) in the context of transcatheter aortic valve implantation (TAVI) are still controversial. The objective of our study was thus to investigate theincidence and prognostic impact of PPM after TAVI. Our analysis included 613 TAVI patients in whom the indexed effective orifice area (iEOA) after TAVI was obtained in vivo using echocardiography. Prosthesis sizing was guided by pre-procedural ECG-gated computed tomography. Based on VARC-2 established criteria for significant PPM (iEOA ≤ 0.85 cm2/m2 in the setting of BMI < 30kg/m2 and iEOA ≤ 0.7 cm2/m2 in the context of BMI ≥ 30kg/m2), patients were attributed to a "No PPM" or a "PPM" group. We observed PPM after TAVI in 192 patients (31.3%) with moderate PPM being present in 150 subjects (24.5%) and severe PPM in 42 patients (6.9%). EuroSCORE, impaired LV function, and male gender were associated with PPM status. The "No PPM" group was characterized by higher rates of self-expandable valves (40.4% vs. 25.5%, p < 0.001). In a multivariate analysis age > 81.2 years, chronic obstructive pulmonary disease, peripheral artery disease, impaired LV function, acute kidney failure stage 3 as well as periprocedural myocardial infarction emerged as independent risk predictors for all-cause mortality after TAVI. After a median follow-up of 12.2 months PPM failed to show a significant association with overall survival (79.2% vs. 79.3%,p = 0.692). The incidence of PPM after TAVI seems to be substantially lower than after SAVR. PPM was less common using self-expandable valves. In our analysis, patients with PPM following TAVI did not have higher rates of all-cause mortality.