Moderate Prosthesis-patient Mismatch Research Articles

Patient-Prosthesis Mismatch After Surgical Aortic Valve Replacement: Analysis of the PARTNER Trials

BackgroundOur objective was to compare the impact of patient-prosthesis mismatch (PPM) for 2 years after surgical aortic valve replacement within the prospective, randomized Placement of Aortic Transcatheter Valves (PARTNER) trials. MethodsSurgical aortic valve replacement patients from the PARTNER 1, 2, and 3 trials were included. PPM was classified as moderate (indexed effective orifice area ≤0.85 cm2/m2) or severe (indexed effective orifice area ≤0.65 cm2/m2). The primary endpoint was the composite of all-cause death and heart failure rehospitalization at 2 years. ResultsBy the predicted PPM method (PPMP), 59.1% had no PPM, 38.8% moderate PPM, and 2.1% severe PPM; whereas by the measured PPM method (PPMM), 42.4% had no PPM, 36.0% moderate, and 21.6% severe. Patients with no PPMP (23.6%) had a lower rate of the primary endpoint compared with patients with moderate (28.2%, P = .03) or severe PPMP (38.8%, P = .02). Using the PPMM method, there was no difference between the no (17.7%) and moderate PPMM groups (21.1%) in the primary outcome (P = .16). However, those with no PPMM or moderate PPMM were improved compared with severe PPMM (27.4%, P < .001 and P = .02, respectively). ConclusionsSevere PPM analyzed by PPMP was only 2.1% for surgical aortic valve replacement patients. The PPMM method overestimated the incidence of severe PPM relative to PPMP, but was also associated with worse outcome. There was higher all-cause mortality in patients with severe PPM, thus surgical techniques to minimize PPM remain critical.

Long term impact of measured and predicted prosthesis patient mismatch following transcatheter aortic valve replacement

Abstract Objectives To investigate the long-term clinical impact of prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve implantation(TAVI). Background Both measured and predicted effective orifice area indexed to the body surface area (EOAi) have been suggested to define PPM in patients undergoing TAVI. The impact of PPM on clinical outcomes may accumulate with extended follow-up and vary according to the definition used. Methods Patients included in a prospective TAVI registry were stratified by the presence of moderate (0.65-0.85 cm2/m2 or 0.55-0.70 cm2/m2 if obese) or severe (≤0.65 cm2/m2 or ≤0.55 cm2/m2 if obese) PPM according to echocardiographically measured EOAi (measured PPM) prior to discharge, predicted EOAi based on published EOA reference values for each valve model and size (predicted PPMTHV), or predicted EOAi based on EOA reference derived from computed tomography measurements of aortic annulus dimension (predicted PPMCT). Results In an analysis of 2,463 patients, the incidence of measured PPM (moderate: 27.0%; severe: 8.7%) was higher than the incidence of predicted PPMTHV (moderate: 11.3%; severe: 1.2%) or predicted PPMCT (moderate: 12.0%; severe: 0.1%). During a median time to death of 843 days, mortality rates at 10 years were comparable in patients with versus without measured PPM or predicted PPMCT. In contrast, patients with moderate predicted PPMTHV had a lower risk of 10-year all-cause mortality compared with those without PPM (HR: 0.69; 95% CI: 0.52-0.90). Conclusions The use of predicted as compared to measured EOAi results in a lower estimate of PPM severity in TAVI ptients. We observed no increased risk of death in patients with PPM throughout 10-year of follow-up.Incidence of PPM after TAVIImpact of Measured an Predicted PPM

Abstract 17651: Long-Term Outcomes of Prosthesis-Patient Mismatch After Surgical Aortic Valve Replacement: Meta-Analysis of Kaplan-Meier-Derived Individual Patient Data

Introduction - It remains controversial whether prosthesis-patient mismatch (PPM) impacts long-term outcomes after surgical aortic valve replacement (SAVR). Hypothesis - PPM is associated with poor outcomes after SAVR. Methods - Study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of studies published by March 2023. Results - Sixty-five studies met our eligibility criteria and included 122,989 patients (any PPM: 68,332 patients, 55.6%). At 25 years of follow-up, the survival rates were 11.8% and 20.6% in patients with and without any PPM, respectively (HR 1.16; 95%CI 1.13-1.18, p&lt;0.001). At 20 years of follow-up, the survival rates were 19.5%, 12.1 and 8.8% in patients with no, moderate and severe, respectively (moderate vs no PPM: HR 1.09; 95%CI 1.06-1.11; p&lt;0.001; severe vs no PPM: HR 1.29; 95%CI 1.24-1.35; p&lt;0.001). RMST was 0.8 years shorter in patients with moderate PPM, and 2.1 years shorter in patients with severe PPM in comparison with patients without PPM (10.2 years and 8.9 years vs. 11.0 years respectively, p&lt;0.001). PPM was associated with higher risk of cardiac death, HF-related hospitalizations and aortic valves reinterventions over time (p&lt;0.001). Statistically significant associations between PPM and worse survival were observed regardless of type of valves (bioprosthetic vs mechanical valves), contemporary PPM definitions unadjusted and adjusted to body mass index and PPM quantification method (in vitro, in vivo, Doppler echocardiography). Our meta-regression analysis revealed that populations with more women tend to have higher HRs for all-cause death associated with PPM. Conclusions - The results of the present study suggest that any degree of PPM is associated with poorer long-term outcomes following SAVR and provide support for implementation of preventive strategies to avoid PPM after SAVR.

Influence of moderate prosthesis–patient mismatch on long-term outcomes in patients with severe aortic stenosis with paradoxically reduced gradients against the background of reduced stroke volume after aortic valve replacement with a biological prosthesis: retrospective comparative study

OBJECTIVE: Our aim was to evaluate the impact of moderate prosthesispatient mismatch on long-term results after aortic valve replacement in patients with severe aortic stenosis with paradoxically reduced gradients against the background of a reduced stroke volume of the left ventricle.&#x0D; MATERIALS AND METHODS: We analyzed data from 88 patients with symptomatic severe aortic stenosis meeting the criteria: paradoxically reduced gradients against the background of a reduced stroke volume of the left ventricle. Patients were divided into 2 groups: Group 1 (n=42, mean age 674 years) with paradoxically reduced gradients against the background of reduced stroke volume of the left ventricle, with a moderate patientprosthesis mismatch; Group 2 (n=46, mean age 686 years) with paradoxically reduced gradients against the background of reduced stroke volume of the left ventricle, without patientprosthesis discrepancy. All patients underwent transthoracic echocardiographic evaluation.&#x0D; RESULTS: The average follow-up period was 84 (quarterly interval 7598) months, during the follow-up period 35 (40%) deaths were registered. There were no significant differences in in-hospital mortality: 2 (4.7%) and 2 (4.3%), respectively (p=0.2). In the long-term follow-up period, there was a significant difference in survival and hospitalization rates for exacerbation of heart failure between patients with and without patientprosthesis mismatch: 46 and 71%, 37 and 72%, respectively (p0.001). In the long-term follow-up period, patients with patientprosthesis mismatch showed a trend towards slower regression of left ventricle mass and left atrial volume, as well as a slower recovery of global longitudinal deformation of the left ventricle and exercise tolerance compared with patients without patientprosthesis mismatch. There were no significant differences in the incidence of stroke (90% and 91%; p=0.7). According to the results of Cox regression, the left ventricular stroke volume index and the aortic valve effective orifice area index were independent predictors of lethal events and the risk of hospitalization for exacerbation of heart failure.&#x0D; CONCLUSION: Moderate patientprosthesis mismatch in patients with paradoxically reduced gradients associated with reduced left ventricular stroke volume is independently associated with increased mortality and increased hospitalization for exacerbations of heart failure.

Long-term outcomes of measured and predicted prosthesis-patient mismatch following transcatheter aortic valve replacement.

Both measured and predicted effective orifice area (EOA) indexed to the body surface area (EOAi) have been suggested to define prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve replacement (TAVR). The impact of PPM on clinical outcomes may accumulate with extended follow-up and vary according to the definition used. We aimed to investigate the long-term clinical impact of PPM in patients undergoing TAVR. Patients in a prospective TAVR registry were stratified by the presence of moderate (0.65-0.85 or 0.55-0.70 cm2/m2 if obese) or severe (≤0.65 or ≤0.55 cm2/m2 if obese) PPM according to echocardiographically measured EOAi (measured PPM), predicted EOAi based on published EOA reference values for each valve model and size (predicted PPMTHV), or predicted EOAi based on EOA reference values derived from computed tomography measurements of aortic annulus dimensions (predicted PPMCT). In an analysis of 2,463 patients, the frequency of measured PPM (moderate: 27.0%; severe: 8.7%) was higher than the frequency of predicted PPMTHV (moderate: 11.3%; severe: 1.2%) or predicted PPMCT (moderate: 12.0%; severe: 0.1%). During a median follow-up of 429 days, 10-year mortality was comparable in patients with versus without measured PPM or predicted PPMCT. In contrast, patients with moderate predicted PPMTHV had a lower risk of 10-year all-cause mortality compared with those without PPM (adjusted hazard ratio: 0.73, 95% confidence interval: 0.55-0.96). The use of predicted versus measured EOAi results in a lower estimate of PPM severity. We observed no increased risk of death in patients with PPM over a median follow-up time of 429 days. gov: NCT01368250.

Prosthesis-patient mismatch after transcatheter implantation of contemporary balloon-expandable and self-expandable valves in small aortic annuli.

Evidence of clinical impact of PPM after TAVI is conflicting and might vary according to the type of valve implanted. To assess the clinical impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) with balloon-expandable (BEV) and self-expandable valves (SEV) in patients with small annuli. TAVI-SMALL 2 enrolled 628 patients in an international retrospective registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 ) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Analyses were performed comparing patients with less than moderate (n = 452), moderate (n = 138), and severe PPM (n = 38). Primary endpoint was incidence of all-cause mortality. Predictors of all-cause mortality and PPM were investigated. At a median follow-up of 380 days (interquartile range: 210-709 days), patients with severe PPM, but not moderate PPM, had an increased risk of all-cause mortality when compared with less than moderate PPM (log-rank p = 0.046). Severe PPM predicted all-cause mortality in patients with BEV (hazard ratio [HR]: 5.20, 95% confidence interval [CI]: 1.27-21.2) and intra-annular valves (IAVs, HR: 4.23, 95% CI: 1.28-14.02), and it did so with borderline significance in the overall population (HR: 2.89, 95% CI: 0.95-8.79). Supra-annular valve (SAV) implantation was the only predictor of severe PPM (odds ratio: 0.33, 95% CI: 0.13-0.83). Patients with small aortic annuli and severe PPM after TAVI have an increased risk of all-cause mortality at early term follow-up, especially after IAV or BEV implantation. TAVI with SAV protected from severe PPM.

Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement

BackgroundData on the long-term impact of prosthesis-patient mismatch (PPM) on outcomes after transcatheter aortic valve replacement (TAVR) remain sparse. We therefore aimed to investigate the incidence, predictive factors, and long-term prognostic impact of PPM on bioprosthesis durability and mortality. MethodsThis was a single-centre retrospective study including 2117 patients who underwent TAVR for aortic stenosis from 2002 to 2022. Moderate PPM was defined by indexed effective orifice area (iEOA) > 0.65 and ≤ 0.85 cm2/m2 (> 0.55 and ≤ 0.70 cm2/m2 if BMI ≥ 30 kg/m2) and severe PPM by an iEOA ≤ 0.65 cm2/m2 (≤ 0.55 cm2/m2 If BMI ≥ 30 kg/m2). ResultsThere were 351 patients (16.6%) with PPM, including 39 patients (1.8%) with severe PPM and 312 patients (14.7%) with moderate PPM. The mean follow-up duration was 31.2 ± 26.5 months. Factors independently associated with the occurrence of PPM were body surface area (odds ratio [OR] 3.32, 95% confidence interval [CI] 1.32-8.35; P = 0.01), valve-in-valve TAVR (OR 6.12, 95% CI 2.29-16.08; P < 0.001), small annulus (OR 2.42, 95% CI 1.41-4.07; P = 0.001), and the use of a balloon-expandable valve (OR 4.17, 95% CI 2.17-8.33; P < 0.001). PPM was associated with increased risk of mortality (hazard ratio [HR] 1.3, 95% CI 1.1-1.5, P = 0.004) and valve thrombosis (HR 4.2, 95% CI 1.4-12.6, P = 0.01), and a trend towards increased risk of structural valve deterioration (HR 1.7, 95% CI 0.9-2.9; P = 0.08). ConclusionsThe results of this study suggest that PPM has a negative long-term impact on outcomes after TAVR. These findings emphasise the importance of preventing PPM.

Self-expanding vs. balloon-expandable transcatheter heart valves in small aortic annuli.

Clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is currently in the focus of clinical research. Patients with small aortic annulus are at higher risk to display PPM. Data on incidence and clinical consequences of PPM after TAVR with either balloon-expandable (BEV) or self-expanding (SEV) transcatheter heart valves in small aortic annulus are sparse. Patients with small aortic annulus (perimeter < 72 mm or aortic annulus area < 400 mm2) who underwent BEV or SEV with contemporary transcatheter heart valve types were identified from the institutional TAVR database. Propensity score matching was applied for imbalanced baseline characteristics between patients undergoing BEV or SEV. Echocardiography and clinical follow-up beyond 3 years was reported following VARC-3 recommendations. Primary endpoint was the incidence of pre-discharge PPM and its association with 3-year mortality. From a total of 507 patients with small aortic annulus, 192 matched patient pairs with SEV or BEV were identified. Mean age was 81 ± 7 (SEV) vs. 81 ± 6 (BEV) years (p = 0.5), aortic annulus perimeter was 69 ± 3 vs.69 ± 3 mm, (p = 0.8), annulus area was 357 ± 27 vs.357 ± 27 mm2 (p = 0.8), and EuroScore II was 5.8 ± 6.6 vs.5.7 ± 7.2 (p = 0.9). SEV resulted in less moderate (20% vs. 31%, p < 0.001) and severe pre-discharge PPM (9% vs.18%, p < 0.001) compared to BEV. At discharge (7 ± 4 vs. 12 ± 9 mmHg, p = 0.003) and at 1-year follow-up (7 ± 5 vs.13 ± 3 mmHg, p < 0.001), SEV displayed lower mean gradients compared to BEV. Estimated survival after SEV was 85% (95% confidence interval (CI): 80%-90%) at 1 year, 80% (95% CI: 75%-86%) at 2 years, and 71% (95% CI: 65%-78%) at 3 years; estimated survival after BEV was 87% (95% CI: 82%-92%) at 1 year, 81% (95% CI: 75%-86%) at 2 years, and 72% (95% CI: 66%-79%) at 3 years, with no significant difference among the groups (p = 0.9) Body surface area (OR: 1.35, p < 0.001), implantation of BEV (odds ratio (OR): 3.32, p < 0.001), and the absence of postdilatation (OR: 2.16, p < 0.001) were independent risk factors for any PPM. At 3 years, patients without PPM had a higher 3-year survival compared with patients with ≥moderate PPM (77% vs. 67%, p = 0.03). BEV implantation in patients with small annulus was associated with a twofold higher incidence of pre-discharge severe PPM compared to SEV implantation. Survival at 3 years after TAVR was similar after BEV and SEV. However, patients with the absence of pre-discharge PPM had a higher 3-year survival compared to patients with ≥moderate PPM.

Correlation between measured and predicted mismatch with valve hemodynamics in transcatheter aortic valve replacement: A sex-based analysis.

Data regarding the reliability of predicted effective orifice area indexed (pEOAi) is scarce in transcatheter aortic valve replacement (TAVR). To assess the validity of the pEOAi in TAVR by correlating its value with echocardiography-derived hemodynamic data. A single-center retrospective cohort study of TAVR patients from 2012 to 2021 with available echocardiograms was conducted. Patient-prosthesis mismatch (PPM) was defined based on the Valve Academic Research Consortium 3 criteria. The main endpoints were the congruence of measured effective orifice area indexed(EOAi) and pEOAi with the hemodynamic data obtained by echocardiography. The secondary endpoint included a correlation of predicted PPM (pPPM) and measured PPM (mPPM) with postoperative New York Heart Association(NYHA) status. A total of 318 patients were included. pPPM was more frequent than mPPM (54 [17%]; all moderate PPM vs. 39 [12.3%]: 32 moderate and 7 severe PPM).Predicted and measured EOAi were statistically correlated with postprocedural transvalvular mean gradient and Doppler velocity index (all p < 0.001), including in both sex-based subgroups. The positive predictive value and negative predictive value (NPV) of pPPM for postprocedural transvalvular mean gradient ≥ 20 mmHg were 16% and 97%, respectively. Only pPPM was significantly more prevalent in the group in which NYHA failed to improve than in those with symptom improvement (30.1% vs. 16%, p = 0.027). Predicted PPM has an excellent NPV for postprocedural transvalvular mean gradient ≥ 20 mmHg and seems to be a good predictor of NYHA status evolution as opposed to measured PPM. Predicted EOAi can be used in procedural planning to reduce the risk of PPM in both TAVR male and female patients.

B-61 | Incidence of Patient Prosthesis Mismatch (PPM) After ViV-TAVI and ViV-TAVI With Bioprosthetic Valve Fracture (BVF)

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is an effective treatment for degenerated bioprosthetic valves in high-risk patients. Unfortunately, patient prosthesis mismatch (PPM) remains an issue. PPM is known to impact functional status, valve longevity, morbidity and mortality. Bioprosthetic valve fracturing (BVF) is a method by which operators fracture the bioprosthetic valve allowing for greater expansion of the new valve or implantation of a larger valve. We sought to determine the incidence of PPM in patients undergoing ViV-TAVI and the safety of BVF. Patients who underwent ViV-TAVI at our institution from 2015-2022 were selected and divided into two groups (with BVF and without BVF). BVF was performed at the discretion of the operator. PPM severity was assessed as insignificant, moderate or severe. Moderate PPM was defined as an indexed effective orifice area (iEOA) <0.85 cm2/m2 (if BMI<30 kg/m2) or <0.70 cm2/m2 (if BMI>30 kg/m2). Severe PPM was defined as an iEOA <0.65 cm2/m2 (if BMI<30 kg/m2) or <0.55 cm2/m2 (if BMI>30 kg/m2). Measurements were taken by TTE on post operative day 1. All-cause mortality was assessed at 30-days and at 1-year. A total of 78 patients underwent ViV-TAVI, of which 25 patients had suboptimal gradients and were successfully treated with BVF. The mean age was 76.71 years old. The overall mean iEOA post ViV-TAVI was 0.69 ± 0.20 cm2/m2. Severe PPM was present in 43.4% that underwent ViV-TAVI, while only in 16% of patients that underwent ViV-TAVI with BVF. 1 patient required a permanent pacemaker in the BVF group. Amongst patients who underwent ViV-TAVI, 96.2% of patients were living at 30-days and 90.6% of patients were living at 1-year. Amongst patients who underwent ViV-TAVI with BVF, 100% of patients were living at 30-days and 96% of patients were living at 1-year. PPM was present more often in ViV-TAVI patients compared to ViV-TAVI with BVF. Short term mortality appears to be similar between groups and complications rates are low.

Figure of eight suture technique in aortic valve replacement decreases prosthesis-patient mismatch

BackgroundWhile the pledget suture technique has been the standard for surgical aortic. valve replacement (AVR), discussion continues regarding the possibility of the nonpledget suture technique to produce superior structural and hemodynamic parameters. This study aims to assess the effectiveness of the figure-of-eight suture technique in AVR, as determined by the incidence of prosthesis-patient mismatch (PPM).MethodsWe reviewed records of patients (N = 629) who underwent a surgical AVR procedure between January 2011 and July 2018 at a single institution. Indexed effective orifice area values and PPM incidence were calculated from implanted valve size and patient body surface area. Incidence of none, moderate, and severe PPM was compared across AVR suture techniques.ResultsA total of 570 pledget and 59 figure-of-eight patients were compared for incidence of PPM. Patients who received AVR with the pledget suture technique had significantly lower echocardiographic measurements of baseline ejection fraction than patients who had received AVR with the figure-of-eight suture technique (p = 0.003). Patients who received the figure-of eight suture had a 14% decrease in moderate PPM compared to patients who received the pledget suture (p = 0.022). Patients who received the figure-of-eight suture also had a significantly higher rate of no PPM (p = 0.044).ConclusionsThe use of the figure-of-eight suture technique in AVR can reduce the incidence of moderate PPM. While the pledget suture is the standard technique in AVR, the figure-of-eight suture technique may offer better structural and hemodynamic outcomes, especially for patients with a smaller aortic annulus.

Influence of prosthesis – patient mismatch on long-term results in patients after aortic valve replacement with a biological prosthesis: retrospective single center study

Background. Despite numerous studies, ambiguity remains at present regarding the impact of prosthesis-patient mismatch (PPM) on long-term outcomes after aortic valve (AV) replacement.&#x0D; Objective. This study evaluates the effect of PPM on long-term results in patients after AV replacement with a biological prosthesis.&#x0D; Material and methods. We retrospectively analyzed the data of 231 patients who underwent AV replacement with a biological prosthesis from 2010 to 2018 at the Penza Federal Center of Cardiovascular Surgery. Patients were implanted with the following biological prostheses: Medtronic Mosaic, Edwards PERIMOUNT, Biocor.&#x0D; Results. Moderate PPM was present in 131 patients (56%), and severe PPM in 1 patient (0.7%). The mean follow-up was 78.832 months. There were no significant differences in hospital mortality in patients with and without PPM, 4 (3%) and 3 (2,9%), respectively, p=0.9. In the long-term period, patients with PPM showed a slower regression of left ventricle (LV) mass and recovery of LV contractile function than patients without PPM, p=0.05. There was no significant difference in survival in the long-term follow-up period between patients with and without PPM long-term survival, 77.7% and 79%, respectively, p=0.6. Also, there were no significant differences in major adverse cardiac events and the freedom from adverse events was 90% and 91%; p=0.7. However, there was a tendency to more frequent hospitalization for chronic heart failure (CHF) exacerbation in the patient group with PPM than in those without PPM, 63.8% and 78%; HR 1.6; 95% CI 0.932.1, p=0.007. There was also a tendency for an increased biological valve structural degeneration in the group with PPM than in the group without PPM 76% and 87%, HR 1.4; 95% CI 1.43.1, p=0.01 According to the Cox regression, the overall postoperative mortality predictors were diabetes mellitus, vascular atherosclerosis HR 5; 95% CI 1.222, p=0.04 and HR 2.9; 95% CI 1.46.6, p=0.01 respectively. Predictors of the risk of hospitalization due to CHF exacerbation were previous myocardial infarction and PPM HR 0.4; 95% CI 0.20.9, p=0.04 and HR 1,5; 95% CI 0.92; p=0.005, respectively PPM HR 2; 95% CI 0.854.1, p=0.01.&#x0D; Conclusion. PPM is a common complication after AV replacement with a biological prosthesis. It is associated with a slower regression of LV mass, an increased risk of structural valve degeneration, and hospitalizations for exacerbated heart failure.

Intermediate Follow-Up of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annuli

The clinical impact of prosthesis-patient mismatch (PPM) in patients with small aortic annuli who underwent transcatheter aortic valve (AV) implantation with either balloon-expandable (BE) or self-expanding (SE) valves remains controversial. We assessed in-hospital and intermediate clinical outcomes in 573 patients with transfemoral transcatheter AV implantation with a small AV annulus, defined as an AV annulus area ≤430mm2. A total of 337 patients treated with a 23-mm BE valve (SAPIEN 3, Ultra) were compared with 236 patients treated with a 26-mm SE valve (Evolut series). Valve-in-valve cases were excluded, and late echo follow-up (mean 674 ± 438days) was assessed in a subset of 292 patients (51.0%). Well-matched BE and SE cohorts did not differ with respect to major in-hospital outcomes, other than a borderline increase in vascular complications and composite bleeding in patients with SE. Patients with BE had a higher incidence of severe PPM on discharge echocardiography (16.9% vs 6.8%, p <0.002). The mean AV gradient at 30days was higher for patients with BE (12.2 ± 4.2 vs 6.2 ± 7.9mm Hg, p <0.001) and at late follow-up (14.0 ± 8.2 vs 7.2 ± 3.5mm Hg, p <0.001). The follow-up left ventricular ejection fraction and incidence of >mild aortic insufficiency were similar. All-cause mortality for the 2 cohorts was similar, with an overall mean (95% confidence interval) survival time of 61.2months (57.8 to 64.5; p=0.98). There were no significant survival differences between combined patients with BE and SE with no, moderate, or severe PPM, with an overall mean (95% confidence interval) survival time of 32.5 (30.5 to 34.5)months combining valve types (p=0.23). In conclusion, despite an increased incidence of PPM with higher mean AV gradients that persist on late echocardiography in the BE cohort, patients with BE and SE with small aortic annuli have similar clinical outcomes at intermediate follow-up. Moderate and severe PPM had no impact on survival at a mean follow-up of 32.5months.

Hemodynamic parameters of aortic valve prostheses - KRAK-AS registry analysis.

The treatment of choice for aortic stenosis is a valve replacement. Some patients have post-procedural increased pressure gradient on the implanted prosthesis because of patient-prosthesis mismatch (PPM), known to adversely influence prognosis. The PPM risk should be initially predicted and effort made to avoid this complication, specifically in large body size patients. To assess the frequency of PPM taking into account the valvular prosthesis type in a real-life population of consecutive patients included in the Krakow aortic stenosis registry. The KRAK-AS registry was conducted in July-October 2016. Patients were assessed before and after valve surgery and during the 3-year follow-up. Patients who underwent aortic valve intervention were clinically and echocardiographically evaluated within a month after surgery and divided into groups depending on the implanted prosthesis type. Analysis of patients with a smaller (< 23 mm) and larger than median (≥ 23 mm) valve diameter was performed. The valve implantation was performed in 229 patients (42 mechanical, 139 biological, 48 transcatheter). No differences between patient groups compared by PPM occurrence was seen at baseline. Median age was 70 years; 55.5% were men. At least moderate PPM (iEOA ≤ 0.85 cm2/m2) was observed in 40% of mechanical valves, 33% of biological valves, and was significantly less frequent (10%) in patients after transcatheter valve implantation, p = 0.0001. Severe PPM (iEOA < 0.65 cm2/m2) was found in 17.6% of mechanical valve PPM patients, 4.3% of biological ones, and no patients after transcatheter procedure. PPM is a frequent phenomenon in the real-life population of patients undergoing surgical aortic valve replacement, being significantly less frequent in the case of a transcatheter procedure.

Prosthetic Valve Function after Aortic Valve Replacement for Severe Aortic Stenosis by Transcatheter Procedure versus Surgery.

Background This study compared the clinical outcomes of transcatheter (TAVR) and surgical (SAVR) aortic valve replacements, focusing on postoperative valvular performance assessed by echocardiography. Method and Results A total of 425 patients who underwent TAVR (230 patients) or SAVR (195 patients) were included. Postoperative effective orifice area index (EOAI) was higher in the TAVR group (1.27 ± 0.35 cm2/m2) than in the SAVR group (1.06 ± 0.27 cm2/m2, p < 0.001), and patient–prosthesis mismatch (PPM) was more frequent in the SAVR group (22.6%) than in the TAVR group (8.7%, p < 0.001). Mild or greater paravalvular leakage (PVL) was more frequent in the TAVR group (21.3%) than in the SAVR group (0%, p < 0.001). Moreover, there was no difference in freedom from all-cause death, stroke, or rehospitalization between the groups. Patients with moderate or greater PPM (EOAI < 0.85 cm2/m2) had lower freedom from composite events than those without this PPM criterion (p = 0.008). Patients with mild or greater PVL also had lower freedom from composite events than those without this PVL criterion (p = 0.017). Conclusions Postoperative valvular performance of TAVR was superior to that of SAVR in terms of EOAI. This merit was counterbalanced by the significantly lower rates of PVL in patients who underwent SAVR. The overall clinical outcomes were similar between the study groups.

Incidence and mechanisms of bioprosthetic dysfunction after transcatheter implantation of a mechanically-expandable heart valve.

The mechanically-expandable transcatheter valve is no longer commercially available, yet clinical and echocardiographic surveillance is imperative for thousands of patients who received transcatheter aortic valve implantation (TAVI) with this platform. We aimed to determine the incidence and mechanism of bioprosthetic valve dysfunction (BVD) following TAVI with mechanically-expandable valves. From 2013 to 2020, all 234 patients who underwent TAVI with the LOTUS valve were included. BVD was categorised as (i) structural valve deterioration (SVD), (ii) non-structural valve dysfunction (NSVD), (iii) clinical valve thrombosis and (iv) endocarditis, according to the Valve Academic Research Consortium-3 criteria. The mean age was 79±7 years, 60% were male, and the mean Society of Thoracic Surgeons score was 4.2±2.9%. The technical success rate was 94% and the 30-day device success rate was 78%. All-cause mortality at 1 year was 15%; median follow-up duration was 36 (IQR 18-60) months during which 47% of patients died. One hundred and three patients had ≥1 type of BVD (44%), which predominantly consisted of NSVD (39%, mostly because of ≥moderate patient-prosthesis mismatch). BVD during follow-up included endocarditis (3.4%), clinical valve thrombosis (3.4%) and SVD (1.3%). Both endocarditis and clinically apparent valve thrombosis occurred early and late after TAVI and resulted in valve-related deaths in 38% and 13% of patients, respectively. Overall, ≥moderate haemodynamic valve deterioration occurred in 5.5% and bioprosthetic failure in 7.3%, leading to valve-related deaths in 36% of cases. BVD represents a relevant health issue after TAVI with a mechanically-expandable valve. Serious but reversible causes of BVD include endocarditis and clinically apparent valve thrombosis, both carrying a time-independent hazard post-TAVI.

Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement: Meta-Analysis of Kaplan-Meier–Derived Individual Patient Data

BackgroundIt remains controversial whether prosthesis-patient mismatch (PPM) (in general considered moderate if indexed effective orifice area is 0.65-0.85 cm2/m2 and severe when <0.65 cm2/m2) affects the outcomes after transcatheter aortic valve replacement (TAVR). ObjectivesThe purpose of this study is to evaluate the time-varying effects and association of PPM with the risk of overall mortality. MethodsStudy-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of studies published by December 30, 2021. ResultsIn total, 23 studies met our eligibility criteria and included a total of 81,969 patients included in the Kaplan-Meier curves (19,612 with PPM and 62,357 without PPM). Patients with moderate/severe PPM had a significantly higher risk of mortality compared with those without PPM (HR: 1.09 [95% CI: 1.04-1.14]; P < 0.001). In the first 30 months after the procedure, mortality rates were significantly higher in the moderate/severe PPM group (HR: 1.1 [95% CI: 1.05-1.16]; P < 0.001). In contrast, the landmark analysis beyond 30 months yielded a reversal of the HR (0.83 [95% CI: 0.68-1.01]; P = 0.064), but without statistical significance. In the sensitivity analysis, although the authors observed that severe PPM showed higher risk of mortality in comparison with no PPM (HR: 1.25 [95% CI: 1.16-1.36]; P < 0.001), they did not observe a statistically significant difference for mortality between moderate PPM and no PPM (HR: 1.03 [95% CI: 0.96-1.10]; P = 0.398). ConclusionsSevere PPM, but not moderate PPM, was associated with higher risk of mortality following TAVR. These results provide support to implementation of preventive strategies to avoid severe PPM following TAVR.

Hemodynamic Performance of Two Current-Generation Transcatheter Heart Valve Prostheses in Severely Calcified Aortic Valve Stenosis.

Background: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients. Methods: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included. Propensity score matching was utilized to create two groups of 170 patients. Results: At discharge, there was significant difference in transvalvular gradients (EPro vs. S3) (dPmean 8.1 vs. 11.1 mmHg, p ≤ 0.001) and indexed effective orifice area (EOAi) (1.1 vs. 0.9, p ≤ 0.001), as well as predicted EOAi (1 vs. 0.9, p ≤ 0.001). Moderate patient prosthesis mismatch (PPM) was significantly lower in the EPro group (17.7% vs. 38%, p ≤ 0.001), as well as severe PPM (2.9% vs. 8.8%, p = 0.03). PPI and the PVL rate as well as stroke, bleeding, vascular complication, and 30-day mortality were comparable. Conclusions: In patients with severely calcified aortic valves, both THVs performed similarly in terms of 30-day mortality, PPI rate, and PVL occurrence. However, patient prothesis mismatch was observed more often in the S3 group, which might be due to the intra-annular design.

Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project.

BackgroundA severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown.AimWe sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR.Materials and methodsThe TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria.ResultsAmong 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases.ConclusionAfter TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality.Clinical trial registration[https://clinicaltrials.gov], identifier [NCT04500964].

Sex Disparities in Hemodynamics and Outcomes in Patients Who Underwent Contemporary Transcatheter Aortic Valve Implantation

Studies have reported worse outcomes after transcatheter aortic valve implantation (TAVI) in women receiving early generation transcatheter heart valves (THVs). They have smaller aortic annuli, which could result in higher gradients and more patient-prosthesis mismatch (PPM) after TAVI. We investigated the interactions between contemporary THV hemodynamics and outcomes in women who underwent TAVI. We conducted a retrospective, observational study of patients who underwent contemporary TAVI from 2015 to 2020. We compared baseline characteristics, in-hospital outcomes, and hemodynamics according to sex. We then dichotomized women according to aortic annular area (<430 or ≥430 mm2). Included were 869 patients who underwent TAVI with the SAPIEN 3 or CoreValve Evolut PRO/PRO+. Most patients with small annuli were female (82.5%). They had nonsignificantly higher mortality (30-day: 1.5% vs 0.6%, p=0.313; 1-year: 4.1% vs 2.7%, p=0.265). Those who received self-expanding THVs had lower gradients (8.0 mm Hg vs 13.8 mm Hg, p <0.001), resulting in less moderate PPM (21.2% vs 73.6%, p <0.001), similar severe PPM (19.5% vs 15.3%, p=0.454), and higher rates of pacemaker implantation (14.4% vs 4.2%, p=0.009). Women with small annuli who received a balloon-expandable THV had nonsignificantly higher mortality (30-day: 2.1% vs 0.8%, p=0.631; 1-year: 6.3% vs 1.7%, p=0.118). In conclusion, women who underwent contemporary TAVI had nonsignificantly higher mortality, which could be due to higher PPM rates. These findings were more pronounced in the subset of women with small annuli, in whom those who received self-expanding THVs demonstrated superior hemodynamics at the cost of increased rates of pacemaker implantation.