Moderate Aortic Valve Stenosis Is Associated With Increased Mortality Rate and Lifetime Loss: Systematic Review and Meta-Analysis of Reconstructed Time-to-Event Data of 409 680 Patients.

BACKGROUND: The mortality risk attributable to moderate aortic stenosis (AS) remains incompletely characterized and has historically been underestimated. We aim to evaluate the association between moderate AS and all-cause death, comparing it with no/mild AS (in a general referral population and in patients with heart failure with reduced ejection fraction). METHODS AND RESULTS: A systematic review and pooled meta-analysis of Kaplan-Meier-derived reconstructed time-to-event data of studies published by June 2023 was conducted to evaluate survival outcomes among patients with moderate AS in comparison with individuals with no/mild AS. Ten studies were included, encompassing a total of 409 680 patients (11 527 with moderate AS and 398 153 with no/mild AS). In the overall population, the 15-year overall survival rate was 23.3% (95% CI, 19.1%-28.3%) in patients with moderate AS and 58.9% (95% CI, 58.1%-59.7%) in patients with no/mild aortic stenosis (hazard ratio [HR], 2.55 [95% CI, 2.46-2.64]; P<0.001). In patients with heart failure with reduced ejection fraction, the 10-year overall survival rate was 15.5% (95% CI, 10.0%-24.0%) in patients with moderate AS and 37.3% (95% CI, 36.2%-38.5%) in patients with no/mild AS (HR, 1.83 [95% CI, 1.69-2.0]; P<0.001). In both populations (overall and heart failure with reduced ejection fraction), these differences correspond to significant lifetime loss associated with moderate AS during follow-up (4.4 years, P<0.001; and 1.9 years, P<0.001, respectively). A consistent pattern of elevated mortality rate associated with moderate AS in sensitivity analyses of matched studies was observed. CONCLUSIONS: Moderate AS was associated with higher risk of death and lifetime loss compared with patients with no/mild AS.

Mortality after cardiac resynchronization therapy or right ventricular pacing in transcatheter aortic valve replacement recipients.

BACKGROUND: Permanent pacemaker implantation (PMI) is associated with increased morbidity after transcatheter aortic valve replacement (TAVR). Cardiac resynchronization-therapy (CRT) is recommended for patients if left ventricular ejection fraction (LVEF) is ≤ 40% and ventricular pacing is expected in favor to sole right ventricular (RV) pacing. Meanwhile, LVEF may recover after TAVR in patients with aortic valve disease and the benefit of CRT is unknown. OBJECTIVE: To analyze the impact of CRT implantation as compared to RV pacing after TAVR. METHODS AND RESULTS: Between 2012 and 2022, 4385 patients (53.1% female, mean age 81 ± 6 years) without prior PMI undergoing TAVR were retrospectively identified in our institutional registry. After stratification of patients in LVEF ≤ 40%, 41-49% and ≥ 50%, Kaplan-Meier analysis revealed significantly different survival rates in each subgroup at 5 years (37.0% vs. 43.5% vs. 55.1%; P ≤ 0.021). At multivariate regression, LVEF and new PMI after TAVR were not relevant for survival. A total of 105 patients with LVEF ≤ 40% received PMI after TAVR (86 patients with RV pacing and 19 with CRT). At 5 years, all-cause mortality was significantly lower in patients with CRT-device as compared to patients without CRT-device (Kaplan Meier estimate of 21.1% vs. 48.8%; HR 0.48, CI 0.204 - 1.128; log rank p = 0.045). In multivariate analysis CRT remained a significant factor for 5-year survival in these patients (HR 0.3, CI 0.095-0.951, p = 0.041). CONCLUSION: In patients undergoing TAVR, PMI did not influence 5-year survival. In patients with LVEF ≤ 40%, CRT-device implantation was associated with improved survival compared to non-CRT-device implantation.

Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Transcatheter or Surgical Treatment of Aortic-Valve Stenosis.

BACKGROUND: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice. METHODS: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year. RESULTS: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively. CONCLUSIONS: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.).

Patterns of aortic valve replacement in Europe and adoption by sex.

OBJECTIVE: Management of patients with severe aortic stenosis (AS) may differ according to the patient sex. This study aimed to describe patterns of aortic valve replacement (AVR) for severe AS across Europe, including stratification by sex. METHODS: Procedure volume data for surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) for six years (2015-2020) were extracted from national databases for Austria, Czech Republic, Denmark, England, Finland, France, Germany, Norway, Poland, Spain, Sweden, and Switzerland and stratified by sex. Patients per million population (PPM) undergoing AVR per year were calculated using population estimates from Eurostat. RESULTS: Between 2015 and 2019, AVR procedures grew at an average annual rate of 3.9%. In 2020, the average total PPM undergoing AVR across all countries was 339, with 51% of procedures being TAVI and 49% SAVR. AVR PPM varied widely between countries, with the highest and lowest in Germany and Poland, respectively. The average total PPM was higher for men than women (423 vs. 258), but a higher proportion of women (62%) than men (44%) received TAVI. The proportion of TAVI among total AVR procedures increased with age, with an overall average of 96% of men and 98% of women aged ≥85 years receiving TAVI; however, adoption of TAVI varied by country. CONCLUSIONS: The analysis of temporal trends in the adoption of TAVI vs. SAVR across Europe showed significant variations. Despite the higher use of TAVI vs. SAVR in women, overall rates of AV intervention in women were lower compared to men.

Non-femoral focused transaxillary access in TAVI: GARY data analysis and future trends.

BACKGROUND: In patients not suitable for transfemoral transcatheter aortic valve implantation (TAVI), several access strategies can be chosen. AIM: To evaluate the use and patient outcomes of transaxillary (TAx), transapical (TA), and transaortic (TAo) as alternative access for TAVI in Germany; to further evaluate surgical cutdown vs. percutaneous TAx access. METHODS: All patients entered the German Aortic Valve Registry (GARY) between 2011 and 2019 who underwent non-transfemoral TAVI were included in this analysis. Patients with TA, TAo, or TAx TAVI were compared using a weighted propensity score model. Furthermore, a subgroup analysis was performed for TAx regarding the percutaneous or surgical cutdown approach. RESULTS: Overall, 9686 patients received a non-transfemoral access. A total of 8918 patients (92.1%) underwent TA, 398 (4.1%) TAo, and 370 (3.8%) TAx approaches. Within the TAx subgroup, 141 patients (38.1%) received subclavian cutdown, while 200 (54.1%) underwent a percutaneous approach. The TA patients had a significantly lower 30-day survival than TAx patients (TA 90.92% vs. TAx 95.59%, p = 0.006; TAo 92.22% vs. TAx 95.59%, p = 0.102). Comparing percutaneous and cutdown TAx approaches, no significant differences were seen. However, more vascular complications occurred (TA 1.8%, TAo 2.4%, TAx 12.2%; p < .001), and the hospital length of stay was shorter (TA 12.9 days, TAo 14.1 days, TAx 12 days; p < .001) after TAx access. CONCLUSION: It may be reasonable to consider TAx access first in patients not suitable for TF-TAVI, because the 30-day survival was higher compared with TA access and the 1-year survival was higher compared with TAo access. It remains important for the heart teams to offer alternative access modalities for patients not amenable to the standard TF-TAVI approaches.

Early and Late Results after Surgical Mitral Valve Repair: A High-Volume Center Experience.

BACKGROUND: Surgical mitral valve repair is the gold standard treatment of severe primary mitral regurgitation (MR). In the light of rapidly evolving percutaneous technologies, current surgical outcome data are essential to support heart-team-based decision-making. METHODS: This retrospective, high-volume, single-center study analyzed in 1779 patients with primary MR early morbidity and mortality, postoperative valve function, and long-term survival after mitral valve (MV) repair. Surgeries were performed between 2009 and 2022. Surgical approaches included full sternotomy (FS) and right-sided minithoracotomy (minimally invasive cardiac [MIC] surgery). RESULTS: Of the surgeries (mean age: 59.9 [standard deviation:11.4] years; 71.5% males), 85.6% (n = 1,527) were minithoracotomies. Concomitant procedures were performed in 849 patients (47.7%), including tricuspid valve and/or atrial septal defect repair, cryoablation, and atrial appendage closure. The majority of patients did not need erythrocyte concentrates. Mediastinitis and rethoracotomy for bleeding rates were 0.1 and 4.3%, respectively. Reoperation before discharge for failed repair was necessary in 12 patients (0.7%). Freedom from more than moderate MR was > 99%. Thirty-day mortality was 0.2% and did not differ significantly between groups (p = 0.37). Median follow-up was 48.2 months with a completeness of 95.9%. Long-term survival was similar between groups (p = 0.21). In the FS and MIC groups, 1-, 5-, and 10-year survival rates were 98.8 and 98.8%, 92.9 and 94.4%, and 87.4 and 83.1%, respectively. CONCLUSION: MV surgery, both minimally invasive and via sternotomy, is associated with high repair rates, excellent perioperative outcomes, and long-term survival. Data underscore the effectiveness of surgical repair in managing MR, even in the era of advancing interventional techniques.

Impact of the COVID-19 Pandemic on Global TAVR Activity: The COVID-TAVI Study.

BACKGROUND: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.

First transaortic transcatheter aortic valve implantation with Acurate Neo: case report and technical recommendations.

Background: In more than 90%, transcatheter aortic valve implantation (TAVI) is performed via transfemoral access. Alternative access routes are necessary for patients with unfavourable femoral arteries. Case summary: We report of a 68-year-old female with symptomatic severe aortic stenosis in whom surgical aortic valve replacement was prohibited due to her severe co-morbidities. Both femoral arteries and both subclavian arteries were unsuitable for TAVI access. Surgical aortic valve replacement and transapical TAVI were deferred due to extremely high operative risk and very low originating left coronary artery of 7 mm from the annulus. Hence, we decided to implant a self-expanding TAVI device with a low risk of coronary obstruction (Acurate Neo 2 prosthesis) via transaortic approach, which to our knowledge is the first case worldwide. Conclusion: The present case demonstrates the feasibility of implanting the Acurate Neo 2 system via transaortic approach when certain key points are respected. Transaortic TAVI with the Acurate Neo 2 offers a minimally invasive treatment of high operative risk patients with low originating coronary arteries.

Infective endocarditis after isolated aortic valve replacement: comparison between catheter-interventional and surgical valve replacement.

BACKGROUND AND AIMS: Prosthetic valve endocarditis (PVE) is the prognostically most unfavourable complication after aortic valve replacement. This study aims to contribute to a better understanding of the different pathological and therapeutical aspects between PVE following surgical (SAVR) and transcatheter aortic valve replacement (TAVI). METHODS: All patients who had undergone primary isolated SAVR (n = 3447) or TAVI (n = 2269) at our Centre between 01/2012 and 12/2018 were analysed. Diagnosis of PVE was based on Duke criteria modified in 2015. Incidence, risk factors, pathogens, impact of complications or therapy on mortality were analysed and compared between SAVR- and TAVI-PVE. RESULTS: PVE incidence did not differ significantly after SAVR with 4.9/100 patient-years and TAVI with 2.4/100 patient-years (p = 0.49), although TAVI patients were older (mean 80 vs. 67 years) and had more comorbidities (STS score mean 5.9 vs. 1.6) (p < 0.001). TAVI prostheses with polymer showed a 4.3-fold higher risk to develop PVE than without polymer (HR 4.3; p = 0.004). Most common pathogens were staphylococci and enterococci (p > 0.05). Propensity-score matching analysis showed that the type of aortic valve replacement had no effect on the development of post-procedural PVE (p = 0.997). One-year survival was higher in TAVI-PVE patients treated with antibiotics only compared to additional surgical therapy (90.9% vs. 33.3%; p = 0.005). In SAVR-PVE patients, both therapies were comparable in terms of survival (p = 0.861). However, SAVR-PVE patients who were not operated, despite ESC-guideline recommendation, had significantly poorer one-year survival (p = 0.004). CONCLUSION: TAVI patients did not have a significantly higher risk to develop PVE. Our data suggest that TAVI-PVE patients in contrast to SAVR-PVE patients can more often be treated with antibiotics only, presumably due to the lack of a polymeric suture ring.

Multicenter comparison of transcatheter aortic valve implantation with the self-expanding ACURATE neo2 versus Evolut PRO transcatheter heart valves.

BACKGROUND: New-generation self-expanding transcatheter aortic heart valves (THV) were designed to overcome technical constraints of their preceding generations. We sought to compare the efficacy and safety of the self-expanding ACURATE neo2 (Neo2) versus Evolut PRO (PRO) devices. METHODS: Seven hundred nine patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with either Neo2 (n = 496) or PRO (n = 213) were included. Propensity score matching (PSM) was performed to account for differences in baseline characteristics. In-hospital and 30-day clinical outcomes were evaluated according to Valve Academic Research Consortium-3 criteria. RESULTS: Baseline characteristics were comparable between both groups after PSM (Neo2: n = 155, Evolut Pro: n = 155). Technical success rates were high in both groups (Neo2: 94.8% vs PRO: 97.4%; p = 0.239). Need for permanent pacemaker implantation was less frequent with Neo2 compared with PRO (7.5% vs 20.6%; p = 0.002), whereas major vascular complications were more frequent with Neo2 (Neo2: 11.6% vs PRO: 4.5%; p = 0.022). Intended valve performance at discharge was high in both groups without relevant differences among groups (Neo2: 97.4% vs. 95.3%; p = 0.328). CONCLUSIONS: Short-term outcomes after TAVI using latest-generation self-expanding THV were excellent, with overall low rates of adverse events. However, Neo2 was associated with lower pacemaker rates and reduced the prevalence of moderate-severe paravalvular leakage. Transprosthetic gradients after TAVI were higher with Neo2 compared with PRO.

Feasibility and outcome of third-generation transcatheter aortic valve implantation in patients with extra-large aortic annulus.

BACKGROUND: Many patients in need for transcatheter aortic valve implantation (TAVI) present with an aortic annulus size larger than recommended by the manufacturer's instructions for use (IFU). AIMS: To investigate procedural and short-term safety and efficacy of TAVI in patients with extra-large annuli (ELA). METHODS: 30-day clinical outcome and valve performance as defined by VARC 3 of 144 patients with an aortic annulus size exceeding the permitted range were compared to a propensity-score matched control cohort of patients with an aortic annulus size consistent with the IFU. RESULTS: Area and perimeter was 730.4 ± 53.9 mm2 and 96.7 ± 6.5 mm in the ELA group. Technical (96.5% vs. 94.4%) and device success (82.3% vs. 84.5%) were comparable in patients with ELA (annulus area 730.4 ± 53.9 mm2) and matched controls (annulus area 586.0 ± 48.2 mm2). There was no significant difference in 30-day mortality rate, major intraprocedural complications, type 3 or 4 bleedings, major vascular complications, or stroke. Moderate paravalvular leakage (PVL) occurred more frequent in the ELA group (8.9% vs 2.2%; p = 0.02). The rate of new pacemaker implantation was 7.0% in the ELA cohort and 15.0% in the control cohort, respectively (p = 0.05). CONCLUSION: Treatment of ELA patients with third-generation TAVI prostheses is feasible and safe, providing similar device success and complication rates as in matched controls with regular-sized aortic annulus. Post-interventional pacemaker implantation rates were low compared to the control group, yet incidence of moderate PVL remains problematic in ELA patients.

Comparison of contemporary transcatheter heart valve prostheses: data from the German Aortic Valve Registry (GARY).

BACKGROUND: Various second-generation transcatheter heart valve (THV) prostheses with high clinical efficacy and safety are available, but there is limited large-scale data available comparing their hemodynamic performance and clinical implications. OBJECTIVE: To compare the hemodynamic performance and short-term clinical outcome of four second-generation THV prostheses. METHODS: 24,124 patients out of the German Aortic Valve Registry who underwent transfemoral transcatheter aortic valve implantation (TAVI) (Evolut™ R n = 7028, Acurate neo™ n = 2922, Portico n = 878 and Sapien 3 n = 13,296) were included in this analysis. Propensity-score weighted analysis was performed to control for differences in age, left ventricular function, STS score and sex. Primary endpoint was survival at one-year, secondary endpoints were 30 days survival, pre-discharge transvalvular gradients, paravalvular leakage and peri-procedural complications. RESULTS: Thirty-day and one-year survival were not significantly different between the four patient groups. Transvalvular gradients in Evolut™ R and Acurate neo™ were significantly lower as compared to Portico and Sapien 3 at hospital discharge. This difference exists across all annulus sizes. Paravalvular leakage ≥ II occurred significantly less often in the Sapien 3 group (1.2%, p < 0.0001). Rate of severe procedural complications was low and comparable in all groups. Permanent pacemaker implantation rate at one year was lowest in the ACUARATE neo group (13.0%) and highest in the Evolut™ R group (21.9%). CONCLUSION: Albeit comparable short-term clinical outcomes there are certain differences regarding hemodynamic performance and permanent pacemaker implantation rate between currently available THV prostheses which should be considered for individual prosthesis selection.

Aortic Valve Repair Results in Better 1-Year Survival Than Replacement: Results From German Aortic Valve Registry.

BACKGROUND: Aortic valve (AV) repair is an evolving surgical strategy in the treatment of nonelderly adults with aortic regurgitation. We aimed to determine the 1-year outcome after AV repair vs surgical AV replacement (sAVR) using real-world data from the German Aortic Valve Registry. METHODS: A total of 8076 aortic regurgitation patients (mean age, 59.1 ± 15.0 years; 76% men; mean The Society of Thoracic Surgeons score, 1.3 ± 1.1), who underwent AV surgical procedures between 2011 and 2015, were identified from German Aortic Valve Registry. The AV was repaired in 2327 patients (29%), and the remaining 5749 patients (71%) underwent sAVR. A weighted propensity score model, including the variables of age, sex, and The Society of Thoracic Surgeons score, was used to correct for baseline differences between AV repair and sAVR cohorts. The primary end point was 1-year survival after AV repair vs sAVR. Secondary end points were freedom from cardiac events and AV reinterventions. RESULTS: Survival at 1 year was 97.7% (95% CI, 97.0%-98.5%) in the AV repair cohort vs 96.4% (95% CI, 95.9%-96.9%) in the propensity score-weighted sAVR cohort (log-rank P < .001). Cox regression revealed a significant advantage of AV repair vs sAVR (hazard ratio, 0.68; 95% CI, 0.51-0.90; P < .0001) on 1-year survival, which was independent of age. Cardiac event-free survival at 1 year was 85.7% (95% CI, 483.8%-87.7%) in the AV repair group vs 81.7% (95% CI, 80.7%-82.9%) in the sAVR group (log-rank P < .001). AV reintervention was required in 38 AV repair patients (1.6%) compared with 1.6% in the sAVR cohort (P = .59). CONCLUSIONS: AV repair surgery, whenever intraoperatively feasible, is associated with a significantly better 1-year survival and 1-year cardiac event-free survival compared with sAVR.

Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: This study aimed to determine whether device position and asymmetry are associated with these outcomes. METHODS: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. RESULTS: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). CONCLUSIONS: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

Impact of left ventricular end-diastolic pressure as a marker for diastolic dysfunction on long-term outcomes in patients undergoing transcatheter aortic valve replacement.

OBJECTIVE: The aim of this study was to investigate the proportion of elevated left ventricular end-diastolic pressure (LVEDP) as an indicator of diastolic function after transcatheter aortic valve replacement (TAVR) and its implication in predicting long-term mortality. METHODS: We analyzed retrospectively collected data on 3328 patients with severe aortic stenosis undergoing TAVR in our institution between July 2009 and June 2021. Patients were stratified into two groups based on invasive post-procedural LVEDP measurements: normal (<15 mmHg) vs. elevated (≥15 mmHg) LVEDP. RESULTS: Mean age of the patients was 81.6 years, and 53.3% were female. Elevated post-procedural LVEDP was identified in 2408 (72.3%) patients. The 5-year mortality rates were higher in the group with elevated LVEDP compared with the group with normal LVEDP (27.4% vs. 8.3%, p = 0.01; hazard ratio [HR] 1.22, 95% CI 1.05-1.41). A multivariate model revealed the following independent predictors of mortality after TAVR: post-procedural elevated LVEDP (HR 1.24, 95% CI 1.01-1.53), pre-procedural significant tricuspid regurgitation (HR 1.24, 95% CI 1.02-1.52) and pulmonary hypertension (PH) (HR 1.53, 95% CI 1.26-1.86). In the present study, a significant paravalvular leak after TAVR was not associated with higher mortality (HR 1.45, 95% CI-0.95-2.19, p = 0.75). CONCLUSION: Elevated post-procedural LVEDP in patients who undergo TAVR is an independent predictor of all-cause mortality. Furthermore, PH and tricuspid regurgitation were also identified as predictors of mortality. These data confirm that diastolic dysfunction is an important predictor of mortality in TAVR and should be considered to guide procedure timing, favoring an early interventional approach and management in aortic stenosis patients.