Contemporary Outcomes and Trends for the Transseptal Mitral Valve-in-Valve Procedure Using Balloon Expandable Transcatheter Valves in the United States.

BACKGROUND: Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement. METHODS: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications. RESULTS: A total of 4243 patients with a mean STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year (P<0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4-8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital (P=0.0005), 30-day (P=0.004), and 1-year mortality rates (P=0.01). CONCLUSIONS: This multicenter, prospective study reports excellent procedural outcomes, 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.

3-Year Outcomes of Balloon-Expandable Valves: 20-mm vs Larger Valves (≥23 mm).

BACKGROUND: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV). OBJECTIVES: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes. METHODS: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality. RESULTS: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF). CONCLUSIONS: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.

Obesity Paradox in Transcatheter Aortic Valve Replacement.

BACKGROUND: Obesity paradox in cardiovascular risk prediction has gained increasing attention in recent years. We aimed to investigate the impact of BMI on mortality following transcatheter aortic valve replacement (TAVR). METHODS: We performed a multi-center retrospective analysis of patients with severe aortic stenosis undergoing TAVR. Patients were categorized into: Underweight (BMI < 18.5), normal weight (18.5 ≤ BMI < 25), overweight (25 ≤ BMI < 30) and obese (BMI ≥ 30). Multivariate cox-proportional hazard model was used to compare all-cause mortality. RESULTS: Total of 6688 patients included (175 underweight, 2252 normal weight, 2368 overweight and 1893 with obesity). Mean age of patients was 81 ± 8 years with 55% males. Patients with obesity had higher prevalence of comorbidities but a lower overall STS score. Mortality at 30-days post-TAVR was lower in the obese population compared to underweight, normal weight, and overweight patients (1.6% vs. 6.9%, 3.6%, and 2.8%, respectively, p < 0.001). Similarly, 3-year mortality was lowest in patients with obesity (17.1% vs. 28.9%, 24.5% and 18.6%, respectively, p < 0.001). On multivariate analysis, long term all-cause mortality at 3-years remained significantly lower in patients with obesity compared to underweight (HR 1.74, 95% CI: 1.30-2.40, p < 0.001) and normal weight (HR: 1.41, 95% CI:1.21-1.63, p < 0.001) but not in overweight patients (HR: 1.10, 95% CI:0.94-1.28, p = 0.240). CONCLUSION: In conclusion, patients with obesity have improved short and long term mortality following TAVR with an observed progressive increase in mortality with lower BMI ranges.

Efficacy and safety of TAVR versus SAVR in patients with small aortic annuli: A systematic review and meta-analysis.

INTRODUCTION: Patients with a small aortic annulus (SAA) undergoing aortic valve replacement are at increased risk of patient-prosthesis mismatch (PPM), which adversely affects outcomes. Transcatheter aortic valve replacement (TAVR) has shown promise in mitigating PPM compared to surgical aortic valve replacement (SAVR). METHODS: We conducted a systematic review and meta-analysis following PRISMA guidelines to compare clinical outcomes, mortality, and PPM between SAA patients undergoing TAVR and SAVR. Eligible studies were identified through comprehensive literature searches and assessed for quality and relevance. RESULTS: Nine studies with a total of 2476 patients were included. There was no significant difference in 30-day Mortality between TAVR vs SAVR groups (OR = 0.65, 95% CI [ 0.09-4.61], P = 0.22). There was no difference between both groups regarding myocardial infarction at 30 days (OR = 0.63, 95% CI [0.1-3.89], P = 0.62). TAVR was associated with a significantly lower 30-day major bleeding and 2-year major bleeding, Pooled studies were homogeneous (OR = 0.44, 95% CI [0.31-0.64], P < 0.01, I2 = 0, P = 0.89), (OR = 0.4 ,95% CI [0.21-0.77], P = 0.03, I2 = 0%, P = 0.62) respectively. TAVR was associated with a lower rate of moderate PPM (OR = 0.6, 95% CI [ 0.44-0.84], p value = 0.01, i2 = 0%, p value = 0.44). The overall effect estimate did not favor any of the two groups regarding short-term Mild AR (OR = 5.44, 95% CI [1.02-28.91], P = 0.05) and Moderate/severe AR (OR = 4.08, 95% CI [ 0.79-21.02], P = 0.08, I2 = 0%, P = 0.59). CONCLUSION: Our findings suggest that both TAVR and SAVR are viable options for treating AS in patients with a small aortic annulus. TAVR offers advantages in reducing PPM and major bleeding, while SAVR performs better in terms of pacemaker implantation. Future studies should focus on comparing newer generation TAVR techniques and devices with SAVR. Consideration of patient characteristics is crucial in selecting the optimal treatment approach for AS.

Effect of Sex and Flow Status on Outcomes After Surgical or Transcatheter Aortic Valve Replacement.

Background: Low stroke volume index <35 ml/m2 despite preserved ejection fraction (paradoxical low flow [PLF]) is associated with adverse outcomes in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). However, whether the risk associated with PLF is similar in both sexes is unknown. Objectives: The purpose of this study was to analyze the risk associated with PLF in severe aortic stenosis for men and women randomized to TAVR or SAVR. Methods: Patients with ejection fraction ≥50% from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were stratified by sex and treatment arm. The impact of PLF on the 2-year occurrence of the composite of death or heart failure hospitalization (primary endpoint) and of all-cause mortality alone (secondary endpoint) was analyzed. Analysis of variance was used to assess baseline differences between groups. Multivariate Cox regression analysis was used to identify predictors of the endpoint. Results: Out of 2,242 patients, PLF was present in 390 men and 239 women (30% vs 26%, P = 0.06). PLF was associated with a higher rate of NYHA functional class III to IV dyspnea (60% vs 54%, P < 0.001) and a higher prevalence of atrial fibrillation (39% vs 24%, P < 0.001). PLF was a significant predictor of the primary endpoint among women undergoing SAVR in multivariate analysis (adjusted HR: 2.25 [95% CI: 1.14-4.43], P = 0.02) but was not associated with a worse outcome in any of the other groups (all P > 0.05). Conclusions: In women with PLF, TAVR may improve outcomes compared to SAVR. PLF appears to have less impact on outcomes in men.

Aortic Regurgitation, Time to Aortic Valve Reintervention, and Mortality in Degenerated Trifecta Versus Non-Trifecta Bioprosthesis.

On July 31, 2023, the Trifecta valve was withdrawn from the market after concerns regarding early (≤5 years) structural valve deterioration (SVD), mainly as aortic regurgitation (AR). Our aim was to determine the timing, mechanism, and impact of bioprosthetic SVD in patients who underwent redo aortic valve replacement (redo-AVR) with either redo-SAVR or valve-in-valve transcatheter aortic valve replacement (TAVR) using Trifecta versus other bioprosthetic valves. Patients who underwent redo-AVR for SVD at our institution were categorized into 2 groups based on the valve type: Trifecta versus non-Trifecta. Multivariate Cox proportional hazard model and Kaplan-Meier curves were used to compare mortality. A total of 171 patients were included; 58 (34%) had previous SAVR with a Trifecta valve and 113 (66%) with non-Trifecta valve. A total of 103 patients (60%) underwent valve-in-valve TAVR and 68 redo-SAVR (40%). The age, gender, and Society of Thoracic Surgeons score were similar between Trifecta and non-Trifecta groups. In patients with bioprosthetic valves requiring redo-AVR, Trifecta valves had an earlier onset of greater than moderate AR (4.5 vs 11.9 years, p <0.001) and earlier time to redo-AVR (5.5 vs 12 years, p <0.001). AR was more common as the mechanism of SVD in Trifecta versus non-Trifecta valves (55.2% vs 30.1%, p = 0.006). All-cause adjusted mortality from index SAVR was higher in the Trifecta than in non-Trifecta group (hazard ratio 4.1, 95% confidence interval 1.5 to 11.5, p = 0.007). In conclusion, compared with non-Trifecta valves, Trifecta valves exhibit early SVD primarily as AR and progress rapidly to significant SVD requiring redo-AVR. Mortality is significantly higher with Trifecta than in non-Trifecta valves, potentially impacting the results of SAVR versus TAVR studies.

Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States.

BACKGROUND: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. OBJECTIVES: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. RESULTS: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). CONCLUSIONS: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

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

BACKGROUND: Our 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. METHODS: Surgical 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. RESULTS: By 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). CONCLUSIONS: Severe 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 Survival and Quality of Life Following Transcatheter Aortic Valve Replacement in Nonagenarians.

Transcatheter aortic valve replacement (TAVR) has emerged as a successful treatment option for severe aortic stenosis. However, the long-term outcomes of TAVR in nonagenarians is lacking. We aimed to examine the long-term mortality and quality of life in nonagenarians after TAVR. This is a multicenter, retrospective analysis on patients with severe aortic stenosis who underwent TAVR. Patients were divided into 2 groups: nonagenarians (age ≥90 years) and age <90 years. The Kansas City cardiomyopathy questionnaire (KCCQ) and New York Heart Association (NYHA) scores were compared before and after TAVR. All-cause mortality was compared between both groups at 30 days, 1 year, and 5 years after TAVR using the Cox proportional hazard model. A total of 6,896 patients were included, of whom 591 were nonagenarians. Nonagenarians had a higher Society of Thoracic Surgeons perioperative risk of mortality (8.1 ± 4.6% vs 5.4 ± 4.2%, p <0.001) before TAVR. Both groups were similar in KCCQ and NYHA scores at baseline. At 1 year after TAVR, there was no significant difference in improvement in the KCCQ overall score between those aged <90 years and nonagenarians (-4.76, 95% confidence interval [CI] -11.4 to 1.9, p = 0.161). Similarly, there was no statistically significant difference in improvement in NYHA class between the 2 groups at 1 year (odds ratio 1.07, 95% CI 0.85 to 1.25), p = 0.526). The unadjusted 30-day (3.2% vs 2.7%, hazard ratio 1.11, 95% CI 0.70 to 1.80, p = 0.667) and 5-year (28.0% vs 26.6%, hazard ratio 1.05, 95% CI 0.89 to 1.24, p = 0.60) all-cause mortality were similar between the 2 groups. In conclusion, this study demonstrates an excellent long-term mortality rate at 5 years after TAVR in nonagenarians, comparable to patients younger than 90 years. There is a significant and enduring improvement in functional status in nonagenarians, observed up to 1 year after TAVR.

Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial.

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. OBJECTIVES: The authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25 and less than moderate AR. RESULTS: A total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found. CONCLUSIONS: In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.

Mortality Outcomes in Patients With Cardiac Implantable Electronic Devices Before and After Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) carries a risk of high-grade AV block requiring cardiac implantable electronic device (CIED) implantation, which has been associated with a higher mortality rate. However, the outcomes of TAVR in patients with preexisting CIEDs are not well understood. We conducted a retrospective analysis of consecutive patients who underwent TAVR from December 2014 to December 2019 at our institution. Patients were categorized into 3 groups: preexisting CIED pre-TAVR (group 1), CIED implanted within 30 days after TAVR (group 2), and no CIED implanted (group 3). Cox proportional hazard was conducted to determine the primary end point of all-cause mortality. A total of 366 patients were included, of whom 93 (25.4%), 51 (13.9%), and 222 (60.7%) comprised group 1, 2, and 3, respectively. The median follow-up time was 2.3 years. The all-cause mortality rate was higher in group 1 than group 2 (hazard ratio [HR] 2.60, 95% confidence interval [CI] 1.09 to 6.18, p = 0.03) and group 3 (HR 1.96, 95% CI 1.24 to 3.08, p = 0.004). On the multivariate analysis, there was no statistically significant difference in mortality among the groups (group 1 vs group 2: HR 1.95, 95% CI 0.70 to 5.44, p = 0.20 and group 1 vs group 3: HR 1.27, 95% CI 0.66 to 2.43, p = 0.47). Preoperative hemoglobin ≤12 g/100 ml was an independent predictor of all-cause mortality (HR 1.75, 95% CI 1.10 to 2.80, p = 0.02). Group 1 had a higher 1 year congestive heart failure readmission rate (29%) than group 2 (17.6%) and group 3 (8.1%; p <0.0001). In conclusion, there was no difference in the adjusted long-term survival based on the CIED grouping. However, patients with preexisting CIEDs had higher all-cause mortality and 1-year congestive heart failure readmission rates owing to their higher co-morbidity burden, irrespective of their Society of Thoracic Surgeons score. This can be taken into account for preoperative risk stratification.

Echocardiographic Versus Invasive Aortic Valve Gradients in Different Clinical Scenarios.

BACKGROUND: The role of echocardiography in deriving transvalvular mean gradients from transaortic velocities in aortic stenosis (AS) and in structural valve degeneration (SVD) is well established. However, reports following surgical aortic valve replacement, post-transcatheter aortic valve replacement (TAVR), and valve-in-valve-TAVR (ViV-TAVR) have cautioned against the use of echocardiography-derived mean gradients to assess normal functioning bioprosthesis due to discrepancy compared with invasive measures in a phenomenon called discordance. METHODS: In a multicenter study, intraprocedural echocardiographic and invasive mean gradients in AS, SVD, post-native TAVR, and post-ViV-TAVR were compared, when obtained concomitantly, and discharge echocardiographic gradients were recorded. Absolute discordance (intraprocedural echocardiographic - invasive mean gradient) and percent discordance (intraprocedural echocardiographic - invasive mean gradient/echocardiographic mean gradient) were calculated. Multivariable regression analysis was performed to determine variables independently associated with elevated postprocedure invasive gradients ≥20 mm Hg, absolute discordance >10 mm Hg, and discharge echocardiographic mean gradient ≥20 mm Hg. RESULTS: A total of 5,027 patients were included in the registry: 4,725 native TAVR and 302 ViV-TAVR. Intraprocedural concomitant echocardiographic and invasive mean gradients were obtained pre-TAVR in AS (n = 2,418), pre-ViV-TAVR in SVD (n = 101), in post-ViV-TAVR (n = 77), and in post-TAVR (n = 823). Echocardiographic and invasive mean gradients demonstrated strong correlation (r = 0.69) and agreement (bias, 0.11; 95% CI, -0.4-0.62) in AS, moderate correlation (r = 0.56) and agreement (bias, 1.08; 95% CI, -2.53 to 4.59) in SVD, moderate correlation (r = 0.61) and weak agreement (bias, 6.47; 95% CI, 5.08-7.85) post-ViV-TAVR, and weak correlation (r = 0.18) and agreement (bias, 3.41; 95% CI, 3.16-3.65) post-TAVR. Absolute discordance occurs primarily in ViV-TVR and is not explained by sinotubular junction size and increases with increasing echocardiographic mean gradient. Percent discordance in AS and SVD (1.3% and 4%, respectively) was lower compared with post-TAVR/ViV-TAVR (66.7% and 100%, respectively). Compared with self-expanding valves, balloon expanding valves were independently associated with elevated discharge echocardiographic but lower invasive mean gradient (odds ratio = 3.411, 95% CI, 1.482-7.852, P = .004; vs odds ratio = 0.308, 95% CI, 0.130-0.731, P = .008, respectively). CONCLUSIONS: Post-TAVR/ViV-TAVR, echocardiography is discordant from invasive mean gradients, and absolute discordance increases with increasing echocardiographic mean gradient and is not explained by sinotubular junction size. Percent discordance is significantly higher post-TAVR/ViV-TAVR than in AS and SVD. Post-TAVR/ViV-TAVR, poor correlation and wide limits of agreement suggest echocardiographic and invasive mean gradients may not be used interchangeably and a high residual echocardiographic mean gradient should be confirmed invasively before considering any additional procedure to "correct" the gradient. Transcatheter aortic valve replacement valve types have variable impact on echocardiographic and invasive mean gradients.

A novel comprehensive radiation shielding system eliminates need for personal lead aprons in the catheterization laboratory.

OBJECTIVES: This clinical study evaluated the efficacy of a novel radiation shielding system for the cardiac catheterization laboratory designed to provide comprehensive protection that obviates the need for personal lead aprons. BACKGROUND: Invasive Cardiologists are exposed to occupational health hazards related directly to radiation exposure (RE) and indirectly to the orthopedic burden of wearing only partially protective lead aprons. Innovations to reduce these risks are warranted. A novel comprehensive shielding system (ProtegoTM , Image Diagnostics Inc, Fitchburg, Ma) has been validated in pre-clinical studies to provide excellent radiation protection, sufficient for the State of Michigan to certify it for use without need for personal lead aprons. METHODS: This clinical analysis measured RE to a single Physician operator utilizing the ProtegoTM shield (and not wearing personal lead apron) during routine cardiac catheterization procedures (diagnostic and interventional). RE was measured at both thyroid and waist level with a real-time dosimetry system (RaysafeTM , Billdal, Sweden), calculated on a median per case basis (mrems). Additional parameters collected included procedure type, access site, per case fluoroscopy time, and patient factors including body mass index. RESULTS: In n=98 cases (25% diagnostic, 75% interventional including 22% chronic total occlusions), median/case RE was 0.4 mrems (thyroid) and 0.2 mrems (waist). RE=0 in 12 cases. In no case did radiation exposure exceed 3.2 mrems. CONCLUSION: The ProtegoTM shield system provides excellent RE protection to the Physician operator, without the need for personal lead aprons and has the potential to reduce catheterization laboratory occupational health hazards.

Valve-in-Mitral Annular Calcification Transcatheter Mitral Valve Replacement After Thrombosis of Extracardiac Valved Conduit.

We report a patient with severe mitral annular calcification, mitral stenosis/regurgitation, hypertrophic obstructive cardiomyopathy, and subaortic membrane treated with valved left atrium-left ventricle conduit, septal myectomy, and membrane resection. Subsequent thrombosis of the conduit prompted successful valve-in- mitral annular calcification transcatheter mitral valve replacement and laceration of the anterior mitral leaflet to prevent outflow obstruction. (Level of Difficulty: Advanced.).

Transvalvular Pressure Gradients and All-Cause Mortality Following TAVR: A Multicenter Echocardiographic and Invasive Registry.

BACKGROUND: Low ejection fraction (EF) and low flow as determined by an echocardiographic stroke volume index (SVi) <35 mL/m2 are associated with low transvalvular gradients and increased mortality in both severe aortic stenosis (AS) and post-transcatheter aortic valve replacement (TAVR). Absence of an elevated echocardiographic transaortic gradient post-TAVR is considered a marker of procedural success despite the absence of data on its impact on mortality. OBJECTIVES: The authors sought to examine the association of invasive and echocardiographic gradients post-TAVR with all-cause mortality in relation to flow and EF. METHODS: In a multicenter retrospective registry of patients undergoing TAVR, Cox models with regression splines explored the relationship between invasive and echocardiographic gradients post-TAVR with 2-year mortality. An invasive gradient <5 mm Hg was considered low, between ≥5 and <10 mm Hg was considered intermediate, and ≥10 mm Hg was considered high. An echocardiographic gradient <10 mm Hg was considered low, ≥10 and <20 mm Hg was considered intermediate, and ≥20 mm Hg was considered high. RESULTS: Higher mortality occurred in low echocardiographic gradients at discharge relative to intermediate gradients (P < 0.001), and low gradient was associated with lower EF and echocardiographic SVi (P < 0.001 and P < 0.008, respectively). Lower mortality occurred in low invasive gradients relative to intermediate gradients (P = 0.012) with no difference in EF and echocardiographic SVi between groups (P = 0.089 and P = 0.947, respectively). There were insufficient observations to determine the impact of high echocardiographic and invasive gradients on mortality. CONCLUSIONS: In this large retrospective analysis, the impact of transaortic gradients on mortality after TAVR was not linear and complex, showing opposite results among echocardiographic and invasive measurements in low-gradient patients.

Transcatheter Mitral Valve Replacement in Failed Bioprosthetic Surgical Valves and Surgical Annuloplasty Rings.

PURPOSE OF REVIEW: Repeat surgery for failed mitral valve prostheses and repairs are fraught with high rates of morbidity and mortality. Therefore, clinicians have evolved transcatheter technology as an alternative therapy. This review serves as an update as the field has moved out of the early learning curve of treating postsurgical mitral valve failures. RECENT FINDINGS: Mitral valve-in-valve procedures have higher rates of technical success and better in-hospital and 1-year mortality rates than mitral valve-in-ring cases. The higher rates of complications, including left ventricular outflow tract obstruction, paravalvular leak, valve embolization, and need for a 2nd valve, may explain these outcomes. Mitral valve-in-ring procedures have attenuated outcomes as compared to valve-in-valve. Clinicians should be cognizant of the nuanced complexities and the potential for suboptimal outcomes in using balloon-expandable valves for mitral valve-in-ring procedures.

Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps: JACC State-of-the-Art Review.

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics.