Transcatheter aortic valve implantation in Italy: an uneven growth.

Transcatheter aortic valve implantation (TAVI) is the treatment of choice in patients with severe symptomatic aortic stenosis who are not suitable for surgery. The procedure has become the preferred strategy in patients at intermediate/high surgical risk with favourable clinical and anatomical characteristics. The collected scientific evidences, as well as the technologic innovations shaping the newer devices, allowed for a progressive reduction of the procedure-related complications as a well as a simplification of the procedure itself, promoting the gradual expansion of the indication for TAVI with the consequent increase in the estimated number of procedures performed each year. There are significant geographic and socio-economic disparities in the use of TAVI around the world and in Italy as well, reflecting an application of the procedure directly related to the economic prosperity of the Health System of the Country examined. The Italian situation, similar to the worldwide reality, reveals an uneven application of the procedure, signalling a disparity in the socio-economic and organizational capabilities of each single region. Standardization of patient selection for treatment, and of the clinical pathway for TAVI are crucial for an homogeneous integration of this new technology in the current Health Care System.

Prognosis of patients with active cancer undergoing transcatheter aortic valve implantation: An insight from Japanese multicenter registry.

Background: Malignancy is common in older adults undergoing transcatheter aortic valve implantation (TAVI), and may affect prognosis. The present study aimed to examine whether active cancer affects all-cause mortality rates among patients undergoing TAVI. Methods: This retrospective study examined data from 1,114 consecutive patients treated between April 2010 and June 2019. Patients with life expectancy of <1 year due to non-cardiac causes were excluded. Results: Active cancer was defined as cancer under treatment or cured within 1 year, and was recognized in 62 patients (5.6%) with (n = 17) and without (n = 45) metastases. In multivariate analysis, being female (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.39-0.77, p < 0.001), body mass index (BMI) (HR = 0.92 per 1 kg/m2 increase, 95% CI 0.87-0.97, p = 0.001), New York Heart Association (NYHA) class III/IV (HR = 1.53, 95% CI 1.06-2.20, p = 0.022), atrial fibrillation (HR = 2.40, 95% CI 1.70-3.38, p < 0.001), albumin levels (HR = 0.41 per 1-g/dl, 95% CI 0.30-0.57, p < 0.001), and cancer metastasis (HR = 5.28, 95% CI 1.86-14.9, p = 0.001) were associated with all-cause mortality after TAVI. Conclusion: In patients undergoing TAVI, being female, high BMI, NYHA class III/IV, atrial fibrillation, albumin levels, and cancer metastasis were factors associated with mortality. Meanwhile, active cancer without metastasis was not associated with increased mortality rates. These findings would help clinical decision-making by patients and physicians.Clinical trial registration: UMIN000031133.

Did ethno-racial disparities in access to transcatheter aortic valve replacement change over time?

Objective: In this study we sought to evaluate whether disparate use of transcatheter aortic valve replacement (TAVR) among non-White patients has decreased over time, and if unequal access to TAVR is driven by unequal access to high-volume hospitals. Methods: From 2013 to 2017, we used the State Inpatient Database across 8 states (Ariz, Colo, Fla, Md, NC, NM, Nev, Wash) to identify 51,232 Medicare beneficiaries who underwent TAVR versus surgical aortic valve replacement. Hospitals were categorized as low- (<50 per year), medium- (50-100 per year), or high-volume (>100 per year) according to total valve procedures (TAVR + surgical aortic valve replacement). Multivariable logistic regression models with interactions were performed to determine the effect of race, time, and hospital volume on the utilization of TAVR. Results: Non-White patients were less likely to receive TAVR than White patients (odds ratio [OR], 0.77; 95% CI, 0.71-0.83). However, utilization of TAVR increased over time (OR, 1.73; 95% CI, 1.73-1.80) for the total population, with non-White patients' TAVR use growing faster than for White patients (OR, 1.06; 95% CI, 1.00-1.12), time × race interaction, P = .034. Further, an adjusted volume-stratified time trend analysis showed that utilization of TAVR at high volume hospitals increased faster for non-White patients versus White patients by 8.6% per year (OR, 1.09; 95% CI, 1.01-1.16) whereas use at low- and medium-volume hospitals did not contribute to any decreasing utilization gap. Conclusions: This analysis shows initial low rates of TAVR utilization among non-White patients followed by accelerated use over time, relative to White patients. This narrowing gap was driven by increased TAVR utilization by non-White patients at high-volume hospitals.

A Novel Interventional Approach to LV Pseudoaneurysm Compressing on LAD by Utilizing LAA Closure Device.

We describe the novel transcatheter approach, with off-label application of LAA closure device, coiling, and concurrent left anterior descending stenting in the setting of left ventricular (LV) pseudoaneurysm. This case underlines collaboration among interventional cardiology, cardiothoracic, and neurosurgery teams in a challenging, nonsurgical candidate with high risk of LV pseudoaneurysm rupture, and death. (Level of Difficulty: Advanced.).

Commissural alignment in transcatheter aortic valve replacement: A literature review.

Introduction: Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure to replace a diseased and faulty aortic valve in patients with severe aortic stenosis. As TAVR gains popularity among lower-risk younger patients with a longer life expectancy; there is a need to investigate the long-term shortcomings and limitations of the procedure for this patient group. One such shortcoming is that commissural alignment of transcatheter heart valves (THV) appears to be random; meaning that the THV neo-commissures can misalign with the native commissures of the aortic valve during deployment or self-expansion. Objectives: Identify techniques and procedures used to obtain commissural alignment in TAVR. Evaluate the effectiveness of these procedures in terms of the degree of commissural alignment. Analyse the impact of commissural alignment on coronary filling and re-access. Methods: Two electronic online databases were searched to identify existing literature relevant to the aim and objectives of this review: EBSCOhost and PubMed. After search filters were applied and duplicates removed; a total of 64 articles from both databases were screened against the inclusion/exclusion criteria. This resulted in a total of thirteen articles which met the objectives of this review and thus; were included. Results: All studies focused on a patient centered approach involving pre-TAVR computed tomography to obtain commissural alignment. Other studies modified this approach and combined techniques. All studies that implemented a technique to reduce commissural misalignment were significantly successful in obtaining commissural alignment when compared to a study in which alignment was random when no technique was implemented. Severe coronary overlapping in commissural aligned heart valves was relatively low compared to severe coronary overlapping when no technique was implemented. Conclusions: An increase in optimal commissural alignment via introduction of an alignment technique may seem attractive; however; the categorization of commissural alignment is arbitrary and does not accurately reflect real life clinical implications. Further research is needed to determine whether a routine procedure to achieve commissural alignment is necessary in low-risk younger patients undergoing TAVR.

Utilization of mechanical prostheses and outcomes of surgical aortic valve replacement at safety net hospitals.

Background: Safety-net hospitals care for a high proportion of uninsured/underinsured patients who may lack access to longitudinal care. The present study characterized the use of mechanical valves and clinical outcomes of surgical aortic valve replacement at safety net hospitals. Methods: All adults undergoing surgical aortic valve replacement were abstracted from the 2016-2018 Nationwide Readmissions Database. Hospitals were divided into quartiles based on volume of all Medicaid and uninsured admissions, with the highest quartile defined as safety net hospitals. Multivariable regression was used to determine the association between safety net hospitals and several outcomes including mechanical valve use, perioperative complications, index hospitalization costs, 90-day readmission, and complications at readmission. Results: Of the 94,580 patients undergoing surgical aortic valve replacement, 14.5% of operations were at safety net hospitals. Patients at safety net hospitals more commonly received mechanical valves (20.3% vs 16.9%, P < .01) compared to those at non-safety net hospitals. After adjustment, safety net hospitals remained associated with a greater odds of mechanical aortic valve use (adjusted odds ratio, 1.13, 95% confidence interval 1.05-1.21). However, operation at safety net hospitals was also associated with increased odds of perioperative complications (adjusted odds ratio 1.10, 95% confidence interval 1.03-1.17) and higher hospitalization costs (ß coefficient +$6.15K, 95% confidence interval +$5.26 - +$7.03) despite similar 90-day readmissions. Upon readmission, safety net hospitals patients were more likely to experience mortality (adjusted odds ratio 1.87, 95% confidence interval 1.18-2.98) and stroke (adjusted odds ratio 2.41, 95% confidence interval 1.23-4.70) compared to those at non-safety net hospitals. Conclusion: Hospital safety net status is associated with increased use of mechanical valves for surgical aortic valve replacement despite also being associated with increased perioperative complications, costs, and significant complications upon readmission. Ability to access adequate follow-up care may be an important consideration for surgical aortic valve replacement at safety net hospitals.

Use of a sutureless aortic valve in reoperative aortic valve replacement.

Objectives: Management of degenerated bioprosthetic aortic valves remains a challenge. Valve-in-valve transcatheter aortic valve replacement (AVR) has limited utility in the presence of small annuli/prosthetic valves. Sutureless valves may offer an advantage over traditional redo AVR by maximizing effective orifice area due to their unique design as well as ease of implant. Methods: Twenty-two patients undergoing redo AVR received a sutureless valve in our institution over the past 5 years. All patients were determined to be poor candidates for valve-in-valve transcatheter AVR due to a combination of small annulus size, low coronary heights, and/or underlying valve characteristics (ie, mechanical valves). Results: Median time from implant to redo AVR was 8 years. One patient died within 30 days. In the 13 patients who had a 21 mm or smaller valve explanted, 5 small, 7 medium, and 1 large Perceval valves were implanted (all with larger internal diameters than the explanted valve). The average postoperative gradient of the cohort valves was 14.8 mm Hg compared with 38.8 mm Hg preoperatively. Conclusions: In addition to their ease of use and rapid deployment, sutureless bioprosthetic aortic valves offer significant physiological advantages in patients with degenerated prosthetic aortic valves and small anatomical annuli. It can also simplify the surgical approach to redo AVR following a Bentall procedure. If long-term durability is confirmed, sutureless valves should be considered in a broader population of patients for both redo and primary aortic valve replacement surgery.

Long-term durability of a new surgical aortic valve: A 1 billion cycle in vitro study.

Background: This study assessed the long-term hemodynamic functional performance of the new Inspiris Resilia aortic valve after accelerated wear testing (AWT). Methods: Three 21-mm and 23-mm Inspiris valves were used for the AWT procedure. After 1 billion cycles (equivalent to 25 years), the valves' hemodynamic performance was compared with that of the corresponding zero-cycled condition. Next, 1 AWT cycled valve of each valve size was selected at random for particle image velocimetry (PIV) and leaflet kinematic tests, and the data were compared with data for an uncycled Inspiris Resilia aortic valve of the same size. PIV was used to quantitatively evaluate flow fields downstream of the valve. Valves were tested according to International Standards Organization 5840-2:2015 protocols. Results: The 21-mm and 23-mm valves met the International Organization for Standardization (ISO) durability performance requirements to 1 billion cycles. The mean effective orifice areas for the 21-mm and 23-mm zero-cycled and 1 billion-cycled valves were 1.89 ± 0.02 cm2 and 1.94 ± 0.01 cm2, respectively (P < .05) and 2.3 ± 0.13 cm2 and 2.40 ± 0.11 cm2, respectively (P < .05). Flow characterization of the control valves and the study valves demonstrated similar flow characteristics. The velocity and shear stress fields were also similar in the control and study valves. Conclusions: The Inspiris Resilia aortic valve demonstrated very good durability and hemodynamic performance after an equivalent of 25 years of simulated in vitro accelerated wear. The study valves exceeded 1 billion cycles of simulated wear, 5 times longer than the standard requirement for a tissue valve as stipulated in ISO 5840-2:2015.

Bioprosthetic Valve Fracture After TAVR Complicated by Balloon Rupture: Bail-Out TAVR in TAVR in SAVR.

Transcatheter aortic valve replacement in surgical aortic valve is a safe and effective procedure to treat patients with failed bioprosthetic surgical valves at high risk for reoperation. Performing bioprosthetic valve fracture has been shown to improve postprocedural hemodynamics of TAVR in surgical aortic valve replacement. However, specific complications related to valve fracture are becoming more common. (Level of Difficulty: Advanced.).

Serial changes of coronary flow reserve over one year after transcatheter aortic valve implantation in patients with severe aortic stenosis.

Background: Impaired coronary flow reserve (CFR) portends a poor prognosis in patients with aortic stenosis. The present study aims to investigate how CFR changes over one year after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis, and to explore factors related to the changes. Methods: Consecutive patients undergoing TAVI were registered. CFR in the left anterior descending artery was measured by transthoracic echocardiography on three occasions pre-TAVI, one-day post-TAVI, and one-year post-TAVI. Results: A total of 59 patients were enrolled, 46 of whom completed one-year follow-up. CFR was impaired in 35 (59.3%) patients pre-TAVI, but the impairment was only seen in 2 patients (4%) one-year post-TAVI. CFR value improved from 1.75 (1.50-2.10) cm/s pre-TAVI, to 2.00 (1.70-2.30) one-day post-TAVI, and further to 2.60 (2.30-3.10) one-year post-TAVI (P < 0.001). The median difference in CFR between pre-TAVI and one-year post-TAVI was 0.90 (0.53-1.20). Patients with significant improvement of CFR (more than the median value of 0.9) had larger aortic valve area (1.55 [1.38-1.92] vs. 1.36 cm2 [1.26-1.69], P = 0.042) and greater improvement in left ventricular ejection fraction (3.10 [-1.67-4.24] vs. -1.46 [-3.42-1.48] percentage points, P = 0.019) than those without. Conclusions: CFR is impaired in a considerable proportion of patients with severe aortic stenosis, but improvement is seen immediately after TAVI, and one year later. Patients with significant improvement of CFR had larger aortic valve area and greater increase in left ventricular ejection fraction after TAVI.

Transcatheter Aortic Valve Replacement in a Patient With Criss-Cross Heart.

This paper presents the first transcatheter management of severe aortic regurgitation in a 77-year-old woman with a criss-cross heart-an extremely rare and complex congenital heart disease. The procedure achieved an elimination of aortic regurgitation and resulted in a remarkable improvement of the patient's physical condition. (Level of Difficulty: Advanced.).

Aortic Valve Calcium Score Is Associated With Acute Stroke in Transcatheter Aortic Valve Replacement Patients.

Background: Transcatheter aortic valve replacement (TAVR) is the treatment of choice for patients with severe aortic stenosis who are at a moderate or higher surgical risk. Stroke is a recognised and serious complication of TAVR, and it is important to identify patients at higher stroke risk. This study aims to discover if aortic valve calcium score calculated from pre-TAVR computed tomography is associated with acute stroke in TAVR patients. Methods: We conducted a retrospective, observational cohort study of 433 consecutive patients undergoing TAVR between January 2017 and December 2019 at the Hammersmith Hospital. Results: This cohort had a median age of 83 years (interquartile range, 78-87), and 52.7% were male. Fifty-two patients (12.0%) had a history of previous stroke or transient ischemic attack. Median aortic valve calcium score was 2145 (interquartile range, 1427-3247) Agatston units. Twenty-two patients had a stroke up to the time of discharge (5.1%). In a logistic regression model, aortic valve calcium score was significantly associated with acute stroke (odds ratio [OR], 1.26; 95% confidence interval [CI], 1.01-1.53; P = .02). Acute stroke was also significantly associated with peripheral arterial disease (OR, 4.32; 95% CI, 1.65-10.65; P = .0018) and a longer procedure time (OR, 1.01; 95% CI, 1.00-1.02; P = .0006). Conclusions: Aortic valve calcium score from pre-TAVR computed tomography is an independent risk factor for acute stroke in the TAVR population. This is an additional clinical value of the pre-TAVR aortic valve calcium score and should be considered when discussing periprocedural stroke risk.

Flow dynamics of surgical and transcatheter aortic valves: Past to present.

Objective: To perform an in vitro characterization of surgical aortic valves (SAVs) and transcatheter aortic valves (TAVs) to highlight the development of the flow dynamics depending on the type of valve implanted and assess the basic differences in the light of flow turbulence and its effect on blood damage likelihood and hemodynamic parameters that shed light on valve performance. Methods: A Starr-Edwards ball and cage valve of internal diameter 22 mm, a 23-mm Medtronic Hancock II SAV, a 23-mm St Jude Trifecta SAV, a 23-mm St Jude SJM (mechanical valve) SAV, a 26-mm Medtronic Evolut TAV, and a 26-mm Edwards SAPIEN 3 TAV were assessed in a pulse duplicator under physiological conditions. Particle image velocimetry was performed for each valve. Pressure gradient and effective orifice area (EOA) along with velocity flow field, Reynolds shear stress (RSS), and viscous shear stress (VSS) were calculated. Results: The SJM mechanical valve exhibited the greatest EOA (1.96 ± 0.02 cm2), showing superiority of efficiency compared with the same-size Trifecta (1.87 ± 0.07 cm2) and Hancock II (1.05 ± 0.01 cm2) (P < .0001). The TAVs show close EOAs (2.10 ± 0.06 cm2 with Evolut and 2.06 ± 0.03 cm2 with SAPIEN 3; P < .0001). The flow characteristics and behavior downstream of the valves differed depending on the valve type, design, and size. The greater the RSS and VSS the more turbulent the downstream flow. Hancock II displays the greatest range of RSS and VSS magnitudes compared with the same-size Trifecta and SJM. The Evolut displays the greatest range of RSS and VSS compared with the SAPIEN 3. Conclusions: The results of this study shed light on numerous advancements in the design of aortic valve replacement prosthesis and the subsequent hemodynamic variations. Future surgical and transcatheter valve designs should aim at not only concentrating on hemodynamic parameters but also at optimizing downstream flow properties.

Staged versus concomitant transcatheter aortic valve replacement and percutaneous coronary intervention: A national analysis.

Objective: Although patients with significant coronary artery disease and aortic stenosis have traditionally undergone open valve replacement and bypass grafting, percutaneous coronary intervention (PCI) and transcatheter aortic valve replacement (TAVR) are increasingly considered. Because of the lack of data regarding timing of PCI/TAVR, in the present study we evaluated associations of staged and concomitant PCI/TAVR on outcomes in a nationally representative cohort. Methods: Adults who underwent TAVR and PCI were identified using the 2016 to 2018 Nationwide Readmissions Database. If PCI/TAVR occurred on the same day, patients were considered Concomitant and otherwise considered Staged. Staged were further classified as Early-Staged if both occurred in the same hospitalization or Late-Staged if TAVR ensued PCI in a subsequent hospitalization. Multivariable regression models were developed to evaluate the association of TAVR timing on outcomes. The primary end point was in-hospital mortality whereas perioperative complications including acute kidney injury and hospitalization costs were secondarily considered. Results: Of an estimated 5843 patients, 843 (14.4%) were Concomitant and 745 (12.7%) and 4255 (72.8%) were Early-Staged and Late-Staged, respectively. Although age and TAVR access were similar, Concomitant had a lower proportion of chronic kidney disease and more commonly underwent single-vessel PCI. Staged showed similar risk-adjusted mortality but greater odds of acute kidney injury (Early-Staged adjusted odds ratio: 2.68; 95% CI, 1.57-4.55 and Late-Staged: 1.97; 95% CI, 1.29-2.99) compared with Concomitant. Although post-TAVR hospitalization duration was similar, total length of stay and costs were increased in Staged. Conclusions: Concomitant PCI/TAVR was associated with similar rates of in-hospital mortality but reduced rates of acute kidney injury and lower resource utilization. While evaluating patient-specific factors, concomitant PCI/TAVR might be reasonable in select individuals.

Late Transcatheter Aortic Valve Thrombosis Leading to Cardiogenic Shock.

A 67-year-old woman with prior transcatheter aortic valve replacement presented with worsening dyspnea. Imaging revealed transcatheter aortic valve thrombosis and aortic stenosis. Despite oral anticoagulation, she progressively deteriorated and developed cardiogenic shock. We highlight the Heart Team's role in treating this unusual late thrombosis. (Level of Difficulty: Intermediate.).

Cardiovascular outcomes and trends of Transcatheter vs. Surgical aortic valve replacement among octogenarians with heart failure: A Propensity Matched national cohort analysis.

Background: Heart failure (HF) is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood. Limited data is available regarding the in-hospital outcomes of TAVR compared to SAVR in the octogenarian population with HF. Methods: The National Inpatient Sample (NIS) database was used to compare TAVR versus SAVR among octogenarians with HF. The primary outcome was in-hospital mortality. The secondary outcome included acute kidney injury (AKI), cerebrovascular accident (CVA), post-procedural stroke, major bleeding, blood transfusions, sudden cardiac arrest (SCA), cardiogenic shock (CS), and mechanical circulatory support (MCS). Results: A total of 74,995 octogenarian patients with HF (TAVR-HF n = 64,890 (86.5%); SAVR n = 10,105 (13.5%)) were included. The median age of patients in TAVR-HF and SAVR-HF was 86 (83-89) and 82 (81-84) respectively. TAVR-HF had lower percentage in-hospital mortality (1.8% vs. 6.9%;p < 0.001), CVA (2.5% vs. 3.6%; p = 0.009), SCA (9.9% vs. 20.2%; p < 0.001), AKI (17.4% vs. 40.8%); p < 0.001), major transfusion (26.4% vs 67.3%; p < 0.001), CS (1.8% vs 9.8%; p < 0.001), and MCS (0.8% vs 7.3%; p < 0.001) when compared to SAVR-HF. Additionally, post-procedural stroke and major bleeding showed no significant difference. The median unmatched total charges for TAVR-HF and SAVR-HF were 194,561$ and 246,100$ respectively. Conclusion: In this nationwide observational analysis, TAVR is associated with an improved safety profile for octogenarians with heart failure (both preserved and reduced ejection fraction) compared to SAVR.

Influence of center surgical aortic valve volume on outcomes of transcatheter aortic valve replacement.

Objective: The utilization of transcatheter aortic valve replacement (TAVR) technology has exceeded that of traditional surgical aortic valve replacement (SAVR). In addition, the role of minimum surgical volume requirements for TAVR centers has recently been disputed. The present work evaluated the association of annual institutional SAVR caseload on outcomes following TAVR. Methods: The 2012-2018 Nationwide Readmissions Database was queried for elective TAVR hospitalizations. The study cohort was split into early (Era 1: 2012-2015) and late (Era 2: 2016-2018) groups. Based on restricted cubic spline modeling of annual hospital SAVR caseload, institutions were dichotomized into low-volume and high-volume centers. Multivariable regressions were used to determine the influence of high-volume status on in-hospital mortality and perioperative complications following TAVR. Results: An estimated 181,740 patients underwent TAVR from 2012 to 2018. Nationwide TAVR volume increased from 5893 in 2012 to 49,983 in 2018. After adjustment for relevant patient and hospital factors, high-volume status did not alter odds of TAVR mortality in Era 1 (adjusted odds ratio, 0.94; P = .52) but was associated decreased likelihood of mortality in Era 2 (adjusted odds ratio, 0.83; P = .047). High-volume status did not influence the risk of perioperative complications during Era 1. However, during Era 2, patients at high-volume centers had significantly lower odds of infectious complications, relative to low-volume hospitals (adjusted odds ratio, 0.78; P = .002). Conclusions: SAVR experience is associated with improved TAVR outcomes in a modern cohort. Our findings suggest the need for continued collaboration between cardiologists and surgeons to maximize patient safety.

Ten-year outcomes of surgical aortic valve replacement with a contemporary supra-annular porcine valve in a Medicare population.

Objective: Bioprosthetic surgical aortic valve replacement remains an important treatment option in the era of transcatheter interventions. Real-world outcomes are not well characterized because of limited prospective follow-up studies. We present the 10-year clinical outcomes of Medicare beneficiaries undergoing surgical aortic valve replacement with a contemporary supra-annular porcine valve. Methods: This is a single-arm observational study using Medicare fee-for-service claims data. De-identified patients undergoing surgical aortic valve replacement with the Epic Supra valve (Abbott) in the United States between January 1, 2008, and December 31, 2019, were selected by International Classification of Diseases 9th and 10th Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure rehospitalization, and aortic valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years using the Kaplan-Meier method. Results: Among 272,591 Medicare beneficiaries undergoing surgical aortic valve replacement during the study period, 11,685 received the Epic Supra valve, of whom 51.6% (6029) had underlying heart failure. Mean age was 76 ± 7 years. Survival at 10 years in patients without preoperative heart failure was 43.5% (95% confidence interval, 41.8-45.2) compared with 24.1% (95% confidence interval, 22.6-25.5) for patients with heart failure (P < .001). The 10-year freedom from heart failure rehospitalization was 64.0% (95% confidence interval, 62.6-65.3). Freedom from aortic valve reintervention was 94.6% (95% confidence interval, 93.8-95.3) at 10 years. Conclusions: This real-world nationwide study of US Medicare beneficiaries receiving the Epic Supra valve demonstrates more than 94% freedom from all-cause valve reintervention and 64% freedom from heart failure rehospitalization at 10 years postimplant. Long-term survival and heart failure rehospitalization in this population with aortic valve disease undergoing surgical aortic valve replacement were found to be impacted by underlying heart failure.

Mid-term results of surgical aortic valve replacement with bioprostheses in hemodialysis patients.

Background: Limited studies have assessed the factors affecting prognosis in hemodialysis (HD) patients who undergo surgical aortic valve replacement with a bioprostheses (SAVR-BP). This study aimed to evaluate the outcomes of HD patients who had undergone SAVR-BP for aortic stenosis (AS) and identify the risk factors for mortality. Methods: This retrospective study included 57 HD patients who had undergone SAVR-BP for AS between July 2009 and December 2020. Multivariate logistic regression was used to predict factors associated with mid-term outcomes and death or survival. Kaplan - Meier curves were also generated for mid-term survival. Results: The in-hospital mortality rate was 8.8%, and the 5-year mortality rate was 42.1%. The independent predictors of 5-year mortality were preoperative age (hazard ratio [HR], 1.57; 95% confidence interval [CI], 1.175-2.083, p = 0.002), hyperlipidemia (HR, 0.02; 95% CI, 0.002-0.297, p = 0.004), left ventricular diastolic diameter (HR, 1.74; 95% CI, 1.142-2.649, p = 0.010), left ventricular systolic diameter (HR, 0.61; 95% CI, 0.392-0.939, p = 0.025), and Japan SCORE (HR, 1.28; 95% CI, 1.052-1.563, p = 0.014). The postoperative predictors included intensive care unit stay (HR, 1.11; 95% CI, 1.035-1.194, p = 0.004) and albumin level (HR, 0.38; 95% CI, 0.196-0.725, p = 0.003). Conclusions: The 5-year prognosis of HD patients undergoing SAVR may be improved by early diagnosis (before the occurrence of LV hypertrophy/enlargement) and nutritional management with oral intake to alleviate postoperative hypoalbuminemia.Registration number of clinical studies: UMIN000047410.

Rationale and design of SAVI-AoS: A physiologic study of patients with symptomatic moderate aortic valve stenosis and preserved left ventricular ejection fraction.

Background: Moderate aortic valve stenosis occurs twice as often as severe aortic stenosis (AS) and carries a similarly poor prognosis. Current European and American guidelines offer limited insight into moderate AS (MAS) patients with unexplained symptoms. Measuring valve physiology at rest while most patients experience symptoms during exertion might represent a conceptual limitation in the current grading of AS severity. The stress aortic valve index (SAVI) may delineate hemodynamically significant AS among patients with MAS. Objectives: To investigate the diagnostic value of SAVI in symptomatic MAS patients with normal left ventricular ejection fraction (LVEF ≥ 50%): aortic valve area (AVA) > 1 cm2 plus either mean valve gradient (MG) 15-39 mmHg or maximal aortic valve velocity (AOV max) 2.5-3.9 m/s. Short-term objectives include associations with symptom burden, functional capacity, and cardiac biomarkers. Long-term objectives include clinical outcomes. Methods and results: Multicenter, non-blinded, observational cohort. AS severity will be graded invasively (aortic valve pressure measurements with dobutamine stress testing for SAVI) and non-invasively (echocardiography during dobutamine and exercise stress). Computed tomography (CT) of the aortic valve will be scored for calcium, and hemodynamics simulated using computational fluid dynamics. Cardiac biomarkers and functional parameters will be serially monitored. The primary objective is to see how SAVI and conventional measures (MG, AVA and Vmax) correlate with clinical parameters (quality of life survey, 6-minute walk test [6MWT], and biomarkers). Conclusions: The SAVI-AoS study will extensively evaluate patients with unexplained, symptomatic MAS to determine any added value of SAVI versus traditional, resting valve parameters.