Femoral vessel complications after transfemoral TAVR-A contemporary sonography-based assessment of 480 patients with third-generation transcatheter valves.

BACKGROUND: Postinterventional sonographic assessment of the femoral artery after transfemoral transcatheter aortic valve replacement (TF-TAVR) has the potential to identify several pathologies. We investigated the incidence and risk factors of femoral vessel complications in a modern TAVR collective using postinterventional sonography. METHODS: Between September 2017 and March 2022, 480 patients underwent TF-TAVR with postinterventional femoral sonography at a single center. Clinical outcomes and adverse events were analyzed after the Valve Academic Research Consortium 3 (VARC-3) criteria. RESULTS: In this cohort (51.2% male; age 80 ± 7.5 years, median EuroSCORE II 3.7) 74.8% (n = 359) were implanted with a self-expandable and 25.2% (n = 121) with a balloon-expandable valve. The main access (valve-delivery) was located right in 91.4% (n = 438), and the primary closure system was Proglide in 95% (n = 456). Vascular complications (VC) were observed in 29.16% (n = 140) of patients; 23.3% (n = 112) presented with minor- and 5.8% (n = 28) with major VC. Postinterventional femoral artery stenosis on the main access was observed in 9.8% (n = 47). Multivariable logistic regression analysis revealed female sex (p = .03, odds ratio [OR] 2.32, 95% confidence interval [CI] 1.09-4.89) and the number of used endovascular closure devices (p = .014, OR 0.11, 95%CI 0.02-0.64) as predictive factors for femoral artery stenosis. CONCLUSIONS: The incidence of postinterventional femoral artery stenosis following TF-TAVR was higher than expected with a number of used closure devices and female sex being independent risk factors. Considering the continuous advance of TAVR in low-risk patients with preserved physical activity, emphasis should be directed at the correct diagnosis and follow-up of these complications.

Revisiting aortic valve prosthesis choice in patients younger than 50 years: 10 years results of the AUTHEARTVISIT study.

OBJECTIVES: This population-based cohort study investigated mid-term outcome after surgical aortic valve replacement with a bioprosthetic or mechanical valve prosthesis in patients aged <50 years in a European social welfare state. METHODS: We analysed patient data from the main social insurance carriers in Austria (2010-2020). Subsequent patient-level record linkage with national health data provided patient characteristics and clinical outcome. Survival, reoperation, myocardial infarction, heart failure, embolic stroke or intracerebral haemorrhage, bleeding other than intracerebral haemorrhage and major adverse cardiac events were evaluated as outcomes. RESULTS: A total of 991 patients were analysed. Regarding demographics, no major differences between groups were observed. Multivariable Cox regression revealed no significant difference in overall survival (P = 0.352) with a median follow-up time of 6.2 years. Reoperation-free survival was decreased (hazard ratio = 1.560 [95% CI: 1.076-2.262], P = 0.019) and the risk for reoperation was increased (hazard ratio = 2.770 [95% CI: 1.402-5.472], P = 0.003) in patients who received bioprostheses. Estimated probability of death after reoperation was 0.23 (CL: 0.08-0.35) after 2 years and 0.34 (CL: 0.06-0.53) after 10 years over both groups. Regarding further outcomes, no significant differences between the two groups were observed. CONCLUSIONS: In patients below 50 years of age receiving aortic valve replacement, implantation of bioprostheses when compared to mechanical heart valve prostheses was associated with a significantly higher rate of reoperations and reduced reoperation-free survival. Nevertheless, we could not observe a difference in overall survival. However, long-term follow-up has to evaluate that a significantly lower rate of reoperations may translate in consistently improved long-term survival.

Risk Assessment of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation in Patients With Preexisting Right Bundle Branch Block.

Preexisting right bundle branch block (RBBB) is the strongest predictor for permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). However, the risk assessment for new PPI and effective procedural strategy for preventing new PPI in patients with preexisting RBBB are still unclear. This study stratified the new PPI risk after TAVI and investigated the impact of implantation strategy in a preexisting RBBB cohort. We analyzed 237 patients with preexisting RBBB who underwent TAVI. The primary endpoint was the incidence of new PPI. Multivariate analyses investigating predictors for new PPI were performed. The overall PPI rate was 33.3%. Significant baseline predictors for new PPI were combination of RBBB, left anterior or posterior fascicular block, and first-degree atrioventricular block (odds ratio [OR] 2.55, 95% confidence interval [CI] 1.09 to 5.04), high calcium volume of noncoronary cusp (OR 2.08, 95% CI 1.05 to 4.10), and membranous septum (MS) length <2 mm (OR 2.02, 95% CI 1.09 to 3.75) in the univariate analysis and MS length <2 mm (OR 2.25, 95% CI 1.06 to 4.82) in the multivariate analysis. On the multivariate analysis including procedural variables, predilatation (OR 2.41, 95% CI 1.01 to 5.83), self-expanding valves (Corevalve, Evolut R, and Evolut Pro/Pro+; Medtronic Inc., Minneapolis, Minnesota) or mechanical expanding valves (Lotus/Lotus Edge; Boston Scientifics, Marlborough, Massachusetts) (OR 3.00, 95% CI 1.31 to 6.91), and implantation depth > MS length (OR 4.27, 95% CI 1.81 to 10.08) were significantly associated with new PPI. The incidence of new PPI increased according to the number of baseline predictors (0: 20.9%, 1: 34.3%, and ≥2: 52.0%) and procedural predictors (0: 3.7%, 1: 20.9%, 2: 40.5%, and 3: 60.0%). New PPI risk in a preexisting RBBB subset could be stratified by baseline factors. Device selection and implantation strategy considering MS length could prevent new PPI even in these high-risk population.

Budget impact analysis of a bovine pericardial aortic bioprosthesis versus mechanical aortic valve replacement in adult patients with aortic stenosis in Romania.

AIMS: An analysis of the budget impact of using a bovine pericardial aortic bioprosthesis (BPAB) or a mechanical valve (MV) in aortic stenosis (AS) patients in Romania. MATERIALS AND METHODS: A decision-tree with a partitioned survival model was used to predict the financial outcomes of using either a BPAB (the Carpentier-Edwards Perimount Magna Ease Valve) or MV in aortic valve replacement (AVR) procedure over a 5-year period. The budget impact of various resource consumption including disabling strokes, reoperations, minor thromboembolic events, major bleeding, endocarditis, anticoagulation treatment and monitoring, and echocardiogram assessments were compared for both types of valves. One-way sensitivity analyses (OWSA) were conducted on the input costs and probabilities. RESULTS: The use of BPAB compared to MV approaches budget neutrality due to incremental savings year-on-year. The initial surgical procedure and reoperation costs for BPAB are offset by savings in acenocoumarol use, disabling strokes, major bleeding, minor thromboembolic events, and anticoagulation complications. The cost of the initial procedure per patient is 460 euros higher for a BPAB due to the higher valve acquisition cost, although this is partially offset by a shorter hospital stay. The OWSA shows that the total procedure costs, including the hospital stay, are the primary cost drivers in the model. LIMITATIONS: Results are limited by cost data aggregation in the DRG system, exclusion of costs for consumables and capital equipment use, possible underestimation of outpatient complication costs, age-related variations of event rates, and valve durability. CONCLUSIONS: Adopting BPAB as a treatment option for AS patients in Romania can lead to cost savings and long-term economic benefits. By mitigating procedure costs and increasing anticoagulation treatment costs, BPAB offers a budget-neutral option that can help healthcare providers, policymakers, and patients alike manage the growing burden of AS in Romania.

Is the outcome of elective vs non-elective patients undergoing transcatheter aortic valve implantation different? Results of a single-centre, observational assessment of outcomes at a large university clinic.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) can either be conducted as an elective (scheduled in advance) or a non-elective procedure performed during an unplanned hospital admission. The objective of this study was to compare the outcomes of elective and non-elective TAVI patients. METHODS: This single-centre study included 512 patients undergoing transfemoral TAVI between October 2018 and December 2020; 378 (73.8%) were admitted for elective TAVI, 134 (26.2%) underwent a non-elective procedure. Our TAVI programme entails an optimized fast-track concept aimed at minimizing the total length of stay to ≤ 5 days for elective patients which in the German healthcare system is currently defined as the minimal time period to safely perform TAVI. Clinical characteristics and survival rates at 30 days and 1 year were analysed. RESULTS: Patients who underwent non-elective TAVI had a significantly higher comorbidity burden. Median duration from admission to discharge was 6 days (elective group 6 days versus non-elective group 15 days; p < 0.001), including a median postprocedural stay of 5 days (elective 4 days versus non-elective 7 days; p < 0.001). All-cause mortality at 30 days was 1.1% for the elective group and 3.7% for non-elective patients (p = 0.030). At 1 year, all-cause mortality among elective TAVI patients was disproportionately lower than in non-elective patients (5.0% versus 18.7%, p < 0.001). In the elective group, 54.5% of patients could not be discharged early due to comorbidities or procedural complications. Factors associated with a failure of achieving a total length of stay of ≤ 5 days comprised frailty syndrome, renal impairment as well as new permanent pacemaker implantation, new bundle branch block or atrial fibrillation, life-threatening bleeding, and the use of self-expanding valves. After multivariate adjustment, new permanent pacemaker implantation (odds ratio 6.44; 95% CI 2.59-16.00), life-threatening bleeding (odds ratio 4.19; 95% confidence interval 1.82-9.66) and frailty syndrome (odds ratio 5.15; 95% confidence interval 2.40-11.09; all p < 0.001, respectively) were confirmed as significant factors. CONCLUSIONS: While non-elective patients had acceptable periprocedural outcomes, mortality rates at 1 year were significantly higher compared to elective patients. Approximately only half of elective patients could be discharged early. Improvements in periprocedural care, follow-up strategies and optimized treatment of both elective and non-elective TAVI patients are needed.

Long-run savings associated with surgical aortic valve replacement using a RESILIA tissue bioprosthetic valve versus a mechanical valve.

BACKGROUND: Prior economic analyses demonstrate that legacy tissue valves are associated with substantial financial savings over the long run after a surgical aortic valve replacement (SAVR). Bioprostheses with RESILIA tissue reduce calcification, the primary cause of structural valve deterioration (SVD), and have demonstrated promising pre-clinical and 5-year clinical results. This economic evaluation quantifies the expected long-run savings of bioprosthetic valves with RESILIA tissue relative to mechanical valves given 5-year clinical results and expected performance through year 15. METHODS: Simulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients in the US over 15 years. One comparison evaluated RESILIA tissue valves relative to mechanical valves. The other compared legacy SAVR tissue and mechanical valves. Health outcome probabilities and costs were based on literature and expert opinion. Incidence rates of health outcomes associated with mechanical valve were calculated using relative risks of expected outcomes in tissue valve versus mechanical valve patients. The comparisons also accounted for anti-coagulation monitoring in both cohorts. Savings estimates are based on US healthcare costs and do not yet account for the premium associated use of RESILIA relative to a standard tissue valve. RESULTS: Relative to mechanical SAVR, the median net discounted savings for a patient receiving SAVR with a RESILIA tissue valve is $20,744 ($US, 2020; 95% CI = $15,835-$26,655) over a 15-year horizon. While 30-day and 1-year savings were not significant, expected savings after 5 years are $9,110 (95% CI = $6,634-$11,969). Net savings for RESILIA SAVR valves were approximately 30-50% larger than savings anticipated using legacy tissue SAVR valves. CONCLUSION: RESILIA tissue valves are associated with lower health expenditures relative to mechanical valves.

Assessment of valve implantation in the descending aorta as an alternative for aortic regurgitation patients not treatable with conventional procedures.

BACKGROUND: Aortic Regurgitation (AR) produces the entrance of an abnormal amount of blood in the left ventricle. This disease is responsible for high morbidity and mortality worldwide and may be caused by an aortic valve dysfunction. Surgical and transcatheter aortic valve replacement (TAVR) are the current options for treating AR. They have replaced older procedures such as Hufnagel's one. However, some physicians have reconsidered this procedure as a less aggressive alternative for patients not eligible for surgical or TAVR. Although Hufnagel suggested a 75% regurgitation reduction when a valve is placed in the descending aorta, a quantification of this value has not been reported. METHODS: In this paper, CFD/FSI numerical simulation is conducted on an idealized geometry. We quantify the effect of placing a bileaflet mechanical heart valve in the descending aorta on a moderate-severe AR case. A three-element Windkessel model is employed to prescribe pressure outlet boundary conditions. We calculate the resulting flow rates and pressures at the aorta and first-generation vessels. Moreover, we evaluate several indices to assess the improvement due to the valve introduction. RESULTS AND CONCLUSIONS: Regurgitation fraction (RF) is reduced from 37.5% (without valve) to 18.0% (with valve) in a single cardiac cycle. This reduction clearly shows the remarkable efficacy of the rescued technique. It will further ameliorate the left ventricle function in the long-term. Moreover, the calculations show that the implantation in that location introduces fewer incompatibilities' risks than a conventional one. The proposed methodology can be extended to any particular conditions (pressure waveforms/geometry) and is designed to assess usual clinical parameters employed by physicians.

Assessment of Coronary Artery Obstruction Risk During Transcatheter Aortic Valve Replacement Utilising 3D-Printing.

BACKGROUND: Current imaging techniques may inadequately rule out coronary artery obstruction (CAO), a potentially fatal complication during transcatheter aortic valve replacement (TAVR). Advancements in three-dimensional (3D)-printing allow the development of models capable of replicating cardiac anatomy and predicting CAO. We sought to simulate TAVR utilising 3D-printed cardiac models to improve CAO risk assessment and procedural safety. METHODS: Thirteen (13) patients with aortic stenosis at high-risk of CAO during TAVR were selected for 3D-printed modelling. The relevant anatomy for TAVR was precisely reconstructed with Materialise Heart Print-Flex (Materialse, Leuven, Belgium) technology. An appropriately sized valve prosthesis was deployed in each 3D-model and coronary ostia assessed for obstruction. RESULTS: Model-derived results were compared to clinical outcomes in 13 cases. One high-risk case underwent TAVR resulting in left main obstruction and subsequent stenting. This outcome was accurately predicted by the 3D-model simulation. Two (2) high-risk TAVR cases were abandoned following transient CAO during balloon aortic valvuloplasty (BAV). The 3D-model simulations correlated with these findings, demonstrating CAO either by a calcium nodule or the native valve leaflet. In another two cases, BAV was uncertain, however the 3D-simulation demonstrated patency and successful TAVR was undertaken. In remaining cases, no obstruction was demonstrated in-vitro, and all underwent uncomplicated TAVR. CONCLUSIONS: In this proof-of-concept study, 3D-model TAVR simulation correlates well to clinical outcomes. 3D-models of patients at high-risk of CAO may be utilised in pre-procedural planning to accurately predict this complication. As lower-risk surgical cohorts are considered for TAVR, 3D-models may minimise complications leading to safer patient outcomes.

Value of 18F-FDG pet/CT for prognostic assessment in patients with infective endocarditis.

BACKGROUND: 18F-FDG PET/CT is a valuable diagnostic tool in infective endocarditis (IE). However, the prognostic value is unclear. This study aims to evaluate the prognostic performance of 18F-FDG PET/CT in native valve endocarditis (NVE) and prosthetic valve endocarditis (PVE). METHODS: We retrospectively included 76 patients treated for definite IE (NVE and PVE) that underwent 18F-FDG PET/CT between January 2016 and December 2018. Clinical, echocardiographic and 18F-FDG PET/CT (pathologic valvular 18F-FDG uptake, extracardiac complications (ECC)) data were collected. The primary endpoint was defined as mortality or recurrence of IE at a one-year follow-up. RESULTS: Pathologic valvular 18F-FDG uptake was detected in 32 of 57 (56.1%) patients, 30% (9/30) in NVE and 85.2% (23/27) in PVE group. Atrial fibrillation (OR 3.90, 95% CI = 1.14-16.3), prior anticoagulation treatment (OR 6.37, 95% CI = 1.89-26.7), large vegetation (≥ 10 mm) (OR 4.05, 95% CI = 1.14-16.1), perivalvular complications (OR 7.22, 95% CI = 1.68-55.1) and abscess (OR 10.9, 95% CI = 1.84-283) were associated with positive PET/CT. Extracardiac complications were found in 27 of 76 (35.5%) patients, 42.9% (18/42) in the NVE and 26.5% (9/34) in the PVE group. Pathological valvular tracer uptake (HR 1.20, 95% CI = 0.43-3.37) or extracardiac complications (HR 0.58, 95% CI = 0.21-1.62) were not associated with the occurrence of the primary endpoint. CONCLUSION: Our study could not demonstrate a prognostic value of 18F-FDG PET/CT in IE, but confirms high diagnostic performance, which may compromise prognostic significance by accelerated optimal treatment because of earlier diagnostic certainty.

The valve uptake index: improving assessment of prosthetic valve endocarditis and updating [18F]FDG PET/CT(A) imaging criteria.

AIMS: Diagnosis of prosthetic valve endocarditis (PVE) by positron emission computed tomography angiography (PET/CTA) is based on visual and quantitative morpho-metabolic features. However, the fluorodeoxyglucose (FDG) uptake pattern can be sometimes visually unclear and susceptible to subjectivity. This study aimed to validate a new parameter, the valve uptake index [VUI, maximum standardized uptake value (SUVmax)-mean standardized uptake value (SUVmean)/SUVmax], designed to provide a more objective indication of the distribution of metabolic activity. Secondly, to re-evaluate the utility of traditionally used PVE imaging criteria and determine the potential value of adding the VUI in the diagnostic algorithm of PVE. METHODS AND RESULTS: Retrospective analysis of 122 patients (135 prosthetic valves) admitted for suspicion of endocarditis, with a conclusive diagnosis of definite (N = 57) or rejected (N = 65) PVE, and who had undergone a cardiac PET/CTA scan as part of the diagnostic evaluation. We measured the VUI and recorded the SUVmax, SUVratio, uptake pattern, and the presence of endocarditis-related anatomic lesions. The VUI, SUVmax, and SUVratio values were 0.54 ± 0.1 vs. 0.36 ± 0.08, 7.68 ± 3.07 vs. 3.72 ± 1.11, and 4.28 ± 1.93 vs. 2.16 ± 0.95 in the 'definite' PVE group vs. the 'rejected' group, respectively (mean ± SD; P < 0.001). A cut-off value of VUI > 0.45 showed a sensitivity, specificity, and diagnostic accuracy for PVE of 85%, 88%, and 86.7% and increased diagnostic ability for confirming endocarditis when combined with the standard diagnostic criteria. CONCLUSIONS: The VUI demonstrated good diagnostic accuracy for PVE, even increasing the diagnostic power of the traditionally used morphometabolic parameters, which also confirmed their own diagnostic performance. More research is needed to assess whether the integration of the VUI into the PVE diagnostic algorithm may clarify doubtful cases and thus improve the diagnostic yield of PET/CTA.

3-Dimensional computed tomographic assessment predicts conduction block and paravalvular leakage after rapid-deployment aortic valve replacement.

OBJECTIVES: Complications like complete atrioventricular block (CAVB) and paravalvular leakage (PVL) following rapid deployment aortic valve (AV) replacement (RDAVR) remain unresolved. Selecting an optimal size of the valve might be important to minimize the incidence of these complications. We sought to determine the impact of prosthesis size relative to the anatomic profile of the AV on the occurrence of CAVB or PVL after RDAVR. METHODS: Preoperative computed tomographic (CT) images were evaluated in patients receiving RDAVR (INTUITY ELITE) between February 2016 and December 2019. The occurrence of CAVB requiring permanent pacemaker implantation and PVL (≥ mild) was evaluated. The relative size of implants against the cross-sectional dimensions of recipients' AV annulus and left ventricular outflow tract (LVOT) were calculated. RESULTS: Among 187 eligible patients, CAVB and PVL (≥ mild) occurred in 12 (6.4%) and 11 patients (5.9%), respectively. CAVB was associated with oversized RDAVR (RDAVR frame width minus average diameter of LVOT calculated from the cross-sectional area [ΔLVOTarea]: odds ratio, 2.05; 95% confidence interval, 1.28-3.30): this was with an area under the curve of 0.78 (P = 0.005). The projected probability of CAVB was <3% when the ΔLVOTarea was <1.3. In contrast, PVL was associated with under-sized RDAVR (RDAVR size divided by the longest diameter of AV annulus [index Annlong]: odds ratio, 0.64; 95% confidence interval, 0.51-0.79): This was with an area under curve of 0.94 (P < 0.001). CONCLUSIONS: CT parameters of the AV annulus and LVOT are highly reliable in the prediction of CAVB or PVL after RDAVR. Our data might justify CT-based sizing of prosthesis for RDAVR.

Computed tomography assessment of the aortic root morphology in predicting the development of paravalvular leak following transcatheter aortic valve implantation.

Introduction: Transcatheter aortic valve implantation (TAVI) is an effective treatment of significant aortic stenosis. Paravalvular leaks (PVLs) are one of the most common complications after the procedure. Objectives: The aim of this study was to assess whether the aortic root morphology affects the occurrence of PVL after TAVI. Patients and methods: We enrolled 50 patients with bicuspid and 50 patients with tricuspid aortic valve who underwent multislice computed tomography (MSCT) and transthoracic echocardiography prior to TAVI. The dimensions of the aortic root were assessed by MSCT. PVL after TAVI was assessed by transthoracic echocardiography. Patients were divided in 2 groups according to the PVL severity: less than moderate PVL (n = 80) and moderate or worse PVL (n = 20), and comparisons between the groups were performed. Results: Patients with at least moderate PVL, compared with those with less than moderate PVL, had greater mean (SD) area (5.2 [1.1] cm2 vs 4.7 [0.8] cm2; P = 0.02), perimeter (8.4 [0.9] cm vs 7.9 [0.7] cm; P = 0.01), and long axis (29.5 [2.7] mm vs 28 [2.7] mm; P = 0.04) of the aortic annulus and greater mean (SD) area (5.3 [1.3] cm2 vs 4.7 [1.1] cm2; P = 0.04) and perimeter (8.6 [1.1] cm vs 8.1 [0.9] cm; P = 0.02) of the left ventricular outflow tract. In multivariable analysis, bicuspid aortic valve disease, interventricular septum hypertrophy, greater left ventricular outflow tract, and postdilatation were significant predictors of moderate PVL following TAVI. Conclusions: The assessment of the aortic root morphology with MSCT can be helpful in predicting PVL after TAVI.

The Assessment of Sleep Quality in Patients Following Valve Repair and Valve Replacement for Infective Endocarditis: A Retrospective Study at a Single Center.

BACKGROUND The aim of this study was to measure sleep quality among patients who underwent infective endocarditis (IE) surgery and identify the risk factors involved in sleep disorders. MATERIAL AND METHODS In this study, we used actigraphy, the Pittsburgh Sleep Quality Index (PSQI), and Epworth Sleep Scale (ESS) to determine the clinical characteristics of sleep disorders in 116 patients with IE who were in rehabilitation after surgery. RESULTS Our results showed that 46 (39.7%) patients had sleep efficiency over 85%, while 70 (60.3%) patients had sleep efficiency below 85%. The correlation analysis showed that sleep efficiency was related to the duration of the disease, with a longer duration leading to lower sleep efficiency (P=0.031). The sleep efficiency of patients with IE following surgery was also affected by alcohol consumption; however, surprisingly, patients with "heavy" alcohol consumption had higher sleep efficiency (P=0.030). We found a significant correlation between sleep efficiency and postoperative interleukin-6 (IL) levels, C-reactive protein (CRP) levels, and preoperative erythrocyte sedimentation rate (P<0.05). No significant correlation was found between brain natriuretic peptide levels and sleep efficiency, PSQI score, or ESS score. Postoperative hemoglobin (Hb) level was associated with sleep efficiency (R=0.194, P=0.036), but there was no statistically significant correlation between the PSQI and ESS scores. Postoperative alanine transaminase (ALT) showed a significant negative correlation with sleep efficiency (R=-0.27, P=0.003). CONCLUSIONS We found a high prevalence of sleep disorders in patients with IE along with an increase in inflammatory factors, including postoperative IL-6, CRP, ALT, and Hb levels.

Quantitative assessment of aortic regurgitation following transcatheter aortic valve replacement.

Introduction: Transcatheter aortic valve replacement (TAVR) is expanding to lower risk and younger patients with severe symptomatic aortic valve disease. Despite clinical and technological improvements, post-procedural aortic regurgitation (AR) remains a limitation of TAVR, particularly when compared to surgical aortic valve replacement. Although several methods for AR quantification after TAVR are currently available, its exact graduation in everyday clinical practice remains challenging.Areas covered: This review describes the currently available evaluation methods of AR after TAVR, with a special emphasis on the quantitative assessment using videodensitometric angiography, echocardiography and cardiac magnetic resonance imaging.Expert opinion: In the majority of clinical scenarios, satisfactory evaluation of post-TAVR AR can be achieved with a combination of post-procedural angiography, hemodynamic indices and transthoracic echocardiography. Nevertheless, some TAVR patients show 'intermediate' forms of post-procedural AR, in which quantitative evaluation is mandatory for prognostic purposes and further decision-making. Notably, interpretation of quantitative measures early post-TAVR is challenging because of the lack of left ventricular enlargement. Video-densitometric angiography is an emerging method that appears to be clinically attractive for immediate post-TAVR assessment, but requires further validation in everyday clinical practice.

Paravalvular Leak Assessment: Challenges in Assessing Severity and Interventional Approaches.

PURPOSE OF REVIEW: With increasing use of prosthetic valves to treat degenerative valvular heart disease (VHD) in an aging population, the incidence and adverse consequences of paravalvular leaks (PVL) are better recognized. The present work aims to provide a cohesive review of the available literature in order to better guide the evaluation and management of PVL. RECENT FINDINGS: Despite gains in operator experience and design innovation, significant PVL remains a significant complication that may present with congestive heart failure and/or hemolytic anemia. To date, clear consensus or guidelines on the evaluation and management of PVL remain lacking. Although the evolution of transcatheter valve therapies has had a tremendous impact on the management of patients with VHD, the limitations and complications of such techniques, including PVL, present further challenges. Incidence of PVL, graded as moderate or greater, ranges from 4 to 7.4% in surgical and transcatheter valve replacements, respectively. Improved imaging modalities and the advent of novel surgical and percutaneous therapies have undoubtedly yielded a better understanding of PVL including its anatomical location, mechanism, severity, and treatment options. Echocardiography, used in conjunction with cardiac computed tomography and cardiac magnetic resonance, provides essential details for diagnosis and management of PVL. Transcatheter intervention has become a favored approach in lieu of surgical intervention in select patients after previous surgical or percutaneous valve replacement. PVL treatment with vascular plugs, balloon post-dilation, and the valve-in-valve methods have shown technical success with promising clinical outcomes in appropriately selected patients.

Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States.

OBJECTIVES: This study sought to evaluate the incidence and outcomes of endocarditis after transcatheter aortic valve replacement (TAVR). BACKGROUND: Data about endocarditis after TAVR are limited. METHODS: The study investigated Medicare patients who underwent TAVR from 2012 to 2017 and identified patients admitted with endocarditis during follow-up using a validated algorithm. The main study outcome was all-cause mortality. RESULTS: Of 134,717 patients who underwent TAVR, 1868 patients developed endocarditis during follow-up (incidence 0.87%/year), with majority of infections (65.0%) occurring within 1 year. Incidence of endocarditis declined in recent years. The most common organisms were Staphylococcus (22.0%), Streptococcus (20.0%), and Enterococcus (15.5%). Important predictors for endocarditis were younger age at TAVR, male sex, prior endocarditis, end-stage renal disease, repeat TAVR procedures, liver and lung disease, and post-TAVR acute kidney injury. Thirty-day and 1-year mortality were 18.5% and 45.6%, respectively. After adjusting for comorbidities and procedural complications, endocarditis after TAVR was associated with 3-fold higher risk of mortality (44.9 vs. 16.2 deaths per 100 person-years; adjusted hazard ratio [aHR]: 2.94; 95% confidence interval [CI]: 2.77 to 3.12; p < 0.0001). End-stage renal disease (aHR: 2.12; 95% CI: 1.72 to 2.60), endocarditis complicated by cardiogenic shock (aHR: 2.50, 95% CI: 1.56 to 4.02), ischemic stroke (aHR: 1.56; 95% CI: 1.07 to 2.28), intracerebral hemorrhage (aHR: 1.67; 95% CI: 1.01 to 2.76), acute kidney injury (aHR: 1.44; 95% CI: 1.27 to 1.63), blood transfusion (aHR: 1.28; 95% CI: 1.09 to 1.50), staphylococcal (aHR: 1.71; 95% CI: 1.49 to 1.97), and fungal endocarditis (aHR: 1.72; 95% CI: 1.23 to 2.39) (p < 0.05 for all) portended higher mortality following endocarditis. CONCLUSIONS: The incidence of endocarditis after TAVR is low and declining. However, it is associated with poor prognosis with one-half the patients dying within 1 year.

Calcification Assessment of Bioprosthetic Heart Valve Tissues Using an Improved In Vitro Model.

Calcification is a recurrent problem in patients suffering from heart valve disease and it is the main cause of failure in biological heart valve prostheses. The development of reliable calcification tests that consider both the material properties of the prostheses and the fluid composition is of paramount importance for the effective testing and subsequent selection of new cardiovascular implants. In this article, a fast, reliable, and highly reproducible method for the assessment of the calcification potential of biomaterials was developed. The developed method simulated closely the chemical environment in vivo, where the supersaturation levels of calcium and phosphate remain constant. Seeded hydroxyapatite (HAP) crystal growth experiments were used as the reference system and compared to the mineralization kinetics and extent of frozen untreated bovine and porcine pericardium, and glutaraldehyde-fixed bovine pericardium. Untreated pericardial patches did not calcify in the supersaturated calcium phosphate solutions whereas glutaraldehyde-fixed bovine pericardial patches mineralized at the same conditions. The present work suggested that the loose collagenous serosa side of the pericardium mineralized at lower rates compared to its dense collagenous fibrous side. Concordant with these findings, the mineralization of bioprostheses may also be attributed, to the structural deterioration of collagen-rich tissues, induced by chemical treatment used to control in vivo structural stability and immunomodulation of the implants.

Early cost-utility analysis of tissue-engineered heart valves compared to bioprostheses in the aortic position in elderly patients.

OBJECTIVES: Aortic valve disease is the most frequent indication for heart valve replacement with the highest prevalence in elderly. Tissue-engineered heart valves (TEHV) are foreseen to have important advantages over currently used bioprosthetic heart valve substitutes, most importantly reducing valve degeneration with subsequent reduction of re-intervention. We performed early Health Technology Assessment of hypothetical TEHV in elderly patients (≥ 70 years) requiring surgical (SAVR) or transcatheter aortic valve implantation (TAVI) to assess the potential of TEHV and to inform future development decisions. METHODS: Using a patient-level simulation model, the potential cost-effectiveness of TEHV compared with bioprostheses was predicted from a societal perspective. Anticipated, but currently hypothetical improvements in performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored in scenario analyses to estimate quality-adjusted life-year (QALY) gain, cost reduction, headroom, and budget impact. RESULTS: Durability of TEHV had the highest impact on QALY gain and costs, followed by infection resistance. Improved TEHV performance (- 50% prosthetic valve-related events) resulted in lifetime QALY gains of 0.131 and 0.043, lifetime cost reductions of €639 and €368, translating to headrooms of €3255 and €2498 per hypothetical TEHV compared to SAVR and TAVI, respectively. National savings in the first decade after implementation varied between €2.8 and €11.2 million (SAVR) and €3.2-€12.8 million (TAVI) for TEHV substitution rates of 25-100%. CONCLUSIONS: Despite the relatively short life expectancy of elderly patients undergoing SAVR/TAVI, hypothetical TEHV are predicted to be cost-effective compared to bioprostheses, commercially viable and result in national cost savings when biomedical engineers succeed in realising improved durability and/or infection resistance of TEHV.

How Did We Get Here?: A Historical Review and Critical Analysis of Anticoagulation Therapy Following Mechanical Valve Replacement.

Managing severe valvular heart disease with mechanical valve replacement necessitates lifelong anticoagulation with a vitamin K antagonist. Optimal anticoagulation intensity for patients with mechanical valves remains uncertain; current recommendations are inconsistent across guideline bodies and largely based on expert opinion. In this review, we outline the history of anticoagulation therapy in patients with mechanical heart valves and critically evaluate current antithrombotic guidelines for these patients. We conclude that randomized trials evaluating optimal anticoagulation intensity in patients with mechanical valves are needed, and that future guidelines must better justify antithrombotic treatment recommendations.