Predictors of outcome in patients with moderate mixed aortic valve disease.

OBJECTIVES: Grading the severity of moderate mixed aortic stenosis and regurgitation (MAVD) is challenging and the disease poorly understood. Identifying markers of haemodynamic severity will improve risk stratification and potentially guide timely treatment. This study aims to identify prognostic haemodynamic markers in patients with moderate MAVD. METHODS: Moderate MAVD was defined as coexisting moderate aortic stenosis (aortic valve area (AVA) 1.0-1.5 cm2) and moderate aortic regurgitation (vena contracta (VC) 0.3-0.6 cm). Consecutive patients diagnosed between 2015 and 2019 were included from a multicentre registry. The primary composite outcome of death or heart failure hospitalisation was evaluated among these patients. Demographics, comorbidities, echocardiography and treatment data were assessed for their prognostic significance. RESULTS: 207 patients with moderate MAVD were included, aged 78 (66-84) years, 56% male sex, AVA 1.2 (1.1-1.4) cm2 and VC 0.4 (0.4-0.5) cm. Over a follow-up of 3.5 (2.5-4.7) years, the composite outcome was met in 89 patients (43%). Univariable associations with the primary outcome included older age, previous myocardial infarction, previous cerebrovascular event, atrial fibrillation, New York Heart Association >2, worse renal function, tricuspid regurgitation ≥2 and mitral regurgitation ≥2. Markers of biventricular systolic function, cardiac remodelling and transaortic valve haemodynamics demonstrated an inverse association with the primary composite outcome. In multivariable analysis, peak aortic jet velocity (Vmax) was independently and inversely associated with the composite outcome (HR: 0.63, 95% CI 0.43 to 0.93; p=0.021) in an adjusted model along with age (HR: 1.05, 95% CI 1.03 to 1.08; p<0.001), creatinine (HR: 1.002, 95% CI 1.001 to 1.003; p=0.005), previous cerebrovascular event (85% vs 42%; HR: 3.04, 95% CI 1.54 to 5.99; p=0.001) and left ventricular ejection fraction (LVEF) (HR: 0.97, 95% CI 0.95 to 0.99; p=0.007). Patients with Vmax ≤2.8 m/s and LVEF ≤50% (n=27) had the worst outcome compared with the rest of the population (72% vs 41%; HR: 3.87, 95% CI 2.20 to 6.80; p<0.001). CONCLUSIONS: Patients with truly moderate MAVD have a high incidence of death and heart failure hospitalisation (43% at 3.5 (2.5-4.7) years). Within this group, a high-risk group characterised by disproportionately low aortic Vmax (≤2.8 m/s) and adverse remodelling (LVEF ≤50%) have the worst outcomes.

Health Care Resource, Economic, and Readmission Implications After Acute Decompensated Aortic Stenosis-A Nationwide Study.

Acute decompensated aortic stenosis (ADAS) is common. The cumulative burden of ADAS from a clinical, health care resource, and financial perspective is unknown. This study sought to assess the national impact of ADAS compared with electively treated, stable patients with aortic stenosis (non-ADAS). Using the National Readmissions Database between 2016 and 2019, patients with ADAS and non-ADAS were identified using International Classification of Diseases, Tenth Revision codes. Patients with ADAS were propensity-matched to non-ADAS patients (1:2) using age, gender, and Charlson co-morbidity index. We compared in-hospital mortality, length of stay (LOS), health care-associated costs, and 90-day readmission data between the 2 cohorts. A total of 51,498 propensity-matched patients were included in this study: median age 75 years, 64% men. The in-hospital mortality for ADAS was higher than non-ADAS (2.8% vs 1.5%, p <0.0001). The LOS during the index admission was longer for ADAS (9 [5 to 13] vs 4 [2 to 6] days, p <0.0001). The health care-associated costs per patient was greater for ADAS ($55,450.0 [41,860.4 to 74,500.7] vs $43,405.7 [34,218.5 to 56,034.8], p <0.0001). Readmission to hospital within 90 days was more frequent in ADAS (21.1 vs 16.8%, p <0.001). The in-hospital mortality during readmission was higher with ADAS (3.9% vs 2.8%, p = 0.004). The readmission LOS was longer with ADAS (4 [2 to 7] vs 3 [2 to 6] days, p <0.0001). In conclusion, ADAS imposes a significant burden clinically and financially and on health care resources compared with non-ADAS during the index admission and 90-day follow-up. There is an urgent need to predict ADAS and optimize the timing of aortic valve replacement to reduce the incidence and the burden associated with ADAS.

Influence of cusp morphology and sex on quantitative valve composition in severe aortic stenosis.

AIMS: Aortic stenosis is characterized by fibrosis and calcification of the valve, with a higher proportion of fibrosis observed in women. Stenotic bicuspid aortic valves progress more rapidly than tricuspid valves, which may also influence the relative composition of the valve. We aimed to investigate the influence of cusp morphology on quantitative aortic valve composition quantified from contrast-enhanced computed tomography angiography in severe aortic stenosis. METHODS AND RESULTS: Patients undergoing transcatheter aortic valve implantation with bicuspid and tricuspid valves were propensity matched 1:1 by age, sex, and comorbidities. Computed tomography angiograms were analysed using semi-automated software to quantify the fibrotic and calcific scores (volume/valve annular area) and the fibro-calcific ratio (fibrotic score/calcific score). The study population (n = 140) was elderly (76 ± 10 years, 62% male) and had a peak aortic jet velocity of 4.1 ± 0.7 m/s. Compared with those with tricuspid valves (n = 70), patients with bicuspid valves (n = 70) had higher fibrotic scores [204 (interquartile range 118-267) vs. 144 (99-208) mm3/cm2, P = 0.006] with similar calcific scores (P = 0.614). Women had greater fibrotic scores than men in bicuspid [224 (181-307) vs. 169 (109-247) mm3/cm2, P = 0.042] but not tricuspid valves (P = 0.232). Men had greater calcific scores than women in both bicuspid [203 (124-355) vs. 130 (70-182) mm3/cm2, P = 0.008] and tricuspid [177 (136-249) vs. 100 (62-150) mm3/cm2, P = 0.004] valves. Among both valve types, women had a greater fibro-calcific ratio compared with men [tricuspid 1.86 (0.94-2.56) vs. 0.86 (0.54-1.24), P = 0.001 and bicuspid 1.78 (1.21-2.90) vs. 0.74 (0.44-1.53), P = 0.001]. CONCLUSIONS: In severe aortic stenosis, bicuspid valves have proportionately more fibrosis than tricuspid valves, especially in women.

Comparing Outcomes Between Surgical and Transcatheter Aortic Valve Replacement in Classical Low-Flow Low-Gradient Aortic Stenosis.

Patients with classic low-flow low-gradient (cLFLG) aortic stenosis (AS) have a poor prognosis but still benefit from aortic valve replacement. There is a paucity of evidence to guide the choice between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). This study compared procedural and midterm outcomes in patients with cLFLG AS between TAVR and SAVR. Patients with cLFLG AS, defined as an aortic valve area ≤1 cm2, mean gradient <40 mm Hg, and left ventricular ejection fraction <50%, were selected from a single center between 2015 and 2020. Inverse probability weighting and regression were used to adjust for differences in baseline characteristics, the nonrandom assignment of treatment modalities, and procedural differences. The primary end point was all-cause mortality. A total of 322 patients (220 TAVR and 102 SAVR) were included. At a follow-up of 4.4 ± 1.5 years, the adjusted hazard ratio (HR) for mortality after inverse probability weighting with SAVR was 0.66, 95% confidence interval (CI) 0.31 to 1.35; p = 0.24. Worse renal function at baseline (per 10 ml/min/m2 increase HR 0.92, 95% CI 0.84 to 1.00, p = 0.04) and multiple valve interventions (HR 5.39, 95% CI 2.62 to 11.12, p <0.001) independently predicted mortality. There was no difference in stroke and permanent pacemaker implantation, but the rates of renal replacement therapy were higher among the SAVR cohort: 13.7% versus 0%; p <0.001. In conclusion, among patients with cLFLG AS, there was no difference in midterm mortality between TAVR and SAVR, supporting the use of either treatment. However, in patients with poor renal function or at risk of renal failure, TAVR may be the preferred option.

Rapid Assessment and Treatment In Decompensated Aortic Stenosis (ASTRID-AS study)- A pilot study.

BACKGROUND: Acute decompensated aortic stenosis (ADAS) is common and associated with higher mortality, acute kidney injury (AKI) and longer hospital length of stay (LoS) compared with electively treated stable AS. The aim of this study was to assess the impact of a dedicated pathway that reduces time to transcatheter aortic valve implantation (TAVI) in ADAS, hypothesizing that LoS can be reduced without compromising patient safety. METHODS AND RESULTS: Using a prospective, open label, cluster design, patients from 5 referring centres were allocated to the ASessment and TReatment In Decompensated Aortic Stenosis (ASTRID-AS) pathway where the diagnosis, referral, investigations and treatment of ADAS were prioritised and expedited. 15 hospitals remained on the conventional pathway that followed the same process, albeit according to a waiting list. The primary efficacy endpoint was hospital LoS and the secondary safety endpoint, a composite of death or AKI at 30 days post-TAVI. 58 conventional patients and 25 ASTRID-AS patients were included in this study. Time to TAVI in the conventional vs. ASTRID-AS cohort was 22 (15-30) vs. 10 (6-12) days; P < 0.001, respectively. Length of hospital stay was 24 (18-33) vs. 13 (8-18) days; P < 0.001, respectively. 13.4 bed days were saved per patient using the ASTRID-AS pathway. Secondary safety endpoint occurred in 12 (20.7%) vs. 1 (4.0%) patients; P = 0.093, respectively. Procedural complications were similar between the two cohorts. CONCLUSION: A dedicated pathway for ADAS that shortens time to TAVI demonstrated reduced hospital LoS without compromising patient safety and a trend towards improving clinical outcomes.

Acute Decompensated Aortic Stenosis: State of the Art Review.

Aortic stenosis (AS) is a progressive disease that carries a poor prognosis. Patients are managed conservatively until satisfying an indication for transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) based on AS severity and the presence of symptoms or adverse impact on the myocardium. Up to 1 in 3 TAVIs are performed for patients with acute symptoms of dyspnea at rest, angina, and/or syncope - termed acute decompensated aortic stenosis (ADAS) and require urgent aortic valve replacement. These patients have longer hospital length of stay, undergo physical deconditioning, and have a higher rate of acute kidney injury and mortality compared to stable patients with less severe symptoms. There is an urgent need to prevent ADAS and to deliver pathways to manage and improve ADAS-related outcomes. We provide here a contemporary review on epidemiological and pathophysiological aspects of ADAS, with a focus on the impact of ADAS from clinical and economic perspectives. We offer a global overview of the available evidence for treatment of ADAS and with priorities suggested for addressing current gaps in the literature and unmet clinical needs to improve outcomes for AS patients.

Preprocedural Prognostic Factors in Acute Decompensated Aortic Stenosis.

Acute decompensated aortic stenosis (ADAS) is common and associated with poor outcomes. Myocardial remodeling and function, including a novel echo staging classification (0 to 4, representing increasing degrees of cardiac damage/dysfunction), impact outcomes in stable aortic stenosis. However, this has not been assessed in patients with ADAS. This study aims to evaluate the impact of the myocardium, echo staging classification, and clinical parameters on mortality in ADAS. ADAS was defined as an acute deterioration in symptoms (New York Heart Association 4, Canadian Cardiovascular Society 3/4, or syncope) that warranted admission to the hospital and urgent aortic valve replacement. Using a retrospective observational study design, 292 consecutive patients with ADAS who underwent transcatheter aortic valve implantation (TAVI) were identified and included in this study. Echocardiographic and clinical characteristics were evaluated using regression analysis. The outcome was all-cause mortality after TAVI. At 1 year after TAVI, advanced echo staging (>2) independently predicted mortality (hazards ratio: 1.85, 95% confidence interval: 1.01 to 3.39; p = 0.045). At a follow-up of 2.4 ± 1.4 years, myocardial, valvular, and clinical parameters did not predict mortality, except for frailty (hazards ratio: 2.31, 95% confidence interval: 1.38 to 3.85; p = 0.001). In patients with ADAS, short-term mortality after TAVI is influenced by more advanced cardiac damage/dysfunction based on the echo staging classification, whereas mid-term mortality is driven by frailty rather than echo staging classification.

Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Differentiating Between Acute Decompensated Aortic Stenosis and Myocardial Infarction.

BACKGROUND: Patients with aortic stenosis (AS) are susceptible to myocardial ischemia and often present acutely, making it challenging to differentiate between a type 1 NSTEMI and acute decompensated aortic stenosis. This study aims to evaluate the diagnostic accuracy of Troponin T (TnT) (>5 fold above the upper limit of normal), ischemic ECG and angina, to predict a type 1 non-ST elevation myocardial infarction (NSTEMI) and obstructive coronary artery disease (CAD) among patients with severe AS and acute presentations. METHODS: Patients with severe AS and acute symptoms: angina (Canadian Cardiovascular Society Class 3/4), dyspnea (New York Heart Association 4) and/or syncope were included. The endpoints were a type 1 NSTEMI defined by the presence of a coronary thrombus or > 90% stenosis and obstructive CAD defined as >70% stenosis, by computed tomography (CT) and/or invasive coronary angiography (ICA). RESULTS: Out of 273 patients, 6.2% had a type 1 NSTEMI. Positive TnT, ischemic ECG and angina demonstrated negative predictive values of 95%, 94% and 97% respectively and positive predictive values of 12%, 9% and 13% respectively. Specificity increased with all three metrics (95%), whilst sensitivity and positive predictive value reduced (18% and 19% respectively). 39.2% of patients had obstructive CAD. Positive TnT, ischemic ECG and angina demonstrated sensitivity of 64%, 34% and 41% respectively and specificity of 57%, 77% and 77% respectively. CONCLUSIONS: Angina, ischemic ECG and positive TnT are common among patients with AS presenting acutely and often not associated with a type 1 NSTEMI. These metrics, if positive, cannot reliably differentiate between a type 1 NSTEMI and acute decompensated AS. Coronary imaging using either CT or ICA is necessary to make a definitive diagnosis of a type 1 NSTEMI in patients with severe AS.

Futility in Transcatheter Aortic Valve Implantation: A Search for Clarity.

Although transcatheter aortic valve implantation (TAVI) has revolutionised the landscape of treatment for aortic stenosis, there exists a cohort of patients where TAVI is deemed futile. Among the pivotal high-risk trials, one-third to half of patients either died or received no symptomatic benefit from the procedure at 1 year. Futility of TAVI results in the unnecessary exposure of risk for patients and inefficient resource utilisation for healthcare services. Several cardiac and extra-cardiac conditions and frailty increase the risk of mortality despite TAVI. Among the survivors, these comorbidities can inhibit improvements in symptoms and quality of life. However, certain conditions are reversible with TAVI (e.g. functional mitral regurgitation), attenuating the risk and improving outcomes. Quantification of disease severity, identification of reversible factors and a systematic evaluation of frailty can substantially improve risk stratification and outcomes. This review examines the contribution of pre-existing comorbidities towards futility in TAVI and suggests a systematic approach to guide patient evaluation.

Early pacemaker implantation for transcatheter aortic valve implantation is safe and effective.

BACKGROUND: Permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve implantation (TAVI). The optimum timing of PPM implantation is still unclear as conduction abnormalities evolve and a balance needs to be struck between conservative delays in the hope of conduction recovery and overutilization of pacing. This study aimed to assess the safety and efficacy of early PPM implantation, without an observation period, among TAVI patients. METHODS: This is a retrospective, observational study of 1398 TAVI patients. Clinical and pacing data were collected at baseline, 30 days and at a median of 15 (4-21) months post-TAVI. Study endpoints included PPM-related complications, pacing utilization and hospital length of stay. RESULTS: One hundred five patients (8.2%) required a PPM, of which 13 were implanted pre and 92 post-TAVI. Seventy-six percent required pacing for either second- or third-degree heart block. Time to implantation for post-TAVI PPM was 1 (0-3) day. Six patients experienced a pacing-related complication- lead displacement (n = 3), hematoma (n = 2), and device infection (n = 1). Pacing utilization defined as pacing >10% of the time or a pacing requirement at the time of the pacing check was demonstrated in 83% of patients. Multivariate analysis revealed complete heart block (CHB) was the only independent predictor of pacing utilization. Hospital length of stay for the post-TAVI PPM group was longer than the group without PPM (4 [2-8] vs. 3 [2-4] days; p < .001). CONCLUSIONS: Early PPM implantation in TAVI patients is safe and majority of patients require pacing in the short and mid-term.

Coronary Revascularization in Patients Undergoing Aortic Valve Replacement for Severe Aortic Stenosis.

Aortic stenosis (AS) and coronary artery disease (CAD) frequently coexist, with up to two thirds of patients with AS having significant CAD. Given the challenges when both disease states are present, these patients require a tailored approach diagnostically and therapeutically. In this review the authors address the impact of AS and aortic valve replacement (AVR) on coronary hemodynamic status and discuss the assessment of CAD and the role of revascularization in patients with concomitant AS and CAD. Remodeling in AS increases the susceptibility of myocardial ischemia, which can be compounded by concomitant CAD. AVR can improve coronary hemodynamic status and reduce ischemia. Assessment of the significance of coexisting CAD can be done using noninvasive and invasive metrics. Revascularization in patients undergoing AVR can benefit certain patients in whom CAD is either prognostically or symptomatically important. Identifying this cohort of patients is challenging and as yet incomplete. Patients with dual pathology present a diagnostic and therapeutic challenge; both AS and CAD affect coronary hemodynamic status, they provoke similar symptoms, and their respective treatments can have an impact on both diseases. Decisions regarding coronary revascularization should be based on understanding this complex relationship, using appropriate coronary assessment and consensus within a multidisciplinary team.

Transcatheter aortic valve implantation in acute decompensated aortic stenosis.

OBJECTIVES: To assess the safety and efficacy of first-line transcatheter aortic valve implantation (TAVI) in patients presenting with acute decompensated aortic stenosis (ADAS). BACKGROUND: ADAS is common and is often treated medically or using balloon aortic valvuloplasty in the first instance. This temporizing measure results in suboptimal outcomes. In the current era, TAVI provides an alternative option. METHODS: Consecutive patients who had either a TAVI for ADAS or electively were included in the study. The primary outcome was procedural and 30-day mortality and hospital length of stay (LOS). Secondary outcomes included 1-year mortality and procedural complications. RESULTS: Of note, 893 patients (mean age 83 ± 7, 50.5% male) underwent TAVI (19% ADAS, 81% elective). ADAS patients were more unwell with worse echocardiographic parameters than elective patients. ADAS patients of 55.9% were known to have significant aortic stenosis prior to their decompensation. Procedural mortality was not different between the ADAS and elective cohorts (1.2 vs. 0.7%; p = .62). The ADAS cohort had a higher 30-day mortality (5.3 vs. 1.1%; p = .002) and longer LOS (31.9 ± 20.7 days vs. 6.1 ± 6.5 days; p < .001). Multivariate analysis identified acute kidney injury and ADAS as significant predictors of 30-day mortality. CONCLUSIONS: TAVI for ADAS is safe and effective with procedural outcomes similar to elective patients. However, compared to elective patients, they have worse physiological baseline features, poorer prognosis at 30 days, and longer hospital admissions. Majority of patients who presented with ADAS were known to have AS prior to admission.

The evolution of device technology in transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has rapidly evolved and changed the landscape of structural interventional cardiology. Advances in transcatheter heart valve (THV) prostheses and TAVI-enabling devices have simplified the procedure, reduced the risk of complications, improved short- and long-term outcomes and broadened the applications of TAVI, not only in challenging patients and complex anatomies but also in intermediate-risk or even in low-risk patients, where surgical valve replacement constitutes an effective and well-established therapy. In this review article, we provide an overview of the developments in TAVI devices which have played a vital role in TAVI evolution: we describe the prostheses that failed to reach clinical practice, we present the characteristics of the first valves that were tested in the clinical arena, we summarise the evidence from the first studies that highlighted the potential but also the limitations of TAVI, and we present the advanced next-generation THV prostheses that have an improved performance and safety profile.

Patterns of solid particle embolization during transcatheter aortic valve implantation and correlation with aortic valve calcification.

OBJECTIVES: To evaluate solid embolization during transcatheter aortic valve implantation (TAVI) and correlate this with aortic valve calcification. BACKGROUND: There is a known stroke risk with TAVI, thought partly to be due to dislodgement of native aortic valve particles during implantation. However, to date there is little evidence that aortic valve calcification actually impacts embolic risk. METHODS: Transcranial Doppler (TCD) was performed on consecutive suitable patients undergoing TAVI, using hardware and software enabling differentiation between solid and gaseous emboli. Data was analyzed by time points during the TAVI procedure. These results were correlated with aortic valve calcification. RESULTS: TCD was successfully performed on 63 patients. The median number of solid emboli was 76.0. The most common time point for solid embolization was during valve positioning. Forty-five of these patients had an appropriate CT scan which could be analyzed for an Agatston calcium score. The mean scores in the aortic valve and aortic root were 3382.4 and 754.9. There were significant correlations between the total number of solid emboli and valve calcium score (P = 0.033) and solid emboli during valve positioning and valve calcium score (P = 0.035). There was no relationship between gaseous emboli and valve calcium score. CONCLUSIONS: TAVI is associated with significant solid particle embolization, with the most common time point being during valve positioning. Solid embolization correlates with aortic valve calcium score, suggesting that valve calcification is a factor in embolic risk. This should be taken into consideration along with other clinical factors when assessing embolic risk.

In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE).

This study presents the in vitro hydrodynamic assessment of the TRISKELE, a new system suitable for transcatheter aortic valve implantation (TAVI), aiming to mitigate the procedural challenges experienced with current technologies. The TRISKELE valve comprises three polymeric leaflet and an adaptive sealing cuff, supported by a novel fully retrievable self-expanding nitinol wire frame. Valve prototypes were manufactured in three sizes of 23, 26, and 29 mm by automated dip-coating of a biostable polymer, and tested in a hydrodynamic bench setup in mock aortic roots of 21, 23, 25, and 27 mm annulus, and compared to two reference valves suitable for equivalent implantation ranges: Edwards SAPIEN XT and Medtronic CoreValve. The TRISKELE valves demonstrated a global hydrodynamic performance comparable or superior to the controls with significant reduction in paravalvular leakage. The TRISKELE valve exhibits enhanced anchoring and improved sealing. The valve is currently under preclinical investigation.

A new transcatheter heart valve concept (the TRISKELE): feasibility in an acute preclinical model.

AIMS: The aim of this study was to introduce and demonstrate the feasibility in an acute preclinical model of a new transcatheter heart valve concept with a self-expanding wire frame, polymeric leaflets and a sealing component. METHODS AND RESULTS: The TRISKELE valve was developed based on a previously validated polymeric leaflet design, an adaptive sealing cuff and a novel nitinol wire frame which reduces stress on the leaflets and radial pressure on the surrounding tissue. A valve prototype of 26 mm nominal diameter was manufactured by automated dip coating of a biostable polymer. The prototype was implanted via brachiocephalic approach in orthotopic position in an acute ovine model through a highly controllable multistage deployment process. The atraumatic retrievability of the valve after full expansion was verified in situ before final release in the optimal position. Observation indicated secure valve anchoring, adequate leaflet motion, and no interference of coronary flow or mitral valve function. CONCLUSIONS: The TRISKELE valve system has the potential to mitigate complications related to imprecise valve positioning, and may offer a safer and more economical TAVI solution to a broad range of patients. The valve is currently under preclinical investigation for its long-term function and durability.

Balloon-Expandable Transcatheter Aortic Valves Can Be Successfully and Safely Implanted Transfemorally Without Balloon Valvuloplasty.

OBJECTIVES: To assess the necessity for balloon aortic valvuloplasty (BAV) during transfemoral transcatheter aortic valve implantation (TAVI) when using balloon-expandable valves. BACKGROUND: BAV is a usual part of TAVI procedures, prior to valve implantation. However, the benefits and necessity of this are unknown and recent evidence in self-expanding valves suggests it may not be necessary. METHODS: Retrospective single-center study of 154 patients undergoing first-time, transfemoral TAVI for native aortic valve stenosis, with (N = 76), and without (N = 78), BAV as part of the procedure. Data collected included demographic, procedural, and outcome data. RESULTS: BAV did not alter VARC-2 defined procedural success or early safety compared to not performing a BAV, including mortality, degree of aortic regurgitation, or need for post-TAVI balloon dilatation, although there was a strong trend to reduced stroke when not performing a BAV. There was a significantly reduced procedural time (P = 0.01) and fluoroscopic time (P < 0.001) without performing a BAV. There were no differences in cerebral embolization (solid, gaseous, or total emboli) noted between the 2 groups, as measured on transcranial doppler (TCD). CONCLUSIONS: TAVI can be effectively and safely performed without a BAV and this results in reduced procedural and fluoroscopic times, although embolization to the brain is not reduced. There is a trend toward reduced stroke risk. (J Interven Cardiol 2016;29:319-324).