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.

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.

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.

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.

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).

Percutaneous closure of postinfarction ventricular septal defect: in-hospital outcomes and long-term follow-up of UK experience.

BACKGROUND: Postinfarction ventricular septal defect carries a grim prognosis. Surgical repair offers reasonable outcomes in patients who survive a healing phase. Percutaneous device implantation represents a potentially attractive early alternative. METHODS AND RESULTS: Postinfarction ventricular septal defect closure was attempted in 53 patients from 11 centers (1997-2012; aged 72±11 years; 42% female). Nineteen percent had previous surgical closure. Myocardial infarction was anterior (66%) or inferior (34%). Time from myocardial infarction to closure procedure was 13 (first and third quartiles, 5-54) days. Devices were successfully implanted in 89% of patients. Major immediate complications included procedural death (3.8%) and emergency cardiac surgery (7.5%). Immediate shunt reduction was graded as complete (23%), partial (62%), or none (15%). Median length of stay after the procedure was 5.0 (2.0-9.0) days. Fifty-eight percent survived to discharge and were followed up for 395 (63-1522) days, during which time 4 additional patients died (7.5%). Factors associated with death after postinfarction ventricular septal defect closure included the following: age (hazard ratio [HR]=1.04; P=0.039), female sex (HR=2.33; P=0.043), New York Heart Association class IV (HR=4.42; P=0.002), cardiogenic shock (HR=3.75; P=0.003), creatinine (HR=1.007; P=0.003), defect size (HR=1.09; P=0.026), inotropes (HR=4.18; P=0.005), and absence of revascularization therapy for presenting myocardial infarction (HR=3.28; P=0.009). Prior surgical closure (HR=0.12; P=0.040) and immediate shunt reduction (HR=0.49; P=0.037) were associated with survival. CONCLUSIONS: Percutaneous closure of postinfarction ventricular septal defect is a reasonably effective treatment for these extremely high-risk patients. Mortality remains high, but patients who survive to discharge do well in the longer term.

Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration.

RATIONALE: A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of ß-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. DESIGN: A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus ß-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (http://www.ctsu.ox.ac.uk/research/meta-trials).

Patent foramen ovale is not associated with hypoxemia in severe chronic obstructive pulmonary disease and does not impair exercise performance.

RATIONALE: Patent foramen ovale (PFO) may be disadvantageous in chronic obstructive pulmonary disease (COPD). It is unknown whether right-to-left shunting through PFO increases during exercise impairing exercise performance. OBJECTIVES: To determine whether (1) PFO prevalence is greater in hypoxemic versus less hypoxemic patients with COPD, (2) PFO is associated with clinically relevant impairment, and (3) right-to-left shunting increases during exercise and impairs exercise performance. METHODS: Patients with COPD and age-matched control subjects underwent contrast transthoracic echocardiography and transcranial Doppler to identify PFO. Patients with COPD with no shunt and patients with large PFO underwent cardiopulmonary exercise tests with contrast transcranial Doppler, esophageal, and gastric balloon catheters. MEASUREMENTS AND MAIN RESULTS: PFO prevalence was similar in 50 patients with COPD and 50 healthy control subjects (46% vs. 30%; P = 0.15). Large shunts were more common in patients with COPD (26% vs. 6%; P = 0.01). In an expanded COPD cohort, PFO prevalence was similar in 31 hypoxemic (Pao2 ≤ 7.3 kPa) and 63 less hypoxemic (Pao2 > 8.0 kPa) patients with COPD (39% vs. 52%; P = 0.27). Patients with intrapulmonary shunting had lower Pao2 than both patients with PFO and those with no right-to-left shunt (7.7 vs. 8.6 vs. 9.3 kPa, respectively; P = 0.002). Shunting significantly increased during exercise in patients with COPD with PFO. Endurance time at 60% Vo2max was 574 (178) seconds for patients with PFO and 534 (279) seconds for those without (P = ns). CONCLUSIONS: Hypoxemic patients with COPD do not have a higher prevalence of PFO. Patients with COPD with PFO do not perform less well either on a 6-minute walk or submaximal exercise testing despite increased right-to-left shunting during exercise.

Post-procedural arterial hypertension: implications for clinical outcome after transcatheter aortic valve implantation.

BACKGROUND AND AIM OF THE STUDY: Persistent arterial hypertension (HT) has been associated with increased morbidity and mortality after surgical aortic valve replacement (AVR). The impact of increased blood pressure (BP) after transcatheter aortic valve implantation (TAVI) has not yet been fully elucidated. METHODS: The mean systolic and diastolic BP after TAVI were calculated from the last 10 non-invasive recordings performed before discharge in 176 patients. The primary end-point was symptomatic improvement after 6-12 months according to BP control at the time of discharge. RESULTS: In patients with controlled BP (<140/90 mmHg), the symptomatic response after TAVI was significantly better compared to patients with uncontrolled BP (> or =140/90 mmHg), as reflected by NYHA functional class (+1.4 +/- 0.8 versus +0.8 +/- 1.0, p = 0.002) and six-minute walk test (6-MWT) distance improvement (+100 +/- 71 m versus +30 +/- 64 m, p < 0.001) at 6-12 months' follow up. A 10 mmHg decrease in systolic BP was associated with an 18 m increase in 6-MWT distance (p = 0.001). In addition, reverse left ventricular (LV) remodeling was significantly impaired in uncontrolled BP individuals, as reflected by regression of LV mass (-15 +/- 61 g versus -37 +/- 54 g, p = 0.041) and relative wall thickness (-0.02 +/- 0.09 versus -0.07 +/- 0.1, p = 0.01). Cumulative all-cause and cardiovascular mortality were significantly lower in patients with controlled BP compared to those with uncontrolled BP (6.5% versus 16%, p = 0.04; cardiovascular 3.7% versus 11.6%, p = 0.035). CONCLUSION: Uncontrolled HT after TAVI may contribute to diminished symptomatic improvement.

'Paradoxical' low-flow, low-gradient severe aortic valve stenosis: an entity with limited improvement following transcatheter aortic valve implantation.

BACKGROUND AND AIM OF THE STUDY: The aim of this single-center observational study was to determine the outcome of patients with 'paradoxical' low-flow, low-gradient aortic valve stenosis (PLF-LG-AS) after transcatheter aortic valve implantation (TAVI). METHODS: Based on pre-procedural echocardiographic data, a total of 150 patients with severe aortic valve stenosis (AS) (indexed aortic valve area (AVA) ≤ 0.6 cm2/m2) who underwent TAVI at the authors' institution were allocated retrospectively to three groups: Group 1: PLF-LG-AS (ejection fraction (EF) ≥ 50%, indexed stroke volume (SV) ≤ 35 ml/m2, mean AV gradient < 40 mmHg; n = 30); Group 2: Classical low-flow, low-gradient AS (CLF-LG-AS: EF < 50%, SV ≤ 35 ml/m2, mean AV gradient < 40 mmHg; n = 21); and Group 3: High-gradient AS (HG-AS: EF < or ≥ 50%, mean AV gradient ≥ 40 mmHg; n = 99). RESULTS: PLF-LG-AS was associated with an increased relative wall thickness (RWT) and a higher post-procedural systolic blood pressure (sBP) and pulse pressure (PP) (RWT 60.6 ± 15.3%, sBP 144 ± 14 mmHg, PP 79 ± 15 mmHg) compared to patients with HG-AS or CLF-LG-AS: (RWT 52 ± 13% and 40 ± 9%, p < 0.001; sBP 138 ± 15 mmHg and 125 ± 25 mmHg, p = 0.006; PP 68 ± 16 mmHg and 60 ± 21 mmHg, p = 0.01). These patients experienced less improvement in a 6-min walk test (improvement for PLF-LG-AS 14 ± 84 m, for CLF-LG-AS 86 ± 83 m, for HG-AS 87 ± 66 m; intergroup p < 0.007). PLF-LG-AS and CLF-LG-AS were also associated with significantly increased one-year overall mortality (PLF-LG-AS 31%, CLF-LG-AS 19%, HG-AS 6%; p = 0.001) and cardiovascular mortality (PLF-LG-AS 20%, CLF-LG-AS 19%, HG-AS 3%; p = 0.002). CONCLUSION: Patients with PLF-LG-AS may represent a subgroup with a worse clinical outcome after TAVI.

Transcatheter Edge-to-Edge Repair in Complex Cyanotic Congenital Heart Disease With a Common Atrioventricular Valve.

A 21-year-old patient with complex cyanotic congenital heart disease and highly symptomatic severe common atrioventricular valve regurgitation was deemed too high risk for surgical intervention or transplantation. She successfully underwent transcatheter edge-to-edge repair with resulting considerable improvement in her symptoms, renal function, and quality of life.

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.

Hemodynamics in the Valsalva sinuses after transcatheter aortic valve implantation (TAVI).

BACKGROUND AND AIM OF THE STUDY: The study aim was to assess, in vitro, the hemodynamic modifications produced by transcatheter valves in the Valsalva sinuses, by mean of phase-resolved particle image velocimetry (PIV) measurements. METHODS: Flow measurements were performed on a glass mock aortic root that included three polymeric valve leaflets, before and after the implantation of a Medtronic CoreValve device and of an Edwards SAPIEN valve. All experiments were carried out in a hydro-mechanical cardiovascular pulse duplicator system (Vivitro Superpump System SP3891) that reproduced physiologically equivalent pressures and flow rates conforming to the requirements of the standard ISO 5840:2005. The flow dynamics, before and after implantation of the two prosthetic devices, was characterized on the basis of phase-resolved velocity field and viscous shear rate measurements. RESULTS: Direct comparison indicated that both transcatheter valves determined a significant variation of flow during the early stages of valve opening and during valve closure. In general, the presence of the two valve implants significantly reduced the flow activity in the Valsalva sinuses, promoting regions of stagnation at their base. CONCLUSION: The reduction in flow in the Valsalva sinuses could be associated with the higher incidence of ischemic events reported after transcatheter heart valve implantation.

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.

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.

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.

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.

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.

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.