TAVI has become the standard treatment in patients at increased surgical risk and is increasingly being performed in patients at intermediate to low surgical risk. While non-inferiority has been ...demonstrated in intermediate risk patients, several challenges-particularly with regard to valve durability-need to be addressed before expansion to lower risk and younger patients can be recommended on a broad basis. Current trends, trials results, and remaining challenges are summarized and discussed in the light of updated treatment guidelines.
•In contrast to frailty, underweight is a simple parameter and body weight is assessed routinely during every hospital stay.•Underweight is associated with increased short- and long-term mortality ...after TAVI and SAVR.•Underweight patients treated by SAVR had increased rates of postprocedural complications, whereas TAVI proved to be safe also in underweight patients.•The impact on mortality was even stronger in patients with severe underweight (BMI <18.5 kg/m2).
According to the Valve Academic Resortium, underweight is one parameter in the definition of frailty, which is associated with increased mortality after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). Aims of our study were (1) to examine the impact of underweight on mortality after TAVI and SAVR and (2) to determine the effect of intervention mode (TAVI vs SAVR) on mortality in underweight patients from the German Aortic Valve Registry. Overall, 35,109 patients treated with TAVI or SAVR were studied. Outcomes of underweight (body mass index BMI <20 kg/m2) TAVI and SAVR patients were compared using propensity score weighting. Prevalence of underweight was 5.7% in patients who underwent TAVI and 2.9% in patients who underwent SAVR. Underweight patients had significantly increased mortality rates for both treatment strategies compared with normal weight patients (BMI 20 to 30 kg/m2). Comparing underweight TAVI and SAVR-patients using propensity score weighting, no statistically significant differences regarding mortality rates were observed. Subgroup analysis of severely underweight patients (BMI <18.5 kg/m²) revealed no significant increase of mortality after TAVI compared with underweight patients (BMI <20 kg/m2), whereas severely underweight SAVR patients showed twofold increased mortality rates. In conclusion, underweight in patients who underwent TAVI or SAVR is rare, but it is associated with increased mortality. Especially severely underweight SAVR patients showed excess mortality rates.
As valve-in-valve (ViV) transcatheter aortic valve implantation is still an evolving method, we evaluated the development of early and midterm outcomes after ViV and conventional redo-surgical aortic ...valve replacement (SAVR) over the past 2 decades. In-hospital databases were retrospectively screened for patients ≥60 years treated for failing bioprosthetic aortic valves at our center. Clinical and follow-up characteristics were compared between patients who underwent ViV or redo-SAVR according to valve academic research consortium-2 (VARC-2) definitions. The comparison of outcome parameters was adjusted for baseline differences between groups. Between June 2002 and April 2020, 209 patients with ViV and 65 redo-SAVR patients met inclusion criteria. No significant differences were found in 30 days (ViV 3.8%, SAVR 3.1%, p = 0.778) or 6-month mortality (ViV 14.0%, SAVR 7.5%, p = 0.283). As patients with ViV less frequently experienced acute kidney injury (stage II or III) and life-threatening bleeding, they more frequently reached the 30-day VARC-2 combined safety end point (79.2% vs 61.5%, odds ratio OR 2.540, p = 0.023). Patients with ViV less frequently reached clinical efficacy (68.3% vs 84.6%, OR 0.408, p = 0.041) and device success (79.9% vs 92.3%, OR 0.311, p = 0.040) end points, because of higher frequency of postprocedural transvalvular gradients >20 mm Hg. However, over the past decade, VARC-2 clinical efficacy and device success rates continuously increased in ViV cases. In conclusion, ViV and SAVR were associated with similar acute mortality and different beneficial and adverse outcome profiles in this single-center cohort. Results after ViV procedures have continuously improved over the past years.
With next‐generation valves such as the ALLEGRA valve from NewValve Technologies (NVT), Hechingen Germany, there is a very likely treatment expansion for patients with aortic valve disease. Besides ...treatment of native valvular aortic stenosis with the ALLEGRA valve, the special implant mechanism seems to be an appealing concept for patients with degenerated surgical bioprostheses. We report the first case of a transfemoral implantation in small degenerated surgical bioprosthesis of a 76‐year‐old woman.
Abstract
OBJECTIVES
The aim of the study was to determine the differences in outcomes of surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) in low-risk ...patients.
METHODS
All patients with a logistic EuroSCORE II <4% who underwent transfemoral TAVI between 2008 and 2016 (n = 955) or SAVR between 2009 and 2014 (n = 886) at our centre were included. One hundred and nine patients per group were available for propensity score matching.
RESULTS
Mortality during the 30-day follow-up showed no differences (SAVR vs TAVI: 1.1% vs 1.8%, P = 1.0) but the rates of permanent pacemaker implantation (0.0 vs 14.8%, P < 0.001) and paravalvular leakage ≥ moderate (0.0 vs 7.0%, P = 0.017) were higher in TAVI patients. No difference was found regarding postoperative effective orifice area and transvalvular pressure gradients. Although, the 1-year survival was similar between both groups; 3- and 5-year survival was significantly inferior in the TAVI patient cohort.
CONCLUSIONS
TAVI yielded similar short-term outcomes compared with SAVR despite higher rates of permanent pacemaker implantation and paravalvular leakage ≥ moderate, but inferior long-term survival. Poorer long-term outcomes of the TAVI patient cohort were attributable to a more comorbid TAVI population. This emphasizes the need for long-term results from randomized controlled trials before TAVI can be broadly expanded to younger low-risk patients.
The growing experience in aortic valve (AV) repair showed that annular stabilization is a crucial component to achieve stable long-term results after AV repair. Dynamic changes in the AV annulus ...during the cardiac cycle may have an impact on annuloplasty design.
We retrospectively analysed full cardiac cycle multislice computed tomography data from 58 consecutive patients (mean age 75.9 ± 6.5 years, 36% men) with normally functioning tricuspid AVs (normal AV subgroup). The following computed tomography parameters were measured during systole and diastole: maximum, minimum and mean AV annulus diameter, AV annular area and AV annular perimeter. The AV annular eccentricity index was calculated (%) (max AV annulus × 100/min AV annulus) - 100 in systole and diastole. Subsequently, multislice computed tomography data from 20 patients with severe aortic regurgitation were analysed aortic valve regurgitation (AR) subgroup.
In the normal AV subgroup, there was a significant decrease in the mean AV annulus diameter from systole to diastole (i.e. 24.6 ± 2.5 mm vs 23.9 ± 2.4 mm, respectively; P < 0.001), which occurred predominantly in the short annular axis (i.e. 21.2 ± 2.4 mm in systole vs 19.9 ± 2.3 mm in diastole; P < 0.001). The mean AV annular area decreased significantly in diastole (i.e. 467.5 ± 94.5 mm2 in systole vs 444.8 ± 86.1 mm2 in diastole; P = 0.012). The annular eccentricity index increased significantly in diastole (33.0 ± 12.2% in systole vs 41.4 ± 13.5% in diastole; P < 0.001). Furthermore, we found an inverse linear correlation between the mean AV annulus diameter and the annular eccentricity index (r = -0.40, P = 0.034). The diastolic annular eccentricity index was significantly reduced in the AR subgroup (i.e. 41.4 ± 13.5% in the normal AV subgroup vs 33.7 ± 14.8% in the AR cohort; P = 0.035).
The normal AV annulus undergoes important geometric deformation during the cardiac cycle that is significantly reduced in diastole in the AR scenario. A novel AV annuloplasty system should ideally adapt for this marked diastolic annular eccentricity and thereby allow for dynamic aortic root changes during the cardiac cycle.
To evaluate whether the serum C-reactive protein to albumin ratio (CAR) could be used for risk stratification of patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic ...stenosis (AS).
Frailty is a predictor of poor outcomes in patients undergoing AS interventions. The CAR reflects key components of frailty (systemic inflammation and nutrition) and could potentially be implemented into assessment and management strategies for patients with AS. From March 1, 2010, through February 29, 2020, 1836 patients were prospectively enrolled in an observational TAVR database. Patients (prospective development cohort, n=763) were grouped into CAR quartiles to compare the upper quartile (CAR Q4) with the lower quartiles (CAR Q1-3). Primary end point was all-cause mortality. Results were verified in an independent retrospective cohort (n=1403).
The CAR Q4 had a higher prevalence of impaired left ventricular function, atrial fibrillation, diabetes, and cerebrovascular disease and a higher median logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) vs CAR Q1-3. After median follow-up of 15.0 months, all-cause mortality was significantly higher in CAR Q4 vs CAR Q1-3 (P<.001). In multivariable analyses, risk factors for all-cause mortality were CAR Q4 (>0.1632; hazard ratio, 1.45; 95% confidence interval, 1.05 to 2.00; P=.03), N-terminal pro-B-type natriuretic peptide Q4 (>3230 pg/mL to convert to ng/L, multiply by 1), high-sensitivity troponin T Q4 (>0.0395 ng/mL to convert to μg/L, multiply by 1), above-median logistic EuroSCORE (16.1%), myocardial infarction, Acute Kidney Injury Network stage 3, and life-threatening bleeding.
Elevated CAR was associated with increased risk of all-cause mortality in patients undergoing transfemoral TAVR. The CAR, a simple, objective tool to assess frailty, could be incorporated into assessing patients with AS being considered for TAVR.
Objectives
Transcatheter aortic valve implantation (TAVI) using balloon‐expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly ...involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients.
Methods
Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC‐3 definitions.
Results
Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (˂750 mm³) even in aortic annuli of 29.0–30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750–3200 mm³). Accordingly, a low calcification group (˂750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p ˂ 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All‐cause 30‐day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented.
Conclusion
Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex ˂750 mm³.
Compared to high gradient aortic stenosis (AS), patients with low-flow, low-gradient AS have higher mortality after transcatheter aortic valve replacement (TAVR), but distinct outcome predictors in ...this patient subset are yet to be determined. The present study investigated the prognostic impact of aortic valve calcification (AVC) in patients with low-flow, low-gradient AS undergoing TAVR.
This retrospective single-center analysis includes all patients undergoing TAVR for severe low-flow, low-gradient AS (n = 526), ie, low EF low gradient AS (LEF-LG AS; n = 290) and paradoxical low-flow, low-gradient AS (PLF-LG AS; n = 236), in whom AVC was quantified from contrast-enhanced multislice computed tomography images. AVCdensity was defined as calcium volume per annulus area. Patients were trichotomized according to sex-specific AVCdensity tertiles in both subgroups. All-cause mortality was assessed by Kaplan-Meier analyses and independent outcome predictors were determined by multivariable analyses.
In both subgroups, patients with high AVCdensity had higher mean transvalvular gradients at baseline and higher rates of PVL after TAVR. High AVCdensity was associated with lowest 1- and 3-year mortality after TAVR in the LEF-LG AS but not in the PLF-LG AS group. According to multivariable analysis AVCdensity was independently associated with better survival in LEF-LG AS patients (HR 0.73 0.60-0.88, P = .0011), but not in those with PLF-LG AS (HR 0.91 0.73-1.14, P = .42).
Quantification of AVC may not only be of diagnostic but also of prognostic value, as it facilitates the selection of LEF-LG AS patients with higher probability of beneficial outcome after TAVR.
Display omitted
Despite continuous improvements in transcatheter aortic valve implantation (TAVI), periprocedural strokes remain a devastating complication. Randomized controlled trials failed to demonstrate a ...reduction in clinically apparent strokes or mortality after TAVI due to cerebral embolic protection (CEP). To identify potential targets of CEP strategies during TAVI, we evaluated affected brain regions, and temporal patterns of stroke onset in a routine clinical sample.
A total of 3,164 consecutive patients treated with TAVI from 2008 to 2019 at a single center were screened for cerebrovascular events. Affected cerebral regions were determined according to clinical symptoms and brain imaging. Rates of disabling stroke and non–disabling stroke at 30 days were 2.2% and 1.4%, respectively. The frequency of all strokes decreased from 5.0% to 3.0% over time (P = .012). Patients with impaired left-ventricular function (OR 2.19), increased CHA2DS2-VASc (OR 1.39) and moderate/severe spontaneous echo contrast (OR 3.60) had a higher stroke risk. Acute symptom onset occurred during TAVI (19.4%), within 24 hours (40.3%) or later (25.0%); 98.3% of strokes were of ischemic origin. In intraprocedural strokes, 53.2% of lesions were found in locations considered protected by current CEP devices, and 37.5% of patients with intraprocedural strokes were exclusively affected in these areas. Baseline or procedural parameters were not associated with embolic distribution patterns.
Most strokes occurred early after TAVI – but not necessarily during the procedure – and affected multiple brain regions only partially protected by current CEP devices. Efficient prevention of cerebrovascular events may require strategies beyond the TAVI procedure to minimize stroke risk and additional randomized controlled trials will be required to clarify the role of CEP in efficient stroke prevention during TAVI.
PDF
