Safety and efficacy of repeated balloon aortic valvuloplasty in patients with symptomatic severe aortic stenosis.

BACKGROUND: Long-term outcomes of balloon aortic valvuloplasty (BAV) in patients with severe symptomatic aortic stenosis (AS) are poor, and this procedure needs to be repeated in selected cases. AIMS: We aimed to investigate the safety and efficacy of repeated BAV (reBAV). METHODS: We included consecutive patients who underwent reBAV in three Polish centers between 2010 and 2019. Baseline clinical, echocardiographic, procedural, and outcome data were analyzed. RESULTS: Thirty-five patients (median age 81.5 years, 57.1% women) who underwent reBAV were enrolled. In 42.9% of the patients, index BAV was considered a palliative treatment, and in 54.3% a bridge to definitive treatment. Index BAV decreased peak aortic valve gradient (pAVG) from a median of 78.0 mm Hg to 46.0 mm Hg (P <0.001). After a mean of 255.8 days, reBAV was performed. In most cases (71.4%), the reason for reBAV was the worsening of heart failure symptoms and in 54.3% of patients, reBAV was still considered a palliative option. A decrease in pAVG max from a median of 73.0 mm Hg to 45.0 mm Hg (P <0.001), comparable to index BAV, was observed. The frequency of complications were numerically higher for repeated procedures. During the median (IQR) follow-up of 403.0 (152.0-787.0) days from the index procedure, 80.0% of the patients died. CONCLUSIONS: Acute hemodynamic results of reBAV are comparable to those achieved during index BAV. However, reBAV may carry an increased risk of complications. Moreover, mortality is high due to unfavorable risk profiles or delays in receiving definitive therapy.

Paravalvular leak prediction after transcatheter aortic valve replacement with self-expandable prosthesis based on quantitative aortic calcification analysis.

BACKGROUND: Paravalvular leak (PVL) is one of the most common complications of transcatheter aortic valve replacement (TAVR) and affects short- and long-term outcomes. The aim of this study was to identify the computed tomography (CT) imaging biomarkers that allow PVL after TAVR to be predicted. METHODS: Patients were included who had severe aortic valve stenosis, had undergone TAVR with a self-expanding valve, and had undergone a pre-procedural CT scan. Data on baseline characteristics, procedural and long-term outcomes were collected retrospectively. We used MATLAB software with a self-developed algorithm for CT scan analysis and found parameters that quantified aortic valve calcifications (AVC) in detail. RESULTS: Fifty patients were included. The identified CT-derived parameters included AVC size, volume, thickness and density, as well as calcium radial distribution. The volume of the largest calcium block, calcium perimeter and calcium size (assessed by Feret's diameter) showed a strong association with PVL occurrence after TAVR (P=0.012, P=0.001 and P=0.045, respectively). The prognostic model showed that a 10 mm2 increase in the local AVC amount in each valve section was associated with a 9.8% (95% CI: 2-18%; P=0.019) increase in the risk of PVL occurrence in the corresponding area after TAVR. ROC analysis revealed that the cut-off point of the AVC area was 96.5 mm2 in the polar coordinate system presentation. Kaplan-Meier curves showed worse PVL-free survival in patients with more than 96.5 mm2 of calcium area (P=0.013; log-rank). CONCLUSIONS: Quantitative AVC assessment for PVL prediction may play an important role in screening before TAVR. In future, the use of quantitative AVC assessment as an imaging biomarker in TAVR candidates and the creation and extension of an online database containing quantitative AVC parameters may help to identify high PVL risk patients.

Predictors of syncope in patients with severe aortic stenosis: The role of orthostatic unload test.

BACKGROUND: There is a paucity of data regarding response of cerebral blood flow to the postural unloading maneuver and its impact on the risk of syncope in patients with aortic stenosis (AS). The aim of the present study was to assess effects of orthostatic stress test on changes in carotid and vertebral artery blood flow and its association with syncope in patients with severe AS. METHODS: 108 patients were enrolled (72 with and 36 patients without syncope) with severe isolated severe AS. Peak systolic blood-flow velocity (PSV) and end-diastolic velocity in the carotid arteries and vertebral arteries were measured by duplex ultrasound in the supine position and at 1-2 min after the assumption of the standing position. RESULTS: The orthostatic stress test induced a significant decrease in carotid and vertebral arterial flow velocities in all examined arteries (p < 0.001). The median (interquartile range) of mean change in PSV for carotid arteries was higher for patients with syncope (syncope [-] vs. syncope [+]: -0.6 cm/s [-1.8, 1.0] vs. -7.3 cm/s [-9.5, -2.0]; p < 0.001) and similarly for vertebral arteries (-0.5 cm/s [-2.0, 0.5] vs. -4.8 cm/s [-6.5, -1.3]; p < 0.001, respectively). Age, aortic valve area, and mean change in PSV for carotid arteries were independently associated with syncope. CONCLUSIONS: In patients with AS, a decrease in carotid and vertebral arterial flow velocities in the standing position was observed and was associated with syncope. The present findings may support the value of an orthostatic test in identifying patients with severe AS and a high risk of syncope.

Calcium Pattern Assessment in Patients with Severe Aortic Stenosis Via the Chou's 5-Steps Rule.

BACKGROUND: Progression of aortic valve calcifications (AVC) leads to aortic valve stenosis (AS). Importantly, the AVC degree has a great impact on AS progression, treatment selection and outcomes. Methods of AVC assessment do not provide accurate quantitative evaluation and analysis of calcium distribution and deposition in a repetitive manner. OBJECTIVE: We aim to prepare a reliable tool for detailed AVC pattern analysis with quantitative parameters. METHODS: We analyzed computed tomography (CT) scans of fifty patients with severe AS using a dedicated software based on MATLAB version R2017a (MathWorks, Natick, MA, USA) and ImageJ version 1.51 (NIH, USA) with the BoneJ plugin version 1.4.2 with a self-developed algorithm. RESULTS: We listed unique parameters describing AVC and prepared 3D AVC models with color pointed calcium layer thickness in the stenotic aortic valve. These parameters were derived from CT-images in a semi-automated and repeatable manner. They were divided into morphometric, topological and textural parameters and may yield crucial information about the anatomy of the stenotic aortic valve. CONCLUSION: In our study, we were able to obtain and define quantitative parameters for calcium assessment of the degenerated aortic valves. Whether the defined parameters are able to predict potential long-term outcomes after treatment, requires further investigation.

A novel approach to quantification of aortic valve calcifications in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Precise calcium evaluation in the aortic complex may be complicated. We aimed to assess the usefulness of a novel semi-automatic algorithm for multi slice computed tomography-derived (MSCT) quantitative estimation of aortic valve calcifications (AVC) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). METHODS: Ten patients with severe AS who underwent TAVI with Edwards Sapien S3 26 mm prosthesis and had a pre-procedural MSCT scan were included. Data on baseline characteristics, procedural and long-term outcomes were collected prospectively. Pre-procedural MSCT data were used for AVC evaluation with 3D modeling (calcium volume, thickness, area, density, and distribution) in a dedicated program. RESULTS: Mean calcium thickness was 4.6 (3.6-5.8) mm. Median calcium are 333.6 (274.7-386.7) mm2. We found a significant correlation between larger maximal calcium layer thickness and PVL occurrence after TAVI (P=0.039). The radial representation of the calcium distribution allowed to divide aortic valve into 3 zones and to compare each zone to parallel zone on TTE images. In zones with PVL ≥2 mean AVC was higher than in zones with PVL <2 (7354.6±4020.4 pixels vs. 4325.1±1790.6 pixels; P=0.018). Based on ROC analysis, the optimal cut-off value of AVC to predict PVL ≥2 was >6506 pixels with 57.1% sensitivity and 90.5% specificity (AUC 0.762 [95% CI: 0.564 to 0.901], P=0.029). CONCLUSIONS: Multiplane AVC quantitative evaluation provided details on total calcium amount, pattern and distribution in aortic valve. Established AVC parameters allowed better visualization of an operating area and prediction of PVL after TAVI.

Impact of Pre-procedural Cerebrovascular Events on Clinical Outcomes After Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an increasingly common treatment of symptomatic severe aortic valve stenosis (AS). Thus, it is reasonable to carefully investigate the impact of individual clinical factors on outcomes after TAVI. OBJECTIVES: We aimed to investigate the impact of the previous cerebro-vascular events (CVEs) on outcomes of patients with severe AS undergoing TAVI. METHODS: A total of 148 consecutive patients scheduled for TAVI were included and stratified as with and without a history of CVEs (stroke or transient ischemic attack). Frailty features were also assessed. The primary endpoint was a 12-month all-cause mortality. RESULTS: Seventeen (11.5%) patients had a history of CVEs (the CVE group). At 30 days and 12 months, all-cause mortality was higher in the CVE group [30-day: 5 (29.4%) vs. 7 (5.3%); p=0.005; 12-month: 9 (52.9%) vs. 13 (9.9%); p=0.001]. Similarly, at the longest available follow-up, mortality was higher in the CVE group [10 (58.8%) vs. 23 (17.6%); p=0.001]. Similar rates of other complications after TAVI were noted, apart from inhospital acute kidney injury (AKI) grade 3 [3 (17.6%) vs. 5 (3.8%); p=0.049] and blood transfusions [9 (52.9%) vs. 35 (26.7%); p=0.026]. Results of 5MWT and Katz index assessment indicated a greater level of frailty in the CVE group. There were no differences in subsequent events including CVEs, bleeding, myocardial infarction, and new-onset of atrial fibrillation (AF) at 12 months between the groups. CONCLUSION: We showed that a history of CVEs in patients with severe AS undergoing TAVI is associated with a higher long-term mortality.

Effect of diabetes mellitus on clinical outcomes and quality of life after transcatheter aortic valve implantation for severe aortic valve stenosis.

BACKGROUND: Diabetes mellitus (DM) is considered a marker of poor prognosis after cardiac surgery. We sought to investigate the effect of DM on clinical outcomes and quality of life (QoL) after transcatheter aortic valve implantation (TAVI). METHODS: A total of 148 consecutive patients with symptomatic, severe aortic stenosis who underwent TAVI were included. Baseline characteristics, procedural and long-term clinical outcomes, and the results of frailty and QoL assessment with EQ-5D-3L questionnaire were compared between patients with and without DM. RESULTS: DM was present in 48 of 148 (32.4%) patients. No differences in periprocedural risk (Logistic Euroscore and Society of Thoracic Surgeons (STS) scale) between groups were observed. There were no differences in 30-day and 12-month all-cause mortality between groups [DM(-) vs. DM(+): 7 (7.0%) vs. 5 (10.4%), p = 0.53 and 12 (12.0%) vs. 10 (20.8%), p = 0.16, respectively]. No influence of DM presence on the risk of death was confirmed after adjustment for age and gender (for 30-day mortality, age/gender-adjusted OR 1.55, 95%CI 0.47-5.17; for 12-month mortality, age/gender-adjusted OR 2.05, 95%CI 0.79-5.32). Similarly, at the longest available follow-up, mortality did not differ between groups [14 (29.2%) vs. 19 (19.0%), p = 0.16; age/gender-adjusted OR 1.81, 95%CI 0.80-4.08]. Similar rates of other complications after TAVI were noted. Frailty measured with the 5-meter walking test was more frequently reported in patients with DM [11 (22.9%) vs. 10 (10.0%), p = 0.035]. No differences in QoL parameters at baseline and 12 months were noted. CONCLUSIONS: Patients with DM undergoing TAVI demonstrated similar mortality, complication rates, and QoL outcomes compared to patients without DM.

Sex-related differences in clinical outcomes and quality of life after transcatheter aortic valve implantation for severe aortic stenosis.

INTRODUCTION: There are inconsistent data on the sex-related differences in clinical outcomes and quality of life (QoL) after transcatheter aortic valve implantation (TAVI). AIM: We sought to investigate sex-related differences in procedural, clinical and QoL outcomes of TAVI. MATERIAL AND METHODS: A total of 101 consecutive patients undergoing TAVI were enrolled. Patients were stratified by gender. Baseline characteristics, procedural and long-term clinical outcomes as well as frailty and QoL indices (EQ-5D-3L questionnaire) were compared between women and men. RESULTS: Women represented 60.4% of the study population. Periprocedural risk measured with the Logistic EuroSCORE and STS scale was similar for women and men. There were no differences in 30-day or 12-month all-cause mortality between groups (women vs. men: 9.8% vs. 12.5%; age-adjusted odds ratio (OR) (95% CI): 1.38 (0.39-4.94); 13.1% vs. 25.0%; age-adjusted OR (95% CI): 2.51 (0.87-7.25)). Men were at higher risk of new onset atrial fibrillation at follow-up (1.6% vs. 17.5%; age-adjusted OR (95% CI): 14.61 (1.68-127.37)). In multivariable Cox regression analysis, a history of stroke/transient ischemic attack (TIA) (hazard ratio (HR)) (95% CI): 3.93 (1.39-11.07) and blood transfusion (HR (95% CI): 2.84 (1.06-7.63)) were identified as independent factors affecting 12-month mortality. No differences in QoL parameters were noted. CONCLUSIONS: The TAVI can be considered as an effective and safe treatment in high-risk patients with severe aortic stenosis, regardless of gender.

Prognostic value of tricuspid regurgitation velocity and probability of pulmonary hypertension in patients undergoing transcatheter aortic valve implantation.

Pulmonary hypertension (PH) is associated with adverse clinical outcomes after transcatheter aortic valve implantation (TAVI). We sought to investigate the effects of tricuspid regurgitant velocity (TRV) and echocardiographic probability of PH on clinical outcomes of patients undergoing TAVI. A total of 148 consecutive patients undergoing TAVI were included and stratified as having "low" (TRV ≤2.8 m/s), "intermediate" (TRV 2.9-3.4 m/s), and "high" (TRV >3.4 m/s) probability of PH. Only the patients from the "high" probability group were considered as patients with PH. All-cause mortality, complications rate and quality of life (QoL) were assessed according to VARC-2 recommendations. Of 148 patients, 65 (43.9%) were considered as patients with PH. These presented with higher NYHA class at baseline (p = 0.027) and had more frequently a history of previous stroke/transient ischemic attack (p = 0.019). A difference in all-cause mortality was noted at 12 months [PH (-) vs. PH (+): 9.6 vs. 21.5%; p = 0.043]; however, it was no longer significant after adjustment for age and gender (OR 2.39, 95% CI 0.91-6.24; p = 0.08). Unadjusted and adjusted rates of all-cause death at maximal follow-up of 13.3 (6.0-31.1) months were higher in patients with PH. However, the presence of PH was not identified as an independent predictor of all-cause mortality at follow-up. No difference in other complications rates and QoL were noted. The presence of TRV >3.4 m/s indicating "high" probability of PH may predict impaired clinical outcomes after TAVI. No impact of PH on QoL outcomes was confirmed.

Reduced periprocedural mortality and bleeding rates of radial approach in ST-segment elevation myocardial infarction. Propensity score analysis of data from the ORPKI Polish National Registry.

AIMS: We sought to evaluate bleeding complications and periprocedural outcomes of the radial approach (RA) as compared to the femoral approach (FA) during percutaneous coronary intervention (PCI) in "real-world" patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The study group consisted of 22,812 consecutive patients with STEMI treated with PCI and stent implantation between January 2014 and June 2015 in 151 tertiary invasive cardiology centres in Poland (the ORPKI Polish National Registry). Patients treated using the RA and FA were compared using a propensity score analysis to avoid possible selection bias. The analysis was carried out in an "as-treated" manner. The FA was used in 9,334 (40.9%) and the RA in 13,478 (59.1%) patients. After propensity score matching, a higher total amount of contrast (191.8±8.0 vs. 174.8±68.8 ml; p=0.001) and lower radiation doses (1,279.5±1,346.3 vs. 1,182.6±887 mGy; p=0.02) were reported in FA. More access-site-related bleeding complications after both angiography (0.17% vs. 0.02%; p=0.004) and PCI (0.23% vs. 0.09%; p=0.049) were reported in the FA group. Periprocedural death (1.94% vs. 0.93%; p=0.001) was more common after PCI performed with the FA. CONCLUSIONS: The radial approach was associated with a lower incidence of periprocedural death in STEMI patients as well as a significant reduction of bleeding complications at the access site.