Impact of chronic obstructive pulmonary disease and frailty on long-term outcomes and quality of life after transcatheter aortic valve implantation.

BACKGROUND: Association between chronic obstructive pulmonary disease (COPD) and long-term mortality as well as the quality of life (QoL) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is still unclear. AIM: We sought to evaluate the impact of COPD on mortality and QoL of patients with AS undergoing TAVI. METHODS: A total of 148 consecutive patients who underwent TAVI were enrolled and stratified by history of COPD. RESULTS: Of 148 patients enrolled, 19 (12.8%) patients had a history of COPD. Patients with COPD were high-risk patients with higher prevalence of incomplete revascularization and frailty features. At follow-up of 15.8 months, all-cause mortality in patients with COPD was over four times higher than in patients without COPD [17.8% vs. 52.6%; p = 0.002-age/gender-adjusted OR (95% CI) 4.73 (1.69-13.24)]. On the other hand, in Cox regression model, the only independent predictors of all-cause death at long-term follow-up were: incomplete coronary revascularization [HR (95% CI) 5.45 (2.38-12.52); p = 0.001], estimated glomerular filtration rate [per 1 ml/min/1.73 m2 increase: 0.96 (0.94-0.98); p = 0.001], and previous stroke/transient ischemic attack [2.86 (1.17-7.00); p = 0.021]. Also, the difference in mortality between patients with and without COPD was not significant after adjustment for the most of frailty indices. Importantly, groups were comparable in terms of QoL at baseline and 12 months. CONCLUSION: COPD may pose an important factor affecting long-term outcomes of patients with severe AS undergoing TAVI. However, its effects might be partially related to coexisting comorbidities and frailty.

Impact of frailty on mortality after transcatheter aortic valve implantation.

BACKGROUND: We sought to investigate the relation between frailty indices and 12-month mortality after transcatheter aortic valve implantation (TAVI). METHODS: We included 101 consecutive patients with severe aortic stenosis who have undergone TAVI. Frailty indices according to Valve Academic Research Consortium-2 recommendations (5-m walk test [5MWT] and hand grip strength) as well as other available scales of frailty (Katz index, Elderly Mobility Scale [EMS], Canadian Study of Health and Aging [CSHA] scale, Identification of Seniors at Risk [ISAR] scale) were assessed at baseline. The primary endpoint was 12-month all-cause mortality. RESULTS: Twelve-month all-cause mortality was 17.8%. According to 5MWT, 17.8% were frail; hand grip test: 6.9%; Katz index: 17.8%; EMS: 7.9%; CSHA scale: 16.9%; and ISAR scale: 52.5%. Associations between frailty indices and 12-month all-cause mortality after TAVI were significant in Cox regression analysis (frail vs not frail, presented as hazard ratio[95%CI] adjusted for logistic EuroSCORE): for 5MWT, 72.38 (15.95-328.44); for EMS, 23.39 (6.89-79.34); for CSHA scale, 53.97 (14.67-198.53); for Katz index, 21.69 (6.89-68.25); for hand grip strength, 51.54 (12.98-204.74); and for ISAR scale, 15.94 (2.10-120.74). Similarly, such relationship was confirmed when 5MWT, EMS, and CSHA were used as continuous variables (hazard ratio [95%CI] adjusted for logistic EuroSCORE: for 5MWT per 1-second increase, 2.55 [1.94-3.37]; for EMS per 1-point decrease, 2.90 (1.99-4.21); and for CSHA per 1-point increase, 3.13 [2.17-4.53]). CONCLUSIONS: Our study confirmed a strong predictive ability of most of the proposed frailty indices for 12-month mortality after TAVI. For patients scheduled for TAVI, the use of frailty indices, which are easy and quick to assess on clinical basis but with strong performance, for example, 5MWT, EMS, or hand grip test, may be advocated.

Association Between Blood Transfusions and 12-Month Mortality After Transcatheter Aortic Valve Implantation.

Blood transfusions are considered as an important predictor of adverse outcome in patients with severe aortic (AS) undergoing transcatheter aortic valve implantation (TAVI). We sought to investigate the association between blood transfusions and mortality after TAVI. We enrolled 101 consecutive patients with severe AS undergoing TAVI. Patients who required transfusion were defined as patients in whom at least one unit of packed red blood cells (PRBCs) was transfused in the perioperative period. Twelve-month outcomes were assessed based on Valve Academic Research Consortium definitions. A total of 28 (27.7%) patients required blood transfusion after TAVI. Baseline characteristics of the patients with and without a transfusion were similar. Median amount of PRBCs was 2 (interquartile range, 2-4). Twelvemonth all-cause mortality was higher in patients with than without a blood transfusion (39.3% versus 9.6%; P = 0.001). Importantly, the need for a blood transfusion after TAVI was an independent predictor of higher mortality rates after 12 months (hazard ratio (HR) 2.84 95%CI (1.06-7.63); P = 0.039; (HR for incomplete coronary revascularization 10.86, 95%CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95%CI 1.39-11.07; P < 0.001). The duration of inhospital stay was longer in patients requiring transfusion (16.0 (14.0-22.0) versus 7.0 (7.0-11.5) days; P = 0.014). In conclusion, blood transfusions after TAVI were associated with higher mortality rates after 12 months, longer in-hospital stay, and were identified as an independent predictor of impaired clinical outcome.

Impact of Coronary Artery Disease Burden on 12-Month Mortality of Patients After Transcatheter Aortic Valve Implantation.

OBJECTIVES: The aim of the study was to compare 12-month mortality rate of patients with and without complete coronary revascularization before transcatheter aortic valve implantation (TAVI). BACKGROUND: There are limited data on the impact of coronary artery disease burden in patients with severe aortic stenosis undergoing TAVI. METHODS: One hundred and one consecutive patients undergoing TAVI were enrolled. Of them 16 (15.8%) had an incomplete coronary revascularization. The primary endpoint was 12-month all-cause mortality. RESULTS: Twelve-month all-cause mortality was higher in patients with incomplete coronary revascularization than in patients with complete coronary revascularization or without significant lesions (75.0% vs 7.1%; P < 0.001). Importantly, incomplete coronary revascularization was an independent predictor of higher mortality rate after 12 months (hazard ratio (HR) for incomplete coronary revascularization 10.86, 95% CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95% confidence interval (CI) 1.39-11.07; P < 0.001; HR for blood transfusion 2.84 95% CI (1.06-7.63); P = 0.039). In 9 of 16 (56.3%) patients, incomplete revascularization was related to the presence of chronic total occlusions (CTO). Patients with CTO had an increased mortality rate after 12 months (55.6% vs 14.1%; P = 0.008) as compared to patients without the CTO. CONCLUSIONS: Incomplete coronary revascularization and a history of stroke or TIA may be independent predictors of all-cause mortality in patients undergoing TAVI. However, further studies are recommended to confirm the results, especially in terms of the impact of CTO presence on long-term mortality after TAVI.

The Usefulness of [18F]F-Fluorodeoxyglucose and [18F]F-Sodium Fluoride Positron Emission Tomography Imaging in the Assessment of Early-Stage Aortic Valve Degeneration after Transcatheter Aortic Valve Implantation (TAVI)-Protocol Description and Preliminary Results.

Transcatheter aortic valve implantation (TAVI) is now a well-established treatment for severe aortic stenosis. As the number of procedures and indications increase, the age of patients decreases. However, their durability and factors accelerating the process of degeneration are not well-known. The aim of the study was to verify the possibility of using [18F]F-sodium fluoride ([18F]F-NaF) and [18F]F-fluorodeoxyglucose ([18F]F-FDG) positron emission tomography/computed tomography (PET/CT) in assessing the intensity of TAVI valve degenerative processes. In 73 TAVI patients, transthoracic echocardiography (TTE) at initial (before TAVI), baseline (after TAVI), and during follow-up, as well as transesophageal echocardiography (TEE) and PET/CT, were performed using [18F]F-NaF and [18F]F-FDG at the six-month follow-up (FU) visit as a part of a two-year FU period. The morphology of TAVI valve leaflets were assessed in TEE, transvalvular gradients and effective orifice area (EOA) in TTE. Calcium scores and PET tracer activity were counted. We assessed the relationship between [18F]F-NaF and [18F]F-FDG PET/CT uptake at the 6 = month FU with selected indices e.g.,: transvalvular gradient, valve type, EOA and insufficiency grade at following time points after the TAVI procedure. We present the preliminary PET/CT ([18F]F-NaF, [18F]F-FDG) results at the six-month follow-up period as are part of an ongoing study, which will last two years FU. We enrolled 73 TAVI patients with the mean age of 82.49 ± 7.11 years. A significant decrease in transvalvular gradient and increase of effective orifice area and left ventricle ejection fraction were observed. At six months, FU valve thrombosis was diagnosed in four patients, while 7.6% of patients refused planned controls due to the COVID-19 pandemic. We noticed significant correlations between valve types, EOA and transaortic valve gradients, as well as [18F]F-NaF and [18F]F-FDG uptake in PET/CT. PET/CT imaging with the use of [18F]F-FDG and [18F]F-NaF is intended to be feasible, and it practically allows the standardized uptake value (SUV) to differentiate the area containing the TAVI leaflets from the SUV directly adjacent to the ring calcifications and the calcified native leaflets. This could become the seed for future detection and evaluation capabilities regarding the progression of even early degenerative lesions to the TAVI valve, expressed as local leaflet inflammation and microcalcifications.

Early results of the ongoing Polish Registry of Valve Thrombosis after Transcatheter Aortic Valve Implantation (ZAK­POLTAVI).

BACKGROUND: Conflicting data exist regarding the risk factors for transcatheter heart valve thrombosis (THVT). In addition, no optimal pharmacological strategy to treat THVT has been established so far Aims: The aim of this study was to assess the incidence, risk factors, diagnostic workup, and treatment of THVT in Poland. METHODS: Data were collected retrospectively in themulticenter registry of patients with THVT (ZAK­POLTAVI) between November 2008 and November 2018. Transcatheter heart valve thrombosis was defined as an increased mean transvalvular gradient accompanied by a decreased effective orifice area or severe aortic regurgitation, reversible after treatment. Baseline characteristics and procedural data were compared between patients with THVT and those without THVT (matched by age, sex, and diabetic status). RESULTS: In a group of 2307 patients undergoing transcatheter aortic valve implantation (TAVI), 26 patients with THVT were identified (incidence, 1.14%). In half of the patients, THVT was diagnosed within 6 months after TAVI. As compared with the control group, patients with THVT more frequently had chronic obstructive pulmonary disease (P = 0.035), a smaller aortic valve area (P = 0.007), a higher mean postprocedural transvalvular gradient (P = 0.037), and a lower platelet count (P = 0.029) at the time of the diagnosis. A total of 24 patients (84.6%) received anticoagulation therapy for THVT, and complete resolution of THVT was noted in 12 individuals (46.1%). We observed thromboembolic complications in 2 patients (7.7%). CONCLUSIONS: Transcatheter heart valve thrombosis is a rare complication of TAVI. However, a higher risk of THVT may be expected in patients with chronic obstructive pulmonary disease, a smaller aortic valve area, a higher mean postprocedural transvalvular gradient, and a lower platelet count. Anticoagulation alone or combined with antiplatelet therapy seems to be the optimal pharmacological treatment in this population.

The obesity paradox in patients undergoing transcatheter aortic valve implantation: is there any effect of body mass index on survival?

BACKGROUND: Conflicting results have been presented regarding the influence of body mass index (BMI) on outcomes among patients undergoing transcatheter aortic valve implantation (TAVI). AIMS: To investigate the impact of BMI on clinical outcomes after TAVI. METHODS: A total of 148 consecutive patients were categorised using baseline BMI according to the World Health Organization criteria. Baseline patient characteristics, frailty, and procedural and clinical outcomes including 30-day and 12-month all-cause mortality were compared between the BMI categories. Patients were followed up for a median of 460.0 (182.0-1042.0) days. RESULTS: Obesity was diagnosed in 37 (25.2%) patients, 73 (49.7%) patients were overweight, and 37 (25.2%) had normal weight. Prevalence of lower frailty as assessed by five-metre walk test was confirmed in obese patients as compared to other groups. A trend towards a lower rate of in-hospital bleeding complications (18 [48.6%] vs. 21 [28.8%] vs. 9 [24.3%] in normal-weight, overweight, and obese patients, respectively; p = 0.06) and less frequent blood transfusions (18 [48.6%] vs. 17 [23.3%) vs. 8 [21.6%]; p = 0.016) was observed in overweight and obese groups. The rate of grade 3 acute kidney injury was lowest in the overweight group (4 [10.8%] vs. 1 [1.4%] vs. 3 [8.1%]; p = 0.05). There was no difference between the groups in terms of 30-day all-cause mortality (p = 0.15). However, 12-month all-cause mortality was lowest in obese pa-tients (12 [32.4%] vs. 10 [13.7%] vs. 2 [5.4%]; p = 0.004). Increase in BMI was independently associated with lower all-cause mortality (hazard ratio [95% confidence interval] per 1 kg/m2 increase: 0.91 [0.845-0.98]; p = 0.018). CONCLUSIONS: Increased BMI was independently associated with survival benefit after TAVI.

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.

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.

Impact of previous cardiac surgery with sternotomy on clinical outcomes and quality of life after transcatheter aortic valve implantation for severe aortic stenosis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has evolved as an effective treatment in patients with symptomatic severe aortic stenosis (AS) and increased operative risk. Data on the influence of previous sternotomy on the risk of TAVI are limited. AIM: We sought to investigate the effect of previous cardiac surgery with sternotomy on clinical outcomes and quality of life (QoL) after TAVI. METHODS: The study included 148 consecutive patients with symptomatic severe AS, who underwent TAVI. Baseline charac-teristics, procedural and long-term clinical outcomes, and QoL assessment with the EQ-5D-3L questionnaire were compared between patients with and without previous sternotomy. RESULTS: Patients with previous sternotomy (23.0% of the population) were younger and more often male, had higher rate of previous myocardial infarction (MI; 26 [22.8%] vs. 22 [64.7%], p = 0.001), and lower median left ventricular ejection frac-tion (60.0% [50.0-65.0] vs. 50.0% [42.0-60.0], p = 0.004). Periprocedural risk measured with the Logistic Euroscore and the Society of Thoracic Surgeons scale was comparable in both groups. There were no differences in 30-day and 12-month all-cause mortality between the groups with and without sternotomy (10 [8.8%] vs. 2 [5.9%], p = 0.7; odds ratio [OR] adjusted for age/sex/previous MI, 0.56, 95% confidence interval [CI] 0.10-3.29; for 12-month mortality adjusted OR 0.19, 95% CI 0.04-0.99). At the longest available follow-up, mortality was higher in patients without sternotomy (30 [26.3%] vs. 3 [8.8%], p = 0.03; adjusted OR 0.10, 95% CI 0.02-0.42). Similar rates of other complications after TAVI were noted. No differences in the EQ-5D-3L questionnaire at baseline and 12-month follow-up were confirmed. CONCLUSIONS: TAVI seems to be a safe and effective technique for the treatment of severe AS in patients with previous cardiac surgery.

Usefulness of Psoas Muscle Area and Volume and Frailty Scoring to Predict Outcomes After Transcatheter Aortic Valve Implantation.

Numerous scales were implemented for frailty assessment. However, limited evidence and recommendations for frailty tools for everyday clinical practice in patients who underwent transcatheter aortic valve implantation (TAVI) exist. Thus, we aimed to determine the long-term predictive value of different frailty scores and objective assessment of sarcopenia by imaging techniques in patients after TAVI. Frailty indexes according to Valve Academic Research Consortium-2 (VARC-2) recommendations, as well as other available scales of frailty, were assessed at baseline. Sarcopenia was evaluated with psoas muscle area (PSA) and psoas muscle volume (PSV) using computed tomography (CT) scans. The primary end point was 12-month all-cause mortality. We enrolled 153 patients who underwent TAVI with analyzable CT scans and complete frailty data. The median of PSA normalized for body surface area was 2,581.1 (2,214.9 to 2,654.9) mm2/m2, and the median of normalized PSV was 338.8 (288.1-365.6) cc/m2. At 12 months, all-cause mortality and new-onset atrial fibrillation were highest in the lowest tertile of normalized PSA. In the receiver operating characteristic analysis, all the tested frailty indexes, as well as PSA and PSV, were good predictors of 12-month all-cause mortality after TAVI with the highest area under the curve value for PSA and PSV normalized for body surface area. In conclusion, normalized PSA and PSV values are strong predictors of long-term mortality after TAVI. CT evaluation of psoas muscles could be incorporated to preprocedural comprehensive clinical models used for prediction of outcomes in patients scheduled for TAVI.

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.

Incidence of Postoperative Delirium and Its Impact on Outcomes After Transcatheter Aortic Valve Implantation.

There are limited data on the occurrence of postoperative delirium after transcatheter aortic valve implantation (TAVI). We sought to investigate the incidence of delirium after TAVI and its impact on clinical outcomes. A total of 148 consecutive patients who underwent TAVI were enrolled. Of these patients, 141 patients survived hospital stay. The incidence of delirium was assessed in these patients for the first 4 days after the index procedure. The patients were divided into 2 groups based on the presence of delirium. Baseline characteristics, procedural and long-term outcomes, and frailty and quality-of-life indexes were compared among the groups. Of the 141 patients analyzed, 29 patients developed delirium. The transapical access was more common in patients with delirium (51.7% vs 8.9%, p <0.001). A greater median contrast volume load in the delirium group was noted (75 vs 100 ml, p = 0.001). Significantly more patients with delirium were considered as frail before TAVI. Thirty-day and 12-month all-cause mortality rates were higher in the delirium group (0.0% vs 17.2%, p <0.001; and 3.6% vs 37.9%, p <0.001, respectively). Differences in mortality were significant even after adjustment for baseline characteristics. The quality of life at 12 months, assessed by the 3-level version of the EuroQol 5-dimensional questionnaire, was similar in both groups. Despite a relatively minimally invasive character of TAVI as compared with surgery, some patients experience delirium after TAVI. Importantly, the occurrence of delirium after TAVI may help to identify patients with worse short- and long-term outcomes.

Impact of post-dilatation on the reduction of paravalvular leak and mortality after transcatheter aortic valve implantation.

BACKGROUND: Post-implantation paravalvular leak (PVL) remains a significant complication of transcatheter aortic valve implantation (TAVI). More importantly, its occurrence may impact long-term mortality. AIM: We sought to evaluate the effects of balloon post-dilatation (PD) on the reduction of PVL and mortality in patients undergoing TAVI. METHODS: A total of 101 consecutive patients undergoing TAVI were enrolled. Angiography, echocardiography, and the aortic regurgitation index (ARI) were used to assess the severity of PVL before and after balloon PD. Patients were divided into two groups based whether or not PD after TAVI was performed. Reduction of PVL, change of ARI, and clinical outcomes were assessed. RESULTS: Balloon post-dilatation was performed in 23 (22.8%) patients. In 95.6%, PVL reduction was successful (no or mild PVL). PD increased the ARI from 23.4% (22.4-24.0) to 27.1% (26.1-28.3); p < 0.001. Thirty-day mortality rate was 14.1% in the PD (-) group vs. 0.0% in the PD (+) group; p = 0.07. One-year mortality (21.8% vs. 4.3%, p = 0.97) and procedural stroke rate (7.7% vs. 8.7%, p = 0.99) were not different between the groups. CONCLUSIONS: Balloon post-dilatation may be a safe and effective technique to reduce moderate to severe PVL after TAVI.

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.

Early- and mid-term outcomes after transcatheter aortic valve implantation. Data from a single-center registry.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is a less invasive treatment option for elderly, high-risk patients with symptomatic severe aortic stenosis (AS) than aortic valve replacement. More importantly, TAVI improves survival and quality of life as compared to medical treatment in inoperable patients. AIM: To assess early- and mid-term clinical outcomes after TAVI. MATERIAL AND METHODS: All consecutive high-risk patients with severe symptomatic AS undergoing TAVI from November 2008 to August 2014 were enrolled. The clinical and procedural characteristics, as well as clinical outcomes including mortality during 12-month follow-up, were assessed. RESULTS: A total of 101 consecutive patients underwent TAVI for native aortic valve stenosis (100%). Patients were elderly, with a median age of 81.0 (76.0-84.0) years, 60.4% were female and 83.2% presented with NYHA III/IV. Median baseline EuroSCORE I and STS scores were 14.0 (10.0-22.5)% and 12.0 (5.0-24.0)%, respectively. The main periprocedural and in-hospital complications were minor vascular complications, bleeding requiring blood transfusions, and the need for a permanent pacemaker. In-hospital, 30-day, 6-month and 12-month mortality rates were 6.9%, 10.9%, 15.8% and 17.8%, respectively. CONCLUSIONS: A mortality rate of < 20% after 12 months seems acceptable given the high-risk population enrolled.

Paravalvular leak after transcatheter aortic valve implantation (TAVI): Short-term results. Data from Polish national POL-TAVI registry.

BACKGROUND: The authors analyzed data from Polish national POL-TAVI registry in terms of paravalvular leak (PVL) occurrence after transcatheter aortic valve implantation (TAVI) and its impact on clinical outcomes. METHODS: A total of 331 patients with severe aortic stenosis underwent TAVI (Edwards Sapien, n = 141; CoreValve, n = 190). The grade of PVL and survival rate were assessed at6-month follow-up. RESULTS: One hundred and eighty-one (54.7%) patients developed mild PVL, and 22 (6.6%) - moderate PVL after TAVI. No severe PVLs were observed. Occurrence of moderate PVL was device dependent and more frequent in the CoreValve group (p = 0.02). Larger CoreValve device used correlated with the grade of PVL (Spearman: r = 0.19; p = 0.01), but for Edwards Sapien devices this correlation was inverted (Spearman: r = -0.62; p = 0.01). Six-month mortality rate was not significant between patients with no or mild PVL compared to those with moderate PVL (p = 0.12). CONCLUSIONS: The PVL occurrence remains a frequent problem after TAVI and is device de-pendent, more common with Edwards 23 mm valve and 31 mm CoreValve prosthesis.

Twelve-month quality of life improvement and all-cause mortality in elderly patients undergoing transcatheter aortic valve replacement.

PURPOSE: Restoration of quality of life (QoL) and improvement of clinical outcomes is crucial in elderly patients undergoing transcatheter aortic valve implantation (TAVI). We sought to evaluate changes in QoL and all-cause mortality 12 months after TAVI. METHODS: A total of 101 patients who underwent TAVI were included. Patients were followed for 12 months. QoL was assessed at baseline and at 1, 6 and 12 months after TAVI using EQ-5D-3L with a visual analog scale (VAS). RESULTS: Patients who reported some problems with mobility at baseline showed better mobility after 12 months (p = 0.001). On the other hand, those who reported issues with self-care, usual activity or pain did not show significant improvement (p = 0.41; p = 0.12; p = 0.27, respectively). Patients reporting anxiety at baseline improved 12 months later (p = 0.003). VAS score showed an incremental increase during follow-up (p<0.001). Transfemoral access was associated with higher VAS score values after 1 month (median (IQR): 65.0 (50.0-75.0) vs. 54.0 (50.0-60.0); p = 0.019) but not after 12 months (70.0 (62.5-80.0) vs. 67.5 (55.0-70.0); p = 0.07) as compared to non-transfemoral access. In multivariable regression analysis, only age and the presence of coronary chronic total occlusion were independently associated with VAS score at 12 months. In-hospital, 1-, 6- and 12-month mortality rates were 6.9%, 10.9%, 15.8 and 17.8%, respectively. CONCLUSIONS: TAVI provides improved QoL with relatively good clinical outcomes. However, not all components of QoL may be improved. Patients treated with transfemoral access might have better QoL than those who had non-transfemoral access, especially early after TAVI.

Long-Term Mortality and Quality of Life After Transcatheter Aortic Valve Insertion in Very Elderly Patients.

BACKGROUND: We sought to compare long-term mortality and quality of life (QoL) in very elderly (≥80 years) patients undergoing transcatheter aortic valve implantation (TAVI) in comparison with younger patients (<80 years). METHODS: A total of 101 patients treated with TAVI were divided into two groups according to age: <80 years (n = 42; 41.6%) and ≥80 years (n = 59; 58.4%). The baseline characteristics, including procedural outcomes as well as frailty and QoL assessment were compared between age groups. RESULTS: Very elderly patients (≥80 years) were more frequently female, with a higher estimated risk of death based on STS score. Other baseline characteristics, including frailty indices, were comparable between groups. No difference in complication rate between age groups was observed. At 12 months, mortality rates were comparable for patients <80 years vs ≥80 years (16.7% vs 18.6%, respectively; P=.99). An improvement in QoL after 12 months as assessed by EQ-5D-3L was confirmed for both age groups, but with more pronounced beneficial effect of TAVI in younger patients. CONCLUSION: The results of our single-center study showed that older age does not seem to be associated with impaired clinical outcomes after TAVI. However, benefit of TAVI in terms of long-term QoL improvement may be less apparent in very elderly patients.