Transcatheter aortic valve implantation (TAVI) has become the guideline-supported treatment of choice for older or higher-risk patients with severe aortic stenosis. With expanding indications the community has faced substantial challenges in meeting the growing demand for TAVI procedures. This led to a transition towards simplification of the procedure and shortening of the hospital stay, defined together as the "fast-track", "minimalist" or "simplified" TAVI. Current data suggest that such approach can be adopted without compromising patients' safety if certain procedural standards are maintained. This document aims at providing a practical guide by highlighting best practices of simplified TAVI with particular focus on the specific features of Polish health care system.
Background: Aortic stenosis (AS) is the most common valvular pathology in Europe and North America, with its prevalence rising due to age-related degeneration and calcification of the aortic valve. The global number of transcatheter aortic valve replacement (TAVR) procedures is rapidly increasing. Nevertheless, the ischemic cerebrovascular events remain among the most significant complications of this procedure. This study aimed to assess the long-term incidence of neurological events and identify the most powerful predictors of stroke following TAVR in a high-volume cardiovascular care center. Methods: 705 patients who underwent TAVR between January 2016 and September 2022, with a median follow-up of 60 months were analyzed. Baseline patient characteristics, procedural data, and long-term neurological outcomes were evaluated. Results: At five years the cumulative incidence of any neurological events, strokes and disabling strokes reached 28.5%, 20.3% and 13.2%, respectively. Periprocedural strokes occurred in 1.4% of patients. The multivariable analysis performed was aimed at identifying the relationship between a range of clinical and procedural variables and the incidence of stroke within five years following TAVR. Conclusions: The findings highlight the importance of long-term neurological follow-up after TAVR, as stroke mechanisms evolve over time - from periprocedural embolization to thrombus formation or chronic conditions like frailty and atherosclerosis. Future research should focus on more targeted stroke prevention and long-term management strategies enhancing safety for the TAVR recipient population.
Objectives: The aim of this study is to evaluate the safety and efficacy of repeat transcatheter aortic valve implantation (redo-TAVI) in the polish population. Methods: In this multicentre nationwide registry (ClinicalTrials.gov identifier, NCT03361046), we provide characteristics, periprocedural variables and long-term outcomes of high-risk patients who underwent redo-TAVI. Results: The mean age among 32 individuals who underwent redo-TAVI was 75 ± 13 years, and 62.5% were male. The mean time from index TAVI to redo-TAVI was 4.7 ± 3.5 years, with failed procedures (up to 1 year) occurring in 7 (21.9%) and failed transcatheter heart valve (THV, beyond 1 year) in the remaining majority of the 25 (78.1%) patients. Computed tomography-based native bicuspid aortic anatomy was found frequently in 37.5% of cases (58.3% in failed procedures and 41.7% in failed THV). The mean failed THV size was large (27.7 ± 3 mm) and predominantly presenting with pure regurgitation (59.4%). In more than two-thirds (68.7%), balloon-expandable or self-expandable THV was the most common strategy of redo-TAVI. None or mild regurgitation was found in 90.6%, and the mean transvalvular gradient was 13.1 ± 5.5 mmHg, with only three cases with >20 mmHg of the residual gradient (9.4%). Peri-procedural and 30-day complications were low, and cardiovascular and all-cause mortality at 1 year was 9.4 and 15.6%, respectively. There was a relatively high incidence of non-procedural stroke after redo-TAVI (n = 5, 15.6%), with all cases observed after 30 days. Conclusions: Initial data of redo-TAVI in Poland suggest that the procedure is safe and characterized by favourable efficacy and low rates of short-term adverse outcomes. A high frequency of baseline native bicuspid anatomy and late stroke occurrence after the redo-procedure warrants further investigation in larger cohorts.
Extracorporeal membrane oxygenation used during transcatheter aortic valve implantation may facilitate the procedure and help to achieve a good result in patients with severely reduced myocardial function or in cardiogenic shock. To highlight the positive, yet still rarely discussed, outcomes of ECMO use we present a comparison of both emergency and elective use of ECMO in 2 TAVI cases.
BACKGROUND:Intestinal microbial metabolites, such as trimethylamine-N-oxide (TMAO) and indoxyl sulfate (IS), have been suggested as markers for the progression of aortic stenosis (AS). However, the impact of transcatheter aortic valve implantation (TAVI) on these intestinal bacterial metabolites has not been evaluated in a multicenter clinical study. The aim of this study was to determine the effect of TAVI on plasma levels of intestinal bacterial metabolites and to assess the predictive value of these metabolites for major adverse cardiovascular events (MACE) following TAVI. M: ETHODS: Consecutive patients with AS referred for TAVI were enrolled in this study. Blood samples were collected one day before TAVI and at hospital discharge. The concentrations of intestinal microbial metabolites were measured using ultra performance liquid chromatograph coupled with a mass spectrometer. RESULTS:Plasma levels of TMAO and IS decreased after TAVI, compared to baseline (p ≤ 0.004 for all). Among 128 patients included in the study, 21 patients (16.4%) developed MACE during the median follow-up time of 404 days. Baseline plasma IS level was higher in patients with MACE, compared to those without MACE (p = 0.001). Increased baseline IS level predicted MACE with 75.0% sensitivity and 74.3% specificity independent of other clinical variables (OR 14.264, 95% CI 3.442-59.117, p < 0.001) and decreased the chance of event-free survival (plog rank < 0.001). CONCLUSIONS:Plasma concentrations of TMAO and IS decreased after TAVI, compared to baseline. Elevated plasma IS levels were associated with a 14-fold increase in the odds of post-TAVI MACE during a median follow-up period of 404 days.
Subclinical leaflet thrombosis is an imaging phenomenon observed after transcatheter aortic valve implantation (TAVI) and characterized by hypoattenuating leaflet thickening (HALT) on computed tomography angiography. The clinical implications and underlying causes remain uncertain. Hypercoagulability, a component of Virchow’s triad, may contribute to thrombus formation on bioprosthetic leaflets, but data on hypercoagulable disorders in TAVI patients and their impact on HALT are limited. The PROSTHESIS study (PROthrombotic States in Transcatheter HEart valve Subclinical leaflet thrombosIS) is a single-center observational cohort study aiming to include 130 TAVI patients. This pilot study aimed to (i) assess the effect of hypercoagulable disorders on HALT prevalence and (ii) evaluate their impact on the natural history of HALT. Patients were screened for common hypercoagulable disorders using genetic and functional assays and underwent multimodal imaging one year after TAVI to detect HALT. In patients with HALT, post-implant imaging was repeated after three months to assess its progression. Early results comparing 52 TAVI patients with 52 matched controls undergoing coronary angiography showed similar thrombophilia prevalence between the groups (16% vs. 12%, p = 0.565). HALT occurred in 15% of TAVI patients, more extensively in those with thrombophilia (712 mm3 vs. 135 mm3, p = 0.036). However, thrombophilia was not an independent predictor of HALT. One-year follow-up CTA revealed spontaneous HALT resolution in 63%, stability in 25%, and progression in 12%. This study aims to provide insights into HALT and its mechanisms, which may help prevent complications and improve bioprosthesis durability.
Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis (AS) in patients at intermediate and high surgical risk. Circulating extracellular vesicles (EVs) are nanoparticles involved in cardiovascular diseases. We aimed to (i) determine the effect of TAVI on plasma concentrations of five EV subtypes and (ii) evaluate the predictive value of EVs for post-TAVI outcomes. Blood samples were collected 1 day before TAVI and at hospital discharge. Concentrations of EVs were evaluated using flow cytometry. Concentration of leukocytes EVs decreased after TAVI, compared to the measurement before (p = 0.008). Among 123 patients discharged from the hospital, 19.5
Introduction: Coexistence of coronary artery disease (CAD) in patients with severe aortic stenosis (AS) referred for transcatheter aortic valve implantation (TAVI) raises questions regarding the safety and efficacy of TAVI in this subset of patients.Aim: To evaluate the impact of previous coronary revascularization in terms of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) on clinical outcomes after TAVI.Material and methods: A total of 507 consecutive patients who underwent TAVI were divided into: non-revascularization (NR), post-PCI and post-CABG groups. The endpoints were established according to VARC-2 definitions.Results: Patients with previous coronary revascularization (36.7% of the population) were younger, more often male and their EuroSCORE II risk evaluation was significantly higher (NR 7.9% vs. post-PCI 8.0% vs. post-CABG 20.5%, p < 0.0001). Patients after PCI or CABG prior to TAVI had similar 30-day all-cause mortality rates as those without coronary revascularization at baseline (NR vs. post-PCI vs. post-CABG: 8.1% vs. 5.5% vs. 6.8%, respectively; p = 0.6). There were no differences in 12-month all-cause mortality rates between groups (NR vs. post-PCI vs. post-CABG: 15.3% vs. 14.2% vs. 16.9%, respectively; log-rankp = 0.67). In the Cox proportional-hazards regression model, acute kidney injury stage 2-3 (HR = 3.7, 95% CI: 2.14-6.33; p < 0.001) and post-TAVI stroke (HR = 3.5, 95% CI: 1.57-7.8; p = 0.002) were independently correlated with 1-year mortality.Conclusions: TAVI seems to be a safe and effective procedure for the treatment of severe AS in patients with previous coronary revascularization.
BACKGROUND:The carotid artery is an alternative access route for transcatheter aortic valve implantation (TAVI), especially useful in patients unsuitable for traditional access routes including transfemoral (TF), subclavian, transapical, and aortic.AIMS:To investigate the feasibility and safety of transcarotid (TC) access for TAVI in comparison to the TF approach in a multicenter setting.METHODS:A total of 41 patients, treated between December 2014 and December 2018, were retrospectively reported to the Polish Registry of Common Carotid Artery Access for TAVI (POL-CAROTID). The median follow-up time was 619 (365-944) days, and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. Clinical outcomes were compared with 41 propensity-matched TF-TAVI patients.RESULTS:The mean (standard deviation [SD]) patients' age was 78.0 (7.2) years, and 29 patients (70.7%) were men. Prohibitive iliofemoral anatomy and/or obesity (46.3%) and/or the presence of a stent graft in the abdominal aorta (31.7%) were the most common indications for TC-TAVI. Device success for TC-TAVI was comparable with the matched TF-TAVI group (90.2% vs. 95.3%, respectively, P = 0.396), and no periprocedural mortality was observed. Moreover, early safety was similar between the two groups (92.7% vs. 95.3%, respectively, log-rank P = 0.658) with only 1 case of non-disabling stroke during the first month after TC-TAVI. Consequently, no cerebrovascular events were observed in the mid-term, and the clinical efficacy of TC-TAVI corresponded well with TF-TAVI (90.2% vs. 92.7%, respectively, log-rank P = 0.716). A total of 4 (9.8%) deaths were noted in the TC-TAVI cohort in comparison to 3 (7.3%) in the TF-TAVI group.CONCLUSIONS:The results of the study indicated that the first cohort of Polish patients with implantations of second-generation transcarotid transcatheter heart valves had a similar prognosis to TF-TAVI with regard to safety and feasibility. TC access may be considered an optimal alternative for patients in whom the TF approach is precluded.
Background: Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI) is an emerging treatment alternative to reoperation in high-surgical risk patients with failed mitral bio-prostheses.Aim: We aimed to describe the characteristics of ViV-TMVI and evaluate its 30-day outcomes in the Polish population.Methods: A nationwide registry was initiated to collect data on all patients with failed mitral bio-prosthesis undergoing ViV-TMVI in Poland. This study presents the results of a 30-day clinical and echocardiographic follow-up.Results: Overall, 27 ViV-TMVI procedures were performed in 8 centers up to May 2022 (85% from 2020 onwards). The mean (standard deviation [SD]) age was 73 (11.6) years with the median (in-terquartile range [IQR]) Society of Thoracic Surgeons score of 5.3% (4.3%-14.3%). Mean (SD) time between surgical implantation and ViV-TMVI was 8.2 (3.2) years. Failed Hancock II (29%) and Perimount Magna (22%) bioprostheses were most frequently treated. Mechanisms of failure were equally often pure mitral regurgitation or stenosis (both 37%) with mixed etiology in 26%. Balloon-expandable Sapien 3/Ultra valves were used in all but 1 patient. Technical success was 96.3% (1 patient required additional prosthesis). Mean (SD) transvalvular mitral gradient reached 6.7 (2.2) mm Hg and mitral valve area was 1.8 (0.4) cm2. None of the patients had moderate or severe mitral regurgitation with only 14.8% graded as mild. We achieved device success in 92.6% of patients (2 patients had mean gradient & GE;10 mm Hg) and procedural success in 85.6%. There were no deaths, cerebrovascular events, or need for mitral valve surgery during the 30-day follow-up.Conclusions: In short-term follow-up, ViV-TMVI is a safe and effective alternative for patients with failed mitral bioprosthesis at high surgical risk of re-operation. Longer observations on larger sam-ples are warranted.
Abstract Aims Prediction of adverse events in mid-term follow-up after transcatheter aortic valve implantation (TAVI) is challenging. We sought to develop and validate a machine learning model for prediction of 1-year all-cause mortality in patients who underwent TAVI and were discharged following the index procedure. Methods and results The model was developed on data of patients who underwent TAVI at a high-volume centre between January 2013 and March 2019. Machine learning by extreme gradient boosting was trained and tested with repeated 10-fold hold-out testing using 34 pre- and 25 peri-procedural clinical variables. External validation was performed on unseen data from two other independent high-volume TAVI centres. Six hundred four patients (43% men, 81 ± 5 years old, EuroSCORE II 4.8 [3.0–6.3]%) in the derivation and 823 patients (46% men, 82 ± 5 years old, EuroSCORE II 4.7 [2.9–6.0]%) in the validation cohort underwent TAVI and were discharged home following the index procedure. Over the 12 months of follow-up, 68 (11%) and 95 (12%) subjects died in the derivation and validation cohorts, respectively. In external validation, the machine learning model had an area under the receiver-operator curve of 0.82 (0.78–0.87) for prediction of 1-year all-cause mortality following hospital discharge after TAVI, which was superior to pre- and peri-procedural clinical variables including age 0.52 (0.46–0.59) and the EuroSCORE II 0.57 (0.51–0.64), P < 0.001 for a difference. Conclusion Machine learning based on readily available clinical data allows accurate prediction of 1-year all-cause mortality following a successful TAVI.
Introduction: Data regarding patients with a previous medical record of immunosuppression treatment who have undergone transcatheter aortic valve implantation (TAVI) are limited and extremely inconclusive. Available studies are mostly short term observations; thus there is a lack of evidence on efficacy and safety of TAVI in this specific group of patients. Aim: To compare the in-hospital and long-term outcomes between patients with or without a medical history of immunosuppressive treatment undergoing TAVI for aortic valve stenosis (AS). Material and methods: We conducted a retrospective registry-based analysis including patients undergoing TAVI for AS at 5 centres between January 2009 and August 2017. The primary endpoint was long-term all-cause mortality. Secondary endpoints comprised major vascular complications, life-threatening or disabling bleeding, stroke and new pacemaker implantation. Results: Of 1451 consecutive patients who underwent TAVI, two propensity-matched groups including 25 patients with a history of immunosuppression and 75 patients without it were analysed. No differences between groups in all-cause mortality were found in a median follow-up time of 2.7 years following TAVI (p = 0.465; HR = 0.73; 95% CI: 0.30-1.77). The rate of major vascular complications (4.0% vs. 5.3%) was similar in the two groups (p = 1.000). There were no statistically significant differences in the composite endpoint combining life-threatening or disabling bleeding, major vascular complications, stroke and new pacemaker implantation (40.0% vs. 20.0%, p = 0.218). Conclusions: Patients who had undergone TAVI for AS had similar long-term mortality regardless of whether they had a previous medical record of immunosuppression. Procedural complication rates were comparable between the groups.
INTRODUCTION Transcatheter aortic valve-in-valve implantation (ViV-TAVI) has emerged as an alternative to redo surgery in patients with failed surgical aortic bioprosthesis. OBJECTIVES We evaluated the safety and efficacy of ViV-TAVI in Polish patients after surgical aortic valve replacement. PATIENTS AND METHODS This was a nationwide multicenter registry of ViV-TAVI procedures. Data were collected using an online form, and the clinical follow-up lasted 1 year. RESULTS From 2008 to 2020, 130 ViV-TAVI procedures were performed (1.9% of all transcatheter aortic valve implantation [TAVI] cases). A considerable increase in ViV-TAVI procedures since 2018 has been observed (n = 59, 45% of ViV-TAVI cases). Hancock II, Freestyle, and homograft were the most frequently treated bioprostheses. The self-expanding supra-annular Corevalve / Evolut valve was used in 76% of cases. In 21% of cases, the mean postprocedural pressure gradient (PG) exceeded 20 mm Hg. All-cause mortal-ity at 1 year was 10.8%. Aortic valve stenosis was associated with a higher mean PG than aortic valve regurgitation or mixed disease (P = 0.004). Supra-annular transcatheter aortic valves were associated with lower mean PGs than intra-annular valves (P = 0.004). Second-generation devices were associated with shorter procedure time (120 min vs 135 min, P = 0.04), less frequent need for additional TAVI (2% vs 10%, P = 0.04), and lower 1 -year cardiovascular mortality (95% vs 82.8%, P = 0.03) than first-generation valves. CONCLUSIONS Transcatheter treatment of failed bioprostheses is increasingly common, with the best hemodynamic effect shown for supra-annular valves. The introduction of second-generation valves has improved procedural and clinical outcomes.
Background: Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis (AS) in patients at increased surgical risk. Up to 29% of patients annually experience major adverse cardiac and cerebrovascular events (MACCE) after TAVI. MicroRNAs (miRNA) are currently widely investigated as novel cardiovascular biomarkers. The aim of this study was to determine the influence of TAVI on the expressions of selected miRNAs associated with platelet function (miR-125a-5p, miR-125b and miR-223), and evaluate the predictive value of these miRNAs for MACCE in 65 patients undergoing TAVI. Methods: Venous blood samples for miRNA expression analysis were collected 1 day before TAVI and at hospital discharge. The expression of miR-223, miR-125a-5p, miR-125b was evaluated in platelet-depleted plasma. Results: The expression of miR-223 and miR-125b increased after TAVI, compared to the measurement before (p = 0.020, p = 0.003, respectively). Among 63 patients discharged from the hospital, 18 patients experienced MACCE (29%) during the median 15 months of observation. Baseline low miR-223 expression was a predictor of MACCE in univariate Cox regression analysis (hazard ratio [HR]: 2.71, 95% confidence interval [CI]: 1.04–7.01; p = 0.041). After inclusion of covariates, age, gender (male), New York Heart Association class and diabetes into the multivariate Cox regression model, miR-223 did not reach statistical significance (HR: 2.56, 95% CI: 0.79–8.33; p = 0.118). Conclusions: To conclude, miR-223 might improve risk stratification after TAVI. Further studies are required to confirm the clinical applicability of this promising biomarker.