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Objective: The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve., Methods: Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years., Results: The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years., Conclusions: This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Transfemoral transcatheter aortic valve implantation (TF TAVI) has recently become an established treatment option for intermediate and high-risk surgical patients with severe aortic stenosis. Despite significant reduction in diameter of valvular delivery systems, access related vascular complications remain a major safety concern. The aim of this study was to evaluate impact of femoral access techniques: surgical versus percutaneous on in-hospital outcomes., Methods: Polish National TAVI Registry (POL-TAVI) was used as a data source. The analysis included 1680 patients treated with TF TAVI in years 2013-2016. 677 patients were treated using percutaneous technique (Group PC) and 1003 using open surgical access (Group S). The two groups were matched and compared. All-cause mortality, length of hospital stay, procedure time and potential risk factors for vascular access site complications after TF TAVI were analyzed., Results: Vascular access site complications were reported in 162 (9.64%) of 1680 patients and were found significantly more often in PC group (13.15% vs. 7.28% P>0.001). There was a significant difference between groups regarding Body Mass Index, arterial hypertension, transient ischemic attack history and NYHA classification. The data analysis showed that increased probability of all vascular complications was associated with percutaneous access. In addition, left-side access and female sex were independent risk factors for all vascular complications., Conclusions: Surgical cut-down in the groin with exposure of the artery and manual suture after the procedure seems to be a safer option for TF TAVI patients.

INTRODUCTION During the last decade, aortic stenosis (AS) has emerged as one of the most significant concerns in cardiovascular diseases. OBJECTIVES We aimed to characterize AS patients on the basis of data derived from a local registry. PATIENTS AND METHODS We used data from the SILesian CARDiovascular (SILCARD) registry, which was developed under the agreement between the Silesian Centre for Heart Diseases in Zabrze and the Silesian branch of the Polish National Health Fund in Katowice to conduct a comprehensive analysis of patients with cardiovascular diseases in Silesian Voivodeship. RESULTS A total of 15 158 patients hospitalized with a diagnosis of AS between 2006 and 2016 were included (mean [SD] age, 69.87 [11.97] years; male patients, 7644 [50.43%]). Heart failure was reported in 4187 patients (27.62%), and coronary artery disease, in 6217 (41.01%). During the first hospitalization, aortic valve intervention was performed in 2137 patients (14.10%), and during a 12‑‑ month follow‑‑ up, in 3416 (25.32%). During the first hospitalization, percutaneous coronary intervention (PCI) was performed in 666 patients (4.39%), and coronary artery bypass grafting (CABG), in 1071 (6.71%). At 12‑‑ month follow‑‑ up, PCI was reported in 560 patients (4.15%), and CABG, in 560 (4.15%). Between 2006 and 2016, 30‑‑ day mortality was 4.35% (659 patients) and remained stable throughout the study (5.4% in 2005 vs 4.0% in 2016, P = 0.28). The 1‑‑ year mortality was 15.88% (2142 patients) and increased from 14.3% in 2006 to 16% in 2015 (P = 0.07). CONCLUSIONS The SILCARD registry has revealed an increase in the number of AS diagnoses. AS has become one of the most critical issues among cardiovascular diseases in Silesian Voivodeship.

Objective: To compare the safety and efficacy of transcathether aortic valve-in-valve implantation (ViV-TAVI) in degenerated stentless bioprostheses with failed stented valves and degenerated native aortic valves., Introduction: Little is known about ViV-TAVI in degenerated stentless valves., Methods: Out of 45 ViV-TAVI procedures reported in the POL-TAVI registry, 20 failed stentless valves were compared with 25 stented prostheses and propensity-matched with 45 native TAVI cases. The mean follow-up was 633 (95% confidence interval [CI], 471-795) days and Valve Academic Research Consortium-2 (VARC-2) definitions were applied., Results: Patients with degenerated stentless valves were younger (65.6, CI 58-73.1 years vs 75.6, CI 72.2-78 [stented] vs 80.1, CI 78.7-81.6 y. [native], P < 0.001). Implantation was required later after surgery (11.5, CI 8-14.9 years) in the stentless cohort as compared with the stented one (6.2, CI 4.7-7.6 years, P = 0.006). ViV-TAVI in the stentless group was also associated with larger amount of contrast (211, CI 157-266 mL vs 135, CI 104-167 mL [stented] vs 132 (119-145) mL [native], P = 0.022). Using VARC-2 composite endpoints, ViV-TAVI in stentless prostheses was characterized by a lower device success (50% vs 76% in stented vs 88.9% in native TAVI, P < 0.001), but comparable early safety up to 30 days (73.7% vs 84% vs 81.8%, respectively, log-rank P = 0.667) and long-term clinical efficacy beyond 30 days (72.2% vs 72% vs 73.8%, respectively, log-rank P = 0.963)., Conclusions: Despite technical challenges and a lower device success, ViV-TAVI in stentless aortic bioprostheses achieves similar safety, efficacy, and functional improvement as in stented or degenerated native valves., (© 2018 Wiley Periodicals, Inc.)

Background: Coronary artery disease (CAD) and degenerative aortic stenosis often coexist. However, the impact of CAD and its management on the prognosis after transcatheter aortic valve implantation (TAVI) remains uncertain. We sought to evaluate the impact of obstructive CAD, SYNTAX score (Ss), and percutaneous coronary intervention (PCI) prior to TAVI on short-term outcome., Methods: Overall, 896 patients who underwent TAVI after heart team decision was included. Pre-procedural angiograms were analysed to calculate baseline Ss (bSs) and residual Ss (rSs). Baseline, procedural and follow-up data up to 30 days was acquired from the national POL-TAVI registry., Results: Patients with obstructive CAD at baseline (n = 462, 52%) had higher mortality as compared with the remaining (8.7 vs. 5.1%, log-rank P = 0.039). Also, after correction for confounding factors obstructive CAD was identified as independent predictor of mortality (hazard ratio [HR] 1.74, 95% confidence intervals [CIs] 1.03-2.94, P = 0.037). In obstructive CAD, neither bSs (AUC 0.47, CI 0.38-0.56, P = 0.47) nor rSs (AUC 0.47, CI 0.30-0.64, P = 0.72 for those undergoing PCI and AUC 0.48, CI 0.37-0.59, P = 0.75 for the remaining) was predictive of mortality. When revascularization status was considered, patients with PCI prior to TAVI had similar outcome as those without obstructive CAD at baseline (7.7 vs. 5.1%, log-rank P = 0.23) with no negative impact on mortality (HR 1.13, CI 0.62-2.09, P = 0.69)., Conclusions: In conclusion, obstructive CAD at baseline evaluation for TAVI has independent negative impact on short-term prognosis. However, neither baseline nor residual Ss values have prognostic ability in patients undergoing TAVI. Revascularization prior to TAVI seems to improve survival to levels comparable with patients without obstructive CAD at baseline., (© 2017 Wiley Periodicals, Inc.)

Background: This observational analysis investigated in-hospital safety and efficacy of periprocedural antithrombotic/antiplatelet therapy used in TAVI patients included into the Polish Nationwide Cardiac Surgical and Cardiology Registry of Transcatheter Aortic Valve Implantation (POL-TAVI)., Methods and Results: All patients who underwent TAVI in the participating centers between 2013 and 2014 were included. The primary endpoints were: severe bleeding, vascular complications, thromboembolic events, myocardial infarction, 30-days mortality, defined according to Valve Academic Research Consortium scale 2. A total of 827 patients were included; 35-93years old (79.31±7.53); 457 (55.29%) women. Endpoints noted: severe bleeding - 130 (15.72%) pts, vascular complications - 135 (16.32%) pts, thromboembolic events - 29 (3.5%) pts, myocardial infarction - 24 (2.90%) pts, deaths - 58 (7.01%) pts. Aspirin premedication, resulted in the least number of vascular complications (OR 0.56 95%CI [0.345-0.938]; p=0.027). Aspirin after TAVI reduced the risk of vascular complications (OR 0.089 95%CI [0.0217-0.372]; p=0.001) and bleeding (OR 0.138 95%CI [0.043-0.447]; p=0.001) with no adverse impact on efficacy endpoints. Beneficial safety profile of postprocedural aspirin monotherapy remained significant in comparison to all other types of prophylaxis also in propensity score analysis: OR 0.068 95%CI [0.009-0.529]; p=0.01 for vascular complications, OR 0.176 95%CI [0.049-0.627]; p=0.007 for bleeding. NNT for vascular complications and bleeding with postprocedural aspirin prophylaxis was 5.5 and 6.42, respectively., Conclusion: Aspirin after TAVI appears to be beneficial than currently recommended dual antiplatelet therapy; therefore, it might be considered as TAVI antithrombotic prophylaxis., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) is an effective therapeutic method for elderly high-risk patients with symptomatic severe aortic stenosis, not eligible for surgical treatment., Aim: The aim of the study was to evaluate short-term changes in elderly people's quality of life following TAVI, based on the POL-TAVI registry., Methods: One hundred and eighty-four octogenarians' and nonagenarians' samples from the POL-TAVI database were included in the study. The quality of life status was assessed with EQ-5D-3L questionnaire at baseline and after one-month follow-up., Results: The mean of patients' age was 84 (80-93) years. Logistic EuroSCORE mean was 19.83% (3.48-83.94%), and transaortic mean gradient was 54.99 (19.0-149.0) mm Hg. At baseline, up to 24.50% of patients declared severe problems in performing usual activities. 13.60% felt extreme pain or discomfort; 9.80% were unable to wash and dress by themselves; 8.20% were extremely anxious or depressed; and 7.10% of the patients in the study were confined to bed. After 30 days the percentage of patients declaring severe problems in each dimension did not exceed 4.00%. The comparison between quality of life data at baseline and after one-month follow-up showed a significant improvement in each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (p < 0.001). Patients' quality of life was increasing regardless of gender (female vs. male), the type of anaesthesia (general vs. local), and the type of procedure (TA vs. TF)., Conclusions: Short-term quality of life in the elderly subjects was significantly improved after one-month follow-up following TAVI.

Background: Paravalvular leak (PVL) has significant impact on long-term outcomes in patients after transcatheter aortic valve implantation (TAVI). This study sought to determine whether multi-slice computed tomography (MSCT)-guided valve selection reduces PVL after CoreValve implantation., Methods: The analysis encompassed 69 patients implanted with CoreValve and were divided into two groups. In Group I (30 patients), valve selection was based on standard procedures, in Group II (39 patients), on MSCT measurements. Paravalvular leak was assessed with angiography and echocardiography., Results: Multi-slice computed tomography results influenced a change of decision as to the size of the implanted valve in 12 (30.9%) patients in Group II and would have caused the decision to change in 9 (37.5%) patients in Group I. The degree of oversizing in Group I and II was 12.8% ± ± 7.6% vs. 18.6% ± 5.1% (p = 0.0006), respectively. The oversizing among the patients with leak degree of 0-1 and ≥ 2 was 18.1% ± 6.0% and 12.8% ± 7.4% (p = 0.0036). Angiographic assessment indicated post-procedural PVL ≥ 2 in 50% of patients in Group I and 20.5% in Group II (p = 0.01), while echocardiographic assessment indicated the same in 73.3% of patients in Group I and 45.6% in Group II (p = 0.0136). The composite endpoint occurred in 26.6% (8/30) patients in Group I vs. 5.1% (2/39) patients in Group II (p = 0.0118)., Conclusions: Selecting the CoreValve device based on MSCT resulted in smaller rates of PVL and less frequent composite endpoint. In 1/3 of patients MSCT led to a change of the valve size. The degree of oversizing had a significant impact on PVL.

Background: Transcatheter aortic valve implantation (TAVI) is presently a recognized treatment mo-dality for patients with severe aortic stenosis ineligible for surgery. It reduces mortality as compared to the conservative treatment. It is further expected from this therapy to improve quality of life by improving of the cardiovascular function performance. The aim of this study is to compare patients' cardiovascular system efficiency in the 6-minute walk test (6MWT) made before and after TAVI and at the 6-12-month follow-up., Methods: From January 2009 until February 2012, in the Silesian Center for Heart Diseases in Zabrze, TAVI was performed in 104 patients. Eighty-two patients who underwent 6MWT before surgery were qualified for the analysis. The average age of the patients was 76.0 ± 9.17 years, women made 45.1%. The risk of surgical treatment according to the Logistic Euroscore averaged 22.76 ± 12.63%, and by the Society of Thoracic Surgeons - 5.55 ± 3.34%. The 6MWT was performed within 1 month before the TAVI procedure, up to a month after the procedure and during the 6-12-month follow-up., Results: The 6-minute walk test after TAVI was performed by 64 patients, and after 6-12 month follow-up by 46 patients. The average distance in 6MWT increased from 268.4 ± 89.0 m before treat-ment to 290.0 ± 98.2 m after the procedure (p = 0.008) and 276.1 ± 93.5 m to 343.1 ± 96.7 m after 6-12 months (p < 0.0001)., Conclusions: Transcatheter aortic valve implantation procedures significantly improve function of the cardiovascular system evaluated by the 6MWT in 1- and 6-12-month observations. (Cardiol J 2017; 24, 2: 167-175).

Objective: Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year., Methods: From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%., Results: One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up., Conclusions: The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Aims: Our aim was to assess one-year outcomes of patients enrolled in the pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation (TAVI)., Methods and Results: One-year outcomes of 4,571 patients (81.4±7.2 years, 2,291 [50.1%] male) receiving TAVI with the SAPIEN XT (57.3%) or CoreValve prosthesis at 137 European centres were analysed using Kaplan-Meier and Cox proportional hazards regression techniques. At one year, 3,341 patients were alive, 821 had died, and 409 were lost to follow-up. Of 2,125 patients who underwent functional assessment, 1,916 (90%) were in New York Heart Association (NYHA) Class I/II at one year, with functional improvement from baseline noted in 1,682 patients (88%). One-year survival based on 4,564 patients was estimated at 79.1%. Independent baseline predictors of mortality were increasing age and logistic EuroSCORE, the presence of NYHA III/IV, chronic obstructive pulmonary disease, and atrial fibrillation. Female gender was associated with a 4% survival benefit at one year. Vascular access routes other than transfemoral were associated with poorer survival. Procedural failure and major periprocedural complications had an adverse impact on survival., Conclusions: Contemporary European experience attests to the effectiveness of routine TAVI in unselected elderly patients.

Objective: To analyse the impact of postprocedural mitral regurgitation (MR), in an interaction with aortic regurgitation (AR), on mortality following transcatheter aortic valve implantation (TAVI)., Methods: To assess the interaction between MR and AR, we compared the survival rate of patients (i) without both significant MR and AR versus (ii) those with either significant MR or significant AR versus (iii) with significant MR and AR, all postprocedure. 381 participants of the Polish Transcatheter Aortic Valve Implantation Registry (166 males (43.6%) and 215 females (56.4%), age 78.8±7.4 years) were analysed. Follow-up was 94.1±96.5 days., Results: In-hospital and midterm mortality were 6.6% and 10.2%, respectively. Significant MR and AR were present in 16% and 8.1% patients, including 3.1% patients with both significant MR and AR. Patients with significant versus insignificant AR differed with respect to mortality (log rank p=0.009). This difference was not apparent in a subgroup of patients without significant MR (log rank p=0.80). In a subgroup of patients without significant AR, there were no significant differences in mortality between individuals with versus without significant MR (log rank p=0.44). Significant MR and AR had a significant impact on mortality only when associated with each other (log rank p<0.0001). At multivariate Cox regression modelling concomitant significant MR and AR were independently associated with mortality (OR 3.2, 95% CI 1.54 to 5.71, p=0.002)., Conclusions: Significant MR or AR postprocedure, when isolated, had no impact on survival. Combined MR and AR had a significant impact on a patient's prognosis., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background and Aim: Transcatheter aortic valve implantation (TAVI) has proven to be a valuable alternative to conventional surgical aortic valve replacement in high-risk and surgically inoperable patients who suffer from severe symptomatic aortic stenosis. With the second generation of TAVI devices improvements in both handling and performance are highly demanded. This brief clinical communication reports the first Polish experience with the second generation of transfemoral TAVI device--Symetis Acurate Neo., Methods: From November 19th 2014 until February 18th 2015 nine (n = 9) patients with severe symptomatic aortic stenosis have been operated on using the Symetis Acurate Neo. Patients were subject to seven-day evaluation and 30-day phone follow-up., Results: The procedure was safely and successfully performed in all patients. A SMALL (S) valve (21-23 mm equivalent) was used in two patients, MEDIUM valve (M; 23-25 mm equivalent) in five patients, and a LARGE valve (L; 25-26 mm equivalent) in two patients. In three cases post-release balloon dilatation was required. There were no intraoperative complications and no major adverse events (as per VARC classification) during initial hospitalisation, including conduction or rhythm disturbances. In all cases, the mean gradient on the prosthetic valves was 7.8 mm Hg (10.2 mm Hg on the "S" valves). Rapid improvement in patients' functional class was noted. Perivalvular leak was evaluated as "mild" in three cases, "trace" in one, and "not existing" in five., Conclusions: This initial experience with the Symetis Acurate Neo demonstrates its good safety profile and excellent haemodynamics. Low radial stress of the valve results in minimal incidence of atrioventricular rhythm disturbances, and a sealing crown for nearly non-existent paravalvular leak.

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.

Background: There is great variability for the type of anaesthesia used during TAVI, with no clear consensus coming from comparative studies or guidelines. We sought to detect regional differences in the anaesthetic management of patients undergoing transcatheter aortic valve implantation (TAVI) in Europe and to evaluate the relationship between type of anaesthesia and in-hospital and 1 year outcome., Methods: Between January 2011 and May 2012 the Sentinel European TAVI Pilot Registry enrolled 2807 patients treated via a transfemoral approach using either local (LA-group, 1095 patients, 39%) or general anaesthesia (GA-group, 1712 patients, 61%)., Results: A wide variation in LA use was evident amongst the 10 participating countries. The use of LA has increased over time (from a mean of 37.5% of procedures in the first year, to 57% in last 6 months, p<0.01). MI, major stroke as well as in-hospital death rate (7.0% LA vs 5.3% GA, p=0.053) had a similar incidence between groups, confirmed in multivariate regression analysis after adjusting for confounders. Dividing our population in tertiles according to the Log-EuroSCORE we found similar mortality under LA, whilst mortality was higher in the highest risk tertile under GA. Survival at 1 year, compared by Kaplan-Meier analysis, was similar between groups (log-rank: p=0.1505)., Conclusions: Selection of anaesthesia appears to be more influenced by national practice and operator preference than patient characteristics. In the absence of an observed difference in outcomes for either approach, there is no compelling argument to suggest that operators and centres should change their anaesthetic practice., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) has proven to be a valuable alternative to conventional surgical aortic valve replacement in high risk and surgically in operable patients who suffer from severe symptomatic aortic stenosis. However, a significant number of complications, associated with both the learning curve and device specificity, have required attention and subsequent improvement. The Symetis transapical TAVR system is a self-positioning bioprosthesis composed of a non-coronary leaflet of surgical quality porcine tissue valve sewn into a self-expanding nitinol stent that iscovered with a PET-skirt., Methods: From June to September 2013 six patients have been operated on severe aortic stenosis using the new TAVR device. All patients have undergone critical assessment of a local Heart Team and have been disqualified from conventional AVR. Five were woman. Mean age was 82.3 ± 2.0 (mean LogEuroScore 23.9 ± 14.3). Four patients suffered from coronary artery disease - two had history of previous percutaneous coronary intervention with intracoronary stents, while the next two had history of coronary artery bypass grafting. Diabetes was frequent (n = 3) as well as chronic obstructive pulmonary disease (n = 4). Carotid artery disease was encountered in three patients similarly to atrial fibrillation. Mean left ventricular ejection fraction (LVEF) was 51.5 ± 11.8%, but one patient had suffered from low-flow-low-gradient aortic stenosis with LVEF of 29%., Results: The procedure was carried out successfully in all six cases. Two patients have received the valve sized L, three - M and one - S. Mean procedure time was 180 ± 19 min, mean cine 7.2 ± 1.2 min. Mean X-ray dose 930 ± 439 mGy, while mean volume of contrast given was 135 ± 61 mL. In all patients but one perivalvular leak (PVL) was not present. One patient had trace of PVL. Also, good LVEF was noted in all patients. Similar findings were obtained 30 days post procedure. No strokes, transient ischaemic attack or other cerebrovascular incidents were observed., Conclusions: This brief clinical communication reports the first Polish experience with the second generation of TAVR device - the Symetis Acurate Transapical Aortic Valve. While it lacks large patient population and longer follow-up, it reveals that TAVR procedure can be performed safely, with minimal X-ray exposure time and contrast given and successfully - with almost nonexistent PVL and no cerebrovascular incidents or heart rhythm disturbances. Heart Team approach is vital, and transapical access should not be treated inferiorly, but rather as an equally appealing TAVR option.

Aims: The aim of this prospective multinational registry is to assess and identify predictors of in-hospital outcome and complications of contemporary TAVI practice., Methods and Results: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective independent consecutive collection of individual patient data entered into a web-based case record form (CRF) or transferred from compatible national registries. A total of 4,571 patients underwent TAVI between January 2011 and May 2012 in 137 centres of 10 European countries. Average age was 81.4±7.1 years with equal representation of the two sexes. Logistic EuroSCORE (20.2±13.3), access site (femoral approach: 74.2%), type of anaesthesia and duration of hospital stay (9.3±8.1 days) showed wide variations among the participating countries. In-hospital mortality (7.4%), stroke (1.8%), myocardial infarction (0.9%), major vascular complications (3.1%) were similar in the SAPIEN XT and CoreValve (p=0.15). Mortality was lower in transfemoral (5.9%) than in transapical (12.8%) and other access routes (9.7%; p<0.01). Advanced age, high logistic EuroSCORE, pre-procedural ≥grade 2 mitral regurgitation and deployment failure predicted higher mortality at multivariate analysis., Conclusions: Increased operator experience and the refinement of valve types and delivery catheters may explain the lower rate of mortality, stroke and vascular complications than in historical studies and registries.

Background: severe symptomatic aortic valve stenosis is an unequivocal indication for surgical valve replacement, assuring symptoms relief and increasing survival. About one third of elderly patients is not being operated due to, among others, high peri-procedural risk and comorbidities. Transcatheter aortic valve implantation (TAVI) has recently become a valuable therapeutic option for these patients., Aim: to present early results of first TAVI Edwards-Sapien procedures in our hospital, performed in symptomatic patients with high operational risk or other contraindications for conventional surgery, as well as the results of 6-month follow-up., Method: twelve patients referred for TAVI were included in the analysis. The valve was implanted in 11 patients and in 1 patient the procedure was finished with aortic valve valvuloplasty. Eight (72.7%) patients underwent transapical (TA) and 3 (27.3%) patients transfemoral (TF) TAVI. Seven (63.6%) 26 mm valves and 4 (34.4%) 23 mm valves were implanted., Results: the efficacy of the procedure was 92%: 100% in the TA group, and 75% in the TF group. During the procedure 1 patient developed ventricular fibrillation. Atrial fibrillation and right ventricle perforation by the endocavitary electrode was observed in another patient. Prolonged wound healing occurred in 4 patients and contrast-induced renal failure occurred in 2 patients. There were no deaths at 30-days. Two patients had a pacemaker implanted during hospitalisation. A significant improvement of echocardiographic parameters was observed: maximum gradient across the aortic valve was 104.4 ± 23.9 mm Hg before vs 25.2 ± 6.1 mm Hg after the intervention, p = 0.000001, mean gradient - 63.8 ± 18.3 vs 12.7 ± 3.7 mm Hg, p = 0.000004, and valvular surface - 0.7 ± 0.2 vs 1.5 ± 0.2 cm2, p = 0.000106, respectively. During the 6-month follow-up period 1 patient died of multiorgan failure and 6 patients required another hospitalisation. After 6 months an improvement in physical capacity was observed in all but one patients (NYHA II - 9 patients, NYHA III - 1 patient)., Conclusions: 1. The authors' initial experiences with TAVI Edwards-Sapien procedure confirm its efficacy and safety in patients with symptomatic aortic stenosis and high surgical risk. 2. Echocardiographic parameters of the implanted valves, assessed during hospitalisation and 6 month later, are satisfactory. 3. Due to the risk of complications, patients require careful observation in the postoperative period and during short-term follow-up.

Patients with severe symptomatic aortic stenosis, who from November 2008 to March 2009 were treated with Edwards-Sapien transcatheter aortic valve implantation (TAVI) within the POL-TAVI First Polish Registry, were included in the analysis. Nineteen patients aged 78+/-4.8 years with high operation risk and Logistic EuroSCORE 25+/-7.6% were reported (74% were females). In 15 (79%) patients the valve was implanted transapically (TA), in the other four (21%)--via the femoral arterial access (TF). The valve was successfully implanted in 16 (84%) patients, in one patient aortic valvuloplasty alone was performed. During in-hospital period two patients died (one during periprocedural period and another one--two months after the implantation). During the mean follow-up of 5+/-1.5 months (except for one patient who is still in hospital) all patients are in NYHA class I or II. Results of the initial series of 19 TAVI patients in Poland are satisfactory, and the trial will be continued with careful medical and economical analysis.