Comparison of outcomes in patients with severe aortic stenosis treated with small and large Medtronic Evolut R and Evolut PRO self-expandable prosthetic valves.

Introduction: Indications for transcatheter aortic valve implantation (TAVI) continue to expand. Very often TAVI must be done in large annuli. Implantation of the bigger prostheses is often associated with more procedural problems, which may affect the outcomes. Aim: To compare the outcomes of TAVI procedures using the self-expandable Medtronic Evolut R 34 with the smaller Evolut R or Evolut Pro 23, 26 or 29. Material and methods: We analysed 87 patients who received self-expandable Medtronic Evolut R and Pro valves. Group I consisted of 59 (67.81%) patients with Evolut 23, 26 or 29, and group II consisted of 28 (32.18%) patients who received an Evolut 34 valve. Results: EuroSCORE II was 5.59 in group I vs 7.87 in group II (p = 0.02). The oversizing rate was higher in group II: 24.1% vs. 18.5% (p < 0.001). The procedure and fluoroscopy times were longer in group II: 209 vs. 187 min (p = 0.03), 44 vs. 27 min (p = 0.01). Moderate paravalvular leak was found more frequently in group II: 5 v 1 (p = 0.04). There was less device success in group II: 22 (78.57%) vs. 57 (96.6%) (p = 0.05). Early safety criteria were similar in both groups: 52 (88.1%) and 24 (92.3%) (p = 0.56). 30-day mortality was similar: 4 (6.7%) vs. 0 in group I and II respectively (p = 0.16). Conclusions: TAVI procedures in patients requiring an Evolut R 34 prosthesis are more challenging than in those who need smaller valves. Paravalvular leaks are more frequently observed after TAVI with Evolut R 34, which results in lower device success.

Comparison of the results of transcatheter aortic valve implantation in patients with bicuspid and tricuspid aortic valve.

INTRODUCTION: Indications for transcatheter aortic valve implantation (TAVI) are constantly expanding, including younger patients. Bicuspid aortic valves (BAV) often occur in this group. In order to achieve optimal treatment results in younger patients, it is necessary to develop an effective method for selecting the size of implanted valves. AIM: To compare the results of TAVI with use of a self-expanding prosthesis in patients with a BAV and a tricuspid aortic valve (TAV) with valve selection based on annular sizing. MATERIAL AND METHODS: The diagnosis of BAV and TAV and measurements (annular sizing) were based on multi-slice computed tomography scans. Eighty-three patients received a self-expanding CoreValve or Evolut R prosthesis. In group I (BAV) there were 21 (25.3%) patients and in group II (TAV) there were 62 (74.7%) patients. RESULTS: The groups did not differ in terms of baseline clinical characteristics. Device success was achieved in 16 (76.2%) and 55 (88.7%) (p = NS) in group I and II respectively. Composite endpoints: early safety occurred in 5 (23.8%) and 11 (17.7%) patients (p =NS) in group I and II respectively; clinical efficacy occurred in 10 (47.6%) and 28 (45.2%) patients (p = NS) in group I and II respectively. 30-day mortality was 4.8% vs 9.7%, 1-year mortality was 28.6% vs 17.7% (p = NS) in group I and II respectively. CONCLUSIONS: TAVI in patients with severe aortic stenosis and BAV is as effective as in patients with TAV using self-expanding prostheses if the valve selection is based on annular sizing.

Female gender and the clinical and periprocedural profile and clinical outcomes of transcatheter aortic valve implantation: experiences of a tertiary Polish centre.

INTRODUCTION: Despite the establishment of multiple factors influencing short- and mid-term outcomes in patients treated with transcatheter aortic valve implantation (TAVI), the real-world data on the association between gender and outcomes after TAVI remain conflicting. AIM: To evaluate the association of female gender with the clinical and periprocedural characteristics along with in-hospital, short- and medium-term outcomes of patients treated with TAVI in comparison with male patients. MATERIAL AND METHODS: Data from the prospective, single-centre registry of consecutive patients with severe AS referred for TAVI from 26 November 2008 to 31 December 2018 were analysed retrospectively. The study population comprised 275 patients who were divided by gender. The primary endpoint of the study was all-cause mortality at 1 year. RESULTS: Women constituted 132 (48.0%) of the overall population. Women were significantly older, but had a significantly higher left ventricular ejection fraction (LVEF) and had less frequently undergone coronary artery bypass grafting (CABG) before TAVI. The implantation success rate was comparable between genders, but women less frequently required implantation of a pacemaker after TAVI, although they more frequently required blood transfusion due to severe bleeding. The primary endpoint occurred in 13.6% of women and 7.7% of men (p = 0.12). CONCLUSIONS: Despite advanced age and prevalence of cardiovascular risk factors, the overall short- and medium-term mortality in patients treated with TAVI in our analysis of the real-world population remains relatively low. Although women seemed to have a slightly better clinical baseline profile, their in-hospital, 30-day, 6-month and 12-month outcomes did not differ significantly from the male patients.

Percutaneous access to coronary arteries in patients after transcatheter aortic valve implantation procedures - is it a real problem?

Transcatheter aortic valve implantation (TAVI) is still developing and changing our approach to treating patients with severe symptomatic aortic stenosis. Aortic stenosis frequently coexists with coronary artery disease. Both diseases have similar risk factors for their development and one should expect a future progression of coronary artery disease. The current guidelines have expanded TAVI indications to include intermediate-risk patients, and perhaps they will be expanded to include low-risk patients in the future. Survival after TAVI in younger patients will depend on the durability of the aortic valves and methods of coronary artery disease treatment. This paper presents some aspects of performing coronary angiography and percutaneous coronary intervention in patients who had TAVI performed using the two most popular aortic valves - balloon expandable aortic valves (Edward Sapien/Edward Sapien XT/Sapien 3) and self-expandable aortic valves (CoreValve/Evolut R) - on the basis of several examples. This paper also focuses on technical aspects associated with a proper implantation of aortic valves to ensure easy access to coronary arteries, as well as on possible problems when the implantation is not optimal. We discuss interactions between the structure of the aortic valve stent, catheters, commissures of new aortic valves, and coronary ostia.

Impact of coronary artery disease on outcomes of severe aortic stenosis treatment with transcatheter aortic valve implantation.

INTRODUCTION: The presence of coronary artery disease (CAD) in patients who underwent transcatheter aortic valve implantation (TAVI) may increase in-hospital and long-term mortality. AIM: To evaluate the impact of CAD in patients who underwent TAVI. MATERIAL AND METHODS: The study group consisted of the first 142 patients treated with TAVI between 26 November 2008 and 31 December 2015. The patients were divided into two groups: group I comprised 103 (72.5%) patients with CAD, and group II comprised 39 (27.5%) patients without CAD. RESULTS: Group I was characterized by a significantly higher risk according to EuroSCORE - 11.2 ±2.5 vs. 9 ±2.3 in group II (p < 0.001) and Logistic EuroSCORE - 25.4 ±13.4 vs. 16.3 ±8.7 (p < 0.001). 30-day mortality was 8 (7.8%) vs. 2 (5.1%) (p = NS) and 1-year mortality was 22 (21.4%) vs. 6 (15.4%) (p = NS) in group I and II respectively. The composite endpoint evaluating the efficacy of TAVI was achieved in 82 (79.6%) vs. 31 (79.5%) (p = NS) in group I and II respectively. The composite endpoint, which involved 30-day observation, occurred in 39 (37.86%) vs. 12 (30.77%) (p = NS) and the composite endpoint, which involved 1-year evaluation of the clinical efficacy of TAVI, occurred in 48 (57.8%) vs. 13 (48.1%) (p = NS) in patients with and without CAD respectively. CONCLUSIONS: The short- and mid-term outcomes of TAVI patients with CAD, despite higher risk profile, did not differ from the outcomes of treatment in patients without CAD.

Impact of CoreValve size selection based on multi-slice computed tomography on paravalvular leak after transcatheter aortic valve implantation.

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.

Assessment of cardiovascular function following transcatheter aortic valve implantation based on six-minute walk test.

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).