Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial.

Importance: In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective: To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants: SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention: Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures: The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results: A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance: Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Percutaneous trans-axilla transcatheter aortic valve replacement.

The left axillary artery is an attractive alternative access route for transcatheter aortic valve replacement (TAVR) and may provide better outcomes compared to other alternatives. Nevertheless, there remain concerns about vascular complications, lack of compressibility, and thorax-related complications. Between March 2019 and March 2021, 13 patients underwent transaxillary TAVR for severe aortic stenosis at the University Hospital Bonn. The puncture was performed with a puncture at the distal segment of the axillary artery through the axilla, with additional femoral access for applying a safety wire inside the axillary artery. Device success was defined according to the VARC 2 criteria. The study participants were advanced in age (77 ± 9 years old), and 54% were female, with an intermediate risk for surgery (STS risk score 4.7 ± 2.0%). The average diameter of the distal segment of the axillary artery was 5.8 ± 1.0 mm (i.e., the puncture site) and 7.6 ± 0.9 mm for the proximal axillary artery. Device success was achieved in all patients. 30-day major adverse cardiac and cerebrovascular events were 0%. With complete percutaneous management, stent-graft implantation was performed at the puncture site in 38.5% of patients. Minor bleeding was successfully managed with manual compression. Moreover, no thorax-related complications, hematomas, or nerve injuries were observed. Percutaneous trans-axilla TAVR was found to be feasible and safe. This modified approach may mitigate the risk of bleeding and serious complications in the thorax and be less invasive than surgical alternatives.

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

OBJECTIVES: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce. METHODS: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low. CONCLUSIONS: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.

Impact of Coronary Artery Disease on Outcomes in Patients Undergoing Percutaneous Edge-to-Edge Repair.

OBJECTIVES: The aim of this observational study was to evaluate the impact of concomitant coronary artery disease (CAD) on outcomes in patients undergoing percutaneous valve repair with the MitraClip system. BACKGROUND: Mitral valve regurgitation and CAD are often coexistent in elderly patients undergoing percutaneous mitral valve repair. The impact of CAD and revascularization on outcomes in this patient cohort, however, remains uncertain. METHODS: In 444 MitraClip patients, CAD severity was assessed, represented by the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), as well as the residual SS (rSS) and SYNTAX score II (SS-II). Patients were stratified according to CAD severity and SS-II values (SS ≤3 vs. SS >3 and SS-II ≤45 vs. SS-II >45) and according to remaining CAD burden into 2 groups (rSS = 0 vs. rSS >0) to compare 1-year all-cause mortality. RESULTS: Higher SS, rSS, and SS-II were associated with mortality (22% for SS >3 vs. 9.6% for SS ≤3 [p < 0.001], 31.4% for rSS >0 vs. 9.6% for rSS = 0 [p < 0.001], and 17.1% for SS-II > 45 vs. 11.2% for SS-II ≤45 [p = 0.044]). The rSS was an independent predictor of 1-year all-cause mortality (p = 0.001) in multivariate analysis. CONCLUSIONS: The complexity of CAD, as assessed using the SS, is associated with outcomes in patients undergoing MitraClip procedures. The burden of residual CAD after percutaneous coronary intervention is an independent predictor of 1-year all-cause mortality. Patients undergoing complete revascularization had the most favorable outcomes independent of mitral regurgitation etiology.

Predictive factors and long-term prognosis of transcatheter aortic valve implantation-associated endocarditis.

BACKGROUND: There are still limited data regarding transcatheter aortic valve implantation (TAVI) endocarditis. OBJECTIVES: The objective of the present study was to investigate the predictor and long-term outcome of TAVI endocarditis. METHODS: Consecutive patients undergoing TAVI at the University of Bonn were prospectively enrolled in this study. Transcatheter heart valve (THV) endocarditis was defined according to Duke criteria. The primary outcome was all-cause death within a 5-year follow-up. RESULTS: 1448 successful TAVI patients were eligible for the study and 17 patients (1.2%) developed THV endocarditis during the follow-up period (median 294 days). A multivariable logistic regression analysis identified age (odds ratio [OR] 0.90; P = 0.001) and residual paravalvular leakage (PVL) ≥ 2 after TAVI (OR 5.15; P = 0.015) as the main predictors for the occurrence of TAVI endocarditis. Additional analyses revealed that younger patients were significantly associated with higher rates of diabetes (P = 0.001), hemodialysis (P < 0.001), prior cardiac surgery (P < 0.001), and chronic obstructive pulmonary disease (COPD) (P < 0.001). A Kaplan-Meier analysis showed a significantly worse prognosis in TAVI patients with endocarditis than in patients without (log-rank; P = 0.03) during the 5-year follow-up. A multivariable Cox proportional hazard analysis revealed that TAVI endocarditis is an independent predictor of long-term mortality (hazard ratio 4.17; 95% CI 1.91-9.07; P < 0.001). CONCLUSIONS: Our study identified lower age and residual PVL ≥ 2 as predictors for THV endocarditis, which itself may be considered as an independent predictor of long-term mortality after TAVI.

Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results From the Randomized SURTAVI Trial.

BACKGROUND: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. METHODS: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years. RESULTS: Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P<0.01) and were more likely to be male (65.1% versus 54.2%; P<0.01) than the 1328 patients not assigned to revascularization. After randomization to treatment, there were 169 patients undergoing TAVR and percutaneous coronary intervention, 163 patients undergoing SAVR and coronary artery bypass grafting, 695 patients undergoing TAVR, and 633 patients undergoing SAVR. No significant difference in the rate of the primary end point was found between TAVR and percutaneous coronary intervention and SAVR and coronary artery bypass grafting (16.0%; 95% CI, 11.1-22.9 versus 14.0%; 95% CI, 9.2-21.1; P=0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5-14.7 versus 12.3%; 95% CI, 9.8-15.4; P=0.76). CONCLUSIONS: For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT01586910.

Predictive Value of the Platelet-to-Lymphocyte Ratio in Cancer Patients Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVES: The purpose of this study is to investigate the predictive value of the platelet-to-lymphocyte ratio (PLR)in cancer patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: The PLR is a promising marker to predict clinical outcomes in various cancer types as well as in cardiovascular disease. METHODS: Consecutive TAVR patients were enrolled in the study. We stratified patients into 2 groups: cancer and noncancer. Baseline complete blood counts with a differential hemogram were collected before TAVR. The primary outcome was all-cause death within a 3-year follow-up. RESULTS: In total, 240 of 1,204 patients (19.9%) had a cancer history. Cancer patients had a significantly higher baseline PLR than noncancer patients (median [interquartile range], 159.8 [109.6 to 244.6] vs. 150.3 [108.7 to 209.0]; p = 0.024). Kaplan-Meier analysis revealed that cancer patients had worse outcomes than noncancer patients (log-rank p < 0.001). Patients who died had a significantly higher baseline PLR than those who survived both in the cancer (p = 0.009) and noncancer (p = 0.027) groups. Multivariable analyses showed that the PLR (by 100 increase) was an independent predictor of adverse outcomes in both cancer (hazard ratio: 1.07; 95% confidence interval: 1.02 to 1.13; p = 0.006) and noncancer (hazard ratio: 1.20; 95% confidence interval: 1.06 to 1.36; p = 0.004). The highest mortality was observed for patients with cancer and increased PLR (above the median) (log-rank p < 0.001). CONCLUSIONS: Cancer patients undergoing TAVR had a significantly higher PLR than those without cancer. Higher PLR was associated with a worse outcome following TAVR.

Transcatheter aortic valve implantation versus redo surgery for failing surgical aortic bioprostheses: a multicentre propensity score analysis.

AIMS: Transcatheter aortic valve implantation for a failing surgical bioprosthesis (TAV-in-SAV) has become an alternative for patients at high risk for redo surgical aortic valve replacement (redo-SAVR). Comparisons between these approaches are non-existent. This study aimed to compare clinical and echocardiographic outcomes of patients undergoing TAV-in-SAV versus redo-SAVR after accounting for baseline differences by propensity score matching. METHODS AND RESULTS: Patients from seven centres in Europe and Canada who had undergone either TAV-in-SAV (n=79) or redo-SAVR (n=126) were identified. Significant independent predictors used for propensity scoring were age, NYHA functional class, number of prior cardiac surgeries, urgent procedure, pulmonary hypertension, and COPD grade. Using a calliper range of ±0.05, a total of 78 well-matched patient pairs were found. All-cause mortality was similar between groups at 30 days (6.4% redo-SAVR vs. 3.9% TAV-in-SAV; p=0.49) and one year (13.1% redo-SAVR vs. 12.3% TAV-in-SAV; p=0.80). Both groups also showed similar incidences of stroke (0% redo-SAVR vs. 1.3% TAV-in-SAV; p=1.0) and new pacemaker implantation (10.3% redo-SAVR vs. 10.3% TAV-in-SAV; p=1.0). The incidence of acute kidney injury requiring dialysis was numerically lower in the TAV-in-SAV group (11.5% redo-SAVR vs. 3.8% TAV-in-SAV; p=0.13). The TAV-in-SAV group had a significantly shorter median total hospital stay (12 days redo-SAVR vs. 9 days TAV-in-SAV; p=0.001). CONCLUSIONS: Patients with aortic bioprosthesis failure treated with either redo-SAVR or TAV-in-SAV have similar 30-day and one-year clinical outcomes.

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.

BACKGROUND: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

Routine Endovascular Treatment With a Stent Graft for Access-Site and Access-Related Vascular Injury in Transfemoral Transcatheter Aortic Valve Implantation.

BACKGROUND: Access-site and access-related vascular injury (ASARVI) is still a major limiting factor in transcatheter aortic valve implantation and affects the outcome of patients. Management strategies for ASARVI include manual compression, stent grafts, and vascular surgery. We hypothesized that the standard use of a self-expanding stent graft for the management of ASARVI is feasible and safe. METHODS AND RESULTS: Of 407 patients treated by transfemoral transcatheter aortic valve implantation, 110 experienced ASARVI (27.0%). Of these, 96 (87.3%) were managed by the implantation of a self-expanding nitinol stent graft. In the majority of patients, minor vascular complications triggered the implantation of a stent graft (86.5%), mainly because of bleeding (90.6%) and dissection (5.2%) of the common femoral artery with high rates of primary treatment success (97.9%). Patients receiving stent grafts were more often female (62.2 versus 45.6%, P<0.01), had higher body mass indices (27.8±6.7 versus 25.7±4.7, P=0.01), and suffered more often from diabetes mellitus (34.4 versus 24.5%, P=0.04). Angiographic assessment after a median follow-up of 345 days (interquartile range, 23-745 days) revealed only one patient with moderate, asymptomatic instent-stenosis (1.0%). Compared with a propensity score-matched cohort of patients without ASARVI, stented patients had comparable long-term mortality, despite the occurrence of a vascular complication (1-year mortality: 17.7% versus 26.6%; stent versus matched cohort, respectively; P=0.1). CONCLUSIONS: Routine use of a self-expanding nitinol stent graft in selected patients experiencing ASARVI after transcatheter aortic valve implantation is feasible, safe, and associated with favorable short- and midterm clinical outcome.

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis (DISCOVER) Study.

OBJECTIVES: The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. BACKGROUND: The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. METHODS: A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. RESULTS: Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2). CONCLUSIONS: At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.

Hydrodynamic Performance of the Medtronic CoreValve and the Edwards SAPIEN XT Transcatheter Heart Valve in Surgical Bioprostheses: An In Vitro Valve-in-Valve Model.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (TAVR) is becoming a valuable option with promising clinical results in failed bioprosthetic heart valves. Sizing recommendations are based on size compatibility rather than on broad clinical data, in vitro measurements, or biomechanical evidence. The hemodynamic performance of transcatheter heart valves within degenerated surgical heart valves is unknown. METHODS: We evaluated the in vitro hydrodynamic performance of two commercially available transcatheter heart valves (Medtronic CoreValve [Medtronic, Minneapolis, MN] and Edwards SAPIEN XT [Edwards Lifesciences, Irvine, CA]) in two different bioprosthetic aortic valves (Edwards Perimount [Edwards Lifesciences] and St. Jude Trifecta [St. Jude Medical, St. Paul, MN]). RESULTS: Within the Edwards Perimount (23 mm) prosthesis, pressure gradients were higher for the SAPIEN XT compared with the CoreValve (11.2 ± 0.1 mm Hg versus 10.1 ± 0.1 mm Hg, p < 0.01), whereas effective orifice area (1.99 ± 0.01 cm(2) versus 1.80 ± 0.01 cm(2), p < 0.01) and total paravalvular leakage (9.0% ± 1.0% versus 5.4% ± 1.3%, p < 0.01) were increased when using the CoreValve. Similarly, measurements in the St. Jude Trifecta revealed higher transvalvular pressure gradients (13.0 ± 0.2 mm Hg versus 10.9 ± 0.3 mm Hg, p < 0.01) and lower effective orifice area for the SAPIEN XT compared with the CoreValve. However, total relative regurgitation was higher with SAPIEN XT as compared with the CoreValve in St. Jude Trifecta prostheses (11.2% ± 1.4% versus 8.3% ± 0.9%, p < 0.01). CONCLUSIONS: Both transcatheter heart valve prostheses performed well in the described valve-in-valve settings. Hydrodynamic results were in line with the International Organization for Standardization standards for all configurations. The observed differences indicate a necessity for preclinical valve-in-valve tests in addition to clinical long-term data about longevity.

Implante percutâneo de prótese valvar aórtica ­ experiência com o dispositivo reposicionável LotusTM / Percutaneous aortic valve implantation ­ an experience with the LotusTM repositionable device

Introdução: A válvula aórtica transcateter de segunda geração LotusTM foi desenhada para proporcionar ao intervencionista o controle completo de sua liberação durante o procedimento. O presente estudo apresenta a experiência inicial e os desfechos hospitalares de pacientes tratados com essa prótese no Brasil. Métodos: Registro observacional, retrospectivo, que incluiu pacientes com estenose aórtica grave sintomáticos, considerados de alto risco cirúrgico, tratados em sete centros.Resultados: Receberam o dispositivo 31 pacientes, sendo 61,3% do sexo feminino, com idade de 82,9 ± 6,9 anos e escore STS de 6,5 ± 4,1%. A área valvar aórtica foi de 0,73 ± 0,18 cm2 e o gradiente médio de 51,7 ± 13,9 mmHg. Todos os procedimentos foram realizados pela via transfemoral, e a pré-dilatação foi necessária em 65% dos casos. A taxa de sucesso do procedimento foi de 96,7%. Não houve complicação vascular com necessidade de intervenção cirúrgica e nem casos de acidente vascular cerebral. O gradiente médio após o procedimento foi de 10,5 ± 5,8 mmHg e não foram observadas regurgitações aórticas de graus moderado/importante. A taxa de implante de marca-passo definitivo foi de 38,7%, e a permanência hospitalar de 8,5 ± 4,8 dias. Conclusões: Na experiência inicial com o implante da válvula aórtica LotusTM, os resultados hospitalares demostraram a segurança e a eficácia do dispositivo, além de ausência de regurgitação aórtica relevante

Background: The second-generation LotusTM transcatheter aortic valve was designed to provide the interventional cardiologist with complete control of its release during the procedure. This study presents the initial experience and in-hospital outcomes of patients treated with this prosthesis in Brazil. Methods: This observational and retrospective study included patients with symptomatic severe aortic stenosis considered at high surgical risk, treated in seven centers. Results: The device was used in 31 patients, 61.3% female, aged 82.9 ± 6.9 years, and with STS score of 6.5 ± 4.1%. The aortic valve area was 0.73 ± 0.18 cm2 and the mean gradient was 51.7 ± 13.9 mmHg. All procedures were performed by the transfemoral access route, and pre-dilation was necessary in 65% of cases. The success rate of the procedure was 96.7%. There were no vascular complications requiring surgical intervention nor cases of stroke. The mean gradient after the procedure was 10.5 ± 5.8 mmHg; no cases of moderate to severe aortic regurgitation were observed. The rate of permanent pacemaker implantation was 38.7%, and mean in-hospital length of stay was 8.5 ± 4.8 days. Conclusions: In the initial experience with the use of the LotusTM aortic valve, in-hospital results demonstrated the safety and efficacy of the device; no cases of significant aortic regurgitation were observed

Outcome in TAVI patients with symptomatic aortic stenosis not fulfilling PARTNER study inclusion criteria.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has rapidly evolved to the standard-of-care for inoperable patients with severe, symptomatic aortic valve stenosis, and to an alternative treatment option for high-risk patients. However, the randomized PARTNER trial excluded patients with conditions frequently encountered in daily clinical practice. METHODS: From 2006 to 2011, 467 high-risk patients, who underwent transfemoral TAVI (Edwards Sapien n = 166; Medtronic CoreValve n = 301) at two German centers were divided into a "PARTNER-like" (n = 227) and a "Real-World" cohort (n = 240), based on the original PARTNER trial in- and exclusion criteria. Differences in 30-day and 2-year mortality and morbidity were assessed. RESULTS: Mean age of patients was 80 ± 8 years with a logistic EuroSCORE of 22 ± 16%. The most frequent exclusion criteria were previous PCI (15.4%), prior valve surgery (13.7%), chronic renal failure (12.0%), and severe mitral regurgitation (10.8%). Despite significant differences in baseline data, estimated perioperative mortality in terms of STS and logistic EuroScore was identical between both groups. However, patients in the "Real-World" cohort had a non-significant trend towards a higher 30-day mortality (10.0% vs. 6.7%, P = 0.088) and a significantly higher 2-year mortality (23.3% vs. 14.5%, P = 0.016) compared with patients of the "PARTNER-like" cohort. CONCLUSION: Patients meeting PARTNER study exclusion criteria had an acceptable outcome at 30 days and 2 years, however, with significant differences to "PARTNER-like" patients. Still, our results indicate that also real-life patients with relevant comorbidities, who would have been excluded from the randomized PARTNER trials, benefit from TAVI with acceptable short- and long-term outcome.

Transcatheter aortic valve replacement in bicuspid aortic valve disease.

BACKGROUND: Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). OBJECTIVES: This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. METHODS: We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. RESULTS: A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥ 2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). CONCLUSIONS: TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.

The Year in Cardiology 2013: valvular heart disease (focus on catheter-based interventions).

2013 was the year of transcatheter heart valve interventions. Not least because of the 2012 European guidelines on the management of valvular heart disease (VHD), the multidisciplinary heart team approach became an established concept. Decision-making, when a patient is too 'sick' for surgery and too 'healthy' for catheter-based interventions, is complex, since VHD is often seen at an older age and, as a consequence, there is a higher frequency of co-morbidity and frailty. However, before TAVI and other transcatheter heart valve interventions can be expanded to intermediate-risk patients, evidence in favour of this less invasive treatment has to be provided by upcoming randomized clinical trials.