Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement.

BACKGROUND: Studies comparing long-term outcomes between non-vitamin K antagonist (VKA) oral anticoagulant agents (direct oral anticoagulant agents [DOACs]) and VKA anticoagulant agents after transcatheter aortic valve replacement (TAVR) are scarce, with conflicting results. OBJECTIVES: The aim of this study was to examine the periprocedural, short-term, and long-term safety and effectiveness of DOACs vs VKAs in patients undergoing TAVR via femoral access with concomitant indications for oral anticoagulation. METHODS: Consecutive patients undergoing transfemoral TAVR in the prospective national SwissTAVI Registry between February 2011 and June 2021 were analyzed. Net clinical benefit (a composite of all-cause mortality, myocardial infarction, stroke, and life-threatening or major bleeding) and the primary safety endpoint (a composite of life-threatening and major bleeding) were compared between the VKA and DOAC groups at 30 days, 1 year, and 5 years after TAVR. RESULTS: After 1:1 propensity score matching, 1,454 patients were available for analysis in each group. There was no significant difference in the rate of the net clinical benefit and the safety endpoints between the groups as assessed at 30 days and 1 and 5 years post-TAVR between VKAs and DOACs. VKAs were associated with significantly higher rates of 1- year (HR: 1.28; 95% CI: 1.01-1.62) and 5-year (HR: 1.25; 95% CI: 1.11-1.40) all-cause mortality. Long-term risk for disabling stroke was significantly lower in the VKA group after excluding periprocedural events (HR: 0.64; 95% CI: 0.46-0.90). CONCLUSIONS: At 5 years after TAVR, VKAs are associated with a higher risk for all-cause mortality, a lower risk for disabling stroke, and a similar rate of life-threatening or major bleeding compared with DOACs. (SwissTAVI Registry; NCT01368250).

Long-Term Risk of Stroke After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry.

BACKGROUND: Stroke after transcatheter aortic valve replacement (TAVR) is associated with considerable morbidity and mortality. Predictors of stroke and the long-term risk after TAVR remain incompletely understood. OBJECTIVES: The authors sought to investigate the short- and long-term incidence and predictors of stroke after TAVR in the SwissTAVI Registry. METHODS: Between February 2011 and June 2021, consecutive patients undergoing TAVR were included. Standardized stroke ratios (SSRs) were calculated to compare trends in stroke of TAVR patients with an age- and sex-matched general population in Switzerland derived from the 2019 Global Burden of Disease study. RESULTS: A total of 11,957 patients (81.8 ± 6.5 years of age, 48.0% female) were included. One-third of the patients (32.3%) had a history of atrial fibrillation, and 11.8% had a history of cerebrovascular accident. The cumulative 30-day incidence rate of stroke was 3.0%, with 69% of stroke events occurring within the first 48 hours after TAVR. The incidence of stroke was 4.3% at 1 year, and 7.8% at 5 years. Compared with an age- and sex-adjusted general population, the risk of stroke was significantly higher in the TAVR population during the first 2 years after TAVR: first year: SSR 7.26 (95% CI: 6.3-8.36) and 6.82 (95% CI: 5.97-7.79) for males and females, respectively; second year: SSR 1.98 (95% CI: 1.47-2.67) and 1.48 (95% CI: 1.09-2.02) for males and females, respectively; but returned to a comparable level to that observed in the matched population thereafter. CONCLUSIONS: Compared with an age- and sex-matched population, TAVR patients experienced a higher risk of stroke for up to 2 years after the procedure, and a comparable risk thereafter. (SwissTAVI Registry; NCT01368250).

Clinical Outcomes in High-Gradient, Classical Low-Flow, Low-Gradient, and Paradoxical Low-Flow, Low-Gradient Aortic Stenosis After Transcatheter Aortic Valve Implantation: A Report From the SwissTAVI Registry.

Background In view of the rising global burden of severe symptomatic aortic stenosis, its early recognition and treatment is key. Although patients with classical low-flow, low-gradient (C-LFLG) aortic stenosis have higher rates of death after transcatheter aortic valve implantation (TAVI) when compared with patients with high-gradient (HG) aortic stenosis, there is conflicting evidence on the death rate in patients with severe paradoxical low-flow, low-gradient (P-LFLG) aortic stenosis. Therefore, we aimed to compare outcomes in real-world patients with severe HG, C-LFLG, and P-LFLG aortic stenosis undergoing TAVI. Methods and Results Clinical outcomes up to 5 years were addressed in the 3 groups of patients enrolled in the prospective, national, multicenter SwissTAVI registry. A total of 8914 patients undergoing TAVI at 15 heart valve centers in Switzerland were analyzed for the purpose of this study. We observed a significant difference in time to death at 1 year after TAVI, with the lowest observed in HG (8.8%) aortic stenosis, followed by P-LFLG (11.5%; hazard ratio [HR], 1.35 [95% CI, 1.16-1.56]; P<0.001) and C-LFLG (19.8%; HR, 1.93 [95% CI, 1.64-2.26]; P<0.001) aortic stenosis. Cardiovascular death showed similar differences between the groups. At 5 years, the all-cause death rate was 44.4% in HG, 52.1% in P-LFLG (HR, 1.35 [95% CI, 1.23-1.48]; P<0.001), and 62.8% in C-LFLG aortic stenosis (HR, 1.7 [95% CI, 1.54-1.88]; P<0.001). Conclusions Up to 5 years after TAVI, patients with P-LFLG have higher death rates than patients with HG aortic stenosis but lower death rates than patients with C-LFLG aortic stenosis.

Transcatheter Aortic Valve Implantation With Balloon-Expandable Valve Prostheses in Patients With Pure Native Non- or Mildly Calcified Aortic Regurgitation: A Case-Series and Literature Review.

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) is an off-label procedure for selected patients at high surgical risk with native non- or mildly calcified aortic regurgitation (AR). Traditionally, self-expanding transcatheter heart valves (THV) have been favored over balloon-expandable THV's probably due to assumed better device fixation. We report a series of patients with native severe AR successfully treated with a balloon-expandable THV. METHODS: Between 2019 and 2022, 8 consecutive patients (5 male, 82 (interquartile range 80-85) years old, STS PROM 4.0 % (interquartile range 2.9-6.0), EuroSCORE II 5.5% (IQR 4.1-7.0) with non- or mildly calcified pure AR were treated with a balloon-expandable THV. All procedures were performed after heart team discussion and standardized diagnostic workup. Clinical endpoints were collected prospectively and included device success, procedural complications (according to VARC-2 definitions) and 1-month survival. RESULTS: Device success was 100% with no device embolization or migration. Two preprocedural nonfatal complications were reported (one access site complication that required stent implantation and one pericardial tamponade). Two patients required permanent pacemaker implantation for complete AV block. At discharge and at 30-day follow-up all patients were alive and no patient showed more than minimal AR. CONCLUSION: This series documents that treatment of native non- or mildly calcified AR with balloon-expandable THV is feasible, safe and offers favorable short-term clinical outcomes. Hence, TAVI with balloon-expandable THVs may offer a valuable treatment option in patients with native AR at high surgical risk.

[Transcatheter Aortic Valve Implantation in Multivalvular Heart Disease]. / Transkatheter-Aortenklappenimplantation (TAVI) bei multivalvulären Herzerkrankungen.

Transcatheter Aortic Valve Implantation in Multivalvular Heart Disease Abstract. The prevalence of multivaluvular heart disease is high in patients undergoing transcatheter aortic valve implantation (TAVI). The most common combination is aortic valve stenosis (AS) and mitral regurgitation, followed by the combination of AS with a tricuspid regurgitation or mitral stenosis. Grading of multivalvular disease is challenging and can quickly lead to underestimation of the disease stage. Therefore, a profound knowledge of pathophysiologic interactions is essential, and the patient should always undergo multimodal evaluation. After a successful TAVI intervention, secondary heart valve defects may improve, deteriorate, or remain unchanged. Due to the still sparse scientific data in this field, the role of the heart team remains central to provide the patient with an individually adapted therapy plan.

Surgical versus transcatheter repair for secondary mitral regurgitation: A propensity score-matched cohorts comparison.

OBJECTIVES: To compare the efficacy and clinical outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) and surgical mitral valve repair (SMVr) among patients with secondary mitral regurgitation (SMR). METHODS: Consecutive patients with SMR treated using either TMVr (n = 199) or SMVr (n = 222) at 2 centers were included and retrospectively analyzed. To account for differences in patient demographic characteristics, 1:1 propensity score matching was performed. The primary endpoint was all-cause death within 2 years after the procedure. RESULTS: The study population consisted of 202 matched patients. At 2 years, all-cause mortality was 24.3% for TMVr and 23.0% for SMVr (hazard ratio, 0.97; 95% confidence interval, 0.55-1.71; P = .909). Severe heart failure symptoms at 2 years were less prevalent after SMVr (New York Heart Association functional class III or IV: 13.5% vs 29.5%; P = .032) than after TMVr. A higher proportion of the SMVr patients had SMR reduction to none or mild at discharge (90.8% vs 72.0%; P < .001) and 2 years (86.5% vs 59.6%; P < .001). Among patients who achieved none or mild MR at discharge, 7 patients (10.1%) in the SMVr group and 15 (34.9%) in the TMVr group had progression to moderate or greater MR at 2 years (P = .003). Left ventricular ejection fraction (LVEF) significantly improved (+10.1% ± 11.1%; P < .001) after SMVr (LVEF at 2 years: 45.7% ± 12.8%), whereas it remained unchanged (-1.3% ± 8.9%; P = .260) after TMVr (LVEF at 2 years: 34.0% ± 13.2%). CONCLUSIONS: In this propensity score-matched analysis, there was no significant difference in 2-year survival between TMVr and SMVr, despite greater and more durable SMR reduction, as well as LVEF improvement in the surgical group.

Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.

AIMS: To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES). METHODS: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years. RESULTS: Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup. CONCLUSION: Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.

Natural history and mid-term prognosis of severe tricuspid regurgitation: A cohort study.

Objectives: The objective of this study was to characterize a population of patients with severe tricuspid regurgitation (TR) evaluated at a tertiary care center, assess mid-term clinical outcomes, and identify prognostic factors. Background: The impact of TR on morbidity and mortality is increasingly recognized. Clinical characteristics and long-term outcomes of patients suffering from TR remain unclear. Methods: This is a retrospective observational single-center study from a tertiary care hospital including patients with echocardiographic diagnosis of severe TR between January 2017 and December 2018. We used the Kaplan-Meier method to estimate survival for up to 4 years. After excluding patients with tricuspid valve (TV) intervention and surgery during follow-up, a multivariate analysis was performed to assess predictors of 2-year mortality using the Cox regression model. Results: A total of 278 patients (mean age 74.9 ± 13.7 years, 47.8% female) with severe TR were included in the study. The majority (83.1%; n = 231) had secondary TR. Comorbidities such as atrial fibrillation (AFib) (68.0%; n = 189), severe renal failure (44.2%; n = 123), pulmonary hypertension (PHT) (80.9%; n = 225), and right ventricular (RV) dysfunction (59.7%; n = 166) were highly prevalent. More than half of patients with a cardiac implantable electronic device (CIED) (54.3%; n = 44) showed echocardiographic signs of lead-leaflet interaction causing or contributing to TR. The estimated 2- and 4-year all-cause mortality was 50 and 69%, respectively. Using multivariate analysis, age, severe renal failure, heart failure with reduced ejection fraction (HFrEF), and vena contracta width ≥14 mm were identified as predictors of 2-year mortality. Nine percent (n = 25) of the study cohort underwent transcatheter or surgical treatment for TR during follow-up. Conclusion: Our study shows the high burden of morbidity and the dismal survival of patients with severe TR. It also highlights the extent of the therapeutic need, since the vast majority of patients were left untreated. Additionally, CIED RV lead-associated TR was prevalent suggesting a need for more attention in clinical routine and research.

Ischemic and Bleeding Outcomes According to the Academic Research Consortium High Bleeding Risk Criteria in All Comers Treated by Percutaneous Coronary Interventions.

Background: The Academic Research Consortium have identified a set of major and minor risk factors in order to standardize the definition of a High Bleeding Risk (ACR-HBR). Aims: The aim of this study is to stratify the bleeding risk in patients included in the Cardio-Fribourg registry, according to the Academic Research Consortium for High Bleeding Risk (ACR-HBR) definition, and to report ischemic and hemorrhagic events at 2-year of clinical follow-up. Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. Patients were considered high (HBR) or low (LBR) bleeding risk depending on the ARC-HBR definition. Primary endpoints were hierarchical major bleeding events as defined by the Bleeding Academic Research Consortium (BARC) grade 3-5, and ARC patient-oriented major adverse cardiac events (POCE) at 2-year follow-up. Results: Follow-up was complete in 1,080 patients. There were 354 patients in the HBR group (32.7%) and 726 patients in the low-bleeding risk (LBR) group (67.2%). At 2-year follow-up, cumulative BARC 3-5 bleedings were higher in HBR (10.5%) compared to LBR patients (1.5%, p < 0.01) and the impact of HBR risk factors was incremental. At 2-year follow-up, POCE were more frequent in HBR (27.4%) compared to LBR group (18.2%, <0.01). Overall mortality was higher in HBR (14.0%) vs. LBR (2.9%, p < 0.01). Conclusions: ARC-HBR criteria appropriately identified a population at a higher risk of bleeding after percutaneous coronary intervention. An increased risk of bleeding is also associated with an increased risk of ischemic events at 2-year follow-up.

Percutaneous Tricuspid Valve Repair: A Promising Treatment for Heart Transplant Patients With Severe Tricuspid Regurgitation.

Two heart transplant patients aged 80 and 83 years with recurrent heart failure due to severe tricuspid regurgitation are reported. In view of their high perioperative risk, both patients underwent percutaneous transcatheter edge-to-edge tricuspid valve repair, and both experienced excellent technical success, with favorable 2-year clinical outcome. (Level of Difficulty: Advanced.).

Age-Related Outcomes After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry.

OBJECTIVES: The aim of this study was to investigate age-related outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) as assessed in a nationwide, prospective, multicenter cohort study. BACKGROUND: TAVR is the preferred treatment for elderly patients with severe aortic stenosis and is expanding into lower age groups. METHODS: Data from the SwissTAVI Registry were analyzed. Clinical outcomes were compared between patients 70 years of age or younger (n = 324), 70 to 79 years of age (n = 1,913), 80 to 89 years of age (n = 4,353), and older than 90 years of age (n = 507). Observed deaths were correlated with expected deaths in the general Swiss population using standardized mortality ratios. RESULTS: Between February 2011 and June 2018, 7,097 patients (mean age 82.0 ± 6.4 years, 49.6% women) underwent TAVR at 15 hospitals in Switzerland. Procedural characteristics were similar; however, older patients more often had discharge to the referring hospital or a rehabilitation facility after TAVR. Using adjusted analyses, a linear trend for mortality (30-day adjusted hazard ratio [HRadj]: 1.45; 95% confidence interval [CI]: 1.18 to 1.77; 1-year HRadj: 1.12; 95% CI: 1.01 to 1.24), cerebrovascular accidents (30-day HRadj: 1.35; 95% CI: 1.09 to 1.66; 1-year HRadj: 1.21; 95% CI: 1.02 to 1.45), and pacemaker implantation (30-day HRadj: 1.23; 95% CI: 1.12 to 1.34; 1-year HRadj: 1.19; 95% CI: 1.09 to 1.30) was observed with increasing age. Furthermore, standardized mortality ratios were 12.63 (95% CI: 9.06 to 17.58), 4.09 (95% CI: 3.56 to 4.74), 1.63 (95% CI: 1.50 to 1.78), and 0.93 (95% CI: 0.76 to 1.14) for TAVR patients in relation to the Swiss population <70, 70 to 79, 80 to 89 and ≥90 years of age, respectively. CONCLUSIONS: Increasing age is associated with a linear trend for mortality, stroke, and pacemaker implantation during early and longer-term follow-up after TAVR. Standardized mortality ratios were higher for TAVR patients younger than 90 years of age compared with expected rates of mortality in an age- and sex-matched Swiss population. (SWISS TAVI Registry; NCT01368250).

Heart valve sizing and clinical outcomes in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To investigate the impact of transcatheter heart valve (THV) sizing on procedural results and clinical outcomes following transcatheter aortic valve implantation (TAVI). BACKGROUND: The impact of individual THV sizing for patients with borderline aortic annulus anatomy remains unclear. METHODS: In the prospective BernTAVI registry, THV sizing conditions were retrospectively evaluated, and patients were categorized into three groups based on the recommendations and the sizing chart of the manufacturers: optimal sizing, borderline sizing (THV size located within 5% to each border of the optimal sizing recommendation), and suboptimal sizing (THV size outside the recommended range). The latter two groups were further subcategorized into THV-oversizing and THV-undersizing. The primary endpoint was a composite of all-cause death and unplanned repeat intervention at 1 year. RESULTS: Out of a total of 1,638 patients who underwent TAVI, 9.5 and 15.6% of patients were categorized into the borderline and suboptimal sizing group, respectively. Device success was achieved in 87.4, 88.9, and 83.6% of patients with optimal, borderline, and suboptimal sizing, respectively. The primary endpoint occurred in 12.3% of patients with optimal sizing, 14.9% of patients with borderline sizing (HRadj 1.35, 95%CI 0.87-2.09), and in 17.4% of patients with suboptimal sizing (HRadj 1.42, 95%CI 1.01-1.99). Within the suboptimal sizing cohort, unfavorable outcomes were mainly associated with THV undersizing (device success: 76.4%, primary endpoint: 23.9%, HRadj 1.98, 95%CI 1.36-2.87). CONCLUSION: Suboptimal TAVI prosthesis sizing is associated with an increased risk of all-cause death and unplanned repeat intervention within 1 year largely attributable to undersized THV prostheses.

Impact of first medical contact to revascularisation time on long-term clinical outcomes in ST-segment elevation myocardial infarction patients.

Increased age impacts the first medical contact to revascularisation delay in patients with STEMI. Patients with shorter treatment delays (<90 minutes after first medical contact) have significantly lower major adverse cardiac events rates at 3 years.

Heart team approach in treatment of mitral regurgitation: patient selection and outcome.

OBJECTIVE: A multidisciplinary heart valve team is recommended for the evaluation of treatment in patients with valvular heart disease, but evidence supporting this concept is lacking. In patients with severe mitral regurgitation, we thought to analyse the patient selection process by the heart team for different treatment options and the outcome after treatment. METHODS: In this single-centre cohort study, all patients treated for mitral regurgitation between July 2013 and September 2018 were included. Primary end points during follow-up were all-cause mortality and a combined end point, consisting of all-cause mortality, cardiovascular rehospitalisation and mitral valve reintervention. RESULTS: 179 patients (44.8%) were treated using Mitraclip, 185 (46.2%) by surgical repair and 36 (9.0%) by surgical replacement. The mortality risk according to EuroScore II differed significantly between treatment groups (6.6%±5.6%, 1.7%±1.5% and 3.6%±2.7% for Mitraclip, surgical repair and replacement, respectively, p<0.001). In-hospital mortality for the 3 groups were 3.4%, 1.6% and 8.3%, respectively (p=0.091). Overall, surgical repair patients had higher 4-year survival (HR 0.40 (95% CI 0.26 to 0.63), p<0.001) and fewer combined end points (HR 0.51 (95% CI 0.32 to 0.80), p<0.001) compared with surgical replacement and Mitraclip patients. However, patients undergoing Mitraclip for isolated, primary mitral regurgitation achieved very good long-term survival. CONCLUSION: The multidisciplinary heart team assigned only low-risk patients with favourable anatomy to surgical repair, while high-risk patients underwent Mitraclip or surgical replacement. This strategy was associated with lower than expected in-hospital mortality for Mitraclip patients and high 4-year survival rates for patients undergoing surgical or percutaneous repair of isolated primary mitral regurgitation.

Mitral and Tricuspid Transcatheter Interventions Current Indications and Future Directions.

Valvular heart disease is responsible for a high rate of morbidity and mortality, especially in the elderly population. With the emergence of new transcatheter treatment options, the therapeutic spectrum for patients with valvular heart disease has considerably expanded during the past years. Interventional treatment of the mitral and tricuspid valve requires an individualized and versatile approach owing to the different etiologies of valvular dysfunction and the complex anatomy of the atrioventricular valves. This article aims to review recent developments, summarize the evidence, indications and limitations of the available systems, and provide a glimpse into the future of transcatheter interventions for the treatment of mitral and tricuspid valve disease.

Infective Endocarditis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Infective endocarditis may affect patients after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was to provide detailed information on incidence rates, types of microorganisms, and outcomes of infective endocarditis after TAVR. METHODS: Between February 2011 and July 2018, consecutive patients from the SwissTAVI Registry were eligible. Infective endocarditis was classified into early (peri-procedural [<100 days] and delayed-early [100 days to 1 year]) and late (>1 year) endocarditis. Clinical events were adjudicated according to the Valve Academic Research Consortium-2 endpoint definitions. RESULTS: During the observational period, 7,203 patients underwent TAVR at 15 hospitals in Switzerland. During follow-up of 14,832 patient-years, endocarditis occurred in 149 patients. The incidence for peri-procedural, delayed-early, and late endocarditis after TAVR was 2.59, 0.71, and 0.40 events per 100 person-years, respectively. Among patients with early endocarditis, Enterococcus species were the most frequently isolated microorganisms (30.1%). Among those with peri-procedural endocarditis, 47.9% of patients had a pathogen that was not susceptible to the peri-procedural antibiotic prophylaxis. Younger age (subhazard ratio [SHR]: 0.969; 95% confidence interval [CI]: 0.944 to 0.994), male sex (SHR: 1.989; 95% CI: 1.403 to 2.818), lack of pre-dilatation (SHR: 1.485; 95% CI: 1.065 to 2.069), and treatment in a catheterization laboratory as opposed to hybrid operating room (SHR: 1.648; 95% CI: 1.187 to 2.287) were independently associated with endocarditis. In a case-control matched analysis, patients with endocarditis were at increased risk of mortality (hazard ratio: 6.55; 95% CI: 4.44 to 9.67) and stroke (hazard ratio: 4.03; 95% CI: 1.54 to 10.52). CONCLUSIONS: Infective endocarditis after TAVR most frequently occurs during the early period, is commonly caused by Enterococcus species, and results in considerable risks of mortality and stroke. (NCT01368250).

Long-term outcomes with balloon-expandable and self-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve implantation for severe aortic stenosis.

BACKGROUND: Data on long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce. METHODS: We investigated long term outcomes of consecutive patients undergoing TAVI with balloon- and self-expandable bioprostheses (Edwards SAPIEN (ESV), Edwards Lifesciences Inc., Irvine, CA, USA; Medtronic Corevalve system (MCS), Medtronic Inc., Minneapolis, MN, USA). RESULTS: Among 628 patients (mean age 82.4 ±â€¯5.8 years, 55% female), 489 (77.8%) underwent transfemoral TAVI. 309 (63.2%) patients received a MCS prosthesis, whereas 180 (36.8%) patients were treated with an ESV prosthesis. The median duration of follow-up amounted to 5.2 years (range 3.4-8.3 years). All-cause mortality did not differ between the two groups (MCS 46.9%, ESV 53.4%, CI 95%: RR 1.21 [0.93-1.57], P = 0.15), whereas cardiac mortality was higher in the ESV cohort after 5 years of follow-up (MCS 35.1%, ESV 45.4%, CI 95%: RR 1.37 [1.01-1.86], P = 0.04). Structural valve deterioration, which was on average diagnosed 41.9 months (range 18-60 months) after TAVI, occurred in 8 cases (1.6%), resulting in one repeat intervention. CONCLUSIONS: While half of all patients died within 5 years after TAVI with no significant differences in all-cause mortality, structural valve deterioration was documented in <2% of cases.

Clinical outcomes in high-risk patients with a severe aortic stenosis: a seven-year follow-up analysis.

INTRODUCTION: The aim of this study was to assess the clinical outcomes of high-risk patients with severe aortic stenosis (AS) allocated to medical treatment (MT), transcatheter aortic valve replacement (TAVR), and surgical aortic valve replacement (SAVR) through extended follow-up. METHODS AND RESULTS: Consecutive patients with severe symptomatic AS included in a prospective single centre registry underwent sweep follow-up between March and August 2016. Clinical outcomes were assessed using a competing risk model. A total of 442 patients (median age 83 years; 52% female) were allocated to MT (n = 78), SAVR (n = 107), or TAVR (n = 257) with a gradient of surgical risk as assessed by logistic EuroSCORE (MT: 27.9 ± 14.5%, TAVR: 24.7 ± 24.9%, SAVR: 12.5 ± 8.2%; p <0.001). Survival after a median duration of follow-up of seven years was 6.4% (MT), 30.4% (TAVR), and 46.7% (SAVR), respectively (p <0.001). One TAVR and one SAVR patient underwent repeat intervention for valvular degeneration between 4.5 and 8.4 years after intervention. Compromised left ventricular function (LVEF <40%) was associated with increased mortality (HR 1.62, 95% CI 1.22–2.15; p <0.0001), whereas female sex was protective (HR 0.68, 95% CI 0.53–0.88; p = 0.0006). CONCLUSION: Both TAVR and SAVR reduced mortality compared to MT throughout a median duration of follow-up of seven years. Repeat interventions for valvular degeneration were rare.