Use of the Lotus Transcatheter Valve to Treat Severe Native Aortic Regurgitation.

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for aortic stenosis in high-risk patients. TAVI for native valve aortic regurgitation is technically more demanding because of a lack of anchoring calcification, a lower index incidence, heterogeneous causes, and larger anatomy. We present 3 cases in which the Lotus TAV was used to treat severe native aortic regurgitation (AR) successfully.

The effect of coronary artery disease defined by quantitative coronary angiography and SYNTAX score upon outcome after transcatheter aortic valve implantation (TAVI) using the Edwards bioprosthesis.

AIMS: We sought to evaluate the effects of significant coronary artery disease (CAD) upon outcome after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We performed a retrospective study of 271 consecutive patients undergoing TAVI using either the Edwards SAPIEN or Edwards SAPIEN XT valve. Pre-procedural coronary angiograms were analysed by quantitative coronary angiography (defining significant CAD as a stenosis of ≥70% or ≥50% if in the left main stem or a vein graft). Ninety-three out of 271 patients had significant CAD. There was no difference in mortality at 30 days or 12 months between the two groups (6.7% vs. 7.5% and 21.5% vs. 23.7%; log-rank p=0.805). A secondary analysis using the SYNTAX algorithm of coronary anatomy complexity was performed on 189 patients. Those in the high SYNTAX score (>33) group had higher mortality at 30 days and 12 months (14.3% and 57.1%) than the low (5.2% and 23.3%) and intermediate-risk groups (11.1% and 22.2%; log-rank p=0.007). ROC analysis identified a SYNTAX score of >9 at the time of TAVI as the optimal cut-off, with an independent association with mortality (HR 1.95 [95% CI: 1.21-3.13]; p=0.006). Patients with a SYNTAX score >9 had greater 30-day, 12-month and overall mortalities than those with a SYNTAX score <9 (3.7% vs. 11.3% and 20.7% vs. 34.3%; log-rank p=0.005). CONCLUSIONS: Significant CAD, as defined using "real-world" QCA margins, did not have a significant effect upon mortality after TAVI for severe aortic stenosis. However, higher-risk SYNTAX groups, including those with a score >9, had increased mortality.

Meta-analysis of the impact of mitral regurgitation on outcomes after transcatheter aortic valve implantation.

Significant mitral regurgitation (MR) constitutes an important co-existing valvular heart disease burden in the setting of aortic valve stenosis. There are conflicting reports on the impact of significant MR on outcomes after transcatheter aortic valve implantation (TAVI). We evaluated the impact of MR on outcomes after TAVI by performing a meta-analysis of 8 studies involving 8,927 patients reporting TAVI outcomes based on the presence or absence of moderate-severe MR. Risk ratios (RRs) were calculated using the inverse variance random-effects model. None-mild MR was present in 77.8% and moderate-severe MR in 22.2% of the patients. The presence of moderate-severe MR at baseline was associated with increased mortality at 30 days (RR 1.35, 95% confidence interval [CI] 1.14 to 1.59, p = 0.003) and 1 year (RR 1.24, 95% CI 1.13 to 1.37, p <0.0001). The increased mortality associated with moderate-severe MR was not influenced by the cause of MR (functional or degenerative MR; RR 0.90, 95% CI 0.62 to 1.30, p = 0.56). The severity of MR improved in 61 ± 6.0% of patients after TAVI. Moderate-severe residual MR, compared with none-mild residual MR after TAVI, was associated with significantly increased 1-year mortality (RR 1.48, 95% CI 1.31 to 1.68, p <0.00001). In conclusion, baseline moderate-severe MR and significant residual MR after TAVI are associated with an increase in mortality after TAVI and represent an important group to target with medical or transcatheter therapies in the future.

The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial.

BACKGROUND: Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting (CABG) in patients undergoing surgical aortic valve replacement. However there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation (TAVI). METHODS/DESIGN: The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial is a randomized, controlled open-label trial of 310 patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention (PCI - test arm) or no PCI (control arm). Significant coronary disease is defined as ≥1 lesion of ≥70% severity in a major epicardial vessel or 50% in a vein graft or protected left main stem lesion. The trial tests the hypothesis that the strategy of performing pre-TAVI PCI is non-inferior to not treating such coronary stenoses with PCI prior to TAVI, with a composite primary outcome of 12-month mortality and rehospitalization. Secondary outcomes include efficacy end-points such as 30-day mortality, safety endpoints including bleeding, burden of symptoms, and quality of life (assessed using the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire). In conclusion, we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the 50% severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding TAVI therapy and improve its safety and efficacy profile of this developing technique. TRIAL REGISTRATION: ISRCTN75836930, http://www.controlled-trials.com/ISRCTN75836930 (registered 19 November 2011).

The effects of VARC-defined acute kidney injury after transcatheter aortic valve implantation (TAVI) using the Edwards bioprosthesis.

AIMS: The aim of this study was to identify the incidence and risk factors for acute kidney injury (AKI) after TAVI, a potentially serious complication of transcatheter aortic valve implantation (TAVI) that has been redefined by the Valve Academic Research Consortium (VARC). METHODS AND RESULTS: We performed a retrospective analysis of 248 patients undergoing TAVI. AKI was defined as a VARC-modified Risk, Injury, Failure, Loss, and End-stage (RIFLE) kidney disease score ≥ 2. Eighty-nine patients suffered AKI (35.9%) and demonstrated increased mortality at 30 days (13.5% vs. 3.8%) and one year (31.5% vs. 15.0%) (p<0.001). Multivariate regression analysis identified diabetes mellitus (p<0.001), peripheral vascular disease (p=0.007), chronic kidney disease stage (p=0.010) as independently associated risk factors for AKI. CONCLUSIONS: More than one third of patients sustain AKI after TAVI using the Edwards bioprosthesis, as defined by the VARC-modified RIFLE score. AKI increased the mortality at both 30 days and at one year. A history of diabetes mellitus, peripheral vascular disease and higher chronic kidney disease stage had the strongest independent associations with post-TAVI AKI.

Successful treatment of a late presentation exercise-induced spontaneous left anterior descending artery dissection.

Spontaneous coronary artery dissection is an unusual condition that mainly happens in fit and healthy women in the peripartum period. Strenuous exercise is a rare cause of dissection in angiographically normal coronary arteries. There is no definitive consensus on the etiology, prognosis and treatment of SCAD. We report a case of successful treatment of a late presentation of a coronary artery dissection secondary to intense physical activity in a 48 year old cyclist who continued to cycle for 3 months post event.