Outcomes Of Transcatheter Aortic Valve Implantation Research Articles

Improvements in Transcatheter Aortic Valve Implantation Outcomes in Lower Surgical Risk Patients: A Glimpse Into the Future

The purpose of this study was to investigate the evolution of patient selection criteria for transcatheter aortic valve implantation (TAVI) and its impact on clinical outcomes. Anecdotal evidence suggests that patient selection for TAVI is shifting toward lower surgical risk patients. The extent of this shift and its impact on clinical outcomes, however, are currently unknown. We conducted a single-center study that subcategorized TAVI patients into quartiles (Q1 to Q4) defined by enrollment date. These subgroups were subsequently examined for differences in baseline characteristics and 30-day and 6-month mortality rate. The relationship between quartiles and mortality rate was examined using unadjusted and adjusted (for baseline characteristics) Cox proportional hazard models. Each quartile included 105 patients (n = 420). Compared with Q4 patients, Q1 patients had higher logistic EuroSCORES (25.4 ± 16.1% vs. 17.8 ± 12.0%, p < 0.001), higher Society of Thoracic Surgeons scores (7.1 ± 5.5% vs. 4.8 ± 2.6%, p > 0.001), and higher median N-terminal pro-B-type natriuretic peptide levels (3,495 vs. 1,730 ng/dl, p < 0.046). From Q1 to Q4, the crude 30-day and 6-month mortality rate decreased significantly from 11.4% to 3.8% (unadjusted hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.11 to 1.01; p = 0.053) and from 23.5% to 12.4% (unadjusted HR: 0.49; 95 CI: 0.25 to 0.95; p = 0.07), respectively. After adjustment for baseline characteristics, there were no significant differences between Q1 and Q4 in 30-day mortality rate (adjusted HR ratio: 0.29; 95% CI: 0.08 to 1.08; p = 0.07) and 6-month mortality rate (HR: 0.67; 95% CI: 0.25 to 1.77; p = 0.42). The results of this study demonstrate an important paradigm shift toward the selection of lower surgical risk patients for TAVI. Significantly better clinical outcomes can be expected in lower than in higher surgical risk patients undergoing TAVI.

PARTNER Cohort B: TAVI Superior to Standard Therapy at Two Years

Transcatheter aortic valve implantation (TAVI) is the recommended treatment for “inoperable” patients with severe aortic stenosis, based on the 1-year results of the PARTNER trial [NCT00530894; Leon MB et al. N Engl J Med 2010]. The objective of this PARTNER trial analysis was to evaluate the clinical outcomes of TAVI compared with standard therapy at 2 years in patients with inoperable AS [PARTNER Cohort B].

Comparison of Outcomes in Patients Having Isolated Transcatheter Aortic Valve Implantation Versus Combined With Preprocedural Percutaneous Coronary Intervention

Coronary artery disease negatively affects the outcome of patients undergoing surgical aortic valve replacement and practice guidelines recommend revascularization at time of surgery. In patients undergoing transcatheter aortic valve implantation (TAVI), the impact of preprocedural percutaneous coronary intervention (PCI) on TAVI outcome has not been examined. We aimed in the present study to assess the feasibility and safety of performing PCI before TAVI and to evaluate procedural, 30-day, and 6-month clinical outcomes. We retrospectively analyzed 125 patients who underwent successful TAVI at a single institution and divided them into an isolated TAVI and a PCI + TAVI group. During the study period, a strategy of preprocedural PCI of all significant (>50%) lesions in major epicardial vessels was adopted. Study end points were adjudicated in accordance with the Valve Academic Research Consortium consensus on event definition. All patients were treated with the Medtronic CoreValve prosthesis (n = 55 with PCI + TAVI and n = 70 with isolated TAVI). Thirty-day mortality was 2% versus 6% for patients treated with PCI + TAVI versus isolated TAVI, respectively (p = 0.27). Neither periprocedural nor spontaneous myocardial infarction occurred in either group. Rates of 30-day stroke, major bleeding, major vascular complications, and the Valve Academic Research Consortium-defined combined safety end point (11% vs 13%, p = 0.74) did not differ between the 2 groups. Patients' symptoms significantly improved in the first month after TAVI, and extent of improvement did not differ between groups. Adverse events at 6 months were comparable. In conclusion, PCI before TAVI appears feasible and safe. Based on these early results revascularization should become an important consideration in patients with coronary artery disease undergoing TAVI.

Clinical Outcomes of Patients With Severe Aortic Stenosis at Increased Surgical Risk According to Treatment Modality

The aim of this study was to assess the role of transcatheter aortic valve implantation (TAVI) compared with medical treatment (MT) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) at increased surgical risk. Elderly patients with comorbidities are at considerable risk for SAVR. Since July 2007, 442 patients with severe AS (age: 81.7 ± 6.0 years, mean logistic European System for Cardiac Operative Risk Evaluation: 22.3 ± 14.6%) underwent treatment allocation to MT (n = 78), SAVR (n = 107), or TAVI (n = 257) on the basis of a comprehensive evaluation protocol as part of a prospective registry. Baseline clinical characteristics were similar among patients allocated to MT and TAVI, whereas patients allocated to SAVR were younger (p < 0.001) and had a lower predicted peri-operative risk (p < 0.001). Unadjusted rates of all-cause mortality at 30 months were lower for SAVR (22.4%) and TAVI (22.6%) compared with MT (61.5%, p < 0.001). Adjusted hazard ratios for death were 0.51 (95% confidence interval: 0.30 to 0.87) for SAVR compared with MT and 0.38 (95% confidence interval: 0.25 to 0.58) for TAVI compared with MT. Medical treatment (<0.001), older age (>80 years, p = 0.01), peripheral vascular disease (<0.001), and atrial fibrillation (p = 0.04) were significantly associated with all-cause mortality at 30 months in the multivariate analysis. At 1 year, more patients undergoing SAVR (92.3%) or TAVI (93.2%) had New York Heart Association functional class I/II as compared with patients with MT (70.8%, p = 0.003). Among patients with severe AS with increased surgical risk, SAVR and TAVI improve survival and symptoms compared with MT. Clinical outcomes of TAVI and SAVR seem similar among carefully selected patients with severe symptomatic AS at increased risk.

One-Year Outcomes of Cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry

Background— Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement. Methods and Results— The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P =0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality. Conclusion— The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured.

Transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving strategy for therapy of aortic stenosis. We describe the effect of the learning curve from the first 270 high-risk patients in Vancouver, Canada. Patients underwent TAVI by transfemoral (63%) or transapical (37%) routes using balloon expandable valves. The experience was divided into the first half (FH, patients 1-135) and second half (SH, patients 136-270). The mean age was 83.2 ± 8 years (FH 83 ± 12 vs. SH 81 ± 7 years, P = 0.12). The mean Society of Thoracic Surgeons Score (STS) was 9.5% ± 5.2%- FH 10.5 vs. SH 8.5% (P = 0.01). The overall procedural success rate in the FH was 92.6%, improving to 97.8% in the SH (P = 0.05). The transfemoral procedural success improved-FH 89.3% to SH 98.8% (P = 0.01). The transapical procedural success remained high-FH 98.0% to SH 96.1% (P = 0.53). The overall 30-day mortality was 9.6%, improving from FH 13.3% to SH 5.9% (P = 0.04). In the transfemoral cases, 30-day mortality decreased by 56% [10.7-4.7%, P = 0.14], and similarly in transapical cases [17.6-7.8%, P = 0.14]. In-hospital stroke occurred in 3.3% (FH 3.7% vs. SH 2.9%, P = 0.74). The overall need for a new permanent pacemaker was 5.9% (FH 5.9% vs. SH 5.9%, P = 1). The overall major vascular injury rate was 6.7% (FH 8.1% vs. SH 5.2%, P = 0.33). The overall incidence of coronary vessel occlusion was 1.1% (FH 1.5 % vs. SH 0.7%, P = 0.56). Device embolization or failure to cross the valve was rare and largely seen in the FH only. Procedural experience (>135 procedures) was an independent predictor of 30-day survival (HR: 6.7, 95% CI: 1.2-18.1, P = 0.03). TAVI outcomes improve with experience and device development. While overall complication rates are low, scope remains to further reduce procedural adverse events.

Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes

Transcatheter aortic valve implantation (TAVI) is a treatment option for high-risk patients with severe aortic stenosis. Previous reports focused on a single device or access site, whereas little is known of the combined use of different devices and access sites as selected by the heart team. The purpose of this study is to investigate clinical outcomes of TAVI using different devices and access sites. A consecutive cohort of 200 patients underwent TAVI with the Medtronic CoreValve Revalving system (Medtronic Core Valve LLC, Irvine, CA; n = 130) or the Edwards SAPIEN valve (Edwards Lifesciences LLC, Irvine, CA; n = 70) implanted by either the transfemoral or transapical access route. Device success and procedure success were 99% and 95%, respectively, without differences between devices and access site. All-cause mortality was 7.5% at 30 days, with no differences between valve types or access sites. Using multivariable analysis, low body mass index (<20 kg/m(2)) (odds ratio [OR] 6.6, 95% CI 1.5-29.5) and previous stroke (OR 4.4, 95% CI 1.2-16.8) were independent risk factors for short-term mortality. The VARC-defined combined safety end point occurred in 18% of patients and was driven by major access site complications (8.0%), life-threatening bleeding (8.5%) or severe renal failure (4.5%). Transapical access emerged as independent predictor of adverse outcome for the Valve Academic Research Consortium-combined safety end point (OR 3.3, 95% CI 1.5-7.1). A heart team-based selection of devices and access site among patients undergoing TAVI resulted in high device and procedural success. Low body mass index and history of previous stroke were independent predictors of mortality. Transapical access emerged as a risk factor for the Valve Academic Research Consortium-combined safety end point.

097 Surgical aortic valve replacement in high risk octogenerians vs transcatheter aortic valve implantation

<h3>Introduction</h3> Transcatheter aortic valve implantation (TAVI) is considered to subject less immediate procedural risk than surgical aortic valve replacement (AVR) in high risk elderly patients. Therefore high risk Octogenarians are now being considered for TAVI in preference to AVR. The evidence for this strategy and methods for patient selection are not established. The use of the Logistic Euroscore (LES) in this context has been questioned. We have prospectively compared our TAVI patient characteristics and outcomes with retrospective analysis of high risk Octogenarians who underwent AVR. <h3>Methods</h3> The records of 273 patients aged 80 and over who underwent AVR at the Bristol Heart Institute between 1996 – 2008 were analysed. Patients with a Logistic Euroscore of 15 and above were identified as high risk including those that had concomitant bypass grafting. All TAVI procedures were performed with the Medtronic Corevalve system between Jan 2008 and Oct 2009. Data was collected prospectively as per the Central Cardiac Audit Database (CCAD) TAVI dataset and all patients were included for comparison. <h3>Results</h3> Abstract 097 Table 1 80 AVR patients and 41 TAVI procedures were identified. The median LES was 20.7 (average age 83.5, male 51.2%) and 16.4 (average age 83.9, male 48%) respectively. More TAVI patients had previous cardiac surgery (19.5% vs. 15%). The postoperative stroke rate was 4.8% in the TAVI group vs. 6% for AVR. The rate of pacemaker implantation was greater in the TAVI group (24.4% vs. 11%). Mortality rates were significantly lower in the TAVI group (30 day mortality 2.4% vs. 14%, 90 day mortality 2.4% vs. 19%). There was a shorter median postoperative recovery for the TAVI patients prior to discharge (7 days vs. 11 days) and more patients were discharged directly home to indepedence (90.2% vs. 44%). <h3>Conclusion</h3> In this historical, clinically selected group of Octogenarians the LES appears to correlate well with subsequent surgical risk of AVR. In our current cohort of high risk elderly patients undergoing TAVI there are comparatively lower mortality rates, shorter recovery times and earlier discharges home to independence. However, Corevalve patients are requiring more post-procedure permanent pacemakers. In elderly patients with symptomatic aortic stenosis it is appropriate to use LES as a factor to identify those who are likely to have a better outcome with TAVI compared to traditional AVR.