Utility of conventional aortic root shot angiography for SAPIEN 3 prosthesis sizing in TAVI: feasibility and inter-reader variability.

Background: The gold-standard approach to prosthesis sizing before transcatheter aortic valve implantation (TAVI) is multislice computed tomography (MSCT). We aimed to investigate whether conventional aortic root angiography (CA) alone can reliably facilitate valve selection and to describe its inter-reader variability. Methods: Five TAVI specialists (3 interventional cardiologists and 2 cardiac surgeons) independently reviewed preprocedural CAs for 50 patients implanted with the Edwards SAPIEN 3 valve. Results: The prosthesis size selected based on visual CA appraisal matched that based on MSCT in 60% of cases (range: 50%-68%), with undersizing in 11% (4%-33%) and oversizing in 29% (10%-46%; p=0.187 for equality of the proportions test). Agreement between CA-based and MSCT-based valve selection was moderate (K=0.41; Kw=0.61). Reassessment of choice following awareness of the annulus long-axis diameter did not significantly improve this agreement (0.40 and 0.63, respectively), though more undersizing (14%) and less oversizing (25%) occurred. Correct valve selection was more common in interventional cardiologists than cardiac surgeons (66% vs 53%; p=0.0391), who made more oversizing errors. Conclusions: There is a modest agreement between CA-based and MSCT-based SAPIEN 3 selection. Although the former should not be performed routinely, it may be informative in settings where MSCT and transoesophageal echocardiography are unavailable.

Standardized methodology for transfemoral transcatheter aortic valve replacement with the Edwards Sapien XT valve under fluoroscopy guidance.

OBJECTIVES: To provide a simplified, standardized methodology for a successful transfemoral transcatheter aortic valve replacement (TAVR) procedure with the Sapien XT valve in patients with severe aortic stenosis (AS). BACKGROUND: TAVR is currently reserved for patients with severe, symptomatic AS who are inoperable or at high operative risk. In many institutions, TAVR is performed under general anesthesia with intubation or with conscious sedation. In addition, many institutions still use transesophageal echo (TEE) during the procedure for aortic root angulations and positioning of the valve prior to implantation. Methods. We enrolled 100 consecutive patients (mean age, 80 ± 7 years; range, 50-94 years; female n=59) with severe symptomatic AS. Annulus measurements were based on computed tomography angiograms. All patients underwent fluoroscopy-guided transfemoral TAVR with little to no sedation and without simultaneous TEE. RESULTS: TAVR was predominantly performed with the use of local and central analgesics; only 36% of our cohort received conscious sedation. Procedural success of TAVR was 99%. Transthoracic echocardiography before discharge excluded aortic regurgitation (AR) >2 in all patients (AR >1; n=6). In-hospital stroke rate was 6%. The vessel closure system was successfully employed in 96%. Major vascular complication rate was 1%. The 30-day mortality was 2%. CONCLUSIONS: Fluoroscopy-guided TAVR with the use of just analgesics with or without conscious sedation is safe and effective, and this potentially enables a more time-effective and cost-effective procedure. This paper provides simplified, stepwise guidance on how to perform transfemoral TAVR with the Sapien XT valve.

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. CONCLUSIONS: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.

Costs of excessive postoperative hemorrhage in cardiac surgery.

BACKGROUND: Excessive postoperative hemorrhage in cardiac surgery is a serious clinical complication placing substantial demands on hospital resources. This study quantifies the exact impact of postoperative hemorrhage on hospital costs in Germany. METHODS: We retrospectively analyzed data collected prospectively in the Quality Assurance Database at the Heart Center of the Klinikum Augsburg, Germany. All relevant perioperative data for resources consumption were analyzed and compared in patients with and without excessive postoperative hemorrhage in cardiac surgery. Multivariate regression analysis identified the incremental costs of postoperative hemorrhage while adjusting for potential confounding. RESULTS: A total of 1118 patients had cardiac surgery between January and December 2006. Six percent were identified with excessive postoperative hemorrhage. The risk of experiencing a postoperative complication (including death) (P < .0001), returning to operating room for reexploration (P < .0001), staying in intensive care unit for longer than 72 hours (P < .0001), receiving ventilation for longer than 24 hours (P < .0001), and receiving any kind of postoperative blood transfusion (P < .0001) was significantly higher in patients with excessive postoperative hemorrhage. Twenty-two percent of patients with excessive postoperative hemorrhage died compared with 6% of the patients without excessive postoperative hemorrhage (P < .0001). When adjusting for potential confounding factors, the incremental costs of excessive postoperative hemorrhage was euro6251 (95% confidence interval, 4594-7909). CONCLUSIONS: The average hospital costs related to excessive postoperative hemorrhage in cardiac surgery in Germany are substantial and associated with a significant risk of postoperative complications and death. Clinical interventions that can effectively prevent or address excessive postoperative hemorrhage in cardiac surgery are likely to have substantial cost-effectiveness potential.