The safety of introducing a new generation TAVR device: one departments experience from introducing a second generation repositionable TAVR.

BACKGROUND: In the evolving field of transcatheter aortic valve replacements a new generation of valves have been introduced to clinical practice. With the complexity of the TAVR procedure and the unique aspects of each TAVR device, there is a perceived risk that changing or adding a new valve in a department could lead to a worse outcome for patients, especially during the learning phase. The objective was to study the safety aspect of introducing a second generation repositionable transcatheter valve (Boston Scientific Lotus valve besides Edwards Sapien valve) in a department. METHODS: In a retrospective study, 53 patients receiving the Lotus system, and 47 patients receiving the Sapien system over a period of three years were compared for short-term outcome according to VARC-2 definitions and 1-year survival. RESULTS: Outcome in terms VARC-2 criteria for early safety and clinical efficacy, stroke rate, and survival at 30 days and at 1 year were similar. The Lotus valve had less paravalvular leakage, where 90% had none or trace aortic insufficiency as compared to only 48% for the Sapien system. CONCLUSIONS: Introduction of a new generation valve can be done with early device success and safety, and without jeopardizing the outcome for patients up to one year. We found no adverse effects by changing valve type and observed improved outcome in terms of lower PVL-rates. Both existing and new centers starting a TAVR program can benefit from the use of a new generation device.

Transcatheter versus surgical treatment for aortic stenosis: patient selection and early outcome.

OBJECTIVES: To describe short-term clinical and echocardiography outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). To explore patient selection criteria for treatment with TAVI. DESIGN: TAVI patients (n = 45) were matched to SAVR patients (n = 45) with respect to age within ± 10 years, sex and systolic left ventricular function. RESULTS: TAVI patients were older, 82 ± 8 versus 78 ± 5 years (p = 0.005) and they had higher logEuroSCORE, 16 ± 11% versus 8 ± 4% (p = 0.001). There were no significant differences in 30 days mortality, stroke and myocardial infarction. TAVI patients received less erythrocyte (53% vs. 78%, p = 0.03) and thrombocyte (7% vs. 27%, p = 0.02) transfusions. Postoperative atrial fibrillation was less common (18% vs. 60%, p = 0.001) in the TAVI group. Paravalvular regurgitation was more common in TAVI patients (87% vs. 0%, p = 0.001) and 27% had access site complications. Aortic transvalvular velocity was 2.3 ± 0.4 m/s versus 2.6 ± 0.5 m/s (p = 0.002) and mean valve pressure gradient was 12 ± 4 mmHg versus 15 ± 5 mmHg (p = 0.01) in the TAVI and SAVR groups, respectively. Twenty-nine (64%) of the TAVI patients had logEuroSCORE = 15%. CONCLUSIONS: Both TAVI and SAVR have good short term clinical outcome with excellent hemodynamic result. In clinical practice, factors other than high logEuroSCORE play an important role in patient selection for TAVI.

Evaluation of the Valve Academic Research Consortium-2 Criteria for Myocardial Infarction in Transcatheter Aortic Valve Implantation: A Prospective Observational Study.

OBJECTIVE: To evaluate the relevance of the individual components of the Valve Academic Research Consortium (VARC)-2 criteria for periprocedural myocardial infarction (MI) in transcatheter aortic valve implantation (TAVI). The association between biomarkers and adverse procedural outcome has been established. However, the additive prognostic importance of signs and symptoms are more uncertain. METHODS: A total of 125 consecutive TAVI patients were prospectively included in this study. Biomarkers for MI were analyzed and signs and symptoms according to VARC-2 criteria were collected from clinical records. RESULTS: The criteria of elevated biomarkers and of signs or symptoms were found in 27 (22%) and 32 (26%) of the patients, respectively. According to VARC-2 definition, 12 (10%) had MI. VARC-2 definition of MI, Troponin T (TnT) > 600 ng/L, and presence of signs or symptoms correlated with 6 months mortality, prolonged ICU stay, elevation of N-terminal prohormone brain natriuretic peptide, and renal impairment. No signs or symptoms were found in 7 (44%) of the patients who fulfilled the criterion of elevated TnT > 600 ng/L. In the group with positive TnT criterion, there were no significant differences between those with and without signs or symptoms in respect to levels of TnT (1014 [585-1720] ng/L versus 704 [515-905] ng/L, p = 0.17) or creatine kinase-MB (36 [25-52] µg/L versus 29 [25-39] µg/L, p = 0.32). In the multivariate Cox regression analysis, TnT > 600 ng/L was the only significant independent variable associated with 6-months postprocedural mortality. CONCLUSIONS: Myocardial injury in TAVI, measured with biomarkers, correlates well with adverse procedural outcome. In this study it is also the strongest predictor for early postprocedural mortality. The additional requirement of signs or symptoms for the diagnosis of MI results in omission of a considerable number of clinically significant MI.