scholarly journals Early Real-World Experience with CoreValve Evolut PRO and R Systems for Transcatheter Aortic Valve Replacement

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Gaurav Rao ◽  
Shikha Sheth ◽  
Joseph Donnelly ◽  
Andrew Scatola ◽  
Umair Tariq ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Real World ◽  
Transcatheter Aortic Valve Replacement ◽  
Vascular Complications ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
Tertiary Center ◽  
Safety Endpoint

Objectives. The purpose of this study was to compare the efficacy and safety of the Evolut PRO to the Evolut R valve in a real-world setting. Background. The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. Methods. We retrospectively studied 134 patients who underwent TAVR with the Evolut PRO or Evolut R valve over one year at a tertiary center. Endpoints, defined by the Valve Academic Research Consortium-2 criteria, included device success, paravalvular leak (PVL), and a composite safety endpoint including mortality, stroke, major vascular complications, life-threatening bleeding, acute kidney injury, coronary artery obstruction, and repeat procedure for valve-related dysfunction. Results. 60 Evolut PRO and 56 Evolut R patients met the study criteria. Both groups had similar device success rates (90 vs. 89%, p=0.44). Incidence of moderate PVL was similar on discharge (5 vs. 11%, p=0.68) and at 30 days (11 vs. 13%, p=0.79), with nil incidence of severe PVL. There were no mortalities, and the VARC-2 safety endpoint at 30 days was comparable. Conclusion. Despite the additional pericardial skirt and larger sheath size of Evolut PRO, outcomes were comparable between the two Evolut systems, supporting adoption of the newest generation valve in the management of severe aortic stenosis as well as continued use of the Evolut R in patients with smaller vasculature warranting a lower profile device.

Abstract 16920: Transcatheter Aortic Valve Replacement in Aortic Regurgitation: The U.S. Experience

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Chinmy T Jani ◽  
Shilpkumar Arora ◽  
Sopan Lahewala ◽  
ZACHARY ZUZEK ◽  
Rahul Jaswaney ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Vascular Complications ◽  
Paravalvular Leak ◽  
Open Heart ◽  
Transcatheter Aortic Valve

Background: Transcatheter aortic valve replacement (TAVR) may be an effective option for high-risk AR patients. Although international experiences of TAVR for AR are published, U.S. data is limited. The primary objective of this study was to investigate periprocedural and 30-days outcomes in terms of mortality and post-procedural complications in patients undergoing TAVR for AR using large national U.S. databases. Hypothesis: TAVR is a promising option in AR Methods: Study cohorts were derived from Nationwide Inpatient Sample (NIS) and Nationwide Readmissions Database (NRD) 2016-17. TAVR and AR were identified using ICD-10-CM-codes. The key outcomes were all-cause mortality, disabling stroke, valvular complications, complete heart block (CHB)/ permanent pacemaker placement (PPM), open heart surgery, acute kidney injury (AKI) requiring dialysis, and vascular complications. Multivariate logistic regression was used to adjust for confounders. Results: 915 patients from the NIS (male-71%, age 65-84.2%) and 822 patients from the NRD (male-69.3%, age 65-80.5%) underwent TAVR for AR. The median length of stay (LOS) was 4 days for both cohorts. In-hospital mortality was 2.7% in NIS and 30-day mortality was 3.3% in NRD. Disabling strokes were noted in 0.6% peri-procedurally and 1.8% at 30-days. Valve-related complications were 18-19% with paravalvular leak being the most common. Approximately 11% of patients developed CHB and/or needed PPM in both cohorts. In NRD, 2.2% of patients required dialysis for AKI, 1.5% developed vascular complications, and 0.6% required open-heart surgery within 30-days post-procedure. Anemia was predictive of increased overall complications and valvular complications, whereas, peripheral vascular disease was predictor of increased valvular complications and CHB/PPM. Conclusion: TAVR is a promising option in AR. Further studies are necessary for the expansion of TAVR as standard treatment in AR.

scholarly journals Concurrent mechanical haemolytic anaemia and heparin-induced thrombocytopenia following transcatheter aortic valve replacement

2018 ◽  
pp. bcr-2017-224069
Author(s):  
Nathan W Furukawa ◽  
Fernando M Jumalon ◽  
Daniel B Friedman ◽  
Linda R Kelly
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Prothrombin Time ◽  
Valve Replacement ◽  
Haemolytic Anaemia ◽  
Transcatheter Aortic Valve Replacement ◽  
Severe Aortic Stenosis ◽  
Paravalvular Leak ◽  
Heparin Induced Thrombocytopenia ◽  
Transcatheter Aortic Valve

A 78-year-old man with a history of severe aortic stenosis presented with confusion, irregular behaviour and dyspnoea 8 days following transcatheter aortic valve replacement. His exam was consistent with a heart failure exacerbation and he had elevated aminotransferases, bilirubin and prothrombin time suggestive of shock liver. A CT head scan demonstrated a subacute large left temporoparietal infarction. His aminotransferase and prothrombin time levels normalised with diuresis, but his indirect bilirubin remained elevated and he developed anaemia and thrombocytopenia consistent with a haemolytic anaemia. A transthoracic echocardiogram demonstrated a paravalvular leak. His thrombocytopenia continued to worsen prompting testing for antibodies against heparin-PF4 complexes which was positive. A serotonin release assay later returned positive, confirming the diagnosis of heparin-induced thrombocytopenia. This case illustrates that the presence of haemolytic anaemia does not necessarily exclude other causes of thrombocytopenia that may occur concurrently.

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