Remdesivir-Associated Acute Liver Failure in a COVID-19 Patient: A Case Report and Literature Review.

There is a broad classification of the causes of acute liver failure (ALF) that include drug-induced liver injury (DILI). In this report, we aim to discuss the association between remdesivir, a novel therapeutic drug for hypoxic coronavirus disease 2019 (COVID-19) pneumonia, and DILI with subsequent ALF in a patient who was recently treated with the drug in question. Remdesivir, which is a direct-acting nucleoside RNA polymerase inhibitor, is one of the only FDA-approved drugs on the market for COVID-19 pneumonia associated with hypoxia. Our case describes a patient with an extensive past medical history who was treated for COVID-19 pneumonia with remdesivir and subsequently developed ALF in the absence of all other possible etiologies. This association has only been highlighted in anecdotal case reports in the past and to a lesser degree in the safety documentation of remdesivir.

Outcomes in Patients With Transcatheter Aortic Valve Replacement and Left Main Stenting: The TAVR-LM Registry.

BACKGROUND: A percutaneous approach with transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI) of the left main coronary artery (LM) is frequently used in high-risk patients with coexisting aortic stenosis and LM disease. Outcomes of TAVR plus LM PCI have not been previously reported. OBJECTIVES: The primary objective of the TAVR-LM registry is to evaluate clinical outcomes in patients undergoing TAVR plus LM PCI. METHODS: Clinical, echocardiographic, computed tomographic, and angiographic characteristics were retrospectively collected in 204 patients undergoing TAVR plus LM PCI. In total, 128 matched patient pairs were generated by performing 1:1 case-control matching between 167 patients with pre-existing LM stents undergoing TAVR and 1,188 control patients undergoing TAVR without LM revascularization. RESULTS: One-year mortality (9.4% vs. 10.2%, p = 0.83) was similar between the TAVR plus LM PCI cohort and matched controls. One-year mortality after TAVR plus LM PCI was not different in patients with unprotected compared with protected LMs (7.8% vs. 8.1%, p = 0.88), those undergoing LM PCI within 3 months compared with those with LM PCI greater than 3 months before TAVR (7.4% vs. 8.6%, p = 0.61), and those with ostial versus nonostial LM stents (10.3% vs. 15.6%, p = 0.20). Unplanned LM PCI performed because of TAVR-related coronary complication, compared with planned LM PCI performed for pre-existing LM disease, resulted in increased 30-day (15.8% vs. 3.4%, p = 0.013) and 1-year (21.1% vs. 8.0%, p = 0.071) mortality. CONCLUSIONS: Despite the anatomic proximity of the aortic annulus to the LM, TAVR plus LM PCI is safe and technically feasible, with short- and intermediate-term clinical outcomes comparable with those in patients undergoing TAVR alone. These results suggest that TAVR plus LM PCI is a reasonable option for patients who are at high risk for surgery.

Feasibility and safety of balloon-expandable transcatheter aortic valve implantation with moderate or without predilatation.

AIMS: Aortic valve preparation by performing balloon aortic valvuloplasty (BAV) has always been considered mandatory during transcatheter aortic valve implantation (TAVI) procedures. We aimed to investigate the feasibility and safety of performing balloon-expandable TAVI with moderate or with no predilatation (PD). METHODS AND RESULTS: Overall, 121 patients underwent TAVI with no PD and 392 with moderate PD. TAVI endpoints and adverse events were considered according to the Valve Academic Research Consortium (VARC)-2 definitions. Device success for the entire cohort was 95.1%. Post-dilatation was performed in nine patients in the no PD group (7.4%) and in 40 patients in the moderate PD group (10.2%) (p=0.06). Total fluoroscopy time and the amount of contrast used were lower in the no PD group. All-cause mortality up to 30 days was 3.3% in the no PD group vs. 3.6% in the moderate PD group (p=0.89). VARC-2 defined complication rates at 30 days including cerebrovascular accident (CVA)/transient ischaemic attack (TIA) were similar between groups. Overall, there was no significant difference in survival rates between the two groups (HR 1.33, 95% CI: 0.75-2.35; p=0.34). CONCLUSIONS: Balloon-expandable TAVI with moderate or without balloon PD is feasible and safe. The omission of PD in appropriate cases was associated with reduced fluoroscopy time without affecting procedural success.

Balloon-expandable transcatheter aortic valve replacement in patients with extreme aortic valve calcification.

OBJECTIVES: To assess the procedural and short-term clinical outcome of performing balloon-expandable TAVR in patients with extremely calcified aortic valves. BACKGROUND: Quantity of aortic valve calcification predicts rates of paravalvular regurgitation (PVR) post transcatheter aortic valve replacement (TAVR). Nonetheless, short-term outcomes of balloon-expandable TAVR in patients with extremely high calcified aortic valves have not been previously described. METHODS: We studied patients with severe aortic stenosis that underwent balloon-expandable TAVR and had a pre-procedural non-contrast CT. Twenty patients that had aortic valve calcification score (AVCS) of more than 8,000 Agatston Units were compared to 279 patients with lower calcification scores. TAVR endpoints, device success and adverse events were considered according to the Valve Academic Research Consortium-2 definitions. RESULTS: Device success was 80% in the extremely high calcification group compared to 95.3% in patients with less calcified aortic valves (P = 0.004). There was significantly more postprocedural PVR in the extreme calcification group: 50%, 35%, 10%, 5% vs. 72.4%, 25.8%, 1.8%, 0% for no/trace, mild, moderate and severe PVR, respectively (P < 0.001). There was one case of ascending aortic perforation resulting in intramural hematoma that resolved with no treatment. In-hospital mortality, new pacemaker implantation and major complications were similar between groups. CONCLUSIONS: Balloon-expandable TAVR in patients with extremely calcified aortic valve is associated with lower device success and greater risk of PVR. © 2015 Wiley Periodicals, Inc.

Comparison of Outcomes of Transcatheter Aortic Valve Implantation in Patients ≥90 Years Versus <90 Years.

Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is increasingly performed in nonagenarians. There is scarce evidence on the feasibility and safety of balloon-expandable TAVI in this patient population. A total of 734 patients who underwent balloon-expandable TAVI at our institute were included in the study. We compared 136 patients who were aged at least 90 years at the time of TAVI (mean age 92.4 ± 2.4 years) with the remaining 598 younger patients (mean age 79.7 ± 7.8 years). Valve Academic Research Consortium 2 end points were compared between the 2 groups. Diabetes mellitus, coronary artery disease (CAD), peripheral artery disease (PAD), and chronic lung disease were significantly less prevalent in patients aged ≥90 years. In contrast, the prevalence of frailty, chronic renal failure, and atrial fibrillation was significantly higher in these patients. Device success was 96% in both groups. All-cause mortality at 30 days and 1 year was 2.9% and 12.5% versus 2.8% and 12.3% in patients aged ≥90 and <90, respectively (p = 0.95 for both). All major complication rates were similar between groups. Nonagenarians had higher rates of minor vascular complications (13.2% vs 7.7%; p = 0.04). In conclusion, performing balloon-expandable TAVI in carefully selected group of nonagenarians is feasible and offers clinical benefit comparable to patients aged <90 years. Advanced age, in the absence of significant co-morbidities, should not deter clinicians from evaluating patients for TAVI for severe AS.