Outcomes of Transcatheter Aortic Valve Replacement in Patients Treated With Systemic Steroids.

BACKGROUND: Chronic steroid therapy is associated with higher vascular complication rates in patients undergoing transcatheter aortic valve replacement (TAVR). The effect of corticosteroids on aortic annular complications has not been directly assessed in this population. METHODS: A retrospective analysis of 1095 patients undergoing transfemoral TAVR was performed. Patients treated with chronic steroids at the time of the procedure (n = 99) were compared with those who received no steroids (n = 992). The primary outcome included a composite of aortic annular complications, defined as a combination of aortic annular rupture, aortic dissection/perforation, and left ventricular perforation. RESULTS: The primary outcome was significantly higher in the steroid group (4.0% vs 0.5%; P<.01). This finding was primarily driven by higher rates of acute annular rupture in the steroid group (2.0% vs 0.2%; P=.04). Steroid use was associated with higher rates of intraoperative cardiac arrest (5.1% vs 1.5%; P=.03), device capture/retrieval (4.0% vs 0.8%; P=.01), and emergent conversion to open heart surgery (4.0% vs 0.6%; P<.01). There were no differences with respect to in-hospital mortality, stroke, myocardial infarction, need for permanent pacemaker, bleeding complications, minor vascular complications, hospital length of stay, hospital 30-day readmission, or 30-day echocardiographic findings. Additionally, within the steroid group, there were no significant differences between balloon-expandable vs self-expanding TAVR prostheses with respect to composite aortic annular complications. CONCLUSION: Chronic steroid therapy increases the risk of aortic annular complications in patients undergoing TAVR, with detrimental consequences including intraoperative cardiac arrest and conversion to open heart surgery. Steroid use should be considered in patient selection and determination of procedural technique for TAVR.

Racial and Ethnic Disparities in the Use of Transcatheter Aortic Valve Replacement in the State of Connecticut.

BACKGROUND: Although prior national reports have identified trends in the underutilization of transcatheter aortic valve replacement (TAVR) in Afro-American and Latino populations, racial and ethnic healthcare disparities in TAVR use in the State of Connecticut have not been previously reported. METHODS: We conducted a retrospective analysis of 1461 patients undergoing TAVR at our institute between from 2012 to 2020. Baseline demographics, procedural characteristics, clinical outcomes, median incomes and insurance coverage were compared between 1417 Caucasian and 44 minority patients, including 23 patients designated as Afro-American and 10 designated as Latino. Demographics of TAVR utilization at our institution were further compared to 6 additional Connecticut TAVR centers using Connecticut Hospital Association (CHA) ChimeData detailing hospital discharges for DRG 266 and 267. RESULTS: In comparison to Caucasian patients, minority cohorts were younger (75.7 ± 9.0 vs 81.5 ± 5.1 years, p < 0.001) and had more co-morbidities including diabetes (64% vs 34%, p < 001), coronary artery disease (95% vs 78%, p = 0.039), end stage renal disease requiring dialysis (9% vs 3%, p = 0.009) and atrial fibrillation (77% vs 62%, p = 0.041). The two groups did not differ with respect to other risk factors or co-morbidities, baseline echocardiographic or CTA findings, STS risk score, or procedural technique. Minority patients had a longer length of hospital stay (9.5 ± 9.0 vs 6.4 ± 6.9 days, p = 0.003), but did not differ with respect to procedural complications. Socioeconomic differences between the two groups included lower median incomes and higher rates of Medicaid or no insurance coverage for minority versus Caucasian patients. CHA ChimeData revealed a similar underutilization of TAVR in minority subgroups in the remaining 6 Connecticut TAVR centers. CONCLUSIONS: Despite statewide demographics describing 10.7% and 15.7% of the total population as Afro-American and Latino, respectively, only 3.0% of the total TAVR procedures performed at a large Connecticut health care facility were performed in minority subgroups. Despite having a higher burden of co-morbidities, minority patients had similar outcomes compared to Caucasian patients. Similar racial and ethnic disparities in TAVR utilization were confirmed statewide using CHA ChimeData.

Outcomes of Transcarotid Versus Trans-Subclavian Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

OBJECTIVES: This study aimed to perform the first meta-analysis of studies comparing transcarotid (TC) and trans-subclavian (TSc) transcatheter aortic valve replacement (TAVR). BACKGROUND: The safety and feasibility of a TC and a TSc approach for performing TAVR in patients with prohibitive femoral anatomy have been well described. The potential advantage of one approach over the other is yet to be ascertained. METHODS: A computerized literature search of key medical databases through September 2020 was performed. Randomized controlled trials (RCTs) and observational studies comparing TC and TSc TAVR with reported 30-day outcomes were considered. The primary endpoint was a composite of all-cause mortality, stroke, life-threatening, and/or major bleeding or major vascular complications. Statistical analysis using random-effects models to report the odds ratio (OR) with 95% confidence interval (CI) was performed. RESULTS: A total of 5 observational studies inclusive of 4164 patients (TC = 1788 and TSc = 2376) met the eligibility criteria. The average age of patients was 81.1 years. There was no difference in the occurrence of the composite endpoint between the groups at 30-days. A statistically insignificant trend towards higher rates of major vascular complications (OR 1.65; 95% CI 0.94-2.89; P = 0.08; I2 = 0%) and the need for permanent pacemaker placement was observed with the TSc approach. CONCLUSIONS: This meta-analysis of studies comparing TC and TSc TAVR showed similar 30-day outcomes between the 2 approaches. A notable trend towards higher rates of major vascular complications and the need for permanent pacemaker placement was observed with the TSc approach.

Benefit of Transcatheter Aortic Valve Replacement in Patients With Paradoxical Low-Flow Low-Gradient Versus High-Gradient Aortic Stenosis and Preserved Left Ventricular Function.

[Figure: see text].

Comparative Outcomes of Transcarotid and Transsubclavian Transcatheter Aortic Valve Replacement.

BACKGROUND: Previous reports described successful use of transcarotid and transsubclavian approaches for the performance of transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who cannot be treated with transfemoral access. The purpose of the present study was to compare these two alternative approaches with respect to safety, efficacy, and procedural efficiency. METHODS: A retrospective analysis of all TAVR procedures performed through either a transcarotid or a transsubclavian approach at a single tertiary care medical center between January 2016 and October 2018 was performed. Outcomes are reported in accordance with the Valve Academic Research Consortium definitions. RESULTS: During the study period, 33 patients had transcarotid TAVR and 38 patients had transsubclavian TAVR. Transcarotid patients were older (mean age, 82.9 ± 7.2 vs 78.1 ± 8.2 years; P = .012), but otherwise the two groups were not significantly different with respect to preoperative characteristics. Valve deployment was similar between the groups (100% vs 97%; P = .348). Procedure time was shorter with the transcarotid approach (110 ± 32 vs 134 ± 45 minutes; P = .014). There was a lower mean fluoroscopy air kerma in the transcarotid group (682.82 ± 713.48 mGy vs 2141 ± 2055 mGy; P < .001), although fluoroscopy dose-area product did not differ between the groups. There was no difference between the groups with respect to in-hospital or 30-day mortality (0% vs 3%; P = .355), stroke (3% vs 8%; P = .393), or vascular complication (3% vs 4%; P = .840). CONCLUSIONS: The transcarotid and the transsubclavian approaches have similar safety and efficacy outcomes. The transcarotid approach had a shorter procedure duration and a trend toward lower fluoroscopy duration and radiation exposure.

Comparison of Benefit of Transcatheter Aortic Valve Implantation in Patients With Low Gradient Versus High Gradient Aortic Stenosis and Left Ventricular Dysfunction.

Patients with low gradient severe aortic stenosis (LG-AS) often exhibit significant limitations in functional status and quality of life. We aimed to evaluate the clinical effect of transcatheter aortic valve implantation (TAVI) on LG-AS patients compared to those with high transvalvular gradients and similar left ventricular dysfunction. Retrospective analysis of records for all patients with a left ventricular ejection fraction <50% who underwent TAVI at our institution was performed. Patients were grouped according to their transvalvular gradient. Data were collected from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Clinical benefit endpoints included improvements in left ventricular ejection fraction and changes in the Kansas City Cardiomyopathy Questionnaire. Additional outcomes analyzed included 1-year all-cause mortality, stroke rates, rates of rehospitalization, need for a permanent pacemaker, and hospital length of stay. Two hundred three patients met our inclusion criteria. one hundred one LG-AS patients (mean transvalvular gradient <40 mm Hg) were compared to 102 patients with high transvalvular gradients (mean transvalvular gradient >40 mm Hg). LG-AS patients yielded similar improvements in left ventricular ejection fraction (43.5% ± 63.7 vs 37.7% ± 58.7; p = 0.525) and Kansas City Cardiomyopathy Questionnaire scores (423.51% ± 1257.02 vs 266.56% ± 822.81; p = 0.352). There were no differences between the groups with respect to 1-year mortality (16.8% vs 12.7%; p = 0.412), stroke rates, hospital length of stay, need for permanent pacemaker implantation or hospital readmissions. In conclusion, we found that TAVI is associated with comparable improvement in clinical and echocardiographic outcomes in LG-AS patients as compared to those with high gradient severe aortic stenosis.

Antithrombotic Therapy After Revascularization in Patients With Peripheral Arterial Disease: What Is Here, What Is Next.

OBJECTIVE: The optimal antithrombotic regimen in peripheral arterial disease (PAD) is not known, leading to significant variations in antithrombotic treatment protocols in randomized trials and clinical practice. In device trials, antithrombotic regimens in patients receiving peripheral vascular interventions have not been clearly reported on. This review summarizes and discusses the most recent evidence on this topic to provide a potential guide to clinical practice. METHODS: A search of the literature was done for publications that reported outcomes of major PAD device trials. Reported outcomes and various antithrombotic regimens were studied. RESULTS: Use of antithrombotic therapy varied significantly between various device trials. Reporting of antithrombotic regimens at the time of follow-up is lacking. CONCLUSION: Outcome data on optimal antithrombotic regimens are presently lacking largely due to the significant heterogeneity and underreporting of antithrombotic regimens at follow-up among prior clinical trials. Standardization and reporting of precise antithrombotic regimens at various points of follow-up in device trials of patients with PAD should be attempted so as to minimize differences in treatment patterns when evaluating new devices.

Propensity Matched Analysis Comparing Conscious Sedation Versus General Anesthesia in Transcatheter Aortic Valve Implantation.

Conscious sedation (CS) has been increasingly utilized in transcatheter aortic valve implantation (TAVI). We aim to compare safety, efficacy, efficiency, and direct cost outcomes of patients who underwent TAVI with general anesthesia (GA) to those with CS. Records for all adult patients undergoing transfemoral TAVI at our institution between February 2012 and September 2018 were retrospectively screened. Patients were grouped by anesthesia treatment (GA or CS) and propensity matched. Safety (in-hospital and 30-day mortality, in-hospital and 30-day stroke, cardiac arrest, need for permanent pacemaker, and composite bleed/vascular adverse events), efficacy (follow-up echocardiographic findings), efficiency (procedure duration, fluoroscopy time, radiation dose, intensive care unit (ICU) stay, hospital length-of-stay, and discharge to home), and direct cost outcomes were compared. A total of 589 patients met our inclusion criteria. Propensity matching yielded 154 GA patients and 154 CS patients. There were no differences in the safety outcomes of in-hospital or 30-day mortality, in-hospital or 30-day stroke, cardiac arrest, and need for permanent pacemaker between GA and CS groups. There was a significant reduction in composite bleeding/vascular events in the CS group (8.4% vs 19.5%, p < 0.01). There were no differences in the follow-up echocardiograms with respect to aortic valve area, left ventricular ejection fraction, and incidence of moderate or severe aortic regurgitation. The CS group had shorter procedural fluoroscopy times and radiation dose, shorter length-of-stay and ICU stay, with similar procedural duration. CS patients were more likely to be discharged to home (59.7% vs 74.7%, p < 0.01). Total direct costs for CS were decreased in almost every departmental category, with a mean 10.4% reduction in overall direct costs (p < 0.001). In conclusion, TAVI with CS is associated with less bleeding and vascular events, lower procedural radiation exposure, reduced length of hospitalization and ICU stay, and lower direct costs in comparison with TAVI with GA. These outcomes occur without sacrificing procedural efficacy or safety.

Comparative Outcomes of Balloon-Expandable S3 Versus Self-Expanding Evolut Bioprostheses for Transcatheter Aortic Valve Implantation.

To date, comparisons between the balloon-expandable Edwards Sapien S3 (S3) versus the self-expanding Evolut R or PRO (Evolut) valves have been limited with respect to procedural outcomes. We aim to compare the safety, efficacy, and procedural efficiency of the S3 versus the Medtronic Evolut bioprostheses in patients who underwent transcatheter aortic valve implantation for severe aortic stenosis. Retrospective analysis was performed of all consecutive transcatheter aortic valve implantation procedures performed through the transfemoral approach with either S3 or Evolut at our hospital between September 2015 and January 2019. A total of 581 patients were included. There were no significant differences between S3 (n = 452) and Evolut (n = 129) concerning in-hospital or 30-day safety outcomes. S3 was associated with significantly shorter fluoroscopy times, lower fluoroscopy Air Kerma, and higher contrast use. S3 had lower postprocedure aortic valve area (1.71 ± 0.45 vs 1.84 ± 0.50 cm2, p = 0.004), larger peak gradient at 30 days (10.7 ± 3.8 vs 7.0 ± 3.2 mm Hg, p <0.001), and lower aortic regurgitation (AR) rates postprocedure (47% vs 33%, p = 0.024) and at 30 days (50% vs 33%, p = 0.008), driven by mild AR. Device type was an independent predictor of AR postprocedure and at 30 days. Patients with ≥mild AR were more likely to have had Evolut valves (odds ratio = 2.94, p <0.001), especially in larger valves (>26 mm). Severe prosthesis-patient mismatch was higher in S3 (14.8% vs 7.9%, p <0.001). In conclusion, S3 is associated with less radiation exposure, higher contrast use, and lower incidence of AR at 30 days. Alternately, S3 has a higher transaortic gradient at 30 days, and higher levels of severe prosthesis-patient mismatch.