Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Cost Utility of Transcatheter Aortic Valve Replacement: Sapien 3 Versus CoreValve Evolut R.

Transcatheter aortic valve replacement (TAVR) has become the preferred treatment for severe aortic stenosis. Previous studies compare clinical outcomes of leading TAVR valves, but there is no evidence of cost-utility comparison, leaving a clinical information gap when selecting valves. Here we share a cost-utility analysis comparing the Sapien 3 (S3) (Edwards Lifesciences, Irvine, CA) and CoreValve Evolut R (ER) (Medtronic, Dublin, IR) across five clinical endpoints. Utility scores from patient surveys and clinical outcomes from the literature were used to estimate quality-adjusted life years (QALYs) associated with successful procedure and postoperative complications for S3 and ER. A decision tree was constructed with rollback analysis to highlight the more cost-effective strategy. An incremental cost-utility ratio (ICUR) analysis was performed with a willingness to pay at $50,000. Deterministic and probabilistic sensitivity analyses were performed to validate robustness of results and account for uncertainty. S3 was found to be more costly ($68,377 vs. $66,072), but more effective (1.87 vs . 1.66) compared with ER. An ICUR of 11,288.12 favored S3, making it the more cost-effective option with a moderate confidence of 73.68% in Monte Carlo analysis. Cost-utility analysis can be used to aid in healthcare economics decision-making when selecting between comparable technologies used for TAVR procedures.

Left ventricular stroke volume index following transcatheter aortic valve replacement is an early predictor of 1-year survival.

BACKGROUND: Adverse cardiac events are common following transcatheter aortic valve replacement (TAVR). Our aim was to investigate the low left ventricular stroke volume index (LVSVI) 30 days after TAVR as an early echocardiographic marker of survival. HYPOTHESIS: Steady-state (30-day) LVSVI after TAVR is associated with 1-year mortality. METHODS: A single-center retrospective analysis of all patients undergoing TAVR from 2017 to 2019. Baseline and 30-day post-TAVR echocardiographic LVSVI were calculated. Patients were stratified by pre-TAVR transaortic gradient, surgical risk, and change in transvalvular flow following TAVR. RESULTS: This analysis focuses on 238 patients treated with TAVR. The 1-year mortality rate was 9% and 124 (52%) patients had normal flow post-TAVR. Of those with pre-TAVR low flow, 67% of patients did not normalize LVSVI at 30 days. The 30-day normal flow was associated with lower 1-year mortality when compared to low flow (4% vs. 14%, p = .007). This association remained significant after adjusting for known predictors of risk (adjusted odds ratio [OR] of 3.45, 95% confidence interval: 1.02-11.63 [per 1 ml/m2 decrease], p = .046). Normalized transvalvular flow following TAVR was associated with reduced mortality (8%) when compared to those with persistent (15%) or new-onset low flow (12%) (p = .01). CONCLUSIONS: LVSVI at 30 days following TAVR is an early echocardiographic predictor of 1-year mortality and identifies patients with worse intermediate outcomes. More work is needed to understand if this short-term imaging marker might represent a novel therapeutic target.

Transcarotid Transcatheter Aortic Valve Replacement With Simple "Flip-n-Flex" Technique.

Transcarotid transcatheter aortic valve replacement (TAVR) is increasingly accepted as a safe and efficacious alternative when transfemoral access is contraindicated. Technical and anatomic considerations unique to transcarotid access warrant several adaptations to the routine TAVR procedure. This report describes an approach to overcome these challenges and improve efficiency, including adoption of the "flip-n-flex" technique originally developed for right transaxillary TAVR. This technique has been used at Tufts Medical Center (Boston, MA) since 2019 in both left and right transcarotid TAVR approaches with success to ensure coaxial alignment of the transcatheter heart valve to the aortic root.

Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients With Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study.

BACKGROUND: Reducing congestion remains a primary target of therapy for acutely decompensated heart failure. The VENUS-HF EFS (VENUS-Heart Failure Early Feasibility Study) is the first clinical trial testing intermittent occlusion of the superior vena cava with the preCARDIA system, a catheter mounted balloon and pump console, to improve decongestion in acutely decompensated heart failure. METHODS: In a multicenter, prospective, single-arm exploratory safety and feasibility trial, 30 patients with acutely decompensated heart failure were assigned to preCARDIA therapy for 12 or 24 hours. The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events through 30 days. Secondary end points included technical success defined as successful preCARDIA placement, treatment, and removal and reduction in right atrial and pulmonary capillary wedge pressure. Other efficacy measures included urine output and patient-reported symptoms. RESULTS: Thirty patients were enrolled and assigned to receive the preCARDIA system. Freedom from device- or procedure-related major adverse events was observed in 100% (n=30/30) of patients. The system was successfully placed, activated and removed after 12 (n=6) or 24 hours (n=23) in 97% (n=29/30) of patients. Compared with baseline values, right atrial pressure decreased by 34% (17±4 versus 11±5 mm Hg, P<0.001) and pulmonary capillary wedge pressure decreased by 27% (31±8 versus 22±9 mm Hg, P<0.001). Compared with pretreatment values, urine output and net fluid balance increased by 130% and 156%, respectively, with up to 24 hours of treatment (P<0.01). CONCLUSIONS: We report the first-in-human experience of intermittent superior vena cava occlusion using the preCARDIA system to reduce congestion in acutely decompensated heart failure. PreCARDIA treatment for up to 24 hours was well tolerated without device- or procedure-related serious or major adverse events and associated with reduced filling pressures and increased urine output. These results support future studies characterizing the clinical utility of the preCARDIA system. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03836079.

Transcatheter mitral valve interventions.

While there are dozens of novel transcatheter mitral devices in various stages of development, they remain years away from FDA approval. The existing approved transcatheter mitral interventions-transcatheter edge to edge repair for primary and secondary mitral regurgitations and transcatheter mitral valve-in-valve and valve-in-ring procedures for failing surgical prostheses-have seen a marked increase in both use and published data over the past several years. Transcatheter edge to edge repair with MitraClip has revolutionized the management of functional mitral regurgitation in heart failure with demonstrated reductions in mortality and heart failure hospitalization and is an appropriate option for patients with primary mitral regurgitation at high or prohibitive surgical risk. In patients with failing surgical mitral prostheses transcatheter mitral valve-in-valve and valve-in-ring procedures are an appealing alternative to repeat mitral valve surgery. Existing data and relevant concerns for these procedures are discussed herein.

Comorbidity Burden and Adverse Outcomes After Transcatheter Aortic Valve Replacement.

Background Transcatheter aortic valve replacement (TAVR) has become the preferred treatment for symptomatic patients with aortic stenosis and elevated procedural risk. Many deaths following TAVR are because of noncardiac causes and comorbid disease burden may be a major determinant of postprocedure outcomes. The prevalence of comorbid conditions and associations with outcomes after TAVR has not been studied. Methods and Results This was a retrospective single-center study of patients treated with TAVR from January 2015 to October 2018. The association between 21 chronic conditions and short- and medium-term outcomes was assessed. A total of 341 patients underwent TAVR and had 1-year follow-up. The mean age was 81.4 (SD 8.0) years with a mean Society of Thoracic Surgeons predicted risk of mortality score of 6.7% (SD 4.8). Two hundred twenty (65%) patients had ≥4 chronic conditions present at the time of TAVR. There was modest correlation between Society of Thoracic Surgeons predicted risk of mortality and comorbid disease burden (r=0.32, P<0.001). After adjusting for Society of Thoracic Surgeons predicted risk of mortality, age, and vascular access, each additional comorbid condition was associated with increased rates of 30-day rehospitalizations (odds ratio, 1.21; 95% CI, 1.02-1.44), a composite of 30-day rehospitalization and 30-day mortality (odds ratio, 1.20; 95% CI, 1.02-1.42), and 1-year mortality (odds ratio, 1.29; 95% CI, 1.05-1.59). Conclusions Comorbid disease burden is associated with worse clinical outcomes in high-risk patients treated with TAVR. The risks associated with comorbid disease burden are not adequately captured by standard risk assessment. A systematic assessment of comorbid conditions may improve risk stratification efforts.

The Effect of Anesthesia Type on Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVES: To assess postoperative outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) either under general anesthesia (GA) or monitored anesthesia care (MAC) as the primary anesthetic. DESIGN: A retrospective, propensity-matched, cohort study, with univariate logistic regression to assess postoperative outcomes. SETTING: Hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP). PARTICIPANTS: The study comprised 559 patients who underwent a TAVR procedure under GA or MAC. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: After propensity score matching, there were no significant differences between the two cohorts in age, sex, race, body mass index, functional status, American Society of Anesthesiologists physical status, and other comorbidities. There were no significant differences in 30-day mortality between the two cohorts, or in the number of complications at 30 days. However, hospital length of stay was significantly shorter in the MAC cohort compared with the GA cohort. CONCLUSIONS: Patients undergoing TAVR under MAC may have similar 30-day mortality and complications, but shorter hospital length of stay, than patients undergoing TAVR under GA.

Systemic Allergic Contact Dermatitis Due to a GORE CARDIOFORM Septal Occluder Device: A Case Report and Literature Review.

Nickel hypersensitivity is a rarely reported complication of percutaneous patent foramen ovale/atrial septal defect closure. Herein, we report a case of systemic allergic contact dermatitis to nickel present in a GORE CARDIOFORM (W.L. Gore, Flagstaff, Arizona) septal occluder that resolved following explanation. To our knowledge this is the first published case of nickel hypersensitivity associated with this device. (Level of Difficulty: Beginner.).