Transcarotid transcatheter aortic valve replacement with cerebral embolic protection.

There remains concern about the risk of stroke with transcarotid transcatheter aortic valve replacement (TAVR). We describe the use of the Sentinel cerebral protection device with transcarotid TAVR in a patient at high risk for embolic complications. Deployment of the Sentinel filter in the innominate artery accommodated the insertion of the TAVR device through the bovine aortic arch via the contralateral carotid artery. By adapting the "flip-n-flex" technique from our previous transaxillary TAVR experience, we performed left transcarotid TAVR with the Sentinel device in an ergonomic manner and achieved coaxial placement of the transcatheter valve. Inspection of the Sentinel filter after the case revealed captured embolic debris.

Tissue Doppler Imaging (E/e') and Pulmonary Capillary Wedge Pressure in Patients With Severe Aortic Stenosis.

OBJECTIVE: Although American and European consensus statements advocate using the ratio of the transmitral E velocity and tissue Doppler early diastolic mitral annular velocity (E/e') in the assessment of left-sided heart filling pressures, recent reports have questioned the reliability of this ratio to predict left atrial pressures in a variety of disease states. The authors hypothesized that there is a clinically significant correlation between E/e' and pulmonary capillary wedge pressure (PCWP) in patients with severe aortic stenosis. DESIGN: Retrospective cohort study. PARTICIPANTS: The study comprised 733 consecutive patients with severe aortic stenosis who underwent transcatheter aortic valve replacement for severe aortic stenosis. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: PCWP and E/e'ave (average of the lateral and medial annulus tissue Doppler velocities) were measured with a pulmonary artery catheter and transthoracic echocardiography during preprocedural evaluation. Patients were grouped by left ventricular ejection fraction (LVEF) ≥50% and LVEF <50%. Spearman rank correlation, analysis of variance, and t and chi-square tests were used to analyze the data. Seventy-nine patients met the inclusion criteria. There was no significant correlation between E/e'ave and PCWP (n = 79, Spearman r = 0.096; p = 0.3994). This correlation did not improve when ventricular function was considered (LVEF <50%: n = 11, Spearman r = -0.097; p = 0.776 and LVEF ≥50%: n = 68, Spearman r = 0.116; p = 0.345). There was no statistically significant difference in mean PCWP between each range of E/e'ave. CONCLUSION: A clinically relevant relationship between E/e' and PCWP was not observed in patients with severe aortic stenosis.

Skeletal Muscle Characteristics May Inform Preprocedural Risk Stratification in Transcatheter Aortic Valve Replacement Patients.

OBJECTIVES: Low psoas muscle mass previously has been associated with mortality after transcatheter aortic valve replacement (TAVR). Evidence from other clinical disciplines suggests that psoas density (PD) may be a better predictor than psoas muscle cross-sectional area indexed to body surface area (PI). The authors hypothesized that PD would be more strongly correlated with patient discharge disposition and survival after TAVR than PI. DESIGN: The authors performed a single-center, retrospective study of TAVR patients from 2013 to 2016. PI and PD were assessed at the third lumbar spine level using computed tomography imaging. Propensity-score matching was used to investigate the association of PI and PD with discharge disposition and mortality. SETTING: Tertiary university hospital PARTICIPANTS: Cohort of 245 TAVR patients. INTERVENTIONS: None MEASUREMENTS AND MAIN RESULTS: A total of 245 patients met inclusion criteria. Following propensity score matching, patients with PI <4 cm2/m2 and PD <25 Hounsfield units (HU) were less likely to survive and to be discharged home compared with patients with PI ≥4 cm2/m2 or PD >25 HU. After repeating the propensity score matching with PI as a covariable, PD remained associated with mortality (90 days: odds ratio [OR] 4.59; 95% confidence interval [CI] 2.96-10.31, p < 0.001, 1 year: OR 6.14; 95% CI 3.45-28.57, p = 0.01, 3 years: OR 4.55; 95% CI 2.41-40.00, p = 0.03). CONCLUSIONS: PD may be more relevant than PI in risk stratification for TAVR patients.

Late Clinical Presentation of Prosthesis-Patient Mismatch Following Transcatheter Aortic Valve Replacement.

Prosthesis-patient mismatch (PPM) is relatively common after aortic valve replacement (AVR) and generally is associated with reduced regression of left ventricular (LV) mass. PPM after valve-in-valve transcatheter aortic valve replacement (TAVR) was reported to be 38%. PPM generally is manifested clinically by dyspnea and echocardiographically by high transvalvular gradients. In this E-Challenge, the authors will review a case of a late clinical presentation of PPM 1-year following a valve-in-valve TAVR.

Twenty-year analysis of trends in the incidence and in-hospital mortality for lower-extremity arterial thromboembolism.

BACKGROUND: Epidemiology data for lower-extremity arterial thromboembolism (LET) are limited and may result from either acute limb ischemia or an acute exacerbation of critical limb ischemia. Given marked changes in both diagnosis and therapy over the last 2 decades, we hypothesized that this time period would have witnessed reductions in both the incidence and in-hospital mortality of LET. METHODS AND RESULTS: Data from 1988 through 2007 from the National Hospital Discharge Survey were analyzed. All admissions for patients with LET were extracted, and the respective International Classification of Diseases, Ninth Revision, Clinical Modification codes were internally validated for both LET and acute limb ischemia. Descriptive statistics were used. The validity of the codes was good for identifying LET cases but poor for identifying acute limb ischemia cases because many of these acute presentations were attributable to critical limb ischemia. Over the 20-year span, there were 1.76 million cases of LET. The incidence of LET decreased significantly from 42.4 per 100 000 persons between 1988 and 1997 to 23.3 per 100 000 persons between 1998 and 2007. The in-hospital mortality for LET decreased significantly from 8.28% between 1988 and 1997 to 6.34% between 1998 and 2007, and male patients achieved greater mortality reduction compared with female patients. Treatments for acute limb ischemia showed decreasing use of surgical bypass and amputation and increasing rates of catheter-based thrombolysis. CONCLUSIONS: Over the 20-year study period, there have been significant reductions in both LET incidence and in-hospital mortality. Unfortunately, LET admissions extracted from an administrative database comprise a diverse group of individuals, including those with acute and chronic forms of limb ischemia and iatrogenic arterial injury, limiting the true assessment of ALI incidence.

The syndrome of degenerative calcific aortic stenosis: prevalence of multiple pathophysiologic disorders in association with valvular stenosis and their implications.

BACKGROUND: We hypothesized that degenerative calcific aortic stenosis (DCAS) is a syndrome influenced by factors beyond aortic valve stenosis (AS). The aim of this study was to assess how frequently DCAS is complicated by increased vascular load, systolic and/or diastolic left ventricular (LV) dysfunction, and comorbid disorders. METHODS: In 215 consecutive patients > 60 years of age with severe and moderate AS, we analyzed systemic arterial compliance, global hemodynamic load, LV ejection fraction (EF), the presence of diastolic dysfunction, and other valvular or systemic disorders. RESULTS: A total of 164 patients had severe AS and 51 had moderate AS. In patients with severe AS, the prevalence of increased vascular load was 42%; LV systolic and diastolic dysfunction was present in 27% and 42%; other valve diseases in 23%; and comorbid disorders in 82%. In the moderate AS group, abnormal vascular load was found in 52%; LV systolic and diastolic dysfunction was prevalent in 26% and 31%; other valve diseases in 17%; and comorbid disorders in 78% patients. More than half the patients in both groups had symptoms. In both severe and moderate AS groups, the prevalence of increased vascular load and systolic dysfunction was higher in the symptomatic group. CONCLUSION: Considerable number of patients with DCAS have abnormal vascular load, abnormal LV function, and significant coexisting disorders. These could influence the total pathophysiologic burden on the heart and symptom expression. Thus, DCAS should not be considered just as valvular stenosis, but a syndrome of DCAS because of the diagnostic, prognostic, and therapeutic implications of various factors associated with it.

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.

Pre-procedural serum albumin concentration is associated with length of stay, discharge destination, and 90-day mortality in patients after transcatheter aortic valve replacement.

Background: As visceral protein expression may influence outcomes in patients with cardiovascular disease, we investigated whether pre-procedural albumin concentration is associated with length of stay (LOS) and 90-day mortality after transcatheter aortic valve repair (TAVR). Methods: We retrospectively analyzed data from TAVR patients at our institution between January 2013 and December 2017. For all patients, baseline albumin concentration was assessed between one and four weeks before the procedure. To investigate the association between albumin concentration and outcomes, we performed regression analyses, controlling for Society of Thoracic Surgeons, New York Heart Association classification, and Kansas City Cardiomyopathy Questionnaire 12 scores. Results: Three hundred eighty patients were included in the analyses. Cox-proportional hazards regression showed that patients with albumin concentrations <3.5 g/dL were 80% more likely to have prolonged ICU LOS (HR 1.79; 95%CI 1.04-2.57, P = 0.03) and 70% more likely to have prolonged hospital LOS (HR 1.68; 95%CI 1.01-2.46, P = 0.04) compared to patients with albumin concentrations >3.5 g/dL. Logistic regression showed that patients with albumin concentrations <3.5 g/dL were four times more likely to not survive to 90 days (OR 3.94; 1.13-12.63, P = 0.03) after their TAVR compared to patients with albumin concentrations >3.5 g/dL. Conclusion: Our data suggest that patients with pre-procedural albumin concentrations <3.5 g/dL are at an increased risk of adverse outcomes after TAVR compared to patients with albumin concentrations ≥3.5 g/dL. Prospective studies are needed to determine whether risk stratification based on pre-procedural albumin can improve outcomes and whether targeted interventions can improve pre-procedural albumin concentrations in potential TAVR candidates.

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.

The pulmonary artery pulsatility index identifies severe right ventricular dysfunction in acute inferior myocardial infarction.

BACKGROUND: Right ventricular dysfunction (RVD) is a major cause of morbidity and mortality in the setting of acute inferior wall myocardial infarction (IWMI), and early detection may improve clinical outcomes. We defined a novel hemodynamic index, the pulmonary artery pulsatility index (PAPi), and explored whether the PAPi correlates with severe RVD in acute IWMI. METHODS: From 2008 to 2010, we identified 20 patients presenting with angiographically confirmed proximal right coronary artery occlusion and suspected RVD (sRVD) as defined by hemodynamic instability, profound bradycardia, or ST-elevation in lead V4R. Two controls groups were studied (1) 50 patients with nonobstructive coronary artery disease (Non-CAD) and (2) 14 patients presenting with acute coronary syndrome requiring left coronary stenting (ACS). Hemodynamic indices analyzed at the time of catheterization included: (1) the right atrial to pulmonary capillary wedge pressure ratio (RA:PCWP), (2) right ventricular stroke work (RVSW), and (3) the PAPi. Qualitative echocardiographic scores of RV systolic function were determined by two blinded investigators within 24 hr of catheterization. RESULTS: Among subjects with sRVD, 7 (35%) received a percutaneous RV support device (pRVSD) for medically refractory RV failure and 4 (20%) died prior to hospital discharge. Compared to Non-CAD and ACS controls, subjects with sRVD had a significantly lower PAPi (4.32 ± 3.04 vs. 5.52 ± 4.40 vs. 1.11 ± 0.57, respectively, P < 0.01) and a higher RA:PCWP ratio (0.48 ± 0.24 vs. 0.51 ± 0.26 vs. 0.81 ± 0.30, respectively, P < 0.05). Both the PAPi and RA:PCWP ratios correlated significantly with RVSW and qualitative echocardiographic grading. The PAPi demonstrated the highest sensitivity (88.9%) and specificity (98.3%) for predicting in-hospital mortality and/or requirement of a pRVSD. Using ROC curve derived cut-points, a PAPi ≤ 0.9 provided 100.0% sensitivity and 98.3% specificity (C-statistic: 0.998) for predicting these outcomes, exceeding the predictive value of the RA:PCWP ratio or RVSW. CONCLUSIONS: The PAPi is a simple, invasive hemodynamic measure that may help identify high-risk patients with acute IWMI with severe RVD. Earlier identification of this high-risk population may improve clinical outcomes.

Elevated soluble fms-like tyrosine kinase-1 levels in acute coronary occlusion.

OBJECTIVE: Early recognition of an acute coronary occlusion (ACO) improves clinical outcomes. Soluble fms-like tyrosine kinase-1 (sFLT1) is an endothelium-derived protein induced by hypoxia. We tested whether sFLT1 levels are elevated in ACO. METHODS AND RESULTS: Serum sFLT1 levels were measured by enzyme-linked immunosorbent assay in patients with ST-segment elevations and angiographically confirmed ACO, unstable angina/non ST-segment elevation myocardial infarction, and 2 control groups. To further explore sFLT1 release, a mouse model of ACO and in vitro human coronary artery endothelial cell injury were used. sFLT1 levels were increased in ACO compared with unstable angina/non-ST-elevation myocardial infarction, catheterized controls, or healthy volunteers (200.7±15.5 versus 70.7±44.0 versus 10.2±4.0 versus 11.7±1.7 pg/mL respectively, P<0.001 versus ACO). At presentation, all ACO patients had elevated sFLT1 levels (>15 pg/mL, 99th percentile in controls), whereas 57% had levels of the MB isoform of creatine kinase levels >10 ng/mL (P<0.01) and 85% had ultrasensitive troponin I levels >0.05 ng/mL (P<0.05). Within 60 minutes after symptom onset, sFLT1 was more sensitive than the MB isoform of creatine kinase or ultrasensitive troponin I for ACO (100% versus 20% versus 20% respectively; P≤0.01 for each). Within 60 minutes of ACO in mice, sFLT1 levels were elevated. Hypoxia and thrombin increased sFLT1 levels within 15 minutes in human coronary artery endothelial cells. CONCLUSIONS: sFLT1 levels may be an early indicator of endothelial hypoxia in ACO.

Association of preprocedural ultrashort-term heart rate variability with clinical outcomes after transcatheter aortic valve replacement: A nested, case-control, pilot study.

Background: Because heart rate variability (HRV) has been linked to important clinical outcomes in various cardiovascular disease states, we investigated whether preprocedural ultrashort-term HRV (UST-HRV) differs between 1-year survivors and nonsurvivors after transcatheter aortic valve replacement (TAVR). Methods: In our single-center, retrospective, nested pilot study, we analyzed data from patients with severe aortic stenosis undergoing TAVR. All patients had preprocedural UST-HRV measured before the administration of any medications or any intervention. To investigate whether preprocedural HRV is associated with 1-year survival, we performed a logistic regression analysis controlling for Kansas City Cardiomyopathy Questionnaire 12 score. Results: In our parent cohort of 100 patients, 42 patients (28 survivors and 14 nonsurvivors) were included for analysis. Root mean square of successive differences (RMSSD) and standard deviation of NN intervals (SDNN) were lower in patients who survived to 1-year post TAVR compared to nonsurvivors [10 (IQR 8-23) vs 23 (IQR 17-33), P = 0.04 and 10 (IQR 7-16) vs 17 (IQR 11-40), P = 0.03, respectively]. Logistic regression demonstrated a trend in the association of preprocedure RMSSD with 1-year mortality and a 5% higher risk of 1-year mortality with each unit increment in UST-HRV using SDNN (OR 1.05; 95%CI 1.01-1.09, P = 0.02). Conclusion: Our data suggest an inverse relationship between preprocedural UST-HRV and 1-year survival post-TAVR. This finding highlights the potential complexity of HRV regulation in chronic vs acute illness. Prospective studies are needed to validate our findings and to determine whether UST-HRV can be used for risk stratification in patients with severe aortic stenosis.

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.

Health-related quality of life in a multicenter randomized controlled comparison of telephonic disease management and automated home monitoring in patients recently hospitalized with heart failure: SPAN-CHF II trial.

BACKGROUND: Although disease management programs have been shown to provide a number of clinical benefits to patients with heart failure (HF), the incremental impact of an automated home monitoring (AHM) system on health-related quality of life (HRQL) is unknown. METHODS AND RESULTS: We performed a prospective randomized investigation, examining the additive value of AHM to a previously described nurse-directed HF disease management program (SPAN-CHF), with attention to HRQL, in patients with a recent history of decompensated HF. A total of 188 patients were randomized to receive the SPAN-CHF intervention for 90 days, either with (AHM group) or without (NAHM, standard-care group) AHM, with a 1:1 randomization ratio after HF-related hospitalization. HRQL, measured by the Minnesota Living With Heart Failure Questionnaire (MLHFQ) (Physical, Emotional, and Total scores on MLHFQ) was assessed at 3 time points: baseline, 45 days, and 90 days. Although both treatments (AHM and NAHM) improved HRQL at 45 and 90 days compared with baseline with respect to Physical, Emotional, and Total domain scales, no significant difference emerged between AHM and NAHM groups. CONCLUSIONS: AHM and NAHM treatments demonstrated improved HRQL scores at 45 and 90 days after baseline assessment. When comparing 2 state-of the-art disease management programs regarding HRQL outcomes, our results did not support the added value of AHM.

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.

A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial.

BACKGROUND: We performed a prospective, randomized investigation assessing the incremental effect of automated health monitoring (AHM) technology over and above that of a previously described nurse directed heart failure (HF) disease management program. The AHM system measured and transmitted body weight, blood pressure, and heart rate data as well as subjective patient self-assessments via a standard telephone line to a central server. METHODS AND RESULTS: A total of 188 consented and eligible patients were randomized between intervention and control groups in 1:1 ratio. Subjects randomized to the control arm received the Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) heart failure disease management program. Subjects randomized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system. The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days. The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 (95%CI [0.25-0.99], P = .05). CONCLUSIONS: Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment. Long-term benefits in this model remain to be studied.

Can Clinical Predictive Models Identify Patients Who Should Not Receive TAVR? A Systematic Review.

BACKGROUND: One third of high- and prohibitive-risk TAVR patients remain severely symptomatic or die 1 year after treatment. There is interest in identifying individuals for whom this procedure is futile and should not be offered. METHODS: We performed a systematic review of the highest reported stratum of risk in TAVR clinical predictive models (CPMs). We explore whether currently available predictive models can identify patients for whom TAVR is futile, based on a quantitative futility definition and the observed and predicted outcomes for patients in the highest stratum of risk. RESULTS: 17 TAVR CPMs representing 69,191 treated patients were published from 2013 to 2018. When reported, the median number of patients in the highest stratum of risk was 569 (range 1 to 1759). Observed mortality for this risk stratum ranged from 9% at 30 days to 59% at 1 year after TAVR. Statistical confidence in these observed event rates was low. The highest predicted event rates ranged from 11.0% for in-hospital mortality to 75.1% for the composite of mortality or high symptom burden 1 year after TAVR. CONCLUSION: No high-risk TAVR group in currently available TAVR CPMs had an appropriate event rate and adequate statistical power to meet a quantitative definition of futility.

Safety and efficacy of transaxillary transcatheter aortic valve replacement using a current-generation balloon-expandable valve.

BACKGROUND: Transaxillary access (TAx) has shown promise as an excellent alternative TAVR option, but data on the Edwards SAPIEN 3 in TAx-TAVR is limited. We sought to study the safety and efficacy of TAx-TAVR using this current-generation balloon-expandable valve. METHODS: A retrospective study of our first 24 TAx and 20 transthoracic (TT) TAVR patients treated with the SAPIEN 3 valve was performed, and the patients' preoperative characteristics, procedural outcomes, and clinical outcomes were compared to our first 100 transfemoral (TF) patients using the SAPIEN 3 device. RESULTS: There were no statistical differences observed for outcomes between the TAx and TF groups, despite the TAx patients having more comorbidities (STS-PROM 11.3 ± 7.6 versus 7.3 ± 5.2, p = 0.042). In addition, no significant difference was found in the fluoroscopy time and contrast amount between the two groups. The patients' baseline characteristics were similar between the TAx and TT groups. Their procedural and clinical outcomes were comparable, but there was a trend towards lower incidence of acute kidney injury (13.0% versus 23.5%), new-onset atrial fibrillation (5.6% versus 33.3%), shorter median length of stay postoperatively (4 versus 6 days), fewer discharges to rehabilitation (16.7% versus 35.0%), and a lower rate of readmission within 30-days (8.3% versus 35.0%), all favoring TAx access. CONCLUSIONS: TAx-TAVR with the SAPIEN 3 valve is a safe alternative to TF access. It offers advantages of improved recovery over TT access, and appears to be a superior alternative-access option for TAVR. TAx access could be preferred when TF access is not feasible.

Right Transaxillary Transcatheter Aortic Valve Replacement Using the "Flip-n-Flex" Technique.

BACKGROUND: Right transaxillary transcatheter aortic valve replacement (TAx-TAVR) is rarely performed due to challenging vascular tortuosity and unfavorable implantation angles. We explored this procedure using the newer-generation balloon-expandable SAPIEN 3 (Edwards Lifesciences, Irvine, CA) valve and our novel "flip-n-flex" technique. The safety and effectiveness of the procedure and the learning curve of our early experiences were investigated. METHODS: The first 10 consecutive patients undergoing right TAx-TAVR performed at our center from June 2016 to May 2018 were included in the study. Patients' preoperative characteristics, procedural outcomes, and clinical outcomes were studied. Intraoperative fluoroscopy times were also reviewed to analyze the procedural learning curve. RESULTS: The 10 patients were a mean age of 81.8 ± 8.7 years, and 5 patients (50%) were women. Mean Society of Thoracic Surgeons Predicted Risk of Mortality was 12.0% ± 9.5%. Procedural success was achieved in all cases without vascular complications. Paravalvular leak was absent or mild in all patients. Two patients (20%) required permanent pacemaker implantation. The median postoperative length of stay was 4 days (range, 2-13 days). The 30-day mortality was 0%. Mean transvalvular gradient improved from 38.4 ± 12.6 mm Hg to 9 ± 4.4 mm Hg postoperatively. New York Heart Association Functional Classification improved in all patients. The fluoroscopy time showed marked reduction from 44.1 ± 8.2 minutes to 17.4 ± 2.9 minutes with the use of the flip-n-flex technique. CONCLUSIONS: Our early experience of right TAx-TAVR with the SAPIEN 3 valve demonstrated satisfactory outcomes and a quick learning as facilitated by the flip-n-flex technique. This could be a beneficial TAVR approach to suitable patients.