Faculty Bibliography

Background Software to fuse transesophageal echocardiography (TEE) images onto live fluoroscopy (FL) allows for fluoroscopic visualization of TEE-derived anatomic landmarks. We compared transcatheter Paravalvular Leak (PVL) Closure using TEE / Truefusion versus TEE / FL guidance only. Methods This prospective pilot study evaluated the safety and feasibility of the TrueFusion software in subjects scheduled for paravalvular leak (PVL) closure. Immediately prior to the procedure, TEE and FL systems were co-registered and anatomical markers for the source of PVL were generated. Procedural outcomes recorded were the reduction in regurgitant grade, procedural time, FL time, and radiation exposure. They were compared between patients who underwent PVL closure with and without TrueFusion. Results The cohort (n=27), Male (60%), age 72 +/- 15 years. 15 subjects underwent TrueFusion-guided PLV closure (10 mitral and 5 aortic). Eleven subjects had non-TrueFusion PVL closure (5 mitral and 2 aortic). TrueFusion-guided PVL closures demonstrated significantly greater achievement of at least one grade reduction in PVL severity (p=0.02). Use of TrueFusion group also showed a non-statistically significant trend toward lower median FL time, mean dose area product, and mean procedural time when compared to PVL closures without TrueFusion guidance (Figure). Conclusion The co-registration of TEE and fluoroscopy images using the TrueFusion software potentially improves efficiency outcomes. [Figure presented]
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Background Patients with chronic kidney disease (CKD) have poor short-term outcomes after transcatheter aortic valve replacement (TAVR). Methods Retrospective review identified 575 consecutive patients not on hemodialysis (HD) who underwent TAVR at a single center between September 2014 and January 2017. Patients were stratified by pre-procedural glomerular filtration rate (GFR) [>60 (n=297), 30-60 (n=242), and <30 (n=36)]. Outcomes were defined by VARC-2 criteria. Median follow-up was 811 days. Results Transfemoral artery access (TFA), used in 98.8%, and VARC-2 defined procedural success, achieved in 81.4%, did not differ between groups. However, rates of peri-procedural stroke (0.7%, 2.1%, 11.1%; p<0.001) and acute kidney injury (0%, 1.7%, 8.3%; p<0.001) were higher with lower GFR. When compared to GFR >60, risk of all-cause mortality was higher with GFR 30-60 (Hazard ratio (HR) 1.61 [1.00-2.59]) and GFR <30 (HR 2.41 [1.06-5.49]). After adjustment for differences in baseline and procedural characteristics, all-cause mortality remained higher with GFR <60 (adjusted HR 1.67 [1.03-2.70]) compared with GFR >60. Rate of long-term all-cause mortality was higher with lower GFR (10.1%, 16.5%, 19.4%). Kaplan-Meier mortality estimates are shown. Conclusion Few patients with a pre-procedural GFR <30 but not HD undergo TAVR. Despite high use of TFA and no difference in procedural success rate, long-term all-cause mortality after TAVR is higher in patients with pre-procedural CKD. [Figure presented]
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Background Transfemoral (TF) Transcatheter Aortic Valve Replacement (TAVR) has been shown to be at least equivalent to surgery. Nevertheless, many patients do not qualify for TF approach due to severe ilio-femoral (I-F) occlusive disease. The use of an atherectomy device in order to facilitate TF-TAVR has only been reported in case reports. We describe our experience using orbital atherectomy in preparation for TF-TAVR. Methods We searched our prospective database for the last 1000 TAVR procedures. Patient demographics, procedural characteristics, CT characteristics and short-term outcomes were recorded. CT scans were reviewed to assess access. Hostile access was defined as luminal size less than 5 mm, or less than 5.5mm and the presence of more than 270degree calcification. The primary end-point was the ability to successfully deliver a transcatheter valve via the intended, pre-treated access site. Secondary end-points were procedural vascular complications including mortality, stroke, bleeding requiring transfusion, and urgent vascular repair at 30 days. Results From April 2016 to July 2019, 1000 TAVR procedures were performed. Six subjects (0.6%) required alternative access; 68 patients (6.8%) were labeled as having a hostile I-F anatomy that required vessel preparation prior to TAVR. 48 (70.6%) had angioplasty only and 20 (29.4%) required atherectomy and angioplasty. Atherectomy was performed in a range of 5-21 days prior to TAVR; transradial approach was used in 90% of the time. Out of 20 patients treated with atherectomy successful TF delivery of the valve was achieved in 19 (95%). The mean vessel reference diameter in atherectomy group was 4.0+/-0.9mm. All had near-circumferential calcification. There was no in-hospital mortality or stroke. There were no perforations. One subject required placement of a self-expandable stent due to severe dissection. None of the end-points occurred between hospital discharge and 30-day follow-up. Conclusion Orbital atherectomy used for vessel preparation is a safe and very effective technique to facilitate TF-TAVR in patients with hostile peripheral anatomy.
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Background Mitral valve (MV) repair using the MitraClip system is indicated for patients with severe mitral regurgitation (MR) and high surgical risk. However, patients with small MV area are at risk of post procedural mitral stenosis (MS) and have typically been excluded from this therapy. We evaluated MitraClip feasibility in patients with small MV area. Methods Consecutive patients with severe MR were identified. MV area was measured using 3D planimetry. Small MV area was defined as < 4 cm². Procedural success defined as reduction to >= 2+ MR in absence of surgery, or mortality. Primary endpoint was clinically significant MS defined as residual MV gradient >= 5 mmHg and NYHA class III or IV symptoms. NYHA class at 30 days was evaluated. Results 295 patients were treated from Mar 2016 to Jul 2019. Procedural success was seen in 281 of 295 patients (95%). 63 patients (21%) had a small MV area [Median 3.5 cm², range 2.0-3.9]. Mean age (85 +/- 7), female (65%). At baseline NYHA class was: II: 11, III: 39, and IV: 13 patients. Median post procedure MV gradient was 4 mmHg (range 2-7) at a median heart rate of 70. 13/63 patients had MV gradient >= 5 mmHg, of those only two patients had no improvement in NYHA class despite a reduction in MR. 30-day NYHA class I, II, III, and IV symptoms were seen in 30, 24, 8, and 1 patients (P<0.01 for trend). (Figure) Conclusion MV repair using MitraClip is feasible for patients with small MV area. Post procedural clinically significant MS was rare. Studies with long term outcomes are warranted. [Figure presented]
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BACKGROUND:There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS:We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS:At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS:Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

OBJECTIVES/OBJECTIVE:The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves. BACKGROUND:Over the past decade there have been rapid advancements in transcatheter aortic valve replacement (TAVR) technologies, including 3 generations of supra-annular self-expanding transcatheter systems. METHODS:Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry for patients undergoing TAVR with CoreValve, Evolut R, or Evolut PRO valves to treat tricuspid aortic stenosis between January 2014 and September 2017 were obtained. Patient risk and echocardiographic data are site reported. Valves analyzed included 23-, 26-, and 29-mm sizes to fit 18- to 26-mm annular diameters. Propensity score matching was performed using the Evolut PRO group as the common reference. RESULTS:Of 18,874 patients undergoing TAVR at 381 centers, 5,514 patients were implanted with CoreValve, 11,295 with Evolut R, and 2,065 with Evolut PRO valves. At 30 days, there were significantly fewer patients with more than mild aortic regurgitation for the unmatched (7.8% CoreValve, 5.2% Evolut R, and 2.8% Evolut PRO; p < 0.001) and matched populations (8.3% CoreValve, 5.4% Evolut R, and 3.4% Evolut PRO; p = 0.032). The mean aortic valve gradients at 30 days in the matched populations were <8 mm Hg for all 3 valves (7.3 mm Hg CoreValve, 7.5 mm Hg Evolut R, 7.2 mm Hg Evolut PRO). CONCLUSIONS:Advancements in transcatheter valve technologies and expanding indications for TAVR have resulted in improved outcomes for patients undergoing TAVR in the United States with self-expanding, supra-annular valves. In particular, the addition of an outer pericardial tissue wrap designed to enhance sealing at the level of the aortic annulus has resulted in very low rates of significant aortic regurgitation while maintaining excellent hemodynamic status.

Introduction: Cardiac function is known to be negatively impacted by sepsis. Monitoring Cardiac Output (CO) and Stroke volume (SV) trends over the course of treatment may provide insight into cardiac function and may be used to predict patient outcome.
Objective(s): The goal of this study was to explore the relationship between the change in cardiac output over time in septic shock.
Method(s): FRESH is randomized controlled study, evaluating hemodynamics in critically ill patients with sepsis or septic shock (NCT02837731). Patients randomized to PLR guided resuscitation received hemodynamic monitoring for 72 or until ICU discharge, whichever occurred first (Starling SV, Cheetah Medical). Patients that exhibited an improvement in stroke volume at 12, 24, 36 and 48 hours were compared to those who did not exhibit improvement. Overall improvement in stroke volume (first SV measurement compared to last SV measurement) was also compared between groups.
Result(s): 90 patients with septic shock received hemodynamic monitoring over a 72 hour monitoring period. 60 % were female, and the average age was 61 years. Overall, 44% of assessments demonstrated a fluid responsive positive response after receiving initial resuscitation fluid of 2.3 L. Patients who exhibited improved SV at 24 and 36 hours exhibited a decreased fluid balance over the course of their ICU stay at both 24 hours (1.06 +/- 3.40 vs 3.15 +/- 4.38, p=0.029) and 36 hours (1.18 +/- 2.58 vs 3.41 +/- 4.52, p=0.032). Notably, patients who exhibited an overall improvement in SV also required less hours on vasopressors (34.50 +/- 41.03 vs 64.28 +/- 65.07, p=0.05) and decreased ICU length of stay (3.93 +/- 3 vs 5.59 +/- 5.24 days, p=0.08) (Figure 1).
Conclusion(s): We have previously shown that patients who improve SV in response to the resuscitation exhibited improved outcome. Trending cardiac output over the 72 hour monitoring period revealed additional usefulness in predicting patients with improved outcome. The results highlight the importance of trending hemodynamics in therapy

BACKGROUND:In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and re-hospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. OBJECTIVES/OBJECTIVE:This study sought to compare health status outcomes of TAVR vs. surgery in low-risk patients with severe AS. METHODS:Between 3/2016 and 10/2017, 1000 low-risk AS patients were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 Trial. Health status was assessed at baseline, 1, 6 and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36 and EQ-5D. The primary endpoint was change in KCCQ-Overall Summary (KCCQ-OS) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS:At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p<0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p<0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥ 75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p=0.03) and 12 months (87.3% vs. 82.8%; p=0.07). CONCLUSIONS:Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.

Transcatheter aortic valve replacement (TAVR) has become the preferred method for management of severe aortic stenosis in patients who are at high and intermediate surgical risk, and has recently gained approval from the Food and Drug Administration in the US for use in patients at low risk for surgery. Thrombocytopenia and thromboembolic events in patients undergoing TAVR is associated with increased morbidity and mortality, and yet there is insufficient evidence supporting the current guideline-mediated therapy for antithrombotics post-TAVR. In this article, the authors review current guidelines for antithrombotic therapy in patients undergoing TAVR, studies evaluating antiplatelet regimens, and studies evaluating the use of platelet function testing after TAVR. They also offer a potential link between thrombocytopenia and antiplatelet treatments in patients undergoing TAVR.