Left atrial to coronary sinus shunting for treatment of heart failure with mildly reduced or preserved ejection fraction: The ALT FLOW Early Feasibility Study 1-year results.

AIMS: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients. METHODS AND RESULTS: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population. CONCLUSIONS: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial.

Effect of Blood Pressure Levels on Sinus Hemodynamics in Relation to Calcification After Bioprosthetic Aortic Valve Replacement.

Coexisting hypertension and aortic stenosis are common. Some studies showed that elevated blood pressures may be associated with progression of calcific aortic valve disease (CAVD) while others showed no correlation. Flow dynamics in the sinuses of Valsalva are considered key factors in the progression of CAVD. While the relationship between hemodynamics and CAVD is not yet fully understood, it has been demonstrated that they are tightly correlated. This study aims to investigate the effect of changing systolic and diastolic blood pressures (SBP and DBP, respectively) on sinus hemodynamics in relation to potential initiation or progression of CAVD after aortic valve replacement (AVR). Evolut R, SAPIEN 3 and Magna valves were deployed in an aortic root under pulsatile conditions. Using particle image velocimetry, the hemodynamics in the sinus were assessed. The velocity, vorticity, circulation ( Γ ) and shear stress were calculated. This study shows that under elevated SBP and DBP, velocity, vorticity, and shear stress nearby the leaflets increased. Additionally, larger fluctuations of Γ and area under the curve throughout the cardiac cycle were observed. Elevated blood pressures are associated with higher velocity, vorticity, and shear stress near the leaflets which may initiate or accelerate pro-calcific changes in the prosthetic leaflets leading to bioprosthetic valve degeneration.

Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial.

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. OBJECTIVES: The authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25 and less than moderate AR. RESULTS: A total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found. CONCLUSIONS: In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.

Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.

BACKGROUND: Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option. OBJECTIVES: The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF. METHODS: A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise. RESULTS: Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices. CONCLUSIONS: In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.

Effect of mitral valve transcatheter edge-to-edge repair on indices of left atrial performance in chronic mitral regurgitation.

INTRODUCTION: Effect of transcatheter edge-to-edge repair (TEER) using MitraClip in patients with mitral regurgitation (MR) on left atrial (LA) kinetic energy (LAKE), an index of LA work, and LA strain, a measure of LA performance, have not been well defined. METHODS: Patients with chronic primary or secondary 3+ or 4+ MR were analyzed pre- and post-TEER using MitraClip. LAKE was determined by echocardiography using LA stroke volume and A-wave velocity. Peak atrial longitudinal strain (PALS), peak atrial strain in early diastole, and peak atrial contraction strain (PACS) were obtained by speckle tracking echocardiography. RESULTS: Thirty-nine patients undergoing TEER with MitraClip were screened, 12 met criteria for analysis (9 primary and 3 secondary MR). Compared to pre-TEER, there was a significant increase post-TEER in LAKE (71.0 ± 64.1 vs. 177.5 ± 167.9 dyne·cm·103 , respectively; p = .008) and Doppler transmitral A-wave velocity (87.8 ± 41.4 vs. 138.5 ± 43.7 cm/s, respectively; p < .001); LA stroke volume did not change significantly. Mitral valve mean gradient significantly increased post-TEER compared to pre-TEER (5.7 ± 2.1 vs. 3.3 ± 2.1 mmHg, respectively; p = .01). There was a trend toward decrease in PALS post-TEER compared to pre-TEER (16.2 ± 4.8 vs. 20.7 ± 9.9%, respectively; p = .05). Peak atrial strain in early diastole significantly decreased post-TEER compared to pre-TEER (7.2 ± 3.0 vs. 14.1 ± 7.2%; respectively, p < .001), while PACS did not significantly change (9.1 ± 3.5 vs. 6.7 ± 5.2%, respectively; p = .07). CONCLUSION: In patients with chronic MR, LAKE increases after TEER with MitraClip driven by an increase in LA emptying velocities. Changes were also seen in LA strain with MitraClip. These procedurally induced changes due to mild mitral stenosis may have clinical implications.

Concomitant anaortic OPCAB and transfemoral TAVR for high-risk patients: A case series.

BACKGROUND: Combined on-pump coronary artery bypass (ONCAB) and surgical aortic valve replacement (SAVR) is the treatment of choice for concomitant severe aortic stenosis and coronary artery disease not amenable to percutaneous coronary intervention. Extensive aortic calcification and atheromatous disease may prohibit cardiopulmonary bypass and aortic cross-clamping. In these cases, anaortic off-pump coronary artery bypass (OPCAB) is a Class I (EACTS 2018) and Class IIA (AHA 2021) indication for surgical coronary revascularization. Transcatheter aortic valve replacement (TAVR) has similar benefits when compared with SAVR for this population (Partner 2 & 3). Herewith we describe a case series of concomitant Anaortic OPCAB and TAVR via the transfemoral approach for patients with coronary artery and valve disease considered too high risk for traditional coronary artery bypass grafting and SAVR due to severe aortic disease. METHODS/RESULTS: Eight patients underwent anaortic OPCAB and transfemoral TAVR during the same anesthetic in a hybrid operating room. Seven patients with multivessel disease had anaortic OPCAB via a sternotomy using composite grafts, one patient with LAD disease had anaortic OPCAB using a Da Vinci-assisted MIDCAB approach. All patients then had an Edwards Sapien 3 TAVR placed percutaneously via the common femoral artery. There was no 30 mortality or CVA in the series and all patients were discharged to home or a rehabilitation facility on Day 4-13. CONCLUSIONS: Combined anaortic OPCAB and transfemoral TAVR is a safe and feasible approach to treating concomitant extensive coronary artery disease and severe aortic stenosis. The aortic no-touch technique provides benefits in the elderly high-risk patients by reducing the risk of postoperative myocardial infarction and cerebrovascular stroke.

Flow dynamics of surgical and transcatheter aortic valves: Past to present.

Objective: To perform an in vitro characterization of surgical aortic valves (SAVs) and transcatheter aortic valves (TAVs) to highlight the development of the flow dynamics depending on the type of valve implanted and assess the basic differences in the light of flow turbulence and its effect on blood damage likelihood and hemodynamic parameters that shed light on valve performance. Methods: A Starr-Edwards ball and cage valve of internal diameter 22 mm, a 23-mm Medtronic Hancock II SAV, a 23-mm St Jude Trifecta SAV, a 23-mm St Jude SJM (mechanical valve) SAV, a 26-mm Medtronic Evolut TAV, and a 26-mm Edwards SAPIEN 3 TAV were assessed in a pulse duplicator under physiological conditions. Particle image velocimetry was performed for each valve. Pressure gradient and effective orifice area (EOA) along with velocity flow field, Reynolds shear stress (RSS), and viscous shear stress (VSS) were calculated. Results: The SJM mechanical valve exhibited the greatest EOA (1.96 ± 0.02 cm2), showing superiority of efficiency compared with the same-size Trifecta (1.87 ± 0.07 cm2) and Hancock II (1.05 ± 0.01 cm2) (P < .0001). The TAVs show close EOAs (2.10 ± 0.06 cm2 with Evolut and 2.06 ± 0.03 cm2 with SAPIEN 3; P < .0001). The flow characteristics and behavior downstream of the valves differed depending on the valve type, design, and size. The greater the RSS and VSS the more turbulent the downstream flow. Hancock II displays the greatest range of RSS and VSS magnitudes compared with the same-size Trifecta and SJM. The Evolut displays the greatest range of RSS and VSS compared with the SAPIEN 3. Conclusions: The results of this study shed light on numerous advancements in the design of aortic valve replacement prosthesis and the subsequent hemodynamic variations. Future surgical and transcatheter valve designs should aim at not only concentrating on hemodynamic parameters but also at optimizing downstream flow properties.

Gradient and pressure recovery of a self-expandable transcatheter aortic valve depends on ascending aorta size: In vitro study.

Objective: In this study we aimed to understand the role of interaction of the Medtronic Evolut R transcatheter aortic valve with the ascending aorta (AA) by evaluating the performance of the valve and the pressure recovery in different AA diameters with the same aortic annulus size. Methods: A 26-mm Medtronic Evolut R valve was tested using a left heart simulator in aortic root models of different AA diameter (D): small (D = 23 mm), medium (D = 28 mm), and large (D = 34 mm) under physiological conditions. Measurements of pressure from upstream to downstream of the valve were performed using a catheter at small intervals to comprehensively assess pressure gradient and pressure recovery. Results: In the small AA, the measured peak and mean pressure gradient at vena contracta were 11.5 ± 0.5 mm Hg and 7.8 ± 0.4 mm Hg, respectively, which was higher (P < .01) compared with the medium (8.1 ± 0.4 mm Hg and 5.2 ± 0.4 mm Hg) and large AAs (7.4 ± 1.0 mm Hg and 5.4 ± 0.6 mm Hg). The net pressure gradient was lower for the case with the medium AA (4.1 ± 1.2 mm Hg) compared with the small AA (4.7 ± 0.8 mm Hg) and large AA (6.1 ± 1.4 mm Hg; P < .01). Conclusions: We have shown that small and large AAs can increase net pressure gradient, because of the direct interaction of the Medtronic Evolut R stent with the AA (in small AA) and introducing higher level of turbulence (in large AA). AA size might need to be considered in the selection of an appropriate device for transcatheter aortic valve replacement.

Comparison of performance of self-expanding and balloon-expandable transcatheter aortic valves.

Objective: To evaluate the flow dynamics of self-expanding and balloon-expandable transcatheter aortic valves pertaining to turbulence and pressure recovery. Transcatheter aortic valves are characterized by different designs that have different valve performance and outcomes. Methods: Assessment of transcatheter aortic valves was performed using self-expanding devices (26-mm Evolut [Medtronic], 23-mm Allegra [New Valve Technologies], and small Acurate neo [Boston Scientific]) and a balloon-expandable device (23-mm Sapien 3 [Edwards Lifesciences]). Particle image velocimetry assessed the flow downstream. A Millar catheter was used for pressure recovery calculation. Velocity, Reynolds shear stresses, viscous shear stress, and pressure gradients were calculated. Results: The maximal velocity at peak systole obtained with the Evolut R, Sapien 3, Acurate neo, and Allegra was 2.12 ± 0.19 m/sec, 2.41 ± 0.06 m/sec, 2.99 ± 0.10 m/sec, and 2.45 ± 0.08 m/sec, respectively (P < .001). Leaflet oscillations with the flow were clear with the Evolut R and Acurate neo. The Allegra shows the minimal range of Reynolds shear stress magnitudes (up to 320 Pa), and Sapien 3 the maximal (up to 650 Pa). The Evolut had the smallest viscous shear stress magnitude range (up to 3.5 Pa), and the Sapien 3 the largest (up to 6.2 Pa). The largest pressure drop at the vena contracta occurred with the Acurate neo transcatheter aortic valve with a pressure gradient of 13.96 ± 1.35 mm Hg. In the recovery zone, the smallest pressure gradient was obtained with the Allegra (3.32 ± 0.94 mm Hg). Conclusions: Flow dynamics downstream of different transcatheter aortic valves vary significantly depending on the valve type, despite not having a general trend depending on whether or not valves are self-expanding or balloon-expandable. Deployment design did not have an influence on flow dynamics.

Comparison of Catheterization Versus Echocardiographic-Based Gradients in Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation.

OBJECTIVES: In patients with transcatheter aortic valve implantation (TAVI), accurate assessment of gradients is important to assess valve function and durability, which drives clinical decision-making. We sought to evaluate discrepancies in aortic valve mean gradients with balloon-expandable and self-expanding TAVI. METHODS: We retrospectively reviewed 507 patients that underwent TAVI and compared mean gradients by catheterization to transthoracic Doppler echocardiography. RESULTS: Mean gradients by Doppler in balloon-expandable (11.0 ± 5.8 mm Hg) and self-expanding devices (8.7 ± 4.5 mm Hg) were significantly higher than catheterization (3.2 ± 4.0 mm Hg vs 3.5 ± 4.1 mm Hg, respectively; P<.001). In a subgroup analysis of skirted valves, Doppler gradients in balloon-expandable (9.8 ± 4.4 mm Hg) and self-expanding devices (8.6 ± 5.1 mm Hg) were significantly higher than catheterization (3.5 ± 4.1 mm Hg vs 4.2 ± 4.8 mm Hg, respectively; P<.001). When the effect of valve size on gradients was analyzed, Doppler gradients were significantly higher than catheterization for all comparisons. When indexed for valve size, patients with large aortas who received a balloon-expandable TAVI had greater pressure differential than those who received a self-expanding TAVI (8.24 ± 0.46 mm Hg vs 5.16 ± 0.66 mm Hg; P<.001). This trend was not seen in patients with a small aorta-to-valve index. CONCLUSION: Following TAVI, aortic valve mean gradients acquired by Doppler were higher than catheterization and the discrepancy was more pronounced in balloon-expandable than self-expanding prostheses. These differences persist in skirted valves and across valve sizes. These observations may reflect periprocedural hemodynamic changes, differences between prosthetic flow acceleration, and/or pressure recovery.

Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses.

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. OBJECTIVES: The purpose of this study was to compare the hemodynamic results between the balloon-expandable valve (BEV) SAPIEN (3/ULTRA, Edwards Lifesciences) and self-expanding valve (SEV) Evolut (R/PRO/PRO+, Medtronic) in ViV-TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve were randomized to receive a BEV or an SEV. The primary endpoint was valve hemodynamics (maximal/mean residual gradients, severe prosthesis patient mismatch [PPM], or moderate-severe aortic regurgitation) at 30 days as evaluated by Doppler echocardiography. RESULTS: A total of 102 patients were randomized, and of these, 98 patients finally underwent a ViV-TAVR procedure (BEV: n = 46, SEV: n = 52). The procedure was successful in all cases, with no differences in clinical outcomes at 30 days between groups (no death or stroke events). Patients in the SEV group exhibited lower mean and maximal transvalvular gradient values (15 ± 8 mm Hg vs 23 ± 8 mm Hg; P ˂ 0.001; 28 ± 16 mm Hg vs 40 ± 13 mm Hg, P ˂ 0.001), and a tendency toward a lower rate of severe PPM (44% vs 64%; P = 0.07). There were no cases of moderate-severe aortic regurgitation. In total, 55 consecutive patients (SEV: n = 27; BEV: n = 28) underwent invasive valve hemodynamic evaluation during the procedure, with no differences in mean and peak transvalvular gradients between both groups (P = 0.41 and P = 0.70, respectively). CONCLUSIONS: In patients with small failed aortic bioprostheses, ViV-TAVR with an SEV was associated with improved valve hemodynamics as evaluated by echocardiography. There were no differences between groups in intraprocedural invasive valve hemodynamics and 30-day clinical outcomes (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses. The 'LYTEN' Trial; NCT03520101).

Impact of blood pressure on coronary perfusion and valvular hemodynamics after aortic valve replacement.

OBJECTIVE: Our objective was to evaluate the impact of various blood pressures (BPs) on coronary perfusion and valvular hemodynamics following aortic valve replacement (AVR). BACKGROUND: Lower systolic and diastolic (SBP/DBP) pressures from the recommended optimal target range of SBP < 120-130 mmHg and DBP < 80 mmHg after AVR have been independently associated with increased cardiovascular and all-cause mortality. METHODS: The hemodynamic assessment of a 26 mm SAPIEN 3 transcatheter aortic valve (TAV), 29 mm Evolut R TAV, and 25 mm Magna Ease surgical aortic valve (SAV) was performed in a pulsed left heart simulator with varying SBP, DBP, and heart rate (HR) conditions (60 and 120 bpm) at 5 L/min cardiac output (CO). Average coronary flow (CF), effective orifice areas (EOAs), and valvulo-arterial impedance (Zva) were calculated. RESULTS: At HR of 60 bpm, at SBP < 120 mmHg and DBP < 60 mmHg, CF decreased below the physiological lower limit with several different valves. Zva and EOA were found to increase and decrease respectively with increasing SBP and DBP. The same results were found with an HR of 120 bpm. The trends of CF variation with BP were similar in all valves however the drop below the lower physiological CF limit was valve dependent. CONCLUSION: In a controlled in vitro system, with different aortic valve prostheses in place, CF decreased below the physiologic minimum when SBP and DBP were in the range targeted by blood pressure guidelines. Combined with recent observations from patients treated with AVR, these findings underscore the need for additional studies to identify the optimal BP in patients treated with AVR for AS.

Neosinus and Sinus Flow After Self-Expanding and Balloon-Expandable Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to evaluate flow dynamics in the aortic sinus and the neosinus (NS) after transcatheter heart valve (THV) implantation in valve-in-valve (ViV). BACKGROUND: Leaflet thrombosis may occur on THVs and affect performance and durability. Differences in flow dynamics may affect the risk for leaflet thrombosis. METHODS: Hemodynamic assessment following THV implantation in a surgical aortic valve was performed in a left heart simulator under pulsatile physiological conditions. Assessment was performed using a 23-mm polymeric surgical aortic valve (not diseased) and multiple THV platforms, including self-expanding devices (26-mm Evolut, 23-mm Allegra, small ACURATE neo) and a balloon-expandable device (23-mm SAPIEN 3). Particle image velocimetry was performed to assess flow in the sinus and NS. Sinus and NS washout, shear stress, and velocity were calculated. RESULTS: Sinus and NS washout was fastest and approximately 1 cardiac cycle for each with the Evolut, ACURATE neo, and Allegra compared with the SAPIEN 3, with washout in 2 and 3 cardiac cycles, respectively. The Allegra showed the largest shear stress distribution in the sinus, followed by the SAPIEN 3. In the NS, all 4 valves showed equal likelihoods of occurrence of shear stress <1 Pa, but the Allegra showed the highest likelihoods of occurrence for shear stress >1 Pa. The velocities in the sinus and NS were 0.05, 0.078, 0.080, and 0.075 m/s for Evolut, SAPIEN 3, ACURATE neo, and Allegra ViV, respectively. CONCLUSIONS: Sinus and NS flow dynamics differ substantially among THVs after ViV. Self-expanding supra-annular valves seem to have faster washouts compared with an equivalent-size balloon-expandable THV.

The hemodynamics of transcatheter aortic valves in transcatheter aortic valves.

BACKGROUND: The durability of transcatheter aortic valves (TAVs) remains their greatest disadvantage, given that fixed tissue leaflets are not immune to structural degeneration from calcification and thrombosis. Therefore, a second intervention is necessary, especially given that TAV in low-risk patients has shown noninferior outcomes compared with surgery. This study aimed to assess the hemodynamic and turbulent properties of the flow downstream with different TAV-in-TAV configurations, to offer basic hemodynamic guidance for future interventions when currently implanted valves structurally degrade. METHODS: Six TAV-in-TAV configurations were chosen: 23 mm Evolut-in-26 mm Evolut, 23 mm Evolut-in-23 mm SAPIEN 3, 26 mm Evolut-in-26 mm Evolut, 26 mm Evolut-in-23 mm SAPIEN 3, 23 mm SAPIEN3-in-26 mm Evolut, and 23 mm SAPIEN3-in-23 mm SAPIEN 3. Their hemodynamic performance was assessed in a pulse duplicator for 100 cycles. High-speed imaging and particle image velocimetry were performed to assess turbulence. Effective orifice area (EOA), pinwheeling index (PI), and Reynolds shear stress (RSS) were evaluated. RESULTS: The largest mean EOA was obtained with 23 mm SAPIEN-in-26 mm Evolut (2.07 ± 0.06 cm2), and the smallest was obtained with 23 mm Evolut-in-23 mm SAPIEN (1.50 ± 0.04 cm2) (P < .001). The highest mean PI was obtained with SAPIEN-in-SAPIEN (26.5 ± 2.00%), and the lowest was obtained with 26 mm Evolut-in-26 mm Evolut (7.5 ± 1.6%) (P < .01). At peak systole, the least detrimental RSS range was obtained with 23 mm Evolut-in-26 mm Evolut (up to ∼340 Pa), and the most detrimental RSS range was obtained with 23 mm Evolut-in-SAPIEN (∼900 Pa) (P < .01). CONCLUSIONS: This study shows that best hemodynamic parameters are TAV-specific (implanted and to be implanted). In addition, it shows that RSS levels, which are indicative of turbulence levels and associated with blood damage, are 2- to 3-fold higher after TAV-in-TAV.

Simple 2-dimensional anatomic model to predict the risk of coronary obstruction during transcatheter aortic valve replacement.

OBJECTIVE: In this study, a 2-dimensional (2D) index relying on preprocedural computed tomography (CT) data was developed to evaluate the risk of coronary obstruction during transcatheter aortic valve replacement (TAVR) procedures. METHODS: Anatomic measurements from pre-TAVR CT scans were collected in 28 patients among 600 who were flagged as high risk (defined as meeting coronary artery height, h, <14 mm and/or sinus of Valsalva diameter, SOVd, <30 mm) for coronary obstruction. A geometric model derived from these anatomic measurements was used to predict the post-TAVR native cusp apposition relative to the coronary ostium. The distance from the cusp to the coronary ostium, DLC2D, was measured from the geometric model and indexed with the coronary artery diameter, d, to yield a fractional obstruction measure, DLC2D/d. RESULTS: Twenty-three of 28 high-risk patients successfully underwent TAVR without coronary obstruction, of whom 1 had coronary obstruction and 4 were deemed non-TAVR candidates. DLC2D/d differed significantly between the 2 groups (P < .0018), but neither h nor SOVd did (P > .32). The optimal sensitivity and specificity for DLC2D/d were 85% and occurred at a cutoff of 0.45. The optimal sensitivity and specificity of h and SOVd in this high-risk group were only 60% and 40%, respectively, for cutoffs of h = 10 mm and SOVd = 30.5 mm. CONCLUSIONS: The 2D geometric model derived in this study shows promise for identifying patients with low-lying coronary ostium and/or small SOVd that may be safely treated with TAVR. DLC2D/d is more predictive of obstruction or poor TAVR candidacy compared with h and SOVd.

Interatrial shunt devices for the treatment of heart failure.

Despite ongoing advances in the treatment of heart failure, overall symptom burden remains high. Underlying the primary symptom of dyspnea are often elevations in left atrial pressures, which occur across the spectrum of heart failure subgroups. Current therapies do not directly address improvements in left atrial pressures; however, passive left atrial decompression may offer a new avenue to treat heart failure. New technologies are currently being evaluated in clinical testing and may offer a novel therapeutic approach to heart failure.

2020 ACC Expert Consensus Decision Pathway on Management of Conduction Disturbances in Patients Undergoing Transcatheter Aortic Valve Replacement: A Report of the American College of Cardiology Solution Set Oversight Committee.

Consensus regarding a reasonable strategy to manage cardiac conduction disturbances after transcatheter aortic valve replacement (TAVR) has been elusive. This is due to the absence of adequately powered, randomized controlled trials; the often transient nature of the conduction disturbances; evolving technologies; and the interplay of cardiology subspecialties involved. In the absence of high-quality trials, numerous practice styles have been developed, and prolonged observation, electrophysiological testing, and pre-emptive pacemaker implantation have been described. Although the 2013 European Society of Cardiology guidelines address pacing post-TAVR, they do not provide in-depth discussion of this topic. Furthermore, a summary and proposed strategy for this problem have not been published by cardiovascular societies in the United States, despite an interest in establishing best practices in TAVR, valvular heart disease, and cardiovascular implantable electrical devices. This document reviews existing data and experience regarding the management of conduction disturbances after TAVR and proposes an evidence-based expert consensus decision pathway for their management. Where evidence is lacking or insufficient, the recommendations herein are based on expert opinion.

Extracorporeal Cardiopulmonary Resuscitation (ECPR) for Out-of-Hospital Cardiac Arrest due to Pulseless Ventricular Tachycardia/Fibrillation.

BACKGROUND: Survival rates for out-of-hospital cardiac arrest are very low and neurologic recovery is poor. Innovative strategies have been developed to improve outcomes. A collaborative extracorporeal cardiopulmonary resuscitation (ECPR) program for out-of-hospital refractory pulseless ventricular tachycardia (VT) and/or ventricular fibrillation (VF) has been developed between The Ohio State University Wexner Medical Center and Columbus Division of Fire. METHODS: From August 15, 2017, to June 1, 2019, there were 86 patients that were evaluated in the field for cardiac arrest in which 42 (49%) had refractory pulseless VT and/or VF resulting from different underlying pathologies and were placed on an automated cardiopulmonary resuscitation device; from these 42 patients, 16 (38%) met final inclusion criteria for ECPR and were placed on extracorporeal membrane oxygenation (ECMO) in the cardiac catheterization laboratory (CCL). RESULTS: From the 16 patients who underwent ECPR, 4 (25%) survived to hospital discharge with cerebral perfusion category 1 or 2. Survivors tended to be younger (48.0 ± 16.7 vs. 59.3 ± 12.7 years); however, this difference was not statistically significant (p=0.28) likely due to a small number of patients. Overall, 38% of patients underwent percutaneous coronary intervention (PCI). No significant difference was found between survivors and nonsurvivors in emergency medical services dispatch to CCL arrival time, lactate in CCL, coronary artery disease severity, undergoing PCI, and pre-ECMO PaO2, pH, and hemoglobin. Recovery was seen in different underlying pathologies. CONCLUSION: ECPR for out-of-hospital refractory VT/VF cardiac arrest demonstrated encouraging outcomes. Younger patients may have a greater chance of survival, perhaps the need to be more aggressive in this subgroup of patients.

Sinus Hemodynamics After Transcatheter Aortic Valve in Transcatheter Aortic Valve.

BACKGROUND: This study evaluated the effect of transcatheter aortic valve (TAV)-in-TAV on sinus hemodynamics and washout. With TAV becoming the standard procedure for aortic valve replacement and with the limited valve durability, a second intervention is necessary (TAV-in-TAV) after first TAV failure. METHODS: Six arrangements of TAV-in-TAV were chosen for this study as follows: (1) Evolut 23 (Medtronic, Minneapolis, MN) in Evolut 26, (2) Evolut 23 in SAPIEN 3 23 (Edwards Lifesciences, Irvine, CA), (3) Evolut 26 in Evolut 26, (4) Evolut 26 in SAPIEN 23, (5) SAPIEN 3 23 in Evolut 26, and (6) SAPIEN 3 23 in SAPIEN 3 23. These TAV-in-TAV configurations were assessed in a pulse duplicator. Particle image velocimetry was performed. RESULTS: During systole, (1) the highest velocity was found with SAPIEN-in-SAPIEN (0.7 m/s) and the lowest was with Evolut 26-in-Evolut 26 (0.2 m/s); (2) the highest shear stress magnitude near the leaflet was with Evolut 23-in-SAPIEN (1.45 Pa) and the lowest was with Evolut 26-in-Evolut 26 (0.55 Pa); and (3) washout was almost equal in all sinuses of these cases (<2.5 cycles). CONCLUSIONS: This study shows that TAV-in-TAV is highly dependent on the valve that is originally implanted and the valve to be implanted. Washout is not significantly degraded after TAV-in-TAV compared with valve-in-valve and TAV replacement. Further studies are needed to optimize valve size and selection.