Echocardiographic Assessment of Melody Versus Sapien Valves Following Transcatheter Pulmonary Valve Replacement

ObjectivesThe aim of this study was to compare the immediate and midterm echocardiographic performance of the Melody (Medtronic Inc) and Sapien (Edwards Lifesciences Inc) valves after transcatheter pulmonary valve replacement (TPVR) in native and conduit right ventricular outflow tracts (RVOTs).BackgroundTPVR is now a common procedure, but limited data exist comparing postimplantation echocardiographic findings between Melody and Sapien valves.MethodsThis was a single-institution retrospective cohort study of all patients who underwent successful TPVR from 2011 to 2020. Patient demographics, procedural details, and immediate and midterm echocardiographic findings were collected and compared between valve types using the Wilcoxon rank sum, chi-square, or Fisher exact test as appropriate. Subgroups were analyzed individually and were adjusted for multiple comparisons using the Bonferroni method.ResultsA total of 328 patients underwent successful TPVR (Melody: n = 202, Sapien: n = 126). The groups had a similar baseline age, weight, and diagnosis. The most common indications for TPVR were pulmonary stenosis (32.2%) or mixed disease (46%) in the Melody group and pulmonary insufficiency in the Sapien group (52.4%) (P < 0.001). Sapien valves were more often placed in native RVOTs (43.7% vs 18.8%; P < 0.001). The discharge and follow-up mean and peak Doppler gradients were similar between the Melody and Sapien groups. Valves implanted in native RVOTs had significantly lower postimplantation gradients at each follow-up period.ConclusionsEchocardiographic performance after TPVR was generally acceptable and similar when comparing Melody and Sapien valves despite differences in the indication and anatomy in each group. The peak and mean gradients were lower in transcatheter valves implanted in native RVOTs compared with those implanted in conduits or bioprosthetic valves.     

Single-Barrel,Double-Barrel,and Fenestrated Endografts to Facilitate Transcatheter Pulmonary Valve Replacement in Large RVOT

ObjectivesThe aim of this study was to test the hypothesis that narrowing the landing zone using commercially available endografts would enable transcatheter pulmonary valve replacement (TPVR) using commercially available transcatheter heart valves.BackgroundTPVR is challenging in an outsized native or patch-repaired right ventricular outflow tract (RVOT). Downsizing the RVOT for TPVR is currently possible only using investigational devices. In patients ineligible because of excessive RVOT size, TPVR landing zones were created using commercially available endografts.MethodsConsecutive patients with native or patch-repaired RVOTs and high or prohibitive surgical risk were reviewed, and this report describes the authors’ experience with endograft-facilitated TPVR (EF-TPVR) offered to patients ineligible for investigational or commercial devices. All EF-TPVR patients were surgery ineligible, with symptomatic, severe pulmonary insufficiency, enlarged RVOTs, and severe right ventricular (RV) enlargement (>150 ml/m²). TPVR and surgical pulmonary valve replacement (SPVR) were compared in patients with less severe RV enlargement.ResultsFourteen patients had large RVOTs unsuitable for conventional TPVR; 6 patients (1 surgery ineligible) received investigational devices, and 8 otherwise ineligible patients underwent compassionate EF-TPVR (n = 5 with tetralogy of Fallot). Three strategies were applied on the basis of progressively larger RVOT size: single-barrel, in situ fenestrated, and double-barrel endografts as required to anchor 1 (single-barrel and fenestrated) or 2 (double-barrel) transcatheter heart valves. All were technically successful, without procedure-related, 30-day, or in-hospital deaths. Two late complications (stent obstruction and embolization) were treated percutaneously. One patient died of ventricular tachycardia 36 days after EF-TPVR. Compared with 48 SPVRs, RV enlargement was greater, but 30-day and 1-year mortality and readmission were no different. The mean transvalvular pressure gradient was lower after EF-TPVR (3.8 ± 0.8 mm Hg vs. 10.7 ± 4.1 mm Hg; p < 0.001; 30 days). More than mild pulmonary insufficiency was equivalent in both (EF-TPVR 0.0% [n = 0 of 8] vs. SPVR 4.3% [n = 1 of 43]; p = 1.00; 30 days).ConclusionsEF-TPVR may be an alternative for patients with pulmonic insufficiency and enlarged RVOTs ineligible for other therapies.     

Adverse Events,Radiation Exposure,and Reinterventions Following Transcatheter Pulmonary Valve Replacement

BackgroundTranscatheter pulmonary valve replacement (TPVR) is associated with a risk of procedural serious adverse events (SAE) and exposure to ionizing radiation.ObjectivesThe purpose of this study was to define the risk of, and associations with, SAE and high-dose radiation exposure using large-scale registry data.MethodsThe analysis of the multicenter C3PO-QI registry was limited to patients who underwent TPVR from January 1, 2014, to December 31, 2016. SAE were defined as the occurrence of ≥1 moderate, major, or catastrophic events. Radiation dose was reported as dose area product adjusted for weight. Associations with outcome measures were explored in univariate and multivariable analyses.ResultsA total of 530 patients (59% male) underwent TPVR at a median age of 18.3 years (interquartile range [IQR]: 12.9 to 27.3 years) and weight of 58 kg (IQR: 43 to 77 kg) at 14 centers. Implant substrate included homograft (41%), bioprosthesis (30%), native right ventricular outflow tract (RVOT) (27%) and other (2%). TPVR indications were pulmonary insufficiency (28%), stenosis (23%), and mixed (49%). AE and SAE occurred in 26% and 13% of cases, respectively, including 1 mortality. SAE were more frequent in homograft conduit than other RVOT substrates, although SAE type and severity differed between implant substrates. Median radiation dose was 198 μGy·m²/kg (IQR: 94 to 350 μGy·m²/kg). Higher radiation dose was associated with older age, greater RVOT obstruction, and concomitant interventions (p < 0.001). During a median follow-up duration of 1 year, 13.3% underwent catheterization, surgery, or both, unrelated to infection. Younger age, smaller size, and hemodynamic and anatomic factors indicative of greater RVOT obstruction were associated with TPV reintervention.ConclusionsThe incidence of SAE during TPVR in the C3PO-QI registry is high, but mortality is uncommon. Radiation dose is greater than for other congenital interventions and is associated with patient and procedural factors. Reintervention is common during early follow-up.     

Transcatheter Aortic Valve Replacement in Failed Transcatheter Bioprosthetic Valves

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Given the longer life expectancy of these patients, the bioprosthetic valve will eventually fail, and aortic valve reintervention may be necessary. Although currently rare, redo-TAVR will likely increase in the future as younger patients are expected to outlive their transcatheter bioprosthesis. This review provides a contemporary overview of the indications, procedural planning, implantation technique, and outcomes of TAVR in failed transcatheter bioprosthetic aortic valves.     

One-Year Follow-Up of the Melody Transcatheter Pulmonary Valve Multicenter Post-Approval Study

ObjectivesThis study sought to confirm that the short-term hemodynamic effectiveness of the Melody transcatheter pulmonary valve (TPV) (Medtronic, Inc., Minneapolis, Minnesota) achieved by real-world providers is equivalent to the historical results established in the initial 5-center Investigational Device Exemption trial.BackgroundTPV replacement has been used to treat right ventricular outflow tract (RVOT) conduit dysfunction for >10 years. The Melody TPV received U.S. Food and Drug Administration approval in 2010 as a Humanitarian Use Device.MethodsPatients with dysfunctional RVOT conduits were entered in this prospective, nonrandomized study at 10 centers. The primary endpoint was acceptable hemodynamic function at 6 months post-implantation, defined as a composite of RVOT echocardiographic mean gradient ≤30 mm Hg, pulmonary regurgitation less than moderate as measured by echocardiography, and freedom from conduit reintervention and reoperation.ResultsCardiac catheterization was performed in 120 patients for potential implantation of the Melody TPV; of these, 100 patients were implanted, with a 98.0% procedural success rate. There were no procedure-related deaths. Acceptable hemodynamic function at 6 months was achieved in 96.7% of patients with evaluable data (87.9% of the entire implanted cohort), with results maintained through 1 year. No patient had moderate or severe pulmonary regurgitation after implantation. No patient required catheter reintervention in the first year after implantation, and 2 patients required reoperation for conduit replacement. The rate of freedom from TPV dysfunction was 96.9% at 1 year.ConclusionsThis first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates at 1 year. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692)     

Three Generations of Self-Expanding Transcatheter Aortic Valves: A Report From the STS/ACC TVT Registry

ObjectivesThe aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves.BackgroundOver 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.MethodsData 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.ResultsOf 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).ConclusionsAdvancements 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.     

Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve

ObjectivesThis study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group).BackgroundThe Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear.MethodsPatients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2.ResultsThe Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p < 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively).ConclusionsThe utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; Safety and Efficacy Study of the Medtronic CoreValve® System In the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910)     

Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials

ObjectivesThe aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve.BackgroundTranscatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium.MethodsBIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol.ResultsPatients’ mean age was 82.4 ± 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage ≥3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient (1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 ± 0.4 cm² and 1.9 ± 0.5 cm², and mean gradient was 6.4 mm Hg at 30 days and 6 months.ConclusionsClinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis.     

Electrosurgical Detachment of MitraClips From the Anterior Mitral Leaflet Prior to Transcatheter Mitral Valve Implantation

ObjectivesThe aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis.BackgroundPatients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI.MethodsThis was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days.ResultsMitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet.ConclusionsTranscatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak.     

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction

BackgroundTranscatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail.ObjectivesThe authors sought to examine outcomes following redo-TAVR.MethodsThe Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.ResultsAmong 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm² and 1.51 ± 0.57 cm²; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.ConclusionsRedo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.     

Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy

BackgroundSubclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction.ObjectivesThe U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes.MethodsThe PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low–surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory.ResultsThe incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04).ConclusionsSubclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.     

Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry

ObjectivesThe aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli.BackgroundTranscatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.MethodsTAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm² on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch.ResultsPre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm²/m² (95% CI: 1.01 to 1.08 cm²/m²) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.ConclusionsTranscatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.     

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial

ObjectivesThe aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV).BackgroundRandomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV.MethodsDIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events.ResultsDevice success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: −4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.ConclusionsDirect TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519)     

Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study

BackgroundTranscatheter aortic valve implantation now has a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation.AimsWe sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves.MethodsWe conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve.ResultsA total of 37 patients (male sex, 73%) with a median age of 81 years (interquartile range 69–85 years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n = 31) had dyspnoea New York Heart Association class ≥ III. The device success rate was 94.6% (n = 35). At 30 days, the all-cause mortality rate was 8.1% (n = 3) and valve migration occurred in 10.8% of cases (n = 4). Dyspnoea New York Heart Association class ≤ II was seen in 86.5% of patients (n = 32), and all survivors had aortic regurgitation grade ≤ 1. At 1-year follow-up, all-cause mortality was 16.2% (n = 6), 89.7% (n = 26/29) of survivors were in New York Heart Association class ≤ II and all had aortic regurgitation grade ≤ 2.ConclusionTranscatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.     

Bioprosthetic Valve Leaflet Displacement During Valve-in-Valve Intervention: An Ex Vivo Bench Study

ObjectivesThe aim of this study was to examine the effect of different transcatheter heart valves (THVs) on valve leaflet displacement when deployed within bioprosthetic surgical valves and, thereby, risk for coronary obstruction.BackgroundCoronary obstruction is a potentially devastating complication during valve-in-valve (ViV) transcatheter aortic valve replacement. Strategies such as provisional stenting and intentional bioprosthetic valve leaflet laceration have been developed to mitigate this risk. Alternatively, the use of a THV that retracts the bioprosthetic leaflet away from the coronary ostium may prevent coronary obstruction.MethodsA 25-mm J-Valve, a 26-mm Evolut Pro, and a 23-mm JenaValve were implanted into both a 25-mm Trifecta surgical valve and a 25-mm Mitroflow surgical valve. A 23-mm and a 26-mm SAPIEN 3 were deployed into the Trifecta and Mitroflow, respectively. Displacement of the surgical valve leaflets (retraction vs. expansion) was measured with implantation of each THV by measuring displacement angle and maximal displacement distance.ResultsWithin both the Trifecta and Mitroflow valves, implantation of the J-Valve and JenaValve resulted in retraction of the surgical valve leaflets, and placement of the Evolut Pro and SAPIEN 3 resulted in tubular expansion of the surgical valve leaflets. There were significant differences in displacement angles and distances between both the J-Valve and JenaValve and the SAPIEN 3 and Evolut Pro (p < 0.0001).ConclusionsViV implantation with new-generation THVs that directly interact with bioprosthetic valve leaflets results in surgical valve leaflet retraction. This might mitigate the risk for coronary obstruction in selected cases of ViV transcatheter aortic valve replacement and also facilitate coronary reaccess after ViV TAVR.     

Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk

BackgroundIn low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year.ObjectivesThis study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial.MethodsThis study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis.ResultsPrimary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years.ConclusionsAt 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114)     

5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial

ObjectivesThe purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years.BackgroundThe CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV.MethodsThe CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability.ResultsAfter 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm² vs. 1.9 ± 0.5 cm²; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63).ConclusionsFive-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202)     

Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study

ObjectivesThe aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment.BackgroundCertain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking.MethodsRE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR.ResultsAmong 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV–sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01).ConclusionsUnsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV–sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204)     

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis

ObjectivesThe aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS).BackgroundTAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials.MethodsThe LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration–approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory.ResultsSixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days.ConclusionsTAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.