key: cord-0929669-bd1gptld
authors: Medranda, Giorgio A.; Yerasi, Charan; Case, Brian C.; Forrestal, Brian; Chezar-Azerrad, Chava; Waksman, Ron
title: Review of structural late-breaking trials from the TVT Connect 2020 and PCR e-Course 2020 virtual meetings
date: 2020-07-26
journal: Cardiovasc Revasc Med
DOI: 10.1016/j.carrev.2020.07.029
sha: 9212c14eface3fedcc60f6d5d73d49135b4c723e
doc_id: 929669
cord_uid: bd1gptld

• COVID-19 pandemic replaced face-to-face meetings with virtual ones. • We give highlights of late-breaking trials presented at the TVT Connect 2020. • We also report on selected structural trials presented at PCR e-Course 2020.

With regard to procedural outcomes, patients who received the SAPIEN 3 Ultra valve had significantly shorter procedural times (75.3 ± 36.6 minutes vs. 81.7 ± 40.6 minutes; p<0.01) and fluoroscopy times (12.3 ± 10.3 minutes vs. 14.7 ± 8.5 minutes; p<0.01). One theory for this marked decrease could be the reduction of post-dilation using the SAPIEN 3 Ultra valve with its taller PET skirt.

J o u r n a l P r e -p r o o f 8 TAVR. Mean aortic gradients or the presence of patient-prosthesis mismatch were not found to be predictors of 1-year all-cause mortality in patients who underwent ViV TAVR with prior SAVR.

The limitations of the study are inherent to data derived from the TVT registry, as it carries a risk of missing data and miscoded data. Additionally, variables not routinely included in the STS predicted risk of mortality could have impacted outcomes. The authors attempted to mitigate some of the cofounders by including them in the heart team surgical risk stratification analysis.

Furthermore, echocardiographic data was not core lab adjudicated. Future prospective studies are required to confirm these findings past 1 year.

Statistical analyses were performed by Edwards Lifesciences.

J o u r n a l P r e -p r o o f 10 0.6%, p=0.133) and valve-related readmissions ( The Evolut Low Risk randomized trial demonstrated similar outcomes in low-risk patients undergoing TAVR using the third-generation self-expandable Evolut PRO valve compared to surgery. [7] This trial randomized patients to receive either TAVR using the Evolut PRO valve or SAVR. Following enrollment of this randomized trial, the continued-access study (CAS) continued to enroll patients at study sites in a non-randomized fashion. Bruce Rutkin, MD, of North Shore University Hospital, Manhasset, New York, and co-investigators studied three cohorts in this study: the low-risk randomized controlled trial (RCT) patients, the CAS patients, and patients designated as low-risk in the STS/ACC TVT registry. [8] Baseline clinical characteristics were similar across the three cohorts, with the exception of male sex, which was more frequent in the RCT and CAS cohorts than in the STS/ACC TVT registry patients (50.9% vs. 50.9% vs. 41.6%). Baseline New York Heart Association Functional Class (NYHA FC) III/IV symptoms were less prevalent in the RCT and CAS cohorts than in the STS/ACC TVT registry patients (20.5% vs. 29.7% vs. 49.5%). Not surprisingly, fewer patients had bicuspid aortic valves in the RCT and CAS cohorts than in the STS/ACC TVT registry (0.0% vs. 0.7% vs. 5.6%).

With regard to procedural data, more patients received general anesthesia in the RCT than in the CAS cohort or the STS/ACC TVT registry (56.5% vs. 38.1% vs. 40.5%). There were no differences in median hospital length of stay (all 2 days). At 30 days, rates of stroke (4.7% vs. Limitations of this study relate to comparison of a strictly adjudicated randomized trial to the less-adjudicated data in the CAS cohort and the STS/ACC TVT registry. This may explain the observed differences in outcomes at 30 days among the cohorts. The review process for eligibility differs among the RCT, CAS, and STS/ACC TVT registry patients.

The primary Evolut Low Risk trial was sponsored by Medtronic. These patients had 30-day and 6-month 4D-CT or 3D-TEE to determine leaflet mobility. HALT was identified using the maximal intensity projection (MIP) on 2D-CT. The investigators defined HALT as the presence of any hypoattenuation in a leaflet. RLM was defined as a leaflet that opens with at least moderate reduction during systole. Furthermore, leaflet motion severity was graded as none, mild (<50% reduction in leaflet opening), moderate (50% to 70% reduction in leaflet opening), severe (>70% reduction in leaflet opening), or immobile. The primary outcome of interest was incidence of RLM at 30 days and 6 months. Additional endpoints included frequency of HALT (in the post hoc analysis), death, stroke, MI, atrial fibrillation, readmissions, structural valve deterioration, and mean aortic gradients.

Of the 364 patients enrolled in the nested CT sub-study, 187 received a Portico valve and 177 received a commercially available TAVR valve. Excluded were patients who did not have sufficient initial CT/TEE data, patients who had ViV TAVR, and those who died. At 30 days, 321 patients with available data and follow-up were analyzed, and at 6 months, 238 patients with available data and follow-up were analyzed. In the post hoc analysis of specific types of TAVR valves, at 30 days, RLM occurred more frequently in patients who received the Portico valve than in those who received commercially available valves (24.6% vs. 6.9% vs. 5.8%, p<0.0001). A similar numerical trend was also seen at 6-months, with RLM occurring more frequently in patients who received the Portico valve than in those who received commercially available valves (19.5% vs. 11.8% vs. 8.8%, p=0.21). Patients had a mean STS score of 5.5%. The following results are at 5-year follow-up. vs. 11.7%; p=0.01). There were no significant differences between the groups in endocarditis, aortic valve re-intervention, or valve thrombosis. Mean aortic gradients did not differ between the two groups (11.2 mmHg vs. 10.6 mmHg; p=0.17).

When examining at least moderate PVL, there was a higher rate in patients who received TAVR versus those who received SAVR at 30 days (4.1% vs. 0.5%; p<0.0001) and 1-year (1.9% vs. 0.4%; p=0.02), but the difference was insignificant at 5 years (0.7% vs. 0.4%; p=1.0000).

Rates of stage 2 or 3 hemodynamic valve deterioration were similar at 5 years between the two groups (0.63% vs. 0.60%; p=0.86) as was bioprosthetic valve failure at 5-years (0.63% vs. The patients' mean age was 74.7 years, and 69% were men. The mean STS score for mitral valve replacement surgery was 7.8%. Of the 100 patients enrolled, there were seven deaths at 30 days, 26 deaths at 1 month, and 40 deaths at 1 year. At 2 years, there were 49 patients who completed follow-up. Operators achieved 96% procedural success with 0% procedural mortality.

Patients were discharged with less than moderate MR 98.9% of the time.

Mortality at 30 days was 6.0%, with mitral valve re-intervention occurring in just one patient. presented the results at the PCR e-Course. [21] The study was simultaneously published online in JACC: Cardiovascular Interventions. [22] MR is the most prevalent valvular disease worldwide, and the COAPT study showed significant benefit with TMVr using the MitraClip. The PASCAL transcatheter valve repair system (Edwards Lifesciences) uses two clasps and paddles to achieve plication of the mitral valve leaflets with an anatomical spacer to fill the regurgitant orifice. The 30-day outcomes of this novel device showed sustained MR reduction with improved functional status, increased exercise capacity, and improved quality of life.

CLASP is an ongoing multicenter, multinational, single-arm, prospective study of the safety, performance and outcomes of the PASCAL repair system. Eligible patients with at least moderate-to-severe MR who were receiving optimal medical therapy and were deemed candidates for TMVr were included in the study.

A total of 109 patients who were treated between June 2017 and September 2019 at 14 sites worldwide were included in the study. Their mean age was 75.5 years, 54% were men, and their mean STS score was 4.7%. All patients had at least moderate-to-severe MR; 67% had functional MR, and 33% had degenerative MR. Procedural success was achieved in 94% of the patients.

The mean number of implants was 1.4 per patient, with 49% of patients receiving only one implant. The mean procedural time was 128 minutes.

The primary safety endpoint, defined as a composite of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding and re-intervention, was 8.3% at 30

days. There was one cardiovascular death at 30 days and two additional deaths at 1 year. At 1 J o u r n a l P r e -p r o o f 31 year, none or trace MR was achieved in 79% of patients, and all patients had less than moderate MR. The 1-year survival rate was 92%, with a high rate of freedom from rehospitalization (80% for functional MR and 100% for degenerative MR). Functional improvements were sustained at 1 year, with 88% of patients in NYHA FC I/II. The patients' average KCCQ score improved by 16 points at 30 days and a showed sustained improvement of 14 points at 1 year.

Real World Experience with the SAPIEN 3 Ultra: A Propensity Matched Analysis from the United States

Paravalvular leak after transcatheter aortic valve replacement: the new Achilles' heel? A comprehensive review of the literature

Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

Transcatheter valve-in-valve implantation for degenerated surgical bioprostheses

Valve-In-Surgical Valve with SAPIEN 3 for Transcatheter Aortic Valve Replacement: Propensity-Matched Analyses of Real World Data Based on the STS Predicted Risk of Mortality

Transcatheter Aortic Valve Replacement with Self-Sexpandable Supra

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

TAVR Using Supra Annular, Self-Expanding Valves in Low Risk Patients

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial -PORTICO IDE

First Prospective RCT Assessing Incidence of Reduced Leaflet Motion and its Clinical Impact Following TAVR

SAPIEN 3 TAVR Versus Surgery in Intermediate-Risk Patients: A Propensity Score Matched Analysis of 5-Year Outcomes

Outcomes of Surgical Explantation of TAVR-A Population-Based

Functional Status and Outcomes After TMVR in HF and Secondary MR: The COAPT Trial

control in TAVI procedures at risk for coronary obstruction: comprehensive corelab adjudicated matched comparison

Non-invasive ultrasound therapy for aortic stenosis Available from

Transcatheter Mitral Valve Replacement with the Transseptal EVOQUE System

Transcatheter Mitral Valve Replacement with the Transseptal EVOQUE System

Comprehensive mitral valve-in-valve and valve-in-ring analysis

Six-month and one-year outcomes with the novel PASCAL transcatheter valve repair

images/Resources/Course-videos-slides/2020/Mitral-interventions-part-1

One-Year Outcomes for Transcatheter Repair in Patients with Mitral Regurgitation from the CLASP Study

The authors concluded that the PASCAL transcatheter valve repair system shows high survival and low complication rates with excellent sustained MR reduction and significant improvement in functional status. However, additional studies showing a head-to-head comparison between the PASCAL system and fourth-generation MitraClip are needed. The PASCAL system might also be a good option in the treatment of tricuspid regurgitation because of its thinner leaflets and larger coaptation gaps. The investigators added that the CLASP IID/IIF randomized clinical trial, which compares the PASCAL system with MitraClip, is ongoing.The study received funding from Edwards Lifesciences.

J o u r n a l P r e -p r o o f