Search

Background: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL)., Aims: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk., Methods: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow-up at 30 days, 1 year, and annually up to 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory., Results: A total of 120 high- or extreme-risk subjects (age 83.5±5.4 years; 58.3% female; Society of Thoracic Surgeons score 4.0±2.0%) were enrolled in the European conformity (CE) mark cohort. Procedural success was high at 97.5%. At 30 days, the rate of all-cause mortality was 0%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 0.8%, life-threatening bleeding was 2.5%, stage 3 acute kidney injury 0%, major vascular complications 0.8%, and new pacemaker implantation 15.0%. At 1 year, the rates of all-cause mortality and disabling stroke were 4.2% and 0.8%, respectively. The rate of moderate PVL was 1.0% at 1 year. Haemodynamic performance with a mean gradient of 7.5±3.2 mmHg and effective orifice area of 1.9±0.4 cm 2 was sustained up to 1 year., Conclusions: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system.

Aims: The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We aimed to evaluate the clinical performance and safety of the Evolut PRO valve in standard practice., Methods and Results: FORWARD PRO is a prospective, multinational, multicentre observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23, 26, or 29 mm) was attempted in 629 non-consecutive patients from 39 centres from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a pre-specified performance goal. An independent clinical events committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN, USA). Baseline characteristics included mean age 81.7±6.1 years, 61.8% female, STS score 4.7±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2%, which was lower than the pre-specified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge., Conclusions: The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap. ClinicalTrials.gov Identifier: NCT03417011

Aims: The REPRISE IIE trial aimed to evaluate outcomes following transcatheter aortic valve implantation of the fully repositionable and retrievable LOTUS valve with a unique seal designed to minimise paravalvular leak (PVL)., Methods and Results: This prospective, multicentre study enrolled 250 patients with severe aortic stenosis considered high-risk for surgery by a multidisciplinary Heart Team. An independent clinical events committee adjudicated events per Valve Academic Research Consortium criteria. Mean age was 84 years; 77% were in NYHA Class III/IV. LOTUS valve implantation produced significant haemodynamic improvements at one year without valve embolisation, ectopic valve deployment, or additional valve implantation. Primary endpoints were met as the 30-day mortality rate in the extended cohort (4.4%, N=250), and mean valve gradient in the main cohort (11.5±5.2 mmHg, N=120) were below (p<0.001) their predefined performance objectives. At 30 days, disabling stroke was 2.8% and new pacemaker implantation was 28.9% in all patients and 32.0% in pacemaker-naïve patients. By one year, all-cause mortality was 11.6%, disabling stroke was 3.6%, 95% of patients alive were in NYHA Class I/II, and there was no core laboratory-adjudicated moderate/severe PVL., Conclusions: LOTUS valve implantation produced good valve haemodynamics, minimal PVL, sustained significant improvement in functional status, and good clinical outcomes one year post implant.

Aims: Our aim was to investigate whether long-term (three-year) clinical outcomes after multivessel treatment with the Resolute zotarolimus-eluting stent (R-ZES) were similar to single-vessel treatment., Methods and Results: The RESOLUTE Global Clinical Trial Program enrolled 7,618 patients, of whom 1,562 underwent multivessel and 6,053 single-vessel treatment with the R-ZES. Patients in the multivessel group were more likely to have complex lesions (58% vs. 44%, p<0.001). Clinical outcomes were compared using a Cox regression model adjusted by propensity score to account for differences in baseline characteristics. Compared with single-vessel treatment, multivessel treatment was associated with more complex anatomy and longer mean total stent length (57.8±28.6 vs. 26.7±15.2 mm, p<0.001). At three years, the cumulative incidence of target lesion failure was similar in patients with multivessel and single-vessel treatment (11.0% vs. 9.1%, adjusted p=0.986), as was the incidence of cardiac death or target vessel myocardial infarction (6.7% vs. 5.7%, adjusted p=0.793), the incidence of clinically driven target lesion revascularisation (5.1% vs. 4.4%, adjusted p=0.904), and the incidence of Academic Research Consortium definite or probable stent thrombosis (1.2% vs. 0.9%, adjusted p=0.544)., Conclusions: Multivessel treatment with R-ZES provided good long-term clinical outcomes that were comparable to those achieved with single-vessel stenting, supporting the efficacy and safety of R-ZES in patients in this setting.

Transcatheter aortic valve implantation (TAVI) has evolved from an exclusive, highly complex and hazardous procedure into a mature, safe and streamlined therapy for patients with severe aortic stenosis (AS). Various successive device iterations and product refinements have created a dynamic and competitive field with a spectrum of different CE-marked transcatheter heart valve (THV) designs. This review provides a practical overview of current CE-marked THVs with a focus on respective sizing algorithms and delivery strategies.

Aims: The aim of this study was to evaluate the safety and performance of the resheathable and repositionable St. Jude Medical Portico self-expanding transfemoral TAVI system., Methods and Results: This prospective, single-arm, multicentre study evaluated the 18 Fr Portico system with either a 23 or a 25 mm valve. Patient follow-up was at 30, 90, 180 days and one year. Results up to 30 days are presented. Adverse events were categorised by VARC definitions and adjudicated by an independent events committee. Echocardiography was evaluated by an independent laboratory and all patients underwent neurological assessment at baseline, post procedure, at 30 days and one year. The primary endpoint was all-cause mortality at 30 days. A total of 102 patients (mean age 84.1±4.8 years; 97% female; median STS score 5.6) were enrolled. The 30-day mortality, disabling stroke and major vascular complications were 2.9%, 2.9% and 5.9%, respectively. Resheathing and repositioning (23.8%) was successful in all instances. Paravalvular leak at 30 days was none/trace in 30.4%, mild in 65.8% and moderate in 3.8%. Mean gradient improved from 45.3±13.8 to 8.9±3.8 mmHg and valve area improved from 0.6±0.2 to 1.7±0.4 cm2. Permanent pacemaker implantation was required in 9.8% of patients., Conclusions: The novel Portico TAVI system is safe and effective at treating high-risk patients with symptomatic severe aortic stenosis, allowing safe repositioning and optimisation of device position.

Transcatheter aortic valve implantation is increasingly being used to treat high-risk patients with symptomatic aortic valve disease. However, challenges still remain with current devices, both in terms of the procedure and the outcome. The St Jude Medical Portico transcatheter valve system is designed to mitigate some of these difficulties. We describe the device characteristics and how the device may impact on a TAVI procedure. An overview of the clinical experiences with the Portico valve system is also described.

Transcatheter aortic valve implantation (TAVI) has taken the world of cardiovascular therapies by storm. The possibility of implanting aortic valves without recourse to sternotomy or cardiopulmonary bypass has been embraced by cardiologists, surgeons and patients alike as a revolution in management. First performed in 2002 by Alain Cribier, the technique has exploded into common use during the last three years, such that over 20,000 implants have now been undertaken worldwide. This article discusses complications of TAVI, their avoidance and management.