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effectiveness and qualitative outcomes.

Analysis revealed that two patients (3.3%) developed early discharge after transradial stenting of coronary arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%).

Pilot study of wire pacing sleeve yields positive results in TAVI and PCI procedures

A first-in-human trial using a purpose-built device to provide direct wire pacing without the need for a temporary venous pacemaker during transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary intervention (PCI) has found that the device was safe and effective.

According to Electroducer, the company behind the Electroducer Sleeve, the device is an electroconductive device made of highly innovative material which is intended to transmit, in a safe way for the patient, the electrical signal from an external pacemaker to the heart through the guidewire.

Results of the first-in-man study were published in the journal EuroIntervention. Researchers from four French medical centres—the Clinique Pasteur in Toulouse, the Cardiovascular Institute in Grenoble, the Médipôle Lyon-Villeurbanne Hospital in Villeurbanne and the Jacques Cartier Private Hospital in Massy—enrolled 60 patients in the study, 39 underwent TAVI, and 21 underwent PCI.

The primary endpoint was an analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of

Conference calendar

25–28 February

Cardiovascular Research Technologies (CRT)

Washington DC, USA crtmeeting.org

4–6 March

American College of Cardiology (ACC)

2023 Scientific Session New Orleans, USA pcronline.com

16–18 March

Houston Aortic Symposium Houston, USA houstonaorticsymposium.com

Analyses of other secondary endpoints showed that two patients (6.3%) presented asymptomatic radial artery occlusion.

Jérôme Wintzer-Wekehind

(Cardiovascular Institute, Grenoble, France) principal investigator on the study, said: “As well as offering benefits for patients, this device is simple and universal—these advantages mean there will certainly be widespread uptake and usage.”

According to a press release from Electroducer, the Electroducer Sleeve is expected to reach the US market in 2023, followed by the European market in 2024, once it receives US Food and Drug Administration (FDA) authorisation and CE marking respectively.

DurAVR heart valve system gets green light from US FDA for early feasibility study

Anteris Technologies has announced that the US Food and Drug Administration (FDA) has conditionally approved its DurAVR transcatheter heart valve system for an investigational device exemption (IDE) application to commence an early feasibility study (EFS).

DurAVR is a balloon-expandable, 3D single-piece aortic valve, which is shaped to mimic the native human valve.

The EFS study will evaluate the safety and feasibility of the device in the treatment of subjects with symptomatic severe native aortic stenosis. The FDA concluded the company provided adequate data to support the initiation of a clinical study in the USA, Anteris Technologies said in a press release. The EFS will enrol 15 subjects at seven heart valve centres of excellence within the USA. It is anticipated the study will commence in early 2023, paving the way for a pivotal, registration aortic stenosis trial in the first half of 2024. confirmatory trial of the Corvia atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.

The primary and key secondary endpoints of this trial include safety and device feasibility assessments such as success of implantation at the anatomically accurate position, and haemodynamic performance assessments including effective orifice area (EOA), mean gradient, aortic regurgitation, paravalvular leak (PVL) and Doppler Velocity Index (DVI). Patient outcomes such as stroke, myocardial infarction, life-threatening bleeds, and all-cause mortality are to be reported at 30 days, three months, and one-year post implantation.

The FDA has categorised DurAVR in this study as a Centers for Medicare & Medicaid Services (CMS) category B device, which permits the device to be sold during the study pending CMS approval.

“I am pleased and eager to begin the DurAVR transcatheter heart valve EFS to further evaluate this promising novel technology. The single piece, native-shape valve design of the DurAVR transcatheter heart valve represents an advancement to existing heart valve technologies. I am excited to see the potential of the DurAVR transcatheter heart valve in treating patients suffering from severe aortic stenosis,” stated Michael Reardon (Houston Methodist Hospital, Houston, USA), study chair for the DurAVR EFS.

The DurAVR THV System is limited for investigational use only.

The first patient was enrolled and randomised by interventional cardiologist Scott Lilly and heart failure cardiologist Rami Kahwash (both Ohio State University Wexner Medical Center, Columbus, USA).

RESPONDER-HF is a randomised, sham-controlled trial including up to 260 patients from 60 centres across the USA, Europe, and Australia. The trial will evaluate the efficacy of the Corvia Atrial Shunt to reduce HF hospitalisations and improve quality of life (QoL). Sanjiv Shah (Bluhm Cardiovascular Institute, Chicago, USA) and and Martin Leon (Columbia University Irving Medical Center, New York, USA) serve as lead investigators for the study.

The RESPONDER-HF confirmatory trial builds on scientific data and progressive learnings from REDUCE LAP-HF II, the largest randomised controlled trial of a device-based therapy for HFpEF patients. As published in Circulation, REDUCE LAP-HF II is the only study of an implantable therapeutic device to show clinical benefit in this population. Within the large responder group, representing 50% of study patients, treatment with the Corvia Atrial Shunt resulted in a 45% reduction in HF events and a 55% greater improvement in QoL compared to sham control.

20–22 March

Technology and Heart Failure Therapeutics (THT) Boston, USA tht2023.crfconnect.com

25–27 April

Charing Cross (CX) Symposium London, UK cxsymposium.com

6–9 May

American Association for Thoracic Surgery (AATS) Annual Meeting Los Angeles, USA events.aats.org/am23

First

patient randomised in RESPONDER-HF trial of Corvia atrial shunt

Corvia Medical has announced that the first patient has been randomised in RESPONDER-HF, a global

“We are committed to demonstrating the potential benefit of atrial shunt therapy and anticipate RESPONDERHF will validate the REDUCE LAP-HF II responder group findings, which correspond to two-thirds of people with HFpEF, or 2 million people in the USA alone,” commented Leon. Shah further added: “The RESPONDER-HF trial will not only continue to advance our scientific understanding of shunting in HFpEF, but also has the potential to change the treatment paradigm, and in doing so, move us one step closer to precision medicine in heart failure.”

16–19 May

EuroPCR 2023 Paris, France pcronline.com

18–20 May

Society for Cardiovascular Angiography and Interventions (SCAI)

2023 Scientific Sessions Phoenix, USA scai.org/education-and-events

7–10 June

The Structural Heart Summit (TVT) Phoenix, USA tvt.crfconnect.com

25–28 August

European Society of Cardiology (ESC) Congress Amsterdam, The Netherlands escardio.org

4–7 October

European Association for CardioThoracic Surgery (EACTS) Annual Meeting

Vienna, Austria eacts.org/annual-meeting/

23–26 October

TCT 2023

San Francisco, USA tct2023.crfconnect.com

Onyx Frontier Zotarolimus-Eluting Coronary Stent System Brief Statement

Indications

The Onyx Frontier™ zotarolimus-eluting coronary stent system is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus or high bleeding risk, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with reference vessel diameters of 2.0 mm to 5.0 mm. In addition, the Onyx Frontier zotarolimus-eluting coronary stent system is indicated for treating de novo chronic total occlusions and non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique.

Contraindications

The Onyx Frontier™ system is contraindicated for use in: • Patients with a known hypersensitivity or allergies to aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticagrelor, ticlopidine, drugs such as zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative • Patients with a known hypersensitivity to the cobalt-based alloy (cobalt, nickel, chromium, and molybdenum) or platinum-iridium alloy • Patients with a known hypersensitivity to the BioLinx polymer or its individual components. Coronary artery stenting is contraindicated for use in: • Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated • Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.

Warnings

• Ensure that the inner package has not been opened or damaged as this would indicate the sterile barrier has been breached. • The use of this product carries the same risks associated with coronary artery stent implantation procedures, which include subacute and late vessel thrombosis, vascular complications, and bleeding events. • This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.

Precautions

• Only physicians who have received adequate training should perform implantation of the stent.

• Subsequent stent restenosis or occlusion may require repeat catheter-based treatments (including balloon dilatation) of the arterial segment containing the stent. The long-term outcome following repeat catheterbased treatments of previously implanted stents is not well characterized. • The risks and benefits of the stent implantation should be assessed for patients with a history of severe reaction to contrast agents.

• Do not expose or wipe the product with organic solvents such as alcohol. • The use of a drug-eluting stent (DES) outside of the labeled indications, including use in patients with more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, myocardial infarction (MI), or death.

• Care should be taken to control the position of the guide catheter tip during stent delivery, stent deployment, and balloon withdrawal. Before withdrawing the stent delivery system, confirm complete balloon deflation using fluoroscopy to avoid arterial damage caused by guiding catheter movement into the vessel.

• Stent thrombosis is a low-frequency event that is frequently associated with MI or death. Data from the RESOLUTE clinical trials have been prospectively evaluated and adjudicated using the definition developed by the Academic Research Consortium (ARC).

The safety and effectiveness of the stent have not yet been established in the following patient populations: risks and benefits of the procedure should be weighed against the possible risk associated with interruption of antiplatelet therapy. Patients who require premature DAPT discontinuation should be carefully monitored for cardiac events. At the discretion of the patient’s treating physician(s), the antiplatelet therapy should be restarted as soon as possible.

Instructions for Stenting of Bifurcation Lesions

The provisional technique of bifurcation stenting recommends a single stent placement in the Main Vessel (MV), finalized with proximal optimization technique (POT). POT includes performing post-dilatation to achieve full apposition of the stent proximal to the bifurcation and reduce the risk of side branch (SB) compromise. If inadequate results are found in the SB such as: threatened SB closure, TIMI flow < 3, dissection type B or worse, or residual stenosis > 80%, the provisional bifurcation stenting technique recommends placing a second stent in the SB as a bailout. As per cardiology societal recommendations, two-stent techniques following single stent provisional bifurcation stenting including T, TAP, and Culotte stenting may be utilized as needed. However, the RESOLUTE ONYX PAS Bifurcation Cohort did not evaluate the safety and effectiveness of two-stent bifurcation techniques, including planned (upfront) two-stent bifurcation techniques (such as DK-crush). Additionally, two-stent bifurcation techniques may introduce additional forces and/or failure modes to the stents, and the performance of the Resolute Onyx stent has not been evaluated under these conditions in nonclinical testing.

Potential Adverse Events

Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. These risks (in alphabetical order) may include but are not limited to: • Abrupt vessel closure • Access site pain, hematoma, or hemorrhage • Allergic reaction (to contrast, antiplatelet therapy, stent material, or drug and polymer coating) • Aneurysm, pseudoaneurysm, or arteriovenous fistula (AVF) • Arrhythmias, including ventricular fibrillation • Balloon rupture • Bleeding

• Cardiac tamponade • Coronary artery occlusion, perforation, rupture, or dissection • Coronary artery spasm

• Death • Embolism (air, tissue, device, or thrombus) • Emergency surgery: peripheral vascular or coronary bypass • Failure to deliver the stent • Hemorrhage requiring transfusion • Hypotension/hypertension

• Incomplete stent apposition • Infection or fever • MI • Pericarditis • Peripheral ischemia/peripheral nerve injury • Renal failure • Restenosis of the stented artery • Shock/pulmonary edema • Stable or unstable angina • Stent deformation, collapse, or fracture • Stent migration or embolization • Stent misplacement • Stroke/ transient ischemic attack • Thrombosis (acute, subacute, or late)

Adverse Events Related to Zotarolimus

Patients’ exposure to zotarolimus is directly related to the total amount of stent length implanted. The actual side effects/complications that may be associated with the use of zotarolimus are not fully known. The adverse events that have been associated with the intravenous injection of zotarolimus in humans include but are not limited to: • Anemia • Diarrhea • Dry skin • Headache • Hematuria • Infection • Injection site reaction

• Pain (abdominal, arthralgia, injection site) • Rash

The potential adverse reactions in nursing infants from zotarolimus have not been determined. The pharmacokinetic and safety profiles of zotarolimus in infants are not known.

Adverse Events Related to BioLinx™ polymer

• Women who are pregnant or lactating

• Men intending to father children

• Patients with target lesions that were treated with prior brachytherapy or the use of brachytherapy to treat in-stent restenosis of the stent

Although the type of risks of the BioLinx polymer coating are expected to be no different than those of other stent coatings, the potential for these risks are currently unknown as the coating has limited previous use in humans. These risks may include but are not limited to the following: • Allergic reaction

• Pediatric patients below the age of 18 years

• Patients with coronary artery reference vessel diameters of < 2.0 mm or > 5.0 mm

• Patients with evidence of an acute ST-elevation MI within 72 hours of intended stent implantation

• Focal inflammation at the site of stent implantation • Restenosis of the stented artery

• Patients with vessel thrombus at the lesion site

• Patients with lesions located in a saphenous vein graft, in the left main coronary artery, or ostial lesions • Patients with diffuse disease or poor flow distal to identified lesions • Patients with 3 vessel disease

The safety and effectiveness of the stent have not been established in the cerebral, carotid, or peripheral vasculature. Additionally, the safety and effectiveness of using atherectomy devices with the stent have not been established. The effect of potential drug interactions on the safety or effectiveness of the Onyx Frontier™ stent has not been investigated. Potential interactions of the stent with other drug-eluting or coated stents have not been evaluated and should be avoided whenever possible.

Clinical studies of the Resolute stent did not suggest any significant differences in safety and effectiveness for male and female patients and did not include sufficient numbers of patients to assess for differences in safety and effectiveness due to ethnicity.

Decisions about duration of DAPT are best made on an individual basis and should integrate clinical judgment, assessment of the benefit/risk ratio, and patient preference. Premature discontinuation or interruption of prescribed antiplatelet medication could result in a higher risk of stent thrombosis, MI, or death. Before PCI, if premature discontinuation of antiplatelet therapy is anticipated, physicians should carefully evaluate with the patient whether a DES and its associated recommended DAPT regimen is the appropriate PCI choice.

Following PCI, if elective noncardiac surgery requiring suspension of antiplatelet therapy is considered, the

Please reference appropriate product Instructions for Use for more information regarding indications, contraindications, warnings, precautions, and potential adverse events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. For further information, please call and/or consult Medtronic at the toll-free numbers or websites listed.