Monday, December 30, 2024

Advances in Endovascular (PAD) Treatments and Devices in 2024

 BASIL-3 Trial: DES/DCB Versus Plain Balloon Angioplasty
  • The BASIL-3 trial found no significant improvement in amputation-free survival for patients with chronic limb-threatening ischemia (CLTI) treated with drug-eluting stents (DES) or drug-coated balloons (DCB) compared to plain balloon angioplasty.
  • Experts debated the trial's endpoints, noting that COVID-related deaths may have diluted the mortality outcomes and that the study was likely underpowered.

Breakthroughs in Below-the-Knee (BTK) Disease Treatment

  • The FDA approved the everolimus-eluting Esprit BTK scaffold (Abbott Vascular) based on the LIFE-BTK study, which showed its safety and efficacy compared to angioplasty alone.
  • The 2-year data revealed fewer reinterventions in scaffold-treated patients, and researchers highlighted its potential to prevent biologic restenosis.
  • Other BTK innovations included the Shockwave E8 peripheral intravascular lithotripsy (IVL) catheter, designed for challenging lesions, and the Bare Temporary Spur system (Reflow Medical), which mimics stenting without long-term implant risks.

DETOUR 2 Trial: Percutaneous Transmural Arterial Bypass

  • The DETOUR 2 trial demonstrated sustained patency at 3 years for percutaneous transmural arterial bypass, an endovascular technique for complex superficial femoropopliteal lesions that eliminates the need for open surgical cutdowns.

  • The technique was noted as a valuable option for patients who failed standard interventions, with no reports of late venous issues or deep vein thrombosis (DVT) complications.

Larger Role for Limus-Based Therapies in PAD

  • The SIRONA trial compared paclitaxel-based DCBs and sirolimus-based DCBs, finding no differences in primary patency or major adverse outcomes at 1 year.
  • The study, which will follow patients for 5 years, aims to clarify the long-term safety and efficacy of sirolimus DCBs for below-the-knee lesions.

LIFE-BTK and Javelin Device Developments

  • The Javelin device (Shockwave Medical), a forward-facing IVL catheter, showed high success rates in crossing heavily calcified peripheral lesions, with pooled data reporting 93% success in achieving full lesion crossing.

PEERLESS Trial: Thrombectomy vs. Thrombolysis

  • The PEERLESS trial demonstrated the superiority of large-bore mechanical thrombectomy with the FlowTriever system (Inari Medical) over catheter-directed thrombolysis for intermediate-risk pulmonary embolism.
  • Patients treated with thrombectomy had fewer clinical deteriorations, shorter hospital stays, lower 30-day readmission rates, and better early recovery outcomes at 24 hours.

Peripheral Artery Disease (PAD) Guidelines and Foot Care

  • Updated PAD guidelines emphasized rigorous medical therapy, collaborative vascular care, and the importance of foot care across the spectrum of PAD and CLTI.

Radial Access in Peripheral Interventions

  • The American Heart Association issued a scientific statement on the benefits of radial access in peripheral vascular interventions while acknowledging barriers to its widespread adoption.

SAFE-IVC Study: Timely Removal of IVC Filters

  • The SAFE-IVC study found that only 15% of Medicare patients with implanted inferior vena cava filters had them removed in a timely manner, a statistic described as “inexplicably and unacceptably low.”

Carotid Artery Stenting (CAS) and Educational Gaps

  • Following Medicare’s expanded coverage for CAS and trans carotid artery revascularization, debates arose over patient safeguards and operator training to address skill gaps.
  • Experts stressed the need for professional societies to close educational gaps among younger operators less experienced in carotid interventions.

Emerging Opportunities in BTK and PAD

  • New devices and therapies for BTK lesions have renewed optimism, particularly in addressing nonhealing wounds and complex cases.
  • Researchers anticipate more real-world data on the effectiveness of devices like the Esprit BTK scaffold and innovations such as the Javelin device and Shockwave E8 IVL catheter in treating difficult peripheral artery cases.

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