Early Lead Extraction for Infected Implanted Cardiac Electronic Devices: JACC Review Topic of the Week.

Infection remains a serious complication associated with the cardiac implantable electronic devices (CIEDs), leading to substantial clinical and economic burden globally. This review assesses the burden of cardiac implantable electronic device infection (CIED-I), evidence for treatment recommendations, barriers to early diagnosis and appropriate therapy, and potential solutions. Multiple clinical practice guidelines recommended complete system and lead removal for CIED-I when appropriate. CIED extraction for infection has been consistently reported with high success, low complication, and very low mortality rates. Complete and early extraction was associated with significantly better clinical and economic outcome compared with no or late extraction. However, significant gaps in knowledge and poor recommendation compliance have been reported. Barriers to optimal management may include diagnostic delay, knowledge gaps, and limited access to expertise. A multipronged approach, including education of all stakeholders, a CIED-I alert system, and improving access to experts, could help bring paradigm shift in the treatment of this serious condition.

Treating post-angioplasty dissection in the femoropopliteal arteries using the tack endovascular system: Tack optimized balloon angioplasty II 24-month results.

OBJECTIVES: The TOBA (Tack Optimized Balloon Angioplasty) II trial is a prospective, single-arm, multicenter study that investigated Tack treatment for patients with dissection after angioplasty in the superficial femoral artery and/or proximal popliteal artery. The Tack device is a nitinol-based, short (6 mm), stent-like implant with low outward force that can be deployed in a targeted fashion to treat vascular dissection. TOBA II primary results through 12 months have been published previously. This report provides follow-up safety and efficacy results through 24 months (RC). METHODS: The TOBA II trial enrolled 213 patients with Rutherford classification 2 to 4 and a de novo or non-stented restenotic lesion in the superficial femoral artery and/or proximal popliteal artery who developed a dissection of any grade after treatment with plain balloon or drug-coated balloon (DCB) angioplasty. Participants were followed for 30 days, 6 months, 12 months, 24 months, and 36 months following the procedure. Evaluations included clinically driven target lesion revascularization (CD-TLR), ankle-brachial index, Rutherford classification, peripheral artery questionnaire, quality of life assessed by the EQ-5D-3L, and the Walking Impairment Questionnaire. RESULTS: At enrollment, mean age was 68.2 ± 9.1 years, 70.9% were male, and 95.8% of patients were categorized as RC 2 or 3. The distribution of balloon types in the study were standard balloons: 42.3%; and drug-coated balloons: 57.7%. At 24-month follow-up, 167 patients (78.4%) had available data. The overall survival rate at 24 months was 95.4% and there were no major amputations during this time. After 24 months of follow-up, the Kaplan-Meier freedom from CD-TLR was 77.7%. Rutherford classification, ankle-brachial index, and quality of life were significantly improved compared with baseline through 24 months. CONCLUSIONS: The TOBA II 24-month data demonstrate durable intermediate-term outcomes with the use of the Tack Endovascular System. Tack deployment was a safe and effective therapeutic option for dissection repair following angioplasty.

No Mortality Signal With Stellarex Low-Dose Paclitaxel DCB: ILLUMENATE Pivotal 4-Year Outcomes.

BACKGROUND: Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited. OBJECTIVES: To report late safety and efficacy outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT). METHODS: ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected. RESULTS: Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929). CONCLUSIONS: Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.

Acute Real-World Outcomes From the Phoenix Post-Approval Registry.

OBJECTIVES: An evaluation of the 30-day safety and performance outcomes of the Phoenix atherectomy system (Philips Volcano Corporation) was performed in real-world patients with peripheral artery disease (PAD). METHODS: The Phoenix Post-Approval Registry is an all-comer study that enrolled patients with infrainguinal PAD. Patients treated with the Phoenix atherectomy system were followed for 30 days to observe device-related complications. Outcomes evaluated include procedural (final target lesion(s) residual stenosis of ≤30% after treatment with Phoenix and any other adjunctive therapy) and technical success (defined as achieving a post-Phoenix [prior to any adjunctive therapy] residual diameter stenosis of ≤50%), target-vessel revascularization (TVR), target-lesion revascularization (TLR), target-limb amputation, ankle brachial index, Rutherford clinical category, and wound, ischemia, foot infection (WIfI) classification. RESULTS: Of the 500 patients enrolled, 259 had CLI, including 26.3% with Rutherford class 6. Procedural success rates were 97.3% for non-CLI patients and 98.2% for CLI patients. Technical success rates were 71.5% for non-CLI patients and 77.9% for CLI patients. Complication rates post Phoenix atherectomy were <1%. Through the 30-day follow-up, there were 6 patients (1.3%; 2 claudicants, 4 CLIs) who underwent TLR and 8 patients who underwent TVR. There were no major amputations in the non-CLI and CLI cohorts. In the CLI cohort, 16/235 (6.8%) underwent minor amputations. Higher stages of Rutherford class and WIfI classification were associated with amputations at 30 days. CONCLUSION: The Phoenix atherectomy system is a safe and effective treatment option in the acute setting for patients with PAD, including those with advanced Rutherford class. Randomized controlled trials are needed to confirm these results.