Cardiac implantable electronic devices (CIEDs) have increased the quality and duration of life for millions of patients. As their utilization continues to grow exponentially, clinicians need to diagnose and manage several device-associated complications that may arise during the CIED life cycle. This primer is tailored for the general internal medicine physician or hospitalist, who will inevitably take care of patients with CIEDs, to provide a contemporary update on the incidence and clinical manifestations of the 4 most common CIED complications, with the latest evidence to guide clinical management and expected outcomes. Specifically, this review focuses on: 1) generator/lead failure, which has decreased to less than 1% per year due to continuous advances in manufacturing and programming and is mostly managed conservatively with close monitoring; 2) CIED infections, which, while also rare at approximately 1% per year, carry a short-term mortality of 10% to 20%, thus requiring immediate diagnosis and often urgent treatment with lead extraction because antibiotic treatment is rarely effective; and 3) lead-related venous obstruction, which has highly variable incidence (5% to 30%) and manifestations, ranging from arm swelling to superior vena cava syndrome. Management options range from anticoagulation to balloon venoplasty, often with unsatisfying results. This review will also focus on 4) lead-related tricuspid regurgitation, which affects 20% to 30% of CIEDs and has become an area of intense interest with the development of percutaneous tricuspid treatments-where evidence is urgently needed to inform the need for lead extraction versus jailing during tricuspid interventions. The progressive adoption of leadless devices may significantly reduce many of these complications. Nonetheless, optimal management requires input from a multidisciplinary team of electrophysiologists and imaging, heart failure, and structural interventional specialists-who should be able to recognize and treat each complication promptly based on a rapidly evolving evidence base.
Publications by Year: 2025
2025
BACKGROUND: Chronic limb-threatening ischemia (CLTI) disproportionately affects racial minority populations, with Black patients experiencing higher amputation rates and reduced access to vascular care. Recent national campaigns have aimed to improve early screening and diagnosis of peripheral arterial disease (PAD), but it is unclear whether these efforts have improved outcomes.
OBJECTIVES: To assess temporal trends in treatment, outcomes, and healthcare utilization for Black versus White Medicare beneficiaries with CLTI undergoing endovascular revascularization.
METHODS: We conducted a retrospective cohort study using Medicare claims data for beneficiaries aged ≥66 years who underwent endovascular revascularization for CLTI from January 2016 to December 2023. The primary outcome was a composite of major amputation or death over 4 years, evaluated using Cox models. Healthcare utilization was assessed via adjusted rate ratios (aRRs) for vascular provider visits, emergency department use, and hospital admissions.
RESULTS: Among 303,906 patients, 17.2% (N=52,376) identified as Black. Black patients were younger, had more comorbidities, and more often presented with gangrene. They more frequently underwent angioplasty alone and less frequently received stents. Over a median 1.7 years of follow-up, Black patients had higher risk of major amputation (HR 1.49; 95% CI, 1.45-1.53) and lower mortality (HR 0.91; 95% CI, 0.90-0.93). They had fewer vascular visits before (aRR 0.91) and after (aRR 0.92) revascularization, but more ED visits (aRR 1.09) and hospital readmissions (aRR 1.28).
CONCLUSIONS: Despite national initiatives, Black patients with CLTI continue to face higher amputation risk and reduced access to longitudinal vascular care, underscoring the need for sustained, equity-focused interventions.
BACKGROUND: Chronic venous disease (CVD) is a common vascular condition that can have debilitating effects on quality of life and daily function. The Society for Cardiovascular Angiography & Interventions (SCAI) sought to develop evidence-based guidelines to support patients, clinicians, and other stakeholders in their treatment decisions about management of CVD.
METHODS: SCAI convened a balanced multidisciplinary guideline panel to minimize potential bias from conflicts of interest. The Evidence Foundation, a registered 501(c)(3) nonprofit organization, provided methodological support for the development of the guidelines. The guideline panel formulated and prioritized clinical questions following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach in population, intervention, comparison, outcome format. A technical review team of clinical and methodological experts conducted systematic reviews of the published evidence, synthesized data, and graded the certainty of the evidence across outcomes. The guideline panel then reconvened to develop recommendations and supporting remarks informed by the results of the technical review, as well as additional contextual factors described in the GRADE evidence-to-decision framework.
RESULTS: The guideline panel reached consensus on 9 recommendations to address variations in treatment of CVD across 8 different clinical scenarios. The panel also identified 4 anatomical scenarios with significant knowledge gaps.
CONCLUSIONS: Key recommendations address patient selection for compression therapy, ablation of saphenous and perforator veins, sclerotherapy, phlebectomy, and deep vein revascularization. Two algorithms for the management of symptomatic varicose veins and venous ulcer disease were created to facilitate implementation of these evidence-based recommendations. The panel also identified several anatomical and clinical areas where future research is needed to advance the CVD field.
BACKGROUND: In recent years, there has been increasing utilization of catheter-based interventions (CBI) for the treatment of acute pulmonary embolism (PE). We aimed to investigate the trends and practice patterns associated with the utilization of CBI among older patients hospitalized with a PE in US hospitals.
METHODS: All Medicare fee-for-service beneficiaries hospitalized with a PE from June 1, 2018, to September 30, 2023, were identified. For outcomes analysis, a subset of patients hospitalized between June 1, 2018, and December 31, 2021, was identified to allow for follow-up to occur.
RESULTS: In total, 313,522 patients were hospitalized with a concomitant PE; of which, 9.12% (n = 28,597) underwent a CBI (4.76% [n = 14,914] catheter-directed thrombolysis and 4.76% [n = 14,918] mechanical thrombectomy). Utilization of CBI increased over time from 5.92% in 2018 to 14.1% in 2023, attributed to increases in mechanical thrombectomy. CBI was used more frequently at teaching hospitals (adjusted OR, 1.10; 95% CI, 1.04-1.15) and in male patients (adjusted OR, 1.15; 95% CI, 1.10-1.21), while less frequently at smaller institutions (adjusted OR, 0.14; 95% CI, 0.09-0.22) and in patients with Black race (adjusted OR, 0.90; 95% CI, 0.85-0.95) or dual enrollment (adjusted OR, 0.80; 95% CI, 0.76-0.86). Older age, Black race, geographic region, and distressed communities were associated with higher rates of death or periprocedural complications.
CONCLUSIONS: In this contemporary nationwide analysis of hospitalized patients with PE, we found that rates of CBI increased over time, although uptake of CBI remains heterogeneous. Our findings suggest that there are differences in access to advanced therapies and outcomes among particular populations following CBI for PE management.
OBJECTIVE: The optimal management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis is controversial and includes intensive medical management (i.e., best medical therapy [BMT]) with/without an additional carotid revascularization procedure (i.e., carotid endarterectomy [CEA], transfemoral carotid artery stenting [TFCAS] or TransCarotid Artery Revascularization [TCAR]). The aim of this international, expert-based, multispecialty Delphi Consensus document was to reconcile the conflicting views regarding the optimal management of AsxCS and SxCS patients.
METHODS: A three-round Delphi Consensus process was performed including 63 experts from Europe (n=37) and the United States (n=26). A total of 6 different clinical scenarios were identified involving patients with either AsxCS or SxCS. For each scenario, 5 treatment options were available: (i) BMT alone, (ii) BMT plus CEA, (iii) BMT plus TFCAS, (iv) BMT plus TCAR, or (v) BMT plus CEA/TFCAS/TCAR. Differences in treatment preferences between U.S. and European participants were assessed using Fisher's Exact Test, and odds ratios were used to quantify the magnitude and direction of association. Consensus was achieved when >70% of the Delphi Consensus participants agreed on a therapeutic approach.
RESULTS: Most participants concurred that BMT alone is not adequate for the management of a 70-year-old fit male or female patient with 80-99% AsxCS (52/63; 82.5% and 45/63; 71.5%, respectively). In contrast, most panelists would opt for BMT alone for an 80-year-old male AsxCS patient with several co-morbidities (48/63; 76.2%). The majority of participants would opt for BMT plus a carotid revascularization procedure for an 80-year-old male SxCS patient with a recent ipsilateral cerebrovascular event, an ipsilateral 70-99% SxCS and a 5-year predicted risk of ipsilateral ischemic event of 10% (54/63; 85.7%), 15% (59/63; 93.6%), or 20% (63/63; 100%). The opinion of U.S.-based participants varied from that of Europe-based respondents in some scenarios.
CONCLUSIONS: The panel agreed that BMT alone is insufficient for most patients with SxCS, and that select subgroups of AsxCS patients may also benefit from revascularization, especially when high-risk features are present. Patients should be stratified according to their predicted stroke risk, as well as their individual clinical/anatomical/imaging features and should be treated accordingly.
BACKGROUND AND AIMS: Femoropopliteal artery disease is associated with high rates of post-revascularization restenosis. Drug-coated devices (DCD), including drug-coated balloons (DCBs) and drug-eluting stents (DES), have demonstrated efficacy in reducing restenosis rates compared to non-drug-coated devices (NDCDs). However, concerns about potential long-term mortality risks have led to regulatory scrutiny. This study represents the final report from the Safety Assessment of Femoropopliteal Endovascular Treatment with Paclitaxel-Coated Devices (SAFE-PAD) study, a pre-specified analysis designed with the US Food and Drug Administration to evaluate the long-term mortality associated with femoropopliteal DCD use.
METHODS: SAFE-PAD was a retrospective cohort study of 168 553 Medicare fee-for-service beneficiaries (≥66 years) who underwent femoropopliteal artery revascularization between 2015 and 2018. Device exposure (DCDs vs. NDCDs) was identified using Medicare claims data. The primary outcome was all-cause mortality, assessed between treatment groups using inverse probability treatment weighting. Secondary outcomes included all-cause hospitalizations, repeat revascularization, major amputation, and cardiovascular medication use. Sensitivity analyses included instrumental variable methods, falsification endpoints, and simulation of hypothetical unmeasured confounders. Subgroup analyses examined outcomes in inpatient vs outpatient settings, in younger/low-risk populations, and in high-risk chronic limb-threatening ischaemia patients.
RESULTS: At a median follow-up of 4.3 years (maximum: 9.0 years), DCD use was not associated with increased mortality (adjusted hazard ratio: 0.98; 95% confidence interval: 0.97, 0.99), meeting the pre-specified 5% non-inferiority relative margin. Sensitivity analyses supported the validity of the primary result. Secondary outcomes showed similar hospitalization and amputation rates between groups but an increase in repeat revascularization with DCDs. Subgroup analyses confirmed safety findings across high/low-risk subgroups and across clinical settings.
CONCLUSIONS: In this final report from the SAFE-PAD study, there was no evidence of long-term mortality risk associated with DCDs used for femoropopliteal revascularization. The SAFE-PAD study helped inform the reversal of regulatory warnings against routine DCD use.
AIMS: Both lipoprotein(a) [Lp(a)] and peripheral artery disease (PAD) are associated with ischaemic events. We sought to assess the association between Lp(a) and major adverse cardiovascular events (MACE) and major lower extremity events (MALE) among patients with baseline PAD.
METHODS AND RESULTS: The Mass General Brigham (MGB) Lp(a) registry includes all individuals with Lp(a) measured at two tertiary care centres from 2000 to 2019. Those with PAD were grouped according to Lp(a) percentile: 1st-25th [Q1, Lp(a) ≤ 14 nmol/L], 26th-50th (Q2, 14-<42 nmol/L), 51st-75th (Q3, 42-<132 nmol/L), and 76th-100th (Q4, 132-855 nmol/L). Outcomes were MACE [composite of cardiovascular (CV) death, myocardial infarction, or coronary revascularization] and MALE (composite of peripheral revascularization, acute limb ischaemia, or major lower extremity amputation). Cox proportional hazard modelling was used to assess the association between Lp(a) and the outcomes of interest after adjusting for traditional risk factors. Among 3757 individuals with PAD [39% female, median age 68 (IQR: 58-77)], individuals with Lp(a) levels in the third and fourth quartiles had a 24 and 30% increased hazard of MACE, respectively [adj. hazard ratio (HR): 1.24, P = 0.005; adj. HR: 1.30, P = 0.001] when compared with those in the first quartile. Individuals in the fourth quartile had a 19% greater hazard of MALE (adj. HR: 1.19, P = 0.043).
CONCLUSION: Elevated Lp(a) in patients with PAD was associated with an increased risk of both MACE and MALE. Accordingly, measurement of Lp(a) may convey important prognostic value and allow for further risk stratification within this high-risk population.