Publications by authors named "David M Safley"

Background: Peripheral artery disease (PAD) guidelines recommend revascularization only for patients with lifestyle-limiting claudication that is refractory to goal-directed medical therapy (class IIA, level of evidence A). However, real-world invasive treatment patterns and predictors of revascularization in patients with symptomatic lower-extremity PAD are still largely unknown.

Aim: We aimed to examine rates, patient-level predictors, and site variability of early revascularization in patients with new or worsening PAD symptoms.

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Article Synopsis
  • Peripheral artery disease (PAD) significantly increases the risk of cardiovascular issues and long-term mortality, highlighting the need for accurate health assessments following diagnosis.
  • The study analyzed data from 711 patients with PAD, using the Peripheral Artery Questionnaire (PAQ) to evaluate health status at baseline and 3 months, discovering that both initial and follow-up scores correlate with 5-year mortality rates.
  • Results indicated that the PAQ score at the 3-month mark is the strongest predictor of survival, suggesting that regular monitoring could help improve patient care and outcomes in PAD management.
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Objectives: To develop a model to predict risk of in-hospital bleeding following endovascular peripheral vascular intervention.

Background: Peri-procedural bleeding is a common, potentially preventable complication of catheter-based peripheral vascular procedures and is associated with increased mortality. We used the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry to develop a novel risk-prediction model to identify patients who may derive the greatest benefit from application of strategies to prevent bleeding.

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Patients with peripheral artery disease (PAD) face a range of treatment options to improve survival and quality of life. An evidence-based shared decision-making tool (brochure, website, and recorded patient vignettes) for patients with new or worsening claudication symptoms was created using mixed methods and following the International Patient Decision Aids Standards (IPDAS) criteria. We reviewed literature and collected qualitative input from patients ( = 28) and clinicians ( = 34) to identify decisional needs, barriers, outcomes, knowledge, and preferences related to claudication treatment, along with input on implementation logistics from 59 patients and 27 clinicians.

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Objectives: The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI.

Background: AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI).

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Background: The American College of Cardiology/American Heart Association Appropriate Use Criteria were designed to aid clinical decision-making, yet their association with health status outcomes after chronic total occlusion percutaneous coronary intervention (PCI) is unknown.

Methods: We analyzed 769 patients with baseline and 1-year health status data after chronic total occlusion PCI. Procedures were categorized as appropriate, may be appropriate, or rarely appropriate.

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Background Underuse of guideline-recommended therapy in peripheral artery disease (PAD) in administrative and procedural databases has been described, but reports on medically managed patients and referral to supervised exercise therapy (SET) in PAD are lacking. We aimed to document the use of PAD guideline-recommended therapy, including SET in patients with PAD symptoms consulting a specialty clinic across 3 countries. Methods and Results The 16-center PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry enrolled 1275 patients with new or an exacerbation of PAD symptoms (2011-2015).

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Background: The ACC/AHA cholesterol guidelines recommend patients with peripheral artery disease (PAD) be treated with a moderate to high-intensity statin. The extent to which patients with new or worsening PAD symptoms are offered guideline therapy is unknown.

Hypothesis: There is significant variability in rate of guideline-directed statin intensification across clinical practices.

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Objectives: To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.

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Objectives: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions.

Background: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions.

Methods: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events.

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Objectives: The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after elective percutaneous coronary intervention (PCI), on hospital costs.

Background: PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs.

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Background: Slow adoption of trans-radial access (TRA) for left heart catheterization (LHC) in the U.S. may be related to concerns about procedural complexity and a steep learning curve.

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Objectives: To explore the association of health status change and long-term survival among patients with symptomatic peripheral artery disease (PAD).

Background: Early gains in health status after successful endovascular therapy (EVT) for symptomatic PAD can be maintained up to 1 year. Whether such health status improvements are associated with long-term survival benefits is unknown.

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Objectives: This study investigates the effects of glycoprotein IIb/IIIa inhibitors (GPIs) on outcomes after percutaneous coronary intervention (PCI).

Background: Ischemic complications are reduced after PCI when a GPI is added to heparin. However, there are limited data on the safety and efficacy in contemporary PCI.

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Objectives: We aimed to compare quality of life benefits of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) with non-CTO PCI.

Background: Data quantifying the benefits of PCI of CTO are inconsistent.

Methods: We leveraged a 10-center prospective PCI registry including Seattle Angina Questionnaire (SAQ) assessment at the time of PCI and in follow-up.

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Objectives: This study sought to evaluate the costs of transradial percutaneous coronary intervention (TRI) and transfemoral percutaneous coronary intervention (TFI) from a contemporary hospital perspective.

Background: Whereas the TRI approach to percutaneous coronary intervention (PCI) has been shown to reduce access-site complications compared with TFI, whether it is associated with lower costs is unknown.

Methods: TRI and TFI patients were identified at 5 U.

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Background: Transradial intervention (TRI) for percutaneous coronary intervention (PCI) is associated with shorter length of stay, fewer bleeding complications, and higher patient satisfaction. Less is known about the economic implications of TRI in contemporary practice.

Methods: This is a retrospective inpatient cohort analysis using medical data from the Premier research database (Premier Inc, Charlotte, NC), which contains approximately one-fifth of all acute care hospitalizations in the US annually.

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Depressive symptoms are known to compromise health status in cardiac disease, but this relationship has not been described in peripheral artery disease (PAD). Depressive symptoms (PHQ-9) and disease-specific health status (Peripheral Artery Questionnaire, PAQ) were assessed in 242 PAD patients undergoing percutaneous transluminal angioplasty (PTA) at baseline and 1 year. Patients were classified by baseline and follow-up depression status (moderate-severe depressive symptoms = PHQ ≥ 10).

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Arterial closure devices (ACDs) provide immediate hemostasis, improve comfort, and allow early ambulation after percutaneous coronary intervention (PCI). The aim of this study was to evaluate ACD utilization and post-PCI major bleeding in an unselected cohort. Patients receiving ACDs were propensity matched to those with manual compression to evaluate a primary end point of National Cardiovascular Data Registry (NCDR) major bleeding and a secondary end point of major bleeding stratified by previously developed NCDR bleeding risk categories.

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Objectives: We assessed the potential for percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) to decrease myocardial ischemia and established objective criteria to predict post-procedure improvement.

Background: Optimal treatment for CTO of coronary arteries is controversial, and selection criteria for PCI of CTO are subjective.

Methods: All patients undergoing CTO PCI at a single center between 2002 and 2007 were included if myocardial perfusion imaging (MPI) was performed within 12 ± 3 months before and a follow-up study within 12 ± 3 months after PCI.

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Purpose: Atherectomy has emerged as an alternative to percutaneous transluminal angioplasty (PTA) for endovascular reopening. Despite increasing use of atherectomy (and higher cost of atherectomy catheters compared with balloon catheters), few studies have compared outcomes and costs with other reopening strategies.

Methods: We performed a retrospective cohort study involving all patients undergoing isolated femoropopliteal PTA (n=69) or atherectomy (n=92) at our institution from 1/2005 to 4/2006.

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Objectives: This study compared health-related quality of life in patients undergoing carotid artery stenting (CAS) versus surgical endarterectomy (CEA).

Background: Carotid artery stenting is approved in the U.S.

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Objectives: This study compared the survival benefit of opening a chronic total occlusion (CTO) of the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA).

Background: Previous analyses demonstrate improved survival following successful percutaneous coronary intervention (PCI) for CTO.

Methods: Eligible patients underwent attempted CTO PCI in a single vessel.

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