Cardiology Commons^™

One-Year Results Of The Liberty 360 Study: Evaluation Of Acute And Midterm Clinical Outcomes Of Peripheral Endovascular Device Interventions., Jihad Mustapha, William Gray, Brad J Martinsen, Ryan W Bolduan, George L Adams, Gary Ansel, Michael R Jaff

Heart and Vascular Articles

PURPOSE: To report the 1-year results of a multicenter study of peripheral artery disease (PAD) treatment with a variety of endovascular treatment strategies employed in routine practice.

MATERIALS AND METHODS: The LIBERTY trial ( ClinicalTrials.gov identifier NCT01855412) is a prospective, observational, core laboratory-assessed, multicenter study of endovascular device intervention in 1204 subjects (mean age 69.8±10.7 years; 770 men) stratified by Rutherford category (RC): claudicants (RC2,3; n=501) and critical limb ischemia (CLI) with no/minimal tissue loss (RC4,5; n=603) or significant tissue loss (RC6; n=100). Key outcomes included quality of life (QoL) measures (VascuQol and EuroQol) and freedom from major adverse events …

Drug-Coated Balloon Treatment Of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From The In.Pact Global Study., Gary M Ansel, Marianne Brodmann, Koen Keirse, Antonio Micari, Michael R Jaff, Krishna Rocha-Singh, Eric J Fernandez, Hong Wang, Thomas Zeller, In.Pact Global Study Investigators

Heart and Vascular Articles

PURPOSE: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded.

METHODS: The 1406 subjects enrolled in the IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death …

One-Year Analysis Of The Prospective Multicenter Sentry Clinical Trial: Safety And Effectiveness Of The Novate Sentry Bioconvertible Inferior Vena Cava Filter., Michael D Dake, Timothy P Murphy, Albrecht H Krämer, Michael D Darcy, Luke E Sewall, Michael A Curi, Matthew S Johnson, Frank Arena, James L Swischuk, Gary M Ansel, Mitchell J Silver, Souheil Saddekni, Jayson S Brower, Robert Mendes, Sentry Trial Investigators

Heart and Vascular Articles

PURPOSE: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE).

MATERIALS AND METHODS: At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, …

Streamlined Surgical Draping Reduces Subcutaneous Implantable Cardioverter-Defibrillator Implant Procedure Preparation Time., Marcy Mcqueen, Lori A Woodford, Eric Holick, Kevin Wolfer, Anish K Amin

Heart and Vascular Articles

The subcutaneous implantable cardioverter-defibrillator (S-ICD) is a proven alternative to transvenous implantable cardioverter-defibrillator systems. One critique of S-ICD use, however, has been the time required for implantation. Here, we discuss the use of an alternative surgical draping technique to reduce preparation time for device implantation.

Premature Ventricular Contraction-Induced Polymorphic Ventricular Tachycardia After Leadless Pacemaker Implantation: A Unique Adverse Effect Of Leadless Pacing., Anish K Amin, Sreedhar R Billakanty, Nagesh Chopra, Eugene Y Fu, Allan J Nichols, James M Kleman, Gregory A Kidwell

Heart and Vascular Articles

No abstract provided.

Very Late Occurrence Of Complete Heart Block Without Preexisting Atrioventricular Conduction Abnormalities: A Rare Complication After Transaortic Valvular Replacement., Nagesh Chopra, Matthew S Tong, Steven J Yakubov

Heart and Vascular Articles

No abstract provided.

Long-Term Detection Of Atrial Fibrillation With Insertable Cardiac Monitors In A Real-World Cryptogenic Stroke Population., Paul D Ziegler, John D Rogers, Scott W Ferreira, Allan J Nichols, Mark Richards, Jodi L Koehler, Shantanu Sarkar

Heart and Vascular Articles

BACKGROUND: The long-term incidence of atrial fibrillation (AF) in cryptogenic stroke (CS) patients has been explored in carefully controlled clinical trials but real-world data are limited. We investigated the two-year incidence of AF in real-world clinical practice among a large cohort of patients with an insertable cardiac monitor (ICM) placed for AF detection following CS.

METHODS: Patients in the de-identified Medtronic Discovery™ Link database who received an ICM (Reveal LINQ™) for the purpose of AF detection following CS were included and monitored for up to 2years. All detected AF episodes (≥2min) were adjudicated. We quantified the AF detection rate using …

Analysis Of The Final Denali Trial Data: A Prospective, Multicenter Study Of The Denali Inferior Vena Cava Filter., S William Stavropoulos, James X Chen, Ronald F Sing, Fakhir Elmasri, Mitchell J Silver, Alex Powell, Frank C Lynch, Ahmed Kamel Abdel Aal, Alexandra Lansky, Bart E Muhs

Heart and Vascular Articles

PURPOSE: To report the final 2-year data on the efficacy and safety of a nitinol retrievable inferior vena cava (IVC) filter for protection against pulmonary embolism (PE).

MATERIALS AND METHODS: This was a prospective multicenter trial of 200 patients with temporary indications for caval filtration who underwent implantation of the Denali IVC filter. After filter placement, all patients were followed for 2 years after placement or 30 days after filter retrieval. The primary endpoints were technical success of filter implantation in the intended location and clinical success of filter placement and retrieval. Secondary endpoints were incidence of clinically symptomatic recurrent …

A Unique Case Of Pulmonary Embolism Presenting As A Paroxysmal Atrial Tachycardia Instigated Only By Recumbency And Stooping., Nagesh Chopra

Heart and Vascular Articles

No abstract provided.

3-Year Outcomes In High-Risk Patients Who Underwent Surgical Or Transcatheter Aortic Valve Replacement., G Michael Deeb, Michael J Reardon, Stan Chetcuti, Himanshu J Patel, P Michael Grossman, Steven J Yakubov, Neal S Kleiman, Joseph S Coselli, Thomas G Gleason, Joon Sup Lee, James B Hermiller, John Heiser, William Merhi, George L Zorn, Peter Tadros, Newell Robinson, George Petrossian, G Chad Hughes, J Kevin Harrison, Brijeshwar Maini, Mubashir Mumtaz, John Conte, Jon Resar, Vicken Aharonian, Thomas Pfeffer, Jae K Oh, Hongyan Qiao, David H Adams, Jeffrey J Popma

Heart and Vascular Articles

BACKGROUND: In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery.

OBJECTIVES: This study sought to determine whether this clinical benefit was sustained over time.

METHODS: Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure.

RESULTS: A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted …

Durable Clinical Effectiveness With Paclitaxel-Eluting Stents In The Femoropopliteal Artery: 5-Year Results Of The Zilver Ptx Randomized Trial., Michael D Dake, Gary M Ansel, Michael R Jaff, Takao Ohki, Richard R Saxon, H Bob Smouse, Lindsay S Machan, Scott A Snyder, Erin E O'Leary, Anthony O Ragheb, Thomas Zeller

Heart and Vascular Articles

BACKGROUND: This randomized controlled trial evaluated clinical durability of Zilver PTX, a paclitaxel-coated drug-eluting stent (DES), for femoropopliteal artery lesions. Outcomes compare primary DES versus percutaneous transluminal angioplasty (PTA), overall DES (primary and provisional) versus standard care (PTA and provisional Zilver bare metal stent [BMS]), and provisional DES versus provisional BMS.

METHODS AND RESULTS: Patients with symptomatic femoropopliteal artery disease were randomly assigned to DES (n=236) or PTA (n=238). Approximately 91% had claudication; 9% had critical limb ischemia. Patients experiencing acute PTA failure underwent secondary randomization to provisional BMS (n=59) or DES (n=61). The 1-year primary end points of event-free …

The Liberty Study: Design Of A Prospective, Observational, Multicenter Trial To Evaluate The Acute And Long-Term Clinical And Economic Outcomes Of Real-World Endovascular Device Interventions In Treating Peripheral Artery Disease., George L Adams, Jihad Mustapha, William Gray, Nick J Hargus, Brad J Martinsen, Gary Ansel, Michael R Jaff

Heart and Vascular Articles

Background: Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations.

Study design: LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc …

The Association Between Cognitive Function And Objective Adherence To Dietary Sodium Guidelines In Patients With Heart Failure., Mary A Dolansky, Julie T Schaefer, Misty Aw Hawkins, John Gunstad, Anup Basuray, Joseph D Redle, James C Fang, Richard A Josephson, Shirley M Moore, Joel W Hughes

Heart and Vascular Articles

BACKGROUND: Although cognitive impairment is common in heart failure (HF) patients, its effects on sodium adherence recommendations are unknown.

PURPOSE: Our aim is to examine if cognitive function is associated with patient sodium adherence.

METHODS: Sodium collection/excretion and cognitive function were assessed for 339 HF patients over a 5-8-week period. Neuropsychological testing was performed at baseline (Visit 1), whereas two 24-hour urine samples were collected within 7 weeks postbaseline. The ability to collect two 24-hour urine samples and the estimation of sodium excretion levels from these samples were used to estimate sodium adherence recommendations.

RESULTS: Nearly half (47%) of the …

Central Retinal Artery Occlusion Following Laser Treatment For Ocular Ischemic Aortic Arch Syndrome., Payal J Shah, Brian Ellis, Lauren R Digiovine, Jeffery P Hogg, Monique J Leys

Heart and Vascular Articles

Objective: Ocular ischemic syndrome is a rare blinding condition generally caused by disease of the carotid artery. We describe a 69-year-old female with a 50 pack-year smoking history with aortic arch syndrome causing bilateral ocular ischemic syndrome.

Methods: The patient presented with progressive visual loss and temple pain. Slit lamp biomicroscopy revealed bilateral iris neovascularization. This finding prompted a cardiovascular work up. Panretinal photocoagulation with retrobulbar block was performed in the right eye.

Results: A temporal artery biopsy was negative. The carotid duplex ultrasound showed only a 1-39% stenosis. MRA revealed a more proximal occlusion of the aortic branch for …