Cardiology Commons^™

Paclitaxel-Coated Zilver Ptx Drug-Eluting Stent Treatment Does Not Result In Increased Long-Term All-Cause Mortality Compared To Uncoated Devices., Michael D Dake, Gary M Ansel, Marc Bosiers, Andrew Holden, Osamu Iida, Michael R Jaff, Aaron E Lottes, Erin E O'Leary, Alan T Saunders, Marc Schermerhorn, Hiroyoshi Yokoi, Thomas Zeller

Heart and Vascular Articles

PURPOSE: Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel.

METHODS: Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan-Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality.

RESULTS: In the RCT, …

Mortality Assessment Of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis Of The Illumenate Clinical Program At 3 Years., William A Gray, Michael R Jaff, Sahil A Parikh, Gary M Ansel, Marianne Brodmann, Prakash Krishnan, Mahmood K Razavi, Frank Vermassen, Thomas Zeller, Roseann White, Kenneth Ouriel, Mark A Adelman, Sean P Lyden

Heart and Vascular Articles

BACKGROUND: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients.

METHODS: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 …

Comparison Of Cyanoacrylate Closure And Radiofrequency Ablation For The Treatment Of Incompetent Great Saphenous Veins: 36-Month Outcomes Of The Veclose Randomized Controlled Trial., Nick Morrison, Raghu Kolluri, Michael Vasquez, Monte Madsen, Andrew Jones, Kathleen Gibson

Heart and Vascular Articles

OBJECTIVE: To evaluate the 36-month efficacy and safety of cyanoacrylate closure for the treatment of incompetent great saphenous veins in comparison with radiofrequency ablation.

METHODS: In this multicenter, prospective, randomized controlled trial, 222 symptomatic subjects with incompetent great saphenous veins were assigned to either cyanoacrylate closure or radiofrequency ablation. The primary endpoint, complete closure of the target great saphenous vein, was determined using duplex ultrasound examination starting from three-month visit.

RESULTS: At month 36, the great saphenous vein closure rates were 94.4% for the cyanoacrylate closure group and 91.9% for the radiofrequency ablation group. Stable improvement in symptoms and quality …

Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis Of A Drug-Coated Balloon., Peter A Schneider, John R Laird, Gheorghe Doros, Qi Gao, Gary Ansel, Marianne Brodmann, Antonio Micari, Mehdi H Shishehbor, Gunnar Tepe, Thomas Zeller

Heart and Vascular Articles

BACKGROUND: Five years of prospective clinical trials confirm that the paclitaxel drug-coated balloon (DCB) (IN.PACT Admiral, Medtronic, Dublin, Ireland) is safe and effective to treat femoropopliteal artery disease. A recent meta-analysis of heterogeneous trials of paclitaxel-based balloons and stents reported that they are associated with increased mortality and that higher doses are linked to higher mortality from 2 to 5 years.

OBJECTIVES: The purpose of this study was to determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up.

METHODS: Data from 2 single-arm and …

The Clinical Rationale For The Sentry Bioconvertible Inferior Vena Cava Filter For The Prevention Of Pulmonary Embolism., Michael D Dake, Gary M Ansel, Matthew S Johnson, Robert Mendes, H Bob Smouse

Heart and Vascular Articles

The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection against pulmonary embolism (PE) during transient high-risk periods and then to bioconvert after 60 days after implantation. At the time of bioconversion, the device's nitinol arms retract from the filtering position into the caval wall. Subsequently, the stable stent-like nitinol frame is endothelialized. The Sentry bioconvertible IVC filter has been evaluated in a multicenter investigational-device-exemption pivotal trial (NCT01975090) of 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, and with contraindications to anticoagulation. Successful filter conversion was …

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.

Guidewire Method For Measuring Local Left Ventricular Electrical Activation Time During Cardiac Resynchronization Implantation., Seth J Rials, Michele Pershing, Christy Collins

OhioHealth Research Institute Articles

The timing of local activation at left ventricular (LV) pacing leads is measured from the onset of the QRS complex to the peak of the LV electrogram (QLV). Pacing from the sites of late activation is associated with higher response rates to cardiac resynchronization therapy (CRT). Prior studies have measured QLV from permanent pacing leads, or have used electroanatomic mapping systems. The current study compares QLV measurements made with a guidewire to those collected from permanent LV pacing leads positioned at the same venous site without the use of electroanatomic mapping systems. In this study, 20 patients undergoing CRT implantation …

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 …