Cardiology Commons^™

Cardiovascular Risk Stratification In Diabetic Retinopathy Via Atherosclerotic Pathway In Covid-19/Non-Covid-19 Frameworks Using Artificial Intelligence Paradigm: A Narrative Review., Smiksha Munjral, Mahesh Maindarkar, Puneet Ahluwalia, Anudeep Puvvula, Ankush Jamthikar, Tanay Jujaray, Neha Suri, Sudip Paul, Rajesh Pathak, Luca Saba, Renoh Johnson Chalakkal, Suneet Gupta, Gavino Faa, Inder M Singh, Paramjit S Chadha, Monika Turk, Amer M Johri, Narendra N Khanna, Klaudija Viskovic, Sophie Mavrogeni, John R Laird, Gyan Pareek, Martin Miner, David W Sobel, Antonella Balestrieri, Petros P Sfikakis, George Tsoulfas, Athanasios Protogerou, Durga Prasanna Misra, Vikas Agarwal, George D Kitas, Raghu Kolluri, Jagjit Teji, Mustafa Al-Maini, Surinder K Dhanjil, Meyypan Sockalingam, Ajit Saxena, Aditya Sharma, Vijay Rathore, Mostafa Fatemi, Azra Alizad, Vijay Viswanathan, Padukode R Krishnan, Tomaz Omerzu, Subbaram Naidu, Andrew Nicolaides, Mostafa M Fouda, Jasjit S Suri

Heart and Vascular Articles

Diabetes is one of the main causes of the rising cases of blindness in adults. This microvascular complication of diabetes is termed diabetic retinopathy (DR) and is associated with an expanding risk of cardiovascular events in diabetes patients. DR, in its various forms, is seen to be a powerful indicator of atherosclerosis. Further, the macrovascular complication of diabetes leads to coronary artery disease (CAD). Thus, the timely identification of cardiovascular disease (CVD) complications in DR patients is of utmost importance. Since CAD risk assessment is expensive for low-income countries, it is important to look for surrogate biomarkers for risk stratification …

Mycotic Aortic Aneurysm: A Rare Etiology Of Septic Shock., Kaitlin M Bowers, Vishnu Mudrakola, Christopher M Lloyd

Heart and Vascular Articles

Mycotic aneurysm of the aorta is a rare disease with a high mortality rate due to its likelihood of aneurysmal rupture. This syndrome is predominantly seen in patients over age 65 with the most common presenting symptoms being fever and back pain. Our case illustrates a mycotic aneurysm of the aorta presenting in an elderly female with vague abdominal pain, flank pain, and generalized weakness. We review the investigative approach, diagnostic modalities, and treatment options in patient management. This case emphasizes the need for a high index of suspicion of mycotic aneurysms of the aorta in critically ill elderly patients …

Supraventricular Tachycardia Ablation And Its Effects On Anxiety Medications., Mohamed Mahmoud, Justin Haloot, Khadija El Kortbi, Vanessa Rodriguez Fuenmayor, Mubeen Cheema, Auroa Badin

Heart and Vascular Articles

BACKGROUND: Patients with true paroxysmal supraventricular tachycardia (PSVT) are frequently misdiagnosed with panic or anxiety disorders due to similar symptoms of palpitations, light-headedness, dyspnea, or chest discomfort. Unrecognized PSVT can lead to unnecessary management with anxiety medications. Treatment of PSVT with catheter ablation may lead to a reduction in anxiety medications.  Methods: A total of 175 patients underwent successful PSVT ablation between January 1, 2010 and December 31, 2020. We examined symptoms at presentation, psychiatric medications prior to PSVT ablation, comorbidities, and psychiatric medications at three months post-ablation.  Results: Fifteen percent of patients who underwent successful PSVT ablation were being …

Pivotal Study Evaluating The Safety And Effectiveness Of The Abre Venous Self-Expanding Stent System In Patients With Symptomatic Iliofemoral Venous Outflow Obstruction., Erin Murphy, Kathleen Gibson, Marc Sapoval, David J Dexter, Raghu Kolluri, Mahmood Razavi, Stephen Black

Heart and Vascular Articles

BACKGROUND: Iliofemoral venous obstruction is recognized with increasing frequency as the underlying cause of lower extremity symptoms including edema, pain, skin changes, and, in advanced cases, ulceration. This study sought to evaluate the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction.

METHODS: The ABRE Study (A Multi-Center, Non-Randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction) is a single-arm, multicenter, prospective study that included 200 subjects from 24 global sites. The primary end points were …

Relationship Between Surpoint Tag Index, A Radiofrequency Ablation Lesion Quality Indicator, And Atrial Wall Thickness In Cavotricuspid Isthmus Ablations Exhibiting Bidirectional Block., Alexander Smith, Anish K Amin, Rayan El-Zein, Sreedhar R Billakanty, Nagesh Chopra

Heart and Vascular Articles

BACKGROUND: An RFA lesion quality indicator, Surpoint Tag Index

OBJECTIVE: To describe the relationship between atrial wall thickness and TI in CTI exhibiting bidirectional block.

METHODS: Data from 492 RFA lesions from 25 patients undergoing PVI and CTI ablations in SR with point-by-point RF lesions (< 45 W) utilizing a Thermocool Smarttouch

RESULTS: In lesions exhibiting bidirectional block, the thinnest (1-2 mm; 5% lesions) and thickest (8-10 mm; 6% lesions) portions of the CTI correlated with the lowest (429 ± 75) and highest (516 ± 64) TI. The bulk of thickness (2-6 mm; 80%) correlated with a TI of 455 ± 72 (

CONCLUSION: A mean …

Nutrition, Atherosclerosis, Arterial Imaging, Cardiovascular Risk Stratification, And Manifestations In Covid-19 Framework: A Narrative Review., Smiksha Munjral, Puneet Ahluwalia, Ankush D Jamthikar, Anudeep Puvvula, Luca Saba, Gavino Faa, Inder M Singh, Paramjit S Chadha, Monika Turk, Amer M Johri, Narendra N Khanna, Klaudija Viskovic, Sophie Mavrogeni, John R Laird, Gyan Pareek, Martin Miner, David W Sobel, Antonella Balestrieri, Petros P Sfikakis, George Tsoulfas, Athanasios Protogerou, Prasanna Misra, Vikas Agarwal, George D Kitas, Raghu Kolluri, Jagjit Teji, Mustafa Al-Maini, Surinder K Dhanjil, Meyypan Sockalingam, Ajit Saxena, Aditya Sharma, Vijay Rathore, Mostafa Fatemi, Azra Alizad, Vijay Viswanathan, P K Krishnan, Tomaz Omerzu, Subbaram Naidu, Andrew Nicolaides, Jasjit S Suri

Heart and Vascular Articles

Background: Atherosclerosis is the primary cause of the cardiovascular disease (CVD). Several risk factors lead to atherosclerosis, and altered nutrition is one among those. Nutrition has been ignored quite often in the process of CVD risk assessment. Altered nutrition along with carotid ultrasound imaging-driven atherosclerotic plaque features can help in understanding and banishing the problems associated with the late diagnosis of CVD. Artificial intelligence (AI) is another promisingly adopted technology for CVD risk assessment and management. Therefore, we hypothesize that the risk of atherosclerotic CVD can be accurately monitored using carotid ultrasound imaging, predicted using AI-based algorithms, and reduced …

Incidence And Outcomes Of Infective Endocarditis After Transcatheter Or Surgical Aortic Valve Replacement., Jonas Lanz, Michael J Reardon, Thomas Pilgrim, Stefan Stortecky, G Michael Deeb, Stanley Chetcuti, Steven J Yakubov, Thomas G Gleason, Jian Huang, Stephan Windecker

Heart and Vascular Articles

Background Data comparing the frequency and outcomes of infective endocarditis (IE) after transcatheter (TAVR) to surgical aortic valve replacement (SAVR) are scarce. The objective of this study is to compare the incidence and outcomes of IE after TAVR using a supra-annular, self-expanding platform (CoreValve and Evolut) to SAVR. Methods and Results Data of 3 randomized clinical trials comparing TAVR to SAVR and a prospective continued TAVR access study were pooled. IE was defined on the basis of the modified Duke criteria. The cumulative incidence of IE was determined by modeling the cause-specific hazard. Estimates of all-cause mortality were calculated by …

4-Dimensional Intracardiac Echocardiography In Transcatheter Mitral Valve Repair With The Mitraclip System., Carlos E Sanchez, Steven J Yakubov, Gagan Singh, Jason H Rogers, Nathan H Kander, Gilbert H L Tang

Heart and Vascular Articles

No abstract provided.

Transcatheter Aortic Valve Replacement With Self-Expandable Supra-Annular Valves For Degenerated Surgical Bioprostheses: Insights From Transcatheter Valve Therapy Registry., Luis Augusto P Dallan, John K Forrest, Michael J Reardon, Wilson Y Szeto, Isaac George, Susheel Kodali, Neal S Kleiman, Steven J Yakubov, Kendra J Grubb, Fang Liu, Cristian Baeza, Guilherme F Attizzani

Heart and Vascular Articles

Background Transcatheter aortic valve replacement with supra-annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self-expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure. Methods and Results Patients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In-hospital, 30-day, and 1-year clinical outcomes …

Predictors Of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion., Trevor Simard, Richard G Jung, Kyle Lehenbauer, Kerstin Piayda, Radoslaw Pracoń, Gregory G Jackson, Eduardo Flores-Umanzor, Laurent Faroux, Kasper Korsholm, Julian K R Chun, Shaojie Chen, Moniek Maarse, Kristi Montrella, Zakeih Chaker, Jocelyn N Spoon, Luigi E Pastormerlo, Felix Meincke, Abhishek C Sawant, Carmen M Moldovan, Mohammed Qintar, Mehmet K Aktas, Luca Branca, Andrea Radinovic, Pradhum Ram, Rayan S El-Zein, Thomas Flautt, Wern Yew Ding, Bassel Sayegh, Tomás Benito-González, Oh-Hyun Lee, Solomon O Badejoko, Christina Paitazoglou, Nabeela Karim, Ahmed M Zaghloul, Himanshu Agrawal, Rachel M Kaplan, Oluseun Alli, Aamir Ahmed, Hussam S Suradi, Bradley P Knight, Venkata M Alla, Sidakpal S Panaich, Tom Wong, Martin W Bergmann, Rashaad Chothia, Jung-Sun Kim, Armando Pérez De Prado, Raveen Bazaz, Dhiraj Gupta, Miguel Valderrabano, Carlos E Sanchez, Mikhael F El Chami, Patrizio Mazzone, Marianna Adamo, Fred Ling, Dee Dee Wang, William O'Neill, Wojtek Wojakowski, Ashish Pershad, Sergio Berti, Daniel Spoon, Akram Kawsara, George Jabbour, Lucas V A Boersma, Boris Schmidt, Jens Erik Nielsen-Kudsk, Josep Rodés-Cabau, Xavier Freixa, Christopher R Ellis, Laurent Fauchier, Marcin Demkow, Horst Sievert, Michael L Main, Benjamin Hibbert, David R Holmes, Mohamad Alkhouli

Heart and Vascular Articles

BACKGROUND: Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited.

OBJECTIVES: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT.

METHODS: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT.

RESULTS: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the …

Three-Year Outcomes From The Liberty 360 Study Of Endovascular Interventions For Peripheral Artery Disease Stratified By Rutherford Category., Stefanos Giannopoulos, Jihad Mustapha, William A Gray, Gary Ansel, George Adams, Eric A Secemsky, Ehrin J Armstrong

Heart and Vascular Articles

PURPOSE: To report the 3-year results of the LIBERTY 360 study, which investigated outcomes of endovascular treatment of symptomatic peripheral artery disease (PAD).

MATERIALS AND METHODS: The LIBERTY trial (

RESULTS: The 36-month KM survival rates were 86.0% in RC 2-3, 79.8% in RC 4-5, and 62.0% in RC 6 groups. The KM estimates of freedom from major amputation at 36 months were 98.5% in RC 2-3, 94.0% in RC 4-5, and 79.9% in RC 6. The 36-month KM estimates for freedom from TVR/TLR were 71.1% in RC 2-3, 64.2% in RC 4-5 and 61.9% in RC 6 groups. Patients …

Prediction Model For Freedom From Tlr From A Multi-Study Analysis Of Long-Term Results With The Zilver Ptx Drug-Eluting Peripheral Stent., Michael D Dake, Fabrizio Fanelli, Aaron E Lottes, Erin E O'Leary, Heidi Reichert, Xiaohui Jiang, Weiguo Fu, Osamu Iida, Kan Zen, Marc Schermerhorn, Thomas Zeller, Gary M Ansel

Heart and Vascular Articles

PURPOSE: Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions.

METHODS: Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was …

Endovascular Mechanical Thrombectomy Versus Thrombolysis In Patients With Iliofemoral Deep Vein Thrombosis - A Systematic Review And Meta-Analysis., Michael K W Lichtenberg, Stefan Stahlhoff, Katarzyna Młyńczak, Dominik Golicki, Paul Gagne, Mahmood K Razavi, Rick De Graaf, Raghu Kolluri, Katarzyna Kolasa

Heart and Vascular Articles

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, …

Integration Of Cardiovascular Risk Assessment With Covid-19 Using Artificial Intelligence., Jasjit S Suri, Anudeep Puvvula, Misha Majhail, Mainak Biswas, Ankush D Jamthikar, Luca Saba, Gavino Faa, Inder M Singh, Ronald Oberleitner, Monika Turk, Saurabh Srivastava, Paramjit S Chadha, Harman S Suri, Amer M Johri, Vijay Nambi, J Miguel Sanches, Narendra N Khanna, Klaudija Viskovic, Sophie Mavrogeni, John R Laird, Arindam Bit, Gyan Pareek, Martin Miner, Antonella Balestrieri, Petros P Sfikakis, George Tsoulfas, Athanasios Protogerou, Durga Prasanna Misra, Vikas Agarwal, George D Kitas, Raghu Kolluri, Jagjit Teji, Michele Porcu, Mustafa Al-Maini, Ann Agbakoba, Meyypan Sockalingam, Ajit Sexena, Andrew Nicolaides, Aditya Sharma, Vijay Rathore, Vijay Viswanathan, Subbaram Naidu, Deepak L Bhatt

Heart and Vascular Articles

Artificial Intelligence (AI), in general, refers to the machines (or computers) that mimic "cognitive" functions that we associate with our mind, such as "learning" and "solving problem". New biomarkers derived from medical imaging are being discovered and are then fused with non-imaging biomarkers (such as office, laboratory, physiological, genetic, epidemiological, and clinical-based biomarkers) in a big data framework, to develop AI systems. These systems can support risk prediction and monitoring. This perspective narrative shows the powerful methods of AI for tracking cardiovascular risks. We conclude that AI could potentially become an integral part of the COVID-19 disease management system. Countries, …

The Cardiovascular Outcomes, Heart Failure And Kidney Disease Trials Tell That The Time To Use Sodium Glucose Cotransporter 2 Inhibitors Is Now., Michael E Johansen, Christos Argyropoulos

Heart and Vascular Articles

Sodium glucose contrasporter 2 inhibitors (SGLT2i) were initially introduced as a novel class of modestly effective antiglycemics. Over the last 5 years, multiple members of this class have been examined for their cardiovascular safety, effects on heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD) in diverse populations with or without diabetes type 2. The plethora of studies and outcomes examined make it difficult for the practitioner to track the entirety of the evidence. SGLT2i improve cardiorenal outcomes and have a beneficial risk benefit ratio across populations with cardiovascular disease, HFrEF and kidney disease. In this quantitative …

Lyme Disease: A Cause Of Polymorphic Ventricular Tachycardia., Jordan Luli, Ishmail Saccoh, Elston Johnson, Eugene Fu, Steven Nelson, Anish Amin

Heart and Vascular Articles

No abstract provided.

The Impact Of Chronic Kidney Disease On Outcomes Following Peripheral Vascular Intervention., Dennis I Narcisse, Elizabeth Hope Weissler, Jennifer A Rymer, Ehrin J Armstrong, Eric A Secemsky, William A Gray, Jihad A Mustapha, George L Adams, Gary M Ansel, Manesh R Patel, William Schuyler Jones

Heart and Vascular Articles

BACKGROUND: Patients with chronic kidney disease (CKD) have worsened clinical outcomes following percutaneous coronary intervention; however, limited evidence exists in patients undergoing peripheral vascular intervention (PVI).

PURPOSE: We aimed to assess the effect of CKD on outcomes following PVI for symptomatic peripheral artery disease.

METHODS: Using patients from the LIBERTY 360 study, we compared the rates of 30 day and 1 year major adverse vascular events (MAVE), a composite of all-cause mortality, major amputation, and target vessel/lesion revascularization, between patients with and without CKD (estimated glomular filtration rate less than 60) following PVI. Multivariable adjustment was performed to assess for …

Paclitaxel Exposure: Long-Term Safety And Effectiveness Of A Drug-Coated Balloon For Claudication In Pooled Randomized Trials., Peter A Schneider, Marianne Brodmann, Laura Mauri, John Laird, Yoshimitsu Soga, Antonio Micari, Gary Ansel, Mehdi H Shishehbor, Prakash Krishnan, Qi Gao, Kenneth Ouriel, Thomas Zeller

Heart and Vascular Articles

BACKGROUND: Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.

OBJECTIVES: To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.

METHODS: The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, …

A Case Of Phlegmasia Cerulea Dolens., Davin Barnett, John Casey

Heart and Vascular Articles

Phlegmasia cerulea dolens (PCD) is a rare presenting condition that carries a high mortality and morbidity risk. It is a cannot miss diagnosis with potentially deadly sequelae, and we highlight the importance of a thorough physical examination and initiation of empiric treatment to help prevent such.

Myocardial Infarction Can Be Safely Excluded By High-Sensitivity Troponin I Testing 3 Hours After Emergency Department Presentation., W Frank Peacock, Robert Christenson, Deborah B Diercks, Christian Fromm, Gary F Headden, Christopher J Hogan, Erik B Kulstad, Frank Lovecchio, Richard M Nowak, Jon W Schrock, Adam J Singer, Alan B Storrow, Joely Straseski, Alan H B Wu, Daniel P Zelinski

Heart and Vascular Articles

BACKGROUND: The accuracy and speed by which acute myocardial infarction (AMI) is excluded are an important determinant of emergency department (ED) length of stay and resource utilization. While high-sensitivity troponin I (hsTnI) >99th percentile (upper reference level [URL]) represents a "rule-in" cutpoint, our purpose was to evaluate the ability of the Beckman Coulter hsTnI assay, using various level-of-quantification (LoQ) cutpoints, to rule out AMI within 3 hours of ED presentation in suspected acute coronary syndrome (ACS) patients.

METHODS: This multicenter evaluation enrolled adults with >5 minutes of ACS symptoms and an electrocardiogram obtained per standard care. Exclusions were ST-segment elevation …

Acute Effusive Pericarditis: A Late Complication Of Covid-19., Kelli Fox, Jessica A Prokup, Kyle Butson, Kim Jordan

Heart and Vascular Articles

As the COVID-19 pandemic evolves, the medical community continues to discover novel clinical manifestations of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. Often, extrapulmonary manifestations occur simultaneously with pulmonary disease. However, there is a paucity of literature describing the cardiac manifestations of COVID-19 in the absence of pulmonary findings. We report a rare case of acute pericarditis presenting with pericardial effusion and cardiac tamponade in a 43-year-old man diagnosed with COVID-19. This case emphasizes the importance of continued investigation regarding diagnosis and treatment of COVID-19 and its related symptoms.

Same-Day Discharge After Subcutaneous Implantable Cardioverter-Defibrillator Implantation Is Safe And Cost-Effective., Jill Swinning, Kelli Fox, Sreedhar Billakanty, Shannon Brown, Nagesh Chopra, Eugene Fu, Jennifer James, Gregory Kidwell, James Kleman, Victoria Murnane, Steven Nelson, Allan Nichols, S Kay Nichols, Andrea Robinson, Anish Amin

Heart and Vascular Articles

The feasibility and safety of same-day discharge after transvenous implantable cardioverter-defibrillator implantation is well-established. However, subcutaneous ICDs (S-ICDs) are now increasingly being implanted, and the feasibility, safety, and potential cost savings associated with same-day discharge after S-ICD placement has not been widely investigated. In a small cohort of patients (n = 24) who underwent S-ICD implantation at our institution, 54% were successfully discharged on the same day as their implant procedure. Procedure-related complications were not apparent in this sampling and the reduction in health care costs was high, suggesting this protocol has immense benefit in today's health care environment. As …

Network Meta-Analysis To Compare Venaseal With Other Superficial Venous Therapies For Chronic Venous Insufficiency., Raghu Kolluri, Janice Chung, Sue Kim, Nibir Nath, Bhoomika Bajaj Bhalla, Tarun Jain, Joseph Zygmunt, Alun Davies

Heart and Vascular Articles

OBJECTIVE: Several randomized controlled trials (RCTs) have compared different interventions for chronic venous insufficiency (CVI) management, but mixed comparison of these interventions is lacking. The aim of this network meta-analysis was to compare VenaSeal closure system (Medtronic, Minneapolis, Minn) with endovenous laser ablation (EVLA), radiofrequency ablation (RFA), mechanochemical ablation, sclerotherapy, and surgery for management of CVI to achieve anatomic success (complete closure of treated vein within 6 months after intervention) as the primary outcome and health-related quality of life (HRQoL; EuroQol-5 Dimension, Aberdeen Varicose Vein Questionnaire), Venous Clinical Severity Score (VCSS), pain scores, and adverse events as secondary outcomes.

METHODS: …

Final Two-Year Outcomes For The Sentry Bioconvertible Inferior Vena Cava Filter In Patients Requiring Temporary Protection From Pulmonary Embolism., 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 report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE).

MATERIALS AND METHODS: In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years.

RESULTS: The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was …

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 …