News | Leads Implantable Devices | September 20, 2019

New Research on Tempo Temporary Pacing Lead to Be Featured at TCT 2019

Multi-center U.S. study demonstrating safety and efficacy of the Tempo Lead also published in Catheterization and Cardiovascular Interventions

New Research on Tempo Temporary Pacing Lead to Be Featured at TCT 2019

September 20, 2019 — BioTrace Medical Inc. announced the company’s key activities at the 31st annual Transcatheter Cardiovascular Therapeutics (TCT) conference, which will take place Sept. 25-29, 2019, in San Francisco.

The company’s Tempo Temporary Pacing Lead will be featured in a breakfast symposium titled “Keeping the Rhythm with the Tempo Lead: Safety, Stability and Ambulation for Transcatheter Aortic Valve Replacement (TAVR) and Other Cardiac Procedures,” which will be chaired by Stanley J. Chetcuti, M.D., director of the cardiac catheterization laboratory at the University of Michigan Health System, and Tamim M. Nazif, M.D., director of clinical services for the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center.

The symposium will feature recent clinical experience from several leading U.S. structural heart centers, highlighting the safety and efficacy of the Tempo Lead, its use in TAVR procedures, and its positive impact on facilitating post-TAVR patient ambulation outside of the ICU and CCU. The session will also provide an opportunity for hands-on demonstrations. 

Nazif will discuss NewYork-Presbyterian/Columbia University Medical Center’s experience using the Tempo Lead during his presentation titled “Conduction Disturbances After TAVR: Current Thinking and Clinical Relevance.” The Tempo Lead will also be utilized during live case broadcasts from NewYork-Presbyterian/Columbia University Medical Center.

Additionally, the company announced the publication of the results of a U.S. multi-center study of 269 cardiac procedures, predominantly TAVR, in Catheterization and Cardiovascular Interventions.[2] The results confirm the Tempo Lead is safe and effective for temporary cardiac pacing, provides stable peri- and post-procedural pacing support, and facilitates post-procedure ambulation.[1] The Tempo lead was successfully positioned and achieved pacing in 264 of 269 patients (98.1 percent). Two patients (0.8 percent) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no safety events, including perforations, pericardial effusions or sustained device-related arrhythmias. The Tempo lead was left in place post-procedure in 189 patients (71.6 percent) for a mean duration of 43.3 ± 0.7 hours with a final mean PCT of 0.84 ± 1.04 mA. With the Tempo lead in place, 159 of 189 patients (84.1 percent) mobilized from bed to chair at a minimum, and 134 patients (70.8 percent) ambulated without any restrictions related to the pacing lead. There were no lead dislodgments or loss of pace capture events for this group of 189 patients.

The study included procedures performed at six leading U.S. centers: NewYork-Presbyterian/Columbia University Medical Center, University of Michigan Health Center, Riverside Methodist Hospital/OhioHealth, Cleveland Clinic Heart & Vascular Institute, Intermountain Medical Center and Yale New Haven Hospital.

Since receiving FDA clearance, the Tempo Lead has been used in more than 4,500 U.S. procedures, with a safety and performance profile superior to conventional temporary leads, according to BioTrace Medical, including a 0.04 percent cardiac perforation rate and a 0.04 percent dislodgment rate with loss of pace capture.[3]

For more information: www.biotracemedical.com

 

References

1. Nazif T.M., Chen S., Codner P., et al. The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions. Catheter Cardiovasc Interv. 2019;1–6. https://doi.org/10.1002/ccd.28476

2. Nazif T.M., Chen S., Codner P., et al. The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions. Catheterization and Cardiovascular Interventions, published online Sept. 2, 2019. https://doi.org/10.1002/ccd.28476

3. Company data on file as of September 2019

Related Content

An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

News | Cath Lab | July 22, 2021
July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of
ast End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCross Transseptal Radiofrequency (RF) Puncture and Steerable Balloon Introducer System. The 3-in-1 system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (RF) puncture dilator, aims to provide a predictable and safe solution for electrophysiology (EP) and structural heart interventions requiring left atrial access.
News | Cath Lab | July 14, 2021
July 13, 2021 — East End Medical announced it received U.S.
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone. #SCAI21 #SCAI2021 Creating a card0-renal program.

There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone.

Feature | Cath Lab | May 14, 2021 | By Dave Fornell, Editor
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal fun
Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting proc

Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting procedures.

News | Cath Lab | May 12, 2021
May 12, 2021 — Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has
SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI heart attack. #SCAI21 #SCAI2021

SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI.

Feature | Cath Lab | May 06, 2021 | By Dave Fornell, Editor
April 29, 2021 — Here is the list of late-breaking study presentations and links to articles about each of them from
Most Stable Ischemic Heart Disease Patients Did Not Meet ISCHEMIA Trial Enrollment Criteria, raising questions about its application in real-world practice. #SCAI2021 Getty Images

Getty Images

News | Cath Lab | May 03, 2021
May 3, 2021 – Results from a new study find a broad range of patients who typically undergo revascularization for sta
New study demonstrates depression, HIV, mental health, obesity, alcohol and drug abuse are risk factors on most common type of heart disease in young black patients. Photo by Dave Fornell
News | Cath Lab | April 29, 2021
April 29, 2021 – A retrospective analysis of risk factors for coronary artery disease (CAD) in young African American
There are far fewer patients coming to hospitals with heart attacks during the COVID-19 pandemic as compared to averages prior to the pandemic. This has raised concerns that delayed treatment will cause an uptick in cardiac deaths and heart failure. Photo from Getty Images 

There are far fewer patients coming to hospitals with heart attacks during the COVID-19 pandemic as compared to averages prior to the pandemic. This has raised concerns that delayed treatment will cause an uptick in cardiac deaths and heart failure. Photo from Getty Images 

News | Cath Lab | April 28, 2021
April 28, 2021 – Results from a retrospective observational study, presented today at...
A cardiac cath lab at Henry Ford Hospital in Detroit. Photo by Dave Fornell

A cardiac cath lab complex PCI case at Henry Ford Hospital in Detroit. Photo by Dave Fornell

News | Cath Lab | April 28, 2021