Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions

Company partners with OrbusNeich as exclusive U.S. distributor of peripheral and coronary balloons, announces OEM agreement for CSI-branded Zilient guidewires

January 24, 2018 — Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is now the exclusive U.S. distributor of OrbusNeich balloon catheter products. Additionally, the company has signed an original equipment manufacturer (OEM) agreement with Integer Holdings Corp. for CSI-branded Zilient guidewires.

OrbusNeich has established balloon technologies in both percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) outside the United States. As the exclusive distributor of OrbusNeich balloon products in the United States, CSI will ultimately offer their full line of semi-compliant, non-compliant and specialty balloons for both coronary and peripheral vascular procedures. OrbusNeich PCI balloons include the Sapphire II Pro, which is currently on schedule this year to obtain U.S. Food and Drug Administration (FDA) clearance for what it calls the first and only 1mm coronary balloon to be available in the United States. Currently, CSI offers both the 1.5-4mm Sapphire II Pro and the 2-4mm Sapphire NC Plus coronary balloons. The company anticipates OrbusNeich’s full balloon product portfolio will become available throughout 2018 and 2019.

CSI has also contracted with Integer Holdings Corporation to produce CSI-branded Zilient guidewires. These guidewires are designed to provide tip resilience and crossability in challenging arterial lesions. CSI is currently offering guidewires to select accounts for use in peripheral interventions in the following sizes/configurations:

• .014-inch diameter with 4, 6, 12 and 30 gram tip stiffness, 300 cm length; and
• .018-inch diameter with 4, 6, 12 and 30 gram tip stiffness, 300 cm length

The broad market launch of the CSI-branded Zilient peripheral guidewires is expected to begin later in the current fiscal year. CSI anticipates that additional Zilient guidewires for coronary interventions and radial peripheral interventions will be available in the future.

For more information: www.csi360.com

BASILICA Procedure Prevents Coronary Obstruction From TAVR

NIH-developed technique helps allow transcatheter valve replacements to be 

used in more high-risk valve-in-valve patients

An illustration of the BASILICA procedure showing the leaflet of the original bioprosthetic valve sliced open to allow coronary blood flow after implantation of a TAVR valve. The new TAVR valve can push the leaflets of the bioprosthetic valve upwards, blocking the coronary arteries. During the BASILICA procedure, a catheter directs an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract (LVOT). After snare retrieval, the mid-shaft of the guidewire is electrified to lacerate the leaflet, and the the leaflet splays after TAVR permitting coronary flow.

A novel technique has proven successful in preventing coronary artery obstruction during transcatheter aortic valve replacement (TAVR), a rare but often fatal complication. Called Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA), the technique will increase treatment options for high-risk patients who need heart valve procedures. The findings by researchers at the National Institutes of Health (NIH) were published in the Journal of the American College of Cardiology: Cardiovascular Interventions June 12, 2019.[1]

For elderly or frail patients, TAVR offers an effective and less invasive alternative to open heart surgery. However, a small subset of these patients may develop coronary artery obstruction during the TAVR procedure. For more than half of these patients, this complication has been fatal.

During TAVR, the surgeon places a catheter inside the heart and uses a balloon to open a new valve inside the aortic valve. However, in some patients whose hearts have uncommon structures, such as unusually large valve leaflets or small aortic roots, the large leaflets block the flow of blood to the coronary arteries as the new valve’s scaffolding opens.

BASILICA was developed at the National, Heart, Lung, and Blood Institute (NHLBI), part of NIH, to offer a solution to the problem of coronary obstruction during TAVR and increase the safety of TAVR for this subset of patients. The interventional cardiologist weaves an electrified wire the size of a sewing thread through a catheter and uses it to split the original leaflet in two so that it cannot block the coronary artery once it has been pushed aside by the new transcatheter heart valve. The procedure can be used on both the native valve leaflet or bioprosthetic valve leaflets in valve-in-valve (VIV) procedures. 

Watch a VIDEO showing how the Basilica procedure is performed. 

After animal experiments proved promising, the researchers successfully performed the procedure on seven patients who qualified for compassionate use of the technique — then untested in humans — because no other care options were available.

The current research builds on the success of the first-in-human trial.[2] From February to July 2018, the BASILICA technique was evaluated in a multicenter early feasibility study, sponsored by NHLBI. It enrolled 30 gravely ill patients who were at high or extreme risk if undergoing surgery. According to the researchers, all patients survived the procedure and underwent a successful TAVR. BASILICA was successful in 93 percent of patients and was feasible in natural as well as prosthetic aortic valves. At the 30 days mark, there were no coronary artery obstructions, nor a need to repeat the procedure due to valve dysfunction. 

Every year, about 5 million people in the United States are diagnosed with heart valve disease, and more than 20,000 die, according to the American Heart Association (AHA). 

Robert J. Lederman, M.D., senior investigator, NIH, NHLBI Division of Intramural Research, and Jaffar M. Khan, M.D., staff clinician, NIH, NHLBI led the study. Other researchers also contributed substantially to this project, including Adam B. Greenbaum, M.D., and Vasilis C. Babaliaros, M.D., from Structural Heart and Valve Center, Emory University Hospital; and Toby Rogers, BM BCh, Ph.D., from Medstar Washington Hospital Center.

Reference:
1. J. M. Khan et al. The BASILICA Trial: Prospective Multi-center Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction. JACC: Cardiovascular Interventions. Volume 12, Issue 13, July 2019. First published online June 12, 2019. DOI: 10.1016/j.jcin.2019.03.035

2. Jaffar M.Khan, Danny Dvir, Adam B.Greenbaum, et al. Transcatheter laceration of aortic leaflets to prevent coronary obstruction during transcatheter aortic valve replacement: concept to first-in-human. JACC: Cardiovascular Interventions. Volume 11, Issue 7, 9 April 2018, Pages 677-689. DOI: https://doi.org/10.1016/j.jcin.2018.01.247

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  During the BASILICA procedure, a catheter directs an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract (LVOT). After snare retrieval, the mid-shaft of the guidewire is electrified to lacerate the leaflet, and the the leaflet splays after TAVR permitting coronary flow.

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  An illustration of the BASILICA procedure showing the leaflet of the original bioprosthetic valve sliced open to allow coronary blood flow after implantation of a TAVR valve. The new TAVR valve can push the leaflets of the bioprosthetic valve upwards, blocking the coronary arteries. 

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Innovations in Cardiology at Henry Ford Hospital

Detroit hospital is at the bleeding-edge of using new technology and techniques 

to improve patient outcomes

Khaldoon Alaswad, M.D., right, director, cardiac catheterization lab, during a complex CTO procedure at Henry Ford Hospital. (Photo by Dave Fornell)

Henry Ford Hospital thought leaders regularly speak at the cardiology conferences about new research and technology innovations. So, it was an honor when DAIC was invited to conduct a site visit at Henry Ford recently to tour its facilities, sit in on procedures and conduct numerous video interviews to better understand the workings of the institution. 

We spent two days at Henry Ford. We started at 5 a.m. and ended a nonstop day at 7 p.m. to get a taste of a day-in-the-life of Henry Ford staff. Some of the physicians we spoke with early in the morning were still hard at work on complex cases into the early evening. 

Henry Ford is known as a pioneer in structural heart interventions, including transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) and transcatheter repair, and left atrial appendage (LAA) occlusion. Several of its physicians are also well known experts in complex percutaneous coronary intervention (PCI), including chronic total occlusion (CTO) procedures. These procedures require a high level of advanced visualization, which Henry Ford has helped develop standards for and uses a large amount of both 3-D printing and 3-D computer modeling to assess patients, plan and guide procedures. In recent years, Henry Ford spearheaded the Detroit Cardiogenic Shock Initiative with several other Detroit area hospitals as an experiment to see if a change in hemodynamic support protocols could improve survival. It did, and that effort has now spread across the country as the National Cardiogenic Shock Initiative. DAIC spoke with the hospital's experts on all of these topics, and the video links can be found below. 

Top-ranked Structural Heart Program

Henry Ford Hospital has built a large, high-volume structural heart program that includes use of cutting-edge new technologies and devices. DAIC spoke with William O’Neill, M.D., director of the Henry Ford structural heart program, Ruth Fisher, MBA, vice president of the program, and Janet Wyman, NP, program manager, about the program in the VIDEO: Overview of the Henry Ford Hospital Structural Heart Program.

They also explained how Henry Ford has been able to build its program and work with hospitals throughout Michigan, including those with their own TAVR programs. They said building relationships with referral centers as partners and ensuring the patients go back to their local physicians for followups and regular care is key. They share their insights in the VIDEO: How to Get Referral Patients Into a Structural Heart Program.

Many patients who qualify for TAVR have anatomical issues with the femoral access route, usually caused by heavy calcium in the femoral and iliac arteries or in the aorta. To overcome this and avoid the need for a surgical cutdown for transapical access to the heart, Henry Ford developed the transcaval access technique. This involves catheter entry into the femoral vein, using an electrosurgical cutter to cross over into the aorta and continuing on to the heart to deliver the TAVR device. 

Hear more about the procedure in the VIDEO: Transcaval Access in TAVR Procedures, or in the article How to Perform Transcaval TAVR Access.

Watch a VIDEO walk through of the main Henry Ford structural heart cath lab.

View an interactive 360 degree photo of the main hybrid cath lab.

Transcatheter Mitral Valve Interventions

The next frontier in structural heart interventions is transcatheter mitral valve repair and replacement technologies. Henry Ford performs a large number of MitraClip procedures each year and uses new technologies in trials, including the Cardioband transcatheter annuloplasty system. 

Marvin Eng, M.D., structural fellowship director, and William O'Neill explain the procedures they perform in the VIDEO: Transcatheter Mitral Valve Interventions at Henry Ford Hospital.

The hospital also performs transcatheter valve-in-valve (VIV) mitral replacements using the Edward's Sapien TAVR valve. These are often done in patients who have been turned down for surgical mitral valve replacements because they are too frail. Henry Ford's Dee Dee Wang, M.D., director of structural heart imaging, has been a pioneer in this area of imaging. Since the Sapien was not designed for the mitral valve anatomy, it hangs down into the left ventricle and can block the left ventricular outflow track (LVOT). Wang said patient survival depends on keeping the the LVOT clear and uses 3-D imaging to predict what the neo-LVOT will look like and to mark proper landing zones to seat the valve prior to VIV or TMVR procedures. She explains what is required in the VIDEO: The Importance of the Neo-LVOT in Transcatheter Mitral Valve Replacement.

The center treats a lot of patients who have been turned down for procedures elsewhere because they were too sick and Henry Ford is a last resort. This has led the center attempting several innovative procedures that use existing off-the-shelf technologies, such as treating severe tricuspid regurgitation with Edwards Sapien valves placed in the vena cava. Here is a 360 degree image of Wang explaining this caval valve implantation (CAVI) procedure and the imaging that is required.  

Henry Ford's Complex PCI and CTO Program

Like its structural heart program, Henry Ford also gets a lot of referrals for very sick patients seeking a last resort treatment in its high risk percutaneous coronary intervention program (CHIP). Many of these are chronic total occlusions (CTOs) of the coronary arteries.  

DAIC spent time with CTO expert Khaldoon Alaswad, M.D., director, cardiac catheterization lab. In his office he flipped through patient case angiograms and read the images like a book, explaining each patient's story and how they tackled difficult situations they encountered in the lab. We also sat in on a CTO case with him. You can hear more about the program and Alaswad's suggestions for tackling CTOs, and see footage from his case in the VIDEO: How to Treat CTOs and Complex PCI Cases.

View a 360 degree photo of one of his CTO procedures.

State-of-the-Art Imaging and Dose Reduction Technology

As interventional cases become more complex, especially with longer and more involved CTO and structural heart procedures, Henry Ford Hospital looked for replacement angiography systems that could provide both improved image quality and reduce dose for both the cath lab staff and patients. Structural heart interventional also requires a transesophageal echo (TEE), and the hospital looked for a system that could integrate TEE with live fluoroscopy for better procedural guidance of devices. The hospital partnered with Philips Healthcare to provide both imaging systems, which includes the Azurion angiography system in its primary hybrid cath lab and the EchoNavigator that fuses live TEE with live fluoro imaging.

Nicolas Bevins, Ph.D., vice chair, physics and research, and Jessica Harrington, RCIS, explain the use of shields, technique and use of newer angiography technologies to reduce X-ray radiation dose in the cardiac cath labs during these longer procedures in the VIDEO: Reducing Cath Lab Radiation Dose at Henry Ford Hospital.

Akshay Khandelwal, M.D., director of medical operations at the Henry Ford Heart and Vascular Institute and associate professor of cardiology at Wayne State University, also explains how Henry Ford has reduced its X-ray radiation dose in the cardiac catheterization labs in the VIDEO: Technologies and Techniques to Reduce Radiation Dose in the Cardiac Cath Lab.

Leader in Reducing Cardiogenic Shock Mortality

Henry Ford Hospital helped spearhead the Detroit Cardiogenic Shock Initiative that morphed into the National Cardiogenic Shock Initiative (NCSI). By starting percutaneous hemodynamic support first before beginning revascularization on heart attack patients in cardiogenic shock, the initiative has seen a 50 percent increase in survival. 

The devastating heart attack complication affects about 5-8 percent of heart attack patients in the United States annually, but has a 50 percent mortality rate, which has remained unchanged for 40 years, O'Neill explained. He said the new protocol takes advantage of the Abiomed Impella system, a catheter-based ventricular assist device that provides forward blood flow from the heart to keep organs perfused until the coronary arteries can be reopened. 

The big increase in survival using the new NCSI protocol was presented at the 2018 TCT and AHA meetings by Babar Basir, D.O., and O'Neill. They discussed the results in the VIDEO: How to Reduce Cardiogenic Shock Mortality by 50 Percent.

O'Neill offers a great overview of the National Cardiogenic Shock Initiative in this VIDEO.

In terms of hemodynamic support for all patients, Henry Ford has adopted a "go big or go home" philosophy. The center opts for Impella, TandemHeart or extracorporeal membrane oxygenation (ECMO) rather than using intra-aortic balloon pumps (IABP), because if a patient needs support, it is better to given them a lot of support early on, said Michele Voeltz, M.D., fellowship program director, interventional cardiology. O'Neill and Voeltz offer a good overview in the VIDEO: Hemodynamic Support Protocols at Henry Ford Hospital.

Use of Advanced Imaging and 3-D Printing in Structural Procedures

Henry Ford Hospital was a pioneer in the use of a 3-D printing lab as part of its renowned structural heart program. “We get a lot of high-risk patients who are turned down by other institutions and because of our heart team and the transcatheter procedures we offer,” Wang said. Many patients referred to her center are too frail, old or sick to be surgical candidates and they come to Henry Ford as a last resort. For this reason, precision is important, so 3-D printing was adopted to review complex anatomies and new types of procedures. Henry Ford recently celebrated treating its 1,000th patient using 3-D printed hearts from the patient's CT scan to help plan and navigate in complex anatomy. 

“There is added value of 3-D printing during procedures, but what we quickly learned was that the real value of 3-D printed anatomy is in the physical shape,” Wang explained. However, she said it was not as impactful in adult structural heart disease or interventions as originally planned. She said the problem with 3-D models is that it freezes the motion of the heart in a static position. Since the physiology of the heart is constantly moving, a 3-D print cannot predict the exact impact of a procedure on the anatomy or function of the moving heart.

CT imaging can determine what device size to put into a patient, Wang said. “What we were missing is computer-aided design (CAD), because then you have the technology to see depth, angulation, diameters and anatomical constrains,” she explained. For this reason, Henry Ford has been an early adopter of the Mimics Innovation Suite CAD software from the 3-D printing vendor Materialise. This medical-grade software creates dynamic, virtual 3-D models where virtual devices can be placed to look at their impact on hemodynamics, or how the movement of the heart is impacted. 

Wang explains more in the VIDEO: Applications in Cardiology for 3-D Printing and Computer Aided Design.

(Editor's note - this article was originally published in May 2019 and was revised Oct. 1, 2019)

Find more news and video from Henry Ford Hospital.

Read about Henry Ford's radiation oncology and radiology innovations.

Edwards Sapien 3 TAVI Granted European Approval to Treat Low-risk Patients

TAVR cleared for low-risk patients in Europe with aortic stenosis using 

minimally invasive transcatheter valve

November 6, 2019 — Edwards Lifesciences announced it received European CE mark to expand use of the Edwards Sapien 3 transcatheter aortic valve replacement (TAVR) device for the treatment of patients diagnosed with aortic stenosis who are at low risk for open-heart surgery. The Edwards Sapien 3 valve is the first transcatheter aortic valve implantation (TAVI) system to have this indication in Europe.

"Now, all European patients diagnosed with aortic stenosis can be considered for TAVI with the Sapien 3 valve based on factors such as anatomical considerations or other individual needs rather than risk scores," said Prof. Helge Möllmann, director, Clinic for Internal Medicine (Cardiology) at St. Johannes Hospital, Dortmund, Germany. "This is particularly important for patients at low risk for surgery, whose only serious health issue may be aortic stenosis and who want to return to their lives more safely and quickly. Previously, their only treatment option was open-heart surgery, and this approval will expand access to the proven Sapieen 3 valve."

This indication expansion in Europe follows on the publication earlier this year of data from the pivotal PARTNER 3 trial, an independently evaluated, randomized clinical trial comparing outcomes between TAVI and open-heart surgery in patients with a low surgical risk. TAVI with the Sapien 3 system achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and re-hospitalization at one year. The data were published in the New England Journal of Medicine. 

An additional study examining quality of life in the PARTNER 3 patients, which was published online in the Journal of the American College of Cardiology,[1] demonstrated significant early and sustained advantages for low-risk patients treated with the Sapien 3 valve. When the treatment strategies of TAVI and surgery were compared for low-risk patients, the TAVI patients improved more rapidly than surgery patients. This study showed, for the first time, patients treated with the Sapien 3 valve experienced a better quality of life even one year after the procedure.

In August 2019, the U.S. Food and Drug Administration (FDA) also approved the Sapien 3 and the Medtronic CoreValve Evolut TAVR systems for use in low-risk patients in the United States. This move is widely seen as opening the floor gates for TAVR procedural volume. Several experts in the field predict TAVR will take over 75 percent of aortic valve replacement procedural volume by 2025 in the U.S., and reduce open-heart surgical volumes to about 25 percent for patients who do not qualify for TAVR for various reasons.

The Sapien TAVR valves are the most widely studied transcatheter valves, with more than 30,000 patients treated in clinical trials and registries in over 65 countries around the world.  Since the first commercial approval of the Sapien transcatheter valve in Europe in 2007, the Sapien family of valves have treated hundreds of thousands of patients worldwide. The more advanced Sapien 3 TAVI system, first approved in Europe in January 2014 for the treatment of high-risk patients and then expanded to intermediate-risk patients, builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards Sapien valves. While prior experience demonstrates that it takes some time for clinical practice to evolve, this new low-risk indication for the SAPIEN 3 valve in Europe should facilitate changes in clinical practice guidelines and reimbursement, to improve future access for patients.

For more information: www.edwards.com

Related TAVR Content:

FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology

VIDEO: The Expansion of TAVR Following the FDA Clearing its Use in All Patients — Interview with Torsten Vahl, M.D. at TCT 2019

Study Finds Sustained Benefit for TAVR vs. SAVR at One Year - Results from the PARTNER Quality of Life Substudy

Edwards Recalls Sapien 3 Ultra Delivery System Due to Burst Balloons During Surgery

VIDEO: Tracking Transcatheter Valve Outcomes in the STS-ACC TVT Registry — John Carroll, M.D.

TAVR Operator and Hospital Requirements Outlined in 2018 AATS/ACC/SCAI/STS Expert Consensus

Hospital Consolidation May Increase Access to TAVR, New Cardiac Technologies

VIDEO: TAVR for Degenerated Surgical Valves - Valve-in-Valve TAVR Procedures — Interview with Sammy Elmariah, M.D.

How to Perform Transcaval TAVR Access

Reference:

1. Suzanne J. Baron, Elizabeth A. Magnuson, Michael Lu, et al. Health Status after Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis. Journal of the American College of Cardiology. September 2019. DOI: 10.1016/j.jacc.2019.09.007.

Study Finds Sustained Benefit for TAVR vs. SAVR at One Year

A Sapien 3 TAVR valve in position as seen under GE Assist guidance on angiography.

October 4, 2019 – A new analysis of the PARTNER 3 Trial data found a modest, but significant, improvement in one-year disease-specific quality of life after transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic stenosis (AS). Findings were reported at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The results were also published simultaneously in the Journal of the American College of Cardiology.[1]

The randomized PARTNER 3 trial demonstrated that TAVR with the Sapien 3 valve resulted in lower rates of death, and re-hospitalization at one year compared with SAVR in patients with severe AS at low surgical risk. However, the effect of treatment strategy on early and late health-related quality of life in this population is unknown.

“This is the first randomized trial to demonstrate a persistent, albeit modest, disease-specific health status advantage with TAVR at six and 12 months – time points at which patients are assumed to have recovered fully from surgery,” said Suzanne J. Baron, M.D., MSc, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass. “Further studies are needed to evaluate the durability of health status benefits with TAVR compared with SAVR beyond one year in this low-risk population.”

The researchers compared health status at one, six and 12 months in low risk patients with severe AS treated with either TAVR or SAVR in the PARTNER 3 trial. The analysis found that over the one-year follow-up period, treatment with either TAVR or SAVR resulted in substantial improvements in both disease-specific and generic health status compared with baseline, despite most patients having only NYHA Class I or II symptoms at baseline. Consistent with previous studies of transfemoral TAVR, TAVR was associated with significantly better health status than SAVR at one month on all scales (mean difference in KCCQ-OS 16.0 points; p<0.001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at six and 12 months (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p<0.04 for both).

In analyses that incorporated both survival and change in health status together, TAVR also demonstrated a significant health status benefit compared with SAVR at all time points (p<0.05). 

Exploratory analyses demonstrated that the late health status benefits seen with TAVR were driven by a difference in the proportion of patients who experienced a large (i.e., ≥20 point) improvement in the KCCQ score. These benefits may be explained, in part, by differential rates of post-procedural complications between TAVR and SAVR.

The PARTNER 3 Quality of Life Substudy was funded by Edwards Lifesciences. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences. 

Find information on other late-breaking TCT trials

Reference:

1. Suzanne J. Baron, Elizabeth A. Magnuson, Michael Lu, et al. Health Status after Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis. Journal of the American College of Cardiology. September 2019. DOI: 10.1016/j.jacc.2019.09.007