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What is the Role of Noninvasive Diagnostic Fractional Flow Reserve (FFR) CT vs Invasive FFR for PCI?

Posted in Invasive FFR for PCI, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Noninvasive Diagnostic Fractional Flow Reserve (FFR) CT, tagged , on February 27, 2018| Leave a Comment »

What is the Role of Noninvasive Diagnostic Fractional Flow Reserve (FFR) CT vs Invasive FFR for PCI?

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/31/2019

During the AHRA presentation, Ali Westervelt cited a study published in the Journal of the American College of Cardiology indicating that questions about obstructive coronary artery disease (CAD) in six of 10 patients who might otherwise be sent for cardiac catheterization could be answered with FFRct.  During the presentation, Westervelt described a slide indicating that FFR-CT can dramatically reduce the need for cardiac catheterization.  Its use, she said, focuses  attention on patients most likely to test positively for CAD, as three of four patients sent to cardiac cath are found to have coronary artery disease.
The slide was based on research presented in the paper “1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease.” Westervelt and her colleague in the presentation, Curt Bush, noted that at one-year follow-up, no cardiac events were seen in 117 patients who had cardiac cath cancelled based on FFR-CT results.  Additionally, mean costs were 33 percent lower with FFRct versus  the usual care strategy — $8,127 compared with $12,145, respectively. The authors of the paper concluded that “selective FFR-CT was associated with equivalent clinical outcomes, quality of life, and lower costs, compared with usual care over one-year follow-up.”
FFR-CT has been proven to reduce unnecessary hospital admissions, according to Bush and Westervelt.  In their presentation, they cited research showing that FFRct provides the information that cardiologists need without the expense, time or patient inconvenience of tests done in the nuclear medicine or cardiac catheterization labs.
Despite the advantages of FFR-CT, however, only about 200 facilities in the United States perform this procedure, according to Westervelt, who speculated that the young age of the procedure and its reimbursement status may have been barriers to wider adoption. “It is only about a three-year-old technology and until recently was not reimbursable,” she said.
The Centers for Medicare and Medicaid Services (CMS) began paying for FFR-CT January 2018.  “I think there was just not a lot of interest because everybody is looking at their business plan,” said Westervelt, who is transitioning to a new job in which she expects to perform FFR-CT.
SOURCE

UPDATED on 7/17/2018

WATCH VIDEO – Interview with Patrick Serruys, MD, PhD, Prof. of Interventional Cardiology, Imperial College, London

VIDEO: Will CT-FFR Replace Diagnostic Angiograms?

VIDEOS | COMPUTED TOMOGRAPHY (CT) | JULY 17, 2018

An interview with Patrick Serruys, M.D., Ph.D., Imperial College London, principal investigator of the SYNTAX III Trial presented earlier this year as a late-breaker at EuroPCR. He presented the trial again at the Society of Cardiovascular Computed Tomography (SCCT) 2018 meeting.

Read the article “SYNTAX III Revolution Trial Shows CT-FFR Could Replace Cine-angiography in Coming Years.”

SOURCE

https://www.dicardiology.com/videos/video-will-ct-ffr-replace-diagnostic-angiograms-0

What is the Role of Noninvasive Diagnostic Fractional Flow Reserve (FFR) CT vs Invasive FFR for PCI?

02/27/2018

We know that FFRCT, the method of obtaining FFR from computed tomography angiographic (CTA) images, has been approved by Medicare and other third-party payers. It is used before patients come to the cath lab. The use of FFRCT in the PLATFORM study1reduced the number of unnecessary cardiac caths that had normal coronary angiography, while maintaining the same number of patients needing PCI.  Before discussing the role of angio-derived FFR, let’s review how FFRCT is obtained (Figure 1). Starting with any good quality CTA, the images are sent, offline, to HeartFlow Inc.2 To derive the FFR, the CTA images are reconstructed into a 3-dimensional coronary tree, segmenting it into individual points with each point undergoing processing by specialized equations (i.e., Navier-Stokes equations) to compute pressure loss along the course of the artery at rest and again during an assumed hyperemic state. These computational fluid dynamic equations require several assumptions from a population model regarding the myocardial blood flow rates as a function of the myocardial arterial branches and the resistance of the myocardium. These values are put into the computational flow dynamics (CFD) model, and using high-power computers, the FFR is generated along the entire course of each vessel. FFRCT has been validated against invasive FFR and found to be about 80% correlative in several studies.3,4 FFRCT has better correlation with FFR than most stress tests, and based on clinical outcome data, will likely replace traditional stress testing, with a reduction in procedures in patients without significant coronary disease. However, there are some operators who may be confused, thinking that FFRCT will replace invasive FFR. FFRCT screens for important coronary artery disease (CAD) before the patient comes to the cath lab, and then once in the lab, the operators can confirm lesion significance with FFR.

Noninvasive FFR Derived From Angiography: Wireless FFR in the Lab?

Wouldn’t it be great to get the FFR from the angiogram without having to put in a guidewire? This is in our near future. The generation of a “virtual” FFR derived from angiography or other modalities (Table 1A-B, Figures 2-4) has been proposed using computational flow dynamics (CFD) or rapid flow analysis to obtain wireless image-based FFR, incorporated into the diagnostic angiography workflow. As one might expect, online implementation of angio-derived FFR requires novel concepts and systems to reduce computation time and make the analysis process acceptable to in-lab functions. Early data shows that angio-derived FFR can be obtained within several minutes during a regular coronary angiogram.5

Angio-FFR Validation StudiesTwo contenders for introduction to the cath labs in the near future are QFR and FFRangio. QFR (Quantitative Flow Ratio, Medis Medical Imaging Systems) validation was reported in the FAVOR II China study, which reported the vessel-level diagnostic accuracy of QFR in identifying hemodynamically-significant coronary stenosis was 97.7% and patient-level diagnostic accuracy was 92.4% (P<0.001 for both).6 In addition, the FAVOR II Europe-Japan trial demonstrated that QFR had superior sensitivity and specificity in comparison to 2-D QCA with FFR as the gold standard: 88% vs 46% and 88% vs 77% (P<0.001 for both). The overall diagnostic accuracy of QFR was 88%.7 For FFRangio (CathWorks), the sensitivity, specificity, and diagnostic accuracy of FFRangio were 88%, 95%, and 93%, respectively.5 The strong concordance with invasive, wire-based FFR will likely make these methods widely available, but of course, early favorable results require confirmation. Once confirmed in larger studies and for a wider spectrum of coronary lesions, angio-derived FFR should become a routine part of diagnostic angiography.

Accuracy in computing noninvasive FFR is based on the implementation of complex computational methods that can differ among the various competing methods. In contrast to FFRCT, which creates a complete and detailed 3D model of the coronary tree from CTA scans, Tu et al8 constructed vessel geometry from routine angiography, applying a simpler model for flow, derived from the division of coronary branches (as opposed to using an estimate of flow from myocardial mass)2, and an approximate algebraic computational method from experimental studies of flow through single arterial stenosis models8 (as opposed to CFD equations) to solve for pressure drop and FFR (Figure 5). Because Tu et al8 do not employ the complicated Navier-Stokes equations, the computational time is almost instantaneous once the geometry is segmented into “sub segments” from the 3D rendering. Pellicano et al5 constructed 3D artery geometry from routing angiography alone, applying rapid flow analysis where all stenoses are converted into resistances in a lumped model, while scaling laws (of branches) are used to estimate the microcirculatory bed resistance.

Competition for a winning method of angiographically-derived FFR is underway, with different companies using different models and different assumptions regarding flow and resistance inputs (Table 1A-B). An example is QFR that uses several assumptions related to flow variables. fQFR is specified hyperemic inflow, assuming a fixed inflow velocity of 0.35 m/s. cQFR is “virtual” hyperemic flow, determined from a model based on TIMI [Thrombolysis In Myocardial Infarction] frame count, relating measured flow under baseline conditions to hyperemic flow. Lastly, aQFR is the variable of directly measured hyperemic flow. From these assumptions, QFR gives highly comparable results to invasive FFR.

Advantages of Angio-Derived FFR

The in-lab computations of angio-derived FFR are fast and have the potential to provide wireless FFR lesion assessment to every angiographic procedure. Other advantages of angio-derived FFR are obvious. There is no need to insert a pressure guidewire. Pharmacologic hyperemia is not necessary. It is nearly operator independent. The angio-derived FFR is also co-registered on the angiogram with accurate and reproducible results. In addition, 3D reconstruction of the coronary tree can enhance the identification of reference vessel diameters for selection of stent sizing, and ultimately predict anatomic and physiological outcomes.5

Limitations of Angio-Derived FFR 

The image acquisition requirements and the user interface of an image-based FFR system should be seamlessly incorporated into the standard work of the catheterization laboratory. Data acquisition should minimally disrupt routine angiography. Angio-derived FFR should only require the acquisition of 2 to 3 conventional radiographic projections in which the lesions can be clearly seen. It is important to visualize the entire coronary tree on the screen and to optimize vessel opacification. Poor images or overlapped segments will limit the accuracy of angio-derived FFR. The image acquisition angles needed for angio-derived FFR are the same as those used for routine procedures. High resolution imaging at >10 frames/sec are needed.5

On the technical side, coronary microvascular resistance (CMV) is a fundamental assumption to compute pressure from flow. CMV in one study was derived from invasive measurements, something which will limit future acceptance.9 As the data sets are accumulated, it is hoped that invasive CMV will not be needed. One angio-derived FFR method, vFFR9,10, requires rotational angiography, which is not yet widely available, and may produce asymmetric coronary segmentations — a concern for accurate analysis.

Finally, the amount of time required to acquire and process the data to produce angio-derived FFR is likely to be longer than the 3-minute computation time. Acquisition time should realistically include the time to overcome the difficulties of imaging complex anatomy, eliminate artifacts, upload the study for CFD analysis, and create the volumetric mesh. Furthermore, there will probably be patient-specific errors related to abnormal coronary physiology which may account for outliers in the correlations between angiography-derived and invasive FFR measurements.11

Angio-derived FFR is currently reported for off-line results, but, recently, online applications have also been presented. Minimal operator interaction is necessary in the flow calculation process, which results in low inter-operator variability.

The Bottom Line

When FFRCT and angio-derived FFR technology ultimately become more widely available, they will radically change the way diagnostic angiography is performed in the same way that invasive FFR changed the way we approach patients needing PCI. 

References

  1. Douglas PS, De Bruyne B, Pontone G, et al. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study.  J Am Coll Cardiol. 2016 Aug 2; 68(5): 435-445. doi: 10.1016/j.jacc.2016.05.057.
  2. Taylor CA, Fonte TA, Min JK. Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of fractional flow reserve: scientific basis. J Am Coll Cardiol. 2013; 61(22): 2233-2241.
  3. Norgaard BL, Leipsic J, Gaur S, et al. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease. J Am Coll Cardiol. 2014; 63: 1145-1155.
  4. Min JK, Leipsic J, Pencina MJ, et al. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012; 308: 1237-1234.
  5. Pellicano M, Lavi I, Bruyne B, et al. Validation study of image-based fractional flow reserve during coronary angiography. Circ Cardiovasc Interv. 2017; 10: e005259. doi: 10.1161/CIRCINTERVENTIONS.116.005259.
  6. Xu B, Tu S, Qiao S, et al. Diagnostic accuracy of angiography-based quantitative flow ratio measurements for online assessment of coronary stenosis. J Am Coll Cardiol. 2017 Dec 26; 70(25): 3077-3087. doi: 10.1016/j.jacc.2017.10.035.
  7. Westra J. Late-Breaking Clinical Trials 2. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver, Colorado.
  8. Tu S, Westra J, Yang J, et al. Diagnostic accuracy of fast computational approaches to derive fractional flow reserve from diagnostic coronary angiography: the international multicenter FAVOR pilot study. J Am Coll Cardiol Intv. 2016; 9: 2024-2035.
  9. Morris PD, van de Vosse FN, Lawford PV, et al. “Virtual” (computed) fractional flow reserve: current challenges and limitations. JACC Cardiovasc Interv. 2015; 8: 1009-1017. doi: 10.1016/j.jcin.2015.04.006.
  10. Morris PD, Ryan D, Morton AC, et al. Virtual fractional flow reserve from coronary angiography: modeling the significance of coronary lesions: results from the VIRTU-1 (VIRTUal Fractional Flow Reserve From Coronary Angiography) study. JACC Cardiovasc Interv. 2013; 6: 149-157. doi: 10.1016/j.jcin.2012.08.024.
  11. Papafaklis MI, Muramatsu T, Ishibashi Y, et al. Fast virtual functional assessment of intermediate coronary lesions using routine angiographic data and blood flow simulation in humans: comparison with pressure wire – fractional flow reserve. EuroIntervention. 2014; 10: 574-583. doi: 10.4244/EIJY14M07_01
  12. Tu S, Barbato E, Köszegi Z, et al. Fractional flow reserve calculation from 3-dimensional quantitative coronary angiography and TIMI frame count: a fast computer model to quantify the functional significance of moderately obstructed coronary arteries. JACC Cardiovasc Interv. 2014 Jul; 7(7): 768-777. doi: 10.1016/j.jcin.2014.03.004.

Disclosure: Dr. Kern is a consultant for Abiomed, Merit Medical, Abbott Vascular, Philips Volcano, ACIST Medical, Opsens Inc., and Heartflow Inc. 

SOURCE

https://www.cathlabdigest.com/article/Noninvasive-Angiographic-Derived-FFR-Wireless-Physiology-Coming-Your-Cath-Lab-Soon

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Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

Posted in endovascular thrombectomy, Frontiers in Cardiology and Cardiovascular Disorders, Stent Retriever in endovascular thrombectomy, Stroke on February 27, 2018| Leave a Comment »

Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

Reporter: Aviva Lev-Ari, PhD, RN

 

The stent retriever from Stryker was cleared for thrombectomy-eligible patients as initial therapy to reduce paralysis and other stroke disability only as an addition to tissue plasminogen activator (tPA). Previously, the device was approved only for use within 6 hours of ischemic stroke onset.

 

FDA Clears Trevo Stent Retriever for Up to 24 Hours Post-Stroke

FDA move follows expanded stroke thrombectomy guidelines

by Nicole Lou, Reporter, MedPage Today/CRTonline.org

“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, in a statement. “Healthcare providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”

The American Heart Association and American Stroke Association recently revised their guidelines to recommend stent retriever use up to 24 hours after symptom onset. This was announced at the International Stroke Conference in January, where the DEFUSE 3 trial added to the evidence from DAWN in demonstrating benefits to relatively late endovascular thrombectomy.

In particular, DAWN data were used to support the FDA’s latest decision. Trial investigators had reported more functional independence when patients were randomized to Trevo thrombectomy over medical management alone.

SOURCE

https://www.medpagetoday.com/cardiology/strokes/71183

 

FDA expands treatment window for use of clot retrieval devices in certain stroke patients

For Immediate Release

February 15, 2018

Summary

FDA expands treatment window for use of clot retrieval devices in certain stroke patients

Release

The U.S. Food and Drug Administration today cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients. This device is cleared for use as an initial therapy for strokes due to blood clots (also known as an acute ischemic stroke) to reduce paralysis, speech difficulties and other stroke disabilities and only as an addition to treatment with a medication that dissolves blood blots called tissue plasminogen activator (t-PA). The device was previously cleared for use in patients six hours after symptom onset.

“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, Ph.D., director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”

A stroke is a serious medical condition that requires emergency care and can cause lasting brain damage, long-term disability or even death. According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the U.S. and is a major cause of serious disability for adults. About 795,000 people in the U.S. have a stroke each year. Ischemic strokes represent about 87 percent of all strokes.

The Trevo device was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy. In 2016, the FDA allowed expanded marketing of the device for certain patients in addition to treatment with t-PA if used within six hours of the onset of symptoms. Today’s expanded indication increases the amount of time that the device can be used once the symptoms are present.

Trevo is a clot removal device that is inserted through a catheter up into the blood vessel to the site of the blood clot. When the shaped section at the end of the device is fully expanded (up to three to six millimeters in diameter), it grips the clot, allowing the physician to retrieve the clot by pulling it back through the blood vessel along with the device for removal through a catheter or sheath.

The FDA evaluated data from a clinical trial comparing 107 patients treated with the Trevo device and medical management to 99 patients who had only medical management. About 48 percent of patients treated with the Trevo device were functionally independent (ranging from no symptoms to slight disability) three months after their stroke compared to 13 percent of patients who were not treated with the Trevo device.

Risks associated with using the Trevo device include a failure to retrieve the blood clot, embolization (blockage) to new territories in the brain, arterial dissections and vascular perforations, and access site complications at the femoral (thigh) artery entry point.

Trevo was reviewed through the premarket notification (510(k)) pathway. A 510(k) is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The FDA granted premarket clearance of the Trevo device to Concentric Medical Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596983.htm

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FDA Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

Posted in Cardiac and Cardiovascular Surgical Procedures, Coagulation Therapy and Internal Bleeding, PCI, Peripheral Arterial Disease & Peripheral Vascular Surgery on January 24, 2018| Leave a Comment »

FDA Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

Reporter: Aviva Lev-Ari, PhD, RN

 

Baxter Announces FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin

Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

https://www.dicardiology.com/product/baxter-announces-fda-approval-ready-use-cardiovascular-medication-bivalirudin?eid=333021707&bid=1983307

Dosing and Uses

https://reference.medscape.com/drug/angiomax-angiox-bivalirudin-342137

 

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Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

Posted in Cardiac and Cardiovascular Surgical Procedures, PCI, Peripheral Arterial Disease & Peripheral Vascular Surgery on June 28, 2017| Leave a Comment »

Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

Reporter and Curator: Aviva Lev-Ari, PhD, RN

 

 

BUSINESS NEWS | Wed Jun 28, 2017 | 10:53am BST

Philips to buy medical device maker Spectranetics for 1.9 billion euros

By Toby Sterling | AMSTERDAM

Dutch healthcare company Philips (PHG.AS) has agreed to buy U.S.-based Spectranetics Corp (SPNC.O), a maker of devices to treat heart disease, for 1.9 billion euros (£1.68 billion) including debt, as it expands its image-guided therapy business.

Spectranetics uses techniques including lasers and tiny drug-covered balloons to clean the insides of veins and arteries that have become clogged due to heart disease.

Philips will pay Spectranetics shareholders $38.50 per share, a 27 percent premium to their closing price on June 27.

Philips Chief Executive Frans van Houten has transformed the former conglomerate into a focused maker of healthcare equipment over the past five years, spinning off its lighting division (LIGHT.AS) and selling most of its remaining consumer products business.

Philips said Spectranetics, which expects sales of around $300 million this year, will continue to grow revenues at double-digit rates and will begin adding to Philips’ earnings in 2018.

SOURCE

http://uk.reuters.com/article/uk-spectranetics-m-a-philips-idUKKBN19J0MZ?em_pos=small&ref=headline&nl_art=1

Home / About Spectranetics / Overview

http://www.spectranetics.com/about/overview/

Spectranetics’ History – 30 years of Innovations and M&A

http://www.spectranetics.com/about/history/

Products

Coronary Intervention

Coronary Artery Disease (CAD) is the leading cause of death among men and women. Each year, one in four deaths are attributed to CAD in the United States, accounting for over a half million lives lost. From scoring balloon technology to laser atherectomy to thrombus aspiration and removal, Spectranetics offers a comprehensive portfolio of solutions to cross, prep and treat compromised vessels. Learn more about CAD by navigating through the tile grid below and exploring the products that are saving lives.

SOURCE

http://www.spectranetics.com/solutions/coronary-intervention/

 

 Peripheral Intervention

Spectranetics is dedicated to helping physicians cross, prep and treat complex clinical challenges of Peripheral Artery Disease, such as Critical Limb Ischemia, Chronic Total Occlusions and In-Stent Restenosis. We provide expert tools, training, ongoing support and patient education so that you can help eradicate restenosis, and amputation and modify all plaque. Explore the tile grid below to learn more about Peripheral Artery Disease and Spectranetics’ comprehensive portfolio of products to successfully treat this challenging cardiovascular condition at every stage.

Products

 SOURCE

Lead Management

Managing cardiac implantable electronic device (CIED) leads has never been more important. Patients with CIEDs are on a lifelong journey, and Spectranetics is there to make sure it’s a healthy one. Making the right decision at the right time, for every patient, is critical. Lives depend on it. Explore the tile grid below to learn more about Lead Management and the products that ensure lead extraction is done safely, responsibly and predictably.

Other related articles published in this Open Access Online Scientific Journal include the following:

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Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Posted in Cardiac and Cardiovascular Surgical Procedures, Interviews with Scientific Leaders, Mitral Valve: Repair and Replacement, PCI on May 17, 2017| Leave a Comment »

Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #235: Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17. Published on 5/17/2017

WordCloud Image Produced by Adam Tubman

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017  BOSTON, MA • UNITED STATES

11:45 am – 12:45 pm
Boston Scientific Ballroom
Disruptive Dozen: 12 Technologies that will reinvent Cardiovascular Care
Moderator: Calum MacRae, MD, PhD
  • Chief of Cardiovascular Medicine, Brigham and Women’s Hospital
  • Associate Professor of Medicine, Harvard Medical School
Anthony Rosenzweig, MD
  • Chief, Cardiology Division, Massachusetts General Hospital
  • Professor of Medicine, Harvard Medical School

12. Aging and Heart Disease: Can we reverse the process?

11.Nanotechnologies for Cardiac Diagnosis and Treatment

10. Breaking the Code: Diagnosis and Therapeutic Potential of RNA

9. Expanding the Pool of Organs for Transplant

8. Finding Cancer therapies without Cardiotoxicity

7. Less is more: Minimalist Mitral Valve Repair

6. Understanding Why exercise works for Just about every thing

5. Power Play: The Future of Implantable Cardiac Devices

4. Adopting the Orphan of Heart Disease

3. Targeting Inflammation in cardiovascular Disease

2. Harnessing Big Data and Deep Learning for Clinical Decision Support

  1. Quantitative Molecular Imaging for Cardiovascular Phynotypes

SOURCE

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

Excerpts from Prem S. Shekar, MD Presentation

The success achieved with TAVR

  1. least traumatic
  2. short recovery
  3. quicker return to normal lifestyle

encouraged Medical devices Manufacturers to develop Mitral Valve Repair technologies to address the large unmet need for percutaneous treatment of patients with Mitral Valve disease:

Mild or Severe (4 Million in the US, alone).

  • Mitral Regurgitation (MR) – imperfect closure of the valve permits blood from LV to return back towards the lungs.

Causes for MR

  1. the degenerative myxomatous disease
  2. senile calcific degenerative disease causing enlargement of the LV, infection or Trauma.
  • Mitral stenosis – narrowing of the valve

Causes for Mitral Stenosis

  1. rheumatic fever
  2. senile calcific degeneration – obstruction to the forward flow of blood resulting in increased fluid pressure inside the lungs.

Symptoms of MR – managed by drugs or Surgery for correction (Open Heart surgery or MIS – both procedures require use of bypass machine, the heart been stopped for the duration of repair/replacement) for Valve Repair or Valve Replacement

  1. shortness of breath
  2. fatigue

Uncorrected Mitral Valve disease can lead to 

  1. irregular heart rhythms
  2. increased risk for stroke
  3. CHF
  4. Death

Transcatheter Mitral Valve Correction

  1. Valve replacement
  2. use of Repair devices on the Mitral leaflets
  3. implantation of neochords
  4. remodeling of the mitral annulus

Comparison of TARV with Transcatheter Mitral Valve Correction

  1. Aortic Valve vs Mitral Valve: difference in complexity and artistic nature of Mitral repair
  2. Ability to perform a Percutaneous repair on a Mitral Valve with same degree of accuracy and reproducibility as a Percutaneous repair on an Aortic Valve — will remain a challenge.
  3. development of advance imaging technologies will play a key role in achieveing success with Percutaneous repair on a Mitral Valve
  4. Percutaneous repair on a Mitral Valve need to overcome the complex structure and integrated relationship with the LV.

Leading Challenges in the Development of Percutaneous repair on a Mitral Valve Technologies

  1. Mitral is a bigger Valve than the Aortic
  2. It is more difficult to access
  3. It is Asymmetrical
  4. It lacks an anatomically well-defined annulus to which to anchor the artificial valve
  5. Its geometry changes throughout the cardiac cycle
  6. Placement of a replacement valve bears the risk of LV outflow tract obstruction

Patient Candidate Profile forPercutaneous repair on a Mitral Valve

  1. Patient with a failed Mitral Valve bioprosthesis – Severe Mitral Valve Disease
  2. Failed Mitral Valve Repairs
  3. Senile calcific degeneration
  4. Mitral Regurgitation unmanaged by medication
  5. Variable surgical risk related to co-morbidities

Other related articles on Mirtal Valve Disease covered in this Open Access Online Scientific Journal Include the following:

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Cardiovascular Medical Devices: Cardiac Surgery, Cardiothoracic Surgical Procedures and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty – 248 articles

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure? – Last Updated on 4/8/2017

Justin Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

Lev-Ari, A. 5/19/2014. Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover Transcatheter Mitral Valve Repair (TMVR)

Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover transcatheter mitral valve repair (TMVR)

 

Lev-Ari, A. 1/26/2014. Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents

https://pharmaceuticalintelligence.com/2014/01/26/transcatheter-valve-competition-in-the-united-states-medtronic-corevalve-infringes-on-edwards-lifesciences-corp-transcatheter-device-patents/

 

Lev-Ari, A. 1/26/2014. Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

https://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

 

Larry H. Bernstein and
Aviva Lev-Ari 6/23/2013 Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

https://pharmaceuticalintelligence.com/2013/06/23/comparison-of-cardiothoracic-bypass-and-percutaneous-interventional-catheterization-survivals/

 

Larry H Bernstein and Lev-Ari, A. 6/23/2013 First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices.

https://pharmaceuticalintelligence.com/2013/06/23/valve-in-valve-replacements-with-transapical-transcatheter-implants/

Larry H Bernstein and  Lev-Ari, A. 6/17/2013 Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

https://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/


Larry H Bernstein and Lev-Ari, A. 6/17/2013 Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

https://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/


Larry H Bernstein and Lev-Ari, A. 6/18/2013 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock

https://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-of-intractable-cardiogenic-shock/

Larry H Bernstein and Lev-Ari, A.6/20/2013 Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure

https://pharmaceuticalintelligence.com/2013/06/20/phrenic-nerve-stimulation-in-patients-with-cheyne-stokes-respiration-and-congestive-heart-failure/

Lev-Ari, A. 2/12/2013 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

https://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

Lev-Ari, A. 12/31/2012 Renal Sympathetic Denervation: Updates on the State of Medicine

https://pharmaceuticalintelligence.com/2012/12/31/renal-sympathetic-denervation-updates-on-the-state-of-medicine/

Lev-Ari, A. 9/2/2012 Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

https://pharmaceuticalintelligence.com/2012/09/02/imbalance-of-autonomic-tone-the-promise-of-intravascular-stimulation-of-autonomics/

Lev-Ari, A. 8/13/2012Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stentshttps://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

Lev-Ari, A. 7/18/2012Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

https://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

Lev-Ari, A. 6/13/2012Treatment of Refractory Hypertension via Percutaneous Renal Denervation

https://pharmaceuticalintelligence.com/2012/06/13/treatment-of-refractory-hypertension-via-percutaneous-renal-denervation/

Lev-Ari, A. 6/22/2012Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

https://pharmaceuticalintelligence.com/2012/06/22/competition-in-the-ecosystem-of-medical-devices-in-cardiac-and-vascular-repair-heart-valves-stents-catheterization-tools-and-kits-for-open-heart-and-minimally-invasive-surgery-mis/

Lev-Ari, A. 6/19/2012Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

https://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

Lev-Ari, A. 6/22/2012Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders)in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

https://pharmaceuticalintelligence.com/2012/06/22/global-supplier-strategy-for-market-penetration-partnership-options-niche-suppliers-vs-national-leaders-in-the-massachusetts-cardiology-vascular-surgery-tools-and-devices-market-for-car/

Lev-Ari, A. 7/23/2012Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

https://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-symphony/

Lev-Ari, A. (2006b). First-In-Man Stent Implantation Clinical Trials & Medical Ethical Dilemmas. Bouve College of Health Sciences, Northeastern University, Boston, MA 02115

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Tommy King Memorial Cardiovascular Symposium, St. Elizabeth’s Medical Center, Boston, May 20, 2017

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cancer Surgery of the Heart, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools, Valves & Tools, tagged on April 24, 2017| Leave a Comment »

Tommy King Memorial Cardiovascular Symposium

Reporter: Aviva Lev-Ari, PhD, RN

 

Saturday CEUs in Boston, May 20, 2017

St. Elizabeth’s Medical Center

Boston, MA

May 20

7:30am – 3pm

PROGRAM SCHEDULE & SESSIONS

07:30am | Registration & Continental Breakfast

08:00am | Hemodynamics; Faisal Khan, MD, St. Elizabeth’s Medical Center

09:00am | Radiation Protection; Satish Nair, PhD, F.X. Masse Associates

10:00am | Break & Exhibits

10:15am | Structural Heart – TAVR Updates and Watchman

Joseph Carrozza, MD, St. Elizabeth’s Medical Center

11:15am | Road to the Cath Lab — Triggers for STEMI Activation 

Lawrence Garcia, MD, St. Elizabeth’s Medical Center

12:15pm | Lunch

01:00pm | HF Program including Cardiomems

Lana Tsao, MD & Jaclyn Mayer, NP, St. Elizabeth’s Medical Center

02:00pm | Cath Lab Pharmacology

Mirembe Reed, Pharm.D, St. Elizabeth’s Medical Center

Register now »

SOURCE

From: <acvp@getresponse.com> on behalf of “Kurt, ACVP” <kurt@acp-online.org>

Reply-To: <kurt@acp-online.org>

Date: Monday, April 24, 2017 at 2:26 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: cardiovascular symposium in Boston, May 20

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ACC 2017, 3/30/2017 – Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries

Posted in Bioresorbable Vascular Scaffold (BVS), Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, PCI, Stents & Tools on April 2, 2017| Leave a Comment »

ACC 2017, 3/30/2017 – Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries

Reporter: Aviva Lev-Ari, PhD, RN

 

WATCH VIDEO:

Bioresorbable Stent Comparable to Xience at Two Years, With Concerns

 

Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses the two year outcomes of the ABSORB III trial of Absorb vs. Xience. The late-breaking trial was presented at ACC 2017. Read the article on the ABSORB III results.  Watch a VIDEO with Gregg Stone, M.D., “Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries.”

 

SOURCE

https://www.dicardiology.com/videos/video-bioresorbable-stent-comparable-xience-two-years-concerns

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Edwards Lifesciences closes $690m a buy of Valtech Cardio and most of the heart valve repair technologies it’s developing

Posted in Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, PCI, tagged on January 25, 2017| Leave a Comment »

Edwards Lifesciences closes $690m a buy of Valtech Cardio and most of the heart valve repair technologies it’s developing

Reporter: Aviva Lev-Ari, PhD, RN

 

Valtech’s  Cardioband device is designed to reshape the mitral valve using specially designed anchors, aka 

transcatheter structural heart disease technologies.

Valtech won CE Mark approval in the European Union for Cardioband in September 2015 but the device is not approved for the U.S. market.

Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August.)

 

Deal Terms:

The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

SOURCE

http://www.massdevice.com/edwards-lifesciences-closes-690m-valtech-cardio-buy/?utm_source=newsletter-170124&utm_medium=email&utm_campaign=newsletter-170124&spMailingID=10291384&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1081981757&spReportId=MTA4MTk4MTc1NwS2

Edwards Lifesciences closes $690m Valtech Cardio buy

JANUARY 24, 2017 BY

EDWARDS LIFESCIENCES COMPLETES ACQUISITION OF VALTECH CARDIO
IRVINE, Calif., Jan. 23, 2017 – Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has closed its acquisition of Valtech Cardio Ltd., a privately held company based in Israel and developer of the Cardioband System for transcatheter repair of the mitral and tricuspid valves. Edwards announced in November that it had signed an agreement to acquire Valtech.
Under the terms of the merger agreement, Edwards paid $340 million in stock and cash for Valtech at closing, subject to typical adjustments. In addition, there is the potential for up to $350 million in pre-specified milestone-driven payments over the next 10 years. Edwards’ financial guidance provided at its Investor Conference in December incorporated the expected financial impact of the transaction in 2017.
“We look forward to the Valtech team joining Edwards. We believe their knowledge, experience and the Cardioband technology are valuable additions to Edwards,” said Michael A. Mussallem, Edwards’ chairman and CEO. “This therapy has the potential to be a breakthrough structural heart therapy to help many patients in desperate need, and we look forward to gaining valuable insights from its commercial use in Europe.”
The Cardioband System is not approved for sale in the United States. The mitral application of the Cardioband System has received CE Mark in Europe.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit http://www.edwards.com and follow us on Twitter @EdwardsLifesci.
SOURCE

 

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Advanced Peripheral Artery Disease (PAD): Axillary Artery PCI for Insertion and Removal of Impella Device

Posted in Assist Devices: LV, Atherogenic Processes & Pathology, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Mechanical Assist Devices: LVAD, PCI, Peripheral Arterial Disease & Peripheral Vascular Surgery on December 13, 2016| Leave a Comment »

Advanced Peripheral Artery Disease (PAD): Axillary Artery PCI for Insertion and Removal of Impella Device

Reporter: Aviva Lev-Ari, PhD, RN

 

 

TOTALLY PERCUTANEOUS INSERTION AND REMOVAL OF IMPELLA DEVICE USING AXILLARY ARTERY IN THE SETTING OF ADVANCED PERIPHERAL ARTERY DISEASE

July 15, 2016
Authors:

Rajiv Tayal, MD, MPH1,2;  Mihir Barvalia, MD, MHA1;  Zeshan Rana, MD2;  Benjamin LeSar, MD1;  Humayun Iftikhar, MD1;  Spas Kotev, MD1;  Marc Cohen, MD1;  Najam Wasty, MD1

Abstract: Traditionally, brachial and common femoral arteries have served as access sites of choice, with many operators recently converting to radial artery access for coronary angiography and percutaneous intervention due to literature suggesting reduced bleeding risk, better patient outcomes, and lower hospital-associated costs. However, radial access has limitations when percutaneous procedures requiring larger sheath sizes are performed. Six Fr sheaths are considered the limit for safe use with the radial artery given that the typical luminal diameter of the vessel is approximately 2 mm, while peripheral artery disease (PAD) may often limit use of the common femoral artery, particularly in patients with multiple co-morbid risk factors. Similarly, the brachial artery has fallen out of favor due to both thrombotic and bleeding risks, while also not safely and reliably accommodating sheaths larger than 7 Fr. Here we describe 3 cases of a new entirely percutaneous technique utilizing the axillary artery for delivery of Impella 2.5 (13.5 Fr) and CP (14 Fr) cardiac-assist devices for protected percutaneous coronary intervention in the setting of prohibitive PAD.

J INVASIVE CARDIOL 2016;28(9):374-380. 2016 July 15 (Epub ahead of print)

Key words: axillary artery, percutaneous access, high-risk PCI

 

SOURCE

http://amptheclimeeting.com/ampcentral/articles/totally-percutaneous-insertion-and-removal-impella-device-using-axillary-artery-setting

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CorPath robotic system for bifurcation lesions with placement of the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) (Abbott Vascular)

Posted in Bioresorbable Vascular Scaffold (BVS), Cardiac and Cardiovascular Surgical Procedures, Robotic-assisted percutaneous coronary intervention on December 7, 2016| Leave a Comment »

CorPath robotic system for bifurcation lesions with placement of the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) (Abbott Vascular)

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 4/8/2017

BVS Stent Pulled From European Market – Bioresorbable stent will still be available in a clinical registry setting

by Larry Husten, CardioBrief, April 06, 2017

Abbott Laboratories sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.”

The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from the ABSORB II trial uncovered a significantly higher rate of target vessel MI. More recently, 2-year results from the pivotal ABSORB III trial confirmed those findings, showing a significant increase in target lesion failure. At the same time the FDA said that it was investigating the stent.

http://www.medpagetoday.com/cardiology/cardiobrief/64391

 

 

Robotic Radial Bifurcation Bioresorbable Vascular Scaffold (BVS) PCI placement of Abbott Vascular’s Absorb GT1

A remote-controlled robotic system was designed to address some of the procedural challenges and occupational hazards associated with traditional percutaneous coronary intervention (PCI) in addition to enhancing the degree of precision and control for the interventional procedure. We report the first large-scale, multicenter study evaluating the safety and efficacy of a novel robotic system for PCI.

 

It demonstrates the capabilities of the technology including double-wire intervention, successful BVS delivery, and the ability to re-cross through a scaffold-strut for branch vessel ostium dilatation. More experience with this technology will potentially add to its utilization in more complex lesions.

Safety and Feasibility of Robotic Percutaneous Coronary Intervention PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study

Giora Weisz, D. Christopher Metzger, Ronald P. Caputo, Juan A. Delgado, J. Jeffrey Marshall, George W. Vetrovec, MarkReisman, Ron Waksman, Juan F. Granada, Victor Novack, Jeffrey W. Moses, Joseph P. Carrozza

Author + information

Abstract

Objectives The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic-assisted percutaneous coronary intervention.

Background Robotic systems have been suggested to enhance the performance of cardiovascular procedures, as well as to provide protection from the occupational hazards that are associated with interventional practice.

Methods Patients with coronary artery disease and clinical indications for percutaneous intervention were enrolled. The coronary intervention was performed with the CorPath 200 robotic system, which consists of a remote interventional cockpit and a bedside disposable cassette that enables the operator to advance, retract, and rotate guidewires and catheters. The primary endpoints were clinical procedural success, defined as <30% residual stenosis at the completion of the robotic-assisted procedure without major adverse cardiovascular events within 30 days, and device technical success, defined as the successful manipulation of the intracoronary devices using the robotic system only.

Results A total of 164 patients were enrolled at 9 sites. Percutaneous coronary intervention was completed successfully without conversion to manual operation, and device technical success was achieved in 162 of 164 patients (98.8%). There were no device-related complications. Clinical procedural success was achieved in 160 of 164 patients (97.6%), whereas 4 (2.4%) had periprocedural non–Q-wave myocardial infarctions. No deaths, strokes, Q-wave myocardial infarctions, or revascularization occurred in the 30 days after the procedures. Radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position.

Conclusions This pivotal multicenter study with a robotic-enhanced coronary intervention system demonstrated the safety and feasibility of the system. The robotic remote-control procedure met the expected technical and clinical performance, with significantly lower radiation exposure to the operator. (Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions [PCI] [PRECISE]; NCT01275092)

Reference

1. Weisz G, Metzger DC, Caputo RP, et al. Safety and feasibility of robotic percutaneous coronary intervention. J Am Coll Cardiol 2013;61:1596–1600.

 

SOURCES

J Am Coll Cardiol 2013;61:1596–1600.

http://www.invasivecardiology.com/files/Corindus%20Clinical%20Case%20Update%20-%20October%202016.pdf

http://www.invasivecardiology.com/files/Corindus%20Clinical%20Case%20Update%20-%20December%202016.pdf?inter_email=Zlk4YUF5VU9UQzE5ckNwTUJnRFd0LzJnNnJXRXZSYSt3Q2t1N1ovSmZYWT0=&inter_date=UHUvalFXSTVmSEJvTTR1L1dobWxyQT09

http://2015.icimeeting.com/wp-content/uploads/2015/12/1858-Mahmud-Hall-I-mon.pdf

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