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Archive for the ‘PCI’ Category


Tommy King Memorial Cardiovascular Symposium

Saturday CEUs in Boston, May 20

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

 

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

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

Reporter: Aviva Lev-Ari, PhD, RN

 

 

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)

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

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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Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

 

WEDNESDAY, NOV 30 2016

“Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves.”

The Hadassah Medical Organization has opened Israel’s first Heart Valve Disease Clinic, which is geared toward detecting and treating the most complicated cases of heart valve disease–a growing problem in an aging population.

Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves. Currently, these invasive procedures are often superseded by less invasive cardiac catheterizations. In any case, however, efficiently treating valve disease and minimizing life-threatening risk factors such as heart attack remains an ongoing struggle for cardiovascular specialists.

As Prof. Ronen Beeri, head of Hadassah’s Cardiovascular Research Center, explains: “A ‘cardio team’ is needed to treat a patient suffering from heart valve disease. The time from referral to our Heart Institute to receive treatment from the relevant specialist can sometimes take months. Generally, patients with complex issues cannot afford to wait that long. The multidisciplinary cardio team solution at our new Clinic will help streamline the process so that a patient will receive all the necessary echocardiograms and other exams needed to diagnose and begin treatment within a week’s time.”

SOURCE

http://www.hadassah.org/news-stories/heart-valve-disease.html

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Robot-assisted coronary intervention program @MGH – The first CorPath Vascular Robotic System, lets Interventional Cardiologists position the right stent in the right place at reduces radiation exposure by 95%

Reporter: Aviva Lev-Ari, PhD, RN

 

Robot in the cath lab takes surgeons out of radiation’s way

October 3, 2016 By Abigail Esposito Leave a Comment

The system consists of a bedside unit and an interventional cockpit. Developer Corindus Vascular Robotics says the radiation-shielded cockpit features a control console with simple-to-use controls for the precise positioning of guidewires, balloons and stent catheters.

An interventional cardiologist loads the single use cassette and later manually introduces the guiding catheter into the coronaries. At that time, the physician can remove their lead covers and sit behind the Interventional Cockpit to perform the remainder of their procedure.

Harmful Exposures in the Cath Lab:

  • One study of self-reported brain tumors in interventionists showed that 86% of the tumors were left-brain—the side of the head most often exposed to radiation during procedures.
  • There’s also the risk of orthopedic injuries from wearing the heavy, leaded equipment used to block radiation (interventionists practicing over 21 years suffer a 60% incidence of spine issues) and
  • Cataracts, another effect of radiation exposure in interventionists. In a RELID study (Retrospective Evaluation of Lens Injuries and Dose), 50% of interventional cardiologists had posterior subcapsular lens changes (precursors to cataracts) caused by radiation exposure, versus less than 10% in the control group.

Benefits of CorPath Vascular Robotic System

One trial (Percutaneous Robotically-Enhanced Coronary Intervention Study) showed a

  • 95.2% reduction in radiation exposure for the primary operator,
  • 98.8% device success and
  • 97.6% clinical success with no device-related complications. What’s more, the trial saw a
  • 9% reduction in stent use as compared to historical data.

http://www.medicaldesignandoutsourcing.com/robot-in-the-cath-lab-takes-surgeons-out-of-radiations-way/?spMailingID=9704333&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1021334606&spReportId=MTAyMTMzNDYwNgS2

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