Putting the future in your hands today.

Transcription

Putting the future in your hands today.
Putting the future
in your hands today.
Minimally Invasive Cardiac Surgery
thinking forward
Minimally Invasive Cardiac Surgery (MICS) starts with
thinking forward
Minimally invasive procedures present new opportunities to reduce trauma and impact
to patients being treated for cardiovascular disease. As the world’s largest medical device
company, Medtronic strives to provide the resources needed to facilitate the evolution of
cardiac surgery toward the least invasive, most effective treatment possible. We’re committed to providing access to the broadest portfolio of therapy, technology and training
resources to help you transition from arrested, open chest procedures to less invasive
procedures patients are requesting today.
moving forward
to provide advanced options for you and your patients.
MICS CABG
Heart Valve Surgery
Surgical Ablation
Perfusion Techniques for
Blood Conservation
innovating forward
with the most
MICS CABG
comprehensive
minimally invasive
CABG products
and training
• Minimally invasive coronary artery bypass graft (CABG) surgery is a beating
heart multi-vessel procedure in which the anastomoses are performed
under direct vision through a lateral mini-thoracotomy.
• MICS CABG is a versatile procedure in which a hybrid or pump-assisted
beating heart approach can be employed to meet your preference.
Not all patients are candidates
for beating heart procedures.
Some patients would require
cardiopulmonary support during
surgery.
•Potential benefits of MICS CABG include reduced hospital stay, faster
recovery, improved cosmetic outcome, and greater patient satisfaction.1, 2
Caution: Care and caution should
be taken to avoid damage to
vessels and cardiac tissue during
cannulation or other cardiac
surgical procedures.
ThoraTrak® MICS
Retractor System
Starfish® NS
Heart Positioner
Octopus® Nuvo
Tissue Stabilizer
Bio-Medicus®
Femoral Cannula
evolving forward
with 35 years of
Heart Valve Surgery
experience to deliver
more innovative
options to help you
treat valve disease
• Minimally invasive valve surgery is characterized by a small incision, usually
performed as a right mini-thoracotomy or a mini-sternotomy under direct vision.
• Access and visibility are facilitated using femoral arterial and venous cannulation
and minimized cardiopulmonary bypass support with augmented venous
return techniques.
Not all patients are candidates
for minimally invasive heart valve
surgery. These products have
unique indications, warnings, and
precautions. Refer to individual
components for specific information.
Devices are not intended for use
except as indicated.
• The most recognized benefit of minimally
invasive valve surgery is a better cosmetic
result. Other potential benefits are reduced
trauma and pain, decreased blood loss,
decreased wound infection,3 and reduced
recovery time.3, 4
Caution: Care and caution should
be taken to avoid damage to
vessels and cardiac tissue during
cannulation or other cardiac surgical
procedures.
Freestyle®
Heart Valve
Mosaic® & Mosaic ULTRA®
Heart Valves
with Cinch® Holder
Profile 3D®
Ring
CG Future®
COMPOSITE Ring and
CG Future® Band
Duran AnCore®
Ring and Band
Simplici-T®
Band
MiAR™ Antegrade
Cardioplegia Cannulae
MiRCSP® Retrograde
Cardioplegia Cannulae
driving forward
with confidence
Surgical Ablation
you’ll achieve consistent
conduction block
in your next
MICS ablation case5
• Minimally invasive ablation surgery is characterized by two small incisions
(right and left mini-thoracotomies) and two small port-sized incisions per side.
• Therapy is similar to a sternotomy-based approach, but access and visibility
are different.
The Cardioblate Surgical Ablation
Device should not be used for
patients who have active endocarditis
at time of surgery.
Potential Complications - Possible
complications related to the ablation
of cardiac tissue in combination with
open heart surgery are:
• Tissue perforation
• E xtension of extracorporeal bypass
• Perioperative heart rhythm disturbances (atrial and/or ventricular)
• Postoperative embolic complications
• Pericardial effusion or tamponade
• Injury to the great vessels
• Valve leaflet damage
• Conduction disturbances
(SA/AV node)
• Acute ischemic myocardial event
• Thrombus formation
Cardioblate® Gemini®-s
Surgical Ablation Device
• Direct vision is supported by endoscopic
visualization and is the recommended
technique for surgeons learning to perform
minimally invasive ablation procedures.
As surgeons gain more experience, they
may choose to reduce the incision size
and move to a completely thoracoscopic
approach.
Cardioblate® Gemini®-x
Surgical Ablation Device
Cardioblate® Navigator®
Tissue Dissector
Cardioblate® MAPS Mapping,
Ablation, Pacing and Sensing Device
staying forward
with perfusion options
Perfusion Techniques for Blood Conservation
that reduce trauma
and impact for
your CABG and
valve surgery patients
• Rethinking Blood Conservation (RBC), an evidence-based educational program
offered by Medtronic, works with you to devise strategies and tactics to improve
cardiac procedures, including MICS. Important aspects of RBC include use of
a centrifugal pump incorporated into a minimized cardiopulmonary bypass
circuit with a biocompatible coating, femoral arterial and venous cannulation
using augmented venous return techniques, and a comprehensive blood
conservation strategy.
• We provide a multi-modality approach to blood conservation that incorporates
reduced-prime and biocompatible extracorporeal circuits, autologous bloodcell salvaging, and hemostasis management. Through various product
selections, techniques and procedures, studies have shown a reduction in
post-op complication rates6 and reduced transfusion requirements both
intra- and post-operatively.6, 7
• Cannulation techniques for minimally invasive procedures are dependent on
the incision and access site as well as surgeon preference. We offer many
cannulae to facilitate femoral and direct cannulation of vessels through
both open and percutaneous insertion methods.
Advance Your Technique With Training
Through Medtronic CardioVascular Academia programs, we offer unique
training involving the latest technologies and advanced techniques in
minimally invasive cardiac surgery. Come and learn the skills that will place
your practice at the leading edge of cardiac surgery.
During a typical session, you can expect to:
• Observe procedures performed by leading surgeons.
• Gain knowledge of patient selection, key procedural steps, instrumentation,
anesthesia management and post-surgical care.
trim
• Interact with surgical teams and discuss protocol changes to achieve the
greatest benefits from the procedure.
moving forward
Seattle, WA
Missoula, MT
with convenient
access to
world class
training
San Francisco, CA
Salt Lake City, UT
Denver, CO
Wichita, KS
Los Angeles, CA
Santa Ana, CA
Rancho Mirage, CA
Mesa, AZ
Phoenix, AZ
Dallas, TX
u MICS CABG
uHeart Valve Surgery
uSurgical Ablation
u Perfusion
u
M
ICS CABG Faculty and
Medtronic MICS Training Sites
Steven Hoff, MD
Vanderbilt Heart, Nashville, TN
Joseph McGinn, MD
Staten Island University Hospital,
Staten Island, NY
Mahesh Ramchandani, MD
Methodist Hospital, Houston, TX
Marc Ruel, MD
University of Ottawa Heart Institute,
Ottawa, Canada
Joseph Sabik, MD
Cleveland Clinic, Cleveland, OH
u
Heart Valve Surgery Faculty and
Medtronic MICS Training Sites
Vincent Gaudiani, MD
Luis Castro, MD
California Pacific Medical Center,
San Francisco, CA
Vinay Badhwar, MD
Cardiac Surgical Associates
of Florida, Orlando, FL
Houston, TX
Vaughn Starnes, MD
Robbin Cohen, MD
Mark Cunningham, MD
Steven Haddy, MD
University of Southern California,
Los Angeles, CA
Aubrey Galloway, MD
Eugene Grossi, MD
New York University, New York, NY
Joseph Lamelas, MD
Mt. Sinai Medical Center, Miami, FL
Michael Moront, MD
Toledo General, Toledo, OH
Michael Reardon, MD
Methodist Hospital, Houston, TX
William Ryan, MD
The Heart Hospital Baylor Plano, Plano, TX
Francis Shannon, MD
Marc Sakwa, MD
William Beaumont Hospital, Royal Oak, MI
Alan Wolfe, MD
St. Joseph’s Hospital, Atlanta GA
Southwest Heart and Lung, Phoenix, AZ
Medtronic Learning Center, Santa Ana, CA
Ottawa, ON, Canada
St. Paul, MN
Royal Oak, MI
Chicago, IL
Staten Island, NY
Wilkes-Barre, PA
Toledo, OH Cleveland, OH
New York, NY
Kokomo, IN
Nashville, TN
Columbia, SC
Atlanta, GA
Orlando, FL
trim
Miami, FL
uSurgical Ablation Faculty and
Medtronic MICS Training Sites
Stephen E. Clayson, MD
John R. Doty, MD
Salt Lake Cardiovascular and
Thoracic Surgery, Salt Lake City, UT
Robert Fleming, MD
Badr Idbeis, MD
Kansas Medical Center, Wichita, KS
Bernard Fogelson, MD
Howard Regional Heath Center, Kokomo, IN
Mark Hill, MD
Virginia Mason Medical Center, Seattle, WA
Richard Lee, MD
Northwestern Memorial Hospital,
Chicago, IL
SN Mitruka, MD
Joseph Wilson, MD
Eisenhower Medical Center,
Rancho Mirage, CA
John Sutton III, MD
Sisters of Charity Providence, Columbia, SC
Stephen Tahta, MD
The International Heart Institute
of Montana, Missoula, MT
u
Perfusion Faculty and
Medtronic MICS Training Sites
Gabriel Aldea, MD
University of Washington, Seattle, WA
Stanley Carson, MD
Exempla-St. Joseph’s Hospital, Denver, CO
Robert W. Emery, MD
Arlen R. Holter, MD
St. Joseph’s Hospital, St. Paul, MN
Michael Harostock, MD
Wilkes-Barre General Hospital,
Wilkes-Barre, PA
Goya Raikar, MD
Regions Hospital, St. Paul, MN
Marc P. Sakwa, MD
William Beaumont Hospital,
Royal Oak, Michigan
Darryl G. Stein, MD
Banner Desert Medical Center, Mesa, AZ
MICS CABG
ThoraTrak® MICS Retractor System
Octopus® Nuvo Tissue Stabilizer
Starfish® NS Heart Positioner
Bio-Medicus® Femoral Cannula
Heart Valve Surgery
Mosaic® & Mosaic
ULTRA® Heart Valves
with Cinch® Holder
Freestyle®
Heart Valve
CG Future®
COMPOSITE Ring and
CG Future® Band
Duran AnCore®
Ring and Band
Profile 3D®
Ring
Simplici-T®
Band
MīRCSP®
Cannulae
Cannulae
Bio-Medicus® Femoral Access Arterial and Venous Cannulae • MīAR™ Antegrade Cardioplegia Cannulae
MīRCSP® Retrograde Cardioplegia Cannulae
Fehling
Instruments*
long and
medium
handled
surgical
instruments
Surgical Ablation
Cardioblate® Gemini®-s
Surgical Ablation Device
Cardioblate® Gemini®-x
Surgical Ablation Device
Cardioblate® Navigator®
Tissue Dissector
Cardioblate® MAPS Mapping,
Ablation, Pacing and Sensing Device
* Medtronic, Inc. is an authorized distributor of these products.
References
1.McGinn JT, Usman S, Lapierre H, Pothula VR, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting: dual center experience in 450 consecutive patients. Circulation. 2009;
120:S78-S84.
2. Poston RS, Tran R, Collins M, et al. Comparison of Economic and Patient Outcomes With Minimally Invasive Versus Traditional Off-Pump Coronary Artery Bypass Grafting Techniques.
Ann Surg 2008;248: 638–646.
3. Liu J, Sidiropoulos A, Konertz W. Minimally invasive aortic valve replacement (AVR) compared to standard AVR. Eur J Cardiothorac Surg. 1999;S80-83.
4. Sharony R, Grossi E, Saunders P, et al. Minimally invasive aortic valve surgery in the elderly: a case control study. Circulation. 2003;108[suppl 11]:11-43-11-47.
5. Premarket Notification (510(k)), K080509, Section 20.6.8, May 5, 2008. Food and Drug Administration (FDA) Center for Devices and Radiological Health.
6.Ranucci M, Isgrò G. Minimally invasive cardiopulmonary bypass: Does it really change the outcome? Critical Care 2007; 11:R45.
7.Harostock M 3rd, Filler JJ, Burak DA, et al. Comparison of transfusion requirements for conventional and miniaturized extracorporeal circuits. Heart Surg Forum. 2008;11(3):E188-92.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
For a complete listing of indications, contraindications, precautions and warnings, please refer
to the Instructions for Use provided with each product.
Bio-Medicus® Cannula
Indications: This percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for
cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended
for use up to six hours or less. Contraindications: Alone, this cannula is not a medical treatment device. Selection of patient as a candidate
for such procedures is the physicians’ responsibility. The outcome is dependent on many variables including patient pathology, surgical
procedure, and perfusion procedures. Do not use if the patient has severe peripheral atherosclerosis or severe arterial dissection. This device
is not intended for use except as indicated.
Cardioblate Gemini Surgical Ablation Device
Indications: The Cardioblate Gemini Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency
energy. The system is indicated for use under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical
procedures. Contraindications: The Cardioblate Gemini Surgical Ablation Device should not be used for:
• Patients that have active endocarditis at the time of surgery
• Ablation in a pool of blood (e.g., through a purse string suture on a beating heart). Effects of this type of ablation are unknown.
Freestyle® Aortic Root Bioprosthesis
Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement.
Contraindications: This device is not intended for use except as indicated. Warnings/Precautions/Adverse Events: Accelerated deterioration
due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients w ith altered calcium
metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: cardiac dysrhythmias, death, endocarditis,
hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve
thrombosis, or intracuspal hematoma.
MiAR™ Cannulae
Indications: For use during cardiopulmonary bypass for the delivery of cardioplegia for up to 6 hours. The cannula may also be used to
aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or
minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques. Contradictions: This device is
not intended for use except as indicated.
Mosaic® Porcine Bioprosthesis
Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Contraindications: This device is
not intended for use except as indicated. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of
bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure,
hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure,
hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural
deterioration, thromboembolism, or valve thrombosis.
MiRCSP® Cannulae
Indications: The MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the
coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques. Contraindications: This device is
not intended for use except as indicated above.
www.MedtronicMICS.com
www.medtronic.com
World Headquarters
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: (763) 514-4000
Fax: (763) 514-4879
Medtronic USA, Inc.
Toll-free: 1 (800) 328-2518
(24-hour technical support for
physicians and medical professionals)
LifeLine
CardioVascular Technical Support
Tel: (877) 526-7890
Tel: (763) 526-7890
Fax: (763) 526-7888
E-mail: [email protected]
Bio-Medicus, Cardioblate, Cinch, CG Future, Duran AnCore, Freestyle, Gemini, MīRCSP, Mosaic, Mosaic ULTRA, Navigator, Octopus, Profile 3D,
Simplici-T, Starfish, and ThoraTrak are registered trademarks of Medtronic, Inc.
MiAR is a trademark of Medtronic, Inc.
UC200705180b EN © Medtronic, Inc. 2008, 2010. All Rights Reserved. Printed in USA.