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MHIF FEATURED STUDY: OPEN AND ENROLLING: PROMINENT … · – Subanalysis 3 fold increase without...

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MHIF FEATURED STUDY: PROMINENT DESCRIPTION: Placebo controlled trial of a potent fibrate, pemafibrate, to prevent MI, ischemic stroke, unstable angina requiring revascularization, and CV death in adults with T2DM. CRITERIA LIST/ QUALIFICATIONS: Inclusion TG > 200, HDL < 40, T2DM, LDL<70 or high dose statin or statin intolerant CONDITION: High triglycerides, low HDL, T2DM, secondary cardiovascular prevention PI: Dr. Matthew Chu SUB I’S: Marc Newell, MD Thomas Knickelbine, MD Amy Cooley, CNP RESEARCH CONTACT: Ezi Ebere [email protected] | 612-863-4393 SPONSOR: Kowa Research Institute OPEN AND ENROLLING: Please Refer Patients! TRIGLYCERIDES MATTER – AND THIS STUDY IS HELPING ADDRESS THEM! Exclusion Type 1 diabetes, HbA1c > 9.5%, NYHA Class IV HF, significant liver disease 1 of 23
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Page 1: MHIF FEATURED STUDY: OPEN AND ENROLLING: PROMINENT … · – Subanalysis 3 fold increase without aortic occlusion – Grossi et al Retrograde perfusion in elderly, PVD, and EF

MHIF FEATURED STUDY:

PROMINENT

DESCRIPTION: Placebo controlled trial of a potent fibrate, pemafibrate, to prevent MI, ischemic stroke, unstable angina requiring revascularization, and CV death in adults with T2DM.

CRITERIA LIST/ QUALIFICATIONS:

InclusionTG > 200, HDL < 40, T2DM, LDL<70 or high dose statin or statin intolerant

CONDITION:High triglycerides, low HDL, T2DM, secondary cardiovascular prevention

PI: Dr. Matthew ChuSUB I’S:Marc Newell, MDThomas Knickelbine, MDAmy Cooley, CNP

RESEARCH CONTACT: Ezi [email protected] | 612-863-4393

SPONSOR:Kowa Research Institute

OPEN AND ENROLLING: Please Refer Patients!

TRIGLYCERIDES MATTER – AND THIS STUDY IS HELPING ADDRESS THEM!

ExclusionType 1 diabetes, HbA1c > 9.5%, NYHA Class IV HF, significant liver disease

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Page 2: MHIF FEATURED STUDY: OPEN AND ENROLLING: PROMINENT … · – Subanalysis 3 fold increase without aortic occlusion – Grossi et al Retrograde perfusion in elderly, PVD, and EF

Minneapolis Heart Institute Foundation® Cardiovascular Grand Rounds Title: From sternotomy to thoracotomy: The evolving minimally

invasive procedures in cardiac surgery Speaker: Bassam Shukrallah, MD

Cardiac Surgeon Minneapolis Heart Institute® at Abbott Northwestern Hospital

Date: February 18, 2019 Time: 7:00 - 8:00 AM

Location: ANW Education Building, Watson Room OBJECTIVES At the completion of this activity, the participants should be able to: 1. List the limits and benefits of minimally invasive procedures. 2. Review the literature behind minimally invasive procedures. 3. Explain how common procedures are performed in minimally invasive procedures. ACCREDITATION Physician - Allina Health is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Nurse - This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.0 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education. DISCLOSURE POLICY & STATEMENTS Allina Health, Learning & Development intends to provide balance, independence, objectivity and scientific rigor in all of its sponsored educational activities. All speakers and planning committee members participating in sponsored activities and their spouse/partner are required to disclose to the activity audience any real or apparent conflict(s) of interest related to the content of this conference.

The ACCME defines a commercial interest as “any entity” producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of clinical service is owned, or controlled by, an ACCME-defined commercial interest.

Moderator(s)/Speaker(s) Dr. Bassam Shukrallah has disclosed that he DOES NOT have any real or apparent conflicts with any commercial interest as it relates to presenting the content in this activity/course.

Planning Committee Dr. Alex Campbell, Jake Cohen, Jane Fox, Dr. Mario Gössl, Dr. Kevin Harris, Dr. Kasia Hryniewicz, Rebecca Lindberg, Amy McMeans, Dr. Michael Miedema, Dr. JoEllyn Moore, Pamela Morley, Dr. Scott Sharkey, and

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Page 3: MHIF FEATURED STUDY: OPEN AND ENROLLING: PROMINENT … · – Subanalysis 3 fold increase without aortic occlusion – Grossi et al Retrograde perfusion in elderly, PVD, and EF

Jolene Bell Makowesky have disclosed that they DO NOT have any real or apparent conflicts with any commercial interest as it relates to the planning of this activity/course. Dr. David Hurrell has disclosed the following relationship -Boston Scientific: Chair, Clinical Events Committee. NON-ENDORSEMENT OF COMMERCIAL PRODUCTS AND/OR SERVICES We would like to thank the following company for exhibiting at our activity. AtriCure

Accreditation of this educational activity by Allina Health does not imply endorsement by Allina Learning & Development of any commercial products displayed in conjunction with an activity.

A reminder for Allina employees and staff, the Allina Policy on Ethical Relationship with Industry prohibits taking back to your place of work, any items received at this activity with branded and or product information from our exhibitors. PLEASE SAVE YOUR SERIES FLIER When you request a transcript this serves as your personal tracking of activities attended. Most professional healthcare licensing/certification boards will not accept a Learning Management System (LMS) transcript as proof of credit; there are too many LMS’s across the country and their validity/reliability are always in question.

If audited by a licensing board or submitting for license renewal or certification renewal, boards will ask you not the entity providing the education for specific information on each activity you are using for credit. You will need to demonstrate that you attended the activity with a copy of your certificate/evidence of attendance, a brochure/flier and/or the conference handout.

Each attendee at an activity is responsible for determining whether an activity meets their requirements for acceptable continuing education and should only claim those credits that he/she actually spent in the activity.

Maintaining these details are the responsibility of the individual.

PLEASE SAVE A COPY OF THIS FLIER AS YOUR CERTIFICATE OF ATTENDANCE.

Signature: __________________________________________________________________________

My signature verifies that I have attended the above stated number of hours of the CME activity.

Allina Health - Learning & Development - 2925 Chicago Ave - MR 10701 - Minneapolis MN 55407

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MHIF CV Grand Rounds – Feb 18, 2019

MINIMALLY INVASIVE MITRAL VALVE SURGERY:

Is it necessary?

Bassam Shukrallah, MD

Outline

• Benefits/drawbacks • Indications/contraindications • Review results, morbidity, mortality, QOL• Building a program

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Page 5: MHIF FEATURED STUDY: OPEN AND ENROLLING: PROMINENT … · – Subanalysis 3 fold increase without aortic occlusion – Grossi et al Retrograde perfusion in elderly, PVD, and EF

MHIF CV Grand Rounds – Feb 18, 2019

• Vanderbilt 2006–2010 – Michael Petracek, MD – Mini-mitral with cold fib. arrest

• AATS 2014 Toronto – Patrick McCarthy, MD– In Defense of The Sternotomy

“We no long perform open Nissen fundoplication. Our trainees are trained in laparoscopic NF, why are we not capable of doing the same in cardiac surgery?”

• 40 right single lung transplant• 27 mini-HVAD

Began considering Mini-mitral valve surgery

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Page 6: MHIF FEATURED STUDY: OPEN AND ENROLLING: PROMINENT … · – Subanalysis 3 fold increase without aortic occlusion – Grossi et al Retrograde perfusion in elderly, PVD, and EF

MHIF CV Grand Rounds – Feb 18, 2019

Right lung transplant

Mini-HVAD

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MHIF CV Grand Rounds – Feb 18, 2019

Endocarditis

• 20 mini-mitral valve replacement (5 combined with tricuspid valve replacement)

Traditional Approach for MVR/r

• Sternotomy• Cardiopulmonary bypass• Arrested heart

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MHIF CV Grand Rounds – Feb 18, 2019

Traditional Approach for MVR/r Advantages

• Comfort• Provides full access • Provides ideal operating conditions• Allows surgical team full control of

circulation and oxygenation

Disadvantages

• Pain• Increased blood loss• Prolonged healing time (2-3

months)• Sternal wound complications• Cosmesis

Minimally Invasive approach Advantages

• Cosmesis • Less pain• Less blood loss• More rapid healing (2-4 weeks)• Minimization/avoidance of sternal

wound complications• Shortened postop ICU and total

hospital length of stay• More cost-effective (?)

Disadvantages

• Technically demanding• Not appropriate for every surgical

team• Not appropriate for every patient• Expensive technology

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MHIF CV Grand Rounds – Feb 18, 2019

Alternative approach

Three approaches

APPROACH• Right thoracotomy • Partial sternotomy • Robot

AORTA

Tool or approach?

Cross-clamp or no cross-clamp.(arrest or fibrillate)

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MHIF CV Grand Rounds – Feb 18, 2019

Minimally Invasive approach •Same Operation as with Sternotomy

– Same durability

– Same results

•Different Technologies (different tools)– Thoracoscopic

– Robotic

– Direct Vision

Who’s Eligible • All valve patients are potential candidates

• Relative contra-indications

– Other cardiac pathology e.g. CAD

– Peripheral vascular disease

– Body habitus

• Extreme obesity

• Severe pectus excavatum

– Previous thoracic surgery

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MHIF CV Grand Rounds – Feb 18, 2019

Demystifying Mitral Valve Repair • 95% of degenerative MVD can repaired

utilizing 5 techniques1.Triangular resection- posterior leaflet 2. Sliding repair- posterior leaflet 3. Artificial chords- anterior leaflet 4. Closure of commissures5. Annuloplasty- all patients

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MHIF CV Grand Rounds – Feb 18, 2019

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MHIF CV Grand Rounds – Feb 18, 2019

NO difference in mortality between conventional vs. minimally invasive approach

Despite MIVS having increased CPB times, there was NO difference in mortality.

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MHIF CV Grand Rounds – Feb 18, 2019

Survival at 1,3,5 years:Mini 98,97,95%Conv97,91,86%

Neurologic events – Risk of stoke 2.1 vs. 1.2 % (95% CI 1.35-2.38, RR 1.79)– Subanalysis 3 fold increase without aortic occlusion – Grossi et al Retrograde perfusion in elderly, PVD, and EF

<30%, and no aortic occlusion all increased risk of stroke (each with P <0.05)

– Murphy et al CT screening in robot MVS 1.6% stroke

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MHIF CV Grand Rounds – Feb 18, 2019

Bleeding, transfusion, reexploration • Robotics Two studies no difference, but decreased CT

output. Two studies reduction in all • Thoracotomy and hemisternotomy 3 out of 10 studies

found a decrease in all, and remaining showed no difference

Atrial fibrillation • 4 studies showed no difference (539 pt., OR .86, 95% CI 0.59-1.27, P =.45)Infection • 3 studies • 1.8% and 7.7% incidence MIVS vs. sternotomy (P <0.03)Pain and quality of live• 2 studies demonstrated less pain, and analgesic use with MIVS• Return to normal activity was seen at 4 weeks ahead of sternotomy

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MHIF CV Grand Rounds – Feb 18, 2019

Length of stay• Mean 3 day shorter • Median 1 day shorter

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MHIF CV Grand Rounds – Feb 18, 2019

Other benefits of alternative approaches

• hybrid procedures

• Zebra’s (special/complex cases)

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MHIF CV Grand Rounds – Feb 18, 2019

Ruptured mycotic aneurysm

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MHIF CV Grand Rounds – Feb 18, 2019

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MHIF CV Grand Rounds – Feb 18, 2019

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MHIF CV Grand Rounds – Feb 18, 2019

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MHIF CV Grand Rounds – Feb 18, 2019

Building a program

Program

• Patient selection• Team training- learn from established successful

programs• Addressing challenges• Institutional support• Ongoing quality improvement and results review

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MHIF CV Grand Rounds – Feb 18, 2019

Final Thoughts

• Minimally invasive mitral valve surgery is a safe and viable alternative to sternotomy

• Same surgery, different cut• Alternative approaches in cardiac surgery expand the

spectrum of disease treated (hybrid procedures)• We can and should build a program!

THANK YOU

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