EVEN THROUGH STORMY DAYS THE HEARTMATE II LVAD GIVES ME MY SUNSHINE :-)

SOME LEFT VENTRICULAR ASSIST DEVICES (LVAD) LOOK LIKE "DOOR KNOBS" OR OLD AUTOMOTIVE WATER PUMPS... MY HEARTMATE II RESEMBLES A MINATURE VERSION OF  THE PLUMBING UNDER MY BATHROOM SINK.  I AM BLESSED AS I CAN NOT IMAGINE LIFE WITH OUT MY "LVADone"... THE NAME I HAVE GIVEN TO MY LVAD.  WHY LVADone? BECAUSE IF THE PRESIDENT FLIES IN AIRFORCEone OR MARINEone... I HAVE LVADone PROTECTING ME THROUGH MY DAYS... MY LIFE... MY LVADone!!!

AND THE GOOD SAGA CONTINUES...

The Most Important LVAD SweetHeart: YOUR OWN HEART! LOVE IT! RESPECT IT! Walk It!

As Valentines Day is here, i would like to emphasize my Love for my Wife and for my Family on Valentines Day 2012.  However MORE importantly is the fact that our BIGGEST SWEETHEART should be our own hearts and those with heart failure... what remains of our functioning heart should be treated well. Loved! Respected! TREATED to healthiest diets possible. And last but not least our Hearts should be walked and if possible... exercised to Healthier and stronger limits.

I have an LVAD which means my Left Ventricle is in dire need of assistance from my Ventricular Device... The LVAD.  I am so blessed to be in the age of the implanted LVAD and to live another day to make a difference.

I OWE IT TO THE  RIGHT SIDE OF MY HEART TO KEEP IT AS HEALTHY AS POSSIBLE as my HeartMate II is taking care of the Left side chores... :-)

Happy Valentines Day to My Wife,Mom,
Daughter,Son-in-law,grandson1,grandson2,Son1,Son2,Sisters and Families, My Extended Family, Friends, My LVAD FAMILY, Dr B and his Family, Columbia New York Presbyterian Hospital Family and to my Thoratec Family.

LVADone BECOMES "LVAD PRESLEY" FROM THE BOTTOM OF MY LVAD LP HEARTMATE HOTEL/Thanks to Thoratec

I HAD AN EXTRAORDINARY TIME IN LAS VEGAS AS I ALONG WITH THE BIONIC BRIDE AND DENNIS HALL WERE SURPRISE GUEST SPEAKERS AT THE ANNUAL THORATEC meeting. There were approximately 200 Thoratec employees on hand.

The lights were dim, the stage was dark as the three of us walked up to the stage. A video of the three of us were playing on screens behind us. Some of the 200 employees recognized our silhouettes in dark as we walked in. I was obvious with my hat :-) Ally Smith Babineaux AKA The Bionic Bride was recognized with her long hair and dress. We even heard from the audience... "thats The Bionic Bride... That's "From The Bottom Of My LVAD". THEN THE LIGHTS came on.

After the standing ovation and cheers we sat down and began to notice a large number of Thoratec employees crying!  I was amazed from the outpouring of LOVE that came from Thoratec... and we hadn't even begun to speak! 

During each of our  on  stage testimonials the audience reacted with applause, laughter and sniffles throughout.  The three of us were stars in the eyes of Thoratec. We all felt that Thoratec holds each LVAD recipient/patient as stars in their own right, but we were blessed to be there to experience first hand  and share it.

Throughout my days in Las Vegas, i was confronted by the Thoratec employees and was told which posts or pictures they loved from my blog.  It was amazing as it seemed they knew my blog better than me :-) It was humbling to know that my Blog work was appreciated and followed

Loads of photos were taken so more posts will follow in the coming days...

(And I always remember the words at Club Presby... by the most peaceful, philosophical and inspiring angels there... Pearl...

 I said to Peral  "goodbye, see you soon!" Pearl quickly quipped back in her confident and shining demeanor "I want to see you, but not for a very long time. If I see you soon, it means you will be back with problems. I want to see you but take your time and live.... enjoy... I will be here"

I often think of her words and kindness that she spreads.  She has a beautiful gift that she lovingly embraces and shares with those who need it.  )

AND THE GOOD  SAGA CONTINUES...

From The Bottom Of My LVAD: OFFICIAL LOGO

From The Bottom Of My LVAD: Official Logo

And The Good Saga Continues...

LIKE AN ASTRONAUT:AN LVAD HERO OF MINE

The Torios and I met two years ago Through this Blog when our LVAD journey began.

How do you show people, that you have met through illlness and survival, that you are so thankful for their Love and Friendship? For me i am putting it in a piece of Art...

WE LOVE YOU Cris and Suzanne :-)
Josh and Anne Marie

AND THE GOOD SAGA CONTINUES...

RECOGNIZING DR DeBakey AND A HEALTHY NEW YEAR!

Something goofy i wanted to work on and here it is :-) HAPPY NEW YEAR TO ALL... I AM BLESSED FOR A BETTER LIFE BECAUSE OF MY LVAD. THANK YOU COLUMBIA NEW YORK PRESBYTERIAN HOSPITAL AND THORATEC...

...THANK YOU FROM MY FAMILY AND FRIENDS

AND THE GOOD SAGA CONTINUES...

RUDOLPH THE LVAD REINDEER SPOTTED IN NYC

TO ALL THOSE THAT KEEPS ME SPINNING AND THE GREEN GLOW OF LIFE SHINNING; TO ALL THAT HAVE SUPPORTED, LOVED AND HUGGED ME; TO ALL THOSE WHO HAVE INSPIRED AND TAUGHT ME; AND TO ALL THOSE WHO HAVE NOT... GOD BLESS YOU...

AND THANK YOU THANK YOU THANK YOU THANK YOU THANK YOU

AND THE GOOD SAGA CONTINUES...

Dear Wife,Mom,Family,Friends,Columbia New York Presbyterian and Thoratec... THANK YOU!!!

Thank You for Fighting The Good Fight and saving lives with your gifts, dicipline and passion. I will never run out of ways to thank you. Not a Single Day goes by that I dont wake up and I Thank you!

And The Good Saga Continues...

HEARTMATES TOO WITH THE HEARTMATE II / "LIVING THE NEW NORM HAPPILY!"

WHO HAS THE LVAD?

Look carefully, the ugly one in the grey hat has the LVAD :-)... Me! My driveline exits my body, yet for a moment, my wife gives me a break wearing my batteries and controller. My whole family plays a roll in living the NEW NORM with me ! My wife and family and my LVAD... Living the new norm happily :-)

AND THE GOOD SAGA CONTINUES...

Understanding The Thoratec HeartMate II LVAD: A VISUAL PERSPECTIVE

The inner works that keep "The Good Saga Continuing..."

AND THE GOOD SAGA CONTINUES...

ANOTHER NEW NORM! WHAT CAN I SAY? I AM BLESSED BY MY TRUST IN GOD, Columbia NY Presbyterian Hospital And Thoratec.

The Noble person who had my life and heart in his hands.

Dr Naka The Selfless Surgeon

(Great Name For A TV SHOW)

This is My Wife, Me and My Mom just 8 hours after pump swap. I already was off the Vent, sitting up in a chair for 3hours and back in bed.

DISCHARGED 7 days after pump swap and heading home :-)

7 days after my LVAD Pump Swap I headed home Happier than before. Stronger than Ive ever been. I have alot of folks to thank but must start with 3 people. My Wife, Mother and Dr Naka who has had my heart in his hands twice.

2 years ago I had the Heartmate II implant. However I always knew I would be back in the hospital... for a Heart Transplant and or perhaps a pump replacement as i am blood type O negative which is the rarest blood type and longest wait for a heart.

Anyway with this mindset from 2 years back, i was always somewhat prepared to return for surgery. Like a Samarai Warrior, i envisioned myself going through different types of scenerios. Good ones and Bad ones... in an effort to always be prepared.

I like to constantly remind myself of the variables and possiblities surrounding me at any given time. I am not trying to be a hero but more a realist so that if something arises I AM THE STRONGEST I CAN BE... mentally or physically. To Me 90% of any battle is mental.

Today is the first day where i do not feel as exhausted as yesterday. :-) so for me this is DAY 1. I will be posting my experience and findings on my pump failure and swap. How it felt when the pump stopped and my native heart took over.

I will also discuss the folks involved in my surgery and recovery... but for now i leave a photo of me upon discharge... in the back seat of my truck as my wife is driving and my mom riding shotgun. One of me and my Caregivers and Dr Naka the most gifted man that has saved/restored/restarted my life TWICE!!!

AND THE GOOD SAGA CONTINUES...

I was Sharon Nesmith's - Phlebotomist Last patient: After 15 years... Time for a Career Change :-)

I was Sharon Nesmith's Last patient: After 15 years... Time for a Career Change :-)
Congratulations Sharon and good luck in your new venture. I know the patients you took care of throughout your first career were blessed to have the least amount of pain :-). And if they were fortunate, they appreciated your humor :-) "you want 1 stick or 3". Too funny :-). God bless you Sharon and I know you will bring the same professionalism to your new career. Big big Hugs From the bottom of my heart and LVAD :-)

Peace

LVAD Leaving The Pioneering Stage. Thank You Thoratec For The "ROADMAP" Study/Taking The Initiative

To me this translates into The LVAD Leaving Its Pioneering Stage and the better understanding of -WHAT Works And What Doesn't Work- Regarding therapies and medicine regiments. Its happening folks, a better quality of life for all LVAD recipients NOW and in the Future through epidemiological studies. Thank You Thoratec.

Purpose
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.


Condition Intervention
Heart Failure
Device: HM II (HeartMate II LVAD)
Drug: OMM (Optimal Medical Management)



Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients


Resource links provided by NLM:


MedlinePlus related topics: Heart Failure
U.S. FDA Resources



Further study details as provided by Thoratec Corporation:


Primary Outcome Measures:
•Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m. [ Time Frame: 12 months ] [ Designated as safety issue: No ]


Secondary Outcome Measures:
•Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint. [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

•Accuracy of prognostic survival risk models including Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS) [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

•Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

•Survival in LVAD group free of pump replacement. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

•Quality of Life using the EQ-5D-5L Health Utility Index. [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

•Depression using Patient Health Questionnaire-9 (PHQ-9). [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

•Questionnaire on patient decisions related to LVAD therapy versus optimal medical management. [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

•Functional status using 6MWT distance and NYHA Classification [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

•Incidence of adverse events, rehospitalizations, days alive and not hospitalized. [ Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment: 200
Estimated Study Completion Date: December 2015
Groups/Cohorts Assigned Interventions
HM II (HeartMate II LVAD)
Subjects who elect to, and receive HM II LVAD therapy at baseline
Intervention: Device: HM II (HeartMate II LVAD) Device: HM II (HeartMate II LVAD)
The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
Other Name: Left Ventricular Assist Device
OMM (Optimal Medical Management)
Subjects who elect to remain on optimal medical management
Intervention: Drug: OMM (Optimal Medical Management) Drug: OMM (Optimal Medical Management)
Optimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists.
Other Name: Medical Management


Detailed Description:
The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV symptoms.

The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD. Together with the investigator, the subjects will decide which cohort to enter into at their baseline visit. This study will include experienced HM II LVAD implant centers as well as community centers that care for a large volume of heart failure patients. Study patients will be followed for up to 24 months post enrollment for survival, quality of life and functional status.

Eligibility


Ages Eligible for Study: 18 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population
HM II implanting centers and community/referral heart failure clinics

Criteria
The following are general criteria; more specific criteria are included in the study protocol:

Inclusion Criteria:

•NYHA Class IIIB/IV (refer to Appendix IV for definitions)
•Left ventricular ejection fraction (LVEF) ≤ 25%
•Not currently listed for heart transplantation, and not planned in next 12 months
•On optimal medical management
•Limited functional status as demonstrated by 6MWT <300 meters •At least: ◦One hospitalization for HF in last 12 months or ◦At least 2 unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for HF in last 12 months Exclusion Criteria: •Presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis •Platelet count < 100,000/mi within 48 prior to enrollment •Any inotrope use within 30 days prior to enrollment •Inability to perform 6MWT for any reason •Any condition, other than heart failure, that could limit survival to less than 2 years •History of cardiac or other organ transplant •Existence of any ongoing mechanical circulatory support (including intraaortic balloon pump, temporary circulatory support devices, etc.) at the time of enrollment •Presence of active, uncontrolled, systemic infection •History of an unresolved stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%)extracranial stenosis
•Contraindication to anticoagulation/antiplatelet therapy
•CRT or CRT-D within 3 months prior to enrollment
•Coronary revascularization (e.g. CABG, PCI) within 3 months prior to enrollment
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452802

Responsible Party: Thoratec Corporation ( Thoratec Corporation )
ClinicalTrials.gov Identifier: NCT01452802 History of Changes
Other Study ID Numbers: TC07272011
Study First Received: October 12, 2011
Last Updated: October 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Thoratec Corporation:
HeartMate II
heart-assist device
medical management
optimal medical management
Heart Failure NYHA Class IIIB/IV



Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases



ClinicalTrials.gov processed this record on November 03, 2011

Direct Link Here:

http://clinicaltrials.gov/ct2/show/NCT01452802?term=roadmap+thoratec&rank=1

AND THE GOOD SAGA CONTINUES...

HAPPY LVAD - WEEN / HALLOWEEN

HAPPY HAPPY HALOWEEN TO MY FAMILY/FRIENDS AND THE FOLKS THAT KEEP ME GOING AND GOING AND GOING... :-)

AND THE GOOD SAGA CONTINUES...

Softball Baseball And The LVAD With A .900 Batting AVG :-)

2 Years Later: Watching The World Series... Still Swinging The Bat... LVAD Undercover

Beneath the baseball jersey you will still find 2 lithium batteries and and a system controller worn at the waist AND the LVAD implanted inside me.

This photo was shot by my son who was taking pictures of a photo shoot i was participating in for Gina LeVay. http://www.ginalevay.com/

More photos and videos to follow shortly. As for Gina's photos of the day...!? I am looking forward to seeing those :-)

And The Good Saga Continues...

Former Vice President Dick Cheney Shows Off Heartmate II Batteries and Alarms,,,

Shown here is Former VP Cheney at an interview showing his LVAD 14 Hour Batteries. He also removed one of his 2 required batteries... showing that the LVAD system has back-up safety features with audible alarms. This is a great photo!

And The Good Saga Continues...

LVAD CATCH OF A LIFETIME: THORATEC'S HeartMate II

The best "Catch" of my lifetime is Thoratec's Heartmate II LVAD. Left with no stamina after a massive Heart attack, 2 years ago the "pump" pictured above serves as an artificial Left Ventricle (Assist Device).

AND THE GOOD SAGA CONTINUES...

Before The LVAD: 2 YEARS AGO MY HEART ATTACK TOOK MY LIFE AWAY

2 years ago i had a Widow-Maker of a heart attack. I couldnt walk more than 5 feet without gasping for air and resting from being too tired to put one foot in front of another. 2 years later, I have an LVAD and it has absolutely restored my life to near normal. I emphasize near normal as i am restricted from taking "true" Showers and I can not swim. Also I can not participate in contact sports however the trade-off is living a life away from hospice care or worse... being on the otherside of the ground... 6 feet under.

Currently I am on the waitinglist for a heart transplant and on an LVAD therapy called "Bridge To Transplant". If i had to do it all over, i would make the decision to have the LVAD implanted... in a heart beat (or less).

Dr Naka/The Man/The Surgeon responsible for giving me my life back

I look back on my dark days of October 2009 and NEVER thought i would make it this far. It wasnt until late November 2009 when i had the LVAD Implant.

At the time of this post i am fortunate enough to make breakfast in bed for my beautiful Wife and Mother :-) Both dont know, but both will be surprised.


Thank you to the Good folks up Columbia-NYPH, Thoratec, Dr Bonoan, My Family/Friends and last but not least God, my Faith.

And The Good Saga Continues :-)

To My Donor Family, THORATEC, THANK YOU... For My 2nd Beautiful Life.

Having an “LVAD Implant” myself and with the notion that this may sound strange to most… I feel that THORATEC is concurrently (as close to being) MY Heart Donor and Donor family. And why not?!?

My Left Ventricular Assist Device (LVAD)… the LVAD, the Heartmate II (HMII) by Thoratec… is born out of Love, passion, dedication, RESPECT and Love for life. The HMII is a the Gift given to folks with end stage heart failure. It is a chance to restore life with quality and stamina; to previous levels or even better… it has for me.

On September 5th, 2011 at Yankee Stadium an LVAD, My LVAD was in attendance.

Is this not what being a donor and donor family is all about too? I say all of this with confidence as I have met with many Thoratec Employees at every level. We’ve exchanged emails and phone calls as well as face to face planned and unplanned meetings, a Company tour of Headquarters and “The Plant” where the Heartmate II is assembled and tested. I even tweet with a few...

Me and my wife, friend and my Caregiver.

Like a caring Family, Thoratec ongoing projects are visionary that constantly update the quality of life for their LVADers now and in the future. Every step of the way, every angle, their daily mission is focused on the NOW and the future. This will ensure the possibility for more folks with End Stage Heart Failure their own re-Birthday, a second chance… Life restored with quality. My LVAD HeartMate II Birthday cake

The Heartmate II constantly gives back to me what my heart attack took away from me. Thank you Thoratec, my donor Family, for my 2nd Beautiful Life. Thank you to all responsible for developing the LVAD throughout history.
(Thoratec, along with every other Medical Device company… is in the business to make money and profit. I do not own $tock in Thoratec nor have any other stock market investments. However, I do want Thoratec and other proven Health Industry manufacturers to be successful and make a profit! Why wouldn’t I? I want them to save even more lives; giving more people that second chance. Sparing families of the immediate loss of a loved one.)

AND THE GOOD SAGA CONTINUES...