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Reporter: Gail S. Thornton

This article appeared on the website of Cardiovascular Business

‘Patient No. 1’ from a Hep C heart transplant study shares his story

By the time three transplant physicians approached Tom Giangiulio Jr. about being the first patient in a new clinical trial to accept a heart from a Hepatitis C-positive donor, Giangiulio didn’t have much of a choice.

He had already been on the heart transplant waitlist for more than two years, he was a live-in at the Hospital of the University of Pennsylvania and he had a body size (6-foot-2, 220 pounds) and blood type (O-positive) that was difficult to match to a donor.

It took Giangiulio less than 24 hours to speak to his previous cardiologist and his family and decide to enroll in the program. The doctors at Penn explained to him that because of new medications that can cure Hepatitis C, they were confident the virus could be eradicated post-transplant.

“There was no hesitation at all, not with me,” said Carin Giangiulio, Tom’s wife of 33 years. “Because I knew what the alternative was and we didn’t have too much choice except for going on a VAD (ventricular assist device) … and he didn’t want to do that. I said, ‘If they have a cure, then it’s a no-brainer. Let’s just do it.’ And I’m glad we did because I don’t think he would’ve been here today.”

Tom, 59, is set to celebrate his second anniversary with his new heart in June. He received the heart the day after Father’s Day in 2017 and subsequently contracted Hepatitis C, which was promptly wiped out with a 12-week regimen of elbasvir/grazoprevir (Zepatier).

Some of Giangiulio’s doctors at Penn published in February their experience with the first 10 patients in the clinical trial, called USHER, in the American Journal of Transplantation. All nine patients who survived were cured of Hepatitis C thanks to the antiviral therapy.

The implications of the research are massive, said Rhondalyn McLean, MD, MHS, the medical director of Penn’s heart transplant program and lead author of the recently published study. For the past two decades, the U.S. has struggled to increase the number of heart transplants above about 3,000 per year. And every year, patients die waiting for a heart transplant or become too sick to handle a transplant surgery.

McLean estimated 700 hearts from donors with Hepatitis C are discarded each year in the U.S. If even half of those are suitable for transplant, it would increase by 10 percent the number of organs that are available for implantation.

“There are so many people who have end-stage heart failure who die waiting for transplant, so anytime that we can increase our access to organs then I think we’re all going to be happy about that,” McLean said. “I think the people believe in the medicine, they believe that Hepatitis C is curable, so the risk to these folks is low. With the results of the study, I think we’ve proven that we can do this safely and the medications have great efficacy.”

Transplanting Hepatitis C-positive hearts isn’t a new idea, McLean explained.

“We used to do this all the time (with) the thinking that Hepatitis C usually doesn’t cause a problem for many, many years, so if hearts are only going to last 13 years or so and Hepatitis C doesn’t usually cause a problem for 30 years in someone, it should be an OK thing to do,” she said.

But then a study published in the 1990s found Hepatitis C-negative patients who accepted a heart from a donor with Hepatitis C actually had an increased risk of death compared to those who received normal hearts, and the practice of using these organs ceased.

However, with the new medications—the first commercially available treatment for Hepatitis C was approved by the FDA in 2014—McLean and her team are systematically studying the safety of implanting these hearts and then wiping out the virus once it’s contracted. And they’re optimistic about the program, which showed the first 10 patients had no evidence of the virus after their 12-week medication regimens.

“That met the criteria for sustained virologic response and those patients are deemed to be cured,” she said. “There’s no reason to think that this population would be any different than your normal, nontransplant population (in terms of Hepatitis C reappearing) so I think it was a pretty successful study.”

Penn researchers are also studying a similar approach in kidney and lung transplant candidates, which could help patients stuck on waitlists for those organs as well.

McLean described the increasing availability of these organs as an “unfortunate benefit” of the opioid epidemic. Through sharing needles, many opioid users are contracting Hepatitis C and dying young. Organs from young donors tend to perform better and often have no other problems, so solving the Hep C issue through medication could have a huge impact if this strategy is eventually rolled out on a broader scale.

“It’s hard when you have single-center studies,” McLean said. “They’re always promising, but in order to get a better assessment of what we’re doing and how the drug is doing I think you need to combine numbers so there has to be a registry that looks at all of the patients who have received these drugs and then using numbers to determine whether this is a successful strategy for us. And I believe that it will be.”

Those are the large-scale implications of this research. Tom Giangiulio can share the personal side.

Patient No. 1

Giangiulio said he feels “extremely gifted” to be Patient No. 1 in the USHER program. He knows he may not be alive if he wasn’t.

He recalls going into ventricular tachycardia about a week before his transplant and said it “scared the daylights” out of him.

“The amount of red tape, meetings and research, technology, and things that had to happen at a very precise moment in time for me to be the first … it’s mind-boggling to think about it,” he said. “But for all that to happen and for it to happen when it happened—and for me to get the heart when I got it—there was a lot of divine intervention along with a lot of people that were involved.”

Giangiulio has also experienced some powerful moments since receiving the transplant. After a bit of written correspondence with his donor’s family, he met the young man’s family one weekend in December of 2018.

He said riding over to the meeting was probably the most tense he’s ever been, but once he arrived the experience far exceeded his expectations.

“We were there for 2 ½ hours and nobody wanted to leave,” Giangiulio said.

The donor’s mother got Giangiulio a gift, a ceramic heart with a photograph of her son. A fellow transplant patient had told Giangiulio about a product called Enso, a kidney-shaped object you can hold in your hand which plays a recording of a user’s heartbeat.

Giangiulio decided to give it to her.

“I was very cautious at the advice of the people here at Penn,” he said. “Nobody knew how she would react to it. It might bother her, she could be thrilled to death. And she was, she was thrilled to death with it and she sleeps with it every night. She boots up the app and she listens to my heartbeat on that app every night.”

Another moment that sticks out to Giangiulio is meeting Patient No. 7 in the USHER program, who he remains in touch with. They ran into each other while waiting to get blood work done, and began talking about their shared experience as transplant recipients.

The clinical trial came up and Giangiulio slow-played his involvement, asking Patient No. 7 about the trial and not letting on that he was ultra-familiar with the program.

When Giangiulio finally told him he was Patient No. 1, Patient No. 7 “came launching out of his chair” to hug him.

“He said, ‘I owe you my life,’” Giangiulio recalled.

After Giangiulio responded that it was the doctors he really owed, Patient No. 7 said he had specifically asked how Patient No. 1 was doing when McLean first offered the program to him.

“She explained that I was going to be No. 7. … I didn’t care about 6, 5, 4, 3 or 2. I wanted to know how No. 1 was doing,” Giangiulio recalled of the conversation. “He said, ‘That was you. … They told me how well you were doing and that if I wanted you’d come here and talk to me, so I owe you.’”

Giangiulio feels strongly about giving back and reciprocating the good fortune he’s had. That’s why he talks to fellow patients and the media to share his story—because it could save other people’s lives, too.

He can’t do as much physical labor as he used to, but he remains involved in the excavating company he owns with his brothers and is the Emergency Management Coordinator for Waterford Township, New Jersey. He also serves on the township’s planning board and was previously Director of Public Safety.

“To me, he’s Superman,” Carin Giangiulio said. “It was insane, completely insane what the human body can endure and still survive.”

That now includes being given a heart with Hepatitis C and then wiping out the virus with the help of modern medicine.

“I would tell (other transplant candidates) to not fear it, especially if you’re here at Penn,” Giangiulio said. “I know there’s a lot of good hospitals across the country, but my loyalty kind of lies here for understandable reasons.”

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

2016

People with blood type O have been reported to be protected from coronary heart disease, cancer, and have lower cholesterol levels.

https://pharmaceuticalintelligence.com/2016/01/11/people-with-blood-type-o-have-been-reported-to-be-protected-from-coronary-heart-disease-cancer-and-have-lower-cholesterol-levels/

2015

A Patient’s Perspective: On Open Heart Surgery from Diagnosis and Intervention to Recovery

https://pharmaceuticalintelligence.com/2015/05/10/a-patients-perspective-on-open-heart-surgery-from-diagnosis-and-intervention-to-recovery/

No evidence to change current transfusion practices for adults undergoing complex cardiac surgery: RECESS evaluated 1,098 cardiac surgery patients received red blood cell units stored for short or long periods

https://pharmaceuticalintelligence.com/2015/04/08/no-evidence-to-change-current-transfusion-practices-for-adults-undergoing-complex-cardiac-surgery-recess-evaluated-1098-cardiac-surgery-patients-received-red-blood-cell-units-stored-for-short-or-lon/

2013

ACC/AHA Guidelines for Coronary Artery Bypass Graft Surgery

https://pharmaceuticalintelligence.com/2013/11/05/accaha-guidelines-for-coronary-artery-bypass-graft-surgery/

On Devices and On Algorithms: Arrhythmia after Cardiac SurgeryPrediction and ECG Prediction of Paroxysmal Atrial Fibrillation Onset

https://pharmaceuticalintelligence.com/2013/05/07/on-devices-and-on-algorithms-arrhythmia-after-cardiac-surgery-prediction-and-ecg-prediction-of-paroxysmal-atrial-fibrillation-onset/

 

Editor’s note:

I wish to encourage the e-Reader of this Interview to consider reading and comparing the experiences of other Open Heart Surgery Patients, voicing their private-life episodes in the ER that are included in this recently published volume, The VOICES of Patients, Hospital CEOs, Health Care Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures.

https://pharmaceuticalintelligence.com/2017/11/21/the-voices-of-patients-hospital-ceos-health-care-providers-caregivers-and-families-personal-experience-with-critical-care-and-invasive-medical-procedures/

 

I also wish to encourage the e-Reader to consider, if interested, reviewing additional e-Books on Cardiovascular Diseases from the same Publisher, Leaders in Pharmaceutical Business Intelligence (LPBI) Group, on Amazon.com.

  • Perspectives on Nitric Oxide in Disease Mechanisms, on Amazon since 6/2/12013

http://www.amazon.com/dp/B00DINFFYC

  • Cardiovascular, Volume Two: Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation, on Amazon since 11/30/2015

http://www.amazon.com/dp/B018Q5MCN8

  • Cardiovascular Diseases, Volume Three: Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics, on Amazon since 11/29/2015

http://www.amazon.com/dp/B018PNHJ84

  • Cardiovascular Diseases, Volume Four: Regenerative and Translational Medicine: The Therapeutics Promise for Cardiovascular Diseases, on Amazon since 12/26/2015

http://www.amazon.com/dp/B019UM909A

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WEGO Health Awards Competition Focuses on Patients

Author: Gail S. Thornton, M.A., PhD(c)

WEGO Health, a network of over 100,000 influential members of the online health community, empowers patients who drive the health care conversation online.

For their annual “health activist” award competition this year, Gail Thornton, was nominated as the editor/author of a series of compelling patient profiles on chronic and invasive medical conditions that are posted on the online scientific journal, Leaders in Pharmaceutical Business Intelligence.

“The story of patients and their health journey is a critical one to tell and I was blessed to have such inspirational, caring people who shared their lives with me,” said Gail Thornton.” Also many thanks to  Aviva Lev-Ari for her vision in creating this series — and for considering me to be part of it all.”

The series also will be part of an e-book, entitled, The VOICES of Patients, Health Care Providers, Care Givers and Families: Personal Experience with Critical Care and Invasive Medical Procedures, Leaders in Pharmaceutical Business Intelligence (LPBI) Group. Here is the link:  https://pharmaceuticalintelligence.com/biomed-e-books/series-e-titles-in-the-strategic-plan-for-2014-1015/2014-the-patients-voice-personal-experience-with-invasive-medical-procedures/

final series E covers volumes 1_4-vol1

 

“Your contribution to the e-Book is very substantial in bringing the LIVE voices of Patients and Health Care Providers to the EAR of the Public at large,” said Aviva Lev-Ari, Ph.D., R.N., on 9/13/2016, Director and Founder, Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston.

Also thanks to Gabriela Contreras for suggesting some of these patients.

Please visit the the link below to review Gail’s nomination details and to endorse her!

https://awards.wegohealth.com/nominees/12485

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Nathalie’s Story: A Health Journey With A Happy Ending

Patient was diagnosed with adenocarcinoma of the duodenum over two years ago and had tumor removed at age 35. Interview was conducted 2+ years post-surgery.

Author: Gail S. Thornton, M.A.

Co-Editor: The VOICES of Patients, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures

 

Nathalie Monette of Laval, the third largest city in Quebec, Canada, counts her blessings each and every day. The 35-year-old is looking forward to making her mark on a bright and promising future as a newly married woman with a supportive family, new job as head of internal communications for a public service organization, and a new lease on life. Diagnosed a little over two years ago with a rare cancer called adenocarcinoma of the duodenum, Nathalie never envisioned that her life would take many twists and turns before she and her doctors arrived at an optimal treatment regimen.

Nathalie describes some of the classic warning signs she had for about six months before her actual medical diagnosis: abdominal cramping, nausea, vomiting, acid reflux and loss of weight.

“I felt sick all the time. I was losing weight and had pain in my upper abdomen after eating. My condition was getting worse with each week. My boyfriend, Jeff, at the time, who is now my husband, took me to several doctors who initially listened to my list of symptoms, examined me and told me to take antacids and avoid stress – and sent me home. It was increasingly becoming more difficult to manage my life, my relationships, and my job.”

The doctors in one hospital that she visited even considered she might be having a cardiovascular incident, since she was vomiting, was nauseous and had a stomach ache. Her blood levels were normal, which didn’t help the doctors, who, again, could find no serious health issue and sent her home.

Image SOURCE: Photographs courtesy of Nathalie Monette on the day of her wedding to Jeff. Top Left: Nathalie with her parents, Céline and Jean-Claude. Top Right: Nathalie with Jeff, and her two sisters, Julie and Marie-Claude. Below Right: Nathalie and Jeff.

For the next few weeks, Nathalie visited hospital after hospital in search of finding a more steadfast diagnosis of her condition – and a doctor who would listen to her and treat her symptoms.

“I was weak and vomiting. At this point, I kept losing weight — about 40 pounds in a total of six months.”

She decided to take the situation in her own hands and changed her diet, eliminating gluten, spices, and other major food groups. Nothing seemed to relieve her symptoms. She knew reading about possible medical conditions on the internet could cause additional stress. Having worked in the pharmaceutical industry, she was glad she knew where to look and what sources of information could be trusted.

Continued Search For Answers

“The medical system in Quebec is complicated,” she said. “In this public system, there is no family doctor assigned to you who follows your care year after year. And since I was perceived by the system as a young, relatively healthy woman, I was put on a waiting list for 3 to 4 years to be assigned to a general practitioner.”

Frustrated, hopeless and fearful for her health, Jeff got more involved in her diagnosis and took her to yet another hospital. Nathalie’s search took her from hospital to hospital and doctor to doctor with no known diagnosis.

“I was very angry, disappointed and at the end my rope. I just wanted to feel better and live my life.”

Then, one day, there was a ray of hope – and it took six months to find it. At a nearby hospital called Hôpital de St-Eustache where Jeff decided to take her, she came across two young physicians, Dr. Annie-Claude Bergeron, an emergency room doctor, and Dr. Marie-Hélène Gingras, a gastroenterologist, who happened to be Nathalie’s same age. Dr. Bergeron listened to her symptoms, examined her, and was determined to help her. A day later, Dr. Gingras ran several diagnostic tests, including an endoscopy and ultrasound, and more specialized blood tests.

“While undergoing the endoscopy, the doctor couldn’t find anything remarkable and was about to remove it. She decided to push the camera 5cm farther into my duodenum – and found the cause of my illness.”

Finally, Nathalie had definitive results. She had a 3½ cm (1.4 inches) tumor in her duodenum.

Dr. Gingras was devastated by the news she had to share. She called specialists in Montreal who would operate on Nathalie. Dr. Simon Turcotte, physician, hepatopancreatobiliary and liver transplantation expert who specializes in gastrointestinal cancer immunobiology and solid tumor immunotherapy, took her case.

“When Dr. Gingras told me about my condition, I was relieved and afraid at the same time. My heart sank when I got the news.”

Nathalie had a rare cancerous condition that only shows up in a handful of older people. It also was unusual that the tumor was situated in the duodenum rather than the colon, where most tumors of this variety normally occur. She also didn’t have history of that type of cancer in her family. She couldn’t even be tested for any genetic markers, since no genes have been identified as markers for this rare condition.

So, three weeks later, Nathalie was transferred to Hôpital Saint-Luc in Montreal, for a, hopefully, life-saving surgery. She had to trust her new expert, Dr. Turcotte, with her life.

“There was no room for error in removing the tumor. It was situated 1mm from my pancreas and every other vital organ I needed to survive.”

By nature, Nathalie is a strong, fiercely independent woman and there was no doubt she would come through the operation with flying colors.

About one month after surgery, she was scheduled for six months of chemotherapy to ensure that the cancer was eradicated. One day every two weeks, she received a powerful cocktail of Folfox (Leucovorin®, 5-FU, Adrucil® and Eloxatin®).

“Because of the chemotherapy, I had a minimal appetite, could not taste any food, could not drink or touch anything cold and needed to keep my weight at the same level.”

Her parents, Céline and Jean-Claude, two sisters, Julie and Marie-Claude, and Jeff, of course — were of great support and encouragement for her. Jeff insisted to meet with her nutritionist to determine a health plan so that she received the necessary nutrients in her food. Because Nathalie could not taste any food because of the chemotherapy, she tricked her mind by eating meals that she remembered from her childhood days. In that way, she was transported back in time mentally and she thought about the great food she had when she was growing up. Her parents were always on hand to cook these traditional meals that were filled with protein, spices, salt and fat to give her the added boost (and some taste) to help her system recover.

Duodenum, A Complex, Powerful Organ

Nathalie describes the duodenum as a complex organ – a C-shaped, hollow tube about 25-38 cm (10-15 inches) long, largely responsible for the enzymatic breakdown of food in the small intestine.

“This small but powerful organ is the shortest part of the small intestine which regulates the rate of how the stomach empties.”

According to the Inner Body web site, the duodenum receives partially digested food, called chyme, from the stomach and plays a vital role in the chemical digestion of chyme in preparation for absorption in the small intestine. Many chemical secretions from the pancreas, liver and gallbladder mix with the chyme in the duodenum to help chemical digestion. http://www.innerbody.com/image_dige02/dige21.html

Back to Normal

Nathalie’s life is back to normal, as much as it can be after such a medical ordeal.

“The past is just the past. I try not to think about the trauma that I’ve been through. I look forward as that is what is important.”

She got married last August (2015) to Jeff, who demonstrated his love to her the best way possible in caring for her throughout this ordeal. They met on the internet in 2010, at a moment when Nathalie wanted to leave the dating scene to focus on personal projects. They talked, met shortly after, and became great friends. Only a year later did Nathalie accept to be in a relationship with Jeff.

“About one week after my surgery when I was home, Jeff proposed marriage to me. I was visiting my family for Easter and Jeff had prepared everything. He had first asked my parents for my hand in marriage in the hospital a few weeks prior to my surgery. Then he prepared a charade with answers that related to the strength of his feelings for me. Funny enough, I did not understand what was going on at that point. Little did I know, he was declaring his love and it’s when he showed me a ring that I understood. Of course, I was overwhelmed with emotion and very touched that he got my family involved in the event.

“I am under regular care of my medical team of seven doctors – a gastroenterologist, oncologist surgeon, family general practitioner and many other specialists. I’ve had follow-up appointments at three months, six months, and one year. Those appointments include a gastroscopy, colonoscopy, scan, and blood tests, and so far, my health is the best ever. I like to tease the doctors when I see my charts – I look like an athlete on paper! In our Canadian medical system, each specialist treats only that part of the body. I make sure that all my test results are xeroxed and sent in advance of my appointment to each doctor. That takes time, but I am assured that everyone sees the same test results and can make educated decisions. That also makes for a more holistic view of my life.”

Advocate for Patient’ Rights

“Knowledge, access to information and caregiver support are probably the three most important factors in patient care. Medicine on its own is just not enough. Patients need a support system to balance out the highs and lows of searching through a medical condition, diagnosis and treatment plan. I hope one day to advocate for patient voices as it is a much needed part of our medical system.

“In hindsight, I realize all the doctors who saw me during the six months that I suffered prior to my diagnosis could not have known about my condition, unless they ran more tests. Surprisingly, I had done blood tests before that time for long-term disability insurance. The insurer had refused to insure me without explanation. Starting to be very sick, I did not pursue the work with them to understand their decision. Unfortunately, I learned a few weeks after my surgery that their test revealed the count of a certain type of protein was too high, therefore, too risky for them to insure me. They knew I was seriously sick but took about eight months to let me know. Had the insurer shared their results sooner, had doctors ran similar blood tests, or done a scan, I would have been diagnosed way sooner, which could have resulted in not needing chemotherapy.”

Incidence of Adenocarcinoma

Adenocarcinomas or malignant tumors of the duodenum are extremely rare, uncommon and difficult to manage and treat, according to Drs. P.L. Fagniez and N. Rotman in a book chapter in Surgical Treatment – Evidence-Based and Problem-Oriented, a medical textbook that assesses currently accepted clinical practice that takes into account when recommendations for patient treatment are made.The tumors represent 0.3 percent of gastrointestinal tract tumors and up to 50 percent of small bowel malignancies. They may arise from duodenal polyps or they may be associated with Celiac Disease. Five-year-survival varies widely according to published reports in the medical literature, but it is generally reported to be greater than 40 percent if the tumor is surgically removed. http://www.ncbi.nlm.nih.gov/books/NBK6953/.

Due to the low incidence of the disease globally, there is no randomized study comparing different types of treatment. In fact, the medical literature only discusses a small number of patients with this condition, who are usually older, or patients who are seen over a period of time. The treatment plan is complete surgical removal of the tumor, which is the only hope for a cure. Nonetheless, good long-term results have been observed with segmented tumor removal, particularly for tumors of the distal part of the duodenum, according to the same book chapter mentioned in the paragraph above.

A Bright Future Ahead

Nathalie believes in second chances and the value of waking up each and every day to new challenges and opportunities.

“Life is to be lived and enjoyed. I love what I do and I cherish my relationships, my work and my free time. In whatever I do, I give 100 percent.”

She believes she is very lucky to have had the diagnosis at this time of her life.

“In a way, my parents, my family, my husband were always present in my health journey. They followed up on doctors’ appointments, helped me with daily living chores, researched the medical literature, contacted new doctors, and generally, were my sounding board on everything. They were invaluable to me and it was my privilege that I am blessed with such a supportive family.

“I believe the road is set for you in life and it is up to all of us to seize the moment. My condition has given me strength to explore who I am and validate the way I always approach life.”

Nathalie Monette provided her permission to publish this interview on July 30, 2016.

 

Search Title:

Duodenum AND Cancer | Open Studies | Exclude Unknown in ClinicalTrials.gov Database. The search was conducted on July 30, 2016 and there were  45 studies found.

Presented, below, is a Subset of Clinical Trials on the List of 45 Studies related to Duodenum AND Cancer

https://clinicaltrials.gov/ct2/results?term=duodenum+AND+Cancer&recr=Open&no_unk=Y

SEE LINK, Below for the list of clinical trials currently recruiting:

Subset of Clinical Trials on the List of 45 Studies – Duodenum AND Cancer (6)

Or you may click on the following individual links below for clinical trials that are currently recruiting:

Spectroscopy From Duodenum

Condition: Pancreatic Adenocarcinoma
Intervention: Other: Spectroscopy device

A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy

Conditions: Pancreatic Neoplasms;   Biliary Tract Neoplasms;   Pancreatitis, Chronic;   Duodenal Neoplasms
Intervention: Procedure: pancreaticojejunostomy

Endoscopic Characteristics of Duodenal and Ampullary Lesions

Condition: Duodenal Diseases
Intervention: Other: Tissue Sampling

EUS GUIDED Transduodenal Biopsy Using the 19G Flex

Condition: Abdominal Neoplasms
Intervention: Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)

Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

Condition: Gastric Cancer
Interventions: Device: gastroduodenal stent placement;   Procedure: gastrojejunostomy

Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

Condition: Polyps
Intervention: Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD

Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla

Condition: Adenoma, Villous
Intervention: Procedure: Endoscopic Mucosal Resection

Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Condition: Adenoma
Interventions: Drug: octreotide;   Other: No octreotide

 

The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy

Condition: Pancreaticoduodenectomy
Interventions: Drug: 3% NaCl Solution;   Drug: Lactated Ringers Solution

Effects of Pancreaticoduodenectomy on Glucose Metabolism

Conditions: Diabetes Mellitus;   Glucose Intolerance
Intervention:  —

 

 

REFERENCES/SOURCES

https://clinicaltrials.gov/ct2/results?term=duodenum+AND+Cancer&recr=Open&no_unk=Y

http://www.innerbody.com/image_dige02/dige21.html

Other related articles:

Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK6953/.

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

 2016

LIVE 8:10 am – 11:20 am 4/27/2016 Combination Cancer Therapies: Drug Resistance and Therapeutic Index & Cancer Diagnostics: New Uses, New Reimbursements? & New Philanthropy: Patients Driving Innovation@2016 World Medical Innovation Forum: CANCER, April 25-27, 2016, Westin Hotel, Boston

https://pharmaceuticalintelligence.com/2016/04/27/live-810-am-1120-am-4272016-combination-cancer-therapies-drug-resistance-and-therapeutic-index-cancer-diagnostics-new-uses-new-reimbursements-new-philanthropy-patients-driving-i/

Colon cancer and organoids

https://pharmaceuticalintelligence.com/2016/04/15/colon-cancer-and-organoids/

Checkpoint inhibitors for gastrointestinal cancers

https://pharmaceuticalintelligence.com/2016/02/14/checkpoint-inhibitors-for-gastrointestinal-cancers/

2015

Gluten-free Diets

https://pharmaceuticalintelligence.com/2015/03/01/gluten-free-diets/

Gastrointestinal Endocrinology

https://pharmaceuticalintelligence.com/2015/02/10/gastrointestinal-endocrinology/

 

 

 

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Troponin I in acute decompensated heart failure: insights from the ASCEND-HF study

 

Writer and Curator: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN 

Felker GM, Hasselblad V, Tang WH, Hernandez AF, Armstrong PW, et al.
Eur J Heart Fail. 2012 Nov;14(11):1257-64. http://dx.doi.org/10.1093/eurjhf/hfs110 Epub 2012 Jul 4.

AIMS: We examined the prognostic importance of cardiac troponin I (cTnI) in a cohort of patients enrolled in the ASCEND-HF study of nesiritide in acute decompensated heart failure (ADHF). Circulating troponins are a prognostic marker in patients with ADHF. Contemporary assays with greater sensitivity require reassessment of the significance of troponin elevation in HF.

METHODS: Cardiac troponin I was measured in a core laboratory in 808 ADHF patients enrolled in the ASCEND-HF biomarkers substudy using a sensitive assay (VITROS Trop I ES, Ortho Clinical Diagnostics) with a lower limit of detection of 0.012 ng/mL and a 99th percentile upper reference limit (URL) of 0.034 ng/mL. Patients with clinical evidence of acute coronary syndrome or troponin >5× the URL were excluded. Multivariable modelling was used to assess the relationship between log(cTnI) and in-hospital and post-discharge outcomes.

RESULTS:

  • Baseline cTnI was undetectable in 22% and
  • elevated above the 99th percentile URL in 50% of subjects.

cTnI levels did not differ based on HF etiology. After multivariable adjustment, higher cTnI was associated with worsened in-hospital outcomes such as

  • length of stay (P = 0.01) and
  • worsening HF during the index hospitalization (P = 0.01), but
  • was not associated with worsened post-discharge outcomes at 30 or 180 days.

The relationship between cTnI and outcomes was generally linear and

  • there was no evidence of a threshold effect at any particular level of cTnI.

CONCLUSION:

  • cTnI is elevated above the 99th percentile URL in 50% of ADHF patients and
  • predicts in-hospital outcome, but
  • is not an independent predictor of long-term outcomes.

This reviewer finds the results quite interesting, and the study was done with care.   The Ortho Diagnostics method of cTnI is high-sensitivity assay, so that the lowest measureable level at < 10% CV is manyfold lower than the 4th generation assay.

Prior to the hs-cTNI, the diagnostic cutoff for

  • AMI was 1.0 ng/ml vs
  • the cTnT at 0.1 ng/ml using a ROC curve.

AMI did occur below the ROC cutoff in both cases, but the reasons for elevations other than AMI were determined to be CRF, and this was more accurate (a small probability with the cTnT between 0.085 and 0.1 ng/ml.

However, the findings in this study did indeed exclude symptomatic ACS, or cTnI at the level not > 5x ULN.  [0.17 ng/ml] with the hs-TnI.  The hs-cTnI assay opened up the identification of non-ACS elevation related to cardiomyocyte damage unrelated to plaque rupture, but related to a persistent coronary ischemia, possibly related to cardiomegaly and/or vascular rigidity.

Test Limitations

Troponins are not normally present in serum, so any amount present in serum (measured at the 99th percentile of the upper limit of normal at a 10% imprecision) indicates structural damage to the heart, although not necessarily AMI.

  • Both troponin I (TnI) and troponin T (TnT) are affected by renal insufficiency, but TnT is to a greater extent
  •  100% of TnT is excreted in urine, but 70% of TnI is degraded by vascular endothelium; this means that minor elevations of troponins have to be considered in the context of comorbidities, especially renal impairment, and risk factors
  • Among heart failure patients, the objective parameter of NT-proBNP seems more useful to delineate the “cardiorenal syndrome” than the previous criteria of a clinical diagnosis of heart failure

However, the NT-proBNP is best interpreted by using the log(NT-proBNP)/eGFR with an adjustment.

These investigators used the log(cTnI), which I would not have thought of in this case, but it is important to do because the distribution of the peptide levels in the study population would be nonparametric.  The median values at the time points are not given.  Actually, there are presumably, not definitely, two populations – if you were to infer short- and long-term outcomes measured as 30-days, and 180-days.  That a baseline cTNI was undetectable in 22% of patients is actually not so different than would be found in a random selection from patients presenting to the emergency department.  It should not be a surprise that the test as a single predictor, did not meet the requirement for long-term prediction of outcome, despite agreement with the in-hospital outcome.   This is consistent with the absence of ACS.

[1] Troponins (Cardiac-specific Troponin I and Troponin T).  LH Bernstein.  http://PathologyOutlines.com/Chemistry
[
2] Effect of renal function loss on NT-proBNP level variations. LH Bernstein, MY Zions, SA Haq, S Zarich, J Rucinski, B Seamonds, et al.  Clin Biochem 2009; 42(10-11):1091-1098. ICID: 937529  http://dx.doi.org/10.1016/j.clinbiochem.2009.02.027.
[3] Enhancing the diagnostic performance of troponins in the acute care setting. SA Haq, M Tavakol, S Silber, L Bernstein, J Kneifati-Hayek, M Schleffer, et al.  J Emerg Med 2008; x:x  ICID: 937619
http://www.nymethodistemergencymedicine.com/program/research.html   
[4] Comparison of test characteristics of cardiac troponin T in patients with normal renal function and chronic renal failure evaluated in the emergency department. S Silber, L Melniker, E Haines, LH Bernstein.
Academic Emergency Medicine 2006; 13(5):S1186-187.   ICID: 939943     http://www.nymethodistemergencymedicine.com/program/research.html
[5}  The ACC/ESC Recommendation for 99th Percentile of the Reference Normal Troponin I Overestimates the Risk of an Acute Myocardial Infarction: a novel enhancement in the diagnostic performance of troponins. “6th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke.” S Haq, M Tavakol, LH Bernstein, J Kneifati-Hayek, M Schlefer, S Silber, T Sacchi, J Pima. Circulation 2005; 111(20):e313-313. ICID: 939931
http://pt.wkhealth.com/pt/re/circ/toc.00003017-200505240-00000.htm
[6]  Minor elevations in troponin T values enhance risk assessment in emergency department patients with suspected myocardial ischemia: analysis of novel troponin T cut-off values. SW Zarich, K Bradley, ID Mayall, LH Bernstein.
Clin Chim Acta 2004; 343(1-2):223-229.  ICID: 825515     http://www.ncbi.nlm.nih.gov/pubmed/15115700
[7]  GOLDmineR: improving models for classifying patients with chest pain. L Bernstein, K Bradley, SW  Zarich.  Yale J Biol Med  2002; 75(4):183-198.  ICID: 825624
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2588788/

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

High-Sensitivity Cardiac Troponin Assays- Preparing the United States for High-Sensitivity Cardiac Troponin Assays

Reporter: Larry Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2013/06/13/high-sensitivity-cardiac-troponin-assays/

Dealing with the Use of the High Sensitivity Troponin (hs cTn) Assays

Larry Bernstein and Aviva Lev-Ari
https://pharmaceuticalintelligence.com/2013/05/18/dealing-with-the-use-of-the-hs-ctn-assays/

Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI – Corus CAD, hs cTn, CCTA
Aviva Lev-Ari
https://pharmaceuticalintelligence.com/2013/03/10/acute-chest-painer-admission-three-emerging-alternatives-to-angiography-and-pci/

  • Redberg’s conclusions are correct for the initial screening. The issue has been whether to do further testing for low or intermediate risk patients.
  • The most intriguing finding that is not at all surprising is that the CCTA added very little in the suspect group with small or moderate risk.
  • The ultra sensitive troponin threw the ROC out the window
  • The improved assay does pick up minor elevations of troponin in the absence of MI.

Critical Care | Abstract | Cardiac ischemia in patients with septic …
Aviva Lev-Ari
https://pharmaceuticalintelligence.com/2013/06/26/critical-care-abstract-cardiac-ischemia-in-patients-with-septic/

  • refer to:  Cardiac ischemia in patients with septic shock randomized to vasopressin or norepinephrine

Mehta S, Granton J,  Gordon AC, Cook DJ, et al.
Critical Care 2013, 17:R117   http://dx.doi.org/10.1186/cc12789
Troponin and CK levels, and rates of ischemic ECG changes were similar in the VP and NE groups. In multivariable analysis

  • only APACHE II was associated with 28-day mortality (OR 1.07, 95% CI 1.01-1.14, p=0.033).

Assessing Cardiovascular Disease with Biomarkers
larryhbern
https://pharmaceuticalintelligence.com/2012/12/25/assessing-cardiovascular-disease-with-biomarkers/

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What is Acute Heart Failure?

What is Acute Heart Failure? (Photo credit: Novartis AG)

Troponin activation. Troponin C (red) binds Ca...

Troponin activation. Troponin C (red) binds Ca2+, which stabilizes the activated state, where troponin I (yellow) is no longer bound to actin. Troponin T (blue) anchors the complex on tropomyosin. (Photo credit: Wikipedia)

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The Automated Second Opinion Generator

Larry H. Bernstein, MD

Gil David and Larry Bernstein have developed a first generation software agent under the supervision of Prof. Ronal Coifman, in the Yale University Applied Mathematics Program that is the equivalent of an intelligent EHR Dashboard that learns.  What is a Dashboard?   A Dashboard is a visual display of essential metrics. The primary purpose is to gather information and generate the metrics relatively quickly, and analyze it, meeting the highest standard of accuracy.  This invention is a leap across traditional boundaries of Health Information Technology in that it integrates and digests extractable information sources from the medical record using the laboratory, the extractable vital signs, EKG, for instance, and documented clinical descriptors to form one or more  provisional diagnoses describing the patient status by inference from a nonparametric network algorithm.  This is the first generation of a “convergence” of medicine and information science.  The diagnoses are complete only after review of thousands of records to which diagnoses are first provided, and then training the algorithm, and validating the software by applying to a second set of data, and reviewing the accuracy of the diagnoses.

The only limitation of the algorithm is sparsity of data in some subsets, which doesn’t permit a probability calculation until sufficient data is obtained.  The limitation is not so serious because it does not disable the system from recognizing at least 95 percent of the information used in medical decision-making, and adequately covers the top 15 medical diagnoses.  An example of this exception would be the diagnosis of alpha or beta thalassemia, with a microcytic picture (MCV low) and RBC high with a low Hgb).  The accuracy is very high because the anomaly detection used for classifying the data creates aggregates that have common features.  The aggregates themselves are consistent within separatory  rules that pertain to any class.  As the model grows, however, there is unknown potential for there to be prognostic, as well as diagnostic information within classes (subclasses), and a further potential to uncover therapeutic differences within classes – which will be made coherent with new classes of drugs (personalized medicine) that are emerging from the “convergence” of genomics, metabolomics, and translational biology.

The fact that such algorithms have already been used for limited data sets and unencumbered diagnoses in many cases using the approach of studies with inclusions and exclusions common for clinical trials, the approach has proved ever more costly when used outside the study environment.   The elephant in the room is age-related co-morbidities and co-existence of obesity, lipid derangements, renal function impairment, genetic and environmental factors that are hidden from view.  The approach envisioned is manageable, overcoming these obstacles, and handles both inputs and outputs with considerable ease.

We anticipate that the effect of implementing this artificial intelligence diagnostic amplifier would result in higher physician productivity at a time of great human resource limitation(s), safer prescribing practices, rapid identification of unusual patients, better assignment of patients to observation, inpatient beds, intemsive care, or referral to clinic, shortened length of patients ICU and bed days.  If the observation of systemic issues in “To err is human” is now 10 years old with marginal improvement at great cost, this should be a quantum leap forward for the patient, the physician, the caregiving team, and the society that adopts it.

 

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Guidelines for the Diagnosis and Treatment of Endocarditis

from

British Society of Antimicrobial Chemotherapy (BSAC)

Clinicians who care for patients diagnosed with infective endocarditis (IE) are (un)fortunate to be able to refer to several guidelines about its diagnosis and treatment. The guidelines vary considerably, especially with regards to antibiotic prescribing recommendations, which generally reflect local practice and expert opinion in light of largely observational data. All guidelines recommend a multidisciplinary approach to the management of IE.

Infective endocarditis

Infective endocarditis (Photo credit: Wikipedia)

Echocardiography remains a cornerstone of IE diagnosis but is neither 100% sensitive nor specific and multiple scans may be needed to identify vegetations. Echocardiography should also be used in all patients with Staphylococcus aureus bacteraemia. The prevalence of IE among patients with S aureus bacteraemia is variable but was reported as 13% in one large prospective US study and 22% in a recent European study. Clinical assessment is unreliable in diagnosing IE in patients with S aureus bacteraemia and without echocardiography the diagnosis may be missed. Transoesophageal echocardiography is now recommended in most cases of suspected or confirmed IE but may be unnecessary in patients with right-sided valve involvement.

Establishing a microbiological diagnosis in an era of increasingly complex infections with unpredictable resistance patterns is important. However, traditional recommendations for blood culture sampling have been amended for patients with suspected IE and severe sepsis or septic shock. In this situation, two (rather than three) sets of blood cultures, taken at different times within an hour before the start of empirical treatment, are now advised. This is a pragmatic recommendation to avoid undue delay in starting empirical antimicrobial treatment. In other patients, the usual need for three sets of blood cultures is recommended but with at least 6 h between sampling times; an important aim of multiple sampling is to demonstrate the presence of a sustained or persistent bacteraemia, which is characteristic of IE. Identification of atypical micro-organisms using serology in culture-negative cases should be limited to Coxiella and Bartonella in the first instance—a reflection of the extremely small numbers of reported cases of IE caused by Mycoplasma, Brucella and Legionella.

Fungal causes of IE should be considered in culture-negative IE if serology is non-diagnostic and the patient is immunocompromised, has a prosthetic valve, is an intravenous drug user or is not responding to empirical antibacterial treatment. The application of broad-range (16S ribosomal RNA gene) PCR on surgically resected valves or embolic material should be used when culture has failed. False-negative 16S ribosomal RNA gene PCR reactions can occur in the presence of inhibitors of the DNA polymerase within clinical samples or as a result of the vagaries of sampling (ie, processing a piece of tissue that does not contain any bacteria). Bacterial DNA has been shown to be present within cardiac tissue several years after successful treatment of IE, so results should be interpreted with caution in a patient with a previous diagnosis of IE. Application of 16S ribosomal gene PCR to blood in patients with IE is problematic owing to the low levels of bacteria present (1–10 fu/ml) and subsequent difficulty in DNA extraction; as a result it is not currently available for routine clinical use.

Empirical treatment (that started before obtaining a microbiological diagnosis) is generally discouraged, except in those who are acutely unwell or shocked. There is no clear evidence that speeding up the diagnosis, and instigation of treatment, improves outcomes, although this would seem intuitive. Early treatment (started within days of onset of symptoms rather than weeks) is a laudable aim, but the few days delay in hospital while appropriate echocardiographic and microbiological tests are undertaken on a stable patient are unlikely to have a negative impact on outcome. Conversely, the administration of broad-spectrum antibiotics when the diagnosis of IE has not been considered (and often when inadequate samples have been obtained) may have considerable impact on the ability to establish the diagnosis and subsequently deliver effective treatment.

Outpatient antibiotic treatment (OPAT) for IE is included in the BSAC guidelines in response to increasing efforts to expand these services and manage more patients outside hospital. Patients who might be considered for OPAT include those who are stable and responding well to treatment, are without signs of heart failure and without any indications for surgery or uncontrolled extracardiac foci of infection. Delivery of OPAT requires appropriate funding, support and infrastructure, coupled with the ability to rapidly access inpatient services and obtain urgent expert advice if needed. This has been proved to be feasible and safe in the UK, even in high-risk IE cases.

Although the guidelines include recommendations for most causes of IE, the predominant pathogens remain staphylococci, streptococci and enterococci. Routine addition of gentamicin to flucloxacillin for the treatment of native valve staphylococcal IE is no longer recommended (see Table 1). This recommendation is unchanged from previous BSAC guidelines but the ESC continue to include gentamicin as an optional addition. Further evidence of the toxicity of gentamicin has been published, based on findings from a randomised controlled trial comparing daptomycin with either vancomycin or cloxacillin plus gentamicin for the treatment of S aureus bloodstream infection or IE Recommendations for meticillin-resistant staphylococci also differ from those of the ESC; although vancomycin is the primary agent in both sets of guidelines, rifampicin is recommended by BSAC in place of gentamicin because of concerns about efficacy and toxicity. Daptomycin, a recently licensed lipopeptide, is also recommended as an alternative agent for patients who are intolerant to vancomycin or have infection caused by vancomycin-resistant isolates.

Previous recommendations for treatment of streptococcal IE have been simplified, with greater emphasis placed on benzylpenicillin rather than amoxicillin as the primary agent to reduce risk of Clostridium difficile infection. Enterococcal treatment regimens are largely consistent with the ESC guidelines, though a low threshold for withdrawing gentamicin in patients with deteriorating renal function or other signs of toxicity is advised, based on observational data that shorter gentamicin courses are not associated with worse outcomes.

The timing of cardiac surgery in IE should be evaluated by the multidisciplinary team on a case by case basis. Attempts to advise whether cardiac surgery should be emergent, urgent or elective can seem artificial. The traditional indications for surgery in IE are well established but it is becoming apparent that patients with IE caused by S aureus, or patients with evidence of systemic embolisation, should also be considered for early surgery, which may confer a mortality benefit.

Device-related infections have been deliberately omitted from the current BSAC guidance as the challenges in preventing, diagnosing and treating cases of intracardiac device IE are different from ‘traditional’ native or prosthetic valve IE. Further specific device-related guidance is likely to be published in the future and a joint working party involving the BSAC, BCS and Heart Rhythm UK has been established. IE guidelines are always imperfect owing to the difficulties in studying this relatively uncommon condition and the scarcity of randomised trials. At present, we are uncertain of the incidence, risk factors, causative micro-organisms (and their antimicrobial sensitivities), and patient outcomes in IE affecting the UK population. A recently established national endocarditis database may help to answer some of these questions, but its success will be crucially determined by the degree of support and national participation. See http://www.neemo.leedsth.nhs.uk/ (only via the N3 network) for details.

see source for more

Reported by: Dr. V. S. Karra, Ph.D

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