Heart Failure Surgeries  
Heartbytes
New CHF Drugs
IV Drugs
Coreg & beta-blockers
ACE Inhibitors
ICDs & More
   
Archived articles here     Updated October 9, 2006

Surgery Links

 

 The More The Better

December 26, 2000 - Angioplasty outcomes are linked to how many of them doctors and hospitals do every year. Dr. David Magid studied data on 63,000 heart attack patients who had either angioplasty or clot-busting therapy in 400 different hospitals. The hospitals were classed by how many angioplasties they did each year. Low volume meant doing less than 16 a year, moderate volume meant 17 to 48 a year and high volume meant 49 or more a year.
     At hospitals doing less procedures, patient survival was about the same as for patients getting clot-busting therapy. At hospitals doing moderate to high numbers of angioplasty, outcomes were much better for angioplasty patients. "We saw a 40% higher survival rate at the highest-volume centers than with clot-busting therapy," Dr. Magid said.
     In the second study, Dr. Paul McGrath studied data on 167,000 patients 65 years or older who had angioplasty in 1997. This included 1000 hospitals and 6500 doctors. "We looked at overall hospital and operator experience with angioplasty. Patients operated on by low-volume operators (doctors) are 45% more likely to need bypass surgery later during the same episode of care. For patients at low-volume centers, risk of death during the same episode of care was 36% higher," Dr. McGrath said.
     A doctor should do at least 75 procedures each year, and do them at centers hosting over 400 procedures each year, according to the American College of Cardiology.
 
Source: JAMA 2000;284:3131-3144,3169-3171

 Fat Particles Cause Harm During Surgery

March 3, 2000 - Many patients on a heart-lung bypass machine during surgery have problems with mental function afterward. New research has shown one likely cause: Tiny fat particles called microemboli enter the bloodstream during heart/lung bypass and may block small blood vessels in the brain.
     The longer a patient spends on the heart-lung machine, the more microemboli that occur in the brain. In fact, every hour on the machine increases microemboli by 91%. At least half of all patients placed on a heart/lung bypass machine have some neurological and mental loss in the week after surgery. Ten to 30% have permanent problems, and 1% to 5% die or become permanently disabled.
     Brown studied the brains of 36 people who died within 3 weeks after surgery; all had used a heart-lung machine. Researchers inspected blood vessels in the basal ganglia - a collection of nerves near the middle of the brain. They chose this area because it has many blood vessels running through it.
     "We saw swollen areas in the blood vessels, which were mainly fat," said Brown. "It looked like a snake that swallowed an egg." As time passed after surgery, the microemboli seemed to break down into smaller particles that could pass through the vessels.
     During heart surgery, surgeons must cut through fatty tissue in the chest. The fat then drips into the blood around the heart. When physicians suction up the blood, they apparently suction up some of this fat as well, which is returned into the heart-lung machine and sent back into the patient's blood stream.
     "This scavenging of blood is now a big concern," said Brown. "And we have evidence that if you don't use scavenged blood, you can considerably reduce this problem." He suggested that patients could donate and store their own blood before surgery so the stored blood could be used instead of the scavenged blood. "Reducing the length of time surgery takes would also help," he added.
 
Source: Stroke (2000;31)

 Different Surgery Techniques Protect Mental Function 

January 26, 2006 - Many people who have CABG suffer reduced ability to think and remember things afterward. A surgical method that causes less stress on the body's main blood vessel - the aorta - may help. Using a single crossclamp on the aorta that uses less force than the usual multiple crossclamps during bypass surgery prevents some mental loss.
     Dr. John Hammon and other researchers studied 67 patients having the usual multiple-clamp method. Another group of 102 patients had surgery using the single-clamp method. Another 68 patients had bypass surgery without using a heart bypass machine, called OPCAB. All patients were at higher than usual risk for mental function problems, with all having either advanced age, diabetes, or high blood pressure.
     Patients had a complete neuropsychological exam before surgery, then again after surgery at 3 to 5 days, 6 weeks, and 6 months. Immediately after surgery, about 60 to 70% of all groups showed reduced mental function. At 6 weeks, the reduced mental function was only 32% in the single-clamp group versus 51% in the usual-surgery group. The OPCAB group showed 39% having reduced mental function.
     At 6 months, 57% of the usual-surgery group showed reduced mental function while 30% of the single-clamp and 32% of the OPCAB patients showed problems. Note that other methods were also used to help prevent mental decline, such as filters and techniques to reduce small particles escaping into the blood and improved equipment.
     Since the off-pump group did almost as well as the single-clamp group, but the usual-surgery group really suffered, shows that surgical techniques matter. A surgical approach that includes different ways to prevent mental decline can really help!
 
Source: Reuters Health
Title: Single crossclamp improves 6-month cognitive outcome in high-risk coronary bypass patients: the effect of reduced aortic manipulation.
Authors: Hammon JW, Stump DA, Butterworth JF, Moody DM, Rorie K, Deal DD, Kincaid EH, Oaks TE, Kon ND.
Source: J Thorac Cardiovasc Surg. 2006 Jan;131(1):114-21.
PMID: 16399302.

 Particle Trap Prevent Stroke

May 21, 2002 - (See a good visualization of a stent at mbbnet.umn.edu/icons/stent.jpeg) A system used when putting a stent in your neck's carotid artery filters loose particles out of blood to prevent clots and strokes.
     Stroke often happens in people having carotid stenting. Particles are knocked loose into the blood stream. Those particles are carried along until they get stuck in a blood vessel too small to let them pass. This blocks blood flow to the brain and causes a stroke.
     Lead author Dr. Patrick Whitlow tested the "Guard-Wire" system for trapping these particles before they caused any harm. The system uses an elastic balloon on a steerable wire. The balloon can be inflated and deflated. A "sucking" catheter removes the trapped particles before the balloon is deflated. This stops them from traveling further through the blood stream.
     Dr. Whitlow tested the procedure in 75 patients with severe carotid artery blockage. All 75 patients were successfully treated with the system. No patients died, had a major or minor stroke, or were re-hospitalized within 30 days. Before the procedure, average blockage was 81% and after the procedure it was 5%.
     All the patients had easy-to-see particles removed by the trap system during the procedure. Twenty-two to 667 particles were taken from each patient - of many different sizes. Particles included plaque debris, and pieces of cholesterol.
 
Source: Stroke 2002;33:1308-1314

 Particle Trap Helps Prevent Stroke

September 24, 2002 - A heart catheter with a vacuum device safely removes particles from the blood during angioplasty and stenting. Dr. Gregg Stone presented results of the X-TRACT trial, including 797 patients having angioplasty with or without stents.
     Patients had either angioplasty alone or angioplasty with the X-SIZER Catheter System. This is a 2-part device with a metal-tipped catheter that breaks up the particle/clot, and a vacuum extractor that removes the particles from the blood.
     Within 30 days of surgery, 25 of 400 device patients (6%) had another heart attack or died, compared to 39 of 397 control patients (10%).
 
Source: Reuters Health

 Off-pump CABG Causes Fewer Strokes

February 9, 2001 - Stroke risk from CABG is less when the procedure is done without using a heart-lung bypass machine. Dr. Jacob Bergsland studied heart-lung machine use on stroke rate from heart surgeries. He recorded stroke rates of 292 patients who had on-pump CABG and 124 patients who had off-pump CABG. All had suffered a prior stroke - greatly raising their risk for stroke with this surgery.
     The surgery was a re-do procedure. Off-pump patients had more blockage in their aorta. The after-surgery stroke rate was over 9.2% in on-pump patients and 5.6% in off-pump patients. Risk of death and complications were the same in both groups.
     The heart-lung machine seems to be partly reponsible for strokes, according to Dr. Bergsland. "If you can do heart bypass operations without the heart-lung machine, you can reduce the stroke rate," he said. "Research has shown a tremendous number of small particles loose in the carotid and middle brain arteries during time on the heart-lung machine," Dr. Bergsland noted.
     "At our center, we do 94% of all our CABGs off-pump and we've had very good results," Dr. Bergsland said.
 
Source: The 37th Annual Meeting of the Society of Thoracic Surgeons

 Off-pump Bypass Gives Better Outcomes

February 22, 2001 - Off-pump CABG causes fewer blood clots to the brain and gives better outcomes than CABG done with a heart-lung bypass machine. Risk of death is the same.
     Dr. Jeffrey Lee studied 137 patients; 70 had standard bypass and 67 had off-pump bypass. The patient groups were very similar. Compared to patients who had standard bypass, off-pump patients had far less brain microemboli (27 versus 1766).
     Off-pump CABG patients also needed fewer transfusions (30% versus 47%), less intubation time (3 hours versus 9 hours), shorter stays in the ICU (1.5 days versus 2.8 days), and had shorter hospitalization (5 days versus 7 days). Dr. Lee's group believes that off-pump bypass "greatly reduces the system-wide inflammatory response caused by heart surgery."
 
Source: Chest 2001;119:25-30

 Stroke and A-Fib - PLAATP Device, 2002

April 9, 2002 - Most a-fib related strokes are caused by a blood clot in the left atrial appendage - a small pouch in the heart's left upper chamber. Such clots can block a blood vessel leading to the brain, causing a stroke. CHF patients with a-fib have an even higher risk for stroke.
     Doctors don't think the appendage is necessary for health. The blocking device is a self-expanding metal cage. The cage is covered with a membrane that blocks the atrial appendage and allows human tissue to grow into the device.
     Researchers sealed off the left atrial appendage in 15 chronic a-fib patients using a procedure called PLAATO. This uses a catheter to place a blocking device at the entrance to the appendage. All these patients were at high risk for stroke but were not able to take blood thinners.
     Using TEE to guide them, researchers move the PLAATO device to the entrance of the atrial appendage by cath. Once in the entrance to the appendage, the cage is expanded. Tiny spikes attached to it hold the device in place. Blood doesn't stick to the device, which effectively becomes part of the heart wall after 4 months in place.
     The appendage was successfully blocked in all 15 patients. During the procedure, 4 patients had the device removed and replaced with one of a different size. One patient had a complication during the procedure, but it was successfully done 4 weeks later. The procedures took about 90 minutes each.
 
Source: American Heart Association and the journal Circulation
Authors: Horst Sievert, Michael Lesh, Thomas Trepels, Heyder Omran, Antonio Bartorelli, Paola Bella, Toshiko Nakai, Mark Reisman, Dirk Fleschenberg, Ulrike Krumsdorf, Detlef Scherer

 Stroke and A-Fib - PLAATO Device, 2003

April 11, 2003 - This trial included 87 high-risk a-fib patients who had a PLAATO device implanted to prevent stroke. None of the patients could take blood thinners and all were high risk for stroke, having either diabetes, high blood pressure or a previous stroke in addition to a-fib.
     The procedure succeeded in all but one patient. Six patients had bleeding around their heart and 3 others had punctures in their heart during the procedure, while 3 had some intestinal bleeding. All these patients recovered with no major problems.
     Follow-up averages 10 months and has been 18 months long in some patients. There have been no major strokes. There have been one minor stroke and 2 TIAs, Dr. Sievert said. Two patients have died from events seemingly unrelated to the device. The first death was from pneumonia following a grand-mal seizure 6 months after the procedure. The second patient died from SCD 7 months after the procedure.
     All this suggests that PLAATO may become an alternative for a-fib patients who can't or won't take blood thinners like Coumadin. Study author Dr. Peter Block said there have been few long-term problems, with only 3 adverse events reported that might be related to the device in over 100 treated patients.
     Since all patients were at very high risk for stroke, the results are encouraging. Phase 3 of the PLAATO trial will enroll 300 patients and should be available in late 2004.
 
Presenter: Dr. Horst Sievert from Germany
Source: ACC Sessions 2003; Medscape CRM News 2003.

 Stroke and A-Fib - PLAATO Device Seems Safe

September, 2003 -The left atrial appendage was blocked using the PLAATO device in 9 patients. Echo, TEE, and neurologic exams were done before and during the procedure, as well as 2 days, 3 months, 6 months, and one year after the procedure. Six of the patients could not take blood thinners because of bleeding tendencies, one because of cerebral aneurysm, and 2 were allergic to warfarin (Coumadin).
     One patient had slight bleeding around the heart 48 hours after the procedure that went away within 3 months. Neurologic exams through a 5-month follow-up showed no new problems. Echoes showed no sticking of blood to the implanted device. The procedure and device seem safe.
 
Title: Mechanical occlusion of the left atrial appendage.
Authors: Omran H, Hardung D, Schmidt H, Hammerstingl C, Luderitz B.
Source: J Cardiovasc Electrophysiol. 2003 Sep;14(9 Suppl):S56-9.
PMID: 12950520.

 The Brain and Bypass Surgery

February 8, 2001 - More than half a million bypass surgeries are done in America every year. It is now known that although bypass restores blood flow to the heart, it has harmful effects on the brain. Four cognitive (ability to think) problems are often seen after CABG:

What about a later decline in mental function as long as 5 years after bypass? The investigators tested patients before surgery and did follow-up testing at hospital discharge and at 6 weeks, 6 months, and 5 years after surgery.
     At hospital discharge, researchers found a 53% decline in mental sharpness from before-surgery tests. This was better 6 weeks later, at 36%. It was better yet 6 months after surgery, at 24%. However, 5 years after surgery, 42% of patients were still below their before-surgery levels.
     The road seems to be up and down with mental changes after surgery. There is an immediate mental loss followed by improvement, then another "late" decline. People with thinking difficulty right after bypass were most likely to have another decline years later. This suggests that late decline is linked to something that happens during the surgery itself.
 
Title: Coronary Artery Bypass Surgery and the Brain
Authors: Ola Selnes, PhD; Guy McKhann, MD
Source: The New England Journal of Medicine; Vol. 344, No. 6

 Slow Warming Preserves Mental Function

May 15, 2000 - During heart surgery, surgeons use cold solutions to cool the patient's body temperature, This allows the heart to stay stopped longer. Now, slower rewarming of patients after CABG shows reduced risk of mental problems after heart surgery.
     Researchers studied 165 patients having CABG. During the operation, the team rewarmed 100 patients with the usual heated solutions. In the other 65 patients, Dr. Alina Grigore's team rewarmed patients more slowly, allowing them about 5 to 10 minutes to return to normal body temperature.
     Dr. Grigore compared measurements of memory, attention, and concentration from tests done before surgery to tests done 6 weeks after surgery. He found that slower rewarming during heart bypass surgery reduced mental loss after the operation. Grigore said, "The additional 5 to 10 minutes in the rewarming process can reduce mental decline, especially in diabetics and patients at increased risk of stroke, or with lung disease."
     Teamwork permits the slower rewarming process to be worked into bypass surgery without increasing the total time of surgery. There were no bad side effects from slower rewarming. This is important because other studies have shown that 1/3 of heart patients suffer loss in memory and learning after heart surgery.
 
Source: The Society of Cardiovascular Anesthesiologists meeting in Florida

 Warming Skin Before Surgery May Help

September 14, 2001 - Gently warming a patient's skin before surgery may reduce risk of infection by 60%. Warming the body before cutting into it may improve the spread of oxygen, allowing the immune system to fight off bacteria that gather around a wound. There are no known side effects to this therapy.
     Dr. Thomas Hunt, a wound healing expert not involved in the research said, "The effect of the warmth is equal to the effect of antibiotics given before surgery. For surgery patients, I think we'll find that this saves a lot of lives and a lot of cost."
     White blood cells kill bacteria in wounds by coating them in highly reactive oxygen. To produce this reactive oxygen, blood cells need about 50 times more oxygen than usual. However, anesthesia cools the body. That cooling shrinks blood vessels near the cut, reducing oxygen supply. When the body is cold - such as in an operating room - the blood vessels near the skin shrink to keep heat inside the body.
     The study included 421 patients having breast, varicose vein, or hernia surgery. One group was warmed only where the cut was to be made, using a small foam doughnut matched to the size of the incision. A metal wafer that radiated heat rested on top of the foam.
     The other heat-treatment group had their whole body warmed, using a perforated plastic quilt that blew warm air onto their bodies. Both heating devices were used for about 30 minutes right before surgery. The third group got no heat treatment.
     14% of the 139 people who got no heat ended up with an infection in their wounds. Only 5% of the 277 heat-treated patients got an infection. Both heating methods worked equally well.
     Dr. Harriet Hopf said the warming technique should work for nearly all types of surgery. "The best way to prevent wound infection is your own immune system. Your white blood cells work better with more oxygen. The better the blood supply, the more oxygen you have, and the less likely you are to get infection."
 
Title: Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial
Authors: Andrew Melling, Baqar Ali, Eileen Scott, David Leaper
Source: Lancet 2001; 358: 876-80

 Thinking Positive Pays Off

September 15, 1999 - During the 6 months after bypass surgery, optimistic patients were much less likely to be rehospitalized than pessimistic people.
     Researchers studied 283 elective bypass patients at a large city hospital. They were having no other surgery, were not in the intensive care unit, and did not have angina. Most patients were men (70%), white (99%), and married (80%), and averaged 63 years of age. Before surgery, each patient had an interview measuring optimism, depression, self-esteem, and neuroticism.
     Six months after surgery, follow-up interviews were done. In all, 26% were rehospitalized at least once for some reason during that period. Seven percent were readmitted for a heart or surgery-related problem. These included chest infection from surgery, angina, heart attack, or need for angioplasty or repeat bypass surgery.
     Optimistic patients were less likely to need rehospitalization. Optimism was the only thing measured that predicted less rehospitalization. The effects of optimism were stronger than the effects of self-esteem, neuroticism, or depression. Why is unknown.
 
Title: Optimism and rehospitalization after coronary artery bypass graft surgery
Authors: Scheier MF, Matthews KA, Owens JF, et al
Source: Arch Intern Med. 1999;159:829-835

 Device Protects Heart In Laparoscopic Surgery

February 16, 2001 - Laparoscopic surgery uses a very small incision. A tiny camera is positioned inside your body through that small opening. The procedure - often used to remove gall bladders - includes pumping gas into your internal stomach area.
     One harmful side effect of the gas used to pressurize your body this way is called PPPn or positive-pressure pneumoperitoneum. This causes reduced heart function and reduced blood flow. A new leg compression device may reverse these side effects.
     Dr. Alfred Cuschieri tested an air-powered compression device called Lympha-press to see how well it reversed these effects in 16 patients having laparoscopic surgery. The procedure was done with patients in a 30° tilted head-up position and a PPPn effect of of 12 mmHg.
     PPPn without the device reduced the heart's pumping strength. There was a 20% reduction in heart output and an 18% reduction in stroke volume. Using the Lympha-press system heart output increased 27% and stroke volume increased 16%. After the Lympha-press was shut down, heart output and stroke volume returned to pre-surgery levels.
     Although more studies are needed, "using the Lympha-press is recommended, especially for patients at risk for heart complications during their surgical hospital stay," say the researchers.
 
Source: Ann Surg 2001;233:176-182.

 Using Device During Surgery Safer

April, 2003 - During angioplasty to unclog the heart's arteries, using an intra-aortic balloon pump (IABP) - whether or not you need it - reduces your risk of major problems.
     Researchers studied 133 consecutive patients, with EFs of 30% or less. The patients had angioplasties between 1998 and 2000 in Italy. Sixty-one had an IABP placed at the start. Seventy-two got an IABP only if there were problems during their procedure.
     Both patient groups were very similar, although the IABP group had worse multiple blockages, said lead author Dr. Carlo Briguori. Severe low blood pressure, stroke, heart attack, and shock occurred in none of the IABP patients, but it happened in 11 patients in the other group. An IABP was quickly placed in those patients but 3 died.
     None of the IABP patients suffered a major adverse event during their procedures, but 17% of patients in the other group did. This is an 89% relative reduction in risk of such events when an IABP is placed at the start of angioplasty.
     The study authors say that in patients with low EF and significant heart damage, there is roughly a 20% chance of blood flow problems during angioplasty that will require an immediate IABP. Placing an IABP as a preventive measure in high-risk patients contributes to a successful outcome.
 
Source: Am Heart J 2003;145:700-707

 Valve Repair Improves Heart Failure

August 30, 2000 - Surgery to repair a leaky heart valve may help even the sickest heart failure patients live longer and enjoy better quality of life. This surgery fixed the mitral valve - the gateway to the left ventricle - by placing a flexible ring around the valve opening to tighten it. See a picture here.
     In heart failure, patients' hearts enlarge, stretching the area around the mitral valve so it can't close properly. This reduces EF. Very low EF can lead to blood clots inside the heart.
     Valve repair surgery tries to "over-correct," using a smaller-than-usual ring to reinforce the valve flaps. "This over-correction stops backward blood flow and helps the left ventricle pump better," Dr. Bolling says. "It may also help weakened heart muscle heal; but it's not a cure. Patients must continue on medication, controlled diets and exercise after surgery."
     In a previous study, a "valve job" improved heart output in CHFers by 50%. Dr. Bolling here reports on 92 patients who had mitral valve repair from 1993 to 1999. All had cardiomyopathy and heart failure, and had severely leaking mitral valves that allowed as much as 70% of blood to flow back through the opening. Patients had an average EF of 23%.
     Similar patients in the previous study had an 80% chance of dying within one year without a heart transplant. With this surgery, 80% were alive after one year, and 70% were still alive after 2 years. Some have now lived more than 5 years since their valve surgery. Two years after surgery, the surviving patients had all improved to class one or class 2.
     Researchers will now compare valve repair surgery plus standard CHF drugs versus drug treatment alone in the PREMIUM trial. The PREMIUM trial will enroll 150 CHFers between ages 18 and 80 with class 3 to class 4 heart failure.
     "The mitral valve is not just a door; It's an active mechanism that helps determine the power of the heart," Bolling says.
 
Source: Kara Gavin, UMHS Public Relations, 734-764-2220
Note - Dr. Bolling is a consultant to all 3 companies sponsoring the trial

 New Easier Cath Method

1999 - Heart failure patients often have a cath, using a flexible hollow tube called a catheter placed through the groin area up to the heart. The catheter is used to take pictures and sometimes to clear clogged arteries.
     A sandbag is usually placed on the patient's groin area (not genitals) for about 8 hours afterward to keep pressure on the incision until the body closes it naturally. It's not comfortable. Now, often a plug is used but this can cause problems as well.
     A newer cath procedure inserts the catheter through the radial artery in the wrist rather than the groin. "The radial artery has been shown to be less risky because nerves travel in the middle of the wrist, away from the arteries," Abittan said. "In the leg, nerves travel very close together and sometimes nerve damage occurs." There is a definite difference in recovery between the 2 procedures. Radial cath patients may be up and walking around within 2 hours.
 
Source: CNN medical correspondent Steve Salvatore

 RFA For A-Fib

November 20, 2000 - For patients with stubborn a-fib, using RFA to isolate the pulmonary veins from the left atrium seems to work. Dr. Carlo Pappone studied 26 patients with resistant a-fib: 14 had a-fib off-and-on, and 12 had permanent a-fib.
     For the 14 patients in a-fib at the start of the procedure, normal rhythm was restored in 64% during RFA. Pulmonary vein isolation was successful in 76%. After 9 months, 85% of patients remained free of a-fib, whether they were taking anti-arrhythmic drugs or not. Sixty-two percent of these patients were no longer taking anti-arrhythmic drugs. Whether a-fib was off-and-on or permanent made no difference to outcome.
     Despite the trials's good results, Dr. Hein Wellens (not part of the study) commented, "This is a procedure not without risk, with uncertainty about long-term outcome, and how to select patients who will best benefit."
 
Source: Circulation 2000;102:2619-2628,2562-2464

 Low EF Patients Benefit From Bypass

October 26, 2000 - Patients with CAD and very low EF can still benefit from bypass surgery, according to researchers from the VA Boston Healthcare System. Dr. Vladimir Birjiniuk says such patients now have options, "especially patients who are considered too old or for other reasons do not qualify for a heart transplant."
     Dr. Birjiniuk studied data on 95 patients with an EF of 25% or less who had bypass surgery for CAD. In these patients, 63% were class 3 or 4, 33% had diabetes, 31% had COPD, 36% had peripheral vascular disease and 21% had disease of blood vessels in the brain.
     Despite being such high risk patients, outcomes were good: surgical-related deaths were 5% and only 2% had heart attacks while in the hospital, said Dr. Birjiniuk. None had stroke or kidney failure while still in the hospital after surgery. Only 6 patients needed more than 48 hours of ventilator support.
 
Source: 2000 Annual Meeting of The American College of Chest Physicians

 Cell Transplant - Muscle Cells Injected Into Heart

March 5, 2003 - Injecting skeletal muscle cells directly into the heart of CHFers during CABG appears safe, according to French researchers. In a phase one trial, Dr. Jean Thomas Vilquin treated 10 men with chronic heart failure. The men averaged 60 years of age and were class 2 to class 4. Average EF was 24%, and all patients were candidates for bypass surgery.
     A muscle biopsy was taken from each patient. The muscle cells were then processed and injected directly into the heart. Left heart function increased afterward and 14 of 22 scarred heart muscle segments showed some pumping function afterward, compared to none before transplant.
     Four patients suffered arrhythmias during the study. No one knows if these are caused by the cell transplants. It remains to be seen how much improvement is from bypass surgery and how much from the injected muscle cells. The first phase 2 trial for this procedure is now underway. That study will recruit 300 patients.
 
Source: Reuters Health

 Adult Stem Cell Therapy 2002

November 18, 2002 - Dr. Manuel Galinanes says that adult bone marrow can become heart cells, smooth muscle cells, connective tissue cells, and other cell types to rebuild damaged areas.
     Fourteen CHFers who had suffered heart attacks had stem cells taken from from their sternums (breast bones) and injected into the scarred parts of their hearts during bypass surgery. Heart wall motion improved in 10 of the 14 patients at 10 months after the procedure. It is still not proven that bone marrow creates new tissue in the heart scars, but Galinanes believes it is happening.
     Another study reported on bone marrow cells implanted into the legs of patients who had very poor blood flow there. Forty-five PAD patients had injections of bone marrow stem cells into their calf muscles. Compared to controls who got saltwater injections, stem cell patients had a "striking" increase in new blood vessel growth. New blood vessels formed and fewer amputations were needed.
     Of the 45 treated patients, 31 had measurable improvement and 39 had less pain and improved treadmill endurance. Ulcers or gangrene from lack of blood flow healed in 21 of 28 treated legs.
 
Source: AHA 75th Scientific Sessions: Abstracts 111623, 101758, 109801. Presented November 18, 2002

 Adult Stem Cell Therapy Trials 2003

April 1, 2003 - Dr. Emerson Perin spoke about a pilot study of 14 patients with severe CAD and weakened hearts, who had bone marrow cells transplanted into their hearts. All were taking maximum drug therapy and were not candidates for surgery. Average EF was 20%.
     The bone marrow cells were delivered to the heart through a catheter. The cells were transplanted just 4 hours after harvesting, filtering, and processing them. Areas of the heart showing reduced blood flow on echo were injected.
     Patients' heart failure symptoms and ability to function improved. There was improved blood flow in the treated areas. Cath done 2 months after the procedure showed improved pumping action. Average EF rose from 20% to 29%.
     Dr. Jon Kobasigawa said, "They're using the same catheters to deliver this cell therapy and gene therapy to restore blood flow. Why not deliver both therapies at the same time?"
 
Source: ACC 52nd Annual Scientific Session: Abstract 823-1

 Bone Marrow Stem Cells Work in CHFers

September 1, 2006 - Researchers studied whether transplanting patients' own adult bone marrow mononuclear cells (BMMCs) into those patients' hearts gave any benefit. All patients had CHF that did not respond well to standard treatment. Twenty-eight CHFers were include. Fourteen got standard CHF meds plus BMMC transplant and 14 got standard meds only (control patients).
     BMMCs were harvested from the 14 CHFers. Physical exam results, test results, rhythm studies, echos, and PET scans were recorded. The 14 patients getting stem cells had improved CHF symptoms within 3 days. EF increased by 9% one week later and 11% 3 months after the procedure compared to study start.
     Left heart end-systolic volume went down 31% after 3 months. BNP level at day 3 after cell implant went way down by 69% and 7 days afterward by 70%, while ANP levels went up by 30% at day - all good 7. PET scans showed a significant increase in cell activity of 10% in the areas affected by heart attack.
     No patient died in the treated group by 6-month follow-up. In contrast, heart failure did not improve in any control patient. EF went down in control patients by 7% after 3 months. Two control patients died from CHF in 6 months. This human trial shows that in-the-heart BMMC transplant is safe and effective for reducing symptoms, increasing heart function, and possibly prolonging life in patients with end-stage heart failure that does not respond to standard therapy.
 
Source: Am J Cardiol. 2006 Sep 1;98(5):597-602. Epub 2006 Jun 30.
Title: Effect of intracoronary transplantation of autologous bone marrow-derived mononuclear cells on outcomes of patients with refractory chronic heart failure secondary to ischemic cardiomyopathy.
Authors: Gao LR, Wang ZG, Zhu ZM, Fei YX, He S, Tian HT, Zhang NK, Chen Y, Xu HT, Yang Y.
PMID: 16923443.

 Injecting Muscle Into The Heart

November, 2003 - Twelve patients with previous heart attack and blocked arteries had bypass surgery. They also had skeletal muscle cells (myoblasts) taken from their own thigh muscles injected into their hearts during surgery. Overall and area-specific heart function was measured by echocardiogram. PET studies also measured blood flow and heart motion.
     EF improved from 36% before surgery to 54% 3 months after surgery. Areas of the heart injected with the muscle cells contracted more strongly than before. PET scans showed more active heart tissue in the areas that suffered a previous heart attack after 3 months. No abnormal heart rhythms were seen.
     This may be a promising addition to standard bypass surgery for people who have suffered heart attacks.
 
Title: Autologous intramyocardial injection of cultured skeletal muscle-derived stem cells in patients with non-acute myocardial infarction.
Authors: Herreros J, Prosper F, Perez A, Gavira JJ, Garcia-Velloso MJ, Barba J, Sanchez PL, Canizo C, Rabago G, Marti-Climent JM, Hernandez M, Lopez-Holgado N, Gonzalez-Santos JM, Martin-Luengo C, Alegria E.
Source: Eur Heart J. 2003 Nov;24(22):2012-20.
PMID: 14613737

 Adult Stem Cell Transplant By Catheter

December 16, 2003 - In a phase one trial, Dr. Pieter Smits did stem cell transplants in 5 CHFers. Each patient had suffered a heart attack in the heart's anterior wall. Skeletal muscle cells were taken from their thighs and multiplied in the lab.
     Roughly 200 million of those muscle cells were then injected into the damaged part of the heart using a catheter. EKG, Holter monitor, diagnostic cath, MUGA, dobutamine stress echo, and MRI were all used to measure heart function.
     All cell transplant procedures went well, with no serious adverse events during follow-up. One patient did get an ICD for runs of ventricular tachycardia. Ejection fraction increased from 36% at study start to 41% at 3 months, and to 45% at 6 months. The heart's walls thickened in the treated areas.
     This pilot study is the first to show that skeletal muscle cell transplant can be successfully done by cath without chest surgery. "The beauty of this study is that ... it was done in the cath lab and it was a stand-alone therapy; nothing else was done, no angioplasty or other therapy that would ... improve left ventricular function ... so whatever was seen was actually because of cell therapy," said Dr. Raj Makkar in an editorial.
 
Source: J Am Coll Cardiol 2003;42:2063-2072;
Source: Reuters Health.

 Heart Wrap May Prevent Enlargement

November 8, 2004 - Results on the dacron heart wrap by Acorn Cardiovascular were presented at the AHA Scientific Sessions this month. This "stocking" or "wrap" is implanted surgically around the heart to help CHFers. Dr. Douglas Mann led a company-funded study of the device.
     The study included 300 patients at 28 hospitals in the USA and one in Canada. The study's first part included 193 people having surgery to fix a leaky heart valve. Standard surgery was done on 102 of them while the other 91 got the surgery plus the heart wrap. The second part of the study included 107 people who did not need valve surgery. Fifty were given standard heart failure meds (ACE inhibitors, beta-blockers and diuretics) while the other 57 got the meds plus surgery to implant the heart wrap.
     After 22 months, 38% of the heart wrap group had improved versus 27% of the other group. About 37% with the heart wrap got worse versus 45% percent of non-heart wrap patients. Nineteen heart wrap patients needed a heart transplant, an LVAD or other major heart surgery versus 33 in the other group.
     Dr. Mann thinks the wrap relieves pressure on the heart, giving it support so it can rest between beats. The hearts of patients with the heart wrap returned to a more normal size and shape. According to Dr. Spencer Kubo of Acorn Cardiovascular, the wrap actually changed the size of the cells making up the heart. So it's not a matter of cramming a large heart into a little bag and calling it smaller. Reverse heart remodeling did occur.
     The heart wrap did not reduce hospital stays and implanting it requires major heart surgery. No one is saying how much this device will cost.
 
Source: AP.
Source: Acorn Cardiovascular web site.

 Heart Wrap Not Recommended For FDA Approval

June 22, 2005 - An FDA panel voted nine to four not to approve the Acorn CorCap device for heart failure, a device already approved for use in Europe. The device is a polyethylene mesh bag that is surgically wrapped around the heart's left ventricle to support or brace the heart chamber as it fills with blood. A recent 300 patient trial showed pretty good results.
     However, the FDA panel said there wasn't enough mortality benefit shown despite significant improvements to heart size and shape using the device. Fourteen percent of patients using CorCap died after 2 years, about the same as non-device trial patients. Another panel member said the trial showed no way to decide which patients would benefit, so there is no way to know which patients should get the device and which should not.
     Acorn plans to discuss the panel's decision with the FDA.
 
Source: www.fda.gov/cdrh/panel/summary/circ-062205.html, FDA Center for Devices and Radiological Health.

 USA Tissue Banks In Spotlight

January 8, 2001 - Many US tissue banks have never been inspected by federal agencies. This may leave tissue recipients open to infection with HIV, hepatitis, and more. A second government report says that donors should be better informed about the uses and profits made from donated tissue.
     "One in every 5 tissue banks has never been inspected," says a report from the HHS. The report says that when inspections do take place, the FDA finds "serious shortcomings in screening and testing practices."
     Over 20,000 people donated tissue after death in 1999. Those donations allowed 750,000 tissue transplants in 1999. However, only 2 states - Florida and New York - require regular safety inspections. The FDA has no rules for regular re-inspection, and even the exact "number and location of the nation's tissue banks are unknown," according to HHS.
     In tissue banks that were inspected, serious oversights were found, including:

In the second report, HHS officials say that donors and their families need to know how tissue and organs are used, and who profits. While most donors and their families assume that donated tissues will be used for "important medical needs," tissues are a commodity that can be used for elective procedures like cosmetic surgery.
 
Source: Reuters Health

 Alcohol Ablation Back in the News

August 25, 2006 - Alcohol septal ablation (ASA) gives continued improvement in diastolic function for hypertrophic cardiomyopathy patients. This trial shows that diastolic improvement lasts at least 2 years after the procedure. Harvard researchers measured diastolic function by echo at study start, and at one and two-year follow-ups after ASA in 30 HCM patients.
     Functional heart class improved from class 3 to class 1-1/2 at one year and to class one at 2 years after the procedure. ASA also improved average LV outflow tract gradients from 75 to 19 mmHg at one year, with the improvement remaining at 2 years. All 30 patients had diastolic dysfunction at study start.
 
Source: Eur Heart J 2006;27:1805-1810.
Authors: Yoerger, Danita, et all.
Source: Reuters Health

All information on this site is opinion only. All concepts, explanations, trials, and studies have been re-written in plain English and may contain errors. I am not a doctor. Use the reference information at the end of each article to search MedLine for more complete and accurate information. All original copyrights apply. No information on this page should be used by any person to affect their medical, legal, educational, social, or psychological treatment in any way. I am not a doctor. This web site and all its pages, graphics, and content copyright © 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006 Jon C.

Talk to Jon Site Index