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March 16, 1997 - In the Batista procedure, a large piece of the heart's lower left chamber (ventricle) is removed and a valve repair is done in patients with severe heart failure. In this study, 24 patients had echocardiograms and other tests done 9 days before and 9 days after surgery. Ejection fraction improved from 17% to 31% and cardiac output also increased. PCWP did not change. It is not clear how much improvement was due to the left ventricular re-sizing and how much was due to the mitral valve repair.
Authors: N Gupta, S Maragos, and MS Lauer
Source: The American College of Cardiology 46th Annual Scientific Session, March 16-19, 1997
Presenter: Akira Kawaguchi, MD
March 16, 1997 - Cleveland Clinic doctors studied 32 patients with DCM who had the Batista procedure. The average weight of heart muscle removed was 89 grams. Echo showed improvements in ejection fraction from 15% to 34%. Echo also showed an improvement in heart size and less blood backing up due to leaky valves.
After surgery, 84% of patients were discharged from the hospital; 30% were readmitted later for heart failure, 4% required LVADs and 11% still needed heart transplant. For the 16 patients in whom 90 day tests were done, EF was still improved and the patients' ability to do everyday tasks improved. The Batista procedure does have a high failure rate and should only be done at centers with a strong LVAD program.
Source: The American College of Cardiology 46th Annual Scientific Session, March 16-19, 1997
Presented by: Randall Starling, MD
August, 1997 - Since May of 1996, we did this surgery in 53 patients, mainly heart transplant candidates. The average patient age was 53 years; 60% were class 4 and 40% were class 3. Before surgery, 51 patients were thought to have idiopathic dilated cardiomyopathy, one had inherited (familial) cardiomyopathy, and one had cardiomyopathy due to valve problems.
As we gained experience, we increased the amount of heart muscle removed and did more complex valve repairs. Echo showed a much smaller left ventricle, less valve leakage, and higher ejection fraction, averaging from 16% to 33%, but there was not much increase in cardiac index. Eight patients required an LVAD during surgery and one patient died. At 11 months, 87% of the patients were still alive and 72% were well enough not to be on the transplant list.
This procedure is good for some patients but we must be very careful to choose only those patients for whom this will succeed. Not all CHFers should have the Batista Procedure. Much more follow-up and study are needed.
Title: Early Results With Partial Left Ventriculectomy
Author: Patrick M. McCarthy, M.D., Director Cardiac Assist Device Program, Cleveland Clinic Foundation, Department of Thoracic and Cardiovascular Surgery
1998 - The Batista procedure - a heart operation introduced just 2 years ago - has been dropped by most heart surgeons, who now doubt that it helps patients. Some patients who had the operation have died while others have needed heart transplant. Dr. Douglas Payne says, "In general, it hasn't been as helpful as we had hoped."
In this procedure, doctors cut out a piece of the patient's enlarged heart, reducing the muscle's size. NEMC doctors did their first Batista procedure in November of 1996 on Albert Silva. He had heart disease and was told he would need a transplant. After the surgery, doctors said Silva appeared to be doing well, and predicted he would be back at work soon; but that never happened. "My heart started enlarging again," Silva says. "I'm back the way I was." Silva is now on a waiting list for a heart transplant.
Batista claimed success with patients in Brazil but the results could not be verified, through no fault of Batista's. "Everybody knew his data was interesting but he was the first to say that he couldn't follow his patients long," Payne said. "That's why we wanted to do some, and wait and see."
Title: Heart procedure pulled at New England Medical Center
Source: The Boston Herald
1997 - TMLR stands for Transmyocardial Laser Revascularization. The procedure may help relieve angina pain. In TMLR, surgeons pierce up to 40 holes in hibernating heart muscle, allowing blood inside the heart chamber to drain out and reach heart tissue, thus bypassing blocked coronary arteries, says Dr. James Lowe.
In a study of 198 CAD patients with class 3 or 4 angina, researchers found that 71% of those treated with the new laser therapy improved to angina class 1 or 2, compared to none of the patients given standard drug therapy. About 39% of patients in the regular treatment group developed unstable angina after 6 months of treatment and were then given TMLR.
The death rate for the group that got TMLR at the start was 3%. "If a cardiologist has a patient with class 3 or 4 angina who is not a candidate for bypass or angioplasty, he might consider TMLR early, instead of waiting for the patient to develop unstable angina," Dr. Lowe said.
Precisely how the new laser procedure works to relieve chest pain is unclear. TMLR takes about 2 hours to perform and patients usually stay in the hospital for 5 to 7 days afterward.
Source: Medical Tribune: Internist & Cardiologist Edition 38(9): 1997
March 6, 2000 - Patients with advanced CAD often have bypass surgery. Those who had bypass plus TMLR had better survival and outcomes than those having bypass alone, according to this study.
The study included 263 patients. The patients needed bypass on certain blocked arteries and they also had one or more blocked arteries that could not be bypassed with surgery. They received either bypass with the non-graftable areas left alone (131 patients) or bypass surgery plus TMLR to help non-graftable areas (132 patients). Patients were followed up at 3, 6, and 12 months after surgery for death or heart attack, angina class, exercise treadmill scores, and need for repeat procedures.
|Bypass plus TMLR||Bypass alone|
|30-day death rate||1.5%||7.6%|
|One-year death rate||5%||11%|
|30-day survival without heart attack||97%||91%|
|one-year survival without heart attack||92%||86%|
Complications after surgery were about the same in both groups. "Combining TMR with bypass improved survival," said the study's lead author, Dr. Keith Allen. "There was also much less need for cardiac support after surgery in the TMR plus bypass group."
Both groups saw improvement in angina at 3, 6, and 12-month follow-up. TMR plus bypass patients had less class 3 to class 4 angina at 12 months compared to patients who had bypass alone.
Title: Transmyocardial Revascularization Combined With Bypass Surgery Improves Survival
Source: Journal of Thoracic and Cardiovascular Surgery/Medscape Wire
March 17, 1998 - LXR Biotechnology has filed an Investigational New Drug application with the FDA to begin a Phase I/II trial. If approved, they will test CP-Cardiosol. This is a liquid solution used during bypass surgery. "Every patient who has heart/lung surgery has the potential to suffer irreversible damage, which is now believed to be partly due to unintended genetically programmed cell death, called apoptosis," said CEO David Tomei. "We believe that CP-Cardiosol will reduce long-term heart damage."
In a pre-clinical study, an earlier version of Cardiosol was tested in 95 heart surgery patients. Results suggest that patients suffered less damage and inflammation to their hearts. This study also reported that 72% of patients had spontaneous recovery of regular heart beat on surgery completion versus 5% of patients in a control group.
February 24, 1998 - We used FGF1 (basic fibroblast growth factor) to start growth of new blood vessels in ischemic hearts
FGF-I was injected close to blood vessels after completing bypass surgery in 20 patients with 3-vessel coronary disease. All patients also had small blood vessel blockages. Twelve weeks later, the bypasses were checked by cath.Capillaries (small blood vessels) had formed around the injection site in all cases. A capillary network sprouting from the coronary artery bypassed the smaller blockages. FGF1 may be useful for patients with small vessel blockages that cannot be surgically repaired.
Title: Induction of neoangiogenesis in ischemic myocardium by human growth factors: first clinical results of a new treatment of coronary heart disease
Author: Schumacher B, Pecher P, von Specht BU, Stegmann T
Source: Circulation 1998 Feb 24;97(7):645-650
Comment: Circulation 1998 Feb 24;97(7):628-9
PMID: 9495299, UI: 98154687
1998 - MICS was developed from regular bypass surgery. It corrects blockage in the left anterior descending artery or LAD. MICS is done through a small chest incision and connects the left internal mammary artery or LIMA to the LAD, without using a heart-lung bypass machine.
One advantage over angioplasty is a lower need for repeat procedures. Compared to standard bypass surgery, MICS also reduces the body's inflammatory response, partly due to the smaller incision and no "handling" of the aorta. This means less complications and a shorter hospital stay.
However, MICS is limited to patients with blockage in only one vessel, the LAD. How can we pass on the benefits of MICS to a larger group of patients with 2 or 3 vessel disease? The answer may be combining MICS for the LAD with angioplasty to repair other blocked arteries. This combination of angioplasty with MICS is called "hybrid-revascularization." High-risk patients are most likely to benefit. Patients with 2 or 3 vessel disease who also have other serious conditions such as COPD, diabetes, kidney, failure, liver failure or blood clotting disorders are candidates.
Hybrid-revascularization can be done in different ways. Ideally, MICS could be immediately followed by angioplasty in the same session. The limiting factor is time. MICS should come before angioplasty for 3 reasons:
We do the angioplasty within 24 hours after the MICS. This keeps the hospital stay as short as possible. The future of "hybrid-revascularization" is still open. Only trials comparing it with standard bypass surgery or multiple angioplasty will show how useful it really is.
Title: Combining Coronary Angioplasty with Minimally Invasive Coronary Surgery: The "Hybrid-Revascularization"
Authors: Massimo Mariani, Piet Boonstra, Jan Grandjean, Peter den Heijer
Source: J Invas Cardiol 10(4):233-236, 1998
January 7, 1998 - Gene therapy may be a new way to treat clogged heart arteries. In 2 new reports, researchers developed a way to inject genetic material directly into the heart. This causes the release of VEGF, which stimulates the growth of new blood vessels. In adults, the gene that stimulates VEGF is normally "turned off" - not functioning anymore.
In the first study, researchers used this procedure to prevent restenosis in patients having angioplasty. Researchers treated 16 male CAD patients by injecting DNA through a small chest incision. Fifteen of the patients had undergone 2 bypass surgeries and 11 had suffered one to 3 heart attacks. Before having the surgery, all had class 4 angina symptoms, but standard treatments had not helped them.
After the procedure, 11 patients were free of angina after 90 days, according to lead researcher Dr. Jeffrey Isner. All 15 patients had less chest pain 10 to 30 days afterward. Four patients required revascularization for restenosis. Isner said, "Even for patients who have had a second or third bypass, and are at greater risk, gene therapy may carry less risk and give similar results." In the future, Dr. Isner hopes it will be possible to use a cath to insert the genetic material.
In a second study, researchers used gene therapy on 14 patients with an average age of 59 years. The VEGF gene was given during bypass surgery by using a disabled version of a human virus. They used adenovirus because "it knows where to go and transfer its genetic cargo," explained Dr. Ronald Crystal.
"In a related study, researchers in Finland looked at gene therapy after angioplasty to prevent restenosis. They used liposomes to carry the VEGF gene into the coronary arteries of 10 patients, average age 56, immediately after angioplasty. At 14 days, none of the patients developed angina, heart attack, or stroke.
Because all these studies were only phase one trials, more and larger trials must be done to prove whether gene therapy is really safe and effective.
Title: Gene Therapy Promising for Atherosclerosis by Samantha Meese
From: Medical Tribune: Internist & Cardiologist Edition v39.n21:1,7, 1998
December, 1998 - We studied aortic debris that is knocked loose during a cath. This knocked-loose plaque in the arteries can cause blood clots and strokes. The rate of recognized stroke from diagnostic heart cath is less than 1%. However, the rate of cath-related blood clots found in autopsies has been as high as 30%. Overall complication rates for angioplasty are higher than for diagnostic cath.
In patients having angioplasty, larger stiffer catheters are used. That can be harder on the arteries than diagnostic catheters, which are more flexible, smaller, and have tapered tips. When the catheter is moved around during angioplasty, plaque scraped from the aorta exits the back of the catheter. This is almost never seen during diagnostic cath.
When aortic debris occurs, using a catheter inserted through the arm and not placing an intra-aortic balloon pump both reduce risk of blood clot and stroke.
Although not frequent, blood clots account for many complications from coronary procedures. They may be due to too-long procedures or the knocking loose of plaque from the aorta during catheter and wire movement. We found a high rate of aortic debris scraped by the guiding catheter: 51% of cases overall.
In 1000 consecutive caths, the amount of plaque debris from large guiding catheters was recorded:
We think that the shapes of the JL, Multi and VL catheters are more traumatic to the aorta owing to their long secondary curves, scraping blood vessel walls as they move.
Studies have shown that people with plaque in the aorta are more likely to have a blood clot or stroke from cath procedures. Our study shows that in more than 50% of angioplasties, guiding catheters scrape debris from the aorta. A doctor should pay extreme attention to allowing debris to exit the back of the catheter. That keeps this knocked-loose debris from entering the blood stream.
Also, allowing sufficient "back bleeding" from the guiding catheter after removing the wire but before attaching the Y-connector, is necessary to avoid debris during dye injections.
Title: Scraping of Aortic Debris by Coronary Guiding Catheters A Prospective Evaluation of 1,000 Cases
Authors: Ellen C. Keeley, Cindy L. Grines
Source: J Am Coll Cardiol - Vol. 32, No. 7, December 1998:1861-1865
July 6, 2000 - Surgeons at the University of Pittsburgh have now done a minimally invasive bypass surgery on a wide-awake patient. Only epidural anesthetic was used, said Dr. Marco Zenati. According to Dr. Zenati, at the end of surgery, the 51 year old patient was sitting up, thanking the team. Dr. Zenati said, "Eventually we will make this procedure so you can go home the same day.".
Dr. Zenati said the surgical team was more surprised than the patient was. The option of avoiding general anesthesia is a powerful way to reassure people that this really is a less invasive surgery, he said.
Getting to this point took years. Surgeons began by eliminating the heart/lung machine, so surgery is done using "beating heart" techniques. Then the incision was made smaller. A robot method using only 5mm pin-size holes is now being practiced.
"We are eliminating what is not necessary while maintaining the core procedure, which is restoring blood flow to the heart." According to Dr. Zenati, "Eventually we want surgical bypass to be the first line of therapy instead of the last resort when everything else fails."
Source: Reuters News
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 Jon C.