Coronary artery bypass surgery

What you need to know about those new, deadly heart-surgery infections

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Coronary artery bypass surgery.

The Centers for Disease Control and Prevention warned open-heart surgery patients recently that they were at risk of a deadly infection linked to a medical device used during their operations. Now, worried consumers say they are having a hard time getting information from hospitals and doctors about what they should do.More than a half-million patients could have been exposed to bacteria that can cause serious illness or death. That’s the estimated number of patients who had open-chest surgery involving potentially contaminated equipment in the past several years. The bacteria are a type of nontuberculous mycobacteria, or NTM. Although infections are rare, experts are worried because patients may not develop symptoms or signs of infection for months, so diagnosis may be missed or delayed.

The device is a heater-cooler unit, which helps keep a patient’s circulating blood at a specific temperature during operations. It’s used in an estimated 250,000 surgeries in the United States every year, including cardiac bypass, valve replacement and  liver transplants. About 60 percent of these procedures use the German-made model that has been linked to the infections, the Stöckert 3T heater-cooler, made by LivaNova PLC, formerly Sorin Group Deutschland GmbH.

The CDC is advising hospitals to notify patients who had open-chest surgery involving these devices going back to Jan. 1, 2012. There is new information that indicates these devices were probably contaminated during manufacturing.

The Washington Post’s Lena H. Sun spoke with consumer advocates and health experts, including CDC’s Mike Bell, deputy director of health-care quality promotion, about what patients should do.

How do I know if I need to be worried?

If you’re not having symptoms, there’s nothing you need to do. But patients who have had open-heart surgery should seek medical care if they’re having nonspecific symptoms associated with infections, such as night sweats, muscle aches or pain, weight loss, fatigue or unexplained fever.

What if I don’t have symptoms but want to make sure my doctors know about this situation?

The CDC has a sample letter that patients can download, customize and take to their cardiologist or family doctor or whomever you see for ongoing medical care. The letter explains the risk of infection and CDC’s recommendation that clinicians consider NTM as a potential cause of unexplained chronic illness.

“Patients should say to their doctors, ‘I want you to put this in my file and be aware this could happen. If I start having infection symptoms, I want to be tested,’ ” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.

What if my open-chest surgery took place before Jan. 1, 2012?

The CDC’s Bell said the vast majority of infections flare up within four years of exposure. But regardless of when you had this type of surgery, if you are having symptoms, you should contact your health-care provider as soon as possible.

Are there any drugs I can take to prevent these infections?

Currently, there aren’t any safe prophylactic treatments.

Are these infections treatable?

Yes. A specific combination of antibiotics can treat NTM infections.

Why is the CDC worried about these devices?

Researchers have found that fans on these units may blow bacteria from inside the machine into the operating room. If the bacteria land on a heart valve that is about to be implanted or a surgical wound, it could cause an infection.

How many hospitals do this kind of operation in the United States?

An estimated 1,200 hospitals in the United States perform bypass operations, according to federal government sources.

What if my hospital used a different brand of heater-cooler?

These machines operate in similar ways. They could be contaminated in similar ways and also pose infection risk.

What is the risk of infection?

In hospitals where at least one infection has been identified and linked to the device in question, the risk was low, between 1 in 100 and 1 in 1,000. CDC officials say patients who had valves or other prosthetic implants are at higher risk.

How long does it usually take for these infections to show up?

It may take months and up to several years after the operation. Virtually all the cases reported so far in Europe and the United States have occurred within four years of surgery.

What are these bacteria? Can an infected person spread it to others?

NTM is common in water and soil. The bacteria rarely make healthy people sick. The danger arises when these bacteria enter the chest cavity or an open wound, especially in someone with a weakened immune system. The bacteria cannot be spread to others.

How many illnesses and deaths have been linked to these infections?

Between January 2010 and August 2016, the FDA received 91 reports from around the world about these devices. At least 79 were patient infections, with 55 in the United States. The infections include at least 12 deaths, including seven U.S. deaths. (In some cases, a report may describe a cluster of patients. In other cases, more than one report may be submitted from the same incident.)

Hospitals in Iowa, Michigan and Pennsylvania have reported infections.

Is there a test to know whether I’ve been exposed?

There is no such test. Infections can only be diagnosed by growing the bacteria in a lab. But that may take up to two months or longer. What’s more, getting the right kind of specimen depends on where the infection is. It could be in the blood, or it might show up in an infected wound.

“It has to be cultured under the right circumstance so the finicky bacteria will actually grow,” Bell said.

Why hasn’t my hospital notified me? There’s nothing on the website, and I can’t reach a person who knows anything.

Many patients say they’re frustrated by their inability to find out anything from the hospital where the operation took place. The hospitals have been getting alerts for the past year from the CDC and the Food and Drug Administration. But the CDC and FDA don’t have authority to require hospitals to notify patients. The American Hospital Association, an industry association, says it has advised its members to review and determine how best to follow the CDC recommendations. But Jay Bhatt, the AHA’s chief medical officer, said it takes time to review records and identify patients who might have been affected

How many of these Stöckert 3T heater-cooler devices are there? Why haven’t these devices been recalled?

As of July 2015, the company publicly reported there were 1,914 devices in health-care facilities around the world, including in the United States. In 2015, the company recalled the instructions for use, but not the device itself. The FDA imposed an import alert in December 2015. The devices are critical for lifesaving surgery, and a recall could result in many patients being harmed.

I’m supposed to have elective surgery to have a heart valve replaced. Should I postpone the surgery?

For nonemergency surgeries, patients might want to ask their doctors if they have the option of waiting for a little while, says CDC’s Bell. Patients should make sure their surgeons and hospitals disclose these risks, in writing, during the pre-surgery informed-consent discussions.

What are hospitals doing in the meantime?

Hospitals are working through the logistics involved in notifying patients.

“Facilities are not well set up to receive a large number of public calls,” said Bell. He said hospitals in Pennsylvania and Iowa that had clusters of infections had to set up a special telephone number to receive inquiries and guide people to the next step.

Hospital officials are also looking to find ways to minimize the risk of infection, such as keeping the devices outside the operating room, or looking for alternative machines that don’t have fans, Bell said.

“Every hospital is thinking about how to make this problem no longer exist,” he said.

 

Does Preop Statin Help Survival in CABG?

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Study suggested simvastatin may help but other preop heart drugs weren’t useful

Going into coronary artery bypass surgery (CABG) on a statin might reduce mortality risk from the procedure, but other heart drugs might not make a difference, an observational study suggested.

The lipid-lowering drugs were associated with 65% to 74% relatively lower odds of perioperative death after adjusting for other factors, which was statistically significant across all five logistic regression models used in the study of 16,192 CABG patients ages 40 years and older in the U.K. Clinical Practice Research Datalink database.

Mortality risk out to 6 months also was significantly reduced among preoperative statin users, with a hazard ratio of 0.63 (95% CI 0.42 to 0.92),Robert Sanders, MD, of the University of Wisconsin in Madison, and colleagues reported at the European Society of Anaesthesiology’s Euroanaesthesia conference in Berlin.

The effect was only significant for the most commonly prescribed statin, simvastatin (adjusted OR 0.33, 95% CI 0.14-0.78), although it wasn’t clear whether this was the result of a statistical power issue or due to some real difference among statins because the study could not draw any causal conclusions.

“Further data are needed on whether all statins exert similar effects,” the researchers concluded.

They pointed to a prior meta-analysis of randomized, controlled trials and observational data that showed a 31% relative reduction in early death from any cause after cardiac surgery among people on a preoperative statin.

“In combination with previous studies, these data suggest that patients not taking statins should be considered for statin therapy based on their perioperative and chronic health risks,” Sanders’s group suggested in a press release.

Perhaps not surprisingly, statins were the most common of the heart medications the patients getting CABG were on in the study (85.1%).

The other medications considered ranged from 72.8% prevalence for beta-blockers to 60.5% for ACE inhibitors and 42.8% for calcium channel blockers all the way down to 1.2% for alpha-2 agonists.

None of them showed any consistent association between preoperative use and perioperative mortality across the propensity score-matched, Cox, and other regression analyses.

Bivalirudin Started during Emergency Transport for Primary PCI.

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BACKGROUND

Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown.

METHODS

We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding.

RESULTS

Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients.

CONCLUSIONS

Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis.

Source: NEJM

 

Major Bleed Risk Falls with Bivalirudin vs Heparin en Route to PCI for STEMI: EUROMAX.

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The 30-day risk of death or major bleeding fell significantly in ST-elevation MI (STEMI) patients treated with bivalirudin (Angiomax, the Medicines Company) compared with heparin-based management, both initiated prior to arrival at a hospital for primary PCI, in a large randomized but open-label study[1].

The bivalirudin benefit for that composite end point in the European Ambulance Acute Coronary Syndrome Angiography(EUROMAX) trial was driven by a significant drop in major bleeding, the definition of which excluded bleeding related to CABG surgery.

The heparin-based strategy consisted of either unfractionated heparin (UFH) or the low-molecular-weight heparin enoxaparin(Lovenox, Sanofi). Both groups could receive a GP IIb/IIIa inhibitor provisionally.

EUROMAX was published today in the New England Journal of Medicine with lead author Dr Philippe Gabriel Steg (Hôpital Bichat, Paris, France) to coincide with his presentation of the trial here at TCT 2013 .

http://img.medscape.com/news/2013/ih_131030_Steg_Philippe_Gabriel_TCT2013_120x156.jpg

Dr Philippe Gabriel Steg

Bivalirudin’s 40% primary-end-point relative risk reduction included a >50% drop in risk for non-CABG major bleeding. On the other hand, the relative risk of stent thrombosis with bivalirudin was nearly threefold what was seen in the heparin group, although absolute rates were very low.

At a media briefing on the trial, Steg said the excess stent thromboses with bivalirudin were driven by events in the acute phase, within 24 hours of PCI. And, he observed, they didn’t translate into more reinfarctions or ischemia-driven revascularization.

Still, “acute stent thrombosis . . . while rarely fatal and not outweighing the advantages of bivalirudin, is the only troubling issue with bivalirudin in STEMI, and we do need strategies to reduce this complication,” according to Dr Gregg W Stone (New York-Presbyterian Hospital/Columbia University Medical Center New York, NY), the assigned discussant following Steg’s formal presentation of EUROMAX.

Shades of HORIZONS AMI

The trial’s findings are reminiscent of the HORIZONS AMI trial 30-day outcomes reported about six years ago and covered then by heartwire . That trial, Steg et al observe, preceded some important changes in STEMI management and PCI technique that likely affected bleeding risk, changes that were a part of EUROMAX. These included the expansion of radial-artery PCI access, newer antiplatelet agents, reduced GP-IIb/IIIa-inhibitor use, and progressively earlier initiation of IV anticoagulants.

In the >3600-patient HORIZONS AMI, anticoagulation wasn’t started early during transport. But both it and EUROMAX with its nearly 2200 patients saw a decreased bleeding risk and increased stent-thrombosis risk with bivalirudin compared with heparin. But in contrast to EUROMAX, the earlier trial also showed a reduced risk of cardiac death in bivalirudin patients.

The two studies taken together have more to say than either alone. “I think the results of EUROMAX will heavily impact clinical use of bivalirudin in Europe,” Steg said to heartwire . “The results are very consistent wih HORIZONS AMI, even to the point of the stent-thrombosis signal” and are “reassuring enough to embrace [bivalirudin] in the prehospital setting.” That is, he added, “If you want to. [The EUROMAX results] are not mind-blowing because we don’t see a mortality reduction. But they suggest that the benefits seen in HORIZONS AMI can be extended to the contemporary prehospital setting. “

At the media briefing, Dr Bernard Gersh (Mayo Clinic, Rochester, MN), who wasn’t involved in the trial, said, “It’s not that often that you see trials that really will change clinical practice, and I think this will.”

The Role of Prehospital Diagnosis and Treatment

Gersh also said, “I’ve never seen really anything that suggests that prehospital administration [of anticoagulants] and [STEMI] diagnosis is not beneficial.”

But whether they are achievable in the field varies by country, even within Europe. Interviewed, Steg pointed out that at most participating centers, there were no physicians in the ambulances. It does take some expertise to interpret the ECGs, unless the tracings can be transmitted to a center for remote reading. But, he said, “It’s been shown in other trials if you have good trained paramedics, they do just as well if not better than physicians.”

Also speaking at the briefing as a EUROMAX observer, Dr Philippe Généreux (NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY) said prehospital STEMI diagnosis and treatment initiation could make the most difference in countries like Canada, “where there aren’t cath labs on every corner” and it might take 45 to 60 minutes for an ambulance to reach a PCI center.

Prospects for prehospital management in the US seem more remote, observers agreed. Dr James B Hermiller, Jr (St Vincent Hospital/The Heart Center of Indiana, Indianapolis,) said at the briefing, “The barrier to this in the US is very great. It’s difficult just to  get ECGs in the field, let alone administer anticoagulants, but we need to get there because this is very important.”

The Open-Label Randomization

EUROMAX randomized patients at centers in nine European countries presenting within 12 hours of onset of symptoms from electrocardiographically defined STEMI, on an open-label basis, to the bivalirudin or heparin strategies. Treatment was initiated in the ambulance or at a non-PCI hospital with subsequent transport to a PCI center.

For the 1089 patients who received bivalirudin, the drug was started as a 0.75-mg/kg bolus followed by an infusion of 1.75 mg/kg/h continued for at least four hours after PCI. The 1109 control patients received UFH at either 100 IU/g or 60 IU/kg with a GP IIb/IIIa inhibitor or were allowed to have enoxaparin at 0.5 mg/kg. Adjuvant GP IIb/IIIa inhibitors were allowed at physicians’ discretion. All patients received aspirin plus a P2Y12 inhibitor.

Relative Risk (95% CI) for Outcomes, Bivalirudin vs Heparin Strategies for STEMI Initiated During Emergency Transport to Primary PCI

End points

RR (95% CI)

p

30-day death from any cause or non-CABG major bleedinga

0.60 (0.43–0.82)

0.001

30-day death from any cause, reinfarction, or non-CABG major bleeding

0.72 (0.54–0.96)

0.02

Non-CABG major bleeding

0.43 (0.28–0.66)

<0.001

Major bleeding (TIMI definition)

0.62 (0.32–1.20)

0.15

Severe or life-threatening bleeding (GUSTO definition)

0.61 (0.22–1.68)

0.33

Definite stent thrombosisb

2.89 (1.14–7.29)

0.02

a. Primary end point 
b. Academic Research Consortium criteria

No significant differences were seen at 30 days for the composite of death, reinfarction, ischemia-driven revascularization, or stroke, or for any stroke or ischemic stroke. A committee blinded to treatment assignment adjudicated bleeding episodes and clinical events.

As discussant, Stone pointed out that PCI via the radial artery, rather than the femoral artery, was done in only 6% of cases in HORIZONS AMI but in 47% of EUROMAX patients. Some predicted that the greater proportion of radial procedures would lead to a much lower major bleeding rate and make it hard for bivalirudin to show an effect. A EUROMAX subgroup analysis found, however, that the benefits of bivalirudin over the heparin-based strategy were consistent for different kinds of patients, including whether their PCI was by the radial or femoral routes.

“Therefore, bivalirudin is beneficial regardless of the access site, and this is because most bleeding in the STEMI and ACS setting is not access-site related,” he said. It’s the non–access-site bleeds to pose the greater threat to later outcomes. So, he said, “the advantages of bivalirudin are present in patients undergoing radial as well as femoral intervention, and radialists should pay attention to this.”

Stone said EUROMAX raises the question of whether using cangrelor (the Medicines Company) as part of the accompanying antiplatelet therapy might help prevent stent thrombosis with bivalirudin, and that’s being addressed in HORIZONS-AMI-2, which is starting soon.

Intraoperative neurophysiological monitoring of extracranial-intracranial bypass procedures.

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Intraoperative neurophysiological monitoring (IONM) represents an established tool in neurosurgery to increase patient safety. Its application, however, is controversial. Its use has been described as helpful in avoiding neurological deterioration during intracranial aneurysm surgery. Its impact on extracranial-intracranial (EC-IC) bypass surgery involving parent artery occlusion for the treatment of complex aneurysms has not yet been studied. The authors therefore sought to evaluate the effects of IONM on patient safety, the surgeon’s intraoperative strategies, and functional outcome of patients after cerebral bypass surgery. Intraoperative neurophysiological monitoring results were compared with those of intraoperative blood flow monitoring to assess bypass graft perfusion.

METHODS

Compound motor action potentials (CMAPs) were generated using transcranial electrical stimulation in patients undergoing EC-IC bypass surgery. Preoperative and postoperative motor function was analyzed. To assess graft function, intraoperative flowmetry and indocyanine green fluorescence angiography were performed. Special care was taken to compare the relevance of electrophysiological and blood flow monitoring in the detection of critical intraoperative ischemic episodes.

RESULTS

The study included 31 patients with 31 aneurysms and 1 bilateral occlusion of the internal carotid arteries, undergoing 32 EC-IC bypass surgeries in which radial artery or saphenous vein grafts were used. In 11 cases, 15 CMAP events were observed, helping the surgeon to determine the source of deterioration and to react to it: 14 were reversible and only 1 showed no recovery. In all cases, blood flow monitoring showed good perfusion of the bypass grafts. There were no false-negative results in this series. New postoperative motor deficits were transient in 1 case, permanent in 1 case, and not present in all other cases.

CONCLUSIONS

Intraoperative neurophysiological monitoring is a helpful tool for continuous functional monitoring of patients undergoing large-caliber vessel EC-IC bypass surgery. The authors’ results suggest that continuous neurophysiological monitoring during EC-IC bypass surgery has relevant advantages over flow-oriented monitoring techniques such as intraoperative flowmetry or indocyanine green–based angiography.

Source: JNS

 

 

Featured in Journal Watch: More Studies from the San Francisco Cardiology Sessions.

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Journal Watch Cardiology summarizes three New England Journal of Medicine studies that were presented at the American College of Cardiology conference:

Nonemergency PCI seems safe to perform at hospitals without on-site cardiac surgery facilities, according to a randomized study that included some 3700 patients. Three fourths underwent PCI at hospitals without on-site cardiac surgery, and the rest were transferred to hospitals with on-site facilities. The rate of a composite outcome (death, MI, repeat revascularization, or stroke) did not differ between the groups at either 30 days or 12 months.

In two studies of relatively high-risk patients undergoing CABG, use or nonuse of cardiopulmonary bypass had no significant effect on the rate of composite outcomes that included death, MI, stroke, repeat revascularization, or renal failure. Joel M. Gore comments that the choice regarding cardiopulmonary bypass “thus depends chiefly on operator expertise and individual patient characteristics and preferences.”

Source: Journal Watch Cardiology

Can We Build a Better SYNTAX Score?

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Adding clinical factors to the anatomical SYNTAX model improved prediction of 4-year mortality with surgery versus stenting for complex coronary artery disease.

The SYNTAX score provides an anatomically based measure of coronary artery disease to help physicians and patients choose an appropriate revascularization strategy. However, other patient characteristics are often important factors in clinical decisions.

To improve the SYNTAX scoring system, investigators used SYNTAX trial data to identify six clinical factors — age, creatinine clearance, left ventricular ejection fraction [LVEF], peripheral vascular disease, female sex, and chronic obstructive pulmonary disease [COPD]) — that independently predicted 4-year mortality or showed an interaction effect between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for long-term mortality (notably, diabetes did not meet either of these criteria and was excluded from the model). These variables were combined with two anatomic measures: SYNTAX score and presence of left main disease.

Compared with the original SYNTAX model, the SYNTAX score II predicted similar 4-year mortality with CABG and PCI at lower scores with some clinical factors (female sex, lower LVEF) and at higher scores with others (older age, COPD, left main disease). The new model discriminated well between CABG and PCI, both in the SYNTAX population and in a validation cohort of 2900 participants in an international registry.

Comment: The inclusion of clinical variables improves the SYNTAX score by allowing clinicians to identify lower-risk patients in high categories of anatomic risk, and vice versa. Although externally validated, the new score requires further validation in randomized studies. In the meantime, clinicians should consider taking this common-sense approach to making revascularization decisions.

Source: Journal Watch Cardiology

Acadesine Does Not Improve Outcomes of CABG.

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In a randomized trial, an adenosine-regulating agent had no apparent cardioprotective effect.

Despite advances in surgical technology, ischemia/reperfusion injury associated with coronary artery bypass grafting (CABG) remains an important cause of morbidity and mortality. To evaluate the protective effect of acadesine, an adenosine-regulating agent, investigators at 300 sites in 7 countries conducted a manufacturer-sponsored, randomized, double-blind, placebo-controlled trial involving intermediate- or high-risk patients undergoing nonemergent, on-pump CABG during 2009–2010. The primary composite endpoint was all-cause mortality, nonfatal stroke, or mechanical support for severe left ventricular dysfunction during CABG or 4 weeks of follow-up.

The trial was stopped for futility after enrollment of 30% of the projected study population. The final cohort included 2986 patients (median age, 66), most of whom were white men with hyperlipidemia, diabetes, and family history of cardiovascular disease. The primary-endpoint rate was 5.0% overall and did not differ significantly between the placebo and acadesine groups (5.0% and 5.1%, respectively), as demonstrated by a Kaplan-Meier curve. No between-group difference in the rate of any secondary endpoint reached or approached statistical significance, nor was any significant difference found among groups stratified by Society of Thoracic Surgeons risk quintile.

Comment: Although previous studies yielded promising findings, this well-designed trial failed to show any benefit of acadesine on outcomes in intermediate- or high-risk patients undergoing coronary artery bypass grafting. The rate of the primary endpoint, although lower than the 10% expected with placebo in this population, underscores the need for continued efforts to prevent ischemia/reperfusion injury during and after CABG.

Source: Journal Watch Cardiology