Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

Title: Hospital Complication Rates With Bariatric Surgery in Michigan
Date Posted: July 27, 2010
Authors: Birkmeyer NJ, Dimick JB, Share D, et al., on behalf of the Michigan Bariatric Surgery Collaborative.
Citation: JAMA 2010;304:435-442.

Study Question:
Do complication rates vary across hospitals and procedure type for bariatric surgery?
Methods:
Data from the Michigan Bariatric Surgery Collaborative (MBSC) were used for the present analysis. MBSC is a consortium of hospitals performing bariatric surgery in Michigan. Participation is voluntary. Hospitals that perform at least 25 bariatric procedures per year were eligible for participation, with participating hospitals submitting data for all bariatric surgery patients. Medical record review was completed through a 30-day postoperative period. Patients undergoing revisional surgery were excluded from this analysis.
Results:
A total 15,275 patients undergoing bariatric surgery in one of 25 participating Michigan hospitals, between 2006 and 2009, were included. Perioperative complications occurred in 7.3% of patients, the majority being minor complications. Serious complications were relatively low, with the most occurring after gastric bypass (3.6%; 95% confidence interval [CI], 3.2%-4.0%), followed by sleeve gastrectomy (2.2%; 95% CI, 1.2%-3.2%) and laparoscopic adjustable gastric band (0.9%; 95% CI, 0.6%-1.1%) procedures (p < 0.001). Mortality rates were 0.04% (95% CI, 0.001%-0.13%) for laparoscopic adjustable gastric band, 0 for sleeve gastrectomy, and 0.14% (95% CI, 0.08%-0.25%) for gastric bypass. Rates of serious complications (after adjustment for patient characteristics and procedure mix) varied from 1.6% (95% CI, 1.3-2.0) to 3.5% (95% CI, 2.4-5.0) across hospitals. Annual procedure volume was inversely associated with rates of serious complications at the hospital level and surgeon level. Adjusted rates of serious complications were similar in center of excellence hospitals and non-center of excellence hospitals (2.7% vs. 2.0, respectively, p = 0.41).
Conclusions:
The investigators concluded that serious complications among patients undergoing bariatric surgery in Michigan were low. Rates of serious complications were inversely associated with hospital and surgeon volume.
Perspective:
This large-scale study highlights the usefulness of such registries to examine factors linked to complications and thus affords an opportunity for quality improvement initiatives.
__________________________________________________ _________________________

Title: Secondary Prevention Through Cardiac Rehabilitation: Physical Activity Counselling and Exercise Training: Key Components of the Position Paper From the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation
Date Posted: July 27, 2010
Authors: Piepoli MF, Carre F, Heuschmann P, et al.
Citation: Eur Heart J 2010;Jul 19:[Epub ahead of print].

Conclusions:
The following are 10 points to remember about this position paper:

1. Cardiac patients after an acute event and/or with chronic heart disease deserve special attention to restore their quality of life and to maintain or improve functional capacity. They require counseling to avoid recurrence through a combination of adherence to a medication plan and adoption of a healthy lifestyle.

2. Cardiac rehabilitation (CR) can be viewed as the clinical application of preventive care by means of a professional multidisciplinary integrated approach for comprehensive risk reduction and global long-term care of cardiac patients. This is accompanied by a flexible follow-up strategy and easy access to a specialized team.

3. CR is underutilized despite having been shown to be a cost-effective intervention following an acute coronary event and heart failure, since it improves prognosis by reducing recurrent hospitalization and health care expenditures, while prolonging life.

4. CR is recommended for stable patients post-acute coronary syndrome and post-primary percutaneous coronary intervention (PCI), stable coronary artery disease, and post-elective PCI, post-coronary artery and valve heart surgery, congestive heart failure (not approved by all third parties in the United States), and post-heart transplant. A baseline symptom-limited exercise test is indicated. The exception is a submaximal exercise test for cardiac surgical patients and a symptom-limited exercise test after wound stabilization.

5. Exercise recommendations need to be individualized based upon usual physical activity, potential barriers, gender, age, left ventricular (LV) function, and special needs including orthopedic and recent surgery. Aerobic activity should be at 50-80% of peak oxygen consumption (or 70-85% of peak heart rate or 70-85% of onset of ischemia), 50% of peak heart rate in high-risk persons with LV dysfunction, at least 20- to 30-minute and preferably 45- to 60-minute sessions, which are at least 3 and preferably 6 days per week.

6. There is less evidence to support resistance training. General recommendations include: training regimens including using 30-40% of the one-repetition maximum for the upper body and 40-50% of the one-repetition maximum for lower body exercises, with 12-15 repetitions in one set repeated two to three times weekly.

7. In CR, all of the goals of secondary prevention are targeted by promoting lifestyle change and patient adherence to pharmacological therapy.

8. While it is clearly understood and accepted that an isolated exercise program is not CR, physical activity and exercise training must be recognized as the core components from which to build a comprehensive CR program.

9. Physical activity will be the carrier of change and of maintenance of healthy behaviors in the longer term, with positive consequences on self-confidence and esteem, socialization, return to work, and normalization of daily life activities.

10. CR programs, with a core of physical activity and exercise training, promote better quality of life, better control of classical cardiovascular risk factors, and, consequently, a lower rate of events and longer higher quality survival. Advocating CR for every patient who can benefit must be on every cardiologist’s agenda.
Perspective:
This summary of European recommendations does not provide guidance for the duration of CR nor follow-up. The American College of Cardiology/American Heart Association expert consensus is in consort with the European guidelines, but also emphasizes the value of including assessment of nutrition, psychological issues, and potential value of follow-up sessions.

[Chevychelov]

Selective In-Lab Clopidogrel a Safe Alternative to Pretreatment
Print Email

Key Points:
MACE equivalent for high-dose in-lab clopidogrel vs. pretreatment in patients undergoing angiography
Forgoing routine pretreatment safer for patients determined to need CABG or no intervention
Risk stratification important in choosing appropriate strategy
By Kim Dalton
Monday, August 02, 2010

Giving patients a 600-mg loading dose of clopidogrel in the cath lab after diagnostic angiography to establish the need for percutaneous coronary intervention (PCI) yields outcomes comparable to routine preloading, according to a study published in the August 10, 2010, issue of the Journal of the American College of Cardiology. The wait-and-see approach to clopidogrel administration avoids unnecessary bleeding risk in patients for whom bypass surgery or medical therapy is deemed more appropriate than PCI.

For the ARMYDA-5 PRELOAD (Antiplatelet therapy for Reduction of Myocardial Damage during Angioplasty) trial, investigators led by Germano Di Sciascio, MD, of Campus Bio-Medico University of Rome (Rome, Italy), evaluated 409 patients who underwent PCI at 3 Italian centers. The cohort had been randomized to receive a 600-mg loading dose of clopidogrel 4 to 8 hours before intervention (n = 204) or in the cath lab after angiography but prior to PCI (n = 205).

Demographic and clinical characteristics of the 2 groups were similar. About one-third of the study population had diabetes and about 40% presented with NSTE-ACS. In addition, more than one-third of patients received DES.

The results were first presented October 22, 2007, at the Transcatheter Cardiovascular Therapeutics 2007 symposium in Washington, DC.

MACE Comparable for the 2 Strategies

At 30 days there was no difference in the primary endpoint of MACE (composite of cardiac death, MI, and unplanned TVR) between the preload and in-lab groups: 10.3% vs. 8.8%; P = 0.72. In both arms, the incidence of MACE was driven by the rate of periprocedural MI (9.3% for preload vs. 8.8% for in-lab; P = 0.99). No instances of subacute stent thrombosis were observed in the in-lab group, and only 2 cases (1 definite and 1 probable) occurred in the pretreatment group, the authors report. In addition, rates of postprocedural elevation of creatine kinase-MB and troponin-I above the upper limits of normal also were similar for the preload and in-lab groups.

In post-hoc subgroup analyses, similar MACE rates for the 2 loading strategies also were seen among patients with stable angina or ACS as well as those who underwent multivessel PCI.

No patient experienced postprocedural major bleeding or required transfusion. Minor bleeding was observed in 7.8% of the pre-load group and 5.4% of the in-lab group (P = 0.42).

Platelet Reactivity Higher During PCI with In-Lab Loading

Before randomization, platelet reactivity was measured in all patients with the VerifyNow P2Y12 assay (Accumetrics, San Diego, CA) and found to be comparable between the 2 groups. When reactivity was assessed again at PCI and 2 hours postprocedure, however, the absolute P2Y12 reaction units (PRU) peak was higher in the in-lab group than in the preload group at both time points (P = 0.043 and P = 0.01, respectively). After 2 hours, however, platelet reactivity levels declined in both groups, and were similar at 8 hours.

The authors draw a number of conclusions from the trial results:
Platelet inhibition is higher with preloading, but ischemia protection is still adequate with in-lab loading, with no increase in thrombotic risk with high-dose in-lab clopidogrel administration
When needed, in-lab loading can be a safe and effective alternative to pretreatment several hours prior to PCI and before knowing angiographic status
Pretreatment does not appear to increase bleeding risk
Accurate patient risk stratification is crucial for choosing the appropriate loading approach; in low-risk patients with little likelihood of undergoing PCI, routine preloading may be unnecessary, while patients in whom PCI is planned or likely—especially those with ACS—may be safely treated with early preloading, as recommended by guidelines

Which Approach in the Real World?

In an accompanying editorial, Goran Stankovic, MD, PhD, and Milorad Zivkovic, MD, of the Medical School of Belgrade (Belgrade, Serbia), note that in the real world most patients are not scheduled for elective PCI but rather for elective diagnostic angiography, with ad hoc PCI performed only if indicated. Thus, clinicians have tended to adopt 1 of 2 strategies:
Preload all patients undergoing diagnostic angiography, thereby exposing the majority who do not need PCI to aggressive antiplatelet therapy and unnecessary bleeding risk, or
Load clopidogrel in the cath lab after diagnostic angiography when anatomy is known and the indication for PCI is established, but without time to achieve optimal platelet inhibition (pharmacodynamic studies have shown it takes at least 2 hours for a 600-mg loading dose to reach that level)

The results of this randomized trial “support the in-lab administration of clopidogrel as a safe alternative to routine pretreatment given before knowing a patient’s anatomy,” the editorialists write.

However, Drs. Stankovic and Zivkovic cautioned against drawing firm conclusions. For instance, the clinical status of the study population was mixed, with about 60% presenting with stable angina and about 40% with ACS. Although the MACE rate was similar for the 2 treatment groups in the overall population, it was 60% higher specifically in ACS patients, and events in the in-lab group mainly were driven by these patients. This subgroup carries a higher thrombotic risk and would benefit more from early pre-load, thereby allowing time for clopidogrel to achieve its full antiplatelet effect, the editorialists comment. “[F]urther studies are needed before concluding that in-lab clopidogrel administration is adequate in all cases regardless of clinical presentation,” they add.

When Do NSTE MIs Occur?

In a telephone interview with TCTMD, Eric R. Bates, MD, of the University of Michigan Medical Center (Ann Arbor, MI), said, “The clinical message people have been promoting is that the earlier you can preload with clopidogrel, the better, because it takes several hours for the drug to become metabolically active and maybe even longer to be clinically active. I’m not sure you get any acute in-lab benefit from clopidogrel given between the angiogram and PCI.

“The question is whether NSTE MIs occur in the hours after PCI or if they actually occur in the lab from embolization of microparticles, side branch occlusions, and other things,” when platelet inhibition from in-lab loading is suboptimal, he continued. “My impression is that most of the complications nowadays with stents occur in the lab and not in the postprocedure period.”

Current guidelines recommend pretreatment of ACS patients, so they should be on clopidogrel by the time they get to the cath lab, Dr. Bates said. “But if a patient is stable, I prefer not to give clopidogrel until the angiogram has been defined so I can see if it’s going to be angioplasty or surgery. Most patients don’t have a problem with reinfarction once they get into the hospital, and they receive PCI within 24 hours.”

Opportunity for Shared Decision Making

Another argument in favor of waiting, Dr. Bates observed, is the increasing emphasis on shared decision making, especially in complex cases. “It’s seductive [for interventionalists] to just do PCI and get it over with,” he said, but ad hoc PCI does not allow time for consultation with a surgeon and cardiologist or for the patient and their family to fully consider the options.

Nonetheless, in many US hospitals ad hoc PCI is the order of the day, Dr. Bates said, and “whether everybody ought to get aspirin and clopidogrel on the way in the front door or wait until after angiography is a reasonable question to address. Based on these data, the conclusion is that you can wait to give it in the cath lab. But I found the results somewhat counterintuitive. I would have expected a benefit from pretreatment.”

Given that fact and the small sample size, the study is unlikely to change what practitioners already do, one way or the other, Dr. Bates predicted, adding, “The question should be studied further.”

The editorialists write that a positive byproduct of lingering questions about the safety of in-lab loading is that it reinforces efforts to develop better antiplatelet regimens and/or agents, such as prasugrel and ticagrelor. “With these new compounds, it may no longer be necessary to consider pretreatment, because of more rapid onset and more pronounced platelet inhibition than clopidogrel,” they conclude.

However, Dr. Bates noted that generic clopidogrel is scheduled to become available next year. “If studies show that the point-of-care platelet function tests can select the 75% of people who will do just fine with clopidogrel—and save a lot of money—then these questions [of when to load clopidogrel] will still be important in clopidogrel responders.”

Study Details

All patients were pretreated with aspirin (100 mg/day); after PCI, they received aspirin (100 mg/day) indefinitely and were continued on clopidogrel (75 mg/day) for at least 1 month (12 months in those with ACS or receiving DES).

[Chevychelov]

Chest Compression Alone Does the Job for Bystander CPR
Key Points:
Rescue breathing does not improve survival when added to chest compression for bystander CPR
Findings do not apply to health care professionals or bystanders who do not need dispatcher assistance
By Jason Kahn
Monday, August 02, 2010

Rescue breathing does nothing to improve survival when added to chest compressions for patients receiving bystander cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest, according to 2 randomized trials published in the July 29, 2010, issue of the New England Journal of Medicine.

In the first study, researchers led by Thomas D. Rea, MD, of the University of Washington (Seattle, WA), assessed outcomes of dispatcher-assisted bystander CPR among 1,941 patients from EMS systems in Washington State and London, United Kingdom. Subjects were randomized to chest compression with or without rescue breathing.

There were no differences between the 2 groups in the rates of survival to hospital discharge (the primary endpoint) or having a pulse at the end of EMS care.

In addition, similar proportions of patients survived to discharge with a favorable neurologic status (14.4% for chest compression alone vs. 11.5% for chest compression plus breathing; P = 0.13) at sites that assessed the endpoint.

Interestingly, in subset analyses, some patient groups showed a trend toward improved survival to hospital discharge with chest compression alone, such as those with a cardiac cause of their arrests (15.5% vs. 12.3% for chest compression plus breathing; P = 0.09) and patients with shockable rhythms (31.9% vs. 25.7% for chest compression plus breathing; P = 0.09).

The researchers stressed that the results do not apply to CPR given by health care professionals. Nor do they apply to bystanders “who have been previously trained, are able to identify a cardiac arrest, and can provide CPR without dispatcher assistance,” they say. “Nonetheless, CPR performed by lay responders trained in compression plus rescue breathing often falls short of the guideline standards during an actual cardiac arrest.”

As such, the investigators conclude, “the results . . . strengthen a layperson CPR strategy that emphasizes chest compression and minimizes the role of rescue breathing.”

In the second trial, researchers led by Leif Svensson, MD, PhD, of the Stockholm Prehospital Center (Stockholm, Sweden), randomized 1,276 out-of-hospital cardiac arrest patients to dispatcher-assisted bystander CPR utilizing chest compressions with or without resuscitative breathing.

Thirty-day survival (the primary endpoint) was equivalent between the 2 groups, as was 1-day survival and survival to hospital discharge, although there was a slight numerical trend favoring the compression-only group for the latter 2 endpoints.

The 30-day survival and 1-day survival comparisons did not differ significantly upon further analyses in numerous subgroups based on age, sex, location of cardiac arrest, interval between call and first EMS response, and first cardiac rhythm.

While making clear that the results do “not apply to cardiac arrest caused by trauma, respiratory failure, or intoxication or to children under the age of 8 years or patients in whom bystanders perform CPR without instructions from dispatchers,” Dr. Svensson and colleagues conclude that “this study lends further support to the hypothesis that compression-only CPR, which is easier to learn and to perform, should be considered the preferred method for CPR performed by bystanders in patients with cardiac arrest.”

Rescue Breathing Still Important

In an editorial accompanying the papers, Myron L. Weisfeldt, MD, of the Johns Hopkins University School of Medicine (Baltimore, MD), notes that the message of the 2 studies is just as straightforward as their results: “[A]dvocating continuous chest compression without ventilation by a bystander should increase the frequency of bystanders’ effectively performing CPR and therefore increase the chances of survival after cardiac arrest.”

But CPR courses should still continue to teach rescue breathing, Dr. Weisfeldt writes, since most cases of cardiac arrest in children are due to obvious respiratory failure. In addition, he notes that not providing rescue breathing in adult patients whose arrests are due to noncardiac causes may even be detrimental.

Randomized studies are still required to investigate these and other issues, including the need for rescue breathing after a prolonged period of CPR and whether the benefits of compression-only CPR are evident primarily in cardiac arrest with initial ventricular tachycardia or fibrillation rather than arrest arising from other rhythms.

According to Dr. Weisfeldt, “The answers to these questions may be paradigm-shifting and will almost certainly be lifesaving.”

[Chevychelov]

AHA Statement Outlines Rapid Triage of Low-Risk Chest Pain Patients

Key Points:
AHA scientific statement reviews testing for low-risk ED patients with chest pain
Early treadmill testing advocated to determine need for further workup
Consensus review meant to help clinicians decide who can be safely discharged
By L.A. McKeown
Friday, July 30, 2010

Many patients who present to the emergency department (ED) with acute chest pain are at low risk of acute coronary syndromes (ACS) and other serious conditions. A new scientific statement from the American Heart Association (AHA), published online July 26, 2010, ahead of print in Circulation, outlines how these patients can be evaluated most efficiently and cost-effectively.

According to the scientific statement, such patients can be effectively risk-stratified based on clinical presentation, cardiac markers, and an exercise treadmill test to differentiate those who can be discharged safely and those who require further workup.

In addition, risk-scoring systems including the Thrombolysis In Myocardial Infarction (TIMI) risk score and the Global Registry of Acute Coronary Events (GRACE) scoring system can be recommended as guides for risk stratification and should be applied as adjuncts to, not substitutes for, clinical judgment, according to the statement.

An AHA expert committee chaired by Ezra A. Amsterdam, MD, of the University of California, Davis (Sacramento, CA), reviewed the published scientific evidence on the application of diagnostic tools in the management of low-risk patients presenting with acute chest pain. The scientific statement covers basic identification measures of low clinical risk and provides an algorithm for evaluating patients presenting with symptoms suggestive of ACS.

Touting the Treadmill

The current American College of Cardiology/AHA guidelines for stress testing and for management of NSTE ACS recommend that exercise treadmill testing without imaging should be performed as the initial test in low- to intermediate-risk patients who present with ischemic symptoms and can exercise, do not have significant baseline ECG changes that preclude interpretation, and are not taking digoxin. Dr. Amsterdam and colleagues say this strategy has been validated by multiple studies that included approximately 3,000 patients who underwent treadmill testing after ≤ 12 hours of negative observation.

“No adverse effects of early [exercise treadmill testing] were reported. Another study of 400 patients who received [exercise treadmill testing] or stress imaging tests after a negative ADP showed similarly excellent prognostic findings,” they write. “Outcomes at 6 months did not differ from those of a control group of chest pain patients who were managed by usual hospital admission at a higher cost.”

Although predischarge exercise treadmill testing is the preferred method, the authors say outpatient testing is an alternative strategy recognized by the guidelines in selected low-risk chest pain patients after a negative evaluation by serial ECGs and cardiac injury markers.

Rest myocardial perfusion imaging is another test that has assumed an important role in the ED setting. According to the authors, multiple studies have demonstrated that nuclear stress testing can accurately identify low- and high-risk patients. Such testing also significantly increases both diagnostic and prognostic information beyond ECG testing and clinical variables, they say.

The authors also devote a considerable portion of the scientific statement to CT coronary angiography, outlining its risks and limitations. They point out that few studies have explored the utility of CT angiography in triaging low-risk populations such as those who present to the ED with chest pain.

Important New Data Overlooked

In a telephone interview with TCTMD, Matthew J. Budoff, MD, of the Harbor-UCLA Medical Center (Torrance, CA), said the scientific statement is a good reference but is not as comprehensive as it could have been.

“This scientific statement provides a state-of-the art summary, with about 170 references, of where we are at this point in time. It’s the kind of thing that I think will be useful for cardiologists, primary care doctors, and emergency room physicians as a reference document,” he said. But, it does not include important new information that has come out recently at major medical meetings, including the AHA’s own annual conference, he added.

“There were some randomized trials of nuclear imaging vs. CT angiography that have been presented but are not included in this because they are not published yet,” he said. One such study, he noted, is the CT-STAT (Computed Tomographic Angiography for the Systematic Triage of Acute Chest Pain Patients to Treatment) trial, which was presented at the AHA Scientific Sessions 2009. In that trial of 750 patients, use of CT angiography in the ED was faster and less expensive than standard diagnostic testing for low-risk patients with chest pain.

In a telephone interview with TCTMD, Michael E. Farkouh, MD, MSc, of Mount Sinai Medical Center (New York, NY), a member of the writing committee, confirmed that the reason CT-STAT was not mentioned in the statement is that it has not yet been published and only published studies were included in their review.

“I personally think there is a role for CT angiography in the ED, but I do think it needs further evaluation,” Dr. Farkouh said. “CT-STAT is one piece of the information that we have currently, but we need more.”

Logistics of Stress Testing Questioned

Michael Poon, MD, of Stony Brook University Medical Center (Stony Brook, NY), commented that while the scientific statement provides a comprehensive overview of the published evidence, the committee did not commit to any recommendations per se.

“It sort of leaves the clinician to decide what is most appropriate for his or her specific practice. For example, the [nuclear stress testing] data look pretty good, but you have to look at it in terms of the logistics. In many hospitals, it’s not feasible,” Dr. Poon said. “I think what would have been better is if they had given a first-line, second-line, third-line test instead of just listing all the diagnostic tests out there and what has been written about them.”

Dr. Poon also took issue with the committee’s suggestion that exercise treadmill testing is a simple way of managing chest pain in the ED.

“In the emergency room, you are dealing with a very high-pressure environment,” Dr. Poon said. “Unless you have a very well-oiled machine in terms of doing a stress test, the ED is going to be packed with patients waiting to get on a treadmill.”

Dr. Farkouh agreed that while logistics could pose a problem, treadmill testing could be done in another part of the hospital. “What we are trying to say is that it needs to be done early in the evaluation process—preferably in the first 12 to 24 hours,” he said. “It’s a strategy for patients in the ED, but it’s not geographically limited to the ED.”

He added that the scientific statement is meant to be a consensus review to help clinicians make better decisions about who can safely be discharged from the ED and who cannot.

“I think most people aren’t aware that plain treadmill testing actually is very effective to triage patients,” Dr. Farkouh. “Hopefully, this scientific statement will allow clinicians to understand the evidence at hand in a very rapidly changing field.”

[Chevychelov]

COURAGE Results Consistent Across Different Health Care Systems

Key Points:
Outcomes largely similar for PCI vs. medical therapy in different health care systems
Possible mortality reduction with PCI in highest risk patients
By Caitlin E. Cox
Friday, July 30, 2010

Although the COURAGE trial enrolled patients from 3 distinct North American health care systems, each with different levels of baseline risk, outcomes largely were similar for optimal medical therapy vs. percutaneous coronary intervention (PCI) within the patient subgroups. Any discrepancies can be explained by baseline differences known to affect long-term prognosis, asserts a paper published online July 27, 2010, in Circulation: Cardiovascular Quality and Outcomes.

Yet Jeffrey W. Moses, MD, of Columbia University Medical Center (New York, NY), described the paper as “defensive.” In a telephone interview with TCTMD, he claimed the analysis demonstrates that the highest risk patients actually appear to have a mortality benefit with the addition of PCI to optimal medical therapy.

Many Faces of COURAGE

The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation) trial, which randomized 2,287 stable CAD patients to optimal medical therapy with or without PCI, found no significant difference between the 2 approaches for the primary endpoint of all-cause death and nonfatal MI or for secondary composite endpoints.

For the current study, Bernard R. Chaitman, MD, of Saint Louis University School of Medicine (St. Louis, MO), analyzed the results of COURAGE patients based on their place of enrollment:
15 US Department of Veterans Affairs (VA) sites (n = 968)
19 US non-VA sites (n = 386)
16 Canadian sites (n = 931)

Within each health care system, baseline characteristics were similar between PCI and optimal medical therapy groups. Yet among the 3 types of health care systems, there were different levels of risk.

The VA group generally was at highest risk, with more patients taking beta-blockers, calcium antagonists, nitrates, and diuretics at baseline and throughout the study compared with the other 2 groups. They also were less likely to have met target HDL levels (> 40 mg/dL). The Canadian group, meanwhile, was more likely to have entered the study having already achieved treatment targets for hypertension, diet, and physical activity. The non-VA group tended to be at intermediate risk between the Canadian and VA patients.

Compared with US patients in general, Canadian patients were younger, had lower BMIs, were more likely to be white, and more regularly performed moderate exercise. They also were more likely to have experienced prior MI or revascularization but less likely to have a history of hypertension or stroke.

At a median of 4.6-year follow-up, both all-cause death/MI and death alone were similar between optimal medical therapy and PCI among the 3 health care systems (table 1).

Table 1. Outcomes Based on Place of Enrollment

Optimal Medical Therapy
Optimal Medical Therapy + PCI
P Value

All-Cause Death/MI

VA
Non-VA
Canadian


21.9%
21.8%
13.5%


22.3%
15.8%
17.3%


0.95
0.24
0.17

Death

VA
Non-VA
Canadian


11.4%
8.3%
5.0%


8.6%
7.5%
6.9%


0.07
0.94
0.37



Logistic regression analysis initially showed a significant interaction between type of health care system and death, with the VA group having higher mortality compared with the Canadian group (OR 1.92; 95% CI 1.34-2.75; P < 0.001). However, adjustment for baseline characteristics somewhat blunted that relationship (adjusted OR 1.55; 95% CI 1.02-2.35; P = 0.04). Other independent predictors of mortality were baseline ejection fraction, smoking status, age, and number of comorbidities.

Analysis Offers ‘Unique Opportunity’

“Our main findings are that type of [health care system] did not influence the primary outcome,” or any other endpoint, when optimal medical therapy and PCI were compared, Dr. Chaitman and colleagues conclude. “A significant difference in mortality was observed at 4.6 years of follow-up among the different [health care systems] that was largely explained by age, comorbid conditions, and ventricular function.”

The investigators say their analysis “provides a unique opportunity to explore treatment differences over a gradient of comorbidity and different processes of care in a large cohort of patients with stable ischemic heart disease treated in a contemporary fashion. The results amplify the overall COURAGE findings and reveal that there are no significant treatment differences between PCI and optimal medical therapy for serious cardiovascular outcomes across different [health care systems].”

They acknowledge several study limitations, among them the lack of power to test for interactions because each health care system represents a subset of the overall trial. In addition, because the optimal medical therapy offered in COURAGE involved free medication and an aggressive approach, the potential to observe differences “was likely minimized compared to what might have been observed with a usual care approach,” the authors write, noting that the trial provides a model for implementing optimal medical therapy in diverse environments.

Missing the Point

Dr. Moses, however, had a different take-away message from the results. “This is a defensive paper,” he commented.

“The most striking thing here is that they make a pretty compelling case that the VA group was the sickest, the US non-VA group was the next sickest, and the Canadian group was the least sick,” he said, pointing out that in the VA group the mortality difference nearly achieved statistical significance at a P value of 0.07.

The COURAGE investigators “hang on to the non-statistical significance, which is naive. Whenever you’re doing these analyses, they’re exploratory by definition,” Dr. Moses said. “When you’re dealing with an underpowered trial [as is the case with COURAGE] and then you do subgroup analyses and see a P value of 0.07, it should at least raise a flag. To see a trend this strong is interesting.”

“Importantly, and this is the more profound point, every analysis of COURAGE where they stratified people on the basis of risk—ie, when they looked at ischemia, multivessel disease with low ejection fraction, silent ischemia—all of them showed trends toward reductions in hard events,” with PCI in moderately high risk patients, Dr. Moses said. He stressed that the study did not include extremely high-risk patients.

Moreover, the mortality difference is not trivial, Dr. Moses stressed. “It’s a little frustrating because there’s a lot in COURAGE that, while not definitive, explains why PCI is important in terms of events and conforms with 30 years of our understanding of risk stratification,” he said. “They just keep burying that message. I guess they think that if they just keep saying it, it will be true.”

[Chevychelov]

Title: CPR With Chest Compression Alone or With Rescue Breathing
Date Posted: July 28, 2010
Authors: Rea TD, Fahrenbruch C, Culley L, et al.
Citation: N Engl J Med 2010;363:423-433.

Study Question:
What are the outcomes with dispatcher-assisted cardiopulmonary resuscitation (CPR) when instructions consisted of chest compression alone and when instructions consisted of chest compression plus rescue breathing?
Methods:
The Dispatcher-Assisted Resuscitation Trial (DART) was a multicenter, randomized trial of dispatcher instructions to bystanders for performing CPR. The patients were persons 18 years of age or older with out-of-hospital arrest for whom dispatchers initiated CPR instruction to bystanders. Patients were randomly assigned to receive chest compression alone or chest compression plus rescue breathing. The primary outcome was survival to hospital discharge. Secondary outcomes included a favorable neurologic outcome at discharge.
Results:
Of the 1,941 patients who met the inclusion criteria, 981 were randomly assigned to receive chest compression alone and 960 to receive chest compression plus rescue breathing. The investigators observed no significant difference between the two groups in the proportion of patients who survived to hospital discharge (12.5% with chest compression alone and 11.0% with chest compression plus rescue breathing, p = 0.31) or in the proportion who survived with a favorable neurologic outcome in the two sites that assessed this secondary outcome (14.4% and 11.5%, respectively; p = 0.13). Prespecified subgroup analyses showed a trend toward a higher proportion of patients surviving to hospital discharge with chest compression alone, as compared with chest compression plus rescue breathing for patients with a cardiac cause of arrest (15.5% vs. 12.3%, p = 0.09) and for those with shockable rhythms (31.9% vs. 25.7%, p = 0.09).
Conclusions:
The authors concluded that the results support a strategy for CPR performed by laypersons that emphasizes chest compression and minimizes the role of rescue breathing.
Perspective:
This study suggests that CPR instructions consisting of chest compression alone did not increase survival to hospital discharge overall, as compared with instructions consisting of chest compression plus rescue breathing. However, it appears that chest compression alone may increase survival among certain subgroups of patients (i.e., those with a cardiac cause of arrest and those with ventricular fibrillation). The results, viewed in the context of other available data, provide support for a CPR strategy that emphasizes chest compression and minimizes the role of rescue breathing. Future studies are needed to further assess type-specific CPR aimed at the underlying cause of arrest.

__________________________________________________ ______________________

Title: Compression-Only CPR or Standard CPR in Out-of-Hospital Cardiac Arrest
Date Posted: July 28, 2010
Authors: Svensson L, Bohm K, Castren M, et al.
Citation: N Engl J Med 2010;363:434-442.

Study Question:
Does compression-only cardiopulmonary resuscitation (CPR) result in better outcomes than conventional CPR?
Methods:
The subjects of this randomized clinical trial were 1,276 patients (mean age 68 years) with out-of-hospital cardiac arrest (OHCA). When the OHCA was reported to the emergency dispatcher by a witness, the dispatcher gave the bystander instructions to perform either compression-only CPR (n = 620) or conventional CPR (n = 656; two mouth-to-mouth ventilations alternating with 15 chest compressions). The 1° endpoint was 30-day survival.
Results:
There was not a significant difference in 30-day survival between the compression-only group (8.7%) and the conventional CPR group (7%).
Conclusions:
The investigators concluded that compression-only bystander CPR before the arrival of emergency medical services personnel does not compromise or significantly improve survival in patients with OHCA.
Perspective:
Experimental studies and retrospective clinical registry studies have demonstrated that elimination of ventilation during bystander CPR does not affect survival or neurological outcomes. At least in theory, compression-only CPR could improve survival by eliminating periodic interruptions in blood flow to the heart and brain during mouth-to-mouth ventilation. There was in fact a trend toward better survival with compression-only CPR in this study, but the difference was not significant, perhaps because the study was underpowered. In any event, there is no evidence that compression-only CPR compromises outcomes. Because it is easier to teach than conventional CPR and because many bystanders understandably are reluctant to perform mouth-to-mouth ventilation, compression-only CPR appears to be the preferred technique for bystander CPR.

[Chevychelov]

Title: Secondary Prevention Through Cardiac Rehabilitation: Physical Activity Counselling and Exercise Training: Key Components of the Position Paper From the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation
Date Posted: July 27, 2010
Authors: Piepoli MF, Carre F, Heuschmann P, et al.
Citation: Eur Heart J 2010;Jul 19:[Epub ahead of print].

Conclusions:
The following are 10 points to remember about this position paper:

1. Cardiac patients after an acute event and/or with chronic heart disease deserve special attention to restore their quality of life and to maintain or improve functional capacity. They require counseling to avoid recurrence through a combination of adherence to a medication plan and adoption of a healthy lifestyle.

2. Cardiac rehabilitation (CR) can be viewed as the clinical application of preventive care by means of a professional multidisciplinary integrated approach for comprehensive risk reduction and global long-term care of cardiac patients. This is accompanied by a flexible follow-up strategy and easy access to a specialized team.

3. CR is underutilized despite having been shown to be a cost-effective intervention following an acute coronary event and heart failure, since it improves prognosis by reducing recurrent hospitalization and health care expenditures, while prolonging life.

4. CR is recommended for stable patients post-acute coronary syndrome and post-primary percutaneous coronary intervention (PCI), stable coronary artery disease, and post-elective PCI, post-coronary artery and valve heart surgery, congestive heart failure (not approved by all third parties in the United States), and post-heart transplant. A baseline symptom-limited exercise test is indicated. The exception is a submaximal exercise test for cardiac surgical patients and a symptom-limited exercise test after wound stabilization.

5. Exercise recommendations need to be individualized based upon usual physical activity, potential barriers, gender, age, left ventricular (LV) function, and special needs including orthopedic and recent surgery. Aerobic activity should be at 50-80% of peak oxygen consumption (or 70-85% of peak heart rate or 70-85% of onset of ischemia), 50% of peak heart rate in high-risk persons with LV dysfunction, at least 20- to 30-minute and preferably 45- to 60-minute sessions, which are at least 3 and preferably 6 days per week.

6. There is less evidence to support resistance training. General recommendations include: training regimens including using 30-40% of the one-repetition maximum for the upper body and 40-50% of the one-repetition maximum for lower body exercises, with 12-15 repetitions in one set repeated two to three times weekly.

7. In CR, all of the goals of secondary prevention are targeted by promoting lifestyle change and patient adherence to pharmacological therapy.

8. While it is clearly understood and accepted that an isolated exercise program is not CR, physical activity and exercise training must be recognized as the core components from which to build a comprehensive CR program.

9. Physical activity will be the carrier of change and of maintenance of healthy behaviors in the longer term, with positive consequences on self-confidence and esteem, socialization, return to work, and normalization of daily life activities.

10. CR programs, with a core of physical activity and exercise training, promote better quality of life, better control of classical cardiovascular risk factors, and, consequently, a lower rate of events and longer higher quality survival. Advocating CR for every patient who can benefit must be on every cardiologist’s agenda.
Perspective:
This summary of European recommendations does not provide guidance for the duration of CR nor follow-up. The American College of Cardiology/American Heart Association expert consensus is in consort with the European guidelines, but also emphasizes the value of including assessment of nutrition, psychological issues, and potential value of follow-up sessions.

[Chevychelov]

Title: Hospital Complication Rates With Bariatric Surgery in Michigan
Date Posted: July 27, 2010
Authors: Birkmeyer NJ, Dimick JB, Share D, et al., on behalf of the Michigan Bariatric Surgery Collaborative.
Citation: JAMA 2010;304:435-442.

Study Question:
Do complication rates vary across hospitals and procedure type for bariatric surgery?
Methods:
Data from the Michigan Bariatric Surgery Collaborative (MBSC) were used for the present analysis. MBSC is a consortium of hospitals performing bariatric surgery in Michigan. Participation is voluntary. Hospitals that perform at least 25 bariatric procedures per year were eligible for participation, with participating hospitals submitting data for all bariatric surgery patients. Medical record review was completed through a 30-day postoperative period. Patients undergoing revisional surgery were excluded from this analysis.
Results:
A total 15,275 patients undergoing bariatric surgery in one of 25 participating Michigan hospitals, between 2006 and 2009, were included. Perioperative complications occurred in 7.3% of patients, the majority being minor complications. Serious complications were relatively low, with the most occurring after gastric bypass (3.6%; 95% confidence interval [CI], 3.2%-4.0%), followed by sleeve gastrectomy (2.2%; 95% CI, 1.2%-3.2%) and laparoscopic adjustable gastric band (0.9%; 95% CI, 0.6%-1.1%) procedures (p < 0.001). Mortality rates were 0.04% (95% CI, 0.001%-0.13%) for laparoscopic adjustable gastric band, 0 for sleeve gastrectomy, and 0.14% (95% CI, 0.08%-0.25%) for gastric bypass. Rates of serious complications (after adjustment for patient characteristics and procedure mix) varied from 1.6% (95% CI, 1.3-2.0) to 3.5% (95% CI, 2.4-5.0) across hospitals. Annual procedure volume was inversely associated with rates of serious complications at the hospital level and surgeon level. Adjusted rates of serious complications were similar in center of excellence hospitals and non-center of excellence hospitals (2.7% vs. 2.0, respectively, p = 0.41).
Conclusions:
The investigators concluded that serious complications among patients undergoing bariatric surgery in Michigan were low. Rates of serious complications were inversely associated with hospital and surgeon volume.
Perspective:
This large-scale study highlights the usefulness of such registries to examine factors linked to complications and thus affords an opportunity for quality improvement initiatives.
__________________________________________________ ______________________
Title: Testing of Low-Risk Patients Presenting to the Emergency Department With Chest Pain. A Scientific Statement From the American Heart Association
Date Posted: July 28, 2010
Authors: Amsterdam EA, Kirk JD, Bluemke DA, et al.
Citation: Circulation 2010;122:756-776.

Perspective:
The following are 10 points to remember about this scientific statement:

1. The management of low-risk patients presenting to emergency departments (EDs) is a common and challenging clinical problem entailing 8 million ED visits annually.

2. The clinician must distinguish between those who require urgent treatment of a serious problem and those with more benign entities who do not require admission.

3. Inadvertent discharge of patients with acute coronary syndrome from the ED is associated with increased mortality and liability, whereas inappropriate admission of patients without serious disease is neither indicated nor cost-effective.

4. Clinical judgment and basic clinical tools (history, physical examination, and electrocardiogram [ECG]) remain pivotal for early identification of low-risk patients with chest pain.

5. Low-risk patients presenting with chest pain are increasingly managed in chest pain units in which accelerated diagnostic protocols are performed, comprising serial ECGs and cardiac injury markers to exclude acute coronary syndrome.

6. Patients with negative findings typically complete the accelerated diagnostic protocol with a confirmatory test to exclude ischemia (typically an exercise treadmill test [ETT] or a cardiac imaging study if the ETT is not applicable).

7. Computed tomography coronary angiography has the potential for major clinical utility in the triage of selected low-risk patients presenting to the ED with chest pain because of its very high negative predictive value.

8. An alternative strategy, recognized by American College of Cardiology/American Heart Association guidelines, approves outpatient ETT in selected low-risk chest pain patients after a negative evaluation by serial ECGs and cardiac injury markers.

9. The criteria for discharge before stress testing are: 1) no further ischemic chest discomfort, 2) normal or nondiagnostic initial and follow-up ECG, and 3) normal cardiac injury marker measurements.

10. A negative accelerated diagnostic protocol evaluation allows discharge, whereas patients with positive findings are admitted. This approach has been found to be safe, accurate, and cost-effective in low-risk patients presenting with chest pain.

[Chevychelov]

Aggregate National Experience With the Wearable Cardioverter-Defibrillator: Event Rates, Compliance, and Survival
Chung MK, Szymkiewicz SJ, Shao M, et al.
J Am Coll Cardiol 2010;56:194-203.
Study Question: How effective is the wearable cardioverter-defibrillator (WCD)?

Paradigm of Genetic Mosaicism and Lone Atrial Fibrillation. Physiological Characterization of a Connexin 43-Deletion Mutant Identified From Atrial Tissue
Thibodeau IL, Xu J, Li Q, et al.
Circulation 2010;122:236-244.
Study Question: Is there a genetic basis for sporadic cases of lone atrial fibrillation (AF)?

Impact of Left Atrial Volume on Clinical Outcome in Organic Mitral Regurgitation
Le Tourneau T, Messika-Zeitoun D, Russo A, et al.
J Am Coll Cardiol 2010;56:570-578.
Study Question: Is there an independent association between left atrial (LA) volume at the time of diagnosis and clinical outcome among patients with organic mitral regurgitation (MR)?

Long-Term Outcomes After Autograft Versus Homograft Aortic Root Replacement in Adults With Aortic Valve Disease: A Randomised Controlled Trial
El-Hamamsy I, Eryigit Z, Stevens LM, et al.
Lancet 2010;Aug 3:[Epub ahead of print].
Study Question: What are the outcomes after autograft aortic root replacement (Ross procedure) versus homograft aortic root replacement in adults?

Improving Evidence-Based Care for Heart Failure in Outpatient Cardiology Practices: Primary Results of the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF)
Fonarow GC, Albert NM, Curtis AB, et al.
Circulation 2010;122:585-596.
Study Question: What is the treatment gap between heart failure (HF) guidelines and the clinical care of patients, and what is the impact of multidimensional practice-specific performance improvement intervention using guideline-based therapies in the ambulatory management of HF?

[Chevychelov]

Title: Comparison of AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting With Direct Stenting Alone in Patients With Acute Myocardial Infarction
Trial Sponsor: Medrad Interventional/Possis
Year Presented: 2010
Year Published: 2010
Topic(s): General Cardiology, Interventional Cardiology, Prevention/Vascular
Summary Posted: 08/4/2010
Writer: Anthony A. Bavry, M.D., M.P.H., F.A.C.C.
Author Disclosure: NOTHING TO DISCLOSE
Reviewer: Deepak L. Bhatt, M.D., M.P.H., F.A.C.C.
Reviewer Disclosure: RESEARCH/RESEARCH GRANTS: Astra Zeneca, Heartscape, Eisai, Sanofi Aventis, The Medicines Company, Ethicon, Bristol Myers Squibb Cogentus, PLx Pharma, Takeda

Description:
The goal of the trial was to evaluate treatment with AngioJet rheolytic thrombectomy plus stenting compared with direct stenting alone among patients with acute myocardial infarction (MI).
Hypothesis:

AngioJet rheolytic thrombectomy would be superior at improving surrogate markers of myocardial reperfusion.
Drugs/Procedures Used:
Patients with ST-elevation MI (STEMI) and at least moderate thrombus burden were randomized to AngioJet rheolytic thrombectomy plus stenting (n = 256) versus direct stenting alone (n = 245).

Temporary pacemaker and balloon predilatation were strongly discouraged unless absolutely necessary. Bare-metal stents were used in both groups.
Concomitant Medications:

All patients received aspirin, clopidogrel 600 mg before or immediately after percutaneous coronary intervention (PCI), heparin 70 U/kg, and abciximab.
Principal Findings:

Overall, 501 patients were enrolled. There was no difference in baseline characteristics between the groups. In the rheolytic thrombectomy group, the mean age was 63 years, 24% were women, 14% had diabetes, cardiogenic shock was present in 2.7%, time from symptoms to admission was 125 minutes, time from the emergency room to PCI was 34 minutes, reference vessel diameter was 2.9 mm, and prewiring Thrombolysis In Myocardial Infarction (TIMI) flow 0/1 was 84%.

Procedural time was 60 minutes in the rheolytic thrombectomy group versus 46 minutes in the direct stenting group (p < 0.001). Stents per patient were 1.26 versus 1.40 (p = 0.022), and mean stent length was 23.7 mm versus 25.9 mm (p = 0.05), respectively.

The primary outcome of at least 50% ST resolution at 30 minutes was 86% with rheolytic thrombectomy versus 79% with direct stenting alone (p = 0.043). Infarct size was 12% versus 13% (p = 0.40), respectively.

Major adverse cardiac events (MACE) at 1 month was 3.1% versus 6.9% (p = 0.05), death was 1.6% versus 2.9%, MI was 0.8% versus 1.2%, target vessel revascularization (TVR) was 0.8% versus 2.5%, and stroke was 0 versus 0.4%, respectively.

MACE at 6 months was 11.2% versus 19.4% (p = 0.011), death was 2.8% versus 4.5%, MI was 0.8% versus 1.2%, TVR was 7.2% versus 13.2%, and stroke was 0.4% versus 0.4%, respectively.

MACE at 12 months was 14.9% versus 22.7% (p = 0.036), death was 3.2% versus 6.4%, MI was 0.9% versus 1.4%, TVR was 9.9% versus 14.5%, and stroke was 0.9% versus 0.4%, respectively.

TIMI major bleeding was 3.9% versus 1.6% (p = 0.12), need for pacing was 0.08% versus 0% (p = 0.17), and perforation was 0% versus 0.04% (p = 0.33).
Interpretation:
Among patients with STEMI, rheolytic thrombectomy did not reduce the study's co-primary efficacy endpoint. The device improved myocardial reperfusion as assessed by ST-segment resolution; however, infarct size was similar between the groups. Rheolytic thrombectomy improved clinical outcomes at 1, 6, and 12 months. Rheolytic thrombectomy increased procedural time; however, it did not appear to increase procedural complications such as need for pacing or vessel perforation. The thrombectomy group was also associated with slightly fewer stents per patient and shorter total stent length.

Importantly, there was no signal for increased strokes, which was a concern in the AiMI trial. Notable differences in the current trial are that pacing was not routinely employed and the use of lytics was an exclusion criteria.

While this trial demonstrated benefit for rheolytic thrombectomy, the use of simpler aspiration thrombectomy catheters likely remains preferential. The Export catheter was beneficial in the TAPAS trial, and meta-analyses of aspiration thrombectomy devices have also demonstrated their benefit.
Conditions:
Coronary heart disease / Acute MI
Coronary heart disease
Therapies:
Rheolytic Thrombectomy (AngioJet)
Study Design:
Parallel. Randomized.
Patients Enrolled: 501
Mean Follow Up: 12 months
Mean Patient Age: 63 years
Female: 24%
Primary Endpoints:
Co-primary efficacy endpoint: early ST-segment resolution, defined as 50% ST resolution at 30 minutes and final infarct size by scintigraphy at 1 month
Secondary Endpoints:
Composite of death, MI, urgent TVR, and stroke at 1, 6, and 12 months
Composite of death and readmission for congestive heart failure at 12 months
TIMI flow, TIMI blush, and corrected TIMI frame count
Patient Population:
Patients with STEMI within 12 hours of symptom onset
TIMI thrombus grade 3-5
Infarct artery vessel diameter ≥2.5 mm
Exclusions:
Thrombolysis
Stroke within 30 days
Major surgery within 6 weeks
Limited life span
Participation in another study
Previous stenting of the infarct artery
Inability to identify the infarct artery

[Chevychelov]

Title: Long-Term Results After a Telephone Intervention in Chronic Heart Failure: DIAL (Randomized Trial of Phone Intervention in Chronic Heart Failure) Follow-Up
Date Posted: August 3, 2010
Authors: Ferrante D, Varini S, Macchia A, et al., on behalf of the GESICA Investigators.
Citation: J Am Coll Cardiol 2010;56:372-378.

Study Question:
Does telephone intervention lead to a sustained improvement in heart failure (HF) outcomes?
Methods:
Subjects with HF in Argentina were randomized to either a centralized phone intervention or standard care for 1 year. The intervention group received a HF education booklet and counseling on diet, compliance, exercise, and HF symptom monitoring. Diuretic adjustments and unscheduled physician visits could be triggered by the telephone nurse based on the above. Control subjects received usual care. The study’s primary endpoint was the combined rate of all-cause mortality or hospital admission for HF 1 year after randomization. Follow-up was extended to examine these events 1 and 3 years after the intervention was completed.
Results:
The mean age for the 1,518 subjects randomized was 65 years, 29% were female, 80% had a left ventricular ejection fraction <40%, and 49% were New York Heart Association class III/IV. The primary endpoint occurred in 26.3% (n = 200 of 758) of intervention subjects and 31% (n = 235 of 760) of controls 1 year after randomization (relative risk [RR], 0.75 [0.60, 0.93]; p = 0.002). This benefit was primarily driven by a reduction in HF hospitalizations (RR reduction [RRR], 29% [9-44%]) with no significant impact on mortality (RRR, 5% [-27%, 23%]). Improvements in medication use, quality of life, and compliance measures were also noted. One and three years after intervention completion, there were 19% (p = 0.013) and 12% (p = 0.05) reductions, respectively, in composite event rates in the intervention group compared with controls.
Conclusions:
Nurse telephone interventions led to short- and longer-term improvements in HF outcomes and patient compliance.
Perspective:
The authors of this analysis should be commended for many reasons: large sample, rigorous statistical techniques, thorough analysis of data to help explain differences found in the primary outcome between groups, and inclusion of an analysis on quality of life. Some important considerations when assessing this study include: 1) patient sample and care access may be different from that of the US citizen with HF, 2) rates for the primary outcomes were low, 3) baseline use of beta-blockers and aldosterone antagonists were modest, 4) subjects with diastolic HF were under-represented, and 5) information on the mean number of phone calls and time spent educating intervention patients was not provided. However, this study supports a need for telemanagement, education, and close practitioner interaction to improve outcomes in HF.

__________________________________________________ _____________________
Title: Long-Term Outcomes After Autograft Versus Homograft Aortic Root Replacement in Adults With Aortic Valve Disease: A Randomised Controlled Trial
Date Posted: August 2, 2010
Authors: El-Hamamsy I, Eryigit Z, Stevens LM, et al.
Citation: Lancet 2010;Aug 3:[Epub ahead of print].

Study Question:
What are the outcomes after autograft aortic root replacement (Ross procedure) versus homograft aortic root replacement in adults?
Methods:
Male and female patients (<69 years) requiring aortic valve surgery were randomly assigned in a one-to-one ratio to receive an autograft or a homograft aortic root replacement in one centre in the United Kingdom. The random allocation sequence was computer generated. Treatment was not masked. The primary endpoint was survival of patients at 10 years after surgery.
Results:
A total of 228 patients were randomly assigned to receive an autograft or a homograft aortic root replacement. Twelve patients were excluded because they were younger than 18 years; 108 in each group received the surgery they were assigned to and were analyzed. There was one (<1%) perioperative death in the autograft group versus three (3%) in the homograft group (p = 0.621). At 10 years, four patients died in the autograft group versus 15 in the homograft group. Actuarial survival at 10 years was 97% (standard deviation 2) in the autograft group versus 83% (4) in the homograft group. Hazard ratio for death in the homograft group was 4.61 (95% confidence interval, 1.71-16.03; p = 0.0060). Survival of patients in the autograft group was similar to that in an age- and sex-matched British population (96%).
Conclusions:
The authors concluded that a living valve implanted in the aortic position can significantly improve the long-term outcomes in patients.
Perspective:
This single-center study demonstrated that the Ross autograft procedure compared with homograft aortic root replacement, improved survival in adults, and was associated with improved freedom from reoperation and quality of life. Furthermore, the proportion of patients who survived after the Ross operation was similar to that in the general population. These findings should be validated in multicenter studies, and future randomized trials should also compare both stented and stentless mechanical prostheses with autograft implantation.

[Chevychelov]

Journal Scan SummaryTitle: Impact of Left Atrial Volume on Clinical Outcome in Organic Mitral Regurgitation
Date Posted: August 2, 2010
Authors: Le Tourneau T, Messika-Zeitoun D, Russo A, et al.
Citation: J Am Coll Cardiol 2010;56:570-578.

Study Question:
Is there an independent association between left atrial (LA) volume at the time of diagnosis and clinical outcome among patients with organic mitral regurgitation (MR)?
Methods:
In a prospective study performed between 1990 and 2000 at a single large tertiary/quaternary center, 492 patients (63 ± 15 years, 60% men) in sinus rhythm with organic MR (regurgitant volume 68 ± 42 ml/beat) underwent baseline echocardiography; MR severity, LA volume, and left ventricular characteristics were quantified. Outcome with medical and surgical management was analyzed.
Results:
LA volume indexed to body surface area (LA index) was 55 ± 26 ml/m2 (<40 ml/m2 in 158, 40-59 ml/m2 in 160, and ≥60 ml/m2 in 174 patients). With medical management, 5-year survival was 80 ± 2.9% and cardiac events (atrial fibrillation or new-onset heart failure) were 28 ± 3%. Adjusting for established predictors of outcome, LA index was independently associated with survival after diagnosis (hazard ratio [HR], 1.3; 95% confidence interval [CI], 1.1-1.5 per 10 ml/m2 increment; p = 0.001). Patients with LA index ≥60 ml/m2 had lower 5-year survival than those with no or mild LA enlargement (p < 0.0001), and lower survival than the expected rate in the US population (53 ± 8.6% vs. 76%, p = 0.017). Compared with patients with LA index <40 ml/m2, those with LA index ≥60 ml/m2 had increased mortality (HR, 2.8; 95% CI,1.2-6.5; p = 0.016) and cardiac events (HR, 5.2; 95% CI, 2.6-10.9; p < 0.0001) with medical management. Mitral surgery was associated with decreased mortality (HR, 0.46; 95% CI, 0.26-0.84; p = 0.01) and cardiac events (HR, 0.38; 95% CI, 0.23-0.62; p = 0.0001); after surgery, patients with LA index ≥60 ml/m2 versus <60 ml/m2 did not incur excess mortality (p = 0.30) or excess cardiac events (p = 0.30).
Conclusions:
In patients with organic MR, LA index at diagnosis predicts long-term outcome, incrementally to other known predictors. This marker of risk is particularly important because mitral surgery in these patients markedly improves outcome and restores life expectancy. LA index should be measured in routine clinical practice for risk stratification and for clinical decision making in patients with organic MR.
Perspective:
This prospective study suggests that LA enlargement (expressed as LA volume index) is a strong and independent predictor of outcome among patients with organic MR. This adds to other studies published by the same group suggesting that morbid and mortal complications are associated with unoperated organic MR despite the absence of conventional criteria for surgical intervention, with the implication that earlier surgery is superior. At least one caveat should be noted. Inasmuch as LA volume is affected by MR severity, it also is affected by other valvular and nonvalvular diseases––including systemic hypertension, atrial fibrillation, and a broad array of conditions that result in elevated LA pressure. Because LA dilation can occur out of proportion to MR severity, caution should be used in considering mitral surgical intervention based on LA enlargement that occurs in the absence of MR that is severe by other criteria.

[Chevychelov]

Most Nonagenarians with STEMI Benefit from Primary PCI

Key Points:
About two-thirds of nonagenarians with STEMI who receive primary PCI are still alive at 6 months
Abciximab, good TIMI flow associated with improved survival
PCI fails to alter poor prognosis in patients with cardiogenic shock
By Kim Dalton
Monday, August 09, 2010

Many very elderly patients who present with ST-segment elevation myocardial infarction (STEMI) are candidates for primary percutaneous coronary intervention (PCI), standing a good chance of surviving at least 6 months, according to a small study published online August 2, 2010, ahead of print in the American Journal of Cardiology. However, mortality risk rises steeply for patients who develop cardiogenic shock.

Investigators led by Gian Battista Danzi, MD, of Ospedale Maggiore Policlinico (Milan, Italy), retrospectively evaluated outcomes of 100 nonagenarians (aged 90-98 years) with STEMI who were treated at 7 Italian centers over a recent 5-year period. All of the hospitals routinely performed primary PCI in STEMI patients regardless of age.

Mean time from symptom onset to PCI was 248 ± 122 minutes, and mean door-to-balloon time was 148 ± 137 minutes. Forty-three patients presented with an anterior wall AMI, 16 were in Killip class III, and 19 were in Killip class IV (cardiogenic shock).

PCI was successful in 85 patients. Eleven patients had complicated PCI, meaning they experienced an adverse event within 24 hours of the procedure. And in 4 patients, PCI failed.

Mortality Driven by Cardiogenic Shock

Overall in-hospital mortality rate was 19%, but it was significantly higher in patients with vs. without cardiogenic shock: 58% vs. 16% (P < 0.001). Despite the fact that abciximab was administered in 45% of cases, major bleeding occurred in only 3 patients—none of whom had received a glycoprotein IIb/IIIa inhibitor (GPI). Reversible acute renal failure developed in 3 patients. Mean hospital stay was 7 ± 5 days.

At 6 months, 68% of patients were still alive. After discharge, 31 patients died of cardiac causes and 1 from pneumonia. Mortality was 84% among patients in cardiogenic shock at admission but only 19% in the remaining patients (P < 0.001). Two subjects were rehospitalized due to congestive heart failure, and 1 suffered a new AMI.

Multivariate analysis identified 3 independent predictors of 6-month mortality. Cardiogenic shock at presentation increased risk, while improved post-PCI TIMI flow and use of abciximab decreased risk (table 1).

Table 1. Independent Predictors of 6-Month Mortality


HR
95% CI
P Value

Cardiogenic Shock
10.82
4.51-25.93
< 0.001

TIMI Flow
0.19
0.07-0.50
0.001

Abciximab
0.32
0.13-0.78
0.01



The authors observe that “[p]rimary PCI is particularly attractive in high-risk patients, and previous studies have shown that the long-term benefit of angioplasty over fibrinolysis is not affected by age.

“Our results appear to support the benefit of using PCI as the default strategy even in very elderly patients presenting with an AMI without cardiogenic shock,” they continue, and “the high initial success rate was sustained [among hospital survivors] for up to 6 months.”

Good TIMI Flow Key to Survival

The investigators note that 6-month mortality was closely tied to the inability to restore optimal TIMI flow after intervention. Moreover, cardiogenic shock imparted an especially high mortality risk (about 85%) even after an angiographically successful procedure.

In addition, the authors write, “[i]n our limited experience, procedural administration of abciximab was safe and did not lead to any episodes of major bleeding or thrombocytopenia. It also significantly [positively] correlated with 6-month survival.” However, they add, it is possible that patients who did not receive the GPI had a worse baseline risk profile associated with an increased risk of bleeding, thereby creating a bias in favor of abciximab.

Times from symptom onset to PCI were prolonged by guideline standards, the authors note. This may be due in part to the fact that older patients often exhibit atypical or no symptoms, which can lead to a missed or late diagnosis with consequent delay in door-to-balloon time and even a reduced chance of receiving reperfusion, they say.

Study Limited by Size, Selection

The main study limitation, the investigators acknowledge, is small sample size. Nonagenarians accounted for only 2% of all STEMI patients (n = 5,023) who underwent primary PCI at the 7 PCI hospitals during the study period, suggesting that many very elderly STEMI patients are not referred for primary PCI, they write.

“This study basically shows that when a selected group of nonagenarians undergoes primary PCI, complications are relatively low and the factors that predict adverse consequences in younger people seem to predict them in older people—which is no surprise,” said Harlan M. Krumholz, MD, of Yale School of Medicine (New Haven, CT).

“The evidence base about how best to manage very elderly patients is virtually nonexistent,” he told TCTMD in a telephone interview. “Unfortunately, a study like this provides very little insight as to the value of various interventions because it is limited by its size.” Moreover, he said, the study patients are highly selected. “The people who are being taken to the cath lab are in the best functional categories, and that puts them in a better risk category [for PCI].” The current results are only representative of this group; it is impossible to predict whether they would hold for the general population of nonagenarians, he noted.

Get Ready for Demographic Change

But the study does underline a pressing need, Dr. Krumholz pointed out. “We have to be prepared for what we know is going to be the marked demographic change in our patient population over the next 10 to 20 years. And right now we are not prepared,” he said. “We cannot simply extrapolate what we know from younger patients to older patients.” Treatment decisions are going to become more complex, he indicated. For example, physicians will have to try to ascertain just how aggressively older patients want to be treated.

“We will have to develop policies around this,” he suggested. For instance, in the cath lab, it may make sense for interventionalists to alleviate a blockage with angioplasty and then “take a step back and decide what to do next,” instead of immediately implanting a DES and committing a patient to a year of dual antiplatelet therapy. Such a pause in the procedure may provide time to more fully assess bleeding risk as well as the patient’s preferences, Dr Krumholz explained.

Study Details

Mean age of the study cohort was 92.1 ± 2.1 years. Mean LVEF was 40 ± 12%; 35 patients were Killip class III or IV; and 78 had multivessel disease. Preprocedural minimal lumen diameter of the stenotic segment was 0.13 ± 0.02 mm and increased to 2.98 ± 0.47 mm after angioplasty. Mean lesion length was 14.9 ± 8.2 mm.

All patients received 325 to 500 mg aspirin before the procedure and 300 to 600 mg clopidogrel. The choice of anticoagulation or use of GPI was left to the operator’s discretion. Procedural success was defined as achievement of TIMI flow grade 2 or 3, less than 50% residual stenosis, and absence of MACE within 24 hours of intervention. Major and minor bleeding events were defined using TIMI criteria. Acute renal failure was an increase in serum creatinine ≥ 25% within 72 hours of angioplasty, with a peak level ≥ 2.0 mg/dl.
Source:
Danzi GB, Centola M, Pomidossi GA, et al. Usefulness of primary angioplasty in nonagenarians with acute myocardial infarction. Am J Cardiol. 2010;Epub ahead of print.

[Chevychelov]

ARMYDA-5 PRELOAD: Clopidogrel administered in advance of PCI yielded similar outcomes to cath lab administration
Di Sciascio G. J Am Coll Cardiol. 2010;56:550–557.
By
Dosage of clopidogrel in the catheterization lab was shown to produce similar clinical outcomes as the standard 4- and 8-hour preloads in patients who underwent percutaneous coronary intervention, according to results of the ARMYDA-5 PRELOAD trial.

The Italian researchers enrolled 409 patients in the study and randomly assigned them to receive either a 600 mg clopidogrel loading dose 4 to 8 hours prior to PCI (n=204) or a 600 mg loading dose given in the catheterization lab after coronary angiography, but prior to PCI (n=205). The primary endpoint was the 30-day incidence of the following major adverse cardiac events: cardiac death, MI or unplanned target vessel revascularization.

Researchers reported no significant difference in the primary endpoint between the two arms (8.8% in-lab vs. 10.3% pre-load), which was driven mainly by periprocedural MI. There was a minor increased risk of bleeding or vascular complications in the pre-load arm (7.8%) vs. the in-lab arm (5.4%). Additional findings showed that patients in the in-lab group showed higher platelet reactivity during PCI (P=.043) and 2 hours after intervention (P=.01) vs. those in the pre-load group, but the levels became similar at 8 and 24 hours.
The trial, the researchers wrote, “indicates that a strategy of 600-mg in-lab clopidogrel load pre-PCI may have similar clinical outcomes as routine 4- to 8-hour pre-load. Thus, when indicated, in-lab clopidogrel administration can be a safe alternative to routine pre-treatment given before knowing patients’ coronary anatomy.”

Goran Stankovic, MD, PhD, and Milorad Zivkovic, MD, both with the Medical School of Belgrade in Belgrade, Serbia, explained in an accompanying editorial that the study addresses a clinically relevant question with a randomized controlled trial, and that the results support the in-lab administration of clopidogrel as a safe alternative to routine pre-treatment given before knowing a patient’s anatomy.

“This study serves the purpose of stimulating more and larger efforts to study the issue of clopidogrel platelet reactivity by developing either new regimens of the same drug or new drugs that have different, more predictable and more powerful effects on platelet function, such as prasugrel or ticagrelor,” they concluded.
__________________________________________________ _____________________

Vena cava filters associated with device fracture, embolization that may cause life-threatening complications
Nicholson W. Arch Intern Med. 2010;doi:10.1001/archinternmed.2010.316.
By

Recently published data suggesting that Bard’s Recovery and G2 vena cava filters are associated with an increased incidence of fracture and embolization has resulted in the FDA’s initiation of quantitative decision analysis modeling to assess the devices’ post-implantation risk/benefit profiles.

Since 2005, 921 adverse events involving inferior vena cava filters have been reported to the FDA. Of these, 328 involved device migration, 146 involved embolization, 70 involved perforation of the device and 56 involved filter fracture. Based on these reports and the current data, the FDA is concerned that these filters, which are intended for short-term use, are left in too long after the risk for pulmonary embolism is gone.

In the current study, researchers conducted a retrospective, single-center, cross-sectional study that included 80 patients who underwent inferior vena cava implantation between 2004 and 2009. Fluoroscopy was performed to assess the filter’s integrity and locate embolized struts. Patients with fragment embolization to the heart underwent echocardiography and cardiac CT.
Sixteen percent of patients had at least one nitinol arm or leg fracture, and the average time from implantation to evaluation was 37.8 months.

Of the 28 Recovery filters placed, at least one in seven (25%) fractured and embolized, and at least one fragment embolized to the right ventricle of the heart in five of the seven cases (71%). Three patients experienced life-threatening symptoms of ventricular tachycardia and/or tamponade; one of these patients experienced sudden death at home, according to the researchers. Overall, 86% of those who received the Recovery filter had a fragment embolize to the right ventricle of the heart or continue moving throughout the venous system through the heart and into the pulmonary arteries.

Although the prevalence of fracture and embolization was not as high for the G2 filters, it was still significant. Of the 52 G2 filters placed, six fractured (12%); two of these cases involved asymptomatic end-organ fragment embolization to the hepatic vein and the lung.

“It is essential that patients and their treating physicians be educated about this previously under-recognized and potentially life-threatening complication of these devices,” the researchers wrote. “Armed with this knowledge, educated patients can be alert to the presence of pleuritic chest pain and other symptoms that should prompt immediate evaluation. Such early awareness and evaluation could certainly be life-saving. In addition, the propensity for filter fragmentation may be directly related to the duration of implantation. Patients and their physicians should be educated about this fact so that they have the opportunity to consider having the filter removed.”

Currently, the FDA recommends that physicians consider removing inferior vena cava filters as soon as protection from pulmonary embolism is no longer needed. In addition, physicians are encouraged to weigh the risks and benefits of filter removal for each patient.

[Chevychelov]

JETSTENT: Thrombectomy before stenting produced benefits over direct stenting alone

Kastrati A. J Am Coll Cardiol. 2010;doi:10.1016/j.jacc.2010.07.003.

Migliorini A. J Am Coll Cardiol. 2010;doi:10.1016/j.jacc.2010.06.011.
By

Rheolytic thrombectomy plus direct stenting resulted in a decrease in major adverse coronary events vs. direct stenting alone, although the primary efficacy endpoints set by the researchers were not met, according to the results of the JETSTENT trial.

The multicenter, international, randomized, prospective study included patients (n=501) with acute MI, angiographic evidence of thrombus grade 3 to grade 5 and a reference vessel diameter ≥2.5 mm. Patients were allocated to either rheolytic thrombectomy before direct infarct artery stenting (n=256) or direct stenting alone (n=245). Co-primary endpoints were early ST-segment resolution and technetium-99m-sestamibi infarct size, and researchers considered an alpha value equal to 0.05 achieved by both co-primary surrogate endpoints or an alpha value equal to 0.025 for a single primary surrogate endpoint as evidence of statistical significance.

Study results showed that ST-segment resolution was more frequent in the thrombectomy arm (85.8%) vs. the direct stenting alone arm (78.8%, P=.043), whereas no difference between groups was revealed in the other surrogate endpoints. Researchers also found that the 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the direct stenting alone arm (P=.011), and the 1-year event-free survival rates were 85.2 ± 2.3% for the thrombectomy patients and 75 ± 3.1% for the direct stenting alone arm (P=.009).
“Although the primary efficacy endpoints were not met, the results of this study support the use of rheolytic thrombectomy before infarct artery stenting in patients with acute MI and evidence of coronary thrombus,” the researchers wrote in the study. “However, the routine use of rheolytic thrombectomy in acute MI should be confirmed by future larger trials.”

In an accompanying editorial, Adnan Kastrati, MD, Robert A. Byrne, MB, BCH, and Albert Schömig, MD, all from the Technische Universität in Munich, wrote that the researchers’ interpretation of the results may be spurred by their attraction to the concept of thrombectomy than by the strength of the evidence shown in the study.

“Device complexity may be a significant limitation of rheolytic thrombectomy, especially in out-of-hours and emergency situations, and what evidence is available is far from being a motivation for its adoption into routine practice,” they wrote.
__________________________________________________ _______________________

Subclinical MI observed in patients with patent foramen ovale
Wöhrle J. J Am Coll Cardiol Img. 2010;3:833–839.
By

More than 10% of patients with patent foramen ovale had detected subclinical MI, according to new study data.

Researchers from Ulm, Germany, analyzed patients (n=74) with patent foramen ovale (PFO) who had a first cryptogenic cerebral ischemic event and did not have a history of MI. The patients underwent CV MRI and coronary angiography, and had right and left ventricular volumes and ejection fractions measured.

Eight (10.8%) of the patients had late gadolinium enhancement (LGE). Researchers determined LGE pattern to be transmural or subendocardial. There was no difference in CV risk factors, type of ischemic event, presence of atrial septal aneurysm, right and left ventricular mass volumes, and ejection fraction in patients with or without LGE. LGE volume was small and consisted of only 7.9 ± 2.4% of LV muscle mass. Overall, patients with LGE vs. those without had a larger PFO size (16.0 ± 2.8 mm vs. 13.2 ± 4.1 mm)
“We were able to demonstrate using CV MRI a 10.8% prevalence of subclinical MIs in patients with PFO after a first cryptogenic cerebral ischemic event,” the researchers commented in their study. “Our results strengthen the pathophysiologic role of a PFO with paradoxical embolism in patients with cryptogenic cerebral ischemic events.”

In accompanying editorial, Y. Chandrashekhar, MD, DM,of the VA Medical Center and University of Minnesota in Minneapolis, explained that this study takes a novel detour compared to previously published literature and adds important information.

“It adds to the growing body of evidence that a PFO has multiple, potentially adverse, consequences that are often not noticed. Although a plethora of literature addresses stroke in patients with a PFO, no systematic study has evaluated embolism in other organ systems,” he wrote. “[This study] also encourages the introduction of better imaging to detect currently unidentified pathology.”