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ARNI in ADHF: PIONEER-HF Trial

Velazquez et al report the findings of the PIONEER-HF trial.   This was a randomized clinical trial of standard therapy versus angiotensin receptor/neprilysin inhibitor therapy in patients with acute decompensated heart failure. This is an important clinical trial.

BACKGROUND

Acute decompensated heart failure accounts for more than 1 million hospitalizations
in the United States annually. Whether the initiation of sacubitril–valsartan therapy
is safe and effective among patients who are hospitalized for acute decompensated
heart failure is unknown.

METHODS

We enrolled patients with heart failure with reduced ejection fraction who were
hospitalized for acute decompensated heart failure at 129 sites in the United States.
After hemodynamic stabilization, patients were randomly assigned to receive sacubitril–valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily)
or enalapril (target dose, 10 mg twice daily). The primary efficacy outcome was the
time-averaged proportional change in the N-terminal pro–B-type natriuretic peptide (NT-proBNP) concentration from baseline through weeks 4 and 8. Key safety
outcomes were the rates of worsening renal function, hyperkalemia, symptomatic
hypotension, and angioedema.

RESULTS

Of the 881 patients who underwent randomization, 440 were assigned to receive
sacubitril–valsartan and 441 to receive enalapril. The time-averaged reduction in
the NT-proBNP concentration was significantly greater in the sacubitril–valsartan
group than in the enalapril group; the ratio of the geometric mean of values obtained at weeks 4 and 8 to the baseline value was 0.53 in the sacubitril–valsartan
group as compared with 0.75 in the enalapril group (percent change, −46.7% vs.
−25.3%; ratio of change with sacubitril–valsartan vs. enalapril, 0.71; 95% confidence interval [CI], 0.63 to 0.81; P<0.001). The greater reduction in the NT-proBNP
concentration with sacubitril–valsartan than with enalapril was evident as early as
week 1 (ratio of change, 0.76; 95% CI, 0.69 to 0.85). The rates of worsening renal
function, hyperkalemia, symptomatic hypotension, and angioedema did not differ
significantly between the two groups.

CONCLUSIONS

Among patients with heart failure with reduced ejection fraction who were hospitalized for acute decompensated heart failure, the initiation of sacubitril–valsartan
therapy led to a greater reduction in the NT-proBNP concentration than enalapril
therapy. Rates of worsening renal function, hyperkalemia, symptomatic hypotension, and angioedema did not differ significantly between the two groups.

 

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Categories: Uncategorized

Safety MRI in Patients with Cardiac Devices

Nazarian et al report a prospective non-randomized trial to assess the safety of MRI in patients with non- MRI compatible (legacy) devices. The abstract follows:

 

BACKGROUND

Patients who have pacemakers or defibrillators are often denied the opportunity to
undergo magnetic resonance imaging (MRI) because of safety concerns, unless the
devices meet certain criteria specified by the Food and Drug Administration (termed
“MRI-conditional” devices).

METHODS

We performed a prospective, nonrandomized study to assess the safety of MRI at a
magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an
implantable cardioverter–defibrillator (42%) that was not considered to be MRI-conditional (termed a “legacy” device). Overall, the patients underwent 2103 thoracic and
nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing
mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and
generator function and interaction with surrounding tissue (device parameters).

RESULTS

No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient’s device reset to a backup
mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing
and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately
after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients.
At long-term follow-up (results of which were available for 63% of the patients), the
most common notable changes from baseline were decreases in P-wave amplitude (in
4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%).
The observed changes in lead parameters were not clinically significant and did not
require device revision or reprogramming.

CONCLUSIONS

We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter–
defibrillator system. No long-term clinically significant adverse events were reported.

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Salt Restriction in Heart Failure

Mahtani et al report a systematic review of salt restriction in heart failure. They observe the paucity of data to support or refute this practice.

Abstract

IMPORTANCE

Recent estimates suggest that more than 26 million people worldwide have
heart failure. The syndrome is associated with major symptoms, significantly increased
mortality, and extensive use of health care. Evidence-based treatments influence all these
outcomes in a proportion of patients with heart failure. Current management also often
includes advice to reduce dietary salt intake, although the benefits are uncertain.
OBJECTIVE To systematically review randomized clinical trials of reduced dietary salt in adult
inpatients or outpatients with heart failure.

EVIDENCE REVIEW

Several bibliographic databases were systematically searched, including
the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and CINAHL.
The methodologic quality of the studies was evaluated, and data associated with primary
outcomes of interest (cardiovascular-associated mortality, all-cause mortality, and adverse
events, such as stroke and myocardial infarction) and secondary outcomes (hospitalization,
length of inpatient stay, change in New York Heart Association [NYHA] functional class,
adherence to dietary low-salt intake, and changes in blood pressure) were extracted.

FINDINGS

Of 2655 retrieved references, 9 studies involving 479 unique participants were
included in the analysis. None of the studies included more than 100 participants. The risks of
bias in the 9 studies were variable. None of the included studies provided sufficient data on
the primary outcomes of interest. For the secondary outcomes of interest,
2 outpatient-based studies reported that NYHA functional class was not improved by
restriction of salt intake, whereas 2 studies reported significant improvements in NYHA
functional class.

CONCLUSIONS AND RELEVANCE

Limited evidence of clinical improvement was available
among outpatients who reduced dietary salt intake, and evidence was inconclusive for
inpatients. Overall, a paucity of robust high-quality evidence to support or refute current
guidance was available. This review suggests that well-designed, adequately powered studies
are needed to reduce uncertainty about the use of this intervention.

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Diabetic Cardiomyopathy

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Patent Foramen Ovale and Left Circulation Embolism

The European position paper on patent foramen ovale and left circulation embolism is here. It is comprehensive and provides useful algorithms.

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Mortality: coronary artery bypass surgery versus percutaneous coronary intervention

Head et al  did a systematic review of randomized clinical trials of CABG versus PCI (pooled  analysis of individual data). The results provide further insight into this complex subject and supports Heart Team approach.

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Arterial Hypertension and Competitive Sports

Niebauer et al provide a useful guideline for assessment and recommendations re: athletic participation for patients with hypertension.

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