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Plaque Erosion

Partida et al present an interesting paper on plaque erosion (European Heart Journal (2018) 0, 1–7, doi:10.1093/eurheartj/ehx786).

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MRI in Patients with Cardiac Devices

Nazarian et al report on the safety of MRI in patients with cardiac devices.

Abstract

BACKGROUND

Patients who have pacemakers or defibrillators are often denied the opportunity toundergo 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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ORBITA

Al-Lamee et al report the results of the ORBITA trial in the Lancet (http://dx.doi.org/10.1016/S0140-6736(17)32714-9). There is an accompanying editorial. This is a multicentre randomised clinical trial with a sham control group to assess the efficacy of percutaneous coronary intervention in patients with stable angina. It has provoked a significant response in professional and lay literature.

Abstract

Background

Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy.

Methods

ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary
endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593.

Findings

ORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and
95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI –8·9 to 42·0, p=0·200).
There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group.

Interpretation

In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a
placebo control, as is standard for pharmacotherapy.

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2017 Hypertension Clinical Practice Guidelines

The 2017 Clinical Practice Guidelines for hypertension have been published in hypertension. They are comprehensive and useful.

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High Atrial Rate Episodes and Thromboembolic Risk in a Japanese Population

Kawakami et al report on the relationship between high atrial rate episodes (defined as episodes of atrial tachyarrhythmias of more than 6 minutes on atrial monitoring) in Japanese patients with pacemakers capable of continuous atrial monitoring.

Abstract

Abstract

Objective

The clinical significance of atrial high-rate
episodes (AHREs) detected by cardiac devices among
patients with implantable pacemakers has recently
emerged. However, the relationship between AHREs and
ischaemic stroke and systemic embolism (SE) is not well
understood in the Japanese population.

Methods

This study included 343 patients with
pacemakers capable of continuous atrial rhythm monitoring (167 males; mean age, 80±7 years). Atrial tachyarrhythmia detection was programmed to the nominal setting of each device, and AHRE was defined as any episode of sustained atrial tachyarrhythmia lasting for more than 6 min. Thromboembolic risk was defined based on the CHADS2 score.

Results

During the follow-up period (52±30 months),
165 (48%) patients had at least one episode of AHREs,
and 19 (6%) patients experienced stroke/SE. Among
patients who experienced stroke/SE, 14 had AHREs
before the stroke/SE. AHREs were significantly associated with stroke/SE (HR 2.87; 95% CI 1.10 to 8.90; p=0.03). Subgroup analysis conducted to investigate the impact of the CHADS2 score severity on stroke/SE revealed that AHREs were not associated with stroke/SE in patients with low or intermediate thromboembolic
risk (CHADS2 score 0–2; n=217). In contrast, among
patients with high thromboembolic risk (CHADS2
score>2; n=126), there was a significant association
between AHREs and the incidence of stroke/SE (HR 3.73;
95% CI 1.06 to 13.1; p=0.04).

Conclusion

AHREs detected by pacemaker were associated with ischaemic stroke/SE in the Japanese population. However, this association was observed only in the high thromboembolic risk group.

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2017 ACC Expert Consensus Decision Pathway on the Management of Mitral Regurgitation

The ACC has provided a consensus decision pathway on the management of mitral
regurgitation. This is a very instructive document.

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CULPRIT-SHOCK Trial

Thiele et al report the results of the CULPRIT-SHOCK trial (DOI: 10.1056/NEJMoa1710261 ; editorial: DOI: 10.1056/NEJMe1713341).

Abstract

BACKGROUND

In patients who have acute myocardial infarction with cardiogenic shock, early
revascularization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients with cardiogenic shock have multivessel disease, and whether PCI should be performed immediately for stenoses in nonculprit arteries is controversial.

METHODS

In this multicenter trial, we randomly assigned 706 patients who had multivessel
disease, acute myocardial infarction, and cardiogenic shock to one of two initial revascularization strategies: either PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, or immediate multivessel PCI. The primary end point was a composite of death or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Safety end points included bleeding and stroke.

RESULTS

At 30 days, the composite primary end point of death or renal-replacement therapy had occurred in 158 of the 344 patients (45.9%) in the culprit-lesion-only PCI group and in 189 of the 341 patients (55.4%) in the multivessel PCI group (relative risk,0.83; 95% confidence interval [CI], 0.71 to 0.96; P = 0.01). The relative risk of death in the culprit-lesion-only PCI group as compared with the multivessel PCI group was 0.84 (95% CI, 0.72 to 0.98; P = 0.03), and the relative risk of renal-replacement therapy was 0.71 (95% CI, 0.49 to 1.03; P = 0.07). The time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke did not differ
significantly between the two groups.

CONCLUSIONS

Among patients who had multivessel coronary artery disease and acute myocardial
infarction with cardiogenic shock, the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI.

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