Background
- Atrial fibrillation (a-fib) and atrial flutter (a-flutter) with rapid ventricular rate (RVR) are potentially life-threatening arrhythmias that are commonly treated in the emergency department.
- Diltiazem (a non-dihydropyridine calcium channel blocker) is a first line medication to treat a-fib/a-flutter with RVR. Hypotension is an adverse-effect of diltiazem and can complicate management of a-fib/a-flutter with RVR. It has been theorized that pretreating patients with calcium before administering diltiazem may prevent hypotension.
Clinical Question
In adult emergency department patients with a-fib or a-flutter with RVR, does pretreatment with intravenous calcium prior to diltiazem decrease the risk of hypotension after diltiazem administration?
Population
- 217 adults ≥ 18 years presenting to the Emergency Department at a single academic center in Turkey
- Atrial fibrillation or atrial flutter with RVR (heart rate > 120)
- Systolic blood pressure (BP) > 90 mmHg
Intervention
- Group 1: Pretreatment 90 mg IV calcium chloride
- Group 2: Pretreatment 180 mg IV calcium chloride
- Control: Pretreatment IV saline (placebo)
- All groups: Diltiazem 0.25 mg/kg IV after completing pretreatment
- All groups: Additional diltiazem (0.35 mg/kg IV) given if inadequate rate control within 15 min
- Adequate rate control defined as heart rate < 100 bpm, decrease in heart rate by >20%, or normal sinus rhythm
- All groups: Additional diltiazem (0.35 mg/kg IV) given if inadequate rate control within 15 min
Outcomes
- Primary Outcome:
- Change in baseline systolic BP at 5, 10, 15 minutes after diltiazem
- Secondary Outcomes:
- Change in baseline heart rate at 5, 10, 15 minutes after diltiazem
- Need for additional dose of diltiazem (rescue treatment)
- Adverse events: hypotension, urticaria, nausea, hypercalcemia
Design
Randomized control trial
Excluded
Excluded
- Pregnant
- Hemodynamic instability requiring electrical cardioversion
- History of sick sinus syndrome, 3rd-degree AV block, or Wolff-Parkinson-White
- Known or suspected hypercalcemia
- Allergy to diltiazem
- Concurrent use of other rate control agents (beta-blockers, amiodarone, digoxin)
Primary Results
Primary outcome:
- In the 180mg calcium pretreatment group, there was no statistically significant change in mean systolic BP
- In the placebo and 90mg calcium pretreatment groups, mean systolic BP decreased after diltiazem administration at each measured time point
- Mean systolic BP was 132 mmHg
- Placebo group: on average, systolic BP decreased to
- 116 mmHg at 5 minutes
- 124 mmHg at 10 minutes
- 117 mmHg at 15 minutes
- 90mg calcium pretreatment group: on average, systolic BP decreased to
- 124 mmHg at 5 minutes
- 125 mmHg at 10 and 15 minutes
- The decreases in mean systolic BP reached statistical significance, but may not be clinically significant
Secondary outcomes:
- Heart rate was lowered significantly in all groups after diltiazem administration (rate control achieved in all groups)
- No significant differences in rates of adverse effects across groups
- No significant differences in rates of additional diltiazem needed across groups
Strengths
Overall, this is a well-designed randomized control trial. The methods suggest adequate randomization, blinding and concealment of randomization.
Limitations
- There is no subgroup analysis based on onset and rhythm
- Only 12 of the patients had new-onset arrhythmia
- Only 8 of the patients had a-flutter
- There is no comparison of mean systolic BP between groups
- The reader could use the data from Table 3 to do their own calculations comparing differences in systolic BP between each group and may find that these differences are not all statistically significant
- This study was done at a single academic center, which could limit generalizability of results to other clinical practice settings
Author's Conclusions
- Administering 180 mg calcium IV prior to diltiazem can effectively prevent drug-induced hypotension in patients with a-fib or a-flutter with RVR over a 15-min timeframe.
- Administration of calcium does not affect the efficacy of diltiazem in achieving and maintaining heart rate control.
- The rates of adverse events and need for additional doses of diltiazem were comparable between groups, suggesting that the use of calcium is safe.
Our Conclusions
- The author’s conclusion that 180 mg of calcium can “prevent drug-induced hypotension” is not supported by their data.
- 9 patients experienced hypotension and there was no statistically significant difference in this adverse event between the treatment groups.
- Additionally, a definition of hypotension or what was considered a clinically significant reduction in blood pressure from baseline is not presented.
- The decreases in blood pressure in the placebo and 90mg calcium groups do not appear to be clinically significant.
- The lowest post-treatment systolic BP at any time was 116 mmHg, representing a 16 mmHg decrease from baseline– many clinicians would feel comfortable seeing this blood pressure.
Potential Impact To Current Practice
- Overall, the body of literature analyzing this practice has not been able to show meaningful benefit of pretreatment with calcium before administering diltiazem.
- In this study, pretreatment with calcium does not appear to cause harm or increase the need for additional doses of diltiazem, but it does not appear to yield clinically significant benefit.
- Some may choose to pretreat with calcium because it is a relatively safe intervention with theoretical reward
- Others may avoid pretreatment with calcium and consider the practice an unnecessary use of resources