cardiology updaytes

1. Recent Cardiology Updates
2018

2. Catheter ABlation vs ANtiarrhythmic Drug Therapy in
Atrial Fibrillation - CABANA
May 10, 2018
• Author/Summarized by Author:Dharam J.
Kumbham, MD, SM, FACCSummary
Reviewer:Deepak L. Bhatt, MD, MPH,
FACCTrial Sponsor:National Institutes of
Health, St Jude Medical Foundation and Corp.,
Biosense Webster, Inc., JnJ Inc., Medtronic
Corporation, and Boston Scientific
Corporation.Date Presented:05/10/2018Date
Updated:05/10/2018Original Posted
Date:05/10/2018

3. • Contribution To Literature:
• The CABANA trial showed that ablation is not
superior to drug therapy for CV outcomes at 5
years among patients with new-onset or
untreated AF that required therapy.

4. Study Design
• Patients were randomized in a 1:1 fashion to either
catheter ablation (n = 1,108) or drug therapy (n =
1,096). Primary ablation was performed with standard
techniques (pulmonary vein isolation [PVI]/wide area
circumferential ablation [WACA], ancillary ablations as
needed). Drug therapy could be either for rate or
rhythm control. All patients received anticoagulation.
• Total number of enrollees: 2,204
• Duration of follow-up: 5 years
• Mean patient age: 67.5 years
• Percentage female: 37%

5. Inclusion criteria:
• Paroxysmal, persistent, or longstanding
persistent AF patients who warrant therapy
• ≥65 years of age
• <65 years of age with ≥1 cerebrovascular
accident (CVA)/cardiovascular (CV) risk factor
• Eligible for ablation
• On ≥2 rhythm or rate control drugs

6. • Other salient features/characteristics:
• Cardiomyopathy: 9%
• Chronic heart failure: 15%
• Prior CVA/transient ischemic attack (TIA): 10%
• Type of AF: paroxysmal: 43%, persistent 47%
• Prior hospitalization for AF: 39%
• Crossover: ablation to drug: 9.2%, drug to
ablation: 27.5%

7. Principal Findings:
• The primary outcome, death, disabling stroke, serious
bleeding, or cardiac arrest at 5 years for ablation vs.
drug therapy, was 8% vs. 9.2% (hazard ratio [HR] 0.86,
95% confidence interval [CI] 0.65-1.15, p = 0.3)
• Death: 5.2% vs. 6.1% for ablation vs. drug therapy, p =
0.38
• Serious stroke: 0.3% vs. 0.6% for ablation vs. drug
therapy, p = 0.19
• Primary endpoint based on treatment received (for
ablation vs. drug therapy): 7.0% vs. 10.9%, p = 0.006;
all-cause mortality: 4.4% vs. 7.5%, p = 0.005; death or
CV hospitalization: 41.2% vs. 74.9%, p = 0.002

8. Secondary outcomes:
• Death or CV hospitalization: 51.7% vs.
58.1% for ablation vs. drug therapy, HR 0.83,
95% CI 0.74-0.93, p = 0.002
• Time to first AF recurrence: HR 0.53,
95% CI 0.46-0.61, p < 0.0001
• Pericardial effusion with ablation: 3.0%;
ablation-related events: 1.8%

9. • The results of this important trial indicate that ablation is not superior to drug
therapy for CV outcomes at 5 years among patients with new-onset or untreated
AF that required therapy. There was a significant reduction in death or CV
hospitalization with ablation, and on as-treated analysis, ablation demonstrated
superior efficacy to drug therapy. In the setting of a negative primary endpoint, the
latter two findings are considered hypothesis generating.
• A couple of caveats exist. The drug-therapy arm is very heterogeneous, and it is
unclear if uniform pursuance of rhythm control in that arm would be better than
the rate control arm. The included population is also somewhat unclear with
respect to the patients who would most benefit with this therapy.
• Finally, this trial is only single-blinded (not to intervention received). That may
have driven the high crossover rates and can confound assessment of the various
endpoints. Based on recent experiences from important sham-controlled trials
(e.g., SYMPLICITY), these findings should prompt consideration of a sham-
controlled trial to assess the true efficacy of catheter ablation in modulating CV
outcomes among patients with AF.

10. Practice Learning Point
• Ablation is well established.
• Many Patients assigned to Drug Therapy will
Require Ablation.

11. PADIT trial 2018
Prevention Of Arrhythmia Device Infection Trial (padit)
• More Antibiotics Around Cardiac Device
Procedures Doesn't Cut Important Infections
• Huge randomized trial shows no better than
possible modest effect

12. Introduction
• Cardiac implantable electronic device (CIED) implantation
is typically performed in specialized centers using
standardized protocols. Device infection is a major
complication, usually requiring device removal.
• A single pre-operative dose of cefazolin is currently
recommended to prevent device infections, but this
regimen does not provide coverage against up to 30% of
microorganisms causing infection.
• We sought to determine whether the use of an incremental
perioperative antibiotics strategy would be superior to a
single preoperative dose of cefazolin to prevent device
infection, using a cluster randomized cross-over trial.

13. Methods:
• Over 4 six-month periods, 28 centers used either conventional or
incremental antibiotic treatment in all patients at the time of device
implant, crossing between treatments in random sequence.
Conventional treatment was pre-surgical cefazolin infusion, with
vancomycin for penicillin allergic patients.
• Incremental treatment was a combination of pre-surgical cefazolin
and vancomycin, bacitracin pocket wash, and post-operative oral
cephalexin for two days.
• Cefazolin was omitted in penicillin allergic patients.
• The primary outcome was hospitalization for device infection within
one year in high risk patients (generator replacement, system
revision or cardiac resynchronization), with additional analysis of
high and low risk patients (new ICD and pacemaker implant were
enrolled in 6 of the 28 sites).

14. Applications:
• Device procedures were performed in 19,603 patients,
of which 12,842 were high risk. The mean age for the
overall population was 72.0±13.1 years, 40% of
patients had a history of heart failure, and 33.9% were
female. The majority of high-risk patients underwent
CIED generator change (N=7916, 61.6%).
Hospitalization for infection rates will be reported for
high risk and all patients, along with sensitivity
analyses. Subgroup analyses will be presented to
identify any relevant patient or site characteristics that
influence the impact of incremental therapy. Antibiotic
related adverse events were rare (0.3%).

15. Results
• Device site infections that there is no
difference between one-dose Cefazolin (1%)
vs. incremental antibiotics (0.8%).

16. • However, the low rates seen in both groups might not hold
up in the rest of the world, he cautioned.
• Indeed, rates tend to be higher than 1% in the United
States and have been as high as 6% in certain types of
procedures like generator replacement, Jagmeet Singh, MD,
PhD, of Massachusetts General Hospital in Boston, who was
not involved in the study, told MedPage Today.
• Wilkoff said the low rates in the trial were "a testament to
the care system in Canada, and they are to be
congratulated. It's also a testament to what happens to if
you have uniformity across a system." In addition,
monitoring of rates in the trial might have made it a
quality-of-care issue at participating centers that drove
rates lower.

17. Syncope: Pacing or Recording in the Later
Years (Spritely)
• Trial: Don't Wait for Pacing in Syncope with Bifascicular Block
Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all
emergency room visits, and probably is responsible for CDN $250
million in health care spending each year. It is associated with
decreased quality of life, trauma, loss of employment, and limitations
in daily activities. It is a particular problem for older people, partly
because of increased frailty, and partly because of a difficult
differential diagnosis. One of the causes in older adults is intermittent
complete heart block in the setting of bifascicular heart block, but they
may also faint due to a variety of tachyarrhythmias, sick sinus
syndrome, and several neurally mediated syncopes

18. • Primary Outcome Measures :The primary outcome
measure will be a composite of Major Adverse Study-
Related Events (MASRE) in a 2-year observation period.
[ Time Frame: 2 years ]MASRE will capture the major
consequences ensuing from both strategies, including
1) syncope, 2) symptomatic bradycardias, 3)
asymptomatic complete heart block, 4) acute and
chronic pacemaker complications, and 5) death.

19. •
Secondary Outcome Measures :Secondary outcome measures will
include total number of syncopal spells. [ Time Frame: 2 years ]
• Secondary outcome measures will include the likelihood of a first
recurrence of syncope. [ Time Frame: 2 years ]
• Secondary outcome measures will include the physical trauma due
to syncope. [ Time Frame: 2 years ]
• Secondary outcome measures will include quality of life of the
participants. [ Time Frame: 2 years ]
•

20. Inclusion Criteria:
• -Patients are eligible if they have:
• >1 syncopal spell within 1 year preceding
enrollment, and
• bifascicular block on a 12-lead ECG, and
• Age > 50 years and
• written informed consent. Syncope will be
defined based on history using a standardized
form.

21. • -Patients will be excluded if they have criteria related to study strategies, including:
• previous pacemaker, ICD, or Implantable Loop Recorder in situ,
• ACC/AHA/HRS Class I indication for permanent pacing or ICD implantation,
• left ventricular ejection fraction < 35% mandating ICD therapy,
• contra-indication to a transvenous pacemaker such as artificial tricuspid valve or
active sepsis.
• -Patients will also be excluded if a potential competing cause of syncope poses a
threat to life, such as:
• hypertrophic cardiomyopathy,
• documented sustained ventricular tachycardia or
• inducible, sustained monomorphic ventricular tachycardia on EP study.
• -They will be excluded if they have:
• a history of myocardial infarction within 3 months prior to enrollment, and
• a major chronic co-morbid medical condition that would preclude 24 months of
follow-up.

22. • An empiric pacemaker-first strategy lowered the combined
rate of syncope, symptomatic or asymptomatic
bradycardia, acute or chronic device complications, or
cardiovascular death compared with an implantable cardiac
monitoring strategy (19 of 57 versus 44 of 58, P<0.001).
• For every 10 such patients implanted with a loop recorder,
there were six with bradycardia leading to pacemaker
implantation, two vasodepressor syncope occurrences, one
death, and one case of dementia or withdrawal, Robert
Sheldon, MD, PhD, of the University of Calgary Health
Sciences Centre in Alberta, reported here at the Heart
Rhythm Society (HRS) meeting.