Using Medicare Claims to Identify Acute Clinical Events Following Implantation of Leadless Pacemakers

Figures & data

Table 1 Event ICD-10-CM Diagnosis Codes

Event Measure	ICD-10-CM Definitions
Deep vein thrombosis	I82.401 or I82.402 or I82.403 or I82.409 or I82.411 or I82.412 or I82.413 or I82.419 or I82.421 or I82.422 or I82.423 or I82.429 or I82.4Y1 or I82.4Y2 or I82.4Y3 or I82.4Y9 or I82.4Z1 or I82.4Z2 or I82.4Z3 or I82.4Z9 or I82.621 or I82.622 or I82.623 or I82.629 or I82.A11 or I82.A12 or I82.A13 or I82.A19
Pulmonary embolism	I26.01 or I26.02 or I26.09 or I26.90 or I26.92 or I26.99
Arteriovenous fistula	I77.0
Cardiac perforation	I97.51
Pericardial effusion	I97.51 + (I30.9 or I31.3)
Cardiac tamponade	I31.4
Device dislodgement or displacement of cardiac electronic device	T82.12++
Infection and inflammatory reaction due to other cardiac and vascula devices, implants and grafts	T82.7+++
Hematoma - post procedural	I97.638
Hemorrhage - post procedural	I97.618

Abbreviation: ICD-10-CM, International Classification of Disease, Tenth Edition.

Table 2 Baseline Characteristics

Patient Characteristic	Patients Enrolled in Micra CED and Micra PAR Studies (N = 230)	US PAR Patients Not Enrolled in the CED (N=261)	P-value
Demographics
Age at implant, mean ± SD	78.8 ± 9.9	74.2 ± 13.6	<0.001
Female, n (%)	95 (41.3%)	114 (43.7%)	0.58
Comorbidities
CHF, n (%)	60 (26.1%)	67 (25.7%)	1.00
COPD, n (%)	32 (13.9%)	23 (8.8%)	0.09
Diabetes, n (%)	75 (32.6%)	84 (32.2%)	1.00
Renal dysfunction, n (%)	59 (25.7%)	60 (23.0%)	0.53
Atrial fibrillation, n (%)	195 (84.8%)	193 (73.9%)	0.002
Hypertension, n (%)	192 (83.5%)	191 (73.2%)	0.008
Treatments
Prior CIED	25 (10.9%)	34 (13.0%)	0.49
Dialysis, n (%)	25 (10.9%)	33 (12.6%)	0.58

Abbreviations: CED, coverage with evidence development; PAR, post-approval registry; CIED, cardiac implantable electronic device; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease.

Figure 1 Study flow chart.

Abbreviations: CED, Coverage with Evidence Development; FFS, fee-for-service; PAR, post-approval registry.

Table 3 Agreement and Disagreement Between Events Reported in the Micra CED and Micra PAR Studies

Acute (30-Day) Event	Agreement Between Events and No Events (%)	Disagreement Between Events (%)	Disagreement Between Physician-Adjudicated Events (%)
All Events	95%	65%	0%
Effusion/Perforation	100%	0%	0%
Deep Vein Thrombosis	98%	100%	N/A
Pulmonary Embolism	99%	67%	0%
Arteriovenous Fistula	99%	50%	0%
Dislodgement	100%	N/A	N/A
Infection	100%	0%	0%
Hemorrhage/Hematoma	98%	75%	0%
All-cause 30-day mortality	100%	0%	0%

Abbreviations: CED, coverage with evidence development; PAR, post-approval registry.