Cardiac Disease, Coronary Artery Disease, Heart Failure
Conditions
Brief summary
The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo Envelope, TYRX Envelope, or no envelope.
Detailed description
A single center will retrospectively review up to 700 subjects who underwent implantation of a CIED with a CanGaroo Envelope, TYRX Envelope, or no envelope. All sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.
Interventions
DEVICECanGaroo Envelope
CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
DEVICETYRX Envelope
TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation
Sponsors
Elutia Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017
Exclusion criteria
* Any patient that had a CIED implanted with any other type of envelope * Any patient that had a CIED implanted prior to March 27, 2017
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Infection Post Procedure | 12 months post procedure | Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g., pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pocket Related Issues Prompting an Office Visit | 12 months post procedure | Any pocket related issues that prompted an office visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CanGaroo Envelope Patients who received a CanGaroo Envelope with their CIED implantation.
CanGaroo Envelope: CanGaroo Envelope with CIED implantation | 165 |
| TYRX Envelope Patients who received a TYRX Envelope with their CIED implantation.
TYRX Envelope: TYRX Envelope with CIED implantation | 219 |
| No Envelope Patients who had their CIED implanted with no envelope. | 71 |
| Total | 455 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | CanGaroo Envelope used during a previous procedure | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 | 0 |
| Overall Study | Subjects did not meet Inclusion criteria after protocol revision B | 70 | 32 | 29 |
| Overall Study | Subjects followed long-term at different health care system | 0 | 4 | 0 |
| Overall Study | Subjects had both CanGaroo Envelope and TYRX Envelope used during procedure | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | CanGaroo Envelope | TYRX Envelope | No Envelope | Total |
|---|---|---|---|---|
| Age, Continuous | 74.0 years STANDARD_DEVIATION 13.2 | 70.3 years STANDARD_DEVIATION 13.5 | 74.2 years STANDARD_DEVIATION 11 | 72.3 years STANDARD_DEVIATION 13.2 |
| BMI, Continuous | 28.6 kg/m² STANDARD_DEVIATION 6.5 | 30.6 kg/m² STANDARD_DEVIATION 7.2 | 31.0 kg/m² STANDARD_DEVIATION 6.3 | 29.9 kg/m² STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants | 206 Participants | 68 Participants | 433 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 10 Participants | 3 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 20 Participants | 3 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 12 Participants | 4 Participants | 21 Participants |
| Race (NIH/OMB) White | 143 Participants | 183 Participants | 64 Participants | 390 Participants |
| Sex: Female, Male Female | 64 Participants | 79 Participants | 24 Participants | 167 Participants |
| Sex: Female, Male Male | 101 Participants | 140 Participants | 47 Participants | 288 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 165 | 10 / 219 | 0 / 71 |
| other Total, other adverse events | 0 / 165 | 0 / 219 | 0 / 71 |
| serious Total, serious adverse events | 9 / 165 | 7 / 219 | 1 / 71 |
Outcome results
Primary
Number of Participants With Major Infection Post Procedure
Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g., pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
Time frame: 12 months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CanGaroo Envelope | Number of Participants With Major Infection Post Procedure | 2 Participants |
| TYRX Envelope | Number of Participants With Major Infection Post Procedure | 0 Participants |
| No Envelope | Number of Participants With Major Infection Post Procedure | 0 Participants |
Secondary
Number of Participants With Pocket Related Issues Prompting an Office Visit
Any pocket related issues that prompted an office visit
Time frame: 12 months post procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Site Drainage | 1 Participants |
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Erythema & Fever | 0 Participants |
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Superficial Surgical Site Infection (SSI) | 1 Participants |
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Thrombosis | 1 Participants |
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Hematoma | 2 Participants |
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Hemothorax | 0 Participants |
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Lead Dislodgement | 1 Participants |
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Pocket Infection | 2 Participants |
| CanGaroo Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Lead Revision | 0 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Thrombosis | 0 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Hematoma | 2 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Pocket Infection | 0 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Lead Dislodgement | 3 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Site Drainage | 0 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Superficial Surgical Site Infection (SSI) | 2 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Lead Revision | 1 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Hemothorax | 1 Participants |
| TYRX Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Erythema & Fever | 0 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Lead Dislodgement | 0 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Hematoma | 0 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Lead Revision | 0 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Pocket Infection | 0 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Erythema & Fever | 1 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Thrombosis | 0 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Site Drainage | 0 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Hemothorax | 0 Participants |
| No Envelope | Number of Participants With Pocket Related Issues Prompting an Office Visit | Superficial Surgical Site Infection (SSI) | 0 Participants |