Outpatient Stenting: Femoral Approach with Vascular Sealing


James R. Wilentz, M.D. Carl D. Reimers M.D. John Fox M.D. Kumar Ravi M.D. Warren Sherman M.D. Denise McDermott R.N. Adam Kupersmith. Beth Israel Medical Center New York NY USA; Gregory J. Mishkel M.D. Prairie Education Research Cooperative Springfield IL USA


Background: Economy in health care has demanded shortened hospital stays for stent implantation. Smaller systems and radial artery (RA) access have decreased ambulation time but have required unfamiliar guide choices and posed the danger of RA occlusion. We attempted out-patient stenting (OPS) in a selected group of 60 patients using the femoral approach with vascular sealing.

Methods: Patients were evaluated for same-day discharge following elective coronary stent implantation if they were able to understand procedures for assisting in access-site hemostasis, if they had a support person to assist them at home, if they had no significant co-morbidity and agreed to follow-up. Patients with 1 or 2 vessel disease and stable or unstable angina were included if there was an operator expectation of >95% chance of success for all lesions and all lesions could be treated with an 8F or smaller device. Patients were excluded for suboptimal stent implantation, post-stent thrombus, post-procedure heparin or use of a GP IIb-IIIa inhibitor. Stents were bare-mounted and implanted using 6-8F guide catheters. Heparin 70U/kg was given and adjusted to ACT >300s. Vascular sealing (V) was performed using the Vasoseal® collagen plug, Angioseal™ or DUETT™ device.

Results: All patients had successful stent procedures. Mean pre-hemostasis ACT was 310. Times to endpoints are shown in the table below. 59/60 patients underwent V; 1/60 did not receive V due to late procedure or operator preference. Of those receiving V, 55/59 were discharged the same day. 1/59 was discharged the next morning by physician preference and 3/59 due to minimal skin ooze and patient concern. There were no stent embolizations. All patients who received V achieved successful hemostasis. At 24h and through one month, no patient had suffered acute closure, subacute thrombosis or any ischemic event. A pseudoaneurysm occurred in one patient at 6h post-discharge requiring readmission and surgical repair. No other patient developed a hematoma requiring treatment or other access complication. Post-procedure observation + V cost was $213 (6F) and $254 (7-8F).

Conclusions: OPS can be safely performed using the femoral approach with vascular sealing. Using PTCA cost figures from a national database, and assuming a non-OPS post-interventional step-down stay of 26h, 6F OPS would save $478/patient, and 7-8F $437 over non-OPS. Given a national Coronary Intervention rate of ~ 500,000 per year, assuming conventional non-OPS care is given in a stepdown unit, 6F OPS could save up to 26,070,000 per year nationwide in the US.


Time to Hemostasis, Ambulation and Discharge
       

(min)

       
       

6F

     

8F

Hemostasis       6.1 (1-18)       11.0 (6-15)
Ambulation       257 (150-545)       351 (260-406)
Discharge       296 (180-600)       489 (335-534)

To download Dr. Wilentz' Powerpoint presentation from TCT XI click Outpatient Stent, but be prepared for a 3-6 min DL time for the slide show.

We are now investigating various closure devices, with only one local complication easily treated as reported above. We are very excited about this as a new way to treat coronary disease safely in an outpatient setting.


Q: What does this mean for me as a patient undergoing elective stenting?

A: You can go in for the procedure at 8 in the morning and be home with your family for dinner. You only have to lie down for 3-4 hours after the procedure. You're more comfortable, and you haven't sacrificed in terms of safety!

 

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