Recanalization of infrainguinal chronic total occlusions with the crosser system: results of the PATRIOT trial.

PURPOSE: To evaluate the angiographic and functional outcomes of the Crosser chronic total occlusion (CTO) recanalization system used to facilitate crossing of infrainguinal occlusions resistant to conventional guidewire techniques. METHODS: Eighty-five patients with a previous or concurrent failed attempt to cross a CTO using conventional guidewire techniques were enrolled at eight United States centers. Occlusions were at least 30 days old and ≤30 cm in length. Primary endpoints included advancement of the recanalization system into or through the occlusion gaining guidewire access in the distal vessel beyond the lesion, and 30-day freedom from clinical perforation requiring treatment. RESULTS: The average age of occlusion was 16 months, the mean occlusion length was 117.5 ± 84.0 mm, 55.7% had unfavorable morphology for crossing, and 75% were moderately to severely calcified. Superficial femoral artery (SFA) occlusions were most commonly treated (61.2%), followed by popliteal artery (20%), and tibioperoneal (16.5%) occlusions. The CTO was crossed and the guidewire successfully advanced into the distal true lumen in 83.5% of cases. Following adjunctive therapy, 81.2% achieved a satisfactory angiographic result (≤50% residual stenosis). At 30 days post procedure, 98.8% of patients were free from clinical perforation. CONCLUSION: Use of the Crosser CTO recanalization system facilitated crossing of guidewire-resistant, chronic, infrainguinal occlusions with minimal risk of clinically significant vessel perforation.

The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device.

OBJECTIVES: The objective of the study was to assess the efficacy and safety of a novel vascular closure device, the Angio-Seal Evolution (EVCD), in patients undergoing routine cardiac catheterization (CATH) and intervention (PCI) via a retrograde femoral artery access. BACKGROUND: Successful use of current-generation vascular closure devices is highly dependent on operator methodology. To reduce dependence on operator technique, the EVCD was modified to automate the closure process, specifically the compaction of the extravascular collagen sponge that creates a sandwich under pressure against the intra-arterial anchor. METHODS: This was a prospective ten-site registry including 1,004 patients undergoing 1,010 procedures with in-laboratory closure using the EVCD after CATH and PCI. The primary outcome measure was the rate of major vascular complications, and secondary outcomes were deployment success, time to hemostasis and in-hospital rates of minor vascular complications through 30 days. Clinical trial identifier NCT 00817349. RESULTS: There were 575 CATH (56.9%) and 435 PCI (43.1%) closures. Overall deployment success was 99.7%; 99.8% for CATH and 99.5% for PCI. Major vascular complications occurred in 0.4% including 0.2% in CATH and 0.7% in PCI. Minor vascular complications occurred in 2.4%, with 0.5% for CATH and 4.9% for PCI. CONCLUSIONS: Automation of the anchor-collagen closure of femoral artery access sites with the Angio-Seal ECVD resulted in excellent efficacy and safety after routine cardiac catheterization and intervention.

Safety and performance of targeted renal therapy: the Be-RITe! Registry.

PURPOSE: To evaluate the safety and patterns of use of targeted renal therapy (TRT) with the Benephit system. TRT, the delivery of therapeutic agents directly to the kidneys by renal arterial infusion, has the advantage of providing a higher local effective dose with potentially greater renal effects, while limiting systemic adverse effects due to renal first-pass elimination. METHODS: The Benephit System Renal Infusion Therapy (Be-RITe!) Multicenter Registry was a post-market registry following patients treated using the Benephit systems for TRT. The registry enrolled 501 patients (332 men; mean age 72.2+/-9.5 years) at high risk for contrast-induced nephropathy (CIN) during coronary or peripheral angiography/intervention or cardiovascular surgery. The Mehran score was used to compare the actual to predicted incidence of CIN within 48 hours post procedure. RESULTS: Bilateral renal artery cannulation was successful in 94.2%, with a mean cannulation time of 2.0 minutes. Either fenoldopam mesylate, sodium bicarbonate, alprostadil, or B-type natriuretic peptide (BNP) was infused for 184+/-212 minutes. Mean creatinine levels did not change significantly (baseline, 24, and 48 hours post procedure: 1.95, 1.99, and 1.98 mg/dL, respectively; p = NS). In 285 patients who received TRT with fenoldopam and were followed for at least 48 hours, the incidence of CIN was 71% lower than predicted (8.1% actual CIN versus 28.0% predicted; p<0.0001). Only 4 (1.4%) patients required dialysis (versus the 2.6% predicted rate, p = NS). CONCLUSION: The Benephit system and TRT during coronary and endovascular procedures in patients at high risk for renal failure is simple to use and safe. With the infusion of intrarenal fenoldopam, the incidence of CIN was significantly lower than predicted by risk score calculations.