Pericardial covered stent for coronary perforations.

OBJECTIVES: To evaluate initial and long term results of coronary perforation treatment with pericardial covered stent. BACKGROUND: Iatrogenic coronary perforation is a rare life threatening complication of percutaneous coronary interventions (PCI) occurring in 0.1-0.8% of cases. Covered stents are the mainstay of therapy for coronary perforation. However, polytetrafluoroethylene covered stents are bulky with limited flexibility and thus may not be easy to deliver in difficult anatomy. Therefore, they are reserved to perforations in proximal or mid straight segments where their delivery is relatively easy. The pericardial covered stent is a highly deliverable fully covered stent that may be used to treat coronary perforations. Only a single case has been reported of the use of this stent in its previous version for the treatment of coronary perforation. METHODS: The electronic databases of four tertiary medical centers were retrospectively reviewed for cases of coronary perforations in which PCS was used. During a five years period, between 2008 and 2013, 18,364 patients underwent PCI in these centers. Nine cases of perforations for which balloon dilatation was not sufficient and pericardial covered stent was used were recorded. RESULTS: All nine cases were successfully treated with pericardial covered stent. Six of the patients underwent repeated angiography at 2-15 months, and in two of them instent restenosis that warranted repeated angioplasty was observed. One of them was catheterized for NSTEMI 3 months after the covered stent implantation, and stent thrombosis was demonstrated. CONCLUSIONS: Pericardial covered stents offer a safe and effective therapy for coronary perforation when balloon inflation and reversal of anticoagulation are insufficient.

Computerized gradual balloon inflation: a novel strategy of coronary angioplasty superior to a standard manual approach.

BACKGROUND: Mechanical trauma caused by PCI is a primary reason for restenosis and subsequent target lesion revascularization (TLR). To minimize this trauma, we developed a computerized angioplasty pressure sensor and inflator device (CAPSID) for gradual inflation. The objective of this prospective randomized study was to examine whether use of CAPSID reduces early and late cardiac events in patients undergoing PCI. METHODS: Patients undergoing PCI were eligible and randomized to CAPSID or standard balloon inflation (plain old balloon angioplasty). In the CAPSID group, a slow, gradual balloon inflation was performed by a personal computer. Stenting was used in both groups only for suboptimal results. Patients with total occlusions and vein grafts were excluded. Clinical follow-up for major adverse cardiac events (MACE) was performed at 6 and 12 months, with repeat coronary angiography performed for clinical symptoms or positive stress testing. RESULTS: A total of 234 patients completed the study. At 1-year follow-up, the CAPSID group had a significantly lower rate of MACE (21% vs. 37%, P<.005). In patients who underwent angiography, there was a significantly lower rate of restenosis in the CAPSID group (20.2% vs. 35.5%). The reduction in TLR was even more pronounced in the subgroup undergoing stenting (8% vs. 24%; P<.001). CONCLUSIONS: We conclude that gradual computerized balloon inflation is more effective than standard manual balloon inflation in reducing adverse coronary events. The combination of CAPSID and subsequent stent deployment was especially effective in reducing TLR.

Effect of gradual computerized angioplasty on outcomes of patients undergoing coronary stenting.

Mechanical trauma caused by percutaneous coronary intervention is a major factor contributing to subsequent cardiac events, restenosis, and the need for target lesion revascularization (TLR). To minimize this trauma, we developed a Computerized Angioplasty Pressure Sensor and Inflator Device (CAPSID) for gradual inflation. The objective of the present prospective randomized study was to examine whether the use of this novel device reduced TLR, as well as cardiac events, in patients undergoing stenting. Patients undergoing coronary stenting were eligible and randomized to receive CAPSID or standard manual percutaneous coronary intervention. In the CAPSID group, slow, gradual balloon inflation was performed using a personal computer. Patients with acute ST-elevation myocardial infarction or the need for percutaneous coronary intervention for total occlusions, left main disease, and vein grafts were excluded. Clinical follow-up for major adverse cardiac events, including death, acute myocardial infarction, and TLR, was performed at 12 months. A total of 310 patients were enrolled in the study. No significant differences were found in the clinical characteristics between the CAPSID and control groups. At 1 year of follow-up, the CAPSID group had had a significantly lower rate of major adverse cardiac events (8% vs 18%, p <0.01) driven by significantly lower rates of acute myocardial infarction (1% vs 7%, p <0.01) and TLR (5% vs 12%, p <0.05). In conclusion, gradual computerized balloon inflation using CAPSID as a platform for angioplasty and stenting significantly reduced TLR and major adverse cardiac events at 1 year in patients undergoing coronary stenting. The use of this novel device may improve outcomes in patients undergoing coronary stenting.