A method based on DIMOND quality criteria to evaluate imaging in diagnostic and interventional cardiology.

Image quality criteria (IQC) for cine-angiography were recently settled. The aim of this study was to test whether these criteria allow a measurement of the quality of cine-angiograms. A questionnaire was derived from IQC where a binary response was required regarding the degree of visibility of anatomic or pathologic structures. Scores were given on a ranking scale. Two quality scores were defined (total score and minimum score) and standard deviation (SD) was assumed to be an indicator of the method's reproducibility. Data of the total score are presented for the first nine angiograms. Six experts obtained thirty-nine readings. The total scores ranged between 83 and 99% (SD 0.8-18.7%); 89% of the readings were within 4% of SD. This preliminary experience indicates that quality criteria can be translated into a scoring system that yields reproducible data in most instances. The analysis of the remaining angiograms will help in understanding how to improve these results.

Dissection During Restenotic Lesion Balloon Angioplasty: Comparison with Initial Angioplasty.

The aim of this study was to assess the frequency and severity of dissection during repeat angioplasty for restenosis, to correlate the occurrence of this event with the lesion characteristics and the procedure-related factors and to examine if dissection during initial angioplasty predisposes to dissection during the repeat procedure. Sixty-nine significant lesions in native coronary arteries were treated with balloon angioplasty (A«PTCA) and retreated for restenosis with balloon angioplasty (B«PTCA). Dissection was detected less frequently during B«PTCA (7/69 vs. 18/69, p < 0.05). Anatomic variables did not differ significantly between A« and B«PTCA. Balloon to artery ratio (B/A ratio) was slightly but significantly higher during B«PTCA (1.03 +/- 0.13 vs. 0.97 +/- 0.14, p < 0.05) and duration of inflation was shorter (377 +/- 218 vs. 473 +/- 305 sec, p < 0.05). In 17 out of the 18 lesions which were dissected during A«PTCA, dissection did not occur during B«PTCA, despite the application of a higher B/A ratio (1.05 +/- 0.13 vs. 0.97 +/- 0.17, p < 0.05). Duration of inflation was shorter during B«PTCA (390 +/- 227 vs. 639 +/- 394 sec, p < 0.05). Six out of seven lesions which were dissected during B«PTCA had not been dissected during A«PTCA. In this subgroup, lesion characteristics did not differ between the two interventions and duration of inflation was shorter during B«PTCA (340 +/- 101 vs. 458 +/- 128, p < 0.05). CONCLUSIONS: Dissection occurred less frequently during restenotic lesion PTCA. Dissection during A«PTCA did not predispose to dissection during B«PTCA. These findings may be ascribed to the proliferative nature of the restenotic process.

Intramural drug delivery by direct injection within the arterial wall: first clinical experience with a novel intracoronary delivery-infiltrator system.

Local drug delivery at the lesion site in patients with coronary artery disease is being intensively studied to prevent restenosis after percutaneous coronary intervention. However, the effective penetration of the delivered agents into the vessel wall and delivery time remain considerable problems for all currently existing devices. A unique, new catheter has been invented, the infiltrator Angioplasty Balloon Catheter (IABC), which has the capability to allow intramural drug delivery by direct injection within the arterial wall. We describe the first clinical experience with this catheter. IABC is an angioplasty catheter with 3 lumens: one for inflating the balloon, one central for the guidewire, and a third for drug delivery. On the surface of the balloon there are 3 longitudinal strips of 6 injection needles, which on inflation stand 0.01" high, and are connected to the drug-delivery lumen. With inflation of the balloon, the needles penetrate the lesion, allowing drug delivery into the media of the vessel wall. We used the IABC in 17 patients (age = 58 +/- 9 years) undergoing coronary angioplasty. All patients were symptomatic, with significant lesions (13 LAD, 3 LCX, 1 RCA) and documented ischemia. Following initial dilatation with a conventional angioplasty balloon (stenosis from 72 +/- 8% to 26 +/- 14%, P < 0.001), the IABC was used to infiltrate the lesion with 0.4 ml (6,000 IU) of low-molecular-weight heparin (Fraxiparine). For the delivery, the IABC was inflated to 1-2 atm for 30-45 s, and the heparin was injected by hand in 5 s. Lesion residual stenosis and morphology remained unchanged after IABC use (26 +/- 14% to 22 +/- 11%, P = NS). In 10 patients, stent placement followed the IABC use. The decision to proceed with stent placement was made after the initial dilatation with the conventional balloon, and it was not influenced by the IABC use. Stent placement greatly improved the final result (for the whole patient group: 22 +/- 11% to 5 +/- 18%, for the stented patients: 22 +/- 13% to -7 +/- 10%, P < 0.001 for both). Hospital course was uneventful, with no electrocardiogram changes and normal cardiac enzymes for all patients. We have shown that the use of a unique new catheter (IABC) for intramural drug delivery in human patients undergoing coronary angioplasty is feasible and safe. This catheter is the first of a new generation of catheters and represents a significant step in local drug delivery. It is very promising as a vehicle to modify plaque behavior and potentially influence restenosis after angioplasty.