A prospective randomized trial of Novoste right versus Judkins catheters for engagement of the right coronary artery during diagnostic catheterization.

There has been little technical advancement in catheter shape for diagnostic cardiac catheterization since the early reports of Sones and colleagues during the development of the procedure. In order to determine the utility of a new catheter that directly, without torque or rotation, engages the right coronary artery (RCA), one hundred patients were randomized between 6Fr standard RCA Judkins (6Fr R4) (Cordis Corporation, Miami, FL, USA) or 6Fr Novoste RCA catheters (Novoste Corporation, Aguadilla, Puerto Rico). Endpoints included the duration of the various aspects of the procedure and a qualitative and quantitative assessment of angiographic quality. The Novoste RCA catheters were associated with statistically decreased times of catheter insertion (42 +/- 37 vs 90 +/- 119 secs), and engagement (31 +/- 35 vs 77 +/- 117 secs), of the right coronary artery as compared to Judkins catheters. Judkins RCA catheters had a significantly higher primary success rate (96%) than the Novoste group (84%, P = 0.045). There was no difference in angiographic quality in either group and no complications occurred during the study. While taller patients (mean 68 in) had increased success with the Novoste catheter, no other clinical, demographic, or anatomical characteristics of the RCA orifice predicted successful engagement and angiography. The direct engagement Novoste RCA catheter is associated with a more expeditious procedure than Judkins catheters when they can engage the RCA orifice. However, Novoste catheters were less successful and required more frequent exchanges to complete the procedure.

A prospective randomized study of 4.1 French catheters utilizing the percutaneous right brachial approach for the diagnosis of coronary artery disease.

To determine the utility of 4.1 French (F) catheters in diagnosing coronary artery disease, 50 patients were randomized to 4.1F Multipurpose or Judkins catheters utilizing the percutaneous right brachial approach. The randomized 4.1F tip shape catheter completed the procedure in 40% of the patients, and overall the 4.1F catheters completed the catheterization in 72% of the cases. With excessive or prolonged manipulation, the catheters were noted to kink and soften and required replacement for a catheter of similar or larger size. In 28% of the cases, larger F sizes (5F and 6F) were used to complete the procedure. There was 1 (2%) procedural complication. The total procedural success (accounting for all F sizes) without clinical complication was 98%. There was no difference between the 4.1F Judkins or Multipurpose catheter shapes for coronary arteriography by either qualitative or quantitative angiographic analysis. Left ventricular opacification was improved with the 4.1F Pigtail vs. the 4.1 Multipurpose by qualitative angiographic analysis. When the 4.1F angiograms were compared by quantitative angiography in blinded, but not randomized fashion to angiograms performed with 6F Judkins catheters, there was improved opacification of the LAD and diastolic frame of the left ventriculogram with the larger catheter. This difference was not noted with qualitative angiography. This study indicates that 4.1F catheters can be utilized from the right brachial approach for the diagnosis of coronary artery disease, thus avoiding the need for supine bedrest associated with routine femoral artery catheterization while maintaining diagnostic accuracy.

Multicenter evaluation of a new fixed-wire coronary angioplasty catheter system: clinical and angiographic characteristics and results.

Coronary angioplasty is increasingly used as an attempt to revascularize patients with severe coronary artery disease. To determine the efficacy of such treatment, a new fixed wire angioplasty catheter was evaluated by a multicenter group in a non-randomized fashion in 50 patients, average 58 +/- 11 years (+/- 1 SD), 58% men. Forty-four percent had a prior revascularization procedure (28% angioplasty, 16% coronary bypass surgery), 38% had a prior Q-wave myocardial infarction, 43% had grade 4 angina, and 60% multiple vessel disease. Angioplasty was attempted in 63 lesions which were located in a mid to distal location in 69%, with a proximal tortuosity score of 1.8 (2 = 45-60 degrees entrance angle), and lesion angulation of 1.4 (1 = 45 degrees lesion bend). In 88%, the device was the primary catheter used and in 6%, it was chosen when another system failed. The balloon was able to successfully cross 94% of all lesions attempted. Six lesions were crossed and dilated but significant residual stenoses remained. There were no significant device malfunctions, or angiographic or clinical complications. This feasibility evaluation of this new fixed wire system yielded excellent angiographic results. Although not a comparative study, this analysis suggests that this new generation of angioplasty catheter may improve the safety and efficacy of complex coronary angioplasty.

Preliminary experience with 5 and 6 French diagnostic catheters as guiding catheters for coronary angioplasty.

With the reduction in profile of balloon dilation catheters, until recently, it has been the internal dimensions and performance of the guiding catheter that has mandated the use of 7, 8 or 9 French (F) systems for the performance of percutaneous transluminal coronary angioplasty (PTCA). A new 5F catheter design (Sherwood Medical Co., St. Louis, MO) provided a large inner lumen (0.4") permitting use of 0.20-0.22" fixed-wire PTCA balloon catheters with good coronary visualization. Potential advantages include reduced coronary artery ostial trauma and catheter induced damping and enhanced patient comfort. We report our initial experience in 14 patients undergoing PTCA with a 5 and 6F guide/fixed-wire system. Mean age was 63 +/- 10 (43-78 years). PTCA indications: Cardiogenic shock (1), post-myocardial infarction angina pectoris (2), grade III angina (5) and unstable angina pectoris (6). Vessel attempted: Left anterior descending (3), circumflex (4), obtuse marginal (2), diagonal (1), right coronary artery (3), and internal thoracic artery (1). Twelve patients had femoral approach; two brachial approach. The USCI Probe (USCI Division, Billerica, MA) was used in 8 lesions and SCIMED ACE (SCIMED Life Systems, Maplegrove, MN) catheter in 7 lesions. Successful 5 or 6F guide/fixed-wire dilations reduced the stenosis (77 +/- 14 to 37 +/- 30%) and were successfully performed in 79% (11/14). One 5F patient required 8F guiding catheter and was dilated with 2.0 fixed-wire balloon. A second failed 5F PTCA could not be dilated with any larger conventional system. A third total occlusion could not be crossed with a guidewire or fixed wire balloon. No patient had a complication.(ABSTRACT TRUNCATED AT 250 WORDS)