Evaluation of a novel sutureless anastomotic connector: from endothelial function to mid-term clinical and angiographic follow-up

OBJECTIVES: We evaluated the effect of the St Jude Medical sutureless anastomotic connector on endothelium-dependent and -independent saphenous vein graft relaxation, as well as on clinical outcomes and graft patency in patients. METHODS: Human saphenous vein grafts were assigned to control or connector groups (loaded for 1 or 5 minutes; n = 18). Isometric dose-response curves to endothelium-dependent and -independent (sodium nitroprusside) vasodilators were constructed in saphenous vein grafts precontracted with phenylephrine. Thrombin-mediated vasorelaxation, an early determinant of saphenous vein graft failure, was also evaluated. Percent maximum relaxation was compared between groups. Patients in whom the St Jude Medical connector was employed underwent clinical follow-up, stress tests, and angiography 6 to 12 months postoperatively. RESULTS: A23187-induced endothelium-mediated relaxation, sodium nitroprusside-induced endothelium-independent relaxation, and thrombin-mediated vasorelaxation did not differ between control and connector saphenous vein grafts at either time point studied. Twenty-seven patients received St Jude Medical connectors. There was no hospital mortality; patients were followed for 679 +/- 241 days. There was 1 late death; the connector saphenous vein graft was patent at postmortem. All connector saphenous vein grafts were patent at follow-up angiography. Four grafts had stenoses (30%-60%), without symptoms or requirement for intervention. All hand-sewn saphenous vein grafts were also patent. CONCLUSIONS: The St Jude Medical connector does not impair endothelium-dependent vasorelaxation. In patients, patency of the connector saphenous vein grafts 6 to 12 months postoperatively was 100% but 22% of grafts had non-flow-limiting stenoses at or near the connector. Further long-term studies are required to confirm the safety of the St Jude Medical connector with regards to endothelial function and restenosis.     

Successful coronary revascularization using the PAS-Port system in a patient with Takayasu's arteritis and Behcet's disease

Coronary artery disease is rare in patients with Takayasu's arteritis or Behcet's disease. We report the case of a patient with concomitant Takayasu's arteritis and Behcet's disease who had angina pectoris develop due to severe narrowing of the left main coronary artery. The patient underwent revascularization with saphenous vein grafts with the assistance of the PAS-Port Proximal Anastomosis System (Cardica, Inc, Redwood City, CA). In conclusion, the PAS-Port Proximal Anastomosis System seems to be a safe and effective method of facilitating revascularization, particularly when severe calcification of the ascending aorta precludes cross-clamping during off-pump coronary artery bypass grafting.     

Adjunctive transmyocardial revascularization: five-year follow-up of a prospective, randomized trial

Background

In a prospective, randomized trial involving 263 patients who would be incompletely revascularized by coronary artery bypass grafting (CABG) alone, CABG plus transmyocardial revascularization (CABG/TMR) provided an early mortality benefit with similar angina relief compared with CABG alone at 1 year. We evaluated the long-term outcome of patients randomized to CABG/TMR or CABG alone.

Methods

Thirteen centers that enrolled 83% (218/263) of the patients in the original trial participated in this longitudinal study. Between 1996 and 1998, these centers randomized 218 patients who would be incompletely revascularized by CABG alone because of diffusely diseased target vessels to either holmium:yttrium-aluminum-garnet (holmium:YAG) CABG/TMR (n = 110) or CABG alone (n = 108). Baseline demographics and operative characteristics were similar between groups. Follow-up (mean 5.0 ± 1.7 years) included survival and blinded angina class assessment.

Results

At this 5-year follow-up both groups experienced significant angina improvement from baseline, however, the CABG/TMR group had a lower mean angina score (0.4 ± 0.7 vs 0.7 ± 1.1, p = 0.05), a significantly lower proportion of patients with severe angina (class III/IV: 0% [0/68] vs 10% [6/60], p = 0.009), and a trend towards greater number of angina-free patients (78% [53/68] vs 63% [38/60], p = 0.08), compared with CABG alone patients. Kaplan-Meier survival at 6 years was similar between CABG/TMR and CABG alone patients (76% vs 80%, p = 0.90).

Conclusions

Five-year follow-up of prospectively randomized patients who would be incompletely revascularized because of diffuse coronary artery disease indicates that the addition of TMR to conventional CABG provides superior angina relief compared to CABG alone.     

Early clinical and angiographic outcome of the pedicled right internal thoracic artery graft to the left anterior descending artery

BACKGROUND: The left internal thoracic artery (LITA) graft to the left anterior descending (LAD) artery became the gold standard graft in coronary surgery. Subsequently, the right internal thoracic artery (RITA) graft was increasingly used. However, there is still some debate about the optimal way of using this conduit. The aim of the present study was to assess our experience in grafting the pedicled RITA graft to LAD in 212 consecutive patients. METHODS: The records of 212 consecutive patients who underwent isolated coronary artery bypass grafting with the pedicled RITA graft to the LAD artery at Harefield Hospital between January 1998 and May 2001 were retrospectively reviewed. We approached the last 35 consecutive patients to obtain an angiographic control group. All 35 patients (16.5%) consented and, before discharge, underwent angiography to look at the quality of anastomoses and the patency of grafts. RESULTS: Successful catheterization and engagement of the RITA grafts was performed in 32 patients. Angiography showed that 32/32 (100%) of the RITA grafts were widely patent with excellent flow. The distal anastomoses of these RITA grafts were also satisfactory. There were no deaths among the study patients. CONCLUSIONS: Our results show that the use of the pedicled RITA graft to the LAD artery provides a good early clinical and angiographic outcome, and suggests that the pedicled RITA graft to the LAD artery is a good alternative to the pedicled LITA graft to the LAD artery.     

Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial

BACKGROUND: In prospective randomized trials at 1 year, transmyocardial revascularization (TMR) provided superior relief of angina, decreased rehospitalizations, and improved exercise times. We evaluated 5-year mortality and angina class in "no-option" patients with diffuse coronary artery disease randomized to TMR or continued medical management. METHODS: Two hundred twelve patients with refractory class IV angina who were not candidates for conventional therapy were randomized to receive holmium:yttrium-aluminum-garnet TMR (n = 100) or continued medical management (n = 112) at nine centers. Follow-up included all-cause mortality along with angina class assessment by blinded evaluators. Mean follow-up was 5.7 +/- 0.8 years. RESULTS: Mean angina scores for TMR patients were 4.0 +/- 0.0 at baseline, 1.5 +/- 1.4 at 1 year, and 1.2 +/- 1.1 at a mean of 5 years (p < 0.001). After an average of 5 years, a significantly greater proportion of TMR than medical management patients experienced two or more class improvement in angina (88% versus 44%; p < 0.001). Kaplan-Meier intention-to-treat survival at 5 years was 65% versus 52% (TMR versus medical management; p = 0.05). Cumulative hazard curves demonstrated a significantly reduced risk of late death for TMR patients; average annual mortality beyond 1 year was 8% versus 13% (TMR versus medical management; p = 0.03). CONCLUSIONS: Five-year follow-up of prospectively randomized, no-option class IV angina patients demonstrated significantly increased Kaplan-Meier survival in patients randomized to TMR. The significant angina relief observed 12 months after sole therapy TMR was sustained long term and continued to be superior to that observed for patients maintained on continued medical management alone.     

Clinical and six-month angiographic evaluation of coronary arterial graft interrupted anastomoses by use of a self-closing clip device: a multicenter prospective clinical trial

OBJECTIVES: To evaluate the safety and effectiveness of a self-closing surgical clip with an interrupted technique in left internal thoracic artery to left anterior descending artery bypass grafting. METHODS: Eighty-two patients were enrolled and treated (February 2000 through August 2001) in a prospective, nonrandomized, multicenter trial. Left internal thoracic artery to left anterior descending artery anastomoses were performed in 60 off-pump coronary artery bypasses (73%), 12 conventional coronary artery bypass grafting (15%), and 10 minimally invasive direct coronary artery bypass (12%) procedures. Angiograms (64 to 383 days, mean 200 days) were obtained on 63 patients (77%). Qualitative and quantitative angiographic assessment was performed by an independent core laboratory. RESULTS: The self-closing surgical clip was used for 82 left internal thoracic artery to left anterior descending artery interrupted anastomoses without the requirement for knot tying or primary suture management. Minimum left internal thoracic artery to left anterior descending artery anastomosis time was 3 minutes. There was one perioperative and one late death (both not heart related) and one reexploration for bleeding unrelated to the anastomotic site. FitzGibbon grades were as follows: A (n = 60, 95.2%), B (n = 3, 4.8%) including one kinked left internal thoracic artery, and O (n = 0, 0%). Quantitative analysis (n = 57) showed mean lumen diameters of left internal thoracic artery proximal to the anastomosis of 2.1 mm, at anastomosis of 2.0 mm, and in the left anterior descending artery distal to the anastomosis of 1.9 mm. The average ratio of the anastomosis to the left anterior descending artery diameter was 1.14 (0.45 to 1.93). Anastomotic stenosis as a percentage of average left internal thoracic artery to left anterior descending artery diameter was -2.3%, comparing favorably with results (23% to 24%) reported from the Patency, Outcomes, Economics, Minimally invasive direct coronary artery (POEM) bypass study. CONCLUSIONS: The interrupted technique, facilitated by a self-closing anastomotic clip, yields favorable 6-month angiographic results when compared with other published studies.     

Skeletonization of gastroepiploic artery graft in off-pump coronary artery bypass grafting: early clinical and angiographic assessment

BACKGROUND: Recently skeletonization has been recognized as an alternative to pedicle harvesting of the internal thoracic artery as a technique that increases the length and caliber size of the graft compared with pedicled internal thoracic artery grafts; however, this is not yet popular for harvesting the gastroepiploic artery (GEA). We report here our experience of skeletonized GEA grafting in off-pump coronary artery bypass grafting with early clinical and angiographic results. The purpose of this study was to evaluate skeletonization of GEA grafting in off-pump coronary artery bypass grafting with a large patient volume. METHODS: One hundred sixty-eight patients including 131 men and 37 women (mean age, 65 years; range, 45 to 87 years) underwent the skeletonized GEA grafting in off-pump coronary artery bypass grafting. These patients represent 41% (168 of 407 patients) of those who underwent off-pump coronary artery bypass grafting operations during the same period. We used the GEA graft of choice in patients with right coronary artery lesion. Skeletonization was performed in a unique manner we developed. RESULTS: There were no in-hospital deaths among the study patients. One patient had a perioperative myocardial infarction, which was considered a result of vasospasm of the GEA graft. None of the other patients had severe morbidity. The patency rate of the skeletonized GEA graft was 98.1% (151 of 154 distal anastomoses). CONCLUSIONS: This study suggests that skeletonization of the GEA graft can enlarge its caliber size and improve its flow capacity. In addition, the acceptable early clinical and angiographic outcome suggests that use of the skeletonized GEA graft in off-pump coronary artery bypass grafting surgery is safe and effective.     

Total arterial off-pump coronary artery bypass grafting for revascularization of the total coronary system: clinical outcome and angiographic evaluation

Background

We assessed the clinical outcome and conducted an angiographic study of total arterial off-pump coronary artery bypass grafting for revascularization of the total coronary system.

Methods

Of 382 consecutive patients who underwent off-pump coronary artery bypass between April 2000 and December 2002, 235 patients (193 men and 42 women, mean age 66 ± 9 years) with three-vessel disease underwent off-pump coronary artery bypass with all arterial grafts. A total of 872 vessels were bypassed (average number of grafts 3.7 ± 0.8). The internal thoracic arteries, radial arteries, and gastroepiploic arteries were used for revascularization of 306, 542, and 24 coronary arteries, respectively. Two hundred twenty-five patients underwent revascularization with composite grafts that were connected to the in situ internal thoracic artery (Y configuration 181, I configuration 55, K configuration 27, X configuration 3, T configuration 1); 10 patients underwent revascularization with all in situ grafts.

Results

Three (1.3%) hospital deaths and 1 late death occurred. There were no occurrences of clinical underperfusion syndrome or new intraaortic balloon pump insertion. Cerebral infarction occurred in 2 patients (0.8%). Early postoperative angiography was performed on 833 grafts in 223 patients (95%); the overall patency rate was 98%. Stratified by coronary distribution, the patency rate was 99% (218/221) in the left anterior descending artery, 97% (84/87) in the diagonal artery, 99% (70/71) in the obtuse marginal artery, 98% (262/268) in the posterolateral artery, 98% (167/170) in the posterior descending artery, and 100% (16/16) in the right coronary artery.

Conclusions

Total arterial off-pump coronary artery bypass yielded good clinical results and an excellent patency rate of revascularization for the total coronary system.     

Assessment of an aortosaphenous vein graft anastomotic device in coronary surgery: clinical experience and early angiographic results

Background

Until now technologic evolution in coronary bypass surgery has focused on extracorporeal circulation, on operation without extracorporeal circulation, and on the exposure of the operative site. Recently a one-shot anastomotic device for the proximal anastomosis in coronary surgery was developed. We investigated whether the use of the aortic connector system (ACS) could facilitate the creation of aortosaphenous vein graft anastomoses in myocardial revascularization.

Methods

From November 2000, 40 ACS devices were used in 36 consecutive patients (mean age 70.7 ± 8.9 years); 12 patients (33.3%) underwent surgery on pump and 24 patients (66.6%) off pump; 50 distal anastomoses were performed. In all cases the connection with the ascending aorta was created before the distal anastomoses because of the necessity to slide the saphenous vein graft (SVG) over the vein transfer sheath. Intraoperative graft function was tested measuring blood flow by Doppler analysis. Postoperative evaluation of the anastomotic patency was carried out by early angiography in 34 patients (94.7%) but was excluded in 5 patients (5.3%) with extensive extracardiac vascular occlusive disease.

Results

Of 38 AC (95%) evaluated, 36 (94.7%) functioned properly. The end-to-side proximal anastomosis without aortic clamping is instantaneous, the quality of anastomoses was highly rated, no additional stitches were required, and all coronary arteries could be reached. Intraoperative quantity flow was measured by Doppler analysis and all but one showed good flow. Early postoperative angiography demonstrated good patency of the grafts in all cases but 2 (5.3%). At 1-year follow-up, 1 patient died of stroke; all other patients remained free of symptoms and no reoperation was required.

Conclusions

The use of ACS makes end-to-side anastomosis rapid, effective, and reproducible while eliminating aortic cross clamping; it opens a new era in beating or nonbeating coronary surgery. Long-term results are mandatory to confirm our favorable preliminary results.