Frank D. Eefting

Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II) A Randomized Comparison of Bare Metal Stent Implantation With Sirolimus-Eluting Stent Implantation for the Treatment of Total Coronary Occlusions

Background— Sirolimus-eluting stents markedly reduce the risk of restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions. Methods and Results— In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n=100) were randomly assigned to receive bare metal BxVelocity stents and half (n=100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment restenosis rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent restenosis rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary restenosis rate of 7% compared with 36% in the bare metal stent group (P<0.001). The in-segment binary restenosis rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P<0.0001), resulting in a target lesion revascularization rate of 4% in the sirolimus group versus 19% in the bare metal group (P<0.001). Patients who received the drug-eluting stent also had significantly lower rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events. Conclusions— In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary restenosis, resulting in significantly less need for target lesion and target vessel revascularization.

Coronary artery bypass grafting without cardiopulmonary bypass using the octopus method: results in the first one hundred patients

OBJECTIVE Cardiopulmonary bypass and global cardiac arrest enable safe coronary artery bypass grafting but have adverse effects. In off-pump coronary bypass grafting, invasiveness is reduced, but anastomosis suturing is jeopardized by cardiac motion. Therefore the key to successful off-pump coronary bypass grafting is effective local cardiac wall stabilization. METHODS We prospectively assessed the safety and efficacy of the Octopus tissue stabilizer (Medtronic, Inc., Minneapolis, Minn.) in the first 100 patients selected for off-pump coronary bypass via full or limited surgical access. To immobilize and expose the coronary artery, two suction paddles (-400 mm Hg), fixed to the operating table-rail by an articulating arm, stabilized the anastomosis site. RESULTS One hundred forty-one grafts (96% arterial) were used to create 172 anastomoses (17% side-to-side), up to 4 per patient, on average 23 in the full access group (46 patients) and 1.2 in the limited access group (54 patients). Complications included conversion to cardiopulmonary bypass (2%), conversion from limited to full access (3%), myocardial infarction (4%), predischarge coronary reintervention (2%), and late coronary reintervention (1%). Median postoperative length of hospital stay was 4 days (limited access) or 5 days (full access). Rapid recovery allowed 96% of patients to resume social activities within 1 month. At the 6-month angiographic follow-up, 95% of anastomoses was patent. At the 2- to 22-month follow-up (mean, 13 months), 98 patients were in Canadian Cardiovascular Society class I and 2 patients were in class II. CONCLUSION These results suggest that off-pump coronary artery bypass grafting with the Octopus tissue stabilizer is safe. Early clinical outcome and patency rates warrant a randomized study comparing this methods with conventional coronary bypass grafting.

Coronary artery disease: arterial remodelling and clinical presentation

OBJECTIVE To investigate the hypothesis that in coronary artery disease large plaques in compensatorily enlarged segments are associated with acute coronary syndromes, whereas smaller plaques in shrunken segments are associated with stable angina pectoris. METHODS Patients selected for percutaneous transluminal coronary angioplasty (PTCA) were divided into two groups, one with stable angina pectoris (stable group, n = 37) and one with unstable angina or postmyocardial infarction angina of the infarct related artery (unstable group, n = 32). In both groups, remodelling at the culprit lesion site was determined by intravascular ultrasound before the intervention. Remodelling was calculated as relative vessel area: [vessel area culprit lesion site ÷ mean vessel area of both proximal and distal reference sites] × 100%. Compensatory enlargement was defined as remodelling of ⩾ 105%, whereas shrinkage was defined as remodelling of ⩽ 95%. RESULTS In the unstable group, the vessel area at the culprit lesion site was larger than in the stable group, at mean (SD) 18.1 (5.3)v 14.6 (5.4) mm2 (p = 0.008). Lumen areas were similar. Consequently, plaque area and percentage remodelling were larger in the unstable group than in the stable group: mean (SD) 14.8 (4.8) v 11.6 (4.9) mm2 (p = 0.009) and 112 (31)%v 95 (17)% (p = 0.005), respectively. Significantly more culprit lesion sites were classified as shrunken in the stable group (21/37) than in the unstable group (8/32; p = 0.014). On the other hand, more lesion sites were classified as enlarged in the unstable group (16/23) than in the stable group (8/37; p = 0.022). CONCLUSIONS In patients selected for PTCA, the mode of remodelling is related to clinical presentation.

Randomized Comparison Between Stenting and Off-Pump Bypass Surgery in Patients Referred for Angioplasty

Background—Stenting improves cardiac outcome in comparison with balloon angioplasty. Compared with conventional surgery, off-pump bypass surgery on the beating heart without cardiopulmonary bypass may reduce morbidity, hospital stay, and costs. The purpose, therefore, was to compare cardiac outcome, quality of life, and cost-effectiveness 1 year after stenting and after off-pump surgery. Methods and Results—Patients referred for angioplasty (n=280) were randomly assigned to stenting (n=138) or off-pump bypass surgery. At 1 year, survival free from stroke, myocardial infarction, and repeat revascularization was 85.5% after stenting and 91.5% after off-pump surgery (relative risk, 0.93; 95% CI, 0.86 to 1.02). Freedom from angina was 78.3% after stenting and 87.0% after off-pump surgery (P =0.06). Quality-adjusted lifetime was 0.82 year after stenting and 0.79 year after off-pump surgery (P =0.09). Hospital stay after the initial procedure was 1.43 and 5.77 days, respectively (P <0.01). Stenting reduced overall costs by

Three-dimensional transoesophageal echocardiography in a patient undergoing percutaneous mitral valve repair using the edge-to-edge clip technique

2933 (26.2%) per patient (

Survival of Transcatheter Mitral Valve Repair Compared With Surgical and Conservative Treatment in High-Surgical-Risk Patients

8276 versus

Percutaneous edge-to-edge mitral valve repair in high-surgical-risk patients: do we hit the target?

11 209; P <0.01). Stenting was more cost-effective in 95% of the bootstrap estimates. Conclusions—At 1 year, stenting was more cost-effective than off-pump surgery while maintaining comparable cardiac outcome and quality of life. Stenting rather than off-pump surgery, therefore, can be recommended as a first-choice revascularization strategy in selected patients.

The Octopus Study: Rationale and Design of Two Randomized Trials on Medical Effectiveness, Safety, and Cost-Effectiveness of Bypass Surgery on the Beating Heart

We report a case of percutaneous mitral valve repair, using the Mitraclip device, in which we show that application of real-time three-dimensional transoesophageal echocardiography (3D-TEE) is extremely helpful for the guidance of this procedure. Because of its excellent visualization capacities, 3D-TEE simplifies the transseptal puncture, the positioning of the clip above the mitral valve orifice, the grasping of the mitral valve leaflets, and the evaluation of the final result. Therefore, we conclude that 3D-TEE has the potential to increase the safety and efficacy of this new technique to treat mitral regurgitation in patients who cannot undergo conventional valve surgery.

Early statin treatment prior to primary PCI for acute myocardial infarction: REPERATOR, a randomized placebo-controlled pilot trial†

OBJECTIVES The goal of this study was to compare survival between transcatheter mitral valve (MV) repair using MitraClip system (Abbott Vascular, Santa Clara, California), MV-surgery, and conservative treatment in high-surgical-risk patients symptomatic with severe mitral valve regurgitation (MR). BACKGROUND Up to 50% of patients with symptomatic severe MR are denied for surgery due to high perioperative risk. Transcatheter MV repair might be an alternative. METHODS Consecutive patients (n = 139) treated with transcatheter MV repair were included. Comparator surgically (n = 53) and conservatively (n = 59) treated patients were identified retrospectively. Surgical risk was based on the logistic European System for Cardiac Operative Risk Evaluation (log EuroSCORE) or the presence of relevant risk factors, as judged by the heart team. RESULTS The log EuroSCORE was higher in the transcatheter MV repair group (23.9 ± 16.1%) than in the surgically (14.2 ± 8.9%) and conservatively (18.7 ± 13.2%, p < 0.0001) treated patients. Left ventricular ejection fraction was higher in surgical patients (43.9 ± 14.4%, p = 0.003), with similar values for the transcatheter MV repair (36.8 ± 15.3%) and conservatively treated (34.5 ± 16.5%) groups. After 1 year of follow-up, the transcatheter MV repair and surgery groups showed similar survival rates (85.8% and 85.2%, respectively), whereas 67.7% of conservatively treated patients survived. The same trend was observed after the second and third years. After weighting for propensity score and controlling for risk factors, both the transcatheter MV repair (hazard ratio [HR]: 0.41, 95% confidence interval [CI]: 0.22 to 0.78, p = 0.006) and surgical (HR: 0.52, 95% CI: 0.30 to 0.88, p = 0.014) groups showed better survival than the conservatively treated group. The transcatheter MV repair and surgical groups did not differ (HR: 1.25, 95% CI: 0.72 to 2.16, p = 0.430). CONCLUSIONS Despite a higher log EuroSCORE, high-surgical-risk patients with symptomatic severe MR treated with transcatheter MV repair show similar survival rates compared with surgically treated patients, with both displaying survival benefit compared with conservative treatment.

Percutaneous mitral valve repair using the edge-to-edge technique in a high-risk population

OBJECTIVES This study sought to assess the feasibility and safety of percutaneous edge-to-edge mitral valve (MV) repair in patients with an unacceptably high operative risk. BACKGROUND MV repair for mitral regurgitation (MR) can be accomplished by use of a clip that approximates the free edges of the mitral leaflets. METHODS All patients were declined for surgery because of a high logistic EuroSCORE (>20%) or the presence of other specific surgical risk factors. Transthoracic echocardiography was performed before and 6 months after the procedure. Differences in New York Heart Association (NYHA) functional class, quality of life (QoL) using the Minnesota questionnaire, and 6-min walk test (6-MWT) distances were reported. RESULTS Fifty-five procedures were performed in 52 patients (69.2% male, age 73.2 ± 10.1 years, logistic EuroSCORE 27.1 ± 17.0%). In 3 patients, partial clip detachment occurred; a second clip was placed successfully. One patient experienced cardiac tamponade. Two patients developed inguinal bleeding, of whom 1 needed surgery. Six patients (11.5%) died during 6-month follow-up (5 patients as a result of progressive heart failure and 1 noncardiac death). The MR grade before repair was ≥3 in 100%; after 6 months, a reduction in MR grade to ≤2 was present in 79% of the patients. Left ventricular (LV) end-diastolic diameter, LV ejection fraction, and systolic pulmonary artery pressure improved significantly. Accompanied improvements in NYHA functional class, QoL index, 6-MWT distances, and log N-terminal pro-B-type natriuretic peptide were observed. CONCLUSIONS In a high-risk population, MR reduction can be achieved by percutaneous edge-to-edge valve repair, resulting in LV remodeling with improvement of functional capacity after 6 months.