Jose L. Navia

Argentine Randomized Study: Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Patients With Multiple-Vessel Disease (ERACI II): 30-Day and One-Year Follow-up Results

OBJECTIVE The purpose of this study was to compare percutaneous transluminal coronary revascularization (PTCR) employing stent implantation to conventional coronary artery bypass graft surgery (CABG) in symptomatic patients with multivessel coronary artery disease. BACKGROUND Previous randomized studies comparing balloon angioplasty versus CABG have demonstrated equivalent safety results. However, CABG was associated with significantly fewer repeat revascularization procedures. METHODS A total of 2,759 patients with coronary artery disease were screened at seven clinical sites, and 450 patients were randomly assigned to undergo either PTCR (225 patients) or CABG (225 patients). Only patients with multivessel disease and indication for revascularization were enrolled. RESULTS Both groups had similar clinical demographics: unstable angina in 92%; 38% were older than 65 years, and 23% had a history of peripheral vascular disease. During the first 30 days, PTCR patients had lower major adverse events (death, myocardial infarction, repeat revascularization procedures and stroke) compared with CABG patients (3.6% vs. 12.3%, p = 0.002). Death occurred in 0.9% of PTCR patients versus 5.7% in CABG patients, p < 0.013, and Q myocardial infarction (MI) occurred in 0.9% PTCR versus 5.7% of CABG patients, p < 0.013. At follow-up (mean 18.5 +/- 6.4 months), survival was 96.9% in PTCR versus 92.5% in CABG, p < 0.017. Freedom from MI was also better in PTCR compared to CABG patients (97.7% vs. 93.4%, p < 0.017). Requirements for new revascularization procedures were higher in PTCR than in CABG patients (16.8% vs. 4.8%, p < 0.002). CONCLUSIONS In this selected high-risk group of patients with multivessel disease, PTCR with stent implantation showed better survival and freedom from MI than did conventional surgery. Repeat revascularization procedures were higher in the PTCR group.

Minimally invasive mitral valve operations

A technique for mitral valve operations is described in which exposure is performed through a small right parasternal incision. Via a transseptal approach, excellent exposure to the mitral valve is obtained, allowing surgical correction of the diseased valve.

Minimally invasive valve operations.

BACKGROUND To reduce the morbidity from valvular heart operations, a right parasternal approach was introduced. We report our initial experience with the procedure. METHODS From January 1996 through July 1996, 115 patients underwent primary isolated valve procedures. One hundred (85%) patients underwent the operation through a right parasternal incision. RESULTS There was one hospital death secondary to a stroke on the fifth postoperative day. Three patients (two with aortic valve operations and one having a mitral valve procedure) required conversion to sternotomy. Mean aortic occlusion time was 71 minutes; mean cardiopulmonary bypass time was 93 minutes. Mean stay in the intensive care unit was 27 hours and mean hospital postoperative stay was 5.7 days. Seventy-seven percent of the patients did not receive blood transfusions. Comparison with median sternotomy demonstrated a reduction in both postoperative length of stay and direct hospital costs. CONCLUSIONS We conclude that this minimally invasive approach is safe for a variety of valve procedures and is effective in reducing surgical trauma and cost.

Surgical management of secondary tricuspid valve regurgitation: Annulus, commissure, or leaflet procedure?

OBJECTIVES Techniques employed today concomitantly with left-sided heart valve surgery address secondary tricuspid valve regurgitation at 3 anatomic levels-annulus, commissure, and leaflet-although success of these alone or in combination in eliminating tricuspid regurgitation is uncertain. Our objective was to assess the comparative effectiveness of these techniques in reducing or eliminating secondary tricuspid regurgitation. METHODS From 1990 to 2008, 2277 patients underwent tricuspid valve procedures for secondary tricuspid regurgitation concomitantly with mitral (n = 1527, 67%), aortic (n = 180, 7.9%), or combined (n = 570, 25%) valve surgery. These included annulus (flexible prosthesis [n = 1052, 46%], rigid prosthesis [standard = 387, 3-dimensional = 197; 26%], Peri-Guard annuloplasty [Synovis Surgical Innovations, St Paul, Minn; n = 185, 8.1%], and De Vega suture [n = 129, 5.7%]), commissure (Kay [n = 248, 11%]), and leaflet (edge-to-edge suture [n = 79, 3.5%] +/- annulus or commissural) procedures. A total of 4745 postoperative transthoracic echocardiograms in 1965 patients were analyzed. RESULTS By 3 months after surgery, only 32% of patients overall had no tricuspid regurgitation. However, by 5 years, this had decreased to 22%, and 3+/4+ tricuspid regurgitation had increased from 11% at 3 months to 17%. Patients with rigid ring annuloplasty alone, either standard or 3-dimensional, had the least increase of 3+/4+ tricuspid regurgitation (to 12% at 5 years) compared with either a commissural or leaflet procedure. CONCLUSION Rigid prosthetic ring annuloplasty, standard or 3-dimensional, provides early and sustained reduction of tricuspid regurgitation secondary to left-sided valve disease without need for an additional leaflet procedure. However, results are imperfect, possibly because other anatomic levels (subvalvular, papillary muscle, and right ventricular) contributing to its pathophysiology are unaddressed.

Minimally invasive versus conventional mitral valve surgery: A propensity-matched comparison

OBJECTIVE Less invasive approaches to mitral valve surgery are increasingly used for improved cosmesis; however, few studies have investigated their effect on outcome. We sought to compare these minimally invasive approaches fairly with conventional full sternotomy by using propensity-matching methods. METHODS From January 1995 to January 2004, 2124 patients underwent isolated mitral valve surgery through a minimally invasive approach, and 1047 underwent isolated mitral valve surgery through a conventional sternotomy. Because there were important differences in patient characteristics, a propensity score based on 42 factors was used to obtain 590 well-matched patient pairs (56% of cases). RESULTS In-hospital mortality was similar for propensity-matched patients: 0.17% (1/590) for those undergoing minimally invasive surgery and 0.85% (5/590) for those undergoing conventional surgery (P = .2). Occurrences of stroke (P = .8), renal failure (P > .9), myocardial infarction (P = .7), and infection (P = .8) were also similar. However, 24-hour mediastinal drainage was less after minimally invasive surgery (median, 250 vs 350 mL; P < .0001), and fewer patients received transfusions (30% vs 37%, P = .01). More patients undergoing minimally invasive surgery were extubated in the operating room (18% vs 5.7%, P < .0001), and postoperative forced expiratory volume in 1 second was higher. Early after operation, pain scores were lower (P < .0001) after minimally invasive surgery. CONCLUSION Within that portion of the spectrum of mitral valve surgery in which propensity matching was possible, minimally invasive mitral valve surgery had cosmetic, blood product use, respiratory, and pain advantages over conventional surgery, and no apparent detriments. Mortality and morbidity for robotic and percutaneous procedures should be compared with these minimally invasive outcomes.

Intraoperative echocardiography is indicated in high-risk coronary artery bypass grafting

BACKGROUND Intraoperative echocardiography is a valuable monitoring and diagnostic technology used in cardiac surgery. This reports our clinical study of the usefulness of intraoperative echocardiography to both surgeons and anesthesiologists for high-risk coronary artery bypass grafting. METHODS From March to November 1995, 82 consecutive high-risk patients undergoing coronary artery bypass grafting were studied in a four-stage protocol to determine the efficacy of intraoperative echocardiography in management planning. Alterations in surgical and anesthetic/hemodynamic management initiated by intraoperative echocardiography findings were documented in addition to perioperative morbidity and mortality. RESULTS Intraoperative echocardiography initiated at least one major surgical management alteration in 27 patients (33%) and at least one major anesthetic/hemodynamic change in 42 (51%). Mortality and the rate of myocardial infarction in this consecutive high-risk study population using intraoperative echocardiography and in a similar group of patients without the use of intraoperative echocardiography was 1.2% versus 3.8% (not significant) and 1.2% versus 3.5% (not significant), respectively. CONCLUSIONS We conclude that when all of the isolated diagnostic and monitoring applications of perioperative echocardiography are routinely and systematically performed together, it is a safe and viable tool that significantly affects the decision-making process in the intraoperative care of high-risk patients undergoing primary isolated coronary artery bypass grafting and may contribute to the optimal care of these patients.

Coronary stenting versus coronary bypass surgery in patients with multiple vessel disease and significant proximal LAD stenosis: results from the ERACI II study

Purpose: To compare percutaneous coronary intervention (PCI) using stent implantation versus coronary artery bypass graft (CABG) in patients with multiple vessel disease with involvement of the proximal left anterior descending coronary artery (LAD). Methods: 230 patients with multiple vessel disease and severe stenosis of the proximal LAD (113 with PCI, 117 with CABG). They were a cohort of patients from the randomised ERACI (Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary artery bypass surgery in multivessel disease) II study. Results: Both groups had similar baseline characteristics. There were no significant differences in 30 day major adverse cardiac events (death, myocardial infarction, stroke, and repeat procedures) between the strategies (PCI 2.7% v CABG 7.6%, p = 0.18). There were no significant differences in survival (PCI 96.4% v CABG 95%, p = 0.98) and survival with freedom from myocardial infarction (PCI 92% v CABG 89%, p = 0.94) at 41.5 (6) months’ follow up. However, freedom from new revascularisation procedures (CABG 96.6% v PCI 73%, p = 0.0002) and frequency of angina (CABG 9.4% v PCI 22%, p = 0.025) were superior in the CABG group. Conclusion: Patients with multivessel disease and significant disease of the proximal LAD randomly assigned in the ERACI II trial to PCI or CABG had similar survival and survival with freedom from myocardial infarction at long term follow up. Repeat revascularisation procedures were higher in the PCI group.

Does successful bridging with the implantable left ventricular assist device affect cardiac transplantation outcome

OBJECTIVES We sought to determine whether cardiac transplant recipients who required a bridge to transplantation with an implantable left ventricular assist device had a different outcome than patients who underwent transplantation without such a bridge. METHODS A retrospective study of 256 cardiac transplants from 1992 to 1996 included 53 patients who received the HeartMate left ventricular assist device and 203 patients who had no left ventricular assist device support. RESULTS Left ventricular assist device transplants increased from 8% of all transplants in 1992 (n = 63) to 32% in 1995 (n = 65) and 43% in 1996 (n = 14 year to date). Patients with and without left ventricular assist device had similar age and sex distributions. Left ventricular assist device recipients were larger (body surface area 1.96 vs 1.86 m2, p = 0.004). They were more likely to have ischemic cardiomyopathy (70% vs 45%, p = 0.001) and type O blood group (51% vs 34%, p = 0.06). All patients with left ventricular assist device and 42% of those without had undergone previous cardiac operations by the time of transplantation (mean number per patient 1.5 vs 0.3, p < 0.001). More patients in the left ventricular assist device group had anti-HLA antibodies before transplantation (T-cell panel reactive antibody level > 10% in 66% of left ventricular assist device group vs 15% of control group, p < 0.0001). Waiting time was longer for the left ventricular assist device than for patients in status I without a left ventricular assist device (median 88 vs 37 days, p = 0.002). There was no difference in length of posttransplantation hospital stay (median 15 days for each) or operative mortality (3.8% vs 4.4%). Mean follow-up averaged 22 months. No significant difference was found in Kaplan-Meier survival estimates. One-year survival was 94% in the left ventricular assist device group and 88% in the control group (difference not significant). Comparison of posttransplantation events showed no significant difference in actuarial rates of cytomegalovirus infection (20% vs 17%) or vascular rejection (15% vs 12%) at 1 year of follow-up. Similar percentages of patients were free from cellular rejection at 1 year of follow-up (12% vs 22%, p = 0.36). CONCLUSIONS Left ventricular assist device support intensified the donor shortage by including recipients who otherwise would not have survived to transplantation. Bridging affected transplant demographics, favoring patients who are larger, have ischemic cardiomyopathy, have had multiple blood transfusions and complex cardiac operations, and are HLA sensitized. Successfully bridged patients wait longer for a transplant than do UNOS status I patients without such a bridge, but they have similar posttransplantation hospital stay, operative mortality, and survival to those of patients not requiring left ventricular assist device support.

Do left ventricular assist device (LVAD) bridge-to-transplantation outcomes predict the results of permanent LVAD implantation?

BACKGROUND Implantable left ventricular assist devices (LVADs) were designed for permanent implant, but we began their use for bridge-to-transplant (BTTx) to study their safety and effectiveness. We review our experience in order to compare the BTTx lessons learned with the outcomes and goals of permanent implants. METHODS From December 1991 until January 2002, 264 patients received 277 LVADs for BTTx. We analyzed temporal trends in pre-LVAD patient factors and device-specific time-related complications. RESULTS Survival to transplant was 69%. Adverse event analysis demonstrated a high risk of infections (0.56, 1.28, and 1.88 per patient at 30 days and 3 and 6 months). HeartMate devices were more prone to infection than Novacor devices (p < 0.0001). Cerebral infarctions occurred less commonly than infections (0.15, 0.25, 0.30 at 30 days and 3 and 6 months), were more common in Novacor than HeartMate (p = 0.0001), and were decreased by the new Novacor Vascutek conduit (p = 0.07), but these were still slightly higher than the HeartMate (p = 0.04). Device failures occurred in 21 instances (all but one were in HeartMate devices [p = 0.04 vs Novacor]), but have significantly decreased (p < 0.0001) in HeartMate since 1998. CONCLUSIONS Infections and device durability limit the chronic use of the HeartMate device, but device failures are decreasing. Novacor has fewer problems with infection and durability, and the new Vascutek conduit will reduce, but not eliminate, strokes.

Moderate tricuspid regurgitation with left-sided degenerative heart valve disease: to repair or not to repair?

BACKGROUND Uncertainty about long-term effects of surgically unaddressed moderate (2+) secondary tricuspid valve (TV) regurgitation (TR) accompanying left-sided degenerative heart valve disease led us to identify reasons for and factors associated with TV repair, compare safety and clinical effectiveness of relieving TR, and identify factors associated with severe (3/4+) postoperative TR. METHODS From 1997 to 2008, 1,724 patients with 2+ TR underwent 830 mitral, 703 aortic, and 191 double-valve procedures; 91 (5%) had concomitant TV repair. Logistic regression analysis was used to identify factors associated with TV repair and for propensity-matched comparison of safety (in-hospital morbidity, mortality) and effectiveness of TV repair (longitudinal echocardiographic assessment of postoperative TR and New York Heart Association class, TV intervention, survival). RESULTS Factors associated with TV repair of 2+ TR included larger right ventricles and left ventricles (p<0.001), greater TV tethering height (p=0.0002), and prior concurrent mitral valve procedures (p≤0.004). In-hospital complications, subsequent TV interventions, and intermediate-term survival were similar for matched patients. The TV repair patients had less 3/4+ TR at discharge (7% versus 15%), sustained out to 3 years. No TV repair (p=0.05), female sex (p<0.0001), and mitral valve replacement (p=0.008) were associated with 3/4+ TR. CONCLUSIONS A TV repair for moderate TR concomitant with surgery for degenerative left-sided heart valve disease is reasonable to provide an opportunity to prevent its progression and development of right ventricle dysfunction, particularly for patients with important right ventricle remodeling and evidence of right ventricular failure, and for patients with advanced left-sided disease requiring mitral valve replacement.