Early Structural Deterioration of a Sutureless Bioprosthetic Aortic Valve.

Sutureless bioprosthetic valves such as the Sorin Perceval S valve (SPV) have been used in patients with aortic stenosis that require surgical aortic valve replacement (SAVR). These prostheses have been marketed on the basis of their rapid implantation techniques with avoidance of sutures and reduced aortic cross-clamp times. We report a case of an early failure of a SPV nearly 4 years after implantation in a 58-year-old woman who was low-risk. While the patient's symptoms initially improved with SAVR with a sutureless bioprosthetic valve, they progressively worsened as the valve degraded, and the leaflets became increasingly calcified and stenotic ultimately, requiring reoperative SAVR with a St. Jude mechanical valve. This case raises the issue of the lack of much-needed data describing the long-term durability and hemodynamic performance of these valves, particularly in a low-risk patient with excellent functional status. We hope to shed further insight into the lack of long-term studies on patients with SPV to assess their longevity and long-term effectiveness, as well as elucidation of possible prevention and monitoring of these potential complications. The use of newer generation prostheses, although attractive for their ease of implantation, potentially carries higher long-term risk due to shorter durability leading to reintervention to address valve deterioration. This is especially true in low-risk patients who are young and active. Cardiology and cardiothoracic surgery societies need to develop a universal registry with follow-up of all valves in order to track and study the durability of these valves, and to evaluate for incidence of known and potential complications.

SYNTAX Score and Long-Term Outcomes: The BARI-2D Trial.

BACKGROUND: The extent of coronary disease affects clinical outcomes and may predict the effectiveness of coronary revascularization with either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score quantifies the extent of coronary disease. OBJECTIVES: This study sought to determine whether SYNTAX scores predicted outcomes and the effectiveness of coronary revascularization compared with medical therapy in the BARI-2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial. METHODS: Baseline SYNTAX scores were retrospectively calculated for BARI-2D patients without prior revascularization (N = 1,550) by angiographic laboratory investigators masked to patient characteristics and outcomes. The primary outcome was major cardiovascular events (a composite of death, myocardial infarction, and stroke) over 5 years. RESULTS: A mid/high SYNTAX score (≥23) was associated with a higher risk of major cardiovascular events (hazard ratio: 1.36, confidence interval: 1.07 to 1.75, p = 0.01). Patients in the CABG stratum had significantly higher SYNTAX scores: 36% had mid/high SYNTAX scores compared with 13% in the PCI stratum (p < 0.001). Among patients with low SYNTAX scores (≤22), major cardiovascular events did not differ significantly between revascularization and medical therapy, either in the CABG stratum (26.1% vs. 29.9%, p = 0.41) or in the PCI stratum (17.8% vs. 19.2%, p = 0.84). Among patients with mid/high SYNTAX scores, however, major cardiovascular events were lower after revascularization than with medical therapy in the CABG stratum (15.3% vs. 30.3%, p = 0.02), but not in the PCI stratum (35.6% vs. 26.5%, p = 0.12). CONCLUSIONS: Among patients with diabetes and stable ischemic heart disease, higher SYNTAX scores predict higher rates of major cardiovascular events and were associated with more favorable outcomes of revascularization compared with medical therapy among patients suitable for CABG. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes; NCT00006305).

Comparison of Radial Artery and Saphenous Vein Graft Stenosis More Than 5 Years After Coronary Artery Bypass Grafting.

BACKGROUND: Graft stenosis may be associated with future graft failure. The purpose of this investigation was to compare graft stenosis between radial artery (RA) grafts and saphenous vein grafts (SVGs) at least 5 years postoperatively using the multicenter Radial Artery Patency Study (RAPS) data. METHODS: Two hundred thirty-four patients underwent late invasive angiography after coronary artery bypass operations. The study population consists of 163 patients with thrombolysis in myocardial infarction (TIMI) 3 flow of both the RA graft and study SVGs. Angiograms were reviewed centrally and in a blinded fashion. Graft stenosis was recorded for the proximal anastomosis, graft body, and distal anastomosis; significant stenosis was defined as greater than or equal to 50%. Major adverse cardiac events (MACE) were reported in patients with and those without significant graft stenosis. RESULTS: There was no difference in significant graft stenosis of the patent RA grafts and SVGs (14 of 163 [8.6%] versus 19 of 163 [11.7%]) or in the proximal anastomosis (5 of 163 [3.1%] versus 5 of 163 [3.1%]), graft body (6 of 163 [3.7%] versus 13 of 163 [8.0%]), or distal anastomosis (4 of 163 [2.5%] versus 5 of 163 [3.1%]) considered separately. However, the overall burden of graft body disease was higher in SVGs (p = 0.03). MACE was higher in patients with significant graft stenosis than in patients without stenosis (10 of 28 [35.7%] versus 7 of 135 [5.2%]; p < 0.0001). CONCLUSIONS: There was no significant difference in the rates of significant stenosis of patent RA grafts and SVGs more than 5 years postoperatively. However, the burden of graft body stenosis was less in RA grafts compared with SVGs, suggesting that the RA grafts will continue to outperform the SVGs late after operation.

The long-term impact of diabetes on graft patency after coronary artery bypass grafting surgery: a substudy of the multicenter Radial Artery Patency Study.

OBJECTIVES: The study objective was to determine the impact of diabetes on radial artery and saphenous vein graft occlusion and clinical outcomes more than 5 years after coronary artery bypass surgery in the multicenter Radial Artery Patency Study (NCT00187356). METHODS: A total of 529 patients aged less than 80 years with triple-vessel disease undergoing coronary bypass surgery participated in this study. Angiographic follow-up occurred more than 5 years after surgery with annual clinical follow-up. The primary objective was to compare the proportion of complete graft occlusion between radial artery and saphenous vein grafts among diabetic and nondiabetic persons. Additional objectives included determining predictors of complete graft occlusion and comparison of major adverse cardiac events defined by cardiac death, late myocardial infarction, and reintervention. RESULTS: There were 148 of 529 patients (27.8%) with diabetes; 269 patients (83/269 [30.9%] diabetic) underwent late angiography at mean of 7.7±1.5 years after surgery. In diabetic patients, the proportion of complete graft occlusion was significantly lower in the radial grafts (4/83 [4.8%]) than in the saphenous grafts (21/83 [25.3%]) (P=.0004), and this was similar in nondiabetic patients (P=.19). Multivariate modeling showed that the use of the radial artery and high-grade target vessel stenosis were protective against late graft occlusion, whereas female gender, smoking history, and elevated creatinine were associated with an increased risk; interaction between diabetic status and conduit type also was significant (P=.02). Major adverse cardiac events were higher in diabetic patients (23/148 [15.5%] vs 35/381 [9.2%], P=.04). CONCLUSIONS: The use of the radial artery should be strongly considered in diabetic patients undergoing coronary bypass surgery, especially with high-grade target vessel stenosis.

Clinical, biochemical, and genetic predictors of coronary artery bypass graft failure.

OBJECTIVES: To identify novel predictors for coronary artery bypass grafting failure, we probed for associations with known clinical and biochemical risk factors for atherosclerosis. We also used microarray analysis to identify novel single nucleotide polymorphisms to better understand the genetics and pathogenesis of graft occlusion. METHODS: The present study was a nested case-control substudy of the Radial Artery Patency Study 5-year follow-up data. From 1996 to 2001, 87 patients underwent coronary artery bypass grafting. Of these, 26 patients (29.9%) had an occluded study graft (saphenous vein or radial artery) at 8.0 ± 1.1 years. The clinical parameters, late angiography, blood biomarker levels, and surgical outcomes data were included in a multivariate analysis to determine the independent predictors of graft failure. RESULTS: The risk factors of graft failure were fibrinogen (odds ratio [OR], 3.94; 95% confidence interval [CI], 1.33-11.63; P = .01), creatinine (OR, 1.06; 95% CI, 1.02-1.10; P = .006), and diabetes mellitus (OR, 5.15; 95% CI, 1.08-24.59; P = .04). High-density lipoprotein (OR, 0.74; 95% CI, 0.53-1.02; P = .06) was weakly protective; however, low-density lipoprotein and total cholesterol were not predictors. We then identified the association of several human single nucleotide polymorphisms with graft failure, including mutations in glutathione-S-transferase α3. Human coronary arteries and bypass grafts demonstrated increased protein expression of glutathione-S-transferase α3, a known cardioprotective factor, in the atherosclerotic regions and surrounding adventitial tissues. CONCLUSIONS: We identified diabetes as a potential clinical predictor and plasma fibrinogen, creatinine, and high-density lipoprotein as potential novel biomarkers. These might help risk stratify patients for the development of graft failure. We also demonstrated a novel association between glutathione-S-transferase α3 and graft failure.

Impact of completeness of revascularization on long-term cardiovascular outcomes in patients with type 2 diabetes mellitus: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D).

BACKGROUND: Patients with diabetes have more extensive coronary disease than those without diabetes, resulting in more challenging percutaneous coronary intervention or surgical (coronary artery bypass graft) revascularization and more residual jeopardized myocardium. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial provided an opportunity to examine the long-term clinical impact of completeness of revascularization in patients with diabetes. METHODS AND RESULTS: This is a post hoc, nonrandomized analysis of the completeness of revascularization in 751 patients who were randomly assigned to early revascularization, of whom 264 underwent coronary artery bypass graft surgery and 487 underwent percutaneous coronary intervention. The completeness of revascularization was determined by the residual postprocedure myocardial jeopardy index (RMJI). RMJI is a ratio of the number of myocardial territories supplied by a significantly diseased epicardial coronary artery or branch that was not successfully revascularized, divided by the total number of myocardial territories. Mean follow-up for mortality was 5.3 years. Complete revascularization (RMJI=0) was achieved in 37.9% of patients, mildly incomplete revascularization (RMJI >0≤33) in 46.6%, and moderately to severely incomplete revascularization (RMJI >33) in 15.4%. Adjusted event-free survival was higher in patients with more complete revascularization (hazard ratio, 1.14; P=0.0018). CONCLUSIONS: Patients with type 2 diabetes mellitus and less complete revascularization had more long-term cardiovascular events. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

Time to significant gradient reduction following septal balloon occlusion predicts the magnitude of final gradient response during alcohol septal ablation in patients with hypertrophic obstructive cardiomyopathy.

OBJECTIVES: The purpose of this study was to investigate whether a relationship exists between an acute reduction in resting left ventricular outflow tract (LVOT) gradient with balloon occlusion and the final invasive gradient response following alcohol septal ablation (ASA). BACKGROUND: ASA is an alternative therapy to myectomy surgery to reduce the basal septal thickness and decrease the resting and/or provocable LVOT gradient in patients with hypertrophic cardiomyopathy. Patients have a variable gradient response to occlusion of the septal perforator artery before ethanol infusion for ASA. METHODS: From November 1998 to November 2008, 120 patients (mean age 60 years [range 16 to 87 years], 50% women) with hypertrophic cardiomyopathy underwent ASA at our institution. The resting LVOT gradient (peak systolic left ventricle [LV] pressure - peak systolic aortic pressure) was measured continuously during the ASA procedure. The time to significant LVOT gradient decrease (defined as >50% decrease from baseline) was recorded following balloon occlusion of the dominant septal perforator coronary artery, which was found to perfuse the basal septum based on contrast echocardiographic studies. RESULTS: The mean baseline resting LVOT gradient was 86 ± 43 mm Hg, and it decreased to 17 ± 11 mm Hg following ASA (-80.2%). The mean time to significant gradient reduction was 3.6 ± 2 min (range 25 s to 11 min). The time to significant LVOT gradient reduction strongly correlated with the final magnitude of gradient reduction following ASA (r = -0.81, p < 0.001). CONCLUSIONS: This study demonstrates a correlation between the time to significant LVOT gradient reduction following septal perforator balloon occlusion and the magnitude of final gradient response after ASA.

Sex, clinical symptoms, and angiographic findings in patients with diabetes mellitus and coronary artery disease (from the Bypass Angioplasty Revascularization Investigation [BARI] 2 Diabetes trial).

Previous studies have reported differences in presenting symptoms and angiographic characteristics between women and men undergoing evaluation for suspected coronary artery disease (CAD). We examined the relation between symptoms and extent of CAD in patients with type 2 diabetes mellitus and known CAD enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Of 1,775 patients (533 women, 30%, and 1,242 men, 70%), women were more likely than men to have angina (65% vs 56%, p <0.001) or an atypical angina/anginal equivalent (71% vs 58%, p <0.001). More women reported unstable angina (17% vs 13%, p = 0.047) or were in a higher Canadian Cardiology Society class compared to men (Canadian Cardiology Society classes II to IV 78% vs 68%, p = 0.002). Fewer women than men had no symptoms (14% vs 22%, p <0.001). Women had a lower mean myocardial jeopardy index (42.5 ± 24.3 vs 47.9 ± 24.3, p <0.001), smaller number of total significant lesions (2.3 ± 1.7 vs 2.7 ± 1.8, p <0.001), and fewer jeopardized left ventricular regions (p <0.001 for distribution) or long-term occlusions (29% vs 42%, p <0.001). After adjustment for relevant covariates, the odds of having CAD symptoms were still higher in women than men (odds ratio for angina 1.31, 95% confidence interval 1.02 to 1.69; odds ratio for atypical angina 1.52, 95% confidence interval 1.17 to 1.96). In conclusion, in a high-risk group of patients with known CAD and diabetes mellitus, women were more symptomatic than men but had less obstructive CAD. These data suggest that factors other than epicardial CAD severity influence symptom presentation in women in this population.

Selective use of embolic protection devices during saphenous vein grafts interventions: a single-center experience.

OBJECTIVES: To report on outcomes with selective use of embolic protection devices (EPD) during percutaneous coronary intervention (PCI) to saphenous vein grafts (SVG). BACKGROUND: PCI to SVG is associated with increased risk and the use of EPD is recommended in this setting. METHODS: Angiographic and clinical outcomes were prospectively obtained from 534 consecutive patients who underwent PCI to SVG with or without EPD at a tertiary cardiac centre. Long-term outcomes were obtained by linkage to a provincial registry. RESULTS: EPD, deployed in 198 of 373 SVGs (53%) suitable for deployment of a distal EPD, were used more often in ectatic (33% vs. 19%, P = 0.003), ulcerated (17% vs. 9%, P = 0.03), thrombotic (26% vs. 10%, P < 0.0001) vein grafts, with longer degenerated segments (P = 0.002), and in lesions involving the body of the graft (85% vs. 66%, P < 0.0001), and less with lesions involving the graft ostium (29% vs. 44%, P = 0.003). Patients suitable for but not receiving EPD tended to be more likely to have a periprocedural myocardial infarction. During 3 years of follow-up, 49% of the patients had a cardiovascular event. Cumulative mortality was 8.4%, 18.8% and 14.7% in patients unsuitable for distal EPD, suitable but without EPD, and with EPD (p = 0.11). Nonuse of EPD was an independent predictor of MACE at 3 years. (P = 0.02). CONCLUSIONS: Selective use of EPD is associated with low in-hospital cardiovascular event rates. Long-term outcomes are manifested by a high rate of events, especially in patients with SVG's suitable for but not receiving EPD. This suggests that routine use of distal EPD may be warranted in unselected patients with suitable SVG anatomy.

The accuracy of noninvasive stress myocardial imaging for detecting coronary artery disease in clinical practice.

BACKGROUND: There is a wide variation in reported accuracy ofnoninvasive stress myocardial imaging as a screening tool for coronary artery disease (CAD). This study was undertaken to determine its current accuracy in a wide spectrum of patients with chest pain syndromes using invasive coronary angiography as the gold standard. METHODS: The patient population consisted of consecutive patients undergoing coronary angiography in whom noninvasive stress imaging, either nuclear or echocardiographic, was performed within 6 months prior to the angiogram. The specificity, sensitivity, positive and negative predictive values, and diagnostic accuracy for detecting > or =1 lesions with > or =50% diameter coronary stenosis were determined for each modality. RESULTS: Of the 227 eligible patients, 141 were men and 86 were women; 70% had significant CAD. The diagnostic accuracy overall was 71% and was no different for nuclear or echocardiographic testing. The positive predictive value (86% vs. 52%; P = 0.002) and diagnostic accuracy (83% vs. 51%; P = 0.002) were better in men than in women. INTERPRETATION: In this study, noninvasive stress imaging lacked the accuracy of a good screening test for significant CAD. This finding was particularly true for women, for whom it was not much better than a coin toss.

Baseline coronary angiographic findings in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial (BARI 2D).

This report describes the baseline angiographic findings in the Bypass Angioplasty Revascularization Investigation (BARI) 2 Diabetes (BARI 2D) trial, a randomized study that was initiated after the original BARI trial (BARI 1). Unlike BARI 1, which compared coronary artery bypass graft surgery with coronary angioplasty (percutaneous coronary intervention) in patients with and without diabetes, BARI 2D is investigating early versus deferred revascularization as needed in selected patients with type 2 diabetes mellitus and significant stable coronary artery disease (CAD). This analysis included 1,773 patients without previous procedures. The intended mode of revascularization, percutaneous coronary intervention or coronary artery bypass graft surgery, was specified before randomization. Angiographic findings in those randomized to revascularization versus medical treatment were similar. Overall, the mean number of lesions >or=20% diameter stenosis was 4.6 +/- 2.3, and the myocardial jeopardy index was 46 +/- 24%. Patients selected for the coronary artery bypass graft stratum had a higher mean number of lesions >or=20% diameter stenosis (5.7 vs 4.0, p <0.0001) and a higher myocardial jeopardy index (61% vs 38%, p <0.0001) than those selected for the percutaneous coronary intervention stratum. Female gender, black race, and higher body mass index were associated with less extensive CAD, whereas a history of hypertension, age at entry, low-density lipoprotein cholesterol, and ankle-brachial index

Therapeutic options in coronary artery disease: focusing on the guidelines.

There are three options for the treatment of patients with coronary artery disease: coronary artery bypass graft surgery (CABG), percutaneous coronary intervention (PCI) and optimal medical treatment alone. While there has been an active interface between CABG and PCI, medical treatment has not been as vociferously advocated. However, it performs well in randomized trials and is still a treatment arm in studies such as the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. The present review compares these options in acute and chronic coronary syndromes, including the indications for each as summarized by recent American College of Cardiology and American Heart Association guidelines. While the landscape in Canada is changing for CABG and PCI, with an increase in the latter procedure for patients with multivessel disease, optimal medical treatment alone is very effective. There are few subsets, particularly in chronic syndromes, in which revascularization is indicated for prognosis alone.

Decreased complication rates using the transradial compared to the transfemoral approach in percutaneous coronary intervention in the era of routine stenting and glycoprotein platelet IIb/IIIa inhibitor use: a large single-center experience.

BACKGROUND: Studies evaluating the efficacy and safety of the transradial approach for percutaneous coronary intervention (PCI) were carried out mainly before the widespread use of stents and glycoprotein (GP) IIb/IIIa inhibitors. We sought to determine the association between the choice of the vascular access site and procedural complications after PCI performed with routine stenting and GP IIb/IIIa inhibition. METHODS: The data source was a prospective registry of 13,499 consecutive cases of PCI at the University Health Network, Toronto, Canada, from April 2000 to September 2006. Logistic regression was used to calculate the probability of selection to the radial access group. Using propensity score methodology, 3,198 patients with femoral access were randomly matched to 3,198 patients with radial access based on clinical, angiographic, and procedural characteristics. Multivariable logistic regression analysis was used to identify the independent predictors of access site-related complications. Major adverse cardiac event was defined as death, myocardial infarction, abrupt vessel closure, or coronary artery bypass surgery. RESULTS: Use of the transradial approach was associated with fewer vascular access complications (1.5% vs 0.6%, P<.001) and a shorter length of hospital stay. Multivariable analysis revealed transradial access (OR 0.39, 95% CI 0.2-0.7) to be an independent predictor of lower risk, whereas primary PCI (OR 4.36, 95% CI 1.4, 13), recent myocardial infarction (OR 2.0 95% CI 1.2, 3.4), age (per 10 years increase: OR 1.37, 95% CI 1.1-1.7) and female gender (0R 2.78 95% CI 1.7, 4.6) were independent predictors of a higher risk of access site complications. CONCLUSIONS: Use of transradial access for PCI is safe and is independently associated with a reduced rate of in-hospital access site complications and reduced length of hospital stay.

The impact of diabetic status on coronary artery bypass graft patency: insights from the radial artery patency study.

BACKGROUND: Despite worse outcomes in diabetics after coronary artery bypass grafting surgery, studies have not examined graft patency in this high-risk group. This study examined the impact of diabetes on graft patency, 1-year postcoronary artery bypass grafting, using data from a multicenter randomized trial. METHODS AND RESULTS: The Radial Artery Patency Study enrolled 561 patients undergoing coronary artery bypass grafting, comparing graft patency of the saphenous vein (SV) versus radial artery 1-year postcoronary artery bypass grafting. Angiographic follow-up was acquired for 440 patients (115 diabetics, 325 nondiabetics), each with a study radial artery and a control SV graft. Preoperative characteristics were similar. The proportion of small-sized target vessels was greater in diabetics (P=0.04). At 1 year, 33 of 230 study grafts (14.4%) were occluded in the diabetics versus 63 of 650 (9.7%) in the nondiabetics (P=0.052). Multivariable regression found diabetes to be a significant independent predictor of 1-year graft occlusion (relative risk, 1.45; 95% CI, 1.03 to 2.05; P=0.03) along with female gender, SV conduit, and small target-vessel size. A significantly higher proportion of SV grafts were occluded in the diabetics (19% versus 12%, P=0.04). Radial artery grafting was protective in the diabetic cohort (radial artery: 11 of 115 occluded [9.5%] versus SV: 22 of 115 occluded [19.1%], McNemar corrected P=0.05; relative risk, 0.42; 95% CI, 0.16 to 1.01) and nondiabetics (radial artery: 25 of 325 occluded [7.7%] versus SV: 38 of 325 occluded [11.7%], McNemar corrected P=0.11; relative risk, 0.63; 95% CI, 0.35 to 1.10). CONCLUSIONS: Coronary artery bypass grafting occlusions were more common among diabetics versus nondiabetics at 1-year angiography, mainly because of more frequent SV graft failure in diabetics. Radial artery, compared with SV grafting, is protective in both diabetic and nondiabetic patients.

Impact of patient and target-vessel characteristics on arterial and venous bypass graft patency: insight from a randomized trial.

BACKGROUND: The purpose of this investigation was to determine optimal patient and target-vessel characteristics to maximize arterial and venous graft patency on the basis of data from a large clinical trial. METHODS AND RESULTS: Angiographic data on 440 radial artery grafts and 440 saphenous vein grafts were analyzed with methodology to account for within-patient clustering. Multivariable models that incorporated patient demographic, operative, anatomic, and postdischarge medical management were constructed to determine predictors of graft occlusion. Radial artery use was strongly protective against graft occlusion at 1 year after adjustment for all covariates, with a larger protective effect seen in women (P=0.05 for a subgroup-by-treatment interaction). Among all grafts, diabetes and small target-vessel diameter were associated with an increased risk of graft occlusion, and grafting to a target vessel with more severe proximal stenosis was associated with a decreased risk of graft occlusion. With regard to gender, radial artery graft occlusion at 1 year occurred in similar proportions of men (8.6%) and women (5.3%, P=0.6), whereas, for saphenous vein grafts the comparable occlusion rates were 12.0% and 23.3% respectively (P=0.02). A history of peripheral vascular disease was associated with an elevated risk of radial artery occlusion but was not associated with early vein graft occlusion (P=0.02 for a subgroup-by-treatment interaction). CONCLUSIONS: Patients benefit from radial artery-coronary artery bypass conduits as opposed to saphenous vein conduits, and this effect is especially strong in women. Small target-vessel size adversely affected graft patency, and grafting to a target vessel with more severe proximal stenosis improved graft patency.

Hypertrophic obstructive cardiomyopathy: comparison of outcomes after myectomy or alcohol ablation adjusted by propensity score.

OBJECTIVE: In November 1998, our center began offering alcohol ablation as an alternative to surgical myectomy for patients with hypertrophic obstructive cardiomyopathy. Patients with concomitant lesions were referred for surgical intervention, and the others were offered either treatment option. We sought to review the early outcomes for both protocols. METHODS: One hundred fifty patients had intervention for hypertrophic obstructive cardiomyopathy to June 30, 2003. Sixty patients elected to have alcohol ablation, and 5 crossed over to surgical intervention. A total of 95 patients had a myectomy. Patients having an isolated myectomy (n = 48) are compared with those who had an ablation. Hospital records were reviewed, and follow-up contact (mean, 2.2 years) with the patient or referring cardiologist and recent echocardiographic reports were obtained. Differences in clinical and hemodynamic outcomes between achieved treatment groups were compared after adjustment for differing baseline patient characteristics, including use of a propensity score, to adjust for the non-randomization. RESULTS: The patients undergoing alcohol ablation (n = 60) were older (58 vs 48 years) and had fewer associated lesions (1 vs 39 patients), lower pressure gradients (67 vs 73 mm Hg), and similar symptomatic status and degrees of mitral regurgitation compared with those in the myectomy group. Alcohol ablation was abandoned in 6 patients, 5 of whom underwent myectomy. Among the completed alcohol ablations, there were 5 late deaths, and 1 other patient was referred for myectomy. One late death occurred after myectomy. At latest follow-up, 3-year survival is 97%, and 92% of the patients are in New York Heart Association class II or I. Adjusted comparisons showed significantly lower postintervention left ventricular outflow gradients at rest in the myectomy group (5 vs 15 mm Hg), with provocation (14 vs 42 mm Hg), mitral systolic anterior motion (67% vs 29%), and New York Heart Association class. No significant difference was present in postintervention septal thickness or freedom from postintervention pacing, although in time-related analysis, the 3-year freedom from pacing is 88% versus 59% (P = .02), favoring myectomy. CONCLUSION: Either alcohol ablation or myectomy offers substantial clinical improvement for patients with hypertrophic obstructive cardiomyopathy. Hemodynamic resolution of the obstruction and its sequelae is more complete with myectomy. Residual lesions after alcohol ablation might affect longer-term outcomes.

N-acetylcysteine reduces contrast-associated nephropathy but not clinical events during long-term follow-up.

BACKGROUND: Contrast-associated nephropathy (CAN) is associated with increased morbidity and mortality following percutaneous coronary intervention (PCI). N-acetylcysteine (NAC) has been shown to reduce the risk of nephropathy; however, the impact of NAC on long-term clinical outcomes has not been assessed. METHODS: This randomized, double-blind, placebo-controlled trial enrolled 180 patients with moderate renal dysfunction undergoing PCI or coronary angiography with a high likelihood of ad hoc PCI; 171 patients completed the clinical follow-up. Patients received oral NAC (2000 mg/dose, n = 95) or placebo (n = 85) twice a day for 3 doses if randomized the night prior to the procedure, and 2 doses if randomized the day of the procedure. The primary end point was the incidence of a > or =25% increase in serum creatinine level 48 to 72 hours after PCI. Secondary end points were the inhospital incidence of death, nonfatal myocardial infarction, or urgent dialysis, and the 9-month incidence of death, nonfatal myocardial infarction, need for dialysis, or repeat hospitalization for cardiac reasons. RESULTS: CAN occurred in 9.6% of patients assigned to NAC and 22.2% of patients assigned to placebo (P =.04); 1 patient receiving NAC required urgent dialysis. The inhospital composite end point occurred in 7 (7.4%) NAC-treated and 3 (3.5%) placebo-treated patients, P = NS. At 9 months, the composite end point occurred in 23 (24.2%) NAC-treated patients and 18 (21.2%) placebo-treated, P = NS. CONCLUSION: Although high-dose NAC prevented periprocedural CAN, this benefit did not translate into a decrease in adverse outcomes over 9 months. Further studies to determine the clinical utility of this drug are required.

Native coronary disease progression exceeds failed revascularization as cause of angina after five years in the Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: Coronary angiograms obtained five years following revascularization were examined to assess the extent of compromise in myocardial perfusion due to failure of revascularization versus progression of native disease. BACKGROUND: The Bypass Angioplasty Revascularization Investigation (BARI) randomized revascularization candidates between bypass surgery and angioplasty. Entry and five-year angiograms from 407 of 519 (78%) patients at four centers were analyzed. METHODS: Analysis of the distribution of coronary vessels and stenoses provided a measure of myocardial jeopardy that correlates with presence of angina. The extent to which initial benefits of revascularization were undone by failed revascularization versus native disease progression was assessed. RESULTS: Myocardial jeopardy fell following initial revascularization, from 60% to 17% for percutaneous coronary intervention (PCI)-treated patients compared with 60% to 7% for coronary artery bypass graft (CABG) surgery patients (p < 0.001), rebounding at five years to 25% for PCI and 20% for surgery patients (p = 0.01). Correspondingly, angina prevalence was higher at five years in PCI-treated patients than in surgery-treated patients (28% vs. 18%; p = 0.03). However, myocardial jeopardy at five years, and not initial treatment (PCI vs. surgery), was independently associated with late angina. Increased myocardial jeopardy from entry to five-year angiogram occurred in 42% of PCI-treated patients and 51% of CABG-treated patients (p = 0.06). Among the increases in myocardial jeopardy, two-thirds occurred in previously untreated arteries. CONCLUSIONS: Native coronary disease progression occurred more often than failed revascularization in both PCI- and CABG-treated patients as a cause of jeopardized myocardium and angina recurrence. These results support intensive postrevascularization risk-factor modification.

Septal ethanol ablation for hypertrophic obstructive cardiomyopathy: early and intermediate results of a Canadian referral centre.

BACKGROUND: Septal ethanol ablation (SEA) is a relatively new interventional nonsurgical treatment for patients with hypertrophic obstructive cardiomyopathy (HOCM). This procedure involves targeted infarction of the basal interventricular septum to reduce left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: To describe the experience with this technique in a large tertiary care centre. METHODS AND RESULTS: Since 1998, 40 HOCM patients with disabling symptoms refractory to medical treatment have undergone SEA. Procedural success was 88% (35 of 40 patients). The LVOT gradient decreased from 86+/-38 mmHg to 16+/-16 mmHg. There were two major complications: one patient died of respiratory failure at 30 days following SEA, and one patient developed a major coronary dissection during the procedure and required emergency myectomy and coronary bypass surgery. There were two late failures (6% of initially successful cases). In both patients, the LVOT gradient and symptoms reappeared some months after the procedure and further interventions were required. In the remaining patients, the gradient continued to decrease to one year; 86% were asymptomatic or have mild symptoms compared with 94% with severe symptoms before SEA. Septal thickness decreased from 20.8+/-2.9 mm to 13.2+/-3.3 mm (P<0.001) at the site of the targeted septal infarct. CONCLUSION: SEA is a feasible option for suitable patients with HOCM.

Coronary bypass graft patency in patients with diabetes in the Bypass Angioplasty Revascularization Investigation (BARI).

BACKGROUND: Few studies have compared long-term status of bypass grafts between patients with and without diabetes, and uncertainty exists as to whether diabetes independently predicts poor clinical outcome after CABG. METHODS AND RESULTS: Among 1526 patients in BARI who underwent CABG as initial revascularization, 99 of 292 (34%) with treated diabetes mellitus (TDM) (those on insulin or oral hypoglycemic agents) and 469 of 1234 (38%) without TDM had follow-up angiography. Angiograms with the longest interval from initial surgery and before any percutaneous graft intervention (mean 3.9 years) were reviewed. An average of 3.0 grafts were placed at initial CABG for patients with TDM (n=297; internal mammary artery [IMA], 33%) and 2.9 grafts for patients without TDM (n=1347; IMA, 34%). Patients with TDM were more likely than those without to have small (<1.5 mm) grafted distal vessels (29% versus 22%) and vessels of poor quality (9% versus 6%). On follow-up angiography, 89% of IMA grafts were free of stenoses > or =50% among patients with TDM versus 85% among patients without TDM (P=0.23). For vein grafts, the corresponding percentages were 71% versus 75% (P=0.40). After statistical adjustment, TDM was unrelated to having a graft stenosis > or =50% (adjusted odds ratio, 0.87; 95% CI, 0.58 to 1.32). CONCLUSIONS: Despite diabetic patients' having smaller distal vessels and vessels judged to be of poorer quality, diabetes does not appear to adversely affect patency of IMA or vein grafts over an average of 4-year follow-up. Previously observed differences in survival between CABG-treated patients with and without diabetes may be largely a result of differential risk of mortality from noncardiac causes.