Andrzej Bochenek

Acute and Late Outcomes of Unprotected Left Main Stenting in Comparison With Surgical Revascularization

OBJECTIVES The purpose of this study was to compare the early and late results of percutaneous and surgical revascularization of left main coronary artery stenosis. BACKGROUND Unprotected left main coronary artery (ULMCA) stenting is being investigated as an alternative to bypass surgery. METHODS We randomly assigned 105 patients with ULMCA stenosis to percutaneous coronary intervention (PCI; 52 patients) or coronary artery bypass grafting (CABG; 53 patients). The primary end point was the change in left ventricular ejection fraction (LVEF) 12 months after the intervention. Secondary end points included 30-day major adverse events (MAE), major adverse cardiac and cerebrovascular events (MACCE), length of hospitalization, target vessel failure (TVF), angina severity and exercise tolerance after 1 year, and total and MACCE-free survival. RESULTS A significant increase in LVEF at the 12-month follow-up was noted only in the PCI group (3.3 +/- 6.7% after PCI vs. 0.5 +/- 0.8% after CABG; p = 0.047). Patients performed equally well on stress tests, and angina status improved similarly in the 2 groups. PCI was associated with a lower 30-day risk of MAE (p < 0.006) and MACCE (p = 0.03) and shorter hospitalizations (p = 0.0007). Total and MACCE-free 1-year survival was comparable. Left main TVF was similar in the 2 groups. During the 28.0 +/- 9.9-month follow-up, there were 3 deaths in the PCI group and 7 deaths in the CABG group (p = 0.08). CONCLUSIONS Patients with ULMCA disease treated with PCI had favorable early outcomes in comparison with the CABG group. At 1 year, LVEF had improved significantly only in the PCI group. After more than 2 years, MACCE-free survival was similar in both groups with a trend toward improved survival after PCI.

Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery a randomized, double-blind, placebo-controlled trial

Background—Postoperative atrial arrhythmias are common and are associated with considerable morbidity. This study was designed to evaluate the efficacy and safety of vernakalant for the conversion of atrial fibrillation (AF) or atrial flutter (AFL) after cardiac surgery. Methods and Results—This was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft, valvular surgery, or both. Patients were randomly assigned 2:1 to receive a 10-minute infusion of 3 mg/kg vernakalant or placebo. If AF or AFL was present after a 15-minute observation period, then a second 10-minute infusion of 2 mg/kg vernakalant or placebo was given. The primary end point was the conversion of postcardiac surgery AF or AFL to sinus rhythm within 90 minutes of dosing. In patients with AF, 47 of 100 (47%) who received vernakalant converted to SR compared with 7 of 50 (14%) patients who received placebo (P<0.001). The median time to conversion was 12 minutes. Vernakalant was not effective in converting postoperative AFL to sinus rhythm. Two serious adverse events occurred within 24 hours of vernakalant administration (hypotension and complete atrioventricular block). There were no cases of torsades de pointes, sustained ventricular tachycardia, or ventricular fibrillation. There were no deaths. Conclusions—Vernakalant was safe and effective in the rapid conversion of AF to sinus rhythm in patients who had AF after cardiac surgery. Clinical Trial Registration—clinicaltrials.gov. Identifier: NCT00125320.

Early and Long-Term Results of Unprotected Left Main Coronary Artery Stenting: The LE MANS (Left Main Coronary Artery Stenting) Registry

OBJECTIVES The aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups. BACKGROUND PCI is an increasingly utilized method of revascularization in patients with ULMCA. METHODS This multicenter prospective registry included 252 patients after ULMCA stenting enrolled between March 1997 and February 2008. Non-ST-segment elevation acute coronary syndrome was diagnosed in 58% of patients; ST-segment elevation myocardial infarction cases were excluded. Drug-eluting stents were implanted in 36.2% of patients. RESULTS Major adverse cardiovascular and cerebral events (MACCE) occurred in 12 (4.8%) patients during the 30-day period, which included 4 (1.5%) deaths. After 12 months there were 17 (12.1%) angiographically confirmed cases of restenosis. During long-term follow-up (1 to 11 years, mean 3.8 years) there were 64 (25.4%) MACCE and 35 (13.9%) deaths. The 5- and 10-year survival rates were 78.1% and 68.9%, respectively. Despite differences in demographical and clinical data in favor of BMS patients, unmatched analysis showed a significantly lower MACCE rate in DES patients (25.9% vs. 14.9%, p = 0.039). This difference was strengthened after propensity score matching. The DES lowered both mortality and MACCE for distal ULMCA lesions when compared with BMS. Ejection fraction <50% was the only independent risk factor influencing long-term survival. CONCLUSIONS Stenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease.

Randomized Comparison of Stentless Versus Stented Valves for Aortic Stenosis Effects on Left Ventricular Mass

Background— Aortic valve replacement (AVR) is the established treatment for severe aortic stenosis. In response to the long-term results of aortic homografts, stentless porcine valves were introduced as an alternative low-resistance valve. We conducted a randomized trial comparing a stentless with a stented porcine valve in adults with severe aortic stenosis. Methods and Results— The primary outcome was change in left ventricular mass index (LVMI) measured by transthoracic echocardiography and, in a subset, by cardiovascular MR. Measurements were taken before valve replacement and at 6 and 12 months. Patients undergoing AVR with an aortic annulus ≤25 mm in diameter were randomly allocated to a stentless (n=93) or a stented supra-annular (n=97) valve. There were no significant differences in mean LVMI between the stentless versus stented groups at baseline (176±62 and 182±63 g/m2, respectively) or at 6 months (142±49 and 131±45 g/m2, respectively), although within-group changes from baseline to 6 months were highly significant. Changes in LVMI measured by cardiovascular MR (n=38) were consistent with the echo findings. There was a greater reduction in peak aortic velocity (P<0.001) and a greater increase in indexed effective orifice area (P<0.001) in the stentless group than in the stented group. There were no differences in clinical outcomes between the 2 valve groups. Conclusions— Despite significant differences in indexed effective orifice area and peak flow velocity in favor of the stentless valve, there were similar reductions in left ventricular mass at 6 months with both stented and stentless valves, which persisted at 12 months.

Cardiac troponin T release during coronary surgery using intermittent cross-clamp with fibrillation, on-pump and off-pump beating heart

OBJECTIVE Troponin T is a unique marker which might be particularly useful in assessing myocardial cell damage in patients undergoing cardiac surgery. The aim of the study was a comparison between intra-operative release of troponin T (TnT) during three different myocardial protection strategies. METHODS Thirty-eight PTS undergoing myocardial revascularization were randomised into 3 groups in whom procedure was performed with intermittent cross-clamp (Group I; n = 13), beating-heart on pump without aortic cross-clamp (Group II; n = 12), beating-heart without use of extracorporeal circulation (Group III; n = 13). Serial venous blood samples were collected for TnT measurement prior surgery, 1, 4, 12, 24, 48, 72 h after the procedure. Haemodynamic measurements were made using a thermodilution PA catheter. RESULTS The groups were similar with respect to age, sex, preoperative LV function, number of grafts, potential risk factors. There were no hospital deaths and no myocardial infarction (MI) in three groups, postoperative haemodynamic measurements showed no significant differences. TnT serum levels were significantly higher in group I when compared to groups II and III. TnT levels were significantly lower in group Ill when compared to group II following 48-h post-operation. CONCLUSIONS Coronary bypass grafting without aortic cross-clamping and without CPB offers superior myocardial protection.

Primary stenting versus MIDCAB: preliminary report–Comparision of two methods of revascularization in single left anterior descending coronary artery stenosis

BACKGROUND Percutaneous revascularization is a well-accepted method of treatment for a single left anterior descending coronary artery (LAD) stenosis. With the introduction of primary stenting, it has become the treatment of choice for a LAD lesion. In the last few years however, the introduction of minimally invasive cardiac surgery, video-assisted left internal thoracic artery (LITA) harvesting, and robotic surgery have raised the question as to whether minimally invasive surgical revascularization would be competitive with percutaneous coronary interventions in cases of single-vessel stenoses. METHODS A group of 100 patients with Canadian Cardiovascular Society class II to IV, and angiographically confirmed single critical stenosis of the LAD (type A or B), were treated with direct primary stenting (group 1, n = 50), or with endoscopic atraumatic coronary artery bypass grafting (group 2, n =50). RESULTS All patients in a group 1, obtained a very good angiographic and clinical effect. No acute postoperative complications were noted at 1 month of follow-up. However, at 1 month of follow-up, 3 patients (6%) developed restenosis of the LAD, and at 6 months follow-up, 6 patients (12%), developed restenosis of the LAD. In these cases, repeated percutaneous coronary interventions of the target vessel were successfully performed. In group 2, very good operative results were observed. In 1 and 6 months of follow-up, all patients remained asymptomatic. Critical stenosis of the left internal thoracic artery-LAD anastomosis was angiographically documented in 1 case (2%). This patient was successfully treated with balloon angioplasty. CONCLUSIONS The study results document the superiority of endoscopic atraumatic coronary artery bypass grafting over direct primary stenting in LAD revascularization, along with the slightly higher costs of the surgical procedure.

Integrated minimally invasive direct coronary artery bypass grafting and angioplasty for coronary artery revascularization

OBJECTIVE Minimally invasive direct coronary artery bypass (MIDCAB) through the anterolateral minithoracotomy has become a promising therapeutic option in patients with lesion in left anterior descending artery (LAD), especially in multimorbid, elderly and reoperated patients with type C or B lesions. To expand the benefits of MIDCAB concept to patients with multivessel disease, a hybrid myocardial revascularization procedure (HMR) combining surgery of the LAD with interventional procedures for additional coronary lesions has recently been introduced. METHODS Between January 1999 and September 2001, 50 patients (37 male, 13 female, mean age 54.8+/-20.1 years) underwent an HMR procedure. MIDCAB with endoscopic left internal thoracic artery (LITA) harvesting, followed by percutaneous coronary intervention (PCI) for additional coronary lesions and percutaneous transluminal coronary angioplasty (PTCA), was performed in 11 patients (22%) and stenting in 39 patients (78%). Angiographic assessment of graft patency was performed in all patients during the PCI procedure. The clinical follow-up period was 3-32 months. RESULTS There were no early and late deaths. Baseline Canadian Cardiology Society (CCS) class was 2.8+/-0.7 versus 1.1+/-0.9 (P<0.001) 30 days after HMR procedure. There were no major acute in-hospital cardiac events. Angiographic studies showed patent LIMA-LAD graft in 50 patients (100%). We showed good quality of anastomosis in 49 patients (98%). There was a moderate graft stenosis in one patient (2%). At long term follow-up, the rate of major cardiac events was 12%. Five patients (10%) developed restenosis after PCI, and one patient (2%) developed significant stenosis in site of LITA-LAD anastomosis; redo PCI was performed successfully. CONCLUSIONS The hybrid procedure is a safe and effective method for complete revascularization in selected patients with double-vessel coronary artery disease (patients with type B or C lesions in the proximal LAD). This method allows performance of complete revascularization with minimization of surgical trauma. So far, long-term results of HMR are limited by the results of PCI.

Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial

OBJECTIVES This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial. BACKGROUND The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown. METHODS In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients. RESULTS At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99). CONCLUSIONS In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.

Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischaemic cardiomyopathy.

AIMS The Surgical Treatment for Ischemic Heart Failure (STICH) trial demonstrated no overall benefit when surgical ventricular reconstruction (SVR) was added to coronary artery bypass grafting (CABG) in patients with ischaemic cardiomyopathy. The present analysis was to determine whether, based on baseline left ventricular (LV) function parameters, any subgroups could be identified that benefited from SVR. METHODS AND RESULTS Among the 1000 patients enrolled, Core Lab measures of baseline LV function with adequate quality were obtained in 710 patients using echocardiography, in 352 using cardiovascular magnetic resonance, and in 344 using radionuclide imaging. The relationship between LV end-systolic volume index (ESVI), end-diastolic volume index, ejection fraction (EF), regional wall motion abnormalities, and outcome were first assessed only by echocardiographic measures, and then by 13 algorithms using a different hierarchy of imaging modalities and their quality. The median ESVI and EF were 78.0 (range: 22.8-283.8) mL/m2 and 28.0%, respectively. Hazard ratios comparing the randomized arms by subgroups of LVESVI and LVEF measured by echocardiography found that patients with smaller ventricles (LVESVI <60 mL/m2) and better LVEF (≥33%) may have benefitted by SVR, while those with larger ventricles (LVESVI >90 mL/m(2)) and lower LVEF (≤25%) did worse with SVR. Algorithms using all three imaging modalities found a weaker relationship between LV global function and the effects of SVR. The extent of regional wall motion abnormality did not influence the effects of SVR. CONCLUSIONS Subgroup analyses of the STICH trial suggest that patients with less dilated LV and better LVEF may benefit from SVR, while those with larger LV and poorer LVEF may do worse. Clinical Trial Registration #: NCT00023595.

Complex Assessment of the Incidence and Risk Factors of Delirium in a Large Cohort of Cardiac Surgery Patients: A Single-Center 6-Year Experience

Background. Previous reports provided inconsistent data on the occurrence of postoperative delirium and emphasized its considerable impact on outcome. This study sought to evaluate the incidence and predictors of delirium, together with its relation to cerebral ischemia in a large cohort of cardiac surgery patients in a tertiary high-volume center. Methods and Results. Consecutive patients (n = 8792) were prospectively enrolled from 2003 to 2008. Exclusion criteria were history of psychiatric disorders, use of psychoactive drugs, alcohol abuse, and data incompleteness. Finally, 5781 patients were analyzed in terms of 100 perioperative patient-specific and treatment variables. The incidence of postoperative delirium (DSM IV criteria) was 4.1% and it coexisted with cerebral ischemia in 1.1% of patients. In bivariate analysis, 49 variables were significantly linked to postoperative delirium. Multivariate analysis confirmed that delirium was independently associated with postoperative stroke (logistic odds ratio (logOR) = 2.862, P = 0.004), any blood transfusions (logOR = 4.178, P < 0.0001), age > 65 years (logOR = 2.417, P = 0.002), carotid artery stenosis (logOR = 2.15, P = 0.01), urgent/emergent surgery (logOR = 1.982, P = 0.02), fasting glucose level, intraoperative oxygen partial pressure fluctuations, and hematocrit. Area under ROC curve for the model was 0.8933. Conclusions. Early identification of nonpsychiatric perioperative determinants of delirium facilitates its diagnosis and might help develop preventive strategies to improve long-term outcome after cardiac surgery procedures.