Marian Zembala

Effectiveness of haemodialysis access with an autologous tissue-engineered vascular graft: a multicentre cohort study

BACKGROUND Application of a tissue-engineered vascular graft for small-diameter vascular reconstruction has been a long awaited and much anticipated advance for vascular surgery. We report results after a minimum of 6 months of follow-up for the first ten patients implanted with a completely biological and autologous tissue-engineered vascular graft. METHODS Ten patients with end-stage renal disease who had been receiving haemodialysis through an access graft that had a high probability of failure, and had had at least one previous access failure, were enrolled from centres in Argentina and Poland between September, 2004, and April, 2007. Completely autologous tissue-engineered vascular grafts were grown in culture supplemented with bovine serum, implanted as arteriovenous shunts, and assessed for both mechanical stability during the safety phase (0-3 months) and effectiveness after haemodialysis was started. FINDINGS Three grafts failed within the safety phase, which is consistent with failure rates expected for this high-risk patient population. One patient was withdrawn from the study because of severe gastrointestinal bleeding shortly before implantation, and another died of unrelated causes during the safety period with a patent graft. The remaining five patients had grafts functioning for haemodialysis 6-20 months after implantation, and a total of 68 patient-months of patency. In these five patients, only one intervention (surgical correction) was needed to maintain secondary patency. Overall, primary patency was maintained in seven (78%) of the remaining nine patients 1 month after implantation and five (60%) of the remaining eight patients 6 months after implantation. INTERPRETATION Our proportion of primary patency in this high-risk cohort approaches Dialysis Outcomes Quality Initiative objectives (76% of patients 3 months after implantation) for arteriovenous fistulas, averaged across all patient populations.

Randomized, Placebo-Controlled Study for Immunosuppressive Treatment of Inflammatory Dilated Cardiomyopathy Two-Year Follow-Up Results

Background—Previous studies have shown disappointing results for immunosuppressive treatment in patients with dilated cardiomyopathy. Therefore, we studied the effectiveness of such therapy in patients with HLA upregulation on biopsy. Methods and Results—Of 202 patients with dilated cardiomyopathy, 84 patients with increased HLA expression were randomized to receive either immunosuppression or placebo for 3 months; they were then followed for 2 years. After 2 years, there were no significant differences in the primary end point (a composite of death, heart transplantation, and hospital readmission) between the 2 study groups (22.8% for the immunosuppression group and 20.5% for the placebo). The secondary efficacy end point included changes in ejection fraction, end-diastolic diameter, end-diastolic volume, end-systolic volume and NYHA class; left ventricular ejection fraction increased significantly in the immunosuppression group compared with the placebo group (95% CI, 4.20 to 13.12;P <0.001) after 3 months of follow-up. The early favorable effects of immunosuppressive therapy on left ventricular volume, left ventricular diastolic dimension, and New York Heart Association class were also present. This improvement was maintained in the immunosuppression group at 2 years (ejection fraction: 95% CI, 6.94 to 19.04;P <0.001). In addition, on the basis of the protocol-specified definition of improvement, 71.8% patients in the immunosuppression group versus 20.9% patients in the placebo group met the criteria of improvement after 3 months (P <0.001). At the end of the follow-up period, 71.4% patients from the immunosuppression group versus 30.8% patients from the placebo group were improved (P =0.001). Conclusions—These data demonstrate a long-term benefit of immunosuppressive therapy in patients with dilated cardiomyopathy and HLA upregulation on biopsy specimens. Thus, restoration of immunosuppressive therapy for such patients should be considered.

The 2011-12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients.

AIMS The aim of this prospective multinational registry is to assess and identify predictors of in-hospital outcome and complications of contemporary TAVI practice. METHODS AND RESULTS The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective independent consecutive collection of individual patient data entered into a web-based case record form (CRF) or transferred from compatible national registries. A total of 4,571 patients underwent TAVI between January 2011 and May 2012 in 137 centres of 10 European countries. Average age was 81.4±7.1 years with equal representation of the two sexes. Logistic EuroSCORE (20.2±13.3), access site (femoral approach: 74.2%), type of anaesthesia and duration of hospital stay (9.3±8.1 days) showed wide variations among the participating countries. In-hospital mortality (7.4%), stroke (1.8%), myocardial infarction (0.9%), major vascular complications (3.1%) were similar in the SAPIEN XT and CoreValve (p=0.15). Mortality was lower in transfemoral (5.9%) than in transapical (12.8%) and other access routes (9.7%; p<0.01). Advanced age, high logistic EuroSCORE, pre-procedural ≥grade 2 mitral regurgitation and deployment failure predicted higher mortality at multivariate analysis. CONCLUSIONS Increased operator experience and the refinement of valve types and delivery catheters may explain the lower rate of mortality, stroke and vascular complications than in historical studies and registries.

A comparison of ST elevation versus non-ST elevation myocardial infarction outcomes in a large registry database: are non-ST myocardial infarctions associated with worse long-term prognoses?

BACKGROUND Prognoses in STEMI and NSTEMI beyond one year from onset remain unclear. We aimed to compare the treatments and the two-year outcomes in patients with myocardial infarction (MI) enrolled at the Polish Registry of Acute Coronary Syndromes (PL-ACS). METHODS A total of 13,441 patients with MI (8250 with STEMI, and 5191 with NSTEMI) underwent medical care between October 2003 and June 2005 in the Silesia region (4.8 million inhabitants). The events analyzed were death, MI, stroke and percutaneous (PCI) or surgical (CABG) revascularization. RESULTS After two years, NSTEMI was associated with a higher incidence of death (hazard ratio (HR) of 1.09 (95% confidence interval (CI) 1.02-1.17, p<0.0001)); a higher incidence of reinfarction, stroke, CABG and a lower rate of PCI. Adjustments for baseline characteristics and treatment strategy (invasive vs. non-invasive) reversed the HR for mortality and eliminated the difference in MI and stroke. The adjusted HR for mortality was 0.76 (95% CI, 0.71-0.83, p<0.0001). STEMI and NSTEMI patients treated non-invasively were older and showed higher incidences of diabetes, obesity, pulmonary edema and cardiogenic shock than their invasively treated counterparts. Invasively treated patients received aspirin, beta-blockers, ACE inhibitors and statins more often during hospitalization and at discharge. CONCLUSIONS The unadjusted long-term prognosis was worse in NSTEMI. After adjustment for the baseline characteristics and treatment strategy, the long-term prognosis was worse in STEMI. Patients with MI treated invasively showed more favorable clinical characteristics and received guideline-recommended therapy more often than patients who did not undergo invasive treatment.

Cardiopulmonary Bypass Increases Postoperative Glycemia and Insulin Consumption After Coronary Surgery

BACKGROUND Perioperative hyperglycemia should be avoided in patients undergoing coronary surgery. The aim of our study was to find out what the influence of cardiopulmonary bypass is on postoperative glycemia and insulin consumption in patients with and without diabetes mellitus undergoing coronary artery surgery and whether a marked hyperglycemia in the early postoperative period is among the factors associated with early mortality and morbidity. METHODS We retrospectively reviewed all patients who underwent first-time coronary artery surgery in our institution during the 11-month period. Among 814 patients, 239 patients (29.4%) had diabetes and 575 patients (70.6%) were nondiabetic. Blood glucose levels were registered every 2 hours in all patients during the first 24 postoperative hours. Outcomes were difficult glycemic control (postoperative blood glucose levels >11.0 mmol/L despite aggressive insulin treatment), hospital mortality, and morbidity (defined as any postoperative complication such as stroke, renal failure, wound infection, perioperative myocardial infarction, ventilation > 24 hours, sepsis, and multiorgan failure). RESULTS Glycemic control was significantly worse in patients who underwent coronary artery bypass grafting, in comparison with off-pump coronary artery bypass grafting surgery, particularly in nondiabetic patients. Patients with difficult glycemic control had more serious postoperative complications resulting in higher mortality (2.5% versus 0.4%; p = 0.02). In the multivariate analysis, difficult glycemic control was significantly associated with a female sex (odds ratio [OR], 2.36), presence of diabetes (OR, 2.22), and the usage of cardiopulmonary bypass (OR, 1.81). Mortality was significantly associated with the left ventricular ejection fraction less than 0.35 (OR, 7.38), difficult glycemic control (OR, 7.06), and previous stroke (OR, 5.66). Difficult glycemic control was also significantly associated with postoperative morbidity (OR, 1.87). CONCLUSIONS Cardiopulmonary bypass increases postoperative glycemia and insulin consumption in both diabetic and nondiabetic patients. The use of cardiopulmonary bypass during coronary artery surgery in diabetic women is associated with a more difficult glycemic control in the early postoperative period. Difficult glycemic control is significantly associated with early mortality and morbidity in patients undergoing coronary artery surgery.

Local and general anaesthesia do not influence outcome of transfemoral aortic valve implantation.

BACKGROUND There is great variability for the type of anaesthesia used during TAVI, with no clear consensus coming from comparative studies or guidelines. We sought to detect regional differences in the anaesthetic management of patients undergoing transcatheter aortic valve implantation (TAVI) in Europe and to evaluate the relationship between type of anaesthesia and in-hospital and 1 year outcome. METHODS Between January 2011 and May 2012 the Sentinel European TAVI Pilot Registry enrolled 2807 patients treated via a transfemoral approach using either local (LA-group, 1095 patients, 39%) or general anaesthesia (GA-group, 1712 patients, 61%). RESULTS A wide variation in LA use was evident amongst the 10 participating countries. The use of LA has increased over time (from a mean of 37.5% of procedures in the first year, to 57% in last 6 months, p<0.01). MI, major stroke as well as in-hospital death rate (7.0% LA vs 5.3% GA, p=0.053) had a similar incidence between groups, confirmed in multivariate regression analysis after adjusting for confounders. Dividing our population in tertiles according to the Log-EuroSCORE we found similar mortality under LA, whilst mortality was higher in the highest risk tertile under GA. Survival at 1 year, compared by Kaplan-Meier analysis, was similar between groups (log-rank: p=0.1505). CONCLUSIONS Selection of anaesthesia appears to be more influenced by national practice and operator preference than patient characteristics. In the absence of an observed difference in outcomes for either approach, there is no compelling argument to suggest that operators and centres should change their anaesthetic practice.

Clinical and haemodynamic outcomes in 658 patients receiving the Perceval sutureless aortic valve: early results from a prospective European multicentre study (the Cavalier Trial)†.

OBJECTIVES The aim of the Cavalier trial was to evaluate the safety and performance of the Perceval sutureless aortic valve in patients undergoing aortic valve replacement (AVR). We report the 30-day clinical and haemodynamic outcomes from the largest study cohort with a sutureless valve. METHODS From February 2010 to September 2013, 658 consecutive patients (mean age 77.8 years; 64.4% females; mean logistic EuroSCORE 10.2%) underwent AVR in 25 European Centres. Isolated AVRs were performed in 451 (68.5%) patients with a less invasive approach in 219 (33.3%) cases. Of the total, 40.0% were octogenarians. Congenital bicuspid aortic valve was considered an exclusion criterion. RESULTS Implantation was successful in 628 patients (95.4%). In isolated AVR through sternotomy, the mean cross-clamp time and the cardiopulmonary bypass (CPB) time were 32.6 and 53.7 min, and with the less invasive approach 38.8 and 64.5 min, respectively. The 30-day overall and valve-related mortality rates were 3.7 and 0.5%, respectively. Valve explants, stroke and endocarditis occurred in 0.6, 2.1 and in 0.1% of cases, respectively. Preoperative mean and peak pressure gradients decreased from 44.8 and 73.24 mmHg to 10.24 and 19.27 mmHg at discharge, respectively. The mean effective orifice area improved from 0.72 to 1.46 cm(2). CONCLUSIONS The current 30-day results show that the Perceval valve is safe (favourable haemodynamic effect and low complication rate), and can be implanted with a fast and reproducible technique after a short learning period. Short cross-clamp and CPB times were achieved in both isolated and combined procedures. The Perceval valve represents a promising alternative to biological AVR, especially with a less invasive approach and in older patients.

Comparison of Five-Year Outcomes of Patients With and Without Chronic Total Occlusion of Noninfarct Coronary Artery After Primary Coronary Intervention for ST-Segment Elevation Acute Myocardial Infarction

The aim of the present study was to evaluate the effect of concurrent chronic total occlusion (CTO) in a noninfarct-related artery (IRA) on the long-term prognosis in patients with ST-segment elevation myocardial infarction and multivessel coronary disease. Of 1,658 consecutive patients with ST-segment elevation myocardial infarction, 666 with multivessel coronary disease who underwent percutaneous coronary intervention from 1999 to 2004 were included in the present analysis. The patients were divided into 2 groups: no CTO and CTO. The first group included 462 patients without CTO (69%) and the second group included 204 patients with CTO in a non-IRA (31%). The in-hospital mortality rate was 6.3% and 21.1% (p < 0.0001) and the 5-year mortality rate was 22.5% and 40.2% (p < 0.0001) for the no-CTO and CTO patients, respectively. Multivariate analysis revealed that after correction for baseline differences CTO in a non-IRA was a strong, independent predictor of 5-year mortality in patients undergoing percutaneous coronary intervention (hazard ratio 1.85; 95% confidence interval 1.35 to 2.53; p = 0.0001). In conclusion, the presence of CTO in a non-IRA in patients with ST-segment elevation myocardial infarction and multivessel coronary disease is a strong and independent risk factor for greater 5-year mortality.

Reperfusion by primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction within 12 to 24 hours of the onset of symptoms (from a prospective national observational study [PL-ACS]).

The aim of the present study was to investigate whether reperfusion by primary percutaneous coronary intervention (PCI) improves 12-month survival in late presenters with ST-segment elevation myocardial infarction (STEMI). We analyzed 2,036 patients with STEMI presenting 12 to 24 hours from onset of symptoms, without cardiogenic shock or pulmonary edema and not reperfused by thrombolysis, of 23,517 patients with STEMI enrolled in the Polish Registry of Acute Coronary Syndromes from June 2005 to August 2006. An invasive approach was chosen in 910 (44.7%) of late presenters and 92% of them underwent reperfusion by PCI. Patients with an invasive approach had lower mortality after 12 months than patients with a conservative approach (9.3% vs 17.9%, p <0.0001). The benefit of an invasive approach was also observed after multivariate adjustment with a relative risk 0.73 for 12-month mortality (95% confidence interval 0.56 to 0.96) and in a subpopulation of patients selected by a propensity-score matching procedure with an adjusted relative risk 0.73 for 12-month mortality (0.58 to 0.99). In conclusion, almost 1/2 of late presenters with STEMI were considered eligible for reperfusion by primary PCI. These patients had a lower 12-month mortality rate than they would have had if they had been treated conservatively, which supports the idea of late reperfusion in STEMI. However, whether all late presenters with STEMI should be treated invasively remains unanswered. Nevertheless, until a randomized trial is undertaken, late presenters with STEMI could be considered for reperfusion by primary PCI.

Prevalence and clinical significance of elevated preoperative glycosylated hemoglobin in diabetic patients scheduled for coronary artery surgery

OBJECTIVE To establish what is the prevalence of elevated HbA1c among diabetic patients scheduled for coronary surgery and whether this may influence their postoperative outcome. METHODS We performed a retrospective review of our departmental cardiac surgical database over a 3-year period (2006-2008). Among the 2665 patients, who underwent coronary revascularization, 782 (29.3%) patients had diabetes mellitus, with 735 (94.0%) patients having their HbA1c assessed preoperatively up to 3 days before the start of the procedure. Patients with preoperative normal or elevated HbA1c (>7%) were compared regarding their hospital mortality, morbidity (defined as any postoperative complication such as stroke, renal failure, wound infection, perioperative myocardial infarction (MI), and others) as well as mean intensive care unit (ICU) and hospital stay. Patients for comparisons were matched to achieve similar preoperative status with a use of a Greedy matching procedure. Chi-square test was performed to compare variables of interest; p<0.05 was considered significant. RESULTS Elevated HbA1c levels were present in 38.4% of diabetic patients - 57.1% of patients among insulin-dependent diabetics, 27.3% of patients on oral medication, and in 7.7% of patients whose diabetes was treated with diet only. In a direct comparison and after matching for preoperative variables, elevated HbA1c levels increased only the frequency of perioperative MI (p=0.01). Other complications, length of ICU and hospital stay as well as early mortality were similar in both the groups. CONCLUSIONS Elevated HbA1c levels are common among diabetic patients scheduled for coronary surgery, particularly in patients receiving insulin, and are associated with more frequent occurrence of perioperative MI.