Femoral Versus Nonfemoral Peripheral Access for Transcatheter Aortic Valve Replacement.

BACKGROUND: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access. OBJECTIVES: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR. METHODS: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed. RESULTS: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers. CONCLUSIONS: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.

Fate of aortic bioprostheses: An 18-year experience.

OBJECTIVE: To report our experience in aortic valve replacement with the Mitroflow (Sorin, Vancouver, Canada) aortic bioprosthesis. METHODS: We retrospectively reviewed all patients who underwent aortic valve replacement with a Mitroflow bioprosthesis at our institution from January 1994 to December 2011. No exclusion criteria were retained. Patients were followed yearly. Echocardiography follow-up was performed systematically before the hospital discharge and annually by patients' cardiologists. RESULTS: Seven hundred twenty-eight patients (mean age, 76 ± 6 years; range, 33-91 years) underwent aortic valve replacement with Mitroflow 12A or LX model and were included in this analysis. 30-day mortality for nonemergent isolated aortic valve replacement was 5.5%. Eight patients (1%) underwent reoperation for structural valve deterioration (SVD) and 30 patients (5.8%) presented echocardiographic signs of SVD. Actuarial freedom from reoperation for SVD was 99% ± 0.5% and 95% ± 5% at 10 and 15 years. Actuarial freedom from echocardiographic signs of SVD was 77% ± 5% and 56% ± 11% at 10 and 15 years, respectively. At the univariate analysis, only the mean gradient at discharge (P = .0200), the prevalence of size 19 (P = .0273), and severe patient-prosthesis mismatch (P = .0384) were significantly different in patients developing SVD at follow-up. Freedom from echocardiographic signs of SVD at 8 years were 88% ± 4% and 64% ± 13% in patients with a Mitroflow > 19 and Mitroflow 19, respectively (log-rank test, P = .0056; Wilcoxon test, P = .0589). CONCLUSIONS: Overall outcomes were satisfactory. However the risk of early SVD seems higher for the Mitroflow size 19. This size should be reserved for applications when annulus enlargement is risky or there is an anatomic contraindication to sutureless or stentless valve.

Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel.

OBJECTIVES: After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS: Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS: Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION: The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.

[From FRANCE 2 to FRANCE TAVI: are indications, technique and results of transcatheter aortic valve replacement the same?]. / De FRANCE 2 à FRANCE TAVI: les indications, la technique et les résultats du remplacement valvulaire aortique percutané sont-ils les mêmes?

Transcatheter aortic valve implantation (TAVI) is indicated in patients with severe symptomatic aortic stenosis who are not suitable for surgery or should be considered when there is a high surgical risk as assessed by a heart team. There is a decrease in mean logistic EuroSCORE since January 2010, which translates a gradual evolution in patients' selection. Expertise of geriatricians to further assess frailty is a key step in the risk stratification process of this elderly population (mean age: 83.4±7.3 years). Femoral access is used in 80% of cases with a procedural success rate higher than 95%. In-hospital mortality rate is 5.9%. The main complications of the procedure are aortic annulus rupture (0.9% in FRANCE TAVI), tamponade (2.3%), stroke (2.2%), severe paravalvular leak (1.3%) and permanent pacemaker implantation (15%). The awaited results of PARTNER II and SURTAVI may lead to expand the indications to lower-risk patients if it is shown that TAVI is non-inferior to surgery in this population which has been suggested by the recent randomized NOTION Trial while the CoreValve Pivotal Trial even points in the direction of a possible superiority of the percutaneous technique over surgery.

Comparison of Outcome of Transcatheter Aortic Valve Implantation With Versus Without Previous Coronary Artery Bypass Grafting (from the FRANCE 2 Registry).

Previous coronary artery bypass grafting (CABG) increases operative risk in conventional valve replacement. Transcatheter aortic valve implantation (TAVI) has been shown to be successful in high-risk patient subgroups. The present study compared outcome and overall survival in patients who underwent TAVI with and without history of CABG. From January 2010 to December 2011, 683 of the 3,761 patients selected for TAVI in 34 French centers (18%) had a history of CABG. Outcomes (mortality and complications) were collected prospectively according to the Valve Academic Research Consortium (VARC) criteria. Patients with previous CABG were younger, with higher rates of diabetes and vascular disease and higher logistic European System for Cardiac Operative Risk Evaluation (29.8 ± 16.4 vs 20.1 ± 13.0, p <0.001) but lower rates of pulmonary disease. Two types of valve (Edwards SAPIEN and Medtronic CoreValve) were implanted in equal proportions in the 2 groups. The 30-day and 1-year mortality rates from all causes on Kaplan-Meier analysis (9.2% vs 9.7%, p = 0.71; and 19.0% vs 20.2%, p = 0.49, respectively) did not differ according to the history of CABG. There were no significant differences in the Valve Academic Research Consortium complications (myocardial infarction, stroke or vascular, and bleeding complications). On multivariate analysis, CABG was not associated with greater 1-year post-TAVI mortality. In conclusion, previous CABG did not adversely affect outcome in patients who underwent TAVI, which may be an alternative to surgery in high-risk patients with severe aortic stenosis and history of CABG.

Prevalence and long-term outcome of aortic prosthesis-patient mismatch in patients with paradoxical low-flow severe aortic stenosis.

BACKGROUND: Patients with severe aortic stenosis (AS) and paradoxical low flow (PLF) have worse outcome compared with those with normal flow. Furthermore, prosthesis-patient mismatch (PPM) after aortic valve replacement is a predictor of reduced survival. However, the prevalence and prognostic impact of PPM in patients with PLF-AS are unknown. We aimed to analyze the prevalence and long-term survival of PPM in patients with PLF-AS. METHODS AND RESULTS: Between 2000 and 2010, 677 patients with severe AS, preserved left ventricular ejection fraction, and aortic valve replacement were included (74±8 years; 42% women; aortic valve area, 0.69±0.16 cm(2)). A PLF (indexed stroke volume ≤35 mL/m(2)) was found in 26%, and after aortic valve replacement, 54% of patients had PPM, defined as an indexed effective orifice area ≤0.85 cm(2)/m(2). The combined presence of PLF and PPM was found in 15%. Compared with patients with noPLF/noPPM, those with PLF/PPM were significantly older, with more comorbidities. They also received smaller and biological bioprosthesis more often (all P<0.01). Although early mortality was not significantly different between groups, the 10-year survival rate was significantly reduced in case of PLF/PPM compared with noPLF/noPPM (38±9% versus 70±5%; P=0.002), even after multivariable adjustment (hazard ratio, 2.58; 95% confidence interval, 1.5-4.45; P=0.0007). CONCLUSIONS: In this large catheterization-based study, the coexistence of PLF-AS before surgery and PPM after surgery is associated with the poorest outcome.

Prevalence of renal artery disease and its prognostic significance in patients undergoing coronary bypass grafting.

Several studies demonstrated the prognostic importance of renal failure and peripheral artery disease in patients undergoing coronary artery bypass grafting (CABG), but data regarding the prognostic value of renal artery disease in this context are scarce. We aimed to study the prevalence and prognostic value of renal artery disease in patients undergoing CABG. We assessed by duplex ultrasound the renal arteries of 429 consecutive patients who underwent CABG, of whom 401 had satisfactory imaging quality to detect >60% renal artery stenosis (RAS) and/or an elevated resistive index (ERI>0.80). Of the 401 subjects included (age 68±10 years, 83% men), 40 (10%) had RAS and 35 (9%) had ERI. Nine patients (2.2%) had both conditions. Patients were followed up for 12.4±7.0 months. The primary outcome was composite, including 30-day death, stroke, and/or myocardial infarction. In a multivariate model adjusted for age, gender, cardiovascular (CV) risk factors, renal function, chronic obstructive pulmonary disease, the use of off-pump CABG, CV co-morbidities, and drugs, the presence of ERI was strongly associated with the occurrence of the composite outcome (odds ratio 4.3, 95% confidence interval 1.7 to 9.9, p=0.0006). Similarly, ERI, not RAS, was significantly associated with the 30-day acute kidney disease and the midterm mortality, as well as fatal and nonfatal CV events. In conclusion, regardless of renal function and other factors, the renal resistive index is a strong predictor of CV and renal events after CABG. Renal duplex ultrasound can identify a subgroup of patients at high risk of CABG.

Uterus retrieval process from brain dead donors.

OBJECTIVE: To describe the feasibility of human uterus retrieval after donation after brain death. DESIGN: Single-center, prospective study. SETTING: University hospital. PATIENT(S): Female brain dead donors. INTERVENTION(S): The families of female brain dead donors were informed about consent to uterus donation. A specific organ retrieval procedure was performed. At the end of the procedure the uterus was removed together with the hypogastric vessels, parametria, and vaginal fornix. The tolerance of the uterus to cold ischemia was evaluated with histology and TUNEL reaction up to 24 hours. MAIN OUTCOME MEASURE(S): Rate of uterus donation refusal. RESULT(S): Between August 1, 2012 and July 31, 2013, seven uteri were retrieved from 14 female multiorgan donors. No refusal to uterus donation occurred. Our surgical protocol did not interfere with vital organ retrieval and was readily accepted by the other transplantation teams. The hypogastric vessels could be preserved in all cases but for one vein loss in the first retrieval. Histology studies did not find major morphologic changes after 24 hours of cold ischemia. Apoptosis was rare. CONCLUSION(S): Uterus retrieval could be part of a reproducible multiorgan procurement procedure. Uterus donation seems readily accepted. This preliminary study is a necessary step before any transplantation project.

Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.

OBJECTIVE: Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. METHODS: A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. RESULTS: TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age ≥90 years, body mass index <30 Kg/m(2), New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, ≥2 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. CONCLUSIONS: Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.

Prognostic implications of pulmonary hypertension in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: study from the FRANCE 2 Registry.

BACKGROUND: Pulmonary hypertension (PH) is associated with poor prognosis in patients with severe aortic stenosis. The aim of this multicenter study was to describe clinical outcome after transcatheter aortic valve implantation. METHODS AND RESULTS: The FRANCE 2 Registry included all patients undergoing transcatheter aortic valve implantation in France in 2010 and 2011. Patients were divided into 3 groups depending on systolic pulmonary artery pressure (sPAP) estimated in transthoracic echocardiography: group I, sPAP <40 mm Hg (no PH); group II, sPAP 40 to 59 mm Hg (mild-to-moderate PH); and group III, sPAP ≥60 mm Hg (severe PH). Patients were followed up for 1 year. A total of 2435 patients whose pre-transcatheter aortic valve implantation sPAP was reported were included. A total of 845 were in group I (34.7%), 1112 in group II (45.7%), and 478 in group III (19.6%). Procedural success, early complications, and 30-day mortality were statistically similar across sPAP groups. One-year mortality was higher in groups II and III (group I, 22%; group II, 28%; and group III, 28%; P=0.032). Mild-to-moderate and severe PH were identified as an independent factor of all-cause mortality. The major adverse cardiovascular event rates did not differ according to sPAP. New York Health Association functional class improved significantly in all groups. CONCLUSIONS: PH (sPAP ≥40 mm Hg) in patients with aortic stenosis undergoing transcatheter aortic valve implantation was associated with increased 1-year mortality especially when severe (sPAP ≥60 mm Hg) but not with increased 30-day mortality, and functional status was significantly improved regardless of PAP level.

Clinical results of transcatheter aortic valve implantation in octogenarians and nonagenarians: insights from the FRANCE-2 registry.

BACKGROUND: Although transcatheter aortic valve implantation has been developing as an alternative treatment in elderly patients with high surgical risk, age-specific differences in clinical outcome have not been fully validated. METHODS: Data were analyzed for 2,254 patients at least 80 years old who were enrolled between January 2010 and October 2011 in the French national transcatheter aortic valve implantation registry, FRANCE-2. Procedural and clinical outcomes defined according to the Valve Academic Research Consortium criteria were compared among subjects in three age groups: 80 to 84 years (n = 867), 85 to 89 years (n = 1,064), and at least 90 years (n = 349; range, 90 to 101 years). RESULTS: The self-expandable prosthesis was implanted in 710 patients, and the balloon-expandable prosthesis was implanted in 1,544 patients. No differences were observed in rates of procedural success, Valve Academic Research Consortium-defined complications, and length of hospitalization among groups. Cumulative 30-day mortalities did not change among the three groups (80 to 84 years, 10.3% versus 85 to 89 years, 9.5% versus ≥ 90 years, 11.2%; p = 0.53). Cumulative 1-year mortalities also showed no statistical differences, although the mortality rate was higher in patients 85 to 89 years old and at least 90 years old compared with those 80 to 84 years old (19.8% versus 26.1% versus 27.7%; p = 0.16). After adjustment for differential baseline characteristics and potential confounders, patient age (85 to 89 years and ≥ 90 years compared with 80 to 84 years) was not associated with increasing risk of 30-day mortality (hazard ratio, 0.92, 1.26; 95% confidence interval, 0.66 to 1.27, 0.83 to 1.94; p = 0.38, 0.28, respectively) and 1-year mortality (hazard ratio, 1.16, 1.36; 95% confidence interval, 0.90 to 1.49, 0.97 to 1.89; p = 0.25, 0.073, respectively). CONCLUSIONS: This study revealed acceptable clinical results of transcatheter aortic valve implantation even in very elderly populations.

Outcome and impact of surgery in paradoxical low-flow, low-gradient severe aortic stenosis and preserved left ventricular ejection fraction: a cardiac catheterization study.

BACKGROUND: The clinical relevance and management of paradoxical low-flow, low-gradient aortic stenosis (LFLG-AS) with preserved left ventricular ejection fraction remain debated. The aim of this study is to determine the features and outcome of LFLG-AS assessed using cardiac catheterization. METHODS AND RESULTS: Between 2000 and 2010, 768 patients with preserved left ventricular ejection fraction (>50%) and severe AS (valve area ≤ 1 cm(2)) without other valvular disease underwent cardiac catheterization. Mean age was 74 ± 8 years, 42% were women, and 46% had associated coronary artery disease. The prevalence of LFLG (indexed left ventricular stroke volume <35 mL/m(2) and mean gradient <40 mm Hg), normal flow high gradient, normal flow low gradient, and low flow high gradient were 13%, 50%, 22%, and 15%, respectively. Compared with patients with normal flow high gradient, those with LFLG were significantly older, with significantly reduced systemic arterial compliance and vascular resistances and increased valvulo-arterial impedance (all P<0.05). Ten-year survival was reduced in LFLG-AS (32 ± 9%) compared with normal flow high gradient (66 ± 4%; P=0.0002). After adjustment for other risk factors, LFLG-AS was independently associated with reduced long-term survival (hazard ratio, 1.85; 95% confidence interval, 1.08-3.07; P=0.02). However, despite higher operative mortality, patients with LFLG-AS undergoing aortic valve replacement seemed to have better long-term survival than those managed conservatively (5-year survival rate: 63 ± 6% versus 38 ± 15%; P=0.007; hazard ratio, 0.23; 95% confidence interval, 0.09-0.59; P=0.002). CONCLUSIONS: This large cardiac catheterization-based study reports that the LFLG-AS entity is not rare and is associated with worse outcome whether treated medically or surgically. However, these patients may have better long-term survival if treated surgically. Further prospective studies are needed to confirm this finding.

Octogenarians with uncomplicated acute type a aortic dissection benefit from emergency operation.

BACKGROUND: The management of acute type A aortic dissection (aTAAD) in octogenarian patients is controversial. This study analyzed the surgical outcomes to identify patients who should undergo operations. METHODS: Beginning in January 2000, we established a registry including all octogenarian patients operated on for type A acute aortic dissection. We evaluated 79 consecutive patients enrolled up to December 2010. Their median age was 81.6 years (range, 80 to 89 years). Sixteen patients (20%) presented a complicated type because of a neurologic deficit, mesenteric ischemia, a requirement for cardiopulmonary resuscitation, or some combination of those features. Operations followed the standard procedure recommended for younger patients. Follow-up was 95% complete (mean, 4.6±2.8 years). RESULTS: The overall in-hospital mortality was 44.3%. The in-hospital mortality among patients with uncomplicated aTAAD was 33.3%. Multivariate analysis identified complicated aTAAD as the only risk factors for in-hospital mortality (p<0.0001). Postoperative complications occurred in 50 patients (68.5%) and were associated with a higher mortality (p<0.0001). The overall survival was 53% at 1 year and 32% at 5 years. In uncomplicated aTAAD, the overall survival was 63% at 1 year and 38% at 5 years. CONCLUSIONS: Octogenarians with uncomplicated aTAAD benefit from emergency surgical repair. In those patients, early and midterm outcomes are good and are similar to those in published series of younger patients. Complicated aTAAD should be medically managed.

Are we running out of thoracic or cardiac surgeons? Demography of thoracic and cardiac surgeons in France in 2012.

OBJECTIVES: The aim of the study was to accurately evaluate the inflow and outflow of thoracic and cardiac surgeons in France. METHODS: The French Society of Thoracic and Cardiovascular Surgery (SFCTCV) built a database of the surgeons involved in thoracic and/or cardiac surgery in France. It included all surgeons who perform cardiac or thoracic surgery regardless of the number of operations performed per year, whether or not they are members of the SFCTCV and all trainees once they have expressed an interest in thoracic and/or cardiac surgery. RESULTS: The database included 552 senior surgeons (professors, attending surgeons in public practice and attending surgeons in private practice) practicing cardiac and/or thoracic surgery. Of these, 206 practiced cardiac, 278 thoracic and 68 both. The 'inflow' includes 128 residents and 83 senior residents. Global analysis of age distribution showed a mean predictable outflow of 17.6 senior surgeons per year between 2013 and 2022. The 'inflow' of finishing senior residents for the next 5 years was 18 per year. The number of residents was 25 per year of residency. Cardiac surgeon 'outflow' was 7.7 per year and the inflow of finishing senior residents 10-11 per year. The difficult period will be 2015-19 with an excess of 5 finishing senior residents per year. Thoracic surgeon 'outflow' was 11.7 and inflow 10 per year. Gender distribution indicated an increasing feminization. The female proportion was 5, 23 and 31% among senior surgeons, senior residents and residents, respectively. CONCLUSIONS: France will not run out of cardiothoracic surgeons. The inflow compensates for the outflow of surgeons liable to stop their activity in the next 10 years.

The prognosis of diabetic patients with high ankle-brachial index depends on the coexistence of occlusive peripheral artery disease.

OBJECTIVES: High ankle-brachial index (ABI) (>1.40) is associated with poor cardiovascular disease (CVD) prognosis. Concomittant peripheral artery disease (PAD) is frequent, although undetectable with the ABI in this situation. We assessed the prognostic value of a high ABI according to the coexistence of occlusive PAD in diabetics. METHODS: In this retrospective longitudinal study, we reviewed the data of 403 consecutive diabetic patients (hospitalized in tertiary care teaching hospital) who had a Doppler assessment of their lower limbs between 1999 and 2000. They were classified as "normal" when Doppler waveform patterns (DWP) were normal and ABI within the 0.91 to 1.39 range, "occlusive-PAD (O-PAD)" when ABI ≤0.90, or in case of abnormal DWP with normal ABI, "isolated medial calcinosis (IMC)" if ABI ≥1.40 with normal DWP, and "mixed disease (MD)" when ABI ≥1.40 with abnormal DWP. The primary outcome was the occurrence of any of the following events: death, stroke or transient ischemic attack (TIA), and acute coronary syndrome. RESULTS: The patients (65.6 ± 13.2 years, 54.6% females) were classified as normal (14.4%), O-PAD (48.4%), IMC (16.4%), and MD (20.8%). During a mean follow-up of 6.5 years, the event-free survival curves of O-PAD and MD groups showed equally poorer prognosis than the IMC and normal groups. Adjusted for age, sex, diabetes type and duration, traditional CVD risk factors, chronic kidney disease, CVD history and treatments, the presence of occlusive disease (hazard ratio [HR]: 2.21, 1.16-4.22, P = .016), but not medial calcinosis, was significantly associated with the primary outcome. CONCLUSIONS: In diabetics with ABI >1.40, only those with concommittant occlusive PAD have poorer prognosis.

Usefulness of postoperative heart rate as an independent predictor of mortality after coronary bypass grafting.

Heart rate (HR) predicts mortality and cardiovascular events in the general population and in patients with coronary artery disease. However, little evidence is available for patients after coronary revascularization. The aim of this study was to assess the prognostic value of ambulatory postoperative HR after coronary artery bypass grafting. Data from a prospective cohort study enrolling patients who underwent nonurgent coronary artery bypass grafting from 1998 to 2002 were analyzed. Baseline postoperative HR was measured 2 months after surgery, and patients were followed annually thereafter. The primary outcome was all-cause mortality. The secondary outcome combined any of the following events: death, nonfatal acute coronary syndromes, stroke or transient ischemic attack, secondary coronary revascularization, or vascular surgery. Seven hundred ninety-four patients (mean age 65.8 ± 9.3 years) were eligible for follow-up, predominantly men (84.1%). The mean follow-up duration was 3.2 ± 1.3 years, during which 40 patients (5.0%) died. In the univariate analysis, HR >90 beats/min was significantly associated with all outcomes. After adjustments for major confounding factors and the use of ß blockers, postoperative HR >90 beats/min remained significantly associated with the secondary outcome (hazard ratio 2.26, 95% confidence interval 1.04 to 4.91, p = 0.04). Association of postoperative HR >90 beats/min with all-cause mortality was only borderline in the multivariate analysis (hazard ratio 3.57, 95% confidence interval 0.90 to 14.17, p = 0.07), because of the limited sample population size. In conclusion, postoperative HR >90 beats/min may be associated with poor prognoses in patients with coronary artery disease, even after surgical revascularization.

The general prognosis of patients with peripheral arterial disease differs according to the disease localization.

OBJECTIVES: The purpose of this study was to assess the general prognosis of patients with peripheral arterial disease (PAD) according to the disease localization. BACKGROUND: PAD is associated with poor cardiovascular disease prognosis. However, it is unknown whether the general prognosis could differ according to PAD topography. METHODS: Data for all patients who underwent a first digital subtraction angiography of their lower limbs between January 2000 and December 2005 at our hospital were reviewed. Arterial stenoses > or = 50% were located by 2 experienced vascular physicians. The following events were collected until April 2007: death, nonfatal myocardial infarction or stroke, and coronary or carotid revascularization. The primary outcome combined all these events. RESULTS: We studied 400 PAD patients (age 68.3 + or - 12.3 years, 77.5% men). Aortoiliac disease (proximal PAD) and infrailiac disease (distal PAD) were noted in 211 (52.8%) and 344 (86.0%) cases, respectively. Male sex and smoking were more prevalent in proximal PAD, whereas older age, diabetes, hypertension, and renal failure were more prevalent in distal PAD (p < 0.05). During the follow-up period (34 + or - 23 months), the event-free survival curves differed according to the PAD localization (p < 0.03). Adjusted for age, sex, cardiovascular disease history and cardiovascular disease risk factors, critical leg ischemia status, and treatments, proximal PAD was significantly associated with a worse prognosis (primary outcome hazard ratio: 3.28; death hazard ratio: 3.18, p < 0.002 vs. distal PAD). CONCLUSIONS: This is the first study to report a poorer general prognosis of patients with proximal (aortoiliac) PAD compared with those with more distal PAD, independent of risk factors and comorbidities.

TachoSil surgical patch versus conventional haemostatic fleece material for control of bleeding in cardiovascular surgery: a randomised controlled trial.

OBJECTIVE: Prolonged bleeding during cardiovascular surgery presents a risk for the patient and increases the time and cost of surgery. TachoSil is a ready-to-use haemostatic agent that consists of an equine collagen patch coated with human fibrinogen and thrombin. This trial evaluated the efficacy and safety (< or =30 days post-surgery) of TachoSil surgical patch compared with standard haemostatic fleece for the control of bleeding in patients undergoing cardiovascular surgery. METHODS: Patients scheduled for elective surgery on the heart, ascending aorta or aortic arch requiring cardiopulmonary bypass were eligible for this open-label multicentre trial. After primary haemostatic measures, patients were randomised to TachoSil or conventional haemostatic fleece if an area of persisting haemorrhage was identified (target area). After the application of trial treatment, haemostasis was evaluated at 3 min (primary endpoint). If haemostasis was not achieved, trial treatment was re-applied and haemostasis assessed at 6 min (secondary endpoint). RESULTS: A total of 120 patients were randomised and 119 received trial treatment (TachoSil, n=59; standard treatment, n=60). Twenty-six percent of patients were female and the mean age was 67 years (range: 23-86 years). Baseline characteristics were similar in both the groups. Bleeding occurred mainly from the aorta (56%), right ventricle (16%) or right atrium (13%), more often from a vessel (68%) than tissue (32%), and was assessed to be arterial in 74% of cases. TachoSil was significantly superior to standard haemostatic fleece in controlling bleeding after insufficient primary haemostasis, with 75% (95% confidence interval (CI): 0.64-0.86) of the TachoSil group achieving haemostasis at 3 min compared with only 33% (95% CI: 0.21-0.45) of the standard treatment group (p<0.0001). This difference persisted at 6 min, with 95% of patients achieving haemostasis in the TachoSil group compared with 72% in the standard treatment group (p=0.0006). Three (5%) TachoSil patients compared with 17 (28%) standard treatment patients failed to achieve haemostasis at 6 min and received rescue treatment. TachoSil was well tolerated with adverse events generally similar in the two treatment groups. CONCLUSIONS: TachoSil was significantly superior to standard haemostatic fleece material in obtaining effective and fast intra-operative haemostasis in cardiovascular surgical procedures. TachoSil was safe and well tolerated.