Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study.

OBJECTIVES: The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs. METHODS: In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device. RESULTS: Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients. CONCLUSIONS: This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

Tako-tsubo cardiomyopathy with left ventricular outflow tract (LVOT) obstruction: case report and review of the literature.

In this report, we describe a case of Tako-Tsubo cardiomyopathy (TTC)--also called 'apical ballooning' syndrome--in which transient left ventricular outflow tract (LVOT) obstruction and mitral regurgitation led to haemodynamic instability. Patients with hypotension should undergo urgent echocardiography to determine if LVOT obstruction is present. This complication has been described in 10-25% of all TTC patients. In patients with hypotension and moderate-to-severe LVOT obstruction, inotropic agents should not be used because they can worsen the degree of obstruction. Instead, it is suggested to use beta-blockers, which can improve haemodynamics by causing resolution of the obstruction. The fact that some patients do not survive their acute TTC event only underscores the importance of prompt recognition and targeted management of dynamic LVOT obstruction.

Are ACE-inhibitors or ARB's still needed for cardiovascular prevention in high risk patients? Insights from profess and transcend.

The HOPE and EUROPA clinical studies have shown that treatment with the angiotensin-converting enzyme (ACE) inhibitors, ramipril and perindopril, may reduce the occurrence of major cardiovascular events in patients with proven atherosclerotic disease. The recently published results of the PRoFESS and TRANSCEND trials completed the much needed information concerning the use of an angiotensin receptor blocker for patients at high risk of cardiovascular events. PROFESS compared a therapy of telmisartan 80 mg daily with placebo in patients with a recent ischemic stroke. The difference in the primary outcome of first recurrent stroke was not statistically significant between telmisartan and placebo. The secondary outcome of major cardiovascular events showed a relative risk reduction (RRR) of 7% in favour of telmisartan. This tended to be significant (p = 0.06) despite a rather short follow-up period of only 28 months. In TRANSCEND 5926 patients at high risk for cardiovascular events were randomized to a treatment with telmisartan 80 mg daily or placebo for a mean duration of follow-up of 56 months. The primary composite outcome of cardiovascular death, myocardial infarction, stroke or hospitalization for heart failure showed a non-significant 8% RRR in favour of the telmisartan treated patients. The main secondary outcome of cardiovascular death and myocardial infarction or stroke as used in the HOPE trial showed a non-significant RRR of 13% in favour of telmisartan treated patients (p = 0.068 adjusted for multiplicity of comparisons). In comparing the Kaplan-Meier curves for the endpoint of major cardiovascular events used in HOPE, EUROPA, TRANSCEND and PRoFESS, the trends are similar. Results of most of the recently published trials have been neutral.This could partly be explained by major improvements in the optimal background therapy of the patients included. Nevertheless, the results of PRoFESS and TRANSCEND do not contradict the results from previous studies with theACE inhibitors ramipril and perindopril and the ARB telmisartan.

Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study.

AIMS: To evaluate the efficacy of switching from a previous statin monotherapy to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg vs. rosuvastatin (ROSUVA) 10 mg. METHODS: In this randomised, double-blind study, 618 patients with documented hypercholesterolaemia [low-density lipoprotein cholesterol (LDL-C) > or = 2.59 and < or = 4.92 mmol/l] and with high cardiovascular risk who were taking a stable daily dose of one of several statin medications for > or = 6 weeks prior to the study randomisation visit entered a 6-week open-label stabilisation/screening period during which they continued to receive their prestudy statin dose. Following stratification by study site and statin dose/potency, patients were randomised to EZE/SIMVA 10/20 mg (n = 314) or ROSUVA 10 mg (n = 304) for 6 weeks. RESULTS: EZE/SIMVA produced greater reductions in LDL-C (-27.7% vs. -16.9%; p < or = 0.001), total cholesterol (-17.5% vs. -10.3%; p < or = 0.001), non-high-density lipoprotein cholesterol (HDL-C) (-23.4% vs. -14.0%; p < or = 0.001) and apolipoprotein B (-17.9% vs. -9.8%; p < or = 0.001) compared with ROSUVA, while both treatments were equally effective at increasing HDL-C (2.1% vs. 3.0%; p = 0.433). More patients achieved LDL-C levels < 2.59 mmol/l (73% vs. 56%), < 2.00 mmol/l (38% vs. 19%) and < 1.81 mmol/l (25% vs. 11%) with EZE/SIMVA than ROSUVA (p < or = 0.001). A borderline significantly greater reduction in triglycerides (p = 0.056) was observed for EZE/SIMVA (-11.0%) vs. ROSUVA (-5.3%). There were no between-group differences in the incidences of adverse events or liver transaminase and creatine kinase elevations. CONCLUSION: EZE/SIMVA 10/20 mg produced greater improvements in LDL-C, total cholesterol, non-HDL-C and apoB with a similar safety profile as for ROSUVA 10 mg.

Lessons from ONTARGET.

The recently published results of the ONTARGET trial shed a new light on the cardiovascular protection of patients at high risk of a cardiovascular event. Despite a number of trials looking at the efficacy of Angiotensin Converting Enzyme inhibitors (ACEis) or Angiotensin Receptor Blockers (ARBs) in the prevention of cardiovascular events in patients with specific high risk profiles, the question of the equivalence of ACEis and ARBs remained unanswered. The ONTARGET trial has shown that telmisartan 80 mg administered for a median duration of 4.5 years to patients at high risk of developing a major cardiovascular event, is equally effective to ramipril 10 mg. In addition, telmisartan was slightly better tolerated. The comparator ramipril has been chosen as it is currently the gold standard ACEi since the results of the HOPE study, in terms of the composite outcome of cardiovascular death, myocardial infarction and stroke. Moreover, ONTARGET is the first trial to test the hypothesis of superiority of adding an ARB (telmisartan 80 mg) to an ACEi (ramipril 10 mg) over the ACEi ramipril monotherapy in cardiovascular protection of the same broad range of high-risk patients. Surprisingly, despite a more pronounced blood pressure lowering, the combination of the two agents did not lead to an additional decrease in the number of events, but had significantly more side-effects compared to ramipril monotherapy. ONTARGET is a landmark study, performed according to the highest statistical and clinical standards, providing compelling evidence and clear answers to two important clinical questions.

Occurrence of peripheral arterial disease in a Belgian cohort of patients with cardiovascular history of atherothrombosis.

RATIONALE: Peripheral arterial disease (PAD) is an underestimated and under diagnosed disease with as much as 60% of the patients having at least one other vascular bed affected. PURPOSE: The study aimed to evaluate the prevalence of PAD defined by different means in high risk Belgian ambulatory patients. METHODS: Participating physicians were to include a least six consecutive high risk ambulant patients for atherothrombosis. Demographical data and cardiovascular risk factors were recorded. The Edinburgh Questionnaire was administered. A vascular examination, including palpation and blood pressure measurement of the relevant arteries was performed. RESULTS: 275 Belgian physicians included a total of 2831 patients with a mean age of 68.0 years. Sixty three point three percent (63.3%) of the patients had a history of coronary artery disease whereas 28.0% reported a history of cerebrovascular disease. Overall, 1777 patients (62.8%, 95% CI: 61-65%) had a PAD diagnosis with an even distribution among males and females and increasing with age. PAD, defined as an ABI (Ankle Brachial Index) < 0.9, was detected in 28.5% of the population. PAD defined as the presence of intermittent claudication with positive Edinburgh Questionnaire or as a history of peripheral vascular revascularisation, was detected in 12.4% and 8.1% of the population respectively. Sixty six point seven percent (66.7%) of the PAD patients reported walking pain. The presence of pulsation of the tibialis posterior and/or dorsalis pedis arteries was not predictive of an ABI > 0.9. In contrast, the absence of pulse of both arteries was correlated with an odds-ratio of 6.4 to 8.1 to find a pathological ABI. CONCLUSION: The prevalence of PAD in ambulant patients with a history of coronary artery disease or cerebrovascular disease varied from 62.8% (composite of intermittent claudication with Edinburgh Questionnaire positive, history of peripheral vascular revascularisation, ABI < 0.9) to 28.5% (ABI < 0.9). Sixty six point seven percent (66.7%) of the PAD population reported walking pain. The absence of pulsation of the tibialis posterior and dorsalis pedis arteries was correlated with an ABI < 0.9.

Renovascular hypertension associated with neurofibromatosis: a case report.

Although vascular involvement in type 1 neurofibromatosis (NF1) is rare, it may lead to renal artery stenosis and renovascular hypertension (RVH). RVH may be treated using antihypertensive drugs, percutaneous transluminal renal angioplasty (PTRA), surgical reconstruction of the renal artery, or nefrectomy. In NF1 the results of PTRA are less predictable than in cases of fibromuscular dysplasia and atherosclerosis. We report a case of RVH associated with NF1. Despite administration of multiple antihypertensive drugs blood pressure remained uncontrolled. Selective left renal arteriography demonstrated two consecutive high-grade stenotic lesions with post-stenotic aneurysmal dilatation treated successfully with balloon dilatation. During the ensuing 2 year follow up complete normalization of blood pressure was observed. This case illustrates that endovascular therapy may be beneficial and should be considered a reasonable first option in these patients. However vascular involvement in NF may be progressive and therefore always requires continuing follow up.

Aortopulmonary artery fistula in atherosclerotic pseudoaneurysm presenting with congestive heart failure after aortic valve replacement.

An exceptional case of a giant pseudoaneurysm of the atherosclerotic ascending aorta complicated by aortopulmonary fistulization twelve years after aortic valve replacement is presented. The patient underwent successful surgical repair. In patients with a marked atherosclerotic thoracic aorta presenting with congestive heart failure and an acquired continuous systolo-diastolic murmur, aortopulmonary fistula should be considered and differentiated from ruptured sinus of valsalva aneurysm. Multi-slice computed tomography was the most useful diagnostic tool in planning surgical strategy and approach. Surgery is the treatment of choice for this serious albeit rare entity.

Mitral insufficiency with congenital double-orifice mitral valve in an elderly patient.

We describe the case of a 79-year-old woman with mitral insufficiency and a double-orifice mitral valve (DOMV), discovered by echocardiography. Transthoracic echocardiography showed two insufficiency jets. Transesophageal echocardiography revealed a DOMV. Each orifice was provided with a subvalvular apparatus. No associated congenital abnormalities were present. Our case demonstrates that even in elderly patients with a double regurgitant jet, DOMV should be suspected and assessed by transesophageal echocardiography.

Relationship between left ventricular mass and blood pressure in treated hypertension.

This study evaluated prospectively whether there is still a relationship between left ventricular mass and blood pressure once hypertension is treated and determined the relative importance of daytime vs night-time blood pressure, systolic vs diastolic blood pressure and office vs ambulatory blood pressure. A total of 649 patients (305 or 47% female) with essential hypertension, treated with antihypertensive drugs for at least 3 months, underwent office blood pressure measurement and both daytime and night-time ambulatory blood pressure measurement, electrocardiography and echocardiography. Correlations were made between blood pressure values and parameters of left ventricular mass. Electrocardiographic voltage criteria and even more so echocardiographic parameters correlate significantly albeit weakly (r < or = 0.28) with blood pressure in treated hypertension. Correlations are consistently higher when systolic blood pressure is considered. Overall, the best correlations are found between 24-h ambulatory systolic or night-time blood pressure and the Sokolow-Lyon voltage as well as the echocardiographic age and body mass index adjusted left ventricular mass. In conclusion, once hypertension is treated, the relationship between blood pressure and left ventricular mass is low. Nevertheless, in this the largest single centre study of its kind, echocardiographic parameters of left ventricular mass in treated hypertensive subjects correlate better with blood pressure than electrocardiographic parameters. Parameters of hypertrophy are more closely related to systolic blood pressure than to diastolic blood pressure. In accordance with the finding that dippers have a better prognosis than non-dippers, night-time blood pressure consistently correlates better with left ventricular mass than daytime blood pressure.

[Addition of beta blockers in chronic heart failure]. / Toediening van beta-blokkers bij chronisch hartfalen.

Chronic heart failure is an increasing cause of hospital admission in the Netherlands and Belgium. Despite numerous medical treatment modalities, the mortality remains high. Recent placebo-controlled randomized studies suggest that the addition of beta-blockers in stabilized, optimally pretreated patients with chronic heart failure using angiotensin converting enzyme (ACE) inhibitors, diuretics and digitalis, is accompanied by an additional absolute decrease in mortality by about 5% and a relative decrease in mortality by about 35%. Also the number hospitalization frequency decreases. Initially, the beneficial effects of beta-blockers on symptoms are only minor or absent. During the initiation period some clinical deterioration may occur which has to be treated accordingly; these patients are, however, difficult to identify. Initiation has to be done using low doses and should be restricted to stabilized, optimally treated patients. Doses should only be increased every 2 to 4 weeks until target doses are reached. These findings must not be extrapolated automatically to all cases of heart failure, since patients in the trials may differ considerably from those encountered in general practice.

Pacemaker lead infection: report of three cases and review of the literature.

Pacemaker lead infection is a rare condition, most often occurring when intervention is needed after pacemaker implantation. Diagnosis is by blood cultures and confirmation by transoesophageal echocardiography; transthoracic echocardiography is often inadequate. A literature review indicated the microorganism most responsible for late lead infection is Staphylococcus epidermidis (which can grow on plastic material). A retrospective analysis of patient files from the authors' institution (1993-97) yielded three patients with proven pacemaker lead endocarditis. The diagnosis of pacemaker endocarditis was by transoesophageal echocardiography. The endocarditis appeared after a long period and in two of the three patients there was S epidermidis infection. Thoracotomy with removal of the infected system was performed because of the large dimensions of the vegetations. A new pacemaker was implanted: in one patient with endocardial leads, in the other two with epicardial leads. All three patients recovered well and follow up was uneventful for at least one year.

Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. The full anticoagulation versus aspirin and ticlopidine (fantastic) study.

BACKGROUND: Dual therapy with ticlopidine and aspirin has been shown to be as effective as or more effective than conventional anticoagulation in patients with an optimal result after implantation of intracoronary metallic stents. However, the safety and efficacy of antiplatelet therapy alone in an unselected population has not been evaluated. METHODS: Patients were randomized to conventional anticoagulation or to treatment with antiplatelet therapy alone. Indications for stenting were classified as elective (decided before the procedure) or unplanned (to salvage failed angioplasty or to optimize the results of balloon angioplasty). After stenting, patients received aspirin and either ticlopidine or conventional anticoagulation (heparin or oral anticoagulant). The primary end point was the occurrence of bleeding or peripheral vascular complications; secondary end points were cardiac events (death, infarction, or stent occlusion) and duration of hospitalization. RESULTS: In 13 centers, 236 patients were randomized to anticoagulation and 249 to antiplatelet therapy. Stenting was elective in 58% of patients and unplanned in 42%. Stent implantation was successfully achieved in 99% of patients. A primary end point occurred in 33 patients (13.5%) in the antiplatelet group and 48 patients (21%) in the anticoagulation group (odds ratio=0.6 [95% CI 0.36 to 0.98], P=0.03). Major cardiac-related events in electively stented patients were less common (odds ratio=0.23 [95% CI 0.05 to 0.91], P=0.01) in the antiplatelet group (3 of 123, 2.4%) than the anticoagulation group (11 of 111, 9.9%). Hospital stay was significantly shorter in the antiplatelet group (4.3+/-3.6 versus 6. 4+/-3.7 days, P=0.0001). CONCLUSIONS: Antiplatelet therapy after coronary stenting significantly reduced rates of bleeding and subacute stent occlusion compared with conventional anticoagulation.

Brachial, radial, or femoral approach for elective Palmaz-Schatz stent implantation: a randomized comparison.

UNLABELLED: From October 1994 to November 1995, 150 male eligible patients were randomly assigned to Palmaz-Schatz stent implantation through 6 French catheters using the femoral (puncture) (n = 56), radial (puncture) (n = 56), or brachial (cutdown) (n = 38) approach at 6 participating Belgian centers. Acenocoumarol was given for 1 month after stenting. END POINTS: Primary-entry site complications (bleeding, haematoma, transfusion, occlusion, surgery) poststent implantation. Secondary-success rate, stent thrombosis, Q or non Q wave MI, repeat PTCA, CABG, CVA, haemorrage, death. There were no statistically significant differences between the three groups for base line and angiographic patient characteristics, procedural characteristics, in hospital outcome, average hospitalisation time after stenting, events during the month after stenting, or local complications at 1 month follow-up. The only statistically significant difference was the arterial time of the procedure: mean +/- SD (minutes) brachial 31.0 +/- 10.02 *P < 0.001, femoral 42.2 +/- 21.8, radial 55.8 +/- 31.3 **P < 0.0001 (*brachial vs. femoral, **brachial vs. radial). There was a clear trend toward more technical difficulties and more problems with the radial approach. In each group: vascular surgery at entry site: 0%, blood transfusion: 0%. In our study, local complications and length of hospital stay were similar with the three possible approaches, and brachial approach was associated with a shorter arterial time.

Clinical experience with the first 100 ATS heart valve implants.

Between May 1992 and March 1994, 100 consecutive patients had 119 new ATS mechanical bileaflet valves inserted (61 aortic, 50 mitral, eight tricuspid). The mean age of the patients was 63.7 (range 13-82) years. The follow-up period ranged from 5 to 27 months and was complete in all cases. Before surgery, 53 aortic valve patients were in New York Heart Association functional class III or higher. This improved to a mean of 1.3 postoperatively, all patients being in classes I or II. One patient died in hospital, and another 3 months after implantation (actuarial survival rate 98%). One patient had an embolic event 9 days after an aortic valve reoperation which caused a parietal infarction. One tricuspid valve blocked in the open position 6 weeks after implantation as a result of inadequate anticoagulation and was successfully unblocked after 2 days of intensive thrombolytic therapy. Patients were treated by mild anticoagulation without developing bleeding complications. Echocardiographic, transoesophageal and transthoracic valvular gradients compared favourably with the gradients reported in other mechanical valves (including small aortic valves). The haemodynamics were excellent without evidence of significant regurgitation. This was confirmed by an in vitro hydrodynamic evaluation of the valve using a pulse duplicator system. The valve closure caused little noise and was as a result well tolerated.

In vivo validation of a fluid dynamics model of mitral valve M-mode echocardiogram.

A fluid dynamics model of mitral valve motion during diastolic filling of the left heart is described. Given a pulsed Doppler velocity pattern in the mitral annulus, the radius of circular mitral orifice, the length of leaflets and the end-systolic left ventricular volume, the numerical model predicts the time course of the mitral leaflets during diastole: the mitral valve M-mode echocardiogram. Results obtained by computer simulation have been validated with in vivo data. It is shown that mitral valve flow is essentially a fluid dynamics process of floating mitral valve leaflets with blood flow due to the atrioventricular pressure gradient. In addition, a partial opening of the mitral valve as the initial boundary condition is required to simulate the overshooting of the leaflets during early peak filling. Some back flow is a condition for perfect closing of the native mitral valve. The higher the unsteady character of mitral flow, the less efficient is the opening and closing processes of the mitral valve.

Surgical treatment of impending paradoxical embolism through patent foramen ovale.

We describe the case of a patient with deep venous thrombosis who had cerebral and extremity paradoxical emboli and an intracardiac thrombus crossing a patent foramen ovale identified by echocardiography. He was treated successfully with immediate intracardiac embolectomy and closure of the patent foramen ovale.

Echocardiography of sinus of Valsalva aneurysm with rupture into the right atrium.

Before the advent of modern techniques, diagnosing unruptured sinus of Valsalva aneurysm in the living patient was rare, with most of the reports coming from autopsy or surgery. Once rupture occurs however, characteristic symptoms and signs, such as precordial distress, a continuous murmur over the base of the heart, pulmonary congestion, and congestive heart failure, usually occur rather abruptly. We describe a case of ruptured aneurysm of the non-coronary sinus of Valsalva diagnosed by transthoracic echocardiography and Doppler as a single examination for quickly establishing a correct diagnosis in patients with a new continuous murmur.