Biventricular versus conventional right ventricular stimulation for patients with standard pacing indication and left ventricular dysfunction: the Homburg Biventricular Pacing Evaluation (HOBIPACE).

OBJECTIVES: The Homburg Biventricular Pacing Evaluation (HOBIPACE) is the first randomized controlled study that compares the biventricular (BV) pacing approach with conventional right ventricular (RV) pacing in patients with left ventricular (LV) dysfunction and a standard indication for antibradycardia pacing in the ventricle. BACKGROUND: In patients with LV dysfunction and atrioventricular block, conventional RV pacing may yield a detrimental effect on LV function. METHODS: Thirty patients with standard indication for permanent ventricular pacing and LV dysfunction defined by an LV end-diastolic diameter > or =60 mm and an ejection fraction < or =40% were included. Using a prospective, randomized crossover design, three months of RV pacing were compared with three months of BV pacing with regard to LV function, N-terminal pro-B-type natriuretic peptide (NT-proBNP) serum concentration, exercise capacity, and quality of life. RESULTS: When compared with RV pacing, BV stimulation reduced LV end-diastolic (-9.0%, p = 0.022) and end-systolic volumes (-16.9%, p < 0.001), NT-proBNP level (-31.0%, p < 0.002), and the Minnesota Living with Heart Failure score (-18.9%, p = 0.01). Left ventricular ejection fraction (+22.1%), peak oxygen consumption (+12.0%), oxygen uptake at the ventilatory threshold (+12.5%), and peak circulatory power (+21.0%) were higher (p < 0.0002) with BV pacing. The benefit of BV over RV pacing was similar for patients with (n = 9) and without (n = 21) atrial fibrillation. Right ventricular function was not affected by BV pacing. CONCLUSIONS: In patients with LV dysfunction who need permanent ventricular pacing support, BV stimulation is superior to conventional RV pacing with regard to LV function, quality of life, and maximal as well as submaximal exercise capacity.

[Polymorphonuclear neutrophils in myocardial ischemia and reperfusion injury. Influence of coronary intervention?]. / Polymorphkernige Neutrophile bei Myokardischämie und Reperfusionsschaden -- Einfluss der Koronarintervention.

UNLABELLED: Circulating polymorphonuclear neutrophils (PMNs) are known to contribute to the pathophysiology of myocardial ischemia and reperfusion injury. The present study was designed to examine whether the duration of ischemia in myocardial infarction, the type of coronary intervention (angioplasty vs. angioplasty plus stenting) and duration of the procedure itself modulate the inflammatory responses of PMNs. METHODS AND RESULTS: In patients with acute myocardial infarction (AMI; n = 20) neutrophil beta-2-integrin Mac-1 (CD11b/CD18) and L-selectin (CD62L) were determined at different time points before and after PTCA or PTCA plus stenting. After PTCA alone but not after PTCA plus stenting a significant rise in Mac-1 (136 +/- 43%) was demonstrated. This elevation decreased after 60 minutes if the duration of the recanalization procedure was shorter than 30 minutes but remained elevated after longer interventions. After delayed intervention a significant and more pronounced increase of Mac-1 (142 +/- 37%) was observed, while early intervention prevented this increase. After PTCA alone or delayed intervention a significant shedding of L-selectin (77 +/- 20%; 77 +/- 23%) was demonstrated. Early intervention or PTCA plus stenting caused no significant changes in L-selectin. CONCLUSIONS: It is concluded that PMN activation is attenuated by early and short intervention as well as by stenting. Induction of PMN activation might contribute to the superior outcome following stenting and early intervention compared to conventional PTCA in particular when performed delayed.

The impact of hyperhomocysteinemia as a cardiovascular risk factor in the prediction of coronary heart disease.

Coronary heart disease often occurs in the absence of traditional risk factors. Consequently, epidemiological studies exploring novel risk factors are necessary to improve the prediction of coronary heart disease. This study evaluated five promising markers of cardiovascular risk: homocysteine, C-reactive protein, fibrinogen, lipoprotein(a) (Lp(a)), free apolipoprotein(a) (apo(a)) and Lp(a) phenotypes. The study included 135 patients with angiographically confirmed atherosclerosis. The control group consisted of 93 sex- and age-matched individuals. The Mann-Whitney U-test was used for group comparison. New risk factors were evaluated by binary logistic regression. The odds ratios were calculated continuously for homocysteine in dependence on C-reactive protein. Low density lipoprotein (LDL)-cholesterol was nearly identical in controls and patients. Homocysteine, C-reactive protein, fibrinogen, high density lipoprotein (HDL)-cholesterol and Lp(a) discriminated highly significantly between both groups. The continuously calculated odds ratio for homocysteine demonstrated a distinct influence of C-reactive protein. In the group with high C-reactive protein levels, homocysteine levels above 9.6 micromol/l resulted in a markedly elevated risk (odds ratio 12), in the group with C-reactive protein levels below 5 mg/dl, a comparable risk increase was observed at a homocysteine level of 16.6 micromol/l. This data strongly suggests that plasma homocysteine helps identify individuals at risk, especially among those with elevated C-reactive protein levels.

Comparison of a silicon carbide coated stent versus a noncoated stent in humans: the Tenax- versus Nir-Stent Study (TENISS).

PURPOSE: Stents coated with hypothrombogenic silicon carbide (a-SiC:H) exhibited low restenosis rates in the rabbit and in an observational study in humans. Thus, the clinical and angiographic outcome was assessed in a large multicenter study. MATERIAL AND METHODS: Four hundred and ninety-seven patients (63.4 +/- 9.8 years) were randomized to either receive the a-SiC:H-coated Tenax stent or the stainless steel Nir stent. Lesions (diameter > or = 2.8 mm, length < 20 mm) were covered with one single stent. RESULTS: Fifty-one of 497 (10.3%) patients were excluded for protocol violation. Three hundred and forty-two of 446 (76.7%) patients presented for scheduled angiographic follow-up after 4.7 +/- 1.2 months and 29 of 446 (6.5%) prematurely. In-hospital complications comprised two deaths (0.8%) (P > 0.99) and one (0.4%) (P > 0.99) CK-elevation in each group, target lesion revascularization in 5 of 250 (2%) of the Tenax and 4 of 244 (1.6%) of the Nir sample (P > 0.99), and subacute thrombosis in 2 of 250 (0.8%) of the Tenax patients (P = 0.5). In the Tenax/Nir patients mean percent diameter stenosis decreased from 82.3 +/- 9.1%/80.7 +/- 8.4% (P = 0.49) to 17.6 +/- 5.5%/17.6 +/- 5.5% (P = 0.99) postprocedure and increased to 34.5 +/- 21.5%/34.2 +/- 23.1% (P = 0.90) at follow-up. CONCLUSIONS: Thus, there appears to be no advantage of the silicon carbide coated stent over a stainless steel stent after 4.7 +/- 1.2 months with regard to clinical and angiographic restenosis rates.

A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts.

We compared a conventional stent (Jostent Flex, Jomed GmbH, Rangendingen, Germany) with a polytetrafluoroethylene (PTFE)-membrane-covered stent (Jostent Stentgraft) in patients undergoing intervention of a stenosis in an obstructed vein graft. The use of stents improved results of percutaneous revascularization of obstructed vein grafts, but did not demonstrate the reduced elevated restenosis rate. In addition, long-term clinical event rate is still high compared with intervention in native vessels. Observational studies suggested that stents covered with a PTFE membrane might be associated with a low complication and restenosis rate in venous bypass grafts. This prospective multicenter study included a total of 211 patients who were randomly assigned to receive either a Flex stent or Stentgraft. The primary end point was binary restenosis rate at six months by core lab quantitative coronary angiography. Acute success and procedural events were comparable between the two groups. Restenosis rate was not significantly different between the Flex (20%) and the Stentgraft (29%) groups (p = 0.15), although there was a nonsignificant trend toward a higher late occlusion rate in the Stentgraft group (7% vs. 16%, p = 0.069) at follow-up. Likewise, after a mean observation period of 14 months, cumulative event rates (death, myocardial infarction, or target lesion revascularization) were comparable in the two groups (31% vs. 31%, p = 0.93). This controlled trial does not indicate a superiority of the PTFE-membrane-covered Stentgraft compared with a conventional stent with respect to acute results, restenosis, or clinical event rates.

Rapid effect of 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibition on coronary endothelial function.

Treatment with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) decreases cardiovascular event rates in hypercholesterolemic patients. Whether statins exert effects within 24 hours on the coronary vasculature in patients with endothelial dysfunction has not been elucidated. Twenty-seven patients with stable angina pectoris and average low-density lipoprotein cholesterol concentrations of 138+/-9 mg/dL at baseline were allocated to treatment with placebo (14 patients) or 40 mg/d pravastatin (13 patients) in a randomized, double-blind, prospective trial. Coronary endothelial function was assessed before and 24 hours after single treatment by quantitative coronary angiography during intracoronary infusion of nitroglycerin or increasing concentrations of acetylcholine (0.01, 0.1, and 1 micromol/L). Coronary blood flow reserve was measured by Doppler velocimetry during adenosine infusion. Intracoronary acetylcholine infusion induced abnormal vasoconstriction in both groups before treatment, indicating coronary endothelial dysfunction. Treatment with a single oral 40-mg dose of pravastatin significantly attenuated acetylcholine-mediated vasoconstriction after 24 hours (mean+/-SE decrease in luminal diameter before and after treatment: 0.01 micromol/L, 6.1+/-2.2% versus 3.0+/-1.2%; 0.1 micromol/L, 15.6+/-2.6% versus 7.4+/-1.8%; P<0.05; 1 micromol/L, 22.9+/-2.9% versus 13.2+/-2.6%; P<0.05). There was no significant difference in the response to acetylcholine in the placebo group (8.1+/-2.4% versus 9.7+/-2.4%, 16.1+/-2.9% versus 16.8+/-3.2%, and 21.4+/-3.9% versus 23.3+/-4.2%). The response to nitroglycerin infusion was not altered in both groups. Increase in coronary blood flow in response to adenosine and coronary flow reserve remained unchanged during placebo and statin treatment. Serum concentrations of blood lipids and high-sensitive C-reactive protein were not significantly altered after 24 hours in response to placebo or pravastatin therapy. Statin treatment improves endothelium-dependent coronary vasomotion within 24 hours in the absence of significant cholesterol reduction. The full text of this article is available online at http://www.circresaha.org.

Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction.

OBJECTIVES: The Southwest German Interventional Study in Acute Myocardial Infarction (SIAM III) investigated potentially beneficial effects of immediate stenting after thrombolysis as opposed to a more conservative treatment regimen. BACKGROUND: Treatment of acute myocardial infarction (AMI) by thrombolysis is compromised by Thrombolysis In Myocardial Infarction (TIMI) 3 flow rates of only 60% and high re-occlusion rates of the infarct-related artery (IRA). Older studies showed no benefit of coronary angioplasty after thrombolysis compared with thrombolytic therapy alone. This observation has been challenged by the superiority of primary stenting over balloon angioplasty in AMI. METHODS: The SIAM III study was a multicenter, randomized, prospective, controlled trial in patients receiving thrombolysis in AMI (<12 h). Patients of group I were transferred within 6 h after thrombolysis for coronary angiography, including stenting of the IRA. Group II received elective coronary angiography two weeks after thrombolysis with stenting of the IRA. RESULTS: A total of 197 patients were randomized, 163 patients fulfilled the secondary (angiographic) inclusion criteria (82 in group I, 81 in group II). Immediate stenting was associated with a significant reduction of the combined end point after six months (ischemic events, death, reinfarction, target lesion revascularization 25.6% vs. 50.6%, p = 0.001). CONCLUSIONS: Immediate stenting after thrombolysis leads to a significant reduction of cardiac events compared with a more conservative approach including delayed stenting after two weeks.

Comparison of a silicon carbide-coated stent versus a noncoated stent in human beings: the Tenax versus Nir Stent Study's long-term outcome.

BACKGROUND: Stents coated with amorphous hypothrombogenic silicon carbide (a-SiC:H) have low restenosis rates in humans. Recurrence in a-SiC:H at mid-term follow-up has been shown to be similar to a stainless steel device. The long-term outcome, however, may be different. METHODS: Four hundred ninety-seven patients (63.4 +/- 9.8 years of age) received either the a-SiC:H-coated Tenax stent (Biotronik, Berlin, Germany) or the 316L Nir stent (Boston Scientific, Maple Grove, Minn). Lesions had to be covered with one stent only (diameter > or =2.8 mm, length <20 mm). Exclusion criteria comprised acute myocardial infarction and angiographic thrombus within the target vessel. Twenty-five of 497 (5%) patients were excluded for protocol violation. Clinical follow-up was completed in 450 of 472 (95.3%) and angiographic follow-up was completed in 365 of 472 (77.3%); 22 of 472 (4.7%) patients were lost to follow-up. RESULTS: Major adverse coronary events occurred in 28 of 233 (12%) of the Tenax recipients and in 31 of 217 (14.3%) of the Nir recipients (P =.50). Acute myocardial infarctions were less frequent in the Tenax recipients after > or =60 weeks. Premature target lesion revascularization was performed in 16 of 233 (6.9%) patients in the Tenax group and 11 of 217 (5.1%) (P =.54) patients in the Nir group. Coronary bypass operations were similar after Tenax or Nir stent deployment (3/233 [1.3%] vs 6/217 [2.8%], P =.43), as were deaths in 7 of 233 (3%) versus 8 of 217 (3.7%) (P =.88), respectively. CONCLUSIONS: Both stents had a low rate of major adverse coronary events at 81 +/- 12 weeks of follow-up, with no definite superiority of any of the devices.

Plasma lidocaine concentrations after local anesthesia of the groin for cardiac catheterization.

This study aimed to investigate serum lidocaine concentrations after subcutaneous infiltration of the groin for cardiac catheterization. One hundred twenty-six patients for planned heart catheterization received five different dosages (5-25 ml) of lidocaine 2% for local anesthesia of the groin in a randomized manner. All of them received an arterial sheath and 13 received both an arterial sheath and a venous sheath for right heart catheterization. Blood samples were taken before as well as 15, 30, and 120 min after subcutaneous application of the drug. Although in 33 patients with an arterial sheath (no venous sheath) excessive doses of lidocaine 2% (20-25 ml) were used, neither symptoms of intoxication nor toxic plasma levels were observed. However, in patients receiving an additional venous sheath, toxic plasma levels were obtained in a third of the cases. One of them showed symptoms of intoxication.

Randomized comparison of success and adverse event rates and cost effectiveness of one long versus two short stents for treatment of long coronary narrowings.

Long stents of high flexibility and low profile have become widely available. Treatment of long coronary lesions by 1 long stent may require less interventional efforts and reduce the rate of restenosis due to a lack of overlapping stent segments. This study sought to evaluate the use of 1 long stent compared with 2 short stents for treatment of long coronary lesions. One-hundred twenty-four patients with a coronary lesion 20 to 40 mm in length, in a vessel 2.5 to 4.0 mm in diameter, were randomly assigned to treatment with 1 long stent (GFX II stents or S670 of 24, 30, or 40 mm lengths; n = 62) or 2 stents (GFX II or S670 stents, n = 62) of equal length. Procedural success, interventional costs, as well as long-term clinical and angiographic outcomes were evaluated. Lesion characteristics were similar for the 2 treatment groups. Stent placement was possible as assigned by randomization in 61 of 62 cases (98%) in the 1-long-stent group and 100% of cases in the 2-short-stents group. There was crossover to successful short-stent placement in 1 case. The in-hospital success rate was 97% for the 1-long-stent group and 98% for the 2-short-stents group. Acute angiographic results were similar for both groups after intervention. The angiographic restenosis rate at 6 months was 38.5% in the 1-long-stent group and 37.5% in the 2-short-stents group (p = 0.919). Intervention time was less, and the need for a contrast agent had a tendency to be lower in the long-stent group. Procedural costs were significantly less in the long-stent group. In conclusion, 1 long stent can be used with identical procedural success and adverse event rates as 2 short stents in long, atherosclerotic coronary lesions. The restenosis rate is not reduced by the use of 1 long stent compared with 2 stents. However, long stent placement is highly cost effective.

Restenosis rates with flexible GFX stents (REFLEX): clinical and angiographic results.

The objective of this prospective, multicenter, observational trial was to evaluate the procedural results and longterm outcomes of the flexible AVE GFX coronary stent in native coronary lesions. The trial included 137 consecutive patients (111 [81%] men, age 63.1 +/- 9.2 years) with one vessel disease (n = 76 [55.5%]), two vessel disease (n = 31 [22.6%]), and three vessel disease (n = 30 [21.9%]) with ischemia secondary to a significant denovo lesion (diameter > or = 3 mm, length < or = 18 mm) in a native coronary artery. Stent deployment was successful in 97.8% (134/137) of patients. Angiographic follow-up at 6.1 +/- 1.2 months was available in 111 (82.8%) of 134 patients. All angiographic images were analyzed by an independent core lab. The primary end point was the binary restenosis rate. In-hospital major cardiac events occurred in 3.7%. No postdischarge major adverse cardiac events occurred, except for one abrupt closure (0.7%). Angiographic restenosis was documented in 22 (19.8%) of 111 patients. The GFX stent is easy to handle with high success and low restenosis rates in patients with simple lesions in native coronary arteries and, thus, compares favorably with other sophisticated stents.