Contemporary management of patent foramen ovale.
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Biomedical subjects
Publications and source records attributed to Bernhard Meier.
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A randomized study was conducted to assess the feasibility of 4 Fr catheters for diagnostic coronary angiograms. A total of 1,114 consecutive patients were randomized to 4 or 5 Fr catheters. Ease of use of catheters was subjectively assessed by the primary operator and the picture quality was assessed by two independent observers with a good interobserver variability (r = 0.94; P < 0.001). Predischarge local complications were recorded by the attending physician. No statistically significant difference was observed in the picture quality for the left coronary artery, right coronary artery, aorta, left ventricle, venous grafts, or renal arteries between the two groups. Fluoroscopy time (7.1 +/- 5.6 for 4 Fr vs. 6.7 +/- 5.7 min for 5 Fr) and contrast quantity (140 +/- 58 vs. 144 +/- 57 ml) were comparable between the two groups. There was a statistically significant difference in favor of the 5 Fr group as regards maneuverability of catheters (93% vs. 79%; P < 0.001), and 5 Fr pigtail catheters crossed the aortic valve easier than the 4 Fr pigtail catheters (91% vs. 81%; P < 0.001). Crossover to the other catheter size or a larger sheath was more frequent with 4 Fr catheters (33/522 vs. 3/592; P < 0.001). Median time to hemostasis was 9 min for 4 Fr and 14 min for 5 Fr (P < 0.001). Of the 4 Fr patients, 84% could be mobilized at 1 hr and 86% of 5 Fr patients at 2 hr. Significant hematomas were observed in 2% with 4 Fr or 5 Fr and small hematomas in 10% and 16%, respectively (P = NS). Time to discharge was comparable in both groups (4.0 +/- 3.2 with 4 Fr vs. 4.3 +/- 3.7 hr with 5 Fr). The 4 Fr catheters are a good alternative for diagnostic coronary angiograms. The increased difficulty in maneuverability and a need for catheter changes in 70% are compensated for in part by easier hemostasis. With increasing use and finesse of these catheters, the difficulty in maneuverability are likely to be overcome.
A case is described of the inadvertent embolization of an Amplatzer duct occluder in the descending aorta in a 10-year-old girl. It was possible to snare the device and bring it in its normal position in the aortic ductus ampulla. With a second snare, the recessed screw of the device could be caught and the device was successfully pulled back into the ductus.
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The Pacman Sign during devise closure of the patent foramen ovale refers to the aspect of the device on fluoroscopy that should be achieved before release. In an orthograde view, the cranial halves of the left and right atrial disks should appear like open jaws biting into the thick septum secundum reminding of arcade game figure Pacman about to gobble up a dot.
It is assumed that over 90% of clinically apparent embolisms in atrial fibrillation originate from the left atrial appendage. Recently, a percutaneous method (PLAATO technique) to occlude the left atrial appendage to the end of preventing thromboembolic complications of atrial fibrillation has been introduced into clinical practice. This technique is quite intricate and requires general anesthesia. The Amplatzer atrial septal occluder lends itself for a more simple approach to this intervention. The first 16 patients treated at four centers are described. Their age varied from 58 to 83 years. All suffered from atrial fibrillation but eight of them were in sinus rhythm at the time of implantation. All but two procedures were done under local anesthesia of the groin only. There was one technical failure (device embolization) requiring surgery. All other patients left the hospital a day after the procedure without complications. There were no problems or embolic events during an overall follow-up of 5 patient-years and all left atrial appendages were completely occluded without evidence of thrombosis at the atrial side of the device at the latest follow-up echocardiography. With the Amplatzer technique, the left atrial appendage can be percutaneously occluded with a venous puncture under local anesthesia, without echocardiographic guidance, and at a reasonable risk. It remains to be evaluated in larger series or randomized trials how the simpler Amplatzer technique compares with the complex PLAATO technique, and whether left atrial appendage closure is competitive with oral anticoagulation with warfarin or the novel ximelagatran to prevent thromboembolism in atrial fibrillation.
BACKGROUND: Increasing practice of less-invasive coronary artery bypass surgery has generated a revival of automated methods to facilitate the creation of vascular connections during coronary artery bypass grafting procedures. METHODS: We have reviewed our clinical experience with 107 patients who received at least one proximal Symmetry aortic connector from St. Jude Medical Anastomotic Technology Group (St. Paul, MN) to connect a saphenous vein graft to the ascending aorta, in whom the minimal follow-up is 6 months. Seventy-five patients were part of an observational study, and 32 patients were enrolled in a prospective randomized study to compare the anastomotic device with the conventional suture technique. Key lessons and pitfalls observed during loading and deployment as well angiographic findings are presented. RESULTS: Hospital mortality was 0.9% (1/107); a 76-year-old woman suffered from cerebral complications and died after combined coronary artery bypass grafting and aortic valve replacement. Two connectors had to be removed because of leakage and one because of incomplete deployment. The residual 104 grafts connected to the ascending aorta were patent at the end of the operation (mean flow, 72 +/- 29 mL/min). Fourteen patients from the prospective study have received 6 months of angiographic assessment so far. Forty-two grafts have been evaluated: all IMA grafts (n = 14) are patent. Four radial artery grafts have been studied: three are patent and one is occluded. Twenty-four vein grafts have been assessed: 11 were hand-sewn and 13 were connected to the aorta with the proximal connector system. Patency rate is not different between the two techniques, but there is an incidence of 38% (5/13) stenosis in the proximal vein graft segment in those patients with a proximal connector. No proximal hand-sewn anastomosis shows any significant stenosis. CONCLUSIONS: The use of proximal devices allows ultrafast connection of a bypass graft to the aorta. The handling of this device is simple, manipulations on the ascending aorta are minimized, and hemostasis is perfect. However, because stenoses have been observed in the vein graft close to the connector site, mid- and long-term patency rates have to be assessed in large prospective trials.
AIMS: The purpose of this registry is to collect data on trends in interventional cardiology within Europe. Special interest focuses on relative increases and ratios in newer revascularization approaches and its distribution in different regions in Europe. METHODS AND RESULTS: Questionnaires distributed to delegates of the national societies of cardiology represented in the European Society of Cardiology to be completed by local institutions and operators yielded that 1,452,751 angiograms and 452,019 PTCAs were performed in 1999. This is an increase of 28% and 16%, respectively, compared with 1998. Most of these increases are due to high relative increases in eastern European countries. The number of PTCAs per 106 inhabitants rose to 714 in 1999. Coronary stenting increased by 31% to about 313,000 stents implanted in 1999. Complication rates remained stable, the need for emergency coronary artery bypass grafting showing a further slight decrease to currently 0.3%. CONCLUSION: Interventional cardiology in Europe is still growing, mainly due to rapid growth in countries with lower socio-economical levels. In some central European countries a saturation seemed to be reached with only minor increases in procedures performed. Coronary stenting remains the only noteworthy and growing complement or alternative to balloon angioplasty.
BACKGROUND: To test the hypothesis that troponin I and echocardiography have an incremental prognostic value in patients with pulmonary embolism (PE). METHODS AND RESULTS: In 91 patients with acute PE, echocardiography was performed within 4h of admission. Troponin I levels were obtained on admission and 12h thereafter. The 0.06 microg/l troponin I cut-off level was identified as the most useful, high-sensitivity cut-off level for the prediction of adverse outcome by receiver operating characteristic analysis with a sensitivity and specificity of 86%, respectively. Twenty-eight (31%) patients had elevated troponin I levels (4.9+/-3.8 microg/l). Twenty-one (23%) patients had adverse clinical outcomes including in-hospital death in five, cardiopulmonary resuscitation in four, mechanical ventilation in six, pressors in 14, thrombolysis in 14, catheter fragmentation in three, and surgical embolectomy in three. The area under the receiver operating characteristic curve from multivariate regression models for predicting adverse outcome without troponin I and echocardiography (0.765), with troponin I (0.890) or echocardiography alone (0.858), and the combination of both tests (0.900) was incremental. Three-month survival rate was highest in patients with both a normal troponin I level and a normal echocardiogram (98%). Positive predictive value for adverse clinical outcomes of the combination of echocardiography and troponin I was higher (75% (95%CI 55-88%)) compared with each test alone (echocardiography: 41%, 95% CI 28-56%; troponin I: 64%, 95% CI 46-79%). CONCLUSIONS: While troponin I measurements added most of the prognostic information for identifying high-risk patients, a normal echocardiogram combined with a negative troponin I level was most useful to identify patients at lowest risk for early death.
In 50 patients undergoing percutaneous transluminal coronary angioplasty because of chronic angina pectoris, a collateral flow index (CFI) was determined at the start and the end of two 1-min coronary occlusions, randomly accompanied by a resting state or a 3-min dynamic handgrip exercise (DHE). CFI expressing collateral flow relative to normal antegrade flow was determined by simultaneous coronary occlusive pressure, mean aortic pressure and central venous pressure measurements. When comparing CFI without and with DHE at the start as well as at the end of balloon occlusions, a significant increase was observed with DHE (overall p < 0.0001); start: 0.18 +/- 0.12 vs. 0.22 +/- 0.13, respectively (p = 0.01); end of occlusion: 0.21 +/- 0.14 vs. 0.25 +/- 0.14, respectively (p = 0.007).
Coronary artery stents have emerged as the preferred tool for percutaneous coronary interventions during the past decade by eliminating abrupt vessel closure and reducing restenosis compared with balloon angioplasty. While coronary artery stents prevent constrictive arterial remodeling and elastic recoil, the implantation is associated with more severe arterial vascular injury than balloon angioplasty alone. The arterial injury initiates a vasculoproliferative response with smooth muscle cell proliferation and migration as well as extracellular matrix formation, which may lead to severe neointimal hyperplasia with in-stent restenosis in 10-30% of cases. Sirolimus, a naturally occurring macrocyclic lactone, has been identified as a pharmacological cell cycle inhibitor with potent antiproliferative and antimigratory effects on vascular smooth muscle cells in vitro. The systemic administration of sirolimus has been shown to effectively reduce neointimal hyperplasia in experimental restenosis models. Subsequently, sirolimus has been incorporated at therapeutically important doses into biocompatible polymers, which made it suitable for stent-based drug elution. Investigation of sirolimus eluting stents in both experimental and clinical restenosis studies have demonstrated dramatic reductions in neointimal hyperplasia. Accordingly, sirolimus eluting stents offer an attractive mode of local drug delivery by minimizing systemic toxicity and maximizing local dose requirements. In addition, sirolimus eluting stents hold great promise to effectively prevent restenosis.
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BACKGROUND: There has been a continuous increase in the frequency of stenting, with recent reports suggesting performing stenting in all coronary angioplasty interventions. The aim of this retrospective investigation was to study the in-hospital and 1-year event rates of the most and the least avid stent user (both highly experienced) at our institution. METHODS: A total of 322 consecutive patients undergoing coronary angioplasty at our institution were retrospectively studied. Post-intervention CK, CK-MB and troponin T values and information of major in-hospital cardiac events were obtained from the charts. Events during a 1-year follow-up were collected. Comparisons were made between patients treated by the most generous (operator 1: 71% stenting) and the most frugal (operator 2: 49% stenting) stent user. RESULTS: The 2 groups were comparable. Post-intervention CK max (418+/- 744 versus 427+/- 1250; p = 0.33), CK-MB (105+/- 159 versus 239+/-263; p = 0.07) and troponin T (149+/-326 versus 282+/- 380; p = 0.3) values were similar in both groups. In-hospital (2% versus 1.8%; p = 1) and 1-year follow-up cardiac events (21% versus 18%; p = 0.58) between both groups were also comparable. CONCLUSIONS: Stenting is a useful tool for selected patients. However, a higher frequency of stenting does not beneficially influence in-hospital or 1-year cardiac events. These findings recommend provisional stenting rather then elective stenting.
OBJECTIVES: We sought to evaluate whether coronary collateral flow is clinically relevant for future cardiac ischemic events. BACKGROUND: The link between good collateral supply related to less myocardial damage and fewer cardiac events has not been established prospectively beyond doubt. METHODS: In 403 patients with stable angina pectoris undergoing percutaneous transluminal coronary angioplasty (PTCA) and quantitative collateral assessment, the occurrence of major adverse cardiac events ([MACE] cardiac death, myocardial infarction, unstable angina pectoris) and stable angina pectoris was monitored during follow-up. Collateral flow index (CFI) was determined using intracoronary pressure or Doppler guidewires. Mean aortic ([P(ao)] mm Hg) and distal coronary artery occlusive pressure ([P(occl)] mm Hg) during balloon angioplasty (PTCA), or distal coronary flow velocity time integral during ([V(occl)] cm) and after ([V(ø-occl)] cm) PTCA were measured continuously. Pressure-derived CFI was calculated as follows: (P(occl) - 5)/(P(ao) - 5). Doppler-derived CFI: V(occl)/V(ø-occl). Patients were subdivided into a group with well (CFI > or = 0.25) and poorly developed collaterals (CFI < 0.25). RESULTS: Average follow-up was 94 +/- 56 (15 to 202) weeks. There were 134 patients with CFI >or =0.25 (61 +/- 11 years) and 269 with CFI <0.25 (61 +/- 10 years). The overall cardiac ischemic event rate (MACE and stable angina pectoris) during follow-up was 23% in patients with CFI > or =0.25 and 20% in patients with CFI <0.25 (p = NS). However, only 2.2% of patients with good collateral flow suffered a major cardiac ischemic event, compared with 9.0% among patients with poorly developed collaterals (p = 0.01). The incidence of stable angina pectoris was significantly higher in patients with well developed collaterals than in those with poorly developed collaterals (21% vs. 12%; p = 0.01). CONCLUSIONS: In this relatively large population with chronic stable coronary artery disease undergoing quantitative collateral measurement, the beneficial impact of well developed collateral vessels on the occurrence of future major cardiac ischemic events is clearly demonstrated.
CONTEXT: Percutaneous coronary intervention (PCI) is associated with excellent short-term improvements in ischemic symptoms, yet only three fifths of PCI patients at 5 years and one third of patients at 10 years remain free of major adverse cardiac events (MACE). OBJECTIVE: To determine whether treatment with fluvastatin reduces MACE in patients who have undergone PCI. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled trial conducted at 77 referral centers in Europe, Canada, and Brazil. PATIENTS: A total of 1677 patients (aged 18-80 years) recruited between April 1996 and October 1998 with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL (3.5-7.0 mmol/L), with fasting triglyceride levels of less than 400 mg/dL (4.5 mmol/L). INTERVENTIONS: Patients were randomly assigned to receive treatment with fluvastatin, 80 mg/d (n = 844), or matching placebo (n = 833) at hospital discharge for 3 to 4 years. MAIN OUTCOME MEASURE: Survival time free of MACE, defined as cardiac death, nonfatal myocardial infarction, or reintervention procedure, compared between the treatment and placebo groups. RESULTS: Median time between PCI and first dose of study medication was 2.0 days, and median follow-up was 3.9 years. MACE-free survival time was significantly longer in the fluvastatin group (P =.01). One hundred eighty-one (21.4%) of 844 patients in the fluvastatin group and 222 (26.7%) of 833 patients in the placebo group had at least 1 MACE (relative risk [RR], 0.78; 95% confidence interval [CI], 0.64-0.95; P =.01). This result was independent of baseline total cholesterol levels (above [RR, 0.76; 95% CI, 0.56-1.04] vs below [RR, 0.77; 95% CI, 0.57-1.02] the median). In subgroup analysis, the risk of MACE was reduced in patients with diabetes (n = 202; RR, 0.53; 95% CI, 0.29-0.97; P =.04) and in those with multivessel disease (n = 614; RR, 0.66; 95% CI, 0.48-0.91; P =.01) who received fluvastatin compared with those who received placebo. There were no instances of creatine phosphokinase elevations 10 or more times the upper limit of normal or rhabdomyolysis in the fluvastatin group. CONCLUSION: Fluvastatin treatment in patients with average cholesterol levels undergoing their first successful PCI significantly reduces the risk of major adverse cardiac events.
BACKGROUND: The platelet glycoprotein IIb/IIIa receptor inhibitor abciximab, a monoclonal antibody, has been shown to improve early and late outcomes among diabetic patients undergoing percutaneous coronary intervention (PCI). It is unknown whether small-molecule agents confer similar benefits. METHODS AND RESULTS: In 18 countries, 4809 patients undergoing PCI with stent implantation were randomized to tirofiban or abciximab. At the time of enrollment, patients were stratified according to diabetes status. As compared with non-diabetic patients, patients with diabetes (n=1117) showed similar 30-day ischemic outcomes, an increased incidence of any target vessel revascularization (TVR) at 6 months (10.3% versus 7.8%; P= 0.008), and a trend toward higher 1-year mortality (2.5% versus 1.6%; P=0.056). Among diabetic patients randomized to tirofiban (n=560), the incidence of death, myocardial infarction (MI), or urgent TVR at 30 days was 6.2%, and among those randomized to abciximab (n=557) it was 5.4% (hazard ratio [HR] 1.16; P=0.540). At 6 months, the composite of death, MI, or any TVR occurred in 15.7% and in 16.9% of tirofiban and abciximab patients, respectively (HR 0.93; P=0.610). Any TVR occurred in 9.5% and 11.1%, respectively (HR 0.84; P= 0.366). The 1-year mortality was 2.1% in the tirofiban group and 2.9% in the abciximab group (HR 0.74; P= 0.436). CONCLUSIONS: Among diabetic patients undergoing PCI, tirofiban and abciximab were associated with comparable event rates, including similar rates of 6-month TVR and 1-year mortality. These findings suggest that the non-glycoprotein IIb/IIIa properties of abciximab do not translate into a discernible long-term clinical benefit among diabetic patients.
BACKGROUND: Stenting has proved beneficial for treating threatened closure and reducing restenosis after balloon angioplasty. However, the implantation of a coronary metallic prosthesis has been related to impaired vasomotion distal to the stent as assessed by acetylcholine infusion. Thus, the purpose of the present study was to determine the vasomotion of stented coronary arteries and to assess its influence on the vasomotion of adjacent vessel segments during bicycle exercise. METHODS AND RESULTS: Biplane quantitative coronary angiography was performed at rest and during bicycle exercise in 26 patients with coronary artery disease. Twelve patients had single vessel disease with stable angina pectoris (controls; group 1). Fourteen patients underwent coronary stenting for therapeutic reasons and were studied 10+/-3 months after the intervention (group 2). Minimal luminal area, stent area, and proximal and distal vessel areas were determined. In controls (group 1), vasoconstriction of the stenotic artery (- 29+/-4%; P<0.001) was observed during exercise, whereas the normal segment showed vasodilation (15+/-4%; P<0.05). In group 2, vasomotion of the stented segment was eliminated (0+/-1%), whereas the proximal and distal segments showed exercise-induced vasodilation (8+/-2% and 11+/-3%, respectively; P<0.005), which was not different from control segments (10+/-2%). Sublingual nitroglycerin was associated with maximal vasodilation of the proximal and distal vessel segments (30+/-8% and 38+/-13%, respectively; P<0.005). CONCLUSIONS: In contrast to the vasoconstriction of vessels in control patients, normal vasodilation of proximal and distal segments occurred during the physiological stress of exercise in patients with coronary stent placement. As expected, vasomotion was abolished in the stented region.
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