The 6Fr Angio-Seal arterial closure device: results from a multimember prospective registry.

Femoral closure devices help early ambulation after cardiac catheterization without incurring additional risk to the patients. This report summarizes the safety and efficacy data of the 6Fr Angio-Seal device.

Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Potential Class Improvement From Intramyocardial Channels.

BACKGROUND: Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty is not possible. We undertook a randomised trial to assess the safety and efficacy of this technique. METHODS: 221 patients with reversible ischaemia of Canadian Cardiovascular Society angina class III (61%) or IV (39%) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned PTMR with a holmium:YAG laser plus continued medical treatment (n=110) or continued medical treatment only (n=111). The primary endpoint was the exercise tolerance at 12 months. Analyses were by intention to treat. FINDINGS: 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-treatment-group patients completed the study. Exercise tolerance at 12 months had increased by a median of 89.0 s (IQR -15 to 183) with PTMR compared with 12.5 s (-67 to 125) with medical treatment only (p=0.008). On masked assessment, angina class was II or lower in 34.1% of PTMR patients compared with 13.0% of those medically treated. All indices of the Seattle angina questionnaire improved more with PTMR than with medical care only. By 12 months there had been eight deaths in the PTMR group and three in the medical treatment group, with similar survival in the two groups. INTERPRETATION: PTMR was associated with increased exercise tolerance time, low morbidity, lower angina scores assessed by masked reviewers, and improved quality of life. Although there is controversy about the mechanism of action, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clinical benefits in the defined population of patients.

Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials.

Despite advances in other aspects of cardiac catheterization, manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management. Suture-mediated closure may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial (STAND I) evaluated the 6Fr Techstar device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 515 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS). Major complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05). Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significantly shorter for suture-mediated closure. Suture-mediated closure of the arterial puncture site thus affords reliable immediate hemostasis and shortens the time to ambulation without significantly increasing the risk of local complications.

A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty.

OBJECTIVES: A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty. Background. Peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures. METHODS: A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques. RESULTS: After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n=90 patients] vs. 17.6 +/- 9.2 min [n= 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving the heparin], 7.6 +/- 11.6 min [n= 85 receiving heparin], 33.6 +/- 24.2 min [n= 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 hours vs. 19.2 +/- 17.8 hours, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 hours, without heparin), as compared with control compression techniques (32.7 +/- 18.8 hours, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14). CONCLUSION: A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.

Outpatient PTCA with same day discharge is safe and produces high patient satisfaction level.

Improved technology and enhanced clinical expertise have allowed physicians to become more cost effective and provide better patient care. A prospective, randomized study was done to determine the safety of same day discharge following PTCA. Of 1911 elective PTCA patients, 262 patients (14%) were stratified as low risk and candidates for same day discharge. Of the 262 eligible patients, 90 (34%) were randomized to either an in-patient (n = 47) or outpatient (n = 43) strategy. Similar procedural and clinical outcomes were found between the two groups, with 33 of 43 outpatients (77%) discharged on the same day as the procedure. No late complications (1 and 7 days post procedure) were observed in this outpatient group. Additionally, a satisfaction survey was conducted of all patients and their family members that showed an overwhelming (p < 0.05) preference and comfort with the same day discharge.

Angiographic and procedural outcome after coronary angioplasty in high-risk subsets using a decremental diameter (tapered) balloon catheter. Tapered Balloon Registry Investigators.

The angiographic and clinical outcomes of 115 patients (129 lesions) treated at 11 clinical centers using a decremental diameter (tapered) balloon catheter were evaluated. The presence of marked tapering of the reference vessel, lesion location involving a bifurcation or anastomosis of a saphenous vein graft, or total coronary occlusion where estimation of the distal vessel size was difficult were indications for this device. The tapered balloon was used as the initial dilatation device in 62 patients (73 narrowings), and as a secondary device in 53 patients (56 narrowings). Lesions selected for tapered balloon angioplasty were generally complex (95% had > or = 1 and 60% had > or = 2 adverse morphologic features). Vessel diameters were larger in the proximal reference segments (3.07 +/- 0.52 mm) than in distal ones (2.48 +/- 0.45 mm) (p<0.001). After tapered balloon angioplasty, the minimal lumen diameter increased from 0.85 +/- 0.34 mm to 2.13 +/- 0.50 mm (p<0.001), and the percent diameter stenosis decreased from 69 +/- 12% to 24 +/- 12% (p<0.001). Coronary dissections occurred in 20% of lesions; they were severe in 4% (National Heart, Lung, and Blood Institute grade C to F). Abrupt closure occurred in 4.3% of patients (2.6% immediate; 1.7% delayed). Procedural success was obtained in 110 patients (96%); major complications (in-hospital death, myocardial infarction, or emergency coronary bypass surgery) occurred in 3 patients (2.7%). Coronary angioplasty using the tapered balloon catheter appears to be a safe and effective technique for the treatment of complex lesion subsets, particularly those involving coronary arteries with marked segmental tapering.

Baseline and 6-month costs of primary angioplasty therapy for acute myocardial infarction: results from the primary angioplasty registry.

OBJECTIVES: This study sought to describe the economic outcomes from a prospective multicenter registry of primary coronary angioplasty. BACKGROUND: Interest in coronary angioplasty without preceding thrombolytic therapy as a primary reperfusion strategy has increased as a result of three recent randomized trials showing outcomes equivalent to or better than standard thrombolytic therapy. METHODS: The Primary Angioplasty Registry enrolled 270 patients with acute myocardial infarction at six private tertiary care medical centers. Baseline and follow-up medical costs and counts of resources consumed were collected from enrollment to the 6-month follow-up visit. Correlates and predictors of cost were identified with multivariable linear regression modeling. RESULTS: Ninety-five percent of patients had a revascularization procedure during the baseline hospital period: 85% had coronary angioplasty only; 4% had coronary bypass surgery only; 6% had both procedures. The total mean baseline hospital cost (not charge) was $13,113, with mean physician fees of $5,694. During the follow-up period, repeat coronary angiography was performed in 21% of patients, whereas 13% had repeat angioplasty and 3% bypass surgery. Mean hospital follow-up costs were $3,174, with mean physician fees of $1,443. Independent correlates of higher baseline hospital costs included older age (p = 0.049), anterior infarction (p = 0.03), initial Killip class (p < 0.0001), more severe coronary disease (p = 0.0015), need for bypass surgery alone or in addition to angioplasty (p < 0.0001) and recurrent ischemia (p < 0.0001). CONCLUSIONS: Costs of primary angioplasty for patients with acute myocardial infarction eligible for thrombolysis were strongly influenced by infarction- and procedure-related complications but only modestly influenced by patient selection factors.

Transluminal extraction catheter for the treatment of diseased saphenous vein grafts: a multicenter experience.

To evaluate the efficacy, safety, and long-term results of atherectomy using the Transluminal Extraction catheter (TEC), patients with diseased saphenous vein grafts were enrolled in a prospective nonrandomized trial. Patients were followed to hospital discharge for acute complications and underwent routine 6-mo reevaluation with repeat cardiac catheterization to assess restenosis. Atherectomy was performed on 650 graft lesions in 538 consecutive patients (male 81%; mean age 66 yr; range 37-81). Mean graft age was 8.3 yr; (range 0.3-20) with 85% of grafts > 3 yr of age. Complex lesion morphology included thrombus (28%), ulceration (13%), and eccentricity (50%). Lesion success was achieved in 606 lesions (93%) with clinical success in 479 patients (89%). Lesion success was achieved in 90% of thrombus containing lesions, 97% of ulcerated lesions, and 97% of grafts > 3 yr. Complications included nonfatal myocardial infarction in 4 (0.7%) of patients, emergency bypass surgery in 2 (0.41%), and in-hospital death in 17 patients (3.2%). Angiographic follow-up at 6 mo was obtained from 268 lesions in 227 patients. The overall lesion angiographic restenosis rate was 60%. TEC atherectomy can be performed in patients with diseased saphenous vein grafts with high primary success and low complication rates. It is suitable for use in aged grafts, particularly in the presence of thrombus and ulcerations, and may be superior to balloon angioplasty alone in this group of patients.

Six-month clinical and angiographic follow-up after direct angioplasty for acute myocardial infarction. Final results from the Primary Angioplasty Registry.

BACKGROUND: After direct angioplasty in the setting of acute myocardial infarction, patients were followed clinically and angiographically for 6 months at six experienced centers to evaluate outcomes. METHODS AND RESULTS: Of 258 patients with 6-month follow-up after surviving initial hospitalization, 5 (2%) died, 8 (3%) had nonfatal infarctions, 56 (22%) had chest pain, of whom 25 (10%) required hospitalization, and 42 (16%) patients needed repeat angioplasty. Of 203 eligible patients, 154 (76%) had angiographic follow-up. The infarct-related artery remained patent (defined as TIMI 2 or 3 flow) in 87%, while 13% developed reocclusion (TIMI 0 or 1 flow) by 6 months after discharge. Patients with reocclusion were more likely to have adverse events, including 35% with clinically evident reinfarction and 59% requiring repeat angioplasty. The median ejection fraction improvement from acute to follow-up study was 6%, with no improvement in patients with a reoccluded infarct-related artery and an 8% improvement in patients with a patent infarct-related artery. CONCLUSIONS: The positive clinical outcomes recorded immediately after direct angioplasty persisted through 6 months of follow-up. Although the incidence of clinical end points was equivalent to or lower than thrombolytic therapy trials, restenosis is a substantial problem. These findings provide evidence beyond the initial hospitalization that direct angioplasty is a reasonable choice for the treatment of acute myocardial infarction.

Primary coronary angioplasty for acute myocardial infarction (the Primary Angioplasty Registry).

During a 14-month period, 6 experienced centers prospectively enrolled 271 patients into a registry in which percutaneous transluminal coronary angioplasty was the primary treatment for acute myocardial infarction. Patients age > 18 years who presented with ST-segment elevation on the 12-lead electrocardiogram were enrolled if symptom duration was < 12 hours and there was no proclivity for bleeding. An independent core angiographic laboratory processed the angiographic data. Of 271 patients giving informed consent, 245 (90%) were deemed anatomically suitable and underwent angioplasty therapy. Upon leaving the catheterization laboratory 98% of patients had achieved reperfusion; 92% had a residual visual stenosis < or = 50%. Emergency bypass surgery was required in 14 patients (5%) for either failed angioplasty (n = 3) or presumed life-threatening anatomy (n = 11). The in-hospital mortality rate was 4%, whereas the reinfarction rate was 3% and the stroke rate was 1%, with 1 intracranial hemorrhage and 2 embolic events. Bleeding requiring > or = 2 units of blood occurred in 46 patients (18%); 14 of these transfusions were related to coronary artery bypass surgery. Primary angioplasty is associated with a high reperfusion rate, low in-hospital mortality and few recurrent myocardial ischemic events. These results point to the need for a large-scale trial comparing angioplasty with thrombolytic therapy in the setting of acute myocardial infarction.

Effectiveness of holmium laser-assisted coronary angioplasty. The Holmium Laser Coronary Registry.

The efficacy of holmium laser-assisted angioplasty was studied in 365 narrowings in 331 consecutive patients with coronary artery disease. Clinical indications for study were unstable angina pectoris in 140 patients (42%), stable angina in 136 patients (41%), postmyocardial infarction angina in 35 patients (10.5%), silent myocardial ischemia in 11 patients (3%), acute myocardial infarction in 1 patient (0.3%) and undefined in 8 patients (2%). Coronary morphology characteristics by Multivessel Angioplasty Prognosis Study group criteria were type A in 12.6%, type B1 in 34.2%, type B2 in 27.4% and type C in 25.4%. The laser successfully crossed the total length of the narrowing in 85.2%. Procedural success was 94.2%. Laser alone reduced mean percent luminal narrowing from 88 +/- 11% to 57 +/- 22%. Subsequent balloon angioplasty further reduced the mean luminal narrowing to 23 +/- 18%. Major complication rate was 2.7% (death 0.3%, Q-wave myocardial infarction 0.5%, and emergent bypass surgery 2.7%). Six-month angiographic restenosis (> 50% stenosis) rate was 44%.

A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty.

OBJECTIVES: A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty. BACKGROUND: Peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures. METHODS: A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques. RESULTS: After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving heparin], 33.6 +/- 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/- 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 h, without heparin), as compared with control compression techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14). CONCLUSIONS: A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.

The traumatic dural sinus injury--a clinical study.

In a period of 13 years 978 cases of severe head injuries were operated on in our clinic. An analysis of the medical reports includes injuries of the superficial dural sinus (39 cases = 4%): among these injuries of the anterior and central part of the superior sagittal sinus (66 per cent), injuries of the transverse sinus (18 per cent), injuries of the posterior part of the superior sagittal sinus (8 per cent), and combined injuries of different dural sinuses (8 per cent). Clinical data, i.e. the causes of accident, radiological examination results, intracranial lesions, operation techniques and outcome are analysed and discussed. The analysis of cases with dural sinus injuries shows a high mortality rate (total mortality rate: 16 patients = 41%; intra-operative mortality rate: 8 patients = 20%).

[Postoperative results following severe craniocerebral trauma]. / Operationsergebnisse nach schwerem Schädel-Hirn-Trauma.

918 patients were operated because a severe head injury in our Neurotraumatological Clinic during a period of 12 years. 733 patients (80 per cent) could been evaluated as well with regard to the Glasgow Coma Scale and the Glasgow Outcome Scale as analysed in four diagnose groups corresponding to the period of live. Patients with epidural haematoma and open head injuries showed a better forecast than patients with acute subdural haematoma. Those with contusion of the brain and less than 8 points in the Glasgow Coma Scale or those in a higher age had a bad prognosis.

[Results of the surgical management of frontobasal injuries]. / Ergebnisse der operativen Versorgung von frontobasalen Verletzungen.

The author reports about 183 patients with frontobasal injuries. 50 per cent of them were operated immediately because open injuries or intracranial complications. The other half was operated in an interval of 5 to 10 days after injury. The localisation of the frontobasal lesion, clinical results according to the Glasgow Coma Scale and Glasgow Outcome Scale as well as the operation methods are demonstrated and discussed. The operative closure of the dura failure with an unipedicled periosteal flaps ensures good results in the most cases.

[Aspects of rehabilitation after early stabilization of complex injury of the cervical spine]. / Aspekte der Rehabilitation nach Frühstabilisierung der komplexen HWS-Verletzung.

Within the scope of catamnestic investigation and a follow-up examination 170 fractures of the cervical spinal cord, operated in a period of 8 years, were explored. Dependent on the neurological starting point the length of stay in hospital, the time of temporary disablement and the results of social rehabilitation were evaluated. The examination results are appraised.

[The need for spongiosa grafting in thoracolumbar vertebral body fractures]. / Zur Notwendigkeit der Spongiosaplastik bei thorakolumbalen Wirbelkörperbrüchen.

Report on examination of 31 patients with fractures of spine in thoracolumbar region. All patients were treated by external fixation without accomplishing a plastic of spongiosa. The permanent SI-Index after operation is coming to 0.85. The outcome by use of external fixation is attesting our opinion, that with this method a plastic of spongiosa isn't necessary.

[Results of surgical treatment of 170 injuries of the middle and lower cervical spine]. / Ergebnisse der operativen Behandlung von 170 Verletzungen der mittleren und unteren Halswirbelsäule.

The article presents the results of examination of 170 patients with a cervical spine injury, who had been operated by ventral interbody fusion. It presents operative procedures and discusses the results concerning to neurological deficit before treatment. Cloward-Crock's and Bailey-Badgley's technique together with anterior plate fixation yields immediate stabilization and provides the best functional outcome.

[Typical CT findings with the intrathecal infusion test in post-traumatic disorders of cerebrospinal fluid dynamics]. / Typische CT-Befunde während des intrathekalen Infusionstestes bei posttraumatischen Störungen der Liquordynamik.

Simultaneous computer tomographic and cerebrospinal fluid dynamics examinations in patients with high-pressure hydrocephalus, normal pressure hydrocephalus and cerebral atrophic processes are presented and discussed. Exclusive CT and MR examinations do not allow a differentiation of patients with normal pressure hydrocephalus and patients with cerebral atrophy. In the simultaneous examinations the morphological substrate during the intrathecal infusion test is represented.

[Indications for the intrathecal infusion test in disorders of cerebrospinal fluid dynamics]. / Indikationen zum intrathekalen Infusionstest bei Störungen der Liquordynamik.

Indications for and results of the intrathecal infusion test including 50 patients with chronic disturbances of the circulation of the cerebrospinal fluid are presented and discussed. The computer-aided infusion test permits in 93 per cent a reliable differentiation between patients with a normal-pressure hydrocephalus and those with cerebro-atrophic processes. Functional checking of the valve systems is a further indication for the intrathecal infusion test. In patients with a classical pressure hydrocephalus or subdural hygromas, however, we do not see an indication for this invasive examination procedure.