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Biomedical subjects

C J Davidson

Publications and source records attributed to C J Davidson.

At least 37 records · Page 2Linked to original sources
PubMed1999

Thrombotic thrombocytopenic purpura associated with ticlopidine in the setting of coronary artery stents and stroke prevention.

BACKGROUND: One of the most unusual causes of thrombotic thrombocytopenic purpura (TTP), a life-threatening disease, is ticlopidine hydrochloride, an antiplatelet agent used to prevent strokes in high-risk populations or following coronary artery stent placement. Recently, Hoffman-LaRoche Pharmaceuticals, following reports of 20 deaths from ticlopidine-associated TTP, updated the information about the hematologic adverse effects of the drug. OBJECTIVES: To review our recent findings on ticlopidine-associated hematologic toxic effects, which served as the impetus for the revised warnings, and to discuss the implications of these findings. METHODS: Data were obtained from the Food and Drug Administration's MedWatch program, published phase 3 clinical trials and case reports, hematologists, and plasmapheresis centers. RESULTS: No cases of TTP have been reported in phase 3 ticlopidine trials. In contrast, postmarketing surveillance has identified serious adverse drug reactions to ticlopidine, resulting in 259 deaths, with TTP accounting for 40 of these deaths. Detailed information was available on 98 cases of ticlopidine-associated TTP. Compared with 42 patients in the coronary artery stent setting, 56 patients with ticlopidine-associated TTP in the stroke prevention setting were more likely to be women (62.5% vs 28.6%; P = .01). Before the onset of TTP in patients receiving stroke prevention therapy and patients with stent placement, ticlopidine had been used for less than 2 weeks in 5.4% and 2.4%, between 2 and 3 weeks in 17.9% and 21.4%, between 3 and 4 weeks in 30.4% and 38.1%, and between 4 and 12 weeks in 46.4% and 38.1%, respectively. Death occurred in almost 60% of all patients not receiving plasmapheresis compared with 21.9% of patients receiving plasmapheresis for stroke prevention and 14.3% of patients receiving plasmapheresis in the stent setting. CONCLUSIONS: Use of ticlopidine requires frequent physician visits and laboratory tests for at least 3 months in the stroke prevention setting, while, with short-term use in the coronary artery stent setting, adverse events are less likely to occur. These factors, as well as competition from clopidogrel bisulfate, a new antiplatelet agent, potentially limit the feasibility of ticlopidine as a stroke prevention agent, while having less impact on its use following coronary artery stent placement.

Coronary Thrombosis↗
PubMed1999

Comparison of immediate and in-hospital results of conventional balloon and perfusion balloon angioplasty using intracoronary ultrasound.

Angiographic studies have demonstrated that perfusion balloon percutaneous transluminal coronary angioplasty (PTCA) may result in modestly improved luminal gains and fewer major dissections than conventional balloon PTCA. However, intracoronary ultrasound (ICUS), which is more sensitive than angiography in evaluating the incidence, extent, and severity of dissection, was not used. We randomized 48 patients with 54 coronary stenoses to conventional or perfusion balloon PTCA. Four 2-minute inflations were permitted with conventional balloon PTCA. Two 10-minute inflations were allowed with perfusion balloon PTCA. Quantitative coronary angiography and ICUS were performed before and after treatment. In-hospital clinical events were recorded. Conventional and perfusion balloon PTCA achieved similar improvements in lumen diameter (1.25+/-0.51 vs 1.28+/-0.51 mm) and reductions in percent stenosis (-45+/-21% vs -44+/-15%) by quantitative coronary angiography. Comparable gains in lumen diameter (0.62+/-0.39 vs 0.50+/-0.38 mm) and lumen area (2.70+/-1.96 vs 2.05+/-1.52 mm2) were observed on ICUS. Angiography demonstrated similar rates of any dissection (36% vs 21%) and major dissection (12% vs 7%). ICUS identified a similar incidence of any dissection (60% vs 76%) and type II dissection (52% vs 62%). The relative dissection area was also similar (9.2+/-5.6% vs 7.8+/-5.8%). One conventional balloon patient experienced postprocedural chest pain. No patient in either group died, or had myocardial infarction, abrupt closure, or urgent revascularization.

Angioplasty, Balloon, Coronary↗
PubMed1998

Internal mammary artery graft angioplasty: acute and long-term outcome.

Secondary to the low attrition rate of internal mammary artery grafts, limited data are available on the clinical and angiographic outcome of patients who have undergone balloon angioplasty of an internal mammary artery stenosis. This study examined a consecutive series of 68 patients who underwent balloon angioplasty of an internal mammary artery graft over a 9-year period. Procedural success was achieved in 60 of 68 (88%) patients. The primary reason for procedural failure was extreme vessel tortuosity. There were no major in-hospital complications. Angiographic follow-up was obtained in 78% of the patients with an angiographic restenosis rate of 19%. The overall event-free survival in patients with an initially successful procedure was 92%. In conclusion, internal mammary artery balloon angioplasty has both an excellent initial success rate as well as a low incidence of restenosis and repeat target lesion revascularization.

Aged↗
PubMed1998

Myonecrosis after revascularization procedures.

The detection of elevated cardiac enzyme levels and the occurrence of electrocardiographic (ECG) abnormalities after revascularization procedures have been the subject of recent controversy. This report represents an effort to achieve a consensus among a group of researchers with data on this subject. Creatine kinase (CK) or CK-MB isoenzyme (CK-MB) elevations occur in 5% to 30% of patients after a percutaneous intervention and commonly during coronary artery bypass graft surgery (CABG). Although Q wave formation is rare, other ECG changes are common. The rate of detection is highly dependent on the intensity of enzyme and ECG measurement. Because most events occur without the development of a Q wave, the ECG will not definitively diagnose them; even the ECG criteria for Q wave formation signifying an important clinical event have been variable. At least 10 studies evaluating > 10,000 patients undergoing percutaneous intervention have demonstrated that elevation of CK or CK-MB is associated not only with a higher mortality, but also with a higher risk of subsequent cardiac events and higher cost. Efforts to identify a specific cutoff value below which the prognosis is not impaired have not been successful. Rather, the risk of adverse outcomes increases with any elevation of CK or CK-MB and increases further in proportion to the level of intervention. This information complements similar previous data on CABG. Obtaining preprocedural and postprocedural ECGs and measurement of serial cardiac enzymes after revascularization are recommended. Patients with enzyme levels elevated more than threefold above the upper limit of normal or with ECG changes diagnostic for Q wave myocardial infarction (MI) should be treated as patients with an MI. Patients with more modest elevations should be observed carefully. Clinical trials should ensure systematic evaluation for myocardial necrosis, with attention paid to multivariable analysis of risk factors for poor long-term outcome, to determine the extent to which enzyme elevation is an independent risk factor after considering clinical history, coronary anatomy, left ventricular function and clinical evidence of ischemia. In addition, tracking of enzyme levels in clinical trials is needed to determine whether interventions that reduce periprocedural enzyme elevation also improve mortality.

Angioplasty, Balloon, Coronary↗
PubMed1997

Predictors of acute and long-term outcome with transluminal extraction atherectomy: the New Approaches to Coronary Intervention (NACI) registry.

The New Approaches to Coronary Intervention (NACI) registry was established to define the role of new coronary devices in overcoming the limitations of balloon angioplasty. The purpose of the present study was to evaluate the acute and long-term efficacy of the transluminal extraction catheter (TEC) device utilizing data from the NACI registry and identify clinical and anatomic patient subsets who may benefit from this device. From 1990-1994, >4,300 patients from 39 clinical sites enrolled consecutive patients treated with one of the 7 new devices to the NACI registry. The study population consists of 331 patients (385 lesions) treated with planned TEC as the sole new device. Of these patients, 243 (292 lesions) were treated for saphenous vein graft (SVG) disease and 88 (93 lesions) for native disease. Patients undergoing SVG treatment were older and more likely to be male. They had lower ventricular function, more unstable angina, and a higher incidence of congestive heart failure. Multivessel disease was more prevalent in the SVG cohort, as was evidence of thrombus before treatment. Although device success was achieved in 50% of SVG lesions and 41% of native lesions, lesion success was achieved in 90% and 78%, respectively, after adjunctive balloon angioplasty, and procedure success rates were 86% and 79%, respectively. The in-hospital major complication (death/Q-wave myocardial infarction/emergency coronary artery bypass graft [CABG] surgery) rate was higher in the SVG cohort (6.2% vs 2.3%), mainly due to higher mortality rate (5.3% vs 1.1%). Multivariate analysis showed that SVG was not an independent predictor for either an in-hospital major complication or clinical failure. The risk factors for major in-hospital complications were history of congestive heart failure (odds ratio = 3.17) and thrombus (odds ratio = 3.36). For clinical failure the risk factors were diabetes (odds ratio = 1.88), thrombus (odds ratio = 2.08), and calcium (odds ratio = 3.09). One-year rates of death, Q-wave myocardial infarction, or any repeat revascularization were 51% in the SVG cohort and 41% in the native cohort. Following adjustment, patients treated for SVG disease did not have a higher risk when compared with those treated for native disease. The factors significantly associated with this composite event at 1 year are male (relative risk = 1.41), patients with history of congestive heart failure (relative risk = 1.56), and total occlusions (relative risk = 1.52). This study shows that for both SVG and native cohorts, device success rates were low with TEC alone, but acceptable lesion success rates were achieved when adjunctive PTCA was used. In-hospital as well as 1-year major complications were higher in the SVG cohort. However, after adjusting for other risk factors, SVG attempt was not significantly associated with either in-hospital or 1-year events.

Aged↗
PubMed1997

In vitro identification of angioplasty-induced injury by use of vascular acoustic emissions.

BACKGROUND: We have developed a novel method of diagnosing stress-induced vascular injury. This approach uses the sound energy released from atherosclerotic arterial tissue during in vitro balloon angioplasty to characterize type and severity of induced trauma. METHODS AND RESULTS: Thirty-two postmortem human peripheral arterial specimens 1.0 cm long were subjected to in vitro balloon angioplasty with simultaneous acoustic emission monitoring. Specimens were examined before and after angioplasty to ascertain the extent of angioplasty-induced injury. Gross observation was used to identify dissection. A three-dimensional intravascular ultrasound reconstruction technique was used to estimate the luminal surface area of the specimen. Change in luminal surface area (postangioplasty minus preangioplasty) was used to quantify induced injury. The energy content and spectral distribution of the digitally acquired vascular acoustic emission (VAE) signals were computed. Comparisons of angioplasty-induced trauma with VAE signal characteristics were made. Dissection (mural laceration of variable depth) was observed in 15 of 32 specimens. Eleven showed no evidence of induced dissection, and 6 had preexisting intimal disruptions. The energy content of the VAE signals collected from specimens with dissection was greater than that obtained from those in which dissection was absent: 845 +/- 89.4 mJ (mean +/- SEM; n = 15) versus 128 +/- 40.8 mJ (n = 1 l; P < .001). Comparison of induced trauma and VAE signal energy demonstrated a proportional relationship (r = .87, P < .001, n = 32). CONCLUSIONS: VAE signals contain information characterizing type and severity of angioplasty-induced arterial injury. Because vascular injury is related to adverse procedural outcome, development of VAE technology as an adjunct to conventional diagnostic modalities may facilitate optimal balloon angioplasty delivery and postprocedural care.

Analysis of Variance↗
PubMed1997

Prognostic implication of creatine kinase elevation following elective coronary artery interventions.

OBJECTIVE: To determine the prognostic significance of creatine kinase (CK) elevation following elective percutaneous transluminal coronary angioplasty (PTCA). DESIGN: Retrospective cohort study. SETTING: Tertiary care referral center. SUBJECTS: A total of 253 consecutive patients with total CK and CK-MB fraction (CK-MB) elevation (case patients) and 120 patients without CK elevation (controls). Control patients had undergone interventions during the same month and year using the same devices. MAIN OUTCOME MEASURES: In-hospital and late cardiac mortality, subsequent myocardial infarction, and the combined end point of cardiac mortality or myocardial infarction. RESULTS: Patient groups were similar with respect to age, sex, extent of coronary artery disease, left ventricular function, number of lesions treated by PTCA, and mean duration of follow-up (>3.5 years). Cardiac mortality was significantly greater (P=.02) for patients with CK elevation after PTCA. When patients were categorized according to peak CK elevation, cardiac mortality differed significantly among patient groups (P=.007), with increased cardiac mortality observed for patients with high (>3.0 times normal) and intermediate (1.5 to 3.0 times normal) CK elevations. In multivariate analyses, higher peak CK and lower ejection fraction were the most important predictors of increased cardiac mortality (both, P<.001); the relative risk for cardiac mortality was 1.05 (95% confidence interval, 1.03-1.08) per 100-U/L increment increase in CK. CONCLUSIONS: Creatine kinase elevation following elective PTCA is associated with increased late cardiac mortality. This increase in cardiac mortality is independent of clinical variables, severity of heart disease, coronary artery lesion characteristics, interventional devices, and procedural outcomes. Even patients with lesser degrees of CK elevation are at significantly increased risk for late cardiac death.

Aged↗
PubMed1997

Influence of coronary atherosclerotic remodeling on the mechanism of balloon angioplasty.

OBJECTIVES: Intracoronary ultrasonography was used to assess coronary arteries before and after balloon percutaneous transluminal coronary angioplasty (PTCA) to determine whether the mode of coronary atherosclerotic remodeling affects the mechanism of balloon dilation. BACKGROUND: Coronary arteries may enlarge or shrink in response to atherosclerotic plaque development. The effect of coronary remodeling on the mechanism of balloon PTCA has not yet been studied. METHODS: Forty-one patients with 47 native de novo coronary artery lesions were studied with a 30 MHz intracoronary ultrasound catheter before and after balloon PTCA. Images were analyzed at the lesion site and the adjacent reference segments. At each site the lumen, vessel, and plaque area and the percent area stenosis were measured. Lesions were separated into two groups based on relative vessel area (lesion vessel area/reference vessel area). A relative vessel area >1.0 defines adaptive enlargement (group 1, n = 25), whereas a relative vessel area < or =1.0 reflects coronary shrinkage (group 2, n = 22). Regression analysis examined whether elastic recoil and the PTCA balloon/vessel area ratio correlated. RESULTS: After balloon PTCA was performed, both the enlargement and shrinkage groups had similar gains in luminal area (2.3 +/- 1.8 mm2 [mean +/- SD] vs 2.8 +/- 1.7 mm2, p = 0.32), reduction in percent stenosis (-19.2% +/- 11.5% vs -14.4 +/- 12.7, p = 0.18), and final lumen area (4.9 +/- 1.7 mm2 vs 4.7 +/- 1.9 mm2, p = 0.73). However, the mechanism of luminal enlargement was different in each group. Reduction in plaque area was significantly greater in the enlargement group (group 1, -2.0 +/- 1.7 mm2 vs group 2, 0.04 +/- 2.2 mm2; p = 0.001), whereas increased vessel area was more important in the shrinkage group (group 1, 0.8 +/- 1.5 mm2 vs group 2, 2.4 +/- 2.3 mm2; p = 0.009). Positive correlation was seen between elastic recoil and the balloon/vessel area ratio in lesions with vessel enlargement (r = 0.80, p < 0.0001). No such correlation was observed in shrinkage vessels (r = 0.28, p = 0.21 ). CONCLUSIONS: The acute luminal gain after balloon PTCA is similar regardless of the type of coronary remodeling. However, the mode of remodeling affects the mechanism of balloon dilation such that enlargement vessels exhibit plaque compression, whereas shrinkage arteries demonstrate vessel stretch. The post-PTCA elastic recoil correlates linearly to the balloon/vessel area ratio in arteries that have undergone adaptive enlargement.

Angioplasty, Balloon, Coronary↗
PubMed1997

Intravascular ultrasound in the setting of directional coronary atherectomy and percutaneous transluminal coronary rotational atherectomy.

The first section of this article reviews how intracoronary ultrasound (ICUS) has been used to identify the mechanisms of action of directional coronary atherectomy (DCA) and examines the influence of plaque composition and morphology on DCA outcomes. The process of restenosis is then described. Results from trial using ICUS-guided DCA are evaluated, demonstrating how the information obtained from ICUS is being used to improve the angiographic and clinical outcomes of directional atherectomy. Finally, data are incorporated to provide practical applications for the use of DCA.

Angioplasty, Balloon, Coronary↗
PubMed1997

Rat tendon morphologic and functional changes resulting from soft tissue mobilization.

Augmented Soft Tissue Mobilization (ASTM) is a new non-invasive soft tissue mobilization technique which has been used successfully to treat a variety of musculoskeletal disorders. The purpose of this study was to determine the effects of ASTM therapy on the morphological and functional characteristics of enzyme induced injured rat Achilles tendons. Four groups of five rats were allocated as follows: (A) control, (B) tendinitis, (C) tendinitis plus ASTM, and (D) ASTM alone. Collagenase injury was induced, and the surgical site was allowed to heal for 3 wk. ASTM was performed on the Achilles tendon of groups C and D for 3 min on postoperative days 21, 25, 29, and 33 for a total of four treatments. Gait data were gathered prior to each treatment. The Achilles tendons of each group were harvested 1 wk after the last treatment. Specimens were prepared for light and electron microscopy, and immunostaining for type I and type III collagen and fibronectin was performed. Light microscopy showed increased fibroblast proliferation in the tendinitis plus ASTM treatment group. Although healing in rats may not translate directly to healing in humans, the findings of this study suggest that ASTM may promote healing via increased fibroblast recruitment.

Achilles Tendon↗
PubMed1996

Accurate three-dimensional reconstruction of intravascular ultrasound data. Spatially correct three-dimensional reconstructions.

BACKGROUND: The geometrical accuracy of conventional three-dimensional (3D) reconstruction methods for intravascular ultrasound (IVUS) data (coronary and peripheral) is hampered by the inability to register spatial image orientation and by respiratory and cardiac motion. The objective of this work was the development of improved IVUS reconstruction techniques. METHODS AND RESULTS: We developed a 3D position registration method that identifies the spatial coordinates of an in situ IVUS catheter by use of simultaneous ECG-gated biplane digital cinefluoroscopy. To minimize distortion, coordinates underwent pincushion correction and were referenced to a standardized calibration cube. Gated IVUS data were acquired digitally, and the spatial locations of the imaging planes were then transformed relative to their respective 3D coordinates, rendered in binary voxel format, resliced, and displayed on an image-processing workstation for off-line analysis. The method was tested by use of phantoms (straight tube, 360 degrees circle, 240 degrees spiral) and an in vitro coronary artery model. In vivo feasibility was assessed in patients who underwent routine interventional coronary procedures accompanied by IVUS evaluation. Actual versus calculated point locations were within 1.0 +/- 0.3 mm of each other (n = 39). Calculated phantom volumes were within 4% of actual volumes. Phantom 3D reconstruction appropriately demonstrated complex morphology. Initial patient evaluation demonstrated method feasibility as well as errors if respiratory and ECG gating were not used. CONCLUSIONS: These preliminary data support the use of this new method of 3D reconstruction of vascular structures with use of combined vascular ultrasound data and simultaneous ECG-gated biplane cinefluoroscopy.

Blood Vessels↗
PubMed1996

Lesion-directed administration of alteplase with intracoronary heparin in patients with unstable angina and coronary thrombus undergoing angioplasty.

Percutaneous coronary revascularization in patients with unstable angina and coronary thrombus carries a high complication rate. A new strategy to reduce thrombus burden before revascularization was tested in a multicenter prospective trial. Patients with unstable angina and coronary thrombus (n = 45) received alteplase through an infusion catheter at the proximal aspect of the target lesion and concomitant intracoronary heparin via a standard guiding catheter. Angiography was performed before and alter lesion-directed therapy and post-intervention. Systemic fibrinogen depletion and thrombin activation were not observed, while fibrinolysis was evident for > or = 4 hr after treatment. Target lesion stenosis did not change significantly after lesion-directed therapy, but thrombus score was reduced, particularly among patients who had large thrombi (mean 2.2 vs. 1.6, P = 0.02). Revascularization was successful in 89% of patients. Median final stenosis was 30% and mean final thrombus score was 0.4. Complications included recurrent ischemia (11%), MI (7%), abrupt closure (7%), severe bleeding (4%), and repeat emergency angioplasty (2%). Patients with overt thrombus appeared to derive the most angiographic benefit from lesion-directed alteplase plus intracoronary heparin. Later revascularization was highly successful. This strategy may be a useful adjunct to percutaneous revascularization for patients with unstable angina and frank intracoronary thrombus.

Adult↗
PubMed1995

Balloon aortic valvuloplasty in adults: failure of procedure to improve long-term survival.

OBJECTIVES: This study sought to determine the long-term outcome of adult patients undergoing percutaneous balloon aortic valvuloplasty. BACKGROUND: Percutaneous balloon aortic valvuloplasty has been offered as an alternative to aortic valve replacement for selected patients with valvular aortic stenosis. Although balloon aortic valvuloplasty produces an immediate reduction in the transvalvular aortic gradient, a high incidence of restenosis frequently leads to recurrent symptoms. Therefore, it is unclear whether balloon aortic valvuloplasty impacts on the long-term outcome of these patients. METHODS: Clinical, hemodynamic and echocardiographic data were collected at baseline in 165 patients undergoing balloon aortic valvuloplasty and examined for their ability to predict long-term outcome. RESULTS: The median duration follow-up was 3.9 years (range 1 to 6). Ninety-nine percent follow-up was achieved. During this 6-year period, 152 patients (93%) died or underwent aortic valve replacement, and 99 (60%) died of cardiac-related causes. The probability of event-free survival (freedom from death, aortic valve replacement or repeat balloon aortic valvuloplasty) 1, 2 and 3 years after valvuloplasty was 40%, 19% and 6%, respectively. In contrast, the probability of survival 3 years after balloon aortic valvuloplasty in a subset of 42 patients who underwent subsequent aortic valve replacement was 84%. Survival after aortic valvuloplasty was poor regardless of the presenting symptom, but patients with New York Heart Association functional class IV congestive heart failure had events earliest. Univariable predictors of decreased event-free survival were younger age, advanced congestive heart failure symptoms, lower ejection fraction, elevated left ventricular end-diastolic pressure, presence of coronary artery disease and increased left ventricular internal diastolic diameter. Stepwise multivariable logistic regression analysis found that only younger age and a lower left ventricular ejection fraction contributed independent adverse prognostic information (chi-square 14.89, p = 0.0006). CONCLUSIONS: Long-term event-free and actuarial survival after balloon aortic valvuloplasty is dismal and resembles the natural history of untreated aortic stenosis. Aortic valve replacement may be performed in selected subjects with good results. However, the prognosis for the remainder of patients who are not candidates for aortic valve replacement is particularly poor.

Aged↗
PubMed1994

Rapid visualization of massive pulmonary emboli utilizing intravascular ultrasound.

Massive pulmonary embolism may result in rapid deterioration prior to diagnostic and therapeutic intervention. Intravascular ultrasound imaging has been utilized previously to evaluate vascular abnormalities as well as normal human pulmonary arteries. We employed this technique to rapidly identify massive pulmonary emboli located in the main pulmonary arteries of two patients. The presence of these emboli was confirmed with pulmonary arteriography. Intravascular ultrasound may be utilized to rapidly confirm the presence of large proximal pulmonary emboli.

Aged↗