ABSTRACT
OBJECTIVE: The main purpose of this study was to compare efficacy, tolerability and influence on quality of life (QOL) of nifedipine gastrointestinal therapeutic system (NI) 30-60 mg once a day vs amlodipine (AM) 5-10 mg once a day in elderly patients with mild-moderate hypertension. DESIGN: This was a randomized, double-blind, parallel-group, multicenter study. After a 2-week single-blind placebo run-in, patients were randomized to either NI 30 mg or AM 5 mg. Responders continued on the same dosage for 16 additional weeks, while non-responders were titrated to 60 mg NI or 10 mg AM. METHODS: Blood pressure was measured by mercury sphygmomanometer and efficacy equivalence of NI and AM tested by covariance analysis. Diastolic blood pressure (DBP) was the primary efficacy parameter, its baseline value being taken as covariate while centers effect and treatment interaction were included as fixed effects in the analysis model. The secondary efficacy variables systolic blood pressure (SBP) and scores for QOL were analyzed according to the same model. RESULTS: At the end of the study, overall mean DBPs, calculated as least-square means (LSMEANS), in the "by protocol" population were 87.5 mmHg for NI and 86.7 for AM (difference 0.8 mmHg with 90% CI -1.2 to 2.8 mmHg). In the "by intention to treat" (ITT) population LSMEANS were 87.6 mmHg for NI and 86.4 mmHg for AM (difference 1.2 mmHg with 90% CI -0.6 to 3.1 mmHg). SBP LSMEANS in the "by protocol" population were 147.7 mmHg for NI and 147.3 mmHg for AM (difference 0.3 mmHg, with 90% CI -3.7 to 4.3); corresponding values in the "by ITT" population were 148.0 mmHg for NI and 147.2 for AM (difference 0.8 mmHg, with 90% CI -2.8 to 4.6). Mean values for QOL parameters were not significantly different. A total of 173 episodes of adverse events were documented in 54 patients (26 NI and 28 AM), dropouts were 15 (20% of group) on NI and 21 (28%) on AM. CONCLUSIONS: NI 30-60 mg was shown to be as efficacious and safe as AM 5-10 mg in elderly patients with mild-moderate hypertension. QOL improved compared to baseline with no significant difference between the two drugs, thus confirming a positive class effect for calcium antagonists.
Subject(s)
Amlodipine/administration & dosage , Calcium Channel Blockers/administration & dosage , Hypertension/drug therapy , Nifedipine/administration & dosage , Quality of Life , Aged , Aged, 80 and over , Amlodipine/adverse effects , Blood Pressure/drug effects , Calcium Channel Blockers/adverse effects , Double-Blind Method , Humans , Hypertension/complications , Middle Aged , Nifedipine/adverse effects , Therapeutic EquivalencyABSTRACT
Surgical treatment of carcinoma of the distal third of the rectum with anal sphincter preservation is increasingly used in accredited cancer centers. This study aimed to evaluate the diagnostic usefulness of radiological investigations in the management of patients who had undergone resection with coloanal anastomosis for carcinoma of the rectum, in the immediate post-operative period, during closure of the protective colostomy and in the follow-up of symptomatic recanalized patients. A total of 175 patients who had undergone total rectal resection with end-to-side anastomosis for carcinoma of the distal third of the rectal ampulla, most of whom had received postoperative radiotherapy, were evaluated radiologically. In the postoperative period radiological investigation was ordered only for symptomatic patients to detect pathology of the anastomosis and the pouch sutures and was used direct film abdominal radiography and contrast-enhanced radiography of the rectal stump with a water-soluble radio-opaque agent. Before closure of the colostomy, 2 months after rectal excision or approximately 4 months after if postoperative radiotherapy was given, the anastomosis and pouch of all patients, even asymptomatic ones, were studied with water-soluble contrast enema to check for normal canalization. In the follow-up after recanalization radiological examinations were done to complete the study of the large intestine if the endoscopist was not able to examine it up to the cecum. Of the 175 patients examined radiologically during the postoperative period and/or subsequent follow-up, 95 showed no pathological findings. Seventy-nine patients had fistulas of the coloanal anastomosis or the pouch, 23 of which supplied a presacral collection. In the absence of severe sepsis, the only therapeutic measures were systemic antibiotics and washing of the surgical catheters to maintain efficient operation. In 2 patients in whom transanal drainage was performed radiologically the fistula was cured in 1 week. In 36 cases of cicatricial stenosis, 17 at the coloanal anastomosis and 19 at the pouch, radiological examination always detected the lesion, correctly defining its anatomical characterisitics, nature and extension. Of the 19 cases of stenosis treated radiologically, 15 recovered an adequate intestinal calibre for tients operated on, 21 cases of reccurrence were detected. Radiological examination was requested as the first investigation in only one of these cases, for a patient with subocclusion. Radiological investigations in patients who have undergone colonanal anastomosis are of read diagnostic value in the immediate post-operative period, during closure of the protective colostomy and in the follow-up of symptomatic recanalized patients.
Subject(s)
Anal Canal/surgery , Colon/surgery , Postoperative Care , Radiography, Interventional , Rectal Neoplasms/diagnostic imaging , Rectal Neoplasms/surgery , Anastomosis, Surgical , Follow-Up Studies , Humans , Postoperative Complications/epidemiologyABSTRACT
BACKGROUND: A growing variety of coronary stents is becoming available on the market. Results of randomized trials may be difficult to apply to less selected patients, and experience with every device cannot be obtained in every center. Detailed information about the immediate and long-term results achieved with one device can be a helpful reference for interventional cardiologists. The aim of this study was to test the applicability and the clinical and angiographic results, both immediate and at 6 months, of the Multilink coronary stent in a cohort of unselected patients undergoing coronary angioplasty. METHODS: From March 1997 to June 1998 coronary angioplasty was performed in 391 patients in our center, with the use of stents in 339 patients. RESULTS: Three hundred and seventeen Multilink stents were successfully implanted in 295 lesions in 277 patients; an acute coronary syndrome was present in 209 cases (75%), and lesion types B2 and C accounted for 30% of lesions. In 7 cases (2.4%) the Multilink stent did not cross the lesion, and another device was implanted. Subacute stent occlusion occurred in 1 patient (0.36%) after primary angioplasty. After 6 months from the procedure, clinical follow-up data were available for 252 out of 254 patients: none had died, and angina or myocardial ischemia occurred in 25 patients (9.9%). A control angiogram was performed in 239 out of 254 patients (94%) at 178 +/- 34 days. Restenosis occurred in 44/239 patients (18.4%) and in 48/247 lesions (19.4%). In patients with vs without restenosis the original lesion was longer (p = 0.009), and diabetes mellitus was more frequent (p = 0.002), as was the use of multiple stents (p = 0.005). In single 15, 25 and 35 mm long stents restenosis occurred in 13.9, 15.5 and 46.2% of cases, respectively (p = NS). CONCLUSIONS: The Multilink stent showed a low rate of subacute occlusion (0.36%) and could be used safely also in patients with acute coronary syndromes. The use of a single, 15 or 25 mm long Multilink stent was associated with a low angiographic recurrence rate (14-16%).
Subject(s)
Angioplasty, Balloon, Coronary , Coronary Angiography , Stents , Coronary Disease/diagnostic imaging , Coronary Disease/therapy , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , RecurrenceSubject(s)
Coronary Disease/therapy , Coronary Vessels/enzymology , Coronary Vessels/injuries , Peptidyl-Dipeptidase A/metabolism , Stents/adverse effects , Wound Healing , Analysis of Variance , Angioplasty, Balloon/instrumentation , Genetic Markers , Humans , Prognosis , Risk Assessment , Sensitivity and SpecificityABSTRACT
OBJECTIVE: Breast calcifications pose a significant diagnostic and procedural dilemma. We evaluated en bloc stereotactic excision of indeterminate and suggestive microcalcifications for histologic diagnosis using a large-bore cannula biopsy device. MATERIALS AND METHODS: We retrospectively reviewed 61 groups of microcalcifications removed with a large-bore cannula biopsy device from 59 patients (age range, 35-72 years old). The cannula diameter was 20 mm in 47 cases, 15 mm in nine cases, and 10 mm in five cases. The median lesion diameter was 6.6 mm (range, 4-17 mm). The procedure was performed by radiologists in an outpatient setting, with patients undergoing local anesthesia. All patients with a diagnosis of malignancy underwent surgery. RESULTS: In all instances, microcalcifications were removed in a single pass, in a single intact tissue specimen, through a maximum skin incision of 2 cm (0.8 inch). Twenty-five malignancies, 34 benign lesions, and two cases of lobular carcinoma in situ were identified. Sixteen malignancies were noninvasive and nine were invasive. No residual tumor was found at surgery in six of the 18 cases with involved margins and in five of the seven cases with uninvolved margins. One case of lobular carcinoma in situ with involvement of the margins additionally showed ductal carcinoma in situ at surgery. CONCLUSION: Mammographically identified microcalcifications are excised en bloc with the large-bore cannula biopsy device, providing a stereotactically localized tissue sample that is comparable with that obtained with open surgical biopsy and allows evaluation of the margins. This surgical radiologic procedure may represent a valid alternative, in selected patients, to conventional surgical biopsy after radiologic localization.
Subject(s)
Biopsy/instrumentation , Breast Diseases/pathology , Breast Diseases/surgery , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Calcinosis/pathology , Calcinosis/surgery , Biopsy/methods , Breast/pathology , Breast/surgery , Catheterization/instrumentation , Female , Humans , Middle Aged , Radiography, Interventional , Stereotaxic Techniques/instrumentationABSTRACT
AIMS AND BACKGROUND: To evaluate the effectiveness of external radiation therapy (ERT), alone or combined with endoluminal brachytherapy (BRT), following percutaneous transhepatic biliary drainage (PTBD) in the treatment of patients affected by inoperable cholangiocarcinoma. METHODS & STUDY DESIGN: From September 1980 to June 1996, 130 jaundiced patients affected by inoperable cholangiocarcinoma were submitted to PTBD at the Division of Radiology C of the National Cancer Institute of Milan. Nineteen were excluded from the present analysis due to the short survival after PTBD (< 30 days). The other 111 patients were divided into three groups according to the following therapy: no further treatment after palliative PTBD in 89 patients (80%, group 1); ERT in 10 patients (9%, group 2); ERT plus BRT in 12 patients (11%, group 3). All the ERT + BRT patients were enrolled after 1990 and were treated with high-energy photon beams followed by endobiliary insertion of one or two iridium-192 wires. RESULTS: Median overall survival among the 111 assessable patients was 126 days; for groups 1, 2 and 3 it was 108, 345 and 428 days, respectively. The patients submitted to radiotherapy (ERT alone or ERT + BRT) were evaluated by radiologic examinations after the end of radiation. In group 2, a partial remission in 3 cases, a progression of disease in 1 case, and no change in 6 cases were observed. Among the patients of group 3, complete remission in 5 and partial remission in 7 patients were achieved. In all the patients achieving complete remission, the PTBD could be removed. CONCLUSIONS: The combination of ERT plus BRT improves survival and quality of life of the patients submitted to PTBD for cholangiocarcinoma. Under the technical point of view, radiation treatment is easy to perform, but much caution is required in defining clinical and planning target volumes. Moreover, drainage during the radiation treatment has to be submitted to a very meticulous surveillance.
Subject(s)
Bile Duct Neoplasms/radiotherapy , Bile Ducts, Extrahepatic , Cholangiocarcinoma/radiotherapy , Iridium Radioisotopes/therapeutic use , Adult , Aged , Aged, 80 and over , Bile Duct Neoplasms/surgery , Bile Ducts, Extrahepatic/surgery , Brachytherapy , Cholangiocarcinoma/surgery , Combined Modality Therapy , Dose-Response Relationship, Radiation , Drainage , Female , Humans , Male , Middle AgedABSTRACT
OBJECTIVES: The aim of the study was to compare randomly assigned primary angioplasty and accelerated recombinant tissue plasminogen activator (rt-PA), in patients with "high-risk" inferior acute myocardial infarction (ST-segment elevation in the inferior leads and ST-segment depression in the precordial leads). BACKGROUND: The ST-segment depression in the precordial leads is a marker of severe prognosis in patients with inferior myocardial infarction. The comparative outcome of treatment with primary angioplasty or lysis with accelerated rt-PA has not been investigated. METHODS: One hundred and ten patients within 6 h of symptoms were randomized to either treatment. To assess the in-hospital and 1-year outcome of both treatments the following results were compared: death or nonfatal infarction, recurrence of angina, left ventricular ejection fraction (LVEF), and the need for repeat target vessel revascularization (TVR). RESULTS: In patients treated with angioplasty (55) and rt-PA (55) the rate of in-hospital mortality and reinfarction was 3.6% versus 9.1% (p=0.4). Recurrence of angina was 1.8% versus 20% (p=0.002), new TVR was used in 3.6% versus 29.1% (p=0.0003), and the LVEF (%) at discharge was 55.2+/-9.5 versus 48.2+/-9.9 (p=0.0001). There were no hemorrhagic strokes, no emergency coronary artery bypass graft (CABG) and identical (5.5%) need for blood transfusions. At 1 year, the incidence of death, reinfarction or repeat TVR was 11% in the percutaneous transluminal coronary angioplasty (PTCA) group versus 52.7% in the rt-PA group (log-rank 22.38, p < 0.0001). CONCLUSIONS: Primary angioplasty is superior to accelerated rt-PA in terms of both myocardial preservation and reduction of in-hospital complications in patients with inferior myocardial infarction and precordial ST-segment depression. Primary angioplasty also yields a better long-term event-free survival.
Subject(s)
Angioplasty, Balloon, Coronary , Electrocardiography , Myocardial Infarction/physiopathology , Myocardial Infarction/therapy , Stents , Thrombolytic Therapy , Adult , Aged , Coronary Angiography , Female , Fibrinolytic Agents/therapeutic use , Humans , Longitudinal Studies , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Recombinant Proteins , Survival Analysis , Tissue Plasminogen Activator/therapeutic use , Treatment OutcomeABSTRACT
BACKGROUND: Concomitant anterior ST-segment depression is a marker of severe prognosis in inferior myocardial infarction. PATIENTS AND METHODS: Prospective observational study in patients with inferior acute myocardial infarction and ST-segment depression > or = 4 mm in the anterior leads, who were treated with primary angioplasty. Angiography was performed at hospital discharge and at six months, and a clinical follow-up was obtained at one year after the infarction. RESULTS: Sixty-three patients were included in the study. Pre-hospital and in-hospital delay were 147 +/- 70 minutes (20-355) and 54 +/- 11 minutes (18-80), respectively. Angioplasty was successful in all patients and 48 stents were implanted in 36 patients (57%). Angiography was performed at hospital discharge in 55 patients (87%) and showed a TIMI grade 3 coronary flow in the infarct-related artery in all cases. The left ventricular ejection fraction was 0.55 +/- 0.09 (0.4-0.8). One patient (1.6%) died before discharge, two (3.2%) had ischemic complications (one had non-fatal reinfarction, another had recurrent angina at rest), and three (4.9%) had local vascular complications. At the six-month follow-up, none of the patients had died. One had suffered reinfarction (1.6%) and another had been readmitted for recurrence of angina at rest (1.6%); none had symptoms of stable angina. The ejection fraction was 0.56 +/- 0.12 and eight patients (14%) showed angiographic restenosis. At twelve months, two patients had died (1.6%) and five (8%) had required readmission to hospital. CONCLUSIONS: Primary angioplasty yielded favorable results in this group of patients. Our data confirm the efficacy of primary angioplasty for the treatment of acute myocardial infarction, with a low rate of clinical (3.2%) and angiographic (14%) restenosis at six months, and a high rate (87%) of event-free survival at one year follow-up.
Subject(s)
Angioplasty, Balloon, Coronary , Electrocardiography , Myocardial Infarction/therapy , Adult , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/statistics & numerical data , Coronary Angiography/statistics & numerical data , Female , Follow-Up Studies , Humans , Italy/epidemiology , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Patient Selection , Prospective Studies , Stents , Survival Analysis , Time FactorsABSTRACT
BACKGROUND: Lipoprotein(a) is a risk factor for coronary artery disease. Although it has been implicated in restenosis after balloon angioplasty, its role in restenosis within coronary stents is unknown. The aim of the study was to assess the role of plasma lipoprotein(a) as a predictor for restenosis after elective coronary stenting. METHODS AND RESULTS: Elective, high-pressure stenting of de novo lesions in native coronary arteries with Palmaz-Schatz stents was performed in 325 consecutive patients. Clinical, angiographic, and biochemical data were analyzed prospectively. Angiographic follow-up was performed at 6 months. Lipoprotein(a) levels were compared in patients with and without restenosis. Angiographic follow-up was obtained in 312 patients (96%); recurrence was observed in 67 patients (21.5%). No clinical or biochemical variable was associated with restenosis. Lipoprotein(a) level was 37.81+/-49. 01 mg/dL (median, 22 mg/dL; range, 3 to 262 mg/dL) in restenotic patients and 36.95+/-40.65 mg/dL (median, 22 mg/dL; range, 0 to 244 mg/dL) in nonrestenotic patients (P=NS). The correlations between percent diameter stenosis, minimum luminal diameter, and late loss at follow-up angiography and basal lipoprotein(a) plasma level after logarithmic transformation were 0.006, 0.002, and 0.0017, respectively. Multiple stents were associated with a higher incidence of restenosis (P=0.006), but biochemical data in these patients were similar to those treated with single stents. CONCLUSIONS: The basal plasma level of lipoprotein(a) measured before the procedure is not a predictor for restenosis after elective high-pressure coronary stenting.
Subject(s)
Coronary Disease/etiology , Lipoprotein(a)/blood , Stents , Adult , Aged , Coronary Angiography , Coronary Disease/blood , Coronary Disease/surgery , Coronary Vessels/pathology , Female , Humans , Male , Middle Aged , Muscle, Smooth, Vascular/pathology , Prospective Studies , Recurrence , Risk FactorsABSTRACT
PURPOSE: To evaluate the advisability of use by interventional radiologists of the ABBI system for stereotactic biopsy in the diagnosis of mammographically detected nonpalpable breast lesions considered suspicious for cancer. MATERIAL AND METHODS: Breast biopsy with the ABBI cannula, available in various diameters, was offered to 61 patients who gave their informed consent and was performed in 36. Reasons for exclusion were insufficient thickness of the compressed breast (37.5%), the lesion site (50%) and the failure to detect the lesion with stereotactic mammography (12.5%). The procedure was carried out under local anesthesia in an outpatient setting. Fifteen nodules, 15 groups of microcalcifications and 6 nodules with calcifications were excised. The diameter of the ABBI cannula used was 20 mm in 32 cases and 15 mm in four cases. RESULTS: A definitive histological diagnosis was obtained in all cases, with the identification of 20 neoplasms (56%) and 16 benign lesions (44%). The lesions margins were involved in 14 cases of malignancy. All the patients with a diagnosis of malignancy underwent surgery. No residual tumor was found in five cases. The mean diameter of the lesions removed was 11-12 mm. The only complications were two late hematomas which were drained by simple percutaneous aspiration. The procedure was well tolerated by all patients except one who experienced a vagal attack due to emotional stress. CONCLUSIONS: Stereotactic breast biopsy with an ABBI surgical cannula can be carried out autonomously by interventional radiologists, safely and with diagnostic accuracy.
Subject(s)
Biopsy, Needle/instrumentation , Breast Neoplasms/pathology , Adult , Aged , Aged, 80 and over , Equipment Design , Female , Humans , Middle Aged , PalpationABSTRACT
BACKGROUND: The early invasive diagnostic approach with extensive use of myocardial revascularization in patients with unstable angina is a matter of debate. Both the advantages of this strategy and the choice of the best candidates are controversial. The widespread applicability of this approach in Italian hospitals is also questionable, due to limited availability of facilities for interventional cardiology. METHODS: A prospective, observational study was done on a cohort of consecutive patients, who were admitted with a diagnosis of unstable angina and treated with an early aggressive approach at a center with interventional cardiology facilities without cardiac surgery. The aim of the study was to evaluate both the immediate and long-term clinical outcome of patients and the efficiency of our therapeutic approach. RESULTS: Two-hundred and two patients were enrolled and 85% were in Braunwald class III. Coronary angiography was performed in 171 patients (85%) at 2.1 +/- 2.4 days after admission: it showed one-, two- and three-vessel disease in 40, 29 and 22% of cases, respectively; 9% of patients had no severe coronary lesion. Left ventricular ejection fraction was 0.58 +/- 0.13. Medical treatment, coronary by-pass surgery and percutaneous myocardial revascularization were chosen in 36, 24 and 40% of cases, respectively. Coronary angioplasty was performed in our center in 58 (73%) of 80 patients at 6.8 +/- 5.6 days after admission and stents were used in 42 cases (74%). Overall hospital stay was 10.4 +/- 4 days. Cumulated adverse events (death and non-fatal myocardial infarction) occurred in 2.5 and 7% of patients during the initial admission and in the following year, respectively. CONCLUSIONS: An early aggressive approach to patients with unstable angina is feasible in a hospital with interventional cardiology in the absence of cardiac surgical facilities. The immediate favorable clinical results of this strategy in an intermediate-risk cohort seem to persist at one-year follow-up.
Subject(s)
Angina, Unstable/therapy , Adrenergic beta-Antagonists/therapeutic use , Adult , Aged , Aged, 80 and over , Angina, Unstable/drug therapy , Angina, Unstable/surgery , Angioplasty, Balloon, Coronary , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Aspirin/administration & dosage , Aspirin/therapeutic use , Calcium Channel Blockers/therapeutic use , Cohort Studies , Coronary Angiography , Coronary Artery Bypass , Coronary Care Units , Data Interpretation, Statistical , Female , Follow-Up Studies , Heparin/administration & dosage , Heparin/therapeutic use , Humans , Infusions, Intravenous , Length of Stay , Male , Middle Aged , Myocardial Revascularization , Nitrates/administration & dosage , Nitrates/therapeutic use , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/therapeutic use , Prospective Studies , Software , Stents , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: The presence of late potentials (LP) after myocardial infarction (MI) is related to an occluded infarct-related coronary artery (IRA). However, the effects of the signal-averaged electrocardiogram (SAECG) of systemic thrombolysis are contradicting. Reperfusion in the IRA is more frequently observed after primary percutaneous transluminal coronary angioplasty (PTCA) than after systemic thrombolysis. The aim of this prospective study was to compare the prevalence of LP in survivors of acute MI treated with either systemic thrombolysis or primary PTCA. METHODS: Between October 1994 and January 1997, 134 patients (pts) with acute MI were treated with reperfusion therapy within 12 hours of the onset of symptoms: seventy-four pts received systemic thrombolysis and 60 underwent primary PTCA. All pts (mean age 61 +/- 10 years, 120 males) had a control coronary angiography 9 +/- 5 and 10 +/- 4 days after acute MI, respectively. The recorded signals were amplified, averaged and filtered with bi-directional Butterworth filtering (band-pass filter range of 40-250 Hz). LPs were defined as the presence of 2 or 3 of the following criteria: filtered duration of the QRS complex > 114 ms, root mean square voltage of signals in the last 40 ms of the QRS < or = 20 mV and duration of the low amplitude signals > 38 ms. RESULTS: The two groups of pts did not differ significantly with respect to age, gender, presence of either diabetes or hypertension, site of MI, previous MI, Killip class, time to treatment, peak CK-MB level, incidence of reinfarction, extent of coronary artery disease and left ventricular ejection fraction. One hundred pts (75%) had patency (TIMI 3 grade flow) of the IRA at control coronary angiography. Twenty-seven pts (20%) had LP: 16 pts (22%) among those treated with systemic thrombolysis and 11 pts (18%) among those treated with primary PTCA (p = ns). Pts treated with primary PTCA had higher patency rates [95% (57/60) vs 58% (43/74); p = 0.00002] and less severe residual stenosis (19 +/- 15% vs 72 +/- 18%; p = 0.0001) in the IRA. LP were found in 15 pts (15%) with TIMI 3 grade flow and in 12 pts (35%) with TIMI 0-2 grade flow (p = 0.017). By multivariate analysis, including 18 clinical and electrocardiographic variables, an occluded IRA was the only independent predictor of the development of LP (Wald chi 2: 6.1453; p = 0.0132). CONCLUSION: Results of this prospective study suggest that primary PTCA alone does not reduce the prevalence of LP when compared to systemic thrombolysis. Only the patency of the IRA, as determined before the hospital discharge, affected the development of LP after acute MI.
Subject(s)
Angioplasty, Balloon, Coronary , Aspirin/therapeutic use , Electrocardiography , Heparin/therapeutic use , Myocardial Infarction/therapy , Streptokinase/therapeutic use , Thrombolytic Therapy , Tissue Plasminogen Activator/therapeutic use , Adult , Aged , Aged, 80 and over , Cardiac Catheterization , Coronary Angiography , Coronary Circulation , Data Interpretation, Statistical , Female , Humans , Male , Middle Aged , Myocardial Infarction/drug therapy , Myocardial Infarction/physiopathology , Prospective Studies , RecurrenceABSTRACT
BACKGROUND: Tissue proliferation is almost invariably observed in recurrent lesions within stents, and ACE, a factor of smooth muscle cell proliferation, may play an important role. Plasma ACE level is largely controlled by the insertion/deletion (I/D) polymorphism of the enzyme gene. The association among restenosis within coronary stents, plasma ACE level, and the I/D polymorphism is analyzed in the present prospective study. METHODS AND RESULTS: One hundred seventy-six consecutive patients with successful, high-pressure, elective stenting of de novo lesions in the native coronary vessels were considered. At follow-up angiography, recurrence was observed in 35 patients (19.9%). Baseline clinical and demographic variables, plasma glucose and serum fibrinogen levels, lipid profile, descriptive and quantitative angiographic data, and procedural variables were not significantly different in patients with and without restenosis; mean plasma ACE levels (+/-SEM) were 40.8+/-3.5 and 20.7+/-1.0 U/L, respectively (P<.0001). Diameter stenosis percentage and minimum luminal diameter at 6 months showed statistically significant correlation with plasma ACE level (r=.352 and -.387, respectively P<.001). Twenty-one of 62 patients (33.9%) with D/D genotype, 13 of 80 (16.3%) with I/D genotype, and 1 of 34 (2.9%) with I/I genotype showed recurrence; the restenosis rate for each genotype is consistent with a codominant expression of the allele D. CONCLUSIONS: In a selected cohort of patients, both the D/D genotype of the ACE gene, and high plasma activity of the enzyme are significantly associated with in-stent restenosis. Continued study with clinically different subsets of patients and various stent designs is warranted.
Subject(s)
Coronary Disease/enzymology , Peptidyl-Dipeptidase A/genetics , Polymorphism, Genetic , Adult , Aged , Aged, 80 and over , Coronary Disease/genetics , Coronary Disease/surgery , Female , Humans , Male , Middle Aged , Prospective Studies , Recurrence , Risk Factors , StentsABSTRACT
BACKGROUND: Spectral turbulence analysis (STA) of the signal-averaged electrocardiogram (SAECG) is a recently described frequency-domain analysis evaluating the changes in the wave front velocity in the QRS complex as a whole. In this study we prospectively assessed the role of STA in predicting arrhythmic events [(EA): ventricular tachycardia, ventricular fibrillation and sudden death] relative to ejection fraction (EF), complex ventricular arrhythmias (CVA) on Holter monitoring and site of myocardial infarction (MI) in 266 patients (pts) (209 M; 57 F; mean age 62.3 +/- 10.3)-14 with bundle branch block-surviving an acute MI. METHODS: SAECG was recorded in all pts 13 +/- 3 days after MI. STA was performed by using a PC software implementing the algorithm proposed by Kelen. The conventional parameters of STA (inter-slice correlation mean, inter-slice correlation SD, low-slice correlation ratio and spectral entropy) were calculated separately for each orthogonal lead (X, Y and Z) and their average (X + Y + Z). Ejection fraction was assessed in 241 pts and Holter recordings were analyzed in 195 pts 13 +/- 4 and 13 +/- 5 days after MI, respectively. RESULTS: During a mean follow-up of 13 +/- 10 months, there were 20 (7.5%) AE: 9 pts had sustained ventricular tachycardia, two had cardiac arrest due to ventricular fibrillation and 9 died suddenly. In 41% of pts STA was abnormal. STA sensitivity was 65%, specificity 61%, positive predictive value 12%, negative predictive value 96%, relative risk (RR) 2.67 (95% confidence bounds = 1.1-6.48; p = 0.023). Sensitivity, specificity, positive predictive value and RR for EF and CVA were 65, 78, 21%, 6.5 and 64, 66, 10%, 3.4, respectively. Abnormal STA was present in 46% of pts with anterior MI and in 42% of pts with inferior MI (ns). Sensitivity, specificity and RR were 88, 58% and 7.95 (p = 0.015) for anterior MI and 50, 59% and 1.41 (p = ns) for inferior MI. CONCLUSION: The value of STA of the SAECG is poor when performed two weeks after MI. STA theoretical advantages over time-domain analysis of the SAECG were not verified in our study.
Subject(s)
Arrhythmias, Cardiac/etiology , Electrocardiography, Ambulatory , Myocardial Infarction/complications , Aged , Arrhythmias, Cardiac/prevention & control , Bundle-Branch Block/etiology , Bundle-Branch Block/prevention & control , Female , Humans , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/physiopathology , Prognosis , Signal Processing, Computer-Assisted , Stroke Volume , Tachycardia, Ventricular/etiology , Tachycardia, Ventricular/prevention & control , Ventricular Fibrillation/etiology , Ventricular Fibrillation/prevention & controlABSTRACT
BACKGROUND: The lower prevalence of ventricular late potentials (LPs) in signal-averaged electrocardiograms (SAECG) observed in patients (pts) treated with systemic thrombolysis, as compared with SAECGs in conventionally treated pts, has been attributed to the patency of the infarct-related artery. Mechanical reperfusion, achieved by means of either primary or rescue percutaneous transluminal coronary angioplasty (PTCA), is associated with higher permeability rates and reduced residual stenosis in the infarct-related artery, when compared to systemic thrombolysis. The aim of this retrospective study was to assess the prevalence of LPs in pts recovering from a first high-risk acute myocardial infarction (AMI) treated with primary or rescue PTCA. METHODS: Fifty-nine pts (48 pts with clinical signs or electrocardiographic evidence of high-risk AMI or in whom systemic thrombolysis was inadvisable, and 11 pts in whom systemic thrombolysis failed) underwent emergency PTCA within 10 hours of the onset of symptoms. All pts (mean age 61 +/- 9 years, 48 M) were monitored via coronary angiography 9 +/- 4 days after AMI. The SAECG was obtained 10 +/- 4 days after AMI. LPs were defined as the presence of 2 or 3 of the following criteria: filtered duration of the QRS complex > 114 ms, duration of the low amplitude signals > 38 ms and mean square-root voltage of signals in the last 40 ms of the QRS < or = 20 microV. RESULTS: Primary and rescue PTCA were performed 3 +/- 1.7 and 6.3 +/- 2 hours after AMI, respectively (p = 0.000). Fifty-six pts (95%) had patency (TIMI 3 grade flow) of the infarct-related artery (mean residual stenosis: 18.3 +/- 14.2%) confirmed by control coronary angiography, while the infarct-related artery was occluded in three pts. Sixteen out of 59 pts (27%) had LPs: 14/56 (25%) with TIMI 3 grade flow and 2/3 (67%) with TIMI 0 grade flow. Pts with and without LPs were comparable for age, sex, infarct location, Killip Class, mean peak CK-MB, time to control coronary angiography, time to SAECG, left ventricular ejection fraction, presence of multivessel disease, infarct-related artery and mean residual stenosis in infarct-related artery. LPs were observed more frequently after rescue PTCA than after primary PTCA (64 vs 19%; p = 0.005). Time to treatment was significantly longer in pts with LPs than in those without (4.9 +/- 2.6 vs 3.2 +/- 1.7 hours; p = 0.025). Multivariate analysis indicated that the type of PTCA (primary vs rescue PTCA) was the only independent predictor for the development of LPs. CONCLUSION: In this study, the prevalence of LPs in pts with patency of the infarct-related artery after primary or rescue PTCA was surprisingly high. Delay to treatment and type of PTCA affected the presence of LPs. The association between infarct-related artery status and prevalence of LPs has not been analyzed, due to the low number of pts with coronary artery occlusion in the control coronary angiography.
Subject(s)
Angioplasty, Balloon, Coronary , Electrocardiography/methods , Myocardial Infarction/physiopathology , Myocardial Infarction/therapy , Adult , Aged , Emergencies , Female , Humans , Male , Middle Aged , Plasminogen Activators/therapeutic use , Recurrence , Retrospective Studies , Salvage Therapy , Thrombolytic Therapy , Urokinase-Type Plasminogen Activator/therapeutic use , Vascular Patency , Ventricular Fibrillation/physiopathologyABSTRACT
Several studies showed that time domain analysis of the signal-averaged ECG may identify groups of patients with low and high risk for arrhythmic events after myocardial infarction (MI). However, the signal averaging methods were not uniform and the definition of abnormal signal-averaged ECG was empiric. To identify the best quantitative signal-averaged variable in predicting arrhythmic events (sustained ventricular tachycardia, ventricular fibrillation and witnessed, instantaneous death) 262 patients surviving acute MI were prospectively evaluated. Twelve clinical variables, left ventricular ejection fraction (LVEF), complex ventricular arrhythmias (CVA) on Holter monitoring and three conventional signal-averaged variables (either at 25-250 or 40-250 Hz) were entered in a Cox proportional hazards regression model. During a mean follow-up of 20.3 +/- 13.7 months 16 (6.1%) patients had arrhythmic events. All six signal-averaged variables were independent predictors of arrhythmic events and the filtered QRS duration (fQRSD) > or = 120 ms at 40 Hz high pass filtering resulted the most predictive. In a regression analysis, including the best signal-averaged variable, LVEF and CVA, only fQRSD > or = 120 ms at 40 Hz and LVEF independently predicted arrhythmic events. Sensitivity, specificity, positive predictive value and odds ratio for fQRSD > or = 120 ms at 40 Hz were 63, 90, 29 and 11%, respectively, and for the combination of fQRSD > or = 120 ms at 40 Hz and LVEF < 40%, were 73, 95, 47 and 39%, respectively. In conclusion, the fQRSD > or = 120 ms at 40 Hz best predicts arrhythmic events in the post-infarction period. The combination of signal-averaged ECG and LVEF is recommended to stratify patients at risk of arrhythmic events after MI.
Subject(s)
Arrhythmias, Cardiac/diagnosis , Electrocardiography/methods , Myocardial Infarction/diagnosis , Aged , Arrhythmias, Cardiac/etiology , Arrhythmias, Cardiac/mortality , Arrhythmias, Cardiac/physiopathology , Electrocardiography/statistics & numerical data , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/mortality , Myocardial Infarction/physiopathology , Prognosis , Prospective Studies , Sensitivity and Specificity , Signal Processing, Computer-Assisted , Stroke Volume , Time FactorsABSTRACT
UNLABELLED: The implementation of Quality Assurance programs for the treatment of acute myocardial infarction in the Cardiac Intensive Care Unit may be specially important. In fact several therapeutic options are available in these patients, and delay in treatment must be as short as possible. A Quality Assurance program has been started in our center with a registry of all patients admitted within 24 hours of onset of acute myocardial infarction. PATIENTS AND METHODS: The following data were recorded: 1) indicators of Organization: pathway to admission, pre-hospital and in-hospital delay; 2) Process Indicators: duration of hospital stay, initial choice of therapy (conservative, intravenous lysis, primary angioplasty), and further diagnostic and interventional procedures; 3) Outcome Indicators: mortality and complications during admission, and 6-12 months follow-up. RESULTS: Since february 1994 to August 1995, 211 consecutive patients were included in the registry; 156 were male, mean age 66 years. Mean pre-hospital delay was 286 minutes. Admission was decided by a physician in 99 cases and by the patient him/herself in 112 cases; pre-hospital delay was 390 min. In the former group, and 194 min. In the latter (p < .001). Mean in-hospital delay was 61 minutes. Conservative treatment, intravenous lysis, and primary angioplasty were chosen by the attending cardiologist in 89 patients (group A), 69 patients (group B), and 53 patients (group C) respectively. The latter group included patients with highest risk on the basis of clinical and electrocardiographic characteristics. In-hospital mortality was 17, 7 and 9% In the 3 groups, respectively. An echocardiogram and coronary angiography were performed before discharge in 81% and 57% of patients, respectively. The mean duration of hospital stay was 11 days, irrespective of the initial therapeutic choice. CONCLUSIONS: A registry for patients with acute myocardial infarction provides information which is essential in the evaluation of therapeutic protocols; it may also help in improving the cooperation between the Emergency Department, the attending cardiologists, and the family physicians.
Subject(s)
Coronary Care Units/standards , Myocardial Infarction/therapy , Quality Assurance, Health Care , Quality of Health Care/standards , Registries , Aged , Female , Hospital Mortality , Humans , Italy , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Patient AdmissionABSTRACT
Nineteen consecutive procedures of coronary stenting were attempted in 70 consecutive patients (27%) with evolving myocardial infarction due to threatened vessel reocclusion after primary (16 cases) or rescue (3 cases) angioplasty. Two patients were in cardiogenic shock. Stent delivery was successful in 18 patients, with a Thrombolysis in Myocardial infarction flow grade 3; residual diameter stenosis and minimum luminal diameter were 19% +/- 11% and 2.96 +/- 0.62 mm, respectively. After the procedure, heparin was continued for 4 days and 250 mg ticlopidine twice a day for 1 month. Acute stent occlusion occurred in one patient 1 hour after the procedure and was successfully treated with emergency repeat angioplasty. Subacute stent occlusion occurred 6 days after the procedure in one patient, with multivessel coronary disease and a suboptimal stent result. He had been referred for surgery, and emergent coronary artery bypass was performed. Coronary bypass surgery was performed in another patient before discharge because of severe multivessel disease. Persistent cardiogenic shock and new myocardial infarction in another location were the causes of death in two patients, 3 and 10 days after the procedure, respectively. Fifteen patients were discharged with a patient infarct vessel and without reinfarction or need for coronary bypass surgery. One patient had repeat angioplasty for intrastent restenosis at 3 months. The remaining 14 patients were free from new coronary events 4 +/- 2 months after the procedure. Although acute myocardial infarction is generally considered a contraindication to the use of coronary stents, stents may play a role in increasing the rates of successful infarct artery reperfusion.
Subject(s)
Angioplasty, Balloon, Coronary , Coronary Vessels , Myocardial Infarction/therapy , Stents , Adult , Aged , Female , Humans , Male , Middle Aged , Myocardial Infarction/mortality , Postoperative Complications , Retreatment , Survival Analysis , Treatment FailureABSTRACT
AIMS: To analyze the radiologic characteristics, clinical course and long-term follow-up of 7 radiologically uncommon pediatric cases of Langerhans cell histiocytosis and to identify prognostic factors related to imaging patterns. METHODS: The clinical records and complete imaging data of 75 patients with LCH diagnosed and treated at the National Cancer Institute of Milan between January 1975 and December 1993 were analyzed, and 43 cases presenting as unifocal bone lesions were identified. The plain film, computed tomography and magnetic resonance characteristics enabled the identification of 7 radiologically aggressive and rapidly progressive cases, which were analyzed at presentation and during follow-up. RESULTS: Although at disease presentation bone lesions appeared lytic destructive, rapidly progressive and often involved adjacent soft tissues, after adequate therapy the disease course was invariably benign and led to almost complete restoration of normal structure and function. Long-term follow-up confirmed the favorable outcome and lack of disease recurrence in all cases. CONCLUSIONS: There is no correlation between radiologically aggressive characteristics and final outcome in Langerhans cell histiocytosis. Radiologists and pediatric oncologists should be acquainted with less common radiologic forms which, at presentation, can mimic more ominous diseases. If recognized and adequately treated, monostotic forms almost invariably have a benign prognosis.
Subject(s)
Histiocytosis, Langerhans-Cell/diagnostic imaging , Adolescent , Child , Child, Preschool , Diagnosis, Differential , Humans , Infant , Magnetic Resonance Imaging , Prognosis , Tomography, X-Ray ComputedABSTRACT
Radiation exposure of cardiac catheterization laboratory staff is a known occupational hazard, and efforts are made to obtain dose levels which are "as low as reasonably achievable". This study assessed the reduction in staff radiation exposure using cine framing at 12.5 f s-1 during coronary cineangiography, instead of 25 f s-1. Thermoluminescent dosemeters were used to measure equivalent dose at several sites for the operator, nurse assistant, and X-ray technician during 15 procedures at both frame rates. Patient-related and procedure-related variables were similar in the two groups of examinations. Mean equivalent dose absorbed (microSv) at the left side of the forehead was reduced by 61%, 60% and 36%, for the operator, nurse assistant and X-ray technician, respectively. With use of the lower frame rate similar reductions by 42%, 62% and 62% were measured at the thyroid level, and by 51%, 40% and 61% at the mid-thorax level. Cinefilming at low frame rates during coronary arteriography allows a substantial X-ray dose reduction at all body sites for all staff. Use of lower frame rates wherever possible is of special interest since it may also reduce patient radiation exposure.