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Biomedical subjects

M R Piedmonte

Publications and source records attributed to M R Piedmonte.

35 records · Page 2Linked to original sources

The Carpentier-Edwards pericardial aortic valve. Ten-year results.

To evaluate the function of the Carpentier-Edwards pericardial valve in the aortic position, we analyzed the results of 310 aortic valve replacements performed between 1982 and 1985. Mean age was 64.2 +/- 10.8 years (range 22 to 95 years); 190 patients (61.3%) were male patients. There were 18 hospital deaths (5.8%), and none were valve related. Follow-up of the 292 survivors was 100% complete at a mean of 7.8 +/- 2.9 years; 2290 patient-years of follow-up were available for analysis. There were 133 late deaths (45.5%). Actuarial survivals at 5 and 10 years were 82.5% and 45.9%, respectively. The 10-year actuarial freedom from events was 88.7% +/- 2.1% for thromboembolism, 90.9% +/- 1.8% for hemorrhage, 94.3% +/- 1.6% for endocarditis, and 91.2% +/- 2.6% for structural deterioration. The 153 hospital survivors 65 years of age or older had an extremely low incidence of structural valve deterioration, with only four explants and 95.5% actuarial freedom from explantation at 10 years, and a linearized rate of 0.3 +/- 0.2 per patient-year compared with 88.6% and 0.7 +/- 0.2 for patients younger than 65 years of age. Twelve valves were explanted for structural deterioration. Of these, 11 (93%) had leaflet calcification causing stenosis and one had a wear-related leaflet tear. The Carpentier-Edwards pericardial valve has a low incidence of valve-related complications. The freedom from structural valve deterioration is low at 10 years, particularly in patients 65 years of age and older.

Actuarial Analysis↗

Open pelvic lymph node dissection for prostate cancer: a reassessment.

OBJECTIVES: To provide a risk-to-benefit analysis of open staging pelvic lymph node dissection (PLND) for prostate cancer. METHODS: The medical records of all patients presenting with prostate cancer from July 1989 to April 1994 were reviewed. A total of 245 patients with clinically localized disease were selected to undergo radical retropubic prostatectomy (RRP) preceded by open PLND. Univariate and multivariate analyses were performed to evaluate the predictive value of the preoperative serum prostate-specific antigen (PSA) concentration, clinical stage, and Gleason score with regard to final nodal status. The cost and morbidity associated with PLND in the setting of RRP was also defined. RESULTS: Overall, only 16 patients (6.5%) had lymph node metastases. Lymph node involvement correlated significantly with elevated serum PSA values (P = 0.0001), high Gleason score (P = 0.0022), and advanced clinical stage (P = 0.0001). Lymph node metastases were particularly uncommon in patients with nonpalpable tumors (1 of 67 [1.5%]), PSA values less than 10 (2 of 154 [1.3%]), and Gleason score less than 6 (1 of 26 [3.8%]). Overall, 179 patients (73.1%) presented with at least one or more of these favorable characteristics, and only 4 (2.2%) had lymph node involvement. Complications related to the lymphadenectomy occurred in 10 patients (4.1%). The cost per metastasis diagnosed in patients with low-risk characteristics was approximatley $43,600. CONCLUSIONS: An open staging PLND may no longer be justified on a routine basis in patients undergoing radical retropubic prostatectomy.

Adenocarcinoma↗

Latent variable models for clustered ordinal data.

Existing methods for the analysis of clustered, ordinal data are inappropriate for certain applications. We propose latent variable models for clustered ordinal data which are derived as natural extensions of latent variable models for clustered binary data (Qu, Williams, Beck, and Medendorp, 1992. Biometrics 48, 1095-1102). These models can be applied to repeated measures data, familial data, longitudinal data, and data with both cluster specific and occasion specific covariates with a wide range of correlation structures.

Analysis of Variance↗

Gender differences for coronary angioplasty.

To determine if differences in early and late outcome after angioplasty were related to gender or body surface area, 5,000 consecutive patients (1,274 women and 3,726 men) were studied. Baseline variables, procedural outcome, and long-term and event-free survival were assessed. Baseline variables included age, history of hypertension, diabetes mellitus, heart failure, myocardial infarction, prior angioplasty or bypass surgery, familial coronary disease, Canadian heart classification, extent of angioplasty, left ventricular function, and body surface area. Overall and event-free survival (freedom from infarction, repeat angioplasty, bypass surgery and death) were assessed at follow-up. The results showed that, compared with men, women were older (p < 0.0001), had a higher prevalence of diabetes (p < 0.0001), familial coronary disease (p = 0.002), hypertension (p < 0.0001), prior infarction (p = 0.004), and more involvement of the anterior descending artery (p = 0.017). Whereas men had similar extents of angioplasty and worse left ventricular function (p = 0.012), women more often had unstable angina (p < 0.0001). The success rates were similar, yet women had a higher procedural mortality (1.1% women, 0.3% men, p = 0.001). When corrected for body surface area, however, women were at no greater risk than men. Follow-up was complete for 97.4% of patients (mean 4 +/- 2 years). Event-free survival was significantly better in women, even after correcting for body surface area. Men were at higher risk for late death and repeat angioplasty on follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Risk stratification for long-term outcome after elective coronary angioplasty: a multivariate analysis of 5,000 patients.

OBJECTIVES: We attempted to develop a statistical model to facilitate risk stratification for long-term outcome after elective coronary angioplasty. BACKGROUND: Our understanding of factors related to long-term outcome after coronary angioplasty is limited. Adequate assessment of risk indexes could potentially lead to more appropriate use of percutaneous revascularization. METHODS: We studied 5,000 consecutive patients and assessed 19 clinical and anatomic variables as predictors of long-term event-free survival. Events were defined as death of any cause, myocardial infarction, bypass surgery or repeat percutaneous transluminal coronary angioplasty. Cox proportional hazards models were used to develop an equation for predicting event-free survival in a subset of 4,000 patients. The equation was validated with the remaining 1,000 patients. Variables that were significantly associated with an adverse outcome in the multivariate model included age > 60 years, extent of disease, Canadian Cardiovascular Society functional class, previous coronary angioplasty, male gender, history of diabetes mellitus, history of hypertension and history of congestive heart failure. RESULTS: The statistical model was used to develop a simplified scoring system, and the patients were assigned to three risk subgroups. Event-free survival curves for the three groups were significantly different (p = 0.0001). High risk patients had worse outcomes for each of the end points compared with low and moderate risk patients (p < 0.02). CONCLUSIONS: We demonstrated that clinical and anatomic variables can be used to risk-stratify long-term outcome after angioplasty, that a simplified scoring system can be used for risk stratification and that high risk patients have a low event-free survival.

Aged↗

Changes in the cervical foraminal area after anterior discectomy with and without a graft.

A controversial point in the management of patients undergoing anterior cervical discectomy is whether an interbody bone graft should be used. Proponents of interbody grafting claim that without a graft, the disc height and the area of the foramina at that level will decrease postoperatively with the potential for persistent symptoms and/or the development of a radiculopathy. Using a two-dimensional digital planimeter, we measured the cross-sectional area (cm2) of cervical foramina on preoperative and postoperative oblique films in patients undergoing anterior cervical discectomy. Group A patients underwent the insertion of an interbody graft after the discectomy; Group B patients did not. Our results indicate that in all the patients in Group A, there was a statistically significant increase in the area of the foramina (P < 0.001) and in Group B, a statistically significant decrease (P = 0.0005). However, when the absolute change in magnitude of the foramina was measured, without respect to an increase or decrease, there was no statistically significant difference (P > 0.8). There was no statistically significant difference (P = 1.000) in the outcome between the two groups. From an anatomical standpoint, our data support the insertion of an interbody graft if the surgeon wishes to increase the area of the foramen. However, the overall magnitude of change is not significant, which may be a factor in why the clinical outcome is similar in both groups.

Adult↗

Nonoperative treatment of superficial femoral artery disease: long-term follow-up.

PURPOSE: Between 1977 and 1991, 405 patients with atherosclerotic occlusive disease of the superficial femoral artery underwent clinical as well as noninvasive laboratory evaluation and were recommended for nonoperative treatment. METHODS: Limbs with uncorrected aortoiliac occlusive disease, aneurysmal degeneration, or previous femoropopliteal bypass were excluded, leaving 568 involved extremities. Complete follow-up, which forms the basis for this report, was available in 377 patients (93%) with 520 limbs (93%). Patients were monitored for a minimum period of 2 years (range, 24 to 164 months; median, 86 months). During the surveillance period 45 limbs (8.6%) in 42 patients (11.1%) required arterial intervention. This entailed operation in 39 cases and endovascular treatment in six cases. With use of life-table analysis, the risk for intervention was found to be 11% at 5 years and 14% at 10 years. A total of 14 limbs (2.7%) in 14 patients (3.7%) ultimately required major limb amputation, either after failed bypass (8 patients) or as a primary procedure (6 patients). RESULTS: Analysis of risk factors revealed that female sex (p = 0.04), chronic renal failure (p = 0.0001), diabetes mellitus (p = 0.0011), history of contralateral femoropopliteal bypass (p = 0.0005), level of disease (p = 0.003), and entry ankle/brachial index less than 0.50 (p = 0.004) were associated with an increased risk over time for intervention. Other factors, including age, current or prior smoking history, hypertension, and the presence of coronary artery disease or cerebrovascular disease failed to reach statistical significance. CONCLUSIONS: These data support the continued conservative approach to surgery for patients with superficial femoral artery occlusive disease without limb-threatening symptoms. Patients with multilevel disease, lower ankle/brachial index, a history of contralateral femoropopliteal bypass, chronic kidney failure, or diabetes mellitus are at increased risk and should be monitored more closely.

Adult↗

Anergic response to delayed hypersensitivity skin testing. A predictor of early mortality in heart transplant recipients.

STUDY OBJECTIVE: We set out to determine if there is a significant difference in the morbidity and mortality between the anergic and reactive groups. DESIGN: A retrospective study of the heart transplant population was performed. SETTING: We studied the results of delayed hypersensitivity skin tests (DHSTs) in all cardiac transplant recipients at the Cleveland Clinic between May 1985 and November 1991 to determine whether DHST results were of prognostic significance. RESULTS: Preoperative skin testing was reactive to two or more antigens in 90 of the 127 patients whose DHSTs were interpretable, and the remainder were anergic. Anergic response was associated with increased bilirubin and decreased albumin levels, but gender, race, primary underlying heart disease, age at transplantation, creatinine level, hematocrit, glucose level, and ejection fraction were not related to anergy. Anergic patients had significantly higher mortality at 30, 60, and 90 days after transplantation, but long-term mortality was not significantly different from patients reactive on DHSTs (p = 0.267). CONCLUSION: We conclude that the DHSTs provide useful information regarding risk of early mortality after heart transplantation.

Adult↗

Thoracoabdominal aneurysm repair: a representative experience.

Between May 1966 and June 1991, 129 patients underwent surgical repair of thoracoabdominal aneurysms, with an overall 30-day mortality rate of 35%. In 75 operations (58%) performed electively, 11 deaths (15%) occurred, and in 54 cases (42%) of either symptomatic or ruptured aneurysms 34 deaths (63%; p less than 0.001) occurred. No one survived among six patients with preoperative hypotension (less than 90 mm Hg) or cardiac arrest. In 16 patients (12%) the etiology of aneurysms was a result of chronic aortic dissection, and the mortality rate in this subgroup was 44%. In the remaining 113 patients (88%) where the etiology was atherosclerosis, 38 deaths occurred (34%; p = 0.433). Spinal cord ischemia occurred in 25 cases (21%) among 116 patients who survived operation. Partial ischemia occurred in six cases (25%), and complete paraplegia occurred in the remainder. Complete and partial paraplegia occurred in 16 of 42 cases (38%) when all of the thoracic aorta was replaced (Crawford groups I, II) and in 9 of 74 cases (12%) when only the abdominal or lower thoracic aorta was replaced (Crawford groups III, IV; p = 0.016). Other complications included myocardial infarction (14 cases, 11%), respiratory failure (46 cases, 36%), and renal failure (33 cases, 27%). The major prospect for improved early survival of patients with thoracoabdominal aneurysms seems to be early detection and elective repair before the occurrence of symptoms.

Adult↗

Determinants of clean surgical wound infections for breast procedures at an oncology center.

OBJECTIVE: To determine the clean surgical wound infection rate for breast procedures and the risk factors predisposing patients to these infections. DESIGN: A survey study. SETTING: Oncology center. PATIENTS: A consecutive sample of adult female patients who underwent surgical breast procedures for suspected carcinoma of the breast. Patients undergoing excisional biopsy, lumpectomy, or mastectomy from January 1985 to January 1987 were included in the study. INTERVENTION: Clean surgical wound infection rates were derived overall and for each procedure type. The medical records of all patients were then reviewed to extract data on patient characteristics and operative information in order to assess the risk factors for infection. RESULTS: Among the breast procedures performed on 448 patients, the overall clean surgical wound infection rate was 8.7% (39/448). The clean surgical wound infection rate for each procedure type was as follows: biopsy 2.3%, lumpectomy 6.6%, and mastectomy 19%. In addition to the type of procedure, factors significantly (p less than .05) associated with the development of clean surgical wound infection in the univariate analysis included: presence of surgical drains (p less than .01); closed suction drainage (odds ratio [OR] = 16.5, 95% confidence interval [CI95] = 5.0-54.7); location of the drain (OR = 3.3, CI95 = 1.7-6.6); prolonged preoperative stay (OR = 1.2, CI95 = 1.0-1.5); length of surgery (OR = 2.2, CI95 = 1.7-3.0); and greater mean age (OR = 1.6, CI95 = 1.2-2.1). CONCLUSION: Clean surgical wound infections are not uncommon in patients undergoing breast procedures. Factors relating to both the patient and operative techniques contribute to the clean surgical wound infection rate. Further consideration should be given to perioperative antibiotic prophylaxis for selected breast procedures, and the role of surgical drains should be reassessed.

Biopsy↗

Stroke following acute myocardial infarction in diabetics.

To investigate the effect of diabetes on stroke after myocardial infarction (MI), we studied consecutive MI patients admitted to the coronary-care unit prospectively, and compared diabetics with non-diabetics. Seven per cent (11/148) of diabetics and 3% (8/297) of non-diabetics had a stroke within 1 month after MI (P = 0.020). Previous stroke and hypertension were significant risk factors for stroke after MI in diabetics, but there were no significant risk factors in non-diabetics. Hypertension was more frequent in diabetics with (12/14; 86%) than in diabetics without (63/134; 47%) a previous stroke (P less than 0.025). Severe hypotension was more frequent in diabetics (9/11) than in non-diabetics with stroke after MI (0/8) (P = 0.002). We conclude that hypertension is a risk factor for stroke after MI in diabetics, and that may be at risk for hypotensive stroke after MI. Stroke after MI may be more frequent in diabetics than in non-diabetics.

Aged↗

Atheroembolism from the ascending aorta. An emerging problem in cardiac surgery.

As the ages of patients undergoing cardiac operations have increased, noncardiac causes of death have increased. To identify these causes of death, we analyzed the autopsy findings in 221 patients undergoing myocardial revascularization or valve operations between 1982 and 1989. Mean age was 65.6 +/- 9.5 years and the range was from 32 to 94 years; 130 patients (58.8%) were male. Autopsies were complete in 129 patients (58.4%) and limited to the chest and abdomen in the remainder. Embolic disease was identified in 69 patients (31.2%). Atheroemboli or abnormalities consistent with atheroemboli were identified in 48 patients (21.7%). Fourteen patients had thromboembolism and 7 had disseminated intravascular coagulation. The prevalence of atheroembolic disease increased dramatically from 4.5% in 1982 to 48.3% in 1989 (p = 0.001). Atheroembolic disease was found in the brain in 16.3% of patients, spleen in 10.9%, kidney in 10.4%, and pancreas in 6.8%. Thirty (62.5%) of the 48 patients had multiple atheroembolic sites. Atheroemboli were more common in patients undergoing coronary artery procedures (43/165; 26.1%) than in those undergoing valve procedures (5/56; 8.9%) (p = 0.008). There was a high correlation of atheroemboli with severe atherosclerosis of the ascending aorta. Atheroembolic events occurred in 46 of 123 patients (37.4%) with severe disease of the ascending aorta but in only 2 of 98 patients (2%) without significant ascending aortic disease (p less than 0.0001). Forty-six of 48 patients (95.8%) who had evidence of atheroemboli had severe atherosclerosis of the ascending aorta. There was a direct correlation between age, severe atherosclerosis of the ascending aorta, and atheroemboli. Incremental risk factors for atheroembolic are peripheral vascular disease and severe atherosclerosis of the ascending aorta.

Age Factors↗

Attributes and survival patterns of multiple primary cutaneous malignant melanoma.

From a series of 1495 patients with primary cutaneous malignant melanoma (PCMM), 26 patients (1.73%) had multiple primary cutaneous malignant melanoma (MPCMM). This report describes the attributes and survival patterns in this small, but important, subgroup of patients with PCMM. Of 26 patients, 23 had two primaries, two had three primaries, and one had six primaries. Five patients had synchronous and 21 patients had metachronous MPCMM. The median interval between the occurrence of the first and subsequent PCMM in these patients was 1.93 years. The estimated 5-year survival rate from the first melanoma was 83.5%; that from the last melanoma was 53.1%. In summary, MPCMM is a distinct biologic phenomenon. A second or subsequent malignant melanoma should be treated like a primary melanoma.

Adult↗

Adoptive immunotherapy using lymphokine-activated killer cells and recombinant interleukin-2 in preventing and treating spontaneous pulmonary metastases of syngeneic Dunning rat prostate tumor.

Lymphokine-activated killer (LAK) cells were generated from splenocytes of rats bearing a weakly immunogenic Dunning prostate tumor (R-3227 AT-3) and activated with recombinant interleukin-2 (rIL-2). The maximal LAK activity was obtained from splenocytes of rats bearing tumors for 10 to 14 days after incubation with 1000 U/ml./day of rIL-2 for five to eight days. The majority of these LAK cells expressed high levels of asialo GM1 (89%), laminin (83%), OX-19 (80%) and OX-8 (88%) surface markers. LAK cells exhibited higher cytotoxicity to rat prostate tumor cells and mouse lymphoma in vitro than to other non-prostate tumor cells or normal rat splenocytes and thymocytes. Splenocytes of rats bearing prostate tumors have higher LAK activity than normal splenocytes. The Winn type assay showed that Dunning prostate tumor growth was inhibited effectively by LAK cells at a tumor cell:LAK cell ratio of 1:50. The therapeutic efficacy of LAK cells in the treatment of primary solid prostate tumors and pulmonary metastases of Dunning rats was evaluated. LAK cells in combination with rIL-2 showed a greater therapeutic benefit in 1) prevention of prostate tumor metastases to lung, 2) retardation of the primary tumor growth, 3) regression of spontaneously established pulmonary metastases, and 4) prolongation of survival as compared to untreated controls or those groups treated with LAK cells or rIL-2 alone. The results of this study indicate that the conjunctive therapeutic approach of using surgical therapy to remove primary solid tumors followed by adoptive immunotherapy with LAK cells plus in vivo administration of IL-2 may be potentially valuable in the treatment of prostate tumors, particularly for the spontaneous pulmonary metastases.

Animals↗

Enuresis and the voiding cystourethrogram: a re-evaluation.

Eighty-three children with a chief complaint of nocturnal enuresis and no history of urinary tract infection (UTI) were prospectively evaluated with a contrast voiding cystourethrogram (VCUG). The following four historical details of presentation were noted: primary vs. secondary enuresis, daytime wetting, urgency, and frequency. Each of these four symptoms were treated as a dichotomous variable, and the prognostic value with respect to vesicoureteral (VUR) reflux was assessed using a linear logistic regression model. Nineteen ureters in 13 patients (16%) demonstrated VUR: grade I, 7 ureters; grade II, 5 ureters; grade III, 3 ureters; grade IV, 4 ureters; and grade V, 0 ureters. Three patients demonstrated renal scarring (16%) and 2 patients underwent surgery. The linear regression analysis revealed that no one symptom, group of symptoms, or absence of all four symptoms segregated those patients likely to have reflux with statistical validity. One of 6 children, therefore, who present with nocturnal enuresis and sterile urine will have reflux. Screening these children with a VCUG should be considered.

Child↗