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Biomedical subjects

C E Mullins

Publications and source records attributed to C E Mullins.

At least 19 recordsLinked to original sources
PubMed1998

Intravascular stents in congenital heart disease: short- and long-term results from a large single-center experience.

OBJECTIVES: This report describes the results of the Food and Drug Administration's phase 1 and 2 clinical trials of intravascular stents at Texas Children's Hospital. BACKGROUND: Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful. METHODS: Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization. RESULTS: At stent implantation, pressure gradients decreased significantly in all three groups (mean +/- SD): from 46 +/- 25 to 10 +/- 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 +/- 45 to 15 +/- 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 +/- 6 to 1 +/- 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 +/- 3 to 12 +/- 3 mm in postoperative PA stenoses (p < 0.001); from 3 + 1 to 9 + 1 mm in congenital PA stenoses (p < 0.001); and from 3 +/- 4 to 12 +/- 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 +/- 0.2 to 0.41 +/- 0.02 (p < 0.001) and from 0.71 +/- 0.3 to 0.55 +/- 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 +/- 17% to 46 +/- 14% (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients. CONCLUSIONS: Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long-term results.

Adolescent↗
PubMed1998

Eradicating acute hemolysis following transcatheter closure of ductus arteriosus by immediate deployment of a second device.

Two patients who underwent transcatheter closure of patent ductus arteriosus, one with a Rashkind umbrella device and the other with a coil, suffered from acute hemolysis following the procedure. Hemolysis ceased after deployment of second device(s) within 48 hr without needing to retrieve the first devices in either patient. We conclude that immediate deployment of a second device(s) is an alternative to surgery when acute hemolysis occurs following transcatheter closure of ductus.

Acute Disease↗
PubMed1997

Single therapeutic catheterization to treat coexisting coarctation of the aorta and patent ductus arteriosus.

A case of a pediatric patient found to have coexisting coarctation of the aorta and patent ductus arteriosus who underwent balloon dilation of the coarctation and coil occlusion of the ductus in a single cardiac catheterization is presented. Review of the English literature revealed no previous reports of this combination of transcatheter interventions during a single catheterization procedure.

Aortic Coarctation↗
PubMed1997

Endovascular stent implantation for severe recoarctation of the aorta: case report with angiographic and 18-month clinical follow-up.

A 45-year-old white male, 35-year status postrepair of coarctation of the aorta, presented with symptomatic recoarctation of the aorta. He was treated successfully by implantation of a single Palmaz stent. The pressure gradient was abolished with complete resolution of symptoms. Seven months poststent implant, angiography revealed good lumen diameter and a small pressure gradient. Over an 18-mo follow-up period, there has been no recurrence of symptoms. Primary stenting may have a significant role in the treatment of patients with symptomatic recoarctation of the aorta.

Angiography↗
PubMed1997

[The role of the stent in non-coronary cardiopathies].

INTRODUCTION: The stent has demonstrated to be a useful device in the prevention of postangioplasty coronary restenosis and it is expected to have a favourable effect as an alternative or complementary treatment of stenotic lesions in arteries or veins associated with congenital defects. The aim of this study is to analyze our experience in this setting. MATERIAL AND METHODS: From February 1992 to March 1996, 28 stenting procedures were performed in 26 patients (mean age: 8.6 +/- 0.7 years; mean weight: 26.2 +/- 3 kg). In 12 patients, stenting was single, and a iliac Palmaz stents were always used. Stenting location was: pulmonary artery branches in 17 patients, right ventricular outflow in 2 patients, in the junction of right atrium with pulmonary artery in 2 patients, systemic veins in 2 patients and in post Mustard intratrial channel stenosis in 2 patients. 25 patients had previously undergone at least one surgical procedure. RESULTS: The stenotic diameter of the treated lesions increased significantly after the procedure (4.4 +/- 0.3 mm before stenting vs 11.6 +/- 0.3 mm after stenting, p < 0.0001) and the transtenotic gradient decreased from 38.1 +/- 5 to 12 +/- 3.8 mmHg. Those changes were associated with a diminution of right ventricular pressure (81.6 +/- 3 vs 56.7 +/- 6 mmHg, p < 0.0001) in patients with pulmonary branch stenosis without septal defects. There was no mortality among the percutaneously treated patients and only one patient needed surgery. Nevertheless, one patient died after bilateral intraoperative stenting. CONCLUSION: The treatment of proximal or distal stenotic lesions in the pulmonary tree, systemic veins, and obstructed intraatrial channels with stents, can replace or complement conventional balloon angioplasty. It also offers a useful and effective alternative to surgery, when it is impossible or carries a risk.

Adolescent↗
PubMed1996

Quantitative echocardiographic analysis of the aortic arch predicts outcome of balloon angioplasty of native coarctation of the aorta.

BACKGROUND: The use of balloon angioplasty for treatment of native aortic coarctation is controversial. Cineangiographic data suggest that aortic arch hypoplasia and isthmic narrowing are associated with angioplasty failure. This study of echocardiographic measurements of preangioplasty aortic arch morphology was performed to identify potential anatomic predictors of outcome noninvasively. METHODS AND RESULTS: The preangioplasty echocardiograms of 105 patients 3 days to 17 years old with native coarctation of the aorta were analyzed off-line. Angioplasty was considered successful if the residual coarctation gradient was < 20 mm Hg and no intervention for recoarctation occurred. Univariate analysis identified young age at angioplasty, presence of a patent ductus arteriosus, and the diameters of the aortic isthmus, distal transverse arch, and aortic valve as predictors of early and late outcomes. Multivariate analysis showed that the preangioplasty aortic isthmus z value was the best independent predictor of outcome, eliminating the effect on outcome of age and associated cardiac defects. An isthmus z value < or = -2.16 predicted early failure with 91% sensitivity and 85% specificity. Kaplan-Meier analysis demonstrated that 90% of patients with an isthmus z value > -1.0 remained free of recoarctation at late follow-up, whereas 89% of patients with a preangioplasty isthmus z value < or = -2.0 developed recoarctation within 36 months. CONCLUSIONS: Echocardiographic measurements of the aortic arch predict both early and late outcomes of balloon angioplasty for native aortic coarctation, and the preangioplasty aortic isthmus z value was the best independent predictor. Quantitative aortic arch analysis may improve selection of angioplasty candidates who are likely to benefit from the procedure.

Adult↗
PubMed1996

Core curriculum for the training of pediatric invasive/interventional cardiologists: report of the Society for Cardiac Angiography and Interventions Committee on Pediatric Cardiology Training Standards.

Within the field of pediatric cardiology, a number of subspecialty fields are generally recognized. Some of these overlap. For example, most electrophysiologists also would consider themselves to be clinical cardiologists. Some fields, however, are relatively mutually exclusive. For example, most clinical pediatric cardiologists would not consider themselves to be electrophysiologists and would admit that there is a different knowledge, skill, and experience base that separates an electrophysiologist from other specialists within the broader field of pediatric cardiology. Likewise, it is our opinion that a separate knowledge, skill, and experience base exists among pediatric Invasive/Interventional cardiologists. The purpose of this report is to define the unique knowledge and skill base required for the training of an invasive pediatric cardiologist. The scope of this report is limited to the training of Invasive/Interventional cardiologists dealing with the treatment of pediatric patients and the cardiac diseases most often encountered in these patients. This report describes in detail the core curriculum suggested for the training of an invasive pediatric cardiologist. For these purposes, invasive pediatric cardiology encompasses all aspects of pediatric diagnostic cardiac catheterization, whether congenital or acquired. Additional curriculum regarding training for therapeutic or interventional procedures is also addressed because of today's needs: most pediatric cardiac catheterizations are performed to acquire specific data that cannot be obtained otherwise by non-invasive technologies and are required for the best medical or surgical management. However, more and more frequently the need for a cardiac catheterization entertains the possibility of having to proceed with an interventional procedure, and therefore, to conserve the vessels of pediatric patients as well as to consider costs, any invasive pediatric cardiologist should be well trained in most of the accepted interventional pediatric cardiology procedures. The curricula is divided here into five major sections followed by a bibliography keyed to those sections. Also included is a suggested format for the objective evaluation and documentation of the progress of invasive pediatric cardiology fellows. It is intended to complement the core curriculum and provide a means for standardizing the evaluation of invasive pediatric cardiology fellows.

Angiography↗
PubMed1996

Transcatheter closure of the patient ductus arteriosus in adults using the Gianturco coil.

BACKGROUND AND HYPOTHESIS: Although results of surgical ligation of the patent ductus arteriosus (PDA) in the pediatric age group are excellent, surgical management of the adult with a PDA may be more problematic. The PDA that presents in adulthood may be calcified and friable, rendering simple ligation via a thoracotomy difficult, inadequate, and hazardous. Patch closure of the ductus arteriosus from either the aortic or pulmonary artery orifice using cardiopulmonary bypass or transient aortic cross-clamping is necessary but increases surgical risk. Furthermore, older patients with diseases unrelated to their PDA and patients with Down's syndrome may have higher risks with intubation, general anesthesia, and surgery. Early results of percutaneous transcatheter occlusion of the PDA with Gianturco coils performed under sedation and local anesthesia are promising. METHODS: Six adults with mean age of 39.1 years (range 23.1-62.0 years) were found to have an isolated PDA with mean minimum diameter of 2.7 mm (range 1.0-5.0 mm) at cardiac catheterization. All underwent percutaneous transcatheter occlusion of the PDA using Gianturco coils. RESULTS: Coil implantation was successful in all patients. There were no complications and all were discharged home within 24 hours. Complete ductal occlusion was seen immediately in 4 of 6 patients (67%) while 2 of 6 (33%) had small residual leaks. However, complete occlusion was achieved in all patients by 6 months following the procedure. CONCLUSION: Transcatheter occlusion of the PDA using coils is safe and efficacious in adults.

Adult↗
PubMed1995

Repeat dilation of intravascular stents in congenital heart defects.

BACKGROUND: Intravascular (Palmaz) stents have been successfully implanted in patients with congenital and acquired branch pulmonary stenosis. Early results are excellent; however, there is no information on restenosis and repeat dilation in patients with congenital heart disease. The purpose of this study is to review the incidence of restenosis and demonstrate the safety and efficacy of repeat dilation of stents in this group of patients. METHODS AND RESULTS: Of 94 patients with 163 implanted stents in this single-center study, 43 patients with 73 implanted stents underwent recatheterization. Only 2 of 73 restudied stents (3%) developed significant restenosis. In 20 patients, 30 stents were redilated. At stent implantation, the mean age of this subgroup was 14.2 years, the mean intraluminal diameter increased from 4.9 to 10.7 mm (P = .0001), and the systolic gradient (mean) across the stent decreased from 52 to 11 mm Hg (P = .0001). At recatheterization (mean, 13 months), all stents were patent. The mean diameter decreased by 1.2 mm (P = .0001), but the increase in the gradient (mean, 3 mm Hg) was not significant (P = .11). After repeat dilation, the diameter increased from 9.5 to 12.2 mm (P = .0001), and the gradient decreased from 14 to 8 mm Hg (P = .0003). The 2 stents with restenosis were redilated successfully. Two patients underwent a successful second redilation of 3 stents at 18 and 26 months. There were no complications. CONCLUSIONS: All stents remained patent. The occurrence of significant restenosis is low (3%), and these restenoses can be redilated and/or restented. Repeat dilation of the Palmaz stent implanted in branch pulmonary artery stenosis can be performed with safety and efficacy (94% success rate) up to 3 years after stent implantation.

Adolescent↗
PubMed1995

Use of intravascular stents in systemic venous and systemic venous baffle obstructions. Short-term follow-up results.

BACKGROUND: Balloon-expandable intravascular stents are well accepted in the management of arterial obstructions. This study was undertaken to detail the immediate and short-term results of intravascular stent implantation in systemic venous and systemic venous baffle obstructions in children. METHODS AND RESULTS: Between September 1991 and June 1994, 12 patients had 21 stents implanted in 13 systemic venous obstructions, 1 patient having stents placed in 2 separate obstructions. In the baffle group, 4 of 13 obstructions were at the superior vena cava/right atrial junction after atrial baffling for transposition of the great arteries. One of 4 patients had complete obstruction requiring transseptal needle perforation before stent implantation. There was an immediate gradient reduction from 12 +/- 8.4 mm Hg (range, 4 to 20 mm Hg) to 1.3 +/- 1.9 mm Hg (range, 0 to 4 mm Hg, P = .05). The obstructed segment diameter increased from 3.5 +/- 3.9 mm (range, 0 to 8.5 mm) to 16 +/- 2.7 mm (range, 14 to 20 mm, P = .002). In the central vein group, 9 of 13 obstructions were in large central veins. Three of 9 patients had complete obstruction requiring transseptal needle perforation before stent implantation. There was an immediate gradient reduction from 10.3 +/- 8.5 mm Hg (range, 0 to 20 mm Hg) to 0.8 +/- 1.1 mm Hg (range, 0 to 3 mm Hg, P = .005). The obstructed segment diameter increased from 1.3 +/- 1.1 mm (range, 0 to 2.8 mm) to 9.4 +/- 1.7 mm (range, 7.6 to 12 mm, P < .001). There were no acute complications in either group. In the follow-up group, patients were scheduled for clinical follow-up at 3, 6, and 12 months with echocardiography or magnetic resonance imaging (MRI) at 3 or 6 months and for repeat cardiac catheterization at 12 months. All stents were patent by echocardiography or MRI when studied at follow-up. Cardiac catheterization in 6 of 12 patients, 2 to 13 months after stent, demonstrated that all stents remained patent without compression or fracture. Follow-up and immediate poststent gradients were not significantly different (1 +/- 1.6 versus 0.7 +/- 1.2 mm Hg, P = NS). Neointimal hyperplasia (5 of 6 patients) reduced the stent lumen only from 12.5 +/- 4.7 mm (range, 8 to 20 mm) to 10.6 +/- 4.7 mm (range, 4.5 to 17.7 mm, P = NS). No stents required redilation. One of 18 stents placed in series had "unlocked" and rotated in the venous lumen but remained fully patent to flow. CONCLUSIONS: Balloon-expandable intravascular stents can be safely and effectively used to relieve systemic venous and systemic venous baffle obstructions, even when obstruction is complete. Short-term follow-up suggests excellent continued patency, but further follow-up is required to observe for progression of neointimal hyperplasia. We postulate that balloon-expandable intravascular stents will become the treatment of choice for the relief of selected systemic venous and venous baffle obstructions in the pediatric population.

Adolescent↗
PubMed1995

New Gianturco-Grifka vascular occlusion device. Initial studies in a canine model.

BACKGROUND: Transcatheter closure of cardiovascular defects remains a challenge. Several occlusion devices are available, but each device has limitations. The purpose of this study was to evaluate the new Gianturco-Grifka vascular occlusion device (GGVOD) in a canine model. METHODS AND RESULTS: A total of 26 GGVODs were implanted as part of short- and long-term studies. In the short-term study, 1 GGVOD was implanted in each of 11 systemic arteries from 3.2 to 9.0 mm in diameter. All 11 arteries were occluded immediately. In the long-term study, an aortopulmonary shunt was placed in 10 dogs (9, Gore-tex graft; 1, subclavian artery) followed by GGVOD implantation; additionally, a GGVOD was implanted in 5 subclavian arteries. The dogs were boarded for 3 to 6 months, then recatheterized and euthanatized. Immediately after implantation, the 5 subclavian arteries and 9 Gore-tex shunts were occluded completely; the 1 subclavian artery shunt had a small residual leak. At recatheterization, all 10 shunts and 5 subclavian arteries were occluded completely. Necropsy revealed all shunts to be occluded, with the aortic and pulmonic orifices covered with a neointimal layer. The mean fluoroscopic time needed for GGVOD implantation was 9 minutes (range, 3 to 22 minutes). CONCLUSIONS: (1) In a canine model, the GGVOD is effective for transcatheter occlusion of arteries and aortopulmonary shunts from 3 to 9 mm in diameter. Possible indications in children include aortopulmonary collateral vessels, long patent ductus arteriosus, systemic-pulmonary shunts, AV malformations, and arteries supplying tumors. (2) GGVOD implantation requires a short fluoroscopic time.

Animals↗
PubMed1995

Balloon angioplasty of native coarctation of the aorta: midterm follow-up and prognostic factors.

UNLABELLED: OBJECTIVES, This retrospective analysis was designed to examine the intermediate and long-term effects of balloon angioplasty for native coarctation of the aorta and to determine whether any factors are predictive of outcome. BACKGROUND: Balloon angioplasty for native coarctation of the aorta is controversial. Concerns exist over lack of long-term follow-up and possible formation of aneurysms. The role of transverse arch and isthmus hypoplasia after balloon dilation is unknown. METHODS: Included in the study were all patients 3 days to 29 years old (mean age 4.6 years) referred for possible balloon dilation to the pediatric cardiac catheterization laboratory with evidence of a discrete coarctation of the aorta. The hemodynamic data, angiograms and clinical records of 102 patients were examined, with follow-up data from 2 to 117 months (median 36.2) available in 92 patients. RESULTS: Immediate success with balloon angioplasty was achieved in 93 (91.2%) of the 102 patients. Seventy-one patients (77.2%) with intermediate follow-up data (range 12 to 117 months) available are asymptomatic and normotensive, with insignificant arm to leg blood pressure gradients (< or = 20 mm Hg). Twenty-one patients (22.8%) with an initial successful result developed an increase in gradient 2 at 86 months after angioplasty, requiring reintervention in 18. Follow-up > 72 months is available in 17 patients, 16 of whom are normotensive and have not required additional intervention. No additional intervention was needed in 88.4% of older children and infants > 7 months old. Ten of the 13 surviving neonates who initially had a successful dilation required reangioplasty or operation 14 days to 10 months (median 4.6 months) after angioplasty. Transverse arch hypoplasia had minimal effect on follow-up blood pressure gradient, whereas isthmic hypoplasia was associated with reintervention in 50%. A small aneurysm was noted in 2 (1.9%) of 102 patients. CONCLUSIONS: Balloon angioplasty of native aortic coarctation is effective in infants and older children. In neonates, balloon angioplasty provides effective palliation only. Aneurysm formation is rare; however, lifetime follow-up is warranted.

Adolescent↗