Thomas J. Forbes

Procedural Results and Acute Complications in Stenting Native and Recurrent Coarctation of the Aorta in Patients Over 4 Years of Age: A Multi-Institutional Study

Background: We report a multi‐institutional experience with intravascular stenting (IS) for treatment of coarctation of the aorta. Methods and Results: Data was collected retrospectively by review of medical records from 17 institutions. The data was broken down to prior to 2002 and after 2002 for further analysis. A total of 565 procedures were performed with a median age of 15 years (mean = 18.1 years). Successful reduction in the post stent gradient (<20 mm Hg) or increase in post stent coarctation to descending aorta (DAo) ratio of >0.8 was achieved in 97.9% of procedures. There was significant improvement (P < 0.01) in pre versus post stent coarctation dimensions (7.4 mm ± 3.0 mm vs. 14.3 ± 3.2mm), systolic gradient (31.6 mm Hg ± 16.0 mm Hg vs. 2.7 mm Hg ± 4.2 mm Hg) and ratio of the coarctation segment to the DAo (0.43 ± 0.17 vs. 0.85 ± 0.15). Acute complications were encountered in 81/565 (14.3%) procedures. There were two procedure related deaths. Aortic wall complications included: aneurysm formation (n = 6), intimal tears (n = 8), and dissections (n = 9). The risk of aortic dissection increased significantly in patients over the age of 40 years. Technical complications included stent migration (n = 28), and balloon rupture (n = 13). Peripheral vascular complications included cerebral vascular accidents (CVA) (n = 4), peripheral emboli (n = 1), and significant access arterial injury (n = 13). Older age was significantly associated with occurrence of CVAs. A significant decrease in the technical complication rate from 16.3% to 6.1% (P < 0.001) was observed in procedures performed after January 2002. Conclusions: Stent placement for coarctation of aorta is an effective treatment option, though it remains a technically challenging procedure. Technical and aortic complications have decreased over the past 3 years due to, in part, improvement in balloon and stent design. Improvement in our ability to assess aortic wall compliance is essential prior to placement of ISs in older patients with coarctation of the aorta.

Comparison of surgical, stent, and balloon angioplasty treatment of native coarctation of the aorta: an observational study by the CCISC (Congenital Cardiovascular Interventional Study Consortium).

OBJECTIVES The purpose of this study was to compare the safety and efficacy of surgical, stent, and balloon angioplasty (BA) treatment of native coarctation acutely and at follow-up. BACKGROUND Controversy surrounds the optimal treatment for native coarctation of the aorta. This is the first multicenter study evaluating acute and follow-up outcomes of these 3 treatment options in children weighing >10 kg. METHODS This is a multicenter observational study. Baseline, acute, short-term (3 to 18 months), and intermediate (>18 months) follow-up hemodynamic, imaging data, and complications were recorded. RESULTS Between June 2002 and July 2009, 350 patients from 36 institutions were enrolled: 217 underwent stent, 61 underwent BA, and 72 underwent surgery. All 3 arms showed significant improvement acutely and at follow-up in resting systolic blood pressure and upper to lower extremity systolic blood pressure gradient (ULG). Stent was superior to BA in achieving lower ULG acutely. Surgery and stent were superior to BA at short-term follow-up in achieving lower ULG. Stent patients had shorter hospitalization than surgical patients (2.4 vs. 6.4 days; p < 0.001) and fewer complications than surgical and BA patients (2.3%, 8.1%, and 9.8%; p < 0.001). The BA patients were more likely to encounter aortic wall injury, both acutely and at follow-up (p < 0.001). CONCLUSIONS Stent patients had significantly lower acute complications compared with surgery patients or BA patients, although they were more likely to require a planned reintervention. At short-term and intermediate follow-up, stent and surgical patients achieved superior hemodynamic and integrated aortic arch imaging outcomes compared with BA patients. Because of the nonrandomized nature of this study, these results should be interpreted with caution.

Intermediate follow‐up following intravascular stenting for treatment of coarctation of the aorta

Background: We report a multiinstitutional study on intermediate‐term outcome of intravascular stenting for treatment of coarctation of the aorta using integrated arch imaging (IAI) techniques. Methods and Results: Medical records of 578 patients from 17 institutions were reviewed. A total of 588 procedures were performed between May 1989 and Aug 2005. About 27% (160/588) procedures were followed up by further IAI of their aorta (MRI/CT/repeat cardiac catheterization) after initial stent procedures. Abnormal imaging studies included: the presence of dissection or aneurysm formation, stent fracture, or the presence of reobstruction within the stent (instent restenosis or significant intimal build‐up within the stent). Forty‐one abnormal imaging studies were reported in the intermediate follow‐up at median 12 months (0.5–92 months). Smaller postintervention of the aorta (CoA) diameter and an increased persistent systolic pressure gradient were associated with encountering abnormal follow‐up imaging studies. Aortic wall abnormalities included dissections (n = 5) and aneurysm (n = 13). The risk of encountering aortic wall abnormalities increased with larger percent increase in CoA diameter poststent implant, increasing balloon/coarc ratio, and performing prestent angioplasty. Stent restenosis was observed in 5/6 parts encountering stent fracture and neointimal buildup (n = 16). Small CoA diameter poststent implant and increased poststent residual pressure gradient increased the likelihood of encountering instent restenosis at intermediate follow‐up. Conclusions: Abnormalities were observed at intermediate follow‐up following IS placement for treatment of native and recurrent coarctation of the aorta. Not exceeding a balloon:coarctation ratio of 3.5 and avoidance of prestent angioplasty decreased the likelihood of encountering an abnormal follow‐up imaging study in patients undergoing intravascular stent placement for the treatment of coarctation of the aorta. We recommend IAI for all patients undergoing IS placement for treatment of CoA.

Treatment of coexistent coarctation and aneurysm of the aorta with covered stent in a pediatric patient.

Intravascular stents have emerged as an effective alternative to surgery and balloon angioplasty in the treatment of native and recoarctation of aorta. Balloon angioplasty, although effective in the treatment of native coarctation of the aorta, is associated with several complications such as recoarctation, aneurysm formation, aortic dissection, and vascular injury. In this report, we present the use of a covered stent to treat a patient who developed recoarctation of the aorta with an associated aneurysm following balloon angioplasty of her native coarctation.

The Genesis stent: A new low-profile stent for use in infants, children, and adults with congenital heart disease

Placement of intravascular stents that can reach adult size in infants and smaller children has been limited by the large profile and poor flexibility of currently available stents. In vitro and in vivo testing of the Genesis stent was performed to evaluate crimpability, predeployment flexibility, and radial strength. Comparisons were made to the Palmaz iliac and IntraStent (IS) LD stents. Nine physicians placed 30 Genesis stents in swine pulmonary and systemic arteries to evaluate stent deliverability/crimpability. Two swine were recovered and underwent a second catheterization 8 weeks later, where the stents (n = 8) were reexpanded to maximal size. Angiographic and intravascular ultrasound (IVUS) assessments were performed. In vitro testing revealed the Genesis stent to have superior crimpability, flexibility, and comparable radial strength to the Palmaz iliac stent, and superior crimpability and radial strength and comparable flexibility to the IS LD series. During in vivo testing, the physicians graded the Genesis stent superior to the Palmaz stent regarding crimpability and deliverability, and superior to the IS LD stent in regard to crimpability, and comparable to or superior in deliverability. In the chronic animals, the Genesis stent was expanded up to maximal diameter 8 weeks following implantation. Angiographic and IVUS revealed no fractures no in‐stent restenosis. The Genesis stent can be easily delivered through smaller sheaths, which will facilitate their use in infants and smaller children with vascular stenosis. Cathet Cardiovasc Intervent 2003;59:406–414.

Trans-catheter closure of patent ductus arteriosus—What is the best device?†

Background: Over the past three decades, transcatheter occlusion of patent ductus arteriosus (PDA) has evolved to be the procedure of choice. Gianturco and Flipper coils are the most commonly used coils in the United States for closure of small and moderate size PDAs. For larger PDAs, interventionalists in the United States commonly use the Amplatzer Duct Occluder (ADO) and those in Europe use the ADO or the Nit‐Occlud Coils (NOC). A comparison between Gianturco coils, Flipper coils, ADO, and NOC has never been made. Objective: To compare the success and complication rate associated with the four different devices used for transcatheter closure of PDA. Success was defined as complete closure of PDA with absence of a residual shunt (R.S.) at six months follow‐up. Methods: Two institutions collaborated in combining their data to evaluate the results of transcatheter closure of PDA. Results: Totally, 546 patients underwent successful PDA occlusion at both institutions. Gianturco and Flipper coils were used in 120 (22%) and 119 (22%) patients respectively. A total of 152 (28%) patients received ADO and 155 (28%) patients received NOC. Immediate R.S. were noted in 226 (41.4%) patients in the entire study group with the NOC group having the highest percentage of R.S. (80/155, 51.6%, P = 0.004). Of the 484 patients with follow‐up echocardiograms at 6 months, 35 (7.2%) patients had persistent R.S. The NOC (3/143, 2.1%) and ADO (5/150, 3.3%) groups had the least R.S. at six months follow‐up. Conclusion: Per our definition of success, the Nit‐Occlud coils and the Amplatzer duct‐occluder devices had significantly higher success rate for PDA occlusion versus the coils.

Transcatheter closure of high-risk muscular ventricular septal defects with the CardioSEAL occluder: initial report from the CardioSEAL VSD registry.

The CardioSEAL VSD registry was created to track safety of the device to close high‐risk Ventricular Septal Defect (VSD).

Risk factors for life-threatening cavopulmonary thrombosis in patients undergoing bidirectional superior cavopulmonary shunt: An exploratory study

We have observed six patients with life-threatening superior vena caval or pulmonary thrombosis after bidirectional superior cavopulmonary shunt. With the use of a case control study we sought to identify perioperative risk factors for this thrombotic complication. Medical records of six patients with cavopulmonary thrombosis and those of 24 patients in a control group were reviewed to abstract data for potential risk factors. Contingency tables and univariate logistic regression were used to determine associations between various perioperative parameters and occurrence of cavopulmonary thrombosis. Preoperative variables associated with thrombosis included bilateral superior vena cavae, odds ratio: 23, p = 0.02, increased age at surgery (p = 0.05), and female sex (odds ratio: 7, p = 0.05). The McGoon Ratio (index of relative pulmonary artery branch diameter) was inversely related to thrombosis risk (p = 0.08). Two torr increases in mean right atrial (p = 0.08) or ventricular end-diastolic (p = 0.05) pressures were associated with approximately 70% increases in thrombosis risk. Intraoperative prolongation of aortic cross-clamp time related directly to thrombosis risk (p = 0.06). Postoperative variables associated with thrombosis included increased superior vena caval pressure within 12 hours after surgery (odds ratio > or = 10 for 5 torr increase in pressure, p = 0.02) and poor ventricular function (odds ratio: 9, p = 0.06) We conclude that high risk variables for patients undergoing a cavopulmonary shunt include bilateral superior vena cavae, female sex, increasing age, decreased McGoon Ratio, and elevated right atrial and ventricular end-diastolic pressure (before surgery), patients with prolonged aortic cross-clamp time (during surgery), and patients with elevated superior vena caval pressure and poor ventricular function (after surgery).

Remodeling and Thrombosis Following Closure of Coronary Artery Fistula With Review of Management: Large Distal Coronary Artery Fistula—To Close or Not to Close?

To evaluate postdiscovery outcome of coronary artery fistulae (CAF). CAF treatment sequelae and risk factors for coronary thrombosis have not been adequately evaluated.

Angiographic and hemodynamic predictors for successful outcome of transcatheter occlusion of patent ductus arteriosus in infants less than 8 kilograms

Transcatheter occlusion of patent ductus arteriosus (PDA) using Gianturco coils (GCs) has been performed for the past decade. However, little has been written regarding anatomical and hemodynamic predictors for successful occlusion of the PDA in infants. This report is to evaluate the outcome of transcatheter occlusion of PDA in symptomatic infants less than 8 kg and to assess predictors of successful occlusion. Retrospective review of catheterization charts and cineangiograms of 42 symptomatic infants who underwent cardiac catheterization for attempted transcatheter occlusion of their PDA was conducted. The hemodynamic and angiographic data evaluated included the length/diameter (L/D) ratio, defined as the length divided by the narrowest diameter of the ductus arteriosus, and preocclusion pulmonary artery pressures. Thirty‐one out of 42 patients (74%) had successful occlusion. Twenty‐nine out of 42 infants had an L/D ratio > 3. Of these, 26 (90%) had successful occlusion of their PDA. Thirteen out of 42 patients had an L/D ratio ≤ 3. Of these, 8 (62%) had unsuccessful occlusion. Complications encountered were transient loss of femoral arterial pulse (n = 6), coil embolization (n = 5), hemolysis (n = 2), and mild left pulmonary artery obstruction (n = 2). No permanent loss of femoral arterial pulse was noted. These complications resulted in no mortality and minimal morbidity. The L/D ratio was the strongest predictor of successful outcome, with an L/D ratio greater than 3.0 being more amenable to transcatheter occlusion (odds ratio of 4.6). Other predictors for success included lower preocclusion systolic, diastolic, and mean pulmonary artery pressure and smaller ductal diameter. Our conclusion was that infants less than 8 kg with an L/D ratio > 3.0 can safely and successfully undergo transcatheter occlusion of their PDA using transcatheter coils. Catheter Cardiovasc Interv 2004;61:117–122.