Thomas E. Fagan

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.

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.

Potential role of three-dimensional rotational angiography and C-arm CT for valvular repair and implantation

Imaging modalities utilized in the interventional cardiology suite have seen an impressive evolution and expansion recently, particularly with regard to the recent interest in three-dimensional (3D) imaging. Despite this, the backbone of visualization in the catheterization laboratory remains two-dimensional (2D) X-ray fluoroscopy and cine-angiography. New imaging techniques under development, referred to as three-dimensional rotational angiography (RA) and C-arm CT, hold great promise for improving current device implantation and understanding of cardiovascular anatomy. This paper reviews the evolution of rotational angiography and advanced 3D X-ray imaging applications to interventional cardiology.

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.

Left ventricular diastolic dysfunction in bronchopulmonary dysplasia.

We report 2 infants with severe bronchopulmonary dysplasia in whom left ventricular diastolic dysfunction contributed to clinical abnormalities, including pulmonary hypertension and recurrent pulmonary edema. We speculate that close monitoring for left ventricular diastolic dysfunction may assist with clinical management and improve outcomes of infants with severe bronchopulmonary dysplasia.

Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves: An International, Multicenter Registry Study.

Background— Off-label use of transcatheter aortic and pulmonary valve prostheses for tricuspid valve-in-valve implantation (TVIV) within dysfunctional surgical tricuspid valve (TV) bioprostheses has been described in small reports. Methods and Results— An international, multicenter registry was developed to collect data on TVIV cases. Patient-related factors, procedural details and outcomes, and follow-up data were analyzed. Valve-in-ring or heterotopic TV implantation procedures were not included. Data were collected on 156 patients with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. The median age was 40 years, and 71% of patients were in New York Heart Association class III or IV. Among 152 patients in whom TVIV was attempted with a Melody (n=94) or Sapien (n=58) valve, implantation was successful in 150, with few serious complications. After TVIV, both the TV inflow gradient and tricuspid regurgitation grade improved significantly. During follow-up (median, 13.3 months), 22 patients died, 5 within 30 days; all 22 patients were in New York Heart Association class III or IV, and 9 were hospitalized before TVIV. There were 10 TV reinterventions, and 3 other patients had significant recurrent TV dysfunction. At follow-up, 77% of patients were in New York Heart Association class I or II (P<0.001 versus before TVIV). Outcomes did not differ according to surgical valve size or TVIV valve type. Conclusions— TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve size. Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for treatment of failing TV bioprostheses.

Reconstruction of Stenotic or Occluded Iliofemoral Veins and Inferior Vena Cava Using Intravascular Stents: Re-establishing Access for Future Cardiac Catheterization and Cardiac Surgery

OBJECTIVES The study evaluated the safety and efficacy of stent reconstruction of stenotic/occluded iliofemoral veins (IFV) and inferior vena cava (IVC). BACKGROUND Patients with congenital heart defects and stenotic or occluded IFV/IVC may encounter femoral venous access problems during future cardiac surgeries or catheterizations. METHODS Twenty-four patients (median age 4.9 years) underwent implantation of 85 stents in 22 IFV and 6 IVC. Fifteen vessels were severely stenotic and 13 were completely occluded. Although guide wires were easily passed across the stenotic vessels, occluded vessels required puncture through the thrombosed sites using a stiff wire or transseptal needle. Once traversed, the occluded site was dilated serially prior to stent implantation. RESULTS Following stent placement, the mean vessel diameter increased from 0.9 +/- 1.6 to 7.4 +/- 2.6 mm (p < 0.05). Twenty-one of 28 vessels had long segment stenosis/occlusion requiring two to seven overlapping stents. Repeat catheterizations were performed in seven patients (9 stented vessels) at mean follow-up of 1.6 years. Seven vessels remained patent with mean diameter of 6.4 +/- 2.0 mm. Two vessels were occluded, but they were easily recanalized and redilated. Echocardiographic follow-up in two patients with IVC stents demonstrated wide patency. In four additional patients, a stented vessel was utilized for vascular access during subsequent cardiac surgery (n = 3) and endomyocardial biopsy (n = 1). Therefore, 13 of 15 stented vessels (87%) remained patent at follow-up thus far. CONCLUSIONS Stenotic/obstructed IFV and IVC may be reconstructed using stents to re-establish venous access to the heart for future cardiac catheterization and/or surgeries.

Fracture of the GORE HELEX septal occluder: associated factors and clinical outcomes.

This study examines factors associated with, and clinical effects of, wire frame fractures (WFF) of the GORE HELEX™ Septal Occluder (HELEX).

3-D guidance of complex pulmonary artery stent placement using reconstructed rotational angiography with live overlay†

Technologies which allow rotational angiographic image acquisition and three dimensional (3‐D) vascular reconstruction with subsequent fluoroscopic registration for live 3‐D image overlay are rapidly being adopted. We present the first use of rotational angiography with integrated 3‐D image overlay for guidance during complex pulmonary artery stent placement. Technical considerations, advantages, and limitations of this procedural strategy are discussed.

CRISP: Catheterization RISk score for pediatrics: A Report from the Congenital Cardiac Interventional Study Consortium (CCISC)

We sought to develop a scoring system that predicts the risk of serious adverse events (SAEs) for individual pediatric patients undergoing cardiac catheterization procedures.