Preoperative prediction of spinal cord ischemia after thoracic endovascular aortic repair

ObjectiveSpinal cord ischemia (SCI) is a devastating but potentially preventable complication of thoracic endovascular aortic repair (TEVAR). The purpose of this analysis was to determine what factors predict SCI after TEVAR.MethodsAll TEVAR procedures at a single institution were reviewed for patient characteristics, prior aortic repair history, aortic centerline of flow analysis, and procedural characteristics. SCI was defined as any lower extremity neurologic deficit that was not attributable to an intracranial process or peripheral neuropathy. Forty-three patient and procedural variables were evaluated individually for association with SCI. Those with the strongest relationships to SCI (P < .1) were included in a multivariable logistic regression model, and a stepwise variable elimination algorithm was bootstrapped to derive a best subset of predictors from this model.ResultsFrom 2002 to 2013, 741 patients underwent TEVAR for various indications, and 68 (9.2%) developed SCI (permanent: n = 38; 5.1%). Because of the lack of adequate imaging for centerline analysis, 586 patients (any SCI, n = 43; 7.4%) were subsequently analyzed. Patients experiencing SCI after TEVAR were older (SCI, 72 ± 11 years; no SCI, 65 ± 15 years; P < .0001) and had significantly higher rates of multiple cardiovascular risk factors. The stepwise selection procedure identified five variables as the most important predictors of SCI: age (odds ratio [OR] multiplies by 1.3 per 10 years; 95% confidence interval [CI], 0.9-1.8, P = .06), aortic coverage length (OR multiplies by 1.3 per 5 cm; CI, 1.1-1.6; P = .002), chronic obstructive pulmonary disease (OR, 1.9; CI, 0.9-4.1; P = .1), chronic renal insufficiency (creatinine concentration ≥ 1.6 mg/dL; OR, 1.9; CI, 0.8-4.2; P = .1), and hypertension (defined as chart history or medication; OR, 6.4; CI, 2.6-18; P < .0001). A logistic regression model with just these five covariates had excellent discrimination (area under the receiver operating characteristic curve = .83) and calibration (χ2 = 9.8; P = .28).ConclusionsThis analysis generated a simple model that reliably predicts SCI after TEVAR. This clinical tool can assist decision-making about when to proceed with TEVAR, guide discussions about intervention risk, and help determine when maneuvers to mitigate SCI risk should be implemented

Initial United States experience with the Paracor HeartNet⁎⁎Paracor Medical, Inc, Sunnyvale, Calif. myocardial constraint device for heart failure

ObjectiveThis study was undertaken to review the initial results and surgical safety data for the US Food and Drug Administration safety and feasibility trial of the Paracor HeartNet (Paracor Medical, Inc, Sunnyvale, Calif.) myocardial constraint device.MethodsPatients with New York Heart Association functional class II or III heart failure underwent device implantation (n = 21) through a left minithoracotomy.ResultsThe average age was 53 years (31–72 years). There were 18 men and 3 women, and 17 patients had nonischemic etiology of heart failure. Mean heart failure duration was 8.3 years (1.4-18.8 years). Average ejection fraction was 22% (11%-33%), with an average left ventricular end-diastolic dimension of 74 mm (55-94 mm). Previous medical therapy included angiotensin-converting enzyme inhibitors, β-blockers, diuretics, digoxin, and aldosterone receptor blockers. At implantation, 17 patients had implantable electronic devices: 1 biventricular pacemaker, 11 biventricular pacemakers with cardioverter-defibrillators, and 5 implantable cardioverter-defibrillators. Patient comorbidities included hypertension in 10 cases, diabetes mellitus in 8, myocardial infarction in 1, and ventricular tachycardia in 8. Mean operative time was 68 minutes (42–102 minutes), and implantation time averaged 15 minutes (5–51 minutes). The average time to ambulation was 1.6 days (1–4 days). The intensive care unit stay averaged 3.3 days (1–16 days), and hospital stay averaged 6.3 days (4–16 days). Atrial fibrillation occurred in 2 patients, and there were 2 in-hospital deaths.ConclusionsThe Paracor device can be implanted in patients with heart failure and reduced left ventricular function with a high degree of success. Significant surgical complications were infrequent. The initial US experience supports the conduct of a randomized, controlled, pivotal trial

Post–cardiac transplant survival after support with a continuous-flow left ventricular assist device: Impact of duration of left ventricular assist device support and other variables

ObjectiveAlthough left ventricular assist devices (LVADs) are associated with excellent outcomes in patients with end-stage heart failure, there are conflicting reports on posttransplant survival in these patients. Furthermore, prior studies with pulsatile LVADs have shown that transplantation, either early (<6 weeks) or late (>6 months) after LVAD implantation, adversely affected post–cardiac transplant survival. We sought to determine factors related to posttransplant survival in patients supported with continuous-flow LVADs.MethodsThe HeartMate II LVAD (Thoratec Corporation, Pleasanton, Calif) was implanted in 468 patients as a bridge to transplant at 36 centers in a multicenter trial. Patients who underwent transplantation after support were stratified by demographics: gender, age, etiology, body mass index, duration of device support, and by adverse events during support. The median age was 54 years (range 18–73 years); 43% had ischemic etiology, and 18% were women. Survival was determined at the specific intervals of 30 days and 1 year after transplantation.ResultsOf 468 patients, 250 (53%) underwent cardiac transplant after a median duration of LVAD support of 151 days (longest: 3.2 years), 106 (23%) died, 12 (2.6%) recovered ventricular function and the device was removed, and 100 (21%) were still receiving LVAD support. The overall 30-day and 1-year posttransplant survivals were 97% and 87%. There were no significant differences in survival based on demographic factors or LVAD duration of less than 30 days, 30 to 90 days, 90 to 180 days, and more than 180 days. Patients requiring more than 2 units of packed red blood cells in 24 hours during LVAD support had a statistically significant decreased 1-year survival (82% vs 94%) when compared with patients who did not require more than 2 units of packed red blood cells in 24 hours during LVAD support (P = .03). There was a trend for slightly lower survival at 1 year in patients with percutaneous lead infections during LVAD support versus no infection (75% vs 89%; P = .07).ConclusionsPost–cardiac transplant survival in patients supported with continuous-flow devices such as the HeartMate II LVAD is equivalent to that with conventional transplantation. Furthermore, posttransplant survival is not influenced by the duration of LVAD support. The improved durability and reduced short- and long-term morbidity associated with the HeartMate II LVAD has reduced the need for urgent cardiac transplantation, which may have adversely influenced survival in the pulsatile LVAD era. This information may have significant implications for changing the current United Network for Organ Sharing criteria regarding listing of heart transplant candidates

Percutaneous thoracic endovascular aortic repair is not contraindicated in obese patients

ObjectiveThere are limited data describing the preclose technique with the Perclose ProGlide device (Abbott Vascular, Redwood City, Calif) in percutaneous thoracic endovascular aortic repair (P-TEVAR), particularly in obese patients, in whom use of this technique is thought to be relatively contraindicated. The purpose of this analysis was to describe our experience with P-TEVAR and to compare outcomes in patients with or without obesity.MethodsAll TEVAR procedures at a single institution from 2005 to 2011 were reviewed, and P-TEVAR patients were stratified by body mass index (obesity ≥ 30 kg/m2). Preoperative computed tomography scans were analyzed for access vessel depth, calcification, and morphology. Technical success was defined as the ability to achieve hemostasis and to maintain limb perfusion without the need for common femoral artery exposure or obligate surgical repair of the vessel within a 30-day postoperative period. Generalized estimating equations and stepwise logistic regression were used to develop prediction models of preclose failure.ResultsThe review identified 536 patients, in whom 355 (66%) P-TEVAR procedures were completed (366 arteries; n = 40 [11%] bilateral). Compared with nonobese patients (n = 264), obese patients (n = 91) were typically younger (59 ± 16 years vs 66 ± 16 years; P = .0004) and more likely to have renal insufficiency (28% vs 17%; P = .05) or diabetes mellitus (19% vs 9%; P = .02). The number of Perclose deployments was similar between groups (P = NS). Mean sheath size (25.4F vs 25.0F; P = .04), access vessel inner diameters (8.5 ± 1.9 mm vs 7.9 ± 2.0 mm; P = .02), and vessel depth (50 ± 20 mm vs 30 ± 13 mm; P < .0001) were greater in obese patients. Adjunctive iliac stents were used in 7% of cases (10 [11%] in obese patients vs 16 [6%] in nonobese patients; P = .2). Overall technical success was 92% (92% for nonobese patients vs 93% for obese patients; P = .7). Three patients required subsequent operations for access complications, two obese patients (2%) and one nonobese patient (0.4%) (P = .3). Independent predictors of failure were adjunctive iliac stent (odds ratio [OR], 9.5; 95% confidence interval [CI], 3.3-27.8; P < .0001), more than two Perclose devices (OR, 7.0; 95% CI, 2.3-21; P = .0005), and smaller access vessel diameter to sheath size ratio (OR multiplies by 1.1 for each .01 decrease in ratio; 95% CI, 1.02-1.2; P = .007) (area under the receiver operating characteristic curve = .75).ConclusionsObesity is not a contraindication to P-TEVAR. P-TEVAR can be performed safely, despite the need for larger diameter sheaths. However, patients predicted to need adjunctive stenting or possessing smaller access vessel diameter to sheath size ratios are at highest risk of preclose failure with the Perclose ProGlide device, and selective use of this technique is recommended