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1.
J Vasc Surg ; 78(6): 1418-1425.e1, 2023 12.
Article in English | MEDLINE | ID: mdl-37558144

ABSTRACT

OBJECTIVE: Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System was designed to improve seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) using EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks through one year. This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory cohort. METHODS: The 70 patients from the ANCHOR Registry were cohort submitted to regulators for approval of the Endurant short neck indication. Patients had an infrarenal neck length of ≥ 4 mm and <10 mm. At 5 years, this short neck cohort had clinical and imaging follow-up compliance rates of 85% (28/33) and 70% (23/33), respectively. RESULTS: The short neck cohort had a mean age of 71.3±8.1 years and was 27.1% (19/70) female. Kaplan Meier freedom from all-cause mortality was 68.5 ± 6.2%, freedom from aneurysm-related mortality was 90.1 ± 4.5%, freedom from any endovascular or surgical secondary procedure was 76.9 ± 7.2%, and freedom from rupture was 95.6 ± 3.2%. Eight patients had a total of nine type IA endoleaks detected through 5 years, of which three resolved spontaneously by the next follow-up visit. There were two patients with renal complications who did not undergo reintervention and there were no device migrations reported through 5 years. After 5 years, 68.2% of patients (15/22) had sac regression, 13.6% (3/22) had stable sacs, and 18.2% (4/22) had increased sac diameter as compared with their 1-month measurements. CONCLUSIONS: After ESAR treatment using Heli-FX EndoAnchors with Endurant, the 5-year outcomes of the short neck cohort from the ANCHOR registry had encouraging results with regards to proximal neck-related complications, secondary procedures, and sac regression. This review of ESAR in patients with short proximal necks showed positive outcomes through 5 years although follow-up of a larger cohort is necessary.


Subject(s)
Aortic Aneurysm, Abdominal , Endoleak , Humans , Female , Middle Aged , Aged , Endoleak/etiology , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aorta , Kidney , Neck
2.
J Vasc Surg ; 77(2): 446-453.e3, 2023 02.
Article in English | MEDLINE | ID: mdl-36028158

ABSTRACT

OBJECTIVE: This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the polymer based Endologix Alto Stent Graft System in treating abdominal aortic aneurysms (AAAs), with sealing 7 mm below the top of the fabric in aortic neck diameters from 16 to 30 mm. METHODS: Seventy-five patients were treated with Alto devices between March 2017 and February 2018 in 16 centers in the United States for infrarenal AAAs (max diameter ≥5.0 cm in diameter or size increase by 0.5 cm in 6 months or diameter ≥1.5 times the adjacent normal aorta). Patients were followed for 30 days, 6 months, and 1 year by clinical evaluation and computed tomography and abdominal x-ray imaging. Treatment success was defined as technical success and freedom from AAA enlargement, migration, type I or III endoleak, AAA rupture or surgical conversion, stent graft stenosis, occlusion, kink, thromboembolic events, and stent fracture attributable to the device requiring secondary intervention through 12 months. Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 1 year were analyzed. RESULTS: The mean patient age was 73 years, with 93% of patients being male. The 30-day major adverse event rate was 5.3%. At 1 year, the primary endpoint was met with a treatment success rate of 96.7%. Through 1-year post-treatment, all-cause mortality was 4.0%. No AAA-related mortality occurred. AAA enlargement was 1.6%, type I endoleak rate was 1.4%, with 100% freedom from type III endoleaks, device migration, device fracture, stent occlusion, or AAA rupture. The device-related secondary intervention rate was 2.7%. CONCLUSIONS: This prospective study demonstrates the Endologix Alto is safe and effective in treating AAAs with appropriate anatomy at 1 year. The safety endpoint is met by a 5.3% 30-day major adverse event rate, whereas the effectiveness endpoint is met by a treatment success rate of 96%.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Male , United States , Aged , Female , Blood Vessel Prosthesis/adverse effects , Prospective Studies , Endoleak/diagnostic imaging , Endoleak/etiology , Endoleak/therapy , Prosthesis Design , Stents/adverse effects , Treatment Outcome , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/complications
3.
J Vasc Surg ; 74(1): 114-123.e3, 2021 07.
Article in English | MEDLINE | ID: mdl-33253871

ABSTRACT

OBJECTIVE: The short- and mid-term outcomes of endovascular aortic aneurysm repair have made it a standard treatment of abdominal aortic aneurysms. However, newer generation devices have yet to demonstrate improved long-term rates for complications, reinterventions, and survival. The TREO stent graft is a latest generation device and was evaluated for approval in the United States. METHODS: In a multicenter, nonrandomized, investigational device exemption clinical trial, we assessed the safety and effectiveness of the TREO device, with core laboratory assessment of the imaging studies and an independent adjudication of safety. The primary effectiveness endpoint was successful aneurysm treatment at 1 year. The primary safety endpoint was the incidence of major adverse events (MAE) at 30 days. RESULTS: A total of 150 patients (132 men; 88.0%) with infrarenal abdominal aortic (87.3%) or aortoiliac (12.7%) aneurysms were enrolled. The data were normally distributed. The mean age was 71.7 ± 7.4 years. The MAE incidence at 30 days was 0.7%. One subject experienced two MAE: myocardial infarction and procedural blood loss of 1000 mL. The proportion of successful aneurysm treatment at 1 year was 93.1%. Longer term follow-up continues, with no aneurysm-related mortality at the latest follow-up. At 3 years, the cumulative all-cause mortality and incidence of type I and type III endoleaks was 10.7% (n = 16), 2.7% (n = 4), and 0% (n = 0), respectively. In addition, aneurysm sac shrinkage >5 mm at 3 years had occurred in 54.3% of patients, and 9.3% had required a secondary intervention (n = 14). CONCLUSIONS: The safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment at 1 year and aneurysm sac shrinkage >5 mm at 3 years in 54.3% of patients. Long-term follow-up continues to determine whether these favorable outcomes will be sustained.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Middle Aged , Patient Safety , Postoperative Complications/mortality , Postoperative Complications/therapy , Prosthesis Design , Reoperation , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States
4.
J Vasc Surg ; 73(3): 867-873.e2, 2021 03.
Article in English | MEDLINE | ID: mdl-32707389

ABSTRACT

OBJECTIVE: We present the 5-year results of a prospective regulatory study of the INCRAFT device, a low-profile endovascular stent graft system for repair of abdominal aortic aneurysms. METHODS: This was an open-label prospective nonrandomized single-arm study enrolling in centers in the United States and Japan. The primary effectiveness outcome was successful aneurysm treatment and the primary safety outcome was the incidence of major adverse events at 30 days after the procedure. Major long-term outcomes were mortality, reintervention, adverse limb outcomes, and suprarenal stent fracture. RESULTS: One hundred and ninety patients (mean age, 73.8 ± 7.6 years; 90% male; 69% white and 30% Asian) were enrolled from 32 centers throughout the United States and Japan. Minimal access vessel size was less than 7 mm on both sides in 43.9% of the study cohort. Thirty-day major adverse events occurred in 3.2% of patients (6/190). Periprocedural technical success was 94.1% (176/187). Successful aneurysm treatment was 100% at 30 days and 87.9% at 1 year. Two patients required open conversion for thromboembolic complications, 3 developed new type I or III endoleaks, and 7 experienced graft or limb occlusion. Freedom from graft occlusion was 96 ± 2% at 1 year and 94 ± 2% at 5 years. Freedom from stent fracture was 97 ± 1% at 1 year and 87 ± 3% at 5 years. Freedom from aneurysm-related mortality was 99 ± 1% at 1 and 5 years. CONCLUSIONS: This study demonstrates good efficacy and safety and a very low rate of aneurysm related deaths with the INCRAFT device in a population with a high proportion of challenging anatomy.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Postoperative Complications/mortality , Postoperative Complications/therapy , Prospective Studies , Prosthesis Design , Prosthesis Failure , Retreatment , Time Factors , Tokyo , Treatment Outcome , United States
5.
J Vasc Surg ; 71(6): 2029-2037, 2020 06.
Article in English | MEDLINE | ID: mdl-31727464

ABSTRACT

BACKGROUND: Historically, the treatment of iliac artery occlusive disease required a surgical bypass usually consisting of an aortobifemoral bypass or an iliofemoral bypass. With the advent of balloon angioplasty and stenting, these procedures are frequently replaced with endovascular options. However, the treatment of diffuse occlusive disease of the external iliac artery (EIA) using balloon angioplasty and/or stenting does not carry a favorable long-term patency rate. Remote endarterectomy of the EIA using ring dissectors with balloon assistance provides a novel, controlled, safe, and durable treatment of the diseased and/or occluded EIA. METHODS: A retrospective review over the past 6 years was performed at our institution identifying patients treated with balloon-assisted remote endarterectomy of the EIA by the current five practicing vascular surgeons. The technique involves exposure of the ipsilateral common femoral artery. With nonocclusive disease, direct access into the common femoral artery is performed, a wire is traversed through the diseased EIA, and a balloon is inflated at the origin of the vessel providing hemostasis and control. A femoral endarterectomy is performed, and a ring dissector is passed over the endarterectomized material including the wire and balloon catheter and advanced remotely through the EIA up to the balloon. The balloon is briefly deflated, repositioned within the ring dissector, and reinflated, thus cutting the plaque. This allows for retraction of the inflated balloon and cutter, removing the endarterectomized core plaque. The procedure is similar for the treatment of an occluded EIA, but wire access across the occluded vessel is normally achieved with contralateral access. In both cases, the balloon provides control and hemostasis and is critically important in the rare treatment of vessel rupture. RESULTS: A total of 101 vessels were treated in 97 patients. The procedure was successful in 98 vessels (97%) with failure related to vessel rupture requiring conversion to an iliofemoral bypass. The estimated patency rate at three years was 94% with a median follow-up of 20 months. Restenosis/occlusion in four patients seemed to be related to a severe sclerotic response. The EIA was occluded 32% of the time. The common iliac artery (CIA) was diseased requiring angioplasty and stenting 29% of the time and a stent was placed at the transition zone between endarterectomized vessel and nontreated proximal most EIA or distal most CIA 58% of the time. There were no perioperative deaths. CONCLUSIONS: Balloon-assisted remote endarterectomy of the diffusely diseased and/or occluded EIA is a safe and durable option. It precludes the need for a prosthetic conduit and the risk of associated infection. It also involves a single groin incision and negates the need for retroperitoneal exposure of the CIA.


Subject(s)
Angioplasty, Balloon , Arterial Occlusive Diseases/therapy , Endarterectomy , Iliac Artery/surgery , Aged , Angioplasty, Balloon/adverse effects , Arterial Occlusive Diseases/diagnostic imaging , Arterial Occlusive Diseases/physiopathology , Combined Modality Therapy , Endarterectomy/adverse effects , Female , Humans , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Male , Middle Aged , Postoperative Complications/surgery , Recurrence , Reoperation , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
6.
J Vasc Surg ; 70(3): 732-740, 2019 09.
Article in English | MEDLINE | ID: mdl-30850297

ABSTRACT

OBJECTIVE: Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA. METHODS: In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months. RESULTS: In this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months. CONCLUSIONS: In this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.


Subject(s)
Aorta, Abdominal/surgery , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Suture Techniques/instrumentation , Sutures , Aged , Aged, 80 and over , Aorta, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/etiology , Endovascular Procedures/adverse effects , Female , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Suture Techniques/adverse effects , Time Factors , Treatment Outcome
7.
Demography ; 55(4): 1567-1582, 2018 08.
Article in English | MEDLINE | ID: mdl-29907922

ABSTRACT

In this article, we examine birth cohort differences in parents' provision of monetary help to adult children with particular focus on the extent to which cohort differences in family structure and the transition to adulthood influence these changes. Using data from the Health and Retirement Study from 1994 to 2010, we compare financial help to children of three respondent cohorts as the parents in these birth cohorts from ages 53-58 to 57-62. We find that transfers to children have increased among more recent cohorts. Two trends-declining family size and children's delay in marriage-account for part of the increase across cohorts. However, other trends, such as the increase in the number of stepchildren and increasing child's income level, tend to decrease the observed cohort trend.


Subject(s)
Adult Children/statistics & numerical data , Family Characteristics , Gift Giving , Parent-Child Relations , Parents , Adolescent , Adult , Cohort Studies , Female , Humans , Intergenerational Relations , Logistic Models , Male , Middle Aged , Socioeconomic Factors , Surveys and Questionnaires , Young Adult
8.
J Gerontol B Psychol Sci Soc Sci ; 73(2): 279-291, 2018 01 11.
Article in English | MEDLINE | ID: mdl-26450959

ABSTRACT

Objective: This study investigates the relationship between intergenerational occupational mobility and objective physical functioning in later life. Method: Data come from The Irish Longitudinal Study of Ageing (TILDA), a nationally representative probability sample of 5,985 respondents aged 50 and older. Walking speed and grip strength are the functional health measures. The intergenerational occupational mobility measure characterizes origin and destination position as: professional/managerial, non-manual, skilled manual/semi-skilled, unskilled, never worked, and farmer. Results: Results indicated no direct association of childhood origin with walking speed or grip strength in later life, except for individuals from farming backgrounds. Those who experienced upward mobility were comparable in speed and strength with those who enjoyed high status (e.g., stable professional/managerial origin and destination) at both time points, whereas the downwardly mobile were comparable with those who were stable across generations at lower occupational positions. The results did not support the central tenets of the accumulation hypothesis. Respondents from farming backgrounds exhibited a clear performance advantage irrespective of destination, which, we speculate, may represent a critical period effect. Discussion: The mechanisms through which childhood origin affects health in later life are complex, but the position attained in adult life is most important. Intergenerational mobility is important only insofar as it leads to a destination occupation. The present findings suggest that the musculoskeletal system may accommodate environmental modification in adulthood.


Subject(s)
Mobility Limitation , Physical Fitness , Social Mobility , Age Factors , Aged , Female , Hand Strength , Humans , Ireland , Longitudinal Studies , Male , Middle Aged , Occupations/statistics & numerical data , Prospective Studies , Social Mobility/statistics & numerical data , Walking
9.
J Aging Health ; 28(3): 440-59, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26148942

ABSTRACT

OBJECTIVES: We examine the cumulative long-term role of childhood health and socioeconomic status in affecting functional health at ages 50 to 59. METHOD: Data on 2,233 respondents to The Irish Longitudinal Study of Aging (TILDA) are used to examine functional health measured by the timed-up-and-go (TUG) test of lower-body mobility. We examine the association of father's education, childhood rural residence, and childhood self-evaluated health with TUG and examine respondent's education, adult health behaviors, measured health, and cognition as mediators of the association of childhood characteristics and TUG. RESULTS: Father's education, rural residence, childhood health, and education are associated with TUG times at ages 50 to 59. While health behaviors mediate most of the rural residence and education associations, the association with childhood self-evaluated health is direct. DISCUSSION: Early life circumstances play substantial direct and indirect roles in molding functional level in late mid-life.


Subject(s)
Activities of Daily Living , Disabled Persons/statistics & numerical data , Child , Educational Status , Female , Health Behavior , Health Status , Humans , Longitudinal Studies , Male , Middle Aged , Risk Factors , Rural Population/statistics & numerical data
10.
J Endovasc Ther ; 22(2): 163-70, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25809354

ABSTRACT

PURPOSE: To explore the use of EndoAnchors as an adjunct to endovascular abdominal aortic aneurysm repair for prevention of proximal neck complications in patients with challenging neck anatomy. METHODS: Over a 28-month period, 208 patients (159 men; mean age 72±8 years) were enrolled in the ANCHOR prospective, multicenter registry (ClinicalTrials.gov; identifier NCT01534819) for prophylaxis against proximal neck complications. Patients were eligible when, in the opinion of the investigators, they were at increased risk for type Ia endoleak or migration owing to a hostile neck (length <10 mm, diameter >28 mm, angulation >60°, mural thrombus or calcium >2 mm in thickness or >180° in circumference, or conical shape). Overall, 123/157 (78.3%) patients met the criteria for a hostile neck according to core laboratory assessment of 157 adequate preoperative computed tomographic (CT) images. RESULTS: Implantation of EndoAnchors was technically successful in 204/208 (98.1%) patients. The frequency of fracture was 0.3% (3/1118); there were no clinical sequelae associated with the fractures. Over the mean 14-month follow-up, 95.2% of patients were alive, and no deaths were attributable to EndoAnchors. There were no ruptures, migrations, or open surgical conversions. Aneurysm-related reinterventions were performed in 8 (3.8%) patients. Among 130 patients with postprocedure contrast CT studies, core laboratory analysis identified 2 (1.5%) patients with type Ia endoleaks. Aneurysm sac diameter decreased >5 mm in 42.9% of patients with CT scans at or beyond 1 year; 1.6% of patients developed sac enlargement >5 mm. CONCLUSION: Prophylactic EndoAnchor use for challenging aortic neck anatomy was associated with satisfactory midterm results.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endoleak/prevention & control , Endovascular Procedures/instrumentation , Foreign-Body Migration/prevention & control , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/etiology , Endovascular Procedures/adverse effects , Female , Foreign-Body Migration/etiology , Humans , Male , Middle Aged , Prosthesis Design , Prosthesis Failure , Registries , Risk Factors , Time Factors , Tomography, X-Ray Computed , Treatment Outcome
11.
J Fam Issues ; 35(9): 1131-1151, 2014 Jul 01.
Article in English | MEDLINE | ID: mdl-24976667

ABSTRACT

Divorce and remarriage have reshaped the American family giving rise to questions about the place of stepchildren in remarried families. In this article, we examine money transfers from a couple to each of their children. We introduce characteristics of the family and estimate the role of shared family membership affecting all children in the family as well as the difference that stepchild status and other individual characteristics make in transfer flows. Data are from the Health and Retirement Study. There are two central results in the analysis. Overall, provision of financial help from parents to children is a family phenomenon. While help to a particular child is episodic, differences between families in provision of help were much greater than the differences in helping one child versus another within families. Second, stepchild status does differentiate one child from another within a family. Stepchildren are disadvantaged, particularly stepchildren of the wife.

12.
J Vasc Surg ; 60(2): 275-85, 2014 Aug.
Article in English | MEDLINE | ID: mdl-25064325

ABSTRACT

OBJECTIVE: Endovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif). METHODS: This prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States. A total of 155 patients were enrolled in the trial (mean age, 73 ± 8 years; male, 93.5%; mean AAA diameter, 53.6 ± 7.9 mm). The Aptus endograft is a two-component system: a multilumen, modular endograft with two docking limbs (Aptus Endograft System) and the Heli-FX Aortic Securement System comprising an electronically controlled applier (Heli-FX Applier) with helical EndoAnchors provided in a cassette and a deflectable sheath (Heli-FX Guide) designed for delivery of the applier to the target location for EndoAnchor implantation. The main eligibility criteria included proximal neck length of ≥12 mm, diameter of 19 to 29 mm, and infrarenal angulation of ≤60 degrees. The primary safety end point was freedom from major adverse events at 30 days, and the primary effectiveness end point was successful aneurysm treatment at 12 months. Thrombus-related events (TRE) were defined as limb occlusion or thromboembolism from the endograft. Subjects were observed for a median of 4.2 years, with imaging end points analyzed by a core laboratory and adverse events adjudicated by a clinical events committee. RESULTS: Among 155 enrolled subjects, 153 (98.7%) underwent successful implantation of the Aptus endograft and a median of five EndoAnchors; two subjects were converted to open surgical repair during the initial procedure. Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with one postdischarge cardiac death 18 days after implantation. There were no AAA ruptures. There were no fractures of stents or EndoAnchors. There was one type I endoleak and one type III endoleak. Stent graft migration was noted in five subjects, none associated with sac enlargement, type I endoleak, or EndoAnchor dislocation from the endograft. AAA sac shrinkage of ≥5 mm at 1, 2, and 3 years was observed in 60.3%, 72.9%, and 81.7%, respectively. Sixty-one subjects (39.4%) experienced 113 TRE, associated with 80 reinterventions (in 58 subjects) unassociated with limb loss or death. A root cause analysis of TRE identified small, out-of-specification docking limbs with graft infolding and high local shear, resulting in thrombus formation within the endograft with subsequent distal embolization in some cases. CONCLUSIONS: Early results of the Aptus endograft trial met its safety and effectiveness end points; however, a high rate of TRE was observed because of manufacturing discrepancies. The findings confirm a low rate of type I and type III endoleaks, migration, and non-TRE reintervention with a high rate of aneurysm sac regression during midterm follow-up.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Postoperative Complications/surgery , Prospective Studies , Prosthesis Design , Reoperation , Risk Factors , Time Factors , Tomography, X-Ray Computed , Treatment Outcome , United States
13.
Gerontologist ; 54(5): 773-83, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24009171

ABSTRACT

PURPOSE OF THE STUDY: This article examines the impact of early- and later-life circumstances on loneliness among people aged 65+ in Ireland. DESIGN AND METHODS: Data are from the first wave of the Irish Longitudinal Study on Ageing, a nationally representative sample of community-dwelling adults aged 50+. The participants (N = 2,645) aged 65+ were included in the analysis. Because of the large number of never married persons in the older Irish population, we first used a multinomial logistic model to examine which childhood circumstances are associated with current marital status. We then estimated multiple regression models for loneliness, in stages conforming to the life course, to examine the extent to which early events are mediated by later events. RESULTS: Poor childhood socioeconomic status (for men and women) and parental substance abuse (for men) have direct effects on loneliness at older ages. IMPLICATIONS: The results indicate the significance of the childhood environment for understanding loneliness in later life. Future research should examine possible pathways not currently measured that may be responsible for the association of early environment and later-life loneliness and explore the links between childhood and other measures of well-being in old age. The relationship of childhood socioeconomic deprivation and parental substance abuse with adult well-being should be an important consideration in social policy planning.


Subject(s)
Aging/psychology , Life Change Events , Loneliness/psychology , Social Support , Activities of Daily Living/psychology , Adult , Aged , Aged, 80 and over , Family/psychology , Female , Humans , Ireland , Longitudinal Studies , Male , Marital Status , Middle Aged , Quality of Life/psychology , Social Environment , Socioeconomic Factors
14.
Aging Ment Health ; 17(3): 349-57, 2013.
Article in English | MEDLINE | ID: mdl-23215764

ABSTRACT

OBJECTIVE: This article contributes to the literature on depression and the life course by examining the impact of both early and later life circumstances on depressive symptoms among men and women aged 65 and over in Ireland. METHOD: Data are from the first wave of The Irish Longitudinal Study on Ageing, a nationally representative sample of 8504 community-dwelling adults aged 50 years and older. About 3507 respondents aged 65 years and over were included in the analysis. Multinomial logistic regression was used to examine the childhood and early adult life circumstances associated with marital status. A series of nested models were estimated to evaluate which childhood and adulthood circumstances are associated with depressive symptoms. Models were estimated separately for men and women. RESULTS: Ill health in childhood and in later life has a strong and direct effect on depression in later life for both men and women. Other early stressors are mediated by later circumstances. Marital status is a significant independent predictor of depression in later life. Later life circumstances mediate between some marital statuses and depressive symptoms. When later life circumstances are included, widowhood and, for men, divorce, are directly associated with depression, but singlehood is not. Income in later life is strongly associated with depressive symptoms for women. CONCLUSION: Both early and later life circumstances affect late-life depressive symptoms. Our findings indicate that previous studies which did not consider both may have underestimated or overestimated the effect of marital status, education, current health and education on depressive symptoms.


Subject(s)
Aging , Depression/etiology , Depression/psychology , Marital Status , Adult , Aged , Aged, 80 and over , Female , Humans , Ireland , Life Change Events , Logistic Models , Longitudinal Studies , Male , Middle Aged , Models, Psychological , Sex Factors , Social Environment , Social Support , Socioeconomic Factors , Time Factors
15.
Soc Sci Res ; 41(4): 876-87, 2012 Jul.
Article in English | MEDLINE | ID: mdl-23017857

ABSTRACT

This article examines the role of family structure in the financial support parents provide for their children's college education. Data are from the Health and Retirement Study. We focus on aspects of family structure that affect parental support and estimate shared family variance in investments as well as within-family variation using a multilevel model. Family membership accounts for about 60% of the variance in payment of college costs. Small family size, living with both biological parents (compared to one biological parent and a stepparent), higher parental education, and having older parents are associated with greater parental expenditures.

16.
J Vasc Surg ; 54(3): 601-8, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21889702

ABSTRACT

OBJECTIVE: To report the 1-year outcomes of the United States (US) regulatory trial of the Endurant Stent Graft System (Medtronic Vascular), a new device for the treatment of abdominal aortic aneurysms (AAA). METHODS: This was a prospective, single arm, multicenter trial conducted at 26 sites in the US. From April 2008 to May 2009, 150 patients with AAA were treated with the Endurant bifurcated stent graft. The main inclusion criteria were an AAA diameter >5 cm, proximal neck length ≥ 10 mm, bilateral iliac fixation length ≥ 15 mm, and a neck angulation of ≤ 60 degrees. A clinical events committee (CEC) adjudicated all adverse events except blood loss, and a core laboratory reviewed all imaging. The primary safety endpoint was freedom from major adverse events at 30 days, and the primary effectiveness endpoint was successful aneurysm treatment at 12 months. RESULTS: One hundred forty-nine patients (99.3%) had a successful stent graft implant, 83.3% under general anesthesia. One failure was due to inability to cannulate the contralateral gate. One patient developed a neck rupture during the procedure, but was still treated successfully. Patients were predominantly male (91.3%), elderly (mean age, 73.1 years) with significant comorbidities. Mean estimated blood loss was 185 mL (range, 0-1450 mL), with blood transfusion required in one patient. Average hospital stay was 2.1 days. At 1 month, the major adverse events rate was only 4% with no operative mortality. Serious adverse events were recorded in 43 of 150 (28.7%) patients. Cardiac (8.7%), fever (6%), urological (4.7%), pulmonary (4%), and vascular events (4%) were the most frequent. Through 12 months of follow up, there were no migrations, ruptures, or conversions. No type I or III endoleaks were identified during the first year. Fifteen of 129 patients (11.6%) had endoleaks at 6 months and 13 of 130 (10%) at 1 year, all type II except for one indeterminate endoleak. One Type II endoleak proved to be a Type IB on later angiography. Ten aneurysm related reinterventions were performed during the first year of follow up, mostly for limb thrombosis or stenosis (5) or for type II endoleak (2). Four of the procedures were endovascular. Aneurysm sac diameter decreased >5 mm at 1 year in 47% of patients and remained stable in 53%. No sac showed an increase of >5 mm. None of seven late deaths (range, 90-458 days post-implant) was adjudicated to be aneurysm related. CONCLUSION: Early results of the Endurant pivotal trial are quite encouraging and suggest a safe and effective new device for the treatment of abdominal aortic aneurysms.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/etiology , Endoleak/surgery , Endovascular Procedures/adverse effects , Female , Humans , Kaplan-Meier Estimate , Male , Postoperative Complications/surgery , Prospective Studies , Prosthesis Design , Prosthesis Failure , Reoperation , Risk Assessment , Risk Factors , Time Factors , Tomography, X-Ray Computed , Treatment Outcome , United States
17.
J Marriage Fam ; 73(2): 383-395, 2011 Apr.
Article in English | MEDLINE | ID: mdl-22553381

ABSTRACT

An adult child's provision of care to an unmarried elderly mother varies both within and between families. Within-family differences address the variation in different children's behavior within in a family. Between-family differences refer to the propensities that members of a family-the children of one mother-share and that differentiate them from other families. Previous research suggests five hypotheses affecting either within-family or between-family differences. Data from multiple waves of the Asset and Health Dynamics Among the Oldest Old (AHEAD) cohort of the Health and Retirement Study (HRS; 16,719 observations on 5,607 mother-child dyads in 1,925 families) are used to estimate a multilevel model with a binary outcome. Results indicate substantial differences between families. Mother's characteristics, family composition, and family history account for about half the between-family differences.

18.
J Aging Health ; 22(8): 1198-212, 2010 Dec.
Article in English | MEDLINE | ID: mdl-20660636

ABSTRACT

OBJECTIVES: This article examines the relationship between lifetime marital history and mortality after age 50. METHOD: Data are drawn from the Health and Retirement Study birth cohort of 1931 to 1941. The analysis utilizes three measures of marital history: number of marriages, proportion time married, and age at first marriage. RESULTS: Three or more marriages and a lower proportion of adult life spent married are each associated with a higher hazard of dying after age 50 for both men and women even after controlling for current marital status and socioeconomic status. Smoking behavior accounts for part of the relationship of marital history and status with mortality. DISCUSSION: Research on marital status and health should consider marital history as well as current status. Two topics are particularly important: examining the relationship in different cohorts and disentangling the potentially causal role of health behaviors such as smoking.


Subject(s)
Aging/physiology , Interpersonal Relations , Marital Status/statistics & numerical data , Mortality/trends , Residence Characteristics/statistics & numerical data , Smoking/adverse effects , Age Factors , Cohort Studies , Female , Health Status , Humans , Male , Middle Aged , Multivariate Analysis , Proportional Hazards Models , Risk Assessment , Risk-Taking , Time Factors , United States
19.
Aging Ment Health ; 12(5): 605-14, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18855176

ABSTRACT

OBJECTIVES: Examine the relationship between early age at first birth and mental health among women in their fifties. METHODS: Analysis of data on women from a British 1946 birth cohort study and the U.S. Health and Retirement Study birth cohort of 1931-1941. RESULTS: In both samples a first birth before 21 years, compared to a later first birth, is associated with poorer mental health. The association between early first birth and poorer mental health persists in the British study even after controlling for early socioeconomic status, midlife socioeconomic status and midlife health. In the U.S. sample, the association becomes non-significant after controlling for educational attainment. CONCLUSIONS: Early age at first birth is associated with poorer mental health among women in their fifties in both studies, though the pattern of associations differs.


Subject(s)
Birth Order/psychology , Mental Health , Mothers , Adolescent , Cohort Studies , England , Female , Humans , Interviews as Topic , Maternal Age , Middle Aged , Pregnancy , Pregnancy in Adolescence , United States
20.
J Health Soc Behav ; 48(3): 254-66, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17982867

ABSTRACT

This article examines the relationship between a woman's childbearing history and her later health and mortality, with primary focus on whether the association between them is due to early and later socioeconomic status. Data are drawn from the Health and Retirement Study birth cohort of 1931-1941. Results indicate that, conditional on reaching midlife and controlling for early and later socioeconomic status, a first birth before age 20 is associated with a higher hazard of dying. In addition, having an early birth is associated with a higher prevalence of reported heart disease, lung disease, and cancer in 1994. Being unmarried at the time of the first birth is associated with earlier mortality, but this association disappears when midlife socioeconomic status is controlled. The number of children ever born does not significantly affect mortality but is associated with prevalence of diabetes.


Subject(s)
Marital Status , Mortality/trends , Pregnancy in Adolescence/statistics & numerical data , Social Class , Women's Health/economics , Adolescent , Cohort Studies , Female , Humans , Maternal Age , Middle Aged , Parity , Pregnancy , Prevalence , Proportional Hazards Models , United States/epidemiology
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