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1.
Circulation ; 149(9): 658-668, 2024 02 27.
Article in English | MEDLINE | ID: mdl-38084590

ABSTRACT

BACKGROUND: Deep hypothermia has been the standard for hypothermic circulatory arrest (HCA) during aortic arch surgery. However, centers worldwide have shifted toward lesser hypothermia with antegrade cerebral perfusion. This has been supported by retrospective data, but there has yet to be a multicenter, prospective randomized study comparing deep versus moderate hypothermia during HCA. METHODS: This was a randomized single-blind trial (GOT ICE [Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest]) of patients undergoing arch surgery with HCA plus antegrade cerebral perfusion at 4 US referral aortic centers (August 2016-December 2021). Patients were randomized to 1 of 3 hypothermia groups: DP, deep (≤20.0 °C); LM, low-moderate (20.1-24.0 °C); and HM, high-moderate (24.1-28.0 °C). The primary outcome was composite global cognitive change score between baseline and 4 weeks postoperatively. Analysis followed the intention-to-treat principle to evaluate if: (1) LM noninferior to DP on global cognitive change score; (2) DP superior to HM. The secondary outcomes were domain-specific cognitive change scores, neuroimaging findings, quality of life, and adverse events. RESULTS: A total of 308 patients consented; 282 met inclusion and were randomized. A total of 273 completed surgery, and 251 completed the 4-week follow-up (DP, 85 [34%]; LM, 80 [34%]; HM, 86 [34%]). Mean global cognitive change score from baseline to 4 weeks in the LM group was noninferior to the DP group; likewise, no significant difference was observed between DP and HM. Noninferiority of LM versus DP, and lack of difference between DP and HM, remained for domain-specific cognitive change scores, except structured verbal memory, with noninferiority of LM versus DP not established and structured verbal memory better preserved in DP versus HM (P = 0.036). There were no significant differences in structural or functional magnetic resonance imaging brain imaging between groups postoperatively. Regardless of temperature, patients who underwent HCA demonstrated significant reductions in cerebral gray matter volume, cortical thickness, and regional brain functional connectivity. Thirty-day in-hospital mortality, major morbidity, and quality of life were not different between groups. CONCLUSIONS: This randomized multicenter study evaluating arch surgery HCA temperature strategies found low-moderate hypothermia noninferior to traditional deep hypothermia on global cognitive change 4 weeks after surgery, although in secondary analysis, structured verbal memory was better preserved in the deep group. The verbal memory differences in the low- and high-moderate groups and structural and functional connectivity reductions from baseline merit further investigation and suggest opportunities to further optimize brain perfusion during HCA. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02834065.


Subject(s)
Aorta, Thoracic , Hypothermia , Humans , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Retrospective Studies , Prospective Studies , Quality of Life , Single-Blind Method , Body Temperature , Circulatory Arrest, Deep Hypothermia Induced/adverse effects , Perfusion/adverse effects , Perfusion/methods , Cognition , Cerebrovascular Circulation , Treatment Outcome
2.
J Vasc Surg ; 79(4): 711-720.e2, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38008268

ABSTRACT

OBJECTIVE: Since its inception in the early 2000s, hybrid arch repair (HAR) has evolved from novel approach to well-established treatment modality for aortic arch pathology in appropriately selected patients. Despite this nearly 20-year history of use, long-term results of HAR remain to be determined. As such, objectives of this study are to detail the long-term outcomes for HAR within an expanded classification scheme. METHODS: From August 2005 to August 2022, 163 consecutive patients underwent HAR at a single referral institution. Operative approach was selected according to an institutional algorithm and included zone 0/1 HAR in 25% (n = 40), type I HAR in 34% (n = 56), and type II/III HAR in 41% (n = 67). Specific zone 0/1 technique was zone 1 HAR in 31 (78%), zone 0 with innominate snorkel (zone 0S HAR) in 7 (18%), and zone 0 with single side-branch endograft (zone 0B HAR) in 2 (5%). The 30-day and long-term outcomes, including overall and aortic-specific survival, as well as freedom from reintervention, were assessed. RESULTS: The mean age was 63 ± 13 years and almost one-half of patients (47% [n = 77]) had prior sternotomy. Presenting pathology included degenerative aneurysm in 44% (n = 71), residual dissection after prior type A repair in 38% (n = 62), chronic type B dissection in 12% (n = 20), and other indications in 6% (n = 10). Operative outcomes included 9% mortality (n = 14) at 30 days, 5% mortality (n = 8) in hospital, 4% stroke (n = 7), 2% new dialysis (n = 3), and 2% permanent paraparesis/plegia (n = 3). The median follow-up was 44 month (interquartile range, 12-84 months). Overall survival was 59% and 47% at 5 and 10 years, respectively, whereas aorta-specific survival was 86% and 84% at the same time points. At 5 and 10 years, freedom from major reintervention was 92% and 91%, respectively. Institutional experience had a significant impact on both early and late outcomes: comparing the first (2005-2012) and second (2013-2022) halves of the series, 30-day mortality decreased from 14% to 1% (P = .01) and stroke from 6% to 3% (P = .62). Improved operative outcomes were accompanied by improved late survival, with 78% of patients in the later era vs 45% in the earlier era surviving to 5 years. CONCLUSIONS: HAR is associated with excellent operative outcomes, as well as sustained protection from adverse aortic events as evidenced by high long-term aorta-specific survival and freedom from reintervention. However, surgeon and institutional experience appear to play a major role in achieving these superior outcomes, with a five-fold decrease in operative mortality and a two-fold decrease in stroke rate in the latter half of the series. These long-term results expand on prior midterm data and continue to support use of HAR for properly selected patients with arch disease.


Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Stroke , Humans , Middle Aged , Aged , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/etiology , Treatment Outcome , Risk Factors , Retrospective Studies , Kaplan-Meier Estimate , Postoperative Complications , Stroke/etiology
3.
Eur J Vasc Endovasc Surg ; 65(1): 112-119, 2023 01.
Article in English | MEDLINE | ID: mdl-36209962

ABSTRACT

OBJECTIVE: Endoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices. METHODS: Reports related to thoracic stent grafts in the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between 2010 and 2020 were reviewed. Proportional reporting ratios (PRRs) and chi squared tests were used to assess for the presence of a signal of association between device type and T3bE. A PRR > 2 and chi squared value > 4 with three or more reports overall constituted a signal of association. The institutional database of patients undergoing TEVAR for thoracic aneurysms since 2002 was also queried for T3bE. RESULTS: There were 7 328 MAUDE reports available for analysis. When analysing T3bEs in the MAUDE database, the lowest PRR was 0.36 (95% confidence interval [CI] 0 - 1.03 in Gore CTAG, nine T3bE among 1 328 reports) and the highest was 2.07 (95% CI 1.72 - 2.42 in Medtronic Valiant, 64 T3bE among 2 520 reports). The T3bE chi squared value for Medtronic Valiant was 17.3. The relationship between Medtronic Valiant and T3bE was ascertainable by MAUDE data as early as 2013. Among 542 TEVARs for an aneurysm indication at Duke University Hospital since 2002, there were eight T3bEs - all in devices with sutured on graft material. CONCLUSION: The Medtronic Valiant device met criteria for association with type IIIb endoleaks in the FDA's MAUDE database and met those criteria as early as 2013. A possible relationship between woven graft fabric and T3bEs is supported by the observation that all types of T3bE that occurred among a large number of TEVARs at the institution followed placement of grafts with sutured on woven fabric.


Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Endoleak/etiology , Endoleak/surgery , Blood Vessel Prosthesis/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Aneurysm Repair , Treatment Outcome , Endovascular Procedures/adverse effects , Stents , Aortic Aneurysm, Thoracic/surgery , Prosthesis Design , Retrospective Studies
4.
Am Heart J ; 224: 105-112, 2020 06.
Article in English | MEDLINE | ID: mdl-32361278

ABSTRACT

BACKGROUND: Patients with bicuspid aortic valve stenosis (BAV) were excluded from all the trileaflet aortic valve stenosis (TAV) pivotal trials, and therefore, their outcomes are not clearly defined. The aim of the study was to evaluate the outcomes of transcatheter aortic valve replacement (TAVR) in patients with BAV and compared them with those of TAV. METHODS: We evaluated the outcomes following TAVR of patients with BAV at our institution between April 2011 and November 2016 and compared them with the outcomes of patients with TAV treated with TAVR. The χ2 and the Mann-Whitney U tests were used to compare the groups, and a Kaplan-Meier analysis was performed to estimate long-term survival. RESULTS: TAVR was performed in a total of 567 patients, from which 50 (8.8%) had BAV and 517 (91.2%) had TAV. Patients with BAV were younger and had higher prevalence of chronic obstructive pulmonary disease, lower prevalence of coronary artery disease, higher body mass index, and lower Society of Thoracic Surgeons score (STS PROM). Patients with BAV had a slightly higher mean aortic valve gradient postoperatively (median 12 mm Hg [10-15] vs 10 [7-13], P < .001), but paravalvular aortic regurgitation was not different between the groups (> mild 4.0% vs 3.5%, P = .541). Clinical outcomes were not different between the groups, including stroke (2.0% vs 1.5, P = .567) and the 30-day all-cause mortality (6.0% vs 1.5, P = .064). The 2-year survival (82.0% vs 83.4, P = .476) was similar between the groups. CONCLUSIONS: This initial experience suggests that TAVR can be safely performed in patients with BAV, achieving similar short-term procedural and clinical outcomes when compared with patients with TAV.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/abnormalities , Heart Valve Diseases/surgery , Postoperative Complications/epidemiology , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Aortic Valve/surgery , Aortic Valve Stenosis/diagnosis , Bicuspid Aortic Valve Disease , Female , Follow-Up Studies , Heart Valve Diseases/diagnosis , Humans , Incidence , Male , Middle Aged , North Carolina/epidemiology , Retrospective Studies , Severity of Illness Index , Survival Rate/trends , Tomography, X-Ray Computed , Treatment Outcome
5.
J Vasc Surg ; 71(3): 723-747, 2020 03.
Article in English | MEDLINE | ID: mdl-32001058

ABSTRACT

This Society for Vascular Surgery/Society of Thoracic Surgeons (SVS/STS) document illustrates and defines the overall nomenclature associated with type B aortic dissection. The contents describe a new classification system for practical use and reporting that includes the aortic arch. Chronicity of aortic dissection is also defined along with nomenclature in patients with prior aortic repair and other aortic pathologic processes, such as intramural hematoma and penetrating atherosclerotic ulcer. Complicated vs uncomplicated dissections are clearly defined with a new high-risk grouping that will undoubtedly grow in reporting and controversy. Follow-up criteria are also discussed with nomenclature for false lumen status in addition to measurement criteria and definitions of aortic remodeling. Overall, the document provides a facile framework of language that will allow more granular discussions and reporting of aortic dissection in the future.


Subject(s)
Aortic Aneurysm, Thoracic/classification , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/classification , Aortic Dissection/diagnostic imaging , Aortic Dissection/surgery , Documentation/standards , Vascular Surgical Procedures , Humans , United States
6.
J Vasc Surg ; 69(3): 701-709, 2019 03.
Article in English | MEDLINE | ID: mdl-30528402

ABSTRACT

BACKGROUND: Subclavian artery revascularization is frequently performed in the setting of thoracic endovascular aortic repair (TEVAR). However, there is little information on the short- and long-term outcomes of patients undergoing carotid to subclavian artery bypass in this clinical setting. As such, this study sought to define the early and late outcomes associated with this procedure. METHODS: Patients undergoing carotid-subclavian bypass in conjunction with TEVAR between June 2005 and September 2016 were retrospectively identified from a prospectively maintained, single-center aortic surgery database. The 30-day outcomes specific to the carotid-subclavian bypass procedure were analyzed, including cervical plexus nerve injury, bleeding complications, and local vascular complications. All preoperative and postoperative chest radiographs were carefully analyzed to assess for hemidiaphragm elevation indicative of phrenic nerve palsy. Long-term outcomes included primary graft patency and anastomotic complications. RESULTS: Of 579 consecutive patients undergoing TEVAR during this time interval, 112 patients (19%) underwent concomitant carotid-subclavian bypass. The cohort was 38% female (n = 43), with a mean age of 65 ± 14 years. The majority of conduits were 8-mm polytetrafluoroethylene grafts (n = 107 [95.5%]), with a minority being reversed saphenous vein (n = 4 [3.6%]) or Dacron (n = 1 [0.9%]) grafts. The bypass procedure was done concurrently at the time of TEVAR in 91% (n = 102) of cases. The short-term complication rate attributed specifically to the carotid-subclavian bypass was 29% (n = 33). These complications included phrenic nerve palsy in 25% (n = 27), recurrent laryngeal nerve palsy in 5% (n = 6), axillary nerve palsy in 2% (n = 2), and neck hematoma requiring re-exploration in 1% (n = 1) of patients. The 30-day in-hospital all-cause mortality rate was 5% (n = 6), and the rate of permanent paraparesis or paraplegia was 0.9% (n = 1). Of the operative survivors (n = 106), follow-up imaging of the bypass graft was available in 87% (n = 92) of patients. Actuarial primary graft patency was 97% at 5 years. There were three patients (3%) with bypass graft occlusions, two of which were clinically silent and detected on follow-up imaging. The third was detected because of symptoms of subclavian steal and required repeated revascularization. Two patients (2%) developed a late anastomotic pseudoaneurysm requiring either endovascular (n = 1) or surgical (n = 1) intervention. CONCLUSIONS: Carotid-subclavian bypass for revascularization of the subclavian artery performed in the setting of TEVAR is durable, although the true complication rate is likely higher than is generally reported in the literature because of a not insignificant rate of phrenic nerve palsy. These data should serve well as "gold standard" comparison data for emerging branch graft devices.


Subject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , Blood Vessel Prosthesis Implantation/methods , Carotid Arteries/surgery , Endovascular Procedures/methods , Subclavian Artery/surgery , Aged , Aorta, Thoracic/diagnostic imaging , Aortic Diseases/diagnostic imaging , Aortic Diseases/mortality , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Carotid Arteries/diagnostic imaging , Databases, Factual , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Hospital Mortality , Humans , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/mortality , Retrospective Studies , Risk Factors , Saphenous Vein/transplantation , Subclavian Artery/diagnostic imaging , Time Factors , Treatment Outcome , Vascular Patency
7.
Curr Cardiol Rep ; 21(4): 23, 2019 03 04.
Article in English | MEDLINE | ID: mdl-30828749

ABSTRACT

PURPOSE OF REVIEW: Detail the current strategies for the management of valve dysfunction in Marfan syndrome (MFS), understand the limitations of surgical interventions, and delineate the likely direction of future innovations. RECENT FINDINGS: Significant advances in both medical and surgical management of MFS have been made over the last 50 years. This has resulted in improved overall outcomes. As MFS patients age, new clinical challenges that were once rare have emerged and can require complex care strategies. Medical management has seen advances and focuses on anti-impulse and molecular-based pharmacotherapy, along with close monitoring with serial imaging to minimize acute aortic dissection risk by selecting appropriate timing of prophylactic surgical intervention with increasing aortic dimensions. Ongoing trials are evaluating other potential drug therapies with the ultimate goal of targeted treatment. Over the last 50 years, significant advances have been made in the understanding and management of MFS. A move to prophylactic surgery for aortopathy and valve disease has progressed from a valve replacement to a valve-sparing strategy in many cases. However, the durability of these repairs is variable and the possibility of reintervention looms.


Subject(s)
Aortic Dissection , Heart Valve Diseases , Marfan Syndrome , Aortic Dissection/complications , Aorta , Heart Valve Diseases/complications , Humans , Marfan Syndrome/complications
8.
J Vasc Surg ; 67(2): 363-368, 2018 02.
Article in English | MEDLINE | ID: mdl-28847657

ABSTRACT

OBJECTIVE: Since thoracic endovascular aortic repair (TEVAR) received U.S. Food and Drug Administration approval for the treatment of descending thoracic aneurysms in March 2005, excellent 30-day and midterm outcomes have been described. However, data on long-term outcomes are lacking with Medicare data suggesting that TEVAR has worse late survival compared with open descending repair. As such, the purpose of this study was to examine the long-term outcomes for on-label use of TEVAR for repair of descending thoracic aneurysms. METHODS: Of 579 patients undergoing TEVAR between March 2005 and April 2016 at a single referral center for aortic surgery, 192 (33.2%) were performed for a descending thoracic aneurysm indication in accordance with the device instructions for use, including 106 fusiform (55.2%), 80 saccular (41.7%), and 6 with both saccular and fusiform (3.1%) aneurysms. All aneurysms were located distal to the left subclavian artery and proximal to the celiac axis, and hybrid procedures including arch or visceral debranching were excluded with the exception of left carotid-subclavian artery bypass. Aortic dissection and intramural hematoma as indications for TEVAR were also excluded. Primary 30-day and in-hospital outcomes included mortality, stroke, need for new permanent dialysis, and permanent paraparesis or paraplegia. Primary long-term outcomes included survival and rate of reintervention secondary to endoleak. The Kaplan-Meier method was used to estimate long-term overall and aorta-specific survivals. RESULTS: The mean age was 71.1 ± 10.4 years. All aneurysms in this series were degenerative in nature and no patients with a connective tissue disorder were included. The mean aortic diameter was 5.9 ± 1.5 cm at time of intervention. Rates of 30-day and in-hospital mortality, stroke, permanent dialysis, and permanent paraparesis and paraplegia were 4.7%, 2.1%, 0.5%, and 0.5%, respectively. At a mean follow-up of 69 ± 44 months (range, 3-141 months), there were 68 late deaths (35.4%), two of which were due to aortic rupture. Overall and aorta-specific survivals at 141 months (11.8 years) were 45.7% and 96.2%, respectively. Endovascular reintervention was required in 14 patients (7.3%) owing to type I (n = 10), type II (n = 2), and type III (n = 2) endoleak, all of which subsequently resolved. No patient required open reintervention for any cause. CONCLUSIONS: Long-term (12-year) aorta-specific survival after on-label endovascular repair of degenerative descending thoracic aneurysms in nonsyndromic patients is excellent (96%) with sustained protection from rupture, and a low rate of reintervention owing to endoleak (7%). Endovascular repair should be considered the treatment of choice for this pathology.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/mortality , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Databases, Factual , Disease-Free Survival , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , North Carolina , Postoperative Complications/mortality , Postoperative Complications/therapy , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
9.
10.
J Card Surg ; 33(1): 7-18, 2018 Jan.
Article in English | MEDLINE | ID: mdl-29314257

ABSTRACT

PURPOSE: Management of acute type A aortic dissection (AAAD) is challenging and operative strategies are varied. We used the STS Adult Cardiac Surgery Database (STS ACSD) to describe contemporary surgical strategies and outcomes for AAAD. METHODS: Between July 2011 and September 2012, 2982 patients with AAAD underwent operations at 640 centers in North America. RESULTS: In this cohort, median age was 60 years old, 66% were male, and 80% had hypertension. The most common arterial cannulation strategies included femoral (36%), axillary (27%), and direct aortic (19%). The median perfusion and cross-clamp times were 181 and 102 min, respectively. The lowest temperature on bypass showed significant variation. Hypothermic circulatory arrest (HCA) was used in 78% of cases. Among those undergoing HCA, brain protection strategies included antegrade cerebral perfusion (31%), retrograde cerebral perfusion (25%), both (4%), and none (40%). Median HCA plus cerebral perfusion time was 40 min. Major complications included prolonged ventilation (53%), reoperation (19%), renal failure (18%), permanent stroke (11%), and paralysis (3%). Operative mortality was 17%. The median intensive care unit and hospital length of stays were 4.7 and 9.0 days, respectively. Among 640 centers, the median number of cases performed during the study period was three. Resuscitation, unresponsive state, cardiogenic shock, inotrope use, age >70, diabetes, and female sex were found to be independent predictors of mortality. CONCLUSIONS: These data describe contemporary patient characteristics, operative strategies, and outcomes for AAAD in North America. Mortality and morbidity for AAAD remain high.


Subject(s)
Aortic Aneurysm/surgery , Aortic Dissection/surgery , Acute Disease , Age Factors , Aged , Aortic Dissection/epidemiology , Aortic Dissection/mortality , Aortic Aneurysm/epidemiology , Aortic Aneurysm/mortality , Cardiovascular Surgical Procedures , Catheterization, Peripheral , Cohort Studies , Databases as Topic , Female , Humans , Hypothermia, Induced , Length of Stay , Male , Middle Aged , Morbidity , North America/epidemiology , Postoperative Complications/epidemiology , Sex Factors , Treatment Outcome
11.
N Engl J Med ; 370(19): 1790-8, 2014 May 08.
Article in English | MEDLINE | ID: mdl-24678937

ABSTRACT

BACKGROUND: We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS: We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS: A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. CONCLUSIONS: In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Bioprosthesis , Cardiac Catheterization , Heart Valve Prosthesis , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/therapy , Cardiac Catheterization/adverse effects , Female , Humans , Kaplan-Meier Estimate , Male , Postoperative Complications , Prosthesis Design , Risk Factors , Survival Rate
12.
J Heart Valve Dis ; 26(6): 735-737, 2017 11.
Article in English | MEDLINE | ID: mdl-30207127

ABSTRACT

The modified Ross procedure, which involves replacement of the aortic valve with a pulmonary autograft root supported within a Dacron tube graft, was developed with the goal of preventing late autograft dilatation and associated aortic insufficiency. The case is reported of an adult patient who had a bicuspid aortic valve (BAV), underwent a modified Ross procedure, and developed severe aortic insufficiency within one year and subsequently required reoperation for aortic valve replacement. While advances have been made to increase the success of the Ross procedure via modifications to prevent aortic root dilatation, no modifications have yet been devised to improve the ability of the pulmonary valve to withstand systemic aortic pressures. The Ross procedure has significant advantages for children, but the risks and benefits should be carefully considered in adults, especially in those with BAV.


Subject(s)
Aortic Valve Insufficiency/etiology , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Adult , Aortic Valve/abnormalities , Aortic Valve/surgery , Aortic Valve Insufficiency/surgery , Autografts , Bicuspid Aortic Valve Disease , Heart Valve Diseases/surgery , Humans , Male , Polyethylene Terephthalates , Postoperative Complications , Pulmonary Valve/transplantation , Reoperation
13.
J Vasc Surg ; 63(2): 323-31, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26518097

ABSTRACT

OBJECTIVE: The role of hybrid repair in the management of aortic arch pathology, and long-term outcomes with these techniques, remains uncertain. We report a decade of experience with hybrid arch repair (HAR) and assess institutional practice patterns with regard to the use of hybrid and open techniques. METHODS: Hybrid and open total and distal arch procedures performed between July 2005 and January 2015 were identified from a prospectively maintained, institutional aortic surgery database. Perioperative morbidity and mortality, freedom from reintervention, and long-term survival were calculated. Hybrid and open procedural volumes over the study period were assessed to evaluate for potential practice pattern changes. RESULTS: During the study period 148 consecutive procedures were performed for repair of transverse and distal aortic arch pathology, including 101 hybrid repairs and 47 open total or distal arch repairs. Patients in the hybrid repair group were significantly older with a greater incidence of chronic kidney disease, peripheral vascular disease, and chronic lung disease. Perioperative mortality and outcomes were not significantly different between the hybrid and open groups, aside from decreased median length of stay after hybrid repair. Need for subsequent reintervention was significantly greater after hybrid repair. Unadjusted long-term survival was superior after open repair (70% 5-year survival open vs 47% hybrid; P = .03), although aorta-specific survival was similar (98% 5-year aorta-specific survival open vs 93% hybrid; P = .59). Institutional use of HAR decreased over the final 3 years of the study, with an associated increased use of open total or distal arch repairs. This was primarily the result of decreased use of native zone 0 hybrid procedures. Concurrent with this apparent increased stringency around patient selection for HAR, perioperative morbidity and mortality was reduced, including avoidance of retrograde type A dissection. CONCLUSIONS: HAR remains a viable option for higher-risk patients with transverse arch pathology with perioperative outcomes and long-term aorta-specific survival similar to open repair, albeit at a cost of increased reintervention. This observational single-institution study would suggest decreased use in more recent years in favor of open repair due to avoidance of native zone 0 hybrid procedures. This decline in the institutional use of native zone 0 hybrid repairs was associated with improved perioperative outcomes.


Subject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , Blood Vessel Prosthesis Implantation/trends , Endovascular Procedures/trends , Practice Patterns, Physicians'/trends , Adult , Aged , Aortic Diseases/diagnosis , Aortic Diseases/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Databases, Factual , Disease-Free Survival , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , North Carolina , Patient Selection , Postoperative Complications/mortality , Postoperative Complications/therapy , Retreatment , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
14.
J Vasc Surg ; 64(5): 1228-1238, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27444368

ABSTRACT

OBJECTIVE: Thoracoabdominal aortic aneurysm (TAAA) repair remains a significant challenge with considerable perioperative morbidity and mortality. A hybrid approach utilizing visceral debranching with endovascular aneurysm exclusion has been used to treat high-risk patients and therefore allow repair in more patients. Limited data exist regarding long-term outcomes with this procedure as well as comparison to conventional open repair. This study describes our institutional algorithmic approach to TAAA repair using both open and hybrid techniques. METHODS: Hybrid and open TAAA repairs performed between July 2005 and August 2015 were identified from a prospectively maintained institutional aortic surgery database. Perioperative morbidity and mortality, freedom from reintervention, and long-term and aorta-specific survival were calculated and compared between the two groups. RESULTS: During the study period, 165 consecutive TAAA repairs were performed, including 84 open repairs and 81 hybrid repairs. Patients in the hybrid repair group were significantly older, were more frequently female, and had a generally greater comorbid disease burden, including significantly more chronic kidney disease. Despite the older and sicker cohort, there was no difference in in-hospital mortality between the two groups (9.9% hybrid vs 7.1% open; P = .59). Major morbidity rates differed by procedure, with patients undergoing open repair having a significantly higher rate of postoperative stroke (9.5% open vs 0% hybrid; P = .017), whereas patients undergoing hybrid repair had a higher rate of new permanent dialysis (14.8% hybrid vs 3.6% open; P = .043). There was no difference between groups in the rate of postoperative permanent paraplegia/paresis (8.3% open vs 7.4% hybrid; P = .294). There was a significantly increased rate of reintervention in the hybrid repair group (12.3% hybrid vs 1.2% open, P = .004), with all hybrid reinterventions performed because of endoleak. One-year survival was similar between groups at 69% in hybrid repairs vs 77% in open repairs. Long-term survival was worse in the hybrid group (5-year survival, 32% hybrid vs 56% open), although late survival appeared to be influenced mainly by comorbid disease burden, given the similar long-term aorta-specific survival between groups. CONCLUSIONS: Use of an algorithmic approach whereby higher risk patients with TAAA are treated by a hybrid approach and lower risk patients with conventional open repair yields satisfactory short- and long-term outcomes. The availability of multiple options for TAAA repair within a single center likely allows repair in more patients with consequent decrease in the risk of aorta-related death, at the expense of increased reinterventions for endoleak.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/methods , Aged , Algorithms , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Clinical Protocols , Databases, Factual , Disease-Free Survival , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , North Carolina , Patient Selection , Postoperative Complications/etiology , Postoperative Complications/mortality , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
15.
Am Heart J ; 169(3): 438-44, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25728735

ABSTRACT

BACKGROUND: Up to one-third of patients diagnosed with left bundle branch block (LBBB) by conventional electrocardiographic (ECG) criteria are misdiagnosed. Strict LBBB shows decreased left ventricular pumping efficiency compared with nonstrict LBBB. However, no previous study has evaluated the frequency of strict LBBB after transcatheter aortic valve replacement (TAVR). The aim of this study was to determine the incidence of developing strict versus nonstrict LBBB after TAVR and test the hypothesis that preprocedure QRS duration does not predict strict LBBB but predicts development of nonstrict LBBB. METHODS: All patients receiving TAVR between 4/2011 and 2/2013 (n = 71) with no preexisting bundle branch block or permanent pacemaker were included. Twelve-lead ECGs were acquired preprocedure and both 1-day and 1-month postprocedure. All ECGs were classified as strict LBBB, nonstrict LBBB, or no LBBB. RESULTS: Sixty-eight patients had ECGs eligible for final analysis. On postprocedure day 1, 25 (37%) of 68 patients developed strict LBBB, and 2 patients (3%) developed nonstrict LBBB. At 1-month follow-up, the 2 patients diagnosed with nonstrict LBBB had resolved to normal, and 5 (20%) of 25 patients with strict LBBB had resolved to normal. Preprocedure QRS duration did not predict strict LBBB (P = .51). Because of the low incidence of nonstrict LBBB, QRS duration as a predictor of nonstrict LBBB could not be tested. CONCLUSIONS: Almost all patients who developed evidence of LBBB after TAVR met the new strict criteria, indicating probable procedural injury to the left bundle branch. Preprocedural QRS duration did not predict the development of strict LBBB.


Subject(s)
Bundle-Branch Block/epidemiology , Postoperative Complications/epidemiology , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve Stenosis/surgery , Bundle-Branch Block/diagnosis , Electrocardiography , Female , Humans , Incidence , Male , Predictive Value of Tests , Retrospective Studies
16.
J Vasc Surg ; 62(6): 1485-94.e2, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26243206

ABSTRACT

OBJECTIVE: This study evaluated the safety and effectiveness of the Zenith Alpha Thoracic Endovascular Graft (Cook Medical, Bloomington, Ind) for the treatment of descending thoracic aortic aneurysms and large ulcers. METHODS: The Zenith Alpha Thoracic Endovascular Graft, with a 16F to 20F delivery system, was developed to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy. This prospective, nonrandomized, multicenter study was conducted in Europe, Japan, and the United States. The main anatomical inclusion criteria included proximal neck seal zone of ≥20 mm, aortic arch radius of ≥20 mm, and a neck diameter of 15 to 42 mm. Patients were evaluated preprocedure, predischarge, and postdischarge 1, 6, and 12 months and yearly thereafter through 5 years. RESULTS: Between March 2010 and January 2013, 110 patients (64 men and 46 women; mean age, 72 ± 10 years) were enrolled in the study for the treatment of descending thoracic aortic aneurysms (n = 90) or ulcers (n = 20). Access was percutaneous in 36% (40 of 110) of patients. The study device was successfully implanted in all but two patients (both due to inability to gain access or advance to the target treatment site). There was no 30-day mortality. Five deaths occurred ≤1 year (only one was aneurysm-related by independent adjudication), resulting in a 95% freedom from all-cause mortality and a 99% freedom from thoracic aortic aneurysm-related mortality. At one or more time points ≤1 year, type I endoleak (all distal) was observed in 4 patients, type III endoleak in 2, and aneurysm growth in 4. Five patients experienced stroke ≤1 year (2 procedure-related). No aortic rupture, paraplegia, paralysis, or permanent spinal cord injury was observed ≤1 year. CONCLUSIONS: Early outcomes after Zenith Alpha implantation appear promising and suggest expanded thoracic endovascular aortic repair applicability in patients with smaller access vessels. Longer-term follow-up is ongoing.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis , Adult , Aged , Aged, 80 and over , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures , Female , Humans , Male , Middle Aged , Multicenter Studies as Topic , Prosthesis Design , Treatment Outcome
17.
J Heart Valve Dis ; 24(6): 666-668, 2015 Nov.
Article in English | MEDLINE | ID: mdl-27997768

ABSTRACT

Osteogenesis imperfecta (OI) is an inherited connective tissue disorder caused by the defective synthesis of type I collagen. The clinical phenotype is dominated by bone fragility, but cardiovascular tissue involvement has also been reported. Here, the case is described of a 37-year-old man with OI who presented with aortic insufficiency, bicuspid aortic valve, dilated aortic root, and anomalous right coronary artery. The patient was treated successfully with a mechanical valved conduit aortic root replacement and anomalous coronary artery unroofing and reimplantation. This case highlights the feasibility of complex surgical repairs in this population, as well as challenges surrounding the choice of valve prosthesis given the congenital bone fragility and predilection for fractures.

18.
Anesth Analg ; 121(4): 861-867, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26237622

ABSTRACT

BACKGROUND: Hypomagnesemia has been associated with an increased risk of postoperative atrial fibrillation (POAF). Although previous studies have suggested a beneficial effect of magnesium (Mg) therapy, almost all of these are limited by small sample size and relatively low Mg dose. We hypothesized that high-dose Mg decreases the occurrence of new-onset POAF, and we tested this hypothesis by using data from a prospective trial that assessed the effect of Mg on cognitive outcomes in patients undergoing cardiac surgery. METHODS: A total of 389 patients undergoing cardiac surgery were enrolled in this double-blind, placebo-controlled trial. Subjects were randomized to receive Mg as a 50-mg/kg bolus immediately after induction of anesthesia followed by another 50 mg/kg as an infusion given over 3 hours (total dose, 100 mg/kg) or placebo. We tested the effect of Mg therapy on POAF with logistic regression, adjusting for the risk of atrial fibrillation (AF) by using the Multicenter Study of Perioperative Ischemia risk index for Atrial Fibrillation after Cardiac Surgery. RESULTS: Among the 363 patients analyzed, after we excluded patients with chronic or acute preoperative AF (placebo: n = 177; Mg: n = 186), the incidence of new-onset POAF was 42.5% (95% confidence interval [CI], 35%-50%) in the Mg group compared with 37.9% (95% CI, 31%-45%) in the placebo group (P = 0.40). The 95% CI for this absolute risk difference of 4.6% is -5.5% to 14.7%. The time to onset of POAF also was identical between the groups, and no significant effect of Mg was found in logistic regression analysis after we adjusted for AF risk (odds ratio, 1.09; 95% CI, 0.69-1.72; P = 0.73). CONCLUSIONS: High-dose intraoperative Mg therapy did not decrease the incidence of new-onset POAF after cardiac surgery.


Subject(s)
Atrial Fibrillation/prevention & control , Cardiac Surgical Procedures/adverse effects , Intraoperative Care/methods , Magnesium/administration & dosage , Postoperative Complications/prevention & control , Adult , Aged , Aged, 80 and over , Atrial Fibrillation/diagnosis , Atrial Fibrillation/etiology , Cardiac Surgical Procedures/trends , Cohort Studies , Double-Blind Method , Female , Humans , Injections, Intravenous , Male , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/etiology , Prospective Studies
19.
J Comput Assist Tomogr ; 39(2): 207-12, 2015.
Article in English | MEDLINE | ID: mdl-25564297

ABSTRACT

PURPOSE: This study aimed to assess vascular contrast opacification and homogeneity using single-bolus contrast administration with hybrid thoracic and abdominopelvic computed tomographic angiography in patients with severe aortic valve stenosis. MATERIALS AND METHODS: Combination electrocardiogram-gated thoracic and dual-source, high-pitch abdominopelvic computed tomographic angiography examinations of 50 patients with severe aortic stenosis between December 2013 and March 2014 were reviewed. Contrast administration was individualized to patient-specific physiology. Image analysis of vascular opacification was obtained and interdependencies of vascular contrast and homogeneity of contrast distribution were assessed. RESULTS: The mean volume of contrast administered was 106 ± 11.7 mL. Mean attenuation was 371 ± 90.7 Hounsfield units (HU) in the thoracic aorta and 388 ± 95.9 HU in the abdominal aorta. Homogeneous opacification was obtained throughout with coefficient of variation of 11%. CONCLUSIONS: Procedural planning for transcatheter aortic valve replacement can be achieved using a single-injection bolus contrast protocol in combination with a 2-part multidetector computed tomographic image acquisition technique with optimal opacification of major arterial structures.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Contrast Media/administration & dosage , Electrocardiography , Preoperative Care , Tomography, X-Ray Computed , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Patient Care Planning , Pelvis , Retrospective Studies , Thorax
20.
J Electrocardiol ; 48(4): 643-51, 2015.
Article in English | MEDLINE | ID: mdl-26002227

ABSTRACT

INTRODUCTION: Left bundle branch block (LBBB) is a known complication of transcatheter aortic valve replacement (TAVR) and has been shown to predict worsened outcomes in TAVR patients. A regional longitudinal strain pattern, termed the "classic" pattern of left ventricular (LV) dyssynchrony, which is thought to be due to LBBB, is highly predictive of response to cardiac resynchronization therapy. Whether LBBB causes this "classic" pattern is not known. METHODS: We retrospectively studied patients undergoing TAVR who also underwent pre- and post-TAVR strain analysis to determine if the "classic" pattern arose in those who developed TAVR-induced true LBBB. After removing patients with baseline conduction abnormalities or insufficient studies 9 patients had sufficient data for analysis. Six patients developed LBBB after TAVR and 3 patients did not develop LBBB after TAVR. ECGs were analyzed for the new onset of LBBB after TAVR. Global longitudinal strain (GLS) and regional longitudinal strain patterns were analyzed for changes between pre- and immediately post-TAVR examinations. RESULTS: Patients who did not develop LBBB showed no significant changes in their regional longitudinal strain pattern. Those patients who did develop LBBB showed significant increase in their difference of time-to-onset of contraction between the septal and lateral walls post-TAVR (22 ± 14 ms vs 111 ± 49 ms; p=0.003) and in their difference of time-to-peak contraction between the septal and lateral walls post-TAVR (63 ± 56 ms vs 133 ± 46 ms; p=0.002). Early lateral wall pre-stretch and delayed lateral wall peak contraction emerged in all patients with LBBB but early septal peak contraction meeting the established criteria was present in only one patient. DISCUSSION: The onset of LBBB led to acute, measurable changes in the regional longitudinal strain pattern consisting of early lateral wall pre-stretch and delayed lateral wall peak contraction. These represent 2 of the 3 findings in the "classic" pattern of LV dyssynchrony. Early termination of septal wall contraction meeting established criteria was not routinely found. Time and/or other factors may be required to develop the full "classic" pattern.


Subject(s)
Bundle-Branch Block/diagnostic imaging , Bundle-Branch Block/etiology , Echocardiography/methods , Transcatheter Aortic Valve Replacement/adverse effects , Ventricular Dysfunction, Left/diagnostic imaging , Ventricular Dysfunction, Left/etiology , Acute Disease , Aged , Elasticity Imaging Techniques/methods , Female , Heart Ventricles/diagnostic imaging , Humans , Image Interpretation, Computer-Assisted/methods , Male , Reproducibility of Results , Sensitivity and Specificity
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