Ascending Aortic Endograft and Thoracic Aortic Deformation After Ascending Thoracic Endovascular Aortic Repair.

PURPOSE: We aim to quantify multiaxial cardiac pulsatility-induced deformation of the thoracic aorta after ascending thoracic endovascular aortic repair (TEVAR) as a part of the GORE ARISE Early Feasibility Study. MATERIALS AND METHODS: Fifteen patients (7 females and 8 males, age 73±9 years) with ascending TEVAR underwent computed tomography angiography with retrospective cardiac gating. Geometric modeling of the thoracic aorta was performed; geometric features including axial length, effective diameter, and centerline, inner surface, and outer surface curvatures were quantified for systole and diastole; and pulsatile deformations were calculated for the ascending aorta, arch, and descending aorta. RESULTS: From diastole to systole, the ascending endograft exhibited straightening of the centerline (0.224±0.039 to 0.217±0.039 cm-1, p<0.05) and outer surface (0.181±0.028 to 0.177±0.029 cm-1, p<0.05) curvatures. No significant changes were observed for inner surface curvature, diameter, or axial length in the ascending endograft. The aortic arch did not exhibit any significant deformation in axial length, diameter, or curvature. The descending aorta exhibited small but significant expansion of effective diameter from 2.59±0.46 to 2.63±0.44 cm (p<0.05). CONCLUSION: Compared with the native ascending aorta (from prior literature), ascending TEVAR damps axial and bending pulsatile deformations of the ascending aorta similar to how descending TEVAR damps descending aortic deformations, while diametric deformations are damped to a greater extent. Downstream diametric and bending pulsatility of the native descending aorta was muted compared with that in patients without ascending TEVAR (from prior literature). Deformation data from this study can be used to evaluate the mechanical durability of ascending aortic devices and inform physicians about the downstream effects of ascending TEVAR to help predict remodeling and guide future interventional strategies. CLINICAL IMPACT: This study quantified local deformations of both stented ascending and native descending aortas to reveal the biomechanical impact of ascending TEVAR on the entire thoracic aorta, and reported that the ascending TEVAR muted cardiac-induced deformation of the stented ascending aorta and native descending aorta. Understanding of in vivo deformations of the stented ascending aorta, aortic arch and descending aorta can inform physicians about the downstream effects of ascending TEVAR. Notable reduction of compliance may lead to cardiac remodeling and long-term systemic complications. This is the first report which included dedicated deformation data regarding ascending aortic endograft from clinical trial.

ARISE: First-In-Human Evaluation of a Novel Stent Graft to Treat Ascending Aortic Dissection.

BACKGROUND: Operative mortality for type A aortic dissection is still 10-20% at centers of excellence. Additionally, 10-20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ). OBJECTIVE: The purpose of this study is to assess early feasibility of using these investigational devices to treat ascending aortic dissection. METHODS: This a prospective, multicenter, non-randomized, single-arm study that enrolls patients at high surgical risk with appropriate anatomical requirements based on computed tomography imaging at 7 of 9 US sites. Devices are delivered transfemorally under fluoroscopic guidance. Primary endpoint is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, and 12 months. RESULTS: Nineteen patients were enrolled with a mean age of 75.7 years (range 47-91) and 11 (57.9%) were female. Ten (52.6%) had DeBakey type I disease, and the rest were type II. Sixteen (84.2%) of the patients were acute. Patients were treated with safe access, (7/19 (36.8%) percutaneous, 10/19 (52.6%) transfemoral, 2/19 (10.5%) iliac conduit), delivery, and deployment completed in all cases. Median procedure time was 154 mins (range 52-392) and median contrast used was 111 mL (range 75-200). MACCE at 30 days occurred in 5 patients including mortality 3/19 (15.8%), disabling stroke in 1/19 (5.3%), and myocardial infarction in 1/19 (5.3%). CONCLUSION: Results from the ARISE early feasibility study of a specific ascending stent graft device to treat ascending aortic dissection are promising.

Emergency and Compassionate Use of a Novel Ascending Endograft for Ascending and Arch Aortic Pathology.

PURPOSE: Patients with complicated ascending aortic pathology, including patients with acute type A aortic dissection may be at extreme risk for open repair. Thoracic endovascular aortic repair (TEVAR), infrequently used for the ascending aorta, may be considered an alternative in this setting. We describe early results for emergency and compassionate (E&C) use of a novel endograft, specifically designed for use to treat pathology of the ascending aorta. MATERIALS AND METHODS: This case series evaluated 19 patients (mean age, 68.84±13.12 years; 57.9% female) treated with ascending TEVAR for acute and chronic acute (4), subacute (1), or chronic (1) aortic dissection or pseudoaneurysm (13). Six of the 19 patients (31.5%) were treated under compassionate use and 13 patients (68.4%) were treated under the emergency use exemption. Ten patients (52.6%) received additional devices to extend treatment into the arch and descending aorta. RESULTS: Device delivery was achieved in all patients (100%). Thirty-day mortality and stroke occurred in 3 patients (15.8%) and in 1 patient (5.3%), respectively. In 1 patient (5.3%), with an Unanticipated Adverse Device Event, the aorta ruptured when the endograft eroded into the adventitial portion of dissection site at the posterior aspect of the ascending wall. Devices were explanted in 2 patients (10.5%), 353 and 610 days after the index procedure, respectively. Six patients had endoleaks (31.6%), including type I (n=2, 10.5%), type II endoleaks (n=3, 15.8%), and indeterminate endoleak (n=1, 5.3%). CONCLUSIONS: Delivery and deployment of a novel ascending thoracic stent graft with or without an additional branched arch extension is feasible in patients with complex anatomy and pathology, including acute aortic dissection and pseudoaneurysm. Additional experience with this novel device will further refine the patient population most suitable for endovascular ascending aortic repair for these pathologies. CLINICAL IMPACT: This study describes a novel stent graft specifically designed for treatment of ascending aortic pathology, including acute type A dissection. The patients described in this series constituted a group outside the formal US FDA sponsored clinical trial, and were those accepted as part of an emergency and compassionate use basis.

Strategies for Complex Reoperative Aortic Arch Reconstruction in Patients With Congenital Heart Disease.

Aortic dilation is common in patients with congenital heart disease including those with a bicuspid aortic valve, connective tissue disease, coarctation of the aorta, and conotruncal defects. In addition, neo-aortic dilation has been described in patients after aortic reconstruction including the Norwood procedure, the arterial switch operation, and the Ross procedure. Although aortic catastrophe is rare in patients with congenital heart disease, common pathologic endpoints in these patients likely manifest with similar aortic tissue behavior. A lifelong care model with similar indications for surveillance and prophylactic repair to other more common aortopathies is therefore warranted. Still, reoperative aortic arch reconstruction in these patients is often a complex and high-risk endeavor, and in all cases, a tailored and adaptable plan ensuring adequate myocardial and cerebral protection with appropriate rescue measures is paramount. A surgical team taking on these challenging cases should possess an armamentarium of open, hybrid, and endovascular techniques which can be individualized to a patient's unique anatomy, surgical history, and concomitant lesions as well as the team's measured outcomes and experience.

Prognostic impact of left ventricular systolic dysfunction in patients with mixed aortic valve disease undergoing aortic valve replacement.

BACKGROUND: The implications of left ventricular remodeling and dysfunction before and after aortic valve replacement (AVR) for mixed aortic valve disease (MAVD) are not well understood. This study aims to evaluate the impact of AVR on left ventricular (LV) systolic function in MAVD, and determine the prognostic value of postoperative LV global longitudinal strain (LV-GLS) and LV ejection fraction (LVEF). METHODS: We retrospectively assessed 489 consecutive patients with MAVD (defined as at least moderate aortic stenosis and at least moderate aortic regurgitation) and baseline LVEF ≥50%, who underwent AVR between February 2003 and August 2018. All patients had baseline echocardiography, whereas 192 patients underwent postoperative echocardiography between 3 and 18 months after AVR. The primary endpoint was all-cause mortality. RESULTS: Mean age was 65 ± 15 years, and 65% were male. AVR in MAVD patients has a neutral effect on LV systolic function quantitated by LVEF and LV-GLS. During a median follow-up period of 5.8 years, 65 patients (34%) of 192 patients with follow-up echocardiography died. The patients with postoperative LVEF ≥50% had better survival than those with postoperative LVEF <50% (P < .001). Furthermore, among patients with postoperative LVEF ≥50%, mortality differed between patients with postoperative LV-GLS worse than -15% and those with postoperative LV-GLS better than -15% (P < .001). CONCLUSIONS: In patients with MAVD who underwent AVR, the mean postoperative LV-GLS and LVEF remain at a similar value to baseline. However, worse postoperative LV-GLS and LVEF were both independently associated with higher mortality in this population.

Racial disparities in presentation and short-term outcomes for patients with acute type B aortic dissection.

OBJECTIVE: Racial disparities in cardiovascular risk factors and disease outcomes have been well documented. A knowledge gap exists regarding the role that health maintenance plays in the development and outcomes of type B aortic dissection (TBAD). In the present study, we evaluated the comparative presentation and short-term outcomes of patients with TBAD across race. METHODS: In the present single-center, retrospective study, TBAD patients who had been admitted to the intensive care unit from 2015 to 2020 were identified. Patients who had self-identified as Black (n = 57) or White (n = 123) were included. The demographics, socioeconomic status, and pre-event health maintenance were compared between the two groups. Socioeconomic disadvantage was quantified using the area deprivation index (ADI). Management strategies included nonoperative and surgical repair. The outcomes assessed included 30-day mortality, hospital length of stay, and the APACHE II (acute physiology and chronic health evaluation) score. RESULTS: The present study included 180 consecutive patients with TBAD. TBAD included complicated (n = 42) and uncomplicated (n = 138) cases, of which 79 had had high-risk features. Black patients were younger than were White patients (58.9 vs 67.6 years; P < .01) and were more likely to have end-stage renal disease (8.8% vs 0.8%; P = .01) and to present with anemia (10.5% vs 2.4%; P = .03). The TBAD anatomic features and management were similar in both groups. The rate of surgical intervention during hospitalization was 40% and 46% for the Black and White patients, respectively (P = .4). Black patients were more likely to be taking three or more hypertension agents (42.2% vs 16.4%; P = .005) and were less likely to be adherent to taking the prescribed agents (27.1% vs 6.7%; P < .001). Also, Black patients had fewer primary care physician visits before TBAD (P = .03) and more emergency department usage before TBAD (57.9% vs 26.9%; P < .001). Black patients had also had higher ADI scores (86.0 ± 14.6 vs 64.4 ± 21.3; P < .001). The median APACHE II score was the same for both Black and White patients (9 [interquartile range (IQR), 6-12] and 9 [IQR, 7-13], respectively; P = .7). The median hospital length of stay was identical for both groups (7 days; IQR, 5-13 days). The readmission rate was 24.5% for Black patients vs 15.5% for White patients (P = .16), with the 30-day mortality similar between the two groups (Black, 7.0%; White, 5.7%; P = .7). CONCLUSIONS: Black patients had presented at a younger age but with similar dissection morphology, rate of anatomic high-risk features, and APACHE II scores. The fewer primary care physician visits, greater emergency department usage, and higher ADI scores suggested lower health maintenance for the Black patients. White patients with TBAD were also highly deprived of health maintenance compared with the national percentile, indicating that TBAD is a disease that affects vulnerable populations, regardless of race.

Outcomes and role of peripheral revascularization in type A aortic dissection presenting with acute lower extremity ischemia.

OBJECTIVE: Limited data exists on management and outcomes of patients presenting with type A aortic dissection (TAAD) and acute lower extremity ischemia (ALI). The role of limb-related revascularization and optimal treatment strategy remains undefined. The objective of this study was to analyze dissection characteristics, treatment modalities, and outcomes of patients undergoing proximal aortic repair for TAAD with ALI. METHODS: Consecutive patients who underwent proximal aortic repair for TAAD were identified from a prospectively maintained database. Clinical data, imaging, operative details, and outcomes of patients with TAAD and ALI were retrospectively analyzed. Kaplan-Meier methodology was used to estimate overall and amputation-free survival. Log-rank tests were used to compare overall curves. Predictors of revascularization and in-hospital mortality were determined using multivariable logistic regression analysis. RESULTS: From 2010 to 2018, 463 patients with TAAD underwent proximal aortic repair. A total of 81 patients (17%) presented with ALI; 48% (39/81) with isolated ALI, and 52% (42/81) with ALI and renovisceral malperfusion. Thirty percent (24/81) required revascularization in addition to proximal aortic repair. Revascularization strategies involved endovascular (46%; 11/24), open (33%; 8/24), and hybrid (21%; 5/24) interventions. The major amputation rate was 4% (3/81), and in-hospital mortality was 21% (17/81). Amputation-free survival was significantly lower in patients requiring revascularization compared with those who did not (log-rank P = .023). Overall survival did not significantly differ between the two groups (log-rank P = .095). Overall survival was significantly lower in patients with concomitant ALI and renovisceral malperfusion compared with those with isolated ALI (log-rank P = .0017). Distal extent of dissection flap into zone 11 (odds ratio [OR], 5.65; 95% confidence interval [CI], 1.58-20.2; P = .008) and partial/complete thrombosis of any iliac artery (OR, 3.94; 95% CI, 1.23-12.6; P = .021) were associated with increased risk of requiring an additional revascularization procedure. True lumen collapse at level of renovisceral aorta (OR, 8.84; 95% CI, 1.74-44.9; P = .0086) was associated with increased risk of in-hospital mortality. CONCLUSIONS: ALI resolves after proximal aortic repair of TAAD in most cases. Distal extent of aortic dissection into zone 11 and iliac thrombosis are risk factors for additional peripheral revascularization. True lumen collapse at the renovisceral aorta and TAAD with concomitant ALI and renovisceral malperfusion portends a poor prognosis. A multi-disciplinary team approach to manage these patients who present with ascending aortic dissection and distal malperfusion may improve outcomes in this complex population.

Computed Tomography Imaging of Aortic Dissections with Endovascular Treatment Considerations.

PURPOSE OF REVIEW: In the present review, we discuss the role of CT imaging in the management of aortic dissection, with a particular emphasis on endovascular treatment considerations. RECENT FINDINGS: Computed tomography imaging is a fundamental tool in the diagnosis and management of acute and chronic aortic dissection. Its diagnostic accuracy and high resolution contribute to and guide operative strategy. Persistent high mortality for patients who develop aortic dissections suggests a need for innovative diagnostic and treatment strategies. In the recent era, considerable advances have been made in computed tomography (CT) image acquisition, processing, and analysis as well as endovascular technologies with expanded roles in the treatment of aortic diseases.

Pregnancy-Associated Myocardial Infarction: A Review of Current Practices and Guidelines.

PURPOSE OF REVIEW: Pregnancy-associated myocardial infarction is a principal cause of cardiovascular disease with a steadily rising incidence of 4.98 AMI events/100,000 deliveries over the last four decades in the USA. It is also linked with significant maternal and fetal morbidity and mortality, with maternal case fatality rate ranging from 5.1 to 37%. The management of acute myocardial infarction can be challenging in pregnant patients since treatment modalities and medication use are limited by their safety during pregnancy. RECENT FINDINGS: Limited guidelines exist regarding the management of pregnancy-associated myocardial infarction. Routinely used medications in myocardial infarction including angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), and statin therapy are contraindicated during pregnancy. Aspirin use is considered safe in pregnant women, but dual antiplatelet therapy and therapeutic anticoagulation can be associated with increased risk of maternal and fetal complications, and should only be used after a comprehensive benefit-to-risk assessment. The standard approach to revascularization requires additional caution in pregnant women. Percutaneous coronary intervention is generally considered safe but can be associated with high failure rates and poor outcomes depending on the etiology. Fibrinolytic therapy may have significant sequelae in pregnant patients, and hemodynamic management during surgery is complex and adds risk during pregnancy. Understanding the risks and benefits of the different treatment modalities available and their utility depending on the underlying etiology, encompassed with a multidisciplinary team approach, is vital to improve outcomes and minimize maternal and fetal complications.

Clostridium septicum-infected aortic aneurysm or graft is a deadly diagnosis.

BACKGROUND: Clostridium septicum is an anaerobic, motile, spore-forming, toxin-producing gram-positive bacillus that can lead to rapidly progressive gas gangrene due to the release of alpha toxin. Aortic aneurysm secondary to C. septicum infection is a rare condition with 60 cases reported in the literature; however, we have recently treated several patients with the condition in our large tertiary care and aortic center. METHODS: Blood and tissue culture results collected between January 2005 and January 2018 and maintained in the microbiology laboratory database at the Cleveland Clinic were reviewed to identify those with C. septicum reported. Each was reviewed to determine radiographic or histopathologic correlation with aortic disease. RESULTS: Seven cases of C. septicum aortitis were reviewed. Underlying malignant disease was found in four cases and a history of remote malignant disease in one case. The most common location for infection was the infrarenal abdominal aorta. Vascular surgery had previously been performed in three of the cases. Five of the seven patients underwent operative repair. All patients were treated with ß-lactam antibiotics. The two patients who did not undergo an operation died, which is consistent with the 100% mortality described in the literature. Of the five patients who underwent an operation, there was only one documented survivor and one was lost to follow-up. CONCLUSIONS: In the largest reported case series, only a small percentage of patients with C. septicum-infected aortic aneurysms survived >1 year. In the patients described, those who did not receive an operation had 100% mortality. Earlier recognition and prompt operation with appropriate antimicrobial therapy are needed to improve the outcome of patients diagnosed with this rare infection.

Coronary Artery Bypass Graft Patency and Survival in Patients on Dialysis.

BACKGROUND: Little is known about graft patency after coronary artery bypass grafting (CABG) performed in patients on dialysis. Our aim was to assess patency of internal thoracic artery (ITA) grafts and saphenous vein grafts (SVGs) in these patients. METHODS: From 1/1997 to 1/2018, 500 patients on dialysis underwent primary CABG with or without concomitant procedures at Cleveland Clinic, 40 of whom had 48 postoperative angiograms for recurrent ischemic symptoms. Complete follow-up was obtained on all but 1 patient lost to follow-up 1 y after CABG. Thirty-six ITA grafts and 65 SVGs were evaluable for stenosis and occlusion. RESULTS: Two of 40 patients (5%) had emergency CABG; 3 (7.5%) with calcified aortas had a change in operative strategy to avoid ascending aortic manipulation, 2 (5%) had poor conduit quality, and 12 (30%) had severe diffuse atherosclerotic disease with calcification of the coronary targets causing technical difficulties. Thirty-three patients (82%) were bypassed with an in situ ITA and 3 (7.5%) had a free ITA graft. Three of 36 ITA grafts were occluded at 0.78, 1.8, and 9.4 y (too few to model). SVG patency was 52% and 37% at 1 and 2 y, respectively. CONCLUSIONS: Among patients on dialysis who underwent CABG, coronary angiography for ischemic symptoms in a select subset revealed that SVG patency was lower than expected from published reports in the general CABG population and may contribute to the poor prognosis of this cohort. Further work is needed to guide graft selection and improve graft patency in dialysis patients.

A 25-Year-Old With an Incidentally Detected Ascending Thoracic Aortic Aneurysm and Bicuspid Aortic Valve.

A woman had shortness of breath and a first-degree relative with a history of ascending aorta dissection. Imaging showed an isolated dilatation in the mid ascending aorta and a bicuspid aortic valve but no pulmonary infiltrates, effusion, or embolism and no aortic stenosis or regurgitation. What would you do next?

Surgical repair of a left main coronary artery aneurysm.

We report the repair of a 6.5 × 5.3-cm left main coronary artery aneurysm by marsupialization of the aneurysm sac and coronary artery bypass grafting.

Aortic Cross-Sectional Area/Height Ratio and Outcomes in Patients With a Trileaflet Aortic Valve and a Dilated Aorta.

BACKGROUND: In patients with a dilated proximal ascending aorta and trileaflet aortic valve, we aimed to assess (1) factors independently associated with increased long-term mortality and (2) the incremental prognostic utility of indexing aortic root to patient height. METHODS: We studied consecutive patients with a dilated aortic root (≥4 cm) that underwent echocardiography and gated contrast-enhanced thoracic aortic computed tomography or magnetic resonance angiography between 2003 and 2007. A ratio of aortic root area over height was calculated (cm2/m) on tomography, and a cutoff of 10 cm2/m was chosen as abnormal, on the basis of previous reports. All-cause death was recorded. RESULTS: The cohort comprised 771 patients (63 years [interquartile range, 53-71], 87% men, 85% hypertension, 51% hyperlipidemia, 56% smokers). Inherited aortopathies, moderate to severe aortic regurgitation, and severe aortic stenosis were seen in 7%, 18%, and 2%, whereas 91% and 54% were on ß-blockers and angiotensin-converting enzyme inhibitors, respectively. Aortic root area/height ratio was ≥10 cm2/m in 24%. The Society of Thoracic Surgeons score and right ventricular systolic pressure were 3.3±3 and 31±7 mm Hg, respectively. At 7.8 years (interquartile range, 6.6-8.9), 280 (36%) patients underwent aortic surgery (76% within 1 year) and 130 (17%) died (1% in-hospital postoperative mortality). A lower proportion of patients in the surgical (versus nonsurgical) group died (13% versus 19%, P<0.01). On multivariable Cox proportional hazard analysis, aortic root area/height ratio (hazard ratio, 4.04; 95% confidence interval [CI], 2.69-6.231) was associated with death, whereas aortic surgery (hazard ratio, 0.47; 95% CI, 0.27-0.81) was associated with improved survival (both P<0.01). For longer-term mortality, the addition of aortic root area/height ratio ≥10 cm2/m to a clinical model (Society of Thoracic Surgeons score, inherited aortopathies, hypertension, hyperlipidemia, medications, aortic regurgitation, and right ventricular systolic pressure), increased the c-statistic from 0.57 (95% CI, 0.35-0.77) to 0.65 (95% CI, 0.52-0.73) and net reclassification index from 0.17 (95% CI, 0.02-0.31) to 0.23 (95% CI, 0.04-0.34), both P<0.01. Of the 327 patients with aortic root diameter between 4.5 and 5.5 cm, 44% had an abnormal aortic root area/height ratio, of which 78% died. CONCLUSIONS: In patients with dilated aortic root and trileaflet aortic valve, a ratio of aortic root area to height provides independent and improved stratification for prediction of death.

Durable outcomes of thoracic endovascular aortic repair with Zenith TX1 and TX2 devices.

OBJECTIVE: Long-term data regarding the safety and durability of thoracic endovascular aortic repair (TEVAR) are limited. The study objective was to evaluate the long-term outcomes of TEVAR in high-risk patients with descending thoracic aortic pathology. METHODS: High-risk patients were treated with thoracic endografts (2001-2011) under a prospective, physician-sponsored, investigational device exemption trial. Three-dimensional reconstructions and measurements were performed on computed tomography scans acquired before discharge, at 1, 6, and 12 months, and then yearly thereafter. RESULTS: The study included 200 patients, of whom 171 were treated for thoracic aneurysm, 28 for chronic dissection, and 1 for aortobronchial fistula. Patients were monitored for an average of 4.8 ± 3.3 years, and 93 (46.5%) were monitored for >5 years. Operative mortality was 6.5%. Survival at 30 days and at 1, 5, and 9 years was 94.0%, 85.8%, 55.6%, and 31.4%, and freedom from aneurysm-related death was 94.0%, 92.4%, 91.7%, 91.7%, respectively. Sixty-one endoleaks occurred in 54 patients (28%). Sixty-seven reinterventions were performed in 50 patients. Overall freedom from reintervention at 30 days, 1, 5, and 9 years was 87.9%, 82.9%, 75.5%, and 64.0%, respectively. Forty-seven reinterventions (70%) were thoracic aneurysm-related, 35 (74%) of which were endovascular procedures. Thirty of these were to correct endoleaks at a median of 1.4 years (interquartile range, 0.2-5.0 years). CONCLUSIONS: TEVAR is durable and associated with high long-term aneurysm-related survival. Long-term imaging follow-up remains critical to identify endoleaks or rare device durability issues, most of which can be monitored or managed with endovascular therapies.

Risk Factors and Outcomes of Patients Requiring a Permanent Pacemaker After Aortic Valve Replacement in the United States.

INTRODUCTION: The need for permanent pacemaker implantation (PCM) following surgical aortic valve replacement (SAVR) is uncommon but can lead to increased hospital resource utilization. Using nationwide data, we sought to (1) identify hospital, patient, and procedure-level risk factors for PCM after SAVR and (2) determine incremental resource utilization. METHODS: We identified 659,692 patients from the Nationwide Inpatient Sample database who underwent SAVR with or without coronary artery bypass grafting (CABG), mitral valvuloplasty (MVr), or mitral valve replacement (MVR) between 1998 and 2009. Patients with pre-existing pacemakers, a concomitant Maze procedure, or endocarditis were excluded. Multivariable regression analysis and propensity matching were used for comparisons of outcomes and costs. RESULTS: Overall prevalence of PCM was 5.1% (n = 34,020; SAVR alone, 4.8%; SAVR + CABG, 4.6%; SAVR + MVr, 7.7%; SAVR + MVR, 10%). Important risk factors for PCM after SAVR were coexisting comorbidities, older age, and addition of mitral valve surgery. Hospital volume and teaching status, location, race, and sex were not associated with PCM. Among matched pairs, patients requiring PCM had lower in-hospital mortality (3.1% vs. 6.4%, p < 0.001) but longer median length of stay (12 vs. 9 days, p < 0.001) and higher hospital costs ($50,000 vs. $37,000, p < 0.001), and they were less likely to be discharged home (33% vs. 36%, p < 0.001). Factors associated with later PCM (postoperative day ≥6) included SAVR + MVR, female sex, fewer comorbidities, northeastern region, and higher hospital volume. Median hospital costs were greater ($57,000 vs. $48,000, p < 0.001) among patients whose pacemakers were implanted later. CONCLUSIONS: PCM following SAVR is associated with lower hospital mortality, but increased cost and length of stay. doi: 10.1111/jocs.12769 (J Card Surg 2016;31:476-485).

Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms.

OBJECTIVE: Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). The Valiant Mona LSA Thoracic Stent Graft System (Medtronic, Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm. Participating in the United States Food and Drug Administration's new Innovation Pathway, this first-in-human, early feasibility study evaluates early clinical experience of the Valiant Mona LSA Stent Graft System in patients with DTAs where the proximal landing zone necessitates LSA coverage. METHODS: This premarket, nonrandomized, single-arm prospective study recruited nine patients (age 72.9 ± 7.6 years). Primary end points were aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Neurologic events were assessed by imaging and by independent neurologists. Inclusion criteria required patients with a DTA or penetrating aortic ulcer to have a distance of ≥10 mm between the left common carotid artery and the LSA. Mean aneurysm diameter was 53.7 ± 10.0 mm. The indication for repair was for saccular DTA in five patients or fusiform DTA in four. Seven patients were at American Society of Anesthesiologists Physical Status Classification III/IV. RESULTS: All nine patients received one main stent graft (diameter 28 to 42 mm) and one branch stent graft (diameter 10 to 14 mm). To extend device coverage distally, a commercial Valiant Captivia device was implanted in seven patients. No uncorrected endoleaks were observed at the end of the implant procedure. Four endoleaks developed before discharge in four of eight evaluable patients. Two were identified as type II and two were of undetermined type. No endoleak resulted in a secondary intervention. Technical success, defined by the clinical investigational plan, was achieved in all nine patients intraoperatively, and treatment success was achieved in all eight evaluable patients at 1 month. There were no major, disabling strokes. Four minor nondisabling strokes were reported in three patients ≤30 days (days 1, 1, 5, and 24). To date, there have been no reports of death, left arm ischemia, paraplegia, rupture, conversion to open surgery, or secondary endovascular procedure. No patients required surgical LSA revascularization. CONCLUSIONS: The Valiant Mona LSA system demonstrates technical and treatment success, relative safety, and early durability in its initial use in DTA patients. Midterm results are expected as patients are monitored at regular intervals to 5 years.

Outcomes after false lumen embolization with covered stent devices in chronic dissection.

OBJECTIVE: Persistent retrograde false lumen perfusion is a common mode of failure after thoracic endovascular aortic repair (TEVAR) for chronic dissection. Objectives were to describe a novel endovascular approach for false lumen occlusion and assess outcomes. METHODS: From 2009 to 2013, 21 patients (mean age, 64 ± 11 years) with chronic thoracoabdominal dissection underwent adjunctive false lumen embolization using covered stent devices for persistent retrograde perfusion. Eight patients had type B dissection, 13 had residual dissection after prior type A repair, and all were deemed high risk for open operation. False lumen embolization in 17 patients was an adjunct at the initial TEVAR or extension, including two as elephant trunk completion. In the other four, this was done as an isolated procedure, and three had previously undergone TEVAR sparing the celiac artery. Covered stent devices included iliac plugs in 18, nitinol embolization plugs in two, and occluded stent graft in one. More than one device was used in 15 patients. RESULTS: There was one hospital death due to left subclavian artery aneurysm rupture but no patient had stroke, paraplegia, myocardial infarction, or renal failure. Mean follow-up was 25 ± 19 months. During surveillance computed tomography imaging, false lumen thrombosis was noted in all patients, but four required further embolization because the thrombosis was incomplete. Mean maximum aortic diameter decreased from 64 ± 14 to 59 ± 15 mm. There was one late death from intracranial hemorrhage and no aortic ruptures. CONCLUSIONS: Adjunctive false lumen embolization with a covered stent device promotes thrombosis and remodeling after stent grafting the true lumen for chronic dissection. Further study of this strategy is warranted.