Adoption and clinical outcomes of fenestrated endovascular aneurysm repair in a regional, multistate community hospital system.

OBJECTIVE: Complex endovascular abdominal aortic aneurysm (AAA) repair techniques have evolved over the last decade, yet patterns of physician and hospital system adoption of fenestrated endovascular aneurysm repair (FEVAR) remain poorly defined. We investigated clinical outcomes, use trends, and surgeon and hospital experience for FEVAR in a large community hospital system. METHODS: We conducted a retrospective cohort study of all FEVAR procedures within our 5-state hospital system between April 2012 and June 2021. AAA repair volumes (open, EVAR, and FEVAR) were captured at the hospital and surgeon levels using Current Procedural Terminology and International Classification of Diseases codes. Clinical and outcomes data were collected for FEVAR patients. To consider if surgeon or hospital experience influenced outcomes, sequential case number was used to divide patients into surgeon experience and hospital experience groups. Inverse probability weighted and generalized linear mixed models, adjusted for demographics and comorbidities, were built to examine risk-adjusted outcomes for surgeon and hospital experience groups. RESULTS: Of 3850 patients treated with AAA procedures of any kind between 2012 and 2021, 160 (4.2%) underwent FEVAR. FEVAR procedures were performed by 34 different surgeons at 12 hospitals, with intraoperative complications and unplanned adjunctive procedures occurring in 18.8% (n = 30) and 19.4% (n = 31) of patients, respectively. Among FEVAR patients, in-hospital mortality was 1.3% (n = 2) and postoperative morbidity was 16.9% (n = 27). Renal function decline occurred postoperatively in 5.1% of patients. Early (<30 day) postoperative endoleaks occurred in 15.3% of patients (n = 21). Target vessel patency was 95.6% on initial postoperative imaging. Surgeon and hospital experience had a small positive impact on outcomes after the first one to three cases. Significant decreases in operative time, fluoroscopy time, and estimated blood loss were observed with increased surgeon experience, relative to a surgeon's first case (P < .05). There were lower odds of intraoperative complications after a surgeon's first case (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.03-0.77, for cases 2-3) or after a hospital's first one to three cases (OR, 0.19; 95% CI, 0.04-0.89, for cases 4-8; OR, 0.12; 95% CI, 0.03-0.55 for cases 9-49). CONCLUSIONS: Clinical outcomes of FEVAR across our hospital system compare favorably with previously published reports. Although system-wide FEVAR adoption increased 3-fold over the last decade, FEVAR continued to be performed by a minority of hospitals in our system. The results from this cohort demonstrate low rates of adverse events, high rates of technical efficiency, and a small impact of surgeon and hospital experience, thereby supporting this advanced endovascular technology as a safe, efficacious, and generalizable treatment alternative to open repair for patients with complex aortic anatomy.

Impella as a bridge-to-closure in post-infarction ventricular septal defect: a case series.

Background: Post-infarction ventricular septal defect (PIVSD) is a rare, life-threatening complication of acute myocardial infarction (AMI). Few studies report the use of mechanical circulatory support (MCS) for the treatment of cardiogenic shock in this setting. We describe our experience using a microaxial, transvalvular device (Impella, Abiomed, Danvers, MA, USA) as a bridge-to-closure for PIVSD. Case summary: We identified 13 patients from two centres with cardiogenic shock due to PIVSD who received an Impella device between January 2016 and February 2022. Nine patients were transferred from another hospital, three with MCS devices [two intra-aortic balloon pumps (IABP), 1 Impella CP]. Eight patients received Impella 5.0, three received Impella 5.5 (one escalated from Impella CP), and two received Impella CP. The median time from AMI to Impella insertion was 5 (3-6) days. Five patients died on Impella support without an attempt to close the ventricular septum (VSD). Seven patients underwent successful VSD closure: six had surgical and one had percutaneous closure. One patient died during attempted percutaneous closure. Time from Impella insertion to VSD closure was 10.5 (7.8-14.0) days. Time from AMI to Impella was 5.0 (2.0-5.3) days in the group that survived to closure, and 6.0 (4.0-7.0) days in those who did not. Thirty-day mortality was 46%. Discussion: Support with Impella improved clinical stability in most patients, yet multi-system organ failure leading to death occurred in many patients. Patients who survived closure had earlier time from AMI to Impella, underscoring that prompt recognition of PIVSD and initiation of MCS may improve survival to surgical or percutaneous closure.

Axillary transvalvular microaxial pump as extended bridge to transcatheter aortic valve replacement in cardiogenic shock with severe aortic stenosis.

Cardiogenic shock in the setting of severe aortic stenosis is associated with poor outcomes. We describe 5 patients with cardiogenic shock and severe aortic stenosis who received an axillary microaxial pump (Impella) as an extended bridge to transcatheter aortic valve replacement. The median (range) age was 65 (61-87) years old, 80% were male, and 80% presented with stage D or E cardiogenic shock. In most cases, balloon aortic valvuloplasty was performed prior to pump insertion. Stabilization by Impella allowed for heart team evaluation and additional interventions, including percutaneous coronary intervention, MitraClip, and cardioversion. After a median (range) of 7 (5-14) days of Impella support, semi-elective transcatheter aortic valve replacement was successfully performed. All patients survived to discharge. Four patients (80%) were alive beyond 1 year. In these high-risk patients, prolonged support with a microaxial pump allowed for stabilization, ancillary interventions, and multi-disciplinary heart team evaluation prior to transcatheter aortic valve replacement.

Transcarotid versus transthoracic access for transcatheter aortic valve replacement: A propensity-matched analysis.

OBJECTIVE: Transcarotid access for transcatheter aortic valve replacement is emerging as an alternative to more traditional nonfemoral access options such as transapical or transaortic; however, comparative data are limited. The purpose of the study was to analyze outcomes after transcatheter aortic valve replacement using transcatheter compared with transthoracic (transapical/transaortic) access. METHODS: The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was queried for patients who underwent transcarotid, transapical, or transaortic transcatheter aortic valve replacement with the SAPIEN 3 (Edwards Lifesciences, Irvine, Calif) transcatheter heart valve between June 2015 and July 2019. Thirty-day unadjusted outcomes were evaluated, and propensity score matching and logistic regression were used to compare transcatheter access with transthoracic access. RESULTS: In the propensity-matched analysis, 667 transcarotid transcatheter aortic valve replacement procedures were compared with 1334 transthoracic procedures. Transcarotid transcatheter aortic valve replacement was associated with lower mortality (4.2% vs 7.7%, P = .004), less new-onset atrial fibrillation (2.2% vs 12.1%, P < .0001), fewer readmissions at 30 days (9.8% vs 16.1%, P = .0006), shorter median length of stay (3.0 vs 6.0 days, P < .0001), shorter median intensive care unit stay (25 vs 47.2 hours, P < .0001), and greater 30-day Kansas City Cardiomyopathy Questionnaire score improvement from baseline (25.1 vs 20.8, P = .007). Stroke (4.3% vs 3.7%, P = .44) and major vascular complications (1.4% vs 1.9%, P = .40) were similar. CONCLUSIONS: Transcatheter aortic valve replacement using transcarotid access is associated with lower 30-day mortality, less atrial fibrillation, shorter intensive care unit and overall length of stay, fewer readmissions, greater improvement in Kansas City Cardiomyopathy Questionnaire scores, and no significant difference in stroke or major vascular complications compared with transthoracic access.

Comparable Outcomes for Transcarotid and Transfemoral Transcatheter Aortic Valve Replacement at a High Volume US Center.

With continued growth of transcatheter aortic valve replacement (TAVR), safe alternative access remains important for patients without adequate transfemoral (TF) access. Registry-based outcomes with transcarotid (TC) TAVR are favorable compared to transapical or transaxillary/subclavian, but TC vs TF comparisons have not been made. Our objective was to compare outcomes between TF and TC access routes for TAVR at a high-volume United States center. Methods: We retrospectively evaluated all TF and TC TAVR procedures from June 11, 2014 (first TC case) through December 31, 2019. The primary outcomes were 30-day stroke and 30-day mortality. Secondary outcomes were 1-year stroke, 1-year survival, and 30-day and 1-year life-threatening/major bleeding, vascular complications, and myocardial infarction. Propensity score weighted (PSW) models were used to compare risk-adjusted TF and TC outcomes. Of 1,465 TAVR procedures, 1319 (90%) were TF and 146 (10%) were TC. Procedure time and length of stay did not differ between groups. Unadjusted 30-day stroke (TF = 2.0%, TC = 2.7%, P = 0.536) and mortality (TF = 2.1%, TC = 2.7%, P = 0.629) were similar between groups. PSW 30-day stroke (odds ratio (OR) (95% confidence interval (CI)) = 0.8 (0.2-2.8)) and mortality (OR (95% CI) = 0.8 (0.2-3.0)) were similar between groups. Unadjusted and PSW 30-day major/life threatening bleeding, major vascular complications, and myocardial infarction did not differ between groups. Survival at one year was 90% (88%-92%) for TF patients and 87% (81%-93%) for TC patients (unadjusted P = 0.28, PSW hazard ratio = 1.0 (0.6-1.7)). Transcarotid TAVR is associated with similar outcomes compared to transfemoral TAVR at an experienced, high-volume center.

Transcarotid Versus Subclavian/Axillary Access for Transcatheter Aortic Valve Replacement With SAPIEN 3.

BACKGROUND: Subclavian/axillary (TAx) access has become the most frequently used alternative access route for transcatheter aortic valve replacement (TAVR). Transcarotid (TC) TAVR has grown in popularity recently. Comparative data between these 2 contemporary access methods is lacking. METHODS: Data were extracted from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry™ (June 2015 to October 2019) for patients undergoing TAVR by TC or TAx access with the SAPIEN 3 and SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, CA) transcatheter heart valves. Procedural, index hospitalization, and 30-day outcomes were analyzed for TC vs TAx groups after 1:2 propensity matching of patient baseline characteristics. RESULTS: The study included 3903 cases, of which 801 TC and 3102 TAx procedures were compared. After 1:2 propensity matching, TC TAVR was associated with similar 30-day mortality (4.3% vs 5.2%, P = .34) but a significantly lower risk of stroke (4.2% vs 7.4%; hazard ratio, 0.56; 95% confidence interval, 0.38-0.83; P = .003) compared with TAx access. Other outcomes that favored TC over TAx included shorter procedure time (117.0 vs 132.4 minutes; P < .001) and fluoroscopy time (16.6 vs 21.6 min; P < .001), lower contrast volume (78.5 vs 96.7 mL; P < .001), shorter length of stay in the intensive care unit (24.3 vs 25.0 hours; P = .02) and hospital (2.0 vs 3.0 days; P = .002), and more patients discharged to home (82.9% vs 74.6%; P < .001). CONCLUSIONS: TC TAVR is associated with similar mortality and a significant reduction in stroke compared with the TAx approach. If femoral access is precluded, TC may be a safe, or at times, preferred avenue of transcatheter valve delivery.

Trends in vascular complications and associated treatment strategies following transfemoral transcatheter aortic valve replacement.

OBJECTIVE: Vascular complications (VC) and bleeding complications impact morbidity and mortality after transfemoral transcatheter aortic valve replacement (TF-TAVR). Few contemporary studies have detailed these complications, associated treatment strategies, or clinical outcomes. We examined the incidence, predictors, treatment strategies, and outcomes of VCs in a multicenter cohort of patients undergoing TF-TAVR. METHODS: We performed a retrospective registry and chart review of all nonclinical trial TF-TAVR patients from seven centers within a five-state hospital system from 2012 to 2016. Bleeding and VC were recorded as defined by the Valve Academic Research Consortium recommendations. Procedural and 30-day outcomes and 1-year mortality were compared between patients with no, minor, or major VC. Multivariable logistic and Cox regressions were used to identify predictors of major VC and mortality, respectively. RESULTS: Over the study period, 1573 patients underwent TF-TAVR, with 96 (6.1%) experiencing a major VC and 77 (4.9%) experiencing a minor VC. The majority of VCs were access site related (74.2%), occurred intraoperatively (52.6%), and required interventional treatment (73.2%). The site, timing, and treatment method of VCs did not significantly change over the study period. Patients with VCs had a greater need for blood transfusion, longer postoperative length of stay, higher rates of cardiac events, increased vascular-related 30-day readmission, and higher 30-day mortality. Female sex (odds ratio [OR], 3.00; 95% CI, 1.91-4.72) and prior percutaneous coronary intervention (OR, 2.14 ; 95% CI, 1.38-3.31) were the strongest predictors of major VC. VCs modestly decreased over the study period: every 90-day increase in surgery date decreased the odds of major VC by 6% (95% CI, 1%-10%). Patients with major VCs had worse 1-year survival (OR, 79%; 95% CI, 69%-86%) compared with patients with minor VCs (OR, 92%; 95% CI, 82%-96%) or no VCs (OR, 88%; 95% CI, 87%-90%; P = .002). However, for patients who survived more than 30 days, the 1-year survival did not differ between groups For patients who survived more than 30 days, male sex (hazard ratio, 1.84; 95% CI, 1.30-2.60) and the logit of STS mortality risk score (hazard ratio, 1.98; 95% CI, 1.48-2.65) were the strongest predictors of mortality. After adjusting for other factors, minor and major VC were not predictors of 1-year mortality for patients who survived more than 30 days. CONCLUSIONS: In our contemporary cohort, VCs after TF-TAVR have modestly decreased in recent years, but continue to impact perioperative outcomes. Patient selection, consideration of alternative access routes, and prompt recognition and treatment of VCs are critical elements in optimizing early clinical outcomes after TF-TAVR.

The Carotid Artery as a Preferred Alternative Access Route for Transcatheter Aortic Valve Replacement.

BACKGROUND: In high-risk patients with severe aortic stenosis, transfemoral (TF) access for transcatheter aortic valve replacement (TAVR) is the preferred access route but is not always feasible. Compared with other alternative access routes, transcarotid (TC) access is often overlooked by many valvular heart teams. METHODS: We report our single-center experience of all patients undergoing TC (n = 25), transapical (TA) (n = 12), or TF (n = 100; limited to most recent cases) TAVR over a 1.5 year period. In-hospital and 30-day outcomes were retrospectively compared between groups using the Kruskal-Wallis and Wilcoxon rank sum tests. RESULTS: TAVR was successfully performed through the left or right carotid artery in all 25 patients. Procedurally, TC and TF procedures were faster than TA procedures (p < 0.001), and patients who underwent TC and TF procedures had shorter intensive care unit (ICU) hours (p = 0.05), ventilator hours (p < 0.001), and length of stay (LOS) (p = 0.01) compared to patients who underwent a TA procedure. No patients who underwent a TC procedure had in-hospital stroke, transient ischemic attack (TIA), or myocardial infarction (MI). One patient who underwent a TC procedure had a TIA by 30-day follow-up, which was not significantly different from the TF (2 patients) or TA groups (0 patients; p = 0.75). In-hospital mortality rates were the same between TC (1 patient) and TF (1 patient) procedures but were significantly greater for TA procedures (2 patients; p = 0.009). Thirty-day mortality rates were low and did not differ between the groups. CONCLUSIONS: In our US community hospital setting, TC-TAVR is a safe alternative to TF-TAVR in appropriate patients and has evolved to be our alternative access route of choice if TF access is not feasible.