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.

Multicenter mitral valve study: a lateral approach using the da vinci surgical system.

OBJECTIVE: : The purpose of this study was to demonstrate the feasibility of simple to complex endoscopic robotic mitral valve repair, using a lateral approach. METHODS: : Data were retrospectively collected on 201 patients undergoing a lateral "ports only" endoscopic robotic mitral valve repair at three institutions. Techniques of aortic occlusion included the endoaortic balloon or a transthoracic clamp. The efficacy of the repair was measured intraoperatively by transesophageal echocardiogram. RESULTS: : Two hundred one patients with a mean age of 55.2 ± 14.2 were intended to undergo elective robotic mitral valve surgery. One hundred eighty-six (92.5%) were scheduled for a repair procedure and 15 (7.5%) were scheduled for replacement. The repair was accomplished in 179 of 186 (96.2%) of patients. Eight patients (4.3%) required a conversion to sternotomy incision. Seven converted patients received a mitral valve repair and one received a replacement mitral valve. Mitral valve pathology included 10% isolated anterior leaflet involvement, 43% isolated posterior leaflet involvement, and 6% bileaflet pathology, and the remaining patients had dilated annulus, chordal rupture, or elongation. One hundred seventy-nine patients (96.2%) had regurgitation grade of 0 to 1 after repair. Two patients (1%) died. Other adverse events included reoperation for valve-related complications, 2 of 201 (1%); reoperation for cardiac-related complications, 3 of 201 (1.5%); and new onset of atrial fibrillation, 35 of 201 (17.4%). CONCLUSIONS: : A lateral endoscopic robotic approach to mitral valve repair is safe, feasible, and can be performed consistently with acceptable postoperative results. Further follow-up is required to determine the long-term efficacy of this approach to robotic mitral valve repair.

Integrated coronary revascularization: percutaneous coronary intervention plus robotic totally endoscopic coronary artery bypass.

BACKGROUND: Robotic totally endoscopic coronary artery bypass (TECAB) of the left anterior descending artery (LAD) coupled with percutaneous coronary intervention (PCI) of a second coronary artery has been investigated in patients with multivessel disease to provide a minimally invasive therapeutic option. METHODS AND RESULTS: TECAB of the LAD was performed using the left internal mammary artery (LIMA). A second lesion was treated with PCI before surgery, simultaneously, or after surgery. Three-month angiographic follow-up was performed in all patients and was subject to independent review. A total of 27 patients requiring double vessel revascularization were treated at 7 centers. Eleven patients underwent PCI before surgery, 12 patients underwent PCI after surgery, and 4 patients underwent simultaneous surgical and percutaneous intervention. Ten patients (37%) were treated with bare metal stents, whereas 17 patients (63%) were treated with drug-eluting stents. Postoperative angiographic evaluation demonstrated an overall LIMA anastomotic patency of 96.3% and PCI vessel patency of 66.7%. There were no deaths or strokes. One patient experienced a perioperative myocardial infarction. Eight of 27 patients (29.6%) required reintervention, 1 LIMA anastomotic stenosis (3.7%), 3 after bare metal stent (30%), and 4 after drug-eluting stent placement (23.5%). CONCLUSIONS: Integrated revascularization treatment plans provide minimally invasive options for patients with multivessel coronary artery disease. This approach may be accomplished with no mortality, low perioperative morbidity, and excellent angiographic LIMA patency. The reintervention rate after PCI in this series was higher than that reported elsewhere and should be investigated further. The choice of suitable vessel, type of stent and timing of the treatment must be carefully considered before implementing this hybrid strategy.

Results of the prospective multicenter trial of robotically assisted totally endoscopic coronary artery bypass grafting.

BACKGROUND: Robotic technology has been proven safe and efficacious in the performance of mitral valve repair and atrial septal defect repair. This report describes a Food and Drug Administration-sanctioned multicenter study of the safety and efficacy of the da Vinci system (Intuitive Surgical, Inc, Mountain View, CA) for totally endoscopic coronary artery bypass (TECAB) surgery. METHODS: Patients requiring left anterior descending (LAD) coronary artery revascularization were eligible. The procedure was performed with femoro-femoral cardiopulmonary bypass (CPB), endoaortic balloon occlusion, and thoracoscopy. All aspects of the procedure were performed with the robotic system, from internal mammary artery harvest to coronary anastomosis. RESULTS: Ninety-eight patients requiring single-vessel LAD revascularization were enrolled at 12 centers. Thirteen patients (13%) were excluded intraoperatively (eg, failed femoral cannulation, inadequate working space). In 85 patients (69 men, age 58 +/- 10 years) who underwent TECAB, CPB time was 117 +/- 44 minutes, cross-clamp time was 71 +/- 26 minutes, and hospital length of stay was 5.1 +/- 3.4 days. There were five (6%) conversions to open techniques. There were no deaths or strokes, one early reintervention, and one myocardial infarction (1.5%). Three-month angiography was performed in 76 patients, revealing significant anastomotic stenoses (> 50%) or occlusions in 6 patients. Overall freedom from reintervention or angiographic failure was 91%. CONCLUSIONS: Robotic TECAB was accomplished with no mortality, low morbidity, and angiographic patency and reintervention rates comparable with published data. Although the use of CPB was a limitation of the technique, this experience represents a step toward more advanced procedures, such as multivessel or off-pump TECAB.