Faculty Bibliography

OBJECTIVE: We report our initial experience with our newly developed percutaneous right-ventricular assist device (VAD) with CentriMag (perc CM-RVAD). METHODS: A flexible outflow cannula placed from the right internal jugular vein to the pulmonary artery and an inflow cannula placed from the femoral vein to the right atrium constituted the perc CM-RVAD. When needed, biventricular support was provided with left VAD (LVAD), either with a percutaneous LVAD placed through axillary or femoral artery access or with a fully implantable LVAD. RESULTS: Between January 2009 and June 2010, all of the attempted patients successfully received perc CM-RVAD (n = 8). Mean blood pressure, heart rate, and central venous pressure showed a trend toward improvement after the perc CM-RVAD, with less inotrope/vasopressor requirement. Mixed venous oxygen saturation (SvO(2)) increased significantly from 64 +/- 20 Torr to 78 +/- 6 Torr (P < 0.01). The percutaneous VADs were explanted after myocardial recovery in seven patients; however, in three of these, perc CM-RVAD was used as a temporary bridge to other devices. One patient was bridged to a surgical biventricular assist device (BiVAD) and transferred back to the referring hospital on support. One death occurred due to multiple-organ failure 8 days after explantation of the RVAD with recovery. CONCLUSIONS: Perc CM-RVAD was feasible and provided hemodynamic improvement.

Stroke is a potential complication of treating patients with aortic stenosis via surgical aortic valve replacement (AVR), transcatheter aortic valve replacement (TAVR), and balloon aortic valvuloplasty. Because there are limited and heterogeneous data on the incidence, risk factors, and outcomes of stroke among patients being treated for aortic stenosis, we performed a comprehensive review of the literature. The risk of stroke after AVR in the general population is approximately 1.5%, and the risk is increased (to approximately 2% to 4%) in older and higher-risk patients. Strokes were reported in 1.5% to 6% of patients treated with TAVR, and in the only randomized trial of AVR versus TAVR, there was an increased risk of 30-day strokes (minor and major strokes and transient ischemic attacks) with TAVR (5.5% vs. 2.4%, p = 0.04).

OBJECTIVES: This study sought to evaluate the technical success and clinical outcomes of an adjunctive crossover balloon occlusion technique (CBOT) combined with the 10-F Prostar percutaneous closure device (PCD) on the incidence of vascular and bleeding complications in patients after transfemoral transcatheter aortic valve implantation (TAVI). BACKGROUND: Vascular closure following large-vessel access has most commonly been performed using a surgical cut-down and repair procedure. METHODS: Between November 2008 and September 2010, 58 consecutive patients with severe aortic stenosis underwent TAVI via a retrograde femoral artery approach using the Edwards-SAPIEN transcatheter valve. Among these patients, 56 were treated with a CBOT using the "pre-close" technique and the 10-F Prostar system. The technical success of this new CBOT and the 30-day frequency of clinical events, including all-cause mortality, major vascular complications, and major bleeding (defined according to a modified version of the Valve Academic Research Consortium criteria), were assessed. RESULTS: Successful closure was obtained in all but 3 patients (94.6%). The 30-day frequencies of mortality, major vascular complications, and major bleeding were 7.1%, 14.3%, and 5.4% respectively. No deaths were directly related to access site complications. Fourteen patients (25%) received at least 1 transfusion during the index hospitalization, of which 8 (57.1%) were not related to vascular complications. The mean and median hospital lengths of stay were 7.8 and 6.0 days. CONCLUSIONS: This new percutaneous adjunctive CBOT combined with the Prostar PCD resulted in controlled, safe, and successful percutaneous closure in most patients after TAVI.

OBJECTIVE: Early invasive strategy, defined as early coronary angiography and subsequent revascularization, when appropriate, is recommended by current guidelines for the management of patients with moderate- to high-risk acute coronary syndromes. We sought to compare the outcomes of patients with acute coronary syndromes undergoing surgical revascularization with an on-pump versus off-pump approach. METHODS: Among a total of 13,819 patients with moderate- to high-risk acute coronary syndromes enrolled in the Acute Catheterization and Urgent Intervention Triage Strategy trial, 1375 patients were triaged to isolated coronary artery bypass grafting. One thousand one hundred fifty-four patients underwent operations with cardiopulmonary bypass (the coronary artery bypass grafting group), and 221 patients underwent off-pump coronary artery bypass grafting (the off-pump coronary artery bypass grafting group). Propensity score matching (1:3) was applied to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 880 matched patients with acute coronary syndromes (220 managed with off-pump coronary artery bypass grafting and 660 managed with coronary artery bypass grafting). RESULTS: At 30 days, patients undergoing off-pump coronary artery bypass grafting had fewer events of bleeding (43.7% vs 56.3%, P = .0005) and myocardial infarction (7.3% vs 12.1%, P = .055) but higher rates of reintervention (3.7% vs 1.2%, P = .02). At 1 year, there was no difference between groups in death, total myocardial infarctions, reinterventions, strokes, or major adverse cardiac events, but there was a lower rate of non-Q-wave myocardial infarctions in the off-pump coronary artery bypass grafting group (4.6% vs 9.2%, P = .03). CONCLUSIONS: In this large-scale study evaluating the outcomes of patients with acute coronary syndromes, off-pump coronary artery bypass grafting was associated with lower rates of bleeding and non-Q-wave myocardial infarction but more reinterventions early after the procedure. At 1 year, there was no major outcome difference between the 2 surgical strategies.

BACKGROUND: The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. RESULTS: The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. CONCLUSIONS: In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).

The Ross procedure or pulmonary autograft has been frequently used for surgical treatment of aortic valve disease. One considerable disadvantage of the Ross procedure is the involvement of two valves (aortic and pulmonary) in treatment of single (aortic) valve disease. Both the aortic and pulmonary valves are at risk for future degeneration. Concurrent failure of both valves after a Ross procedure is rare but presents a significant technical challenge when reoperation is necessary. We describe a novel approach to this complication using composite biological valved conduits comprised of stentless bioprosthetic valves and polyester grafts.