Faculty Bibliography

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.

Transcatheter aortic valve implantation (TAVI) with the Cribier-Edwards prosthesis may provide an alternative to conventional aortic valve replacement in high-risk patients with aortic stenosis. Previous studies have indicated that TAVI is feasible in this patient population. Transcatheter implantation of a Cribier-Edwards prosthesis was attempted in 55 patients in a United States Food and Drug Administration-approved prospective observational study. Clinical and echocardiographic outcomes were assessed in hospital and at 30 days, 6 months, and 12 months. Fifty-five patients (55% women, mean age 83 years) with a mean aortic valve area of 0.57 +/- 0.14 cm(2) and a mean logistic European System for Cardiac Operative Risk Evaluation score of 33.5 +/- 17.0% were enrolled. Transcatheter heart valves were implanted successfully in 48 patients (87%). Mean echocardiographic aortic valve area improved from 0.56 +/- 0.14 to 1.6 +/- 0.48 cm(2) after the procedure (p <0.0001). Thirty-day all-cause mortality and major adverse cardiac and cerebrovascular events were 7.3% and 20%, respectively. There were also 7 major procedural vascular complications (12.7%). Mortality and major adverse cardiac and cerebrovascular events increased to 23.6% and 32.7%, respectively, at 1 year, with most late events related to underlying co-morbidities. Mean New York Heart Association functional class improved from 3.22 +/- 0.66 at baseline to 1.50 +/- 0.85 at 1 year follow-up (p <0.001). In conclusion, TAVI in high-risk patients with aortic stenosis was feasible, with sustained clinical benefit at 12 months. Procedural complications and late major adverse cardiac and cerebrovascular events, however, overshadowed the overall clinical benefit of TAVI in this high-risk patient population.

OBJECTIVES: The aim of this study was to evaluate outcomes of patients with moderate- and high-risk acute coronary syndromes (ACS) and multivessel coronary artery disease managed with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). BACKGROUND: There is uncertainty about the preferred revascularization strategy for high-risk patients with multivessel disease. METHODS: Among 13,819 moderate- and high-risk ACS patients enrolled in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, 5,627 had multivessel disease (including left anterior descending artery involvement) and were managed by PCI (n = 4,412) or CABG (n = 1,215). Propensity score matching was applied to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 1,056 patients (528 managed by PCI, and 528 managed by CABG). RESULTS: Propensity-matched patients undergoing CABG had higher 1-month rates of stroke (1.1% vs. 0.0%, p = 0.03) and myocardial infarction (13.3% vs. 8.8%, p = 0.03), received more blood transfusions (40.3% vs. 6.3%, p < 0.0001) and more frequently developed acute renal injury (31.7% vs. 14.2%, p < 0.0001), whereas PCI was associated with higher rates of unplanned revascularization at both 1 month and at 1 year (0.8% vs. 5.2%, p < 0.0001; and 3.8% vs. 16.5%, p < 0.0001, respectively). There were no significant differences between the CABG and PCI groups in 1-month or 1-year mortality (2.5% vs. 2.1%, p = 0.69; and 4.4% vs. 5.7%, p = 0.58, respectively). CONCLUSIONS: In this propensity-matched comparison from the ACUITY trial, moderate- and high-risk patients with ACS and multivessel disease treated with PCI rather than CABG had lower rates of peri-procedural stroke, myocardial infarction, major bleeding, and renal injury, with comparable 1-month and 1-year rates of mortality, but more frequently developed recurrent ischemia requiring repeat revascularization procedures during follow-up. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158)

BACKGROUND: The purpose of this study was to compare posttransplantation morbidity and mortality in orthotopic heart transplant recipients bridged to transplant with a left ventricular assist device with nonbridged recipients. To account for potential differences across device types, we stratified bridge-to-transplant recipients by type of ventricular assist device: extracorporeal (EXTRA), paracorporeal (PARA), and intracorporeal (INTRA). METHODS: The United Network for Organ Sharing provided de-identified patient-level data. The study population included 10,668 orthotopic heart transplant recipients aged 18 years old or older and undergoing transplantation between January 1, 2001, and December 31, 2006. Follow-up data were provided through August 3, 2008, with a mean follow-up time of 3.17 +/- 2.15 years (range, 0-8.11 years). The primary outcome was actuarial posttransplant graft survival. Other outcomes of interest included infection, stroke, and dialysis during the transplant hospitalization; primary graft failure at 30 days; transplant hospitalization length of stay; and long-term complications including diabetes mellitus, transplant coronary artery disease, and chronic dialysis. Multivariable Cox proportional hazards regression (backward, P < .15) was used to determine the relationship between groups and overall graft survival, and multivariable logistic regression analysis (backward, P < .15) was used to determine the relationship between groups and secondary outcome measures. RESULTS: In multivariable Cox regression analysis, when compared with the nonbridged group, risk-adjusted greater than 90-day graft survival was diminished among the EXTRA group (hazard ratio = 3.54, 2.28-5.51, P < .001), but not the INTRA group (1.04, 0.719-1.51, P = .834) or the PARA group (1.06, 0.642-1.76, P = .809). There were no significant differences in risk-adjusted graft survival across the 4 groups during the 90-days to 1-year or 1- to 5-year intervals. However, at more than 5 years, risk-adjusted graft survival in the INTRA group (0.389, 0.205-0.738, P = .004) was better than in the nonbridged group. The EXTRA, PARA, and INTRA groups all experienced increased risks of infection. The EXTRA group had increased risks of dialysis, stroke, and primary graft failure at 30 days, whereas neither the PARA nor the INTRA group differed from the nonbridged group. Long-term complications did not differ by group. CONCLUSION: The use of implantable left ventricular assist devices as bridges to transplantation, including both intracorporeal and paracorporeal devices, is not associated with diminished posttransplant survival. However, 90-day survival was diminished in recipients bridged with extracorporeal devices.