Molly Szerlip M.D.

Goldsweig, A. M., H. J. Tak, L. W. Chen, H. D. Aronow, B. Shah, D. S. Kolte, P. Velagapudi, N. Desai, M. Szerlip and J. D. Abbott (2019). “The Evolving Management of Aortic Valve Disease: 5-Year Trends in SAVR, TAVR, and Medical Therapy.” Am J Cardiol 124(5): 763-771

Full text of this article.

Aortic stenosis (AS) and regurgitation (AR) may be treated with surgical aortic valve replacement (SAVR), transcatheter AVR (TAVR), or medical therapy (MT). Data are lacking regarding the usage of SAVR, TAVR, and MT for patients hospitalized with aortic valve disease and the characteristics of the patients and hospitals associated with each therapy. From the Nationwide Readmissions Database, we determined utilization trends for SAVR, TAVR, and MT in patients with aortic valve disease admitted from 2012 to 2016 for valve replacement, heart failure, unstable angina, non-ST-elevation myocardial infarction, or syncope. We also performed multinomial logistic regressions to investigate associations between patient and hospital characteristics and treatment. Among 366,909 patients hospitalized for aortic valve disease, there was a 48.1% annual increase from 2012 through 2016. Overall, 19.9%, 6.7%, and 73.4% of patients received SAVR, TAVR, and MT, respectively. SAVR decreased from 21.9% in 2012 to 18.5% in 2016, whereas TAVR increased from 2.6% to 12.5%, and MT decreased from 75.5% to 69.0%. Older age, female sex, greater severity of illness, more admission diagnoses, not-for-profit hospitals, large hospitals, and urban teaching hospitals were associated with greater use of TAVR. In multivariable analysis, likelihood of TAVR relative to SAVR increased 4.57-fold (95% confidence interval 4.21 to 4.97). TAVR has increased at the expense of both SAVR and MT, a novel finding. However, this increase in TAVR was distributed inequitably, with certain patients more likely to receive TAVR certain hospitals more likely to provide TAVR. With the expected expansion of indications, inequitable access to TAVR must be addressed.

Wood, D. A., Z. Krajcer, J. Sathananthan, N. Strickman, C. Metzger, W. Fearon, M. Aziz, L. F. Satler, R. Waksman, M. Eng, S. Kapadia, A. Greenbaum, M. Szerlip . . . and J. G. Webb (2019). “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device.” Circ Cardiovasc Interv 12(7): 1-11 e007258.

Full text of this article.

BACKGROUND: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. METHODS AND RESULTS: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65+/-157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). CONCLUSIONS: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Szerlip, M., A. Zajarias, S. Vemalapalli, M. Brennan, D. Dai, H. Maniar, B. R. Lindman, R. Brindis, J. D. Carroll, M. Hamandi, F. H. Edwards, F. Grover, S. O’Brien, E. Peterson, J. S. Rumsfeld, D. Shahian, E. M. Tuzcu, D. Holmes, V. H. Thourani and M. Mack (2019). “Transcatheter Aortic Valve Replacement in Patients With End-Stage Renal Disease.” J Am Coll Cardiol 73(22): 2806-2815.

Full text of this article.

BACKGROUND: In patients with end-stage renal disease (ESRD), surgical aortic valve replacement is associated with higher early and late mortality, and adverse outcomes compared with patients without renal disease. Transcatheter aortic valve replacement (TAVR) offers another alternative, but there are limited reported outcomes. OBJECTIVES: The purpose of this study was to determine the outcomes of TAVR in patients with ESRD. METHODS: Among the first 72,631 patients with severe aortic stenosis (AS) treated with TAVR enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT (Transcatheter Valve Therapies) registry, 3,053 (4.2%) patients had ESRD and were compared with patients who were not on dialysis for demographics, risk factors, and outcomes. RESULTS: Compared with the nondialysis patients, ESRD patients were younger (76 years vs. 83 years; p < 0.01) and had higher rates of comorbidities leading to a higher STS predicted risk of mortality (median 13.5% vs. 6.2%; p < 0.01). ESRD patients had a higher in-hospital mortality (5.1% vs. 3.4%; p < 0.01), although the observed to expected ratio was lower (0.32 vs. 0.44; p < 0.01). ESRD patients also had a similar rate of major vascular complications (4.5% vs. 4.6%; p = 0.86), but a higher rate of major bleeding (1.4% vs. 1.0%; p = 0.03). The 1-year mortality was significantly higher in dialysis patients (36.8% vs. 18.7%; p < 0.01). CONCLUSIONS: Patients undergoing TAVR with ESRD are at higher risk and had higher in-hospital mortality and bleeding, but similar vascular complications, when compared with those who are not dialysis dependent. The 1-year survival raises concerns regarding diminished benefit in this population. TAVR should be used judiciously after full discussion of the risk-benefit ratio in patients on dialysis.

Hamandi, M., R. L. Smith, W. H. Ryan, P. A. Grayburn, A. Vasudevan, T. J. George, J. M. DiMaio, K. A. Hutcheson, W. Brinkman, M. Szerlip, D. O. Moore and M. J. Mack (2019). “Outcomes of Isolated Tricuspid Valve Surgery Have Improved in the Modern Era.” Ann Thorac Surg 108(1): 11-15.

Full text of this article.

BACKGROUND: Surgery for isolated tricuspid valve (TV) disease remains relatively infrequent because of significant patient comorbidities and poor surgical outcomes. This study reviewed the experience with isolated TV surgery in the current era to determine whether outcomes have improved. METHODS: From 2007 through 2017, 685 TV operations were performed in a single institution, of which 95 (13.9%) operations were isolated TV surgery. Patients were analyzed for disease origin, risk factors, operative mortality and morbidity, and long-term survival. RESULTS: A total of 95 patients underwent isolated TV surgery, an average of 9 patients per year increasing from an average of 5 per year to 15 per year during the study period. Surgery was reoperative in 41% (38 of 95) of patients, including 11.6% (11 of 95) with prior coronary artery bypass grafting and 29.4% (28 of 95) with prior valve surgery (9 TV, 11 mitral, 2 aortic, 5 mitral and aortic, and 1 mitral and TV). Repair was performed in 71.6% (68 of 95) of patients, and replacement was performed in 28.4% (27 of 95). Operative mortality was 3.2% (3 of 95), with no mortality in the most recent 73 patients over the last 6 years. Stroke occurred in 2.1% (2 of 95) of patients, acute kidney injury requiring dialysis in 5.3% (5 of 95), and the need for new permanent pacemaker in 16.8% (16 of 95). CONCLUSIONS: In the current era with careful patient selection and periprocedural management, isolated TV surgery can be performed with lower morbidity and mortality than has traditionally been reported with good long-term survival. These outcomes can also serve as a benchmark for catheter-based TV intervention outcomes.

Goldsweig, A. M., H. J. Tak, L. W. Chen, H. D. Aronow, B. Shah, D. S. Kolte, P. Velagapudi, N. Desai, M. Szerlip and J. D. Abbott (2019). “The Evolving Management of Aortic Valve Disease: 5-Year Trends in SAVR, TAVR, and Medical Therapy.” Am J Cardiol Jun 7. [Epub ahead of print].

Full text of this article.

Aortic stenosis (AS) and regurgitation (AR) may be treated with surgical aortic valve replacement (SAVR), transcatheter AVR (TAVR), or medical therapy (MT). Data are lacking regarding the usage of SAVR, TAVR, and MT for patients hospitalized with aortic valve disease and the characteristics of the patients and hospitals associated with each therapy. From the Nationwide Readmissions Database, we determined utilization trends for SAVR, TAVR, and MT in patients with aortic valve disease admitted from 2012 to 2016 for valve replacement, heart failure, unstable angina, non-ST-elevation myocardial infarction, or syncope. We also performed multinomial logistic regressions to investigate associations between patient and hospital characteristics and treatment. Among 366,909 patients hospitalized for aortic valve disease, there was a 48.1% annual increase from 2012 through 2016. Overall, 19.9%, 6.7%, and 73.4% of patients received SAVR, TAVR, and MT, respectively. SAVR decreased from 21.9% in 2012 to 18.5% in 2016, whereas TAVR increased from 2.6% to 12.5%, and MT decreased from 75.5% to 69.0%. Older age, female sex, greater severity of illness, more admission diagnoses, not-for-profit hospitals, large hospitals, and urban teaching hospitals were associated with greater use of TAVR. In multivariable analysis, likelihood of TAVR relative to SAVR increased 4.57-fold (95% confidence interval 4.21 to 4.97). TAVR has increased at the expense of both SAVR and MT, a novel finding. However, this increase in TAVR was distributed inequitably, with certain patients more likely to receive TAVR certain hospitals more likely to provide TAVR. With the expected expansion of indications, inequitable access to TAVR must be addressed.