William H. Ryan M.D.

Posted February 15th 2020

Misclassification of Mitral Valve Disease and Rate of Surgical Repair in the STS Database.

Mohanad Hamandi, M.D.
Mohanad Hamandi, M.D.

Hamandi, M., W. H. Ryan, P. A. Grayburn, E. Huff, L. Mallari and M. J. Mack (2020). “Misclassification of Mitral Valve Disease and Rate of Surgical Repair in the STS Database.” Ann Thorac Surg Jan 18. [Epub ahead of print].

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BACKGROUND: Surgical repair of primary mitral regurgitation (MR) is considered an indicator of quality performance. Therefore, accurate data reporting is critical for quality assessment. During an institutional quality review, MR etiology could not be determined in 40% of operations in our Society of Thoracic Surgeons (STS) database entries and thus our true repair rate could not be reliably ascertained. Therefore, we reviewed all source documents and echocardiograms to assess our true disease etiology and repair rate. METHODS: Sourse records and echocardiograms of all operations performed in a single healthcare system for a one-year period were reviewed by an experienced MV surgeon, an echocardiographic core lab and a data manager. Disease etiology and operation were compared to data previously entered in the database by post hoc chart abstraction. RESULTS: 314 isolated MV operations were performed. MR was originally classified as primary- 163 (52%), secondary- 22 (7%), rheumatic- 37 (12%), endocarditis- 24 (8%), other- 33 (10%), and unknown- 35 (11%). Reported repair rate for primary MR was 142/163 (87.1%). After review, etiology was determined to be primary- 177 (56%), secondary-33 (11%), rheumatic- 61 (20%), endocarditis- 25 (8%), and others- 18 (5%) resulting in a change of classification in 99/314 (31.5%) patients and a true repair rate for primary MR of 165/177 (93.2%). CONCLUSIONS: Source document and imaging review of MV surgery revealed significant discordance with post hoc chart abstraction methods. A more detailed data entry methodology is necessary to accurately report the true disease etiology and repair rates for primary MR.


Posted July 15th 2019

Outcomes of Isolated Tricuspid Valve Surgery Have Improved in the Modern Era.

Michael J. Mack M.D.

Michael J. Mack M.D.

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.

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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.


Posted April 15th 2019

Outcomes of Isolated Tricuspid Valve Surgery Have Improved in the Modern Era.

Michael J. Mack M.D.

Michael J. Mack M.D.

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 Apr 2. [Epub ahead of print].

Full text of this article.

BACKGROUND: Surgery for isolated tricuspid valve (TV) disease remains relatively infrequent due to significant patient comorbidities and poor surgical outcomes. We reviewed our experience with isolated TV surgery in the current era to determine if outcomes have improved. METHODS: From 2007 through 2017, 685 TV operations were performed in a single institution of which 95 (13.9%) were isolated TV surgery. Patients were analyzed for disease etiology, risk factors, operative mortality and morbidity and long term survival. RESULTS: 95 patients underwent isolated TV surgery, an average of 9 patients/year increasing from an average of 5/year to 15/year during the study period. Surgery was reoperative in 41% (38/95), including 11.6% (11/95) with prior CABG and 29.4% (28/95) with prior valve surgery (9 tricuspid, 11 mitral, 2 aortic, 5 mitral/aortic and 1 mitral/tricuspid).Repair was performed in 71.6% (68/95) and replacement in 28.4% (27/95). Operative mortality was 3.2% (3/95) with no mortality in the most recent 73 patients over the last 6 years. Stroke occurred in 2.1% (2/95), acute kidney injury requiring dialysis in 5.3% (5/95) and need for new permanent pacemaker in 16.8% (16/95). 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 tricuspid valve intervention outcomes.


Posted July 15th 2017

The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue.

William Ryan M.D.

William Ryan M.D.

Puskas, J. D., J. E. Bavaria, L. G. Svensson, E. H. Blackstone, B. Griffith, J. S. Gammie, D. A. Heimansohn, J. Sadowski, K. Bartus, D. R. Johnston, J. Rozanski, T. Rosengart, L. N. Girardi, C. T. Klodell, M. A. Mumtaz, H. Takayama, M. Halkos, V. Starnes, P. Boateng, T. A. Timek, W. Ryan, S. Omer and C. R. Smith (2017). “The commence trial: 2-year outcomes with an aortic bioprosthesis with resilia tissuedagger.” Eur J Cardiothorac Surg: 2017 Jun [Epub ahead of print].

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OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve with RESILIA tissue (Model 11000A) in a prospective, multinational, multicentre ( n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. RESULTS: Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 +/- 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 +/- 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 +/- 0.5 cm 2 ; mean gradient was 10.1 +/- 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. CONCLUSIONS: These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA).


Posted February 15th 2017

TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve.

Michael J. Mack M.D.

Michael J. Mack M.D.

Arsalan, M., J. J. Squiers, M. A. Herbert, J. C. MacHannaford, T. Chamogeorgakis, S. L. Prince, B. L. Hamman, C. Knoff, D. O. Moore, K. B. Harrington, J. M. DiMaio, M. J. Mack and W. T. Brinkman (2017). “Comparison of outcomes of operative therapy for acute type a aortic dissections provided at high-volume versus low-volume medical centers in north texas.” Am J Cardiol 119(2): 323-327.

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Immediate surgery is standard therapy for acute type A aortic dissections (TAAD). Because of its low incidence, many smaller cardiac surgery programs do not routinely perform this procedure because it may negatively affect outcomes. Many high-risk, low-volume (LV) surgical procedures are now preferentially performed in reference centers. We compared the outcomes of surgery for TAAD in high-volume (HV) and LV centers in a single metropolitan area to determine the optimal setting for treatment. Thirty-five of the 37 cardiac surgery programs in the Dallas Ft. Worth metropolitan area participate in a regional consortium to measure outcomes collected in the Society of Thoracic Surgeons Adult Cardiac Database. From January 01, 2008, to December 31, 2014, 29 programs had treated TAAD. Those programs performing at least 100 operations for TAAD were considered HV centers and the others LV. Surgery for TAAD was performed in 672 patients over the 7-year study period with HV centers performing 469 of 672 (70%) of the operations. Despite similar preoperative characteristics, operative mortality was significantly lower in HV versus LV centers (14.1% vs 24.1%; p = 0.001). There was no significant difference in postoperative paralysis rates (2.6% vs 4.5%; p = 0.196), stroke rates (10.7% vs 9.4%; p = 0.623), or 30-day readmission rates (12.1% vs 15.5%; p = 0.292). An improved survival rate in HV centers was maintained over a 5-year follow-up period. Surgery for TAAD in a single large metropolitan area was most commonly performed in HV centers. In conclusion, the treatment of acute thoracic aortic dissection is recommended to be performed in reference centers because of lower early and midterm mortality.