Michael J. Mack M.D.

Thourani, V. H., J. Forcillo, W. Y. Szeto, S. K. Kodali, E. H. Blackstone, A. M. Lowry, M. Semple, J. Rajeswaran, R. R. Makkar, M. R. Williams, J. E. Bavaria, H. C. Herrmann, H. S. Maniar, V. C. Babaliaros, C. R. Smith, A. Trento, P. J. Corso, A. D. Pichard, D. C. Miller, L. G. Svensson, S. Kapadia, G. Ailawadi, R. M. Suri, K. L. Greason, R. T. Hahn, W. A. Jaber, M. C. Alu, M. B. Leon and M. J. Mack (2018). “Outcomes in 937 Intermediate-Risk Patients Undergoing Surgical Aortic Valve Replacement in PARTNER-2A.” Ann Thorac Surg 105(5): 1322-1329.

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BACKGROUND: The Placement of Aortic Transcatheter Valves 2A (PARTNER-2A) randomized trial compared outcomes of transfemoral transcatheter and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpose of the present study was to perform an in-depth analysis of outcomes after SAVR in the PARTNER-2A trial. METHODS: From January 2012 to January 2014, 937 patients underwent SAVR at 57 centers. Mean age was 82 +/- 6.7 years and 55% were men. Less-invasive operations were performed in 140 patients (15%) and concomitant procedures in 198 patients (21%). Major outcomes and echocardiograms were adjudicated by an independent events committee. Follow-up was 94% complete to 2 years. RESULTS: Operative mortality was 4.1% (n = 38, Society of Thoracic Surgeons predicted risk of mortality: 5.2% +/- 2.3%), observed to expected ratio (O/E) was 0.8, and in-hospital stroke was 5.4% (n = 51), twice expected. Aortic clamp and bypass times were 75 +/- 30 minutes and 104 +/- 46 minutes, respectively. Patients having severe prosthesis-patient mismatch (n = 260, 33%) had similar survival to patients without (p > 0.9), as did patients undergoing less-invasive SAVR (p = 0.3). Risk factors for death included cachexia (p = 0.004), tricuspid regurgitation (p = 0.01), coronary artery disease (p = 0.02), preoperative atrial fibrillation (p = 0.001), higher white blood cell count (p < 0.0001), and lower hemoglobin (p = 0.0002). CONCLUSIONS: In this adjudicated prospective study, SAVR in intermediate-risk patients had excellent results at 2 years. However, there were more in-hospital strokes than expected, most likely attributable to mandatory neurologic assessment after the procedure. No pronounced structural valve deterioration was found during 2-year follow-up. Continued long-term surveillance remains important.

Mack, M. and M. Hamandi (2018). “Is it time for national systems of care for valvular heart disease?” EuroIntervention 13(18): e2109-e2111.

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There are new proposals posited in both Europe and the USA to create “systems of care” for diagnosing, managing and treating valve disease patients. The operating principle of both is to provide the right treatment, to the right patient, at the right time, while taking into account the patient’s wishes. Although this system of care concept is a relatively recent one for the management of patients with valvular heart disease, it is not a new concept in healthcare for the treatment of other diseases. Numerous examples exist in the USA that serve as precedent for a valve disease system of care. Starting in 1960, the National Cancer Institute in the USA created a highly successful nationwide three-tiered system for cancer care2. The American College of Surgeons in 1976 built a universally adopted four-tiered system of trauma centres. Likewise, national systems of care have been built for acute stroke management (Brain Attach Coalition), treatment of acute myocardial infarction (ACC/AHA door-to-balloon time programme) and bariatric surgery centres for patients with obesity. Building on the experience and lessons learned from the national programmes for management of these conditions, national systems of care for patients with valvular heart disease are being proposed in both Europe and the USA. A pilot programme for TAVI exists that gives some insight into how a system of care could work. In the Canadian province of British Columbia, a province-wide programmatic approach has been undertaken. There are four programmes performing TAVI in the province. They are linked together in a network in which three “primary valve centres” perform transfemoral TAVI while more complex patients with extensive comorbidities and/or needing alternative access approaches or valve-in-valve procedures are referred to a single advanced tertiary valve centre in Vancouver. Open lines of communication, readily available consultation and mentoring are maintained within the network. With TAVI, in which there is evidence for a “volume-outcome” relationship, they seem to have struck the right balance between maintaining optimal care while providing broad geographic patient access. So, can this concept of a valve network system of care be scaled to a national level? (Excerpt from text, p. e2110; no abstract available.)

Jabbour, R. J., A. Tanaka, A. Finkelstein, M. Mack, C. Tamburino, N. Van Mieghem, O. de Backer, L. Testa, P. Gatto, P. Purita, Z. Rahhab, V. Veulemans, A. Stundl, M. Barbanti, R. Nerla, J. M. Sinning, D. Dvir, G. Tarantini, M. Szerlip, W. Scholtz, S. Scholtz, D. Tchetche, F. Castriota, C. Butter, L. Sondergaard, M. Abdel-Wahab, H. Sievert, O. Alfieri, J. Webb, J. Rodes-Cabau, A. Colombo and A. Latib (2018). “Delayed Coronary Obstruction After Transcatheter Aortic Valve Replacement.” J Am Coll Cardiol 71(14): 1513-1524.

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BACKGROUND: Delayed coronary obstruction (DCO) is an uncommon and barely reported complication following transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to describe the incidence and pathophysiological features of DCO after TAVR, obtained from a large international multicenter registry. METHODS: Data were retrospectively collected from an international multicenter registry consisting of 18 centers between November 2005 and December 2016. RESULTS: During the study period, 38 DCO (incidence 0.22%) cases were identified from a total of 17,092 TAVR procedures. DCO occurred more commonly after valve-in-valve procedures (0.89% vs. 0.18%; p < 0.001) and if self-expandable valves were used during the index procedure (0.36% vs. 0.11% balloon expandable; p < 0.01). DCO was most likely to occur /=60 days. The most frequent presentation was cardiac arrest (31.6%; n = 12), followed by ST-segment elevation myocardial infarction (23.7%; n = 9). The left coronary artery was obstructed in most cases (92.1%; n = 35). Percutaneous coronary intervention was attempted in the majority of cases (74.3% left main; 60% right coronary), and stent implantation was successful in 68.8%. The overall in-hospital death rate was 50% (n = 19), and was higher if DCO occurred

Szerlip, M., S. Gualano, E. Holper, J. J. Squiers, J. M. White, D. Doshi, M. R. Williams, R. T. Hahn, J. G. Webb, L. G. Svensson, A. J. Kirtane, D. J. Cohen, P. S. Douglas, M. C. Alu, A. Crowley, E. M. Tuzcu, R. R. Makkar, H. C. Herrmann, V. Babaliaros, V. H. Thourani, M. B. Leon, S. K. Kodali and M. J. Mack (2018). “Sex-Specific Outcomes of Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve: Insights From the PARTNER II S3 High-Risk and Intermediate-Risk Cohorts.” JACC Cardiovasc Interv 11(1): 13-20.

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OBJECTIVES: The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. RESULTS: Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive

Dvir, D., T. Bourguignon, C. M. Otto, R. T. Hahn, R. Rosenhek, J. G. Webb, H. Treede, M. E. Sarano, T. Feldman, H. C. Wijeysundera, Y. Topilsky, M. Aupart, M. J. Reardon, G. B. Mackensen, W. Y. Szeto, R. Kornowski, J. S. Gammie, A. P. Yoganathan, Y. Arbel, M. A. Borger, M. Simonato, M. Reisman, R. R. Makkar, A. Abizaid, J. M. McCabe, G. Dahle, G. S. Aldea, J. Leipsic, P. Pibarot, N. E. Moat, M. J. Mack, A. P. Kappetein and M. B. Leon (2018). “Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves.” Circulation 137(4): 388-399.

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Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.