Research Spotlight

Makkar, R. R., S. H. Yoon, T. Chakravarty, S. R. Kapadia, A. Krishnaswamy, P. B. Shah, T. Kaneko, E. R. Skipper, M. Rinaldi, V. Babaliaros, S. Vemulapalli, A. Trento, W. Cheng, S. Kodali, M. J. Mack, M. B. Leon and V. H. Thourani (2021). “Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke Among Patients at Low Surgical Risk.” Jama 326(11): 1034-1044.

Full text of this article.

IMPORTANCE: There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. OBJECTIVE: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. DESIGN, SETTING, AND PARTICIPANTS: Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. EXPOSURES: TAVR for bicuspid vs tricuspid aortic stenosis. MAIN OUTCOMES AND MEASURES: Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. RESULTS: Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). CONCLUSIONS AND RELEVANCE: In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

Garcia, S., R. J. Cubeddu, R. T. Hahn, J. Ternacle, S. R. Kapadia, S. K. Kodali, V. H. Thourani, W. A. Jaber, C. R. Asher, S. Elmariah, R. Makkar, J. G. Webb, H. C. Herrmann, M. Lu, C. M. Devireddy, S. C. Malaisrie, C. R. Smith, M. J. Mack, P. Sorajja, J. L. Cavalcante, M. Goessl, G. R. Shroff, M. B. Leon and P. Pibarot (2021). “5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease.” JACC Cardiovasc Interv 14(18): 1995-2005.

Full text of this article.

OBJECTIVES: The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). BACKGROUND: Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. METHODS: Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m(2)) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory-adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed. RESULTS: The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. CONCLUSIONS: In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

Tremblay, G., P. Daniele, J. Breeze, L. Li, J. Shah, S. Shacham, M. Kauffman, M. Engelhardt, A. Chari, A. Nooka, D. Vogl, M. Gavriatopoulou, M. A. Dimopoulos, P. Richardson, N. Biran, D. Siegel, P. Vlummens, C. Doyen, T. Facon, M. Mohty, N. Meuleman, M. Levy, L. Costa, J. E. Hoffman, M. Delforge, D. Kaminetzky, K. Weisel, M. Raab, D. Dingli, S. Tuchman, F. Laurent, R. Vij, G. Schiller, P. Moreau, J. Richter, M. Schreder, K. Podar, T. Parker, R. F. Cornell, K. Lionel, S. Choquet and J. Sundar (2021). “Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study.” BMC Cancer 21(1): 993.

Full text of this article.

BACKGROUND: Selinexor is an oral, selective nuclear export inhibitor. STORM was a phase 2b, single-arm, open-label, multicenter trial of selinexor with low dose dexamethasone in patients with penta-exposed relapsed/refractory multiple myeloma (RRMM) that met its primary endpoint, with overall response of 26% (95% confidence interval [CI], 19 to 35%). Health-related quality of life (HRQoL) was a secondary endpoint measured using the Functional Assessment of Cancer Therapy – Multiple Myeloma (FACT-MM). This study examines impact of selinexor treatment on HRQoL of patients treated in STORM and reports two approaches to calculate minimal clinically important differences for the FACT-MM. METHODS: FACT-MM data were collected at baseline, on day 1 of each 4-week treatment cycle, and at end of treatment (EOT). Changes from baseline were analyzed for the FACT-MM total score, FACT-trial outcome index (TOI), FACT-General (FACT-G), and the MM-specific domain using mixed-effects regression models. Two approaches for evaluating minimal clinically important differences were explored: the first defined as 10% of the instrument range, and the second based on estimated mean baseline differences between Eastern Cooperative Oncology Group performance status (ECOG PS) scores. Post-hoc difference analysis compared change in scores from baseline to EOT for treatment responders and non-responders. RESULTS: Eighty patients were included in the analysis; the mean number of prior therapies was 7.9 (standard deviation [SD] 3.1), and mean duration of myeloma was 7.6 years (SD 3.4). Each exploratory minimal clinically important difference threshold yielded consistent results whereby most patients did not experience HRQoL decline during the first six cycles of treatment (range: 53.9 to 75.7% for the first approach; range: 52.6 to 72.9% for the second). Treatment responders experienced less decline in HRQoL from baseline to EOT than non-responders, which was significant for the FACT-G, but not for other scores. CONCLUSION: The majority of patients did not experience decline in HRQoL based on minimal clinically important differences during early cycles of treatment with selinexor and dexamethasone in the STORM trial. An anchor-based approach utilizing patient-level data (ECOG PS score) to define minimal clinically important differences for the FACT-MM gave consistent results with a distribution-based approach. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov under the trial-ID NCT02336815 on January 8, 2015.

Ghodsizad, A., A. Gant, M. M. Koerner and M. Loebe (2021). “Venovenous ECMO application as bridge to recovery or lung transplantation; ongoing challenge as we look at a pre- and post-COVID-19 era.” J Card Surg 36(10): 3747-3748.

Full text of this article.

Since the coronavirus outbreak (coronavirus SARS‐CoV‐2/Wuhan, China 2019) there have been millions of confirmed cases and deaths worldwide. If we look at new infection and vaccination rates as competing factors, clearly there is an ongoing race between the number of vaccinated individuals and the ability of the virus undergoing new mutations. New virus variants—first described by the geographic location variant found at including “Delta (+),” have again challenged several eastern and middle eastern countries. Observing the current situation in the Middle East the importance of vaccination choice and timing clearly becomes visible.[No abstract; excerpt from article].

Kent, M. S., M. G. Hartwig, E. Vallières, A. E. Abbas, R. J. Cerfolio, M. R. Dylewski, T. Fabian, L. J. Herrera, K. G. Jett, R. S. Lazzaro, B. Meyers, B. A. Mitzman, R. M. Reddy, M. F. Reed, D. C. Rice, P. Ross, I. S. Sarkaria, L. Y. Schumacher, W. B. Tisol, D. A. Wigle and M. Zervos (2021). “Pulmonary Open, Robotic and Thoracoscopic Lobectomy (PORTaL) Study: An Analysis of 5,721 Cases.” Ann Surg.

Full text of this article.

OBJECTIVE: The aim of this study was to analyze outcomes of open lobectomy (OL), video-assisted thoracoscopic lobectomy (VATS) and robotic-assisted lobectomy (RL). SUMMARY BACKGROUND DATA: Robotic-assisted lobectomy has seen increasing adoption for treatment of early-stage lung cancer. Comparative data regarding these approaches is largely from single-institution case series or administrative datasets. METHODS: Retrospective data was collected from 21 institutions from 2013-2019. All consecutive cases performed for clinical stage IA-IIIA lung cancer were included. Neoadjuvant cases were excluded. Propensity-score matching (1:1) was based on age, gender, race, smoking-status, FEV1%, Zubrod score, ASA score, tumor size and clinical T and N stage. RESULTS: A total of 2,391 RL, 2,174 VATS, and 1,156 OL cases were included. After propensity-score matching there were 885 pairs of RL vs. OL, 1,711 pairs of RL vs. VATS, and 952 pairs of VATS vs. OL. Operative time for RL was shorter than VATS (p < 0.0001) and OL (p = 0.0004). Compared to OL, RL and VATS had less overall postoperative complications, shorter hospital stay (LOS), and lower transfusion rates (all p < 0.02). Compared to VATS, RL had lower conversion rate (p < 0.0001), shorter hospital stay (p < 0.0001) and a lower postoperative transfusion rate (p = 0.01). RL and VATS cohorts had comparable postoperative complication rates. In-hospital mortality was comparable between all groups. CONCLUSIONS: RL and VATS approaches were associated with favorable perioperative outcomes compared to OL. Robotic-assisted lobectomy was also associated with a reduced length of stay and decreased conversion rate when compared to VATS.