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Journal and News Scan

Source: Journal of the American College of Cardiology
Author(s): Suzanne V. Arnold, Rebecca T. Hahn, Vinod H. Thourani, Raj Makkar, Moody Makar, Rahul P. Sharma, Christiane Haeffele, Charles J. Davidson, Akhil Narang, Brian O’Neill, James Lee, Pradeep Yadav, Firas Zahr, Scott Chadderdon, Mackram Eleid, Sorin Pislaru, Robert Smith, Molly Szerlip, Brian Whisenant, Nishant Sekaran, Santiago Garcia, Terri Stewart-Dehner, Paul A. Grayburn, Anna Sannino, Clayton Snyder, Yiran Zhang, Michael J. Mack, Martin B. Leon, Philipp Lurz, Susheel Kodali, David J. Cohen

In this study, the authors conducted an in-depth analysis of the health status of patients enrolled in the TRISCEND II pivotal trial (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device) to help quantify the benefit of intervention for these patients. The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater tricuspid regurgitation (TR) to transcatheter tricuspid valve replacement (TTVR) with the EVOQUE tricuspid valve plus optimal medical therapy (OMT), or OMT alone. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-OS) and the 36-Item Short Form Health Survey. Changes in health status in the span of one year were compared between treatment groups using mixed-effects repeated-measures models. The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 plus or minus 7.6 years, 75.5 percent women, 56.1 percent with massive or torrential TR). Patients had substantially impaired health status at baseline (mean KCCQ-OS 52.1 plus or minus 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 plus or minus 8.4). TTVR plus OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up point. Mean between group differences in the KCCQ-OS favored TTVR plus OMT at each point: 11.8 points (95 percent CI: 7.4-16.3 points) at 30 days, 20.8 points (95 percent CI: 16.1-25.5 points) at six months, and 17.8 points (95 percent CI: 13.0-22.5 points) at one year. Furthermore, TTVR plus OMT improved health status to a greater extent among patients with torrential or massive TR compared to those with severe TR (treatment effect 23.3 versus 22.6 versus 11.3; interaction P = 0.049). At one year, 64.6 percent of TTVR plus OMT patients were alive and well (KCCQ-OS greater than or equal to 60 points and no decline of greater than or equal to 10 points from baseline) compared with 31.0 percent in the OMT-only group. In conclusion, compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR plus OMT resulted in substantial improvement in patients’ symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through six months, and remained durable through one year. 

Source: Clinical Lung Cancer
Author(s): Marcus Taylor, Glen P. Martin, Udo Abah, Michael Shackcloth, Felice Granato, Richard Booton, Aman Coonar, Stuart W. Grant

This study examines the external validation of the RESECT-90 model, designed to predict 90-day mortality in lung resection patients. Analyzing data from 12,241 patients across 12 UK centers, the study found an overall 90-day mortality rate of 2.9 percent. After recalibrating the model to address calibration heterogeneity, the model demonstrated an area under the curve (AUC) of 0.74, indicating acceptable discrimination, while calibration metrics improved significantly. 
 
This validation is important for the cardiothoracic surgery specialty, as it confirms the RESECT-90 model's utility in clinical practice and enhances risk assessment for lung resection patients. The findings support the adoption of reliable prediction models that can aid in clinical decision-making, ultimately improving patient outcomes and surgical planning in thoracic surgery. 

Source: New England Journal of Medicine
Author(s): Rebecca T. Hahn, Raj Makkar, Vinod H. Thourani, Moody Makar, Rahul P. Sharma, Christiane Haeffele, Charles J. Davidson, Akhil Narang, Brian O’Neill, James Lee, Pradeep Yadav, Firas Zahr, Scott Chadderdon, Mackram Eleid, Sorin Pislaru, Robert Smith, Molly Szerlip, Brian Whisenant, Nishant K. Sekaran, Santiago Garcia, Terri Stewart-Dehner, Holger Thiele, Robert Kipperman, Konstantinos Koulogiannis, D. Scott Lim, Dale Fowler, Samir Kapadia, Serge C. Harb, Paul A. Grayburn, Anna Sannino, Michael J. Mack, Martin B. Leon, Philipp Lurz, Susheel K. Kodali

In the TRISCEND II trial, a total of 400 patients with severe symptomatic tricuspid regurgitation were randomized in a 2:1 ratio to undergo either transcatheter tricuspid valve replacement with medical therapy (valve-replacement group) or medical therapy alone (control group). A total of 267 patients were assigned to the valve replacement group and 133 to the control group. At one-year, tricuspid valve replacement and medical therapy were superior to medical therapy alone, with a win ratio of 2.02 (95 percent confidence interval [CI], 1.56 to 2.62; P<0.001). This was based on a hierarchical composite primary outcome that included death from any cause, implantation of a right ventricular assist device or heart transplantation, post-index tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score, an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 meters on the six-minute walk distance. Patients in the valve replacement group had more wins than the control group with respect to death from any cause (14.8 percent versus 12.5 percent), post-index tricuspid-valve intervention (3.2 percent versus 0.6 percent), and improvements in the KCCQ-OS score (23.1 percent versus 6.0 percent), NYHA class (10.2 percent versus 0.8 percent), and six-minute walk distance (1.1 percent versus 0.9 percent).  

However, the valve replacement group had fewer wins than the control group regarding the annual heart failure hospitalization rate (9.7 percent versus 10.0 percent). Furthermore, severe bleeding occurred in 15.4 percent of the valve replacement group and 5.3 percent of the control group (P=0.003), and new permanent pacemaker implantation was required in 17.4 percent and 2.3 percent, respectively (P<0.001).  

These findings suggest that transcatheter tricuspid valve replacement combined with medical therapy is superior to medical therapy alone in patients with severe tricuspid regurgitation, particular in terms of the primary hierarchical composite outcome, which was primarily driven by improvements in symptoms and quality of life. 

Source: The Annals of Thoracic Surgery
Author(s): Joseph E. Bavaria, Mubashir A. Mumtaz, Bartley Griffith, Lars G. Svensson, Philippe Pibarot, Michael A. Borger, Vinod H. Thourani, Eugene H. Blackstone, John D. Puskas

This article examines the results of the COMMENCE trial, which evaluated the safety and effectiveness of surgical aortic valve replacement using RESILIA tissue valves during a five-year period in patients with native bicuspid aortic valves, comparing outcomes with those of patients with tricuspid aortic valves. 
 
Of the 689 patients in the COMMENCE trial, 645 had documented valve morphology and evaluable echocardiograms. A total of 214 patients had bicuspid aortic valves, while 458 had tricuspid valves. Notably, the bicuspid cohort was significantly younger, with an average age of 59.8 years compared to 70.2 years for the tricuspid cohort (P < .001). 
 
The results showed no structural valve deterioration in the bicuspid aortic valve group during the five years, along with low rates of paravalvular leak (0.7 percent) and transvalvular regurgitation (2.9 percent), all classified as mild. These findings were comparable to those observed in the tricuspid valve group. Additionally, linear mixed-effects models indicated that the estimated postoperative mean gradient and effective orifice area, and their changes over time, did not differ significantly between the two patient groups after adjusting for age, body surface area, and bioprosthesis size. 
 
In conclusion, RESILIA tissue valves demonstrated excellent durability and safety in patients with bicuspid aortic valves during the five-year follow-up period. The absence of structural valve deterioration and minimal rates of regurgitation are particularly promising, suggesting that RESILIA tissue could be a viable option for younger patients requiring aortic valve replacement. 

Source: The Annals of Thoracic Surgery
Author(s): Samuel S. Kim, David T. Cooke, Biniam Kidane, Luis F. Tapias, John F. Lazar, Jeremiah W. Awori Hayanga, Jyoti D. Patel, Joel W. Neal, Mohamed E. Abazeed, Henning Willers, Joseph B. Shrager

This article provides a consensus-based approach for determining the resectability and optimal management strategies for locally advanced non-small cell lung cancer (NSCLC). The expert panel recommends evaluating resectability through multidisciplinary tumor board (MDT) discussions, with a focus on up-front decisions based on patient operability and tumor biology. It supports neoadjuvant chemoimmunotherapy over adjuvant options for most operable patients without driver mutations, highlighting the increased survival benefits. The guidelines also advise caution with post-induction surgery in patients with extensive or bulky N2 disease, favoring non-surgical treatments unless a multidisciplinary review deems surgery feasible. 
 
This consensus provides evidence-based strategies that integrate modern immunotherapies with surgical options to improve patient outcomes in NSCLC treatment. 

Source: European Journal of Cardio-Thoracic Surgery
Author(s): Lukadi Joseph Lula, Rita Costa, Amr Rushwan, Clara Forcada Barreda, Matic Domjan, Beatrice Trabalza Marinucci, Crt Jasovic, Emrah Gökay Özgür, Cornel Savu, Erino Angelo Rendina, Nural Bekiroglu, Pedro Fernandes, Marcelo Jimenez, Tomaz Stupnik, Antonio D’Andrilli, Emmanuel Martinod, Alessandro Brunelli

This article assesses the outcomes of segmentectomy versus lobectomy in treating peripheral, early-stage lung adenocarcinoma. In a multicenter study involving 674 patients, the authors compared overall survival (OS), lung cancer-specific survival (LCSS), and disease-free survival (DFS) between the two groups. Five-year survival rates were comparable between patients undergoing segmentectomy and those receiving lobectomy, even for cases with aggressive adenocarcinoma patterns (e.g., solid or micropapillary). Segmentectomy did not emerge as an independent risk factor for worse outcomes, and no significant difference in locoregional recurrence was found. 
 
This study is significant to the field of cardiothoracic surgery as it supports segmentectomy as a viable, less invasive alternative to lobectomy for specific patients, aligning with trends toward personalized surgical approaches.  

Source: JAMA Network
Author(s): Krithika Loganath, Neil J. Craig, Russell J. Everett, Rong Bing, Vasiliki Tsampasian, Patrycja Molek, Simona Botezatu, Saadia Aslam, Steff Lewis, Catriona Graham, Audrey C. White, Tom MacGillivray, Christopher E. Tuck, Phillip Rayson, Denise Cranley, Sian Irvine, Ruth Armstrong, Lynsey Milne, Calvin W. L. Chin, Graham S. Hillis, Timothy Fairbairn, John P. Greenwood, Richard Steeds, Stephen J. Leslie, Chim C. Lang, Chiara Bucciarelli-Ducci, Nikhil V. Joshi, Vijay Kunadian, Vassilios S. Vassiliou, Jason N. Dungu, Sandeep S. Hothi, Nicholas Boon, Sanjay K. Prasad, Niall G. Keenan, Dana Dawson, Thomas A. Treibel, Mani Motwani, Christopher A. Miller, Nicholas L. Mills, Ronak Rajani, David P. Ripley, Gerry P. McCann, Bernard Prendergast, Anvesha Singh, David E. Newby, Marc R. Dweck

Development of myocardial fibrosis in patients with aortic stenosis precedes left ventricular decompensation and is associated with an adverse long-term prognosis. This study aimed to investigate whether early valve intervention reduces the incidence of all-cause death or unplanned aortic stenosis-related hospitalization in asymptomatic patients with severe aortic stenosis and myocardial fibrosis. In this trial, asymptomatic patients with severe aortic stenosis and myocardial fibrosis were randomized to undergo early valve intervention with either transcatheter or surgical aortic valve replacement or guideline-directed conservative management. The primary outcome was a composite of all-cause death or unplanned aortic stenosis-related hospitalization in a time-to-first-event intention-to-treat analysis. The trial enrolled 224 eligible patients (mean age, 73 years; 63 women [28 percent]), a subset of the originally planned 356 patients. Surgical aortic valve replacement was performed in 80 patients (75 percent), and transcatheter aortic valve intervention in 26 patients (25 percent). The primary end point occurred in 20 of 113 patients (18 percent) in the early intervention group and 25 of 111 patients (23 percent) in the guideline-directed conservative management group (hazard ratio, 0.79 [95 percent CI, 0.44-1.43]; P = 0.44; between-group difference, -4.82 percent [95 percent CI, -15.31 percent to 5.66 percent]). All-cause death occurred in 16 of 113 patients (14 percent) in the early intervention group and 14 of 111 (13 percent) in the guideline-directed group (hazard ratio, 1.22 [95 percent CI, 0.59-2.51]). Unplanned aortic stenosis-related hospitalization occurred in 7 of 113 patients (6 percent) in the early intervention group and 19 of 111 patients (17 percent) in the guideline-directed group, respectively (hazard ratio, 0.37 [95 percent CI, 0.16-0.88]). The authors concluded that in asymptomatic patients with severe aortic stenosis and myocardial fibrosis, early aortic valve intervention had no demonstrable effect on all-cause death or unplanned aortic stenosis-related hospitalization. 

Source: World Journal for Pediatric and Congenital Heart Surgery
Author(s): Justin Smith, Jeffrey D. Zampi, Sowmya Balasubramanian, Bryan Mosher, Karen Uzark, Ray Lowery, Sunkyung Yu, Jennifer C. Romano

This study explores the use of Hybrid Stage 1 Palliation (HS1P) in patients with congenital heart disease (CHD), particularly in those with single ventricle (SV) and biventricular (BiV) conditions. The researchers conducted a retrospective analysis of 39 patients who underwent HS1P, either with an expected BiV repair or an undetermined outcome. The results show that 68 percent of patients with anticipated BiV repair eventually underwent successful BiV repair, while 26 percent died before further intervention. Among patients with undetermined outcomes, 65 percent underwent BiV repair, and 30 percent had SV palliation. The study found that resolution of intracardiac risk factors (ICRF) was strongly linked to BiV repair success, while persistent ICRF correlated with SV palliation or death. Post-surgery complications and reinterventions were common, highlighting the high-risk nature of these patients. The study concludes that HS1P can be used to delay the decision between BiV repair and SV palliation, but mortality remains high, particularly for patients with marginal BiV potential. 

Source: Journal of the American College of Cardiology
Author(s): Nicolas M. Van Mieghem, Sammy Elmariah, Ernest Spitzer, Philippe Pibarot, Tamim M. Nazif, Jeroen J. Bax, Rebecca T. Hahn, Alexandra Popma, Ori Ben-Yehuda, Faouzi Kallel, Björn Redfors, Michael L. Chuang, Maria C. Alu, Wietze Lindeboom, Dhaval Kolte, Firas E. Zahr, Susheel K. Kodali, Justin A. Strote, Renicus S. Hermanides, David J. Cohen, Jan G.P. Tijssen, Martin B. Leon

Neurohormonal modulation and afterload reduction are essential for treating heart failure with reduced ejection fraction (HFrEF). In HFrEF patients with concomitant moderate aortic stenosis (AS), therapy with transcatheter aortic valve replacement (TAVR) may be complementary to guideline-directed medical therapy (GDMT). In this study, the authors sought to determine whether TAVR for moderate AS provides clinical benefits to patients with HFrEF in addition to GDMT.  

Patients were randomized to either TAVR or clinical surveillance with aortic valve replacement upon progression to severe AS. The primary end point was the hierarchical occurrence of: 1) all-cause death, 2) disabling stroke, 3) disease-related hospitalizations and heart failure equivalents, and 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score analyzed using the win ratio. A total of 178 patients were randomized to TAVR (n = 89) or clinical surveillance (n = 89). The mean age was 77 years, 20.8 percent were female, and 55.6 percent were in NYHA functional class III or IV. The median follow-up duration was 23 months (Q1-Q3: 12-33 months).  

A total of 38 (43 percent) patients in the clinical surveillance group (of whom 35 had progressed to severe AS) underwent TAVR at a median of 12 months post randomization. TAVR was associated with wins in 47.6 percent of pairs, compared with 36.6 percent in the clinical surveillance group, resulting in a win ratio of 1.31 (95 percent CI: 0.91-1.88; P = 0.14). At one year, TAVR significantly improved the Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared with the clinical surveillance group (12.8 ± 21.9 points versus 3.2 ± 22.8 points; P = 0.018). The authors concluded that TAVR was not superior to AS clinical surveillance for the primary hierarchical composite end point in patients with moderate AS and HFrEF on GDMT. 

Source: The Journal of Thoracic and Cardiovascular Surgery
Author(s): Sarah Yousef, Derek Serna-Gallegos, Nidhi Iyanna, Dustin Kliner, James A. Brown, Catalin Toma, Amber Makani, David West, Yisi Wang, Floyd W. Thoma, Danial Ahmad, Pyongsoo Yoon, Danny Chu, David Kaczorowski, Johannes Bonatti,  Ibrahim Sultan

This study compared outcomes between patients undergoing valve-in-valve transcatheter aortic valve replacement (ViV TAVR) and redo surgical aortic valve replacement (redo SAVR) using a retrospective analysis of institutional databases, which included data from 2013 to 2022 for TAVR and 2011 to 2022 for SAVR. A total of 198 patients underwent ViV TAVR and 147 patients underwent redo SAVR. Both groups had an operative mortality rate of 2 percent, but the observed-to-expected operative mortality ratio was higher in the redo SAVR group (1.2) compared to ViV TAVR (0.32). Patients in the redo SAVR group were more likely to experience complications, including transfusions, reoperations for bleeding, new onset renal failure requiring dialysis, and the need for permanent pacemakers. 
 
Echocardiographic outcomes showed that the mean gradient across the aortic valve was significantly lower in the redo SAVR group at both postoperative day 30 and one year. Survival estimates for one year were similar for both procedures, and multivariable Cox regression indicated no significant difference in mortality risk between the two groups (hazard ratio 1.39, 95 percent CI 0.65-2.99; P = .40). However, heart failure readmission rates were higher in the ViV cohort. 
 
While both ViV TAVR and redo SAVR demonstrated comparable mortality rates, the redo SAVR group had better mean gradients and lower rates of heart failure readmissions but faced more postoperative complications. These findings suggest that despite a higher risk profile, redo SAVR may offer certain advantages over ViV TAVR in selected patients. 

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