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Journal and News Scan

Source: Journal of the American College of Cardiology
Author(s): Alexander Iribarne, Sundos H. Alabbadi, Alan J. Moskowitz, Gorav Ailawadi, Vinay Badhwar, Marc Gillinov, Vinod H. Thourani, Keith B. Allen, Michael E. Halkos, Nirav C. Patel, Robert S. Kramer, David D’Alessandro, Samantha Raymond, Helena L. Chang, Lopa Gupta, Kathleen N. Fenton, Wendy C. Taddei-Peters, Michael W.A. Chu, Volkmar Falk, Joanna Chikwe, Neal Jeffries, Emilia Bagiella, Patrick T. O’Gara, Annetine C. Gelijns, and Natalia N. Egorova

This study assessed the incidence rates of permanent pacemaker implantation (PPM) and the associated long-term clinical consequences of PPM implantation after isolated mitral valve (MV) repair compared to concomitant MV repair and tricuspid annuloplasty. Data from public hospital discharge databases from New York and California were queried for patients undergoing MV repair (isolated or with concomitant tricuspid annuloplasty) between 2004 and 2019. Patients were stratified by whether they received a PPM within 90 days of index surgery. After propensity score matching, survival, heart failure hospitalizations, endocarditis, stroke, and reoperation were compared between patients with or without PPM. A total of 32,736 patients underwent isolated MV repair (n = 28,003) or MV repair with tricuspid annuloplasty (n = 4,733). The incidence of PPM implantation less than 90 days after surgery was 7.7 percent for MV repair and 14.0 percent for MV repair with tricuspid annuloplasty. PPM was associated with reduced long-term survival among MV repair patients (HR: 1.96; 95 percent CI: 1.75-2.19; P < 0.001) and MV repair with tricuspid annuloplasty patients (HR: 1.65; 95 percent CI: 1.28-2.14; P < 0.001). In both surgical groups, PPM was also associated with an increased risk of heart failure hospitalizations (HR: 1.56; 95 percent CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95 percent CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation.

Source: European Journal of Cardio-Thoracic Surgery
Author(s): Aung Y Oo, Mahmoud Loubani, Marc W Gerdisch, Joseph Zacharias, Geoffrey M Tsang, Michael J Perchinsky, Robert Carl Hagberg, Mark Joseph, Mohanakrishnan Sathyamoorthy

This paper reports the interim findings from the clinical registry that was initiated after FDA approval to validate the findings of the 386 PROACT trial for the On-X aortic valve. The original trial showed that low dose warfarin (INR range 1.5-2.0) and aspirin were safe starting at least three months after On-X aortic valve implantation. This interim report validates the findings of the trial in a real-world setting and explores outcomes (e.g., bleeding and thromboembolic events) among various subgroups of INR monitoring methods in patients.

Source: Perfusion
Author(s): Gianni D Angelini, Barnaby C Reeves, Lucy A Culliford, Rachel Maishman, Chris A Rogers, Kyriakos Anastasiadis, Polychronis Antonitsis, Helena Argiriadou, Thierry Carrel, Dorothée Keller, Andreas Liebold, Fatma Ashkaniani, Aschraf El-Essawi, Ingo Breitenbach, Clinton Lloyd, Mark Bennett, Alex Cale, Serdar Gunaydin, Eren Gunertem, Farouk Oueida, Ibrahim M Yassin, Cyril Serrick, John M Murkin, Vivek Rao, Marco Moscarelli, Ignazzo Condello, Prakash Punjabi, Cha Rajakaruna, Apostolos Deliopoulos, Daniel Bone, William Lansdown, Narain Moorjani, Sarah Dennis

The COMICS trial is the largest randomized trial of minimally invasive extracorporeal circulation (MiECC) compared to conventional ECC (CECC). MiECC reduced the frequency of SAEs prespecified to qualify for the primary outcome. This finding was of borderline significance due to stopping recruitment early, but is consistent with the results of large-scale, published meta-analyses. MiECC improved a visual analogue quality-of-life measure. MiECC was safe with respect to other SAEs and adverse events that were reported. It did not reduce mortality, any SAE not included in the primary outcome, time to ICU or hospital discharge or transfusion of any red cells or any other blood product. However, all treatment effect estimates for these outcomes, except for hospital stay, favored MiECC; and the magnitude of the reductions in mortality and risk of any SAE not included in the primary outcome were consistent with the reduction in risk observed for the primary outcome.

Source: The Journal of Thoracic and Cardiovascular Surgery
Author(s): David R. Jones, Raphael Bueno, David H. Harpole Jr., Ara A. Vaporciyan

This editorial summarizes the landscape that led to the founding of the Thoracic Surgical Oncology Group in 2017, in an era when, due to various oncology group reorganizations, a need developed for a focused committee to conduct thoracic surgery oncology-based clinical trials. The group has expanded over the years to include 32 hospitals. It has completed two clinical trials, with three more actively recruiting patients, and four new studies planned in the near future. There remain multiple challenges, however, with increasing interest, there are more opportunities going forward.

Source: The Annals of Thoracic Surgery
Author(s): Konstantinos Gioutsos, Lasse Ehrenreich, Luis Filipe Azenha, Christopher Siegbert Quapp, Gregor Jan Kocher, Jon Andri Lutz, Stephan Peischl, Patrick Dorn

In this trial of 337 patients undergoing open or thoracoscopic lung resection randomized to postoperative chest drain removal based on a standard threshold of 200 mL/24 hours or 5 mL/kg/24 hours, there were no differences in pleural effusion, dyspnea, or time to chest drain removal; however, the weight-adjusted threshold was associated with earlier hospital discharge.

Source: The Annals of Thoracic Surgery
Author(s): Vinod H. Thourani, Amr E. Abbas, Julien Ternacle, Rebecca T. Hahn, Raj Makkar, Susheel K. Kodali, Isaac George, Samir Kapadia, Lars G. Svensson, Wilson Y. Szeto, Howard C. Herrmann, Gorav Ailawadi, Jonathon Leipsic, Philipp Blanke, John Webb, Wael A. Jaber, Mark Russo, S. Chris Malaisrie, Pradeep Yadav, Marie-Annick Clavel, Omar K. Khalique, Neil J. Weissman, Pamela Douglas, Jeroen Bax, Abdellaziz Dahou, Ke Xu, Vinayak Bapat, Maria C. Alu, Martin B. Leon, Michael J. Mack, Philippe Pibarot

In an analysis of 1,826 patients randomized to surgical aortic valve replacement in the three Placement of Aortic Transcatheter Valves (PARTNER) trials, patient-prosthesis mismatch was assessed using transthoracic echocardiography and by the normal reference value for each size and model of implanted valve. Compared with transthoracic echocardiography (21.6 percent), reference values underestimated the incidence of severe patient-prosthesis mismatch (2.1 percent), which was associated with worse all-cause mortality and heart failure rehospitalizations at the two year follow-up.

Source: European Heart Journal
Author(s): Mateo Marin-Cuartas, Gilbert H L Tang, Philipp Kiefer, Shinichi Fukuhara, Rudiger Lange, Katherine B Harrington, Shekhar Saha, Christian Hagl, Neal S Kleiman, Sachin S Goel, Joerg Kempfert, Paul Werner, George A Petrossian, Arnar Geirsson, Nimesh D Desai, Michael W A Chu, Oliver D Bhadra, Christian Shults, Andrea Garatti, Flavien Vincent, Kendra J Grubb, Joshua B Goldberg, Michael J Mack, Thomas Modine, Paolo Denti, Tsuyoshi Kaneko, Vinayak N Bapat, Michael J Reardon, Michael A Borger, Syed Zaid

Surgical explantation of transcatheter heart valves (THV) is rapidly increasing, but data on patients with THV-associated infective endocarditis (IE) is lacking. This study assessed the outcomes of patients undergoing THV explant for IE based on data from the international TAVR-EXPLANT Registry. All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD). A total of 372 patients were included. Among them, 184 (49.5 percent) patients underwent THV explant due to IE and 188 (50.5 percent) patients due to BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < 0.05) and higher stroke rates at 30 days (8.6 percent vs. 2.9 percent, P = 0.032) and 1 year (16.2 percent vs. 5.2 percent, P = 0.010). Adjusted in-hospital, 30-day, and one-year mortality was 12.1 percent, 16.1 percent, and 33.8 percent, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients three years following surgery (29.6 percent for BVD vs. 43.9 percent for IE), Kaplan–Meier analysis showed no statistically significant differences between groups (P = 0.16).

Source: The Thoracic and Cardiovascular Surgeon
Author(s): Michael Schmoeckel, Matthias Längin, Bruno Reichart, Jan-Michael Abicht, Martin Bender, Sebastian Michel, Christine-Elena Kamla, Joachim Denner, Ralf Reinhard Tönjes, Reinhard Schwinzer, Georg Marckmann, Eckhard Wolf, Paolo Brenner, Christian Hagl

This report comprises the contents of the presentations and following discussions of a workshop of the German Heart Transplant Centers in Martinsried, Germany on cardiac xenotransplantation. Summary: This report comprises the contents of the presentations and following discussions of a workshop of the German Heart Transplant Centers in Martinsried, Germany, on cardiac xenotransplantation. The production and current availability of genetically modified donor pigs, preservation techniques during organ harvesting, and immunosuppressive regimens in the recipient are described. Selection criteria for suitable patients and possible solutions to the problem of overgrowth of the xenotransplant are also discussed. Obviously, microbiological safety for the recipient and close contacts is essential, and ethical considerations to gain public acceptance for clinical applications are addressed. The first clinical trial will be regulated and supervised by the Paul Ehrlich Institute as the National Competent Authority for Germany, and the German Heart Transplant Centers agreed to cooperatively select the first patients for cardiac xenotransplantation.

Source: Circulation Research
Author(s): Marina E. Michaud, Lucas Mota, Mojtaba Bakhtiari, Beena E. Thomas, John Tomeo, William Pilcher, Mauricio Contreras, Christiane Ferran, Swati Bhasin, Leena Pradhan-Nabzdyk, Frank W. LoGerfo, Patric Liang and Manoj K. Bhasin

This paper details an under-development animal model to study the vascular pathology of vein grafts in a variation of the initial Carrel canine bypass experiment. The possible findings on detrimental effects of hydrostatic distention, if and when quantified, may alter surgeons’ harvesting techniques.

Source: The New England Journal of Medicine
Author(s): Stefan Blankenberg, Moritz Seiffert, Reinhard Vonthein, Helmut Baumgartner, Sabine Bleiziffer, Michael A. Borger, Yeong-Hoon Choi, Peter Clemmensen, Jochen Cremer, Martin Czerny, Nina Diercks, Ingo Eitel, Stephan Ensminger, Derk Frank, Norbert Frey, Andreas Hagendorff, Christian Hagl, Christian Hamm, Utz Kappert, Matthias Karck, Won-Keun Kim, Inke R. König, Markus Krane, Ulf Landmesser, Axel Linke, Lars S. Maier, Steffen Massberg, Franz-Josef Neumann, Hermann Reichenspurner, Tanja K. Rudolph, Christof Schmid, Holger Thiele, Raphael Twerenbold, Thomas Walther, Dirk Westermann, Erion Xhepa, Andreas Ziegler, and Volkmar Falk

The DEDICATE-DZHK6 is a non-industry sponsored randomized noninferiority trial conducted at 38 sites in Germany, where patients with severe aortic stenosis who were at low or intermediate surgical risk were randomly assigned to undergo either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). TAVI and SAVR prostheses were selected at the operator's discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at one year. A total of 1,414 patients underwent randomization, 701 to the TAVI group and 713 to the SAVR group). The mean age was 74±4 years, 57 percent were men, and the median Society of Thoracic Surgeons risk score was 1.8 percent. The Kaplan–Meier estimate of the primary outcome at one year was 5.4 percent in the TAVI group and 10 percent in the SAVR group (hazard ratio (HR) for death or stroke, 0.53; 95 percent confidence interval [CI], 0.35 to 0.79; P <0.001 for noninferiority). The incidence of death from any cause was 2.6 percent in the TAVI group and 6.2 percent in the SAVR group (HR 0.43; 95 percent CI, 0.24 to 0.73). The incidence of stroke was 2.9 percent and 4.7 percent in the TAVI and SAVR groups, respectively (HR 0.61; 95 percent CI, 0.35 to 1.06). The authors concluded that among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at one year.

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