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Journal and News Scan

Source: The New England Journal of Medicine
Author(s): Michael J. Mack, Martin B. Leon, Vinod H. Thourani, Philippe Pibarot, Ph.D., Rebecca T. Hahn, Philippe Genereux, Susheel K. Kodali, Samir R. Kapadia, David J. Cohen, Stuart J. Pocock, Michael Lu, Roseann White, Molly Szerlip, Julien Ternacle, S. Chris Malaisrie, Howard C. Herrmann, Wilson Y. Szeto, Mark J. Russo, Vasilis Babaliaros, Craig R. Smith, Philipp Blanke, John G. Webb, and Raj Makkar, for the PARTNER 3 Investigators

The outcomes of the Transcatheter Aortic Valve Replacement in Low-Risk Patients at Five Years (5y PARTNER 3 trial) were presented during the late-breaking clinical trial session of TCT 2023 and simultaneously published in the New England Journal of Medicine. The results give valuable insights and add new evidence for the decision making and treatment of low-risk patients with severe symptomatic AS.

The PARTNER 3 trial randomly assigned 1,000 patients with severe symptomatic aortic stenosis (AS) and low surgical risk (STS-PROM < 4 percent) to undergo either transcatheter aortic valve replacement with a balloon expandable bioprosthesis (503 patients) or surgical aortic valve replacement (497 patients) with a prespecified superiority hypothesis. The two primary endpoints were composite of death, stroke, or rehospitalization, and hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days.

At five years, there was no significant difference in the risk of death, stroke, or rehospitalizations between the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms. The Kaplan–Meier estimates were 22.8 percent vs. 27.2 percent in the TAVR and SAVR groups, respectively; p=0.07. Furthermore, Kaplan-Meier curves did not show a statistical difference in the five-year all-cause mortality. At five years, there was a mortality of 10.0 percent vs. 8.2 percent in the TAVR and SAVR groups, respectively; HR 1.23 and 95 percent CI 0.79-1.90. Remarkably, the Kaplan-Meier all-cause mortality curves initially showed an early result favoring TAVR, but beyond one year, attenuation of the observed differences occurred, with the curves crossing close to 36 months. The risk of cardiovascular (HR 1.08; 95 percent CI 0.61–1.92) and noncardiovascular (HR 1.46; 95 percent CI 0.74–2.90) mortality was similar in both groups. Valve hemodynamics were similar in both study arms, with a mean valve gradient 12.8±6.5 mmHg vs. 11.7±5.6 mmHg in the TAVR and SAVR groups, respectively. 

Moreover, bioprosthetic valve failure defined by VARC-3 criteria occurred at similarly low rates in both groups: 3.3 percent vs. 3.8 percent in the TAVR and SAVR groups, respectively. However, TAVR was associated with an increased risk of valve thrombosis: 0.2 percent vs. 2.5 percent; HR 10.52 (95 percent CI 1.37–80.93). Patient-reported health status was similar in the two groups, with a mean Kansas City Cardiomyopathy Questionnaire–Overall Summary score (KCCQ-OS) of 86.2 vs. 85.9 in the TAVR and SAVR groups, respectively. Similarly, 84.4 percent vs. 86.0 percent of the patients in the TAVR and SAVR groups presented with a New York Heart Association (NYHA) class I or II at five years, respectively.

Source: The Annals of Thoracic Surgery
Author(s): Vinod H. Thourani, Robert Habib, Wilson Y. Szeto, Joseph F. Sabik, Jennifer C. Romano, Thomas E. MacGillivray, Vinay Badhwar

To create a benchmark for the use of TAVR for aortic stenosis treatment in low-risk patients, this study evaluated outcomes of similar patients undergoing SAVR. The STS database was used to isolate low-risk SAVR patients from 2011–2019. Results revealed that when STS predicted risk of mortality (PROM) was below 1 percent or the patient age was below seventy-five years, the eight-year survival rate after SAVR was 95 percent. The authors concluded that the survival rate following SAVR remains excellent, and that this data can be used in the balanced interpretation of further trials comparing SAVR and TAVR.

Source: Interdisciplinary Cardiovascular and Thoracic Surgery
Author(s): Ponte C, Alkhatiri O, Olland A, and Falcoz P-E

The authors performed a structured review of the evidence surrounding the effect of donor age in lung transplantation. They examined whether or not lungs from donors over sixty years old had equivalent outcomes to lungs from younger donors. Twelve articles supplied the best evidence to answer this question. It was notable that recipients with interstitial lung disease, pulmonary hypertension, or cystic fibrosis had worse overall survival with grafts from older donors. The authors concluded that when allocated to the recipient who would most benefit, lung grafts from older donors offer results comparable to those obtained with younger donors.

Source: JACC
Author(s): Amanda M. Craig, Alexa Campbell, Sarah C. Snow, Toi N. Spates, Sarah A. Goldstein, Anna E. Denoble, Marie-Louise Meng, Jacob N. Schroder, Karen P. Flores, Richa Agarwal, Cary C. Ward, and Jerome J. Federspiel

The authors investigated over 100 cases of pregnancies among heart transplant recipients in the US using a national dataset. Heart transplant mothers had a staggering sixteen-fold adjusted risk of severe maternal morbidity (24.8 percent vs. 1.7 percent in the general population) at 330 days of follow up. These mothers also had elevated risks of preterm birth, readmission, transfusion, and nontransfusion associated complications. Among these patients, nearly 30 percent required readmission, and 6 percent experienced heart transplant related complications. 

Although outcomes of heart transplant continue to improve, pregnancy after transplant should be treated with significant caution. 

Source: TCTMD
Author(s): Michael O’Riordan

This article brings attention to the need for representation of women in cardiovascular research trials, with women typically accounting for only 20 percent of participants. This comes following a Lancet commission aimed at reducing the global burden of cardiovascular disease in women. From this, investigators of the ROMA trial have launched ROMA-Women, given that women only represented 15 percent of their sample. The ROMA-Women trial is a nested design, one not previously seen in cardiovascular trials. This is achieved by leveraging the ROMA infrastructure and looks to be the first cardiac surgery trial dedicated to women.

Source: Communications Engineering
Author(s): Giovanni Pittiglio, James H. Chandler, Tomas da Veiga, Zaneta Koszowska, Michael Brockdorff, Peter Lloyd, Katie L. Barry, Russell A. Harris, James McLaughlan, Cecilia Pompili, Pietro Valdastri

Lung cancer has the highest worldwide cancer mortality rate. Early non-small cell lung cancer accounts for 84 percent of cases, with curative surgical intervention being the standard treatment. The authors of this paper explore the use of a patient-specific magnetic catheter at the end of a bronchoscope in order to deliver laser treatment to peripheral lung tumors.Lung cancer has the highest worldwide cancer mortality rate. Early non-small cell lung cancer accounts for 84 percent of cases, with curative surgical intervention being the standard treatment. The authors of this paper explore the use of a patient-specific magnetic catheter at the end of a bronchoscope in order to deliver laser treatment to peripheral lung tumors.

Source: World Journal for Pediatric and Congenital Heart Surgery
Author(s): J. Chancellor Fox, Horacio G. Carvajal, Fei Wan, Matthew W. Canter, Taylor C. Merritt, Pirooz Eghtesady

Transcatheter pulmonary valve replacement (tPVR) is a key therapy in RVOT pathologies but is associated with long term risks such as infective endocarditis (IE). In fact, some reports claim a higher IE risk compared to surgical pulmonary valve replacement. This paper investigates outcomes to different management strategies used to treat IE in patients who underwent tPVR. A total of 69 cases were identified with 98 admissions due to a readmission rate of 29 percent. During the initial admission, surgical rates were 22 percent. Surgical rates were 36 percent overall, as the likelihood of surgical intervention increased with each subsequent admission. Mortality rate in the overall and surgical cohort was 4.3 percent and 8 percent respectively.

Source: The European Journal of Cardio-Thoracic Surgery
Author(s): Giuseppe Cardillo, René Horsleben Petersen, Sara Ricciardi, Akshay Patel, Joshil V Lodhia, Michael R Gooseman, Alessandro Brunelli, Joel Dunning, Wentao Fang, Dominique Gossot, Peter B Licht, Eric Lim, Eric Dominique Roessner, Marco Scarci, Milan Milojevic

The European Association of Cardio-Thoracic Surgery and the European Society of Thoracic Surgeons has collaborated to produce a review on the management of pure ground-glass and part-solid pulmonary nodules. The increase in CT scanning for the detection of early stage lung cancer is giving rise to a higher proportion of lesions presenting on the ground-glass to part-solid spectrum. With surgical resection being the gold standard, there is a growing demand for guidelines pertaining to the surgical management of such nodules. The scope of these guidelines covers main areas of interest as follows: managing solitary or multiple pure ground-glass nodules and solitary part-solid nodules, identifying non-palpable lesions, the role of minimally invasive surgery, and the decision making behind sublobar versus lobar resection.

Source: The Journal of Heart and Lung Transplantation
Author(s): Dominic Emerson MD, Pedro Catarino MD, Reinaldo Rampolla MD, Joanna Chikwe MD, Dominick Megna MD

Lung transplantation remains the best option for patients with end-stage lung disease. Despite improving outcomes, the procedure confers significant morbidity risk. This paper presents a single right-sided lung transplant in a sixty-nine-year-old recipient utilizing the Da Vinci robotic system. The patient had a diagnosis of end-stage choleric obstructive pulmonary disease refractory to medical management and was oxygen dependent at baseline. The authors describe their perioperative planning, intraoperative details, and the course of the patient following transplantation and at the eighteen month follow up.

Source: European Journal of Cardio-Thoracic Surgery
Author(s): Sowmya Ramanan, Arun Gopalakrishnan, Soumya Sundaram, Ravi Prasad Varma, Deepak Gopakumar, Vinitha K Viswam, Rahul Satheesan, Sudip Dutta Baruah, Sabarinath Menon, Baiju S Dharan

The paper aimed to inform answers to questions of parents to those born with congenital defects necessitating arterial switch correction. Authors explored the quality of life in children undergoing the arterial switch operation beyond the early postoperative period. They investigated parental and socioeconomic factors that could influence quality of life. A total of 208 patients were enrolled in the study at a single tertiary cardiac center between 2012-2018. PedsQL 3.0 was used to calculate HRQOL. The immediate survival rate was 94.2 percent and most children (98.9 percent) started formal school in age-appropriate classes. Social factors were not significantly associated with quality-of-life parameters in this cohort.

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