Research Spotlight

Yarlagadda, B., T. Deneke, M. Turagam, T. Dar, S. Paleti, V. Parikh, L. DiBiase, P. Halfbass, P. Santangeli, S. Mahapatra, J. Cheng, A. Russo, J. Edgerton, M. Mansour, J. Ruskin, S. Dukkipati, D. Wilber, V. Reddy, D. Packer, A. Natale and D. Lakkireddy (2019). “Temporal relationships between esophageal injury type and progression in patients undergoing atrial fibrillation catheter ablation.” Heart Rhythm 16(2): 204-212.

Full text of this article.

BACKGROUND: Currently, little is known about the onset, natural progression, and management of esophageal injuries after atrial fibrillation (AF) ablation. OBJECTIVES: We sought to provide a systematic review on esophageal injury after AF ablation and identify temporal relationships between various types of esophageal lesions, their progression, and clinical outcomes. METHODS: A comprehensive search of PubMed and Web of Science was conducted until September 21, 2017. All AF ablation patients who underwent upper gastrointestinal endoscopy within 1 week of the procedure were included. Patients with esophageal lesions were classified into 3 types by using our novel Kansas City classification: type 1: erythema; type 2a: superficial ulcers; type 2b: deep ulcers; type 3a: perforation without communication with the atria; and type 3b: perforation with atrioesophageal fistula. RESULTS: Thirty studies met our inclusion criteria. Of the 4473 patients, 3921 underwent upper gastrointestinal evaluation. The overall incidence of esophageal injuries was 15% (570). There were 206 type 1 lesions (36%), 222 type 2a lesions (39%), and 142 type 2b lesions (25%). Six of 142 type 2b lesions (4.2%) progressed further to type 3, of which, 5 were type 3a and 1 was type 3b. All type 1 and type 2a and most type 2b lesions resolved with conservative management. One type 3a and 1 type 3b lesions were fatal. CONCLUSION: Based on our classification, all type 1 and most type 2 lesions resolved with conservative management. A small percentage (4.2% [6 of 142]) of type 2b lesions progressed to perforation and/or fistula formation, and these patients need to be followed closely.

Vasudevan, A., J. W. Choi, G. A. Feghali, S. R. Lander, L. Jialiang, J. M. Schussler, R. C. Stoler, R. C. Vallabhan, C. E. Velasco and P. A. McCullough (2019). “Event dependence in the analysis of cardiovascular readmissions postpercutaneous coronary intervention.” J Investig Med Jan 18. [Epub ahead of print].

Full text of this article.

Recurrent hospitalizations are common in longitudinal studies; however, many forms of cumulative event analyses assume recurrent events are independent. We explore the presence of event dependence when readmissions are spaced apart by at least 30 and 60 days. We set up a comparative framework with the assumption that patients with emergency percutaneous coronary intervention (PCI) will be at higher risk for recurrent cardiovascular readmissions than those with elective procedures. A retrospective study of patients who underwent PCI (January 2008-December 2012) with their follow-up information obtained from a regional database for hospitalization was conducted. Conditional gap time (CG), frailty gamma (FG) and conditional frailty models (CFM) were constructed to evaluate the dependence of events. Relative bias (%RB) in point estimates using CFM as the reference was calculated for comparison of the models. Among 4380 patients, emergent cases were at higher risk as compared with elective cases for recurrent events in different statistical models and time-spaced data sets, but the magnitude of HRs varied across the models (adjusted HR [95% CI]: all readmissions [unstructured data]-CG 1.16 [1.09 to 1.22], FG 1.45 [1.33 to 1.57], CFM 1.24 [1.16 to 1.32]; 30-day spaced-CG1.14 [1.08 to 1.21], FG 1.28 [1.17 to 1.39], CFM 1.17 [1.10 to 1.26]; and 60-day spaced-CG 1.14 [1.07 to 1.22], FG 1.23 [1.13 to 1.34] CFM 1.18 [1.09 to 1.26]). For all of the time-spaced readmissions, we found that the values of %RB were closer to the conditional models, suggesting that event dependence dominated the data despite attempts to create independence by increasing the space in time between admissions. Our analysis showed that independent of the intercurrent event duration, prior events have an influence on future events. Hence, event dependence should be accounted for when analyzing recurrent events and challenges contemporary methods for such analysis.

Testa, G. and L. Johannesson (2019). “Letter to the Editor: Current status and future direction of uterus transplantation.” Curr Opin Organ Transplant 24(1): 4.

Full text of this article.

We would like to direct your attention to a statement written in the article “Current status and future direction of uterus transplantation” authored by Dr. Mats Brannstrom and published in Current Opinion in Organ Transplantation, October 2018. In the Section, “Live Donor Uterus Transplantation: Results”, it is stated that “Although the case proved to be successful, it has to be pointed out that bilateral use of utero-ovarian veins will necessitate donor oophorectomy and this will lead to premature menopause, with may lead to increase morbidity in this 32-year-old altruistic donor.” This statement is incorrect. In the publication announcing the first live birth after uterus transplantation in the United States, G. Testa et al. American Journal of Transplantion, May 2018, we clearly specified that “The utero ovarian veins were identified as they run closely to the fallopian and dissected free from the ovary. The ovaries were left in situ.” This donor surgical technique has been used routinely by us. In fact, the second mother to give birth in our programme also received a uterus transplant in which the venous outflow was based exclusively on the utero-ovarian vein segment and who donor did not require and oophorectomy. We thank you for the attention given to reporting the correct information. (Excerpt from text of this correspondence; no abstract available.)

Sundi, D., J. J. Tosoian, Y. A. Nyame, R. Alam, M. Achim, C. A. Reichard, J. Li, L. Wilkins, Z. Schwen, M. Han, J. W. Davis, E. A. Klein, E. M. Schaeffer, A. J. Stephenson, A. E. Ross and B. F. Chapin (2019). “Outcomes of very high-risk prostate cancer after radical prostatectomy: Validation study from 3 centers.” Cancer 125(3): 391-397.

Full text of this article.

BACKGROUND: Among men with localized high-risk prostate cancer (PCa), patients who meet very high-risk (VHR) criteria have been shown to experience worse outcomes after radical prostatectomy (RP) in a previous study. Variations of VHR criteria have been suggested to be prognostic in other single-center cohorts, but multicenter outcomes validating VHR criteria have not been described. This study was designed to validate VHR criteria for identifying which PCa patients are at greatest risk for cancer progression. METHODS: Patients with high-risk PCa undergoing RP (2005-2015) at 3 tertiary centers were pooled. The outcomes of men with VHR PCa were compared with the outcomes of those who did not meet VHR criteria. The high-risk criteria were a clinical stage of T3 to T4, a prostate-specific antigen level > 20 ng/mL, or a biopsy Gleason grade sum of 8 to 10. The VHR criteria were multiple high-risk features, >4 biopsy cores with a Gleason grade sum of 8 to 10, or primary Gleason grade pattern 5. Biochemical recurrence, metastasis (METS), and cancer-specific mortality (CSM) were assessed with competing risks regressions. Overall mortality was assessed with Cox survival models. RESULTS: Among 1981 patients with high-risk PCa, men with VHR PCa (n = 602) had adverse pathologic outcomes: 37% versus 25% for positive margins and 37% versus 15% for positive lymph nodes (P < .001 for both comparisons). Patients with VHR PCa also had higher adjusted hazard ratios for METS (2.78; 95% confidence interval [CI], 2.08-3.72), CSM (6.77; 95% CI, 2.91-15.7), and overall mortality (2.44; 95% CI, 1.56-3.80; P < .001 for all comparisons). CONCLUSIONS: In a validation study of patients who underwent treatment for high-risk PCa, VHR criteria were strongly associated with adverse pathologic and oncologic outcomes.

Shahian, D. M., T. G. Gleason, R. J. Shemin, J. D. Carroll and M. J. Mack (2019). “TAVR 2.0: Professional Societies Collaborating to Measure, Assure, and Improve Quality.” Ann Thorac Surg 107(2): 329-330.

Full text of this article.

The 2018 TAVR [transcatheter aortic valve replacement] Multisociety Expert Consensus Systems of Care Document is a remarkable paradigm of professional society cooperation to advance patient quality and safety. Written by representatives of the four relevant specialty organizations—the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and The Society of Thoracic Surgeons (STS)—this document provides important recommendations that will sustain the steadily improving quality trajectory that has characterized this evolving field since the first Multisociety document was published in 2012 . . . Compared with the 2012 recommendations, this new document has stronger and more comprehensive requirements for quality and experience. TAVR quality measures include risk-adjusted in-hospital and 30-day mortality, and unadjusted 30-day neurologic events, vascular complications, bleeding, and aortic regurgitation (risk models are under development). In addition, there are plans to measure 1-year survival and patient-reported health status (Kansas City Cardiomyopathy Questionnaire [KCCQ]) and to develop 30-day and 1-year composite measures of mortality and morbidity. A STS/ACC Transcatheter Valve Therapy (TVT) Registry public reporting initiative is also planned. For surgical AVR (SAVR), perioperative outcomes and long-term durability have been extensively studied for almost 60 years. STS has implemented sophisticated composite performance measures for a variety of procedures, including AVR, and these are voluntarily publicly reported by 65% of adult cardiac programs. STS is planning to add 1-year KCCQ and survival status so that outcomes are fully comparable with those of TAVR. (Excerpt from text of this editorial, p. 329. Refers to article: Joseph E. Bavaria, et al. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement, The Annals of Thoracic Surgery, Volume 107, Issue 2, February 2019, Pages 650-684.)