Reduction in Right Atrial Pressures Is Associated With Hemodynamic Improvements After Transcatheter Edge-to-Edge Repair of the Tricuspid Valve

2021 ◽  
Author(s):  
Madeline K. Mahowald ◽  
Rick A. Nishimura ◽  
Sorin V. Pislaru ◽  
Sunil V. Mankad ◽  
Vuyisile T. Nkomo ◽  
...  
Keyword(s):  
Right Atrial ◽  
Study Cohort ◽  
Event Free Survival ◽  
Severe Tricuspid Regurgitation ◽  
Free Survival ◽  
Improved Outcomes ◽  
Procedural Guidance ◽  
V Wave ◽  
Conventional Echocardiography

Background: Investigational transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation (TR) has shown promise as an alternative to surgery, but factors influencing outcomes, optimal patient selection, and procedural timing remain incompletely defined. Given the limitations of determining TR severity by conventional echocardiography, our objectives were to determine whether invasive right atrial (RA) pressures performed during the procedure are related to patient outcomes. Methods: This study was a retrospective review of patients who underwent off-label tricuspid TEER using MitraClip (Abbott Vascular, Menlo Park, CA) for significant TR at a single institution. Intraprocedural mean RA pressure, RA peak V-wave, RA pressure nadir, and systolic increase in RA pressure (XV height) were recorded. Results: Thirty-eight patients underwent tricuspid TEER; 33 underwent concomitant mitral TEER for mitral regurgitation. The study cohort was 39% female with a mean age of 78.6±14.3 years. Median follow-up was 339 days (interquartile range, 100–601). Any reduction in mean RA pressure, RA peak V-wave, RA nadir, and XV height occurred in 74%, 82%, 45%, and 87% of patients, respectively. At 1 year, event-free survival was 47%. Postprocedure XV height correlated with TR severity as determined by echocardiography ( P <0.0001). The highest quartile of postprocedure XV height (>8 mm Hg) had worse event-free survival compared with those who had concluding XV height ≤8 mm Hg ( P =0.02). Attainment of a concluding XV height less than or equal to median value was associated with a lower creatinine the next day (1.27±0.47 versus 1.64±0.47 mg/dL, P= 0.04). Conclusions: Intraprocedural XV height correlates with TR severity after tricuspid TEER, and lower concluding pressures are associated with improved outcomes. Analysis of RA pressures may serve as a complementary tool for the evaluation of disease severity and procedural guidance.

Abstract 16154: Baseline Left Ventricular Diameter Predicts Recovery in New Systolic Heart Failure Syndromes

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Daniel Gold ◽  
Nathan Kong ◽  
Matthew Gold ◽  
Tess Allan ◽  
Anand Shah ◽  
...  
Keyword(s):  
Left Ventricular ◽  
Medical Decision ◽  
Left Ventricular Ejection ◽  
Internal Diameter ◽  
Event Free Survival ◽  
Short Term Treatment ◽  
Ventricular Ejection Fraction ◽  
Free Survival ◽  
Advanced Therapies

Introduction: It is unknown how often patients with very advanced left ventricular (LV) dilation at initial presentation demonstrate meaningful recovery with medical therapy. Understanding short term treatment outcomes may impact medical decision making and counseling. Hypothesis: Patients with left ventricular end diastolic internal diameter (LVEDD) > 6.5cm will be less likely to recover left ventricular ejection fraction (LVEF) as compared to patients with LVEDD < 6.5cm. Methods: Patients were retrospectively identified by a database search of echocardiogram studies obtained at the University of Chicago between 2008-2018. Manual review was performed to ensure new diagnosis of systolic dysfunction with LVEF ≤ 35% and follow up echocardiogram study within 3 to 9 months of index study. LVEDD was determined from parasternal long axis views per routine. LVEF recovery was specified as LVEF > 35%. Chart review was done to assess for composite death, hospice, transplant, left ventricular assist device, and sustained ventricular tachycardia. Chi-square, multivariable logistic regression, and Kaplan-Meier survival were used for analysis. Results: Out of 100 patients included for analysis, mean age was 59.7 years, 41 were female and 82 were African American. 17.7% of patients’ with LVEDD > 6.5 cm had LVEF recovery compared to 53.0% of patients’ with LVEDD ≤ 6.5 cm (p = 0.008). LVEDD > 6.5 cm was associated with less LVEF recovery even when adjusted for age, gender, hypertension, and diabetes (adjusted odds ratio 0.18, 95% CI 0.04 to 0.65). LVEDD > 6.5cm was associated with worse event free survival (p = 0.004) with a median follow-up time of 2.4 years. Conclusions: An LVEDD of > 6.5cm is associated with diminished LVEF recovery and event free survival when compared to those patients with an LVEDD ≤ 6.5cm. Delaying consideration for advanced therapies and device based therapies in hopes of recovery may be inappropriate for many such patients.

scholarly journals CRT-720 Mitral Balloon Valvuloplasty Long-Term Follow-Up of Single Balloon Versus Inoue Balloon Techniques. Independent Predictors of Survival and Event Free Survival

2014 ◽  
Vol 7 (2) ◽  
pp. S57
Author(s):  
Edison Sandoval Peixoto Peixoto ◽  
Ivana Picone Borges ◽  
Rodrigo Trajano Sandoval Peixoto ◽  
Ricardo Trajano Sandoval Peixoto
Keyword(s):  
Balloon Valvuloplasty ◽  
Event Free Survival ◽  
Free Survival ◽  
Long Term Follow Up ◽  
Single Balloon ◽  
Inoue Balloon

Clinical significance of translocation t(1;19) in childhood acute lymphoblastic leukemia in the context of contemporary therapies: a report from the Children's Cancer Group.

1998 ◽  
Vol 16 (2) ◽  
pp. 527-535 ◽  
Author(s):  
F M Uckun ◽  
M G Sensel ◽  
H N Sather ◽  
P S Gaynon ◽  
D C Arthur ◽  
...  
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Lymphoblastic Leukemia ◽  
Prognostic Significance ◽  
Newly Diagnosed ◽  
Event Free Survival ◽  
Free Survival ◽  
Cancer Group ◽  
Improved Outcomes ◽  
B Lineage ◽  
The Individual

PURPOSE The nonrandom translocation t(1;19) has been associated with poor outcome in pediatric B-lineage acute lymphoblastic leukemia (ALL). Because most patients treated by contemporary therapies now achieve improved outcomes, we have reassessed the prognostic significance of t(1;19). PATIENTS AND METHODS Cytogenetic data were accepted for 1,322 children (<21 years old) with newly diagnosed ALL enrolled between 1988 and 1994 on risk-adjusted studies of the Children's Cancer Group (CCG). Forty-seven patients (3.6%) were t(1;19) positive (+); 1,275 (96.4%) were t(1;19) negative (-). Clinical characteristics and treatment outcome were compared using standard methods. RESULTS Translocation (1;19)+ patients were more likely than t(1;19)- patients to be 10 years of age or greater (P < .001) or CD10+ CD19+ CD34- (P < .0001), or nonwhite (P = .02). Patients with a balanced t(1;19) were less likely to be hyperdiploid than patients with an unbalanced der(19)t(1;19). Event-free survival (EFS) was similar for the overall group of t(1;19)+ and t(1;19)- patients, with 4-year estimates of 69.5% (SD, 6.8%) and 74.8% (SD, 1.3%; P = .48), respectively. However, patients with unbalanced der(19)t(1;19) had significantly better outcomes than patients with balanced t(1;19): 4-year EFS were 80.6% (SD, 7.1%) and 41.7% (SD, 13.5%), respectively (P = .003). These differences were maintained within the individual studies analyses and after exclusion of t(1;19)+ patients whose cells were hyperdiploid with more than 50 chromosomes. CONCLUSION The overall group of t(1;19)+ patients, as well as the subgroup with an unbalanced der(19)+ (1;19) had outcomes similar to that of t(1;19)- patients, whereas patients with balanced t(1;19) had poorer outcomes. Thus, although the overall prognostic significance of t(1;19) has been obviated by contemporary risk-adjusted protocols, the balanced t(1;19) translocation remains an adverse prognostic factor.

Event free survival in adults with relapsed ALL who underwent front-line therapy with CALGB 10403.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19005-e19005
Author(s):  
Suravi Raychaudhuri ◽  
Ilana Yurkiewicz ◽  
Gabriel N. Mannis ◽  
Bruno C. Medeiros ◽  
Steve E. Coutre ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cohort Study ◽  
Survival Time ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Event Free Survival ◽  
Front Line ◽  
Free Survival ◽  
First Relapse

e19005 Background: CALGB 10403 is a pediatric-inspired ALL regimen that has recently been shown to have improved survival rates in adolescents and young adults with ALL when compared to historical outcomes with traditional adult ALL regimens (Stock et. al, 2019). Methods: This is a retrospective cohort study of ALL patients who received induction CALGB 10403 at Stanford University (both on and off trial), achieved CR1, and subsequently relapsed. Primary outcome of interest was event free survival from time of diagnosis. Events were defined as relapse or death. Secondary outcomes were overall survival and event free survival from first relapse. Patients were censored at time of last clinical follow up. Results: 25 patients met inclusion criteria and received front-line CALGB 10403 from April 2010 to September 2018. At the time of initial diagnosis median age was 30 years (range 18 – 39 years). 68% of patients were male. 48% of patients were overweight and 40% were obese. 76% of patients had precursor B cell ALL while 24% had T cell ALL. 12% had CNS disease at diagnosis. 36% of patients had WBC greater than 30k. 12% of patients had CRLF2 rearrangement. 12% of patients were MRD positive after first induction. 20% of patients received rituximab. Median event free survival time from diagnosis was 20 months (range 3 – 79 months) and median overall survival time was 53 months. Blinatumomab was the most common salvage therapy after 1st relapse, followed by inotuzumab. 15 patients (60%) achieved CR2, of which 4 (27%) were MRD positive after 2nd induction. 15 patients (60%) went to HSCT. Of the patients who achieved CR2, 8 relapsed for a second time. Median event free survival time after first relapse was 23 months. Survival 1 year after relapse was 60%. 11 of the 25 patients were alive at last follow up. Median follow up time of survivors was 6 years. Conclusions: This is a descriptive retrospective cohort study of adult patients in a real world setting who received CALGB 10403 induction and subsequently relapsed. Compared to other studies of relapsed ALL patients who were induced with traditional chemotherapy (Fielding et. al, 2007), survival 1 year after relapse was much higher (60% vs. 22%). As CALGB 10403 becomes an increasingly common induction regimen for AYA and adults with ALL, further outcomes study is required.[Table: see text]

Abstract 2266: Development of Tricuspid Regurgitation Late After Left-Sided Valve Surgery in Patients without Significant Preoperative Tricuspid Regurgitation :A Single-Center Experience with Long-term Echocardiographic Examinations

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Jae-Jin Kwak ◽  
Min-Kyung Kim ◽  
Hyung-Kwan Kim ◽  
Jin-Shik Park ◽  
Kyung-Hwan Kim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Tricuspid Regurgitation ◽  
Mitral Valve Surgery ◽  
Valve Surgery ◽  
Right Atrial ◽  
Systolic Pulmonary Artery Pressure ◽  
Free Survival ◽  
Single Center Experience

Aim: We investigated the incidence and predictors of tricuspid regurgitation (TR) development long after left-sided valve surgery in patients without significant preoperative TR. Methods: Of 615 patients who underwent surgery for left-sided valve disease between 1992 and 1995, 335 patients without preoperative TR who completed at least 5 years of clinical and echocardiographic follow-up were enrolled. Late significant TR development was assessed by echocardiography with a mean follow-up duration of 11.6 ± 2.1 years. Results: Significant late TR was found in 90 patients (26.9%). Patients with late TR showed; an advanced age, a higher prevalence of atrial fibrillation and prior valve surgery, and a greater left atrial dimension. In addition, late TR was more frequent in patients with mitral valve surgery. Systolic pulmonary artery pressure and mean right atrial pressure were not different between the groups. Multivariate analysis showed that the preoperative atrial fibrillation (OR 5.37; 95% CI. 2.71–10.65; p<0.001) was the only independent factor of late TR development. Patients that developed late TR had a lower event-free survival rate than those that did not (p=0.03). Conclusion: The development of significant TR long after left-sided valve surgery is not uncommon and is associated with a poor prognosis. The preoperative atrial fibrillation is an independent predictor of the late TR. Main Clinical and Echocardiographic Characteristics According to the Presence of Significant Late TR

P1783Prognostic implications of significant tricuspid regurgitation in patients with atrial fibrillation in the absence of left-sided heart disease or pulmonary hypertension

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M F Dietz ◽  
E A Prihadi ◽  
P Van Der Bijl ◽  
N Ajmone Marsan ◽  
V Delgado ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Hypertension ◽  
Heart Disease ◽  
Tricuspid Regurgitation ◽  
Left Ventricular ◽  
Right Atrial ◽  
Left Ventricular Ejection ◽  
Event Free Survival ◽  
Free Survival ◽  
Rv Function

Abstract Background Tricuspid regurgitation (TR) can be caused by atrial fibrillation (AF) in the absence of left-sided heart disease or pulmonary hypertension. The prognostic impact of AF-TR has not been investigated. Purpose The aim of this study was to investigate the prognostic significance of TR in AF patients who do not show left-sided heart disease, pulmonary hypertension or primary structural abnormalities. Methods A total of 63 AF patients with moderate and severe TR were identified and matched by age and gender to 116 patients with AF without significant TR, resulting in a total study population of 179 patients (mean age 71±7 years, 59% male). As per design of the study, patients with primary TR, significant (moderate or severe) aortic and/or mitral valve disease, previous valvular surgery, congenital heart disease, left ventricular ejection fraction <50%, systolic pulmonary artery pressure >40mmHg, pacemaker or implantable cardioverter defibrillator leads in situ were excluded as well as patients with AF de novo. Patients were followed for the combined endpoint of all-cause mortality, hospitalization for heart failure and stroke. Results Patients with AF-TR had more often paroxysmal AF as compared to patients without TR (60% vs. 43%, p=0.028). In addition, right atrial volumes and the tricuspid annulus diameter (TAD) were significantly larger in patients with AF-TR compared to their counterparts (p<0.001 for all). Furthermore, tricuspid annular plane systolic excursion was significantly lower in patients with AF-TR (17±5 mm vs. 21±6 mm, p<0.001). During follow-up (median 62 [32–95] months) 55 events for the combined endpoint occurred. One- and 5-year event-free survival rates for patients with TR were 71% and 53%, compared to 92% and 85% for patients without TR, respectively (Log rank Chi-Square p<0.001; Figure). In the multivariable Cox proportional hazard model adjusted for age, gender, NYHA functional class >2, renal function, right ventricular (RV) function and TAD, the presence of significant TR was independently associated with the combined endpoint (HR, 2.495; 95% CI, 1.167–5.335; p=0.018), while RV function was not (HR, 1.026; 95% CI, 0.971–1.085; p=0.364). Figure 1. Kaplan-Meier curves Conclusion In the absence of left-sided heart disease and pulmonary hypertension, significant TR is independently associated with worse event-free survival in patients with AF.

Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17.

1998 ◽  
Vol 16 (2) ◽  
pp. 441-452 ◽  
Author(s):  
B Fisher ◽  
J Dignam ◽  
N Wolmark ◽  
E Mamounas ◽  
J Costantino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Radiation Therapy ◽  
Breast Cancer Incidence ◽  
Resected Specimen ◽  
Cumulative Probability ◽  
Event Free Survival ◽  
Free Survival ◽  
National Surgical Adjuvant Breast ◽  
Bowel Project

PURPOSE In 1993, findings from a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial to evaluate the worth of radiation therapy after lumpectomy concluded that the combination was more beneficial than lumpectomy alone for localized intraductal carcinoma-in-situ (DCIS). This report extends those findings. PATIENTS AND METHODS Women (N = 818) with localized DCIS were randomly assigned to lumpectomy or lumpectomy plus radiation (50 Gy). Tissue was removed so that resected specimen margins were histologically tumor-free. Mean follow-up time was 90 months (range, 67 to 130). Size and method of tumor detection were determined by central clinical, mammographic, and pathologic assessment. Life-table estimates of event-free survival and survival, average annual rates of occurrence for specific events, relative risks for event-specific end points, and cumulative probability of specific events comprising event-free survival are presented. RESULTS The benefit of lumpectomy plus radiation was virtually unchanged between 5 and 8 years of follow-up and was due to a reduction in invasive and noninvasive ipsilateral breast tumors (IBTs). Incidence of locoregional and distant events remained similar in both treatment groups; deaths were only infrequently related to breast cancer. Incidence of noninvasive IBT was reduced from 13.4% to 8.2% (P = .007), and of invasive IBT, from 13.4% to 3.9% (P < .0001). All cohorts benefited from radiation regardless of clinical or mammographic tumor characteristics. CONCLUSION Through 8 years of follow-up, our findings continue to indicate that lumpectomy plus radiation is more beneficial than lumpectomy alone for women with localized, mammographically detected DCIS. When evaluated according to the mammographic characteristics of their DCIS, all groups benefited from radiation.

scholarly journals Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86

Blood ◽  
1994 ◽  
Vol 84 (9) ◽  
pp. 3122-3133 ◽  
Author(s):  
A Reiter ◽  
M Schrappe ◽  
WD Ludwig ◽  
W Hiddemann ◽  
S Sauter ◽  
...  
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Risk Group ◽  
Lymphoblastic Leukemia ◽  
Multicenter Trial ◽  
Low Risk ◽  
Event Free Survival ◽  
Free Survival ◽  
Risk Patients ◽  
To Receive

Abstract In trial ALL-BFM 86, the largest multicenter trial of the Berlin- Frankfurt-Munster (BFM) study group for childhood acute lymphoblastic leukemia (ALL), treatment response was used as an overriding stratification factor for the first time. In the previous trial ALL-BFM 83, the in vivo response to initial prednisone treatment was evaluated prospectively. A blast cell count of > or = 1,000/microL peripheral blood after a 7-day exposure to prednisone and one intrathecal dose of methotrexate (MTX) identified 10% of the patients as having a significantly worse prognosis. In trial ALL-BFM 86 patients with > or = 1,000/microL blood blasts on day 8 were included in an experimental branch EG. Patients with < 1,000/microL blood blasts on day 8 were stratified by their leukemic cell burden into two branches, Standard Risk Group (SRG) and Risk Group (RG). SRG patients received an eight- drug induction followed by consolidation protocol M (6-mercaptopurine, high-dose [HD] MTX 4 x 5 g/m2) and maintenance. RG patients were treated with an additional eight-drug reinduction element. For EG patients protocol M was replaced by protocol E (prednisone, HD-MTX, HD- cytarabine, ifosfamide, mitoxantrone). All patients received intrathecal MTX therapy; only those of branches RG and EG received cranial irradiation. In branch RG, patients were randomized to receive or not to receive late intensification (prednisone, vindesine, teniposide, ifosfamide, HD-cytarabine) in the 13th month. During the trial reinduction therapy was introduced in branch SRG, because in the follow-up of trial ALL-BFM 83 the randomized low-risk patients receiving reinduction did significantly better. Nine hundred ninety- eight evaluable patients were enrolled, 28.6% in SRG, 61.1% in RG, 10.3% in EG. At a median follow-up of 5.0 (range 3.4 to 6.9) years, the estimated 6-year event-free survival was 72% +/- 2% for the study population, 58% +/- 5% in branch SRG for the first 110 patients without reinduction therapy, 87% +/- 3% for the next 175 patients with reinduction therapy, 75% +/- 2% in branch RG, and 48% +/- 5% in branch EG. Late intensification did not significantly affect treatment outcome of RG patients; however, only 23% of the eligible patients were randomized. Prednisone poor response remained a negative prognostic parameter despite intensified therapy. The results confirmed the benefit of intensive reinduction therapy even for low-risk patients. The strategy of induction, consolidation, and intensive reinduction may offer roughly 75% of unselected childhood ALL patients the chance for an event-free survival.

scholarly journals Event-Free Survival, a Prostate-Specific Antigen–Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation

2020 ◽  
Vol 38 (26) ◽  
pp. 3032-3041 ◽  
Author(s):  
Wanling Xie ◽  
Meredith M. Regan ◽  
Marc Buyse ◽  
Susan Halabi ◽  
Philip W. Kantoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
Event Free Survival ◽  
Free Survival ◽  
Patient Level ◽  
End Point

PURPOSE Recently, we have shown that metastasis-free survival is a strong surrogate for overall survival (OS) in men with intermediate- and high-risk localized prostate cancer and can accelerate the evaluation of new (neo)adjuvant therapies. Event-free survival (EFS), an earlier prostate-specific antigen (PSA)–based composite end point, may further expedite trial completion. METHODS EFS was defined as the time from random assignment to the date of first evidence of disease recurrence, including biochemical failure, local or regional recurrence, distant metastasis, or death from any cause, or was censored at the date of last PSA assessment. Individual patient data from trials within the Intermediate Clinical Endpoints in Cancer of the Prostate–ICECaP–database with evaluable PSA and disease follow-up data were analyzed. We evaluated the surrogacy of EFS for OS using a 2-stage meta-analytic validation model by determining the correlation of EFS with OS (patient level) and the correlation of treatment effects (hazard ratios [HRs]) on both EFS and OS (trial level). A clinically relevant surrogacy was defined a priori as an R2 ≥ 0.7. RESULTS Data for 10,350 patients were analyzed from 15 radiation therapy–based trials enrolled from 1987 to 2011 with a median follow-up of 10 years. At the patient level, the correlation of EFS with OS was 0.43 (95% CI, 0.42 to 0.44) as measured by Kendall’s tau from a copula model. At the trial level, the R2 was 0.35 (95% CI, 0.01 to 0.60) from the weighted linear regression of log(HR)-OS on log(HR)-EFS. CONCLUSION EFS is a weak surrogate for OS and is not suitable for use as an intermediate clinical end point to substitute for OS to accelerate phase III (neo)adjuvant trials of prostate cancer therapies for primary radiation therapy–based trials.

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