Comparison of de novo and upgrade to resynchronization therapy: a propensity-score matched analysis

Abstract Background Upgrade to resynchronization therapy (CRT) from conventional pacemaker (P) or defibrillator (D) is common practice in Europe. However, guidelines (GL) are discordant: Pacing GL give a class I recommendation, while Heart Failure (HF) GL provide a class IIb indication. Previous studies suggested worse outcomes in upgraded patients (pts). Aim To compare response rate and clinical outcomes in a cohort of pts receiving de novo or upgrade to CRT. Methods Single-center retrospective study of consecutive pts submitted to CRT implantation (2007–2017). Major adverse cardiac events (MACE) included HF hospitalization (HHF) or all-cause mortality. Clinical response was defined as New York Heart Association class improvement without MACE in the first year of follow-up (FU). Left ventricle end-systolic volume reduction of >15% denoted echocardiographic (echo) response. Survival analysis with Kaplan-Meier method and Log-rank test was performed. Propensity-score matching (PSM) analysis was made to adjust for possible confounder variables. Results 230 CRT recipients (70.9% male, mean age 67±11 years, 71.5% non-ischemic cardiomyopathy, 39.6% CRT-P) were included, of whom 46 (20%) underwent an upgrade. Upgraded pts were older (69.8 vs 65.9 years, p=0.015), with higher rates of permanent atrial fibrillation (37.0% vs 12.7%, p=0.001), moderate to severe valve disease (45.7% vs 22.3%, p=0.002), chronic kidney disease (37.0% vs 17.2%, p=0.005) and treatment with mineralocorticoid receptor antagonists (79.1% vs 52.0%, p=0.002). They were more likely to receive CRT-P (65.2% vs 33.2%, p<0.001) and CRT-D were more often implanted for secondary prevention (60.0% vs 17.9%, p=0.001). No differences emerged in procedural complications, clinical (74.4% vs 71.4%, p=0.712) or echo (66.7% vs 69.7%, p=0.822) response rates. During a median FU of 3±4 years, all-cause mortality was similar among groups (Log Rank test, p=0.522, unadjusted hazard ratio [HR] 1.25, confidence interval [CI] 95% 0.62–2.49, p=0.534). There was a statistical tendency for higher MACE rate in the upgrade group (Log Rank test, p=0.064, HR 1.66, CI 95% 0.95–2,91, p=0.076). No differences were found in lead dislodgement (10.9% vs 7.1%, p=0.368) or endocarditis (2.2% vs 4.3%, p=0.692) rates. PSM analysis identified 88 matched pairs (46 upgrade/42 de novo pts). In this cohort, all-cause mortality (Log Rank test, p=0.77, HR 0.89, CI 95% 0.39–2.03, p=0.78) and MACE (Log Rank test, p=0.36, HR 1.38, CI 95% 0.68–2.81, p=0.37) were comparable between groups [graph no. 1]. Conclusion Upgrade to CRT was similar to de novo implantation in terms of complications and clinical and echo response, in this cohort. The risk for MACE and mortality was also comparable. Graph 1 Funding Acknowledgement Type of funding source: None

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Clinical outcomes after upgrade to resynchronization therapy: a propensity-score matched comparative analysis

EP Europace ◽

10.1093/europace/euab116.448 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

M Brandao ◽

J Goncalves Almeida ◽

P Fonseca ◽

F Rosas ◽

E Santos ◽

...

Keyword(s):

Propensity Score ◽

Clinical Outcomes ◽

De Novo ◽

Nyha Class ◽

Rank Test ◽

Complication Rates ◽

Resynchronization Therapy ◽

Log Rank Test ◽

Device Infection ◽

All Cause Mortality

Abstract Funding Acknowledgements Type of funding sources: None. BACKGROUND Upgrade to resynchronization therapy (CRT) is common practice in Europe. However, guideline recommendations are discordant and randomized trials are lacking. Previous studies have shown worse outcomes in upgraded patients. AIM To compare clinical outcomes in a cohort of patients receiving de novo or upgrade to CRT. METHODS Single-center retrospective study of consecutive patients submitted to CRT implantation (2007-2018). Major adverse cardiac events (MACE) included heart failure hospitalization or all-cause mortality. Clinical response was defined as NYHA class improvement without MACE in the 1st year of follow-up (FU). Left ventricle end-systolic volume reduction of >15% designated echocardiographic (echo) response. Survival analysis with Kaplan-Meier method and Log-rank test was performed. Propensity-score matching (PSM) analysis was performed to adjust for possible confounder variables. RESULTS 295 CRT patients (70.5% male, mean age 67 ± 11 years, 72.5% non-ischemic cardiomyopathy, 54.6% implanted with CRT-D) were included. Fifty-six patients (19%) underwent an upgrade: 43 (78.2%) from a pacemaker and 12 (21.8%) from a defibrillator device. Indications for upgrade were mainly pacemaker dependency or pacing-induced LV dysfunction (76.6%) and de novo left bundle branch block (23.4%). Upgraded patients were older (70 vs 66 years, p=.034), with larger baseline QRS (185 ± 25 vs 163 ± 30 ms, p<.001) and higher rates of atrial fibrillation (58.2% vs 26.7%, p<.001), coronary artery disease (41.8% vs 26.2%, p=.033), moderate to severe valve disease (42.9% vs 22.6%, p=.003) and chronic kidney disease (36.4% vs 18.7%, p=.008). Upgraded patients more frequently received CRT-P (71.4% vs 39.3%, p<.001). CRT-D were more often implanted for secondary prevention (53.3% vs 20.2%, p=.011) in the upgrade group. There were no differences in procedural complications, clinical (59.3 vs 62.6%, p=.765) or echo (72.2% vs 71.9%, p=.970) response rates. During a median FU of 3 ± 5 years, all-cause mortality was similar among groups (Log-rank test, p=.688). MACE occurred more frequently in the upgrade group (Log-rank test, p=.025). No differences emerged in lead complications (8.9% vs 8.4%, p=.892) or device infection (1.8% vs 2.9%, p=.986). PSM analysis identified 106 matched pairs (56 upgrade/50 de novo patients), without baseline statistical differences. All-cause mortality (Log-rank test, p=.555) and MACE (Log-rank test, p=.574) were comparable between groups. CONCLUSION In this cohort, upgrade to CRT was comparable to de novo implantation in terms of clinical and echo response. Moreover, upgrade to CRT was not associated with higher complication rates. All-cause mortality and MACE were similar between groups.

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Outcomes and predictors of clinical response after upgrade to resynchronization therapy

EP Europace ◽

10.1093/europace/euab116.446 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

M Brandao ◽

J Goncalves Almeida ◽

P Fonseca ◽

F Rosas ◽

E Santos ◽

...

Keyword(s):

New York ◽

Left Ventricle ◽

Clinical Response ◽

De Novo ◽

Nyha Class ◽

Heart Association ◽

Resynchronization Therapy ◽

Cardiac Events ◽

Systolic Volume ◽

New Device

Abstract Funding Acknowledgements Type of funding sources: None. BACKGROUND Upgrade to resynchronization therapy (CRT) is common practice in Europe. However, patient selection remains a challenge. Data regarding predictors of response to upgrade is currently lacking. AIM To identify predictors of clinical response after upgrade to CRT. METHODS Single-center retrospective study of consecutive patients submitted to upgrade to CRT (2007-2018). Patients underwent clinical and echocardiographic (echo) evaluation at baseline, 6-months and 1-year. Major adverse cardiac events (MACE) included hospitalization for heart failure (HF) or all-cause mortality. Clinical response was defined as New York Heart Association (NYHA) class improvement without MACE in the 1st year of follow-up (FU). Left ventricle end-systolic volume reduction of >15% designated echo response. Multivariate logistic regression was performed to identify predictors of clinical response to CRT. RESULTS Fifty-six patients submitted to upgrade to CRT (80.4% male, mean age 70.0 ± 9.6 years) were included; 43 patients (78.2%) previously had a pacemaker and 12 (21.8%) had a defibrillator device. Most patients had non-ischemic HF (67.9%), with a mean baseline left ventricle (LV) ejection fraction of 27.9 ± 6.4%. Indications for upgrade were mainly pacemaker dependency or pacing-induced LV dysfunction (76.6%) and de novo left bundle branch block (23.4%). Thirty-one (59.3%) patients were clinical responders. MACE occurred in 37.5% of patients; 28.6% were hospitalized for HF and 13% died during the 1st year of FU. Clinical responders had a lower rate of atrial fibrillation (AF) (46.9% vs. 53.1%, p=.025) and a higher rate of pacemaker rythm prior to upgrade (80.6% vs 47.6%, p=.013). Among responders, the previous device was more frequently a pacemaker (87.5% vs 61.9%, p=.029), and the new device a CRT-P (81.2% vs 54.5%, p=.035). HF etiology did not differ between responders and non-responders. Multivariate analysis identified absence of AF (odds ratio [OR] 4.4, 95% confidence interval [CI] 1.1-17.6, p=.037), CRT-P (OR 5.7, 95% CI 1.3-25.8, p=.022) and quadripolar lead implant (OR 3.8, 95% CI 1.3-25.8, p=.024) as predictors of clinical response in upgraded patients. CONCLUSIONS In this cohort, absence of AF, implantation of CRT-P and use of a quadripolar lead predicted clinical response to upgrade to CRT. Larger studies are warranted to tailor selection of patients for upgrade procedures.

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Outcomes in AML patients age ≥70: A very large single institution experience.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.7031 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 7031-7031

Author(s):

Jeffrey E. Lancet ◽

Jongphil Kim ◽

Najla Al Ali ◽

Marina Sehovic ◽

Tea Reljic ◽

...

Keyword(s):

Clinical Trial ◽

Propensity Score ◽

De Novo ◽

Older Age ◽

Rank Test ◽

Term Survival ◽

Poor Risk ◽

Log Rank Test ◽

Significant Difference ◽

Ecog Ps

7031 Background: AML in older adults is associated with poor outcomes. The Moffitt Cancer Center AML Database was used to evaluate a very large cohort of patients (pts) age ≥ 70 with untreated AML to identify key prognostic variables affecting outcome. Methods: Overall survival (OS): Kaplan-Meier method and was compared across groups using the log-rank test. Association between OS and predictors: Cox regression model. Impact of participation of initial clinical trial on OS: Propensity score with stratified log-rank test. A predictive model for 12 month OS was developed using multiple logistic regression with backward elimination method. Results: Nine hundred eighty (980) pts were identified. M/F(%): 66/34. Median age at diagnosis: 75.7 years (range 70 – 95.7 years). De novo/secondary (%): 43/57. Fifty two % of pts had prior hematologic disease (AHD). Baseline karyotype at AML diagnosis: adverse in 31% and non-adverse in 58%. Baseline ECOG PS: 0-1 in 79%; ≥2 in 19%. Median OS was 7.1 months (95% CI 6.4 – 7.9) for the entire cohort. In the univariable model, factors associated with inferior survival included: secondary AML (sAML) status, poor-risk karyotype, ECOG ≥2, non HMA therapy (including clinical trials), Charlson Comorbidity Index ≥3, older age, increased WBC, decreased platelets (plts), and decreased hemoglobin (hgb). Independent negative predictors for OS in the multivariate model included sAML, poor-risk karyotype, ECOG ≥2, non-HMA initial therapy, older age, increased WBC, decreased plts, and decreased hgb. Propensity score matching revealed no significant difference in OS amongst pts receiving initial treatment on a clinical trial (median 7.8 months, 95% CI 6.4 – 10.4) vs not (median 7.0 months, 95% CI 6 –7.9). A model to predict OS at 12 month was developed in a subset of 446 pts. Independent predictive variables included karyotype, ECOG PS, AML type (de novo vs sAML), age, and WBC, with AUC of 0.78, indicating strong discriminatory capacity. Conclusions: In this largest reported cohort of AML pts age ≥ 70, prognostic modeling identifies differences in longer-term survival with conventional therapies, discriminating the highest risk subsets. Decision modeling to further assist choice of optimal therapies for these pts is in progress.

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Prognostic Value of Elevated Cardiac Troponin I After Aneurysmal Subarachnoid Hemorrhage

Frontiers in Neurology ◽

10.3389/fneur.2021.677961 ◽

2021 ◽

Vol 12 ◽

Author(s):

Fa Lin ◽

Yu Chen ◽

Qiheng He ◽

Chaofan Zeng ◽

Chaoqi Zhang ◽

...

Keyword(s):

Troponin I ◽

Aneurysmal Subarachnoid Hemorrhage ◽

Rank Test ◽

Cardiac Events ◽

Neurological Outcomes ◽

Log Rank Test ◽

Kaplan Meier ◽

All Cause Mortality

Object: Patients with aneurysmal subarachnoid hemorrhage (aSAH) have an increased incidence of cardiac events and short-term unfavorable neurological outcomes during the acute phase of bleeding. We studied whether troponin I elevation after ictus can predict future major adverse cardiac events (MACEs) and long-term neurological outcomes after 2 years.Methods: Consecutive aSAH patients within 3 days of bleeding were eligible for review from a prospective observational cohort (ClinicalTrials.gov Identifier: NCT04785976). Potential predictors of future MACEs and unfavorable long-term neurological outcomes were calculated by Cox and logistic regression analyses. Additional Kaplan–Meier curves were performed.Results: A total of 213 patients were enrolled with an average follow-up duration of 34.3 months. Individuals were divided into two groups: elevated cTnI group and unelevated cTnI group. By the last available follow-up, 20 patients had died, with an overall all-cause mortality rate of 9.4% and an annual all-cause mortality rate of 3.8%. Patients with elevated cTnI had a significantly higher risk of future MACEs (10.6 vs. 2.1%, p = 0.024, and 95% CI: 1.256–23.875) and unfavorable neurological outcomes at discharge, 3-month, 1-, 2-years, and last follow-up (p = 0.001, p < 0.001, p = 0.001, p < 0.001, and p < 0.001, respectively). In the Cox analysis for future MACE, elevated cTnI was the only independent predictor (HR = 5.980; 95% CI: 1.428–25.407, and p = 0.014). In the multivariable logistic analysis for unfavorable neurological outcomes, peak cTnI was significant (OR = 2.951; 95% CI: 1.376–6.323; p = 0.005). Kaplan–Meier analysis indicated that the elevated cTnI was correlated with future MACE (log-rank test, p = 0.007) and subsequent death (log-rank test, p = 0.004).Conclusion: cTnI elevation after aSAH could predict future MACEs and unfavorable neurological outcomes.

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Superresponse to cardiac resynchronization therapy: clinical outcomes and predictors

EP Europace ◽

10.1093/europace/euab116.447 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

M Brandao ◽

J Goncalves Almeida ◽

P Fonseca ◽

F Rosas ◽

E Santos ◽

...

Keyword(s):

Heart Failure ◽

Ejection Fraction ◽

Female Gender ◽

Left Ventricular ◽

Older Age ◽

Rank Test ◽

Resynchronization Therapy ◽

Log Rank Test ◽

Lower Baseline ◽

All Cause Mortality

Abstract Funding Acknowledgements Type of funding sources: None. BACKGROUND Resynchronization therapy (CRT) reduces morbidity and mortality in selected patients with heart failure with reduced ejection fraction (HFrEF). Patients that experience significant reverse remodelling and left ventricular (LV) ejection fraction (LVEF) improvement have been called "superresponders". AIM To describe a cohort of superresponders and identify predictors of superresponse to CRT. METHODS Single-center retrospective study of consecutive patients submitted to CRT implantation (2007-2018). Patients underwent echocardiographic (echo) assessment at baseline, 6-months and 1-year. Superresponse was defined as LVEF≥50% during the 1st year of follow-up (FU). Major adverse cardiac events (MACE) included heart failure hospitalization or all-cause mortality. Multivariate logistic regression was performed to identify predictors of superresponse. Survival analysis with Kaplan-Meier method and Log-rank test was performed to compare outcomes between superresponders and non-superresponders. RESULTS 295 CRT patients (70.5% male, mean age 67 ± 11 years) were included. Fifty-nine (21.4%) patients were superresponders. Superresponders were more often female (42.4% vs 25.8%, p=.021), tended to be older (69.6 vs 66.7 years, p=.054) and had lower rates of coronary disease (17.2% vs 32.9%, p=.032), atrial fibrillation (20.3% vs 38.0%, p=.018), valve disease (13.6% vs 30.0%, p=.018) and chronic kidney disease (6.9% vs 26.0%, p=.003). Superresponders had higher rates of non-ischemic HF (88.1% vs 69.1%, p=.006) and were more often implanted with CRT-P (69.5% vs 37.8%, p<.001). HFrEF medication did not differ between groups. Superresponders had lower baseline LV end-systolic volumes (115.5 vs 166.2 ml, p<.001) and N-terminal pro B-type natriuretic peptide (NT-proBNP) values (1232.6 vs 5252 pg/ml, p<.001). Baseline QRS duration did not differ (171.7 vs 171.3 ms, p=.883). During a median FU of 3 ± 5 years, there were no differences in terms of ventricular arrythmias (5.3% vs 6.8%, p=.913) or appropriate defibrillator therapies (1.8% vs 6.8%, p=.147) between groups. In addition to LVEF improvement (53.7% vs 35.3%, p<.001), superresponders also showed higher tricuspid annular plane systolic excursion values (22.1 vs 19.8 mm, p=.004) during FU. MACE occurred less frequently (Log-rank test, p=.003) and all-cause mortality (Log-rank test, p < 0.001) was lower in superresponders. Multivariate analysis identified female gender (odds ratio [OR] 5.7, 95% confidence interval [CI] 1.03-31.73, p=.045), older age (OR 1.1, 95% CI 1.02-1.24, p=.017) and lower baseline NT-proBNP (OR 0.9, 95% CI 0.99-1.00, p=.011) as independent predictors of superresponse to CRT. CONCLUSION In superresponders, in addition to a significant improvement in LVEF, we observed an improvement in right ventricular function. As expected, MACE and all-cause mortality were lower. Female gender, older age and lower baseline NT-proBNP predicted super-response to CRT.

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New York Heart Association Functional Class Correlates Poorly with Peak Oxygen Consumption during Cardiopulmonary Exercise Tolerance Testing: Implications for Cardiac Resynchronization Therapy

Journal of Cardiac Failure ◽

10.1016/j.cardfail.2008.06.352 ◽

2008 ◽

Vol 14 (6) ◽

pp. S102

Author(s):

Paul L. Eugenio ◽

Eugen C. Palma ◽

Timothy J. Vittorio ◽

Daniel M. Spevack ◽

Ronald Zolty

Keyword(s):

New York ◽

Heart Association ◽

Functional Class ◽

Peak Oxygen Consumption ◽

Cardiac Resynchronization ◽

Resynchronization Therapy ◽

Cardiopulmonary Exercise ◽

Exercise Tolerance Testing ◽

New York Heart Association ◽

Tolerance Testing

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Reduced Albuminuria and Potassemia Indicate Early Renal Repair Processes after Resynchronization Therapy in Cardiorenal Syndrome Type 2

Cardiology Research and Practice ◽

10.1155/2020/2727108 ◽

2020 ◽

Vol 2020 ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Agnieszka Gala-Błądzińska ◽

Janusz Romanek ◽

Danuta Mazur ◽

Tomasz Stepek ◽

Marcin Braun ◽

...

Keyword(s):

New York ◽

Renal Function ◽

Nyha Class ◽

Kidney Injury ◽

Heart Association ◽

Cardiorenal Syndrome ◽

Syndrome Type ◽

Class Iii ◽

Resynchronization Therapy

Background. Patients with chronic cardiorenal syndrome type 2 (T2-CRS) who qualify for resynchronization therapy (CRT) are exposed perioperatively to potentially nephrotoxic factors including contrast agents and blood loss. Methods. The objective of this prospective interventional study was to assess the effects of CRT on renal function in patients with T2-CRS within the first 48 hours following implantation. Initially, 76 patients (15% female; aged 69 ± 9.56 years) with heart failure (New York Heart Association classes II–IV), ejection fraction ≤ 35%, and QRS > 130 ms were included in the study. During CRT implantation, a nonionic contrast agent (72.2 ± 44.9 mL) was administered. Prior to and 48 hours following implantation, renal function was evaluated using the following serum biomarkers: creatinine (sCr), estimated glomerular filtration rate (using the Chronic Kidney Disease Epidemiology Collaboration equation [eGFRCKD-EPI]), and the electrolyte and urine biomarkers albumin (uAlb), albumin/creatinine ratio (UACR), and neutrophil gelatinase-associated lipocalin (uNGAL). Results. Before CRT, patients classified as NYHA class III or IV had higher uNGAL levels in comparison to uNGAL levels after CRT (43.63 ± 60.02 versus 16.63 ± 18.19; p=0.041). After CRT implantation, uAlb, UACR, and potassium levels were reduced (p<0.05), and uNGAL, sCr, and eGFRCKD-EPI were unchanged. The contrast medium volume did not correlate with the test biomarkers (p>0.05). Conclusions. In patients with T2-CRS, uNGAL is a biomarker of kidney injury that correlates with the NYHA classes. A stable uNGAL value before and after CRT implantation confirms the lack of risk of contrast-induced nephropathy. Reduced albuminuria and blood potassium are biomarkers of improving T2-CRS in the early post-CRT period.

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