An “actual” problem: Another issue of apples and oranges

Bodnár, E; Blackstone, Eugene H.

doi:10.1016/j.jtcvs.2005.11.013

Cited by 17 publications

(15 citation statements)

References 9 publications

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“…With the prosthesis as the unit of measure [7], explant and each indication for explant, including SVD, were assessed nonparametrically using the Kaplan-Meier method, and the time-varying instantaneous risk of explant (hazard function) was assessed parametrically using a multiphase hazard model [8]. A competing risks analysis was performed considering the mutually exclusive outcomes explant for SVD, endocarditis, or other cause, and death before explant [9].…”

Section: Methodsmentioning

confidence: 99%

Long-Term Durability of Bioprosthetic Aortic Valves: Implications From 12,569 Implants

Johnston

Soltesz

Vakil

et al. 2015

The Annals of Thoracic Surgery

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393

256

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Background Increased life expectancy and younger patients’ desire to avoid lifelong anticoagulation requires a better understanding of bioprosthetic valve failure. This study evaluates risk factors associated with explantation for structural valve deterioration (SVD) in a long-term series of Carpentier-Edwards PERIMOUNT aortic valves (AV). Methods From June 1982 to January 2011, 12,569 patients underwent AV replacement with Edwards Lifesciences Carpentier-Edwards PERIMOUNT stented bovine pericardial prostheses, models 2700PM (n = 310) or 2700 (n = 12,259). Mean age was 71 ± 11 years (range, 18 to 98 years). 93% had native AV disease, 48% underwent concomitant coronary artery bypass grafting, and 26% had additional valve surgery. There were 81,706 patient-years of systematic follow-up data available for analysis. Demographics, intraoperative variables, and 27,386 echocardiographic records were used to identify risks for explant for SVD and assess longitudinal changes in transprosthesis gradients using time-varying covariable analyses. Results Three hundred fifty-four explants were performed, with 41% related to endocarditis and 44% to SVD. Actuarial estimates of explant for SVD at 10 and 20 years were 1.9% and 15% overall, respectively, and in patients younger than 60 years, 5.6% and 46%, respectively. Younger age (p < 0.0001), lipid-lowering drugs (p = 0.002), prosthesis–patient mismatch (p = 0.001), and higher postoperative peak and mean AV gradients were associated with explant for SVD (p < 0.0001). The effect of gradient on SVD was greatest in patients younger than 60 years. Conclusions Durability of the Carpentier-Edwards PERIMOUNT aortic valve is excellent even in younger patients. Explant for SVD is related to gradient at implantation, especially in younger patients. Strategies to reduce early postoperative AV gradients, such as root enlargement or more efficient prostheses, should be considered.

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Section: Methodsmentioning

confidence: 99%

Long-Term Durability of Bioprosthetic Aortic Valves: Implications From 12,569 Implants

Johnston

Soltesz

Vakil

et al. 2015

The Annals of Thoracic Surgery

Self Cite

393

256

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“…Unfortunately, in many publications, it has been and is being incorrectly labeled as "actual freedom from SVD." "Actual freedom" is not a statistical term (80). The definition of actual in English is "existing in fact; real" (81, 82), and the actual method provides a value that neither exists in fact nor is real.…”

Section: Svd Of Bioprosthesis In Younger and Older Patientsmentioning

confidence: 99%

“…The definition of actual in English is "existing in fact; real" (81, 82), and the actual method provides a value that neither exists in fact nor is real. The statistical aspects of the actual method have been discussed in an editorial and letters to the editors by statisticians and their colleagues (80,83,84). Two journals have stated they will no longer publish "actual freedom" results in articles reporting longterm intrinsic performance of PHV (80).…”

Section: Svd Of Bioprosthesis In Younger and Older Patientsmentioning

confidence: 99%

“…The statistical aspects of the actual method have been discussed in an editorial and letters to the editors by statisticians and their colleagues (80,83,84). Two journals have stated they will no longer publish "actual freedom" results in articles reporting longterm intrinsic performance of PHV (80). Many comorbid conditions listed in Table 3 contribute to, or are a cause of, both death and nonfatal events, and thus contribute to both of the "competing risks" (death and nonfatal events), but very few publications provide data on these comorbid conditions.…”

Section: Svd Of Bioprosthesis In Younger and Older Patientsmentioning

confidence: 99%

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Choice of Prosthetic Heart Valve in Adults

Rahimtoola

2010

Journal of the American College of Cardiology

327

234

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In the last 7 years, more data have reconfirmed that patients' comorbid conditions are very important factors determining patient outcomes. Prosthetic heart valves (PHVs) that require aortic root replacement in the absence of aortic root disease are associated with poorer outcomes. For the vast majority of patients, the choice of PHV is between a mechanical valve and a stented bioprosthesis. The choice is largely dependent upon the age of the patient at the time of PHV implantation and on which complication the patient wants to avoid: specifically, anticoagulation therapy and its complications with the mechanical valve, and structural valve deterioration with a bioprosthesis. Data on the pros and cons of the choices and exceptions to the rules are discussed, and a new algorithm is developed.

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“…Statistical methods to properly analyze competing causes of failure are available 5 and have been a mainstay in heart valve diseases for some 30 years. 6,7 Although appropriate use of competing risks analysis has been advocated in structural valve deterioration, 8,9 the competing risk approach has not been translated yet to ICD research.…”

Section: Editorial P 1912 Clinical Perspective P 1926mentioning

confidence: 99%

Death Without Prior Appropriate Implantable Cardioverter-Defibrillator Therapy

et al. 2008

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Background-Implantable cardioverter-defibrillators (ICDs) improve survival in selected patients with left ventricular systolic dysfunction in randomized trials. Competing death without prior appropriate ICD therapy might preclude benefit from ICD implantation in a less selected routine-care population. Methods and Results-We selected all patients with ischemic or dilated cardiomyopathy with an ICD implanted for primary or secondary prevention from a single-center prospective registry between 1994 and 2006. The end point was time to first appropriate ICD therapy/confirmed ventricular fibrillation or death without prior appropriate ICD therapy. We analyzed cumulative incidence functions and used competing risk regression to study predictors of appropriate ICD therapy or prior death. In 442 patients, 73 deaths occurred during a median follow-up of 3.6 years (maximum, 12.7 years). The cumulative incidence of first appropriate ICD therapy until year 7 was 52%, whereas 11% died without prior ICD therapy. The cumulative incidence of appropriate ICD therapy for ventricular fibrillation was 13%, whereas 23% died without prior therapy for ventricular fibrillation. Appropriate ICD therapy was twice as likely in secondary prevention compared with primary prevention, whereas death rates before ICD therapy were similar in both groups. Diuretic use for heart failure compared with nonuse predicted a 4-fold-increased risk of death prior to ICD therapy, although the incidence of appropriate ICD therapy was similar in both groups. Conclusion-In a contemporary ICD population, the risk of death without prior appropriate ICD therapy is substantial, especially in patients with advanced heart failure.

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An “actual” problem: Another issue of apples and oranges

Cited by 17 publications

References 9 publications

Long-Term Durability of Bioprosthetic Aortic Valves: Implications From 12,569 Implants

Long-Term Durability of Bioprosthetic Aortic Valves: Implications From 12,569 Implants

Choice of Prosthetic Heart Valve in Adults

Death Without Prior Appropriate Implantable Cardioverter-Defibrillator Therapy

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