Learning Curve in Left Ventricular Assist Device Implantation: Low Volumes Do Not Equate Bad Outcomes

ABSTRACT Introduction: Most implantations of left ventricular assist devices (LVAD) are performed in low-volume centers. This study aimed to evaluate the procedural learning curve of HeartMate II (HM2) implantations by comparing outcomes between two time periods in a low-volume center. Methods: All 51 consecutive patients undergoing HM2 implantation between January 2009 and December 2017 were reviewed and allocated into 2 groups: early-era group (from 2009 to 2014; n=25) and late-era group (from 2015 to 2017; n=26). The primary outcome was the 90-day mortality rate, and the secondary outcome was a composite of mortality, neurological event, reoperation for bleeding, need for temporary right ventricular assist device, and pump thrombosis at 90 days. Median follow-up time was 51 months (0-136). A cumulative sum (CUSUM) control analysis was used to establish a threshold of implantations that optimizes outcomes. Results: Patients in the early era had a higher rate of diabetes, previous stroke, and inotrope support before HM2 implantation. The 90-day mortality rate was not significantly higher in the early era (24% vs. 15%, P=0.43), but the composite endpoint was significantly higher (76% vs. 42%, P=0.01). The CUSUM analysis found a threshold of 23 operations after which the composite endpoint was optimized. Conclusion: Patients undergoing HM2 implantation in a low-volume center have improving outcomes with number of cases and optimized results after a threshold of 23 cases. Significant changes in patient selection, surgical techniques, and patient management might lead to improved outcomes after LVAD implantation.

Reassessment of the dementia diagnosis of Alzheimers disease in patients enrolled on the cholinesterase inhibitors dispensation program / Reavaliação do diagnóstio de demência da doença de alzheimer em pacientes inscritos no programa dedispensação de inibidores de colinesterase

Reassess the diagnosis of Alzheimers Disease (AD) in patients treated with anti-cholinesterasesdispensed by High Cost Drug stores (Exceptional Drugs Program). Methods: A prospective study to reassess the diagnosisof probable Alzheimers Disease was conducted (AD). The patients were submitted to the protocol of dementia investigationat the Neurogeriatric Outpatient Clinic of the Teaching Hospital de Base de São José do Rio Preto. Groups were classifiedusing the criteria of the National Institute of Neurologic and Communicative Diseases and Vascular Cerebral Accident andAlzheimer Disease Related Association (NINCDS-ADRDA). The study was completed by applying the Disability Assessmentfor Dementia (DAD). The significance level was set at 5%. Results: 106 patients participated, selected randomly from agroup of 390 patients contacted when receiving their medication at the High Cost Drug store. Two groups were formed:the first, containing 52 patients who fulfilled criteria for AD (FC Group); and a second, with 54 patients not fulfilling criteria(NFC). The FC Group had older age, worse performance on the Mini-Mental State Exam (MMSE) and poorer performanceon the DAD. Also, treatment time was longer and drugs doses higher in the FC Group. Conclusion: Study results showed ahigh number of patients using anti-cholinesterases that did not fulfill the diagnosis criteria for probable AD. Comparison ofthe two groups revealed different behavior between them, corroborating the hypothesis of inadequate inclusion of the NFCGroup patients in the Exceptional Drugs Program.

Reavaliar o diagnóstico de Doença de Alzheimer (DA) nos pacientes em tratamento com anticolinesterásicosdispensados pelas farmácias de alto custo (Programa de Medicamentos Excepcionais). Métodos: Estudoprospectivo, para reavaliação do diagnóstico de Doença de Alzheimer (DA) provável. Os pacientes foram submetidos aoprotocolo de investigação de demências do ambulatório de Neurogeriatria do Hospital de Base de São José do Rio Preto.Utilizou-se para classificação nos grupos critérios do Instituto Nacional de Doenças Neurológicas e Comunicativas e AcidenteVascular Cerebral e Associação da Doença de Alzheimer e Doenças Relacionadas (NINCDS-ADRA). Completou-se o estudoutilizando-se a Escala para Avaliação de Incapacidades na Demência (DAD). Foi estabelecido o nível de significância em 5%.Resultados: Participaram 106 pacientes, selecionados aleatoriamente de um grupo de 390 pacientes contactados quandorecebiam o medicamento na farmácia de alto-custo. Obtiveram-se dois grupos: o primeiro que preencheu critérios paraDA (Grupo PC), que incluiu 52 pacientes e o segundo grupo o qual não preencheu critérios (Grupo ÑPC) com 54 pacientes.O Grupo PC apresentou: idade mais elevada, pior performance no Mini Exame do Estado Mental (MEEM) e desempenhoinferior na DAD. O tempo de tratamento era maior e doses mais elevadas dos medicamentos no Grupo PC. Conclusão:De acordo com os resultados do estudo, observou-se um grande número de pacientes utilizando anticolinesterásicos quenão preencheram os critérios diagnósticos para DA provável. Na comparação dos dois grupos observou-se comportamentodiferente dos mesmos, que permitiram corroborar com a hipótese de inclusão inadequada dos pacientes do Grupo ÑPC noPrograma de Medicamentos Excepcionais.