Mechanical circulatory support devices for acute heart failure syndromes: considerations for clinical trial design.

Mechanical circulatory support (MCS) devices are a guideline-recommended treatment option for a small subset of advanced heart failure patients. MCS has the potential to become more prominent in the management of Acute Heart Failure Syndromes (AHFS) as device technology advances and as clinical trials consistently discover neutral or harmful effects with pharmacologic therapies hypothesized to be beneficial in this population. While it is now possible to identify AHFS patients who are at high risk of death, the therapeutic options available to improve their long-term outcomes are limited. MCS therapy in this population offers a "bridge to recovery" strategy; these patients may have viable myocardium that responds favorably to the influence of MCS on neurohormones, cytokines, and/or reverse remodeling. Patients at high risk for mortality who have a substantial likelihood of benefiting from MCS can be easily identified using standard clinical criteria developed from large observational databases. MCS technology is rapidly evolving, and risks related to implantation are declining. It is evident that rigorous clinical trial testing of the potential risks, benefits, and economic implications of MCS in patients with AHFS will need to be conducted before the "routine" application of this aggressive therapy. This paper examines the rationale for conducting trials of MCS devices in patients with AHFS, and it explores considerations for patient selection and appropriate endpoints. This manuscript was generated from discussions on this issue during the third international meeting of the International Working Group on AHFS held in Washington, DC, April 8-9, 2006.

Mechanical circulatory support: new advances, new pumps, new ideas.

Mechanical circulatory support (MCS) is a viable therapy for severe end-stage heart disease. Most obstacles to long-term MCS therapy have been overcome, and a number of clinical trials, including the recent REMATCH trial, have shown a clear benefit in terms of survival and improved quality of life. MCS should therefore no longer be considered as simply a temporary bridge to other therapies, but also a destination therapy whose potential should continue to expand through the development and use of newer, more innovative devices such as continuous flow pumps, next-generation centrifugal pumps, and total artificial hearts. The homebound heart failure patient and the patient facing imminent death from massive myocardial infarction receive little statistical benefit from current therapies, and the new and evolving MCS technologies offer the potential for effective therapy to these desperately ill patients.

Assistência circulatória mecânica: aspectos atuais / Mechanical cardiac assistance: an update

Säo apresentados o desenvolvimento histórico da assistência circulatória mecânica e seu impacto sobre a cirurgia cardíaca e sobre o tratamento da insuficiência cardíaca grave, principalmente nas seguintes situaçöes: choque cardiogênico pós-cirurgia cardíaca, choque cardiogênico pós-infarto do miocárdio, ponte para transplante aguardando doaçäo de órgäo e ponte para recuperaçäo aguardando melhora funcional do coraçäo e desmame. Säo descritos os diversos dispositivos de fluxo pulsátil e contínuo, seu modo de atuaçäo, bem como as configuraçöes sériee paralelo e os acessos mais utilizados nas conexöes ao paciente. Säo discutidos os critérios de indicaçäo e os resultados dos vários métodos e dispositivos quando utilizados nas situaçöes acima.

[Methods and modern apparatus for assisted circulation. The basic trends in their development]. / Sposoby i sovremennaia apparatura vspomogatel'nogo krovoobrashcheniia. Osnovnye tendentsii ikh razvitiia

A systematization of methods for assisted circulation, based on the formulation of a concrete procedure, the nature of the deranged or lost function substitution and conditions for effective realization of such a substitution, is offered. This made it possible to classify the equipment for assisted circulation and to analyze the current trends of its further development. The most characteristic automation levels of the equipment under consideration and of generations of some apparatus, differing in the degree of automation, control and monitoring the process of assisted circulation, are presented in the form of tables and pictures.