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Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study.
van Kleef, Monique E A M; Devireddy, Chandan M; van der Heyden, Jan; Bates, Mark C; Bakris, George L; Stone, Gregg W; Williams, Bryan; Spiering, Wilko.
Afiliação
- van Kleef MEAM; Department of Vascular Medicine, University Medical Center Utrecht, Utrecht University, the Netherlands.
- Devireddy CM; Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia, USA.
- van der Heyden J; Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
- Bates MC; CAMC Institute of Academic Medicine and West Virginia University, Charleston, West Virginia, USA.
- Bakris GL; Department of Medicine, American Society of Hypertension Comprehensive Hypertension Center, University of Chicago Medicine, Chicago, Illinois, USA.
- Stone GW; The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, New York, New York, USA.
- Williams B; University College London Institute of Cardiovascular Science and National Institute for Health Research UCL Hospitals Biomedical Research Centre, London, United Kingdom.
- Spiering W; Department of Vascular Medicine, University Medical Center Utrecht, Utrecht University, the Netherlands. Electronic address: w.spiering@umcutrecht.nl.
JACC Cardiovasc Interv ; 15(3): 321-332, 2022 02 14.
Article em En
| MEDLINE| ID: mdl-35144789
- ABSTRACT
ABSTRACT
OBJECTIVES:
The aim of this study was to evaluate the long-term (3-year) safety and effectiveness of endovascular baroreflex amplification (EVBA) from both the European and American CALM-FIM cohorts.
BACKGROUND:
The CALM-FIM study demonstrated that EVBA in patients with resistant hypertension significantly lowered blood pressure (BP) with an acceptable safety profile during 6-month follow-up.
METHODS:
The CALM-FIM studies were prospective, nonrandomized, first-in-human studies that enrolled patients with resistant hypertension (office systolic BP≥160mm Hg and mean 24-hour ambulatory BP≥130/80mm Hg despite a stable regimen of≥3 antihypertensive medications, including a diuretic agent). The incidence of (serious) adverse events and changes in BP, heart rate, and prescribed antihypertensive medication up to 3 years after implantation were determined.
RESULTS:
The Mobius device was implanted in 47 patients (30 in Europe, 17 in the United States; mean age 54 years, 23women). Five serious adverse events (hypotension, n=2; hypertension, n=1; vascular access complications, n=2) and 2 transient ischemic attacks occurred within 30days postprocedure. Two strokes and 1 transient ischemic attack occurred more than 2 years postimplantation. Mean office BP at baseline was 181 ± 17/107 ± 16mm Hg and decreasedby25/12mm Hg (95%CI 17-33/8-17mm Hg) at 6months and 30/12mmHg (95%CI 21-38/8-17mm Hg) at3years.Mean24-hour ambulatory BP at baseline was 166 ± 16/98 ± 15mm Hg and decreased by 20/11mm Hg (95%CI 14-25/8-15mm Hg) at 6months.
CONCLUSIONS:
EVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated implantation, although data from randomized sham-controlled trials are needed to further evaluate the risk-benefit profile. (Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_EUR], NCT01911897; Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_US], NCT01831895).
Assuntos
Barorreflexo; Hipertensão; Anti-Hipertensivos/efeitos adversos; Barorreflexo/fisiologia; Pressão Sanguínea; Monitorização Ambulatorial da Pressão Arterial; Feminino; Humanos; Hipertensão/diagnóstico; Hipertensão/tratamento farmacológico; Masculino; Pessoa de Meia-Idade; Estudos Prospectivos; Resultado do Tratamento
Palavras-chave
antihypertension device; baroreceptor modulation; baroreflex; endovascular baroreflex amplification; hypertension
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Barorreflexo / Hipertensão Tipo de estudo: Clinical_trials / Diagnostic_studies / Observational_studies / Risk_factors_studies Limite: Female / Humans / Male / Middle aged Idioma: En Revista: JACC Cardiovasc Interv Assunto da revista: ANGIOLOGIA / CARDIOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Holanda
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Barorreflexo / Hipertensão Tipo de estudo: Clinical_trials / Diagnostic_studies / Observational_studies / Risk_factors_studies Limite: Female / Humans / Male / Middle aged Idioma: En Revista: JACC Cardiovasc Interv Assunto da revista: ANGIOLOGIA / CARDIOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Holanda
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(instance:"regional") AND ( year_cluster:("2002") AND pais_afiliacao:("^iUnited States^eEstados"))(instance:"regional") AND ( year_cluster:("2002") AND pais_afiliacao:("^iUnited States^eEstados"))(instance:"regional") AND ( year_cluster:("2002") AND pais_afiliacao:("^iUnited States^eEstados"))(instance:"regional") AND ( year_cluster:("2002") AND pais_afiliacao:("^iUnited States^eEstados"))
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