Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study. (2025)

Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study. (1)

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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.

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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Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study. (3)

Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study. (2025)

FAQs

What is the new treatment for resistant hypertension? ›

The US Food and Drug Administration (FDA) has approved aprocitentan (Tryvio) to lower blood pressure, in combination with other antihypertensive agents, in adults with treatment-resistant hypertension. Aprocitentan is the first endothelin receptor antagonist approved for patients with hypertension.

How do you get rid of resistant hypertension? ›

Most people with resistant hypertension can manage their blood pressure with medication. In addition to prescribing medication, your provider might need to try some different approaches, like replacing one diuretic with a stronger one or having you take one of your non-diuretic medicines at night.

What is the drug of choice for resistant hypertension? ›

Aldosterone excess is common in patients with resistant hypertension, and addition of spironolactone or amiloride to the standard 3-drug antihypertensive regimen is effective at getting the blood pressure to goal in most of these patients.

What is Baroreflex activation therapy for hypertension? ›

Baroreflex activation therapy is a novel technique for treating patients with resistant hypertension. Although short-term studies have demonstrated that it lowers blood pressure, long-term results have not yet been reported.

Can you get disability for resistant hypertension? ›

If you have resistant hypertension – high blood pressure that does not respond to 3 or more drugs – you may be entitled to Social Security Disability benefits. It is important that you have an ambulatory blood pressure readings if you have resistant hypertension.

What are the side effects of resistant hypertension? ›

As the arteries become narrower and less flexible, the heart has to work harder to move blood through the body. Uncontrolled high blood pressure can lead to stroke, heart attack, heart failure and other heart conditions; cause damage to your kidneys, memory and vision; and contribute to erectile dysfunction.

What is the prognosis for resistant hypertension? ›

Patients with resistant hypertension are at higher risk of complications including cardiovascular disease, stroke, kidney failure, and death. It is important to identify common factors that contribute to resistant hypertension to mitigate their effects.

What doctor treats resistant hypertension? ›

Your Resistant Hypertension Care Team

There are many healthcare providers you might meet throughout your journey, including: Cardiologists (heart specialists). Nephrologists (kidney specialists). Endocrinologists (hormone specialists).

What are the two worst blood pressure medications? ›

5 of the worst blood pressure medications
  1. Beta blockers. Usually, beta blockers aren't used as first-choice therapies to lower blood pressure. ...
  2. Loop diuretics. Furosemide (Lasix) is a type of diuretic (water pill) known as a loop diuretic. ...
  3. Alpha blockers. ...
  4. Vasodilators. ...
  5. Alpha-2 agonists.

What is the best diuretic for resistant hypertension? ›

Spironolactone is the most effective fourth medication for treating RHTN in patients already on treatment with triple regimens that include an ACE inhibitor or ARB, amlodipine, and a thiazide-like diuretic.

What is the surgery for resistant hypertension? ›

Renal denervation (also called renal ablation) is a minimally invasive, investigational procedure to treat hypertension (high blood pressure) that hasn't improved with other treatments. This type of hypertension is called resistant hypertension.

What is the new triple pill for blood pressure? ›

Patients were randomly assigned to receive either the combination pill or usual care – their doctor's choice of blood pressure lowering medication. The Triple Pill, consisted of the commonly used blood pressure medications telmisartan (20 mg), amlodipine (2.5 mg), and chlorthalidone (12.5 mg).

Can baroreflex failure be cured? ›

The outcome for baroreflex failure can vary depending on factors such as the underlying cause of the condition, the severity of symptoms, response to treatment, and a person's overall health. Often, the condition responds to treatment.

What medication is used for baroreflex failure? ›

Clonidine attenuates the pressor and tachycardic surges in baroreflex failure.

What triggers baroreflex? ›

Any change in your body's demand for blood can trigger your baroreceptor reflex. For example, your body may need to adjust your blood pressure when you: Change your body position, such as when you stand. See or experience something that frightens you.

What is the best combination for resistant hypertension? ›

Spironolactone is the most effective fourth medication for treating RHTN in patients already on treatment with triple regimens that include an ACE inhibitor or ARB, amlodipine, and a thiazide-like diuretic.

What are the new drugs for hypertension in 2024? ›

It was therefore with cautious optimism that on March 19, 2024, the US Federal Drug Administration (FDA) approved aprocitentan (TRYVIO™) an endothelin (ET) receptor antagonist (ETRA) for resistant hypertension. This is the first new class of oral antihypertensive medicines to be approved by the FDA in almost 40 years.

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