Cardiac Resynchronization Therapy: Relevance of the Surgical Approach in the Implantation of the Left Ventricular Probe

Heart failure is very common and reaches more than 56 million people worldwide. 17 to 45 percent die in the first year of hospitalization. The most affected populations live in Western countries like Europe or the USA.

It is defined by a set of signs and symptoms such as dyspnea, asthenia, edema or tachycardia but must be objectified, preferably by ultrasound. Its basic treatment is based on a lifestyle improvement and a reduction of the risk factors (hypertension, dyslipidemia, diabetes, ...), as well as an optimal medical treatment based on ACE inhibitors, B-blockers, ARA2 (Sartans), spironolactone or digoxin.

When the optimal treatment is no longer working and that the cardiac desynchronization is demonstrated, be it atrio-ventricular, inter-ventricular or intra-ventricular, the patient can benefit from a three-probes cardiac resynchronization to resynchronize the two ventricles. The classic approach, performed by a cardiologist, is to perform an endovenous procedure in order to place the 3 probes under local anesthesia.The first one goes in the right atrium, the second one in the right ventricle and the third one goes in the left ventricle. It is the placement of this third one that often causes trouble. It is more difficult to place since it must pass through the coronary sinus, outside of the heart, unlike the first two probes that are placed endocavitary. When the practitioner fails to place the probe correctly or obtains inappropriate levels of detection, stimulation, or impedance thresholds, a cardiac surgeon must intervene and carry out a mini-thoracotomy.

The CHU Brugmann Hospital is in favor of a mixed surgical approach. The probes are placed by a cardiac surgeon, who first starts by a endo-venous placement under local anesthesia. If that approach fails, the local anesthesia can be transformed into general anesthesia at the same operative time and a mini-thoracotomy is performed.

The aim of this study is to evaluate the immediate impact of this surgical management within the CHU Brugmann hospital, in patients suffering from cardiac insufficiency despite proper medication.The hypothesis is that the mixed surgical approach improves the prognosis of cardiac resynchronization.

Study Overview

• Status: Completed
• Conditions: Cardiac Insufficiency
• Intervention / Treatment: Other: Medical Files data extraction

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiac insufficiency (i.e in NYHA class III or IV) or refractory to optimal medical treatment (155 patients since 2003) in the Brugmann University Hospital, in the cardiac surgery department.

Description

Inclusion Criteria:

• Patient who underwent cardiac resynchronization within the Brugmann University Hospital from 2003 til July 2016

• Cardiac insufficiency, whatever the origin, demonstrated by a cardiologist with demonstrated ventricular asynchronism.

  • With left ventricular ejection fraction <35%
  • And / or a left ventricular diastolic diastolic diameter> 55 mm
  • And / or QRS measuring> 130 milli sec
  • And / or left branch block
• Redo procedure on a pacemaker

Exclusion Criteria:

• Change of case on a patient who has already benefited from a triple chamber stimulator

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac insufficiency; Patients with cardiac insufficiency (i.e in NYHA class III or IV) or refractory to optimal medical treatment (155 patients since 2003) in the Brugmann University Hospital, in the cardiac surgery department	Other: Medical Files data extraction; Medical Files data extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct failure rate of the mixed approach	Direct failure rate of the mixed approach	7 years
Demographic data	Demographic data (descriptive analysis)	7 years
Risks factors	Descriptive analysis of the risks factors linked to the failure of the procedure	7 years
Type of cardiopathy	Type of cardiopathy	7 years
PR interval	PR interval	7 years
QRS interval	QRS interval	7 years

Collaborators and Investigators

• Sponsor: Pierre Wauthy
• Investigators: Study Director: Pierre Wauthy, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): May 29, 2018
• Study Completion (Actual): May 29, 2018

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac resynchronisation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CHUB-cardiac resynchronization

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No