Cardiac Catheter

The module Cardiac Catheter is used to document a cardiac catheter examination. This examination enables a better phenotyping of cardiomyopathies, an assessment of the degree of severity and of the prognosis.
The examinations ought to be performed according to DZHK-SOP-K-05 .

Content

Examination details
Right heart catheterisation
Left heart catheterisation
Myocardial biopsy
Storage diseases
Histological/ Immunohistological/ viral findings report
Procedural complications

Examination details

Quality level

Level 1: The examination is performed in accordance with the guidelines of the medical associations.

Level 2: The examination is performed in accordance with the specifications of the DZHK SOP. Minimum requirements to ensure the quality of the implementation and the examiners are defined in the SOP.

Level 3: The examination is performed in accordance with the specifications of the DZHK SOP and certification of the examiners: Definition of intr-observer and interobserver-variability (standard of epidemiological studies).

DZHK-SOP-K-05: Cardiac Catheterization, Version: V1.0, Valid as of: 01.09.2014

  Fieldname: herzkat_qualitaet
  Data type: Integer with following options
    1
    2
    3

Right heart catheterisation

Catheterization of the right side of the heart is performed in accordance with the relevant standards and the respective study protocol. Puncture of the right femoral vein is performed under aspiration approx. 2 cm medial to the arterial puncture site. The guide wire is introduced through the indwelling catheter into the cranial vein until the tip reaches the inferior vena cava. To widen the puncture channel, the 7 French dilatator is fully inserted and subsequently exchanged for the 7F multipurpose catheter (MPC). The MPC is positioned above the guide wire in the upper part of the superior vena cava. After removal of the guide wire, the venous oxygen saturation levels are taken.
DZHK-SOP-K-05: Cardiac Catheterization, Version: V1.0, Valid as of: 01.09.2014

Was the right heart catheterisation performed

  Fieldname: herzkat_rechtsjanein
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Date of examination

  Fieldname: herzkat_daterechts
  Data type: Timestamp with day, month and year

Left ventricular end-diastolic pressure (LVEDP)

  Fieldname: herzkat_lvedp
  Data type: Integer with maximum 2 digits in mmHg

Heart time volume

Calculation according to Fick's equation:(vO2 *avDO2-1)
vO_{2 Men}= KO*(161-age*0,54) (ml*min^-1) (empiric)

vO_{2 Women}= KO*(147,5-age*0,47) (ml*min^-1)(empiric)

avDO₂= CO_2art-CO_2ven

CO_2art=O2 saturation (femoral artery)*Hb*1,34

CO_2ven=O2 saturation (pulmonary artery)*Hb*1,34

DZHK-SOP-K-05: Cardiac Catheterization, Version: V1.0, Valid as of: 01.09.2014

  Fieldname: herzkat_herzvol
  Data type: Floating point number with 2 places before and 1 place after comma in l/min

Systolic pulmonary artery pressure

  Fieldname: herzkat_sys
  Data type: Integer with maximum 3 digits in mmHg

Diastolic pulmonary artery pressure

  Fieldname: herzkat_dia
  Data type: Integer with maximum 2 digits in mmHg

Mean pulmonary artery pressure

  Fieldname: herzkat_mittpuldruck
  Data type: Integer with maximum 2 digits in mmHg

Pulmonary capillary pressure (PCWP)

  Fieldname: herzkat_pcwp
  Data type: Integer with maximum 2 digits in mmHg

Mean RA

  Fieldname: herzkat_ramittel
  Data type: Integer with maximum 2 digits in mmHg

Central venous oxygen saturation

  Fieldname: herzkat_zentrvensaet
  Data type: Integer with maximum 2 digits in %

Arterial oxygen saturation

  Fieldname: herzkat_artersaet
  Data type: Integer with maximum 2 digits in %

Transpulmonary gradient

  Fieldname: herzkat_gradient
  Data type: Integer with maximum 2 digits in mmHg

Pulmonary vascular resistance

Calculation:
80*(mPAP-mPCPW)*HZV^-1(normal range: 45-120)

DZHK-SOP-K-05: Cardiac Catheterization, Version: V1.0, Valid as of: 01.09.2014

  Fieldname: herzkat_lungwider
  Data type: Integer with maximum 3 digits in dyn*s*cm-5

Systemic vascular resistance (SVR)

Calculation:
80*(mAP-ZVD)*HZV^-1(normal range: 900-1400)

DZHK-SOP-K-05: Cardiac Catheterization, Version: V1.0, Valid as of: 01.09.2014

  Fieldname: herzkat_svr
  Data type: Integer with maximum 4 digits in dyn*s*cm-5

Body height

  Fieldname: herzkat_koerpgroess
  Data type: Integer with maximum 4 digits in cm

Weight

  Fieldname: herzkat_gewicht
  Data type: Integer with maximum 3 digits in kg

Haemoglobin

  Fieldname: herzkat_haemogdl
  Data type: Floating point number with 2 places before and 2 places after comma in g/dl

  Fieldname: herzkat_haemmoll
  Data type: Floating point number with 2 places before and 1 place after comma in mmol/l

Left heart catheterisation

Was the left heart catheterisation performed

  Fieldname: herzkat_linksjanein
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Date of recording

  Fieldname: herzkat_datelinks
  Data type: Timestamp with day, month and year

Coronary heart disease (CHD)

  Fieldname: herzkat_khk
  Data type: String with following options
    none
    1-vessel CHD
    2-vessel CHD
    3-vessel CHD
    unknown
    not assessed

Pump function

Assessment of left ventricular (pump)function is qualitative:
1. Evaluation of wall motion abnormalities according to the nomenclature defined by Herman at al. (Herman et al.).

2. The classification and evaluation of specific wall regions are to be documented according to the Coronary Artery Disease Reporting System of the AHA (Austen et al.).

DZHK-SOP-K-05: Cardiac Catheterization, Version: V1.0, Valid as of: 01.09.2014

  Fieldname: herzkat_pumpfunk
  Data type: String with following options
    good
    mildly impaired
    moderately impaired
    severely impaired
    unknown
    not assessed

Myokardial biopsy

Removal of endomyocardial biopsies is performed in accordance with the relevant standards and the respective study protocol. After the coronary angiography has been performed the arterial 4F sheath is exchanged for the 8F sheath. This is followed by retrograde catheterization of the aortic valve in 20° RAO projection and placement of a 7F guiding catheter in the left ventricle. Under fluoroscopy, the tip of the catheter is positioned in the target region. Contrast agent is injected to ensure adequate distance to the endomyocard and to avoid injuries of the papillary muscles. The biopsy forceps is inserted through the 7F guiding catheter and biopsies are collected from different parts of the left ventricle. Immediately after collection of the myocardial biopsy, transthoracic echocardiography is performed to exclude the presence of pericardial effusion.
DZHK-SOP-K-05: Cardiac Catheterization, Version: V1.0, Valid as of: 01.09.2014

Was the myokardial biopsy performed

  Fieldname: herzkat_myokjanein
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Date of recording

  Fieldname: herzkat_datemyokard
  Data type: Timestamp with day, month and year

Ventricle

  Fieldname: herzkat_ventrikel
  Data type: String with following options
    LV
    RV
    LV and RV
    unknown
    not assessed

Institution performing the assessment

  Fieldname: herzkat_institut
  Data type: Free text

Previous biopsies

Previous biopsies available

  Fieldname: herzkat_vorbiopsien
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Date of previous biopsy

  Fieldname: herzkat_vorbiopsdate
  Data type: Timestamp with day, month and year

Previous diagnosis

  Fieldname: herzkat_vordiagn
  Data type:Freetext

Number of biopsies

The recommended number of biopsies depends on the clinical question under consideration and whether material is to be collected for the purpose of addressing research questions. The latter is only possible if an application for ethical approval exists. For the clinical clarification of, e.g. storage diseases, experience has shown that 1-2 samples are needed for histological analyses, 1 sample for immune-histological analysis and, where applicable, 1-3 samples for molecular biology questions. For questions related to inflammatory responses and/or virus identification, experience has shown that 6 additional samples are required. It is important to note that the quality/size of each biopsy obtained also determines the number of samples taken. We recommend to collect at least 5 samples per procedure and up to 10 to guarantee reliable results. Samples for histology and immunohistochemical analysis should be at least 1-2 mm in size.
DZHK-SOP-K-05: Cardiac Catheterization, Version: V1.0, Valid as of: 01.09.2014

  Fieldname: herzkat_anzahl biops
  Data type: Integer with one digit

Ventricle

  Fieldname: vorbiopsven
  Data type: String with following options
    LV
    RV
    LV and RV
    unknown
    not assessed

Institution performing the assessment

  Fieldname: herzkat_vorbiopsinst
  Data type: Free text

Storage diseases

  Fieldname: herzkat_speichererkr
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Amyloidosis

  Fieldname: herzkat_amyloidose
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Other storage disease

  Fieldname: herzkat_sonstspeich
  Data type: String with following options
    yes
    no
    unknown
    not assessed

  Fieldname: herzkat_speichersp
  Note in CRF: Please specify
  Data type: Free text

Histological/ Immunohistological/ viral findings report

Histological findings report

Histological findings report available

  Fieldname: herzkat_histbefund
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Dallas criteria positive (including cell analysis)

  Fieldname: herzkat_dallaskriter
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Positive for fibrosis

  Fieldname: herzkat_fibrose
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Demonstration of fibrosis

  Fieldname: herzkat_fibronachw
  Data type: String with following options
    Biopsie
    MRT
    beides
    unknown
    not assessed

Quantified (Late Gadolinium Enhancement)

  Fieldname: herzkat_mrtquantif
  Data type: String with following options
    yes
    no
    unknown
    not assessed

  Fieldname: herzkat_quantifproz
  Data type: Integer with maximum 3 digits in %

Localisation (Late Gadolinium Enhancement) (multiple answers possible)

  Fieldname: herzkat_lokallv
  Note in CRF: left ventricular
  Data type: Checkbox

  Fieldname: herzkat_lokalrv
  Note in CRF: right ventricular
  Data type: Checkbox

  Fieldname: herzkat_lokalsept
  Note in CRF: Septum
  Data type: Checkbox

Necrosis

  Fieldname: herzkat_nekrose
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Granulomas

  Fieldname: herzkat_granulom
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Giant cells

  Fieldname: herzkat_riesenzellen
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Myozyte hypertrophy

  Fieldname: herzkat_myozhypert
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Immunhistological findings report

Immunhistological findings report available

  Fieldname: herzkat_immhistbef
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Positive for inflammation

  Fieldname: herzkat_entzuendpos
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Virus and other pathogens in the myocardium

Positive for virus and other pathogens in the myocardium

  Fieldname: herzkat_viruserreger
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Adenovirus

  Fieldname: herzkat_adenovirus
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Coxsackie Virus

  Fieldname: herzkat_coxsackvir
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Epstein-Barr Virus

  Fieldname: herzkat_epsteinbarr
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Parvovirus B19

  Fieldname: herzkat_parvovirus
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Herpes Simplex Virus 1/2

  Fieldname: herzkat_herpsimpl
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Humanes Herpesvirus 6

  Fieldname: herzkat_humanherp
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Humanes Cytomegalovirus

  Fieldname: herzkat_humcytomeg
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Influenza A und B

  Fieldname: herzkat_influenza
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Hepatitis C

  Fieldname: herzkat_hepatitisc
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Other pathogens (in myocardium)

  Fieldname: herzkat_anderreg
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Chagas

  Fieldname: herzkat_chagas
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Borrelia

  Fieldname: herzkat_borrelien
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Fungi

  Fieldname: herzkat_erregpilze
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Other

  Fieldname: herzkat_sonstmyoka
  Data type: String with following options
    yes
    no
    unknown
    not assessed

  Fieldname: herzkat_sonsterreg
  Note in CRF: Please specify
  Data type: Free text

Virus detection in the blood

Positive virus detection in the blood

  Fieldname: herzkat_virnachwpos
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Determined by

  Fieldname: herzkat_virnachwaus
  Data type: String with following options
    plasma
    serum
    unknown
    not assessed

Please specify virus

  Fieldname: herzkat_virusblut
  Data type: Freetext

Procedural complications

  Fieldname: herzkat_prozkompl
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Apoplexy

  Fieldname: herzkat_komplapo
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Pericardial effusion

  Fieldname: herzkat_komplperi
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Perikardial tamponade

  Fieldname: herzkat_komplperitampo
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Access site

  Fieldname: herzkat_komplaccess
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Minor bleeding

  Fieldname: herzkat_komplminorbleed
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Major bleeding

  Fieldname: herzkat_komplmajorbleed
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Death

  Fieldname: herzkat_kompltod
  Data type: String with following options
    yes
    no
    unknown
    not assessed

Other

  Fieldname: herzkat_komplsonstige
  Data type: String with following options
    yes
    no
    unknown
    not assessed

  Fieldname: herzkat_komplsonst
  Note in CRF: Other, please specify
  Data type: Free text