Änderungen in den Ausfüllhinweisen im Vergleich zur Vorgängerversion
Datensatz Zeile Bezeichnung Neuer Text Alter Text
HCHDAR
180
Technical success (nach VARC-3)
Technischer Erfolg (am Prozedurende)
  • Keine Sterblichkeit
  • Erfolgreicher Zugang, Einbringung der Prothese und Entfernung des Einführsystems
  • Korrekte Positionierung der  Herzklappenprothese an der richtigen anatomischen Position
  • Kein erneuter Eingriff im Zusammenhang mit der Prothese oder keine schwerwiegenden vaskulären, zugangsbedingten oder kardial strukturellen Komplikationen
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HCHDAR
gravierende Gefäß- oder Zugangskomplikation (gemäß VARC-3)
Major vascular complication
One of the following:
  • Aortic dissection or aortic rupture
  • Vascular (arterial or venous) injury (perforation, rupture, dissection, stenosis, ischaemia, arterial or venous thrombosis including pulmonary embolism, arteriovenous fistula, pseudoaneurysm, haematoma, retroperitoneal haematoma, infection) or compartment syndrome resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
  • Distal embolization (non-cerebral) from a vascular source resulting in death, amputation, limb or visceral ischaemia, or irreversible end-organ damage
  • Unplanned endovascular or surgical intervention resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
  • Closure device failure‡ resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
Major access related non vascular complication
One of the following:

  • Non-vascular structure, non-cardiac structure§ perforation, injury, or infection resulting in death, VARC type ≥2 bleeding, irreversible nerve injury or requiring unplanned surgery or percutaneous intervention
  • Non-vascular access site (e.g. trans-apical left ventricular) perforation, injury, or infection resulting in death, VARC type ≥2 bleeding, irreversible nerve injury or requiring unplanned surgery or percutaneous intervention
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HCHDAR
große strukturelle kardiale Komplikation (gemäß VARC-3)
Major
One of the following:
  • Cardiac structure perforation, injury, or compromise resulting in death, VARC type ≥2 bleeding, haemodynamic compromise or tamponade, or requiring unplanned surgical or percutaneous intervention
  • New pericardial effusion resulting in death, VARC type ≥2 bleeding, haemodynamic compromise or tamponade, or requiring unplanned surgical or percutaneous intervention
  • Coronary obstruction† resulting in death, haemodynamic compromise, myocardial infarction, or unplanned surgical or percutaneous intervention. Coronary obstruction may be acute (during the procedure) or delayed (after completion of the procedure).
  • Coronary artery access difficulties for needed coronary angiography or intervention, resulting in death, haemodynamic compromise, myocardial infarction, coronary or aortic root injury, compromise in aortic valve prosthesis integrity, unplanned surgical or percutaneous intervention, or the inability to perform the intended procedure
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HCHDAR
214
In diesem Aufenthalt neu aufgetretenes zerebrales / zerebrovaskuläres Ereignis nach VARC-3?

Acute stroke severity
  • Mild neurological dysfunction: NIHSS 0-5
  • Moderate neurological dysfunction: NIHSS 6-14
  • Severe neurological dysfunction: NIHSS ≥15
Stroke disability
  • Fatal Stroke: death resulting from a stroke
  • Stroke with disability: mRS score of ≥ 2 at 90 dayse and increase of ≥1 from pre-stroke baseline
  • Stroke without disability: mRS score of 0 (no symptoms) or 1 (able to carry out all usual duties and activities) at 90 dayse or no increase in mRS category
from pre-stroke baseline

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HCHDAR
Datum des (ersten) zerebralen / zerebrovaskulären Ereignisses
Sollten in dem aktuellen Krankenhaus-Aufenthalt mehrere zerebrale/zerebrovaskuläre Ereignisse aufgetreten sein, so ist hier das Datum des ersten zerebralen/zerebrovaskulären Ereignisses während oder nach dem Aortenklappen-Eingriff zu dokumentieren.
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HCHDAR
215
In diesem Aufenthalt neu aufgetretener Myokardinfarkt nach VARC-3?
Type 5 Periprocedural (post-SAVR, TAVR or CABG) MI (48 h after the index procedure)
  • In patients with normal baseline CK-MB: The peak CK-MB measured within 48 h of the procedure ≥10 the local laboratory ULN or CKMB ≥5 ULN with one or more of the following:
  • New pathologic Q-waves in ≥2 contiguous leads
  • New persistent LBBBc
  • Flow-limiting angiographic complications in a major epicardial vessel or >1.5 mm diameter branch
  • Substantial new loss of viable myocardium on imaging related to the procedure
  • In the absence of CK-MB measurements and a normal baseline cTn, a cTn (I or T) level measured within 48 h of the procedure rises to ≥70 the local laboratory ULN or ≥35 ULN with one or more of the following:
  • New pathologic Q-waves in ≥2 contiguous leads
  • New persistent LBBBc
  • Flow-limiting angiographic complications in a major epicardial vessel or >1.5 mm diameter branch
  • Substantial new loss of viable myocardium on imaging related to the procedure
  • In patients with elevated baseline CK-MB (or cTn): The CK-MB (or cTn) rises by an absolute increment equal to those levels recommended above from the most recent pre-procedure level plus new ECG changes as described.

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HCHDAR
229
Zugangsassoziierte Gefäßkomplikationen nach VARC-3
Vascular complications† Minor
One of the following:
  • Vascular (arterial or venous) injury (perforation, rupture, dissection, stenosis, ischaemia, arterial or venous thrombosis including pulmonary embolism, arteriovenous fistula, pseudoaneurysm, haematoma, retroperitoneal haematoma, infection) not resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
  • Distal embolization treated with embolectomy and/or thrombectomy, not resulting in death, amputation, limb or visceral ischaemia, or irreversible end-organ damage
  • Any unplanned endovascular or surgical intervention, ultra-sound guided compression, or thrombin injection, not resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
  • Closure device failure‡ not resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment

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