Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 7 - TEXAS MEDICAL DISCLOSURE PANEL
Chapter 602 - PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS-LIST A
Section 602.2 - Cardiovascular System Treatments and Procedures
Universal Citation: 25 TX Admin Code ยง 602.2
Current through Reg. 49, No. 38; September 20, 2024
(a) Cardiac.
(1) Coronary artery bypass.
(A) Acute myocardial infarction (heart
attack).
(B) Hemorrhage (severe
bleeding).
(C) Kidney
failure.
(D) Stroke.
(E) Sudden death.
(F) Infection of chest wall/chest
cavity.
(2) Heart valve
replacement by open surgery, structural heart surgery.
(A) Acute myocardial infarction (heart
attack).
(B) Hemorrhage (severe
bleeding).
(C) Kidney
failure.
(D) Stroke.
(E) Sudden death.
(F) Infection of chest wall/chest
cavity.
(G) Valve related delayed
onset infection.
(H) Malfunction of
new valve.
(I) Persistence of
problem for which surgery was performed, including need for repeat
surgery.
(3) Heart
transplant.
(A) Infection.
(B) Rejection.
(C) Death.
(4) Coronary angiography (Injection of
contrast material into arteries of the heart), coronary angioplasty (opening
narrowing in heart vessel), and coronary stent insertion (placement of
permanent tube into heart blood vessel to open it).
(A) Injury to or occlusion (blocking) of
blood vessel which may require immediate surgery or other intervention
including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm),
possibly life threatening.
(C)
Hemorrhage (severe bleeding).
(D)
Myocardial infarction (heart attack).
(E) Worsening of the condition for which the
procedure is being done.
(F) Sudden
death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(5) Percutaneous (through the skin) or
minimally invasive heart valve insertion/replacement.
(A) Injury to or occlusion (blocking) of
blood vessel which may require immediate surgery or other intervention
including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm),
possibly life threatening.
(C)
Hemorrhage (severe bleeding).
(D)
Myocardial infarction (heart attack).
(E) Worsening of the condition for which the
procedure is being done.
(F) Sudden
death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(J) Malfunction of new valve.
(K) Need for permanent pacemaker
implantation.
(6) Left
atrial appendage closure (closing of small pouch on left side of heart) -
percutaneous (through the skin) or minimally invasive.
(A) Injury to or occlusion (blocking) of
blood vessel which may require immediate surgery or other intervention
including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm),
possibly life threatening.
(C)
Hemorrhage (severe bleeding).
(D)
Myocardial infarction (heart attack).
(E) Worsening of the condition for which the
procedure is being done.
(F) Sudden
death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(J) Device embolization (device moves from
intended location).
(K) Pericardial
effusion (development of fluid in the sack around the heart) and cardiac
tamponade (fluid around heart causing too much pressure for heart to pump
properly).
(7) Patent
foramen ovale/atrial septal defect/ventricular septal defect closure by
percutaneous (through the skin) or minimally invasive procedure (closing of
abnormal hole between the chambers of the heart).
(A) Injury to or occlusion (blocking) of
blood vessel which may require immediate surgery or other intervention
including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm),
possibly life threatening.
(C)
Hemorrhage (severe bleeding).
(D)
Myocardial infarction (heart attack).
(E) Worsening of the condition for which the
procedure is being done.
(F) Sudden
death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(J) Atrial fibrillation (irregular heart
rhythm).
(K) Pulmonary embolus
(development of blood clot that travels to blood vessels in lungs).
(L) Device embolization (device moves from
where it is placed).
(M) Cardiac
perforation (creation of hole in wall of heart).
(8) Electrophysiology studies (exams of heart
rhythm), arrhythmia ablation (procedure to control or stop abnormal heart
rhythms).
(A) Injury to or occlusion
(blocking) of blood vessel which may require immediate surgery or other
intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm),
possibly life threatening.
(C)
Hemorrhage (severe bleeding).
(D)
Myocardial infarction (heart attack).
(E) Worsening of the condition for which the
procedure is being done.
(F) Sudden
death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(J) Rupture of myocardium/cardiac perforation
(hole in wall of heart).
(K) Cause
or worsening of arrhythmia (damage to heart electrical system causing abnormal
heart rhythm), possibly requiring permanent pacemaker implantation, possibly
life threatening.
(L) Pulmonary
vein stenosis (narrowing of blood vessel going from lung to heart.
(9) Pacemaker insertion, AICD
insertion (implanted device to shock the heart out of an abnormal rhythm).
(A) Injury to or occlusion (blocking) of
blood vessel which may require immediate surgery or other intervention
including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm),
possibly life threatening.
(C)
Hemorrhage (severe bleeding).
(D)
Myocardial infarction (heart attack).
(E) Worsening of the condition for which the
procedure is being done.
(F) Sudden
death.
(G) Stroke.
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during the procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(J) Rupture of myocardium/cardiac perforation
(hole in wall of heart).
(K) Cause
or worsening of arrhythmia (damage to heart electrical system causing abnormal
heart rhythm), possibly requiring permanent pacemaker implantation, possibly
life threatening.
(L) Device
related delayed onset infection (infection related to the device that happens
at some time after surgery).
(10) Electrical cardioversion (shocking the
heart out of an abnormal rhythm).
(A) Heart
arrhythmias (abnormal heart rhythm), possibly life threatening.
(B) Skin burns on chest.
(11) Stress testing.
(A) Acute myocardial infarction (heart
attack).
(B) Heart arrhythmias
(abnormal heart rhythm), possibly life threatening.
(12) Transesophageal echocardiography
(ultrasound exam of the heart from inside the throat).
(A) Sore throat.
(B) Vocal cord damage.
(C) Esophageal perforation (hole or tear in
tube from mouth to stomach).
(13) Circulatory assist devices (devices to
help heart pump blood).
(A) Injury to or
occlusion (blocking) of blood vessel which may require immediate surgery or
other intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm),
possibly life threatening.
(C)
Hemorrhage (severe bleeding).
(D)
Myocardial infarction (heart attack).
(E) Worsening of the condition for which the
procedure is being done.
(F) Sudden
death.
(G) Stroke.
(H) Contrast nephropathy or other kidney
injury (kidney damage due to the contrast agent used during the procedure or
procedure itself).
(I) Thrombosis
(blood clot forming at or blocking the blood vessel) at access site or
elsewhere.
(J) Hemorrhage (severe
bleeding) possibly leading to sudden death.
(K) Hemolysis (blood cells get broken
apart).
(L) Right heart failure
(poor functioning of the side of heart not assisted by device).
(M) Acquired von Willebrand syndrome
(platelets do not work).
(N)
Arrhythmia (irregular or abnormal heart rhythm).
(O) Cardiac or vascular injury or perforation
(hole in heart or blood vessel).
(P) Limb ischemia (lack of blood flow or
oxygen to limb that device placed through).
(Q) Device migration or
malfunction.
(R) Exposure of
device/wound break down with need for surgery to cover/reimplant.
(14) Extracorporeal Membrane
Oxygenation (ECMO).
(A) Injury to or occlusion
(blocking) of blood vessel which may require immediate surgery or other
intervention including emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm),
possibly life threatening.
(C)
Hemorrhage (severe bleeding).
(D)
Myocardial infarction (heart attack).
(E) Worsening of the condition for which the
procedure is being done.
(F) Sudden
death.
(G) Stroke.
(H) Contrast nephropathy or other kidney
injury (kidney damage due to the contrast agent used during the procedure or
procedure itself).
(I) Thrombosis
(blood clot forming at or blocking the blood vessel) at access site or
elsewhere.
(J) Thrombocytopenia
(low platelets) or other coagulopathy (blood thinning).
(K) Vascular or cardiac perforation (hole in
blood vessel or heart).
(L)
Seizure.
(M) Device migration or
malfunction.
(N) Ischemia to limb
(lack of blood flow or oxygen to limb that device placed through).
(O) Thromboembolism (blood clots in blood
vessels or heart and possibly traveling to blood vessels in lungs).
(b) Vascular.
(1) Open surgical repair of aortic,
subclavian, iliac, or other artery aneurysms or occlusions, arterial or venous
bypass or other vascular surgery.
(A)
Hemorrhage (severe bleeding).
(B)
Paraplegia (unable to move limbs) (for surgery involving the aorta or other
blood vessels to the spine).
(C)
Damage to parts of the body supplied or drained by the vessel with resulting
loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the
procedure is being done.
(E) Stroke
(for surgery involving blood vessels supplying the neck or head).
(F) Kidney damage.
(G) Myocardial infarction (heart
attack).
(H) Infection of graft
(material used to repair blood vessel).
(2) Angiography (inclusive of aortography,
arteriography, venography) - Injection of contrast material into blood vessels.
(A) Injury to or occlusion (blocking) of
artery which may require immediate surgery or other intervention.
(B) Hemorrhage (severe bleeding).
(C) Damage to parts of the body supplied by
the artery or drained by the vessel with resulting loss of use or amputation
(removal of body part).
(D)
Worsening of the condition for which the procedure is being done.
(E) Stroke and/or seizure (for procedures
involving blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or
memory loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and
inflammation of nerves (for procedures involving blood vessels supplying the
spine).
(H) Contrast nephropathy
(kidney damage due to the contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(3) Angioplasty (intravascular dilatation
technique).
(A) Injury to or occlusion
(blocking) of blood vessel which may require immediate surgery or other
intervention.
(B) Hemorrhage
(severe bleeding).
(C) Damage to
parts of the body supplied by the artery or drained by the vessel with
resulting loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the
procedure is being done.
(E) Stroke
and/or seizure (for procedures involving blood vessels supplying the spine,
arms, neck or head).
(F)
Contrast-related, temporary blindness or memory loss (for studies of the blood
vessels of the brain).
(G)
Paralysis (inability to move) and inflammation of nerves (for procedures
involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(J) Failure of procedure or injury to blood
vessel requiring stent (small, permanent tube placed in blood vessel to keep it
open) placement or open surgery.
(4) Endovascular stenting (placement of
permanent tube into blood vessel to open it) of any portion of the aorta, iliac
or carotid artery or other (peripheral) arteries or veins.
(A) Injury to or occlusion (blocking) of
blood vessel which may require immediate surgery or other
intervention.
(B) Hemorrhage
(severe bleeding).
(C) Damage to
parts of the body supplied by the artery or drained by the vessel with
resulting loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the
procedure is being done.
(E) Stroke
and/or seizure (for procedures involving blood vessels supplying the spine,
arms, neck or head).
(F)
Contrast-related, temporary blindness or memory loss (for studies of the blood
vessels of the brain).
(G)
Paralysis (inability to move) and inflammation of nerves (for procedures
involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(J) Failure of procedure or injury to blood
vessel requiring stent (small, permanent tube placed in blood vessel to keep it
open) placement or open surgery.
(K) Change in procedure to open surgical
procedure.
(L) Failure to place
stent/endoluminal graft (stent with fabric covering it).
(M) Stent migration (stent moves from
location in which it was placed).
(N) Impotence (difficulty with or inability
to obtain penile erection) (for abdominal aorta and iliac artery
procedures).
(5)
Vascular thrombolysis (removal or dissolving of blood clots) - percutaneous
(through the skin) (mechanical or chemical).
(A) Injury to or occlusion (blocking) of
blood vessel which may require immediate surgery or other
intervention.
(B) Hemorrhage
(severe bleeding).
(C) Damage to
parts of the body supplied by the artery or drained by the vessel with
resulting loss of use or amputation (removal of body part).
(D) Worsening of the condition for which the
procedure is being done.
(E) Stroke
and/or seizure (for procedures involving blood vessels supplying the spine,
arms, neck or head).
(F)
Contrast-related, temporary blindness or memory loss (for studies of the blood
vessels of the brain).
(G)
Paralysis (inability to move) and inflammation of nerves (for procedures
involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due
to the contrast agent used during procedure).
(I) Kidney injury or failure which may be
temporary or permanent (for procedures using certain mechanical thrombectomy
devices).
(J) Thrombosis (blood
clot forming at or blocking the blood vessel) at access site or
elsewhere.
(K) Increased risk of
bleeding at or away from site of treatment (when using medications to dissolve
clots).
(L) For arterial
procedures: distal embolus (fragments of blood clot may travel and block other
blood vessels with possible injury to the supplied tissue).
(M) For venous procedures: pulmonary embolus
(fragments of blood clot may travel to the blood vessels in the lungs and cause
breathing problems or if severe could be life threatening).
(N) Need for emergency surgery.
(6) Angiography with occlusion
techniques (including embolization and sclerosis) - therapeutic.
(A) For all embolizations/sclerosis:
(i) Injury to or occlusion (blocking) of
blood vessel other than the one intended which may require immediate surgery or
other intervention.
(ii) Hemorrhage
(severe bleeding).
(iii) Damage to
parts of the body supplied or drained by the vessel with resulting loss of use
or amputation (removal of body part).
(iv) Worsening of the condition for which the
procedure is being done.
(v)
Contrast nephropathy (kidney damage due to the contrast agent used during
procedure).
(vi) Unintended
thrombosis (blood clot forming at or blocking the blood vessel) at access site
or elsewhere.
(vii) Loss or injury
to body parts with potential need for surgery, including death of overlying
skin for sclerotherapy/treatment of superficial lesions/vessels and nerve
injury with associated pain, numbness or tingling or paralysis (inability to
move).
(viii) Infection in the form
of abscess (infected fluid collection) or septicemia (infection of blood
stream).
(ix) Nontarget
embolization (blocking of blood vessels other than those intended) which can
result in injury to tissues supplied by those vessels.
(B) For procedures involving the thoracic
aorta and/or vessels supplying the brain, spinal cord, head, neck or arms,
these risks in addition to those under subparagraph (A) of this paragraph:
(i) Stroke.
(ii) Seizure.
(iii) Paralysis (inability to
move).
(iv) Inflammation or other
injury of nerves (for procedures involving blood vessels supplying the
spine).
(v) For studies of the
blood vessels of the brain: contrast-related, temporary blindness or memory
loss.
(C) For female
pelvic arterial embolizations including uterine fibroid embolization, these
risks in addition to those under subparagraph(A) of this paragraph:
(i) Premature menopause with resulting
sterility.
(ii) Injury to or
infection involving the uterus which might necessitate hysterectomy (removal of
the uterus) with resulting sterility.
(iii) After fibroid embolization: prolonged
vaginal discharge.
(iv) After
fibroid embolization: expulsion/delayed expulsion of fibroid tissue possibly
requiring a procedure to deliver/remove the tissue.
(D) For male pelvic arterial embolizations,
in addition to the risks under subparagraph (A) of this paragraph: impotence
(difficulty with or inability to obtain penile erection).
(E) For embolizations of pulmonary
arteriovenous fistulae/malformations, these risks in addition to those under
subparagraph (A) of this paragraph:
(i) New or
worsening pulmonary hypertension (high blood pressure in the lung blood
vessels).
(ii) Paradoxical
embolization (passage of air or an occluding device beyond the
fistula/malformation and into the arterial circulation) causing blockage of
blood flow to tissues supplied by the receiving artery and damage to tissues
served (for example the blood vessels supplying the heart (which could cause
chest pain and/or heart attack) or brain (which could cause stroke, paralysis
(inability to move) or other neurological injury)).
(F) For varicocele embolization, these risks
in addition to those under subparagraph (A) of this paragraph:
(i) Phlebitis/inflammation of veins draining
the testicles leading to decreased size and possibly decreased function of
affected testis and sterility (if both sides performed).
(ii) Nerve injury (thigh numbness or
tingling).
(G) For
ovarian vein embolization/pelvic congestion syndrome embolization: general
angiography and embolization risks as listed in subparagraph (A) of this
paragraph.
(H) For cases utilizing
ethanol (alcohol) injection, in addition to the risks under subparagraph (A) of
this paragraph: shock or severe lowering of blood pressure (when more than
small volumes are utilized).
(I)
For varicose vein treatments (with angiography) see paragraph (12) of this
subsection.
(7)
Mesenteric angiography with infusional therapy (Vasopressin) for
gastrointestinal bleeding.
(A) Injury to or
occlusion (blocking) of blood vessel which may require immediate surgery or
other intervention.
(B) Hemorrhage
(severe bleeding).
(C) Damage to
parts of the body supplied or drained by the vessel with resulting loss of use
or amputation (removal of body part).
(D) Worsening of the condition for which the
procedure is being done.
(E)
Contrast nephropathy (kidney damage due to the contrast agent used during
procedure).
(F) Thrombosis (blood
clot forming at or blocking the blood vessel) at access site or
elsewhere.
(G) Ischemia/infarction
of supplied or distant vascular beds (reduction in blood flow causing lack of
oxygen with injury or death of tissues supplied by the treated vessel or
tissues supplied by blood vessels away from the treated site including heart,
brain, bowel, extremities).
(H)
Antidiuretic hormone side effects of vasopressin (reduced urine output with
disturbance of fluid balance in the body, rarely leading to swelling of the
brain).
(8) Inferior
vena caval filter insertion and removal.
(A)
Injury to or occlusion (blocking) of blood vessel which may require immediate
surgery or other intervention.
(B)
Hemorrhage (severe bleeding).
(C)
Worsening of the condition for which the procedure is being done.
(D) Contrast nephropathy (kidney damage due
to the contrast agent used during procedure).
(E) Thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere including caval
thrombosis (clotting of main vein in abdomen and episodes of swelling of
legs).
(F) Injury to the inferior
vena cava (main vein in abdomen).
(G) Filter migration or fracture (filter
could break and/or move from where it was placed).
(H) Risk of recurrent pulmonary embolus
(continued risk of blood clots going to blood vessels in lungs despite
filter).
(I) Inability to remove
filter (for "optional"/retrievable filters).
(9) Pulmonary angiography.
(A) Injury to or occlusion (blocking) of
blood vessel which may require immediate surgery or other
intervention.
(B) Hemorrhage
(severe bleeding).
(C) Damage to
parts of the body supplied or drained by the vessel with resulting loss of use
or amputation (removal of body part).
(D) Worsening of the condition for which the
procedure is being done.
(E)
Contrast nephropathy (kidney damage due to the contrast agent used during
procedure).
(F) Thrombosis (blood
clot forming at or blocking the blood vessel) at access site or
elsewhere.
(G) Cardiac arrhythmia
(irregular heart rhythm) or cardiac arrest (heart stops beating).
(H) Cardiac injury/perforation (heart
injury).
(I) Death.
(10) Percutaneous treatment of
pseudoaneurysm (percutaneous thrombin injection through the skin versus
compression).
(A) Thrombosis (clotting) of
supplying vessel or branches in its territory.
(B) Allergic reaction to thrombin (agent used
for direct injection).
(11) Vascular access - nontunneled catheters,
tunneled catheters, implanted access.
(A)
Pneumothorax (collapsed lung).
(B)
Injury to blood vessel.
(C)
Hemothorax/hemomediastinum (bleeding into the chest around the lungs or around
the heart).
(D) Air embolism
(passage of air into blood vessel and possibly to the heart and/or blood
vessels entering the lungs).
(E)
Vessel thrombosis (clotting of blood vessel).
(12) Varicose vein treatment (percutaneous
(through the skin), via laser, radiofrequency ablation (RFA), chemical or other
method) without angiography.
(A)
Burns.
(B) Deep vein thrombosis
(blood clots in deep veins).
(C)
Hyperpigmentation (darkening of skin).
(D) Skin wound (ulcer).
(E) Telangiectatic matting (appearance of
tiny blood vessels in treated area).
(F) Paresthesia and dysesthesia (numbness or
tingling in the area or limb treated).
(G) Injury to blood vessel requiring
additional procedure to treat.
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