LOOKING FOR OPINIONS FROM PEDIATRIC INTERVENTIONAL CARDIOLOGISTS ONLY
This infant was born on 4/29/16 at 39 wks.
On 5/9/16 an echocardiogram revealed a moderate sized VSD.
The infant did not gain appropriate amounts of weight and was placed on Lasix.
During hospitalization (10/6/16 – 10/8/16) a repeat echocardiogram on 10/6/16 showed improvement of VSD, and appropriate weight gain - he was taken off Lasix.
The attending cardiologist consulted with defendant pediatric interventional cardiologist to see if the infant would be a candidate for an Amplatzer Occluder device.
On 12/14/16 defendant cardiologist saw the infant, reviewed his “most recent echocardiogram”, noted a heart murmur, but “NO signs of heart failure”, then scheduled the infant for VSD closure.
Parents were not told to start the infant on baby aspirin 24 hours prior to the procedure, nor were they told that a muscular VSD may close on its own, thus rendering the procedure unnecessary.
The defendant doctor told the parents he had previously performed 300 hundred/hundreds of these VSD closure procedures, but at his deposition he testified to having previously performed only 3 prior VSD closures with Amplatzer devices – in the 7 years since completing training, from 2007 – 2017, although he had done multiple ASD closures.
The parents were not offered the option of a surgical closure.
On 2/7/17, the infant had a small to moderate-sized (4-6mm, ) mid-muscular ventricular septal defect. The cardiac catheterization showed a left-to-right shunt with the Qp:Qs of around 2-2.4:1 (borderline increased?). The pulmonary artery pressure was normal at 27/14-16 mmHg and the pulmonary vascular resistance was also normal at 1.00 units x m2.
On 2/7/17, the percutaneous VSD closure was performed with an Amplatzer VSD Occluder.
During the procedure, ACT levels were not maintained >200 seconds throughout the procedure.
8:55 case starts
8:58 ACT Level 139 seconds;
9:00 Heparin 650 units IV push (the infant’s wt: 6.8 kg, under dosed if supposed to be 100 mg/kg?);
9:05 Marking pigtail catheter inserted; a .035 x150 cm J Fixed core wire used; .025 145 TSF St. wire used; 4F x 65 cm Marking Pigtail Catheter.
9:08 Glide catheter inserted. 0.35 x 2 60 cm Angled glidewire used;
9:08 Balloon Wedge Catheter inserted; pressure and sats obtained.
9:08 5F x 60 cm wedge catheter used;
9:20 0.18 x 60cm Hitinol wire used;
9:23 4F JR cath used;
9:32 0.15 x180 cm x 5cm Nitrex used;
9:35 15mm x 120cm Amplats Neck wire used;
Rosen curved wire Guidex 260 cm used;
9:57 4F JR 1.5 catheter used;
10:02 4F jr 1.5 catheter across the left ventricle septum to right ventricle;
10:10 ACT drawn;
10:12 Amplatzer 160 degree delivery sheath inserted over wire in femoral vein;
10:13 ACT results: 154 seconds;
10:13 Heparin 500 units IV by Anesthesia for anticoagulation;
10:35 Marking pigtail catheter inserted; 4F x 65 cm Marking pigtail catheter used;
10:39 .014 x 300cm Choice Floppy wire used;
10:40 Occluder positioned across the ventricular septum in the VSD under Tee/Fluor;
10:42 Occluder positioned.
10:45 Occluder deployed under tee/flour guidance;
10:50 the Amplatzer VSD muscular occluder 8mm x 7 mm was completely released
10:56 Berman Angiographic catheter was inserted. 6F x 90 cm Berman catheter was used
11:05 type & screen sent and blood ordered;
11:15 Balloon wedge catheter inserted, pressures and sats obtained. 5F x 60 cm wedge catheter used;
11:19 ACT drawn;
11:21 ACT result: 198 seconds;
11:25 Heparin 100 units IV by Defendant cardiologist for anticoagulation (no further insertions into the vascular space appear to have been made after this dose of heparin).
11:41 R femoral vein closed by manual compression, sheath removed, hemostasis achieved;
11:41 R Femoral artery closed by manual compression; sheath removed, hemostasis .
12:06 case completed;
12:06 sterile 4x4 and pressure dressing applied to site, no oozing or hematoma noted.
12:25 Pt transferred from procedure room to ped.
Following the surgery, the infant remained lethargic/drowsy, did not awaken as anticipated.
On the evening of 2/8/17 defendant attempted to discharge the infant home, but parents refused because infant was not able to suck on a bottle.
Head imaging on 2/9/17 revealed multifocal regions of acute ischemic infarcts in the brain, a follow up MRI revealed a basilar artery infarction.
The infant required a VP shunt for hydrocephalus.
Subsequently, the infant tested positive for functional Protein S deficiency with functional protein S of 52% (Range: 58 – 128%).
Plaintiff’s pediatric hematology expert’s opinion is that the infant’s ACT level was subtherapeutic (<200 sec) in the timeframe prior to when his 2nd ACT level was checked, at 10:10 (results: 154), and when there were catheters in the left and right ventricle at 10:02, and the delivery sheath inserted at 10:12 am, until he received his 2nd dose of Heparin, 500 u, at 10:13 am.
It is the expert’s opinion that the infant would have become therapeutic at about 10:15 am and remained therapeutic or near therapeutic thereafter.
It is also this expert’s opinion that since the infant was subtherapeutic re ACT level in the early part of the procedure, when there were instruments in the vascular system, including the sheath, it is likely that clots were allowed to form, and once the heparin level reached a therapeutic level, the clots that had previously formed could then break off, embolize and cause the stroke.
It is also this expert’s opinion that the patient’s degree of Protein S deficiency is mild, noting there is disagreement in the literature as to whether this Protein S level would be sufficient to significantly increase the risk of thrombosis, particularly if the infant had been adequately heparinized.
Plaintiff’s expert radiologist interpreted the images as follows:
02/09/2017 MRI of the brain: occlusion of the distal basilar artery as well as multiple acute infarctions in the distribution of the basilar artery. Infarctions in the pons, the left peduncle, the left anterior thalamus, the left posterior-medial temporal lobe and occipital lobe, and the right caudate nucleus. There are multiple infarctions of the cerebellum.
02/10/17 MR angiography: occlusion of the distal basilar artery and the distal right vertebral artery.
02/15/17 MR angiography: evolution of the infarcts described above. The lateral ventricles and temporal horns are now enlarged from hydrocephalus because of swelling of the cerebellum and compression of the fourth ventricle.
02/20/17 MRI brain: ventricle now smaller and near normal size. A right ventricular shunt had been placed.
02/23/17 MRI brain: right ventricular shunt still in place, with the ventricles decompressed to near normal size.
09/30/23 MRI brain: ventricles now normal, with the shunt removed. There is gliosis (scarring) and encephalomalacia (destruction of brain tissue) in the regions of the prior infarctions, especially the left cerebellum.
The infant, now 8 yo, has serious consequential injuries, including a seizure disorder, behavioral disorder, speech and learning deficits.
Questions:
1) Was it a departure from the standards of care to take this patient to the cath lab for this procedure at this time rather than giving the infant more time to see if he would gain weight and/or if the muscular VSD would close on its own without the necessity of the procedure?
2) Was it a departure from the standards of care to fail to advise the family to start the infant on baby aspirin 24 hours prior to the procedure?
3) Was it a departure from the standards of care not to properly inform the parents that the procedure was neither urgent nor necessary at the time, but could be delayed to see if the VSD closed on its own, or that the procedure has serious associated potential risks, or that the defendant doctor had performed only 3 these procedures?
4) Was it a departure to fail to maintain the ACT >200 seconds prior to placement of catheters and instruments into the vascular system, and throughout the procedure?
5) Did these departures increase the infant’s risk for clot formation during the procedure?
6) Did the clot formation increase the risk for the development of brain infarctions?
7) Although the infant was later diagnosed with functional protein S deficiency, as noted above, would appropriate pre – treatment with aspirin and maintenance of an ACT of 200 seconds throughout the procedure have provided the infant the opportunity to avoid the clots/infarctions?
8) In your opinion, were there any other departures from the standards of care that caused/contributed to this infant’s development of brain infarctions?
Files:
No questions yet!
Do you believe there might have been medical error?
The main issue from my perspective would have been the indication to consider VSD closure at months of age and would be based upon the clinical findings (symptoms and growth curve) with or without the need for anti-congestive medications. The echocardiographic imaging would also be important in the decision-making process if there was evidence of left heart volume overload, mitral valve insufficiency with or without pulmonary artery hypertension. I would have to personally review the echocardiograms and any previous clinic visits to render an opinion.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I do not see from the summary provided that the technical aspect of the catheterization procedure was performed incorrectly although the management of anti-coagulation during the procedure might be an issue based on the pediatric hematology expert opinion. There are some other questions that need to be answered before I would definitively support this opinion.
What makes you a good expert for this case?
I have been practicing pediatric cardiology for over 34 years and direct the pediatric cardiac cath lab at my institution. since my arrival. I have performed thousands of cardiac cath procedures on newborns, infants, children and adults with congenital heart disease most of which are interventional in nature
How often do you encounter cases similar to this one in your practice?
I have never personally experienced this type of cardiac catheterization complication and I suspect it would be considered very unusual. This particular type of procedure (VSD device closure) is not performed frequently in most institutions since the patient population that would theoretically benefit from this procedure is small
Do you believe there might have been medical error?
The problem with this case is that the kid had hemodynamic criteria for closure (shunt >2:1) but generally we would wait to close this defect in te setting of no heart failure, good growth and no evidence of pulmonary hypertension. At 7 kg device closure of a muscular VSD is more commonly done outside the U.S. all the time. I'm worried we are missing some information as the cardiologist requested a device closure of the VSD, so I wonder what was the indication at that point (moderately to severely dilated LV?, increasing mitral regurgitation?), need to hear how the echo was back then to complete the picture. The ACT was low but re-dosed timely and there are some procedures done without heparin (for different reasons) and this is not a typical outcome. Protein S deficiency seems a risk factor in this case even if doesn't seem to be severely abnormal, it is enough when there is a trigger like a cath procedure and catheters in the left side, as well as a new device in the heart. The event could have happened from clot forming in the device rather than during the procedure but this is hard to tell. Aspirin prior to VSD closure is not standard. This is true for PFO closures in patients with history of thrombosis or coagulation issues like this baby. Not having a diagnosis at time of the cath is relevant.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Although uncommon stroke is a risk with procedures that involved the left heart, this case is really an unfortunate series of events and the main problem is that likely in our traditional practice (with the information given at this time), the kid may have done well without closing the VSD.
What makes you a good expert for this case?
Congenital interventional cardiologist for 7 years in a high volume center
How often do you encounter cases similar to this one in your practice?
Patients with VSDs at this age that need decision making to close are often. Percutaneous VSD closures are less frequent ( approx 5-10/year)
Do you believe there might have been medical error?
1. The procedural indications are at best marginal. Small to moderate muscular VSD's may close spontaneously. Doing the procedure at 10 months does not provide time for this to occur. Furthermore, the diagnostic data from the catheterization showed a significant shunt, but no pulmonary hypertension. This data supports the case for waiting to see if there may be spontaneous closure without risking patient harm. 2. The patient was not pretreated with an anti-platelet medication as suggested by the device manufacturer. 3. Anticoagulation as assessed by the ACT was inadequate during the first portion of the procedure. 4. Full informed consent was probably not provided to parents. Especially with regard to operators experience of lack there of and the procedural indications.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
1. Lack of pretreatment with antiplatelet medication. 2. In adequate anticoagulation during initial part of procedure. 3. Also possibly related to small patient size and prolonged procedure (these details not provided in case summary, but also might be very significant).
What makes you a good expert for this case?
1. I have significant experience as an interventional pediatric cardiologist. I have personally performed a number of the muscular VSD closures. 2. I have been the Directors of the Pediatric Catheterization Laboratories at UCLA and UCSD/Rady for many years. 3. I have multiple publications pertaining to Amplatzer device closure of VSDs and ASDs, as well as Catheterization Laboratory organization.
How often do you encounter cases similar to this one in your practice?
I retired in 2021. Prior to retirement, I performed muscular VSD closures 2-3 times a year. Frankly this is a relatively rare procedure even in a high volume lab.
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