pellicle
Professional Dingbat, Guru and Merkintologist
So one really obvious error (probably a brain fart) in one sentence and EVERYTHING said by one side is dismissed. Excellent
A little evidence
- Thread starter clay_from_nj
- Start date
Help Support Valve Replacement Forums:
So one really obvious error (probably a brain fart) in one sentence and EVERYTHING said by one side is dismissed. Excellent
Glad to hear people are finding this interesting, I almost decided not to post my next reply, because it got sooo long ...even for me lol but will post it now
WE live pretty close to echelon Mall, but my DH and Justin work in AC so yes we are south
Yes Deborah still a great heart hospital, but that is pretty much the only area CHD center Justin hasnt used, we lived in SW phila when he was born so went to CHOP then Nemourse in Del for a while and back to CHOP and ST Chris. when was your daughter there?
Last edited:
Always good to know the cause of mistakes especially after I asked for clarification earlier in the thread. Better late than never, though, as we all strive for accuracy in what we write.
Sorry in advance this got very long.
I'm not exactly sure what you are looking for, If it helps here are the guidelines (IN the US) for Valve replacement Morbidity and Mortality reporting http://aats.org/multimedia/files/guidelines/aats08-april-guidelines-manuscript.pdf That gives pretty good details of everything short and long term that they should be reporting and keeping track of. I'm sure that is where they get many of the stats quoted for valves, surgeries etc. The Purpose states that the reason for all this reporting is so they can use the results to make clinical reports and compare all the different info on various valves, surgeries, interventions etc..my words don't know how to copy it
One of the problems when looking for different complications like you are asking for, is for the most part they lump many of the heart surgeries together, when reporting pacemakers, or infections, or effusions etc and different heart surgeries have higher/lower rates of different complications, Luckily for people here, as many studies have shown and doctors tell patients the risk of morbidity /mortality of 1st and 2nd valve surgeries and 3rd depending on surgeon is very good I think about 1-3%. Even Valves, some surgeries have even better stats than others, like Aortic valves compared to tricuspid, for example, Pacemakers are more Common for Aortic valves than other valves or surgeries like CABGs or different Congenital Heart surgeries because of where it is located in the heart by the AV node, but DEEP sternal infections tend to be higher in patients having CABGs "probably" alot has to do with age and other comorbidites like diabetes , obesity, chronic obstructive pulmonary disease, osteoporosis, tobacco use, reoperation....
Any way ..
Since the group that usually require Multiple REDOs 3+ OHS are congenital patients, most of the studies on REDOs relate to them, for example http://www.ncbi.nlm.nih.gov/pubmed/18721579
"Repeat sternotomy in congenital heart surgery: no longer a risk factor"
background The risk of repeat sternotomy (RS) is often taken into account when making clinical management decisions. Current literature on RS suggests a risk of approximately 5% to 10% for major morbidity. We sought to establish the true risk of RS in a contemporary pediatric series
ll RS between October 2002 and August 2006 were analyzed (602 RS in 558 patients). Median age was 3.6 years (range, 0.1 to 45.1); weight, 14.2 kg (2.0 to 112.2). Operations performed at RS were Glenn 22% (131), Fontan 21% (129), aortic valve repair/replacement 12% (72), right ventricle-pulmonary artery conduit 11% (67), Rastelli 7% (39), heart transplant 5% (31), and other 22% (133). Forty-seven percent of patients (280) had single-ventricle physiology. Incidence of second sternotomy was 67% (406), third 28% (166), fourth 4% (24), fifth 0.8% (5), and sixth 0.2% (1). A major injury upon RS was defined as one causing hemodynamic instability requiring vasopressor support or emergent transfusion; femoral cannulation or emergent cardiopulmonary bypass; and any morbidity. A minor injury is any other injury during RS.
Results The incidence of a major injury was not different between RS (0.3%; 2 of 602) and first-time sternotomy (0%; 0 of 1,274; p > 0.1). Incidence of a minor injury was 0.66% (4 of 602). No injury resulted in hemodynamic instability, neurologic injury, or death. Two patients (0.3%) required a nonemergent blood transfusion secondary to injury. (Nonemergent was defined as adminstration rate of less than 0.2 cc/kg/min and less than 10 cc/kg in total.) Femoral cannulation was performed in 4 of 602 RS cases (< 0.6%). Sternal wound infection was 0.5% (3 of 602); reoperation for postoperative bleeding was 1% (8 of 602). Median intensive care unit stay was 3 days (1 to 174); median hospital stay was 7 days (1 to 202). Hospital survival was 98%.
CONCLUSIONS:
Repeat sternotomy can represent a negligible risk of injury and of subsequent morbidity or mortality. Therefore, the choice of management strategies for patients should not be affected by the need for RS"
I picked that study, because even tho many of the surgeries were very/most complex CHD surgeries and a large percentage were single ventricle or had pulmonary conduits, which increase the risk of safely opening the chest, there were quite a few REDO Aortic valves /Aorta surgery. Since one of the toughest parts for the surgeons in multiple REDOs is opening the chests safely, I hpught it was helpful.
Also http://www.ncbi.nlm.nih.gov/pubmed/23998402 Repeat sternotomy: no longer a risk factor in mitral valve surgical procedures has the same type of info.
For longterm Morbidity, most studies for that valve or valves being studied, usually have breakdowns like this http://www.ncbi.nlm.nih.gov/pubmed/12091820
(This is just the abstract so not all the details that the fall study has, its from 2002 so followed for 18 years )
Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards Perimount pericardial bioprosthesis.
From January 1984 to December 1995, the Carpentier-Edwards pericardial bioprosthesis was used for aortic valve replacement in 254 patients (male/female ratio 117:137) with a mean age of 71 years (range 25-87 years). Before the operation, 216 patients (85%) were in New York Heart Association functional class III or IV. The predominant diagnosis was aortic stenosis (n = 219, 86%). Associated surgical procedures included coronary artery bypass grafting in 130 cases (51%), mitral valve replacement in 11 cases (4%), and tricuspid or mitral valve repair in 12 cases (5%). Previous cardiac operations had been performed in 36 cases (14%). Follow-up was 100% complete at a mean of 60 +/- 31 months....."
Under results it says,
"There were 11 early deaths (4%) and 58 late deaths. Actuarial survivals at 5, 10, and 12 years were 80% +/- 3%, 50% +/- 8%, and 36% +/- 9%, respectively. At 12 years the freedom from cardiac death was 73% +/- 7%, the freedom from valve-related death was 84% +/- 11%, the freedom from valve reoperation was 83% +/- 9%, the freedom from primary tissue failure was 86% +/- 9%, the freedom from thromboembolism was 67% +/- 13%, and the freedom from endocarditis was 98% +/- 1%. Echocardiography was performed on long-term survivors (mean follow-up 67 +/- 25 months) and showed that transvalvular peak and mean pressure differences measured with Doppler echocardiography were 23.2 +/- 9.6 and 12.3 +/- 4.8 mm Hg, respectively. Aortic regurgitation was found by Doppler echocardiography to be none or trivial, mild, moderate, and severe in 64%, 30%, 3%, and 1% of patients, respectively"
IF you are talking about a certain morbidity specifically like the chances of sternal infections I know in recent Aortic Valve guidelines they have alot of information about short and long term and they mention about 0.3% for deep sternal infections etc page 14-15 I'm sure one of the ways they got the data to determine various morbidity / mortality rates for this is reports like the Morbidity /mortality guidelines above,
the http://www.sts.org/sites/default/fi...GuidelinesforManagementandQualityMeasures.pdf
But for the most part when I need to find info like when Justin had the sternal osteomyelitis with mediastinitis and was having the debridment and muscle flap surgery, or ran into his other "rare" complications, I found it best just to search for info for THAT problem, most things I found in the sternal osteomyelitis with mediastinitis or Mediastinitis with sternal osteomyelitis, (yes it made a difference in which it was classified by and treatment antibiotic course) was info like this
Sternal osteomyelitis and poststernotomy mediastinitis is a severe and life-threatening complication after the cardiac surgery. The incidence ranges up to 3% with a mortality rate up to 29%. ( that rate is for all heart surgery not just valve--Not really something a Mom wants to read while her son is in the OR for it)
http://icvts.oxfordjournals.org/content/12/6/914.long
or this one http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3140234/
Sternal wound infection is a life-threatening complication after cardiac surgery associated with high morbidity and mortality. Past treatment options have included closed suction and continuous irrigation. Current paradigms in the management of sternal wound infection include surgical debridement, vacuum-assisted closure therapy, flap coverage, and sternal plating. We provide a general overview of sternal wound infection and treatment options for the plastic surgeon"
"Deep sternal wound infection (DSWI), also termed mediastinitis, is a life-threatening complication after median sternotomy with an incidence of 1 to 5%.1 Patients with DSWI die at a rate that is twice that of those without mediastinitis.2 The associated mortality rate in the literature ranges from 10 to 47%.3,4Risk factors for the development of DSWIs after median sternotomy include diabetes, obesity, chronic obstructive pulmonary disease, osteoporosis, tobacco use, reoperation, prolonged intensive care unit stays, and use of assist devices.3 Patients with sternal wound complications accumulate an average of 20 additional hospital days and incur an estimated 2.8 times the cost of that for patients with uncomplicated postoperative courses.4 One study suggested an additional cost of $500,000 per incident of poststernotomy mediastinitis.5
It is important to distinguish DSWIs from superficial sternal wound infections (SSWIs). An SSWI involves the skin, subcutaneous tissue, and pectoralis fascia only. The incidence of SSWIs is 0.5 to 8% with an associated morbidity and mortality rate ranging from 0.5 to 9%.6,7 The diagnosis may be made clinically by the presence of erythema, drainage, fever, and sternal instability but is often occult with a low-grade fever as its only presentation. SSWIs are often completely eradicated with intravenous antibiotics and local wound care if necessary without long-term sequelae."........
Under Conclusions it says
"Perioperative optimization has significantly decreased the incidence of sternal wound infection in the modern era of cardiac surgery. When sternal wound infections do occur, however, prompt recognition and treatment is paramount. Although treatment algorithms may vary among surgeons, thorough debridement and culture-directed antibiotics are standard. VAC is a useful bridge to definite closure. Muscle or omental flaps are often necessary to ensure successful closure. Sternal plating is beneficial in stabilizing the sternum in selected patients. Future innovations addressing DSWI will likely involve the interplay between tissue engineering and cellular-based therapy."
That article has quite a few studies listed in the references, if that helps
Justin's infection was caused by "Staph warneri" which almost "never" happens, he had his surgery at one of the leading very busy Childrens heart hospital, and in the previous 25 years, they never had another patient w/ S warneri in their sternum. So I just focused on studies for either mediastinitis, or Sternal Osteomyelitis
As for other complications, effusions, pacemakers I always find it easier to just do searches on each thing, here is an interesting article about pacemakers needed after surgery (FWIW Justin needed his after going into Complete hear block following cath)
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1764945/ for some reason i can't copy it, it is about "predictors of perm pacemaker following valve surgery in it it says
"Approximately 5% of the 100,000 patients who undergo cardiac valve surgery each year require postoperative PPM implantation before discharge from the hospital.4 In fact, the requirement for PPM implantation is more frequent after valve surgery (ranging from 3%–6%) than after isolated coronary artery bypass grafting (0.8%).5 We performed the present study in order to determine the contemporary incidence of permanent pacing after valve surgery and to evaluate the risk factors for PPM insertion"
Well this is probably WAAY too long and most people trying to read it fell asleep, so Ill stop
I just wanted to mention for people who read this in the future, this article was from 2011, there MAY be some anticoag in the future that can be used for mech valves, but right now they only have been approved for Non-valvular Afib.
They halted the trials for Dabigatran in Mech valve patients (RE-ALIGN http://clinicaltrials.gov/ct2/show?term=REALIGN&rank=1) in late 2012 because to quote the company "did not achieve the desired results," http://www.medscape.com/viewarticle/776089 "Study of Dabigatran in Mechanical Heart Valve Patients Halted"
..."The study was testing three doses of dabigatran in patients with newly or previously implanted mechanical aortic valves, but concerns have been raised about the risk of valve thrombosis with the newer anticoagulant. In September 2012, as reported by heartwire , Canadian physicians reported the cases of two women who had undergone valve replacement years prior and had been faring well on warfarin but who subsequently suffered valve thrombosis when they were switched to dabigatran. (they were using it off label *)
Dabigatran is not approved for patients with mechanical valves. It is approved by the Food and Drug Administration for preventing strokes and systemic embolism in patients with nonvalvular atrial fibrillation as well as in preventing venous thromboembolism following elective knee- or hip-replacement surgery.
The presence of an artificial heart valve in patients is a clinical condition that is distinct from those for which dabigatran is an approved treatment," Boehringer Ingelheim stated in a press release. "In view of the interim trial results, the company is currently in discussions with the relevant regulatory authorities to reinforce the product label text accordingly and to discuss appropriate communication to physicians and relevant healthcare providers."
The RE-ALIGN study was started in December 2011, and approximately 370 patients were expected to be enrolled. The study's completion date was initially sometime in 2018"
There was an update w/ a few more details http://www.medscape.com/viewarticle/776481
"FDA Contraindicates Dabigatran for Those With Mechanical Heart Valves"
"SILVER SPRING, Maryland — The US FDA is following in the footsteps of the European Medicines Agency (EMA) in warning that the anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) should not be used to prevent stroke or major thromboembolic events in patients with mechanical (also known as mechanical prosthetic) heart valves
And the agency reveals the reason behind the recent decision to stop the RE-ALIGN trial with dabigatran in such patients: dabigatran users were more likely to experience strokes, MI, and thromboses forming on the mechanical heart valves than were users of warfarin, details that have hitherto not been reported by Boehringer Ingelheim. There was also more bleeding after valve surgery in the dabigatran users than in the warfarin users, says the FDA, which is now stating that dabigatran is contraindicated in patients with mechanical heart valves...." (more at link)
* Here is an article about the "off label" warning, from Canadian Doctors, http://www.medscape.com/viewarticle/771727
September 26, 2012 (Ottawa, Ontario) — Primary-care practitioners may be putting the lives of patients with prosthetic heart valves at risk by switching their anticoagulation from warfarin to newer agents such as dabigatran (Pradaxa, Boehringer Ingelheim), say Canadian researchers [1]. Dr Joel Price (University of Ottawa Heart Institute, ON)
...."The message is that dabigatran has really been approved only for patients who have non-valvular AF, but people are starting off-label use because of the perceived convenience of the medication," senior author Dr Munir Boodhwani (University of Ottawa Heart Institute, ON ) told heartwire . "To go and use it off-label is potentially harmful. There is a need to educate a variety of people who are involved in the management of anticoagulation--for example, hematologists, family physicians, and internal-medicine specialists, as well as cardiologists."
The article has a lot of good info, but it is from 9/12 before the RE-ALIGN trial was stopped
Lyn welcome back as a regular contributor. I always look forward to reading your well researched and referenced articles.
