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Posts Tagged ‘safety’

It looks like the rest of the medical community is finally speaking up about the overuse and safety issues of TAVI/ TAVR for aortic stenosis, but it’s still few and far between – and in specialty journals…  But in the same week that Medscape, and the Heart.org reported on a newly published article in the British Medical Journal on the overuse of TAVI therapies, and the need for earlier diagnosis and treatment of Aortic Stenosis – the Interventionalists over at the Heart.org (a cardiology specialty journal)  have published a series of articles promoting / pushing the procedure including an article entitled, “The TAVR Heart team roles.”

JAMA recently published a paper by Robert Bonow and Chintan Desnai, discussing the benefits, risks and expectations with TAVI.  This paper discusses the very real need for clinicians to address heightened patient expectations regarding TAVI as an ‘easy’ alternative to surgery.

TAVI is vastly overused – Reed Miller, The Heart.org

Here at Cartagena Surgery – we’ve been doing our own research – contacting and talking to a multitude of practicing cardiologists and cardiac surgeons to get their opinions – in addition to reviewing the latest data.

In related news, a review of the latest research on the ‘transcatheter’ valve therapies demonstrates considerable concern: including data on peri-valvular leaks as reported in the last national TAVI registries in Europe and in the US:

The incidence of  paravalvular leaks  after TAVI is extremely high  ( > 60%)

• It is technically challenging today to quantify these leaks.

• Most of them are quoted “mild”, but more than 15 % are estimated  “moderate” and “severe”.

• In > 5% of patients, the peri-valvular or valvular regurgitation grade increased significantly over time.

• there is no significant difference between Edwards SAPIEN and Medtronic COREVALVE

As one cardiologist explained:

“Importantly, the thrombogenic potential of mild leaks was recently demonstrated by Larry Scotten ( Vivitro System Inc. Victoria, Canada). High reverse flow velocities expose glycoprotein GP Ib-IX-V  platelet receptors  to circulating Von Willebrand molecule with, as results, platelet aggregation and fibrin formation.  The incidence of brain spots and stroke after TAVI was of great concern in the PARTNER A and B studies.  Whereas, Aspirin is not mandatory  in  patients implanted with bioprosthetic valves,   Plavix +  Aspirin is recommended for all TAVI patients. The rationales of such therapy were not explained so far.”

Valve oversizing – a surgeon explains

“To reduce  these peri-valvular leaks , cardiologists tentatively use large valve size, up to 29-mm.  The very large majority of valve sizes used in conventional aortic valve replacement are smaller than 25-mm.  Oversizing may increase the risk of late aortic aneurysms (aortic rupture has been reported) [emphasis added].

Moreover, atrio-ventricular conduction may be impaired  with the need of permanent pacing. Poorer outcomes have been reported in patients when the need for permanent pacemaker occurs.

“As we like to say about clothes and shoes, you forget the price overnight but you remember the quality for ever . The price of TAVI may be cheaper but patients may experience inferior outcomes. In view of these results, using TAVI would not be appropriate for the great majority of  heart valve candidates.  Moreover trans-catheter delivery and sub-optimal fit are not likely to increase tissue valve durability…  and everybody knows that tissue valves are not enough durable for young adults and children.  TAVI is thus a suitable strategy only for the neglected population of high risk patients who are no longer candidates for surgery [emphasis added].

Worth pointing out again  that there would be no need for TAVI and long-term outcomes of patients would be much better if severe aortic stenosis were correctly managed at the right time.  Enclosed the recommendations of Robert Bonow   (Circulation, July 25, 2012) for early valve replacement in ASYMPTOMATIC  patients.  A large cohort of accurate biomarkers is available today for correct timing of surgery  and consequent prevention of  irreversible myocardium damage. In the study of Lancellotti (enclosed) 55% of “truly asymptomatic patients” with severe aortic stenosis developed pulmonary hypertension during exercise and had  poor clinical outcomes. The measurement of both mean trans-aortic pressure gradient and systolic pulmonary pressure, which are technically easy, rapid and with good reproducibility may improve the management of such patients.

These updates on the natural history of aortic stenosis illustrate the present paradoxical and intriguing  focus of the industry on an experimental procedural innovation for end-stage old patients when more efficient heart valves are today feasible and could be used sooner for the benefit of all patients .

Enclosed an article on The Need For A Global Perspective On Heart Valve from Sir Madgi Yacoub.

Additional Reference / supporting data:

Modified from  Ross J and Branwald E   (Circulation 1968 (Suppl): 61-67)

• The  incidence of stroke was 9% after TAVI in  the 214 patients of the enclosed study published last week in the American Journal of Cardiology. The incidence of stroke with TAVI was >  two times higher than with conventional surgery in the PARTNER study.  Pooled proportion of postoperative stroke was 2.4%  with conventional surgery  in the  large meta-analysis of patients > 80 years old (enclosed)

• Peri-valvular aortic insufficiency is observed in more than  60% of patients undergoing trans-catheter aortic valve replacement.  Moderate or severe aortic insufficiency was seen in 17.3 % of the PARTNER inoperable and high risk cohorts at 1 year.  They have been reportedly associated with dyspnea, anemia,  cardiac failure and diminished survival. Most interestingly,  the FDA does not accept more than  1%   peri-valvular insufficiency in patients implanted with conventional prosthetic heart valves… The SJM Silzone mechanical heart valve was re-called  because of peri-valvular leakage rate of…  1.5 % .

• Traditionally, aortic stenosis involving a 2-cuspid aortic valve has been a contraindication to TAVI.  Of 347 octogenarians and 17 nonagenarians  explanted valves , 78 (22%) and 3 ( 18%) had stenotic congenitally bicuspid aortic valve, respectively.  Because the results of TAVI are less favorable in patients with stenotic congenitally bicuspid valves, proper identification of the underlying aortic valve structure is critical when considering TAVI in older patients . More than 50% of patients with aortic stenosis have bicuspid aortic valve and are not, therefore,  good candidates for TAVI. Most importantly, the great majority of patients with calcified stenotic  bicuspid aortic valves is  young ( < 60 years old)  and not candidate for tissue valve replacement.

•  The French Registry of trans-catheter aortic-valve implantation in high-risk patients was published in the New England Journal of Medicine on May 3,  2012. It reports  3195 TAVI procedures during the last two years at 34 centers.

The mean age was 83 years.  The incidence of stroke was 4.1%.  Peri-prosthetic aortic regurgitation was 64 %. The rate of death was 24% at one year. At the same time, the meta-analysis published in the American Heart Journal reports 13,216     CONVENTIONAL AORTIC VALVE REPLACEMENT in patients > 80 years old.    The rate of death was 12.4%  at one year,   21.3%  at 3 years and  34.6%  at 5 years

 

Full references for works cited in text:

Bonow, R. O. (2012). Exercise hemodynamics and risk assessment in asymptomatic aortic stenosisCirculation 2012, July 25.

Lancelloti, P., Magne, J., Donal, E., O’Connor, K., Dulgheru, R., Rosca, M., & Pierard, L. (2012).  Determinants and prognostic significance of exercise pulmonary hypertension in asymptomatic severe aortic stenosis.  Circulation, 2012 July 25.

Takkenberg, J. J. M., Rayamannan, N. M., Rosenhek, R., Kumar, A. S., Carapitis, J. R., & Yacoub, M. H. (2008).  The need for a global perspective on heart valve disease epidemiology: The SHVG working group on epidemiology of heart disease founding statement.  J. Heart Valve Dis. 17 (1); 135 – 139.

Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A,Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S,Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Collaborators (184). Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3; 366(18):1705-15 [full abstract below].

BACKGROUND:

Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses.

We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2.

METHODS:

All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause.

RESULTS:

A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women.

All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%).

The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively.

At 1 year, the incidence of stroke was 4.1%, and   the incidence of periprosthetic aortic regurgitation was 64.5%.

In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival.

CONCLUSIONS:

This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option.

Rutger-Jan Nuis, MSc,  Nicolas M. Van Mieghem, MD,  Carl J. Schultz, MD, PhD,  Adriaan Moelker, MD, PhD ,  Robert M. van der Boon, MSc, Robert Jan van Geuns, MD, PhD, Aad van der Lugt, MD, PhD,  Patrick W. Serruys, MD, PhD, Josep Rodés-Cabau, MD,  Ron T. van Domburg, PhD,  Peter J. Koudstaal, MD, PhD,  Peter P. de Jaegere, MD, PhD.  Frequency and Causes of Stroke During or After Trans-catheter Aortic Valve Implantation. American Journal of Cardiology Volume 109, Issue 11 , Pages 1637-1643, 1 June 2012 [full abstract provided].

Transcatheter aortic valve implantation (TAVI) is invariably associated with the risk of clinically manifest transient or irreversible neurologic impairment. We sought to investigate the incidence and causes of clinically manifest stroke during TAVI. A total of 214 consecutive patients underwent TAVI with the Medtronic-CoreValve System from November 2005 to September 2011 at our institution. Stroke was defined according to the Valve Academic Research Consortium recommendations. Its cause was established by analyzing the point of onset of symptoms, correlating the symptoms with the computed tomography-detected defects in the brain, and analyzing the presence of potential coexisting causes of stroke, in addition to a multivariate analysis to determine the independent predictors.  Stroke occurred in 19 patients (9%) and was major in 10 (5%), minor in 3 (1%), and transient (transient ischemic attack) in 6 (3%). The onset of symptoms was early (≤24 hours) in 8 patients (42%) and delayed (>24 hours) in 11 (58%). Brain computed tomography showed a cortical infarct in 8 patients (42%), a lacunar infarct in 5 (26%), hemorrhage in 1 (5%), and no abnormalities in 5 (26%). Independent determinants of stroke were new-onset atrial fibrillation after TAVI (odds ratio 4.4, 95% confidence interval 1.2 to 15.6), and baseline aortic regurgitation grade III or greater (odds ratio 3.2, 95% confidence interval 1.1 to 9.3).

In conclusion, the incidence of stroke was 9%, of which >1/2 occurred >24 hours after the procedure. New-onset atrial fibrillation was associated with a 4.4-fold increased risk of stroke. In conclusion, these findings indicate that improvements in postoperative care after TAVI are equally, if not more, important for the reduction of peri-procedural stroke than preventive measures during the procedure.

Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Müller C, Grube E,Nickenig G, Werner N. (2012).  Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation.  J Am Coll Cardiol. 2012 Mar 27;59(13):1134-41. [full abstract provided].

OBJECTIVES:

The aim of this study was to provide a simple, reproducible, and point-of-care assessment of peri-prosthetic aortic regurgitation (periAR) during trans-catheter aortic valve implantation (TAVI) and to decipher the impact of this peri-procedural parameter on outcome.

BACKGROUND:

Because periAR after TAVI might be associated with adverse outcome, precise quantification of periAR is of paramount importance but remains technically challenging.

METHODS:

The severity of periAR was prospectively evaluated in 146 patients treated with the Medtronic CoreValve (Minneapolis, Minnesota) prosthesis by echocardiography, angiography, and measurement of the aortic regurgitation (AR) index, which is calculated as ratio of the gradient between diastolic blood pressure (DBP) and left ventricular end-diastolic pressure (LVEDP) to systolic blood pressure (SBP): [(DBP – LVEDP)/SBP] × 100.

RESULTS:

After TAVI, 53 patients (36.3%) showed no signs of periAR and 71 patients (48.6%) showed only mild periAR, whereas 18 patients (12.3%) and 4 patients (2.7%) suffered from moderate and severe periAR, respectively. The AR index decreased stepwise from 31.7 ± 10.4 in patients without periAR, to 28.0 ± 8.5 with mild periAR, 19.6 ± 7.6 with moderate periAR, and 7.6 ± 2.6 with severe periAR (p < 0.001), respectively. Patients with AR index <25 had a significantly increased 1-year mortality risk compared with patients with AR index ≥25 (46.0% vs. 16.7%; p < 0.001). The AR index provided additional prognostic information beyond the echocardiographically assessed severity of periAR and independently predicted 1-year mortality (hazard ratio: 2.9, 95% confidence interval: 1.3 to 6.4; p = 0.009).

CONCLUSIONS:

The assessment of the AR index allows a precise judgment of periAR, independently predicts 1-year mortality after TAVI, and provides additional prognostic information that is complementary to the echocardiographically assessed severity of periAR.

Gotzmann M, Lindstaedt M, Mügge A. (2012). From pressure overload to volume overload: Aortic regurgitation after transcatheter aortic valve implantation.  Am Heart J. 2012 Jun;163(6):903-11.  [full abstract provided].

Severe aortic valve stenosis is a common valvular heart disease that is characterized by left ventricular (LV) pressure overload. A lasting effect of pressure overload is LV remodeling, accompanied by concentric hypertrophy and  increased   myocardial stiffness. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients with severe symptomatic aortic valve stenosis and high surgical risk.   Although TAVI has  favorable hemodynamic performance, aortic valve regurgitation (AR) is the most frequent complication because of the specific technique used for implantation of transcatheter valves.

During  implantation, the calcified native valve is pushed aside, and the prosthesis usually achieves only an incomplete prosthesis apposition. As a consequence, the reported prevalence of moderate and severe AR after TAVI is  6% to 21%,  which is considerably higher than that after a surgical valve replacement. Although mild AR probably has minor hemodynamic effects, even moderate AR might result in serious consequences. In moderate and   severe  AR  after TAVI,  a normal-sized LV with increased myocardial stiffness has been exposed to volume overload. Because the noncompliant LV is unable to raise end-diastolic volume, the end-diastolic pressure increases, and  the  forward stroke volume    decreases. In recent years, an increasing number of patients have successfully undergone TAVI. Despite encouraging overall results, a substantial number of patients receive neither symptomatic nor prognostic benefits from TAVI.   Aortic valve regurgitation has been considered a potential contributor to morbidity and mortality after TAVI. Therefore, various strategies and improvements in valve designs are mandatory to  reduce the prevalence of AR after TAVI.

Walther T , Thielmann M, Kempfert J, Schroefel H, Wimmer-Greinecker G, Treede H, Wahlers T, Wendler O. (2012). PREVAIL TRANSAPICAL: multicentre trial of transcatheter aortic valve implantation using the newly designed bioprosthesis (SAPIEN-XT) and delivery system (ASCENDRA-II).  Eur J Cardiothorac Surg. 2012 Aug;42(2):278-83. Epub 2012 Jan 30.  [full abstract provided].

OBJECTIVE

Transapical (TA- aortic valve implantation (AVI) has evolved as an alternative procedure for high-risk patients.  We evaluated the second-generation SAPIEN xt ™ prosthesis in a prospective multicentre clinical trial.

METHODS

A total of 150 patients  (age : 81.6;  40.7 % female) were included. Prosthetic valves (diameter :23 mm (n= 36), 26 mm (n= 57) and 29 mm (n= 57) were implanted. The ASCENDRA-II™ modified delivery system was used in the smaller sizes.   Mean logistic EuroSCORE was  24.3%  and mean STS score was 7.5 ± 4.4%.  All patients gave written informed consent.

RESULTS:

Off-pump AVI was performed using femoral arterial and venous access as a safety net.  All but two patients receivec TA-AVI, as planned.  The 29-mm valve showed similar function as the values of two other diameters did.  Three patients (2%) required temporary bypass support.

Postoperative complications included renal failure requiring long-term dialysis in four, bleeding requiring re-thoracotomy in four, respiratory complication requiring re-intubation in eight and septsis in four patients, respectively.

Thirty day mortality was 13 ( 8.7%)  for the total cohort and 2/57  (3.5%) receiving the 29 mm valve respectively.   Echocardiography at discharge showed none or trivial incompetence (AI) in  71%  and mild-AI in 22% of the patients.  Post-implantation AI was predominantly para-valvular and > 2+  in 7% of patients.  One patient required re-operation for AI within 30 days.

CONCLUSION

The PREVAIL TA multicenter trial demonstrates good functionality and good outcomes for TA-AVI, using the SAPIEN xt ™ and its second generation ASCENDRA-II™ delivery system, as well successful  introduction of the 29-mm  SAPIEN XT ™ valve for the benefit of high-risk elderly patients.

Subramanian S, Rastan AJ, Holzhey D, Haensig M, Kempfert J, Borger MA, Walther T, Mohr FW. (2012).  Conventional Aortic Valve Replacement in Transcatheter Aortic Valve Implantation Candidates: A 5-Year ExperienceAnn Thorac Surg.   July 19 2012  [full abstract provided].

BACKGROUND:

Patient selection for transcatheter aortic valve implantation (TAVI) remains highly controversial. Some screened patients subsequently undergo conventional aortic valve replacement (AVR) because they are unsuitable TAVI candidates. This study examined the indications and outcomes for these patients, thereby determining the efficacy of the screening process.

METHODS:

Between January 2006 and December 2010, 79 consecutive patients (49% men), aged older than 75 years with high surgical risk, were screened for TAVI, but subsequently underwent conventional AVR through a partial or complete sternotomy. The indications, demographics, and outcomes of this cohort were studied.

RESULTS:

Mean age was 80.4 ± 3.6 years. Mean left ventricular ejection fraction was 0.55 ± 0.16, and the mean logistic European System for Cardiac Operative Risk Evaluation was 13% ± 7%. Of the 79 patients, 6 (7.6%) had prior cardiac surgical procedures. Indications for TAVI denial after patient evaluations were a large annulus in 31 (39%), acceptable risk profile for AVR in 24 (30%), need for urgent operation in 11 (14%), and concomitant cardiovascular pathology in 5 (6%). Mean cross-clamp time was 55 ± 14 minutes, and cardiopulmonary bypass time was 81 ± 21 minutes. Concomitant procedures included a Maze in 12 patients (15%). Postoperative morbidity included permanent stroke in 2 (2.5%), respiratory failure in 9 (11%), and pacemaker implantation in 2 (2.5%). Hospital mortality was 1.3% (1 of 79). Cumulative survival at 6, 12, and 36 months was 88.5%, 87.1% and 72.7%, respectively.

CONCLUSIONS:

Our existing patient evaluation process accurately defines an acceptable risk cohort for conventional AVR. The late mortality rate reflects the advanced age and comorbidities of this cohort. The data suggest that overzealous widening of TAVI inclusion criteria may be inappropriate.

Industry fights back

Now it looks like Edwards Lifesciences,  the company that manufacturers the Sapien valve is speaking out to dispute recent findings that show TAVI to have less than optimal results.  Of course, the author at the site, Med Latest says it best, “Setting aside the conflict of interest stuff, which might be a red-herring, what we’re left with is a situation where evidence-based medicine, while being something all would sign up to, is not that straightforward.”


[1] Several cardiologists and cardiac surgeons contributed to this article.  However, given the current politics  within cardiology, none of these experts were willing to risk their reputations by publically disputing the majority opinion.  This is certainly understandable in today’s medico-legal climate in wake of widespread scandals and credibility issues. However, all quotes are accurate, even if unattributable with minor formatting (such as the addition of quotations, and paragraph headings have been added for increased clarity of reading in blog format.)  I apologize for the ‘anonymous nature’ of my sources in this instance – however, I can assure you that these ‘experts’ know what they are talking about.

  [All commentary by Cartagena Surgery are in italics and brackets]. 

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Finally caught up with the busy Dr. Gabriel Ramos, MD, oncologic surgeon and spent several hours with him in the operating room at IMSS (the social security hospital) for a couple of cases on Wednesday..  I’ll be writing more about him soon.

Dr. Gabriel Ramos, Oncologic Surgeon

Yesterday was a full day with clinics here and San Luis.  Also – more homework, so I have to get some studying in before heading back in this afternoon.

On the radio with Cartagena Surgery:

Recorded my very first radio interview with Ilene Little at Traveling 4 Health..  I hope I don’t sound too bad (when I get nervous, I laugh..)  It’s not a pre-determined format, so I didn’t know the questions until she asked them – which makes it more interesting, but I sound less polished as I search my brain for names, dates, places etc.  Trying to remember the name of the researchers who published a paper in 1998, 2008, or 1978 is daunting when you worry about ‘dead air’.. I was so nervous I was even forgetting my abbreviations.  I hope it comes across better to listeners.

We talked about the books, what I do (and how I am surviving on savings to do it).  We also talked about some of the great doctors I’ve interviewed, treatments such as HIPEC as well as some of the quackery and false hope being peddled by people with a lot to gain.. I kind of wish HIPEC and quackery weren’t in the same segment.  Since it was off the cuff – I didn’t have all of my medical references and literature to talk about to distinguish the two (so if you are here looking for information on HIPEC – search around the site – I have links to on-going studies, and research going back over a decade, both here at BogotaSurgery.org .  Of course, the crucial difference between the two is:

HIPEC is a new treatment, but there is NO assurance of success – in fact, some patients die from the treatment itself.

– There is a body of scientific literature on HIPEC for advanced abdominal cancers (ovarian, uterine, etc)

Quakery or pseudo-science can be a bit trickery.  Maybe they take an existing or  promising treatment (like therapies for stroke, Parkinson’s etc.) and apply it to something else – like treatment of serious cancers.  (Yes – people will find papers written about the ‘treatment’, but these papers may not meet scientific rigor, or may not be about the condition or treatment that they are receiving.)  They also promise miracles and cures.

In medicine, even the very best doctors and surgeons can’t promise these things – because medicine itself isn’t an exact science, and different people respond to the same treatments differently – ie. one patient may have complications and another patient doesn’t.

Lastly  – we just touched on it – but I think it’s an important concept – is patient self-determination.  That no matter what I, or anyone writes, does or says – people always have the right to determine their own medical treatment.

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Syringe of unknown contents

 

 

 

Dr. Fix-a-flat (Oneal Morris) in Ft. Lauderdale, Florida has been re-arrested as more victims of his scam surgeries have come forward.

This arrest comes as other American cities, (most notably, Las Vegas) make a concerted push to protect consumers with a new campaign against fraudulent practices and unlicensed physicians.  However, these ‘campaigns’ are primarily informational commercials aimed at the Latino community.

There is a new statewide task force aimed at addressing these incidents, but as of yet – there have been no legislative changes to protect victims of these scams.  Equally disturbing, in at least one of these cases – one of the pretend doctors used his fake status to sexually assault his victims.

In another disturbing sidenote out of Nevada – Teva pharmaceuticals settled a case against them for the distribution of propofol outside of proper channels/ and in improper quantities.  (If you remember, this is how Dr. Conrad Murray obtained the anesthetic for use on Michael Jackson.)  As a result of this distribution of multi-use medications that should be exclusively used in hospital settings – several patients were inadvertently exposed to Hepatitis C (including the plaintiff who developed Hepatitis C as a result.)

[Multi-use vials mean that the same container of medication is used for multiple people – if the medication is drawn up using needles or other instruments that have already been exposed to patients – this places future patients in contact with blood and infectious agents.]   Multi-use vials are a cost-containment measure for many institutions.

I hope that someone takes issue with out-patient colonoscopies as a whole since this in itself can be a very dangerous practice – and the research proves it.  (The issue behind outpatient procedures such as colonoscopies is the use of unmonitored anesthesia.  Most patients aren’t on monitors, no anesthesiologist is present, and the doctors performing the procedure are often unprepared in the event that a patient loses his airway (or stops breathing.)  There was a landmark study several years ago – that showed that 70% of nonaesthesiologists underestimated the level of sedation in patients undergoing out-patient / office procedures.  [I will continue looking for the link to this source.]

Frighteningly, a related paper demonstrated similar findings in a pediatric population.  This South African paper voices similar concerns.

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For anyone traveling to Bogotá or Cartagena, I have created some FREE mobile apps for Android phones. (Still working on iTunes versions).  These apps contain maps, local resources, travel links, and emergency information.  Where to go if you are experiencing chest pain?  Got you covered.. Where to stay?  also covered.. Cheapest flights – in the app..  Where to get a good meal – it’s in there too.. The apps will also keep you connected to the blog where I post all updates to the books, and news about the destination.

Bogotá Apps:
Bogotá Surgery – primarily based on the blog – for those who can’t stand to miss a post.

The Bogotá Companion– maps, travel resources and references, emergency information.

Cartagena app:
The Cartagena Companion – chock full of information, including short videos about Cartagena.

You don’t have to be a medical tourist to enjoy these apps – best thing is, they are all FREE..

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Another case of sketchy plastic surgery reported – this time in Myrtle Beach, South Carolina.   Yet again, I would like to caution readers about seeking ‘cheap’ plastic surgery on the internet.  (I’m not saying don’t look – please do!  But look smartly.)  This doesn’t only apply to plastic surgeons, but to all surgeons, physicians, and healthcare professionals.

‘The internet’ is not all the same – the grade of information can vary widely from scientific journals (highly reputable/ reliable) to fiery but heavily opinionated blogs (unreliable/ unscientific) to frankly fraudulent such as in this instance (in the story above).  People need to use caution, due diligence and common sense when researching anything, but particularly medical information on the internet.  You need to do your homework.

There are a few things to consider when researching medical information/ providers on the internet.

1.  Is the information independently verifiable?  (and by what sources?) 

As a medical writer – this is a huge portion of my job – verifying the information obtained during interviews, etc.  But when you are looking to purchase goods or services – you need to do a little investigative work yourself.  Luckily, once again – the internet makes this simple.

The first thing you should investigate is – the person making the claims/ and what their focus is.  Use this website for an example, if you like.  So take the following information (below) – that is easily available on the site..

(If this information isn’t readily available on the site – that should make you suspicious.  “Anonymous” blogs or hidden author websites are NOT reputable.  People with valid, truthful information have nothing to hide, and are not ashamed to stand by their work/ writings.)

so you’ve gathered the following information  from the site:

Author – XXXX   credentials claimed/ authority source:  Physician (MD/ DO etc.)

Product or service advertised on the site:  surgical procedure XX

Use this information to answer the following questions:

1. Who is this person?

2. How do they know this/ what special knowledge do they possess?  (for example – a hairdresser shouldn’t be giving medication advice)

3.  Can I verify this?

– Medical personnel can be verified thru state licensing boards. 

Some states make this easier than others, but ALL states have this information available to consumers.  So go to the website of the licensing board (medical board for doctors, nursing board for nurses) and look the person up.

In this example, I am currently licensed in several states – so pick one, and do an internet search for the board of nursing for that state.  (Tennessee is particularly easy since they post educational information, license violations etc. on-line).  If this licensing information isn’t easy to find on the website, call the board.**

If the website (ie. plastic surgery clinic) lists an address – use that state for your search.

In another example – as seen below – we’ve looked up a surgeon at the Colorado Medical Board.

Looking up a medical license

Looking up a medical license

– All physicians should be licensed in the state of practice (where their clinic is.)  If they aren’t licensed in that state – STOP and find another provider.  Even if the doctor claims to be from another country, he or she is STILL required to have an active license in the state they are working in.**

Here is an example of physicians sanctioned by the Texas medical board (all of this information is freely available on the internet for your safety.)


Here is another example of a surgeon with multiple medical board actions against her.

licence details

license details

Many of the state medical boards will let you read the complaints, actions and disciplinary measures against physicians licensed in that state.  However, some states allow physicians under investigation to ‘surrender’ or inactive their license to avoid having disciplinary measures recorded.

– All surgeons, or specialty doctors should also be listed with specialty boards – such as the American College of Surgeons, or the American Society of Plastic Surgery(While membership is not mandatory, the vast majority of specialty trained surgeons maintain memberships in their specialty organizations.)  Other things to consider while investigating credentials:

Do the credentials match the procedure?  (Is this the right kind of doctor for this procedure?)

These credentials should match the procedure or treatment you are looking for: such as Plastic surgeons advertising breast augmentation.

This may sound obvious but it isn’t always the case.  (for example:  dermatologists shouldn’t be doing eyelid lifts or plastic surgery, primary care physicians shouldn’t be giving Botox injections, general surgeons shouldn’t be performing lung surgery etc.)
If you aren’t sure what procedures the doctor should be performing, look at the specialty surgery board – it should list the procedure.  i.e plastic surgery and liposuction.

4.  After verifying this information, it is time to do a basic internet search on the individual.  To do this – perform both a Yahoo! and Google search.   This should give you at minimum, 10 to 15 results.

These results should include several non-circular results.  “Circular results” are results that return you to the original website, or affiliated websites.   For example: Using the information from above – both Google and Yahoo! return several results that link directly to this website.  These results also return links for the sister sites.  All these of these are circular results – that return you to the starting point without providing any additional outside information.

However, if you scroll down the results:  outside links should appear.  These should include articles/ publications or scholarly work.  Other search results may include more personal information, social networking sites and other newsworthy articles.  This gives you a more comprehensive picture of the provider.

One of the things we should mention, is patient testimonials.  While many providers include extensive patient testimonials, I disregard these for several reasons:

– There is usually not enough information to verify the authenticity of these patient claims.  “I love my doctor. He’s a great surgeon.” – Gina S.  doesn’t really tell you anything.  In particular, there is no way to verify if there really is a Gina S. or if she is a fictitious creation of the website author.  (There have been several cases where people working for the doctors have created ficticious accounts including before and after photos talking about procedures that they never had).  Don’t be lulled into a false sense of security with patient testimonials.

– Some people use blogs, or message boards for the same purpose, and the same caveats apply.

– Another reason that patient testimonials are not useful in my opinion, is that patients (and their families) are only able to provide subjective information.  Several of the cases in the news recently (of fraudulent individuals posing as doctors) had several “happy patients’ to recommend them.  Patients, for the most part – aren’t awake and able to judge whether the surgery proceeded in a safe, appropriate fashion.  The testimonials are merely a comment on the physician’s charisma, which may give future patients a false sense of security.

I’ve finished my search – Now what?

   Use commonsense:

– Surgical treatments should be performed in an appropriate, sterile environment like a hospital or freestanding clinic.  A reputable surgeon does not operate in the back of a motor home, a motel room or an apartment.  (All of these have been reported in the media.)  If the setting doesn’t seem right – leave.  You can also investigate the clinic.

– Bring a friend.  In fact, most surgeons will require this, if you are having liposuction or another large procedure.  Doctors don’t usually drive their patients around (as was done in several recent cases.)  The exception to this rule is medical tourism packages.  These packages often include limousine transportation services but these services are provided by a professional driver (not the doctor, or ‘his cousin’).  Your friend/ companion is not just your driver – they are also there to help feel out the situation.  If something seems amiss – do not proceed.

– if the price is too cheap – be suspicious.  If every other provider in the same location charges a thousand dollars – why is this doctor only charging a hundred dollars? Chances are, it’s not a sale – and he/ she is not a doctor.

– Use reputable sources to find providers – Craigslist is not an appropriate referral source.

– Are the claims over-the-top?  Is the provider claiming better outcomes, faster healing or an ‘easier fix’ than the competition? (We will talk more about this in a future post on  “miracle cures’ and how to evaluate these claims.

I hope these hints provide you with a good start to your search for a qualified, safe, legitimate provider.  The majority of health care providers are excellent, however the internet has given criminals and frauds with an easy avenue to lure/ and trap unsuspecting consumers.

** The majority of cases that have been recently reported have taken place in the United States (Nevada, New Jersey, Florida and South Carolina.)  Many of the people perpetrating these crimes have posed as Latin American surgeons to capitalize on the international reputation of plastic surgeons from South America.  They also used these claims to try and explain away the lack of credentials.  A legitimate doctor from Brazil,  Argentina, Colombia, Costa Rica or another country, who is practicing in the United States WILL HAVE an American license.

Additional references/ stories on fraudulent surgeons.

(Hopefully this section will not continue to grow)

More on the Myrtle Beach story

Myrtle Beach – a nice article explaining why people should see specialty surgeons

Basement surgery

Article on unlicensed clinics in Asia (medical tourists beware!)

A truly bizarre story about unlicensed dentistry in Oregon

Additional references:

American College of Surgeons – lists doctors distinguished/ recognized as “fellows” in the academic organization, and provides a brief summary of specialties.

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Dr. Francisco Holguin, and his charming wife, Ximena Reyes

Spent a charming afternoon with Dr. Francisco Holguin Rueda and his wife, Ximena Reyes (RN) on a sunny afternoon here in Bogota.   Now that I had a chance to sit down with Dr. Holguin, we talked about Medical City, what it was, and what he expected it to bring to the Cartagena area.  We are planning another sit down later next week – to talk more in-depth, so I can bring it to all of your here.

Medical City is Dr. Holguin’s latest creation – to bring large-scale, centralized medical care to Cartagena that is designed to attract, and serve the needs of medical tourists from around the globe.  Cartagena’s convenient and strategic location makes it an ideal destination for medical tourists from North , Central and South America, and well as the entire Caribbean.. By creating a medical center, just outside Cartagena (10 km) from the airport, in an upscale neighborhood, that is already home to many Americans and other ex-pats – patients can receive a wide range of medical and surgical services all in one place, without having to navigate Cartagena city traffic, or transverse the city from one specialist to another.

All the major surgical specialties will be represented with specialized centers; cardiac surgery, orthopedic surgery, plastic surgery, and of course, Dr. Holguin’s specialty, Bariatric surgery.  I am looking forward to our next meeting, so I can bring you more information.  Check back next week.

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Here’s another re-post from Heartwire :

Midei and unnecessary stents—or lack thereof—make news again

April 25, 2011            |            Shelley Wood

Baltimore, MD and Greensburg, PA – “Unnecessary stents” and the people who place them have been back in the news this past week with a confusing twist of the tale in Pennsylvania, previously reported by heartwire, where two cardiologists stepped down on charges of unnecessary stenting [1], and a published Commentary, by Dr Mark Midei, in the Baltimore Sun [2].

The latest development in the Greenburg, PA case, reported Saturday in the Pittsburgh Tribune-Review, involves an admission by the hospital’s chief medical officer that at least six of 141 Westmoreland Hospital patients sent letters telling them they may have received “unnecessary stents” in fact never got stents in the first place. Instead, the hospital now says, these six patients underwent angioplasty procedures that appeared, on review, to not have been medically warranted, although no stents were placed.

The two cardiologists who treated the 141 patients—Drs Ehab Morcos and George Bousamra—voluntarily resigned after hospital administrators first questioned the medical necessity of the procedures. Those questions stemmed from the conclusions of eight independent cardiologists, as part of a review by the American Medical Foundation in Philadelphia. The hospital alerted patients to the situation via a letter, and 19 patients have since launched lawsuits against the two cardiologists and the parent health organization for the hospital, Excela Health.

The hospital has now sent new letters “of clarification,” the Tribune-Review reports, a move that has been slammed by lawyers handling the lawsuits and by outside observers.

“It is confusing,” Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple) is quoted in the article. “The bottom line is that it was an unnecessary procedure, whether they got a stent or not.”

Midei’s day in the Sun

Meanwhile, Dr Mark Midei, whose predicament in Baltimore is viewed by many as the catalyst for the stepped-up scrutiny of interventionalists around the US, once again lays out his side of the story—this time in the Baltimore Sun, the newspaper that has meticulously covered this saga. In the article, published Friday, Midei notes that he will soon be appearing before the Maryland Board of Physicians to “make the case for retaining my license to practice medicine” but in the meantime wants his voice heard.

Midei repeats an allegation he made when he first spoke out on the case, in an interview with heartwire, saying that St Joseph used him as a “decoy” when the hospital was embroiled in a federal investigation.  He has also, he says, been falsely portrayed as “manipulating” the peer-review process at the hospital, when in fact “any doctor, nurse, technologist, or physician assistant could suggest additional cases for review.” As well, he notes, he was not paid by the hospital based on the number of cases he performed, as press reports have suggested.

As for his relationship with stent manufacturers, he says he never accepted gifts or offers from companies, and any personal honoraria were donated to outside charities or foundations. He does not specifically address the now famous “appreciation pig roast” paid for by Abbott held for St Joseph’s cardiac staff in Midei’s backyard.

But he does, with some humility, acknowledge that may not “have been perfect in my practice of medicine; no doctor can make that claim.”

And he concludes: “I can say unequivocally that my decisions as a doctor have been motivated by one thing only: The well-being of my patients.”

As reported by heartwire, two cardiology organizations recently asked the state of Maryland to legislate cath lab oversight in an effort to avoid the tangles unraveling in Baltimore and Pittsburgh; that plan has since been nixed.

Update: 22 July 2011 – Dr. Midei’s medical license has been revoked. (article re-post – Heartwire.com in another report by Shelley Wood).

Dr Mark Midei’s medical license revoked

July 13, 2011            |            Shelley Wood

Baltimore, MD (updated) – The Maryland Medical Board has concluded its review of Dr Mark Midei, deciding to revoke his license, calling his violations of the Medical Practice Act “repeated and serious.”

The disciplinary actions alert published on the board’s website today notes that the board will not accept any application for reinstatement by Midei for at least two years. At that time, it is up to the board whether it will consider reinstatement of his license.

As previously reported by heartwire, Midei is alleged to have implanted hundreds of unneeded stents when he worked at St Joseph Medical Center in Towson, MD. The imbroglio was ultimately taken up by the US Senate Finance Committee, which issued a damning report back in December 2010.

For years, however, watchers have been waiting to hear what the Maryland Board of Physicians concluded, having charged Midei with violating the Medical Practice Act back in July 2010, focusing specifically on five patients it was alleged may have received stents unnecessarily. A subsequent seven-day hearing before an administrative law judge (ALJ) led to her issuing a 77-page “proposed decision” that Midei have his license revoked for having violated five provisions of the act, specifically those prohibiting:

  • Unprofessional conduct in the practice of medicine.
  • Willfully making a false report or record in the practice of medicine.
  • Gross overutilization of health care services.
  • Violations of the standard of quality care.
  • Failure to keep adequate records.

In its “findings of fact,” the board concluded that Midei implanted six cardiac stents unnecessarily in four out of the five cases reviewed and noted in his charts that the extent of the stenosis was 80%, when in fact it was lower “and in most cases much lower.” In three cases he falsely reported that patients had unstable angina, when in fact they didn’t, and in all five patients he failed to obtain the active coagulation time and instead administered heparin while inserting the catheter. In one of the patients, Midei “also failed to look at or disregarded the hospital’s note that the patient had already been given an anticoagulant and should not be given another.”

In June, Midei filed exceptions with the board in an oral hearing, which was considered in advance of today’s announcement. Those included a request by Midei that the board reverse the judge’s opinion on which expert reviewer to believe. The ALJ had used Dr Matthews Chacko (Johns Hopkins Hospital, Baltimore, MD) as expert reviewer, whereas Midei’s primary expert witness was Dr William O’Neill (University of Miami, FL). The board’s “consideration of exceptions” notes that all of the experts were “qualified” but that the ALJ “made her determination based on the consistency of Dr Chacko’s testimony and his clear presentation and demeanor” as well as her consideration of professional publications. By contrast, the ALJ “noted some inconsistencies or equivocations in the testimony” of O’Neill. Also at issue was the fact that Chacko was paid $1400 for his report and expert testimony—something Midei raised as problematic. The board report notes that O’Neill, Midei’s expert, was “paid more than 20 times that much.”

Asked to comment, O’Neill emailed heartwire to say: “I think it’s a tragedy that a fine doctor’s reputation and livelihood are ruined when there was never a single shred of proof that he harmed any patient. I stand by my [previous] comment that after reviewing all the records and films personally, I would have no problem letting Dr Midei treat me or a family member. I pity any interventional cardiologist practicing in Maryland today; if Dr Midei can lose his license, any of them could.”

The board agreed with the ALJ’s conclusions and, “using its own expertise,” agreed that Chacko’s testimony “represents an accurate statement of the standard of quality care.” The board clearly took exception to Midei’s suggestion that he sometimes wrote “80%” as a form of shorthand for blockages that in fact were less than 50%, calling that “a justification for a blatant falsehood that resulted in patients receiving unneeded stents as well as the creation of false records.”

The board also questioned the believability of Midei’s testimony that his decision to stent certain patients was on the basis of “remembered” symptoms not recorded in patients’ medical records. “The ALJ found it not credible that Dr Midei could remember these unrecorded symptoms in the cases of patients who were among thousands that he saw only once, for very brief period of time (from 20 to 37 minutes) three years previously.”

As reported by heartwire, Midei, who is being sued by hundreds of former patients believing they received unnecessary devices, is himself suing his former hospital, St Joseph, alleging in part that he was a scapegoat in “an epic campaign of corporate deception, trickery, and fraud” relating to past business deals and a federal investigation. In his medical-board hearing, Midei was permitted to present evidence to support this claim; the board, ultimately, agreed with the ALJ that “nothing St Joseph Medical Center did or failed to do is relevant to the issues of this case.”

The final decision and order, signed by board chair Dr Paul T Elder, contains a number of scalding conclusions about Midei’s conduct, stating that he failed to deal honestly with patients and colleagues and that his reports intentionally and nonaccidentally “exaggerated” patient symptoms and degree of stenosis.

“Dr Midei’s violations were repeated and serious. They unnecessarily exposed his patients to the risk of harm,” the decisions states. “They increased the cost of the patients’ medical care. Dr Midei’s willful creation of false percentage numbers for the degree of occlusion of coronary arteries is indefensible and amounts to a deliberate and willful fabrication of medical records.”

Requests for a reaction from Midei’s lawyers have not been returned. Midei has 30 days to ask for a judicial review of the decision.

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