Miami plastic surgeon tied to multiple deaths


From the Miami Herald comes a terrifying story about a plastic surgery group tied to multiple patient deaths.  The surgical group which operated out of three different south Florida clinics are responsible for at least three deaths, including the recent death of a young woman from West Virginia, Heather Meadows, 29,  who had traveled to south Florida looking for cheap plastic surgery.

bandaid

In addition to this case, come reports that the group housed post-operative patients in a local horse stable.  The clinics; Encore Plastic Surgery in Hialeah, and two Miami clinics; Vanity Plastic Surgery and Spectrum Aesthetics have also been linked with multiple serious medical complications including the case of Nyosha Fowler who was comatose for 28 days after surgeons at the clinic accidentally perforated her intestine and then injected the fecally contaminated fluid into her sciatic nerve during a liposuction/ fat transfer procedure.  Ms. Fowler, who is lucky to be alive, is now permanently disabled and facing a two-million dollar medical bill for the life-saving care she received at an outside facility.

Now, Heather Meadow’s death has been ruled accidental, which is no comfort to her family or the numerous patients harmed by these surgeons. While the state of Florida has reprimanded two of the surgeons in the surgical group in the past, this hasn’t affected their practice, and the surgical clinics continue to accept new patients from across the United States and operate on unsuspecting clients.

money

Beauty, at any price?

While Florida state health officials issued an emergency restriction prohibiting one of the group’s surgeons, Dr. Osak Omulepu from operating, no charges have been made despite cell phone photographs documenting horrific conditions at the horse stables where patients were forced to stay while they recuperated from various procedures.  In fact, Dr. Osak Omulepu continues to have four star ratings on several online sites.  His license is listed as active on the Florida Medical Board, with no complaints listed under his profile page.  However, under the disciplinary actions page, there are eight separate listings that do not appear on his general profile.

One of these Complaints, (posted here) related to the death of a 31-year-old woman due to repeated liver perforation during liposuction.  The complaint also cites several other cases against the doctor and notes that Dr. Osak Omulepu is not a board certified plastic surgeon.  In fact, according to the complaints filed in March, the good doctor, holds no certification in any recognized medical specialty.

Related posts:

Plastic surgery safety & Buttloads of Pain

Patient satisfaction scores vs. clinical outcomes: The Yelp! approach to surgery

Is your ‘cosmetic surgeon’ really even a surgeon?

Patient Safety & Medical Tourism

Liposuction in a Myrtle Beach apartment

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From news of the weird: Wrong-sided surgery


Admittedly, this is not where I usually look for information on medical quality and safety measures – but this case, as presented in News of the Weird for this week deserves mention:

Neurosurgeon Denise Crute left Colorado in 2005 after admitting to four serious mistakes (including wrong-side surgeries on patients’ brain and spine) and left Illinois several years after that, when the state medical board concluded that she made three more serious mistakes (including another wrong-side spine surgery).

Nonetheless, she was not formally “disciplined” by either state in that she was permitted merely to “surrender” her licenses, which the profession does not regard as “discipline.” In November, Denver’s KMGH-TV reported that Dr. Crute had landed a job at the prestigious Mount Sinai Medical Center in New York, where she treats post-surgery patients (and she informed Illinois officials recently that she is fully licensed in New York to resume performing neurosurgery). [KMGH-TV, 11-4-2012]”

This is an excellent example of the importance of the ‘Time-out” which includes ‘surgical site verification’ among all members of the surgical team.  This also shows some of the limitations in relying on the health care professions to police themselves.  Does this mean that I can absolutely guarantee that this won’t happen in any of the operating rooms I’ve observed?  No – but it does mean that I can observe and report any irregularities witnessed (or deviations from accepted protocols) – such as ‘correct side verification’ or failure of the operating surgeon to review medical records/ radiographs prior to surgery.

It also goes to show that despite lengthy credentialing processes and the reputations of some of the United States finest institutions are still no guarantee of quality or even competence.

What about Leapfrog?

This comes at the same time as the highly controversial Leapfrog grades are released – in which medical giants like UCLA and the Cleveland Clinic received failing marks.  (UCLA received an ‘F” for avoidable patient harm, and the Cleveland Clinic received a “D”.)

Notably, the accuracy of the Leapfrog scoring system has been under fire since it’s inception – particularly since the organization charges hospitals for the right to promote their score.

But then – as the linked article points out – so do most of the organizations ‘touting’ to have the goods on the facilities such as U.S. News and Reports and their famed hospital edition.

Guess there aren’t very many people like me – that feel like that’s a bit of a conflict of interest..

New venture with Colombia Reports


While I have written several books about surgery and surgeons in Colombia, much of this information I’ve obtained from my research has been consigned to sitting on the shelves of various bookstores.

But, now with the help of Colombia Reports, I am hoping to change that.  As I mentioned in a previous post, Colombia Reports.com and it’s founder, Adriaan Alsema have been amazingly supportive of my work, ever since they printed my first article on Cartagena in 2010.

Since returning to Colombia, I have kept in touch with Colombia Reports while we discussed ways to bring more of my research and work to the public.  Colombia Reports is a perfect platform – because it serves a community of English-speaking (reading) individuals who are interested in/ and living in Colombia.   With this in mind, Colombia Reports has created a new Health & Beauty section which will carry some of my interviews and evaluations.

It is an ideal partnership for me; it allows me to bring my information to the people who need it – and continue to do my work as an objective, and unbiased reviewer.  We haven’t figured out all of the details yet – but I want to encourage all of my faithful readers to show Colombia Reports the same dedication that you’ve shown my tiny little blog, so that our ‘experiment’ in medical tourism reporting becomes a viable and continued part of Colombia Reports.

This is more important to me that ever – just yesterday as I was revisiting a surgeon I interviewed in the past (for a new updated article), I heard a tragic story that just broke my heart about a patient that was recently harmed by Dr. Alfredo Hoyos.  While I was unable to obtain documents regarding this incident – this is not the first time that this has happened.

Previous accusations of medical malpractice against this surgeon have been published in Colombian news outlets including this story from back in 2002.

The accusations are from Marbelle, a Colombian artist regarding the intra-operative death of her mother, Maria Isabeth Cardona Restrepo (aka Yolanda) during liposuction.  These accusations were published in Bocas – which is part of El Tiempo, a popular Colombian newspaper, in which the singer alleges that Dr. Hoyos was unprepared, and did not have the proper equipment on hand to treat her mother when she went into cardiac arrest during the surgery.

story about the death of one of Dr. Alfredo Hoyos' patients.

story about the death of one of Dr. Alfredo Hoyos’ patients.

Kristin 002 Kristin 003 Kristin 004

Now – as many of you remember, I interviewed Dr. Alfredo Hoyos back in 2011, and followed him to the operating room, giving me first hand knowledge of his surgical practices.

Readers of the book know he received harsh criticism for both failure to adhere to standard practices of sterility and patient intra-operative safety (among other things.)  I also called him out for claiming false credentials from several plastic surgery associations – and notified those agencies of those claims..   In the book, readers were strongly advised not to see Dr. Hoyos or his associates for care.

But – as I mentioned, my book is sitting lonely on a shelf, here in Bogotá – and in the warehouses of Amazon.com and other retailers.. So, people like that patient – didn’t have the critical information that they needed..

This is where Colombia Reports – and I hope to change all that.   So in the coming weeks, I am re-visiting some of surgeons we talked to in 2011, and interviewing  more (new) surgeons, more operating room visits..

The truth about TAVI/ TAVR


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]. 

Why read Bogota and other hidden gem titles?


 

As readers of my sister site, Cartagena Surgery know, I am currently hard at work on my third title in the ‘Hidden Gem’ series – with the latest offering on Mexicali, Mexico.  But I continue to get comments from readers, friends, and everyone else asking, “Why bother?”

Why bother reading Hidden Gem?

People should read these titles because we can’t assume that all medical providers have been vetted, or that all medical facilities meet acceptable criteria for safe care.  It is a dangerous assumption to expect that ‘someone’ else has already done the research. [lest you think this could only happen in Sri Lanka, be forewarned.  With new legislation, the critical doctor shortage in the USA will only worsen.]

Medical tourism has the potential to connect consumers with excellent providers around the world.  It may be part of a solution to the long waits that many patients are experiencing when seeking (sometimes urgent) surgical care.  It also offers an opportunity to fight the runaway health care costs in the United States.

But..

But it also has the potential, if unchecked, unvetted, unverified and left unregulated to cause great harm.

Another reason to read Hidden Gem is to find out more about the surgeons themselves, their training, and many of the new, and innovative practices in the realm of surgery. Often the best doctors don’t advertise or ‘toot’ their own horn, so you won’t find them advertised in the pages of your in-flight magazine as “One of the best doctors in XXX” even if they are.  (Many people don’t realize those segments are paid advertisements, either.)

Why bother writing Hidden Gem?

Because ‘someone’ needs to.

I am that ‘someone’ who does the fieldwork to find out the answers for you.  I can never assume that it’s been done before, by someone else.  I have to start from ‘scratch’ for every book, for every provider and every hospital.

I also believe that the public should know, and want to know more about the people we entrust to take care of us during serious illness or surgery.  We should know who isn’t practicing according to accepted or current standards and evidence – and we should know who has/ and is offering the latest cutting edge (but safe and proven) therapies.

 

Read more about the doctor shortages:

NYT article on worsening doctor shortage  (and one of the proposed solutions is a loosening of rules governing the training and credentials of doctors from overseas – coming to practice in the USA).

Hospital ranks and measures: Medical Tourism edition?


It looks like Consumer Reports is the newest group to add their two cent’s worth about hospital safety, and hospital safety ratings.  The magazine has compiled their own listing and ratings for over 1,100 American hospitals.  Surprisingly, just 158 received sixty or greater points (out of a 100 possible.)  This comes on the heels of the most recent release of the LeapFrog results.  (Leapfrog is controversial within American healthcare due to the unequal weight it gives to many of its criterion.  For example, it is heavily weighed in favor of very large institutions versus small facilities with similar outcomes.)

Consumer Reports has a history providing consumers with independent evaluations and critiques of market products from cars to toasters since it’s inception in the 1930’s.  It’s advent into healthcare is welcome, as the USA embraces new challenges with ObamaCare, mandated EMRs, and pay-for-performance.

While there is no perfect system, it remains critical to measure outcomes and performances on both an individual (physician) and facility wide scale.  That’s why I say; the more scales, scoring systems and measures used to evaluate these issues – the better chance we have to accurately capture this information.

But – with all of the increased scrutiny of American hospitals, can more further investigation into the practices and safety at facilities promoting medical tourism overseas be far behind?

Now it looks like James Goldberg, a bioengineer that we talked about before, is going to be doing just that.  Mr. Goldberg, who is also an author of the topic of medical tourism safety recently announced that his firm will begin offering consulting services to consumers interested in knowing more about medical tourism – and making educated decisions to find the most qualified doctors and hospitals when traveling for care.  He may be one of the first to address this in the medical tourism industry, but you can bet that he won’t be the last..

If so, the winners in the international edition will be the providers and facilities that embrace transparency and accountability from the very beginning.

Dr. Ramos, HIPEC and Radio Broadcasts


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.