Start here…


This is a page re-post to help some of my new readers become familiarized with Latin American Surgery.com – who I am, and what the website is about..

As my long-time readers know, the site just keeps growing and growing.  Now that we have merged with one of our sister sites, it’s becoming more and more complicated for first time readers to find what they are looking for..

So, start here, for a brief map of the site.  Think of it as Cliff Notes for Latin American surgery. com

Who am I/ what do I do/ and who pays for it

Let’s get down to brass tacks as they say .. Who am I and why should you bother reading another word..

I believe in full disclosure, so here’s my CV.

I think it’s important that this includes financial disclosure. (I am self-funded).

I’m not famous, and that’s a good thing.

Of course, I also think readers should know why I have embarked on this endeavor, which has taken me to Mexico, Colombia, Chile, Bolivia and continues to fuel much of my life.

Reasons to write about medical tourism: a cautionary tale

I also write a bit about my daily life, so that you can get to know me, and because I love to write about everything I see and experience whether surgery-related or the joys of Bogotá on a Sunday afternoon.

What I do and what I write about

I interview doctors to learn more about them.

Some of this is for patient safety: (Is he/she really a doctor?  What training do they have?)

Much of it is professional curiosity/ interest: (Tell me more about this technique you pioneered? / Tell me more about how you get such fantastic results?  or just tell me more about what you do?)

Then I follow them to the operating room to make sure EVERYTHING is the way it is supposed to be.  Is the facility clean?  Does the equipment work?  Is there appropriate personnel?  Do the follow ‘standard operating procedure’ according to international regulations and standards for operating room safety, prevention of infection and  overall good patient care?

I talk about checklists – a lot..

The surgical apgar score

I look at the quality of anesthesia – and apply standardized measures to evaluate it.

Why quality of anesthesia matters

Are your doctors distracted?

Medical information

I also write about new technologies, and treatments as well as emerging research.  There is some patient education on common health conditions (primarily cardiothoracic and diabetes since that’s my background).  Sometimes I talk about the ethics of medicine as well.  I believe strongly in honesty, integrity and transparency and I think these are important values for anyone in healthcare.  I don’t interview or encourage transplant tourism because I think it is intrinsically morally and ethically wrong.  You don’t have to agree, but you won’t find information about how to find a black market kidney here on my site.

What about hospital scores, you ask.. Just look here – or in the quality measures section.

Cultural Content

I also write about the culture, cuisine and the people in the locations I visit.  These posts tend to be more informal, but I think it’s important for people to get to know these parts of Latin America too.  It’s not just the doctors and the hospitals – but a different city, country and culture than many of my readers are used to.

Why should you read this?  well, that’s up to you.. But mainly, because I want you to know that there is someone out there who is doing their best – little by little to try to look out for you.

How the site is organized

See the sidebar! Check the drop-down box.

Information about surgeons is divided into specialty and by location.  So you can look in plastic surgery, or you can jump to the country of interest.  Some of the listings are very brief – when I am working on a book – I just blog about who I saw and where I was, because the in-depth material is covered in the book.

information about countries can be found under country tabs including cultural posts.

Issues and discussions about the medical tourism industry, medical safety and quality are under quality measures

Topics of particular interest like HIPEC have their own section.

I’ve tried to cross-reference as much as possible to make information easy to find.

If you have suggestions, questions or comments, you are always welcome to contact me at k.eckland@gmail.com or by leaving a comment, but please, please – no hate mail or spam.  (Not sure which is worse.)

and yes – I type fast, and often when I am tired so sometimes you will find grammatical errors, typos and misspelled words (despite spell-check) but bear with me.  The information is still correct..

Thank you for coming.

Why quality of anesthesia matters: who is administering your anesthesia?


Now that Colombia Moda is over – let’s get back to the stuff that really matters.. Let’s warm up but reviewing some older posts for our newer readers.

Guide to Surgery in Latin America

I know some readers find some of my reporting dry and uninspired, particularly when talking about methodology, measurements and scales such as Surgical Apgar Scoring.  But the use of appropriate protocols, safety procedures and specialized personnel is crucial for continued patient safety.

There is a saying among medical professionals about our patients.. We want them all to be boring and routine.   That is what I strive for, for each and every one of my readers – safe, boring and routine.

Excitement and drama are only enjoyable when watching Grey’s Anatomy or other fictionalized medical dramas.  In real life, it means something has drastically and horribly gone awry.  Unlike many of its fictional counterparts – outcomes are not usually good.

In a not-so-sleepy hollow of upstate New York, a medical tragedy serves to illustrate this point, while also bringing up questions regarding the procedure.  While we don’t know the circumstances behind this case – (and don’t really want to…

View original post 1,047 more words

In the operating room with Dr. Luis Botero, plastic surgeon


Please note that some of the images in this article have been edited to preserve patient privacy.  

Today, Dr. Luis Botero has invited me to observe surgery at IQ Interquirofanos in the Poblado section of Medellin.  He is performing full-body liposuction and fat grafting of the buttocks.

Dr. Luis Botero, in the operating room

Dr. Luis Botero, in the operating room

The facility: IQ Interquirofanos

Interquirofanos is located on the second floor

Interquirofanos is located on the second floor

IQ Interquirofanos is an ambulatory surgery center located on the second floor of the Intermedica Building across the street from the Clinica de Medellin (sede Poblado).  The close proximity of this clinic to a hospital is an important consideration for patients in case of a medical emergency.

The anesthesiologists estimate that 90% of the procedures performed here are cosmetic surgeries but surgeons also perform gynecology, and some orthopedic procedures at this facility.

The are seven operating rooms that are well-lit, and feature modern and functional equipment including hemodynamic monitoring, anesthesia / ventilatory equipment/ medications.  There are crash carts available for the operating rooms and the patient recovery areas.

There are fourteen monitored recovery room beds, while the facility currently plans for expansion.  Next door, an additional three floors are being built along with six more operating rooms.

Sterile processing is located within the facility with several large sterilization units.  There is also a pharmacy on-site.  The pharmacy dispenses prosthetics such as breast implants in addition to medications.

The only breast prosthetics offered at this facility are Mentor (Johnson & Johnson) and Natrelle brand silicone implants (Allergan).  In light of the problems with PIP implants in the past – it is important for patients to ensure their implants are FDA approved, like Mentor implants.

In the past seven years, over 31,000 procedures have been performed at Interquirofanos.  The nurses tell me that during the week, there are usually 30 to 35 surgeries a day, and around 15 procedures on Saturdays.

Prior to heading to the Operating Room:

Prior to surgery, patients undergo a full consultation with Dr. Botero and further medical evaluation (as needed).  Patients are also instructed to avoid aspirin, ibuprofen and all antiplatets (clopidogrel, prasugrel, etc) and anti-coagulants (warfarin, dabigatran, etc.) for several days.  Patients should not resume these medications until approved by their surgeon.

Complication Insurance

All patients are required to purchase complication insurance.  This insurance costs between 75.00 and 120.00 dollars and covers the cost of any treatment needed (in the first 30 days) for post-operative complications for amounts ranging from 15,000 dollars to 30,000 dollars, depending on the policy.   All of his clients who undergo surgery at IQ Interquirofanos are encouraged to buy a policy from Pan American Life de Colombia as part of the policies for patient safety at this facility. International patients may also be interested in purchasing a policy from ISPAS, which covers any visits to an ISPAS-affiliated surgeon in their home country.

Today’s Procedures: Liposuction & Fat Grafting

Liposuction – Liposuction (lipoplasty or lipectomy) accounts for 50% of all plastic surgery procedures.   First the surgeon makes several very small slits in the skin.  Then a saline – lidocaine solution is infiltrated in to the fat (adipose) tissue that is to removed. This solution serves several purposes – the solution helps emulsify the fat for removal while the lidocaine-epinephrine additives help provide post-operative analgesic and limit intra-operative bleeding.  After the solution dwells (sits in the tissue) for ten to twenty minutes, the surgeon can begin the liposuction procedure.  For this procedure, instruments are introduced to the area beneath the skin and above the muscle layer.

During this procedure, the surgeon introduces different canulas (long hollow tubes).  These tubes are used to break up the adipose tissue and remove the fat using an attached suctioning canister.  To break up the fat, the surgeon uses a back and forth motion.  During this process – one hand is on the canula.  The other hand remains on the patient to guide the canulas and prevent inadvertent injury to the patient.

fat being removed by liposuction

fat being removed by liposuction

Due to the nature of this procedure, extensive bruising and swelling after this procedure is normal.  Swelling may last up to a month.  Patients will need to wear support garments (such as a girdle) after this procedure for several weeks.

Types of liposuction:

In recent years, surgeons have developed different techniques and specialized canulas to address specific purposes during surgery.

Standard liposuction canulas come in a variety of lengths and bore sizes (the bore size is the size of the hole at the end of the canister for the suction removal of fat tissue.)  Some of these canulas have serrated bores for easier fat removal.

Ultrasound-assisted liposuction uses the canulas  to deliver sound waves to help break up fat tissue.  These canulas are designed for patients who have had repeated liposuction.  This is needed to break up adhesions (scar tissue) that forms after the initial procedure during the healing process.

Laser liposuction is another type of liposuction aimed at specifically improving skin contraction.  This is important in older patients or in patients who have excessive loose skin due to recent weight loss or post-pregnancy.  However, for very large amounts of loose skin or poor skin tone in areas such as the abdomen, a larger procedure such as abdominoplasty may be needed.

During laser liposuction, a small wire laser is placed inside a canula to deliver a specific amount of heat energy to the area (around 40 degrees centrigrade).  The application of heat is believed to stimulate collagen production (for skin tightening).  Bleeding is reduced because of the cautery effect of the heat – but post-operative pain is increased due to increased inflammatory effects.  There is also a risk of burn trauma during this procedure.

There have been several other liposuction techniques that have gone in and out of fashion, and many of the variations mentioned are often referred to by trademark names such as “Vaser”, “SmartLipo”, “SlimLipo” which can be confusing for people seeking information on these procedures.

Fat Grafting

Fat from liposuction procedure to be used for buttock augmentation

Fat from liposuction procedure to be used for buttock augmentation

Fat grafting is a procedure used in combination with liposuction.  With this procedure, fat that was removed during liposuction is relocated to another area of the body such as the buttocks, hands or face.

In this patient, Dr. Botero injects the fat using a large bore needle deep into the gluteal muscles to prevent a sloppy, or dimpled appearance.  Injecting into the muscle tissue also helps to preserve the longevity of the procedure.  However, care must be taken to prevent fat embolism*, a rare but potentially fatal complication – where globules of fat enter the bloodstream.  To prevent this complication, Dr. Botero carefully confirms the placement of his needle in the muscle tissue before injecting.

Results are immediately appreciable.

fat being injected for buttock augmentation. (Photo edited for patient privacy).

fat being injected for buttock augmentation. (Photo edited for patient privacy).

The Surgery:

Patient was appropriately marked prior to the procedure.   The patient was correctly prepped, drapped and positioned to prevent injury or infection.  Ted hose and sequential stockings were applied to lessen the risk of developing deep vein thrombosis.  Pre-operative procedures were performed according to internationally recognized standards.

Sterility was maintained during the case.  Dr. Botero appeared knowledgeable and skilled regarding the techniques and procedures performed.

His instrumentadora (First assistant), Liliana Moreno was extremely knowledgeable and able to anticipate Dr. Botero’s needs.

Circulating nurse: Anais Perez maintained accurate and up-to-date intra-operative records during the case.  Ms. Perez was readily available to obtain instruments and supplies as needed.

Overall – the team worked well together and communicated effectively before, during and after the case.

Anesthesia was managed by Dr. Julio Arango.   He was using an anesthesia technique called “controlled hypotension”.  (Since readers have heard me rail about uncontrolled hypotension in the past – I will write another post on this topic soon.)

Controlled Hypotension

However, as the name inplies – controlled hypotension is a tightly regulated process, where blood pressure is lowered to a very specific range.  This range is just slightly lower than normal (Systolic BP of around 80) – and the anesthesiologist is in constant attendance.  This is very different from cases with profound hypotension which is ignored due to an anesthesia provider being distracted – or completely absent.

With hypotensive anesthesia – blood pressure is maintained with a MAP (or mean) of 50 – 60mmHg with a HR of 50 – 60.  This reduces the incidence of bleeding.

However, this technique is not safe for everyone.  Only young healthy patients are good candidates for this anesthesia technique.  Basically, if you have any stiffening of your arteries due to age (40+), smoking, cholesterol or family history – this technique is NOT for you.  People with high blood pressure, any degree of kidney disease, heart disease, peripheral vascular disease or diabetes are not good candidates for this type of anesthesia. People with these kinds of medical conditions do not tolerate even mild hypotension very well, and are at increased risk of serious complications such as renal injury/ failure or cardiovascular complications such as a heart attack or stroke.  Particularly since this is an elective procedure – this is something to discuss with your surgeon and anesthesiologist before surgery.

The patient today is young (low 20’s), physically fit, active with no medical conditions so this anesthesia poses little risk during this procedure. Also the surgery itself is fairly short – which is important.  Long/ marathon surgeries such as ‘mega-makeovers‘ are not ideal for this type of anesthesia.

Dr. Julio Arrango keeps a close eye on his patient

Dr. Julio Arango keeps a close eye on his patient

However, Dr. Arango does an excellent job during this procedure, which is performed under general anesthesia.   After intubating the patient, he maintained a close eye on vital signs and oxygenation.  The patient is hemodynamically stable with no desaturations or hypoxia during the case.  Dr. Arango remains alert and attentive during the case, and remains present for the entire surgery.  Following surgery, anesthesia was lightened, and the patient was extubated prior to transfer to the recovery room.

He also demonstrated excellent knowledge of international protocols regarding DVT/ Travel risk, WHO safety protocols and intra-operative management.

Surgical apgar score: 9  (however, there is a point lost due to MAP of 50 – 60 as discussed above).

Results of the surgery were cosmetically pleasing.

Post -operative care:

Prior to discharge from the ambulatory care center after recovery from anesthesia the patient (and family) receives discharge instructions from the  nurses.

The patient also receives prescriptions for several medications including:

1. Oral antibiotics for a five-day course**. Dr. Botero uses this duration for fat grafting cases only.

2. Non-narcotic analgesia (pain medications).

3. Lyrica ( a gabapentin-like compound) to prevent neuralgias during the healing period.

The patient will wear a support garment for several weeks.  She is to call Dr. Botero to report any problems such as unrelieved pain, drainage or fever.

Note: after some surgeries like abdominoplasty, patients also receive DVT prophylaxis with either Arixtra or enoxaparin (Lovenox).

Follow-up appointments:

Dr. Botero will see her for her first follow-up visit in two days (surgery was on a Saturday).  He will see twice a week the first week, and then weekly for three weeks (and additionally as needed.)

* Fat embolism is a risk with any liposuction procedure.

**This is contrary to American recommendations as per the National Surgical Care Improvement Project (SCIP) which recommends discontinuation within the first 24 hours to prevent the development of antibiotic resistance.

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]. 

Wrapping up and saying “Thanks!”


It’s a busy Sunday in Mexicali – presidential elections are today, so I am going to try to get some pictures of the nearest polling station later.. In the meantime, I am spending the day catching up on my writing..

a polling station in Mexicali

Lots to write about – just haven’t had the time..  Friday morning was the intern graduation which marks the end of their intern year – as they advance in their residencies.. Didn’t get a lot of pictures since I was at the back of the room, and frankly, unwilling to butt ahead of proud parents to get good pics.. This was their day, not mine and I was pleased that I was invited.

I did get a couple of good pictures of my ‘hermanito’ Lalo and Gloria after the event.  (I’ve adopted Lalo as my ‘kid’ brother.. Not sure how he feels about – but he’s pretty easy-going so he probably just thinks it’s a silly gringa thing, and probably it is..)

Dr. ‘Lalo” Gutierrez with his parents

Lalo’s parents were sitting in the row ahead of me, so of course, I introduced myself and said hello.. (They were probably a little bewildered by this middle-aged gringa talking about their son in atrocious Spanish) but I figured they might be curious about the same gringa that posts pictures of Lalo on the internet.. I also feel that it’s important to take time and tell people the ‘good things’ in life.  (Like what a great person their son has turned out to be..)

Same thing for Gloria.. She is such a hard-worker, and yet, always willing to help out.. “Gloria can you help me walk this patient?”  It’s not even her patient, (and a lot of people would say – it’s not our jobs to walk patients) but the patient needs to get out of bed – I am here, and I need some help (with IV poles, pleurovacs, etc.)  and Gloria never hesitates.. that to me – is the hallmark of an excellent provider, that the patient comes first .. She still has several years to go, but I have confidence in her.

She throws herself into her rotations.. When she was on thoracics, she wanted to learn.. and she didn’t mind learning from a nurse (which is HUGE here, in my experience.)

Dr. Gloria Ayala (right) and her mother

She wasn’t sure that her mom would be able to be there – (she works long hours as a cook for a baseball team) but luckily she made it!

Met a pediatric cardiologist and his wife, a pediatrician.. Amazing because the first thing they said is, “We want nurse practitioners in our NICU,” so maybe NPs in Mexico will become a reality.. Heard there is an NP from San Francisco over at Hospital Hispano Americano but haven’t had the pleasure of meeting her.  (I’d love to exchange notes with her.)

I spent the remainder of the day in the operating room of Dr. Ernesto Romero Fonseca, an orthopedic surgeon specializing in trauma.  I don’t know what it is about Orthopedics, but the docs are always so “laid back”, and just so darn pleasant to be around.  Dr. Romero and his resident are no exception.

[“Laid back” is probably the wrong term – there is nothing casual about his approach to surgery but I haven’t had my second cup of coffee yet, so my vocabulary is a bit limited.. ]  Once I finish editing ‘patient bits’ I’ll post a photo..

Then it was off to clinic with the Professor.

Saturday, I spent the day in the operating room with Dr. Vasquez at Hospital de la Familia. He teased me about the colors of the surgical drapes,(green at Hospital de la Familia), so I guess he liked my article about the impact of color on medical photography.  (Though, truthfully, I take photos of surgeons, not operations..)

Since the NYT article* came out a few days ago – things have changed here in Mexicali.  People don’t seem to think the book is such a far-fetched idea anymore.  I’m hopeful this means I’ll get more response from some of the doctors.  (Right now, for every 15 I contact – I might get two replies, and one interview..)

Planning for my last day with the Professor  – makes me sad because I’ve had such a great time, (and learned a tremendous amount) but it has been wonderful.  Besides, I will be starting classes soon – and will be moving to my next location (and another great professor.)

Professor Ochoa and Dr. Vasquez

But I do have to say – that he has been a great professor, and I think, a good friend.  He let me steer my education at times (hey – can I learn more about X..) but always kept me studying, reading and writing.  He took time away from his regular life, and his other duties as a professor of other students (residents, interns etc.) to read my assignments, make suggestions and corrections when necessary.    and lastly, he tolerated a lot with good grace and humor.  Atrocious Spanish, (probably) some outlandish ideas and attitudes about patient care (I am a nurse, after all), a lot of chatter (one of my patient care things), endless questions…  especially, “donde estas?” when I was lost – again.

So as I wrap up my studies to spend the last few weeks concentrating on the book, and getting the last interviews, I want to thank Dr. Carlos Ochoa for his endless patience, and for giving me this opportunity.  I also want to thank all the interns (now residents) for welcoming me on rounds, the great doctors at Hospital General..  Thanks to Dr. Ivan for always welcoming me to the ER, and Dr. Joanna for welcoming me to her hospital.  All these people didn’t have to be so nice – but they were, and I appreciate it.

* Not my article [ I wish it were – since I have a lot to say on the topic].

Back in the OR with Drs. Ham & Abril, bariatric and general surgeons


My first case this morning with another surgeon was cancelled – which was disappointing, but I still had a great day in the operating room with Dr.  Ham and Dr. Abril.  This time I was able to witness a bariatric surgery, so I could report back to all of you.

Dr. Ham (left) and Dr. Abril

I really enjoy their relaxed but detail oriented style – it makes for a very enjoyable case.  Today they performed a sleeve gastrectomy** so I am able to report – that they (Dr. Ham) oversewed the staple line (quite nicely, I might add).  If you’ve read any of the previous books, then you know that this is an important step to prevent suture line dehiscence leading to leakage of stomach contents into the abdomen (which can cause very serious complications.)  As I said – it’s an important step – but not one that every doctor I’ve witnessed always performed.   So I was a pleased as punch to see that these surgeons are as world-class and upstanding as everything I’d seen already suggested..

** as long time readers know, I am a devoted fan of the Roux-en-Y, but recent literature suggests that the sleeve gastrectomy is equally effective in the treatment of diabetes.. Of course – we’ll be watching the research for more information on this topic of debate. I hope further studies confirm these results since the sleeve gives patients just a little less of a drastic lifestyle change.. (still drastic but not shot glass sized drastic.)

Dr. Ham

They invited me to the show this evening – they are having several clowns (that are doctors, sort of Patch Adams types) on the show to talk about the health benefits of laughter.  Sounds like a lot of fun – but I thought I better catch up on my writing..

I’ll be back in the OR with Los Doctores again tomorrow..

Speaking of which – I wanted to pass along some information on the anesthesiologist for Dr. Molina’s cases since he did such a nice job with the conscious sedation yesterday.  (I’ve only watched him just yesterday – so I will need a few more encounters, but I wanted to mention Dr. Andres Garcia Gutierrez all the same.

In the OR with Los Doctores, Dr. Ham & Dr. Abril


Haven’t had time to sit down and write about my trip to the operating room with Dr. Horacio Ham and Dr. Rafael Abril until now, but that’s okay because I am going back again on Saturday for a longer case at a different facility.  Nice surprise to find out that Dr. Octavio Campa was scheduled for anesthesia.  Both Dr. Ham and Dr. Abril told me that Dr. Campa is one their ‘short list’ of three or four preferred anesthesiologists.  That confirms my own impressions and observations and what several other surgeons have told me.

campa

Dr. Campa (left) and another anesthesiologist at Hispano Americano

That evening we were at Hispano – Americano which is a private hospital that happens to be located across the street from the private clinic offices of several of the doctors I have interviewed.  It was just a quick short case (like most laparoscopy cases) – but everything went beautifully.

As I’ve said before, Dr. Campa is an excellent anesthesiologist so he doesn’t tolerate any hemodynamic instability, or any of the other conditions that make me concerned about patients during surgery.

Dr. Ham  and Dr. Abril work well together – everything was according to protocols – patient sterilely prepped and draped, etc..

laparoscopy

laparoscopy with Dr. Ham & Dr. Abril

I really enjoy talking with the docs, who are both fluent in English – but I won’t get more of an interview with Dr. Abril until Saturday.

w/ Dr. Ham

with Dr. Horacio Ham in the operating room after the conclusion of a successful case

Then – on Wednesday night – I got to see another side of the Doctors Ham & Abril on the set of their radio show, Los Doctores.  They were interviewing the ‘good doctor’ on sympathetectomies for hyperhidrosis – so he invited me to come along.

Los Doctores invited me to participate in the show – but with my Spanish (everyone remembers the ‘pajina’ mispronunciation episode in Bogotá, right?)  I thought it was better if I stay on the sidelines instead of risking offending all of Mexicali..

Los Doctores

on the set of Los Doctores; left to right: Dr. Rafael Abril, Dr. Carlos Ochoa, Dr. Mario Bojorquez and Dr. Horacio Ham

It really wasn’t much like I expected; maybe because all of the doctors know each other pretty well, so it was a lot more relaxed, and fun than I expected.  Dr. Abril is the main host of the show, and he’s definitely got the pattern down; charming, witty and relaxed, but interesting and involved too.. (my Spanish surprises me at times – I understood most of his jokes…)  It’s an audience participation type show – so listeners email / text their questions during the show, which makes it interesting but prevents any break in the format, which is nice.  (Though I suppose a few crazy callers now and then would be entertaining.)

Dr. Ochoa did a great talk about sympathectomy and how life changing it can be for patients after surgery, and took several questions.  After meeting several patients pre and post-operatively for hyperhidrosis, I’d have to say that it’s true.  It’s one of those conditions (excessive palmar and underarm sweating) that you don’t think about if you don’t have – but certainly negatively affects sufferers.  I remember an English speaking patient in Colombia telling me about how embarrassing it was to shake hands -(she was a salesperson) and how offended people would get as she wiped off her hands before doing so.  She also had to wear old-fashioned dress shields so she wouldn’t have big underarm stains all the time..  This was in Bogota (not steamy hot Cartagena), which is known for it’s year-round fall like temperatures and incredibly stylish women so you can imagine a degree of her embarrassment.

It (bilateral sympathectomy) is also one of those procedures that hasn’t really caught on in the USA – I knew a couple people in Flagstaff who told me they had to travel to Houston (or was it Dallas?) to find a surgeon who performed the procedure..  So expect a more detailed article in the future for readers who want to know more.

Tomorrow, (technically later today) I head back to San Luis with the good doctor in the morning to see a couple of patients – then back to the hospital.. and then an interview with a general surgeon.. So it should be an interesting and fun day.