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].

Readers write in: TAVI


Thanks again to ‘Lapeyre’, who as it turns out is Dr. Didier Lapeyre, a renowned, French cardiothoracic surgeon credited with the development of the first mechanical valves.

Dr. Didier Lapeyre was gracious enough to send some additional literature to add to our ongoing discussions regarding severe aortic stenosis and TAVI/ TAVR therapies.  He also commented that the best way to avoid these ‘high risk situations’ is by earlier intervention with conventional surgery – something we discussed before in the article entitled, “More patients need surgery.”

He also points out that ‘elderly’ patients actually do quite well with aortic valve replacement and offers a recently published meta-analysis of 48 studies on patients aged 80 or older.

As readers know, on June 13, 2012 – the FDA ruled in favor of expanding the eligibility criteria for this therapy.  Previously, this treatment modality, due to its experimental nature and high rate of complications including stroke and serious bleeding, has been limited in the United States to patients deemed ineligible for aortic valve replacement surgery.

Now on the heels of the Partner A trial, in which researchers reported favorable results for patients receiving the Sapien device, the FDA has voted to approve expanding criteria to include patients deemed to be high risk candidates for surgery.  As we have discussed on previous occasions, this opens the door to the potential for widespread abuse, misapplication of this therapy and potential patient harm.

In the accompanying 114 page article, “Transcatheter aortic valve implantation (TAVI): a health technology assessment update,” Belgian researchers (Mattias, Van Brabandt, Van de Sande & Deviese, 2011) looking at transcatheter valve procedures have found exactly that in their examination of the use of TAVI worldwide.

Most notably, is the evidence of widespread abuse in Germany (page 49 of report), which has become well-known for their early adoption of this technology, and now uses TAVI for an estimated 25 – 40% of valve procedures*.  Closer examination of the practices in this country show poor data reporting with incomplete information in the national registry as well as a reported mortality rate of 7.7%, which is more than double that of conventional surgery.  Unsurprisingly, in Germany, TAVI is reimbursed at double the amount compared to conventional surgery**, providing sufficient incentive for hospitals and cardiologists to use TAVI even in low risk patients. (and yes, german cardiologists are often citing “patient refused surgery” as their reason, particularly when using TAVI on younger, healthy, low risk patients.)

In their examination of the data itself, Mattias et al. (2011) found significant researcher bias within the study design and interpretation of results.  More alarmingly, Mattias found that one of the principle researchers in the Partner A study, Dr. Martin Leon had major financial incentives for reporting successful results.  He had recently received a 6.9 million dollar payment from Edward Lifesciences, the creators of the Sapien valve for purchase of his own transcatheter valve company.   He also received 1.5 million dollar bonus if the Partner A trial reached specific milestones.  This fact alone, in my mind, calls into question the integrity of the entire study.

[Please note that this is just a tiny summary of the exhaustive report.]

Thank you, Dr. Lapeyre for offering your expertise for the benefit of our readers!

* Estimates on the implantation of TAVI in Germany vary widely due to a lack of consistent reporting.

** At the time of the report, TAVI was reimbursed at 36,000 euros (45,500 dollars) versus 17,500 euros (22,000 dollars) for aortic valve replacement.

For more posts on TAVI and aortic stenosis, see our TAVI archive.

References

Mattias, N., Van Brabandt, H., Van de Sande, S. & Deviese, S. (2011).  Transcatheter aortic valve implantation (TAVI): a health technology assessment .  Belgian Health Care Knowledge Centre.

Vasques, F., Messori, A., Lucenteforte, E. & Biancari, F. (2012).  Immediate and late outcome of patients aged 80 years and older undergoing isolated aortic valve replacement: a systematic review and meta-analysis of 48 studies.  Am Heart J 2012; 163: 477-85.

Bariatric Surgery Safety: More than your weight is at risk!


Dying to be thin?  These patients are… A look at the Get-Thin clinics in Beverly Hills, California..

This series from LA Times writers, Michael Hiltzik and Stuart Pfiefer highlights the importance of safety and the apparent lack of regulation in much of the bariatric procedure business here in the United States.

In these reports – which follow several patient deaths from lap-band procedures, both surgeons and surgical staff alike have made numerous reports against the ‘Get Thin” clinics operating in Beverly Hills and West Hills, California.  These allegations include unsafe and unsanitary practices.  One of the former surgeons is involved in a ‘whistle-blower’ lawsuit as he describes the dangerous practices in this clinic and how they led to several deaths.

Regulators ignore complaints against Beverly Hills clinics despite patient deaths  – in the most recent installment, Hiltzik decries the lack of action from regulatory boards who have ignored the situation since complaints first arose in 2009!

House members call for probe into Lap-Band safety, marketing – California legislators call for action, but the clinics stay open. (article by Stuart Pfiefer)

Plaintiffs allege ‘gruesome conditions’ at Lap-Band clinics – mistakes and cover-ups at the popular weight loss clinics.  (article by Stuart Pfiefer)  This story detailing a patient’s death made me ill – but unfortunately reminded me of conditions I had seen at a clinic I wrote about in a previous publication..  The absolute lack of the minimum standards of patient care – is horrifying.  This woman died unnecessarily and in agony.  It proves my point that anesthesiologists need to be detailed, and focused on the case at hand.. (not iPhones, crosswords or any of the other distractions I’ve seen in multiple cases.. Now this case doesn’t specifically mention a distracted anesthesiologist – but given the situation described in the story above, he couldn’t have been paying attention, that’s for sure.

Nurse Practitioners and Medscape


A couple of new articles over at Medscape highlight the role of Nurse Practitioners (and Physician’s Assistants) in patient care.

The Role of Nps and PAs with MDs in today’s care

A study from Loyola showed that surgical NPs reduced emergency room visits  : here’s a link to the article abstract by Robles et al. (2011).

Reducing cardiovascular risk with NPs: the Coach trial

And yet again, Nurse Practitioners trump physicians in patient satisfaction surveys.

This is just a sampling of the articles featured over at Medscape’s NP perspective.

From the free-text files: a selection of articles showing the growing use of Nurse Practitioners around the world

Nurse practitioners improve quality of care in chronic kidney disease: two-year results of a randomised study.  – a study from the Netherlands

A Parallel Thrombolysis Protocol with Nurse Practitioners As Coordinators Minimized Door-to-Needle Time for Acute Ischemic Stroke.  A taiwanese study showing the impact of nurse practitioners in reducing door-to-needle time in acute coronary syndromes.

Helping patients attain and maintain asthma control: reviewing the role of the nurse practitioner.

Type 2 diabetes, cardiovascular disease and the utilisation of primary care in urban and regional settings.  An Austrailian study discussing the impact of NPs in rural care.

Hospital General de Mexicali


Following surgery at Hospital Alamater, we proceed to the Hospital General de Mexicali.  This is the largest public facility in Mexicali, and is surprisingly small.  After a recent earthquake, only three floors are currently in use, with the two remaining upper floors undergoing demolition for repair after earthquake-related damage.  The facility is old and dated, and it shows.  There are ongoing construction projects and repairs throughout the facility.

On the medical and surgical floors there are dormitory style accommodations with three patients in each room.  Sandwiched across from the nursing station are several rooms designated as ‘Intermediate’ care.  These rooms are full with patients requiring a higher level of care, but not needing the intensive care unit which is located downstairs adjacent to the operating theater.

 

surgical nurses at Hospital General

The intensive care unit itself is small and crowded with patients.  There are currently five patients, all intubated and in critical condition.  Equipment is functional and adequate but not new, with the exception of hemodynamic monitors.  There is no computerized radiology (all films are printed and viewed at bedside.)

We visit several post-operative patients upstairs on the surgical floors, and talk with the patients at length.  All of the patients are doing well, including several patients who were hospitalized after holiday-related trauma (stabbing with chest and abdominal injuries.) The floors are busy with internal medicine residents and medical students on rounds.

Despite it’s unattractive facade, and limited resources – the operating room is similar to operating rooms across the United States.. Some of the equipment is older, or even unavailable (Dr. Ochoa brings his own sterile packages of surgical instruments for cases here.)  However, during a case at the facility – all of the staff demonstrate appropriate knowledge and surgical techniques. The anesthesiologist invites me to look over his shoulder (so to speak) and read through the chart..

Since respiratory therapy and pulmonary toileting is such an important part of post-operative care of patients having lung surgery – we stopped in to check out the Respiratory department.  I met with Jose Luis Barron Oropeza who is the head of Respiratory Therapy.  He graciously explained the therapies available and invited me to the upcoming symposium, which he is chairing.  (The symposium for respiratory therapy in Mexicali is the 18th thru the 20th of this month.  If anyone is interested in attending, send me an email for further details.)

After rounding on patients at the General Hospital – despite the late hour (it is after midnight) we make one more stop, back at the Hospital Alamater for one last look at his patients there.  Dr. Ochoa makes a short stop for some much-needed food at a small taco stand while we make plans to meet the next morning.

Due to the limitedavailable resources, I wouldn’t recommend this facility for medical tourists.  However, the physicians I encountered were well-trained and knowledgeable in their fields.

Fired!!


As I review the few short film clips I delegated to my ‘cameraman’ (my husband) – all I can say is that he is totally, and completely fired!!  (and I am pretty irritated.)

All I needed was a few background clips of Mexicali for the first new video cast for the iTunes series – I took all the stills, interviewed the surgeons and got all the intra-operative footage..  He just needed to get about two minutes worth – for the introductory segments..

Totally.  Fired.

So, readers, I apologize but my first iTunes video cast won’t be the wonderful, glossy creation I had hoped for.. More like a schizophrenic, slightly generic – art house production.

But we’ll try again on our next journey – (with a new cameraman!)

In the operating room with Dr. Carlos Ochoa, thoracic surgeon


Mexicali, Baja California (Mexico)

Dr. Carlos Cesar Ochoa Gaxiola, Thoracic Surgeon

We’ve back in the city of Mexicali on the California – Mexico border to interview Dr. Carlos Cesar Ochoa Gaxiola as part of the first of a planned series of video casts.   You may remember Dr. Ochoa from our first encounter back in November 2011.  He’s the personable, friendly thoracic surgeon for this city of approximately 900,000 residents.  At that time, we talked with Dr. Ochoa about his love for thoracic surgery, and what he’s seen in his local practice since moving to Mexicali after finishing his training just over a year & a half ago.

Now we’ve returned to spend more time with Dr. Ochoa; to see his practice and more of his day-to-day life in Mexicali as the sole thoracic surgeon.  We’re also planning to talk to Dr. Ochoa about medical tourism, and what potential patients need to know before coming to Mexicali. He greets me with the standard kiss on the cheek and a smile, before saying “Listo?  Let’s go!”  We’re off and running for the rest of the afternoon and far into the night.  Our first stop is to see several patients at Hospital Alamater, and then the operating room for a VATS procedure.

He is joined in the operating room by Dr. Cuauhtemoc Vasquez, the newest and only full-time cardiac surgeon in Mexicali.  They frequently work together during cases.  In fact, that morning, Dr. Ochoa assisted in two cases with Dr. Vasquez, a combined coronary bypass/ mitral valve replacement case and a an aortic valve replacement.

Of course, I took the opportunity to speak with Dr. Vasquez at length as well, as he was a bit of a captive audience.  At 32, he is just beginning his career as a cardiac surgeon, here in Mexicali.  He is experiencing his first frustrations as well; working in the first full-time cardiac surgery program in the city, which is still in its infancy, and at times there is a shortage of cases[1].  This doesn’t curb his enthusiasm for surgery, however and we spend several minutes discussing several current issues in cardiology and cardiac surgery.  He is well informed and a good conversationalist[2] as we debate recent developments such as TAVI, carotid stenting and other quasi-surgical procedures and long-term outcomes.

We also discuss the costs of health care in Mexicali in comparison to care just a few short kilometers north, in California.   He estimates that the total cost of bypass surgery (including hospital stay) in Mexicali is just $4500 – 5000 (US dollars).  As readers know, the total cost of an uncomplicated bypass surgery in the USA often exceeds $100,000.

Hmm.. Looks like I may have to investigate Dr. Vasquez’s operating room on a subsequent visit – so I can report back to readers here.  But for now, we return to the case at hand, and Dr. Ochoa.

The Hospital Alamater is the most exclusive private hospital in the city, and it shows.   Sparkling marble tile greets visitors, and patients enjoy attractive- appearing (and quiet!) private rooms.  The entire hospital is very clean, and nursing staff wears the formal pressed white scrub uniforms, with the supervisory nurse wearing the nursing cap of yesteryear with special modifications to comply with sanitary requirements of today.

The operating rooms are modern and well-lit.  Anesthesia equipment is new, and fully functional.  The anesthesiologist is in attendance at all times[3].  The hemodynamic monitors are visible to the surgeon at all times, and none of the essential alarms have been silenced or altered.  The anesthesiologist demonstrates ease and skill at using a double lumen ETT for intubation, which in my experience as an observer, is in itself, impressive.  (You would be surprised by how often problems with dual lumen ETT intubation delays surgery.)

Surgical staff complete comprehensive surgical scrubs and surgical sterility is maintained during the case.  The patient is well-scrubbed in preparation for surgery with a betadine solution after being positioned safely and correctly to prevent intra-operative injury or tissue damage.  Then the patient is draped appropriately.

The anesthesiologist places a thoracic epidural prior to the initiation of the case for post-operative pain control[4].  The video equipment for the case is modern with a large viewing screen.  All the ports are complete, and the thoracoscope is new and fully functioning.

Dr. Ochoa demonstrates excellent surgical skill and the case (VATS with wedge resection and pleural biopsy) proceeds easily, without incident.  The patient is hemodynamically stable during the entire case with minimal blood loss.

Following surgery, the patient is transferred to the PACU (previously called the recovery room) for a post-operative chest radiograph.  Dr. Ochoa re-evaluates the patient in the PACU before we leave the hospital and proceed to our next stop.

Recommended.  Surgical Apgar: 8


[1] There is another cardiac surgeon from Tijuana who sees patients in her clinic in Mexicali prior to sending patients to Tijuana, a larger city in the state of Baja California.  As the Mexicali surgery program is just a few months old, many potential patients are unaware of its existence.

[2] ‘Bypass surgery’ is an abbreviation for coronary artery bypass grafting (CABG) aka ‘open-heart surgery.’  A ‘triple’ or ‘quadruple’ bypass refers to the number of bypass grafts placed during the procedure.

[3] If you have read any of my previous publications, you will know that this is NOT always the case, and I have witnessed several cases (at other locations) of unattended anesthesia during surgery, or the use poorly functioning out-dated equipment.

[4] During a later visit with the patient, the patient reported excellent analgesia (pain relief) with the epidural and minimal adjuvant anti-inflammatories.

French implant update


More scary news for women around the globe – as the manufacturer, PIP discloses frightening information regarding their defective implants.  It has been discovered that the company knew that the implants were defective since 2005 – but continued to sell the implants for use world-wide, particularly in Latin America.

More disturbingly, this manufacturer did not use medical grade materials – instead opting for cheaper, construction grade chemicals including petroleum and fuel additives, components which have never been tested for [internal] human use.  The health effects of exposure to these materials is unknown.  The risks associated with the use of these materials is enhanced due to the high rate of rupture among this brand of implant.  These chemicals certainly have carcinogenic potential and the implications for thousands and thousands of women are terrifying.

French officials have urged women to have their implants surgically removed.

A preliminary search of PubMed and other published research shows mixed results – and primarily discusses the results of exposure to benzene (and other petroleum derivatives) via water contamination, or occupational exposure.   (In fact, only limited information is available regarding the safety of breast implants in general, and the material is fairly dated.)

As we stated in a previous story, while researching Bogota! and interviewing plastic surgeons – I investigated the types of implants used by the surgeons profiled in the book.  (None of the surgeons used this company’s implants at the time of my interviews in Winter/ Spring 2011).

Update:  In fact, the Colombian government has offered to pay for the removal of PIP implants.  More on this story here.

Aortic Valve Replacement & the elderly


I just read an interesting article in the Annals of Thoracic Surgery.

Unfortunately, the full-text article is not available for free – but I did find a nice article abstract (which I’ve posted below.)  It confirms some of the previous discussions we’ve had here at Cartagena Surgery on the role of surgery in Aortic Stenosis, even in ‘elderly’ patients.  [I put elderly in quotes since the definition can be fairly elastic depending on who is doing the judging.]

The article below is from Medscape.com

Aortic valve replacement in the elderly: the real life.

Ann Thorac Surg. 2012; 93(1):70-8 (ISSN: 1552-6259)

Langanay T; Flécher E; Fouquet O; Ruggieri VG; Tour Bde L; Félix C; Lelong B; Verhoye JP; Corbineau H; Leguerrier A Department of Cardiovascular and Thoracic Surgery, University Hospital, Rennes, France.

BACKGROUND: Aortic stenosis is of concern in the elderly. Although aortic valve replacement provides good long-term survival with functional improvement, many elderly patients are still not referred for surgery because of their age. Percutaneous aortic valve implantation offers an alternative to open-heart surgery. Concerns about the management of aortic valve stenosis in the elderly will be reviewed.

METHODS: We retrospectively analyzed 1,193 consecutive aortic valve replacements, performed in octogenarians since January 2000. A total of 657 patients (55%) had at least one associated comorbidity (eg, respiratory failure) and 381 (32%) associated coronary lesions. Valve replacement was the only procedure in 883 patients (74%), and was associated with coronary revascularization in 262 cases, or with another cardiac procedure in 48 patients.

RESULTS: Overall operative mortality was 6.9% (83 of 1,193 patients); 5.5% for single replacement and 11.5% if associated with coronary artery bypass surgery. Univariate and multivariate analyses identified 11 operative risk factors related to general status, cardiologic condition, and the procedure itself: older age (p< 0.015); respiratory failure (p <0.03); aortic regurgitation (p <0.001); emergency surgery (p <0.0029); New York Heart Association class IV (p < 0.0007); right heart failure (p < 0.03); atrial fibrillation (p < 0.04); impaired ejection fraction (p < 0.001); coronary disease (p < 0.01); redo surgery (p < 0.02); associated coronary revascularization (p < 0.008).

CONCLUSIONS: Today, valve replacement has acceptable low hospital mortality, even in the elderly. Thus, older patients should not be denied surgery due to their advanced age alone. Conventional surgery remains the gold standard treatment for aortic stenosis; the decision should be made on an individual basis. If several risk factors suggest very high-risk surgery, then percutaneous valve implantation should be considered instead.

In more disturbing news:

As predicted, the unproven ‘easy option’ of TAVI is now being pursued by more low-risk patients.  These lower risk patients are people who should have been encouraged to undertake the more durable, safe and proven surgical therapy [Aortic Valve Replacement.]  I guess this just shows how quickly those new recommendations [for patient protection and safety] were thrown out the window.

In this article (posted below) by Kurt Ullman at Medpage Today – German researchers discuss their preliminary findings and discuss the use in low risk patients.

The bar for transcatheter aortic valve implantation (TAVI) is dropping as more lower-risk patients are undergoing the procedure and their outcomes are favorable, a single-center study from Germany found. [Unfortunately – as we’ve seen so many times in the past, and as I am finding out while preparing this presentation on the Syntax trial – studies such as this can be quite deceiving – and LONG term data is needed. – Cartagena Surgery].

When stratified by quartiles based on enrollment date, Q1 patients had higher logistic EuroSCOREs, higher Society of Thoracic Surgeons (STS) scores, and higher median N-terminal pro-B-type natriuretic peptide levels compared with those enrolled later in Q4, noted Nicolo Piazza, MD, PhD, and colleagues from the German Heart Center in Munich.

Although there were significant decreases in 30-day and six-month mortality from Q1 to Q4 in the crude analysis, after adjustments for baseline characteristics, the significant differences disappeared (HR 0.29 for 30-day mortality and HR 0.67 for six-month mortality), according to the study published online in the Journal of the American College of Cardiology.

“These results suggest that underlying comorbidities play an important role in acute and intermediate-term survival after TAVI,” the researchers wrote.

The researchers noted anecdotal information suggesting a shift toward using TAVI in patients who are less sick than those enrolled in premarket trials. Additionally, the next wave of trials involving the CoreValve (Medtronic) and the Sapien XT (Edwards Lifesciences) devices will involve intermediate to high surgical risk patients, providing “yet another indication that TAVI is being directed at the treatment of lower and lower surgical risk patients,” Piazza and colleagues wrote.  [There are significant ethical considerations here which seem to be ignored – similar to criticisms of the Syntax trial – Cartagena Surgery.]

A single-center French study of low-risk TAVI patients found the procedure to be safe in this population. The study was presented at the European Society of Cardiology meeting in Paris.

The impact on this shift in patient selection was uncertain, they said, prompting a retrospective review of 420 patients who underwent TAVI at their institution from June 2007 to June 2010.

The consensus that a patient was suitable for TAVI was derived from a team that comprised cardiologists, cardiac surgeons, and anesthesiologists. This team approach is exemplified by the recent announcement that the American College of Cardiology and the Society of Thoracic Surgeons will jointly sponsor a TAVI registry to monitor the safety and efficacy of the procedure as it rolls out in the U.S.

Patients received either the CoreValve or Sapien device, the latter of which was just approved for use in the U.S. based on the PARTNER trial. PARTNER found that TAVI was as good as surgery in high-risk patients with severe aortic stenosis. [‘as good as’ – ah.. another ‘non-inferiority’ study….. view with skepticism folks..]

Researchers divided patients into four quartiles of 105 patients each. Those in Q1 were seen earlier in the study time frame than those in Q4.

Compared with Q4, Q1 patients had higher EuroSCOREs (25.4% versus 17.8%, P<0.001), STS scores (7.1% versus 4.8%, P<0.001), and NT-proBNP levels (3,495 versus 1,730 ng/dL, P<0.046).

There were significantly less transfemoral access approaches from Q1 to Q4, with a concomitant rise in transapical approaches. There also were significantly less intubations moving from Q1 to Q4, and the use of contrast significantly decreased over time.

Researchers noted that transfemoral complications decreased by 17% from Q1 to Q4 (P=0.008), but found no significant differences in the rate of stroke or transient ischemic attack or the need for a permanent pacemaker.

However, there was a shift in the later quartiles toward the treatment of younger patients with fewer comorbidities and lower surgical risk scores, Piazza and colleagues wrote.

Univariable analysis for 30-day mortality showed it was associated with age, STS score, atrial fibrillation, previous heart surgery, and previous stroke (P<0.10).

The factors associated with six-month mortality were age, logistic EuroSCORE, STS score, left ventricular ejection fraction, atrial fibrillation, previous cardiac surgery, chronic obstructive pulmonary disease, and N-terminal pro-B type natriuretic peptide (P<0.10).

Because only baseline characteristics were included, the authors noted the possibility that procedure-, operator-, or device-related factors might influence both 30-day and six-month mortality. The study is also limited by potential unmeasured confounding.

The investigators cautioned that little is known of the long-term durability of these devices should they be routinely implanted in younger patients with a longer expected life span.  [especially since the lifespan of the patients these valves were designed for was six months to one year..]

Piazza is a consultant and proctor for Medtronic and CardiAQ. Other authors revealed consultant status with Medtronic and Edwards Lifesciences, or instuctors for Medtronic

French Implants recalled


Hundreds of thousands of french made breast implants have been recalled – sending women all over the globe into a panic.  These implants which are no longer in use in France, have been linked to an increased rate of rupture, and possible increased incidence of cancer.

But good news for readers – as you may recall from my interviews with several of the surgeons (as written in the book) – none of the surgeons I interviewed used french implants.  The majority used FDA approved implants (only one brand currently FDA approved.)  Several others use german made implants*.. But this is an example of the details I’ve ferreted out for my readers..

* Brand information and other details are available in the book, “Bogota: a hidden gem guide to surgical tourism.”

More stories about fake docs including this one about a phony performing liposuction while smoking a cigar on AWAKE patients..

This guy was actually a doctor, but that didn’t stop ten of his patients from dying after bariatric procedures..

Cartagena on CNN


It looks like our Hidden Gem of a city is finally getting some of the attention it deserves – earlier this month, the city of Cartagena was featured as a ‘secret treasure’ on CNN Travel.    The article talks about the Caribbean flavor of this bright, diverse and colorful city and its rich history.

photo by CNN

Across ‘the pond’ in the UK – the Telegraph was also singing the praises of this tropical, elegant paradise and it’s status as a ‘cultural capital’..