!Eres Absurdo!


aortic barbosa

Eres Absurdo!

I’ve heard that several times since I’ve been here – but it’s not exactly as it sounds.  It’s slang: like saying “goofy-footed” when referring to snowboarders.  It means that I am left-handed, or left-hand dominant, since the operating room requires you to be somewhat ambidextrous.

So this week – that was one of the things I set out to do – to become more proficient with suturing with my right hand.  It wasn’t as hard as I expected but I certainly don’t have the speed I have with my left hand (which sadly, isn’t that fast).

Barbosa aortic

Monday

Today wasn’t a great day. Everything went well – harvested vein, closed incisions, in the operating room so it should have been another fantastic day – but…. I just a felt, a little lonely today, I guess.  Or maybe lonely is the wrong term – since I live with three other people here in Sincelejo.  I guess what I meant to say is it’s the first time I’ve really felt alone since I’ve been here – and it was kind of surprise to feel that way.

I guess because I am used to traveling frequently and in making unfamiliar surroundings my home that it came as an unexpected pang when I suddenly missed the camaraderie I have had at other hospitals.  Everyone has been fantastic here – particularly Iris, who I consider to be a good friend, but it’s not quite the same.

My name is Kristin.. Kristina is someone else

Here in Colombia, many people struggle to pronounce my name so it’s usually simplified to “Kristina”.  But that’s not me.  Just like my name, I feel like a bit part of my personality just doesn’t translate into Spanish well.  Not as a cultural metaphor or anything ‘deep’ like that – but literally.  When something that you take for granted – like having an extensive vocabulary at your disposal, is redacted, it kind of changes how you express yourself.  It also changes peoples’ perceptions of you.

Just for five minutes – I desperately wanted at least one person who really “knew” me to be there.

Dr. Barbosa is a fantastic teacher and a very intelligent and kind person – but we don’t have the kind of friendship that I had with either Dr. Embrey (in Virginia) or Dr. Ochoa (in Mexicali).  Part of that is probably due to the fact that I just haven’t been here all that long.  I worked with Dr. Embrey for almost three years.  Dr. Ochoa and I were together five to six times a week for months.

aortic valve 010

The other part is Dr. Barbosa himself.  Our perspectives are fairly different, so that tends to complicate things.  He is always friendly but still a bit reserved with me.  That might be due to the fact that I am still lacking fluency in Spanish.  (I understand a heck of a lot more that I can speak – but even so, colloquial phrases and subtle nuances in speech are usually a complete mystery to me).  So I miss most of the jokes in the operating room, or figure it out about five minutes too late to be part of the conversation.

But after a little while that feeling of intense ‘alone’ dissipated – and everything went back to normal, whatever that is.

aortic valve 012

Tuesday

This morning I went by the Cancer Institute of Sucre.  I had written to them last week, but received no reply, so I decided to stop in.  After about an hour, I was able to talk to one of the administrators but she said that I had to submit all my questions about their cancer treatment programs in writing, in advance.  I explained that is not how it usually works, and left my card.  I am sure that will be the last I hear from them.  It’s a shame because the facility is beautiful, sparkling and new.  They advertise a wide variety of cancer treatments including brachiotherapy and thoracic surgery so I would have liked to know more.  (The website looks like something circa 1996, so it’s not really possible to get information from there.)

Another case today – another saphenectomy!  But this one came with a potent reminder.   While I still need practice, I feel more capable of performing the procedure that I did before.  Things proceeded well, if slowly (still need a headlamp!) but then it turned out that the internal mammary wasn’t useable so Dr. Barbosa needed more vein conduit.  Which he proceeded to harvest himself, in about five minutes.  So – I still plenty to aim for.

The holiday week started mid-week, but I am still hopefully for a few new consults tomorrow.  I know we probably won’t have any surgeries over the ‘Semana Santa” period, but I can’t help but keep my fingers crossed anyway.

Wednesday

Aortic valve replacement*** today.  Dr. Salgua showed up early today – and looked pretty determined, so I decided just to stay out-of-the-way.  I figured since it wasn’t a vein harvesting case, I shouldn’t make a fuss.  After all, I am just a visitor here – and I’ll be leaving soon.

aortic valve 027

Not my best photo by far – but my favorite part of this surgery – placing the new aortic valve into position

Instead, I stayed behind the splash guard and took pictures – since aortic replacement is the “prettiest” of all cardiac surgeries.  Unfortunately, my position was a little precarious, balanced in two steps – and still barely above the splash guard.  So many of the best shots – ended up partially obscured.  (But I don’t want to give up any more surgeries to get better photos.)

Received a consult from the cath lab today but surgery will probably be delayed due to the Easter week holiday.  (The team is willing to operate 24/ 7 – but few else are.)

Both our patients from earlier this week are doing great.  Monday’s patient passed me several times doing laps on the med-surg floor.  He’ll probably go home tomorrow or Friday.

Thursday

No surgery scheduled for today.  Rounded on the patients from this week and spent some time explaining medications, post-discharge instructions and other health information with the patients and their families.  While I love the operating room – this is the part I enjoy the most: getting to know my patients, and getting to be part of their lives for just the briefest of moments.  It is this time with patients – before and after surgery that makes them people, families – not legs or valves or bypasses.  Without this part, I am not sure I would have the same satisfaction and gratification in my work*.  I love seeing patients when they return to the clinic for their first post-operative visit – to see how good they look, and how much better many of them already feel.

This afternoon – was exactly that as one of my first patients returned to the clinic after surgery.  The patient looked fantastic!  All smiles, and stated that they already felt better.

After seeing patients in the clinic, we packed up and headed for home.  Since we currently have no surgery scheduled for next week (Semana Santa), and our other consults are pending insurance authorization, I don’t know when or if I will be returning to Sincelejo before I depart for the United States.

*As I say this, ironically, I am hoping for a ‘straight surgery’ position for one of my future contracts, so I can refine/ improve my surgical skills for future contracts in different settings that encompass a variety of duties.

***More Aortic Valve articles, including my famous “Heinz 57” post can be found here:

Aortic Stenosis and Heinz 57 : (what is Aortic stenosis?)

Aortic Valve Replacement and the Elderly

Aortic Stenosis : More patients need surgery

Cardiac surgery and valvular heart disease: More than just TAVR

There is a whole separate section on TAVI/ TAVR.

 

 

Advertisements

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]. 

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.

Spending the weekend with Dr. Vasquez, and medical photography


For internet searches for medical photography – all of my images are free for your use, but please give proper credit for my work, ie. “Photo by K. Eckland”.  For commercial uses, contact me, (so that I can contact the subjects of my work).

Please note that patient privacy is protected – and patient permission is obtained prior to photographs.  For the most part – I photograph surgeons – not patients, or surgery.

Spent much of the weekend in the operating room with Dr. C. Vasquez, cardiac surgeon at two different facilities, and the differences couldn’t be more apparent – and perhaps not what one might expect.  Much of it comes from perspective; as a person behind the lens, I see the scene differently than others might.

harvesting the radial artery

In fact, this prompted me to write an article on the subject of medical photography, complete with a slide show to illustrate the effects of color on surgical photographs. I’ve also re-posted much of the article here (see below).  Once you see the photos from today, you’ll understand the article.

the beige operating room

The case today went beautifully, with the patient extubated in the operating room.

Dr. Vasquez, and Lupita, scrub nurse

While we were there – had an unexpected surprise! Dr. Gutierrez ‘Lalo’ showed up.  I have been trying to get him into the cardiac OR since he confessed his interest in cardiac surgery.  It was great to see him – and I like encouraging him in his educational goals.   (I kind of miss being a mentor, and preceptor to students..)

Lalo peeks over the curtain..

Dr. Gutierrez (Lalo) in the cardiac OR

Medical Photography

Medical photography is many ways is more art, and luck that skill – at least for people like me who never set out to be medical photographers in the first place.  It was a natural development prompted by dire necessity during the early days of interviewing surgeons and medical writing.  I am still learning, and hopefully improving.

But as I said before, much of it is luck, and timing, particularly in this field, where the subjects are always in motion and a slight movement of the hand tying the suture knot can result in either a breath-taking shot or an utter failure to capture the moment.

The most dramatic and vivid photographs often come at mundane moments, or unexpected situations.  In medical photography, where the subject matter combines with a dramatic interplay of color, light and shadow to illustrate some of life’s most pivotal moments such as birth, death and life-saving operations – it is surprising how important the background elements are.

Here in Mexicali, I have been taking photographs of different surgeons for several weeks at different facilities across the city.  But, almost unanimously, all of the photographs, regardless of subject at Hospital Almater are lackluster and uninspiring.  Contrast this with the glorious photos from the public facilities such as Hospital General de Mexicali, and Issstecali.

The culprit is immediately apparent, and it demonstrates how such carefully planned such as aesthetics and interior design can have unintended consequences.  The very studied, casual beigeness used to communicate upscale living in the more public parts of the hospital are destroying the esthetics of the operating room services they are selling.  Whereas, the older facilities, which have continued the use of traditional colored drapes and materials do not have the problem.

Historically, surgical drapes were green for a very specific reason.  As the complementary color to red, it was believed to be a method of combating eye fatigue for surgeons looking at the red, bloody surgical fields for hours at a time.  Over the years, operating room apparel and drapes evolved away from this soft green to a more vivid blue, know as ‘ceil’.  The reasons for this change are probably more related to manufacturing that medicine, and since that evolution, surgical drapes now come in a variety of colors – hence the color matching here, of the paint, the tile, the patients, the operating room and the surgeons itself.  Somewhere, an interior decorator is filled with gleeful satisfaction – but I can only muster up a groan; knowing I will be here again and that most of my photos will be unusable.

While the consequences of poor medical photographs may seem trivial to anyone but myself (and my interviewees) at this junction – it runs far deeper than that.  With the advent of the internet, and the complicated legalities of getty and other corporate images, small, independent photographers such as myself are gaining wider exposure than ever before.   Alas! – much of it is uncredited, but several of my more popular images are downloaded thousands of times per week, to grace slideshows, powerpoint presentations and other illustrations for discussions of anything from medicine and surgery to travel, technology and even risk assessment.  In an era of branding, and logo recognition, places like Hospital Almater are certainly missing out.

In  other news/ happenings: Upcoming elections!**

Finally found someone to talk to and explain some of the issues in Mexican politics – but he hates Quadri, and doesn’t really explain any of it except to say ‘He’s corrupt..”  (From my understanding, ‘corrupt’ is an understatement, and that all of the parties are corrupt – and it’s pretty well understood by everyone involved – so of course, if I hear something like that – please explain.. explain..)  It’s not like I am capable of voting anyway, but I’d sure like to hear perspectives..

It looks like I’m not the only one who is a little leary of pretty boy pena’s party’s dubious history.  His numbers have fallen in recent polls in advance of tonight’s televised debates.  (Let’s hope these debates are better than the last.)

My personal “favorite”, Quadri is still trailing in the dust, but it looks like Lopez has a chance to take the election from Pena (much like it was ‘taken’ from him in 2006 with his narrow defeat..  Lopez is a socialist which is hard for Americans like me to understand – but then again, it’s not my country, and the levels of inequity here are certainly wider than at home – so maybe someone like Lopez can bring some much needed support to the lower classes.

I mean, a lot of what we take for granted in the USA doesn’t exist here, like a decent free public school education.   (Okay – I know critics will argue about the value of an inner city education – but we still provide a free elementary & secondary school education to all our citizens.)  So socialism for the purpose of providing basic services in all areas of Mexico seems pretty reasonable.  (It would help if I could read some primary source stuff – without using translation software, so I would have a better idea of the specifics of AMLO’s ideas.)

I did ask my friend about the student demonstrations for Yo Soy 132.  I guess as an American growing up after the 1960’s – we tend to not too make much of a big deal over student demonstrators – after all – we have the ‘Occupy’ movements going on right now in our own/ other countries – but he was telling me that this is pretty uncommon in Mexico.

** No, I’m not really into politics but I feel like it’s important to try and understand as much as possible about the places (countries) where I am residing.

Blue Cross/ Blue Shield of Mexicali & Dr. Cuauhtemoc Vasquez Jimenez


Note:  I owe Dr. Vasquez a much more detailed article – which I am currently writing – but after our intellectually stimulating talk the other day, my mind headed off in it’s own direction..

Had a great sit down lunch and a fascinating talk with Dr. Vasquez.  As per usual – our discussion was lively, (a bit more lively than usual) which really got my gears turning.  Dr. Vasquez is a talented surgeon – but he could be even better with just a little ‘help’.  No – I am not trying to sell him a nurse practitioner – instead I am trying to sell Mexicali, and a comprehensive cardiac surgery program to the communities on both sides of the border..  Mexicali really could be the ‘land of opportunity’ for medical care – if motivated people and corporations got involved.

During lunch, Dr. Vasquez was explaining that there is no real ‘heart hospital’ or cardiac surgery program, per se in Mexicali – he just operates where ever his patients prefer.  In the past that has included Mexicali General, Issstecali (the public hospitals) as well as the tiny but more upscale private facilities such as Hospital Alamater, and Hospital de la Familia..

Not such a big deal if you are a plastic surgeon doing a nip/tuck here and there, or some outpatient procedures – okay even for general surgeons – hernia repairs and such – but less than ideal for a cardiac surgeon – who is less of a ‘lone wolf’ due to the nature and scale of cardiac surgery procedures..

Cardiac surgery differs from other specialties in its reliance on a cohesive, well-trained and experienced group – not one surgeon – but a whole team of people to look out for the patients; Before, During & After surgery..  That team approach [which includes perfusionists, cardiac anesthesiologists (more specialized than regular anesthesia), operating room personnel, cardiology interventionalists and specialty training cardiac surgery intensive care nurses]  is not easily transported from facility to facility.

just a couple members of the cardiac surgery team

That’s just the people involved; it doesn’t even touch on all the specialty equipment; such as the bypass pump itself, echocardiogram equipment, Impella/ IABP (intra-aortic balloon pump), ECMO or other equipment for the critically ill – or even just the infrastructure needed to support a heart team – like a pharmacy division that knows that ‘right now’ in the cardiac OR means five minutes ago, or a blood bank with an adequate stock of platelets, FFP and a wide range of other blood products..

We haven’t even gotten into such things such as a hydrid operating rooms and 24/7 caths labs – all the things you need for urgent/ emergent cases, endovascular interventions – things a city the size of Mexicali should really have..

But all of those things take money – and commitment, and I’m just not sure that the city of Mexicali is ready to commit to supporting Dr. Vasquez (and the 20 – something cases he’s done this year..) It also takes vision..

This is where a company/ corporation could come in and really change things – not just for Dr. Vasquez – and Mexicali – but for California..

It came to me again while I was in the operating room with Dr. Vasquez – watching him do what he does best – which is sometimes when I do what I do best.. (I have some of my best ideas in the operating room – where I tend to be a bit quieter.. More thinking, less talking)..

Dr. Vasquez, doing what he does best..

As I am watching Dr. Vasquez – I starting thinking about all the different cardiac surgery programs I’ve been to: visited, worked in – trained in.. About half of these programs were small – several were tiny, single surgeon programs a lot like his.. (You only need one great surgeon.. It’s all the other niceties that make or break a program..)

All of the American programs had the advantages of all the equipment / specialty trained staff that money could buy***

[I know what you are thinking – “well – but isn’t it all of these ‘niceties’ that make everything cost so darn much?”  No – actually it’s not – which is how the Cardioinfantils, and Santa Fe de Bogotas can still make a profit offering world-class services at Colombian prices…]

The cost of American programs are inflated due to the cost of defensive medicine practices (and lawyers), and the costs of medications/ equipment in the United States****

the possibilities are endless – when I spend quality time in the operating room (thinking!)

Well – there is plenty of money in Calexico, California** and not a hospital in sight – just a one room ‘urgent care center’.  The closest facility is in El Centro, California – and while it boasts a daVinci robot, and a (part-time?) heart surgeon (based out of La Mesa, California – 100 + miles away)– patients usually end up being transferred to San Diego for surgery.

Of course, in addition to all of the distance – there is also all of the expense..  So what’s a hard-working, blue-collar guy from Calexico with severe CAD going to do?  It seems the easiest and most logical thing – would be to walk/ drive/ head across the street to Mexicali.. (If only Kaiser Permanente or Blue Cross California would step up and spearhead this project – we could have the best of both worlds – for residents of both cities.. 

 A fully staffed, well-funded, well-designed, cohesive heart program in ONE medium- sized Mexicali facility – without the exorbitant costs of an American program (from defensive medicine practices, and outlandish American salaries.)  Not only that – but as a side benefit, there are NO drug shortages here..

How many ‘cross-border’ cases would it take to bring a profit to the investors?  I don’t know – but I’m sure once word got out – people would come from all over Southern California and Arizona – as well as Mexicali, other parts of Baja, and even places in Sonora like San Luis – which is closer to Mexicali than Hermasillo..  Then Dr. Vasquez could continue to do what he does so well – operate – but on a larger scale, without worrying about resources, or having to bring a suitcase full of equipment to the OR.

The Mexican – American International Cardiac Health Initiative?

But then – this article isn’t really about the ‘Mexican- American cross-border cardiac health initiative’

It is about a young, kind cardiac surgeon – with a vision of his own.

That vision brought Dr. Vasquez from his home in Guadalajara (the second largest city in Mexico) to one of my favorite places, Mexicali after graduating from the Universidad Autonomica in Guadalajara, and completing much of his training in Mexico (D.F.).  After finishing his training – Dr. Vasquez was more than ready to take on the world – and Mexicali as it’s first full-time cardiac surgeon.

Mexicali’s finest: Dr. Vasquez, (cardiac surgeon) Dr. Campa(anesthesia) and Dr. Ochoa (thoracic surgeon

Since arriving here almost two years ago – that’s exactly what he’s done.. Little by little, and case by case – he has begun building his practice; doing a wide range of cardiovascular procedures including coronary bypass surgery (CABG), valve replacement procedures, repair of the great vessels (aneurysm/ dissections), congenital repairs, and pulmonary thrombolectomies..

Dr. Vasquez, Mexicali’s cardiac surgeon

Dr. Cuauhtemoc Vasquez Jimenez, MD

Cardiac Surgeon

Calle B No. 248 entre Obregon y Reforma

Col. Centro, Mexicali, B. C.

Email: drcvasquez@hotmail.com

Tele: (686) 553 – 4714 (appointments)

Notes:

*The Imperial Valley paper reports that Calexico makes 3 million dollars a day off of Mexicali residents who cross the border to shop.

***In all the programs I visited  – there are a couple of things that we (in the United States do well..  Heart surgery is one of those things..)

**** Yes – they charge us more in Calexico for the same exact equipment made in India and sold everywhere else in the world..

Six month TAVI/TAVR data released


The Core Valve by Medtronic

Medtronic, the makers and financial backers of a recent study on the Core Valve used for percutaneous aortic valve replacement (aka non-surgical valve replacement) released their findings showing the six month mortality data on patients receiving this valve.

This study which was performed using data from European cardiologists (who have been using this technology longer) were unsurprising – with a higher risk of stroke and overall mortality.  Notably, this study was performed on patients deemed to be ‘at high risk’ for surgery, not ineligible for surgery.  As we’ve discussed before, the term ‘high risk’ is open to considerable interpretation.

A total of 996 frail, elderly patients at high risk for heart surgery were  implanted with Medtronic’s CoreValve device, used to treat severe narrowing of  the aortic valve. Mortality rates at one month and six months were 4.5% and  12.8%, respectively. Stroke rates were 2.9% and 3.4%.

Medtronic said the rates  were consistent with previously reported data from national registries in Europe.”

Unfortunately, the general media’s coverage of these findings have been less than straightforward as Bloomberg proclaims in blazing headlines, “Edwards heart valve skirts rib-cracking for a 2.5 billion dollar market.”  That’s a pretty eye-opening headline that manages to avoid mentioning the real issues – longevity and durability.

Another article from business week proclaims, “Heart Valves found safe.”  Safe, I guess is a relative term – if you aren’t one of the 12.8% that died within six months..

Illustration showing the core valve in place

More about Aortic Stenosis and Valve Replacement therapies at Cartagena Surgery:  (you can also find a link to these stories under the TAVI tab on the sidebar.)

Aortic Stenosis as Heinz 57

More patients need surgery

Aortic Stenosis, surgery and the elderly

Aortic stenosis and TAVI

Aortic Stenosis: New Recommendations for TAVI

Transcatheter Valve Therapies: an overview

TAVI and long-term outcomes

Peri-operative outcomes with TAVI

Talking about TAVI/ TAVR with Dr. Kevin Brady

Will Medicare cover TAVI?

Will Medicare cover TAVI/ TAVR?


Updates to this story have been posted here.

In an article re-post from the Heart.org, Lisa Nainggolan discusses a recent memo issued by Medicare & Medicaid services (CMS) on potential coverage for TAVI/ TAVR.    This memo lays out the necessary criteria and conditions that must be met for CMS coverage.

Don’t have medicaid or medicare?  Well, the privately insured should still sit up and take notice:  CMS decisions usually set the pace for everyone else – meaning, if Medicare won’t pay for it – then Blue Cross, Anthem and most of the big private insurances won’t either.

CMS draft of proposed coverage – the Heart.org 

Lisa Nainggolan

Baltimore, MD – The US Centers for Medicare & Medicaid Services (CMS) has issued a memo detailing its proposed coverage for transcatheter aortic-valve replacement (TAVR) [1]. The move follows a request for national coverage determination (NCD) from the ACC and Society for Thoracic Surgeons (STS), made last September.

The memo—which is a draft and will be open for public comment until March 3—outlines the conditions under which the CMS will cover TAVR, also known as transcatheter aortic-valve implantation (TAVI), and follows hard on the heels of an expert consensus document on the new technology, published earlier this week.

An estimated 45 000 patients have received TAVI worldwide, with most procedures so far being performed in Europe. US approval of the Edwards Sapien valve at the end of last year means that the country must now gear up to introduce this technology nationwide, and the expert guidance has been designed to act as a roadmap for the rollout of TAVI in the US.

Five conditions must be met for Medicare coverage of TAVR

TAVR will be covered for the treatment of severe symptomatic aortic-valve stenosis only, says the CMS, and the following five conditions must be met:

  • The procedure is performed for an approved indication with a valve and implantation system that has received FDA approval for this indication.
  • Two cardiac surgeons have evaluated the patient’s suitability for open valve-replacement surgery. (traditional cardiac surgery)
  • The procedure is performed in a facility that meets certain requirements with regard to surgical and interventional cardiology expertise. In addition, institutions with prior TAVR experience must participate in ongoing trials or postapproval studies, and all centers performing TAVR must commit to the “heart-team” concept and enroll in a prospective national TAVR study.
  • TAVR must be carried out by sufficiently qualified and experienced physicians.
  • The treating team must participate in a national registry that enrolls TAVR patients and tracks the following outcomes: major stroke; all-cause mortality; minor stroke/transient ischemic attack; major vascular events; and acute renal injury.

For unlabeled uses of TAVI, the CMS proposes coverage only in the context of a clinical trial, for which it lists 13 conditions.

The CMS also indicates that it will not cover TAVR for any other indications not specified in its memo, nor will it cover the procedure in patients who also have concomitant conditions, including: mixed aortic-valve disease; isolated aortic regurgitation; untreated clinically significant coronary artery disease requiring revascularization; hypertrophic cardiomyopathy; echocardiographic evidence of intracardiac mass; significant aortic disease; and severe obstructive calcification or tortuosity of the iliofemoral vessel or small vessel size.

It’s a mixed win for American cardiologists and cardiac surgeons – and certainly opens the door to the expanded use of this criteria.  The good news is that CMS is taking the initiative to stem off a flood of inappropriate procedures.  The release of this memo, along with the recent publication of new guidelines re-affirming the role of CABG, and relegating PCI to specific circumstances  is almost certainly a response to the numerous scandals and allegations affecting cardiology in 2011 (and ongoing.)

Which hospitals should have TAVR/ TAVI programs?

This article outlines the basic requirements for a safe and successful TAVR program – including the minimum skill requirements for surgeons and interventionalists.

But I suspect – it won’t be long before more and more hospitals open their own programs.  This article highlights the financial gains for hospitals with TAVR programs.