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Archive for the ‘TAVI / AVR’ Category

A frightening decision by the FDA just as a savvy reader forwarded an episode of last season’s Grey’s Anatomy – which highlights the issues involved in the use of TAVI.   In this article, “FDA extends Sapien use to high-risk surgical patients“, Shelly Wood at the heart.org explains the FDA’s recent decision to expand eligibility criteria for TAVI use to patients eligible for surgery, (but deemed high risk).  No mention is made of the recent controversy over TAVI due to higher than expected complications.

At the same time, a reader encouraged me to watch last season’s Grey’s Anatomy episode where a low-risk patient demands (and RECEIVES) TAVI instead of traditional surgery because he doesn’t want a scar to mar his physique.  Of course, there is no mention on the show of post-procedural complications (because it’s a fictional program on television) but the very manner in which the episode was handled is frightening.

There was no discussion of unnecessary risk for the patient using experimental technology, or of the Major vascular complications that occur in more than one in seven TAVR patients: according the PARTNER trial.  There is also no mention of the drastic increase in mortality if these complications occur.  In the episode, the resident researches the procedure – and decides (appropriately) that the procedure is not suitable for the patient.  He is then scooped by the cardiac surgeon, who decides, “hey – what the heck – seize the day!”

Link to clip of Grey’s Anatomy

But as I said – it’s only television, right?  Except that it isn’t.  It’s a powerful medium used to disseminate information to the millions of people who watch that program.  (9.5 million people, according to recent ratings information.)  They also make a pretty huge leap on the program – changing TAVI from a procedure supposedly for patients with no other option (surgery ineligible) to a low-risk patient who wants to avoid a scar..

and now – the FDA expands criteria – despite a turbulent summer which included  previous criticism (by the FDA) based on irregularities in the PARTNER trial itself – and a violent controversy over the safety of this procedure.  The British Medical Journal also published an article over the summer decrying the overuse of the procedure.

Additional References – more in archives

1.  Amabile N, Azmoun A, Ghostine S, Ramadan R, Haddouche Y, Raoux F, To NT, Troussier X, Nottin R, Caussin C. (2012).  Incidence, predictors and prognostic value of serious hemorrhagic complications following transcatheter aortic valve implantation. Int J Cardiol. (2012 Oct 15). pii: S0167-5273(12)01131-X. doi: 10.1016/j.ijcard.2012.09.025. [Epub ahead of print]

Since the article is not available – I have included the abstract.

Abstract

BACKGROUND:

TAVI is an alternative solution for patients with aortic valve stenosis (AS) who are refused for conventional surgery. We sought to evaluate the incidence, characteristics, predictors and prognosis impact of serious hemorrhagic complications following transcatheter aortic valve implantation (TAVI).

METHODS:

One hundred and seventy-one consecutive patients with symptomatic severe AS (83.5±6.1y; 53% women; mean EuroSCORE=22.1±12.3) underwent transapical (TA) or transfemoral (TF) TAVI in our institution using Edwards SAPIEN© and Medtronic CoreValve© devices. The primary evaluated criterion was the incidence of any bleeding complication, according to the Valve Academic Research Consortium (VARC) criteria.

RESULTS:

VARC serious hemorrhagic complications occurred in 34.5% of patients (n=23 life-threatening/disabling (LT/D) and n=36 major bleedings). Most of these complications were related to access site complications (69%). Multivariable analysis revealed that TA access, low weight and underlying coronary artery diseases were independent predictors for development of serious bleeding. The mortality was significantly higher in patients with serious events compared to patients without bleeding (p=0.008, log-rank analysis). Although the survival didn’t significantly differ in patients with major hemorrhagic events, subjects with LT/D bleeding events had a higher mortality than the subjects with no hemorrhagic complications (p<0.001, log-rank analysis). Occurrence of VARC LT/D event independently predicted all-cause mortality (HR=5.35 [2.51-11.43], p<0.001) during the first year following TAVI in multivariate Cox regression analysis.

CONCLUSION:

Severe bleeding is frequent following TAVI procedure and is mainly related to local hemorrhage. VARC LT/D events are associated with decreased survival after AS correction.

2.  Gul M, Erkanli K, Erol MK, Bakir I. (2012).  Ventricular Embolization of Edwards SAPIEN Prosthesis Following Transcatheter Aortic Valve Implantation.  J Invasive Cardiol. 2012 Oct;24(10):537-8.  While this is a single case, this illustrates much of the data presented in a previous post.

3.  Latsios G, Toutouzas K, Tousoulis D, Stathogiannis K, Tentolouris C, Synetos A, Filis K, Stefanadis C.  (2012).   Prosthetic aortic valve removal from the abdominal aorta after successful “valve-through” TAVI.  Int J Cardiol. 2012 Oct 12. pii: S0167-5273(12)01285-5. doi: 10.1016/j.ijcard.2012.09.164. [Epub ahead of print]
Given that the patient almost lost his leg (and was taken to the operating room for emergency limb salvage surgery with a vascular surgeon), I think ‘success’ is a bit presumptuous for the title.  Reminds me of an old medical joke around the hospital when I was in training (which I have made some adjustments to.)
Dr. [exhultant as he leaves the cath lab] “I successfully implanted the new TAVI valve.”
Nurse:  But doctor, the patient died twenty minutes ago, [as she covers wheels corpse out of cath lab.]
Want more information on TAVI and aortic stenosis?  Just look in our archives.
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It looks like the rest of the medical community is finally speaking up about the overuse and safety issues of TAVI/ TAVR for aortic stenosis, but it’s still few and far between – and in specialty journals…  But in the same week that Medscape, and the Heart.org reported on a newly published article in the British Medical Journal on the overuse of TAVI therapies, and the need for earlier diagnosis and treatment of Aortic Stenosis – the Interventionalists over at the Heart.org (a cardiology specialty journal)  have published a series of articles promoting / pushing the procedure including an article entitled, “The TAVR Heart team roles.”

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

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

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

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

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

• It is technically challenging today to quantify these leaks.

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

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

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

As one cardiologist explained:

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

Valve oversizing – a surgeon explains

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

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

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

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

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

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

Additional Reference / supporting data:

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

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

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

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

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

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

 

Full references for works cited in text:

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

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

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

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

BACKGROUND:

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

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

METHODS:

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

RESULTS:

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

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

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

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

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

CONCLUSIONS:

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

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

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

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

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

OBJECTIVES:

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

BACKGROUND:

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

METHODS:

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

RESULTS:

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

CONCLUSIONS:

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

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

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

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

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

OBJECTIVE

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

METHODS

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

RESULTS:

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

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

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

CONCLUSION

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

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

BACKGROUND:

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

METHODS:

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

RESULTS:

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

CONCLUSIONS:

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

Industry fights back

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


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

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

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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.

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As reported by heartwire, and a savvy reader, Lapeyre here at Cartagena Surgery, the FDA has gone ahead and approved TAVI/ TAVR for patients that are eligible for open surgery.  [We must think alike, as I was drafting this post when I received the reader mail].

Despite the FDA’s previously cited concerns over the excessive stroke rate with the Sapien device (as discussed in the article re-posted below) – the FDA approved the use of this therapy as an alternative to surgery on June 13th.

Now we can sit back and watch as the up selling of this device to the public as news hits the US media and the television advertisements begin.  Soon this device will crowd out surgery as interventionalists cite “patient refused surgery” as the criteria for implantation, no matter what the best interest of the patient really is.  I wonder if they will even disclose the heightened stroke rate when they start implanting this into patients at a much higher rate.  Of the 12 members of the FDA panel, only one member voted against the expansion criteria.

As reported by Shelley Wood in a follow-up Heartwire article , only Dr Valluvan Jeevanandam spoke out against expanding the criteria for use, stating,   “I think this is a very good technology, and it gives us an alternative to AVR surgery, and I’m sure the device will continue to get better,” Jeevanandam, a cardiovascular surgeon, told heartwire after the meeting.

“However, at the current time, compared with standard AVR, this device has a higher stroke rate and a high rate of aortic insufficiency, did not meet the criteria for noninferiority* in males, and has a high incidence of vascular complications.”

These are all issues that need to be very clearly explained to patients as part of the informed-consent process, he stressed. Otherwise, patients who are “enamored at the idea of avoiding a sternotomy” may not fully understand these risks.”  

I fully concur with Dr. Valluvan Jeevanandam except that I might re-phase the term ‘enamored of.’  Actually, I think our so-called peers need to quit coercing patients by intentionally scaring them – in order to bill more procedures out of them.  [Don’t believe it?  Then check out Mark Midei and our overstenting archives.]

I will continue to champion well-established therapies with strong long term data.  I know this will get me labeled as ‘old-fashioned’ (or worse) but as we’ve seen in cardiology – numerous times; easy is not always the best answer..

The is no easy button

Yes, conventional surgery hurts – it’s not glamorous, it’s not pretty.  But it’s (statistically) darn safe these days, and most of the surgeons doing it have done it thousands of times.. Even the bioprosthetic valves have a long durability than previously thought – meaning not everyone has to take warfarin..

We shouldn’t exploit people’s fears of surgery to use quasi-experimental procedures, no matter how “cool” they sound..

* I hope readers remember that ‘noninferiority’ is a lesser standard that superior to, or even EQUAL to..

FDA flags strokes, trial conduct, as TAVI maker seeks expanded role for Sapien – from Heartwire.com (Shelley Wood).

Gaithersburg, MD – A higher risk of stroke and differences in how patients randomized to different procedures were actually treated and evaluated within the PARTNER A trial, which compared transcatheter aortic-valve implantation (TAVI) with surgery, are issues the US Food and Drug Administration (FDA) hopes its expert advisors can help clarify in weighing the pros and cons of expanding approval of the Sapien transcatheter valve (Edwards Lifesciences) [1,2]. Those issues and others are detailed in an FDA briefing document, posted online today, that the agency’s Circulatory System Devices Panel will consider in advance of Wednesday’s meeting.

As previously reported by heartwire, the FDA last year reviewed and subsequently approved the Sapien valve and transfemoral delivery system in patients not suited to open-valve replacement, based primarily on the PARTNER B results. Wednesday’s meeting, drawing heavily on the  PARTNER A results, will help the FDA decide whether to expand approval to high-risk patients who are surgery eligible and whether to approve the transapical approach also tested in PARTNER A.

In briefing documents posted online today, the FDA directed its advisors to pay special attention to a number of issues relating to trial conduct as well as patient outcomes.

In particular, the FDA review cites the “doubling” of neurological events seen in the Sapien-treated patients in the first 30 days postprocedure, with a higher stroke rate seen among transapical as compared with the transfemoral group.

The FDA documents also query “attempt-to-treat” decisions, including the higher number of patients randomized to surgery in whom no treatment was attempted; longer delays to treatment in surgical patients; and the higher number of concomitant operations seen in the surgical aortic-valve-replacement group—all factors that could have influenced adverse-event and survival rates in this group.

FDA is also asking its expert panel to weigh in on whether both the transfemoral and transapical approaches should be approved, given the numerically higher mortality in the transapically treated patients as compared with the transfemorally treated patients in the device arm.

General questions the FDA panel will be answering Wednesday include those related to the issues above, as well as to different outcomes seen in men and women, the importance of paravalvular regurgitation seen in patients treated with TAVI, valve durability, the required anticoagulation/antiplatelet regimen, and obtaining true informed consent.

Voting questions center on whether the evidence is sufficient to demonstrate safety and efficacy and whether the benefits of the new device outweigh the risks.

Industry analysts reading the tea leaves in the FDA’s review see the agency’s briefing document as largely promising, with Wells Fargo’s Larry Biegelsen predicting a “tough day, but positive panel outcome” and JP Morgan’s Michael Weinstein stating that the FDA synopsis contained “no major surprises; positive outcome expected.”

In other cardiology news, 

New guidelines recommend the discontinuation of prasugrel a full seven days before surgery to prevent catastrophic bleeding complications. (The cynical side of me expects to see a bigger push by the industry to use prasugrel now that clopidogrel is generic.)  Expect to see a couple more “Ask your doctor” ads..

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In an update to a previous story here at Cartagena Surgery, in the attached article, “Medicare to pay for TAVI” from Medpage.com by Chris Kaiser, the guidelines for CMS payment for TAVI/ TAVR have been released.   These criterion include the restriction that only surgery ineligible patients be included and that implanting surgeons must participate in the TAVI registry.

More importantly, this criteria requires that TWO cardiac surgeons determine the patient’s suitability to withstand surgery versus TAVI.  This is a crucial requirement as we’ve discussed before, since only a surgeon can accurately decide/ predict how a patient might tolerate surgery.  (Multiple previous studies showed that primary care providers and cardiologists were poor judges of patient’s surgical risk. )  Also, the lack of this requirement in Europe has caused several ethical problems as interventional cardiologists began the widespread implantation of experimental technologies in lower risk patients (particularly in Germany.)

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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?

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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.

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