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Bifurcations: EPISODE 3 – TAP TECHNIQUE

As the summer holidays wind down to the final few days, many of us are heading back to the routine of work, school and home.  With the end of summer, my Bifurcation Series comes to a close as well. The final episode is the TAP technique.

Operators find this to be the least cumbersome of all the 2-stent strategies. Many resort to it during emergencies as the access to the main branch (MB) is maintained throughout the procedure. The steps are fewer which ensures expeditious coverage of both vessels followed by the conventional optimization steps including kissing and proximal optimization with a non-compliant balloon. Similar to culotte, this strategy allows operators to start with a provisional strategy and convert to TAP should the need arise. In addition, there is minimal stent overlap. This technique is considered a modification of what was formally known as T-stenting. The primary limitation of the original T-stenting was missing the ostium of the side branch (SB). This geographic miss is what prompted many operators to perform minimal protrusion to mitigate in-stent restenosis at that missed segment. Hence the name TAP, T and small protrusion, was coined. Although this technique has been adopted worldwide, there are no large randomized trials with long term outcome data to reference. There are some published data; however, that are worth reviewing.

 

Study TAP strategy Patients (n) Unprotected
left main stem
Follow-up
duration
TVR Definite stent
thrombosis
Burzotta et al’ Bail-out TAP in provisional 73 37.0% 9 months 6.8% 1.40%
Al Rashdan
et al7
Systematic TAP 156 10.3  % 36 months
(range 24-48 months)
5.3% 0.06%
Burzotta et a1 Bail-out TAP in
provisional procedures
19 5.0% 12 months 5.3% none
Naganuma et al Bail-out TAP (type B dissection or
TlMI <3 or stenosis >50% in the SB)
95 18.9% 36 months 9.7% none
ARTEMIS
study10
Bail-out TAP (type B dissection or
TlMI <3 or stenosis >75% in the SB)
71 26.8% 12 months 8.5% none
 SB:side branch;TVR: target vessel revascularisation

 

Burzotta et al, 2007

The modification of the T-stenting was first described in 2007 by Burzotta et al.1 It was evaluated in vitro and in two independent series of patients undergoing elective drug-eluting stent (DES) implantation on a bifurcation lesion. In vitro testing demonstrated perfect coverage of the bifurcation with minimal stent’s struts overlap at the proximal segment of SB ostium with a single layer stent struts. Sirolimus, paclitaxel, or zotarolimus DES were deployed in 73 patients (67% with Medina 1,1,1 lesions and 44% of unprotected distal left main disease) using the TAP technique. The procedural success was achieved in all cases. At 9 months the clinically-driven target vessel revascularization (TVR) was 6.8%. Since this was a pilot study, the investigators recommended larger outcome trials to further evaluate this technique. No comparison arm was available in this initial trial.

 

Al-Rashdan et al, 2009

In 2009 Al-Rashdan et al published their series of 156 consecutive patients who underwent TAP stenting.2 This was a single center study that resulted in a 99% procedural success rate and a major adverse cardiac events (MACE) free survival rate of 88% at 36 months average follow up. The TVR rate was 5.3%. Although to date this represents the largest cohort of TAP cases, the results are limited to a single center with no randomization which precludes further conclusions.

 

Burzotta et al, 2009

In 2009, Burzotta’s group prospectively enrolled 266 consecutive patients requiring treatment of a bifurcation lesion.3 The MB was treated with a DES and TAP was reserved as a bailout strategy. Only 19 of the total required a bailout 2-stent strategy. Nine percent of the total had unprotected left main disease. At one year, the MACE rate was 8.2%. A non-hierarchical analysis revealed a 0.4% cardiac death, 4.1% MI, 4.5% TVR and 2 of the total had probable stent thrombosis (ST).  Given the small number of bailout 2-stent strategy arm, this study only demonstrates safety.

 

Naganuma et al, 2013

Naganuma et al retrospectively analyzed data of all patients who underwent TAP technique with DES between July 2005 and January 2012.4 A total of 95 patients were enrolled. Angiographic procedural success was achieved in all cases. A true bifurcation was found in 78.9% of those enrolled. The 3-year MACE, cardiac death or myocardial infarction, TVR and target lesion revascularization (TLR) rates were 12.9%, 3.1%, 9.7%, and 5.1%, respectively. No ST was observed in this cohort. Once again, the investigators recommend larger trials to make solid recommendations.

Naganuma et al, JACC Cardiovasc Interv. 2013;6:554-61.

Naganuma et al, JACC Cardiovasc Interv. 2013;6:554-61.

 

ARTEMIS Study 2014

The ARTEMIS study was published in 2014.5 It evaluated the mid-term angiographic results of TAP as the bailout strategy in symptomatic patients who were treated with one-stent strategy (DES of the MB) and kissing balloon inflation of the SB who subsequently developed impingement of the branch. TAP was performed if residual diameter stenosis of SB was ≥75%, presence of ≥type B dissection or flow impairment of the SB occurred. A total of 71 patients were enrolled with a MEDINA classification 1,1,1 lesions occurring in 60% of the total. At 9 months, restenosis was occurred in 12.5% of the total. Late lumen loss in the MB and SB was 0.22 ± 0.19 and 0.34 ± 0.37 mm, respectively.

 

Dzavik et al, 2014

In 2014, there was much hype revolving around bioresorbable technology. Dzavik et al performed in vitro bifurcation stenting employing different modalities on synthetic arterial models.6 The everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) (BVS) was used. A low-pressure final kissing balloon inflation was performed to complete the procedures. The results demonstrated that a single-stent technique optimally opened the SB without deforming the BVS in the MB. T or TAP-stenting covered the SB ostium completely. Culotte and crush with 2 BVS stents was successful; however, disruption was reported after the low pressure kissing inflation in one case. Investigators concluded that it was feasible to perform bifurcation stenting with BVS in large caliber vessels. They also recommended that a provisional strategy as the default. TAP or T-stenting with a metal DES is preferable. As the overall in vivo outcome data for BVS remains cautionary at best, the use of BVS outside clinical trials is not recommended whether for focal type A lesions or complex bifurcations.

The technique itself is illustrated below. As mentioned earlier, it is one of the simpler 2-stent strategies. Like other strategies, appropriate sizing, positioning and optimization ultimately dictate the final angiographic and clinical outcomes. Intracoronary imaging facilitates these crucial steps. Yet, as with all interventions, judgment is the cornerstone of any successful procedure. When appropriate, and based on both Syntax score and clinical scores, surgical revascularization should be considered. When one opts for percutaneous revascularization, the indication for the procedure, its potential risks and complexity should be shared with the patient. For operators, judging the significance of the SB, the angle of the bifurcation, the size of both vessels and the need for mechanical circulatory support is valuable. Finally, complex bifurcation stenting is not for everyone. When appropriate, such complex procedures should be referred to expert operators for the best outcomes.

Animations/illustrations courtesy of Graphic Designer Dania Al-Shaibi

Email: dn.alshaibi@gmail.com

 

 

References:

  1. Burzotta F, Gwon HC, Hahn JY, Romagnoli E, Choi JH, Trani C, Colombo A. Modified T-stenting with intentional protrusion of the side-branch stent within the main vessel stent to ensure ostial coverage and facilitate final kissing balloon: the T-stenting and small protrusion technique (TAP-stenting). Report of bench testing and first clinical Italian-Korean two-centre experience. Catheter Cardiovasc Interv.2007;70:75-82.
  2. Al Rashdan I, Amin H. Carina modification T stenting, a new bifurcation stenting technique: clinical and angiographic data from the first 156 consecutive patients. Catheter Cardiovasc Interv.2009;74:683-90.
  3. Burzotta F, Sgueglia GA, Trani C, Talarico GP, Coroleu SF, Giubilato S, Niccoli G, Giammarinaro M, Porto I, Leone AM, Mongiardo R, Mazzari MA, Schiavoni G, Crea F. Provisional TAP-stenting strategy to treat bifurcated lesions with drug-eluting stents: one-year clinical results of a prospective registry. J Invasive Cardiol.2009;21:532-7.
  4. Naganuma T, Latib A, Basavarajaiah S, Chieffo A, Figini F, Carlino M, Montorfano M, Godino C, Ferrarello S, Hasegawa T, Kawaguchi M, Nakamura S, Colombo A. The long-term clinical outcome of T-stenting and small protrusion technique for coronary bifurcation lesions. JACC Cardiovasc Interv. 2013;6:554-61.
  5. Jim MH, Wu EB, Fung RC, Ng AK, Yiu KH, Siu CW, Ho HH. Angiographic result of T-stenting with small protrusion using drug-eluting stents in the management of ischemic side branch: the ARTEMIS study. Heart Vessels.2014 Mar 14.
  6. Dzavik V, Colombo A. The absorb bioresorbable vascular scaffold in coronary bifurcations: insights from bench testing. JACC Cardiovasc Interv.2014;7:81-8.

 

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Bifurcations – EPISODE 2: CULOTTE TECHNIQUE

It’s been a very hot summer so far. These days many of us are spending time with our families under the sun. Somehow, medicine still creeps into our summer days. Many of us will steal brief moments to check emails, open a link to an article or interact with colleagues on social media under a colorful parasol umbrella with a cold iced juice in our hand.

My last blog was the first of a series describing bifurcation stent strategies. This month the focus is Culotte technique. My intention is to provide a breezy summer reading that’s concise and illustrative, designed especially for those of us still on our summer ventures.

Here is Episode 2: CULOTTE TECHNIQUE

The Culotte technique, also commonly known as Y or Trouser stenting, was initially described by Chevalier et al in 1998.1 At that time, two equal sized bare metal stents were deployed in the main branch (MB) and side branch (SB) with an overlapped segment in the MB before the bifurcation. This was studied in a small population of only 50 patients with true bifurcation lesions. There was a 94% clinical success rate with 3 non-Q wave myocardial infarctions. A 24% late target lesion revascularization rate (TLR) was reported. Although this trial registered excellent short-term results, the technique itself was largely abandoned in the absence of any robust long-term data.  With the advent of drug-eluting stents (DES), culotte stenting resurfaced as a viable technique. In principal, this strategy is a trade-off. There is complete coverage of the carina and the ostium of the SB as well as a more uniform drug distribution. However, this is only achieved with a long segment of double layers of metal proximally. The culotte strategy using DES was evaluated in several randomized trials summarized below.

 

Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using dedicated quantitative coronary angiographic analysis and 12-month clinical outcomes. 

A decade after Chevalier, Adriaenssens et al in 2008 published the results of their prospective randomized trial that enrolled patients undergoing culotte stenting with DES (Cypher, Endeavor, polymer-free rapamycin-eluting, Taxus).2 The Medina classification was used to describe the lesions. Angiographic follow-up was performed between 6 and 12 months post-index procedure. Clinical follow-up was 12 months. Culotte technique was used in 134 lesions of which 92.5% were true bifurcations. Angiographic success was achieved in all cases. Restenosis occurred in 22% (0% in the proximal MB, 9.1% in the distal MB, and 16% in the SB). At 12 months, 21% had TLR and stent thrombosis (ST) was 1.5%. Predictors of restenosis were older age, increased bifurcation angle, small SB reference diameter and severe distal main branch stenosis.

 

Randomized Comparison of Coronary Bifurcation Stenting With the Crush Versus the Culotte Technique Using Sirolimus Eluting Stents

In 2009, Ergilis et al compared two dedicated bifurcation stent strategies, the crush and the culotte, using sirolimus eluting stents.3 A total of 424 patients were randomized (crush [n=209] and culotte [n=215]). The primary end point was major adverse cardiac events (MACE); cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), or ST at 6 months.  The results noted that at 6 months there were no significant differences in MACE rates between both groups; crush 4.3%, culotte 3.7% (P=0.87). Procedure and fluoroscopy times and contrast volumes were similar. The rate of myocardial injury defined by elevated biomarkers was 15.5% in crush versus 8.8% in culotte (P=0.08). In-segment restenosis was 12.1% versus 6.6% (P=0.10) and in-stent restenosis (ISR) was 10.5% versus 4.5% (P=0.046) for crush and culotte groups, respectively. The investigators conclude that the angiographic results of both strategies were similar with a trend to less ISR with culotte.

Ergilis et al, Circ Cardiovasc Interv. 2009;2:27-34

Ergilis et al, Circ Cardiovasc Interv. 2009;2:27-34

 

 

Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions: Results From a Multicenter, Randomized, Prospective DKCRUSH-III Study

More comparative data was made available in 2013 by Chen et al that employed more contemporary and developed techniques: Double Kiss Crush (DK) and Culotte.4 This study also examined the utility of these techniques in left main lesions. A total of 419 patients with unprotected left main bifurcation lesions were randomly assigned to Double Kiss Crush (210) or Culotte (209) strategies. The primary endpoint was MACE at 1 year, including cardiac death, MI, and target vessel revascularization (TVR).  ISR at 8 months was a secondary endpoint. ST was as a safety endpoint. Patients were stratified by SYNTAX (Synergy between Percutaneous Coronary Intervention   with Taxus and Cardiac Surgery) and NERS (New Risk Stratification) scores. In this cohort, the Culotte group had significant higher 1-year MACE rate (16.3%), driven by increased TVR (11.0%), compared with the DK group (6.2% and 4.3%, respectively; all p < 0.05). ISR of the SB was reported to be 12.6% in Culotte and 6.8% in DK (p = 0.037). ST rate was 1.0% in Culotte and 0% in DK (p = 0.248). Furthermore, when stratifying patients with bifurcation angle ≥70°, NERS score ≥20, and SYNTAX Score ≥23, the 1-year MACE rate for DK was 3.8%, 9.2%, and 7.1%, respectively. These rates were higher in Culotte (16.5%, 20.4%, and 18.9%, respectively; all p < 0.05). The investigators concluded that Culotte stenting for unprotected Left Main bifurcation lesions is associated with significantly higher MACE.

Chen et al, J Am Coll Cardiol. 2013;61:1482-8

Chen et al, J Am Coll Cardiol. 2013;61:1482-8

 

 

Clinical Outcome After Crush Versus Culotte Stenting of Coronary Artery Bifurcation Lesions: The Nordic Stent Technique Study 36-Month Follow-Up Results

The Nordic trialists also examined the outcomes of this technique in their study.5 The trial provided long term outcome data which is lacking in some of the other published data. A total of 424 patients were randomized to crush or culotte techniques using sirolimus-eluting stents and followed for 36 months. The primary endpoint was MACE (composite of cardiac death, MI, ST or TVR) at 36 months. At 36 months, the primary endpoint rate was 20.6% versus 16.7% (p = 0.32), TLR 11.5% versus 6.5% (p = 0.09), and ST 1.4% versus 4.7% (p = 0.09) in the crush and the culotte groups, respectively. The investigators concluded that outcomes were similar in both strategies.

Kervinen et al, JACC Cardiovasc Interv. 2013;6:1160-5

Kervinen et al, JACC Cardiovasc Interv. 2013;6:1160-5

 

 

Differential Prognostic Impact of Treatment Strategy Among Patients With Left Main Versus Non–Left Main Bifurcation Lesions Undergoing Percutaneous Coronary Intervention: Results From the COBIS (Coronary Bifurcation Stenting) Registry II

In 2014, Song et al provided outcome data from their retrospective Korean COBIS II registry.6 This registry was unique in that it compared outcomes of left main and non-left main bifurcation lesions using a two stent and single stent strategy. A total of 2,044 patients with non-left main bifurcation lesions and 853 with left main bifurcation lesions were enrolled. The primary outcome was TLF defined as a composite of cardiac death, MI, and TLR.  The 2-stent strategy was used more frequently employed in left main disease. At 36 months, the 2-stent strategy was not associated with a higher incidence of cardiac death, MI or target lesion failure (TLF) in the non-left main bifurcation group. However, in those with left main lesions, the 2-stent strategy was associated with a higher incidence of cardiac death, MI and TLF. Investigators, therefore, recommend a single strategy when possible especially for left main lesions.

Song et al, JACC Cardiovasc Interv.2014;7:255-63

Song et al, JACC Cardiovasc Interv.2014;7:255-63

 

 

Culotte stenting for coronary bifurcation lesions with 2nd and 3rd generation everolimus-eluting stents: the CELTIC Bifurcation Study

The CELTIC study provides more contemporary outcome data for patients with Medina 1,1,1 lesions treated with a culotte two-stent technique using latest generation Everolimus DES, the 3-connector XIENCE and the 2-connector SYNERGY.7 A total of 170 patients were included. Technical success was noted in >96% of those enrolled. MACE was reported in 5.9% by 9 months. The primary endpoint was a composite of death, MI, CVA, TVF, ST and binary angiographic restenosis. At nine months, the primary endpoint occurred in 19% of XIENCE group and 16% of SYNERGY group (p=0.003). Although this was not a direct comparison of 2-stent strategy to provisional strategy, this trial is more representative of modern day practice with radial access in 96%, latest generation DES and standard proximal optimization techniques.

Walsh et al, EuroIntervention 2018;14:e318-e324

Walsh et al, EuroIntervention 2018;14:e318-e324

 

As noted in the trials, the rate of employing this varies considerably, 2% in the COBIS II registry and 66% in Nordic Baltic Bifurcation Study IV. This strategy is most suitable when the SB and MB are similar in size. A mismatch can lead to incomplete SB stent apposition. Additionally, a wide angle between the two branches is an independent predictor of restenosis after culotte stenting. The advantages of this strategy are numerous. It permits one to begin with a provisional strategy that can be converted to 2-stents if necessary. With culotte technique there are only two and not three stent layers in the proximal segment. This facilitates re-wiring into the SB when performing kissing inflations. Culotte ensures complete coverage of all segments especially the ostium with little recoil at the ostium and stent distortion. Below is an illustration of the different steps.

Animations/illustrations courtesy of Graphic Designer Dania Al-Shaibi

Email: dn.alshaibi@gmail.com

 

 

References:

  1. Chevalier B, Glatt B, Royer T, Guyon P. Placement of coronary stents in bifurcation lesions by the “culotte” technique. Am J Cardiol.1998;82:943-9.
  2. Adriaenssens T, Byrne RA, Dibra A, Iijima R, Mehilli J, Bruskina O, Schömig A, Kastrati A. Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using dedicated quantitative coronary angiographic analysis and 12-month clinical outcomes. Eur Heart J.2008;29:2868-76.
  3. Erglis A, Kumsars I, Niemelä M, Kervinen K, Maeng M, Lassen JF, Gunnes P, Stavnes S, Jensen JS, Galløe A, Narbute I, Sondore D, Mäkikallio T, Ylitalo K, Christiansen EH, Ravkilde J, Steigen TK, Mannsverk J, Thayssen P, Hansen KN, Syvänne M, Helqvist S, Kjell N, Wiseth R, Aarøe J, Puhakka M, Thuesen L; Nordic PCI Study Group. Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: the Nordic stent technique study. Circ Cardiovasc Interv. 2009;2:27-34.
  4. Chen SL, Xu B, Han YL, Sheiban I, Zhang JJ, Ye F, Kwan TW, Paiboon C, Zhou YJ, Lv SZ, Dangas GD, Xu YW, Wen SY, Hong L, Zhang RY, Wang HC, Jiang TM, Wang Y, Chen F, Yuan ZY, Li WM, Leon MB. Comparison of double kissing crush versus Culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective DKCRUSH-III study. J Am Coll Cardiol.2013;61:1482-8.
  5. Kervinen K, Niemelä M, Romppanen H, Erglis A, Kumsars I, Maeng M, Holm NR, Lassen JF, Gunnes P, Stavnes S, Jensen JS, Galløe A, Narbute I, Sondore D, Christiansen EH, Ravkilde J, Steigen TK, Mannsverk J, Thayssen P, Hansen KN, Helqvist S, Vikman S, Wiseth R, Aarøe J, Jokelainen J, Thuesen L; Nordic PCI Study Group. Clinical outcome after crush versus culotte stenting of coronary artery bifurcation lesions: the Nordic Stent Technique Study 36-month follow-up results. JACC Cardiovasc Interv.2013;6:1160-5.
  6. Song YB, Hahn JY, Yang JH, Choi SH, Choi JH, Lee SH, Jeong MH, Kim HS, Lee JH, Yu CW, Rha SW, Jang Y, Yoon JH, Tahk SJ, Seung KB, Oh JH, Park JS, Gwon HC. Differential prognostic impact of treatment strategy among patients with left main versus non-left main bifurcation lesions undergoing percutaneous coronary intervention: results from the COBIS (Coronary Bifurcation Stenting) Registry II. JACC Cardiovasc Interv.2014;7:255-63.
  7. Simon J. Walsh, Colm G. Hanratty, Stuart Watkins, Keith G. Oldroyd, Niall T. Mulvihill, Mark Hensey, Alex Chase, Dave Smith, Nick Cruden, James C. Spratt, Darren Mylotte, Tom Johnson, Jonathan Hill, Hafiz M. Hussein, Kris Bogaerts, Marie-Claude Morice, David P. Foley. Culotte stenting for coronary bifurcation lesions with 2nd and 3rd generation everolimus-eluting stents: the CELTIC Bifurcation Study. EuroIntervention 2018;14:e318-e324.

 

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Bifurcations: From An Interventional Cardiologist’s Perspective

Approximately 15-20% of all coronary interventions are bifurcations1. Based on the overall Syntax Score, coronary artery bypass grafting is often recommended particularly in the setting of multi-vessel disease, diabetes and impaired left ventricular function. Once a decision to proceed with percutaneous revascularization is made, it is imperative that operators select the most appropriate revascularization strategy suited for an individual patient.

Briefly, the published data still recommends a provisional strategy as the default1. Of course, a two-stent strategy is commonly employed for bail out. An up-front two stent strategy is reserved for the following:

  1. This strategy is recommended for true Bifurcation Lesions with a Medina (111,011,101). This is of importance if the lesion is long and extends > 5-10 mm beyond the ostium of a sizeable side branch (> 2.5mm).
  2. If the side branch is very large, poor myocardial reserve, and a high jeopardy score, the hemodynamic consequences may be significant warranting revascularization of the side branch.
  3. Finally, if the angle to the side branch is acute rendering access too difficult, it is advisable to proceed with a two-stent strategy.

Over the course of the next couple of blogs, I will briefly review the randomized trials and steps of the different strategies. This month, my focus will be on DK-Crush.

DK Crush II was a randomized trial comparing DK-Crush to provisional stenting in symptomatic patients with a Medina 1,1,1 or 0,1,1 lesion. One-hundred and eight five were enrolled in each arm. The primary endpoint was major adverse cardiac events (MACE), namely cardiac death, MI and target vessel revascularization (TVR) at 5 years. It concluded that DK-Crush was associated with a lower 5-year MACE rate compared to provisional stenting.

 

Chen et al. Circ Cardiovasc Interv 2017;10:e 004497

Chen et al. Circ Cardiovasc Interv 2017;10:e 004497

 

DK Crush III was a randomized trial comparing DK-Crush to Culotte stenting in symptomatic patients with a distal Left Main lesion that is Medina 1,1,1 or 0,1,1. Approximately, 210 were enrolled in each arm. The primary endpoint was a composite of MACE and TVR at 3 years. It concluded that DK-Crush was associated with a lower 3-year MACE rate compared to Culotte stenting.

Chen et al. JACC. Cardiovasc. Interv 2015;8:1335-42                                 

3-years outcome DK crush Culotte p-value
Death % 1.4 2.9 0.34
MI % 3.4 8.2 0.037
TVR % 5.8 18.8 <0.001
Definite ST % 0 3.4 0.007

Chen et al. JACC. Cardiovasc. Interv 2015;8:1335-42

 

DK Crush V was a randomized trial comparing DK-Crush to a provisional strategy in symptomatic patients with a distal Left Main lesion that is Medina 1,1,1 or 0,1,1.  It enrolled approximately 240 patients in each arm. The primary endpoint was target lesion failure defined as cardiac death, target vessel myocardial infarction or target lesion revascularization at 12 months. It concluded that DK-Crush was superior at 12 months.

Chen et al. J Am Coll Cardiol. 2017;70:2605-17

Chen et al. J Am Coll Cardiol. 2017;70:2605-17

 

The steps of this technique can be summarized in the illustration (Image A). It is noteworthy, that critical steps in any bifurcation technique include intracoronary imaging and proximal optimization (POT). Imaging allows appropriate determination of size of the vessels in question, length of the disease and characterization of the lesion before the planned strategy. It, therefore, permits the operator to perform the necessary lesion preparation if calcified. Upon completion of the procedure, imaging allows appropriate evaluation of the stent expansion and apposition with additional post-dilatation if need be. Proximal optimization is a fundamental step irrespective of the technique adopted. It permits the operator to expand the main branch stent to facilitate the remainder of the steps, prevent the wire from entering behind the stent struts, prevent stent compression and ultimately permit appropriate stent apposition. This in itself facilitates future intervention and reduces stent thrombosis. Many have added an additional POT before the second kissing inflation to facilitate crossing into the SB. It is important that fluoroscopic imaging is sharp to allow appropriate positioning of the non-compliant balloon at the proximal stent edge and at the neo-carina. Several techniques including “Stent Boost” and “Clear Stent” specific to each vendor are readily available. Finally, given the multiple steps in bifurcation stenting, radiation safety is imperative for any and all techniques.

Image: Steps of DK Crush

Illustrations are the production of Graphic Designer Dania Al-Shaibi (dn.alshaibi@gmail.com)

 

References:

  1. Jens Flensted Lassen1* MD, PhD; Niels Ramsing Holm1, MD; Goran Stankovic2, MD, PhD; Thierry Lefèvre3, MD; Alaide Chieffo4, MD; David Hildick-Smith5, MD; Manuel Pan6, MD; Olivier Darremont7, MD; Remo Albiero8, MD; Miroslaw Ferenc9, MD; Yves Louvard3, MD. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention 2014;10:545-560.
  2. Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH. Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesion: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation. 2010;121:1235-43.
  3. Behan MW, Holm NR, Curzen NP, Erglis A, Stables RH, de Belder AJ, Niemela M, Cooter N, Chew DP, Steigen TK, Oldroyd KG, Jensen JS, Lassen JF, Thuesen L, Hildick-Smith D. Simple or complex stenting for bifurcation coronary lesions: a patient-level pooled-analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Circ Cardiovasc Interv. 2011;4:57-64.
  4. Colombo A, Bramucci E, Sacca S, Violini R, Lettieri C, Zanini R, Sheiban I, Paloscia L, Grube E, Schofer J, Bolognese L, Orlandi M, Niccoli G, Latib A, Airoldi F. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study. Circulation. 2009;119:71-8.
  5. Ferenc M, Gick M, Kienzle RP, Bestehorn HP, Werner KD, Comberg T, Kuebler P, Buttner HJ, Neumann FJ. Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions. Eur Heart J. 2008;29:2859-67.
  6. Maeng M, Holm NR, Erglis A, Kumsars I, Niemela M, Kervinen K, Jensen JS, Galloe A, Steigen TK, Wiseth R, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Christiansen EH, Lassen JF, Thuesen L. Long-term results after simple versus complex stenting of coronary artery bifurcation lesions: Nordic Bifurcation Study 5-year follow-up results. J Am Coll Cardiol. 2013;62:30-4.
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Intermittent Fasting

Recently, there has been growing interest in intermittent fasting. In clinic, I find it is much easier to answer questions about coronary angiography and interventions than it is about fasting. This month, I invited Dr. Christian Assad to provide us with an overview of intermittent fasting in a Video Interview.

Dr. Assad is currently an Interventional Cardiologist and the Director of the CardioMetabolic Clinic at RGV Cardiology in McAllen, Texas. His previous research involves the role of the immune system with heart failure, application of google glass in tele-mentoring. Since he moved to McAllen, Texas (arguably the most obese city in United States) he started focusing on prevention and the therapeutic roles of Intermittent Fasting, Ketogenic diet, Low Carbohydrate diet and other lifestyles that have helped many of his patients revert the metabolic syndrome and put DMII in remission.

The interview addresses all the following:

  1. Is it just a fad or are there health benefits? (Are there health benefits beyond weight loss?)
  2. What are the different methods of intermittent fasting and which do you recommend from your own experience?
  3. Is intermittent fasting recommended for life or only brief periods?
  4. What are the physiological effects of intermittent fasting?
  5. In which individuals would intermittent fasting be contraindicated?
  6. Can we debunk these myths?
    • Diabetes control becomes difficult with interrupted fasting compared to regular frequent meals.
    • Pregnant women who fast can harm the fetus.
    • Elderly individuals don’t benefit from fasting. In fact, fasting may accelerate dementia.
    • Intermittent fasting curtails the effects of exercise and body building programs?

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Referral Letter

A typical referral letter arrives in my tray:

A 55-year-old diabetic female noticed pain and discoloration of the right foot for several days.

 

Immediate admission was arranged for this patient:

A junior resident presents the case. She has clerked the patient and filled all the necessary forms and ticked all the necessary boxes. Everything is dated and signed appropriately. Her ankle brachial index is 0.7 on the right and 1.1 on the left. The patient falls in a Rutherford Class IV. With such thorough documentation, we were ready to pay the patient a visit and consent her for the planned peripheral angiogram and revascularization. This resident rounds with me every day and has clearly understood the process of consenting: procedural steps and complications included. I told my resident that I appreciate her energy and proactivity. I was so proud of her and thought “Hmm very little left for me to teach this young lady”. So, we walked over to the patient’s room to meet her and her family.

 

We enter the patient’s room:

My resident starts introducing the patient to me and recapping her history. In the meantime, I look at my patient from a distance. I immediately notice the anxious look. Perhaps she’s nervous about her foot and a possible amputation. I also notice how thin she is. Something doesn’t add up.  Diabetes is on the rise worldwide. Most of our poorly controlled diabetics who present with peripheral vascular disease have other end organ damage like some nephropathy or retinopathy. Most are overweight. She has none. I flip the chart in my hand and notice that her HbA1C is 7%. I ask about her weight loss. “It’s all very recent”, she says. I ask about other constitutional signs and she states there are none. She also has had no history of claudication. This doesn’t sound like long standing atherosclerosis. I approached her to examine her. I held her hand for the first time to feel her pulse. Oh, the lost art of a physical examination..Why examine her when her peripheral vasculature will be defined by a CTA and all the boxes in the chart are ticked?  The answer was right there: she was in atrial fibrillation. I glance at her EKG and sure enough she is in atrial fibrillation. Her hands told me more. She was sweating and had a tremor. I knew at this point what I needed to teach my resident. Medicine is so vast and so integrated. We cannot presume cardiovascular diseases and endocrine disorders are not interrelated. After all, this patient needed an endocrinologist.

 

Later that day she was taken to the cathlab:

Her TSH was high. Her transesophageal echocardiogram confirmed a left atrial thrombus. We discussed acute limb ischemia with the endocrinologist. We administered B blockers and obtained a consent for the procedure. Her angiogram revealed a thrombus at the right tibioperoneal trunk. Instead of whipping out the QuickCross microcatheter and GlideAdvantage wire, I performed manual aspiration of the thrombus. Fortunately, flow was restored almost immediately. The Society for Vascular Surgery and the North American Chapter of the International Society of Cardiovascular Surgery created a classification that ranged from non-threatened extremity, threatened extremity to finally ischemia with no possible salvage in 2002. Timely intervention is warranted in salvageable cases. Fogarty established surgical thromboembolectomy as the standard of care in the 1960s. Dotter introduced thrombolysis in the 1970s which evolved to current day catheter directed thrombolysis and aspiration. Both surgical and catheter directed thrombectomy have been studied. Theodoridis et al published a review article that indicated the technical success rate of endovascular techniques reaches 79.3%. A second procedure was required in 77.8% of those enrolled. The overall complication rate was 28.7%. Novel techniques that combine catheter directed low dose thrombolysis with and without mechanical thrombectomy have also been evaluated and found to be largely comparable.1-3 Procedural questions related to my patient were confined to the following:

  1. Use of a distal protection device: Trials have demonstrated a wide variation in the rate of distal embolization. This wide range is explained by the different lesion types, lengths, treatment modalities. The highest rate is in those with TASC C and D lesions, acute and subacute presentations, and with the use of atherectomy devices.4-10 However, major adverse events and amputations rates have not been significantly reduced with the use of distal protection devices.
  2. Use of an infusion catheter is usually reserved for cases where adequate flow and removal of thrombus is inadequate.

 

Upon returning to her room, there was more to discuss:

Her thyrotoxicosis was under investigation and control. Her atrial fibrillation needed to be addressed at this point. She needed rate control until she becomes euthyroid. With a thrombus in her left atrium and embolization to her lower extremity, she needed anticoagulation. The choice of an agent is another lesson for another day.

The resident and I walked out of her room with a sense of satisfaction. Both of us learned something that day. A patient is more than a referral letter..much more.

 

REFERENCES:

  1. Shrikhande GV, Khan SZ, Hussain HG, et al. Lesion types and device characteristics that predict distal embolization during percutaneous lower extremity interventions. J Vasc Surg2011;53(2):347–52.
  2. Shammas NW, Shammas GA, Dippel EJ, et al. Predictors of distal embolization in peripheral percutaneous interventions: a report from a large peripheral vascular registry. J Invasive Cardiol2009;21(12):628–31.
  3. Mendes BC, Oderich GS, Fleming MD, et al. Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices. J Vasc Surg2014;59(2):359–67.e1.PMCID: PMC4492297
  4. Shammas NW, Coiner D, Shammas GA, et al. Distal embolic event protection using excimer laser ablation in peripheral vascular interventions: results of the DEEP EMBOLI registry. J Endovasc Ther2009;16(2):197–202.
  5. Karnabatidis D, Katsanos K, Kagadis GC, et al. Distal embolism during percutaneous revascularization of infra-aortic arterial occlusive disease: an underestimated phenomenon. J Endovasc Ther2006;13(3):269–80.
  6. Shammas NW, Dippel EJ, Coiner D, et al. Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry. J Endovasc Ther 2008;15(3):270–6.
  1. Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry. Leung DA, et al. J Endovasc Ther. 2015
  2. Acute on chronic limb ischemia: From surgical embolectomy and thrombolysis to endovascular options. de Donato G, et al. Semin Vasc Surg. 2018
  3. Thrombolysis in Acute Lower Limb Ischemia: Review of the Current Literature. Theodoridis PG, et al. Ann Vasc Surg. 2018.
  4. Comparison of Low-Dose Catheter-Directed Thrombolysis with and without Pharmacomechanical Thrombectomy for Acute Lower Extremity Ischemia. Gandhi SS, et al. Ann Vasc Surg. 2018.

 

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Women In Cardiology & The 2:00am Leadership

The Women In Cardiology (WIC) community has grown in recent years and has represented professional women in many ways. Tangible accomplishments include advocacy for more women on panels (#NoManels), curbing harassment (#MeToo), opening leadership opportunities and much more. Many have recruited men into the campaign for women (#HeForShe). Guidance into what men can do has also been emphasized, for example, speaking up when a committee lacks diversity and lending an early career woman a research opportunity. But, have we given women enough guidance? I fear not. Allow me to display examples where women have failed other women. It’s a collection that I’ve discussed over the course of the last several months in WIC workshops across the globe.

 

Time: 2:00 am

Place: Cathlab

Setting: STEMI & shock

Woman interventional cardiologist (IC) calls the on-call anesthetist (a fellow woman) to provide deep anesthesia because “I need to cardiovert this patient who had primary PCI and now in AF with RVR and is hemodynamically unstable”.

Anesthetist: Okay the patient is asleep, but does he really need cardioversion?

IC: Yes.

IC calls to technician: 200 Joules.

Anesthetist: No. It should be 100 Joules according to the AHA algorithm.

With an unstable patient on the table, is this the time to be questioning a colleague’s judgment in front of her staff? I fear using “patient advocacy” as an excuse to lecture a qualified cardiologist on the management of arrhythmias is inappropriate. Many electrophysiologists have reservations about the very conservative algorithm. 2:00 am in the cathlab is hardly the time or place for such a discourse. Perhaps at a more suitable time, a scientific discussion can educate everyone on the indications of cardioversion for AF. Why is this incident reckless and detrimental on many levels?

  1. It undermines a colleague in front of her staff to whom she has to prove herself every day.
  2. It doesn’t help a patient who is unstable. Every failed shock reduces the chance for the next shock to work.
  3. It portrays an image of two professional women “bickering” over a crashing patient.

 

Time: 2:00 am

Place: Email

Setting: Clinic Schedule

Cardiologist (a woman) fires off an email to the Chief of Staff expressing disillusion with the “disruptive” clinic schedule that was planned by her immediate section head (a woman). Why is this incident reckless and detrimental on many levels?

  1. It undermines the leadership of the section head, a woman nonetheless.
  2. It negatively impacts the relationship between colleagues (2 women).

Wouldn’t it have been more constructive if she spoke to her head first and made her recommendations? The worst part of this whole story is that the immediate section head did not design the clinic schedule. It was the Chief of Staff. The “backstabbing” backfired and the notion was that this cardiologist is not a team player. It would have been wiser and more respectable to go through the appropriate channels with suggestions for improvements. Why is this incident reckless and detrimental on so many levels?

  1. It doesn’t build team spirit or trust. It does the exact opposite.
  2. It damages future prospects for both women in the workplace. It leaves the impression that the head cannot inspire or lead and the other woman is not a trustworthy team player (late night backstabbing email).
  3. On a larger scale, it suggests men can be more professional even when competitive.

 

Time: 2:00 am

Place: International Teleconference

Setting: Planning of a Scientific Activity

A woman participant claims ownership of an idea that belongs to the chair of one of the subcommittees (a woman) and bypasses her. The worst part of this story is the director of this scientific activity (also a woman) allows her to do so. She does not empower the head of the subcommittee by channeling all projects/decisions through her. She does not acknowledge the other participants. Instead, this woman’s name is placed first in all communications. Why is this incident reckless and detrimental on so many levels?

  1. It proves that women can do other women more injustice by stripping them of credit and authority.
  2. It projects an image that women leaders lack fair leadership suggesting that it’s no better (perhaps worse) than men’s leadership.
  3. It casts doubt on the efficiency of the various WIC programs in providing leadership training and addressing such inconsistencies.

 

The purpose of this month’s blog is not to be critical of women. To the contrary, there have been many women exhibiting true leadership and effecting concrete changes. Now we find lactation areas at major meetings, opportunities for women to serve as proctors and live transmission operators, and emphasis on diversity in training programs and the workplace. I do believe we have to build on that momentum. The purpose of this blog is to allow for some self-reflection on our part as women in the field. Whether we like it or not we are held to higher standards. Any deviation by one woman is considered a setback for all and any success story of one woman is a stride forward for all. It is not a fair world and prejudice/inconsistencies are noted on all fronts. I am a catheterization laboratory director and have been for a couple of years now. Every single day I have to prove I’m capable and reliable. Every single day, and no matter how much time has passed, I still need to assert my authority and earn respect from men and women. I know that when men are given leadership opportunities, the respect and authority are automatic until proven otherwise. For a woman, it gets exhausting after a while…and that’s why we have more work to do & more self-reflection can only help.

 

Not references for this blog, but worthwhile data for WIC:

  1. O’Sullivan S. Women in medicine: deeds not words. Lancet. 2018;392(10152)1002-1003.
  2. Mehran R. Women’s Voices in Cardiology: An Uncomfortable Silence. JAMA Cardiol.2018;3(8):676–677. doi:10.1001/jamacardio.2018.1289
  3. Breaking the Catheterization Laboratory Ceiling. JACC 2017;69(21)2668-2271.
  4. Lautenberger DM, Dandar VM, Raezer CL, Sloane RA. 2013–2014 The State of Women in Academic Medicine: The Pipeline and Pathways to Leadership. Washington, DC: Association of American Medical Colleges, 2014.
  5. Prasad M. Gender in cardiology: work yet to be done. J Am Coll Cardiol 2016;67:3016–9.
  6. Wang TY, Grines C, Ortega R, et al. Women in interventional cardiology: update in percutaneous coronary intervention practice patterns and outcomes of female operators from the National Cardiovascular Data Registry. Catheter Cardiovasc Interv 2016;87:663–8.
  7. Carr PL, Gunn CM, Kaplan SA, Raj A, Freund KM. Inadequate progress for women in academic medicine: findings from the National Faculty Study. J Womens Health 2015;24:190–9.
  8. Lewis SJ, Mehta LS, Douglas PS, et al., for the American College of Cardiology Women in Cardiology Leadership Council. Changes in the professional lives of cardiologists over 2 decades. J Am Coll Cardiol 2017;69:452–62.
  9. Bates C, Gordon L, Travis E, et al. Striving for gender equity in academic medicine careers. Acad Med 2016;91:1050–2.
  10. Marchant A, Bhattacharya A, Carnes M. Can the language of tenure criteria influence women’s academic advancement? J Womens Health (Larchmt) 2007;16:998–1003.
  11. Hlatky MA, Shaw LJ. Women in cardiology: very few, different work, different pay. J Am Coll Cardiol 2016;67:542–4.

 

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Women & TAVR: “I Don’t Want Any Procedure”

Round 1…

Patient’s son-in-law: “My mother has been turned down for surgery. They tell me her mortality rate at 2 years is high since she had fluids collecting in her lungs. They told me to ask you about catheterization.”

Me: “Yes, she does have a tight aortic valve and did develop heart failure. She is also very high risk for surgery. Percutaneous or catheter-based replacement may be an option. She will need a CT Scan first to determine if she is suitable for that treatment.”

The patient’s son-in-law asked me only one question, but a number of questions rushed through my head.

When is a good time to give the patient a contrast load after her recent admission with pulmonary edema? How safe is contrast given her borderline renal dysfunction and recent pulmonary edema? What is the outcome of trans-catheter aortic valve replacement (TAVR) in women?

I realized that there were no concrete answers. Irrespective of risk of contrast induced nephropathy, she needs the CT Angiogram. Irrespective of the timing, she remains high risk for recurrent pulmonary edema with or without the 50-60 cc of contrast given during the CT scan. Irrespective of her gender, TAVR maybe her only option. So, the CT scan was done with a small amount of contrast & her renal function remained unchanged and she did not develop pulmonary edema. She had borderline parameters with a short distance from the aortic valve annulus to left main, significant calcification into her LVOT, small tortuous and calcified common iliac arteries bilaterally. She was not an “ideal” candidate.

 

Round 2…

 

Me: “You are at a higher risk of coronary occlusion. We can place an undeployed stent preemptively in the coronary artery. Your risk of requiring a pacemaker is high and we’ve notified our electrophysiologist. Your risk of rupture is high, so we plan to use a self-expanding valve. We may need to use an alternative access like your armpit artery.”

Patient: “I don’t want any procedure.”

Patient’s son-in-law: “Is there anything else that we can do that is less risky?”

Me: “Palliative balloon valvuloplasty, but the gradient will increase again in 6-12 months.”

Patient: “I don’t want any procedure.”

Patient’s son (in-law): “Can we repeat this valvuloplasty every 6 months if need be?”

Patient: “I don’t want procedure.”

*Awkward silence.*

Me: “She does not want any procedure. It is time you and I listen to her.”

 

This patient was referred to me by a colleague from another hospital. She had no sons of her own but had her son-in-law to accompany her. She was a small, frail, soft spoken, elderly lady. She was also grateful for the care she received. We immediately had the surgeons evaluate her. While the surgeons were examining her, I did a quick literature review:

Data from Vancouver demonstrated that the mortality rate at 30 days after TAVR was 6.5% in women and 11.2% in men after accounting for other variables.1 This advantage for the female gender was maintained at 1 year as confirmed by the PARTNER Trial sub-analysis. Whether this was due to worse surgical outcomes in women or an advantage of TAVR in women was further explored by Humphries et al. Although vascular complications were higher in women, the overall survival rate at 2 years was 72.1% for women and 61.7% for men. Real world international registry and the first WIN TAVR registry further confirmed that high risk women had low 30-day and one-year mortality and stroke rates.2-4

Naturally, I picked up the conversation where the surgeons left off. In retrospect, even as a woman interventional cardiologist, was I dismissive of my patient’s own preference? Do we have a tendency to ignore female patients’ wishes more than men? Do we have a tendency to ignore elderly patients’ wishes more than younger ones? Or do we find it difficult to resolve to hospice care even before exhausting all options? It may be a combination of all of these. I don’t normally dismiss my patients’ wishes, but this time, I was clearly not listening. Maybe I listened to my colleague (a physician) and maybe I just grew attached to this soft spoken grateful woman…and I couldn’t resign myself to writing hospice care for her. Women..men..no matter, we make imperfect choices at times driven by our humanity. May that imperfection continue to drive us to care.

 

References:

1. Humphries KH, Toggweiler S, Rodés-Cabau J, et al. Sex differences in mortality after transcatheter aortic valve replacement for severe aortic stenosis. J Am Coll Cardiol 2012;60:882–6.

2. Williams M, et al. Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Apr 22;63(15):1522-8.

3. Chieffo A, et al. 1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement: Results From the First WIN-TAVI Registry. JACC Cardiovasc Interv. 2018 Jan 8;11(1):1-12.

4. Chieffo A, et al. Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women’s INternational Transcatheter Aortic Valve Implantation) Real-World Registry. JACC Cardiovasc Interv. 2016 Aug 8;9(15): 1589-600.

 

 

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Practice Change & CME

There are many scientific sessions happening around the globe that issue continuous medical education (CME) credits. Although the AHA Scientific Sessions 2018 covered a wide breadth of topics, I took particular interest in how the new Lipid Management Guidelines apply to women. My previous blog ended by citing a clinic encounter with a female patient. When I see how, as a woman cardiologist, I gained a newer perspective on hyperlipidemia, I realize these CME hours don’t capture the actual impact and changes in practice effected by presented data. Most busy clinicians don’t read every page of published guidelines. The lipid guidelines were summarized into ten key take home messages.

These points didn’t include women as a special population. I avail this opportunity to highlight two very different clinic visits: one before AHA Scientific Sessions 2018 & the second soon after it.

 

October 2018:

This is a 42-year-old female whose cardiovascular risk factors include poorly controlled Type II Diabetes, obesity and hypertension. She suffered an acute inferior myocardial infarction 3 months ago for which primary Percutaneous Intervention was performed with a second-generation drug eluting stent. She was on dual antiplatelet therapy, Lisinopril, Bisoprolol and Atorvastatin 40mg daily. She had not repeated any blood works since discharge (HbA1C 11.1 g/dL & LDL 162 mg/L). Her physical examination was unremarkable aside from weight gain (82 Kg to 85 Kg).

Me: Any chest pain or dyspnea?

She: No

Me: Why did your weight increase?

She: Shrug

Me: Ok I’ll get a dietician and educator to discuss this with you. You need to see your diabetologist. Continue DAPT. We need to drop your LDL, so I’d like to increase the dose of statin.

 

November 2018:

This is a 45-year-old female whose cardiovascular risk factors include Type II Diabetes, obesity and hypertension. She had a positive myocardial perfusion scan performed for angina. A coronary angiogram revealed non-obstructive coronary artery disease in January 2018. She was on aspirin, oral hypoglycemic agents, Bisoprolol and Atorvastatin 40mg daily. Her HbA1C 8 g/dL & LDL 118 mg/L. Her physical examination was unremarkable (weight 71 Kg).

Me: Any chest pain or dyspnea?

She: No, I’m feeling well.

Me: You’re only 45 years old. How many children do you have? Do you plan on having anymore?

She: Why? Will I have a heart attack if I do?

Me: I’m asking because of the statin. We need to discuss contraception if you aren’t planning anymore or alternatives if you do.

She: How about aspirin? Can I stop it now?

Me: …

 

As my mentor always told me, “If you don’t know what to look for, you won’t see what you should.” If I wasn’t directed through the AHA Scientific Sessions to search for the topic of women and statin therapy, I would have failed my second patient as I did my first.

But the second encounter sparked a different discussion related to cardiovascular disease prevention in women: What is the role of Aspirin in prevention? This too was discussed at Scientific Sessions 2018.

The Physicians Health Study published in 1989 demonstrated a 44% reduction in myocardial infarctions with aspirin therapy. The evidence for stroke reduction and cardiovascular deaths was inconclusive.1 The Women’s Health Study published in 2005 demonstrated a 17% reduction in stroke.2 This was primarily ischemic with an insignificant increase in hemorrhagic stroke. There was no net effect on fatal and nonfatal myocardial infarctions or overall cardiovascular deaths. The US Preventive Services’ latest statement (see link) recommends low dose aspirin for individuals between 50-59 years with a > 10% 10- year ASCVD risk and a life expectancy of at least 10 years for the primary prevention of cardiovascular disease and colorectal cancer.

Neither of my patients fit the age group; nevertheless, it is worth the pause. Would my second patient qualify in 5 years?

This year three trials on the role of aspirin in prevention were published and all conflict with these recommendations: ASPREE, ASCEND, ARRIVE. ASCEND in particular is relevant to my second patient who is diabetic rendering her ACVD risk > 20%. There was a small reduction in major adverse cardiac events and a significant increase in bleeding.3 How do we reconcile these differences. Subjects in the earlier trials had an important additional risk factor: smoking. The use of statin therapy was also significantly lower in the earlier studies. Perhaps the impact of the two accounts for the conflicting results in the more recent trials.

Is there any role for aspirin in primary prevention? Preliminary data from MESA suggests that high coronary artery calcium score and high plasma lipoprotein (a) may warrant aspirin therapy.4

Scientific Sessions offers CME. However, what we take back to our patients is far more…Aspirin or not, Statin or not, CACs or not. All these were thought provoking discussions this year.

 

I thank both my patients for consenting to using their information in this blog.

 

REFERENCES:

  1. Steering Committee of the Physicians’ Health Study Research Group. N Engl J Med 1989; 321: 129-35
  2. Ridker P, et al. A Randomized Trial of Low-Dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women. N Engl J Med 2005; 352: 1293-1304.
  3. The ASCEND Study Collaborative Group N Engl J Med 2018; 379: 1529-39.
  4. Chasman D, et al. Polymorphism in the apolipoprotein (a) gene, plasma lipoprotein(a), cardiovascular Disease and Low-dose Aspirin Therapy. Atherosclersosis: 2009 Apr; 203 (2):371-6.

 

 

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Women in the New Lipid Management Guidelines

The American Heart Association‘s annual meeting, Scientific Sessions, remains a Mecca for cardiologists worldwide. Those of us who were unable to attend in person followed the scientific discussions virtually through the Live Streaming option.  This year the much anticipated update to the Lipid Management Guidelines were presented at the meeting.  A focus on women as a special population was addressed separately by Dr. Lynne Braun. As cardiologists, we are not trained to search for atherosclerotic cardiovascular disease (ASCVD) enhancers specific to women, namely premature menopause (less than 40 years old), pregnancy associated disorders such as preeclampsia, gestational diabetes and preterm labor. Moreover, we often fail to discuss pregnancy and contraception with women of childbearing age who require statin therapy based on their ASCVD risk assessment. The majority of our key performance indicators in a cardiac unit or clinic require that patients are discharged on a statin if they are at risk. Yet, women should be advised to discontinue statin therapy 1-2 months prior to attempting pregnancy. It seems counter-intuitive to discuss discontinuation of statin therapy in a system that measures performance by the intensity of the prescribed dose. This in itself requires retraining of cardiologists and the AHA offered a unique opportunity to highlight its importance during Dr. Braun‘s presentation.

Another related topic addressed extensively at this year’s meeting was the role of calcium scoring (CACS) in risk stratification in the new lipid management guidelines. It is noteworthy that several large studies demonstrated that CACS improves risk assessment when combined with the conventional risk parameters.1-3 Women often have lower CACS compared to age-matched men. A meta-analysis by Kavousi et al in 2016 examined 5 large cohorts of women with an ASCVD risk <7.5% (low risk by current guidelines).CACS was identified in 36% of the women which led to a 2-fold increase risk of ASCVD. Ensuant to this discussion, is the topic of a coronary artery calcium score of 0 that denotes a very low risk, ie 1.1–1.5% 10-year risk of ASCVD events. This is commonly referred to as the power of zero calcium.5  The latest guidelines suggest CACS may assist in further stratifying women particularly those in the intermediate and borderline categories of risk given the older age of onset of ASCVD in women. It may also assist in the shared decision making with women of different ages and women with additional risk enhancers as discussed above.

As this year’s meeting drew to a conclusion, I’m grateful I could keep pace with the discussions on lipid management in women from the other end of the globe. More importantly, as a woman cardiologist, I was able to go to work the next morning and reevaluate the discussions I have with my female patients. For the first time, I tailored my discussion on statin therapy to the woman sitting across from me, my patient.

 

References:

  1. Paixao, A.R., Berry, J.D., Neeland, I.J. et al. Coronary artery calcification and family history of myocardial infarction in the Dallas heart study. JACC Cardiovasc Imaging. 2014; 7: 679–686
  2. Elias-Smale, S.E., Proenca, R.V., Koller, M.T. et al. Coronary calcium score improves classification of coronary heart disease risk in the elderly: the Rotterdam study. J Am Coll Cardiol. 2010; 56: 1407–1414
  3. Arad, Y., Goodman, K.J., Roth, M., Newstein, D., and Guerci, A.D. Coronary calcification, coronary disease risk factors, C-reactive protein, and atherosclerotic cardiovascular disease events: the St. Francis Heart Study. J Am Coll Cardiol. 2005; 46: 158–165
  4. Kavousi, M., Desai, C.S., Ayers, C. et al. Prevalence and prognostic implications of coronary artery calcification in low-risk women: a meta-analysis. J Am Med Assoc. 2016; 316: 2126–2134
  5. Nasir, K., Bittencourt, M.S., Blaha, M.J. et al. Implications of coronary artery calcium testing among statin candidates according to american College of cardiology/american heart association cholesterol management guidelines: MESA (Multi-Ethnic study of atherosclerosis). J Am Coll Cardiol. 2015; 66: 1657–1668
  6. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol
    • Scott M. Grundy, Neil J. Stone, Alison L. Bailey, Craig Beam, Kim K. Birtcher, Roger S. Blumenthal, Lynne T. Braun, Sarah de Ferranti, Joseph Faiella-Tommasino, Daniel E. Forman, Ronald Goldberg, Paul A. Heidenreich, Mark A. Hlatky, Daniel W. Jones, Donald Lloyd-Jones, Nuria Lopez-Pajares, Chiadi E. Ndumele, Carl E. Orringer, Carmen A. Peralta, Joseph J. Saseen, Sidney C. Smith, Laurence Sperling, Salim S. Virani, Joseph Yeboah
      Journal of the American College of Cardiology Nov 2018, 25709