Spotlight on Balloon Aortic Valvuloplasty

As transcatheter aortic valve replacement procedures evolve, the importance of predilation, the trade-off with postdilation, and the impact of balloon aortic valvuloplasty (BAV) on complication rates are moving targets. In this month’s issue of the Journal of Invasive Cardiology, Abramowitz et al show that the newest iteration of the Sapien family, the Sapien 3, can be delivered without a preprocedure BAV if desired. This article is accompanied by a commentary by Feldman and Reardon, who offer their insights into whether or not BAV is necessary in this setting.

Abramowitz Y, Jilaihawi H, Chakravarty T, et al. Sapien 3 Transcatheter Aortic Valve Implantation With Moderate or Without Predilation. J Invasive Cardiol. 2016 Oct;28(10):421-426.

Feldman T, Reardon MJ. Balloon Predilation for TAVR: Over-Inflated or Under-Rated? J Invasive Cardiol. 2016 Oct;28(10):427-428.

Recent articles on Balloon Aortic Valvuloplasty

Gao K, Sachdeva R, Goldstein BH, Lang S, Petit CJ. Aortic Valve Morphology Correlates With Left Ventricular Systolic Function and Outcome in Children With Congenital Aortic Stenosis Prior to Balloon Aortic Valvuloplasty. J Invasive Cardiol. 2016 Sep;28(9):381-8.

Koshy TP, Kumbhani DJ. The Balloon Aortic Valvuloplasty Makeover: From “Treatment” Procedure to “Bridge” Procedure. J Invasive Cardiol. 2016 Aug;28(8):349-50.

Kumar A, Paniagua D, Hira RS, Alam M, Denktas AE, Jneid H. Balloon Aortic Valvuloplasty in the Transcatheter Aortic Valve Replacement Era. J Invasive Cardiol. 2016 Aug;28(8):341-8.

Burzotta F, Nerla R, Trani C. Bail-Out Use of Impella CP as a Bridge to TAVI in a Cardiogenic Shock Patient: The “Pump-Rewiring” Technique. J Invasive Cardiol. 2016 Jan;28(1):E1-5.

Shah AP, Retzer EM. Repeated Aortic Balloon Valvuloplasty in Elderly Patients With Aortic Stenosis Who Are Not Candidates for Definitive Treatment. J Invasive Cardiol. 2015 Dec;27(12):E285-6.

Moretti C, Chandran S, Vervueren PL, et al. Outcomes of Patients Undergoing Balloon Aortic Valvuloplasty in the TAVI Era: A Multicenter Registry. J Invasive Cardiol. 2015 Dec;27(12):547-53.

Bordoni B, Moretti C, Marrozzini C, et al. Repeated Aortic Balloon Valvuloplasty in Elderly Patients With Aortic Stenosis Who Are Not Candidates for Definitive Treatment. J Invasive Cardiol. 2015 Dec;27(12):E277-84. Epub 2015 Sep 15.

Sakata Y, Matsubara K, Tamiya S, Hayama Y, Usui K. The Efficacy and Safety of Antegrade Inoue-Balloon Aortic Valvuloplasty to Treat Calcific Critical Aortic Stenosis. J Invasive Cardiol. 2015 Aug;27(8):373-80.

Leclercq F, Delseny D, Nogue E, et al. Decrease of vascular and bleeding complications after balloon aortic valvuloplasty performed without heparin. J Invasive Cardiol. 2014 Oct;26(10):528-33.

Inohara T, Hayashida K, Fukuda K. Double balloon aortic valvuloplasty in TAVI era: insight from intracardiac echocardiography and multidetector computed tomography findings. J Invasive Cardiol. 2014 Jul;26(7):E95-7.

Advertisements
Posted in spotlight topic, TAVI | Tagged , | Leave a comment

Spotlight on Pericardiocentesis

This month’s issue of the Journal of Invasive Cardiology features two articles on the topic of pericardiocentesis. The first article, by Lakhter et al, is an Original Contribution on the procedural success and safety of pericardiocentesis using continuous ultrasonographic visualization of a long (7 cm) micropuncture needle to standard access with an 18 gauge needle without continuous ultrasound guidance. The second feature is a Clinical Images article by Mohanan Nair et al, which explores arterial discordance that resolved with the use of pericardiocentesis.

Lakhter V, Aggarwal V, Bashir R, O’Murchu B, Cohen HA. Pericardiocentesis Under Continuous Ultrasonographic Guidance Using a 7-Centimeter Micropuncture Needle. J Invasive Cardiol. 2016;28(10):397-402. Epub August 15.

Mohanan Nair KK, Gopalakrishnan A, Ganapathi S, Harikrishnan S, Valaparambil A, Tharakan J. Arterial Discordance in Cardiac Tamponade. J Invasive Cardiol. 2016;28(10):E124-E125.

Related Articles
Mcunu BN, Trilesskaya M, Frohlich T. The Role of Multimodality Imaging in a Case of Traumatic Cardiac Pseudoaneurysm. J Invasive Cardiol. 2016;28(8):E71-E72.

Nakatsuma K, Yamamoto E, Watanabe S, et al. Ultrathin Endoscopy-Guided Pericardiocentesis: A Pilot Study in a Swine Model. J Invasive Cardiol. 2016;28(3):78-80.

Lee MS, Shamouelian A, Dahodwala MQ. Coronary Artery Perforation Following Percutaneous Coronary Intervention. J Invasive Cardiol. 2016 Mar;28(3):122-31.

Stathopoulos I, Kossidas K, Panagopoulos G, Garratt K. Cardiac tamponade complicating coronary perforation during angioplasty: short-term outcomes and long-term survival. J Invasive Cardiol. 2013 Oct;25(10):486-91.

Saltzman AJ, Paz YE, Rene AG, et al. Comparison of surgical pericardial drainage with percutaneous catheter drainage for pericardial effusion. J Invasive Cardiol. 2012 Nov;24(11):590-3.

Inglis R, King AJ, Gleave M, Bradlow W, Adlam D. Pericardiocentesis in contemporary practice. J Invasive Cardiol. 2011 Jun;23(6):234-9.

Posted in pericardiocentesis, Uncategorized | Tagged , , , | Leave a comment

Resting Non-hyperemic Indices and the Goal of 100% Accuracy

By Khawaja Afzal Ammar, MD

We all use fractional flow reserve (FFR) in evaluating intermediate lesions in coronary arteries. This increases the procedure time, but it also increases the probability of appropriate interventions that will actually help the patients with their symptoms. In order to decrease procedure time, resting non-hyperemic indices such as instantaneous wave-free ratio (iFR) and the ratio of coronary pressure to aortic pressure (Pd/Pa) prior to infusion of adenosine have been promoted. In an article published in this month’s Journal of Invasive Cardiology, we looked at almost 1000 FFR measurements made in our practice and discovered that if we use a Pd/Pa of <0.87 as indicative of an FFR of <0.8, then the positive predictive value is 100% with a 0% error rate. Other classification guidelines, whether using iFr or Pd/Pa of 0.88 to 0.93, result in too many classification errors and a much lower positive predictive value than 100%. Since FFR measurement after adenosine infusion does not add more than 5 to 8 minutes in the cath lab, we should not settle for anything less than 100% accuracy, 100% positive predictive value, and 0% misclassification rate.

Read the entire article in this month’s JIC:
Use of Resting Non-hyperemic Indices for Avoidance of Fractional Flow Reserve Measurement: The Goal of 100% Accuracy.
Khawaja Afzal Ammar, MD;  Syed Shahab Kazmi, MBBS;  Mirza Nubair Ahmad, MBBS;  Mirza Mujadil Ahmad, MBBS;  Arsalan Riaz, MBBS;  Imran Husain, BS;  Fatima Husain, MBBS;  Suhail Allaqaband, MD;  Tanvir Bajwa, MD;  Anjan Gupta, MD
J INVASIVE CARDIOL 2016;28(7):265-270

Read the accompanying commentary:

No Stenosis Left Behind – The Holy Grail of 100% Predictive Accuracy

James R. Wilentz, MD

Posted in Coronary Flow Dynamics, Uncategorized | Tagged , , , | Leave a comment

Radial Caths in Training Programs – How Are We Doing?

By Gurpreet Singh, MD and Neeraj Jolly, MD

July is always an interesting month, not the least because new fellows start their training. It is a good time to observe the learning curve of the fresh recruits to the world of cardiology, and begin observing what is difficult to learn. This thought appealed to us two years ago and we decided to compare the procedural variables in radial and femoral diagnostic cardiac catheterization cases, primarily from a fellow’s learning perspective. This was a relevant topic because there is a lot of new literature regarding utility of radial caths, primarily based on data derived from advanced operators’ experience. The relevance of this study was even more for the training programs because more data can help design better training protocols.
Interesting facts came to fore when we analyzed the data. We found that procedure times were longer in radial cases. With training, we observed an improvement in time to gain vascular access. This, therefore, can be a low hanging fruit for improving procedure times in radial cases. Vascular access to procedure end time, however, did not improve substantially in the radial group, suggesting difficulty in learning catheter manipulations. Learning catheter manipulations might be difficult because of the variety of catheters used and variable techniques between operators, not to mention the inherent difficulty in catheter manipulations from a radial access. This is in contrast to femoral access procedures, where Judkins catheters are ubiquitous, and instructions to fellows regarding manipulations of these catheters are fairly uniform.
Another important observation we made is a higher radiation exposure with radial caths. Shah et al found this to be true for experienced operators as well.(1) This is clearly an area that needs further work.
In summary, we hope that radial access catheter selection, instructions to fellows regarding gaining access, and instructions regarding catheter manipulations become more standardized over time. This might help to achieve better procedural variables. We also want to stress that retaining femoral cath skills is essential for many reasons – greater use of hemodynamic support devices and structural heart procedures that require large-bore arterial or venous sheaths, to name a few.

Reference
1. Shah B, Bangalore S, Feit F, et al. Radiation exposure during coronary angiography via transradial or transfemoral approaches when performed by experienced operators. Am Heart J. 2013;165(3):286-292.

 

Read entire article in this month’s Journal of Invasive Cardiology:

J INVASIVE CARDIOL 2016;28(6):254-257. Epub 2016 May 15
Posted in Fellowship Training, transradial intervention | Tagged , | Leave a comment

Does Newer Mean Better?

Neil Ruparelia, DPhil, MRCP1,2;  Azeem Latib, MD1; and Antonio Colombo, MD1

1San Raffaele Scientific Institute, Milan, Italy
2Imperial College, London, United Kingdom

Transcatheter aortic valve implantation (TAVI) has rapidly expanded following the first reported case in 2002 to now being the recommended treatment option for high-risk or inoperable patients with severe symptomatic aortic stenosis (AS). While the first studies clearly demonstrated safety and efficacy of this revolutionary technology, they also identified some limitations including vascular complications, stroke, the requirement for permanent pacemaker implantation, and residual aortic regurgitation. Subsequent studies have consistently demonstrated that the presence of more-than-mild paravalvular regurgitation and the occurrence of a vascular complication to be independent predictors of mortality. In an attempt to reduce the incidence of these limitations, a number of technological refinements have been made to TAVI devices and their delivery systems. We therefore aimed to investigate the impact of these changes relating to intraprocedural and 30-day safety.

We found that there was a significant safety benefit associated with newer devices when compared with first-generation devices. This was predominantly accounted for by a reduction in vascular and bleeding complications, while newer devices were also associated with a lower rate of significant paravalvular leak. These findings are of particular interest because they demonstrate an objective benefit of newer devices in a “real-world” patient population truly reflecting contemporary clinical practice and support their preferential use over first-generation devices.

There is currently great excitement with regard to the use of TAVI for the treatment of lower-risk patients; however, before this can be recommended as the default treatment option, complications should be comparable to the current “gold standard” of surgical aortic valve replacement. It would appear from this study that the use of newer devices is associated with a safety benefit in the short term, but future research will need to determine if these benefits translate into longer-term outcome benefits and also if the very reassuring valve durability data seen with first-generation devices are also true for the current-generation devices.

Read the entire article at:

A Comparison Between First-Generation and Second-Generation Transcatheter Aortic Valve Implantation (TAVI) Devices: A Propensity-Matched Single-Center Experience
Neil Ruparelia, DPhil, MRCP;  Azeem Latib, MD;  Hiroyoshi Kawamoto, MD;  Nicola Buzzatti, MD;  Francesco Giannini, MD;  Filippo Figini, MD;  Antonio Mangieri, MD;  Damiano Regazzoli, MD;  Stefano Stella;  Alessandro Sticchi, MD;  Akihito Tanaka, MD;  Marco Ancona, MD;  Eustachio Agricola, MD;  Fabrizio Monaco, MD;  Pietro Spagnolo, MD;  Alaide Chieffo, MD;  Matteo Montorfano, MD;  Ottavio Alfieri, MD;  Antonio Colombo, MD
J INVASIVE CARDIOL 2016;28(5):210-216

Posted in TAVI | Tagged , , | Leave a comment

The Carillon Mitral Contour System

Mechanical treatment for functional (or secondary) mitral regurgitation (FMR), is being addressed now more than any time previously in history. In this month’s Journal of Invasive Cardiology, Dr. Klein and his group from Leipzig (who honored me by allowing me to assist as a coauthor) have presented their series of patients using the second most widely used percutaneous device to treat FMR, the Carillon Mitral Contour System.    Although MitraClip is not approved for use in FMR in the US, MitraClip is most commonly used outside the US to treat FMR, accounting for approximately 2/3 of MitraClip cases. The recently reported follow-up of the CTSN (Cardiothoracic Surgical Trials Network) has cast concerns over the use of surgical mitral repair in treating FMR due to an unexpectedly high recurrence of MR in follow-up. It is interesting with this context to note that the group from Leipzig found that there was a tendency to improvement in MR over time with the Carillon device, unlike the worsening over time seen with surgery. These observations of MR improvement are consistent with the published findings from the safety and efficacy studies of the Carillon device, supporting those unexpected findings. It is unclear what causes this seeming paradox (MR improvement with Carillon over time versus MR worsening with surgically placed annular rings), although many possible theories may be entertained. First, the MR reduction at the time of surgery is excellent, so deterioration is the only possible avenue, although the degree of worsening after surgery has been surprising to many. Why would an indirect annuloplasty be associated with improvement in MR, whereas a direct annuloplasty be associated with worsening? One possibility is that the flexible Carillon device allows for greater dynamic functioning of the mitral annulus, which is inhibited by a rigid surgical ring. Some have postulated that dynamic functioning of the mitral annulus is underappreciated in the mechanism of mitral valve functioning. Additional studies will need to be done to evaluate this mechanism to understand if it is playing a role. One may also wonder if cardiopulmonary support or other insults at the time of cardiac surgery may have an impact in patients with underlying cardiomyopathic conditions, accelerating cardiac deterioration – a phenomenon not impacted by a percutaneous therapy such as Carillon.
Another important observation in this observational post-market study is the inclusion of patients who were not studied in the previous safety and efficacy studies. For example, the prior safety and efficacy studies only examined patients with ejection fractions less than 40%, yet the mean ejection fraction was 40% in this study, and went all the way to include patients with normal ejection fractions. This experience, as well as at other centers using Carillon commercially, has caused Cardiac Dimensions, Inc. (the company making Carillon) to expand the evaluation of such patients in the ongoing randomized, blinded study, REDUCE FMR (being done in Europe, Australia, and New Zealand) to now include patients with ejection fractions up to 50% (similar to what is being done in COAPT). The excellent results seen in this Leipzig study suggest that patients with less severe disease than studied in the previous studies may also benefit from this therapy.

Disclosure: Dr. Steven Goldberg is a consultant and Chief Medical Officer for Cardiac Dimensions, Inc., the maker of the Carillon Mitral Contour System.

Read the entire article here:

Norbert Klein, MD;  Dietrich Pfeiffer, MD, Prof;  Steven Goldberg, MD;  Maika Klein, MD
Mitral Annuloplasty Device Implantation for Non-Surgical Treatment of Mitral Regurgitation: Clinical Experience After the Approval Studies. J INVASIVE CARDIOL 2016;28(3):115-120. Epub 2016 January 15.

 

Posted in new device, Uncategorized | Tagged | Leave a comment

Slender Transradial PCI – How Small is Small Enough?

By Dr Giovanni Amoroso, Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.

Transradial approach (TRA) has shown to be as effective as transfemoral approach in cases of percutaneous coronary inteventions (PCI), but significantly safer in terms of access-site related complications. Therefore, TRA has become the standard of care in Europe and Asia, and is also propagating fast throughout the transfemoral-minded United States. The Achilles’ heel of TRA is the diameter of the radial artery, which is on average 3x smaller than the femoral artery. If we consider a 6 Fr introducer as the norm, 20%-40% of patients will have a radial artery smaller than that. This would not be the case for the femoral artery. Introducer/guiding catheter mismatch vs the radial artery will lead to higher procedural failure rates and/or vascular trauma, and in terms, to more postprocedural radial artery occlusions (RAO).(1) While RAO is rarely clinically relevant, it will however preclude the use of the radial artery for repeated procedures: a significant drawback for TRA.
To overcome this problem, Japanese cardiologists first, and European cardiologists later, felt the urge to initiate the Slender (R)evolution. The mission of both the Slender Club Japan and Europe is to demand, promote, and test catheters and devices, sufficiently miniaturized not to pose a danger anymore for the radial artery, but performant enough to provide the same outcomes after PCI.(2) The “virtual 3 Fr” guiding catheter (Medikit Co Ltd, Japan) is one of these. It consists basically of a 5 Fr guiding catheter, which can be introduced into the radial artery, without the need for an arterial sheath (the “sheathless” technique). Virtually no patient would have a radial artery smaller than this guiding catheter. Takeshita et al had already tested the feasibility of this guiding catheter in a Japanese population.(3) In our study, we confirmed these positive results in a Western population. Moreover, we could demonstrate that “virtual 3 Fr” guiding catheters, by drastically reducing hemostasis times, help prevent RAO and allow day-care PCI in the vast majority of patients. In particular, procedural success was 96% (25/26 lesions), and mean procedural time and contrast usage were 26 ± 15 minutes and 94 ± 69 mL, respectively. Patent hemostasis was successful in 10/11 patients, all patients were discharged home within 6 hours, and no acute RAO occurred.
Should we expect that Slender PCI techniques will soon go “mainstream,” such as TRA is doing? Probably not yet. First of all, the reproducibility of positive outcomes is determined by the learning curve. In our series, all procedures were conducted by the same operator, experienced both in TRA and “sheathless” techniques. Other operators would experience more difficulties with smaller catheters, mostly because of lack of support. To cope with that, one of the purposes of the Slender Club Europe will be to teach Slender techniques to peers by means of dedicated workshops. Secondly, the range of Slender materials is still not complete. In order to apply the Slender approach to more complex procedures (kissing techniques, acute PCI, chronic total occlusion), interventional devices need to be at least 5 Fr compatible (or less). The recent introduction of the Slender IDS (Svelte Medical Systems, New Jersey), the world’s lowest-profile drug-eluting stent, is an example of going in the correct direction.

References

  1. Garg N; Madan BK; Khanna R. Incidence and predictors of radial artery occlusion after transradial coronary angioplasty: Doppler-guided follow-up study. J Invasive Cardiol. 2015 Feb;27(2):106-12.
  2. Kiemeneij F; Yoshimachi F; Matsukage T. Focus on maximal miniaturisation of transradial coronary access materials and techniques by the Slender Club Japan and Europe: an overview and classification. EuroIntervention. 2015 Feb;10(10):1178-86.
  3. Takeshita S; Saito S. Transradial coronary intervention using a novel 5-Fr sheathless guiding catheter. Catheter Cardiovasc Interv. 2009 Nov 15;74(6):862-5.
  4. Stucchi Devito F; de Andrade PB;  Faria CE. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery System via Radial Approach With 5 Fr Catheters. J Invasive Cardiol. 2015;27(12):E312-E318.

Read Dr. Amoroso’s article on the safety and feasibility of “virtual 3 Fr” transradial percutaneous coronary intervention (TRA-PCI) in an outpatient setting in this month’s issue of the Journal of Invasive Cardiology.

 

 

Posted in transradial intervention | Tagged , | Leave a comment