Article
Debate
REC Interv Cardiol. 2019;1:51-53

Debate: MitraClip. The heart failure expert perspective
A debate: MitraClip. Perspectiva del experto en insuficiencia cardiaca
aServicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, Valencia, Spain bCIBER de Enfermedades Cardiovasculares (CIBERCV), Spain
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Debate: MitraClip. The interventional cardiologist perspective
QUESTION: What is the rationale for proposing distal radial access (DRA)?
ANSWER: DRA, first described in coronary intervention by Kiemeneij in 2017,1 has been proposed as an alternative to conventional radial access (CRA) to reduce postoperative radial occlusion (PRO), a complication occurring in 2%–10% of cases. Although PRO is usually asymptomatic due to collateral circulation through the palmar arch, it can limit future use of the artery for repeat procedures, arteriovenous fistula creation, or even as an aortocoronary graft. Puncture in the anatomic snuffbox is distal to the superficial palmar arch, thereby preserving perfusion of the proximal radial artery and minimizing the risk of occlusion. Previously, in 2011, Babunashvili and Dundua2 used DRA in patients with prior radial thrombosis after CRA to reestablish vascular access.
In general, DRA is more comfortable for both patient and operator. In CRA, prolonged arm supination—especially with right-sided access—can cause discomfort, particularly in obese patients, those with arthritic deformities, or during long procedures. DRA allows a more natural arm position (pronation or neutral), and improves ergonomics. Furthermore, it facilitates left DRA for operators used to right radial access, since cannulation can be performed from the patient’s right side. Its smaller vessel diameter shortens hemostasis times, thereby reducing recovery and the length of stay, which is especially valuable in outpatient procedures.
Therefore, DRA is proposed as an evolution of CRA, maintaining its advantages while improving vascular preservation, ergonomics, and recovery efficiency, making it an attractive alternative in contemporary coronary intervention.
Q.: What evidence supports DRA?
A.: Although scientific evidence supporting DRA has grown significantly, it remains less extensive than that for CRA. Key sources include:
- – Initial series: in 2017, Kiemeneij1 reported the first DRA results, with a cannulation success rate of 89% and local complication rates, such as hematoma or spasm < 1%.
- – Randomized clinical trials:
- Tsigkas et al3 studied a total of 1042 patients, comparing DRA and CRA, and found that DRA was associated with a lower rate of PRO (3.7% vs 7.9%; P = .014) and shorter hemostasis times, but higher crossover rates (9.3% vs 3.2%; P < .001), higher radiation dose, and longer procedures (44 vs 40 minutes; P = .02). Local complications were similar (4.8% vs 5.3%; P = .71). More puncture attempts were required with DRA (2.1 vs 1.6; P = .01).
- The DISCO RADIAL trial4 compared DRA and CRA, showing similar PRO rates (0.31% vs 0.91%; P = .29). DRA had higher crossover (7.4% vs 3.5%; P = .002) and spasm rates (5.4% vs 2.7%; P = .015) but shorter hemostasis times (153 vs 180 minutes; P < .001). PRO rates were very low in the 2 groups because of a strict patent hemostasis protocol that favored CRA. This protocol differs from routine clinical practice in most centers, although it demonstrates that meticulous hemostasis with CRA can equalize the 2 techniques in terms of PRO.
- The multicenter TENDERA trial5 (1162 patients) showed reduced PRO with DRA at 30 days (1.2% vs 4.8%; P = .003) and 6 months (2.1% vs 5.5%; P = .007). DRA exhibited fewer local complications such as hematoma (3.1% vs 6.7%; P = .01), pain (5.2% vs 9.8%; P = .004), and minor hemorrhage (2.4% vs 5.3%; P = .02). Procedural efficacy (97.8% vs 98.1%; P = .72), and procedural times (42 vs 43 minutes; P = .58) were comparable.
- – Meta-analyses: Ferrante et al6 analyzed 14 studies with > 6000 patients, confirming lower PRO with DRA (0.7% vs 3.0%; P < .001), shorter hemostasis times (120 vs 180 minutes; P < .01), and fewer hematomas (0.4% vs 1.7%; P = .02).
- – Multicenter registries: the KODRA registry7 included a total of 4977 patients in 14 hospitals, with reported success rates of 100% for angiography, 98.8% for percutaneous coronary intervention, 94.4% for vascular access, and a 1-month PRO rate of 0.8%.
- – Spanish studies: in Spain, several groups have been active in DRA. The registry of Rivera et al.8 included a total of 1000 DRA procedures, with a cannulation success rate of 97.4% and a PRO rate of 0.5%. After years of implementation, it would be desirable to include DRA-specific data in the annual activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology to obtain a more precise picture of its impact in Spain.
Q.: What advantages has this vascular access demonstrated?
A.: DRA offers several important benefits over CRA, particularly in specific settings:
- – Reduction in PRO: as previously noted, rates vary and are difficult to compare because of the different hemostasis protocols used across various studies. However, the reported rates of PRO are very low, ranging from 0.3% to 3.7%.
- – Shorter hemostasis times: because of the smaller diameter of the distal radial artery (1.5–2.5 mm) and its ease of compression in the anatomic snuffbox, DRA requires significantly shorter hemostasis times. Studies establish 120–150 minutes for DRA compared with 180–240 minutes for CRA. In my routine clinical practice, for diagnostic procedures with 50 U/kg of unfractionated heparin, compression times are approximately 20 minutes for 5-in-4 Fr introducer sheaths and 45 minutes for 6-in-5 Fr introducer sheaths. For interventional procedures with 100 U/kg of heparin, compression times are 120 minutes for 6-in-5 Fr and 150 minutes for 7-in-6 Fr introducer sheaths. This reduction, which may reach 50%, decreases the length of stay and improves efficiency in outpatient procedures, a particularly relevant aspect during the COVID-19 pandemic to minimize hospital contact.
- – Greater patient comfort: the natural arm position (pronation or neutral) in DRA reduces discomfort compared with the prolonged supination required in CRA, especially for right-sided access and in bilateral procedures for chronic occlusions. The lower compression pressure required minimizes postoperative pain too.
- – Greater operator comfort: puncture from the right side for left DRA, with the hand in a neutral midline position, improves ergonomics.
- – Improved introducer sheath control: in CRA, patient hand pronation after cannulation may hinder visualization of the introducer sheath; by contrast, DRA allows uninterrupted control throughout the procedure.
- – Lower rate of local complications: with DRA, the rate of hematoma is generally lower due to the smaller arterial caliber and easier compression against the bony plane.
- – Preferred access for recanalization after prior PRO: DRA is particularly useful in patients with proximal radial thrombosis following previous CRA procedures, allowing effective restoration of vascular access.
- – Preservation of the proximal radial artery: especially relevant for repeat procedures, creation of arteriovenous fistulas, or use as an aortocoronary graft.
- – Ease of crossover to CRA: in the event of distal cannulation failure, DRA allows rapid conversion to CRA without the need for substantial changes to the approach, providing greater operator flexibility.
Q.: Are there technical aspects worth noting?
A.: DRA requires precise technique and specific considerations. Several aspects are important:
- – Anatomic location: the anatomic snuffbox is bordered laterally by the tendons of the abductor pollicis longus and extensor pollicis brevis, medially by the extensor pollicis longus, and basally by the radial styloid process. The floor is formed by the scaphoid, trapezium, and the carpometacarpal joint of the thumb. Vascular ultrasound is essential to evaluate the patency and diameter of the distal radial artery before the procedure and to guide puncture, which is ideally performed over the scaphoid plateau to ensure effective compression against a bony plane. Very distal (over the thenar eminence) or proximal punctures (near the styloid process) may compromise compression efficacy or the benefits of DRA.
- – Puncture technique: the use of 20–22 G needles (preferably 21–22 G) is recommended, with a puncture angle close to 90° under ultrasound guidance. Tilting or rotating the needle horizontally is usually required to facilitate passage of the metallic microwire. Puncture with an Abbocath is not recommended because of the superficiality of the bony structures.
- – Adjacent structures: the superficial branch of the radial nerve crosses the snuffbox, requiring caution to avoid injury. Tendons and bony structures must also be considered.
- – Spasm prevention: a standard antispasmodic cocktail (nitroglycerin 100–200 µg or verapamil 2.5–5 mg, plus heparin 50–100 U/kg) is recommended to prevent spasm and thrombosis.
- – Hemostasis: selective hemostasis using wristband-type compression devices is essential to precisely control pressure and minimize the risk of PRO. These devices allow adjustment of compression to the minimum level required to prevent bleeding. Either dedicated devices (eg, PreludeSYNC DISTAL, Merit Medical, United States) or those commonly used for CRA (e.g, TR Band, Terumo, Japan, with the inner plastic splint removed) may be employed.
- – Learning curve: proficiency in DRA requires 50–100 procedures, with adequate training in vascular ultrasound and detailed knowledge of local anatomy.
- – Catheter selection: the greater distance to the aortic arch (approximately, 4 cm longer) may require longer catheters (110 cm) in tall patients or those with complex anatomy. When limited, catheters with longer-than-usual curves or sheathless systems (which provide a few extra centimeters) can be used.
- – Type of introducer sheath: slender, hydrophilic introducer sheaths are recommended to facilitate cannulation. In diagnostic procedures, slender 5-in-4-Fr introducer sheaths are particularly useful.
Q.: Are there situations where DRA may not be indicated?
A.: Yes, and these contraindications include:
- – Insufficient arterial diameter: < 1.5 mm-arteries increase the risk of spasm and failure.
- – Complex radial anatomies: absence of a functional palmar arch, hypoplastic distal arteries, and anatomic variations may contraindicate DRA. These conditions are uncommon and difficult to predict without detailed prior ultrasound evaluation.
- – Procedures requiring catheters > 7-Fr: although rare, they are limited by arterial size.
- – Operator inexperience: the learning curve for DRA is longer than for CRA.
- – ST-segment elevation acute coronary syndrome: although DRA is safe in experienced hands, longer cannulation times in novice operators may delay revascularization.
- – Ipsilateral repeat procedures: there is a risk of prior thrombosis; careful assessment of the anterior radial pulse is required, as inadvertent thrombectomy may occur.
FUNDING
None declared.
STATEMENT ON THE USE OF ARTIFICIAL INTELLIGENCE
None used.
CONFLICTS OF INTEREST
None declared.
REFERENCES
1. Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography and interventions. EuroIntervention. 2017;13:851-857.
2. Babunashvili A, Dundua D. Recanalization and reuse of early occluded radial artery within 6 days after previous transradial diagnostic procedure. Catheter Cardiovasc Interv. 2011;77:530-536.
3. Tsigkas G, Papageorgiou A, Moulias A, et al. Distal or Traditional Transradial Access Site for Coronary Procedures:A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022;15:22-32.
4. Aminian A, Sgueglia GA, Wiemer M, et al. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention (DISCO RADIAL). JACC Cardiovasc Interv. 2022;15:1191-1201.
5. Babunashvili AM, Pancholy S, Zulkarnaev AB, et al. Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures:Final Results of the TENDERA Multicenter, Randomized Controlled Study. Catheter Cardiovasc Interv. 2024;104:1396-1405.
6. Ferrante G, Condello F, Rao SV, et al. Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention:A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2022;15:2297-2311.
7. Lee J, Kim Y, Lee B, et al. Distal Radial Access for Coronary Procedures in a Large Prospective Multicenter Registry:The KODRA Trial. JACC Cardiovasc Interv. 2024;17:329-340.
8. Rivera K, Fernandez-Rodriguez D, Garcia-Guimaraes M, et al. Distal radial access for coronary procedures in an all-comer population:the first 1000 patients in a prospective cohort. REC Interv Cardiol. 2024;6:287-295.
QUESTION: Are there anatomical reasons to propose distal radial access over conventional radial access?
ANSWER: The answer is yes. The hand has 2 arterial arches: a superficial arch, formed by the ulnar artery and the distal radial artery under discussion here, and a deep arch, formed by the radial and ulnar arteries. It cannot be denied that access via superficial radial artery is useful due to its location in the anatomic snuffbox, over bones such as the scaphoid and trapezium, which make it easily compressible. This results in a 49% lower hemorrhage rate after use and a 49% lower rate of thrombosis1 compared with conventional radial access. Furthermore, in the presence of a superficial radial artery occlusion, either the radial or ulnar artery could later be used as an alternative access site.
However, in my opinion, this access is more difficult to perform, with a longer learning curve and a higher puncture failure rate, which leads to a greater number of cases in which conversion to a different type of access (cross-over) is necessary. On the other hand, conventional radial access is available in the 2 hands, and both ulnar arteries are equally feasible for vascular access, with less tortuosity.
Q.: What evidence exists in favor of distal radial access?
A.: The meta-analysis conducted by the University of Kentucky working group2 with data from 18 randomized clinical trials with 8205 patients found a significantly lower rate of radial artery occlusion (P < .001) and a significantly shorter hemostasis time (P < .001). Although these figures are statistically significant, the rate of radial artery occlusion with conventional access ranges from 4% to 10%, compared with 0.3% to 2.8% with distal access.2 When best clinical practices are implemented with conventional access, such as controlled non-occlusive hemostasis, the occlusion rate is 0.91%.3 These are very low rates, closer to those of our routine clinical practice, which reduces the relevance of that theoretical benefit.
Q.: What specific complications can be associated with this vascular access?
A.: Performing distal radial access is more complex and challenging, likely because we initially learned conventional radial access, and any change feels less comfortable. The study results show several important points:
- – It takes more time to cannulate the artery, puncture duration is longer and more puncture attempts are nedded.4
- – The learning curve is longer (> 200 patients to achieve > 94% success rate).5
- – Cross-over is 3 times more common, requiring an alternative access site to successfully complete the procedure.4 Although there are no serious complications, delays occur in the management of patients in interventional cardiology units.
Q.: Are there situations in which this access might be particularly indicated?
A.: Yes, indeed. Whenever we need to preserve the radial artery patency, the lower risk of occlusion should be considered—for example, in patients requiring an arteriovenous fistula for hemodialysis or in cases where the radial artery may be needed as an arterial graft for coronary artery bypass graft surgery. On the other hand, in patients with prior bleeding complications associated with conventional vascular access, or in those with severe obesity in whom effective compression of the radial artery becomes more difficult, distal radial access may be considered because it is more easily compressible and has lower hemorrhage rates.1
FUNDING
None declared.
STATEMENT ON THE USE OF ARTIFICIAL INTELLIGENCE
None used.
CONFLICTS OF INTERESTS
None declared.
REFERENCES
1. Corcos T. Distal radial access for coronary angiography and percutaneous coronary intervention:A state-of-the-art review. Catheter Cardiovasc Interv. 2019;93:639-644.
2. Mufarrih SH, Haider S, Qureshi NQ, et al. Distal Versus Proximal Radial Arterial Access for Percutaneous Coronary Angiography and Intervention:Updated Meta-Analysis of Randomized Controlled Trials. Am J Cardiol. 2024;218:34-42.
3. Aminian A, Sgueglia GA, Wiemer M, et al. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention:The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022;15:1191-1201.
4. Ferrante G, Condello F, Rao SV, et al. Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention:A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2022;15:2297-2311.
5. Roh JW, Kim Y, Lee OH, et al. The learning curve of the distal radial access for coronary intervention. Sci Rep. 2021;11:13217.
QUESTION: What are the implications of aortic valve calcification on the outcomes of transcatheter aortic valve implantation (TAVI)?
ANSWER: By design, currently marketed TAVI prostheses require a certain degree of annular calcification to ensure proper fixation. In fact, treating non-calcified valves, such as in pure aortic regurgitation (a scenario for which TAVI has not been approved yet), is associated with a higher risk of malapposition, valve migration, and need for a second prosthesis.1 However, severe valve calcification also poses implantation challenges, as it may compromise the initial procedural success and long-term outcomes.2
Since the planning stage, the presence of severe calcification can hinder the accurate reconstruction of the aortic annular plane and the ability to obtain reliable measurements of its dimensions, thus introducing uncertainty into valve sizing.
Procedurally, severe calcification is associated with a higher risk of immediate complications, such as annular rupture, aortic regurgitation (whether central or paravalvular), and conduction disturbances.3 Furthermore, severe calcification can impede valve crossing and limit the expansion of the prosthesis, which is why valvuloplasty prior to implantation is usually performed to ease valve crossing and allow for greater expansion and better apposition of the prosthesis to the annulus. This increases the number of maneuvers in the aortic root and promotes the embolization of debris, which is associated with a higher risk of ischemic events.
Severe calcification can limit the expansion of the prosthesis and alter leaflet configuration (the so-called pin-wheeling phenomenon), which increases leaflet stress and has been associated with in vitro studies with reduced durability. Furthermore, underexpansion is associated with elevated gradients and a higher rate of central (due to leaflet distortion) and paravalvular (due to annular malapposition) regurgitation.
Q.: What morphological and quantitative aspects of valvular calcification do you assess at your center?
A.: The gold standard for quantifying valvular calcium is computed tomography (CT), which uses either the Agatston score from non-contrast scans or calcium volume from contrast-enhanced CT angiography.4 The degree of calcification, its location, morphology, and distribution asymmetry are key determinants of procedural success and risk of complications. Several studies have associated moderate or severe calcification at the landing zone with a higher risk of paravalvular regurgitation, conduction disturbances, and annular rupture.3 It seems that calcifications protruding into the lumen are most associated with complications, while flatter calcifications have less impact. In addition, severe commissural calcification has been associated with residual regurgitation in that region too.5
The predominant location of calcification on the leaflets body is related to the degree of underexpansion and the prosthesis functionality, which can also influence the risk of coronary compromise in cases where leaflets are calcified at the level of the coronary ostium, especially with low-lying coronary arteries and narrow sinuses.
Ultimately, the interaction between calcium and prosthesis depends on the type of device. Thus, supra-annular prostheses better preserve the geometry of the leaflet when calcification is located at the annulus or left ventricular outflow tract (LVOT), while prostheses with narrower waists and lower radial forces result in less displacement of the leaflets toward the coronaries.
Calcium eccentricity is a major challenge, and the morphology of the valve plays a key role here: bicuspid valves usually show more complex calcification patterns than tricuspid valves do, with greater asymmetry and often calcified raphes that promote asymmetric expansion and prosthesis displacement toward areas of lower resistance, which are features that can also hinder positioning and stable release.
In summary, beyond describing the degree of calcification, what we need to do is target its location (annulus, LVOT, leaflet body, commissures, extension to the sinotubular junction, prominent nodules facing the coronary origins, etc.), the presence of nodules protruding into the lumen or flatter annular-aligned calcifications, as well as their eccentricity.
Q.: How does the degree of calcification affect valve type selection?
A.: Severe calcification increases the risk of complications, particularly paravalvular regurgitation, annular rupture, underexpansion, and conduction disturbances.3 We, therefore, try to select the prosthesis that best matches each case, based on calcium location and characteristics.
Generally, we prefer self-expanding valves and avoid aggressive pre- and post-dilatations in cases with prominent calcium nodules, as their interaction with the balloon increases the risk of dissection or rupture, which are complications with an associated mortality rate close to 100%. Another less common scenario where balloon- expandable valves should be avoided is a small, calcified sinotubular junction relative to the annular size, due to the risk of balloon- induced injury or aortic dissection.
Self-expanding valves, with a more gradual release than balloon- expandable ones, theoretically offer better adaptability to irregular anatomies and may be preferable in annuli with very irregular calcification. However, this is a complex trade-off, as they provide less complete sealing due to their lower radial force but still may reduce the risk of rupture. Balloon-expandable valves may be a very good option when calcification is limited to a specific annular area, especially if it does not protrude excessively.
Additionally, in the presence of significant calcification, it is essential to favor prostheses with an outer sealing skirt and high radial force.
Since LVOT calcification increases the risk of conduction disturbances, we often opt for recapturable valves to optimize final positioning.
In conclusion, valve choice seeks to balance the risks of regurgitation, conduction disturbances, aortic complications, and residual gradients.6
Q.: And how does the degree of calcification affect valve sizing?
A.: Calcification of the leaflet base and LVOT complicates the identification of the cusp nadirs and annular reconstruction, impeding accurate annular boundary definition and precise measurement. Since valve sizing relies primarily on these measurements, excessive calcification may lead to under- or oversizing.
Excessive calcification clearly impacts balloon-expandable valve sizing, generally leading to smaller oversizing (by reducing balloon inflation volume or valve size). However, its influence is not as direct in self-expanding valves where the risk of aortic rupture or dissection is lower due to their reduced radial force, meaning we can aim for standard oversizing or, in cases of borderline annuli between 2 valve sizes, even slightly larger. This is done to achieve better sealing, provided that the anatomy of the sinuses of Valsalva allows for adequate leaflet expansion without a higher risk of coronary compromise. Furthermore, while slight undersizing of balloon-expandable valves can be mitigated by adding a few milliliters of volume to the balloon without compromising its functionality, the problem of an undersized self-expanding valve has no solution because the nitinol material of the valves recovers its factory design at body temperature, even after aggressive post-dilation, which, in turn, perpetuates the problem.
On the other hand, calcium may prevent the adequate expansion and apposition of an oversized valve, thus degrading procedural outcomes and making sizing decisions particularly difficult in many cases.
Q.: Does the procedure differ based on valve calcification?
A.: In cases of severe calcification, we always perform predilatation regardless of the type of valve we’ll be using. Postdilatation is also frequently required, and often more aggressive, to optimize the degree of regurgitation.7
Although optimal positioning is always desired, it is especially critical in “champagne cork”–shaped prostheses designed to achieve optimal oversizing at a certain implant depth; deeper positioning reduces oversizing and increases the risk of regurgitation.
In cases of LVOT calcification, repeated valve movement in and out of the ventricle should be avoided to reduce the risk of conduction system injury.
Finally, significant underexpansion may lead to hemodynamic instability until adequate expansion is achieved via postdilatation. Therefore, one must be ready to support the patient hemodynamically while performing these maneuvers. In this situation, it is of paramount importance to maintain ventricular guidewire access, as crossing a severely underexpanded valve may be difficult. In cases of severe hemodynamic compromise before release, it may be advisable to recapture (if the system allows it) the valve and perform a more aggressive valvuloplasty.
Q.: What are the advantages of self-expanding prostheses in the most severely calcified valves?
A.: In these prostheses, expansion occurs gradually, allowing progressive adaptation to annular irregularities. However, a key limitation compared with balloon-expandable valves is their lower radial force, which increases the risk of regurgitation (a problem noted since the early days of the technique). Next-generation prostheses include features to mitigate this risk. Many incorporate an outer skirt to improve sealing and reduce paravalvular regurgitation. Moreover, several self-expanding valves are now recapturable, allowing assessment of implant height and regurgitation before full release, and repositioning if necessary. Release systems now offer greater stability, more predictable deployment, easier positioning, and fewer recaptures and manipulations in the aortic root.
Secondly, in supra-annular self-expanding valves, normal leaflet configuration is unaffected by calcification at the annulus or LVOT, given their higher positioning, thus generally preserving valve function and excellent hemodynamics even with significant calcification.
Moreover, in severe calcification, the risk of aortic dissection or annular rupture (complications whose mortality rate is close to 100%) is primarily linked to balloon expansion. In this context, a self-expanding valve protects against such complications, provided aggressive pre- or post-dilatation is avoided.
Lastly, self-expanding prostheses typically have a better profile than balloon-expandable ones, enhancing trackability and crossing ability, and facilitating the procedure.
Q.: Are all prostheses the same in this context?
A.: First-generation self-expanding valves were associated with higher rates of paravalvular regurgitation, malapposition, embolization, and need for a second valve in moderate-to-severe calcification. These outcomes have improved parallel to the technical advancements made in the latest versions,8 such as repositionability, recapture capability, and outer skirts. Therefore, in severe calcification, if a self-expanding valve is going to be used, one should prefer models with higher radial force, outer skirt, and repositioning and recapture capabilities. It is essential to remember that even within the same type of valve, several models can have different characteristics that must be well understood.
FUNDING
None declared.
STATEMENT ON THE USE OF ARTIFICIAL INTELLIGENCE
Artificial intelligence was not used.
CONFLICTS OF INTEREST
R. del Valle reports having received speaker fees from Medtronic Ibérica and Mercé V for educational courses, and from Medtronic International for consultancy work.
REFERENCES
1. Yoon SH, Schmidt T, Bleiziffer S, et al. Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. J Am Coll Cardiol. 2017;70:2752-2763.
2. Alperi A, Del Valle R, Avanzas P. Impact of aortic valve calcification on TAVI. Should we rethink existing concepts?Rev Esp Cardiol. 2025;78:519-520.
3. Okuno T, Asami M, Heg D, et al. Impact of Left Ventricular Outflow Tract Calcification on Procedural Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020;10:1789-1799.
4. Flores-Umanzor E, Keshvara R, Reza S, et al. A systematic review of contrast-enhanced computed tomography calcium scoring methodologies and impact of aortic valve calcium burden on TAVI clinical outcomes. J Cardiovasc Comput Tomogr. 2023;17:373-383.
5. Ewe SH, Ng AC, Schuijf JD, et al. Location and severity of aortic valve calcium and implications for aortic regurgitation after transcatheter aortic valve implantation. Am J Cardiol. 2011;108:1470-1477.
6. Kim WK, Blumenstein J, Liebetrau C, et al. Comparison of outcomes using balloon-expandable versus self-expanding transcatheter prostheses according to the extent of aortic valve calcification. Clin Res Cardiol. 2017;106:995-1004.
7. John D, Buellesfeld L, Yuecel S, et al. Correlation of device landing zone calcification and acute procedural success in patients undergoing transcatheter aortic valve implantations with the self-expanding CoreValve prosthesis. JACC Cardiovasc Interv. 2010;3:233-243.
8. Farhan S, Stachel G, Desch S, et al. Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves:a post hoc analysis from the SOLVE-TAVI trial. EuroIntervention. 2022;18:759-768.
QUESTION: What are the implications of aortic valve calcification on the outcomes of transcatheter aortic valve implantation (TAVI)?
ANSWER: Aortic valve calcification has, undoubtedly, been a major influence on TAVI outcomes and the evolving design of heart valves. Severe calcification has been associated with an increased likelihood of complications or poor outcomes, particularly in terms of residual paravalvular leak, need for postoperative pacemaker implantation, or aortic annular rupture, among others.1 Several generations of TAVI prostheses have mainly evolved with the aim of reducing paravalvular leak,2 through the use of skirts and coverings that facilitate sealing by adapting to the irregularities caused by annular and outflow tract calcifications. The goal is to balance sealing capacity with the optimal radial force needed, preventing excessive force that could cause conduction disturbances or, more critically, annular rupture. This emphasizes the critical role of procedural planning, which must account for the extent of calcification in all affected tissues. This meticulous planning, combined with experienced judgment and a deep understanding of the behaviour of each prosthesis is crucial for selecting the correct valve size.
Q.: What morphological and quantitative aspects of valvular calcification do you assess at your center?
A.: In addition to the usual annular measurement, in patients with severe calcification it is important to systematically identify the distribution and extent of calcium:
- – Sinotubular junction: at this level, it is crucial, especially when using a balloon-expandable valve, to determine whether calcification may compromise balloon inflation and, in the worst-case scenario, trigger balloon rupture, resulting in incomplete valve deployment with the risk of embolization, and the possibility of barotrauma-related dissection or aortic rupture in extreme cases. Therefore, it’s important to measure the minimum diameter between the most prominent calcium spicules and the contralateral border to confirm that the size of the balloon inflated with the necessary volume to deploy the selected prosthesis is not larger than that diameter.
- – Coronary ostium: Calcified plaques in the aortic wall near the coronary artery origins can increase the risk of coronary occlusion if displaced during valve deployment. Identifying this risk is crucial for implementing appropriate coronary protection strategies.
- – Sinuses of Valsalva and leaflets: first, it must be determined whether 3 sinuses are present or if we are facing a bicuspid valve, which has typical calcification patterns. The presence of calcified commissural fusions may require balloon predilatation to ensure passage through the valvular plane with the prosthesis and predict the leaflet behavior relative to the coronary arteries. The calcium will redistribute but will not disappear, so if calcium nodules are present on the leaflets occupying the sinus floor, we must consider the depth of the sinuses, and the association between leaflet length and coronary ostium height. If these sizes are suboptimal, the calcified leaflet may evert and occlude the coronary artery detaching from its base, or perforating the aortic wall if space is extremely limited.
- – Aortic annulus: evaluating calcium distribution at this level is crucial, as this is where the prosthesis will exert its greatest radial force. Symmetrical distribution throughout the annular circumference (360°) is rare but undoubtedly one of the most complex scenarios to deal with. In this case, one must assess the depth of calcium into the outflow tract and consider higher or lower implantation depths if it achieves sealing in a less calcified area. If not, an additional measurement beyond the annulus in the outflow tract should be taken to determine if the annular/tract anatomy is straight tubular, flared, or tapered. This information can help us oversize or undersize the prosthesis. However, typically, calcium is more focally distributed, with “teeth” extending toward the outflow tract, especially from the left coronary sinus toward the mitral-aortic continuity. A critical point is often a thinning area where the annulus transitions to the outflow tract, which is precisely where the distal end of the valve is usually positioned. This distribution presents one of the highest risks of rupture, specifically at the calcium thinning site, due to a physical principle: denser calcium regions are more resistant to deformation, so if density is not uniform, energy tends to be released where resistance is at its lowest point, potentially causing rupture. Therefore, planning should account for transitions between highly and minimally calcified zones when making decisions on implantation depth. Heterogeneous calcific density likely increases the risk of complications.
Q.: How does the degree of calcification affect valve type selection?
A: Perhaps the operator’s experience with the chosen valve model is the most influential factor in minimizing complications in heavily calcified scenarios, as operators know the limits of the technology they’re using. However, assuming comparable experience, in my opinion, balloon-expandable valves offer an advantage in expansion capacity and deployment control, allowing for more precise positioning. The combination of a low-recoil alloy and a balloon that inflates progressively and uniformly provides the necessary radial force to overcome calcium resistance while enabling control to stop inflation if high resistance or asymmetry is detected, preventing complications. While the idea that the prosthesis adapts to annular morphology is attractive, despite many self-expanding valves having supra-annular valve mechanisms, the risk of underexpansion is likely high3 requiring aggressive pre- and post-dilatations to create space and prevent recoil. Balloon-expandable technology allows for better sphericity indices in a more controlled and progressive way when appropriate proper implantation technique is used.
Q.: And how does the degree of calcification affect valve sizing?
A: Generally, in these scenarios, the goal with a balloon-expandable valve should be to avoid exceeding 5% oversizing, achieved by adjusting the inflation volume based on the valve nominal size, which usually leads to choosing smaller sizes or inflation volumes than usual for the same annular size in the absence of calcium. Caution in size and inflation volume selection is a great ally in avoiding complications. You can always opt for more aggressive inflations later if necessary and if the initial calcium modification allows. Of note, these valves will gradually expand and modify calcium, so controlled inflation is arguably more important than the final volume used.
Q.: Does the procedure differ based on valve calcification?
A: Technically, several peculiarities should be considered in the presence of a heavily calcified valve:
- – Predilatation: in standard cases, direct implantation of the balloon-expandable valve without predilatation is typical. In high calcium scenarios, predilatation offers several advantages, such as assessing calcium behavior in the sinuses of Valsalva and its relationship with coronary arteries, especially with simultaneous contrast injection. If calcification affects the sinotubular junction, predilatation may help determine the actual risk of balloon rupture during valve release. Most importantly, in cases of calcified commissural fusion, effective predilatation facilitates passage through the valve plane without the need fr aggressive push maneuvers. However, balloon predilatation in such situations may theoretically increase the risk of embolizing calcium debris during inflation, making it a potential indication for cerebral protection devices. Non-homogeneous calcium distribution can cause the asymmetric expansion of the prosthesis, thus shortening more in areas with less or no calcium compared with denser regions. While this does not compromise the functionality of valve, it should be considered when planning very high implantation depths. With balloon-expandable valves, residual leak is usually absent in standard implantation. In cases of high-grade calcification, we must be cautious in pursuing this goal, as it may involve forcing expansion that endangers the patient, especially during postdilatation. Remember that in reducing paravalvular (not central) regurgitation, skirt design is highly effective, and its effect may take a few minutes. Therefore, before aggressive postdilatation, it is advisable to allow time for the distal skirts to take effect.
- – Postdilatation: the first postdilatation should be performed with the same volume as deployment inflation, keeping it fully inflated for, at least, 5 seconds before increasing the volume in subsequent inflations.
If planning reveals a real risk of coronary artery occlusion, protection techniques should be considered.
Q.: What are the advantages of self-expanding prostheses in the most severely calcified valves?
A.: In addition to previously discussed aspects, of note, the ability of balloon-expandable technology to yield excellent results in reducing paravalvular leak,4,5 which is one of the main causes of poor outcomes in calcified prostheses. Moreover, with good planning and proper sizing, highly precise implantations can be achieved, with direct and progressive calcium modification, minimal recoil risk, and less need for postdilatation. The ability to achieve more precise implantations reduces the need for pacemaker implantation as well. Additionally, excellent outcomes have been demonstrated in patients with bicuspid valves, even though these often present with high calcium loads and varied distributions. In conclusion, balloon-expandable technology offers potential advantages in these patients due to its radial strength, control, implantation precision, and lower rates of paravalvular leak and need for pacemaker implantation,6 provided that proper planning goes beyond simple annular sizing, including thorough assessment of calcium distribution and correct size selection, and, above all, adequate knowledge of the prosthesis and the experience needed to handle this complex scenario. Undoubtedly, scientific evidence is needed to determine, beyond opinions, what technology is better, an answer that must come from ongoing clinical trials comparing the new TAVI valves under specific clinical conditions, such as extensive valve calcification.
FUNDING
None declared.
STATEMENT ON THE USE OF ARTIFICIAL INTELLIGENCE
No artificial intelligence was used.
CONFLICTS OF INTEREST
Cristóbal A. Urbano-Carrillo is a proctor for Edwards Lifesciences and participates in advisory groups for Medtronic Spain.
REFERENCES
1. Guimarães L, Ferreira-Neto AN, Urena M, et al. Transcatheter aortic valve replacement with the balloon-expandable SAPIEN 3 valve:Impact of calcium score on valve performance and clinical outcomes. Int J Cardiol. 2020;306:20-24.
2. Mauri V, Frohn T, Deuschl F, et al. Impact of device landing zone calcification patterns on paravalvular regurgitation after transcatheter aortic valve replacement with different next-generation devices. Open Heart. 2020;7:e001164.
3. Eckel C, Kim WK, Sötemann D, et al. ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification:A Propensity-Matched Analysis. Circ Cardiovasc Interv. 2024;17:e013608.
4. Thiele H, Kurz T, Feistritzer HJ, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation:the randomized SOLVE-TAVI trial. Eur Heart J. 2020;41:1890-1899.
5. Elnaggar HM, Schoels W, Mahmoud MS, et al. Transcatheter aortic valve implantation using Evolut PRO versus SAPIEN 3 valves:a randomized comparative trial. REC Interv Cardiol. 2023;5:94-101.
6. Webb J, Wood D, Sathananthan J, Landes U. Balloon-expandable or self-expandable transcatheter heart valves. Which are best?Eur Heart J. 2020;41:1900-1902.
